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CLINICAL
LABORATORY
SCIENCE
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Spring 2002 Volume 15/Number 2

Focus: Component Therapy

A S C L S

JOURNAL OF THE AMERICAN SOCIETY FOR CLINICAL LABORATORY SCIENCE

SpringCover_spine 1 4/10/02, 3:16 PM

 ASCLS Vision Statement AMERICAN SOCIETY FOR ASCLS Mission Statement
CLINICAL LABORATORY SCIENCE
The American Society for Clinical Laboratory Science, as the pre- The mission of the American Society for Clinical Laboratory
eminent organization for clinical laboratory science practitioners, 7910 Woodmont Avenue, Suite 530 Science is to promote the profession of clinical laboratory
provides dynamic leadership and vigorously promotes all aspects Bethesda, Maryland 20814 science and provide beneficial services to those who practice
of clinical laboratory science practice, education and management (301) 657-2768, (301) 657-2909 (fax) it. To enable its members to provide quality services for all
to ensure excellent, accessible cost-effective laboratory services for www.ascls.org/ consumers, the society is committed to the continuous quest
the consumers of health care. for excellence in all its activities.

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ASCLS MEMBER EDITORS REVIEW BOARD ASCLS BOARD OF DIRECTORS 2001-2002

Editor-in-Chief Richard Bamberg/Key West FL David Fowler, President
Susan J Leclair PhD CLS(NCA) Kathleen Blevins/Oklahoma City OK Paula Garrott, President-Elect
Department of Medical Laboratory Science Peter Colaninno/Jamaica NY Cheryl Caskey, Past President
University of Massachusetts Dartmouth Jo Ann Fenn/Salt Lake City UT Scott E Aikey, Secretary/Treasurer
North Dartmouth MA 02747-2715 Ellis Frohman/St Louis MO Ellen M Libby, Director Region I
sleclair@umassd.edu Mildred Fuller/Norfolk VA Bernie Bekken, Director Region II
Abraham Furman/Portland OR Lynn Ingram, Director Region III
Continuing Education Editor Richard Gregory/Indianapolis IN Suzanne Butch, Director Region IV
Carol McCoy PhD CLS(NCA) Denise Harmening/Baltimore MD Leola Olson, Director Region V
Department of Clinical Science Jean Hengesbaugh/Salt Lake City UT Dianne Cearlock, Director Region VI
University of Wisconsin–La Crosse Linda Hogan/Wichita KS Shirlyn B McKenzie, Director Region VII
La Crosse WI 54601 Cherry Horn/Washington NC Susanne Zanto, Director Region VIII
mccoy.caro@uwlax.edu Elizabeth Kenimer/Augusta GA Karen Bennett, Director Region XI
Nancy Konopka/Gettysburg PA Marcia Armstrong, Director Region X
Clinical Practice Editor Linda Laatsch/Milwaukee WI Melissa Nedry, Student Representative
Bernadette Rodak Hal Larsen/Lubbock TX
Clinical Laboratory Science LouAnn Lawrence/New Orleans LA ASCLS Headquarters Executive Staff
Indiana University, 409 Fesler
Donna Leach/Winston-Salem NC Elissa Passiment, Executive Director
1120 South Avenue Lauralynn Lebeck/La Jolla CA
Indianapolis IN 46202-5133 Craig Lehmann/Stony Brook NY EDITORIAL OFFICE
brodak@iupui.edu Lynn Little/Dallas TX Schwabbauer and Associates
Research and Reviews Editor David McGlasson/Lackland AFB TX 1405 11th Street
Shirlyn McKenzie/San Antonio TX PO Box 5399
Isaac D Montoya PhD
Affiliated Systems Corporation Sharon Miller/St Charles IL Coralville IA 52241-5399
3104 Edloe, Suite 330 Isaac Montoya/Houston TX (319) 351-2922; (319) 351-2927 (fax)
Houston TX 77027-6022 Harriette Nadler/King of Prussia PA cls@ia.net
imontoya@affiliatedsystems.com Alison Pohl/Alameda CA www.ia.net/~ischwab/office/
Joan Prince/Milwaukee WI
Consulting Editors Margaret Reinhart/Philadelphia PA Executive Editor
Dianne Cearlock/DeKalb IL Leticia San Diego/Clinton Township MI Marian Schwabbauer PhD
George Fritsma/Aurora CO John Seabolt/Lexington KY
Sandra Heatherley/Corpus Christi TX Catherine Sheehan/Middletown RI Managing Editor
Jean Holter/Morgantown WV Stephen Sodeke/Tuskegee AL Ivan Schwabbauer
Rebecca Laudicina/Chapel Hill NC
Connie Mahon/San Antonio TX P.A.C.E.® Liaison Trends and Technology Editor
Teresa Nodder/Richmond VA Vicki S Freeman/Galveston TX Mary Jane Gore
Claudette Ryan/Nashville TN 7910 Woodmont Avenue, Suite 530
Linda Smith/San Antonio TX PRODUCTION Bethesda MD 20814
Michelle Wright-Kanuth/Galveston, TX Baum Graphics clstt@aol.com
2416 “E” Avenue, N.E.
Cedar Rapids, IA 52402

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Clinical Laboratory Science (ISSN 0894-959X) is published The cost of single copies is $10. Requests to replace missing copy on disk. Disk label must clearly indicate author(s),phone
quarterly by the American Society for Clinical Laboratory issues free of charge are honored up to 6 months after the date number, manuscript title, current date and year, type of com-
Science, 7910 Woodmont Avenue, Suite 530, Bethesda MD of issue. Send requests to ASCLS headquarters. Annual mem- puter used, and name/version of word processing program.
20814; (301) 657-2768; (301) 657-2909 (fax). bership dues of ASCLS are $80, $40 of which is allocated to a Detailed instructions for authors are available on the
Postmaster: Send address changes to Clinical Laboratory subscription of CLS. Periodical postage paid at Bethesda, MD ASCLS and the CLS web sites. Contact the CLS Editorial
Science, 7910 Woodmont Avenue, Suite 530, Bethesda MD and other additional mailing offices. Office for more information.
20814. Advertising for CLS is accepted in accordance with the All articles published represent the opinions of the authors
Correspondence related to editorial content should be advertising policy of the ASCLS. Contact the CLS advertising and do not reflect the official policy of ASCLS or the authors’
mailed to: CLS Editorial Office, 1405 11th Street, PO Box representative at (301) 657-2768. institutions unless specified.
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cil of Biology Editors Manual for Authors, Editors, and Pub-
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Institutions $60 $65 $100 be included in both the hard copies (camera-ready) and the

Masthead Vol.15-2 1 4/11/02, 2:16 PM

 CLINICAL
SPR I N G 200 2 LABORATORY VOL U M E 1 5 /NUMBE R 2

SCIENCE
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DIALOGUE AND DISCUSSION

66 Payment for Laboratory Services
Kathy Hansen, Don Lavanty
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CLINICAL PRACTICE
67 Dyslipidemia Prevalence in a Laboratory Initiated Screening Program
Jane F Emerson, Mahtab Jafari
71 Lessons Learned in Student Recruiting
J Michele Stuart, JoAnne P Fenn
76 Clinical Laboratory Educators Conference 2002 Abstracts
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86 ASCLS 2002 ANNUAL MEETING PROGRAM

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REPOR TS AND REVIEWS

91 A Comparison of INRs after Local Calibration of Thromboplastin International Sensitivity Indexes
David L McGlasson
96 Fetal Fibronectin
Mary E Koenn
99 Perceived Barriers to Articulation: Institutional Characteristics
Jeanne Krumpelmann
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RESEARCH
102 Knowledge Fields and Inner Patterns in Clinical Laboratory Science
Elisabet Borgar
111 A Procedure for the Detection of Stealth™ Adulterant in Urine Samples
Sandra Valtier, John T Cody
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FOCUS: COMPONE NT THERAPY

116 Developments in Component Therapy: Novel Components and New Uses for Familiar Preparations
Michelle S Wright-Kanuth, Linda A Smith
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125 CONTINUING EDUCATION QUESTIONS

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128 TRENDS AND TECHNOLOGY

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VOL 15, NO 1 WINTER 2002 CLINICAL LABORATORY SCIENCE 65

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 WASHINGTON B EAT
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Payment for Laboratory Services

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KATHY HANSEN. DON LAVANTY
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Laboratories, along with many other healthcare providers, have resentatives of other Coalition organizations were in Washington
been ‘squeezed’ for many years now by the payment policies of the the morning of September 11 to lobby on behalf of Dunn/Hatch.
outpatient Medicare program (Part B), and by those of managed
care organizations. As has been stated frequently, this has con- Now that Congress has reconvened for the 2002 session, ASCLS is
verted the laboratory from the status it historically enjoyed of a carefully watching legislation that will affect laboratory reimburse-
‘profit center’ to a ‘cost center’. An illustration of this dilemma is ment, and also watching for provisions in the Bush administration
the fact that the Medicare Fee Schedule payments for outpatient budget that could affect laboratories. There is concern that the slow-
laboratory tests have been frozen at the same level, without even a down in the economy might cause the administration or Congress
consumer price index (CPI) increase, for nine of the past 13 years. to propose extending the freeze. Or other strategies that ASCLS has
We all know that our employers’ costs have not remained stable opposed in the past could be raised again. Examples are the imposi-
during that time—we certainly hope that our salaries have not tion of a co-pay for Medicare beneficiaries for laboratory tests, or
been frozen—so this is an issue of concern to all laboratorians, perhaps a competitive bidding process among laboratories to pro-
whether they are in management or not. vide services to Medicare. Fortunately, at the date of this writing,
none of these three items is part of the administration’s budget pro-
ASCLS has taken the lead for many years by including equitable posal, nor have they been proposed in legislation introduced to date.
payment for laboratory services in the issues presented at its Legisla-
tive Symposium. Nearly every year, one of the ‘leave-behind’ papers Dunn/Hatch itself has not been brought back to this Congress for
which we discuss with our Senators and members of Congress ad- consideration. However, there are some new pieces of legislation
dresses Medicare payment for laboratory services. In addition, ASCLS that address some of the reimbursement concerns that ASCLS and
is an active participant in the Clinical Laboratory Coalition, which the Coalition are working to support. One of these is the Medi-
has the slogan “Committed to Ensuring Access to Quality Labora- care Appeals, Regulatory, and Contracting Improvements Act,
tory Services”. Other groups which are members of the Coalition S1738 (MARCIA). This is a broad Medicare reform bill. The Coa-
include: AdvaMed; American Association of Bioanalysts (AAB); lition has contacted Senators and members of Congress who sit
American Association for Clinical Chemistry (AACC); American on the committees that will review the bill to urge inclusion of
Clinical Laboratory Association (ACLA); American Medical Tech- language originally in the Dunn/Hatch bill about new tests in the
nologists (AMT); American Society of Clinical Pathologists (ASCP); MARCIA bill. The portion in question addresses the IOM rec-
American Society for Microbiology (ASM); and CLMA – Leader- ommendation for “an open, timely, and accessible process” for in-
ship in Clinical Systems Management. corporating new tests into the Medicare Laboratory Fee Schedule.

Support for the position of the laboratory has been heard strongly In addition, ASCLS supports the Medicare Laboratory Services
from a report commissioned by Congress and published by the Act of 2001 (HR 3388), introduced on November 30, 2001 by
Institute of Medicine (IOM) in December 2000. (See details in Representatives Phil English of PA and Peter Deutsch of FL. This
the Washington Beat column in the Spring 2001 issue of Clinical bill focuses specifically on the reimbursement for specimen collec-
Laboratory Science.) The IOM’s recommendations lend the sup- tion (venipuncture) which was set at $3.00 seventeen years ago
port of an independent non-governmental commission to posi- and has never changed. It may never have completely covered the
tions that ASCLS has taken over the years. cost of a venipuncture, but with the increased costs of safer needles
and other safety devices, as well as rising personnel costs, it is ob-
During the late summer of 2001, two companion bills were intro- viously quite inadequate now. The bill would raise the specimen
duced in the Senate and the House of Representatives: S1066 spon- collection fee to $5.25, which is the level it would have reached
sored by Senator Orrin Hatch (R-UT) and HR 1798 sponsored by had CPI adjustments been applied for the last 17 years.
Representative Jennifer Dunn (R-WA). ASCLS and the laboratory
community were hopeful that the passage of a version of these bills These are two very specific but important issues for the economic
would have lifted the five year freeze before the fifth year began in viability of the laboratories we all work in. The ASCLS Govern-
October 2001. There were also provisions that would address more ment Affairs Committee counts on its members to help contact
expeditious and fair adoption of, and price setting for, new tests. their Senators and Representatives in support of these pieces of
This effort was put on hold by the events of September 11 and the legislation and others that may come along. Our history of activ-
change in focus for Congress. Ironically, ASCLS members and rep- ism is a long and proud one!

66 VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE

01-Washington Beat 66 4/11/02, 2:04 PM

 CLIN ICAL PR ACTICE: CHEMISTR Y
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Dyslipidemia Prevalence in a Laboratory Initiated

Screening Program
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JANE F EMERSON, MAHTAB JAFARI
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OBJECTIVE: Evaluate utilization and diagnosis rates in a self- cholesterol; NCEP = National Cholesterol Education Program;
pay, self-referred screening program for dyslipidemia. RF = risk factor; TG = triglyceride.

DESIGN: 301 patients self-referred to the clinical laboratory for INDEX TERMS: cardiovascular; direct-access laboratory testing;
lipid testing in a two-year period. The patient population that dyslipidemia; lipids; risk factors; screening.
participated was characterized in terms of insurance status, gen-
der, age, and known cardiovascular risk factors. Lipid profiles were Clin Lab Sci 2002;15(2):67
characterized as measured by total cholesterol, triglycerides (TGs),
low-density lipoprotein cholesterol (LDL), high-density lipopro- Jane F Emerson MD PhD is Chief of Clinical Pathology at the Uni-
tein cholesterol (HDL), and total cholesterol to HDL risk factor. versity of California, Irvine Medical Center, Orange CA.

SETTING: Clinical laboratory in an academic medical center. Mahtab Jafari PharmD is Assistant Clinical Professor, Department
of Medicine, University of California, Irvine CA.
PATIENTS: Data from all patients that self-selected for screening
were included. Address for correspondence: Jane F Emerson MD PhD, Chief of Clini-
cal Pathology, Rt 38, University of California, Irvine Medical Center,
INTERVENTIONS: Immediate laboratory results with both ver- 101 The City Drive, Orange CA 92868. (714) 456-7557, (714)
bal and written interpretations and recommendations were pro- 456-8272 (fax). jemerson@uci.edu
vided to the patients.
Dyslipidemia is a condition that satisfies the cardinal rules for pro-
MAIN OUTCOME MEASURES: Age, gender, insurance status, moting widespread screening. It is highly prevalent, asymptom-
number of known risk factors, and lipid profiles in the subject group. atic, associated with disease which results in significant morbidity
and mortality; screening is negligibly invasive; and effective inter-
RESULTS: The mean age of participants was 57 years. Men (197) ventions which are themselves relatively low risk and proven to
outnumbered women (104) by almost 2:1; most (94%) had health decrease morbidity and mortality are available. Despite this,
insurance. At presentation, 44% of the patients had more than dyslipidemia continues to be under-diagnosed and too often un-
one risk factor for coronary heart disease (CHD). 151 individuals successfully treated.1,2 Various factors are attributed to a general
(50%) had lipid findings that would require at least dietary inter- lack of compliance in seeking medical care and following through
vention by NCEP guidelines. with recommended treatment plans. These include, among oth-
ers, lack of education, resistance to lifestyle changes, denial, ad-
CONCLUSION: A self-pay, self-referred screening program for verse effects of pharmacological therapeutics, and personal incon-
lipid disorders is an effective means of improving screening and veniences. Because of the magnitude of this public health prob-
diagnosis rates. Patients with insurance were willing to pay for the lem, which accounts for the majority of deaths per year in the
convenience offered and men in particular were more likely to United States and over 100 billion dollars per year in direct and
self-refer than women, independent of previous knowledge of risk indirect healthcare costs, successfully addressing any of these fac-
factors or lipid disorders. tors will have significant benefit to the public.3

ABBREVIATIONS: CHD = coronary heart disease; HDL = high- Lipid profiles are typically obtained on patients at the request of
density lipoprotein cholesterol; LDL = low-density lipoprotein their personal physician following an office visit. Abbreviated
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The peer-reviewed Clinical Practice section seeks to publish case stud- through health fairs and at some pharmacies. Both of these ap-
ies, reports, and articles that are immediately useful, of practical na- proaches have features that may discourage utilization. Inconve-
ture, or demonstrate improvement in the quality of laboratory care. niences and time requirements are cited as cause for avoiding or
Direct all inquiries to Bernadette Rodak MS CLS(NCA), CLS Clini- procrastinating office visits. Lipid testing in the health fair or drug
cal Practice Editor, Clinical Laboratory Science Program, Indiana store setting is limited in its scope and usually insufficient educa-
University, Fesler 409, 1120 South Avenue, Indianapolis, IN 46202- tion and consultation are provided. Direct-access laboratory test-
5113. brodak@iupui.edu ing for lipid disorders and other conditions has been made avail-

VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE 67

02-Emerson 67 4/11/02, 2:05 PM

 C L I NI CAL PR AC T I C E: C HEMI ST R Y

able in a small number of institutions and the practice has been about the availability and effects of lipid-lowering medications, and
controversial. Anecdotal and hypothetical situations arguing both encouraging patients to seek medical care from their primary care
for and against such programs have been presented; however for- provider or specialist. A letter was mailed to each patient re-stating
mal evaluations have not been documented. their results and general recommendations; a referral service was
offered for those patients without providers.
The purpose of this study was to assess a self-pay, self-referred screen-
ing program in which immediate results and consultations are pro- Laboratory results were interpreted according to National Choles-
vided to the patient. The intent was to determine the types and preva- terol Education Program (NCEP) guidelines. For patients with
lence of dyslipidemias newly diagnosed by this program and to char- less than two CHD risk factors, LDL values above 160 mg/dL
acterize the patient population for which this type of healthcare deliv- were classified as undesirable and requiring intervention. For pa-
ery holds promise. The hypothesis was that complementing conven- tients with two or more risk factors, the decision level for LDL
tional healthcare delivery pathways by promoting direct-access labo- was greater than or equal to 130 mg/dL; with a history of CHD
ratory testing for dyslipidemias, along with review of other risk factors the decision level was greater than or equal to 100 mg/dL. The
for coronary heart disease (CHD), will improve diagnosis rates and decision level for HDL was less than or equal to 35 mg/dL. TGs
treatment outcomes for certain patient populations. Conventional above 200 mg/dL were classified as undesirable for all patients.
medical care delivery, characterized by physician-ordered testing fol-
lowing an office visit, deters some individuals from seeking appropri- RESULTS
ate care. This study provides the preliminary data needed to formally A total of 301 patients participated in this program over a two-
evaluate outcomes from this type of healthcare delivery. year period (August 1998 through July 2000). Men (197, 65%)
outnumbered women (104, 35%) by almost 2:1. Subjects ranged
METHODS in age from 26 to 86 years (mean age 57 ± 13). 94% of the sub-
A walk-in self-pay screening program for lipid profiles was made jects had health insurance.
available to the general population. The clinical laboratory at the
University of California, Irvine Medical Center was opened to
patients, without appointment, two mornings a week. The service
was minimally promoted; announcements were made through the Figure 1. Distribution of number of known risk factors
medical center’s community newsletter on two occasions. at presentation for lipid screening

Upon presentation for testing, patients completed a questionnaire

addressing family medical history, medical history, aspects of
lifestyle including exercise habits, dietary fat estimates, tobacco
use, and alcohol use. On the questionnaire, medical history was
obtained by subjects’ selection of conditions phrased as high blood
pressure, diabetes, heart attack, stroke, high cholesterol, and ‘other’
as a write-in. Family history was phrased similarly with a field to
specify which relative(s) was (were) involved. Medical and family
histories as reported by the patients were used to assess the num-
ber of CHD risk factors and were not confirmed by chart review
or physical examination.

A capillary (fingerstick) sample of blood was analyzed on a

Cholestech LDX System (Cholestech Corporation, Hayward CA)
for total cholesterol, TGs, HDL, LDL, VLDL, and a cholesterol-
to-HDL risk ratio was calculated. For cases in which the Cholestech
system was unable to provide the complete profile because of
analytes exceeding linearity ranges, a venipuncture was offered to
the patients for subsequent testing on a Beckman LX20.

Patients were given printed results at completion of testing (approxi-

mately 5 minutes) and received a verbal consultation with either a Distribution of number of known risk factors (RF) for CHD at
presentation. Number of RF was determined by answers to a
clinical pharmacist experienced in lipid management or the medical questionnaire as described in the text. Three percent of the sub-
director of the laboratory. Approximately 10 to 15 minutes were jects did not provide the information; that data is denoted ‘NA’.
spent explaining results, addressing risk factors, answering questions

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 C L I NI CAL PRAC T I C E: C HEMI ST RY

Figure 1 charts the distribution of number of risk factors present DISCUSSION

in the participants. Forty-four percent of the subjects had more No-appointment, self-pay screening as a method of accessing medi-
than one risk factor for CHD and 5% reported a history of CHD. cal care was utilized by a population that in the majority was in-
Using NCEP guidelines, 87 (29%) were found to have LDL val- sured. The types of patient that self-selected for this program in-
ues above target, 69 (23%) had triglycerides above recommended cluded both those with known risk factors for CHD and those
levels, and 62 (21%) had HDL values below desirable. Overall, without. During consultations, patients cited convenience and
151 patients (50%) had a condition that would require at least immediate consultation as factors inducing them to make use of
dietary intervention. Categories of lipid disorders found at screen- the service. Patients in whom a lipid disorder had been previously
ing are shown in Figure 2. Nine percent had combined LDL and diagnosed but who had ceased to comply with treatment recom-
TG elevations, 20% had elevated LDL only, 14% had elevated mendations reported that the availability of this program served
TG only, and 7% had low HDL only. to encourage them to return to their providers or seek new ones.
Of the subjects for whom lipid findings warranted interventions, Some patients made use of this service to monitor their treatment
34% were previously undiagnosed. Of the total number of par- themselves, reporting that more frequent monitoring was an aid
ticipants, 17% were found to have a previously undiagnosed to compliance. However, previous knowledge of a lipid disorder
dyslipidemia for which intervention is recommended by NCEP did not seem to be a major factor in determining those patients
guidelines. By gender, 49% of the women presenting had no knowl- that self-select for this screening for either men or women; in both
edge of a previously diagnosed lipid disorder and 41% of the men groups, roughly half had no previous diagnosis.
were previously undiagnosed (Figure 3). Of the total number of
participants, 33% had a previous diagnosis of lipid disorder but Women are characterized as using more healthcare services than
were not currently treated to target values. men.4 Of note is that men used this service at a rate of almost
twice that of women. For men in particular, this entry point into
medical care may effectively capture more patients than the con-
Figure 2. Dyslipidemias found in the self-referred screen-
ing program
Figure 3. Participants with and without previously
diagnosed lipid disorders by sex

Findings from the lipid panel performed on this self-referred

population. ‘Desirable’ indicates LDL, TG, and HDL were de-
sirable according to NCEP guidelines and accounting for num-
A comparison of the self-referral pattern for men and women and
ber of CHD risk factors. ‘TG’ denotes elevated triglycerides;
the dependence on previous knowledge of a lipid disorder. Forty-
‘LDL+TG’ denotes elevations in both LDL and TG; ‘LDL’ de-
nine percent of the women and 41% of the men presenting had
notes LDL levels above target values; ‘Low HDL’ indicates HDL
no knowledge of a lipid disorder.
levels below desirable.

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 C L I NI CAL PR AC T I C E: C HEMI ST R Y

ventional office-visit approach. Evidently, the rate of diagnosis of patients, 94% of whom had health insurance and alternate means
lipid disorders would be improved by making this type of pro- of obtaining medical care. The male to female ratio of patients
gram widely available. Whether this approach results in a higher that self-selected for this program indicates that this may be an
rate of successfully treating dyslipidemia deserves formal study. effective means to increase diagnostic and treatment rates in men.

CONCLUSIONS REFERENCES
The prevalence of dyslipidemia in this patient group was over 50%. 1. Pearson TA, Laurora I, Chu H, Kafonek S. The lipid treatment assessment
The majority of these, 60 subjects (20%), had an isolated increase project (L-TAP): a multicenter survey to evaluate the percentage of
dyslipidemic patients receiving lipid-lowering therapy and achieving low-
in LDL. Elevated TGs accounted for 14%, 9% had combined density lipoprotein cholesterol goals. Arch Intern Med 2000;160(4):459-67.
elevated LDL and TGs, and 7% did not have elevated lipids but 2. Frolkis JP, Zyzanski SJ, Schwartz JM, Suhan PS. Physician noncompliance
had HDL levels below desirable. Of the patients with dyslipidemia, with the 1993 National Cholesterol Education Program (NCEP-ATPII)
34% were previously undiagnosed. guidelines. Circ 1998;98(9):851-5.
3. American Heart Association. 2001 Heart and Stroke Statistical Update. Dal-
las TX: American Heart Association, 2000.
A screening program, which increased convenience for patients 4. Bertakis KD, Azari R, Helms LJ, Calahan EJ, Robbins JA. Gender differences
and provided sufficient education was utilized and paid for by the in the utilization of health care services. J Fam Pract 2000;49(2):147-52.

Clinical Laboratory Science Announces 2001 Distinguished Author Award Recipients

Recipients of the Clinical Laboratory Science (CLS) Distinguished Author Awards are chosen by CLS readers and editorial board
members. Nominations are based upon originality, quality of writing, and relevance and value to the clinical laboratory science
profession. The Editorial Board of CLS is pleased to announce the following recipients of the 2001 Distinguished Author Awards:

Clinical Practice Section

Janice Matthews-Greer PhD, Kenneth L McRae MS, Ethylyn B LaHaye MS, and Richard M Jamison PhD for their article,
Validation of the Roche COBAS Amplicon System for Chlamydia trachomatis, published in the Spring 2001 issue of CLS.

Reports and Reviews/Research Sections

Mary E Koenn MS, Beverly A Kirby MS, Linda L Cook MD FCAP FASCP, Julie L Hare, Sharon H Hall, Paula M Barry, Cheryl
L Hissam, and Stephanie B Wojcicki for their article Comparison of Four Automated Hematology Analyzers in the Fall 2001 issue of
CLS.

Focus Section
Teresa S Nadder PhD CLS(NCA) and Michael R Langley CLSp(MB) for their article The New Millennium Laboratory: Molecular
Diagnostics Goes Clinical in the Fall 2001 issue of CLS.

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Lessons Learned in Student Recruiting

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
J MICHELE STUAR T, JOANN P FENN
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Nationally, clinical laboratory science programs are struggling for able ‘slots’.1 Three factors contributing to the difficulty of recruit-
student applicants. Major challenges facing the laboratory profes- ing potential students into the laboratory science profession are:
sion include: 1) low salaries, 2) lack of public awareness, and 3) 1) salaries, 2) lack of public awareness of the profession; and 3) the
the myriad of career choices for new graduates. Increasing public myriad of choices for careers that students now have.2,3,4
awareness and actively recruiting students can overcome one of
these challenges. This paper focuses on the successful student re- In Laboratory Industry Report, medical technologist/clinical labo-
cruiting lessons learned at the University of Utah Medical Labora- ratory scientist (CLS/MT) salaries were published based on salary
tory Science Program. Specific indicators show increased interest survey data from Salary.com.5 The report compares salaries for
and activity for this program of study. professionals with two to four years experience: medical technolo-
gists – $29,877; biotechnology chemist – $41,894; pharmacy clini-
ABBREVIATIONS: CLS = clinical laboratory science; CLT = clini- cal research assistant – $38,070; computer scientist – $45,000 to
cal laboratory technician; CLS/MT = medical technology/clinical $55,000. Salaries represent a major challenge when attracting sci-
laboratory science. ence-oriented students into CLS/MT instead of other areas of study.

INDEX TERMS: academic advisor; clinical laboratory scientists; Low student enrollment, fewer accredited programs, an aging
Internet; medical technology; NAACLS; recruiting. workforce, and skills mobility add to the dilemma of the current
national personnel shortage for CLS/MTs. The National Accred-
Clin Lab Sci 2002;15(2):71 iting Agency for Clinical Laboratory Science (NAACLS) reports a
significant decrease in graduates of CLS/MT programs - from 5318
J Michele Stuart MSPH/HSA CLS(NCA) is Instructor, Academic graduates in 1983 to 2491 in 1999.1,6 Skills mobility makes it
Advisor, and Program Recruiter at the University of Utah, School of difficult to retain graduates in the profession. Biotechnology com-
Medicine, Department of Pathology and ARUP Laboratories, Salt panies, computer firms, pharmaceutical companies, and research
Lake City UT centers ‘lure away’ our well-trained and knowledgeable laboratory
employees.4,7 NAACLS also reports a decrease in accredited CLS/
JoAnn P Fenn MS is Associate Professor and Director of Education MT programs—638 in 1983 to 271 in 1999—a closure of 367
Medical Laboratory Sciences at the University of Utah, School of programs. During the two-year period of 1997 to 1999, 40 CLS/
Medicine, Department of Pathology and ARUP Laboratories, Salt MT programs closed. Recent information from NAACLS shows a
Lake City UT decrease in 11 programs from 1999 to 2000.8 Considering that
the average age of practicing CLS/MTs is 45 years, the current
Address for correspondence: J Michele Stuart MSPH/HSA personnel shortage will worsen during the next 10 to 15 years.
CLS(NCA), University of Utah, School of Medicine, Department of The U.S. Bureau of Labor Statistics projects that 5,300 new posi-
Pathology and ARUP Laboratories, 50 North Medical Drive, 5R477, tions for CLS/MTs and clinical laboratory technicians (CLTs) will
Salt Lake City UT 84132. (801) 585-5452, (801) 585-2463 (fax). be created each year through 2008. In addition, another 4,000
michele.stuart@path.utah.edu positions will be vacated annually because of retiring CLS/MTs.
These projections equate to a need for 9300 new CLS/MTs and
Nationwide, educators in medical technology/clinical laboratory CLTs each year, while in 1999 a total of approximately 5000
science (CLS/MT) programs report decreases in applicants for laboratorians graduated into the work force, including CLS/MTs,
1997, 1998, and 1999, with many programs unable to fill avail- CLTs, cytotechnologists, histotechnologists, and histotechnicians.

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Two years ago, the Medical Laboratory Science Program (MLS),

The peer-reviewed Clinical Practice section seeks to publish case stud- Department of Pathology, University of Utah School of Medicine,
ies, reports, and articles that are immediately useful, of practical na- created a 0.5 FTE position to oversee student recruitment and
ture, or demonstrate improvement in the quality of laboratory care. academic advising. With low numbers of applicants and difficulty
Direct all inquiries to Bernadette Rodak MS CLS(NCA), CLS Clini- by area laboratory facilities in hiring qualified CLS/MTs, it be-
cal Practice Editor, Clinical Laboratory Science Program, Indiana came clear that this program had to be more successful with re-
University, Fesler 409, 1120 South Avenue, Indianapolis, IN 46202- cruitment. This article outlines the lessons learned and the suc-
5113. brodak@iupui.edu cesses of the recruitment process.

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DESIGNATING A RECRUITER/ACADEMIC ADVISOR be utilized to promote the educational program, rather than rely-
Selecting the appropriate recruiter/academic advisor is critical. He ing on only one marketing/recruiting technique. The following
or she will be the liaison between prospective clinical laboratory are recruitment strategies to consider:
science (CLS) students and the program. The selected individual
should possess strong multitasking abilities and people skills. Internet
A well designed Web site is a valuable recruitment tool. The Internet
Adding a personal touch is imperative when assisting students site conveys messages to large numbers of prospective students
during their pre-clinical laboratory educational experience. Stu- quickly and very inexpensively. The Internet puts information in
dents find added value in having a specific person to contact for the students’ hands instantaneously. Think of the Internet as the
support, advice, and general program information. program’s business card. One can pass out thousands of business
cards inexpensively 24 hours a day.
IDENTIFYING THE CURRENT PERCEPTIONS OF THE
CLS PROGRAM The Internet presence should be open, honest, and direct. The
Defining, developing, and enhancing a recruitment program is an Web page must convey a clear introduction of the program and
ongoing process. Success begins by developing a solid foundation. essential information the searcher can access. Some ‘tips’ and ap-
To assess how the program is promoted by the academic commu- proaches the authors find useful are:
nity, these focus questions should be asked: 1) How does the office • Make the site user-friendly and attractive.
of student recruitment and high school services, the critical liaison • Provide for mobility between Web pages.
between prospective undergraduate students and the institution, • Link to the home page at the bottom of each page.
present the CLS program information to students? 2) Is the pro- • Update the site frequently, maintain it for accuracy, and make it
gram listed in the University’s majors and degrees listing? 3) How easy to access information.
accurately does the promotional material represent the program? • Register with powerful search engines, .e.g., AltaVista, Yahoo,
4) Is the material relevant? 5) Is the Web site address listed cor- and SearchEd.
rectly? 6) Does the University General Catalog give up-to-date • Create a short Web address making the site easily accessible.
program information; 7) Are current recruiting documents accu- Allow simple navigation of the site.
rate? The authors found several omissions and mistakes as they • Use hyperlinks to connect to additional academic departments,
answered these questions about their program. e.g., biology, pre-medicine, chemistry, other colleges, clinical
laboratory sites, and professional organizations, e.g., American
UPDATING AND REVISING EXISTING RECRUITMENT Society for Clinical Laboratory Science, American Society of
DOCUMENTS Clinical Pathologists, and American Society of Microbiology.
One must update the available University information to accu- • Provide an e-mail address on each page, making it effortless for
rately reflect current program status, and activities. For example, the searcher to request information or ask questions.
the updated CLS/MT program information should be shared with
the office of student recruitment and high school services. Most After the Web site has established a history, one can gather statis-
universities and colleges have similar services that distribute valu- tics to determine the number of user sessions, length of user ses-
able recruitment information not only to students but to parents sions, and dates of high usage (Table 1). This information can be
and school administrators, as well. correlated with recruiting plans. For example, an open house or
information meeting can be planned around high user dates when
If a program does not have a mission statement, it is time to de- students are thinking about the program. At the University of
velop one. A mission statement is critical to an organization or Utah we combine ‘high tech with high touch’ by holding open
program and justifies its existence. When was the last time the house events during mid-March and mid-November which re-
mission statement was revised? Is it outdated? Does it reflect the lates to our high student user dates.
organization’s values, beliefs, and philosophy? Does the mission
statement reflect the program’s purpose? Since developing a mis- Personal student contact
sion statement for the University of Utah Medical Laboratory Sci- Building personal relationships with prospective students and pro-
ence program, it has been used in a number of important docu- jecting a welcoming and friendly atmosphere are critical for recruit-
ments and has been shared with other departments, faculty, labo- ment. As a recruiter/advisor one should be available for students’
ratory managers, clinical site teaching specialists, and students. It questions. We recommend at least one hour per student as adequate
is also displayed in the program’s conference room. advising time. Immediate follow up (within one week) with letters,
phone calls, and e-mail should be provided. Staying in touch with
RECRUITMENT STRATEGIES students, and selling the program on a ‘one on one level’ is vital.
Once the basic information materials have been refined, it is time Students value attention and promptness, and they want to know
to begin the recruitment strategies. A variety of approaches should that the advisor cares about them and their academic progress.

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Table 1. University of Utah MLS Web site statistics

Timeframe 10/11/99 to 12/30/99 to 03/25/99 to 07/01/00 to 10/01/00 to 01/01/01 to

12/30/99 03/25/00 06/30/00 09/30/00 12/31/00 03/31/01

Average hits/week 2058 2667 1666 1400 1932 2149

Average user sessions/week 448 616 546 462 504 518
Average user session length 4:15 4:37 5:37 5:22 7:23 5:35

To allow for ease of student follow-up we developed a Recruit-

ment Contact Form (Figure 1). By using the Recruitment Con- Figure 1. University of Utah - MLS Recruitment Contact
tact Form prospective student databases can be created. With a Form
good database more students receive general information and in-
vitations to attend program activities. School of Medicine
Department of Pathology
Our experience indicates that prospective students seek and appre- University of Utah
ciate advice on career-related issues. Individual comments reaffirm
the importance of personal student contact. Four examples follow: MLS Recruitment Contact Form

“Thank you so much for meeting with Andy and your very nice Date: _______________________________________
follow-up letter. Andy was feeling a little lost and overwhelmed
with college, but your gracious response and interest in him have Name: ______________________________________
really given him new focus and enthusiasm to go on and become a
success in CLS!” (Parent of prospective CLS student) Address: _______________________ Apt. No. ______

“Thank you for the follow-up letter. Your efforts continue to in- City: _____________ State: ______ Zip: ___________
spire me to pursue this degree.” (Prospective CLS student)
Telephone Number: ___________________________
“Thank you so much for the nice and encouraging letter and thanks
so much for your help and care.” (Prospective CLS student) E-mail: _____________________________________

“Thank you so much. You got back to me so quickly. I appreciate Grade: __ Present School/College: ________________
the information.” (Prospective CLS student)
MT _____Cytology _____ Master’s Degree _________
Personal professional contact
While the Internet and published materials may initiate interest, How Did You Hear About The MLS Program? ______
personal contact with prospective students and organizations is still ___________________________________________
one of most productive ways to enhance program awareness. There ___________________________________________
are a number of ways to make and develop personal contacts. Date and Follow-up: ___________________________
___________________________________________
Developing and maintaining relationships with high school counse- Comments: __________________________________
lors can be as simple as giving lectures or demonstrations at biology or ___________________________________________
career search courses, attending career fairs, becoming involved in sci- ___________________________________________
ence organizations, e.g., Health Occupations Students of America,
arranging for student clinical laboratory visits, and sponsoring week-
end workshops for junior and senior high school teachers.
partment is a ‘gold mine’ for potential students. Faculty can speak
Several recruitment opportunities are usually available on the col- at undergraduate clubs, e.g., a science club, or pre-medicine soci-
lege/university campus. We have had success by sponsoring open ety, attend freshmen orientation activities, and serve on college/
house information sessions in the biology department. This de- university committees. The focus is to identify and recruit science

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 CL I NI CAL PRAC T I C E: EDU CAT I ON

minded students who are not passionately pursuing another ma- e.g., pharmacy, nursing, and biology, to obtain student applica-
jor and to let other academic departments know the program ex- tion lists. Then every student on the list is invited to explore the
ists. The recruiter should regularly meet with college counselors world of CLS that may seem more attractive to them.
and advisors, and keep them updated on program curriculum and
informed about employment opportunities. Word-of-mouth
Word-of-mouth is the least expensive way to advertise. Clinical
Program accessibility laboratory professionals, students, and other college program ad-
In this age of instant information and communication it is even visors can successfully ‘spread the word’ about the CLS/MT pro-
more important to be accessible. The easier it is for someone to gram. Our experience indicates that personal student contacts are
find out about a program the more contacts one will have. To the most successful form of recruiting and ‘sparking an interest’ in
accomplish this important goal of being accessible, it is crucial to prospective students.
use a variety of recruitment approaches. Pre-professional courses
can be expanded to overlap other science majors’ requirements, MEASURABLE EFFECTS
e.g., pre-medical, pharmacy. The program should allow for ease of Our creative recruiting methods resulted in a diverse group of 2001
the application and admission process, offer a flexible admission applicants. The entering 2001 CLS class welcomed two students
date, and correlate admission dates with other disciplines. There from pharmacy, one transfer student from a local four-year college,
should be a smooth transition from community or junior colleges and four transfer students from three Utah community/junior col-
through course articulation. Also, when meeting with potential leges. Student applications increased from 15 in the year 2000 to 26
transfer students a prepared articulation course guide for that col- in 2001. We have not had more than 20 applicants since 1996.
lege is useful.
Current Web statistics have increased to over 500 user sessions/
Public awareness week, with an average user session time of 5 minutes 35 seconds
More exposure brings more contacts. Most programs utilize one (Table 1). The number of students seeking personal advising in-
or more of the following strategies: creased from 15 in 1999 to 79 students in the year 2000 (Figure 2).
• Advertise in the local city newspapers’ career section.
• Submit articles to local newspapers focusing on careers and the
current CLS/MT shortage.
• Advertise your program in high school newspapers. Figure 2. Summary of student contact and declared Pre-
• Participate in school health fairs at all academic levels. MLS majors
• Speak at local civic organizations.
• Celebrate National Medical Laboratory Week activities.
• Provide information about your CLS/MT program using post-
ers, flyers, brochures, videotapes, and computer presentations.
• Invite former students to promote the program at recruiting
activities.
• Consider reminder items such as pens, bookmarks, calendars,
brochures, or key chains.
• Include Web address on program envelopes and letterheads.

Employers
There are many benefits when program faculty maintain working
relationships with potential employers, and participate in joint
recruiting events. By staying current on employment opportuni-
ties to present to prospective and current students, the program
becomes a valuable resource. More directly, students are informed
about employer tuition reimbursement benefits and employment
opportunities during and following CLS/MT education.

Students from other disciplines

Students often do not know their exact career track, which is why
the successful recruiter will maintain a presence through other
programs. To help students make that important career choice,
the recruiter can talk with other closely related college programs,

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Over a five-month period the number of students who were de- ulty members are encouraged to develop and improve recruiting
clared ‘Pre-MLS Majors’ increased from 15 in April 1999 to 40 strategies. These strategies are working and generating renewed
students in September 1999 (Figure 2). The number of students interest in our CLS program.
requesting program applications for the 2001–2002 school year
was 44, an increase of 29 over the 2000–2001 year applications. REFERENCES
1. Ward-Cook K, Simpson P, O’Neill TR. 1999 Annual survey of medical labo-
CONCLUSIONS ratory science programs. Lab Med 2000;31:550-4.
2. King D. Laboratorians in demand despite staffing cutbacks. Advance 1999;20-
For a program to succeed, students need to know it exists. CLS pro- 3.
grams have to work harder at marketing than most health profession 3. Foubister V. Bench press - the technologist/technician shortfall is putting the
programs. A recruiting program should formulate strategies to wisely squeeze on laboratories nationwide. CAP Today 2000; Sept:84-90.
combine a variety of recruiting tools and marketing approaches. Each 4. Kipp J. Who wants to work in a lab? Med Lab Observ 2000; August:24-9.
recruiting tool contributes to the success of the others. It is important 5. Weissman DW. Demand for laboratory personnel far outstripping supply.
Lab Indust Report; May 2000:5-7.
to maintain accurate, up-to-date lists of interested students and to 6. Weissman DW. Med tech shortage: a bad situation that is getting worse. Lab
advertise current program activities. Professional contacts, word-of- Indust Report; May 2000:4.
mouth, and Internet recruiting activities may not work on their own, 7. Mooney B. Solving the staff shortage crisis. Advance 2000; Jan 17:8-9.
but together they will make a difference.9 8. Report of NAACLS. ASCP Board of Registry Board of Governors Meeting,
San Diego, CA. Oct. 2000.
9. Waller KV. Program revitalization: strategies for survival. National Accredit-
It is our experience that personal student contact has the greatest ing Agency for Clinical Laboratory Sciences. February 1999. Chicago.
impact on successful recruiting. As program stakeholders, all fac-

NIAID Unveils Bioterrorism Research Agenda

The National Institute of Allergy and Infectious Diseases (NIAID) recently released the NIAID Counter-Bioterrorism
Research Agenda for CDC Category A Agents, a document describing the Institute’s accelerated research plan for the most
threatening agents of bioterrorism. The agenda outlines the research NIAID will undertake to help protect civilian populations
from diseases such as smallpox, anthrax, and plague should they be unleashed intentionally by those who wish to do harm. The
comprehensive plan includes short-, intermediate- and long-term research goals and describes specifically how bioterrorism
countermeasures will be developed for each microbe. The document also contains a copy of the Strategic Plan for Counter-
Bioterrorism Research of the NIAID, which provides a general overview of the Institute’s broad plans for attacking the full
range of potential bioterrorism pathogens.

The NIAID Counter-Bioterrorism Research Agenda for CDC Category A Agents is available online at http://
www.niaid.nih.gov/dmid/pdf/biotresearchagenda.pdf. Researchers can find information on bioterrorism-related research
funding opportunities at http://www.niaid.nih.gov/dmid/bioterrorism.

NIAID is a component of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent,
diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases,
illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma, and allergies.

Press releases, fact sheets, and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

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Clinical Laboratory Educators Conference

2002 Abstracts
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P
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POSTERS A CLT Program’s Assessment of Regional Laboratory

Authors listed in bold face type will be the presenters. Shortages and Salary Comparisons of Allied Health
Professionals

An Ethnographic Report of Laboratory Practitioners Stacey Rohrbaugh MEd, Molly Saunders MEd, Allegany College
of Maryland, Cumberland MD
Kory Ward-Cook PhD FACB, Laura Culver Edgar MBA, Pamela
Frommelt MS, American Society of Clinical Pathologists–Board A regional survey was conducted by Allegany College of Mary-
of Registry, Chicago IL land, the last public institution in Maryland offering the clinical
laboratory technician (CLT) curriculum. The purpose of the sur-
As the initial step in a multi-method approach to conducting a vey was to accurately document regional employment and salary
practice analysis of medical technologists (MTs), medical labora- data. The response rate to the survey was 60%. The survey data is
tory technicians (MLTs), and phlebotomy technicians (PBTs), these being used to establish the future workforce needs in our area as
practitioners were observed and interviewed in their practice set- well as to compile accurate salary information for recruitment pub-
tings. This ethnographic, i.e., describing the characteristics of a lications. The data are essential for the development of future sur-
group, report provided the qualitative data for a survey instru- vival strategies. The survey asked respondents to provide salary
ment that will be used to validate the performance domains of data on laboratory professionals as well as other healthcare profes-
MTs, MLTs, and PBTs. The method of gathering this data was sionals. The regional survey included personnel categories that were
direct observation (n = 160). Certified medical technologists ob- based on the National Occupational Employment and Wage Esti-
served and conducted structured interviews in three geographi- mates. This national data shows the CLT to be the lowest paid
cally diverse regions of the U.S.—California, Florida, and Illinois. healthcare employee with an associate degree credential. Many of
Practitioners in these states represented those with and without our local clinical laboratory employees have felt underpaid com-
licensure requirements. California was also chosen because there pared to other regional allied health professionals as well as to the
is licensure of MTs, but not MLTs. The areas observed in 22 dif- national laboratory salary averages. In regard to the average salary
ferent facilities included, but were not limited to the traditional data for the laboratory categories, the survey revealed strong paral-
areas of a clinical laboratory, research, industry, and educational lels to the 1999 National Occupational Employment and Wage
institutions. As expected, the tasks performed by these profession- Estimate data as well as to the 2000 ASCP Wage and Vacancy
als did vary depending on location and type of facility. Although Survey. In regard to the average salary data for the other healthcare
task analyses for these laboratory professionals have been performed salaries, the regional survey revealed the nursing scale to be the
in the past, a practice analysis has not. This ethnographic report highest and the CLT salary to be the lowest as the national data
shows that although MTs perform routine tasks as well as high had suggested. The regional survey showed that some institutions
complexity testing and research, there was still a clear distinction have the same salary scale for ancillary services like respiratory,
of duties between them and the MLTs. In most cases the PBTs did radiology, and the laboratory. In other institutions, the laboratory
more than specimen collection. Type of tasks performed differed has fallen behind the scales of similar ancillary service areas. The
by region of the country, type of practice setting, and under what salary survey also revealed that the regional CLS average is below
conditions the practitioner worked. the national average. In addition to salary information, the re-
spondents were also asked to identify the number of laboratory
employees in each category according to age. The regional data
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
confirmed suspicions that the regional laboratory workforce is older.
Therefore, a recruitment plan to attract future laboratory person-
The peer-reviewed Clinical Practice section seeks to publish case stud-
nel is necessary. The information collected in the survey was dis-
ies, reports, and articles that are immediately useful, of practical na-
seminated to regional laboratories.
ture, or demonstrate improvement in the quality of laboratory care.
Direct all inquiries to Bernadette Rodak MS CLS(NCA), CLS Clini-
cal Practice Editor, Clinical Laboratory Science Program, Indiana
University, Fesler 409, 1120 South Avenue, Indianapolis, IN 46202-
5113. brodak@iupui.edu

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Designing Web-based Courses in CLS: A Team technology option was designed that shares CLT courses. This
Approach combination track allows career flexibility between both curricu-
lums. Graduates of the CLT curriculum can add a biotechnology
Connie R Mahon MS CLS, Walter Reed Army Medical Center, certificate or degree within one year. The biotechnology graduate
Washington DC; Shirlyn B McKenzie PhD CLS, Cheri Burns MS can also finish the few missing CLT courses in one year; therefore,
CLS, Linda Smith PhD CLS, George Kudolo PhD, Betty Dunn MS, a student could finish an associate in applied science degree in
Nancy Hudepohl, PhD, Elaine Demps, Brian Neuenschwander, The both options in three years. The benefits of developing the bio-
University of Texas Health Science Center at San Antonio, San technology curriculum in this integrated fashion include: cost sav-
Antonio TX ings to the college, increased enrollment in clinical laboratory tech-
nology courses, infusion of biotechnology techniques into the CLT
The concept of offering courses via the Web has become more ac- courses, a mechanism for existing CLT practitioners to complete a
ceptable as people are challenged with the difficulty of taking time biotechnology certificate, and decreased start-up time when bio-
away from work to complete a degree. The World Wide Web, a technology is started as a program option rather than a new stand-
desirable educational resource that can enhance and augment stu- alone program.
dent learning, is increasingly being used to deliver courses in clinical
laboratory sciences (CLS). However, designing and teaching a Web-
based course is a new endeavor for most faculty. Faculty need to Development and Implementation of a Course for
consider issues such as instructional design, faculty-student interac- Medical Students Focused on Bedside Procedures and
tions, technology skills, and student learning outcomes. To address Related Clinical Laboratory Testing
these issues, the faculty at the UTHSCSA developed Web-based
advanced level CLS courses using a team approach. The team con- Judith Tamburlin PhD, Mabel Gordon, Charles Severin MD PhD,
sisted of CLS faculty, an instructional development specialist, an Paul S Spurgeon MD, State University of New York at Buffalo,
instructional program designer, a Web designer, a graphic artist, and Buffalo NY
an audio-TV staff. This team collaboratively worked out strategies
in designing and delivering a template course. Student focus groups Medical students and residents are required to perform specific
helped the team design the template. The first course completed is a bedside procedures involving the collection of specimens for labo-
case-based course in medical microbiology that incorporates multi- ratory analysis. Unfortunately, they rarely receive any formal edu-
media technology and a Web-based discussion software program cation on the proper technique involved in specimen collection
for on-line discussion. Pre-implementation student evaluation sur- and handling and in the interpretation of laboratory results.
vey results indicated approval of the course content organization Through a collaborative effort between clinical laboratory science
and design, ease of navigation, and appropriate incorporation of and medical school faculty we have developed and implemented a
images. In conclusion, implementing Web-based instruction in CLS course designed to provide second year medical students the op-
requires shared efforts of a multidisciplinary team. Strategies devel- portunity to perform specific medical procedures and examine and
oped by a team helped address and minimize faculty’s and student’s discuss the role the laboratory plays in analyzing patient speci-
anxieties regarding telecommunication, faculty-student relation, and mens. A patient case study approach is used to introduce each
student performance in the course. topic. After reviewing the patient history and physical findings,
students learn the appropriate way to prepare the patient for the
procedure. The use of universal precautions and aseptic technique
Developing a Biotechnology Option within a is emphasized along with proper collection and transport of speci-
CLT Program mens such as CSF, blood, urine, and other body fluids. The labo-
ratory analysis of specimens collected by each student from mod-
Molly Saunders MEd, Stacey Rohrbaugh MEd, Allegany College of els and cadavers is discussed to ensure that students develop an
Maryland, Cumberland MD understanding of what occurs in the clinical laboratory and the
impact the quality of the specimen has on patient results. Students
The clinical laboratory technician (CLT) program at Allegany Col- have the opportunity to learn to interact with laboratory person-
lege of Maryland developed a truly integrated biotechnology op- nel who can assist them in the interpretation of results and in
tion within an existing CLT curriculum. Biotechnology is usually ordering additional tests. It is anticipated that this course will bet-
an expensive stand-alone curriculum that competes with CLT pro- ter prepare future physicians to provide appropriate specimens for
grams for students interested in science fields. The biotechnology laboratory testing and establish a rapport with the clinical labora-
and CLT skills and knowledge base are similar; therefore, a bio- tory with the ultimate goal of improving patient care.

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Development and Implementation of a Model On- northeast United States. A 24-item survey was developed to assess:
Campus Blood Bank Rotation in Response to Declin- 1) the need for individuals specifically trained in molecular diag-
nostics; 2) the requirements for training on molecular procedures
ing Clinical Practicum Sites based on current and future laboratory utilization; and 3) the im-
pact of trends, e.g., insurance coverage, automation, medical ad-
Faye E Coleman MS CLS(NCA), C Thomas Somma EdD SC, Tracy vances, and ethical issues, that will impact the future of molecular
S Harrison MS, Old Dominion University, Norfolk VA diagnostics. The survey underwent content validation by three
experts in the field of molecular diagnostics and clinical labora-
In an attempt to address the decreasing opportunities for clinical tory education, as well as pilot testing. Survey results from a mail-
practicum sites, the 2+2 medical technology/clinical laboratory sci- ing to directors of 247 molecular and cytogenetic laboratories in
ence program at Old Dominion University modified an existing the United States and Canada (listed in the Association of Genetic
blood bank practicum course with the goal of providing some of the Technologist’s Laboratory Directory) will provide direction on the
clinical training on campus. This pilot course was initiated in the development of a comprehensive educational program in molecu-
fall of 2000 and repeated in the summer of 2001. The on-campus lar diagnostics.
practicum course is structured to offer six weekends of simulated
clinical work followed by a two-week rotation at clinical sites. The
curriculum plan, evaluation issues, costs, mechanisms for ensuring
student competence, and the assessment of the effectiveness of this
Diversification of a CLS Program: Meeting Student
non-traditional approach to clinical education are addressed. The and Institutional Needs
shortened clinical time resulted in an increase of clinical sites willing
to take program students because of the reduced time commitment Julie A Hammerling MS, Clifford M Renk PhD, Jo Ann Wilson
on their part. The preliminary feedback from both instructors and PhD CLD(NCA), Florida Gulf Coast University, Ft Myers FL
students has been very positive. Students have indicated that they
are very satisfied and instructors have found the students to be “well During the years 1994 to 2001, 149 CLS/MT programs have closed
prepared” and the “program effective”. This on-campus practicum their doors, with many pointing to the lack of student numbers and
course serves as a model for MT/CLS program faculty to address the cost-effectiveness ratio. Florida Gulf Coast University’s clinical
the decline in clinical practicum sites. laboratory science program was designed from its conception with
diversification in mind, diversification that fulfilled both student
and institutional needs. Student needs are fulfilled by offering a bac-
Development of a Survey to Assess the Need for a Bac- calaureate degree in clinical laboratory science, with a choice of three
concentrations: clinical laboratory technology, biotechnology/pre-
calaureate-Level Program in Molecular Diagnostics professional and forensic science. The department currently also offers
two post-baccalaureate certificate programs in molecular biology and
Martha Keagle MEd CLSp(CG), Bobbi-Jo Rainey CLSp(CG) clinical laboratory technology. This year additional certificates in
CLSp(MB), Valerie Duffy PhD RD, University of Connecticut, forensic science, pre-medical/pre-professional education, infection
Storrs CT control, occupational health and safety, and public health microbi-
ology will be offered. Institutional needs of increasing student en-
Since the late 1980s, the field of molecular diagnostics has evolved rollment are also fulfilled by giving the department flexibility and
into a multitude of sophisticated testing strategies to diagnose in- stability when there are fluctuations in demand for traditional clini-
herited, acquired, and infectious diseases. Programs currently avail- cal laboratory science majors. By having diverse choices for students,
able for training individuals competent in molecular diagnostics the department taps into varied student populations including tra-
are limited to post-baccalaureate certificate programs and existing ditional baccalaureate seeking students, articulating associate degree
medical technology or cytogenetics programs that have integrated students, and post-baccalaureate students seeking certification and
molecular diagnostics into the curriculum. In July 2001, the Na- licensure to practice or continued education for entry into profes-
tional Accrediting Agency for Clinical Laboratory Sciences sional schools of medicine, veterinary medicine, dentistry, or physi-
(NAACLS) published the Molecular Essentials as a guideline “for cal therapy. Other educational opportunities await the criminal jus-
the development and evaluation of molecular diagnostic science tice student desiring coursework in crime scene evidence analysis,
and molecular biotechnology programs”. As the first step to pro- and the professional community seeking continuing education and
gram development, the present study aimed to determine the need career advancement.
for a baccalaureate level program in molecular diagnostics in the

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Educating Pre-Medicine Students about the CLS Cur- ognize international boundaries, students as well as faculty can
riculum and Profession gain from international exchanges. There have been limited op-
portunities in the health sciences to engage in exchanges because
Marcella L Stevens PhD CLS (NCA), Indiana State University, of the very structured nature of the academic curricula with ulti-
Terre Haute IN mate control exerted by government ministries; academic accred-
iting agencies; and licensure boards. Because of these conditions,
The gap between clinical laboratory science practitioners, and their very few educators have tried to form such linkages. We have es-
effective use as part of the healthcare team, exists primarily due to tablished a student exchange program with several European in-
inadequate education of the healthcare team members. Primary stitutions in England and Norway. Here we present our on-going
care providers such as physicians, nurse practitioners, physician results on these exchanges in terms of the students’ experiences.
assistants, and nurses are unaware of the clinical laboratory scientist’s To date we have hosted more than fifty British and four Norwe-
expertise and ability to contribute to the quality and efficiency of gian students in this program with a similar number of University
healthcare. This work was done to address and find solutions to of Kentucky allied health students sent in exchange. Students ro-
this problem by reaching the pre-medicine students enrolled at tated through clinical facilities, attended didactic lectures for aca-
Indiana State University. Several approaches were taken to this demic credit as well as conducted independent research under fac-
problem including faculty participation in freshman biology labo- ulty supervision. These research projects have produced student
ratories, encouraging use of the Clinical Laboratory Science Spe- presentations done locally, nationally, and internationally. We are
cial Topics course as a pre-medicine elective, and clinical labora- encouraged with the progress made to date with this program and
tory science alumni addressing the pre-medicine advisement group are actively recruiting more students and institutions to partici-
within the University. Participation in the freshman biology labo- pate in this international initiative.
ratories resulted in establishing a connection with the pre-medi-
cine majors as well as an increase in undecided majors committing
to a clinical laboratory science major. Working with pre-medicine Entry-Level Skills for CLSs in Arkansas
students through the Clinical Laboratory Science Special Topics
course was very beneficial to the student and the faculty member Martha J Lake EdD, Ruth M Allen PhD, University of Arkansas
with positive results beyond this single course experience. Address- for Medical Sciences, Little Rock AR
ing the pre-medicine advisement group was similar to high school
recruitment and yielded no known positive effect. The most effec- Many forces drive curriculum changes, including new accredita-
tive avenue for educating the pre-medicine students was through tion standards, improvements in technology, changes in student
the use of the Clinical Laboratory Science Special Topics course as preparation, and shifts in employer expectations. Our profession
a pre-medicine science elective. Small strides in education, such as is one that is under continual pressure to change—now perhaps
this, can result in increased clinical laboratory practitioner involve- more than ever before. As our program seeks to adapt our curricu-
ment with the primary care provider. lum to present and future needs, we sought to match the entry-
level skills to the expectations of our graduates’ future employers.
To accomplish this task clinical laboratory managers in Arkansas
Effective CLS Education—Facilitation via Use of In- completed a questionnaire on expected entry-level skills for clini-
cal laboratory scientists. The entry-level skills on the survey were
ternational Student Exchange Programs based upon the July 2001 draft of the National Accrediting Asso-
ciation for Clinical Laboratory Sciences’ Essentials for CLS/MT
Vincent S Gallicchio PhD, Raymond Olesinski PhD PAT SH, Chan- programs. The survey instrument was designed for data tabula-
dler Medical Center, University of Kentucky, Lexington KY; tion using Remark® software. Descriptive statistics were used to
Synnøve Hofseth Ålmas, Ålesund College, Ålesund Norway analyze the data generated. Of the 125 surveys returned, 122 were
usable for a 22.5% return rate with 95% from either hospitals
The specific problem addressed is that there are virtually no edu- (34%) or POLs (61%). Small laboratories predominated with 74%
cational experiences that train biomedical/clinical laboratory sci- of the respondents performing less than 250,000 tests/year. Over
entists for the workforce of the future, which will be transnational 80% of the respondents rated entry-level skills in test performance
in nature. Knowledge and work are no longer reserved within na- and interpretation; decision making; quality assurance; applica-
tional boundaries. Although presently we do not educate biomedi- tion of regulations, and demonstration of ethics and professional-
cal/clinical laboratory scientists internationally, health issues are ism as important or very important. However, less than half of the
international in scope. American health science education has suf- respondents rated entry-level skills in new instrument research,
fered from isolation. European health science practitioners have development, evaluation, and implementation; financial manage-
had limited opportunities to learn about the unique American ex- ment; marketing; personnel management; and career planning as
perience. Since knowledge is universal and learning does not rec- either important or very important. Information collected will be

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 CL I NI CAL PRAC T I C E: EDU CAT I ON

used to help with planning changes and/or additions to the cur- ing in non-traditional jobs (NTJ) were differentiated from a larger
riculum in our CLS-level program. sample group of technologists whose career paths were being stud-
ied by the ASCP–BOR Research and Development Committee.
Individuals were asked whether they applied the following generic
Integrating Point of Care Testing with Multiple Man- skills: problem solving, decision making, troubleshooting, analyti-
agement Activities cal reasoning, data correlation, precision studies, research, quality
assessment, communication, teaching, technical writing, computer
Patsy C Jarreau MHS CLS(NCA), Louann W Lawrence DrPH use, utilization review and supervision to their current NTJ; and
CLS(NCA), Louisiana State University Health Sciences Center, whether they learned these skills as CLS/MT students and/or prac-
New Orleans LA titioners. Comparisons for both learning and applying the skills were
made between graduates of NAACLS approved CLS/MT programs,
In response to increased emphasis on management in CLS pro- and individuals holding other baccalaureate degrees. The response
grams, we recognized the need to develop creative methods to teach rate was 48% (50/103). Chi square analyses indicated a statistically
management principles. At the same time, an opportunity to per- significant difference (p <0.05) between CLS/MT majors and Non-
form cholesterol testing at health fairs arose. Strategies to integrate CLS/MT majors for learning problem solving, correlation, preci-
the health fair clinical experience with management projects in a sion, research, analytical reasoning, and troubleshooting. Frequen-
realistic patient care setting were investigated. Point of care testing cies for CLS/MT majors learning was higher for all skills except
(POCT) instruments for cholesterol assay were purchased for use teaching and utilization studies. There were no significant differ-
at two health fairs. Health fair participation allowed students to ences between doing the skills in the NTJ and being a CLS/MT
interact with patients, gain more experience performing finger major. The results indicate that generic skills learned as CLS/MT
sticks, work with classmates as a team, and educate patients about students and/or practitioners are applied to a variety of NTJ. Fur-
laboratory test results. Prior to the health fair, method evaluation thermore, CLS/MT majors learned these generic skills at least as
was performed to compare the POCT method with traditional well, if not better, than laboratory practitioners with baccalaureate
cholesterol testing and cost analysis was used to estimate revenue degrees in other areas.
potential. Students performed workload time studies while set-
ting up workstations and performing tests at the health fairs. Rev-
enue generated was used to help defray costs of reagents and pay Involving CLS Students in Establishing and Moni-
students’ expenses for the state professional society meeting. Stu- toring Quality Compliance of Point of Care Testing
dents learned by realistic application of management techniques
through the health fair experience rather than passive classroom Marvin D Bearden MA, Linda A Smith PhD CLS (NCA). Shirlyn
lectures. This community outreach project allowed development B McKenzie PhD CLS (NCA), The University of Texas Health Sci-
of confidence in working with actual patients and enhanced pro- ence Center at San Antonio, San Antonio TX
fessionalism. POCT can be used for multiple management as well
as clinical learning experiences and also to generate revenue for For many years, point of care testing (POCT) was performed out-
student projects. Instrument costs are minimal and easily justified side the clinical laboratory without oversight. Now, the Joint Com-
by the benefits achieved. In addition, correlation of multiple man- mission on Accreditation of Health Care Organizations has fo-
agement activities with real life clinical experiences exposes stu- cused on control of POCT performed in all areas of the healthcare
dents to practical uses of management techniques. organization. During their clinical rotations, CLS students have
little or no exposure to POCT competency assessment activities.
One of our affiliate clinical laboratories had no extra personnel for
Investigation of the Application of Learned Generic a scheduled POCT competency assessment activity. Since the se-
Skills by CLS/MT Graduates and Practitioners Work- nior CLS students at UTHSCSA needed the experience, they par-
ticipated in the “POCT Competency Assessment Fair”. Student
ing in Non-Traditional Jobs preparation involved lectures, assignments, and audio conferences.
They evaluated a rapid group A strep kit and wrote a procedure
H Jesse Guiles EdD, University of Medicine and Dentistry of New and competency checklist for the test. During the “Fair”, nursing
Jersey, Newark NJ personnel rotated through various competency assessment stations
and teams of students were responsible for verifying competency
During the past decade, the economic climate of corporate mergers of the staff in glucose testing, group A strep testing, spun hemat-
and position freezes changed job opportunities for CLS/MT gradu- ocrits, pregnancy testing, and chemical urinalysis. Students also
ates and practitioners. Consequently, individuals were driven from posed questions concerning the procedures, specimen collection,
laboratory bench work to alternate jobs within healthcare and other and trouble-shooting. Students indicated it was a worthwhile
industries. A cohort of CLSs/MTs who considered themselves work- project and they came to appreciate that not all healthcare work-

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ers know the importance of quality control in patient testing. The remediation became the responsibility of the Program Chair. Direct
quality and compliance manager related that she received only personal contact is the most effective means to attract and retain
positive comments. Nursing personnel stated that the testing was students. Three-quarters of incoming students need remedial
non-threatening and their learning needs were addressed at the coursework, but the early and continued contact keeps them con-
appropriate skill level. The project was so successful that compe- nected to the program. Connecting students with employers as they
tency assessment of nursing personnel by CLS students will be enter the program has increased retention. One-third to one-half of
provided in the fall of 2001 and spring of 2002. incoming students are employed as laboratory support personnel as
they begin their studies, which acclimates them to the field and
provides motivation for coursework. These student employees ac-
Job Task Mix of the Same Medical Technologists: crue benefits, including tuition reimbursement. One large hospital
1993, 1995, 1997 and 1999 Compared group and a rural hospital offer substantial scholarships in exchange
for two- to three-year work commitments after graduation. Even
Kory Ward-Cook PhD FACB, Donna Surges Tatum PhD, Laura with financial assistance, some students are unable to enroll full-
Culver Edgar MA, ASCP Board of Registry, Chicago IL time, but are anxious to enroll in clinical laboratory classes. The
1998 introduction of a clinical assistant certificate that parallels the
In 1993, the ASCP Board of Registry (BOR) began a ten-year pro- associate degree has enabled students to get started in the field, and
spective study of the careers of medical technologists (MTs). The become employable as phlebotomists and processors while earning
aim of this report is to describe the self-reported changes in job an associate degree over a three-year period. The certificate is re-
responsibilities of the same group of MTs certified by the ASCP sponsible for 20% of retained students.
Board of Registry from 1993 to 1999. The objectives were to map
the frequency of various job tasks over time, determine if the fre-
quencies of core, managerial, and advanced technical tasks varied Management Competencies Expected of CLSs at
significantly as MTs careers progressed, and to determine if job re- Entry Level and Beyond
sponsibilities between genders, ethnic groups, facility location, and
job titles changed significantly during the seven-year period. The Susan Beck PhD CLS (NCA), University of North Carolina at
survey instrument consisted of a laboratory responsibility scale de- Chapel Hill, Chapel Hill NC
veloped by the BOR Research and Development Committee. The
MTs in the study (n = 293) were asked to rate how frequently they This study was undertaken to evaluate the level of education re-
performed each of the 29 tasks (core, managerial, and advanced quired to perform tasks related to laboratory management. The 560
technical). All respondent data was converted into an objective unit respondents to the national survey included educators, managers,
of measure, called logits, using Rasch analysis. Once the objective and practitioners who reviewed a list of 44 tasks and indicated
measures were obtained, differential statistics were applied to detect whether the task would be expected of a CLS at entry level, in the
differences between tasks at each time period. Five years later MTs first three to five years of practice with no additional education, or
still performed core tasks more frequently than managerial or ad- in the first three to five years of practice with additional education.
vanced technical tasks. However, in 1999 MTs performed both man- The percent of respondents classifying a task in each educational
agement and advanced technical tasks more frequently, compared category was tabulated. Tasks were further grouped into one of four
to core tasks. Differences in the task mix were influenced by gender, major management functions: laboratory operations, human resource
job title, schedule (full-time vs. part-time), and shift. management, financial operations, and communications and con-
sultation. All tasks classified as expected at entry-level were labora-
tory operations functions, e.g., routine testing and explaining test
Making Critical Connections to Increase Enrollment principles. With three to five years of experience but no additional
education, expectations in laboratory operations included tasks that
A Janelle Gohn MA CLS (NCA), Cincinnati State Technical and went beyond testing and encompassed the total testing process, e.g.,
Community College, Cincinnati OH turn around time studies. In this educational category, graduates
were also expected to have a high level of communication and con-
This session presents innovations that have led to enrollment growth sultation skills. The laboratory operations tasks classified as expected
in a clinical laboratory technician (CLT) program during a period with three to five years of practice plus additional education in-
of increasing competition for qualified students in health programs cluded specialized testing and tasks that require an understanding
and well-documented shortages of laboratory practitioners. Since of the healthcare system, e.g., developing compliance programs. Most
1997, the enrollment in this mid-western urban community college of the tasks in human resource management and financial manage-
program has doubled due to connections made with the program, ment areas were in this educational category. Educators can use this
employers, and a certificate program. In 1998, with program re- information to select the appropriate level of instruction for compe-
trenchment a possibility, the advising of CLT students who needed tencies in the CLS curriculum.

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Multiple Site Clinical Experiences for Students in a Partnering with Industry to Provide a State-of-the-
CLS Program Art, Cost-Effective, CLS Molecular Diagnostics Course

Carol A Golyski MS CLS(NCA), University at Buffalo, The State Sharon S Ehrmeyer PhD, Sue Beglinger MS, University of Wis-
University of New York, Buffalo NY consin, Madison WI; Rick Salatino MS, Karin Borgh PhD, Promega
Corporation, Madison WI
The merging of laboratory services, downsizing of healthcare fa-
cilities, introduction of core laboratories, and laboratory person- Clinical laboratory science (CLS) programs must provide an up-to-
nel shortages have forced clinical education coordinators to seek date curriculum to prepare graduates for an ever-changing healthcare
various clinical sites for placement of students. The medical tech- environment. To that end, the University of Wisconsin’s CLS pro-
nology program in the Department of Biotechnical and Clinical gram undertook an extensive curriculum revision; part of the revi-
Laboratory Sciences at the University at Buffalo assigns students sion included a new course in molecular diagnostics. Because of
to multiple sites for clinical training. In this program, students budgetary constraints, we sought industry support. Madison WI is
rotate at the clinical sites during the second semester of the senior fortunate to be the home of Promega Corporation, a nationally and
year. The rotation schedule is divided into five blocks of a three- internationally recognized biotechnology company. As part of its
week duration. Students experience one block each of clinical chem- educational mission, Promega was interested in partnering with the
istry, microbiology, hematology, and blood banking at different University to provide an introductory course in the principles and
facilities. The fifth block is an elective, and students are placed in practices of molecular diagnostics. Discussions were undertaken with
a variety of settings based on individual interests. Examples of elec- the intent to design a model partnership. The CLS program faculty
tive rotations include: a police department laboratory, public health and Promega collaborated to plan appropriate course content and
nuclear medicine laboratory, milk cooperative testing laboratory, materials, laboratory experiences, exams, and evaluation procedures.
student health laboratory, and experience in departments of virol- The entire 40-hour course is conducted in Promega’s facilities and
ogy, flow cytometry, cytogenetics, or histopathology. During the taught by their MS and PhD scientists. The CLS program pays
elective rotation, students also have a phlebotomy experience. Clini- Promega $250 for each student to offset the cost of reagents used in
cal sites affiliated with the University at Buffalo include hospital the laboratory sessions. To date, over 50 CLS students have com-
laboratories, a health maintenance organization laboratory, and a pleted the course. Students benefit from the knowledge and exper-
physician group laboratory within the greater Buffalo area. Hospi- tise of highly qualified instructors and the opportunity to view an
tal laboratory sites include government and community hospitals. industrial setting first hand. Promega is able to fulfill its educational
Students are exposed to a variety of methodologies and automa- mission, including its desire to partner with the University. The CLS
tion, and also interact with many laboratorians. This approach is curriculum includes a state-of-the-art molecular diagnostics course
advantageous to both the students and the clinical affiliations. The at a cost far less than would be incurred on the University campus.
students have the opportunity to experience different clinical set- Consequently, this arrangement has proven to be a synergistic “town
tings and observe differences in organizational structures among and gown” collaboration.
the various government and community facilities. Students work
on many different laboratory instruments that provide them with
a vast technical background that they may not have received if Program Recruitment in CLS Programs
placed in one clinical setting for their entire clinical experience.
Students make more contacts for employment opportunities and Janelle M Chiasera MS, The Ohio State University, Columbus OH
job references when placed in multiple clinical settings than the
student placed in only one setting. Satisfaction with clinical rota- There is a current shortage of our professionals available for em-
tions was highly rated by the students upon their exit question- ployment. Our accredited CLS programs have steadily decreased
naire. The clinical laboratories benefit by having students placed to almost half over the past ten years resulting in a substantial
in multiple settings. During times of personnel shortage, labora- decrease in the number of our students graduating from our pro-
tory remodeling, or equipment installation a student will not be grams and entering the profession. Concurrently, the bureau of
placed in a particular clinical setting. This relieves the clinical fac- labor statistics anticipates the need for 93,000 more CLS profes-
ulty of teaching duties and allows time to take care of other priori- sionals by the year 2008, which is 57,000 (17%) more jobs than
ties. Any given clinical faculty has the opportunity to observe the in 1998. This renders program recruitment a necessity to assure
performance of most students in the program. This enables the the survival of our programs and the growth of our profession.
sites with a large pool of applicants for employment. Surveys were sent electronically (55%) or by mail (45%) to pro-
gram directors of NAACLS- and CAAHEP-accredited CLS pro-
grams across the country to gather information about program
recruitment at their institutions. We sent a total of 265 surveys

82 VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE

04-Abstracts 82 4/22/02, 3:34 PM

 C L I NI CAL PRAC T I C E: EDU CAT I ON

and received 152 that yielded a response rate of 57%. Of the re- tory personnel exists, the extent of the shortage, and the actions to
sponses, 47% were from university-based programs and 50% were address any shortage. A survey of laboratory managers found an
from hospital-based programs. Ninety-seven percent of respon- average vacancy rate of 3.7% for CLS/MTs and 8.9% for CLT/
dents stated that they needed to recruit with 84% of them actively MLTs. The six training programs reported declining numbers of
recruiting. Twenty-five percent of those that did recruit had a mean applicants. A targeted mailing was sent to all high school counse-
allotted budget figure of $2000. Of those that do not recruit, over lors and science teachers describing the clinical laboratory profes-
half reported that they lack funds and personnel to support pro- sions and a questionnaire assessing their knowledge of the profes-
gram recruitment. From the data we collected, it will be possible sions. Counselors and teachers were invited to an educational ses-
to identify recruitment efforts that worked best at programs across sion at the Northwest Medical Laboratory Symposium. A website
the country so that time and money can be focused on only a few for the clinical laboratory profession was established,
efforts that have proved to be successful at other institutions. www.labcareers.org. A statewide salary survey was conducted to
obtain current salary information. Recruitment materials includ-
ing posters and flyers were updated. An article was written for the
Recruitment Strategies and their Effect on Program state professional society newsletter describing how laboratories
Recruitment in a University-Based CLS Program can become a training site for an educational program. To follow
up on these activities, a new survey of training programs showed
Janelle M Chiasera MS, The Ohio State University, Columbus OH that enrollments increased by approximately 65%. There were also
more facilities interested in becoming clinical sites for the training
In general, clinical laboratory science (CLS) programs are under programs. In summary, the WLPSW has successfully increased
tough scrutiny by academic administrators because of low enroll- knowledge about the clinical laboratory profession and is begin-
ment and high cost per student. Many programs over the years ning to reverse the laboratory personnel shortage.
have been closed, and those that remain are at an increased risk for
closure. In an effort to remain viable, our university-based CLS
program has been involved in active aggressive student recruit- The Sensitivity and Specificity of the Allied Health
ment for the past year. Our recruitment efforts over the past year Professions Admissions Test
included: campus career days, dormitory presentations, letters to
recent college graduates, campus-wide fliers, mailbox stuffers, e- Nancy Goodyear PhD, Mary F Lampe PhD, University of Wash-
mail messages to undecided undergraduates, counselor informa- ington, Seattle WA
tion days, updated website, campus advertisement, and the devel-
opment of a CLS club. In addition, we created a database to moni- The purpose of this study was to set criteria for the Allied Health
tor the effectiveness of each recruitment effort so we can focus our Professions Admissions Test (AHPAT) (The Psychological Cor-
energy in the future on those activities that generated the best poration, San Antonio TX) to be used as predictors of success in
return on investment. We found that flyers, word of mouth, and the University of Washington Medical Technology Program
pre-allied medical profession student letters generated the most (MTP). The sensitivity and specificity of several cutoff schemes
amount of inquiries (24%, 25%, and 17% respectively). Career/ were calculated for 183 students admitted to the MTP between
job fairs, undergraduate letters, and table tents generated the least 1990 and 2000. Failure was defined as first-try failure on the BOR
amount of inquiries (2%, 2%, and 1% respectively). Therefore, or dismissal from the MTP for low scholarship. The cutoff schemes
our program will focus primarily on a combination of flyers, word consisted of combinations of the following limits: AHPAT total:
of mouth, and pre-allied medical profession student letters as our 100 or 150; Verbal subsection: no cutoff or 5; Biology subsection:
source of recruitment activities. no cutoff or 10. True negative was defined as a failure that fell
below the cutoff, false negative as a success below the cutoff, true
positive as a success above the cutoff, and false positive as a failure
Report on the State of Washington Laboratory Per-
above the cutoff. The scheme that primarily eliminated the fewest
sonnel Shortage Workgroup successes (sensitivity) while secondarily identifying the most fail-
ures (specificity) was a requirement where the applicant must ex-
Dave Abbott, Linda Briewick, Cynthia Hamby, Ann O’Neill, Claudia ceed two of the following three criteria: AHPAT total: 150; Biol-
Steen, Mary Lampe, University of Washington, Seattle WA ogy: 10; and Verbal: 5. Sensitivity for this cutoff was 100%, and
specificity was 26.7%. When applied to the database, no students
A laboratory personnel shortage workgroup (WLPSW), composed who succeeded would have been eliminated, while five of 13 fail-
of representatives of laboratory professional organizations, train- ures would have been admitted. While other criteria would have
ing program directors, and members of the Department of Health eliminated more of the failures (higher specificity), they would
Advisory Council, was formed in September 1999. The goal of have also eliminated some of the successes. These new criteria were
the workgroup was to determine if a shortage of clinical labora- applied for the first time for applicants for Autumn Quarter, 2002.

VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE 83

04-Abstracts 83 4/22/02, 3:34 PM

 CL I NI CAL PRAC T I C E: EDU CAT I ON

Statewide Management Symposium for CLS Students structor efficiency while enhancing student-learning. A variety of
Web-based course management computer programs exists. Most
Elaine M Keohane PhD CLS(NCA), H Jesse Guiles EdD of the programs provide components that allow students to access
CLS(NCA), Bernadette Bekken CLS(NCA), University of Medi- course materials on a 24/7 basis, communication opportunities
cine and Dentistry of Newark NJ; Janet Hiler Bowman MEd, Au- among students and faculty, links to other Web sites, student as-
gusta Medical Center, Fishersville VA sessment with immediate feedback, and grade book management.
A problem arises in deciding which of the programs may be most
Knowledge of laboratory management, laboratory utilization, the appropriate to meet the needs of instructors and students. Two
healthcare environment, and professionalism is essential for today’s computer management programs currently available to educators
clinical laboratory science (CLS) graduates. Typically, this content include WebCT and Prometheus. The integration of these pro-
is delivered in individual programs at various levels of quantity and grams into the laboratory course curriculum will be demonstrated.
quality due to the difficulty in identifying content experts who are Interaction with each of these two programs will allow partici-
available to teach relatively small groups of students in each pro- pants the opportunity to compare functional components of the
gram. In an effort to present up-to-date and relevant content in programs and to identify advantages and disadvantages of each
these areas in an efficient, cost-effective, and high quality manner, program. Individuals will gain a foundation upon which to make
CLS educators in New Jersey and in Virginia developed two to three more informed decisions concerning course management programs.
day management symposia that were conducted for all the CLS stu-
dents in each state. The topics were approved by the faculty of the
various programs and included human resource management; labo- Reaching the Rural Frontier and Beyond…MED Net:
ratory finance including costs, budgets and reimbursement; labora- Connecting Outside the Box
tory accreditation, laws and regulations; and trends in healthcare
and laboratory practice including managed care. Experienced fac- Mary Banman CLS (NCA), Susan Kuntz MS, University of North
ulty, highly recognized at the state and national level, were identi- Dakota, Grand Forks ND
fied to serve as presenters as well as role models. Participation among
the CLS Programs in each state was high, and the feedback from The CLS program at the University of North Dakota School of
students and faculty was excellent. An added benefit was the input Medicine and Health Sciences encompasses four states, eight higher
of faculty from various programs into the content and the opportu- education institutions, and over 40 medical centers. Continuing
nity for student interaction and networking across programs. Plans education opportunities currently provided span a global spectrum,
are to continue this activity into the future. reaching across North America to as far as the Middle East. Op-
portunities exist for undergraduate and graduate students and also
the adult learner. MED Net (Medical Education and Distance
TECHNOLOGY DEMONSTRATION Learning via the Internet) was created primarily to offer continu-
ing education opportunities to the rural professional. However,
Course Management Computer Programs: Compari- additional benefits include enhanced quality of instruction, im-
proved communications, and increased program efficiency. MED
son of WebCT with Prometheus Net is a complete Internet access system in a box. It consists of a
metal carrying case, a high-speed laptop, and a video conferencing
Joyce A Bulgrin MSA, Susan L Raab EdD, University of Wiscon- camera. Connectivity options allow the user to connect via tele-
sin/Stevens Point, Stevens Point WI phone, DSL, Ethernet, or wireless router. An internal firewall pro-
vides facility protection. The system is completely mobile and
CLS instructors are continuously challenged to provide additional weighs less than 35 pounds. CLS program faculty in conjunction
educational experiences with minimal increases in funding for fac- with the UND SMHS Medical Instructional Technology faculty
ulty positions. The search for innovative resources is essential. have developed a curriculum designed to meet the needs of the
Course management programs represent a means to improve in-

84 VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE

04-Abstracts 84 4/22/02, 3:34 PM

 C L I NI CAL PRAC T I C E: EDU CAT I ON

distant learner. MED Net allows for asynchronous learning yet both image (photos and graphics) and explanatory (primarily text)
provides face-to-face communication opportunities, which further information. These Web pages may be authored inside and out-
enhances the learning process. side of our respective institutions (the latter widening our scope of
instruction). In the laboratory, students can access voluminous
Web-Enhanced Instruction for Laboratory Sciences material directly related to the bench procedure at hand, using
already-in-place bench top computers without having to concern
Cheryl Jackson-Harris MS CLS, California themselves about amassing a large library of contaminated texts
State University, Dominguez Hills CA; Carol and other learning materials. Students and instructors also may
Moeller MS CLS, David Dietzel CLS, Cedars- interact at any time in a dedicated computer discussion room, en-
Sinai Medical Center, Los Angeles CA abling students and licensed technologists alike to learn from each
other’s questions and answers. Likewise, students can be outside
Our purpose in demonstrating this technology is to exemplify the of the hospital or classroom, and can greatly expand their infor-
advantages of integrating laboratory instruction via computer uti- mation by accessing computer-based material. The goal of this
lization. Web-enhanced instruction is incorporated into the clini- type of enhanced instruction is to enable a closer, more compre-
cal component of the CLS student program. This direction is hensive connection between the practical and the didactic aspects
achieved by posting objectives on our internal Web site (http:// of laboratory learning. Exercises are dispersed throughout allow-
www.cedars-sinai.edu/pathology/MTCourseDescription.htm), ing the instructor to assess learning by the students’ ability to dem-
with relevant Web pages and images linked to specific learning onstrate specific performance skills, evaluate data, and apply cog-
task objectives. Students are directed to Internet sites that offer nitive knowledge relevant to the skill.

ASCLS ANNUAL MEETINGS INFORMATION

Forms for submitting program proposals and abstracts for future

ASCLS Annual Meetings will be available on the ASCLS Web
site under meeting information. The Web site address is: http://
www.ascls.org/

VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE 85

04-Abstracts 85 4/22/02, 3:34 PM

Registration bro_86-90 4/15/02 3:17 PM Page 1

WORLD CONGRESS 2002 PROGRAM

TUESDAY = Requires pre-registration and additional fee ($); see page 29. = Included in full registration.
Tues., July 30, 2002 Workshops Governance
8:30 am – 10:00 am W01 Intestinal W02 Una Vista W03 Hematology IAMLT Council
Protozoa: What’s global y actual- Instrumentation: (Continued from Monday)
New, What’s izada de la Technology & ASCLS Board of Directors
Different, What’s Parasitología Interpretation
Possible with MIC ADM, GEN, HEM
Collection,
Ordering &
Identification
Options
MIC
10:00 am – 10:30 am Break
10:30 am– 12:00 pm W01 (Continued) W02 (Continued) W03 (Continued) IAMLT Council
ASCLS Board of Directors

1 12:00 pm– 1:00 pm

1:00 pm – 2:30 pm
Break
W01 (Continued) W04 Risk
Management
2002
ADM, CON, GEN
W05 Abnormal
Morphologic
Manifestations
Encountered in
ASCLS Committee Chairs
Orientation
IAMLT GAD-Open Forum
(1:00 pm – 4:00 pm)
the Hematology
Laboratory
HEM

2:30 pm – 3:00 pm Break

3:00 pm – 4:30 pm W01 (Continued) W04 (Continued) W05 (Continued) ASCLS CLS Consulting Editors
ASCLS CEAC
ASCLS P.A.C.E.® Committee
ASCLS PAC Board
ASCLS Presidents’ Seminar
ASCLS Student Orientation
4:30 pm – 6:00 pm ASCLS Abstract Review Committee
ASCLS Awards Committee
ASCLS Educational Affairs Committee
ASCLS Govt. Affairs Committee
ASCLS Nominations Committee
ASCLS Scientific Assembly Chairs
6:00 pm – 7:30 pm NCA/NAACLS Update
7:00 pm – 8:30 pm ASCLS Bylaws Committee
ASCLS Judicial Committee
ASCLS Professional Affairs Committee
ASCLS Publications Committee

7:00 pm – 9:30 pm Alpha Mu Tau Board

Registration bro_86-90 4/15/02 3:17 PM Page 2

WEDNESDAY
Wed., July 31, 2002 Governance
8:00 am – 10:30 am Opening Ceremony, Awards and Keynote Presentation: ASCLS CLS Editors-in-Chief
#1 Stress and Disease: Staying Sane and Healthy in a Changing World (8:00 am – 5:00 pm)
GEN
10:30 am – 11:00 am Shuttles to Convention Center
11:00 am– 12:30 pm #2 Specimen #3 What’s New #4 U.S. State #5 How to
Management in in Coagulation: Legislative & Facilitate
Microbiology Managing the Licensure Issues Effective
MIC Bleeding Patient GEN, PSD International
HEM, I/IH Student
Exchanges
EDU

12:30 pm – 1:45 pm Break

1:45 pm – 3:15 pm #6 Synthetic #7 The Global #8 P.A.C.E.® #9 HIV #10 (2:45pm –
Oxygen Carriers Movement Your Way to Resistance 5:00 pm)
I/IH Toward Quality Success Testing: Guidance Healthcare Forum
Systems PSD Choice in ADM, CON, GEN
ADM, EDU Individualized
Therapy
ADM, GEN, MIC

3:15 pm – 3:30 pm Break

3:30 pm – 5:00 pm #11 Clonar o no #12 Body Fluid #13 Bioterrorism
Clonar - Esta no Cellular Preparedness for
es la única inter- Morphology Level A&B Labs
rogante BUL, GEN, HEM ADM, GEN, MIC
GEN, I/IH

5:00 pm – 5:30 pm Return shuttles to Sheraton World

5:30 pm – 7:30 pm ASCLS Presidents’ Council &
Issues Update
7:00 pm – 8:00 pm ASCLS Student Forum
8:00 pm – 11:00 pm Presidents’ Reception and Welcome Mixer
Registration bro_86-90 4/15/02 3:17 PM Page 3

THURSDAY
Thurs., August 1, 2002 Governance
7:00 am - 8:00 am ASCLS 2003 CLEC Planning Committee
7:00 am – 9:00 am ASCLS Forum for Concerns of Minorities Business Meeting and Breakfast
8:00 am Shuttles to Convention Center
8:30 am – 10:00 am #14 Editing & #15 CLT to CLS: #16 Cell-Dyn #17 (8:45 – 10:00)
Publishing Your On-line Hematology The Clinical
Organization’s Articulation Users Group Laboratory:
Newsletter EDU HEM Abettor of or
PSD Defender Against
Bioterrorism
ADM, BUL, GEN,
MIC

10:00 am –1:30 pm Dedicated Time for Exhibits ASCLS “Meet the Candidates”
(10:30 am – 12:00 pm)
12:00 pm – 1:00 pm Administrators/Industry/Consultants Lunch
Men’s Lunch
1:45 pm – 3:15 pm #18 Routine #19 #20 Human #21 Disaster ASCLS President’s Elect Seminar
Genital Cultures: Implementation Genome Project Preparedness: (1:45 pm – 5:00 pm)
A Test of the Past of a Coagulation Issues & The 2002 G8
MIC Instrument/Reag Implications Summit
ent System in a GEN Experience
Multiple Hospital ADM, GEN, I/IH
Network
HEM
3:15 pm – 3:30 pm Break
3:30 pm – 5:00 pm #22 La comuni- #23 Products & #24 Common #25 Mycology:
cación involucra Practices for College of From Bench to
algo más que un Needlestick American Bedside
proceso de dos Safety Pathologists MIC
direcciones ADM, GEN (CAP) Laboratory
ADM, GEN Deficiencies
ADM, CON, GEN
5:00 pm – 5:30 pm Return shuttles to Sheraton World
5:30 pm – 6:30 pm ASCLS Scientific Assembly Meetings:
• Education
• Laboratory Administration
• Inspectors/Surveyors
• Consultants
• Industry
6:30 pm – 7:30 pm T’nT Boot Scootin’ Boogie Bash
Registration bro_86-90 4/15/02 3:17 PM Page 4

FRIDAY
Fri., August 2, 2002 Governance
7:30 am – 8:45 am ASCLS Regional Caucus Meetings
9:00 am– 10:00 am #26 Using #27 Dade #28 Building, ASCLS Scientific Assembly Meetings:
Outcomes Behring Enhancing and • Biochemistry/Urinalysis/Ligand
Measurement to Chemistry Users Marketing Your • Hematology/Hemostasis
Reduce Medical Group Organization’s • Immunology/Immunohematology
Errors and BUL Web Site • Cytology/Histology/Phlebotomy
Improve Patient ADM, EDU, GEN, • Microbiology
Safety - Part I PSD ASCLS Student Elections
ADM, GEN
10:00 am – 10:15 am Break
10:15 am – 11:45 am #29 Using #30 Nutritional #31 DNA #32 Membership #33 Case
Outcomes Assessment: Fingerprinting Development - Studies/Short
Measurement to What the GEN, I/IH Integrated Papers
Reduce Medical Dietitian Needs Marketing: The GEN
Errors and From the Profession is the
Improve Patient Laboratory Message
Safety - Part II BUL, HEM, GEN PSD
ADM, GEN
11:45 am – 12:30 pm ASCLS Elections
12:30 pm – 2:00 pm Roundtables
R01 Continuing R02 R03 Emergence R04 Web- R05
Education Interdisciplinary of Clinical Assisted Clinical Development of
Provider: An Clinical Research in the Chemistry a Master’s
Opportunity for Professional Clinical BUL, EDU Program in
Clinical Development Laboratory Diagnostic
Laboratory Seminar Sciences Molecular
Scientists EDU EDU, GEN Pathology
ADM, EDU ADM, EDU, GEN
R06 CLIA 88 y R07 R08 How to R09 Genetic R10 Congenital
Política de Pago Implementation Prepare Scientific Based Testing in Parasitic
de Medicare en & Management Materials for the Traditional Diseases:
Puerto Rico y su of Point-of-Care Publication in Clinical Diagnosis &
Impacto en la Testing CLS Laboratory Clinical
Práctica del ADM, CON, GEN EDU, GEN Science Fields Relevance
Tecnólogo EDU, GEN MIC
Médico
ADM, GEN
2:00 pm – 2:15 pm Break
2:15 pm – 3:45 pm #34 Management #35 HIPPA: The #36 Anthrax #37 Leadership #38 Research
Issues of Impact on Outbreak: The Development: Papers / Short
Centralized & Clinical Florida Preparing & Papers
Decentralized Laboratory Department of Mentoring Future GEN
Phlebotomy Operation & Health’s Leaders
ADM, GEN Information Response PSD
Exchange MIC, GEN
ADM, GEN
3:45 pm – 4:00 pm Break
4:00 pm – 5:30 pm #39 Strategic #40 New WHO #41 Blood Bank #42 Meeting #43 Research
Planning for Classification of Case Studies Planning for Papers / Short
Health Care Acute Leukemias I/IH Professional Papers
Worker and Organization GEN
Shortages Myelodysplastic Conferences
ADM, EDU, GEN Syndrome (MDS) PSD
HEM
6:30 pm – 10:00 pm IAMLT Farewell Banquet and Alpha Mu Tau Fraternity Dinner
Registration bro_86-90 4/15/02 3:17 PM Page 5

SATURDAY
Sat., August 3, 2002 Governance
8:30 am – 10:00 am #44 Moving To #45 Defining ISO ASCLS 2003 Annual Meeting
Competency- Standards Steering Committee
Based ADM, GEN, I/IH ASCLS Education & Research
Certification Fund Board
ADM, GEN ASCLS Forum for Concerns
of Minorities Board
ASCLS New Board Orientation
ASCLS PAC Board
ASCLS Scientific Assembly
Chairs Committee
ASCLS Student Forum Officers’
Orientation
Alpha Mu Tau Board
10:00 am – 10:30 am Break
10:30 am – 12:00 pm #46 Comparisons
and Contrasts in
Exotic Animal
Hematology
GEN, HEM

12:00 pm – 2:00 pm Break

2:00 pm – 5:00 pm IAMLT General Assembly of Delegates
ASCLS House of Delegates
 R EPOR TS AND R EV IEWS
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

A Comparison of INRs after Local Calibration of

Thromboplastin International Sensitivity Indexes
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
ZDAVID L MCGLASSON
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

There are approximately 300 reagent/instrument combinations for international sensitivity index; MNPT = mean normal prothrom-
performing prothrombin times/international normalized ratios (PT/ bin time; OAT = oral anticoagulant therapy; PIVKAS = proteins
INR) in the United States. Manufacturers and laboratories continu- induced by Vitamin K antagonists; PT = prothrombin time; TC+
ally struggle to ensure that the International Sensitivity Index (ISI) = Thromboplastin C+; TRS = Thromborel S; WHO = World
of their thromboplastin is accurate for assaying PT/INR. Health Organization.

OBJECTIVE: This study reports the feasibility of a new method INDEX TERMS: international normalized ratios; international
to locally calibrate ISI of thromboplastin using the mechanical sensitivity index; local calibration; prothrombin time; reagent/in-
STA automated coagulation analyzer (Diagnostica-Stago Inc.) and strument combinations.
two photo-optic coagulation analyzers, the BCS (Dade-Behring)
and CA-540 (Sysmex). Clin Lab Sci 2002;15(2):91

DESIGN: Neoplastine CI+ (CI+) (Diagnostica-Stago Inc); Throm- David L McGlasson is a Research Clinical Laboratory Scientist at
boplastin C+ (TC+); Thromborel S (TRS); and Innovin (I) (Dade- the 59th Clinical Research Squadron, Lackland AFB TX.
Behring) were used in this study. A mean normal PT (MNPT)
was determined for each reagent/instrument combination using Address for correspondence: David L McGlasson MS CLS/NCA,
samples from 25 normal individuals. Manufacturer instrument 59th Clinical Research Squadron/MSRL, 1255 Wilford Hall Loop,
specific ISI values were not available for the STA with TC+, TRS Lackland AFB TX 78236-5319. (210) 292-6555, (210) 292-6053
and I. The CA540 had no ISI value for CI+ and the BCS system (fax). davemcglasson@hotmail.com
had no manufacturer assigned ISI values for TC+ and I; generic
photo-optic and mechanical ISI manufacturer values were used Although the PT is the principal assay for monitoring patients
for these two systems. Local on-site calibration was performed using undergoing oral anticoagulant therapy, there are many variables
frozen plasma calibrators to determine ISI values for each throm- such as proper sampling and testing techniques that can have an
boplastin. Post-calibration, 95 patient samples were assayed for effect on the accuracy of the assay. Probably the most important of
each reagent/instrument system combination using the manufac- these variables is the thromboplastin reagent selected for the assay.
turer ISI and the local calibrated ISI to determine the INR result. Commercial thromboplastins vary widely in their sensitivities to
warfarin. Instrument choice can also play a significant role in the
PATIENTS: Patients from whom samples were obtained included performance of the PT assay. With so many variables, clinicians
five with a lupus anticoagulant, 30 on heparin therapy, and 60 on can be easily confused when having to compare patient results
coumadin therapy. from a variety of laboratories using different thromboplastin re-
agent/instrument combinations. High sensitivity thromboplastin
RESULTS: Differences between manufacturer versus local cali- reagents lead to greater prolongation of the PT time results than
brated ISI ranged from 0.9% to 18.9% for normal sample INRs assays performed with a lower sensitivity. Thus, a patient may have
and from 0.8% to 16.4% for patient sample INRs. The number a PT of 14 seconds with a low sensitive thromboplastin and a PT
(or proportion) of patient specimens with clinically significantly of 18 seconds with a more sensitive thromboplastin. Therefore, a
different INR values (>10.0% difference) ranged from zero for patient monitored with insensitive thromboplastins would require
several reagent combinations to more than half (or >50.0%) of a higher dosage of warfarin to result in an appropriate prothrom-
those tested for several other combinations. bin time ratio.1,2,3

CONCLUSION: Our results indicated that by locally calibrating In 1977, the World Health Organization (WHO) recognized the
ISI values, each laboratory may eliminate variability and guess- difficulty of comparing PT times performed with different throm-
work between different reagent/instrument systems for ISI values boplastins and introduced a thromboplastin that was to serve as
when performing PT/INR assays and potentially improve the clini- an international reference preparation. Then in 1983, the WHO
cal accuracy of their patients’ PT/INR results. described a model for PT standardization based on a method in
which the PT value is reported as an international normalized ra-
ABBREVIATIONS: CI+ = Neoplastine CI+; INR = international tio (INR). Theoretically, the INR is the PT that one would obtain
normalized ratio; IRP = international reference preparation; ISI = if the assay were performed using a WHO primary reference with

VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE 91

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 R EPOR T S AND R EVI EWS

an ISI value of 1.0. The ISI compares the sensitivity of a given This is a one-day protocol that uses the local reagent/instrument
thromboplastin to an international reference plasma that has been combination with the PT assays being performed in quadrupli-
calibrated using the WHO reference plasma. The INR is calcu- cate and analyzed with orthogonal regression analysis.18 This pro-
lated using the formula: tocol may not take into account the day to day variability seen in
a laboratory setting.
ISI
INR = (Patient PT)
Mean Normal PT Recently, the idea of frozen calibration plasmas for local calibra-
tion of ISI values has been introduced. Precision BioLogic
The advantage of the INR method of reporting is that the patient’s (Dartmouth NS Canada) has produced an ISI calibration set con-
result is compensated for between differing thromboplastins or sisting of five frozen OAT frozen plasmas and one frozen normal
instruments. While thromboplastins now have ISI values that may plasma that have been assayed against a standard WHO IRP of
range from 0.9 to 3.0, as assigned by the manufacturer, the patient human recombinant thromboplastin (RTF/95).11,19 In a study with
values can be compared using the calculated INR. The INR al- 122 participating laboratories the normal frozen reference plasma
lows for a better regulation of the dosage of oral anticoagulation.2 gave an INR of 1.06. The frozen OAT calibrators had a range of
1.72 to 4.62. The INR results of the normal plasma and the OAT
Concerns regarding the INR system have concentrated primarily calibrator plasmas encompassed the four therapeutic categories used
on the assignment of ISI values, method or instrument variations, in OAT (<2.0; 2.0 to 3.0; 3.1 to 4.5; and >4.5).
and calculation errors. ISI values appear to be instrument-depen-
dent. The ISI is used exponentially in calculating the INR and, In a study sponsored in part by Dade-Behring Inc (Deerfield IL),
therefore, any error in this number may result in significantly in- we evaluated the frozen plasma calibrants to determine if local
accurate values. INR variability, which may occur when there ex- calibration of ISIs for a variety of thromboplastins could be sim-
ists significant differences in ISI values from reagents with low ISI plified to improve correlation of INR results between different
values versus reagents with high ISI values, has been reported.4-10 reagent/instrument combinations.
These differences could result in inappropriate management of
patients on oral anticoagulant therapy (OAT) with possible dire MATERIALS AND METHODS
consequences of thrombotic or bleeding episodes. Instrumentation: electro-mechanical STA automated coagulation
analyzer (Diagnostica-Stago Inc, Parsippany NJ) and two photo-
The individual variability between reagent/instrument test systems optic coagulation analyzers, the BCS (Dade-Behring, Deerfield
suggests that each laboratory may need to calibrate its own PT/ IL) and CA-540 (Sysmex, Kobe Japan).
INR test systems. One method that has been somewhat reliable is
the WHO protocol. The method uses an International Reference Thromboplastins: Neoplastine CI+ (CI+) (Diagnostica-Stago Inc),
Preparation (IRP) of thromboplastin with the manual (tilt-tube) Thromboplastin C+ (TC+) (Deerfield IL), Thromborel S (TRS)
method with 20 fresh samples from normal subjects and 60 fresh (Deerfield IL), and Innovin (I) (Dade-Behring, Deerfield IL).
samples from normal subjects on OAT, performed in quadrupli- Thromboplastin CI+ is a rabbit-brain source thromboplastin as is
cate. Obviously this is not a practical method for many clinical TC+. TRS is a human placenta source. I is human recombinant
laboratories due to lack of practice with the manual procedure or thromboplastin.
the unavailability of so many patient samples.11,12
All of the specimens for this study were obtained after informed
Local system calibration using well characterized plasma calibrants consent was obtained from each subject. All of the patient samples
may be a practical alternative to the WHO protocol. However, for this study were obtained previously and stored in the following
until recently there have been no FDA cleared calibrator plasmas manner. An atraumatic venipuncture was performed using a
commercially available. Controversy exists regarding the use of Vacutainer collection system with 3.2% sodium citrate in a 9:1
artificially depleted vitamin-K plasmas or actual OAT plasmas. blood to anticoagulant ratio on each test subject. Platelet-poor
Results with these plasmas in various investigations have given dis- plasma was obtained by centrifuging each specimen at 2500g for
parate results, presumably due to the influence of proteins induced 15 minutes. The specimens were aliquoted into cryovials and stored
by Vitamin K antagonists (PIVKAS).13-15 Lyophilization may also at approximately –70 °C until ready for testing. Just prior to test-
cause changes in plasma and affect results in coagulation assays.15- ing, the samples were thawed rapidly at approximately 37 °C. A
17
This effect may vary for different reagent/instrument systems. mean normal PT (MNPT) was determined for each reagent/in-
In addition, there are many investigators who recommend using strument combination by assaying 25 normal individuals with no
large plasma pools instead of individual patient plasmas.12 One known coagulation abnormalities and who were not on any medi-
manufacturer uses 20 artificially depleted plasma calibrators pre- cation that could influence their coagulation system. The samples
pared from normal donors that cover the OAT therapeutic range. from normal donors were assayed three separate times, with each

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reagent/instrument system using three different sets of reagents DISCUSSION

for each combination, over a three-day period. Manufacturer in- The accuracy and precision of the INR is dependent on the PT
strument specific ISI values were not available for the STA with assay and the ISI of thromboplastin. Other researchers have noted
TC+, TRS, and I. The CA540 had no ISI value for CI+. The BCS that, since the ISI is the exponent of the INR equation, the higher
system had no manufacturer assigned ISI values for TC+ and I. the ISI assigned to thromboplastin the greater the imprecision of
Generic photo-optic and mechanical ISI manufacturer values were the INR as a result of the mathematical outcome. The large differ-
used for these two systems. The MNPT was determined using a ence in assigned ISI values is one variable that influences the poor
geometric mean. Currently Dade-Behring Inc can now furnish correlation seen in reagent/instrument combinations. Thrombo-
instrument specific ISI values for all of their own reagent/instru- plastins with an ISI less than 1.20 produce a wider range of values
ment combinations. in the PT and PT ratio. Consequently, the precision of the INR is
improved. Since the calculation of the INR requires using the ISI
A local on-site calibration to determine international sensitivity exponentially, the farther the ISI value is above 1.0, the greater
index (ISI) values for each thromboplastin was performed using a any system inaccuracies will be magnified in terms of INR. Manu-
protocol for frozen ISI calibration plasma sets from Precision facturer assigned ISI not specific to the local reagent/instrument
BioLogic (Dartmouth NS Canada). Calibrators were run in du- set-up may introduce even more inaccuracy. Instrumentation can
plicate for five individual runs, with freshly diluted reagents on also greatly influence the INR values. In our institution we saw
each reagent/instrument system. A total of 60 PT data points (10 serious clinically significant differences in INR results between
normal and 50 abnormal) for each reagent/instrument combina- photo-optic and mechanical reagent/instrument systems using
tion were derived. The results were sent to Precision BioLogic, manufacturer generated ISI values particularly at the upper limits
which used orthogonal regression analysis to determine the local of the OAT INR range (>3.0).20 This could lead to serious errors
calibrated ISI of each system. in OAT treatment decisions. Table 4 demonstrates the large INR
differences that resulted for selected patient samples between dif-
After the local ISI results had been determined, we assayed 95 ferent reagent/instrument combinations.20 Because manufactur-
patient samples on each reagent/instrument system using the manu- ers provide limited guidelines for all instruments assigned ISI val-
facturer ISI and the local calibrated ISI to determine the INR re- ues, the laboratory should be able to validate INR results by per-
sult. The patient samples included five from subjects with a lupus forming local on-site ISI calibration. Early researchers in INR stud-
anticoagulant, 30 from heparinized subjects, and 60 from ies used the tilt tube method making today’s studies comparing
coumadin patients. We then compared the PT/INR results using photo-optic and mechanical clotting endpoint values suspect, at
the manufacturer ISI to the INR results achieved using the locally best. For mechanical endpoint clot detection systems most manu-
generated ISI values. facturers still use the Fibrometer to assign ISI values. With today’s

RESULTS
Table 1 shows the geometric mean results of each reagent/instru-
ment combination MNPT. The times ranged from 8.9 to 13.9 Table 1. Summary of MNPT according to reagent/
seconds. In Table 2 it is interesting that the percent difference in instrument test system
the ISI did not directly correlate to the sensitivity of the thrombo-
plastin with each reagent/instrument combination. The differences Instrument Reagent MNPT (sec)
in INR means ranged from 0.9% to 18.9%. We note that some of
the reagents were made for mechanical systems while others are Diagnostica Neoplastine CI+ 13.9
directed towards photo-optic instruments. The local ISI calibra- Stage/STA Thromborel S 12.9
tion is designed to correct the reagent/instrument generated bias Thromboplastin CI+ 13.9
that the INR calculation is supposed to correct. Table 3 shows that Innovin 9.9
there can be clinically significant mean differences (>10.0%) be-
tween INR results using manufacturer ISI values versus locally Sysmex Neoplastine CI+ 12.7
calibrated ISI results. The last column (Results >10.0% difference) 540 Thromborel S 11.9
expresses the number of patient samples (n = 95) that had INR Thromboplastin CI+ 11.7
values of >10.0% difference between the different ISI generated Innovin 10.6
values. It was noted that the TRS thromboplastin gave no values
that had a >10.0% difference in the subject values with any in- Dade Neoplastine CI+ 13.8
strument. Some other reagent/instrument combinations had 64.9% Behring BCS Thromborel S 12.6
of the patient samples with a >10.0% difference between the ven- Thromboplastin CI+ 11.0
dor assigned ISI and a locally calibrated ISI. Innovin 8.9

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 R EPOR T S AND R EVI EWS

Table 2. Summary of mean INR results on 25 normal patient samples before and after local ISI calibration with each reagent/
instrument test system

Instrument Reagent Mean INR using Mean INR using Difference in INR means (%)
vendor assigned ISI locally calibrated ISI

Diagnostica Neoplastine CI+ 1.24 1.29 -3.9

Stago/STA Thromborel S 1.12 1.13 -0.9
Thromboplastin C+ 1.96 1.76 10.1
Innovin 0.92 1.00 -8.5

Sysmex CA Neoplastine CI+ 1.24 1.09 11.9

540 Thromborel S 1.06 1.02 3.4
Thromboplastin C+ 1.95 1.81 7.4
Innovin 1.02 0.92 10.3

Dade Behring Neoplastine CI+ 1.24 1.16 6.9

BCS Thromborel S 1.06 1.02 3.5
Thromboplastin C+ 1.77 1.57 11.1
Innovin 0.90 1.07 -18.9a

Table 3. Summary of mean INR results on 95 patient samples before and after local ISI calibration according to test system

Instrument Reagent Mean INR using Mean INR using Difference in Results >10%
vendor assigned ISI locally calibrated ISI INR means (%) difference

Diagnostica Neoplastine CI+ 2.58 2.69 4.1 0.0

Stago/STA Thromborel S 2.56 2.58 0.8 0.0
Thromboplastin C+ 2.39 2.15 10.0 37.1
Innovin 2.45 2.67 7.9 22.1

Sysmex CA Neoplastine CI+ 3.46 2.90 16.1 63.9

540 Thromborel S 2.69 2.58 4.1 0.0
Thromboplastin C+ 2.82 2.60 7.8 27.8
Innovin 2.49 2.25 9.6 39.2

Dade-Behring Neoplastine CI+ 2.81 2.60 7.5 20.6

BCS Thromborel S 2.67 2.57 3.7 0.0
Thromboplastin C+ 2.86 2.51 12.6 52.6
Innovin 2.66 3.29 16.4 64.9

highly automated mechanical clot-detection systems, this appears CONCLUSION

to be a less than optimal instrument method for assigning ISI val- In our protocol we used 12 different reagent/instrument combina-
ues. Photo-optical coagulation systems use many diverse methods tions and determined the local ISI by calibration for each coagula-
for determining a clot formation that may also greatly influence tion system. We then compared the results using samples from nor-
the ISI of different reagents. mal subjects and specimens from variety of patients. Our results
indicate that this local on-site calibration protocol may help elimi-
nate variability and guesswork between any reagent/instrument sys-
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 R EPOR T S AND REVI EWS

Table 4. Comparison of selected INR differences of OAT subjects plasma on the STA and MLA 900C with thromboplastins
CI+, T-D, T-R, and the MLA 1600C with T-D only

Human MLA 900C MLA 900C MLA 900C MLA 1600C STA STA STA Difference in
Sample CI+ T-D T-R T-D CI+ T-D T-R INR (%)
167 2.77 3.41 3.72 3.62 2.68 3.24 3.41 38.8
1181 2.53 3.20 3.65 3.36 2.64 2.85 2.91 44.2
1180 3.95 5.98 5.83 7.16 4.02 4.93 5.05 81.2
1398 2.94 3.94 3.44 4.14 3.06 3.61 3.35 40.8
1393 3.57 4.98 4.48 5.00 3.57 4.39 4.18 40.1
1391 3.03 4.14 3.41 4.43 3.13 3.82 3.14 46.2
1684 3.72 5.82 4.99 6.29 3.99 5.57 4.47 69.1
1688 2.95 3.94 3.93 4.44 3.12 3.70 3.79 50.5
1814 3.15 1.97 4.00 4.85 3.24 4.23 3.58 146.2
1669 3.25 2.41 3.66 3.93 3.24 4.29 3.28 78.0

CI+ (Neoplastine CI+, Diagnostica-Stago Inc. Parsippany NJ); T-D (Thromboplastin-D, Pacific-Hemostasis, Huntersville NC;,
T-R (Recombiplastin, Hemoliance, Pleasantville NY).

tems for ISI values when performing PT/INR assays and potentially its, limits and improvements. Int J Clin Lab Res 1995;25:56-7.
improve the clinical accuracy of PT/INR results for patients on OAT. 8. Brophy MT, and others. Comparison of a standard and a sensitive thrombo-
plastin in monitoring low intensity oral anticoagulant therapy. AJCP
1994;102(1):134-7.
ACKNOWLEDGEMENTS 9. Cunningham MT, Johnson GF, Pennell BJ, Olson JD. The reliability of
I would like to thank Dade-Behring Inc for their financial and manufacturer-determined, instrument-specific international sensitivity in-
technical assistance in support of this protocol. I would like to dex values for calculating the international normalized ratio. AJCP.
thank the following individuals for their personal support: Julie 1994;102(1):128-33.
10. Ts’ao C, Swedlund J, Neofotistos D. Implications of use of low international
Carlucci, Diane Shafer, Ruben Siller, Tom Hogan, and Sherry sensitivity index thromboplastins in prothrombin testing. Arch Pathol Lab
Hagman from Dade-Behring Inc for technical and administrative Med 1994;118:1183-7.
support. Steve Duff from Precision BioLogic was always available 11. McGlasson DL. A review of variables affecting PTs/INRs. Clin Lab Sci
for support. Captain Eric Olsen and Rachel Montez gave out- 1999;12:353-8.
standing editorial assistance. 12. Fairweather RB, Ansell J, Anton M, and others. College of American Pa-
thologists Conference XXXI on laboratory monitoring of anticoagulant
therapy: laboratory monitoring of oral anticoagulant therapy. Arch Pathol
The views expressed in this article are those of the author and do Med 1998;122:768-81.
not reflect the official policy of the Department of Defense or 13. Houbouyan IL, Goguel AF. Procedure of reference calibrated plasmas for
other Departments of the U.S. Government. prothrombin time standardisation. Thromb Haemost 1993;69:663. Abstract.
14. Stevenson KJ, Craig S, Dufty JMKL, Taberner DA. System ISI calibration: a
universally applicable scheme is possible only when coumarin plasma
This article was presented in part at the ASCLS meeting 2000. calibrants are used. Br J Haematol 1997;96:435-41.
15. Houbouyan LI, Gouguel AF. Long-term French experience in INR
REFERENCES standardisation by a procedure using plasma calibrants. Am J Clin Pathol
1. Ens GE. A proposed inter-laboratory INR support system. Clin Hemos Rev 1997;108:83-9.
1997;10:3-5. 16. Tripodi A, Chantarangkul V, Akkawat B, and others. A partial factor V defi-
2. Jensen R. Monitoring anticoagulant therapy. Clin Hemos Rev 1996;10:4-6. ciency in the external quality assessment scheme. Thromb Res 1995;79:283-92.
3. Hirsch J, Poller L. The international normalized ratio-a guide to understanding 17. Van den Besselaar AMHP. Field study for lyophilized plasmas for local pro-
and correcting its problems. Arch Intern Med 1994;154:282. thrombin time calibration in the Netherlands. J Clin Pathol 1997;50:371-4.
4. Pi DW, and others. Effect of thromboplastin and coagulometer interaction 18. Poller L, Barrowcliffe TW, Anton MH, and others. Minimum lyophilized plasma
on the precision of the international normalized ratio, J Clin Pathol requirement for ISI calibration. Am J Clin Pathol 1998;109:196-204.
1995;103:358. 19. Adcock DM, Duff S. Enhanced standardization of the international normal-
5. Poller L, Thomson JM, Taberner DA. Effect of automation on the prothrom- ized ratio (INR) through the use of plasma calibrants-A concise review. Blood
bin time test in NEQAS Surveys. J Clin Pathol 1989;42:97. Coag Fibrin 2000;11:
6. Brien WF, Crawford L, Wood DE. Discrepant results in INR testing. Throm 20. McGlasson DL, Hickman JR, More LE, and others. Discrepancies in inter-
Hemost 1994;72(6):985-9. national normalized ratios (INR) in swine and humans. Clin Lab Sci
7. Carraro P, Varagnolo MC, Plebani M. International normalized ratio: mer- 1998;11:156-9.

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○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Fetal Fibronectin

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
MARY E KOENN
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

OBJECTIVES: The objectives of this review paper are to: describe Address for correspondence: Mary E Koenn MS CLS(NCA), Medi-
the fetal fibronectin assay, its purpose, and clinical significance; cal Technology Program, West Virginia University, Room 2163C, PO
evaluate the sensitivity and specificity of the fetal fibronectin test; Box 9211, Morgantown WV 26506-9211. (304) 293-1632, (304)
describe the specimen collection and measurement of the fetal 293-6249 (fax). MKoenn@hsc.wvu.edu
fibronectin test; and present the advantages and disadvantages of
incorporating fetal fibronectin testing in routine prenatal care. A 25-year-old pregnant female, 26 weeks gestation, presented to her
obstetrician with onset of uterine contractions, backache, and ab-
DATA SOURCES: Current literature. dominal discomfort. She had delivered a healthy baby at preterm,
32 weeks gestation, three years previously. Both she and her physi-
DATA SYNTHESIS: Fibronectin proteins function in plasma and cian were concerned because of prior preterm delivery and the ges-
extracellular matrix in cell adhesion and migration. Recently, a tational week of this episode. A digital cervical examination was
fibronectin protein has been evaluated and proposed as a predic- performed and vaginal cultures for microbiology were collected.
tor of preterm delivery. A simple, qualitative assay detects this pro- Before the examination and culture collection, a fetal fibronectin
tein, fetal fibronectin, in cervicovaginal secretions of women who collection kit was obtained. The swab was used to collect a sample
are at risk for or have symptoms of preterm delivery. The test is of cervicovaginal secretions; it was placed in the tube of buffer pro-
positive when there has been a rupture in the membranes attach- vided and was sent to the laboratory for a fetal fibronectin test.
ing the fetus to the uterus, thus indicating pending preterm deliv-
ery. Sensitivity and specificity studies have been performed to evalu- Fetal fibronectin (fFN) is detected in the cervicovaginal fluid of preg-
ate its reliable prediction of preterm delivery. nant women as a predictor of risk for preterm delivery (PTD). A
recently developed qualitative solid-phase immunosorbent assay for
CONCLUSION: Evaluation of sensitivity and specificity studies fFN may significantly reduce hospital stay and costs for these women.
document that the fetal fibronectin test predicts preterm delivery. Presently in the United States, delivery before 37 weeks gestation,
For symptomatic women, a sensitivity of 89% and specificity of PTD, occurs in approximately 10% of births and is a leading cause
86% was found. of neonatal morbidity and mortality.1,2,3 This rate has not changed
significantly in the past forty years despite advances in perinatal care.4
ABBREVIATIONS: fFN = fetal fibronectin; PTD = preterm delivery. Early detection of PTD risk will hopefully allow clinicians deliver-
ing prenatal care to reduce its occurrence and resulting morbidity
INDEX TERMS: cervicovaginal secretions; fetal fibronectin; and mortality. At the same time, healthcare costs should be reduced
fibronectin; preterm delivery. by designating those with symptoms of PTD from those that are
truly at risk and require intervention.
Clin Lab Sci 2002;15(2):96
Fibronectin proteins are found in plasma and extracellular matrix
Mary E Koenn MS CLS(NCA) is Assistant Professor at the West and function as components of cell adhesion and migration. They
Virginia University School of Medicine, Morgantown WV. also play a role in cell differentiation and growth.2 One of these
fibronectins, fFN, is an oncofetal antigen present in some malig-
nant cell lines. Similar to other oncofetal antigens, it is a normal
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ protein in fetal life, present in amniotic fluid and placental tissue.
The Reports and Reviews Section seeks to publish information on im- In fetal life, it exists in the extracellular matrix where the implanted
portant clinical laboratory-related topics such as technological, clinical, ovum and placental membranes come in contact with the uterine
and experimental advances and innovations. Case studies and litera- wall. It most likely functions as an adhesion protein, connecting
ture reviews are also included. In addition, brief reviews of books, com- the placenta to the uterus. When this extracellular matrix is bro-
puter programs, audiovisual materials or other materials of interest to ken down because of stress, infection, or hemorrhage, fFN leaks
readers are appropriate for this section. Manuscripts and literature re- into cervicovaginal secretions.2,4,5,6,7
views published as a Report are peer reviewed. Direct all inquiries to
Isaac Montoya PhD, Affiliated Systems Corporation, 3104 Edloe, Suite fFN concentrations in vaginal and cervical secretions in pregnancy
330, Houston TX 77027-6022. (713)439-0210, (713)439-1924 follow a pattern that correlate with its role in implantation and
(fax). imontoya@affiliatedsystems.com adhesion. In the early weeks of pregnancy before 20 weeks gesta-

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 R EPOR T S AND R EVI EWS

tion, fFN is measurable in significant concentrations. In a normal fFN to other biochemical markers of PTD and other researchers in-
pregnancy, after 20 to 22 weeks gestation when the gestational sac cluded cervical dilatation, transvaginal ultrasound, or presence of bac-
would be attached to the endometrium, fFN decreases to <50 ng/ terial vaginosis. Most studies included symptomatic and asymptom-
mL, an undetectable level by routine assays.8 Therefore, its pres- atic patients. Some researchers have compiled the data and published
ence in detectable concentrations after 20 weeks should indicate meta-analysis of results, reporting fFN sensitivities and specificities
some type of premature rupture in the attachment of fetal mem- overall, and for specific weeks’ gestation. In a meta-analysis published
branes in the uterus. A rupture of these membranes places a woman in May 1999, Leitich reviewed 27 studies published in English.21 Table
at high risk for premature delivery (delivery before 37 weeks). 1 lists sensitivity and specificity for all patients for delivery at <37 and
<34 weeks’ gestation. Table 2 depicts overall sensitivity and specificity
Symptoms of premature delivery, most often uterine contractions rates for delivery within 7, 14, 21, and 28 days of sample collection
before 37 weeks, do not always result in premature birth. Digital for all patients and Table 3 for symptomatic patients. This data sup-
cervical examination and other procedures such as transvaginal ports their conclusion that fFN is an effective predictor of PTD in
ultrasound to evaluate the cervix, are performed to help deter- symptomatic women.21 Another earlier meta-analysis by Revah in
mine risk of PTD. The patient may be treated with tocolytic agents 1998, reviewed 24 studies and found similar sensitivities and speci-
to arrest contractions and/or antibiotics, if a bacterial infection ficities.22 Their overall specificity was 80% for all outcomes, very close
places patient at risk for early delivery. Researchers have been seek- to 84% and 83% on Table 1. Their sensitivities and specificities were
ing a biochemical marker or markers for PTD measurable in blood grouped differently than those on Table 2 and Table 3 but were also
or secretions. Utilization of biochemical marker(s) in conjunction lower for asymptomatic women. For a patient with symptoms of PTD,
with tocolytic therapy and antibiotics may increase fetal survival a negative test for fFN is useful in ruling out delivery in the next seven
rates. In 1995, the FDA approved the fFN enzymatic immunoas- to ten days. These authors concluded that testing for fFN is not as
say as a biochemical marker for preterm labor.3,4 It has been ap- useful in asymptomatic women as in symptomatic individuals.22
proved for the diagnosis of PTD in symptomatic women and as a
screening assay for premature labor in asymptomatic women who
are at risk for PTD.
Table 1. Sensitivity and specificity by delivery for all
To perform a fFN assay, cervicovaginal secretions are collected with patients
a Dacron swab and placed in a tube of buffer provided in Delivery <37 weeks <34 weeks
manufacturer’s specimen collection kit (Adeza Biomedical Corpo-
ration, Sunnyvale CA). The qualitative assay is performed on a Sensitivity 56% 61%
solid-phase immunosorbent cassette containing a monoclonal anti- Specificity 84% 83%
fetal fibronectin antibody. The specimen is extracted, filtered, and
dispensed into a sample well and resulting color intensities are
interpreted by the instrument in 20 minutes. Color intensity is
compared to a reference calibrator of 50 ng/mL; a positive reac-
tion indicates a concentration of fFN greater than or equal to the Table 2. Sensitivity and specificity by sample collection
calibrator and a negative indicates a concentration of less than 50 date for all patients
ng/mL. A quantitative assay that uses antibody coated micro titer
Specimen collection within days of delivery
wells is also available.9,10
7 days 14 days 21 days 28 days
If a patient is to have a digital examination or vaginal cultures Sensitivity 76% 68% 61% 43%
collected, the fFN sample should be collected first. These proce- Specificity 88% 89% 91% 93%
dures are disruptive to the membranes and may cause leakage of
fFN into vaginal secretions. Moderate and gross vaginal bleeding
also interfere with result interpretation. Since fFN is normally
present in amniotic fluid and fetal membranes, patients with ad-
vanced cervical dilatation and rupture of amniotic membranes are Table 3. Sensitivity and specificity by sample collection
unsuitable for the test. The manufacturer also recommends not date for symptomatic patients
collecting samples on patients who have had sexual intercourse in
the past 24 hours; test results on these patients are also difficult to Specimen collection within days of delivery
interpret.9,10,11,12,13 7 days 14 days 21 days 28 days
Sensitivity 89% 78% 76% 71%
There have been numerous studies evaluating fFN measurement and Specificity 86% 86% 88% 83%
preterm delivery prediction.5,7,11,14-20 Several of these studies compared

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Reductions in healthcare costs with the ad- does not necessarily decrease its occurrence. CONCLUSION
dition of fFN testing in preterm labor care Others are concerned that the test results The fFN test offers a rapid and easily per-
and treatment have been evaluated. De- may cause unnecessary anxiety for some formed assay to predict preterm delivery.
creased hospital admissions for preterm la- patients. The successful use of tocolytic fFN is an adhesion protein, part of the at-
bor, reduced length of hospital stays, and agents in preventing PTD needs further tachment of the gestational sac to the uter-
fewer prescriptions administered without investigation. Also needed is documenta- ine membranes. Its presence in
adverse consequences for these patients tion that antibiotic administration is effec- cervicovaginal fluid of pregnant women
would justify routine addition of fFN as- tive when a patient has a positive fFN and signals a rupture in this adhesion and pend-
says. Joffe evaluated 243 subjects in a 12- follow-up cultures indicate a vaginal or cer- ing fetal delivery. A qualitative assay has
month study and found significant reduc- vical bacterial infection. More research is been developed to evaluate women symp-
tions in healthcare costs.12 They compared required to find interventions to prevent tomatic of or at risk for preterm delivery.
their study group costs that included fFN PTD when it is predicted to occur.21 Sensitivity and specificity studies have
assays to a baseline group before the addi- documented its usefulness as a predictor
tion of fFN in patient care. There were no Other biochemical markers of PTD are of preterm delivery.
changes in neonatal intensive care admis- also being investigated.1,3,24-26 Table 4 lists
sions, neonatal intensive care length of stays, those found in literature on PTD. REFERENCES
or days of ventilator support per patient in Interleukin-6 (IL-6), other cytokines, and 1. Lockwood CJ, Kuczynski E. Markers of risk for
the two patient groups. They calculated a C-reactive protein (CRP) indicate the pres- preterm delivery. J Perinat Med 1999;27:5-20.
2. Hampel DJ, Kottgen B, Dudenhausen JW, and
savings of $416,120 for the study group; ence of an inflammatory process or infec- others. Fetal fibronectin as a marker for an
this included the additional costs incurred tion. Proteases such as collagenase, granu- imminent (preterm) delivery. A new technique
for fFN assays on follow-up clinic visits.12 locyte elastase, and matrix metallopro- using the glycoprotein lectin immunosorbent
teinases, increase in breakdown in the pla- assay. J Immunol Methods 1999;224:31-42.
Though the fFN test is a useful marker in cental uterine protein interface. Increased 3. Von Der Pool BA. Preterm labor: diagnosis and
treatment. Am Fam Physician 1998;57:2457-64.
evaluating PTD, some researchers and prac- levels of the hormones listed on Table 4 4. Weismiller DG. Preterm labor. Am Fam Phy-
titioners are still hesitant to advocate its indicate maternal or fetal stress. sician 1999;59:593-602.
use.21,23 The accurate prediction of PTD 5. Lockwood CJ, Senyei AE, Dische MR, and
others. Fetal fibronectin in cervical and vagi-
nal secretions as a predictor of preterm deliv-
ery. N Engl J Med 1991;325:669-74.
6. Leeson S, Maresh MJ. Predicting preterm de-
livery: the fetal fibronectin test. Prof Care
Table 4. Other biochemical markers of preterm delivery Mother Child 1994;4:38-9.
7. Lockwood CJ, Wein R, Lapinski R, and oth-
Marker Specimen ers. The presence of cervical and vaginal fetal
fibronectin predicts preterm delivery in an in-
Cytokines: ner-city obstetric population. Am J Obstet
Interleukin-6 (IL-6) Amniotic fluid, cervicovaginal fluid, and Gynecol 1993;169:798-804.
maternal plasma 8. Pastore LM, Royce RA, Jackson TP, and oth-
ers. Association between bacterial vaginosis and
Tumor necrosis factor (TNF) Cervicovaginal fluid fetal fibronectin at 24-29 weeks’ gestation.
Obstet Gynecol 1999;93:117-23.
Proteins: 9. Adeza Biomedical Rapid fFN Cassette, Cat.
C-reactive protein (CRP) Maternal plasma No: 00864, Adeza Biomedical Corporation,
Sunnyvale, CA. February 1999.
Proteases: 10. Giles W, Bisits A, Knox M, and others. The
Collagenase Maternal plasma effect of fetal fibronectin testing on admissions
Granulocyte elastase Cervicovaginal fluid and maternal plasma to a tertiary maternal-fetal medicine unit and
cost savings. Am J Obstet Gynecol
Matrix metalloproteinases (MMPs): Maternal plasma 2000;182:439-42.
11. Lukes AS, Thorp JM Jr, Eucker B, and others.
Hormones: Predictors of positivity for fetal fibronectin in
Human chorionic gonadotropin Maternal plasma patients with symptoms of preterm labor. Am
Corticotropin releasing hormone Maternal plasma J Obstet Gynecol 1997;176:639-41.
12. Joffe GM, Jacques D, Bemis-Heys R, and oth-
Estradiol-17β Maternal plasma ers. Impact of the fetal fibronectin assay on
Estriol Maternal saliva, plasma, and amniotic fluid admissions for preterm labor. Am J Obstet
Progesterone Maternal plasma Gynecol 1999;180:581-6.
References continued on page 115.

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Perceived Barriers to Articulation:

Institutional Characteristics
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
JEANNE KRUMPELMANN
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

It has been generally acknowledged that a number of obstacles, or In the earlier days of the community college, during the 1950s,
barriers, exist in the articulation process. Based on literature re- when they were still called “junior colleges”, the student transfer
view, student characteristics as well as institutional characteristics rates were approximately 50%. What might be the reason for a
may act as barriers. This paper focuses on institutional characteris- continual decline in transfer rates over the years? Researchers have
tics. The changed mission of the community college and a lack of addressed this question with another question: “What is the rela-
standardization of curricula between two-year and four-year insti- tive impact of initial attendance at community colleges versus ini-
tutions of higher education have been identified as barriers to ar- tial attendance at senior institutions on baccalaureate attainment?”5
ticulation. Suggested reforms are described.
Three different national longitudinal surveys, initiated in the early
INDEX TERMS: articulation; barriers; junior college; transfer 1970s, “found that, on the average, 70% of four-year college en-
student trants received a baccalaureate degree when followed up four to
fourteen years later, whereas only 26% of public two-year college
Clin Lab Sci 2002;15(2):99 entrants reached the same destination.”2,3 Kevin Dougherty, an
educator in favor of collegiate reform, reiterates what other re-
Jeanne Krumpelmann MEd is employed as a clinical microbiologist searchers have concluded: “There really is a baccalaureate gap, and
at Fairview University Medical Center, Minneapolis MN. it is only partially explained by the different characteristics of the
two student bodies. Even when these differences are controlled,
Address for correspondence: Jeanne Krumpelmann MEd, 5209 students entering community colleges with the hope of receiving
Shoreview Ave So, Minneapolis MN 55417, (612) 722-4084. a bachelor’s degree are 11% to 19% less likely to do so than com-
jkrumpelmann@aol.com parable students entering four-year colleges.”3

“Perhaps the most critical question in the sociology of education is With over five million undergraduate students attending commu-
whether it is what a student brings to school or what schools do to nity colleges in the 1990s, it became more urgent to seek out the
students that explains ultimate educational achievement”.1 In the causes of this problem.6 The body of research is in agreement.
process of articulation, especially from the two-year to four-year in- Student characteristics such as academic skills, socioeconomic fac-
stitution, there are both student characteristics, as well as institu- tors, social integration, and emotional strengths are often predic-
tional and curricular characteristics, that influence various outcomes. tors of success (or failure) in persistence toward attaining the bac-
calaureate degree. However, characteristics due to the nature of
The low percentage of students who successfully transferred from the institution (institutional and curricular characteristics) also act
two-year colleges into four-year baccalaureate degree programs as barriers to articulation.
throughout the 1970s created a stimulus for research that has taken
place throughout the last two decades. Educators throughout the INSTITUTIONAL CHARACTERISTICS
country took seriously the data indicating that, although transfer Institutional characteristics are defined as those characteristics rooted
rates had begun to decline during the 1960s, by the late 1970s the in the organization, governance, history, and mission of the higher
national transfer rate had reached a low point of 25% or less.1-4 education system. Both two-year institutions and four-year bacca-
laureate degree institutions present their own barriers to articula-
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ tion. However, critics as well as advocates of the community col-
The Reports and Reviews Section seeks to publish information on im- leges agree that the changed mission of the community college is
portant clinical laboratory-related topics such as technological, clinical, largely responsible for the perceived barriers to articulation and the
and experimental advances and innovations. Case studies and litera- general decline in transfer rate and subsequent graduation. This situ-
ture reviews are also included. In addition, brief reviews of books, com- ation is explored briefly prior to consideration of specific barriers.
puter programs, audiovisual materials or other materials of interest to
readers are appropriate for this section. Manuscripts and literature re- COMMUNITY COLLEGES: CHANGE IN MISSION
views published as a Report are peer reviewed. Direct all inquiries to An open-door policy in higher education had been well established by
Isaac Montoya PhD, Affiliated Systems Corporation, 3104 Edloe, Suite the time U.S. veterans returned home following the end of World War
330, Houston TX 77027-6022. (713)439-0210, (713)439-1924 II. The G.I. Bill of Rights was passed, providing funding for their edu-
(fax). imontoya@affiliatedsystems.com cation. A sharp rise in enrollments in community colleges followed.

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“In 1947, the philosophy of open access was further advanced by Community colleges: barriers and suggested reforms
the Truman Commission on Higher Education, which strongly Lack of academic quality
advocated education for all and established the basic functions of “In many community colleges, programs ostensibly designed to
community colleges—providing proper education for all the people prepare students for eventual transfer to four-year colleges have
of the community without regard to race, sex, religion, color, geo- become essentially open-door programs with virtually no entry or
graphical location, or financial status.”7 exit requirements. Consequently, transfer courses are often not up
to university standards of instruction.”2 Some researchers propose
Originally called junior colleges and intended to function prima- that faculty do not maintain high academic expectations for their
rily as two-year academic pre-transfer institutions, community students, that they grade relative to the class norm, and assign
colleges were considered a “point of entry into the hierarchy of fewer difficult readings and essay exams than university faculty
U.S. higher education”.4 Junior colleges also offered postsecondary members.
education up to a terminal associate degree.
Solutions include suggestions such as: improving pre-transfer aca-
Democratizing sentiments in society, such as those evidenced in demic preparation by familiarizing community college instructors
the Truman Commission on Higher Education, demanded greater of the university’s academic expectations, increasing academic ex-
accessibility to education for all. As a result, throughout the 1950s pectations of students, and pre-testing students to determine if
and 1960s, two-year colleges took on a comprehensive focus, of- they are academically prepared to enroll in courses that will trans-
fering a variety of programs, including academic, general educa- fer to a four-year school.
tion, as well as vocational education. Their name was changed to
‘community college’, and the increased access to higher education Lack of transfer advising
that they offered became known as the ‘community college move- Studies suggest that transfer aspirants receive minimal advice and
ment’. Between 1950 and 1970 enrollments increased by 750%.4 encouragement, and that community college counselors are often
uninformed about transfer courses.3
As these colleges became increasingly comprehensive in nature,with
an emphasis on vocational programs, their academically oriented Solutions include suggestions such as: establishing centers at the
pre-transfer curricula decreased. The needs of a diverse and community college with specific transfer information, clearly la-
unselected student population were diverting the two-year college beling transfer courses, and establishing more interaction between
from its original mission. Even community college advocates ad- student and advisor to assess the student’s progress in transfer
mit that during the late 1960s and 1970s, known as ‘transition courses. Gallego also suggests certain interventions, such as addi-
years’ for the community college, these schools relaxed their pre- tional mentoring by counselors for remedial students who have
transfer function, leaving the setting of standards up to the post- transfer as a goal.8
transfer institution.4 A lack of good counseling left students, who
had initially intended to transfer, to inform themselves of the cri- Four-year colleges/universities: barriers and suggested reforms
teria of the post-transfer institution and to plan accordingly. By Loss of credits
the late 1970s the transfer rate was slightly less than 25%. Because of the selective admission policies of four-year colleges/
universities, students who wish to transfer to baccalaureate degree
“While the removal of academic, economic, social, and geographical programs often lose credits in the process. Lower division credits
barriers serves to democratize higher education, it also poses a di- may not be recognized by four-year institutions. Dougherty cites
lemma: the problem of providing open access with quality.”7 For a recent study in which 58% of community college students from
the last two decades, many educators researching this issue have nine urban universities across the country reported losing credits
been critical of the community college, claiming that it actually in transferring, with 29% losing ten credits or more.2 Four-year
hinders students from transferring to four-year colleges. They as- colleges often are reluctant to accept technical credits from an oc-
sociate the change in mission from ‘academic’ to ‘comprehensive’ cupational or vocational program (Associate of Applied Science
with a perceived decrease in quality of education. degree), essentially because there are no comparable courses in their
own curricula.
INSTITUTIONAL BARRIERS AND SUGGESTED SOLUTIONS
A number of institutional barriers have been identified. Because they The ‘capstone’ or ‘inverted’ program has been suggested as a solu-
exist independently of student characteristics, and are attributable tion for the technical school graduate who desires to articulate.
to the nature of the institution, they are responsible for what The concept of the capstone initiative involves the acceptance of
Dougherty refers to as the “negative institutional effect”.2,3 For brev- technical credits by the four-year institution, while allowing the
ity, a few selected barriers and suggested reforms are discussed. student to complete general education credits in the last two years
of upper-division education. It has also been suggested that four-
year institutions increase their flexibility in acceptance of credits,

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 R EPOR T S AND R EVI EWS

and, in fact, increase their overall receptiveness to the ever-grow- CONCLUSIONS

ing numbers of nontraditional students. Students entering higher education bring with them individual
strengths and weaknesses. Student characteristics, such as academic
Lack of established common course numbering or course equivalence skills, social integration, as well as emotional strengths, are often
Four-year institutions have been known to deny credit earned in a predictors of success, or failure when these strengths are found
community college course, although the course content has been lacking. In addition, the socioeconomic background of a student
comparable to one of their courses. Claiming that the course be- may influence academic achievement.
longs in their upper division curriculum and has been taken out of
sequence, or that the content does not meet their criteria, they Institutional and curricular characteristics, independent of student
require that the course be repeated. This is a common situation, characteristics, may also present barriers to academic achievement.
for example, with business courses. Referred to as a ‘negative institutional effect’, both two-year and
four-year baccalaureate degree institutions present their own bar-
The following anecdotal information gleaned from two interviews riers, particularly for the articulating student.
initiated during the course of personal research, confirms this bar-
rier. In one case, a state legislator related the story of a student The changed mission of the community college, from ‘academic’
who had taken an accounting class at a community college. In the to ‘comprehensive’, may be responsible for barriers encountered
process of articulating, the post-transfer institution required that in the articulation process. At the community college level a per-
the course be repeated in its upper-division. The student agreed. ceived lack of academic quality and transfer advising has been cited
However, when he entered the classroom, he found the same in- as barriers. The consensus of research indicates that just as able
structor teaching this class. The instructor, recognizing him, stated: and motivated students will not necessarily be hindered by the
“You don’t have to be here. You have already taken this course”. community college experience, neither will academically or so-
cially disadvantaged students be likely to find the institutional as-
A similar situation was described by the president of a local tech- sistance they may need in order to negotiate transfer and progress
nical institute. He referred to these barriers as “turf issues”, indi- to the baccalaureate degree.
cating that faculty at different institutions are apprehensive of en-
croachment on what they consider to be their domain. Appar- At the four-year baccalaureate degree post-transfer level, selectiv-
ently, job security is a concern, because the technical college presi- ity and lack of standardized curricula between the two- and four-
dent remarked: “the perfect solution would be that everyone trans- year institutions are cited as perceived barriers. This has often re-
fers and everyone keeps their jobs”. sulted in a significant loss of credits for the articulating student.

A legislative mandate requiring common course numbering or the Reforms include establishing course equivalence and common
clear labeling of equivalent courses has been suggested as a means course numbering between the two systems of higher education.
of ensuring that “transfer courses indeed parallel university courses Initiatives, such as ‘dual or joint admission’ or ‘capstone’ programs
in credit hours, course sequencing, and prerequisites”.3 This solu- have been either suggested or instituted in many states. However,
tion involves, not only four-year college administrators, but com- all reforms involve the common thread of increased communica-
munity and technical college administrators, as well as state tion and cooperation among state legislatures, faculty at all levels
policymakers (including Board of Higher Education administra- of higher education, and students in order to facilitate the articu-
tors and state legislators) working together to meet the needs of lation process.
students by facilitating articulation.
REFERENCES
Recent initiatives, known as ‘dual admission’ or ‘joint admission’ 1. Alba R, Lavin D. Community colleges and tracking in higher education. Sociol
programs have been implemented between two- and four-year Educ 1981;54:223-37.
2. Dougherty K. The community college at the crossroads: the need for structural
colleges across the country. According to Cohen: “One of the most reform. Harvard Educ Rev 1991;61:311-36.
powerful aids to transfer is a set of inter-institutional agreements 3. Dougherty K. Community college and baccalaureate attainment. J Higher Educ
erected program-by-program so that students who want to obtain 1992;188-214.
bachelor’s degrees in certain fields are encouraged to begin at the 4. Lee VE, Mackie-Lewis C, Marks HM. Persistence to the baccalaureate degree for
local community college, with the assurance that the curricula ar- the student who transfers from community college. Am J Educ 1993;102:80-114.
5. Nespoli LA. New Jersey’s dual admission program. Comm Coll J 1997;Feb/
ticulate and that a place in the university’s junior class will be avail- Mar:22-6.
able to them”.6 6. Cohen AM. The case for the community college. Am J Educ 1990;98:426-62.
7. Roueche JE, Baker GA III. Access and excellence: the open-door college. Wash-
For the 30% to 40% baccalaureate aspirants attending commu- ington DC: Community College Pr; 1987.
nity/technical colleges, these initiatives will provide an alternative 8. Gallego A. The many faces of transfer. Comm Coll J 1997;Oct/Nov: 3.
and less expensive route to attaining the baccalaureate degree.2,3

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 RESEARCH
○ ○ ○ ○ ○ ○ ○ ○

Knowledge Fields and Inner Patterns

in Clinical Laboratory Science

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
ELISABET BORGAR
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

OBJECTIVE: The purpose of the study was to clarify the knowl- Address for correspondence: Elisabet Borgar, Swedish Vocational In-
edge base of clinical laboratory science (CLS). This research was stitute, Health Care and Social Welfare, Seriegatan 2, FIN - 65320
motivated by questions concerning the knowledge base itself and VASA. +358 (0) 6 324-2321, +358 (0) 6 324- 2310 (fax).
its abilities to meet the demands of reality. The following ques- elisabet.borgar@syi.fi
tions were therefore asked to achieve the purposes of the study:
• What are the knowledge fields and inner patterns in CLS? Marcel Proust’s “The real voyage of discovery consists not in seeking
• Which research objects could CLS focus on in order to pro- new lands, but in seeing with new eyes” was the polestar in this
mote development in practice, education, and research? research process. Representatives of the clinical laboratory have
worked hand in hand with other fields of healthcare and nursing,
DESIGN: The findings of the study were arrived at by means of to seek the knowledge base of their work. My interest in this in-
hypothetical-deductive approach and inductive, content analyti- quiry has always been in providing the best for the patient, in
cal strategy. The journal Clinical Laboratory Science of the Ameri- developing a knowledge base from a holistic perspective and, thus,
can Society for Clinical Laboratory Science (ASCLS) provides the developing the content of education and training.
source material for the analysis.
The central aim of clinical laboratory practice is—with good care
SETTING: Åbo Akademi University. Faculty of Social and Car- as a guiding principle—to protect and safeguard the patient’s in-
ing Sciences. tegrity and health. This goal leads to different types of activities
within a clinical perspective, thus examining both a body of knowl-
RESULTS: The findings of the study are discussed in the light of edge and an activity. In Finland, medical technologists (MTs) are
starting points of the theory of science and lead to nine hypoth- trained at Polytechnics and the length of the education is three
eses concerning CLS. and a half years. Discussions concerning the body of knowledge
(knowledge base) have been carried out among educators who rep-
CONCLUSION: The purpose of the present study was to create resent today’s education of MTs in Finland. Discussions, however,
clarity in CLS as a science of its own. This has been achieved by have not been undertaken regarding an intrinsic description of
capturing and describing facts and qualities, and thereafter pre- the knowledge and skills at a fundamental ontological level; rather
senting fundamental hypotheses in CLS. The results of this study descriptions have often remained at scientific technological knowl-
give a thought structure for continued development and deepen- edge levels. To move forward toward a university degree, a sepa-
ing within the theory and practice of CLS. rate body of knowledge and professional description that could
reflect the unique knowledge for MTs in Finland, has been dis-
ABBREVIATIONS: ASCLS = American Society for Clinical Labo- cussed, principally among technically engaged MTs and educators
ratory Science; CLS = clinical laboratory science; MT = medical involved in the training of MTs. The aim of this study, thus, is to
technologist. create clarity in CLS as it is seen as a science.

INDEX TERMS: Clinical laboratory science; epistemology; on- THE KNOWLEDGE BASE WITHIN CLINICAL LABORA-
tology; origins. TORY PRACTICE
During the last several years, evaluation of the various areas of
Clin Lab Sci 2002;15(2):102 health services has come more and more to the fore in discussions
concerning the content of science and possibilities for application.
Elisabet Borgar MSc MT is Senior Lecturer at Swedish Vocational This is also the case in clinical laboratory work. The intent is to
Institute and Swedish Polytechnic, Vasa Finland. evaluate and develop the knowledge and sphere of activity. This
involves asking whether laboratory work consists of its own unique
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ knowledge and if it is founded on its own science. In international
The peer-reviewed Research section seeks to publish reports of original literature, and above all, in American literature, the concept of
research related to the clinical laboratory or one or more subspecialties. CLS is encountered.1 The stand taken for CLS in the United States
Direct all inquiries to Isaac Montoya PhD, Affiliated Systems Corpo- appears primarily in the journal Clinical Laboratory Science, partly
ration, 3104 Edloe, Suite 330, Houston TX 77027-6022. (713)439- in the journal’s name, as well as in many articles. In a lead article
0210, (713)439-1924 (fax). imontoya@affiliatedsystems.com from 1988 in Clinical Laboratory Science, Doig and others, pur-

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 RESEARCH

port that it is CLS and not sciences; since CLS is something more losing its own profile. CLS’s technology, as a scientific sub-area, com-
than a collection of various disciplines such as clinical chemistry prises knowledge about aims, methods, and conditions for clinical
and hematology, etc. It is also pointed out that those carrying out laboratory work. Technological knowledge is, by its very nature, in-
their profession within CLS are in possession of knowledge that terdisciplinary and consists of empirical and ethical knowledge. The
has been developed from a broad, general basis.2,3 The philosophic interdisciplinary nature of technology leads to a body of concepts
application of CLS is seen primarily in the Code of Ethics that consisting of concepts from many different sciences. Technology’s
was accepted by the ASCLS in June 1995.4 The International As- field of knowledge spans theoretical, practical, social, communica-
sociation of Medical Laboratory Technologists (IAMLT) has stated tive, innovative, and informative qualifications.9-12
in its Code of Ethics, point 1, that “medical laboratory technolo-
gists shall be dedicated to the use of clinical laboratory science to METHODS
benefit mankind”.5 CLS is still trying to find its form and position. Hence the goal of
the study becomes to get a clear picture of CLS as a science using
The distinctive criterion for a science, especially in northern Eu- the journal Clinical Laboratory Science as its starting-point. By cap-
rope and Scandinavia, is autonomy. Autonomy can be examined turing and interpreting data and qualities in order to arrive at what
as a synthesis of three levels, that is to say, theoretical, sociological, is ‘really real’ in CLS, this researcher endeavors to offer a thought
and psychological. The theoretical level defines the scientific knowl- structure for a ‘deepening’ of understanding within the field. In
edge, the ideology of the science, and the nature and function of order to achieve the aim of the study the following questions are
research. The sociological level is represented by the social norms posed:
within that science: possession of a professor’s position, the right • What are the knowledge fields and inner patterns in CLS?
to present doctoral dissertations and to publish scientific journals. • Which research objects could CLS focus on in order to pro-
The psychological level sheds light on the identity, the researcher’s mote development in practice, education, and research?
paradigm, and the occupational paradigm within the science. The
three levels have a certain autonomy in relation to each other. At Design of the study
the same time they are dependent upon each other. The levels are The routes to seeking knowledge can be described as “the way of
related to the stage of development of the science.6 To be able to discovery or the way of proof ”.13 In qualitative research the way of
clearly define a science, a clear and explicit choice of approach is discovery exists as a means for obtaining and developing knowl-
implied. If the aim is to reach the heart of the science and describe edge. The way of discovery results in theories or hypotheses. Ac-
what is unique about it, the researcher should be open-minded cording to Eneroth, the first foundation stone in a qualitative
and have a holistic approach. However if a researcher chooses to method is a holistic approach to the world and its various phe-
concern himself or herself with the traditional ‘doing level’ it can nomena.14 With the help of a qualitative method, a researcher
be difficult to find the ontology of the science.7 wishes to obtain information about what kinds of qualities a cer-
tain phenomenon contains.
The development of knowledge within science can occur on vari-
ous levels. The metatheoretical level is concerned with issues that Qualitative research methods take as their starting point ‘patterns’,
touch upon the formation of knowledge and in paradigm devel- meaning the phenomena that are being studied.14 An explorative
opment. This takes place through fundamental research. The is- approach can be applied when a new area of science is to be de-
sues concerning science are clarified and established. This is where, scribed. CLS is ‘still in the making’ and therefore the central phe-
among other things, the demand that method-theory-ontology nomena and concepts within the science must be discovered and
form a coherent form for current science is established. The onto- explained. With the help of an explorative descriptive design, fun-
logical starting-points become the foundation upon which science damental information about the ‘what-why-when-how-where-and-
rests. At the theoretical level, the factual knowledge concerning in-which context’ may be arrived at and can be described.15
current activities is developed. Science at this level is not identical
with technology or practical activities. The data that are devel- The present research approach is hypothetical-deductive. Research
oped here constitute the starting point for the clinical laboratory according to the hypothetical-deductive method starts with a prob-
theories.8,9 The activities at the technological level differ from the lem, which is clearly delineated. A hypothesis is put forward as an
scientific level by having a different goal. The goal of technology is explanation to the problem. The hypothesis is then tested through
practical benefit. observations or experiments until proven false, or assumed to be
true if it cannot be proved to be false. The purpose of the hypotheti-
Clinical laboratory theories are also developed at this level. These cal-deductive method is to obtain true hypotheses. However, the
consist of a theoretical and a practical part. Although the utilitarian main aim of some research is the hypotheses themselves.17 Thus this
aspect here is very important, it is of the greatest importance to study ends in the putting forward of hypotheses. The core content
preserve the unique element in one’s own area. If science is directed of the theory of science forms a foundation for reflection. Data pro-
too much by society’s demand for it to be useful, it runs the risk of cessing is based upon an inductive strategy. With the help of various

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dialogues within the text, structures emerge. The structures in the the journal during the first reading and during a review of con-
categories are examined, where quality and meaning in the category tents. Articles that concerned administration, health policy, and
are considered an aspect of reality. This appears in direct quotations teaching methods were excluded.
from the data. In the same way, data in the text form aspects of each
quality. The shape that emerges is then discussed in view of the ANALYSIS AND SUMMARY OF DATA
theory of science and background of the study. Content analysis can be applied to a study in which the purpose is
to analyze documents: written, spoken, or symbolic materials.
DATA ACQUISITION AND SELECTION Methods can be quantitative, manifest, or qualitative latent. A
The journal, Clinical Laboratory Science, forms the source for the quantitative content analysis means, among other things, that the
analysis for this study. The journal is American in origin and spe- researcher presents, numerically, the degree in which the analyzed
cific to the science from a conceptual point of view. Articles from material is represented in various categories. In a qualitative con-
the 1988 to 1997 volumes covering ten years, were chosen. Each tents analysis the study is directed at certain properties in the con-
volume contained six issues. The researcher had access to 55 issues tent materials. To answer the question concerning the knowledge
out of a total of 60. field and inner pattern of CLS, a ‘latent contents analysis’ was
chosen. By means of this method, the researcher seeks to reach the
The background to the journal Clinical Laboratory Science is found underlying meaning and qualities in the material. The meaning
in the striving for professionalization that has existed for many emerges inductively in the material and cannot be forced onto the
decades and especially during the latter part of the 1900s. Begin- material in advance.6,14,18-22
ning in 1935 the journal was published under the name The Ameri-
can Journal of Medical Technology. In 1984 the name was changed In the examination of this material, analysis and synthesis are
to The Journal of Medical Technology. Since 1988 the journal has united. The material is differentiated into conceptual elements and
been published under the name Clinical Laboratory Science. ASCLS brought together to a scientific conclusion.6 The data analysis pro-
has published the journal on a bimonthly basis, six issues per year. cess can occur on various abstract levels and levels of understand-
Over the years this publication has given practitioners, research- ing that can be noticed in a concept formation. On a surface level,
ers, administrators, educators, students, and representatives of in- the linguistic structure and construction of the texts are exam-
dustry the opportunity to influence the development of clinical ined; on the context level, the texts are examined in relation to
laboratory work, both on a theoretical and a practical level.16 Space their context; and on the existential level, the texts’ deeper mean-
has been given for specialist articles, review focus articles, research ings are studied. The researcher aims at studying the texts at the
findings from a theoretical and practical perspective, and discus- contextual and existential levels. Data are summed up finally in
sions as well as room for students’ work and related articles. one or more essential forms. From the static perspective, the per-
manence of the material is sought.14
With a view to giving a clear presentation of the journal together
with doing justice to this publication, the researcher first read care- The process for data analysis and data processing can be described
fully all the articles and then chose to examine the contents more step-by-step as follows:
closely.1 The study excluded commercial texts and discussions on 1. The researcher reads the materials and obtains an overall view
American healthcare policy as well as training issues related to clini- of the contents of the journal.
cal laboratory practice. The contents were pre-grouped into sub- 2. The researcher reads the materials again and notes what could
ject areas such as the clinical laboratory entity, education, man- construe various categories in the material (semi-structured pre-
agement, and organization together with quality issues. Subject coding).
areas were specified with subheadings related to content, partly to 3. Detailed data analysis is taken. The researcher separates the
facilitate a summary and also to be able to evaluate a primary em- text in order to obtain similar categories. At this stage the re-
phasis concerning the journal’s contents. searcher asks the following questions: What is the text about?
What is its starting point? What are the contents? What is hap-
To capture and describe qualities in CLS a selection of major ar- pening? What is the aim? Why does the activity described in
ticles for closer analysis was undertaken using articles concerning the text exist?
all the phases of the clinical laboratory process including: patient´s 4. The researcher codes the content of the text entity 1, for ex-
problem and need–clinical question; clinical question–test selected ample, as A.
and ordered; guidance of the patient–preparation for the exami- 5. The researcher analyzes text entity 2 and if the contents are
nation; examination; collection of the specimen (sample) for clinical the same as in the text entity 1, designates it as A, otherwise
testing; preparing the sample; analyzing the sample; recording the it is designated as B and so on. The researcher continuously
result; assessment of the result; and notification of the result to the compares new coded data in one category with previous texts
caring department or directly to the patient. The selection of ar- coded in the same category in order to be able to develop its
ticles was made easier by the researcher familiarizing herself with characteristics.

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6. The analysis proceeds in this manner such that the contents in

Subcategory B
each text entity are compared and coded with previously ana-
Biological person/patient
lyzed material, and thus new contents are discovered and new
categories emerge on the basis of the coded text entities. The
Content of the subcategory
work with coding continues until a theoretical saturation is
Biological structure, function and development. Specific
reached, which happens when the analysis no longer contrib-
qualities are related to the level of cells and molecules,
utes to discovering something new about the category.
tissue and substance, and organs.
RESULTS
The subcategory is manifested by:
The articles reviewed in Clinical Laboratory Science related to the
“Tetraiodothyronine (T4; thyroxine) is a low molecular weight
clinical laboratory process were analyzed by means of the latent
(777 daltons), iodine containing hormone secreted by the thyroid
content analysis. After having read the articles in question, the
gland. Derived peripherally from conversion of T4 to T3 at sites
researcher made an outline description of the field of knowledge
of tissue action, triodothyronine (T3) is the more biologically po-
and patterns of facts (semi-structured pre-coding) that appear in
tent hormone. Important physiologic functions, including carbo-
the text. Next, a more detailed analysis of the data was made; the
hydrate, protein, and lipid metabolism,.... T4 overproduction (hy-
researcher separated the original text into main categories and sub-
perthyroidism) or underproduction (hypothyroidism) result in
categories, and stated the contents of the categories. With the aim
clinically important consequences.”25
of illustrating the foundation for the categorization, typical ex-
amples from all the articles are presented in the form of direct
In summary, it can be noted that the person/patient as an origin in
quotations.
CLS is perceived both from a holistic perspective and from a bio-
logical perspective. The person/patient is seen, on the one hand,
During the course of the analysis process, essential forms in CLS were
as a unique individual with his/her own thoughts, feelings, experi-
developed. After presentation of results in each essential form, includ-
ences, suffering, and vulnerability that must be understood in re-
ing main and subcategories, a summary of the figuration of facts in
lation to his/her total life situation, and as a biological individual
each main category as well as what is important in it is provided.
with specific biological qualities. These specific qualities relate to
levels of cells and molecules, levels of tissues and substance, and
The person/the patient - the origin of CLS
levels for which organs are manifested, e.g., in the form of mo-
The person, the patient is the origin in CLS and is therefore the first
lecular weight, cell morphology; color, shape, size, degree of ma-
essential form. The main category — person/patient includes the
turity, number of cells, cell division; concentrations; or as normal
subcategories of a person/patient as a unique, indivisible entity as
physiological-pathophysiological properties. Equally important,
well as a person/patient as an individual with various levels of ex-
humans are unique individuals, as described above. The core of
istence, e.g., at the level of cells and molecules, the levels of tissue
meaning in this category is respect for a person’s/patient’s integrity
and substance, and the level of organs.
from a holistic and a biological perspective.
Subcategory A
Encounter and relationship—a unifying force in CLS
Unique person/patient
A unifying force—encounter with the patient as well as the relation-
ship to what the patient submits to the professional, e.g., a specimen
Content of the subcategory
constitutes essential form number two in CLS. The patient’s wish
Indivisible entity, dignity, existence
to relate to the professional, the encounter between the patient
and the professional, including technology, as well as the relation-
The subcategory is manifested by:
ship between the patient’s specimen and the professional appear as
“I want to let you know exactly who I am. I am a human being
subcategories in the main category of encounter/relationship.
with all the emotions and needs of other human beings… I am
still a person, a person with feelings who has a certain amount of
Subcategory A
pride. Please do not take this from me. Many times, pride is all I
Patient’s wish to relate to the professional
have left...I have lost my job and may lose my home and savings....
Is that any legacy to leave a loving spouse and two young children?
Content of the subcategory
I need food, water, friendship, warmth, love, sex, and security,
To relate to the whole individual. Reciprocity
both physical and financial. I also need to be touched by another
human being. This is called skin hunger.”23
The subcategory is manifested by:
“ I also need to be touched by another human being. Will you stay
“...viewing patients as a member of their family and the commu-
near as I leave this life and enter another? ...see me as a human
nity, not as a tube of blood on an automatic sampler...24
being and not a number or a disease. Please help me to under-

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stand.... Give me a little of your precious time. Not a lot of time in CLS. Closeness, commitment, respect, security, relief, reciproc-
but quality time. Time enough to remind me that I am a worthy ity, trust, and trustworthiness are qualities that originate from the
human being.... Please forgive me if I am less than courteous to encounter between the patient and professional as well as from a
you.... If you can dry but one tear, do it.”23 relationship to the patient’s specimen—something that the patient
submits to the professional, to take care of in the best possible
“Patients who wish to take control of their healthcare want to skip way. Awareness of the vulnerability of the unique patient moti-
the middle man, and deal directly with the laboratories.”26 vates an ethical point of view, including respect for a unique pa-
tient by means of listening, discussing, attempting to understand
Subcategory B each patient and his/her situation, and by helping him/her in ac-
Encounter between the patient and the professional, in- cordance with his/her needs. The figuration of facts concerning
cluding an encounter with technology. the unique, fragile, and vulnerable patient’s specimen/test is per-
meated by precision, a use of systems, scientifically verified knowl-
Content of the subcategory edge, and a qualitative adjustment of methods and equipment when
Unique human/patient, unique patient specimen, unique the professional is entrusted with the unique patient specimen or
human patient test/examination. Specific problem solv- when the test is conducted in the patient’s presence. The core of
ing—harmony between the unique patient and valid qual- meaning in this category is reverence for and care of the patient.
ity requirements
The patient’s health—the goal-orienting force in CLS
The subcategory is manifested by: The patient’s health as the committing and goal-orienting force ap-
“..as we participate in office and home testing, where our contact pears as essential form number three in CLS. The main category
and expertise with patients is maximized... to assist seniors in deal- of a patient’s health includes the subcategories of: patient’s health
ing with medical terminology...”27 pattern from a holistic perspective, patient’s biological health pat-
tern from a general perspective, and a patient’s specific biological
“At the time of original venipuncture, the technologist had noted health pattern form the basis of the data gathered.
that the patient´s blood had a bright red, arterial-like color, even
though it was a venous sample”28 Subcategory A
Patient’s health pattern from a holistic perspective
“Patient identification: The blood collection process can be moni-
tored and tracked by using a closed system once the patient and Content of the subcategory
specimen have been positively identified”29 Health as a part of life
Health, suffering, reconciliation
Subcategory C Health resources, obstacles to health
Relationship between the patient’s specimen and the pro-
fessional. The subcategory is manifested by:
“I want to let you know exactly who I am. I am a human being
Content of the subcategory with all the emotions and needs of other human beings. Because
A unique fragile, vulnerable patient and his/her speci- of my medical condition my emotions and needs may be some-
men. Qualitative adjustment of methods and equipment what exaggerated... Because of my medical condition I have lost
to the unique patient specimen my job and may lose my home and my savings. I may even lose
my life. I have many fears. A fear of death... Do you know what it
The subcategory is manifested by: feels like to have your body fail you when you need it so badly? I
“...observed lower reticulocyte counts on patient smears prepared do not know what to expect on the other side of life. I fear finan-
outside the routine laboratory hours....the problem of EDTA speci- cial ruin... I fear loss of control... I fear loss of family and friends...
men stability for reticulocyte counting.”30 I fear dying alone... I fear the unknown... I am afraid... I fear pain...
I want to tell you how much you mean to me. You are often my
“A complete patient history including exercise habits is an essen- only link to life. I need you. I also need you to respect me as a
tial part of patient information in all circumstances and should be person.23
available when interpreting laboratory data.”31
“... complaining of exhaustion, headaches, dizziness, blurring of
In summary, it can be noted that the figuration of facts in the vision, nausea and lack of appetite.”28
essential form encounter and relationship confirm a unifying force
“Patients who wish to take control of their healthcare...”26

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Clarification of the patient’s biological health pattern—a moti-

Subcategory B
vating force in CLS
Patient’s biological health pattern from a general perspec-
A motivating force in CLS is to clarify the patient’s biological health
tive
pattern and this constitutes essential form number four. This essen-
tial form is characterized by the process, including technology, that
Content of the subcategory
a patient’s specimen/test is submitted to in order to achieve a labora-
Comparability, generalizability
tory test result. The main category of bioanalysis as well as the
subcategories of biological materials include the objects of analysis,
The subcategory is manifested by:
reference materials of analysis, methods and instruments of analy-
“It should be noted that the literature divides reference ranges for
sis, procedures of analysis, and quality of analysis that are formed on
newborns and infants into several categories, e.g., at birth, 12 hours,
the basis of articles in the journal Clinical Laboratory Science.
one day, and one week. The reference range for white blood cell
(WBC) counts is actually quite large. Newborns can have leuko-
Subcategory A
cyte counts from 9.0 to 30.0 x 109/L, with a mean of 15.0 to 20.0
Biological materials as the object of analysis
x 109/L.”32
Content of the subcategory
“All results from the 20 healthy individuals tested were between
Goal-oriented, specific
5.9 and 11.2 µg/dL, confirming the validity of the suggested range
of 4.5 to 12.0 µg/dL.”25
The subcategory is manifested by:
“The data on pathogenic versus non-pathogenic zymodemes (dif-
Subcategory C
ferences based on isoenzyme patterns) suggests that some of the
Patient’s specific biological health pattern
strains of E. histolytica may not cause disease... antigen detection
in stool...”35
Content of the subcategory
Relativity, individuality, exactness
“...and provides a testing menu appropriate for a family practice
clinic: CBC, chemistry profile, thyroid testing, urinalysis, pre-na-
The subcategory is manifested by:
tal screens, and serological tests...”24
“Initially, the patient’s hemoglobin (HGB) and hematocrit (HCT)
were evaluated... On the third hospital day, however, the HGB
Subcategory B
and HCT began to drop and continued to decline for the next six
Reference material of analysis
days... Laboratory results reflect a variety of influences: direct tis-
sue damage, expected compensatory mechanisms, treatment ef-
Content of the subcategory
fects, and postburn complications.”33
Comparability, exactness
“For most analytes, the patient condition is a relatively minor con-
The subcategory is manifested by:
sideration, but blood gas data can vary from minute to minute.”34
“We evaluated RE by a precision study using single-lot multi-con-
stituent (Lypho-check, Levels I, II, and III; Bio-Rad laboratories,
In summary, it must be noted that the patient and his/her experi-
ECS div., Anaheim Ca), and Abbott assay-specific T4 control
enced, total, and objectively biological health is the goal-orienting force
materials. Each control material was assayed in duplicate for T4
in CLS. Health is to be seen as more than a part of life and not
concentration in a minimum of 16 runs on different days. A
only as a result of biological analysis. A laboratory test that ex-
hemolysate of red blood cells (RBCs) was prepared by washing a
plores the biological health pattern is to be seen in relation to the
sample of RBCs three times with physiological saline, followed by
patient’s total health situation, to the agreed reference ranges and
1:4 dilution and lysis with distilled water.”25
to the patient’s own biological reference values. ‘Health is relative’,
and the biological health pattern may vary from one individual to
Subcategory C
another, from day to day, depending on age, gender, and the like.
Methods and instruments of analysis
CLS may be able to provide patient a choice, because of increased
awareness of health hazards and biological health patterns. The
Content of the subcategory
core of meaning in this main category comprises care of the patient’s
Analytical performance; physical and biochemical quali-
total and biological health.
ties; analytical capacity and purposefulness

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The category is manifested by: In summary, it can be noted that the motivating force to clarify a
“We can look forward to more specific and sensitive diagnostic patient’s biological health pattern by means of scientific methods
techniques, ...which use monoclonal antibodies coupled with vari- comprises a responsibility to protect the patient’s biological integrity,
ous methodologies such as enzyme-linked immunosorbent assay including exactness in relation to the method, equipment and pro-
(ELISA) and immunofluorescent assay (IFA)....Electron micros- cedure in achieving a laboratory test result. Each subcategory in-
copy is presently the most sensitive method for examining intesti- cludes specific qualities. The biological material as an object of
nal tissue,...”35 analysis is well defined. Methods, instruments, and reagents are
essential to analyze the ‘object’. They must be specific for the pur-
“This method uses dry-reagent technology in the form of test cards pose, have certain biochemical and physical qualities, reference
(Keto-Site®) to determine exclusively B-OHB levels in blood, se- capacity, and an advanced control system. The procedure of analysis
rum or plasma based on the enzymatic reaction....Optical density is described clearly step by step with specific quality requirements.
measurements were obtained using a Gilford Spectrophotometer The quality of analysis is examined from a method-of-analysis-
Model 250 for both specimens and GDS B-OHB controls at a related and biomedicine-related point of view, including such quali-
wavelength of 505 nm.”36 ties as analytic and diagnostic specificity and sensitivity, precision,
correlation, interference, etc.
“Differential information would be entered directly through a dif-
ferential pad. The results would be generated by the instrument and CONFIGURATION OF FACTS IN CLS
transmitted directly from the instrument to the computer. The an- The reason for defining CLS has been born from the need to develop
swers would be checked for accuracy on a word sheet that would the work, and the need to define the knowledge base for a specific
become part of the chart copy when the patient report was printed.”37 professional body, that is to say MTs. An aim of this study thus be-
came to create clarity in CLS as a science. In order to be able to cap-
Subcategory D ture that ‘something’, the ‘really real’ configuration of facts, that could
Procedure of analysis lead to the adoption of the science and its origin, the study has been
characterized by an open view on knowledge and reality.
Content of the subcategory
Analytical flow including well-defined sequences The configuration of facts that has emerged by means of a latent
content analysis of certain selected articles from the journal Clini-
The subcategory is manifested by: cal Laboratory Science expresses the essence and inner patterns of
“Four drops of blood were added to a commercially available reticu- CLS. The person/the patient is the origin within CLS and he/she
locyte staining system utilizing dry brilliant cresyl blue stain...mixed is seen from a holistic point of view and from a biological point of
and incubated between 10 to 20 minutes. Wedge smears were pre- view. The unifying force is the encounter and the contact with the
pared and allowed to air dry. Reticulocytes was counted under a patient, as well as the relationship to which the patient submits to
100X oil objective over five fields of approximately 200 RBCs/field.”30 the professional, often the specimen. The goal-orientating force is
the patient and his experienced, total and objective biological
Subcategory E health. Elucidating the patient’s biological health pattern is what
Quality of analysis constitutes a primary motivating force. Other forces that emerge
set in motion activities and processes in order to help the patient
Content of the subcategory in the best way. What is essential in CLS is one’s regard for a human’s
Exactness, regularities related to the method of analysis; integrity from a holistic and a biological point of view, reverence
exactness, regularities related to biomedical diagnosis for and care of the patient, and his/her health including a respon-
sibility for safeguarding the biological integrity of a patient.
The subcategory is manifested by:
“A stepwise multiple regression analysis was performed using sex, The statement that the idea of a human within CLS is synony-
age, body mass index (BMI), previous cholesterol value, and smok- mous with that to be found in caring science is not in total agree-
ing as independent variables and cholesterol as the dependent vari- ment with the configuration of facts that have appeared in the
able... to predict cholesterol levels.”38 journal Clinical Laboratory Science.39 Knowledge about the bio-
logical human is predominant. It can be noted that knowledge
“Linearity-defined as the percent difference between observed ver- about a human from a holistic perspective and about the encoun-
sus expected T4 concentration calibrator solutions containing ter with the human/the patient in a clinical laboratory context is
....Precision of the T4 method in the AxSYM immunoassay ana- imperfect. This appears clearly in the subcategory ‘the patient’s
lyzer was good (<10%) to excellent (<5%) at T4 concentrations desire to meet the professional’. Does this indicate that research-
ranging from low (3.4 µg/dL) to high (18.4 µg/dL)....Although ers, educators, and all persons involved in a clinical laboratory con-
the value we obtained for the analytical sensitivity...25 text have not opened their eyes to the whole task?

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Health should be seen as a part of life and basis for the practical work. This is seen in According to Fawcett and Downs certain
not merely as the result of biological analy- the possibility to study this science, in the issues have to be borne in mind in the de-
sis. The laboratory examination and infor- scientific journal, and in the effort to carry velopment of the science.41 Is the phenom-
mation that ensues and that charts the bio- out basic research and development mod- enon of interest? Does it have a relevance in
logical health pattern, is to be seen in rela- els. The scientific paradigm is weak in that a practical task? Is it possible to implement
tion to the patient’s health viewed as a disagreement exists concerning the knowl- the innovations that may possibly be devel-
whole. Knowledge from CLS can serve edge base. An autonomous science con- oped? Are the innovations equal in all re-
patients and facilitate freedom of choice tains a unique theoretical core, based upon spects with the ‘clients’ expectations? Do the
for the patient, starting from an increased its own basic motive and can never consti- innovations result in favorable results, etc.?
awareness about the relation of health haz- tute a series of reduced scientific theories In the studies of clinical laboratory work it
ards to his/her biological health pattern. or realities, but it is a unique reality where can be noted that there are phenomena and
The need for laboratory professionals to a unique pattern emerges.40 Basic research, problem situations, which no one deals with
safeguard each patient’s biological health which is not directly connected to eco- because they do not ‘belong to their area of
and biological integrity, by reliable labo- nomic activity and vocational training, is competence’. An example is the phenom-
ratory examination performance is seen in needed in order to discover the unique enon related to collecting of specimens/ex-
the demands for quality, which character- knowledge pattern in a science without amination from the patient’s point of view.
ize the entire bioanalytical processes. being influenced by the complexity and
the multi-disciplinary application of As for the development of methods in the
Whether CLS is based on an interdiscipli- knowledge in practice. By developing bioanalytical process, research regarding
nary or a multidisciplinary foundation, has knowledge within the fundamental re- the specificity and sensitivity of laboratory
not been thoroughly discussed. Doig states search and establishing it through applied diagnostics in relation to various states of
in the Clinical Laboratory Science lead ar- research and development work, the new ill-health falls within the scope of clinical
ticle in 1988 that the science is CLS and knowledge reaches an acceptance among laboratory medicine. Proposals for research
not sciences since CLS is more than a col- the people involved in the practical work. objects within CLS and clinical laboratory
lection of various sciences.2 She does not The issue of whether CLS is an autono- work are shown in Table 1. Knowledge is
take a position concerning multi-disciplin- mous science or whether it is founded on given its significance by means of the con-
ary or interdisciplinary science but, instead, an inter-disciplinary or a multi-disciplin- text. Research and knowledge development
gives a viewpoint for a science of its own. ary basis is not answered in this study. are absolutely necessary within the
Hentinen points out that training in the However, it can be stated that the techno- metatheoretical, theoretical, and techno-
option CLS should be multidisciplinary. logical level is represented by logical levels of CLS in order to arrive at a
My interpretation in the study of the para- multidisciplinary and interdisciplinary body of knowledge, which will be able to
digm of Medical Laboratory Technologists application of knowledge. The figuration serve the whole of clinical laboratory work.
(MT) 1988 is that professionals put into of facts shows that systematic and applied
practice interdisciplinary knowledge in the research is needed in CLS, among other Without genuine interest and care for the
exercise of their profession. things, to promote development in clini- patient the researcher, educator, or practi-
cal laboratory practice (Table 1). tioner cannot develop qualitatively good
Representatives of CLS endeavor to find clinical laboratory activities. In order to be
an autonomous science of their own as a able to keep the wording of one’s promise;
“I promise to put into practice my knowl-
edge of CLS for the welfare of mankind
Table 1. Clinical laboratory science divided into systematic and applied science and also to work for the development of
clinical laboratory work”, research and
Clinical Laboratory Science development work for the whole field of
Systematic Applied, contextual activities should be encouraged. The find-
ings of the study are discussed in the light
Motives and basic values The patient and his/her health of the starting points of the theory of sci-
Concepts, terminology, Encounter with the patient ence and lead into the following nine hy-
definitions, clauses potheses about CLS:
Model construction Care for the patient • The person/the patient is the origin in CLS.
Theory formation Care for the specimen submitted by the patient • The encounter and the relationship is a
Goals, methods, and conditions of the caring process unifying force in CLS.
Goals, methods, and conditions of the caring technology • The patient’s health is the goal-orient-
Goals, methods, and conditions of bioanalysis ing force in CLS.

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• Clarification of a patient’s biological health ture and theoretical growth, discourse, and 12. Volanen VM. Kuinka uudistaa ammatillista
pattern is the motivating force in CLS. heuristic value, as well as empirical foun- koulutusta hävittämättä tai eristämättä sitä? In:
Nikkanen P, Mäkinen R, editors. Ammatillisen
• The core of meaning in CLS comprises dation for the evaluation of qualitative re- koulutuksen kehittäminen. Koulutuksen
respect for a person’s/patient’s integrity search.43 The critical discussion of this tutkimuslaitos; Jyväskylän Yliopisto. Jyväskylä;
from the holistic and biological perspec- study is not included in this article. It was 1997. p 105-18.
tive, reverence for and care of the pa- principally carried out in accordance with 13. Starrin B, Larsson G, Dahlgren L, Styrborn S.
tient and his/her total, experienced, and Larsson’s criteria on the grounds that these Från upptäckt till presentation.
Lund;Studentlitteratur: 1991.
biological health including responsibil- criteria are the latest ones to have emerged 14. Eneroth B. Hur mäter man vackert? Grundbok
ity to protect the patient’s biological in- in research methodology. i kvalitativ metod. Stockholm; Natur och
tegrity. Kultur:. 1987.
• CLS studies intradisciplinary motives, The purpose of the present study was to 15. Wallén G. Vetenskapsteori och
develops concepts, models and theories. create clarity in CLS as a science of its own. forskningsmetodik. Lund; Studentlitteratur:
1993.
• CLS studies specific qualities in a This has been achieved by means of cap- 16. Schwabbauer M. 1991. Collaboration as a pub-
person’s/patient’s biological health pat- turing and describing facts and qualities, lication tool. Clin Lab Sci 1991;4(6):343.
tern in his/her prenatal development and thereafter presenting fundamental 17. da Silva A, Andersson M. Vetenskap och
stage, during his/her whole lifetime and hypotheses in CLS. The results of this människosyn i sjukvården. En introduktion till
even post mortem. study give a thought structure for contin- vetenskapsfilosofi och vårdetik. Uppsala;
Teologiska institutionen: 1991.
• CLS studies qualities concerning the ued development and deepening within 18. Alvesson M, Sköldberg K. Tolkning och
encounter between the patient and the the theory and practice of CLS. reflektion. Vetenskapsfilosofi och kvalitativ
professional and qualities concerning the metod. Lund; Studentlitteratur: 1994.
relationship to a patient’s specimen. ACKNOWLEDGEMENT 19. Brink P J, Wood MJ. Advanced design in nurs-
• CLS studies goals, methods, and condi- The study upon which this article is based ing research. Newbury Park; Sage: 1990.
20. Kim HS. The nature of theoretical thinking in
tions in the context of a specific caring was originally published as a Master’s The- nursing. Connecticut; Appleton-Century-
process, caring technology, and sis by the author. Crofts: 1983.
bioanalysis. 21. Patton MQ. How to use qualitative methods
REFERENCES in evaluation. Newbury Park; Sage publica-
The formal requirements that are placed 1. Clin Lab Sci (55 of 60 volumes) 1988–1997. tions: 1987.
2. Doig KM, Pittiglio DH, Posey LM. A journal 22. Woods NF, Catanzaro M. Nursing research:
on research and its findings are that they theory and practice. St Louis MO; CV Mosby
for a united profession. Clin Lab Sci
shall be able to be considered valid and 1988;1(1):20. Company: 1988.
agree with generally accepted requirements 3. Posey LM. A maturing journal. Clin Lab Sci 23. Ramsey MK I am the patient. Clin Lab Sci
for scientific objectivity. In natural science 1989;2(6):342. 1989;2(6):327.
and quantitative studies the results are 4. ASCLS. The American Society for Clinical 24. Ackall G. Clinical laboratory science students
Laboratory Science. Code of Ethics of the and primary care. Clin Lab Sci 1997;10(1):8-9.
judged among other things, on the basis 25. Koch DD, Wians FH Jr, Davis D, Burton D.
American Society for Clinical Laboratory Sci-
of criteria such as probability, reliability, ence. Clin Lab Sci 1996;9(1):1. Analytical performance: characteristics of the
and validity.6 The appropriateness of quali- 5. Koskinen MK, Schreiner A, Fiorella B. T4 method in the Abbot AxSYM immunoas-
tative research methods should be exam- IAMLT:n eettiset ohjeet. SLABY 1993;2:30- say analyzer. Clin Lab Sci 1995,8(6), 327-30.
ined from other aspects than the ones just 2. 26. Longo MM. Legal and ethical issues of patient
6. Eriksson K. Broar, introduktion i access to laboratory results. Clin Lab Sci
cited.14,42,43 Eneroth says further that while 1997;2(2):64-7.
vårdvetenskaplig metod. Vasa: Åbo Akademi.
qualitative research methods strive to find Institutionen för vårdvetenskap; 1992. 27. Ciesla B. Proposed laboratory-sponsored edu-
a concept (a connected whole of qualities) 7. Molander B. Vetenskapsfilosofi. En bok om cational program for the senior health-care con-
on the basis of observations, quantitative vetenskapen och den veten-skapande sumer. Clin Lab Sci 1988;1(6):353-4.
research methods try to find certain ob- människan. Stockholm; Norstedt: 1983. 28. Waclawik LH. Visual signs in diagnosis and
8. Dahn I, Kiil M. Från vårdpraktik till vårdteori treatment. Clin Lab Sci 1989;2(4):202-3.
servations in relation to a given concept to 29. Garza D, Murdock S, Garcia L, Trujillo JM.
och tillbaka. Lund; Studentlitteratur: 1991.
measure the degree/extent of its appropri- 9. Eriksson K. Introduktion till vårdvetenskap. Bar codes in the clinical laboratory. Clin Lab
ateness for the phenomenon. 14 Burns Stockholm; Almqvist & Wiksell: 1986. Sci 1991;4(1):23-5.
points out that a qualitative study should 10. Eriksson K, Byfält H, Leijonqvist G-B, and 30. Guiles HJ, Almeda A, Wong A. The effect of
be examined in relation to its descriptive others. Vårdteknologi. Stockholm; Almqvist & storage on the stability of manual reticulocyte
Wiksell: 1986. counts with and without the use of the Miller
clarity and vividness, its methodological Disc. Clin Lab Sci 1996;9(5):288-91.
11. Salo P. Från techne till teknologi. En tolkning
congruity, its analytical precision, its theo- av yrkesutbildningens och den yrkesinriktade 31. Neisler HM. Effects of exercise on laboratory tests:
retical connection, and heuristic rel- vuxenutbildningens roll och uppgift ur ett an overview. Clin Lab Sci 1991;4(3):164-7.
evance.42 Larsson has proposed the crite- vuxenpedagogiskt och organisationsteoretiskt 32. Sibal SS. Tackling newborn peripheral blood
ria awareness of perspective, internal logic, perspektiv. Vasa; Pedagogisk rapport, Åbo smears. Clin Lab Sci 1989;2(3):160.
Akademi. Österbottens högskola. Pedagogiska References continued on page 115.
and ethical value, wealth of meaning, struc-
institutionen: 1994.

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○ ○ ○ ○ ○ ○ ○ ○

A Procedure for the Detection of

Stealth™ Adulterant in Urine Samples
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
SANDRA VALTIER, JOHN T CODY
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

StealthTM is an adulterant that is advertised as not only preventing Adulterants have always posed a problem in drug testing laborato-
a positive drug test in urine, but also to be undetectable by cur- ries. In the past, many of these adulterants were easily detected in
rently available adulteration testing. It has previously been described urine either by appearance, smell, pH or specific gravity measure-
as a peroxidase and peroxide that is added to urine for the sole ments.1-4 In more recent years, the substances ingested or added to
purpose of preventing a positive drug test. The product was found urine to prevent a positive drug test have become more difficult to
to have a significant impact on the ability to detect several drugs identify and detect. Some of the more commonly used products
of abuse, however, detecting the presence of the adulterant in urine include the fixative glutaraldehyde (UrinAid and Clear Choice),
had not yet been reported. A simple procedure to detect the pres- strong inorganic acid (Amber-13 and THC-Free), and strong oxi-
ence of this adulterant in urine was developed. This simple color dants such as nitrite (Klear, Whizzies, and Randy’s Klear) and chro-
test procedure using commercially available reagents commonly mate (Urine Luck, LL 418, Sweet Pee’s Spoiler, and Randy’s Klear
used in clinical laboratories is based on the use of a chromogen to II).2,5-15 These adulterants were designed specifically to avoid de-
detect the peroxidase reaction in urine samples. If Stealth is present tection of illicit drugs in urine.
in the urine, the test sample will show an immediate color change
from clear to dark brown. This qualitative test can also be adapted One of the newer adulteration products, Stealth, was reported to
for use with a spectrophotometer or autoanalyzer. consist of two vials, one containing a powder (peroxidase) and the
other vial containing a liquid (peroxide).16 Combining the con-
ABBREVIATIONS: GC/MS = gas chromatography/mass spec- tents of both vials results in a strong oxidation potential, capable
trometry; LSD = lysergic acid diethylamide; PCP = phencyclid- of oxidizing many compounds including several drugs and drug
ine; THC-COOH = 11-nor-delta-9-tetrahydrocannibinol-9-car- metabolites. The peroxidase catalyzes transfer of electrons between
boxylic acid; TMB = 3,3’,5,5’-tetramethylbenzidine. peroxide and another compound. This coupled reaction mecha-
nism is used as the basis of a number of different clinical labora-
INDEX TERMS: adulteration; peroxidase detection; Stealth. tory tests, e.g., cholesterol, glucose, etc. There are a number of
commercially available assays designed to detect peroxidase activ-
Clin Lab Sci 2002;15(2):111
ity, however, they are not routinely used to assess samples for adul-
Sandra Valtier MS is Research Medical Technologist, Clinical Re- teration. Often times, laboratories that perform drug screening
search Squadron, Lackland AFB TX. assays are unaware of the various adulterants, detection methods,
or their effects on the assay. Adulterants often have varying effects
John T Cody PhD is Director of Biomedical Science Division, on different drugs-of-abuse testing assays. Even when there is rea-
Interservice Physician Assistant Program at Academy of Health Sci- son to believe a sample has been adulterated, chances are that most
ences, Fort Sam Houston TX. clinical laboratories are not equipped with the appropriate materi-
als to test for a specific adulterant.
Address for correspondence: Sandra Valtier MS, 59th MDW/MSRL,
59th Clinical Research Squadron, 1255 Wilford Hall Loop, Lackland In many cases, laboratory tests have been developed to detect the
AFB TX 78236-5319. (210) 292-6172, (210) 292-6053 (fax). presence of some of the more commonly used adulterants and in
sandra.valtier@59mdw.whmc.af.mil some cases, manufacturers have designed test kits for use on
autoanalyzers to detect the active component of these adulterants.
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ However, most of the test kits provided for these purposes are de-
The Reports and Reviews Section seeks to publish information on im- signed for high volume drug testing laboratories. An automated
portant clinical laboratory-related topics such as technological, clinical, test for detection of peroxidase will more than likely be available
and experimental advances and innovations. Case studies and litera- in the near future; however, for the small volume or clinical labo-
ture reviews are also included. In addition, brief reviews of books, com- ratories doing relatively few drug tests, purchasing a test kit for a
puter programs, audiovisual materials or other materials of interest to few samples may prove to be unattractive due to the cost. A manual
readers are appropriate for this section. Manuscripts and literature re- procedure using commercially available reagents for the detection
views published as a Report are peer reviewed. Direct all inquiries to of Stealth in urine was developed as part of this study. The color
Isaac Montoya PhD, Affiliated Systems Corporation, 3104 Edloe, Suite test is a simple and inexpensive procedure that can quickly and
330, Houston TX 77027-6022. (713)439-0210, (713)439-1924 easily be performed in nearly any laboratory.
(fax). imontoya@affiliatedsystems.com

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MATERIALS AND METHODS dure for these assays is to add acid to stop the reaction after a
Materials specified incubation period followed by measurement of the sample
TMB (Tetramethylbenzidine) Substrate Reagent Set for detection absorbance at a specific wavelength (450 nm). Addition of the
of peroxidase activity was obtained from Pharmingen and horse- acid not only stops the enzyme reaction, it changes the color of
radish peroxidase (1,100 units/mg) was obtained from Sigma. the complex to yellow. This procedure was modified by not add-
Clinical dipsticks (Multistix SG) used for testing the samples were ing the acid; thus the only samples that turned yellow were those
from Bayer Corp. Stealth was obtained from the supplier and pro- that had strong redox potential.
vided to these investigators by the Research Triangle Institute and
the Air Force Office of Special Investigation. Drugs were obtained Spectrophotometer: Peroxidase activity was monitored on the
from the following sources: Sigma [amphetamine, phencyclidine Beckman DU Spectrophotometer. Using the wavelength scan pro-
(PCP), morphine, morphine glucuronide, lysergic acid diethyla- gram, the instrument was first blanked against phosphate buffer.
mide (LSD), secobarbital, 11-nor-delta-9-tetrahydrocannibinol- 10 µL sample was added to a spectrophotometer cuvette contain-
9-carboxylic acid (THC-COOH)]; Alltech (benzoylecgonine, ing 50 µL TMB working reagent (TMB:peroxide solution 1:1 v/
LSD, PCP); Radian (secobarbital, LSD); and Research Triangle v) in 500 µL 0.1 M phosphate buffer (pH 7.0). The sample and
Institute (THC-COOH). Immunoassay reagents for THC me- working reagent were mixed and immediately monitored. Spec-
tabolite, cocaine metabolite, opiates, barbiturates, PCP, and am- trophotometer parameters used were: 10 scans per sample, inter-
phetamines were OnLine reagents from Roche Diagnostics and val time of 60 seconds, scan from 260 to 800 nm. Peroxidase ac-
CEDIA from Microgenics. LSD immunoassay reagents used were tivity was detected by monitoring peaks at 650 and/or 450 nm.
EMIT II from Behring and CEDIA from Microgenics.
RESULTS AND DISCUSSION
Methods Detection of peroxidase in samples was accomplished using 500 µL
Sample Preparation. of 0.1 M phosphate buffer, pH 7.0 and 50 µL of the reagent mix-
Drug free urine (no preservatives) was split into two portions. One ture. Following the addition of sample to the reagent mix, the mix-
was used as the negative control and the other was spiked with the ture was observed for an immediate color change. Horseradish per-
drugs listed above in the Materials section. The spiked urine was oxidase concentrations of 0.001 and 0.0002 mg/mL (1.1 and 0.22
further split into two portions, where one was used as the positive units respectively) were monitored and compared to the activity seen
control and the other portion had Stealth added. The Stealth pack- in the negative, drug positive, and adulterated urine. No color change
age contains two microcentrifuge plastic vials, one containing a was seen for the negative or drug positive urine controls. The pres-
powder (peroxidase) and the other vial containing a liquid activa- ence of Stealth was easily detected in the adulterated urines. In all
tor (peroxide). As per Stealth package directions, the powdered cases, the color change observed for the adulterated urine was rapid
catalyst is added to the empty sample cup, approximately 60 mL and dramatic from clear to dark brown (Photo 1).
of sample liquid (urine) is added followed by the addition of the
liquid activator and the sample is stirred briefly. (Note: for experi- Results for the microplate assay were comparable to the test tube
mental purposes, smaller volumes of urine were prepared using assay where all Stealth adulterated samples and peroxidase con-
proportionate portions of each vial). trols showed a dramatic color change to dark brown. Peroxidase
activity in samples was also monitored using a spectrophotometer.
Reagent Preparation Positive drug control, negative control, and Stealth adulterated
Horseradish peroxidase at concentrations ranging from 0.0002 to urine results were based on the relationship between the sample
0.1 mg/mL prepared in 0.1 M phosphate buffer, pH 7.0 were
used as control samples. As per product insert, the TMB working
solution was prepared by mixing equal volumes of Substrate Re-
agent A (hydrogen peroxide in a buffered solution) and Substrate Photo 1. Color test for Stealth adulteration
Reagent B (3,3',5,5'-tetramethylbenzidine in organic solvent).

Procedures
Test tube: The test was performed by adding 10 µL of urine to a
test tube containing 50 µL of TMB working solution in 500 µL of
0.1 M phosphate buffer (pH 7.0). The sample was mixed and
observed for an immediate color change.

Microplate: 100 µL of sample was pipetted into a microplate test

well, followed by the addition of 100 µL TMB working solution
and sample observed for a color change. Note: The normal proce-

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 RESEARCH

absorbance and the absorbance of the peroxidase control. The ab- Evaluation of peroxidase controls in urine required considering
sorbance and wavelength of peroxidase activity in samples for the the potential effect of sodium azide, a commonly used preserva-
spectrophotometer were established by using the parameters de- tive in urine control samples, on the enzyme activity. To test the
scribed earlier. Evaluation of the spectral data showed the absor- effects of the azide on peroxidase activity, 100 µL of 0.01% so-
bance maxima associated with TMB following reaction with hy- dium azide in urine was added to phosphate buffer containing
drogen peroxide in the presence of peroxidase were 450 and/or 0.001 mg/mL peroxidase. After the addition of TMB reagent, the
650 nm. Initially, following a single electron transfer, TMB forms sample was scanned from 400 to 800 nm. Sodium azide had a
a complex that absorbs at 650 nm. Transfer of another electron significant negative effect on peroxidase activity with absorbance
results in an increase in absorbance at 450 nm with corresponding seen at 450 nm; therefore, urine control samples containing this
diminution of the peak at 650 nm. The absorbance of the Stealth preservative cannot be used to control this assay. Controls must
adulterated sample was compared and found to show rapid in- either be prepared fresh or be in a stable and predictable matrix
crease in absorbance at 450 nm. When diluted, the Stealth adul- such as a buffer.
terated samples showed the characteristic initial absorbance at 650
nm followed by formation of a peak at 450 nm with correspond- Parameters normally used to assess sample adulteration did not re-
ing decrease in the 650 nm peak. It was demonstrated that low veal any significant changes of the urine samples following addition
concentration of peroxidase produced a peak at 650 nm but, un- of Stealth. The color of the urine did change to a darker amber-
less the amount of enzyme was high, there was little or no forma- brownish shade after addition of Stealth; however, the color change
tion of the peak at 450 nm. The peak absorbance of adulterated was not significant enough to warrant suspicion and there was no
samples was high enough to leave no question of the presence of change in odor of the adulterated sample. Several other parameters
Stealth in the urine sample. This dramatic difference in activity were measured before and after adulteration of these samples. Spe-
was used as the basis for the qualitative assay. cific gravity, pH, creatinine, urea, and chloride in each of the samples
were measured over time (0, 24, 48, 72 hr and 7, 14, 21 days). Urea
Because peroxidase activity can result from blood or bacterial con- is a denaturant capable of inactivating peroxidase over time by chang-
tamination, 167 urine samples from the clinical laboratory that ing the structural integrity of the enzyme. Chloride can have an
tested positive for blood and/or bacteria by clinical dipstick were effect on pH by reacting to produce hydrochlorous acid. There was
tested for peroxidase activity using the color test procedure. Most little or no change in either urea or chloride measurements in the
samples showed no color change at all; the few that did, developed adulterated samples. The pH of the adulterated samples were con-
a faint blue-green tint. However, the blue-green color from these sistently lower than the unadulterated, but still within pH range
samples was easily distinguished from the dark brown color seen commonly seen in the clinical laboratory. Little or no differences
in samples adulterated with Stealth. Whole blood and hemolyzed were seen in specific gravity and creatinine results. Clinical dipstick
blood were also used to directly assess the pseudoperoxidase activ- results showed strong positive readings for glucose, blood, and ni-
ity of hemoglobin. These samples, along with the two clinical trite in all samples adulterated with Stealth (Table 1). It should be
samples that had shown slight color development were monitored noted the instructions with the Stealth adulterant indicate it should
by spectrophotometer. No absorbance was seen for any of these not be used for physicals, which would involve clinical testing. A
samples at 450 nm under the experimental conditions described strong positive for glucose, blood, and nitrite in a single clinical
above. These results demonstrate that the possibility of getting sample is unusual and might raise the veil of concern that the sample
false positives from samples containing blood and/or bacteria when is contaminated with this adulterant.
using the parameters described is unlikely.

Horseradish peroxidase in buffer stored in a refrigerator has an

extended shelf life, however, the stability of Stealth in urine samples Table 1. Physical effects of Stealth on urine
is, to this date, unknown. In reality, there may be no predictable
stability for peroxidase in urine samples. Peroxidase activity changes Urine Urine + Stealth
over time in individual samples. For example, one sample adulter- pH 5.264 5.135
ated with Stealth was monitored on the same day, 15 days, and Sp. Gr. 1.011 1.012
one month after Stealth was added. At 15 days, peroxidase activity Creatinine 43.3 mg/dL 41.2 mg/dL
showed a slight decrease; however after approximately one month, Dipstick*
the sample showed no peroxidase activity. Refrigeration or freez-
ing will help to prevent degradation, but may well depend on the Blood Neg +++
individual sample matrix. Enzyme activity can be affected by many Glucose Neg +++ (>2,000 mg/dL)
different variables that cannot be changed or controlled in ran- Nitrite Neg Positive
dom urine samples. * Dipstick – Bayer Multistix SG

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The impact of the adulterant on a sample can differ considerably of the assay makes it ideal for laboratories that would test only a
depending on its methodology or on the assay used. The effect of small number of samples. Using the reagents used for the manual
Stealth was evaluated in several studies, including one reported by procedure, however, the test could be adapted to most automated
Davis that indicated this adulterant caused the screening assay for chemistry analyzers. The procedure is presented here to provide
the THC acid metabolite (THC-COOH) to yield a negative re- laboratories with a quick and inexpensive method for the detec-
sult when the drug metabolite was actually present.16 The effect of tion of Stealth in urine.
Stealth on immunoassays for several drugs-of-abuse was studied
in this laboratory (Table 2). Stealth had no effect on the assays for Most assays designed for the analysis of peroxidase activity are
amphetamines, PCP, benzoylecgonine (cocaine metabolite), or bar- designed to detect relatively small amounts of activity since nor-
biturates. It did cause samples positive for THC-COOH and opi- mal urine samples have no activity. This sensitivity makes them
ate (morphine) to screen negative by both the OnLine and CEDIA valuable in the laboratory for routine assays but such sensitivity
immunoassays. Samples positive for LSD were also negative by is not necessary when determining the presence of Stealth. The
EMIT II and CEDIA immunoassays following adulteration with reduction-oxidation reaction of TMB involves first a single elec-
Stealth. The THC-COOH and LSD positive controls adulterated tron transfer that yields a maximum absorbance at 650 nm. This
with Stealth gave values that were comparable to the negative urine complex has a very faint blue color at neutral pH. If there is
control. Although the result for the sample containing 2500 ng/ sufficient redox potential in the sample, the TMB complex un-
mL morphine yielded a negative immunoassay result, some mea- dergoes another electron transfer to yield a complex with an ab-
surable activity was seen (approximately 30% of positive control sorbance maximum at 450 nm. Monitoring of the reaction us-
value). Samples spiked with higher concentrations of opiates (6,000 ing a scanning UV spectrophotometer showed the development
ng/mL) did test positive, indicating the effect of Stealth on the first of a peak at 650 nm. This peak continued to grow until it
immunoassays for opiates is dependent on drug concentration. eventually began to diminish with the appearance of a new peak
Upon confirmation testing of these samples by gas chromatogra- at 450 nm. Under ordinary conditions, assays are conducted by
phy/mass spectrometry (GC/MS), THC-COOH, morphine, co- allowing the reaction to occur for a specified amount of time at
deine, and LSD were undetectable. Subsequent evaluation of opi- which point a strong acid is added. The purpose of the acid is to
ates showed the initial interference with morphine/codeine con- stop the reaction to accommodate reading all samples at a later
firmation could be reversed by addition of disulfite.17 time. Another consequence of the acid is to drop the pH of the
reaction mixture which changes the absorbance to 450 nm. In
CONCLUSION the procedure described in this study, the pH was maintained at
With new adulterants being developed at an alarming rate, it has 7.0. This allowed the reaction of samples containing components
become increasingly difficult to keep up with the development that react with the reagent to do so but the resulting reaction
of methods to detect these products. Once a method is devel- gave absorbances in the 650 nm range. The presence of Stealth,
oped to detect presence of a specific adulterant, it will more than owing to its high redox potential, quickly changed the solution
likely be provided commercially as a kit that may be more suit- to have a significant absorbance at 450 nm. Since the pH was
able for a high volume drug testing or toxicology laboratory. A maintained at 7.0, the only samples that demonstrated the ab-
color test using commercially available reagents for the detec- sorbance peak at 450 were those adulterated with Stealth.
tion of peroxidase was developed in our laboratory and found to
be a reliable method in detecting Stealth in urine. The simplicity ACKNOWLEDGMENTS
Many thanks to Stephanie Martin, Rene Ramon, Ed Hubster, and
Dan Castro for assistance in preparation and analysis of samples.
Thanks also to Willford Hall Medical Center clinical laboratory
Table 2. Effect of Stealth on drugs of abuse
personnel for creatinine, urea, chloride, glucose, blood, and ni-
trite measurements and also to Research Triangle Institute and the
OnLine CEDIA
Air Force Office of Special Investigation for providing the Stealth
THC – –
used in this study.
Cocaine + +
Opiates – –
The views expressed in this article are those of the authors and do
Barbiturates + +
not reflect the official policy of the Department of Defense or
PCP + +
other Departments of the U.S. Government.
Amphetamine + +
LSD* – –
Funding for this project was provided by the USAF Surgeon
* LSD tested by EMIT II in place of Online and CEDIA immu-
General’s Office (00EX045) and the Air Force Office of Special
noassay reagents Investigation.

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REFERENCES 10. George S, Braithwaite RA. The effect of glutaraldehyde adulteration of urine
1. Cody JT. Specimen adulteration in drug urinalysis. Forensic Sci Rev specimens on Syva EMIT II drugs-of-abuse assays. J Anal Toxicol
1990;2:63-75. 1996;20(3):195-6.
2. Cody JT. Adulteration of urine specimens. In: Liu RH, Goldberger BA, edi- 11. Goldberger BA, Caplan YH. Effect of glutaraldehyde (UrinAid) on detec-
tors. Handbook of workplace drug testing; Washington DC: AACC Press; tion of abused drugs in urine by immunoassay. Clin Chem 1994;40:1605-6.
1995. p 181-208. 12. Lewis SA Sr, Lewis LA, Tuinman A. Potassium nitrite reaction with 11-nor-
3. Edwards C, Fyfe MJ, Liu RH, and others. Evaluation of common urine delta 9-tetrahydrocannabinol-9-carboxylic acid in urine in relation to the
specimen adulteration indicators. J Anal Toxicol 1993;17(4):251-2. drug screening analysis. J Forensic Sci 1999;44:951-5.
4. Liu RH. Important considerations in the interpretation of forensic drug test 13. Liu RH. Comparison of common immunoassay kits for effective application
results. Forensic Sci Rev 1992;4:52-65. in workplace drug urinalysis. Forensic Sci Rev 1994;6:19-57.
5. Wu AH, Bristol B, Sexton K, and others. Adulteration of urine by “Urine 14. Paul BD, Martin KK, Maguilo J Jr, and others. Effects of pyridinium
Luck”. Clin Chem 1999;45:1051-7. chlorochromate adulterant (urine luck) on testing for drugs of abuse and a
6. Wu A, Schmalz J, Bennett W. Identification of UrinAid-adulterated urine method for quantitative detection of chromium (VI) in urine. J Anal Toxicol
specimens by fluorometric analysis. Clin Chem 1994;40:845-6. 2000;24(4):233-7.
7. Urry FM, Komaromy-Hiller G, Staley B, and others. Nitrite adulteration of 15. Tsai LS, ElSohly MA, Tsai SF, and others. Investigation of nitrite adultera-
workplace urine drug-testing specimens. I. Sources and associated concen- tion on the immunoassay and GC-MS analysis of cannabinoids in urine
trations of nitrite in urine and distinction between natural sources and adul- specimens. J Anal Toxicol 2000;24(8):708-14.
teration. J Anal Toxicol 1998;22(2):89-95. 16. Davis KH. Adulterants update. 1999 Society of Forensic Toxicologists an-
8. Tsai SC, ElSohly MA, Dubrovsky T, and others. Determination of five abused nual meeting, San Juan PR.
drugs in nitrite-adulterated urine by immunoassays and gas chromatogra- 17. Cody J, Valtier S, Kuhlman J. Analysis of morphine and codine in samples of
phy-mass spectrometry. J Anal Toxicol 1998;22(6):474-80. adulterated with Stealth™. J Anal Tox 2001;25(7):572-5.
9. Singh J, Elberling JA, Hemphill DG, and others. The measurement of ni-
trite in adulterated urine samples by high-performance ion chromatography.
J Anal Toxicol 1999;23(3):137-40.

Fetal Fibronectin (continued from page 98)

33. Laudicina RJ, Jackson GM. Hematologic effects of severe burn injury: a case 39. Borgar E. Laboratorieskötarens paradigm. En teoretisk och empirisk
study. Clin Lab Sci 1996;9(2):115-22. beskrivande undersökning av laboratorieskötarens intresse, kompetens,
34. Fallon K. Nonanalytical considerations in the blood gas laboratory. Clin Lab världsbild och vetenskapssyn i förhållande till hälsoprocesser som vårdmål.
Sci 1988;1(4):208-9. Helsingfors; Examensarbete i vårdvetenskap. Helsingfors svenska
35. Garcia LS. New issues in the field of diagnostic parasitology. Clin Lab Sci sjukvårdsinstitut: 1988.
1989;2(1):25-6. 40. Eriksson K. Vårdvetenskap som disciplin, forsknings- och
36. Gibson RG, Fineberg SE, Bridges JM. Accuracy of a rapid quantitative bed- tillämpningsområde. Vasa; Vårdforskningsrapport. Åbo Akademi.
side beta-hydroxybutyrate test system. Clin Lab Sci 1996;9(5):282-7. Institutionen för vårdvetenskap: 1988.
37. Rose JP. Computerization of a small hospital laboratory. Clin Lab Sci 41. Fawcett J, Downs FS. The relationship of theory and research. Connecticut;
1988;2(4):227-9. Appleton-Century-Crofts/Norwalk: 1986.
38. Walker PW, Stewart CK, Lockwood WB. Analysis of cholesterol-screening 42. Burns N. Standards for qualitative research. Nurs Sci Quarter 1989;2:44-52.
data as a component of health-promotion program evaluation. Clin Lab Sci 43. Larsson S. Om kvalitetskriterier i kvalitativa studier. In: Starrin B, Svensson
1995;8(6):327-30. P-G, editors. Kvalitativ metod och vetenskapsteori. Stockholm;
Studentlitteratur: 1994. p 163-89.

Knowledge Fields and Inner Patterns in Clinical Laboratory Science (continued from page 110)
13. McKenna DS, Chung K, Iams JD. Effect of digital cervical examination on 20. Nageotte MP, Casal D, Senyei AE. Fetal fibronectin in patients at increased
the expression of fetal fibronectin. J Reprod Med 1999;44:796-800. risk for premature birth. Am J Obstet Gynecol 1994;170:20-5.
14. Coleman MA, McCowan LM, Pattison NS, and others. Fetal fibronectin 21. Leitich H, Egarter C, Kaider A, and others. Cervicovaginal fetal fibronectin
detection in preterm labor: evaluation of a prototype bedside dipstick tech- as a marker of preterm delivery: a meta-analysis. Am J Obstet Gynecol
nique and cervical assessment. Am J Obstet Gynecol 1998:179:1553-8. 1999;180:1169-76.
15. Faron G, Boulvain M, Irion O, and others. Prediction of preterm delivery by 22. Revah A, Hannah ME, Sue-A-Quan AK. Fetal fibronectin as a predictor of
fetal fibronectin: a meta-analysis. Obstet Gynecol 1998;92:153-8. preterm birth: an overview. Am J Perinatol 1998;15:613-21.
16. Goldenberg RL, Mercer BM, Iams JD, and others. The preterm prediction 23. French L. Fetal fibronectin to predict preterm delivery. J Fam Pract
study: pattern of cervicovaginal fetal fibronectin as predictors of spontane- 1998;47:250-1.
ous preterm delivery. Am J Obstet Gynecol 1997;177:8-12. 24. Inglis SR, Jeremias J, Kuno K, and others. Detection of tumor necrosis fac-
17. Rozenberg P, Goffinet F, Malagrida L, and others. Evaluating the risk of tor-alpha, interleukin-6, and fetal fibronectin in the lower genital tract dur-
preterm delivery: a comparison of fetal fibronectin and transvaginal ing pregnancy: relation to outcome. Am J Obstet Gynecol 1994;171:5-10.
ultrasonographic measurement of cervical length. Am J Obstet Gynecol 25. Burrus DR, Ernest JM, Veille JC. Fetal fibronectin, interleukin-6, and C-
1997;176:196-9. reactive protein are useful in establishing prognostic subcategories of idio-
18. Peaceman AM, Andrews WW, Thorp JM, and others. Fetal fibronectin as a pathic preterm labor. Am J Obstet Gynecol 1995;173:1258-62.
predictor of preterm birth in patients with symptoms: a multicenter trial. 26. Lockwood CJ. The diagnosis of preterm labor and the prediction of preterm
Am J Obstet Gynecol 1997;177:13-8. delivery. Clin Obstet Gynecol 1995;38:675-87.
19. Iams JD, Casal D, McGregor JA, and others. Fetal fibronectin improves the
accuracy of diagnosis of preterm labor. Am J Obstet Gynecol 1995;173:141-5.

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 F OCUS: COMPONENT THER APY
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Developments in Component Therapy: Novel

Components and New Uses for Familiar Preparations

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
MICHELLE S WRIGHT-KANUTH, LINDA A SMITH,
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Over the years, the significant role of blood components in treating ABBREVIATIONS:
certain diseases or conditions has been recognized. The use of these AML = acute myeloid leukemia; APT = antigen presenting cell;
components has expanded as patients undergo chemotherapy for CML = chronic myeloid leukemia; CRP = cryoprecipitate reduced
bone marrow ablation and require short-term component support. plasma; CRYO = crytoprecipitated anti-hemophiliac factor; DC =
On the other hand, these transfusions can cause reactions ranging dendritic cell; DCLHb = diaspirin cross-linked hemoglobin;
from mild to severe. Despite advances in serological testing for in- DCLHb = diaspirin cross-linked hemoglobin; DLI = donor
fectious disease agents, the risk of infectious complications from lymphocyte infusion; DMSO = dimethylsulfoxide; FFP = fresh
transfusion still remains. In addition, newly identified agents that frozen plasma; GVHD = graft-versus-host disease; GVL = graft-
may be transmitted via transfusion are constantly identified. versus-leukemia; HbOC = hemoglobin-based oxygen carrier; HLA
= human leukocyte antigens; IPMs = infusible platelet membranes;
The cellular components most people are familiar with include IVIG = intravenous immunoglobulin; LEHb = liposomes
packed red blood cells (PRBC), washed PRBC, leukoreduced containing hemoglobin; PAP = prostatic acid phosphatase; PBMC
PRBC, and pooled or apheresis platelets. Plasma products such as = peripheral blood mononuclear cells; PEG = polyethylene glycol;
fresh frozen plasma (FFP) or crytoprecipitated anti-hemophiliac POE = polyoxyethylene; PRBC = packed red blood cells; TPE =
factor (CRYO), on the other hand, may not be as familiar. As our therapeutic plasma exchange.
understanding of how the immune system functions and as tech-
nology has progressed, specialized components or manufactured INDEX TERMS: blood and platelet substitutes; blood component
products such as blood substitutes have been advanced as rem- therapy; blood components; novel blood components.
edies to some of the complications with component transfusion
or to meet the ever-increasing need for these products. Clin Lab Sci 2002;15(2):116

In this article we will focus on some of the new uses of common Michelle S Wright-Kanuth PhD CLS(NCA) is Associate Professor,
components and uncommonly used or newly developing compo- Department of Clinical Laboratory Sciences at the University of Texas
nents. We will discuss their origins, composition, and the condi- Medical Branch, Galveston TX.
tions or diseases they are used to treat. These components include:
• donor leukocyte infusions Linda A Smith PhD CLS(NCA) is Professor and Graduate Program
• dendritic cell vaccines Director at the University of Texas Health Science Center at San An-
• blood substitutes tonio, San Antonio TX.
• novel platelet products and substitutes
• intravenous immunoglobulin (IVIG) Address for correspondence: Michelle S Wright-Kanuth PhD
• fresh frozen plasma and cryosupernatant in therapeutic plasma exchange. CLS(NCA), Department of Clinical Laboratory Sciences, 301 Uni-
versity Boulevard, Galveston, TX 77555-1140. (409) 772-3055, defi-
The variety of products and conditions reflect the ever-expanding nitions, clauses (409) 772-9470 (fax). mskanuth@utmb.edu
role of immunohematology in the treatment of disease.
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Michele S Wright-Kanuth PhD is the Focus:Component Therapy
The Focus section seeks to publish relevant and timely continuing guest editor.
education for clinical laboratory practitioners. Section editors, topics,
and authors are selected in advance to cover current areas of interest in Focus Continuing Education Credit: see pages 125 to 127 for learn-
each discipline. Readers can obtain continuing education credit (CE) ing objectives, test questions and application form.
through P.A.C.E.® by completing the tearout form/examination ques-
tions included in each issue of CLS and mailing it with the appropri- LEARNING OBJECTIVES
ate fee to the address designated on the form. Suggestions for future At the end of the article the learner will be able to:
Focus topics and authors, and manuscripts appropriate for CE credit 1. Identify the major diseases treated with each of the compo-
are encouraged. Direct all inquiries to Carol McCoy PhD, CLS nents discussed.
Continuing Education Editor, Department of Clinical Sciences, 343 2. Discuss the preparation of DLI and why CD4 cells are re-
Cowley Hall, University of Wisconsin, La Crosse WI 54601; tained, while CD8 cells are depleted.
(608) 785-6968. cmccoy@mail.uwlax.edu

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3. Describe the general process of making a dendritic cell vaccine. greatly reduced at the lowest remission T cell dose of 1 x 107/kg.3
4. Describe the different types of red cell substitutes and differ- Mandigers also studied a target T cell dose along with CD8+ cell
entiate between them. depletion and saw similar results.4
5. Explain at least two of the possible ways in which intravenous
immunoglobulins may interact with the immune system. Because the treatment of early CML relapse with DLI after stem
6. Explain why cryoprecipitate reduced plasma is effective in cell transplant induces remission in the majority of patients stud-
treating thrombotic thrombocytopenia. ied, it is becoming an important treatment option. There is also
7. List and describe the platelet products under development. promising data indicating that the use of DLI will affect remis-
sions in relapsed acute myeloid leukemia (AML) patients.5 These
The role of the routine blood bank in providing therapeutic prod- remissions may not be as common as those for CML patients, but
ucts has changed dramatically within the past five years. More some patients have stayed in remission for up to two years. In
emphasis is being placed on new and improved blood compo- addition, DLI has been shown to have a graft-versus-myeloma ef-
nents and alternate uses for products. In addition, new sources for fect in multiple myeloma patients.6 As DLI becomes an increas-
blood products have been researched, particularly in the field of ingly documented and effective treatment, it will likely become
blood substitutes. A review of the state of the art in some of these the standard of care for such patients. Undoubtedly, blood centers
areas is timely. Donor lymphocyte infusion (DLI) is a new use for and blood banks will be involved in the future procurement and
the lymphocyte fraction obtained from apheresis. Blood substi- cell manipulation of the DLI and in DLI storage and thawing, as
tutes are coming of age and several sources of hemoglobin based they are becoming similarly involved in stem cell transplantation.
oxygen carriers are currently in Phase III clinical trials. A promis-
ing immunotherapeutic approach to cancer therapy is dendritic DENDRITIC CELL VACCINES
cell vaccines. A number of dendritic cell vaccines are in Phase I Dendritic cells (DCs) are the most potent of the antigen present-
and II clinical trials. FFP and cryosupernatent (the supernatent ing cells (APCs). DCs can be found in most organs, the T cell
left after cryoprecipitate is made) are being used in therapeutic areas of secondary lymphoid tissues, and circulating in the periph-
plasma exchange (TPE). Intravenous immunoglobulin (IVIG) has eral blood. During a normal immune response, the APCs phago-
been used for over ten years; however, new applications for the use cytize and process antigen and then present it along with MHC
of this product are being studied. Cryopreservation and lyophiliza- Class II molecules. The individual’s T cells specific to that antigen
tion of platelets and platelet substitutes are all being studied as will bind to the APC through the presented antigen and MHC
remedies for the short shelf life of platelet components. These, molecule. The T cell will then be stimulated to respond and ini-
then, are the areas that will be explored here. tiate the primary immune response. It is known that many tumor-
associated antigens are weak immunogens and do not stimulate
DONOR LYMPHOCYTE INFUSION the immune response well. This lack of immunogenicity may be
Patients with chronic myeloid leukemia (CML) are offered the due to tolerance to self-antigens that is normally induced in the
opportunity of a cure with allogeneic hematopoietic stem cell trans- immune system during the education of T cells in the thymus.7
plantation. Disease-free survival rates at five years reach 70% in Because it appears to be difficult to encourage natural antigen pre-
transplanted patients. The cure is most likely partially due to the sentation of tumor-associated antigens, several groups of investi-
graft-versus-leukemia (GVL) effect mediated by donor-derived T gators have tried exposing the patient’s DCs to exogenous sources
lymphocytes. The GVL effect is primarily due to the derivation of of these antigens in vitro.
the T cells from a healthy donor individual. The T cells in CML
patients have been compromised by the tumor escape mechanisms A phase I clinical trial was conducted in patients having prostate can-
that facilitate the growth of the CML in the patient.1 When trans- cer. The investigators used mouse prostatic acid phosphatase (PAP)
planted patients relapse after achieving remission, the administra- instead of the patient’s own PAP to stimulate DCs obtained from the
tion of donor T lymphocytes is considered the initial response. patient by peripheral blood leukaphoresis. The DCs and mouse PAP
DLI is achieved by collecting the transplant donor’s white blood were incubated together overnight at 37 °C. The resulting antigen-
cells through apheresis. The donor cells are treated to deplete CD8+ treated DC vaccines were then reinfused into the patient. A T cell
T cells or other potentially harmful donor cells to prevent graft- response to the self-PAP was then seen in 11 of 21 patients treated.
versus-host disease (GVHD). The CD4+ T cells are necessary for Six of the patients showed stabilization of a previously progressing
the GVL reaction to occur.2 prostate cancer. No toxicity to the vaccine was seen.7

Various studies have shown that optimal numbers of CD4+ cells In another phase I clinical trial, solid tumors from children were
are required to induce remissions. Mackinnon and colleagues stud- reduced to single cell suspensions and cultured. The tumor cells
ied limiting the T cell dose given to induce remission. They found were then lysed and the cell suspension, presumably containing
that most patients achieved remission at a dose of 1 x 107 T cells/ tumor-associated antigens, was incubated with DCs collected from
kg body weight or above. However, the incidence of GVHD was the patient by peripheral blood leukapheresis. The resulting DC

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vaccines were now tumor specific for each patient’s tumor. The currently in clinical trials, as is a polymerized bovine Hb product.
vaccines were reinfused into the patient. No toxicity to the vac- The bovine HbOC has completed phase III clinical trials and has
cine was seen in any of the 15 patients enrolled in the study. Six of been approved in South Africa for treatment of perioperative ane-
the 15 patients were evaluated for immune response to the tumor mia in adult surgical patients.12
lysate and three of the patients demonstrated a significant increase
in response. The other nine patients did not have sufficient clini- Perfluorocarbon-based red cell substitutes consist of carbon back-
cal material for evaluation.8 Similar responses have been shown to bones highly substituted with fluorine. While they can dissolve
occur in malignant gliomas.9 large amounts of oxygen, the perfluorocarbons themselves are not
water-soluble. To deliver them intravenously, they must be emul-
Metastaic melanoma tumor antigens having epitopes recognized sified. This is accomplished using a surfactant such as a phospho-
by MHC Class I restricted cytotoxic T cells (CD8+) cells have also lipid. Perfluorocarbons were the original red cell substitutes and
been identified. Thus, DC vaccines may not be the only useful cell have potential due to the ability to synthesize them from non-
vaccines. In vitro stimulation of peripheral blood mononuclear cells biological sources. This not only allows large-scale production, but
(PBMC) with tumor antigen derived epitopes and then returning also eliminates the transmission of diseases to recipients. The
the PBMC to the patient can induce a high number of tumor perfluorocarbons are biologically inert; however, the phospholip-
antigen reactive T cells in the patient.10 ids required to emulsify them are not, leading to complications
when they interact with the immune system.
The advent of cell-based vaccines for cancer immunotherapy may
be another area into which the future blood center and blood bank Three perfluorocarbons have entered clinical trials. The first to do
may expand. The preparation of these vaccines on a scale neces- so was marketed as Fluosol-DA and was licensed by the FDA in
sary for the treatment of multiple patients will require more space 1989.13 However, it was withdrawn from the market due to lack of
and effort than a research laboratory can provide. sales. Oxyfluor, an emulsion of perfluordichloroactane and egg
yolk phospholipid with safflower oil, began clinical trials.14 How-
RED CELL SUBSTITUTES ever, its development has been discontinued. The only
There are three types of red cell substitutes currently being studied for perfluorcarbon that remains in clinical trials is Oxygent, an emul-
use in transfusion medicine. The goal is to enhance oxygen-carrying sion of perfluoroocytl bromide and egg yolk phospholipid. Oxygent
capacity for patients suffering from acute anemia due to blood loss. is being studied for use in perioperative hemodilution to allow
All of these have shown some promise for use in patients who refuse more extensive hemodilution.15
blood or in situations where blood is not readily available.
Hemoglobin-containing liposomes (LEHb) are formed using spheres
Hemoglobin-based oxygen carriers (HbOCs) are being studied as of phosphatidylcholine to form a lipid bilayer that replicates the red
oxygen carrying substitutes for blood cells. They are purified cell- cell membrane. Hb solution is then introduced inside the bilayer.16
free hemoglobins, where the globin portion of the molecule has been Since this is not a cell-free Hb, some of the potential for toxicity is
modified chemically by conjugation, cross-linking or polymerizing. diminished. Replicating the cellular format also results in a longer
Modification increases the oxygen releasing ability of the hemoglo- half-life in the circulation than the perfluorocarbons and most of
bin. HbOCs fall into three categories: surface modified hemoglo- the HbOC preparations. LEHb does, however, have a higher affin-
bins, cross-linked hemoglobins, and polymerized hemoglobins. Sur- ity for oxygen than some of the other red cell substitutes. Standard-
face modified Hbs have molecules attached to the lysine residues on izing the size of liposomes is also problematic.11
the surface of the hemoglobin molecule. Such attachments can be
made using polyethylene glycol (PEG) and polyoxyethylene (POE). PLATELET PRODUCTS AND SUBSTITUTES
Such small molecules stabilize the hemoglobin and increase its mo- Platelets participate in primary hemostasis by initially adhering to
lecular weight. Two of these products, PEG-Hb and pyridoxyl Hb- the vascular subendothelium and then using interactions between
POE, are currently in clinical trials. Cross-linked Hbs consist of Hb glycoproteins on the platelet surface and fibrinogen to initiate ag-
subunits attached to each other using internal covalent bonds. gregation with the eventual formation of a platelet plug. Patients
Diaspirin cross-linked hemoglobin (DCLHb) is produced by using with low platelet counts may have petechiae or ecchymoses and
a reagent that cross-links the lysine residues in the Hba chains. These those with extremely low platelet counts are at risk for spontane-
cross-links delay clearance of the free Hb from the circulation by ous hemorrhage.
stabilizing the Hb tetramer.11 Most of the clinical studies have been
done using human DCLHb. DCLHb trials were halted in 1999 Major indications for transfusing platelets include prophylaxis in
due to increased mortality in some trial enrollees.12 Polymerized Hbs inheritable conditions that result in thrombocytopenia or dysfunc-
are cross-linked at lysine residues with glutaraldehyde, which then tional platelets and to end active bleeding in thrombocytopenic
has active aldehyde groups at both ends of the molecule. This allows patients. A little over 50 years ago, the only sources of platelets
polymers of Hb tetramers to form.11 Human polymerized Hb is were from fresh whole blood or platelet rich plasma. Since that

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time, the first separation of platelets by centrifugation yielded a lets include: cryopreservation with or without synthetic additives,
product with a shelf life of about two hours and refrigeration of lyophilized platelets, photochemically treated platelets, infusible
platelet concentrates at 1 °C to 6 °C provided products with a platelet membranes, and fibrinogen coated albumin
shelf-life of 24 hours. Thirty years ago we began to store platelets microspheres.17,18,19
only at room temperature. The advent of new plastic containers
allows platelets to be kept for up to five days before outdating. Cryopreservation
Platelets suspended in dimethylsulfoxide (DMSO) at -80 °C have
In recent years platelet transfusion therapy has focused on the use been preserved up to ten years and represent the ‘gold standard’ of
of two products—random donor pooled platelets or apheresis plate- preserved platelet products. During the thawing and post-thaw
lets. Obtaining a ‘pooled platelet’ preparation is a two-step proce- processing however, these platelets develop functional and mor-
dure. First, one unit of platelets is harvested from a unit of red phologic defects. Although there is some loss of functional activity
cells. Then four to six of these individual units (from different when compared to fresh platelets, cryopreserved platelets do dem-
donors) are ‘pooled’ together in a single pack to be given to a throm- onstrate a reduced level of primary hemostatic activity.17,20-22 The
bocytopenic patient. Apheresis platelets, on the other hand, are numbers of platelets that are recovered is about 75% of the origi-
those collected from a single donor using cell separator instru- nal number and they have a short circulation time in vivo.17,20
mentation. As blood cycles through the machine, platelets are re- Because of the complexities of storing, processing, and thawing
moved and all other blood constituents returned to the donor. frozen platelets, the current use is limited. Several studies have
The amount of platelets collected with this procedure represents been done using a decreased concentration of DMSO with a plate-
the equivalent of four to six units of random donor platelets. let-stabilizing solution (ThromboSol™) to decrease problems such
Leukoreduction filters can be used with either of these to remove
the majority of white blood cells before infusion and therefore
decrease the risk of sensitization to human leukocyte antigens Table 1. Biological risks associated with platelet transfusion
(HLA), symptoms caused by production of cytokines in the stored
PRBCs, or the risk of transmission of cytomegalovirus. Alloimmunization (development of antibodies to HLA or
platelet specific antigens)
The risks associated with sensitization include development of al- –refractory state
loantibodies to HLA antigens or to platelet-specific antigens. These –febrile non-hemolytic transfusion reactions
antibodies may cause the patient to experience a febrile non-
hemolytic transfusion reaction or become refractory to a platelet Bacterial, viral or parasitic contamination
transfusion. A patient who is ‘refractory’ does not have the expected –disease transmission
increment in the post-transfusion platelet count due to antibody- –septic shock
mediated destruction of transfused platelets. In some cases in which Immune system effects [uncommon]
the patient has developed antibodies to HLA antigens and become –immunosuppression
refractory, apheresis platelets that are HLA matched to the patient’s –graft-versus-host disease
antigens may be used. A summary of problems and biological risks
associated with platelet transfusions are listed in Table 1.

Platelets have short shelf life and also develop changes in func-
tional ability during storage. Even with the short shelf life, storage
Table 2. Selected criteria for platelet substitutes or novel
at room temperature increases the risks of bacterial growth. Over
platelet products
the past 40 years, unsuccessful attempts were made to cryopreserve
or lyophilize platelets to overcome these problems and today the
Function hemostatically as ‘live platelets’
search for alternative ways of preserving platelets or creating plate-
–attach to vascular surfaces
let substitutes continues. Numerous criteria that novel platelet
–provide a procoagulant surface
products or platelet substitutes should meet have been described
in the literature and some of these are listed in Table 2.17,18 How- Avoid initiating consumptive coagulopathy or thrombosis
ever, just as with the functional comparison between packed red
Not transmit infectious diseases
blood cells and blood substitutes, these products are designed for
short term treatment of active bleeding and do not possess all the Be non-immunogenic
functions of fresh human platelets.
Have a long shelf life and simple storage requirements
Products under development to augment platelet function, de- Be easy to prepare
crease risks associated with transfusion, or to substitute for plate-

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as decreased recovery and short circulation time that occur with Contamination of platelets
current methods of cryopreserving platelets. This solution inhib- A peripheral but important issue with transfusion of human pooled
its platelet activation pathways and protects against cold storage platelets is the risk of transfusion transmitted diseases—especially
lesions. Results of these studies have shown higher recovery rates bacterial–and the associated potential for septic shock and death.
and longer survival times than with the 6% DMSO method as While serologic tests for transfusion transmitted viruses such as hepa-
well as fewer processing steps.23,24 There are investigations under titis B have reduced the incidence of viral transmission significantly,
way to develop methods that do not require processing after freez- there have not been concurrent advances for detecting bacterial con-
ing and can be directly infused after thawing. tamination. Platelets stored at room temperature create an ideal in-
cubation environment for growth of bacteria. Studies indicate that
Lyophilized platelets 1 in 2,000 to 1 in 3,000 platelet units are bacterially contaminated,
Lyophilized platelets are created after treatment with a paraformal- with sepsis occurring with about 1/6 of the contaminated units trans-
dehyde solution and then freeze-dried.25,26 Specific advantages of fused.31,32,33 Units at the end of the four to five day storage period are
this product include storage measured in years instead of days, re- the most likely to be contaminated.31,34 Contamination can origi-
duced storage space and true sterility. Once rehydrated, they appear nate from occult bacteremia in the donor, induction of skin bacteria
to retain structural integrity and attach only to damaged subendot- such as Staphylococcus epidermidis during phlebotomy, or contami-
helial surfaces.25 They will also change shape and extend pseudo- nated collecting devices. Detection of contaminated units is diffi-
pods in preparation for plug formation.27 Thus it appears that the cult and a number of methods have been proposed to determine
GpIb receptor which binds to vonWillebrand factor and then to contamination prior to transfusion.31,35 These include examination
collagen of the injured surface is not significantly affected by freeze- of Gram’s stains of units at day four or five, or surrogate methods
drying.25,26 Data for other receptor complexes such as GPIIbIIIa , such as measuring low pH or glucose levels of units with a urine
which is the fibrinogen receptor, are not as clear cut. The number of dipstick. The major disadvantage of these methods is that they are
these receptors and their function appears to be diminished but not not sensitive and require large numbers of organisms for detection.
entirely eliminated.27 There appears to be minimal risk for develop- One study showed that detection methods must be sensitive enough
ing systemic thrombosis after administration. Animal studies have to detect 100 CFU/ml by day three of storage.36 Several researchers
shown that the rehydrated lyophilized platelets have hemostatic ef- have evaluated an automated culture system which could detect or-
ficiency–measured by bleeding time–similar to that of fresh plate- ganisms with concentrations as low as 10 to 100 colony forming
lets; however this effect continues for only several hours.25 units /mL in 9 to 26 hours.36,37 The results indicated that short-time
culture in automated systems may be useful in screening platelet
Infusible platelet membranes units for contamination. Methods used to prevent contamination
Infusible platelet membranes (IPMs) are manufactured from have also been investigated. One method is use of a photochemical
outdated platelet units in an attempt to provide a stable product agent and ultraviolet light (UV) to inactivate bacteria and viruses in
that mimics the actions of the platelet-derived microparticles.28 conventional platelet units. The chemical, in the presence of UV
Platelet derived microparticles (microvesicles) are the particles that light, will bind to DNA to prevent transcription and replication.38,39,40
form spontaneously from a platelet during collection and processing Studies have shown this treatment will inactivate high concentra-
of components. They have been found in platelet concentrates, tions of bacteria and viruses without significantly affecting the he-
fresh frozen plasma, and cryoprecipitate.19 They appear to have mostatic activity of the platelets.39,40
the ability to function as a platelet—they are procoagulant active,
adhere to vascular subendothelium, and enhance platelet adhesion Intravenous immunoglobulin
to form a primary hemostatic plug. Studies have shown that the Once the fractionation of immunoglobulins was successfully per-
IPMs do retain some function of GpIb receptor and bind to vWF formed in the 1940s, the use of immunoglobulins (especially
and can initiate local fibrin formation, but much of the GpIIb/ gamma globulin) became an established method of providing pro-
IIIa is lost.29,30 One application for IPMs may be in patients who tective, passive immunity for some diseases. However, intravenous
are refractory to platelet transfusions and for whom finding HLA administration was not possible because the method of prepara-
matched plateletpheresis donors is difficult. One problem appears tion often resulted in a variety of patient side effects including
to be a relatively short life (less than 24 hours) in vivo.28 anaphylaxis. During the 1980s and 1990s changes in manufactur-
ing allowed fractionation of the product into IgG portions that
Miscellaneous microspheres could be solublized and used intravenously.41
There are a number of products that use formaldehyde fixed plate-
lets, liposomes, or 10% albumin spheres as a basis on which to Intravenous immunoglobulin (IVIG) is made from large pools of
coat fibrinogen or platelet membrane glycoproteins. Results from donor plasma (hundreds to thousands of donors). This polyclonal
some of the pre-clinical trials show that these products appear to preparation contains 90% to 98% IgG and small amounts of IgA
be able to enhance the adhesion of platelets and formation of ag- and IgM.41 Bacteria are removed by filtration and viral agents are
gregates but in vivo stability remains a problem. inactivated by a variety of mechanisms. This pooling of donor

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plasma provides a diversity of antibodies that have led to the use of ages and reaction of anti-idiotypic antibodies with autoantibod-
IVIG for treatment in a wide spectrum of diseases. In contrast, ies. It appears that more immediate effects are due to inhibition of
monoclonal antibodies have a use that is limited to a specific dis- the RES and the anti-idiotypic antibodies may function in a long
ease. For example anti-tumor necrosis factor can be used as ad- term protective role.43,46 A study of antibody coated platelets showed
junct treatment for rheumatoid arthritis. that the Fc fragments of immunoglobulins in IVIG gave protec-
tion by inducing expression of an inhibitory receptor on effector
The mechanism of how IVIG works is not completely known. cells. This decreased or prevented the clearance of the antibody-
Studies with specific diseases and animal models have shown that coated platelet.46 In another study, high-dose IVIG therapy accel-
the therapeutic action includes one or more of the mechanisms erated clearance of autoantibodies but could only explain 20% to
listed in Table 3.42-45 The most commonly recognized mechanisms 40% of the decrease in autoantibody concentration after therapy.44
appear to be those of competition for binding sites on the Fc re- When ITP occurred in pregnant women the IVIG was also effec-
ceptors of phagocytic cells and the binding of anti-idiotypic anti- tive in decreasing platelet damage in the fetus.
bodies (antibodies to human antibodies) to autoantibodies by at-
taching to the Fab portion of the immunoglobulin molecule. Another obstetrically-related condition in which IVIG has been
used is neonatal alloimmune thrombocytopenia (NAIT). In this
IVIG was first licensed in the early 1980s to be used as treatment for disease, the mother develops antibodies against fetal platelet anti-
primary immunodeficiency diseases characterized by hypogamma- gens, most commonly the Human Platelet Antigen 1a, formerly
globulinemia and/or recurrent infection. For individuals with these known as PLal. Infants with this condition are born with clinical
diseases, it provides a source of antibodies and decreases the inci- indications of moderate or severe thrombocytopenia and may be
dence and severity of infections in this population. After its initial at risk for intracranial hemorrhage.47 As with other fetal-maternal
use as a replacement therapy, it was also found to have an alloimmune conditions, the risk to the fetus and the severity of
immunomodulatory effect and its use expanded to include selective the condition can become more severe with each subsequent preg-
treatment for hematologic, inflammatory, and infectious diseases nancy. Once the condition has been identified, IVIG can be given
that have an immunologic component. The FDA has approved the to the mother during the pregnancy. IVIG crosses the placenta
use of IVIG for treatment of more than 30 disease conditions in- and provides protection to the fetus. It may also inhibit maternal
cluding primary immune deficiency, B-cell chronic lymphocytic leu- immunoglobulin synthesis through a feedback mechanism or in-
kemia, idiopathic thrombocytopenia purpura (ITP), pediatric hu- hibit transport of the maternal antibodies across the placenta. This
man immunodeficiency virus infection, Kawasaki syndrome, and is effective in decreasing platelet destruction in 50% to 80% of
neuroimmunologic diseases such as Guillain-Barre syndrome and cases.47,48 A study by Gaddipati linked the initial fetal platelet count
selected obstetric conditions. In addition, it has been approved for to the subsequent efficacy of IVIG therapy. If the fetal platelet
use in allogeneic bone marrow transplant patients to prevent GVHD count was >20,000/microliter then approximately 89% of future
as well as infections. The relative success of IVIG in many condi- counts were above that level. If the platelet count was <20,000
tions, however, has also led to use in treating many other conditions then only 51% had an increased count after the IVIG.49
for which it has not been approved.
Although the use of Rh immunoglobulin (RhIg) has successfully
One of the first conditions in which IVIG was recognized as effec- reduced the number of cases of Rho (D) hemolytic disease of the
tive treatment was ITP. In ITP the two major mechanisms for newborn due to anti-D, there are some RhIg failures. In addition
action of IVIG include blocking Fc receptors on splenic macroph- hemolytic disease of the newborn may be due to antibodies to
other blood group system antigens. In cases where the maternal
antibody is extremely high and intrauterine transfusion is unable
to be performed, IVIG has been used to decrease maternal anti-
Table 3. Potential mechanisms of IVIG body titer.47,50

Binding to complement proteins Because neonates have an immature immune system and may be
Inhibition and regulation of cytokine action at increased risk for infection, the use of IVIG in treating sepsis
has also been studied. Studies as well as a meta-analysis of studies
Interference with antigen recognition by T cells
of IVIG use in treating neonatal sepsis showed that IVIG may be
Activation of neutrophils of significant benefit in addition to standard treatment for neo-
Competition for binding to Fc receptors nates early in the onset of sepsis but had minimal benefit when
used prophylactically.51,52
Interaction with superantigens
Binding to autoantibodies Autoimmune diseases are another area in which IVIG has been
used. These diseases present challenges for treatment. One is bal-

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 F OC U S: C OMPONENT T HERAPY

ancing the suppression of the immune system against the risks of ing degrees of success in diseases such as cold agglutinin disease,
infection. Another challenge is dealing with exacerbation or crises systemic vasculitis, chronic inflammatory demyelinating polyneur-
in the disease when the antibody titer reaches very high levels. opathy, hemolytic uremic syndrome (HUS), and to remove high
IVIG has been useful in treating autoimmune diseases such as levels of antibody in pregnant women when uterine transfusion
myasthenia gravis. The culprit in this condition is an autoanti- cannot be accomplished. Although TPE generally will not cure
body to acetylcholine receptors that interferes with nerve impulse the underlying condition, the procedure will often temporarily
transmission. It is characterized by weakness of voluntary muscles alleviate symptoms by decreasing the concentration of the under-
and affects both women and men of any age. Although drugs are lying problematic plasma component. Table 5 lists some of the
the usual long-term therapy, IVIG is a temporary treatment to specific components that can be removed by TPE.
decrease antibody production. One study determined that there
may be some efficacy in using IVIG as a replacement treatment The disease in which TPE has been used most successfully is TTP
for patients with Guillain-Barre syndrome who could not undergo and this disease will be used as an example of how TPE may allevi-
plasma exchange.53 ate underlying conditions.

Kawasaki syndrome is a leading cause of acquired heart disease in TTP is characterized by a pentad of symptoms including thromb-
North America and Japan. Its cause is unknown although an infec- ocytopenia, microangiopathic hemolytic anemia, fever, neurological
tious agent has been suggested. It is a self-limiting disease that leads to symptoms, and renal dysfunction. It may manifest as a single acute
coronary artery lesions.54 Therapy with IVIG along with aspirin dur- episode or a chronic relapsing condition. The cause of the disease
ing the first ten days of the illness decreases risk of coronary artery is unknown but it may be triggered by a variety of conditions in-
damage. There is some evidence to suggest that the IVIG may also cluding pregnancy and infections. In TTP a combination of en-
decrease circulating cytokines that mediate much of the damage. dothelial cell damage and platelet aggregation agents results in
microthrombi and a consumptive thrombocytopenia. Research has
There are multiple studies of other possible applications of IVIG shown that in contrast to the usual platelet plugs that are com-
therapy in diseases with infectious or immunologic origins.54-56 In posed of platelets and fibrinogen, those in TTP are composed of
pediatric HIV patients who have hypergammaglobulinemia but platelets and ultra large multimers of vonWillebrand Factor
the impaired ability to produce specific antibodies, IVIG was used (uLvWF).61,62 The presence of these uLvWF multimers led research-
to decrease episodes of acute pneumonia but unfortunately did ers to investigate why these multimers were present. Findings in-
not increase survival.54 Another study looked at whether IVIG could dicate it may be an absence of a vWF cleaving protein in the plasma
be used in treatment of acute rheumatic fever.55 Despite the un- of patients with TTP. Plasma exchange using FFP removes some
derlying immunologic basis for acute rheumatic fever, IVIG showed of the multimers and provides a source of enzyme, however, the
no effect on clinical progress or other disease parameters. In an- FFP itself remains a source of vWF.61,62 Although TPE treatments
other study IVIG was studied as a supplemental treatment in pa- are successful in many cases, there were a number of patients who
tients with sepsis and septic shock.56 Again there was no overwhelm- did not respond. The research of causes and the identification of
ing improvement in those who received the IVIG, but it appeared vWF as a possible cause led to the use of another blood compo-
to decrease morbidity and mortality in some patients when used nent in TPE—cryoprecipitate reduced plasma (cryosupernatant
as part of the treatment protocol. or cryo-poor plasma).63-66

COMPONENTS USED IN THERAPEUTIC PLASMA EXCHANGE

Fresh frozen plasma
Fresh frozen plasma (FFP) is the component created when plasma Table 4. Indications for use of fresh frozen plasma
is removed from a unit of blood and frozen at –18 °C within eight
hours after collection. It contains stabile and labile coagulation Consumptive coagulopathies such as disseminated
factors, immunoglobulins, and proteins and has been used in treat- intravascular coagulation (DIC)
ing a number of conditions (Table 4). One of the most common
ways it is used is in therapeutic plasma exchange (TPE). TPE in- Multiple coagulation factor deficiencies
volves removal of a patient’s plasma and a return of the cellular Liver disease
elements in a liquid medium replacement. FFP is the preferred
medium over crystalloids such as physiologic saline or albumin Dilutional coagulopathies such as those seen in massive
because it is not only a volume expander, but is also a source of transfusion
proteins and immunoglobulins. Over the years, TPE has become Thrombotic thrombocytopenia purpura (TTP)
accepted therapy for a number of diseases such as cryoglobuline-
mia, myasthenia gravis, Guillain-Barre syndrome, and thrombotic Deficiencies of Protein C, Protein S
thrombocytopenic purpura (TTP).57-60 It has been used with vary-

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Cryoprecipitate reduced plasma REFERENCES 11. Stowell CP, Levin J, Spiess BD, and others.
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23. Currie LM, Lichtiger B, Livesey SA, and others.
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Immune complexes SLE thrombocytopenia: a pilot study. Br J Haematol
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26. Bode AP. Preclinical testing of lyophilized plate-
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27. Fischer TH, Merricks EP, Russell KE, and others. Intracellular function 48. Bussel JB, Barques RL, Lynch L, and others. Antenatal management of
in rehydrated lyophilized platelets. Br J Haematol 2000;111:167-74. alloimmune thrombocytopenia with intravenous immune globulin: a ran-
28. Chao FC, Kim BK, Houranieh AM, and others. Infusible platelet mem- domized trial of the addition of low dose steroid to intravenous immune
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sion 1996;36:536-42. 49. Gaddipati S, Berkowitz RL, Lembet AA, and others. Initial fetal platelet counts
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ies under flow conditions. Transfusion 2001;40:1074-80. 50. Porter TF, Silver RM, Jackson G, and others. Intravenous immune globulin in
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partial functionality of the platelet GPIb/IX/V receptor complex. Am J Clin Survey 1997;52:193-7.
Path 2001;115:144-7. 51. Hill HR. Additional confirmation of the lack of effect of intravenous immuno-
31. Yomtovian R, Lazarus HM, Goodnough LT, and others. A prospective mi- globulin in the prevention of neonatal infection. J Pediciatr 2000;137:595-97.
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32. Engelfriet Co, Reesink HW, Blajchman MA, and others. Bacterial contami- 1997;99:E2.
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33. Sazama K. Bacteria in blood for transfusion. A review. Arch Pathol Lab Med lins inpatients with Guillain-Barre syndrome and contraindications to plasma
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34. Morrow JF, Braine HG, Kickler TS, and others. Septic reactions to platelet 2001;71:235-8.
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35. Barrett BB, Andersen JW, Anderson KC. Strategies for the avoidance of bac- immunoglobulin. Curr Opin Pediatr 1999;11:533-9.
terial contamination of blood components. Transfusion 1993;33:228-33. 55. Voss LM, Wilson NJ, Neutze JM, and others. Intravenous immunoglobulin in
36. Brecher ME, Means N, Jere CS, and others. Evaluation of an automated acute rheumatic fever: A randomized controlled trial. Circ 2001;103:401-6.
culture system for detecting bacterial contamination of platelets: An analysis 56. Werdan K. Pathophysiology of septic shock and multiple organ dysfunction
with 15 contaminating organisms. Transfusion 2001;41:477-82. syndrome and various therapeutic approaches with special emphasis on im-
37. Liu HW, Yeun KY, Cheng T, and others. Reduction of platelet transfusion- munoglobulins. Ther Apher 2001;5:115-22.
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38. Corash L. Inactivation of viruses, bacteria, protozoa, and leukocytes in platelet 1995;74:240-5.
concentrates. Current research perspectives. Transf Med Rev 1999;13:18-30. 58. Bosch T, Buhmann R, Lennertz A, and others. Therapeutic plasma exchange
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long-wavelength ultraviolet light. Transfusion 1997;37:423-35. 59. Parry GJ. When is antibody testing useful and what therapy is effective in
40. VanRhenen D, Gulliksson H, Pamphilon D, and others. S-59(HelinxTM) immunomediated neuropathies? Adv Neuroimmunol 1995;2:18-22.
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bocytopenia: Results of the Eurosprite phase 3 trial. Blood 2000;96:819. ized trial of plasma exchange, intravenous immunoglobulin, and combined
41. Swenson MR. Autoimmunity and immunotherapy. J IV Nurs 2000;23 treatments in Guillain-Barre syndrome. Lancet 1997;349:225-30.
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42. Teeling, JL, Bleeker WK, Rigter GMM, and others. Intravenous immunoglo- ing protease in thrombotic thrombocytopenic purpura and the hemolytic-
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43. Crow AR, Song SI, Semple JW, and others. IVIG inhibits reticuloendothe- Willebrand factor-cleaving protease in chronic relapsing thrombotic throm-
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topenia independent of anti-idiotype reactivity. Br J Haematol 2001;115:679- 63. Rock G, Shumak KH, Sutton DM, and others. Cryosupernatant as replace-
86. ment fluid for plasma exchange in thrombotic thrombocytopenic purpura.
44. Bleeker WK, Teeling JL, Hack CE. Accelerated autoantibody clearance by in- Members of the Canadian Apheresis Group. Br J Haematol 1996;94:383-6.
travenous immunoglobulin therapy: studies in experimental models to deter- 64. Rock G, Anerson DR, Benny WB, and others. Changes in vWF levels in
mine the magnitude and time course of the effect. Blood 2001;98:3136-42. TTP patients treated with cryosupernatant versus fresh frozen plasma. Br J
45. Sacher R. Intravenous immunoglobulin consensus statement. J Allergy Clin Haematol 1998;102(I-1):369.
Immunol 2001;108 supplement:S139-46. 65. Blackall, DP, Uhl L, Spitalnik SL, and others. Cryoprecipitate-reduced plasma:
46. Samuelsson A, Towers TL, Ravetch JV. Anti-inflammatory activity of IVIG rational for use and efficacy in the treatment of thrombotic thrombocytopenic
mediated through the inhibitory Fc receptor. Science 2001;291:484-6. purpura. Transfusion 2001;41:840-4.
47. Branch DW, Porter TF, Paidas MJ, and others. Obstetric uses of intravenous 66. Ellis J, Theodossiou C, Schwarzenberger P. Treatment of thrombotic
immunoglobulin: successes, failures, and promises. J Allergy Clin Immunol thrombocytopenic purpura with the cryosupernatant fraction of plasma: a
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Continuing Education Questions

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SPRING 2002
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To receive 2.0 contact hours of intermediate level P.A.C.E.®‚ credit 3. A hemoglobin-based oxygen carrier is a:
for Focus: Component Therapy, insert your answers in the ap- a. perfluorocarbon backbone structure.
propriate spots on the immediately following page; then complete b. hemoglobin encased in liposomes.
and mail the form as directed. Refer to the first page of each article c. cell-free hemoglobin.
for the learning objectives for that article. d. product derived only from human sources.

NOTE: There may be more answer spaces on the answer sheet 4. Fibrinogen-coated albumin microspheres are being studied
than needed. If so, leave them blank. Make sure the number of the as:
answer space you fill in matches the number of the question you a. red cell substitutes.
are answering. b. platelet substitutes.
c. dendritic cell vaccine carriers.
LEARNING OBJECTIVES d. a method for CD8+ cell depletion.
1. Identify the major diseases treated with each of the compo-
nents discussed. 5. Cryoprecipitate reduced plasma (CRP) retains normal
2. Discuss the preparation of DLI and why CD4 cells are re- amounts of:
tained, while CD8 cells are depleted. a. von Willibrand’s factor.
3. Describe the general process of making a dendritic cell vaccine. b. factor VIII.
4. Describe the different types of red cell substitutes and differ- c. fibrinogen.
entiate between them. d. von Willibrand’s enzyme.
5. Explain at least two of the possible ways in which intravenous
immunoglobulins may interact with the immune system. 6. In ITP, the clearance of immunoglobulin coated platelets from
6. Explain why cryoprecipitate reduced plasma is effective in the circulation is inhibited by treatment with:
treating thrombotic thrombocytopenia. a. cryosupernatent.
7. List and describe the platelet products under development. b. perfluorocarbons.
c. DC vaccines.
CONTINUING EDUCATION QUESTIONS d. IVIG.

1. The CD4+ T cells are necessary for: 7. Chronic myeloid leukemia relapses are being treated with:
a. graft-versus-host disease to develop. a. IVIG.
b. graft-versus-leukemia effect to occur. b. DC vaccines.
c. engraftment of CD8+ cells. c. DLI.
d. CD8+ cell depletion to occur. d. cryoprecipitate reduced plasma.

2. Dendritic cells: 8. Therapeutic plasma exchange is performed using:

a. engulf and process antigen from foreign material. a. cryosupernatent.
b. present antigen along with MCH class I. b. fresh frozen plasma.
c. phagocitize MHC class II molecules. c. cryopreserved platelets.
d. cannot be found in the peripheral blood. d. donor lymphocyte infusion.

9. Acetylcholine antibodies are the source of damage in:

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a. diopathic thrombocytopenic purpura.
Vicki S Freeman PhD, of the Department of Clinical Laboratory Sci- b. thrombotic thrombocytopenic purpura.
ences, University of Texas Medical Branch is P.A.C.E.® liaison for the c. myasthenia gravis.
CLS Continuing Education section. She reviews Focus articles, as- d. graft-versus-leukemia effect.
signs contact hours, and edits learning objectives and test questions.
Direct all continuing education inquiries to Vicki S Freeman PhD at
(409) 772-3056, (409) 747-1610 (fax). vfreeman@utmb.edu

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12-CE Questions 125 4/10/02, 3:32 PM

 F OC U S: C OMPONENT T HER APY

10. Carbon backbones substituted with fluorine are characteris- 14. IVIG interacts with the immune system by:
tic of: a. competing for binding sites on the Fc portion of phago-
a. hemoglobin-based oxygen carriers. cytes.
b. cell-free hemoglobins. b. binding to the Fab portion of phagocytic cells and anti-
c. perfluorocarbons. idiotypic antibodies.
d. liposome encased hemoglobins. c. clearing autoantibodies from the peripheral circulation.
d. inducing hypogammaglobulinemia.
11. Phosphatidyl choline is characteristic of
a. myasthenia gravis. 15. The source of dendritic cells used in making a DC vaccine is:
b. liposome encased hemoglobins. a. donor leukocytes.
c. donor lymphocyte infusion preparation. b. patient peripheral blood.
d. perfluorocarbons. c. mouse spleen.
d. none of the above.
12. Cryopreservation of platelets is accomplished using:
a. DMSO. 16. CD8+ T cells are involved in the development of:
b. hydroxyethyl starch. a. GVL effect.
c. glycogen. b. DLI product.
d. glycerol. c. GVHD.
d. DC vaccines.
13. Paraformaldehyde solution is used in preparation of:
a. infusible platelet membranes.
b. DMSO.
c. liposome encased hemoglobins.
d. lyophilized platelets.

126 VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE

12-CE Questions 126 4/10/02, 3:32 PM

 Continuing Education Registration Form
To earn continuing education (P.A.C.E.®) credit, (1) complete the form below, (2) record your answers, and (3) tear out and mail this
form with a check or money order ($18 for ASCLS members, $28 for non-members for all articles) to:

American Society for Clinical Laboratory Science

P.O. Box 79154
Baltimore, MD 21279-0154

A certificate and credit will be awarded to participants who achieve a passing grade of 70% or better. Participants should allow 8 weeks for
notification of scores and receipt of certificates.

Focus: Component Therapy carries 2.0 contact hours of intermediate level credit. This form can be submitted for credit for up to one year
from the date of issue.

Print or type carefully.

(01) NAME ______________________________________________________ ASCLS membership number _______________

Last First Middle

(02) ADDRESS _________________________________________________________________________________________

(03) CITY_____________________(04) STATE/COUNTRY _______________(05) ZIP/POSTAL CODE_________________

(06) DAYTIME PHONE ( ____ )__________________________(07) E-MAIL:_____________________________________

(08) CREDIT CARD # ____________________________ TYPE (CIRCLE) AE MC VIS EXP. DATE __________

Check all that apply 2. Specialty: (a) biochemistry/urinalysis (b) microbiology

❑ I am an ASCLS member (c) lab administration (d) hematology/hemostasis (e) education
❑ I am not an ASCLS member (f )immunology (g) immunohematology
❑ I would like to receive ASCLS membership information 3. Workplace: (a) hospital over 500 beds (b) hospital 200–499
❑ I have previously participated in Focus beds (c) hospital 100–199 beds (d) hospital under 100 beds
❑ I would like information on other continuing education sources (e)private lab (f ) community blood bank (g) group practice
(h) private physician (i) clinic (j) other
Answers
4. Salary range: (a) under $10,000 (b) $10,000 to $20,000
Circle correct answer (questions are on previous two pages). (c) $20,000 to $30,000 (d) $30,000 to $40,000
(e) over $40,000
1. a b c d e 8. a b c d e 15. a b c d e 22. a b c d e
2. a b c d e 9. a b c d e 16. a b c d e 23. a b c d e 5. Did these articles achieve their stated objectives?
(a) yes (b) no
3. a b c d e 10. a b c d e 17. a b c d e 24. a b c d e
4. a b c d e 11. a b c d e 18. a b c d e 25. a b c d e 6. How much of these articles can you apply in practice?
5. a b c d e 12. a b c d e 19. a b c d e 26. a b c d e (a) all (b) some (c) very little (d) none
6. a b c d e 13. a b c d e 20. a b c d e 27. a b c d e
7. Employment status: (a) full time (b) part time (c) student
7. a b c d e 14. a b c d e 21. a b c d e 28. a b c d e (d) not employed (e) retired

Participant Information 8. How long did it take you to complete both the reading
Please circle the most appropriate answers. and the quiz? ___________minutes

1. Is this program used to meet your CE requirements for: 9. What subjects would you like to see addressed in future
(a) state license (b) NCA (c) employment (d) other Focus articles?
VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE 127

12-CE Questions 127 4/10/02, 3:32 PM

 T REND S AND TECHNOL OGY
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Trends and Technology: Spring 2002

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
MARY JANE GORE
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Trends and Technology welcomes releases claims to be the largest clip-art gallery
and information about new products, ser- online, plus many other sites for using
vices, Web sites, trends, and upcoming technology effectively, creating web sites,
events. If your company has a Web site learning HTML, and so on.
that you would like for us to review, please
send us news for our Online section, or This review space cannot do it justice—so
tell us about sites that would interest clini- many of the major diseases and their diag-
cal laboratory scientists. These sites, as nostic tests, all of the laboratory profes-
well as the new product information, are sional associations I could think of, gov-
offered for reader information only. We ernment and industry resources, handy
cannot vouch for them and their presence documents, recommended reading lists—
here does not constitute an endorsement it was all there. My only beef is that he
by CLS or ASCLS. includes absolutely everything—I started
to count the sheer number of links but gave
ONLINE up: you must visit this site yourself. Per-
I felt I was unearthing a real treasure when haps the sitemaster could sponsor a con-
a routine search took me to Clinical Labo- test by popular vote of the most valuable
ratory Science Internet Resources©, com- clinical laboratory sites. P.S. Dr. Caruana Heraeus HERAsafe® HS 12 biological
piled by Louis B. Caruana, Ph.D. (http:// encourages you to contact him if you find safety cabinet
members.tripod.com/~LouCaru/index- any of the lists are not functional:
5.html). Caruana is professor emeritus of loucaruana@rocketmail.com. Ohaus has introduced new precision mod-
the Clinical Laboratory Science Program, els for its Explorer® and Voyager® lines. By
college of Health Professions, Southwest NEW PRODUCTS adding the 610 g x 1 mg and 6100 g x 10
Texas State University in San Marcos. I The new VIDAS assay from bioMérieux is mg models, Ohaus has expanded the range
hope that those of you unfamiliar with it a reliable test for monitoring prostate can- of weighing capability. The company also
will visit and share in the wonder. cer. The VIDAS TPSA assay provides an has introduced a Draftshield for its Adven-
accurate means for determining total PSA turer® line of balances. The new square
He has compiled what looks to be the most and delivers high-quality results for precise Draftshield protects the entire weighing
comprehensive list of laboratory related and reliable monitoring. Single-dose re- chamber from external elements and offers
sites anywhere. The main pages are divided agents and calibration concepts ensure the multiple entry points for the user. Contact
into the traditional categories of labora- cost of analysis remains the same when run- Michael Guzy at (973) 944-7031.
tory medicine, including mycology and ning single tests or batches. Contact Bob
parasitology, but he also includes educa- Bokerman (800) 638-4835, ext. 8090. Zeiss has a new release of the KS Elispot
tion resources, laboratory management image analysis software for microscopic
resources, phlebotomy, professional asso- The Heraeus HERAsafe® HS 12 biological examination and measurement of large
ciations and organizations, and student safety cabinet (Class II, type A/B3, accord- serum quantities, for both routine and re-
resources. Just to be esoteric, here are some ing to NSF Standard 49) offers unmatched search applications. For example, the soft-
of the links I found: operator and sample protection. There is ware can be used to monitor tumor or
an aerosol-tight, motor-driven front win- AIDS therapies. The KS Elispot 4.3 release
The Academy of Medical Laboratory Sci- dow that seals the inner chamber to protect system provides high sample throughput
ence—The AMLS is an academic body users and samples. The SampleGUARD™ and optimum measuring accuracy, which
representing the majority of medical labo- system also eliminates the need for time- is extremely important to immunologists
ratory scientists in Ireland. Five separate consuming taping before decontamination. and oncologists. Zeiss also has introduced
sites providing information on myelopro- North American Kendro customers contact a new 3D Deconvolution software mod-
liferative disorders. Clip-Art Alley, which (800) 522-7746. ule to improve image quality in fluores-

128 VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE

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 T RENDS AND T EC HNOL OGY

cence microscopy. The new software of- business teams work together, making an Polaroid PhotoMAX PDC 2300Z digital
fers major benefits in functionality and out-of-the-box implementation much easier camera, with 1792 x 1200 image resolu-
operating conveniences. These functions than traditional workflow systems. tion and is available with a seven-inch or
include automatic reading of all recording TeamLeader 2002 allows users to assign, 11-inch hood. The Polaroid GelCam in-
parameters from the image data; preview track and manage work, documents, forms cludes sophisticated image analysis soft-
of Region-of-Interest function; and and other types of information without re- ware, Gel-Pro® Express 4.0. Contact Kim
deconvolving of the image with an auto- placing existing systems. Contact Cary Reingold at (781) 386-3573;
matic calculation stop when the optimum Landis at (304) 296-9100. reingok@polaroid.com.
image quality has been achieved. Contact
M. Yurovitsky at (914) 681-7645. The Olympus OLA4000 Workcell auto- Quater Research & Development an-
mation system is designed for laboratories nounces the release of its new XYZ-1000
The BD Vacutainer™ Anaerobic Speci- in medium- and high-volume hospitals Series of high-precision micropositioners.
men Collector maintains an oxygen-free and commercial reference laboratories. The These small devices provide for ultra-pre-
environment for fragile anaerobic swab, OLA4000 fully automates the labor-inten- cise manual positioning of probes, test
tissue, or liquid specimens that maintain sive tasks associated with sample process- heads, lasers, optics and numerous other
an oxygen-free environment up to 72 ing by automating sample identification, subassemblies in a broad range of test, in-
hours. When the plunger on top of the centrifugation, decapping, and output strumentation, and analytical applications.
system is pressed, an oxygen-eliminating sorting of specimen tubes. It also integrates The XYZ-1000 Series provides X–, Y–,
system is activated, which converts oxy- Olympus AU analyzers for automated rack and Z– axis positioning with 1 inch
gen and hydrogen into water. This media- loading and unloading along with central- (25mm) of travel on each axis. Designed
free device is provided in a sterile, easy- ized data processing. Sample tracking ca- for both space and cost efficiency, these
peel pouch designed for use in the operat- pabilities allow for quick identification of positioners measure just 3.75 x 4.0 x 4.75
ing room or other sterile environments. specimens while reducing biohazard and inches. For further information, visit the
Contact Joy Sussman at (410) 316-4467. blood-borne pathogen contact by labora- Quater website: www.quater-research.com.
tory personnel. OLA 4000 can process a
wide variety of sample tubes and specimen NEW PURCHASING ARRANGEMENTS
closure containers that use the most com- Dade Behring and Consorta Catholic Re-
mon bar code formats. Contact Timothy source Partners today announced they have
Votapka at (631) 756-7160. signed a sole source contract for Dade
Behring’s MicroScan® line of microbiol-
ogy instruments, reagents, and supplies.
With this contract, Dade Behring now
provides the group purchasing and re-
source management company with its
complete line of diagnostics equipment
and supplies. Consorta is the third largest
group purchasing organization (GPO) in
the country in purchases per facility. Dade
BD Vacutainer™ anaerobic specimen Behring has also struck a deal with
collector Olympus OLA4000 Workcell MedAssets HSCA to renew and expand
current contracts for laboratory products.
KeyLogic Systems, Inc. unveiled Polaroid Corporation has introduced the “With its broad range of equipment for
TeamLeader 2002, the latest release of its Digital GelCam – a new, high-resolution small, medium and large-sized laborato-
team automation system designed to help digital camera system that addresses the ries, as well as an extensive service network,
people work together more effectively. photographic needs of scientists and medi- Dade Behring provides solutions that meet
TeamLeader 2002 offers fast relief to orga- cal professionals who use gel electrophore- the needs of our diverse membership base,”
nizations like laboratories that want to au- sis to study and document DNA separa- said Mary Ellen Kimmeth, MedAssets
tomate teamwork functions without invest- tion and protein analysis. The GelCam HSCA, Inc.’s Director of Clinical Labora-
ing heavily in workflow customization or provides a total solution for professionals tory Services. For further information,
business process reengineering. The 2002 to analyze, document and archive their contact Pattie Overstreet-Miller at Dade
release strongly resembles the way small- work. The system includes a 2.3 megapixel Behring, (847) 267-5426.

VOL 15, NO 2 SPRING 2002 CLINICAL LABORATORY SCIENCE 129

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