1899_Ch01_001-024 23/12/11 12:51 PM Page 5

Chapter 1

The Clinical Laboratory

Constance L. Lieseke, CMA (AAMA), MLT, PBT(ASCP)

CHAPTER OUTLINE
The Clinical Laboratory Laboratory Directory
Physician Office Laboratories (POLs) Laboratory Reports
Hospital Laboratories Three Phases of Laboratory Testing
Reference Laboratories Summary
Laboratory Departments Time to Review
Why Is Laboratory Testing Performed? Case Study
The Role of the Medical Assistant in the Clinical Resources and Suggested Readings
Laboratory
Information Flow in the Clinical Laboratory
Laboratory Requisitions
Advance Beneficiary Notice of Noncoverage

Learning Outcomes After reading this chapter, the successful student will be able to:

1-1 Define the key terms for this chapter. 1-8 Explain the purpose of a laboratory directory, as
1-2 Describe the different types of laboratories pre- well as how a laboratory directory may be used
sented in the text and the common tests available when preparing to collect a specimen.
in each. 1-9 Compare and contrast the function of a labora-
1-3 Identify the different departments in a hospital tory requisition and a laboratory report.
or reference laboratory and list some of the tests 1-10 Identify the different phases of laboratory test-
performed in these departments. ing, and explain the flow of the laboratory testing
1-4 Provide several reasons that laboratory testing process.
might be performed. 1-11 Provide examples of preanalytical, analytical, and
1-5 Explain the roles a medical assistant might play postanalytical procedures and how they affect the
in a laboratory setting. quality of laboratory testing.
1-6 List and justify the various pieces of information
that must be included on a laboratory requisition.
1-7 Explain the concept of Advance Beneficiary No-
tice of Noncoverage (ABN) and how it affects
laboratory reimbursement.

5
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6 Section I Overview of the Laboratory

CAAHEP/ABHES STANDARDS

CAAHEP 2008 Standards ABHES Standards

II.A.2: Distinguish between normal and abnormal test • None
results

KEY TERMS

Advance Beneficiary Notice of ICD-9 code Point-of-care testing (POCT)

Noncoverage (ABN) Laboratory Profiles
Ambulatory Laboratory directory Quality control (QC)
Asymptomatic Laboratory report Reference laboratories
CLIA-waived Laboratory requisition Reference ranges
Complexity Normal ranges Serum
CPT code Panels Specimens
Efficacy Physician office laboratories (POLs) STAT
Hospital laboratories Plasma

T he clinical laboratory plays a vital role in patient

care. Diagnostic puzzles are solved each day by us-
ing results obtained from testing procedures performed
laboratory. As of January 2010, the Centers for Medicare
& Medicaid Services identified more than 216,000 clin-
ical laboratories in the United States.1 To simplify our
on blood, tissue, and other body fluids. Quality patient discussion of the various types of laboratories, we will
care depends on excellent laboratory practices, so it is classify them into three basic groups as described below
important to build a solid understanding of the structure (Table 1-1).
and function of the clinical laboratory before performing
testing procedures. This chapter explains the reasons that
laboratory testing may be ordered and identifies the Physician Office Laboratories
types of laboratories where testing is performed. The role Physician office laboratories (POLs) are clinical laborato-
of the medical assistant in the clinical laboratory as well ries within physician offices where laboratory testing is
as the roles played by other laboratory personnel are also carried out on specimens obtained from the practices’ own
introduced. To expand understanding of how the clini- patients. More than half of all the laboratories in the United
cal laboratory operates, the flow of information in the States are POLs. This type of laboratory can be advanta-
laboratory setting is also explained. geous because the results for tests performed on site are
available quickly and patient treatment can begin immedi-
THE CLINICAL LABORATORY ately if necessary. Testing and specimen collection in these
office laboratories may be accomplished by various mem-
A clinical laboratory is any place where specimens from bers of the health-care team, such as medical assistants,
the human body may be collected, processed, examined,
or analyzed. With this broad definition in mind, then, a
1Data From CLIA Update—January 2010
laboratory might be someone’s home, a long-term care
Division of Laboratory Services
facility, the office of a health-care provider, a free clinic, Centers for Medicare & Medicaid Services
a hospital, a small facility used strictly for specimen col- Laboratories by Type of Facility
lection and processing, or a large and complex reference https://www.cms.gov/CLIA/downloads/factype.pdf
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Chapter 1 The Clinical Laboratory 7

TABLE 1-1 trained to perform such procedures. More details about

Types of Laboratories and Sample of Testing the Clinical Laboratory Improvement Amendment and
Performed the classification of laboratory tests are provided in
Chapter 2.
Type of Laboratory Testing Performed
Physician office CLIA-waived tests Hospital Laboratories
laboratory Moderate complexity testing
(with appropriate training, Hospital laboratories generally offer laboratory test-
staffing, and supervision) ing that meets the needs of their respective institution.
Microscopic examinations For instance, if a hospital specializes in a certain type
(performed by health-care of surgical procedure or treatment, the hospital labora-
provider or qualified staff) tory will offer extensive testing in that specialty area,
Hospital laboratory CLIA-waived tests in addition to the standard tests required to monitor
CLIA moderate- and the health of the other patients in the hospital. In most
high-complexity tests (based situations, hospital laboratories perform high volumes
on the needs of the patients of routine test procedures. Hospital laboratories may
served in the facility) also serve as a reference laboratory for the local com-
Point-of-care testing munity, especially for STAT testing needs. (STAT tests
Microscopic examinations
are those that require immediate results.) Tests
Reference laboratory CLIA-waived tests performed at a hospital laboratory may include the
Moderate- and high-complexity following:
tests
Microscopic examinations • Electrolytes
• Kidney function tests
• Liver function analysis
clinical or medical laboratory technicians who have been • Blood typing and crossmatches for transfusions
trained in laboratory testing, or phlebotomists who are • Identification of microorganisms and antibiotic
trained to draw blood and perform some simple laboratory sensitivity testing
procedures. These ambulatory (outpatient) laboratories • Urine analysis
generally perform low complexity tests that are designated • Coagulation testing
as Clinical Laboratory Improvement Amendment–waived • Cardiac enzyme assays
(CLIA-waived) tests by the U.S. Food and Drug Adminis- • Complete blood counts (CBCs) and other hematology
tration (FDA). CLIA-waived tests are laboratory examina- testing
tions and procedures that use simple and accurate methods Hospital laboratories may also offer another method
requiring very little interpretation to report correct results. for testing samples, called point-of-care testing
These tests may include the following: (POCT). Point-of-care tests are actually performed at
• Rapid microbiology testing for the presence of group the patient’s bedside rather than in the laboratory, using
A Streptococcus and influenza a portable instrument that gives immediate results.
• Urine analysis These tests may be performed by laboratory personnel
• Pregnancy testing or in some situations by other hospital employees
• Tests such as those for mononucleosis, Helicobacter who have been trained to perform the testing.
pylori, and HIV
• Coagulation testing to monitor patients who are Reference Laboratories
taking anticoagulants
Reference laboratories perform more tests annually
• Glucose levels and other tests used to monitor diabetic
than either POLs or the hospital laboratories, processing
patients
perhaps thousands of specimens per day. These tests in-
• Fecal occult blood tests for the presence of blood in
clude those that are performed at hospital laboratories,
the stool
but reference laboratories may offer specialized testing
• Cholesterol testing
that is not performed at either hospital laboratories or
Physician office laboratories may also provide testing POLs. Specimens may be sent to a reference laboratory
that is more complex if staff members are properly from all over the country.
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8 Section I Overview of the Laboratory

Test Your Knowledge 1-1 departments for testing. The specimen processing de-
partment may also prepare specimens for transport to
Which type of laboratory offers the widest variety of
reference laboratories.
tests? (Outcome 1-2)
• Hematology: Whole blood testing, which focuses
on the formed elements (the blood cells) in the blood.
Coagulation testing is also performed in this
LABORATORY DEPARTMENTS
department.
• Clinical Chemistry: Testing performed on plasma or
Testing in hospital and reference laboratories is usually de-
serum (the liquid portion of the blood) and includes
partmentalized for efficiency, as presented in Table 1-2.
analysis of the substances dissolved in the blood-
This allows all testing that uses similar instrumentation or
stream. Most testing is automated, and many of the
methods to be performed in the same area of the labora-
tests are performed as panels or groups of tests.
tory. These departments may include the following:
• Serology/Immunohematology: Testing that focuses
• Specimen Processing: The area of the laboratory primarily on the presence of antigens or antibodies
where all incoming specimens are sorted, accessioned on cells or in the liquid portion of the blood. Blood
into the computer system of the laboratory, and typing and antibody screens and crossmatches for
appropriately labeled for transport to their respective transfusions may also be performed in this department.

TABLE 1-2
Summary of Laboratory Departments, Common Tests Performed, and Specimen Types
Laboratory Department Common Tests Performed Specimen Types
Specimen Processing Incoming specimens sorted All types
Specimens accessioned into computer system
Specimens labeled and prepared for testing in separate
department
Hematology Complete blood count Whole blood
Hemoglobin and hematocrit measurements
Coagulation studies
Erythrocyte sedimentation rate
Differential white blood cell count
Platelet counts
Clinical Chemistry Electrolytes Serum, plasma,
Glucose urine, cerebrospinal
Blood urea nitrogen fluid, amniotic fluid
Creatinine
Thyroid testing
Cardiac enzyme testing
Comprehensive metabolic panel
Cholesterol/lipid testing
Many automated chemistry tests and panels
Serology and Various tests looking for antigens and/or antibodies such as: Serum, plasma,
Immunohematology RPR whole blood
Mononucleosis testing
HIV tests
Chlamydia testing
Antistreptolysin O test
Pregnancy testing
C-reactive protein
ABO/Rh blood typing
Antibody screens and crossmatches for transfusions
Newborn testing
Prenatal testing
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Chapter 1 The Clinical Laboratory 9

TABLE 1-2–cont’d
Summary of Laboratory Departments, Common Tests Performed, and Specimen Types
Laboratory Department Common Tests Performed Specimen Types
Urinalysis Physical appearance of urine Urine
Urine chemical analysis
Microscopic urine analysis
Microbiology/Parasitology Identification of pathogenic microorganisms Blood, urine, wound
Streptococcal screens specimens, tissue,
Antibiotic sensitivity testing stool, cerebrospinal
fluid, sputum, ure-
thral and vaginal
discharge, nails,
skin scrapings
Cytology Examination of various specimens for abnormal cells Urine, skin, tissue
Chromosomal studies specimens, sputum
Pap smears
Coagulation Testing for presence or absence of adequate clotting factors Whole blood
Histology/Pathology Examination for abnormal form and structure in tissues Tissue/organs,
biopsy specimens
from various parts
of the body, pre-
served and fresh
specimens examined

• Urinalysis: The physical appearance of urine is assessed, body are essential for the health-care provider to gain
and urine chemical and microscopic analysis is per- information that is not available through the patient
formed. history or physical examination. Health-care providers
• Microbiology/Parasitology: Identification of patho- generally order laboratory tests for at least one of these
genic microorganisms and antibiotic sensitivity testing. reasons:
• Cytology: Examination of various specimens for ab-
1. To assign a diagnosis. Laboratory testing may be used
normal cells, chromosomal studies, Pap smears.
to help with a differential diagnosis when the pa-
• Coagulation: Specimens testing for the presence of
tient’s symptoms are vague or similar to those of
various clotting factors.
other disease states. Diagnostic testing can also con-
• Histology/Pathology: Tissue samples examined for
firm a clinical diagnosis (such as diabetes or a my-
abnormal function and form.
ocardial infarction) when that confirmation could
lead to more effective treatment for the patient.
Test Your Knowledge 1-2 Microbiological testing may also fall into this cate-
Which laboratory department would perform a test to gory, as the identification of the bacteria and/or virus
see if someone had a pathogenic microorganism in a involved in the infection will be essential to establish
wound? (Outcome 1-3) an appropriate plan of action.
2. Prevention or early detection of disease through screen-
ing tests. Many chronic health conditions are asymp-
tomatic in the early disease stages. If these conditions
WHY IS LABORATORY TESTING are identified with routine screening tests (such as
PERFORMED? cholesterol measurements and routine prostate cancer
screening) early in the disease process, treatment may
Laboratory testing is critical for appropriate patient be much more effective in keeping the patient
treatment. The results obtained from a blood test or healthy. These screening tests are being ordered with
evaluation of other types of specimens from the human more frequency in the general population as more
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10 Section I Overview of the Laboratory

information becomes available about the advantages A clinical medical assistant working in a hospital or
of early diagnosis and treatment. reference laboratory may function as a phlebotomist or
3. Ongoing assessment of the patient’s progress and treat- may work as a laboratory assistant. A laboratory assistant
ment. Once a diagnosis has been established and treat- may be responsible for setting up microbiology cultures,
ment has begun, it is very important that the patient answering phones and responding to requests for labora-
is monitored closely. This often requires frequent tory results, assisting with bone marrow aspiration or
blood tests to determine therapeutic drug levels, other collection procedures, processing specimens and
hepatic profiles when a particular medication may delivering them to the various laboratory departments,
cause liver damage, or hemoglobin tests to see how performing CLIA-waived or moderate-complexity tests
effective the treatment might be for someone who is available in that laboratory setting, or assisting with
anemic. Patients may need to have their blood drawn preparation of tissue and cellular samples for examina-
daily, monthly, or quarterly. The frequency is depen- tion. Medical assistants may also perform point-of care
dent on the pathological condition. It may be neces- testing and assist with quality assurance in the laboratory.
sary to use specimens other than blood to monitor the An administrative medical assistant in a laboratory set-
treatment for a patient. Sometimes repeat cultures are ting might help with inventory and ordering of supplies,
also necessary to verify the efficacy (effectiveness) of data input, answering telephone calls, scheduling, billing
the antibiotic used to fight an infection. and coding, production and transmission of laboratory
reports, creation of other laboratory forms, and various
Test Your Knowledge 1-3 nonclinical patient interactions. These duties are neces-
sary in every laboratory, regardless of size or location.
When a pregnant young woman sees her nurse-midwife
for a routine checkup, the practitioner requests a test to
see if the patient is developing diabetes during the preg- Test Your Knowledge 1-4
nancy. Why is the test being performed? True or False: A medical assistant can work only in an
a. To assign a diagnosis administrative capacity in a hospital or reference
b. To screen for prevention or early disease detection laboratory. (Outcome 1-4)
c. To assess the ongoing status of treatment
d. None of the above (Outcome 1-4)
Test Your Knowledge 1-5
Are medical assistants able to perform laboratory
testing? (Outcome 1-5)
THE ROLE OF THE MEDICAL ASSISTANT IN
THE CLINICAL LABORATORY

A medical assistant can contribute in the clinical labora- INFORMATION FLOW IN THE CLINICAL
tory in various ways. The comprehensive training LABORATORY
received by medical assistants allows them to perform
clinical duties with direct patient contact, as well as In addition to understanding the organization of the clini-
offering employment opportunities in an administrative cal laboratory setting and identifying the reason laboratory
capacity. A clinical medical assistant working in a physi- testing might be performed, it is important to know how
cian office laboratory may be called on to perform phle- information is exchanged within the laboratory. To ensure
botomy or supervise urine drug screen collections for that laboratory test results are as meaningful as possible to
routine employment purposes, educate patients concern- the health-care provider, all those involved with specimen
ing collection protocols, collect and process microbiol- collection, processing, and testing must use the required
ogy specimens, and perform various test procedures. paperwork and database correctly. This information ex-
Medical assistants performing clinical duties may also be change will involve a laboratory requisition, a laboratory
asked to prepare microscopic specimens for examination, directory, a computer database, and a laboratory report.
and focus the microscope for providers to evaluate the
specimen. In addition, the medical assistant with appro-
Laboratory Requisitions
priate training may also perform microscopic examina-
tions such as white blood cell differential counts and A laboratory requisition (Fig. 1-1) is the form used by a
urine microscopy examinations. physician (or other qualified health-care professional) to
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Chapter 1 The Clinical Laboratory 11

Patient (Last, First, MI)

774911
CB LABORATORY Sex
Male Female
Date of Birth (required)

Patient Number Room # 774911

Guarantor Required if insurance or patient billing Day Phone

CLIENT ACCOUNT NO. 774911
790338
Shore Physicians Address PM Phone
13 Waterview Dr.
Seattle, WA 98103 City State Zip 774911
CALL RESULTS TO: 425-377-8571
FAX RESULTS TO: 425-792-1608 INSURANCE INFO (PLEASE ATTACH COPY OF CARD, W/GROUP # & ADDRESS)
774911
ORDERING PRACTITIONER - FULL NAME(S) REQUIRED
DRS NAME (Last, First, MI):
ADDL. COPY TO: 774911
ADDRESS:
PATIENT RELATIONSHIP TO SUBSCRIBER: SPOUSE CHILD OTHER

PHONE: FAX: TESTS HIGHLIGHTED IN RED OR MARKED

WITH A Δ MAY REQUIRE
ADDITIONAL TESTS/COMMENTS - DIAGNOSIS CODES REQUIRED FOR EACH TEST ORDERED A SIGNED ADVANCE BENEFICIARY
NOTICE (ABN), IF BILLING MEDICARE.
Collection Code: B = LIGHT BLUE FS = FROZEN SERUM L = LAVENDER R = RED TOP (PLAIN)
ADDITIONAL LCD TESTS NOT LISTED MAY
S = SERUM (GOLD TOP OR TIGER TOP) U = URINE REQUIRE AN ABN.

Specimen Information
Phone ( ) Collected by Date Drawn Time Drawn A.M. Fasting 24 Hour Urine
STAT or
Fax ( ) P.M. Random Volume

CPT Tests or Panels ICD9-CM CPT Tests or Panels (cont’d) ICD9-CM CPT Single Tests (cont’d) ICD9-CM CPT Single Tests (cont’d) ICD9-CM
Panel or Single tests may be selected Panel or Single tests may be selected 82378 CEA S 84702 Beta HCG Quant S
80051 Electrolytes Panel S 80069 Renal Function Panel S 82550 CK (CPK) S 84146 Prolactin S
84295 Sodium S 84153 PSA S
84132 Potassium S 80162 Digoxin R G0103 PSA Screen S
82435 Chloride S 84100 Phosphorus S 80101 Drug, Screen, Urine U 85610 PT with INR B
82374 Carbon Dioxide S 80061 Lipid Profile S x7 Is pt. taking Coumadin? Y N
80048 Basic Metabolic Panel S 82465 Cholesterol S 82728 Ferritin S 85730 PTT B
80051 Na, K, CL, CO2 S 84478 Triglycerides S 82746 Folate FS Is pt. taking Heparin? Y N
84520 BUN S 83718 HDL Cholesterol S 83001 FSH FS 85044 Retic Count L
82310 Calcium S 80074 Acute Hepatitis Panel S 82977 Gamma GT S 86592 RPR S
82465 Creatinine S 86709 Hepatitis A Antobidy IGM S 83036 Hgb A1C (Glycohemo) L 86762 Rubella Ab S
82947 Glucose S 86705 Hepatitis B Core 85014 Hematocrit L 85651 Sed Rate L
S
80053 Comprehensive Antibody IGM 85018 Hemoglobin L 84480 T3 Total S
S
Metabolic Panel 87340 Hepatitis B Surface 86701 HIV 1 Ab w/Western 84479 T3 Uptake S
S S
80048 Basic Metabolic Panel S Antigen Blot confirmation 84439 T4 Free S
82040 Albumin S 86803 Hepatitis C Antibody S 83540 Iron S 84436 T4 Total S
84075 Alkaline Phos. S 83550 Iron Binding (TIBC) S 84403 Testosterone Total S
82247 Bilirubin, Total S 83615 LD (LDH) S 80198 Theophylline R
84450 SGOT/AST S 84443 TSH S
84460 SGPT/ALT S CPT Single Tests 83002
ICD9-CM LH Luteinizing Hormone FS 81001 Urinalysis w/Micro,
84155 Total Protein S 86900 ABO Blood Group L, R 80178 Lithium R auto if indicated U
80076 Hepatic Function 86901 RH (D) Type L, R 83735 Magnesium S 82575 Urine Creatinine Clearance 24 hr U/S
(Liver) Panel S 86850 Antibody Screen L, R 86308 Mono S 84156 Urine Total Protein 24 hr U
82040 Albumin S 80184 Phenobarbital R 84540 Urine Urea Nitrogen 24 hr U
82247 Bilirubin, Total S 82150 Amylase S 80185 Phenytoin/Dilantin R CPT Microbiology ICD9-CM
82248 Bilirubin, Direct S 86038 Antinuclear Antibody S 85049 Platelet Count Auto L Aerobic Culture
84450 AST/SGOT S 82607 B-12 Vitamin FS 84703 Pregnancy, Qual. Serum S Source
84460 ALT/SGPT S 86141 hs-CRP S 81025 Pregnancy, Qual. Urine U Anaerobic Culture
84075 Alkaline Phos. S 80156 Carbamazepine/Tegretol R REQUIRED LAST CODE Source
84155 Total Protein S 85025 CBC w/auto diff L DATE A.M. Other
85007 Manual Diff. L TIME P.M. Source
Other Tests

Only tests or Medicare Approved Panels that are medically necessary for the diagnosis or treatment of a Medicare or Medicaid patient will be reimbursed.
Screening tests will not be reimbursed and should not be submitted for payment. The OIG states that a physician who orders medically unnecessary tests for which
Medicare or Medicaid reimbursement is claimed may be subject to civil penalties under the False Claims Act.

Figure 1-1 Sample laboratory requisition. Current Procedural Terminology © 2011 American Medical Association, All
Rights Reserved.
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12 Section I Overview of the Laboratory

document the tests that are to be performed for a pa-

Test Your Knowledge 1-6
tient. The form is filled out by the health-care provider
who orders the test or by the provider’s office staff. This Why is it important to have the name of the ordering
requisition must be complete with various data linking physician/practitioner on a requisition when ordering
the patient to the tests ordered, and must provide billing laboratory testing? (Outcome 1-6)
information for that patient. The laboratory staff will use
this requisition to enter the orders into their database for
the patient, and the form is often used for reimburse- Laboratory tests may be ordered as panels or profiles,
ment procedures as well. Although all laboratories may which consist of a group of tests that are designed to in-
use unique formats, standardized information should be dicate a problem with a specific organ system or disease
present on all requisitions for testing and reimbursement process. Tests may also be ordered individually, or the
purposes: requisition may contain orders for a combination of
both. Often the requisitions are organized according to
• Patient demographic information, including name, the general types of tests, such as hematology, serology,
address, phone number, and birth date. or chemistry. On the requisition, each test will have a
• Patient gender. five-digit procedure code (known as a CPT code), which
• Complete patient insurance and billing information. is necessary for reimbursement purposes. There may also
• Date and time of collection, and identification of the be a code or symbol included on the requisition, indicat-
person who performed the collection. ing the type of tube or specimen container that is neces-
• Documentation of how the results are to be relayed to sary for that specific test. This information is valuable as
the health-care provider who ordered the tests, and a quick reference for the phlebotomist when collecting
documentation of any other practitioner who is to the specimen.
receive a copy of the results. Most requisitions also include some sort of label that
• Appropriate diagnostic information in the form of an can be peeled off and applied to the specimen container.
ICD-9 code to allow for reimbursement for the test This label may have numbers, bar-code symbols, or both.
ordered. An ICD-9 code is the numeric indicator for These labels link the patient information provided on
the diagnosis or symptom associated with the labora- the requisition with that specific sample once it has been
tory test ordered. entered into the database for the laboratory.
• Test selection, clearly marked with a check, circle, or X
in the appropriate area on the requisition. Tests may Advance Beneficiary Notice of
also be written in if they are not preprinted on the
Noncoverage
requisition used.
• Any additional comments that may assist with the or- An Advance Beneficiary Notice of Noncoverage
dering or interpretation of the test. (ABN) is a document that may be necessary to receive

Procedure 1-1: Completing a Laboratory Requisition

TASK CONDITIONS
Correctly fill out a laboratory requisition, including all • Laboratory requisition
necessary information for reimbursement. Include an • Patient demographic information
ABN if necessary. • Patient insurance information
• Laboratory order from qualified health-care professional
CAAHEP/ABHES Standards • ICD-9 code for diagnosis or symptoms
• Advance Beneficiary Notice of Noncoverage
None
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Chapter 1 The Clinical Laboratory 13

Procedure Rationale

1. Greet and identify patient using at least two All patients must be identified properly before collect-
unique identifiers. ing samples or performing laboratory testing.
2. Verify test ordered. All laboratory test orders should be verified by check-
ing the chart and/or requisition more than once.
3. Fill in the requisition with the patient’s demographic The patient’s demographic information (including age
information by printing it clearly, or by using a data and gender) is used for reimbursement as well as
entry program if available at your location. establishing reference ranges for the tests ordered.
4. Ask patient for an insurance card if he or she is The insurance card should be used for the information
insured. added to the requisition; do not rely on information
that the patient provides from memory.
5. Copy both sides of the insurance card, and add the Be sure to include the insurance identification number
information to the requisition in the appropriate as well as the group number for appropriate reim-
site. bursement. The back of the card is important to
copy, as it provides the insurance company’s contact
information in case of claim questions.
6. Establish the relationship of the patient to the Sometimes the patient is not listed on the insurance card;
insured. Document that on the requisition. it may be a spouse or a child or other dependent.
7. If the patient has a medication level ordered (such Some medication levels are clinically significant only
as digoxin), ask when the patient took the last when drawn at a specific interval after the last dose.
dose. Use the laboratory directory if necessary to
verify whether it is the correct time to draw the
specimen. Note the time of the last dose on the
requisition.
8. If the patient has Medicare Part B as his or her pri- The laboratory may have a database established in which
mary insurance coverage, verify whether an Advance the employee can type in the name of the test ordered
Beneficiary Notice of Noncoverage is necessary. This and the diagnosis code provided, and the software will
must be completed and signed before the specimen be able to determine whether an ABN is necessary. If
collection begins. there is no automated system in place, the employee
may need to use an alternative reference. Many labo-
ratories provide their clients with a book of covered
diagnosis codes for the tests with limited coverage.
9. Clarify which physician ordered the test and doc- Many times the requisitions will be preprinted with the
ument that on the requisition. If additional copies name of the physician office or practice group. It is
are to be sent to other health-care providers, add still necessary to document which physician within
this information to the requisition as well. the practice actually ordered the laboratory test to
be performed.
10. Document whether the test was ordered as STAT If the test was ordered as STAT, it needs to be drawn
or routine. and processed immediately. It may be necessary to
contact a laboratory courier to pick up the sample
immediately, or to notify the technician that there is
a STAT order.
Continued
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14 Section I Overview of the Laboratory

Procedure 1-1: Completing a Laboratory Requisition—cont’d

Procedure Rationale

11. Check the requisition for an ICD-9 code for each An ICD-9 code is necessary for every test for success-
test to be performed. If a code is not present, con- ful reimbursement.
tact the health-care provider or check the chart to
obtain a code.
12. Have the patient wait in a comfortable environ- Sometimes the employee who fills out the requisition is
ment until the sample can be collected. Place the not the same person who will collect the sample.
requisition in an appropriate location to alert other
staff members that a specimen collection is waiting.

reimbursement for laboratory services. It is specifically a specimen collected, the laboratory employee responsible
used for patients who have Medicare Part B as their for the specimen collection must verify whether the test
primary insurance coverage. The purpose of an ABN is ordered will be covered by Medicare for the reason that
to inform Medicare-covered patients that payment the test is ordered. The regulations affecting coverage are
may be denied for a specific laboratory test and that different for geographical regions across the country, and
the patient will be billed for the full cost of that test if change frequently. Most laboratories now have a way to
he or she chooses to have it performed. The ABN al- verify coverage by using a computer database, but it can
lows the patients to make an informed decision about be difficult to keep abreast of changes. It is unlawful to
whether they wish to have the tests performed, with have every Medicare patient fill out an ABN “just in
the realization that they may be responsible for the case”; it is the responsibility of those collecting the speci-
total cost. men to make their best effort to verify coverage before an
The ABN must be verbally reviewed with the pa- ABN is signed.
tient, and any questions about potential reimburse- The format for this Advance Beneficiary Notice of
ment must be answered before it is signed, whether or Noncoverage document is defined by the Centers for
not the patient wishes to have the laboratory work per- Medicare & Medicaid Services (CMS), and is updated
formed. This process must occur before the specimen periodically (CMS document number CMS-R-131).
is collected from the patient. The person collecting the Medicare bases its decision for coverage on “medical
specimen must ensure that the test ordered has been necessity” rules, which define those tests that the
identified on the ABN form and that there is docu- agency deems medically necessary for specific health
mentation of the anticipated reason for noncoverage. conditions, and how frequently these tests should be
Figure 1-1 shows an example of an ABN. The em- performed. It is important to remember that just be-
ployee filling out the form also must provide an esti- cause Medicare has limited coverage on specific tests,
mated cost in writing so that the patient knows what the patient should never be told that the health-care
the financial responsibility may be if he or she decides provider gave a “bad code” or that the test was ordered
to have the laboratory test performed. The patient’s for the “wrong reason.”
decision about having the test performed must be doc-
umented on the form, along with the patient’s signa- Test Your Knowledge 1-7
ture and that day’s date. The patient must receive a What is the purpose of an ABN? (Outcome 1-7)
copy of the form after it is signed, and a copy must
also be kept on file with the laboratory.
Medicare coverage for laboratory tests may be denied
Laboratory Directory
for various reasons, including frequency of testing, the
diagnosis provided by the health-care provider for a spe- As discussed, laboratory requisitions often provide in-
cific test, or because the test ordered is considered exper- formation about what type of tube to use for a blood
imental. Whenever a patient with Medicare coverage has draw for a specific test by using a code or symbol, but
1899_Ch01_001-024 23/12/11 12:51 PM Page 15

Chapter 1 The Clinical Laboratory 15

CB LABORATORY 2692 Millenium Rd. • Seattle, WA 98103 ADVANCE BENEFICIARY NOTICE (ABN)
425-353-8778

Patient’s Name: John Smith Identification Number: 23995500

ADVANCE BENEFICIARY NOTICE OF NONCOVERAGE (ABN)

NOTE: If Medicare doesn’t pay for the Laboratory Test(s) Below you may have to pay.
Medicare does not pay for everything, even some care that you or your health-care provider have good reason to think you
need. We expect Medicare may not pay for the Laboratory Test(s) below.

Laboratory Test(s): Reason Medicare May Not Pay: Estimated Cost:

PROSTATIC SPECIFIC AG Denied as too frequent $50.10

TSH Denied for your condition $41.34

WHAT YOU NEED TO DO NOW:

• Read this notice, so you can make an informed decision about your care.
• Ask us any questions that you may have after you finish reading.
• Choose an option below about whether to receive the Laboratory Test(s) listed above.
Note: If you choose Option 1 or 2, we may help you use any other insurance that
you may have, but Medicare cannot require us to do this.

OPTIONS: Check only one box. We cannot choose a box for you.

OPTION 1. I want the Laboratory Test(s) listed above. You may ask to be paid now, but I also want Medicare billed
for an official decision on payment, which is sent to me on a Medicare Summary Notice (MSN). I understand that if
Medicare doesn’t pay, I am responsible for payment, but I can appeal to Medicare by following the directions on the
MSN. If Medicare does pay, you will refund any payments I made to you, less co-pays or deductibles.

OPTION 2. I want the Laboratory Test(s) listed above, but do not bill Medicare. You may ask to be paid now as I am
responsible for payment. I cannot appeal if Medicare is not billed.

OPTION 3. I do not want the Laboratory Test(s) listed above. I understand with this choice I am not responsible for
payment, and I cannot appeal to see if Medicare would pay.

Additional Information:
This notice gives our opinion, not an official Medicare decision. If you have any other questions on this notice or
Medicare Billing, call 1-800-MEDICARE (1-800-633-4227/TTY: 1-877-486-2048).
Signing below means you have received and understand this notice. You also receive a copy.

Signature: Date:

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless
it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0566. The time
required to complete this information collection is estimated to average 7 minutes per response, including the time to review
instructions, search existing data resources, gather the data needed, and complete and review the information collection. If
you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to:
CMS, 7500 Security Boulevard, Attn: PRA reports Clearance Officer, Baltimore, Maryland 21244-1850.

Form CMS-R-131 (03/08) Form Approved OMB No. 0938-0566

HNL-18 (03/09) WHITE: LAB COPY CANARY: PATIENT COPY ADVANCE BENEFICIARY NOTICE (ABN)

Figure 1-2 Example of an Advance Beneficiary Notice of Noncoverage (ABN).

the information provided on the requisition is limited the laboratory performs that specific analysis if
at best. The requisition does not include information the physician needs to know this information. This
about how to process and store the specimen, or what additional information about specimen collection
the minimum volume may be for the test ordered. It and handling may be found in a laboratory directory
also does not include information about how often (Fig. 1-3).
1899_Ch01_001-024 23/12/11 12:51 PM Page 16

16 Section I Overview of the Laboratory

POINT OF INTEREST 1-1 completed. If the specimen was collected by an

Advance beneficiary notice employee at a physician office and transported to the
of noncoverage laboratory for testing, the physician office will often
receive a bill for the service from the laboratory, because
If a laboratory accepts Medicare assignment, it is not that laboratory cannot be reimbursed in any other way.
legal to bill Medicare beneficiaries for laboratory tests It is illegal to have every Medicare patient fill out
that are covered by Medicare Part B. However, an ABN; these forms are to be used only when neces-
Medicare does not cover all laboratory tests, so there sary for noncovered tests. In addition, the laboratory
are many situations in which the health-care must retain a copy of the ABN and the patient must
providers may order tests that are not covered by also be given a copy. Advanced Beneficiary Notices of
Medicare but that provide valuable information for Noncoverage are also used for other medical services;
patient treatment. The only way that the laboratory it is necessary to have a specific one for each type of
can be reimbursed for these tests is to have the patient noncovered service.
complete a valid Advance Beneficiary Notice of Non-
coverage, also known as an ABN. This form must be
completed and signed prior to the specimen collec-
tion. The ABN form informs the Medicare benefici- Commonly, a laboratory directory is a computer
ary of the test that has been ordered, and specifies the database of specific information about tests that are per-
reason that Medicare may not pay for the tests, as formed by that laboratory. The directory may also be
well as providing the estimated cost for the test. provided in a book format, which can be consulted by
The ABN is necessary in these situations: facilities that do not have Internet access. The laboratory
directory (also known as a directory of services) provides
• When the test ordered is not medically necessary in the following types of information:
Medicare’s opinion for the ICD-9 code (diagnosis)
that is provided. This situation is also present if • The internal test number used to enter the test order
there is no ICD-9 code given for the test ordered. into the database
• Many screening tests are not covered by Medicare; • CPT five-digit code used for reimbursement for that test
these are often not covered if there is no evidence • Related information if there is more than one place
of disease. within the directory where the test is addressed
• Tests that are ordered more frequently than what is • Acronyms or abbreviations that may be listed on the
recommended by Medicare. requisition for that test, or perhaps used to order
• Any test that is still considered to be investigational the test in the computer system for that laboratory
or experimental in nature. These tests have not yet • The type of specimen required, and in some cases the
been approved by the FDA. type or color of tubes to use for the blood draw or
identification of the additives that must be present in
Often those who work with Medicare patients will the tubes
use the term limited coverage to refer to the rules that • The requested specimen volume and the minimum
govern laboratory reimbursement. This means that acceptable specimen volume
Medicare will pay for laboratory tests only when they • Collection notes and/or specific requirements neces-
meet certain criteria. These may be national coverage sary for some tests
decisions or local coverage decisions. Nationally, there • Storage instructions for the specimen after collection
are several tests established that have limited coverage and during transportation (room temperature, frozen,
(based on the ICD-9 codes, frequency of testing, or the refrigerated, etc.)
investigational status) and regional restrictions may • Reference ranges (also known as normal ranges) for
add to the list that is established on a national basis. the test ordered
By signing the ABN, the Medicare patient is giving • Clinical significance and interpretation of the test
the laboratory permission to bill him or her directly for results
the test to be performed. If the employee who draws the • Testing intervals/frequency and testing locations
blood does not get an ABN signed when appropriate,
the laboratory will be performing the test for free, as Once the specimen requirements have been established,
it cannot have the ABN signed after the process is the collection process can continue. The employee who is
performing the collection must document two unique
1899_Ch01_001-024 23/12/11 12:51 PM Page 17

Chapter 1 The Clinical Laboratory 17

CB LABORATORY 2692 Millenium Rd - Seattle, WA 98103

425-353-8778

GLYCOHEMOGLOBIN
Order Test
GLYCO GLYCO
Represents average glucose concentration over a 6–8 week period.
Synonyms HbA1C; Hemoglobin A1C
Specimen Required
Container Type Lavender top tube (EDTA)
Specimen Type Whole blood
Minimum Volume 1 mL
Specimen Processing Store and transport refrigerated.
Stability Room Temp 24 hours Refrigerated 7 days Frozen (–20°C) 2 weeks
Alternate Specimens Sodium flouride/potassium oxalate whole blood (grey top tube).
Department Immunochemistry
CPT Codes 83036
Test Schedule Sun-Fri nights
Turnaround Time 24–48 hours
Method HPLC
Test Includes
HbA1c, %
Reference Ranges
HbA1c 4.0–6.0 Non-diabetic %
The American Diabetes Association
considers a result of less than 7% to be
the goal of diabetic therapy.

Figure 1-3 Sample of information found in a laboratory directory.

Procedure 1-2: Use a Laboratory Directory

TASK CONDITIONS
Use a laboratory directory to clarify the collection require- • Laboratory requisition
ments and processing procedures for a laboratory order. • Laboratory order from qualified health-care
professional
CAAHEP/ABHES Standards • Laboratory directory book or database including
laboratory service information
None
Continued
1899_Ch01_001-024 23/12/11 12:51 PM Page 18

18 Section I Overview of the Laboratory

Procedure 1-2: Use a Laboratory Directory—cont’d

Procedure Rationale

1. Obtain the laboratory requisition or the laboratory Some tests, such as creatinine or total protein, are com-
order from the health-care provider. Verify the test monly ordered on blood but may also be ordered
ordered, especially if it is a test that may be per- using a urine specimen.
formed on more than one body fluid.
2. Look up the test alphabetically using the computer This can sometimes be difficult if the test is ordered
database or the laboratory directory reference book. under an acronym or abbreviation or if there are two
names used for the test, such as Tegretol, which may
also be known as carbamazepine. Many laboratory
directories will include a cross-reference that may
help the user to find the correct entry.
3. Identify the type of specimen to be collected. The information may be very straightforward, specify-
ing the color of tube to be used. (For example,
lavender-top or green-top tube.) However, some-
times the specimen requirements are described as
“heparinized plasma” or “EDTA plasma.” The
employee needs to know which type of tube to use
for this type of specimen.
4. Verify any restrictions on specimen type, or nota- For instance, many tests cannot use hemolyzed sam-
tions of unacceptable specimens. ples, or sometimes samples that are over 2 hours old
cannot be used.
5. Verify the acceptable minimum volume, if listed. There may be a requested volume (e.g., 1 mL) as well
as a minimum volume listed. The minimum vol-
ume may be important if drawing the specimen
from a child or other patient with difficult-to-
access veins.
6. Identify the specimen processing instructions. Is the specimen supposed to be spun within a certain
time after the blood draw? Is the plasma or serum to
be frozen? The processing instructions are very im-
portant for the specimen to be acceptable when it
arrives at the testing laboratory.
7. Identify the schedule for performance of the test The reference laboratory may list the testing schedule
ordered. so that the health-care provider will be aware of how
long it will take before he or she can expect the
results for the test.
8. Prepare the necessary supplies to perform the speci- If a specimen must be frozen immediately or kept at
men collection. a certain temperature, it is necessary to have the
supplies at hand immediately after the specimen
is collected. These should be prepared before
proceeding.
1899_Ch01_001-024 23/12/11 12:51 PM Page 19

Chapter 1 The Clinical Laboratory 19

identifiers for the patient, the employee ID (or initials), the performed, as well as the reference ranges (also known as
date of collection, and the time of collection on the requi- normal ranges) that have been established by the labora-
sition and on the tube or alternative collection container. tory for that test. Reference ranges are the results that are
This same employee may also be responsible for entering expected in the general healthy population 95% of the
the patient information into the computer database, time for a particular laboratory test. A range is necessary
whereas in other laboratories the specimen and paperwork (instead of a specific value) because of differences in the
may be prepared for transport to another location where population due to age, race, and gender. Geographical
the information will be added to the database upon arrival. locations may also affect the reference range, as will the
testing methods used by that laboratory. A notation will
Test Your Knowledge 1-8 be present on the laboratory report for all results that are
Why would a medical assistant use a laboratory directory
outside the expected reference range for that patient,
before performing a blood draw? (Outcome 1-8)
based on demographics, the testing method, and the test
ordered. The gender and age of the patient may affect
the reference ranges used for interpretation of the results,
so it is critical that this information is provided whenever
Laboratory Reports a sample is collected.
Once the specimen has been processed, delivered to the The laboratory report will also include the date and
correct department, and tested within the laboratory, a time of the specimen collection, the name and identifi-
laboratory report is generated to transmit the test results cation number for the patient, and the name and address
back to the health-care provider. An example of a labo- of the laboratory where the test was performed. The
ratory report is presented in Figure 1-4. The laboratory specimen source is identified, as well as the date and time
report document will list the results for the tests the report was generated.

CB LABORATORY
Patient: Sally Seashore Date/Time: 7/20/2012 16:50
DOB: 08/07/1957 Sex: Fe Report Status: Final
ID# 774909

PROCEDURE RESULT ABN REFERENCE UNITS

VALUES RANGES
Rapid strep screen
Rapid strep screen Positive
Dipstick UA only
Appearance-UA Clear
Color-UA Yellow
Glucose-UA Neg
Ketone-UA Neg
UA spec gravity 1.010 1.002 – 1.030
Occult-blood-UA Neg
pH-UA 6.0 5 – 7.9
Protein-UA Neg
Nitrite Neg
Leukocyte esterase Neg
Electrolytes
Sodium 141 136 – 145 mEq/L
Potassium 4.8 3.5 – 5.0 mEq/L
Chloride 100 96 – 106 mEq/L
CO2 25 22 – 30 mEq/L
Hemoglobin + Hematocrit
Hgb 10.9 L 12 – 16 g/dL
HCT 33 L 37 – 48 g/dL

Flags: H = High L= Low A = Abnormal Crit = Critical

Tests performed at: CB Laboratory, 2692 Millenium Rd., Seattle, WA 98103
Figure 1-4 Sample laboratory report.
1899_Ch01_001-024 23/12/11 12:51 PM Page 20

20 Section I Overview of the Laboratory

Procedure 1-3: Distinguish Between Normal and Abnormal Test Results

TASK ABHES Standards

Use a laboratory report to identify normal and abnor- None
mal test results for a patient.
Conditions
CAAHEP/ABHES Standards
• Laboratory report
• Pen, pencil, or highlighter
CAAHEP 2008 Standards
II.A.2: Distinguish between normal and abnormal test
results

Procedure Rationale

1. Examine the laboratory report for all necessary All laboratory reports must include the following:
information. 1. The name of the patient
2. The patient ID
3. The gender and age of the patient
4. Laboratory results with documented reference
ranges
5. The name of the ordering health-care provider
6. The date and time of specimen collection
7. The date and time that the specimen was tested
8. The name of the laboratory where the test was
performed
2. Identify the column on the laboratory report where This column is usually near the patient results, and the
the reference ranges are noted for each of the test data are often listed as a range, except in the case of
results. tests that provide a positive and negative test result,
or in the case of microbiology testing, antibiotic
sensitivity testing, or immunology testing.
3. Compare the patient results to the reference range Remember that the reference ranges may take the age
column. and gender of the patient into consideration; the
ranges will not necessarily be the same for all patients
tested.
4. Circle or highlight the results that are not within the Highlighting or circling these results may bring them to
reference ranges. Document High or Low next to the attention of the provider. When a laboratory
the values in the provided area. report is printed in the office (rather than one used
in the classroom) the High or Low results are noted
on the laboratory report when it is printed. However,
the office protocol may also include highlighting or
circling the results when the report arrives in the
office to make certain that they are not overlooked.
1899_Ch01_001-024 23/12/11 12:51 PM Page 21

Chapter 1 The Clinical Laboratory 21

Laboratory reports may be hand-delivered to the or- the testing process, it is important to realize that there
dering health-care provider by a medical assistant within are three components, known in laboratory jargon as
an office or via a courier service from a reference labo- phases, associated with laboratory testing: preanalytical,
ratory. They may also be faxed, mailed, or in some cases analytical, and postanalytical. A description of each
transmitted via e-mail. In some situations, the labora- phase of testing is detailed below and summarized in
tory reports may also be available online through a ded- Table 1-3.
icated laboratory link so that the provider can view the
• Preanalytical Phase: The preanalytical phase of labo-
results on site. These results must be reviewed as soon as
ratory testing refers to the situations and actions that
possible so that appropriate action can be taken for
take place prior to the collection, during the collection,
those outside of the normal reference range. Laboratory
and during the processing/storage/transportation of the
reports are a legal document that becomes part of the
specimen. Phlebotomists and medical assistants often
patient’s health record.
participate in this phase of laboratory testing. The im-
portance of this phase cannot be emphasized enough.
Test Your Knowledge 1-9 Generally speaking, the majority of problems associated
In which ways are laboratory requisitions and labora- with laboratory tests result from inadequate or inappro-
tory reports similar? (Outcome 1-9) priate specimen collection, processing, storage, and
transportation (i.e., the preanalytical phase of testing).
• Analytical Phase: The analytical phase of laboratory
THREE PHASES OF LABORATORY TESTING testing refers to the performance of the tests that have
been ordered. This phase also includes maintenance
As we begin to understand the way that a laboratory is and calibration of laboratory equipment and instru-
organized and how information is transferred through ments associated with the testing and performing

TABLE 1-3
Identification of, Definition of, and the Personnel Responsible for the Three Phases of Laboratory Testing
Phase Definition Personnel Responsible
Preanalytical All procedures/processes that occur before the speci- Medical assistant, phlebotomist, CLT
men is actually tested. Includes patient preparation, or MLT, other laboratory profession-
accurate paperwork and data entry, appropriate als involved in this process
specimen collection, processing, storage and
transportation.
Analytical All procedures/processes involved in the testing of the Medical assistant, medical laboratory
specimen. This includes the way the testing instrument professional performing the test,
was prepared and maintained, how the testing sup- supervisor responsible for training
plies were stored, appropriate training of the person- and overseeing the process, person-
nel performing the test, and quality control to ensure nel performing maintenance on
that the testing methods are working properly. instruments
Postanalytical All procedures/processes that affect how the test results Various laboratory professionals that
are handled when the analysis has been completed. perform the test, administrative
These may include review and analysis of the results laboratory support personnel that
by the person performing the test, appropriate follow- process the results, medical assis-
through on extremely high or low results, how the tants or other physician office
results are recorded (in a computer or on paper, etc.) personnel who perform charting
phone calls, report printing, report sorting, appropri- procedures, physicians and other
ate fax procedures, charting procedures within an health-care professionals who
office, physician review procedures, contact with interact directly with the patients.
patient if necessary for follow-up.
1899_Ch01_001-024 23/12/11 12:51 PM Page 22

22 Section I Overview of the Laboratory

quality control (QC) measures, which are in place to provide the ordering practitioner with the final test
validate the test reagents/kits, the testing process, and results and reference ranges. Reimbursement procedures
training of the laboratory personnel performing the test. may involve laboratory personnel, so it is important
• Postanalytical Phase: The postanalytical phase of that these individuals understand the processes
laboratory testing includes the processes associated involved with the necessary documentation on a req-
with the recording and reporting of laboratory results, uisition and the use of an ABN.
storage and/or disposal of specimens after testing, and There are three phases of laboratory testing, includ-
provider and patient notification of test results. Even ing the procedures surrounding specimen collection
if the other two phases of testing occur without any and handling, the actual testing process, and the man-
exceptions, if this phase isn’t handled appropriately, ner in which the results are reported back to the physi-
then the overall experience will not be a positive one, cian. These are the preanalytical phase, the analytical
and may negatively affect patient treatment. phase, and the postanalytical phase. All three phases
must be handled correctly for laboratory results to be as
Test Your Knowledge 1-10
meaningful as possible as part of quality patient care.
List the three phases of laboratory testing.
(Outcome 1-10)
TIME TO REVIEW

Test Your Knowledge 1-11 1. If a patient is asymptomatic, it means Outcome 1-1

that he or she:
If a specimen is collected into a tube with the wrong type
of anticoagulant for the test ordered, which phase of a. Demonstrates specific symptoms of a disease state
laboratory testing has gone wrong? (Outcome 1-11) b. Complains of multiple symptoms
c. Does not exhibit symptoms
d. Is not ill
2. True or False: A specimen may be Outcome 1-1
SUMMARY defined as a part of something that demonstrates the
Laboratory testing is vital to the diagnosis of patient characteristics of the whole.
disease and implementation of proper patient treat-
ment, as it provides critical information that cannot be 3. What do hospital and reference Outcome 1-2
gathered with a physical examination alone. Testing laboratories have in common?
may occur in physician office laboratories, in hospital 4. Is urine analyzed only in physician Outcome 1-2
laboratories, or in large reference laboratories. The office laboratories?
larger laboratories may be organized by departments as
needed for efficient specimen handling. Various person- 5. A medical assisting student needs to Outcome 1-3
nel perform the testing procedures, and their education have a blood test performed to see if she has antibodies
and titles will vary depending on their responsibilities to hepatitis B in her bloodstream. This test would most
and the type of testing performed in the respective likely be performed in this laboratory department:
laboratory. Medical assistants play an important role in a. Blood Banking
the laboratory by providing direct patient interaction, b. Hematology
specimen collection, and processing or performance of c. Serology
laboratory tests. d. Microbiology
Laboratory information, such as that provided on
6. Which laboratory department is Outcome 1-3
a requisition, is vital for proper testing procedures,
responsible for accessioning specimens into the labo-
result interpretation, and reimbursement for services
ratory information system when they arrive at the
provided. The exchange of information begins with a
laboratory?
requisition and may involve the use of a laboratory di-
rectory for specimen requirements and other specifics. 7. Mr. Earl has a laboratory test performed Outcome 1-4
The process ends with the laboratory reports that to see if the diet and exercise changes suggested by
1899_Ch01_001-024 23/12/11 12:51 PM Page 23

Chapter 1 The Clinical Laboratory 23

his health-care provider have helped to lower his

cholesterol levels. Which of these reasons explains Case Study 1-1: Potential for growth
why this test is being ordered?
Cindy Lee, a certified medical assistant (CMA) working
a. Assignment of a diagnosis in a gynecology office, leaves early one Friday before
b. Ongoing assessment of the patient’s progress and her office closes. When she returns on Monday morn-
treatment ing, she finds a box containing agar plates for microbi-
c. Prevention or possible early detection through ology specimen growth on the counter in the laboratory
screening tests area. Cindy notices that the box has KEEP REFRIGER-
d. None of the above ATED printed on the outside, but it appears that the box
has been left out all night, and the cold packs within the
8. Which of these duties might a medical Outcome 1-5 box are at room temperature.
assistant perform in a laboratory setting?
• Should Cindy be concerned about this situation?
a. Urine drug screen collections • Which phase of laboratory testing may be affected
b. Phlebotomy by this oversight?
c. Urinalysis testing
d. Preparation of microbiology specimens for testing
and/or analysis
e. All of the above RESOURCES AND SUGGESTED READINGS
9. True or False: A diagnosis code does Outcome 1-6 American Society for Clinical Laboratory Science Consumer
not need to be included on a requisition at the time Lab Testing Information
the laboratory test is ordered. http://www.ascls.org/labtesting/index.asp
Numerous questions and answers on general laboratory
10. True or False: A requisition is used Outcome 1-6 testing.
only for ordering the laboratory tests. American Society for Clinical Laboratory Science Introduction
to Laboratory Testing
11. The abbreviation ABN stands for: Outcome 1-7
http://www.ascls.org/labtesting/labintro.asp
a. Advance Beneficiary Notice of Noncoverage Introduction to the three phases of laboratory testing; also
b. Advance Beneficiary Notification basic terms referring to analytical aspects of quality control.
c. Action Bulletin of Noncoverage Centers for Medicare & Medicaid Services Overview of
d. Advance Bulletin of Noncoverage Beneficiary Notices Initiative
http://www.cms.hhs.gov/bni
12. The laboratory directory will includeOutcome 1-8 Links to various ABN information, including the new and old
___________________ instructions for a specimen after forms in use and answers to various commonly asked questions.
collection and during transportation. Good Laboratory Practices for Waived Sites
http://www.cdc.gov/mmwr/preview/mmwrhtml/
13. True or False: The terms laboratory Outcome 1-9 rr5413a1.html
requisition and laboratory report may be used An overview of some problems that have occurred in
interchangeably. waived test sites and an introduction to the three phases of
laboratory testing. Recommendations for good practices
14. Which phases of laboratory testing Outcome 1-11
overall.
might be affected by the actions of a medical CLIA Update—January 2010. Division of Laboratory Services,
assistant in his or her various laboratory roles? Centers for Medicare & Medicaid Services; Laboratories by
Type of Facility (Exempt/Nonexempt combined)
http://www.cms.gov/CLIA/downloads/factype.pdf
Lists the number of different types of laboratories registered
with CMS as of January 2010.