UNIT LABORATORY SERVICES

Structure

1.0 Objectives
1.1 Introduction
1.2 Role and Functions of Laboratories
Types and Functional Components of Laboratories (Laboratory Medicine)
1.3.1 Functional Components
1.3.2 Types of Laboratories
Concepts of Planning Organisation
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1,J.I Physical Facilitics and Layout

1.4,2 Equiprncnt/Rcngentsand Pncilitics
1.4.3 Rescurch ant1 Training
Policies and Procedures
1.5.1 Laboratory Administrntion
1 S.2 Quality Control, Quality Asscssmcnt. Accreditation and Tolnl.Quulity Mu~iapcmcnt
(TQM)
1.5.3 hadcrship and Motivation
1.5.4 Personncl Management
1.5.5 Pcrsonncl Policies
1.5.6 Job Dcscription and Stilffing
1.5.7 Rccruitmcnt, Policics and Procedures
Information Management
Managerial Issues
1,7.1 Problc~nsof Management
1.7,2 Labaratory Huzards
1.7.3 Safely Prccautions in the Laboratory
1.7.4 Laboratory Waste Managemcnt
Control and Evaluation
Let Us Sum Up
Answers to Check Yaur Progress
Further Readings

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1.0 OBJECTIVES
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After going through this unit, you should be able to:
list the roles und functions of laboratory:
describe the types and functional components of a laboratory service;
discuss the planning concepts in organisation of laboratory services;

describe the policies and procedures concerned with laboratory services: and
identify the key managerial issues in planning and or&onisalion nf laboratory services.

1.1 INTRODUCTION
In this unit you will learn about definition, types and choractcri~ticsof laboratory services
and also about planning consideration, physical faoilities and layout, You will also learn
DiDgmtk nnd Thornpcutlc about the use of equipment for various types of laboratories and staff requirement, need for
Servke6
training and research requirements. Further you will learn about the maintenance of
minimum standards of lnboratory quality assessment and various progralnmes of the
country. Towards the end you will learn about the application of sound principles for
personnel management, efficient and cost effective operation of a clinical laboratory with
timely, effective delivery of medical laboratory services to clinicians and patients.

1.2 ROLE AND FUNCTIONS OF LABORATORIES

The laboratory as you know exists for the sole purpose of proyiding diagnostic and
management information for the physicians to aid in the patient care, The ultimate goal of
laboratory is to attend to the ailing patients, carry out the investigations asked and prompt
issue of nccurate results for favour of diagnosis and treatment.

The clinician uses the laboratory to get assistance in diagnosis and management of the I

patient. Infact, a test requisition is a request for consultative services which sets in motion
a vnst array of activities to generiite a laboratory report. Usefulness of the data in making
clinical judgements depends upon prompt, accurate reporting of the result. Each procedure i,
to generate a result consists of series of steps, or processes. An adequate understanding of I
each process enables the laboratorian to achieve more nearly optimal conditions and,
consequently, to improve the accuracy and precision of each measurement. Collection, i
handling and processing the specimen prior to analysis must receive prime consideration.
Validity of data obtained on the specimen itself is highly dependent upon the excellence of

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laboratory technique, including proper manipulation of equipment, use of reagents of
specified purity.
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Check Your Progress 1
I

1) Define laboratory,

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3) Enlist three functions of laboratory.

1.3 TYPES AND FUNCTIONAL COMPONENTS OF

LABORATORIES (LABORATORY MEDICINE)

Having learnt the definition and functions of laboratory, now you will learn the functional
components and types of laboratories.

1.3.1 Functional Components

I
The Functional components of a clinical laboratory are:

i) Histopathology
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ii) Clinical Pathology
iii) Microbiology
iv) Haematology
v) Biochemistry
vi) Research laboratories

There are further subdivisions of each of the above components related to sub or super
 specialisation. However, these are not enumerated here. Only the functional laboratories Laboratory Scrvlccs
in routine day to day diagnostic work are summarised.

( i) Histopathology
Laboratory performing organ, tissues, cell examination for the diagnosis of various types of
abnormalitiesldiseasesis called as Histopathology Laboratory. Examinations of
tissueslorgans are from livingldead body, in the form of either surgical specimen; biopsy or
autopsy.
I ii) Clinical Pathology
This is the branch of pathology in which all body fluids such as blood, urine, sputum, stool,
pleural, peritoneal fluid are examined for physical, chemical, bacteriological and
microscopic examination for normal or abnormal contents.
1 iii) Microbiology
This is the science which deals with study of microbes such as bacteria, viruses, parasites
etc. The study involves the identification, morphological and cultural studies, serology and
sensitivity of organisms responsible for cnusing the disease or commonly found as
commensals.
iv) Haematology
Branch of laborntory Medicine in which the study of blood and blood components js,done
for detection of various abnormalities in normal and ill health.
1 V) Chemical Pathology (Biochemistry)
Science which determines and measures various chemical substances in normal and
abnormal amounts produced during disease process. The study includes examination of
various groups of clinical substances, hormones, enzymes, isoenzyme, vitamin and
metabolites etc.
vi) Clinical Research Laboratories
Are those laboratories which den1 with research related to patient care system or services,
research related to development of techniques, methods and applications, therapeutic trials
of drugs, reagents, kits, equipment development and nnimnl experimentations. Research
nnd development is an integral part of patient care services and such lnborntories are
designed for research and academic purpose.

1 1.3.2 Types of Laboratories

Most of the hospital laboratories function as:
i) OPD Services
ii) Ward Services
iii) Emergency Services

i) OPD Services
OPD Laboratories are basically Central laboratories in a large hospital which caters to the
need of out patient department during OPD hours.
ii) Ward Services
Ideally each ward is attached with functioning laboratory cntering to needs of the ward for
routine investigations. However, some ward laboratories are attached to respective
specialities (Block system) i.e. Surgical; Medical; Paediatric; Orthopaedics; Obstetrics and
Gynnecology etc. The investigations other than bed sidelroutine tests are referred to central
ward laboratories of specific departments between 9-10 AM to 4-5 PM, normal duty hours
of hospital.
iii) Emergency Services
These can be 24 hours (round the clock) services or restricted emergency services,
a) Round the Clock Services
Majority of hospitals~having100 bed oapacity"and above should give round the clock
emergency services. Each Emergency Service includes 3 shifts of duties (24 hours).
 I
I)irgna\tic and 'rher~peutlc b) Restricted Emergericy Services
Scrviccs !
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These types of emcrgency laboratory services are restricted to one or two shifts excluding I
public holidays and national holidays.

These services are restricted to augment manpower in particular specific organisation and
j
depends on str~~cturaland functional requirements of hospital.

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Check Your Progress 2 I
Name the functional components of the Clinical Laboratory.

1.4 CONCEPTS OF PLANNING ORGANISATION

The efl'icicnt operation of clinical laboratory and effective delivery of medical laborntory
services to clinicians and their patients require a complex interaction of expertise in
medical, scientific and technical areas, of resources in the form of personnel, laboratory and
data processing equipmelit supplics and facilities, and of skill in organisation, management
and communication. Awnreness of accreditation standards and Governmentcll regulations of
laboratory practice should be known to I-Iead of laboratory services and he must ensure
quality laboratory performances.

The steps in systemic nppronch to the orgnnisation and manngement is to establish general
goals and specific objectives, To maxirnise the effectiveness and efficiency of operations.
the functioning laboratory must have the following:

a) Adequ~itefacilities (including Lab, wash rooms, store, rengent preparation rooms, staff
common library. toilets, conference room etc,)
b) Approprinte Equipments
C) Standurd Reagents/Chemicnls regular supply

d) Adequate number of qualified staff.

1.4.1 Physical Facilities and Layout 1~

Physical fnciIities for laboratory function and its complete layout depends upon the
structure, culture and environment of organisation. Specific design considerations include:

I) The concern of size in planning a laboratory is always a major question. Factors for
consideration in dotermining space requirements include the scope of procedures to be
performed, intended operationnl approach for performing procedures, and the
anticipated size of the laboratory depnrtment.
a) Square Footage: Depending on design of the laboratory, the net square footage
in the modern laboratory varies approximately 65-90% of gross square footage.
ii b) Scope of Services: Depends upon type of hospital and facilities to serve e,g.
! teaching hospital, research hospital etc. Adequnte scope for future expansion must
4 be kept.
i/
I c) Mechanical Services: Proper planning for mechanical services essential specially
1 civil and electrical work of PWD (CPWD), provision of safety devices etc.
d) Operational Approach: The amount of space required in laboratory somewhat
depends upon how tests are being performed, the space requirement gradually
reduced with use of automation computerised technology. The interior design to
be suitably modified with consultation and coordination of architect engineer and
Laboratory Manager.
c) Laboratory Information System: Provision of communication between -
laboratory with ward/OPD and treating physician be maintained.
 Laboratory Safety: Various safety measures for staff and property etc. as against Lnboratory Scrviccs
f)
fire, biological toxic waste, radioactive material, following the universal
precaution etc, be made adequately.

2) ,FunctionalConsideration in Laboratory Design

. Considering recent *ends and advanced technology, changes from traditional laboratory set
up to be made in relation to clinical problems, disease orientation nnd functional.efficiency.
Various sub-units of laboratory medicine viz. Clinical Chemistry, Clinical Pathology,
Microbiology, Histopathology, Haematology etc. have different functional set up of
orientation. The organisational approach must have its value in future along with
alternative functional approaches being considered.

Pathologist having the opportunity to design a new laboratory or make major renovation in
older laboratory, should,think in functional terms about the laboratory operations and their
facility needs.

Traditionally laboratories have been organised without due regard to the functional
requirement. The whole concept of a laboratory has changed during the last decade.
Unfortunately there has been a lot of proliferation of laboratories which are sub-standard
and with no knowledge of quality control. The only way to curb such practices is to start
good laboratories and provide facilities at reasonable oosts, by qualified pathologists.
Today, a planned laboratory can be started with a budget of one lakh rupees. 'The basic
needs to start a laboratory can be worked out on the basis of a survey made which will give
the probable sample turnover.

The accommodation initially, should be reasonably good to start the common tests that are
in demand and should be properly planned so that it will be functional and convenient.

A few samples of plan (Plan A, Plan B, Plan C) are given below which are scientifically
developed. Depending upon the area available, these plans may be applied suitably.

f
u u

L.....
EXAM ANDTEST PATHOLOGIST
OFFICE k7

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STERlLlSATlON b.
VENIPUNCTURE CLASS WASHING
CUBICLE

WAITING CLERK SECRETARY /

TYPIST TECH.
TECH. TOILET &
LOCKERS 1
b.

IZE OF 150-200 BEDS

PLAN- B (40,000-75,000) TESTS ANNUALLY FOR AVERAGE SIZE OF 100-150 BEDS
 Lnborutory Services
3) Spatial Considerations in Laboratory Design

Spatial relationships within the institution are important. It is critical that location of the
laboratories be studied in relationship to the other hospital services, traffic, supporting
services, and users. Emergency laboratory system should be readily accessible to
emergency, surgical, medical, orthopaedic, gynaecology etc. wards, ICU, ICCU and
casualty.

Organisation in the clinical laboratory refers to both structure and process whereas structul
exemplifies stated relationship or framework and process deals with interaction.

The following is the flow diagram in Laboratory function system:

pizGGq
INVESTIGATIONS .

1 REPORT
GENERATION

LABORATORY
MANAGEMENT

SAMPLE ANALYSIS
Y
z QUALITY
CONTROL

Three key elements of organisation are:

A) The clinical laboratory: as a work place
B) StaF. who performs the test
C) The task: to be performed (Investigations and Reporting) , .
A) The Clinical Laboratory

The first important object is:

t i L ,>,! ,
i) Traffic flow planning: The intra laboratory traffic is separated from out side traffic.
Adequate provisions should be made for ambulatory patients andlbload 'bAnkdonors
where ever applicable. Usually blood bank has separate building iq ~ajgr,ity
of,
hospitals with provisions of independent functioning unit.
3 " 4 3
 Diagnostic and Therapeutic ii) Specimen and Data flow: The authentic schematic layout to be available with Head of
Services
Department for strict compliance.
iii) Process and Storage: Pre-analytical process and storage of specimenImaterial to be
done with each laboratory or to be done centrally if organised.
iv) Emergency Sample: Provision of emergency samples to be arranged.
v) LIS: The laboratory information system to develop according to available resources.

B ) Staff Requirement

There use to be a relation between number of tests and staff requirement, given in old text
books, Now due to development of automation in clinical, chemical pathology and all
branches of laboratory medicine the conventional techniques are being replaced by
automated techniques. Hence it is difficult to calculate the number of test performed by an
individual per day and relate it to day to day activities. A time study format has been
developed by Rappoport in 1975 in which standard time of each investigation (job activity)
to be calculated and related to time availability of working technical personnel on day to
day basis to evaluated per day investigations.

I The following formulae are used to determine average investigatiodday/technicalstaff.

I Standard time = Total basic time x Time allowance

i) Total basic time = Total average basic time of job element

Basic time . = Average observed time x Rating

ii) Time allowance = Contingency allowance (5% of the total basic time) x Relaxation
time (12% of the basic time)

I Parameters

i) ElementJjob description steps (which should also include job elements other than
investigation steps)

ii) Observation 5-10 times

iii) Total observed time in each step

iv) Average observed time of one test

v) Rating of individual as 100% by an average working

Total laboratory functioning job activities from reception of sample, registration, solution .
' preparation etc., processing, reporting entry, indexing, despatch, laboratory waste disposals
etc. are considered in job element per day.

Day functioning technical staff = 6% hour of duty (36 hours per week)

I Observed worWdayItechnica1staff when both automation/conventional

=60-70 testdday
techniques are shared in mixed type of spectrum of investigations

I 1.4.2 EquipmentAXeagents and Racilities

While planning equipments, reagents and other facilities for laboratories following need to
be considered:
 i v) Microscope - Mono occularlBinoccular Laborntory Services

v) Hot air oven

vi) Autoclave
vii) Incubator
viii) Ph-Meter
i x) Automated Biochemistry analyser
x) Automated Haernatology analyser
xi) ELISA - Reader
xii) ELISA - Washer
xiii) Microtome
xiv) Wax melting bath
xv) Hot plate

The requirement of specialised functions of laboratory depends upon the type of speciality
developed in organisation. The spectrum of investigations and number increases
accordingly. The advances in laboratory medicine is tremendous, more sophisticated,
technology equipments are being added day by day. The need to acquire depends upon:
i) Type of hospitallorganisation and structure of the institute
ii) Daily attendance of patients either from out patientdinpatients with available speciality
are important factors in deciding procurement of high sophisticated automated
equipment. The cost effectiveness to be evaluated as per standard parameters. The
choice of high technology equipment to be related to number of test performed per day
and spectrum of test needed to be performed on day to day basis, The specification of
equipment for procurement is a very vital parameter in decision of choice of equipment
and procurement. The head of Deptt. and hospitallinstitute procurement authorities
should discuss at length the use coefficient, the need and justification before placing
order.
b) Purchase and product specification should be viewed justifying the need of the
equipment and the use of instrument in relation to number of investigations and
spectrum of investigations.
c) Type of automation and availability facilities which are essential pre-requisite for
installation of equipment.
d) After sales service, availability of reagents as open system, warranty and availability of
spares till life of instruments and possibility of upgradation of instrument in due course
of time.
e) Every person working in a laboratory should be thoroughly familiar with storage
specifications, irrespective of chemicals, reagent or instruments, A constant check is
maintained on expiration dates. Chemicals and reagents after the expiration dates
should be disposed without delay to prevent impending hazards.
f) Apart from basic amenities like water, electric supply the measures should be taken for
condemnation and disposal of all items as per inventory.
g) Laboratory wastes and its disposal is an essential element of focus to all laboratories
for early and immediate compliance,
h) Basic record cards or register should be maintained as per laid down guidelines issued
from time to time from the organisation of the structurea Computerised inventory
system if available should be encouraged for constant use.

Check Your Progress 3 I

1) What are the minimum facilities, a laboratory should have for its better functioning'?
 I

Diagnostic and Therapeutic

Scrviccs 2) List three key elements of organisiltion of ;I L:ibnrntor.y?

iii) .................................................................................................................................
I
I 3 Enumerate the provisions necessary for working o f a L'~b~~ra:c,iv.

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1.4.3 Research and Training
Research

Research is an integral part of laboratory system. Various research projects pertaining t o

hdkital's functioning, equipment development; technology upgradation; disease
ificidences; treatment progress and all matters in relation to diagnosis and monitoring of
patient are part of the system management.

Training

Training of technical personnel either in service or who intend to join service or engaged in
practice of technology should undertake complete, prescribed, identified, recognised course
of stipulated period before rendering any type of service in the field of laboratory medicine.
Continuing Medical Education(CME)programme for technical people should be made
compulsory if not mandatory. Participation in training programmes, workshops, seminars
are to be encouraged amongst all working technical personnel from time to time.

Orientation

Early introduction to laboratory staff of the new employee contributes to the development
of an effective inter personal relationship, which is necessary to build teamwork. An
orientation programme is one of the most over looked management tools. Apart from
institutional orientation, each laboratory should have a defined programme of orientation
for all new employees to make them aware of policies, SOP (Standard Operative
Procedures) and standard performance are expected in laboratory environment and cultme.
Orientation serves to correct potential misunderstanding that are so often present with n e w
employees and establish channel of communication between management and the new
employee. During orientation, rules and regulatory demands regarding quality assurance,
universal precautions, hazardous waste, the right to know etc., are clearly defined and ,
expectations well presented. 1:

1.5 POLICIES AND PROCEDURES

The provisions of quality laboratory services with efficient reporting, interpretive diag
depends on the application of sound principles for personnel management. Efficie~ta
cost effective operation of a clinical laboratory with timely, effective delivery of servi
requires a complex balance of expertise in medical, technical and scientific activities.

1.5.1 Laboratory Administration

There are four basic elements of laboratory administration:

1) Objectives: Goals and purposes consistent with high quality and cost effectiv
delivety of laboratory services.
2) Guiding People: Leading and directing in such a manner that professionals feel sense
of responsibility, achievement and appreciation of work performed.

3) Resources: Proper utilization of physical resources such as instrumentation, desk top

computers, space, Laboratory Information Service (LIS) etc.

4) Organisation: The dynamic organisational unit where labour policy, procedure and
operations are managed in a reasonable cost effective, safe and productive manner.

1.5.2 Quality Control and Assessment, Accreditation and Total Quality

Management (TQM)
Quality Control and Assessment

Quality Control and Assessment is the process to ensure a test from being done wrongly.
The primary aim of Quality Control and Assessment is to see that the very purpose for
which a test is performed is not defeated due to unreliability of the result. Quality
assessment of all process of testing sample, analysis pattern, check of reporting and result
with precision and accuracy has to be done. The following are techniques of Quality
Control:

i) Internal Q.C. (Intra Laboratory Q.C.)

Performed by individual laboratory at their own level.
0 Forms the basis of day to day work of quality assurance.

ii) External Q. C.
0 Performed by many laboratories at the same time monitored by one.
Periodic monitoring for the performance of the laboratories.

Accreditation

Laboratory accreditation is a procedure by which an authoritative body gives formal

recognition of technical competence (including qunlity system mas8gern~e.t)of testing and
or calibration for a laboratory to carry out specific tests. This is b~.'""':8 third party
assessment against set standards.

Accreditation is considered to be the essential first step toward mutual acceptance of test
results and test certificates. An increasing number of health care organisations now require
that diagnostic laboratories meet national standards for accreditation. The laboratory
accreditation is a means to improve customer confidence in the calibration and testing
reports issued by the laboratories so that all interested parties shall accept the reports with
confidence.

Total Quality Management(TQM)

This is one of the most promising managerial innovations introduced within the health
sector within the last several decades. TQM increases the efficiency and effectiveness of
health care services.

The following factors are to be considered:

Top Management Leadership
Creation of an organisational frame work for quality improvement in hospitals
Transformation of hospital work culture
Customer focus
Process facus
Employee education and training
Learning by practice and teaching
0. Bench marking
Diagnostic and Therapeutic
Services Quality measurement and statistical reports at every level
0 Recognition and reward
0 Management integration

1.5.3 Leadership and Motivation

It is the integral part of laboratory management system. Studies have been conducted to
know the effects on productivity and concluded that the administrative process of
management includes planning, decision-making, organising, directing and controlling.
This process completed with management inputs (financial, physical, and human) has a
direct effect on outputs (cost benefit, performance, products and behaviour).

1.5.4 Personnel Management

Personnel policies, procedures and records are vital to the efficient and cost effective
operation of any laboratory. In addition, policies and procedures are necessary to meet
accreditation and regulatory requirements. In fact, a proper staffing and effective
scheduling have more impact than any other management tool in establishing qunlity
laboratory service and cost reduction.
1
1.5.5 Personnel Policies i

With regard to personnel policies following must be taken care of:

i) Qualified persons should be recruited.
ii) A good rapport should be maintained between person-in-charge and the working staff.
iii) Basic needs and comforts should be provided.
iv) The person is given the job description.
v) Duty allotment schedule among the staff should be carefully prepared.
vi) Opportunities should be provided for betterment of skills and position.

1.5.6 Job";5$
Ifa iption and Staffing
Staff pattern depends upon member and spectrum of investigations in clinical laboratory,
Scheduling and staffing are important management responsibilities that must be review4
and revised as often as necessary to maintain efficient and cost effective services,

Job description is a summary of all important and significant facts about a particular job,
Duties and responsibilities of working technical personnel to be clearly defined and
illustrated and should be confined to gazette notification of recruitment rules approved by
Department of Personnel in Government Organisation. For other organisations it is
between employee and employer with clear understanding and written document contract
mutually agreed upon. Finally, although job descriptions are essential management tools
for staffing process, they also sense as both training and evaluation guides for establishing
employee incentive,

The basic job description as you know should include a job title, duties, qualification, job
relationship, and necessary work aids. (Conventional techniques and Automation.) Day
and hours to be worked out as per existing norms laid down by institutionsJrespective
Government.
1

1.5.7 Recruitment, Policies and Procedures

Recruitment policies differ according to organisation structure. However it is advl
follow strictly the Recruitment Rules of the designated post and appointment to be
strictly under rules of the institutionlGovernmentby competent authorities to avoid
complications. Adhoc appointments for vacent position whenever filled up to be
regularised within limited period.

It is recommended that prior to interview process a list of establish criteria and ink
question based on job description, be prepared, qualitative criteria be made to tnsu
 all candidates are compared equitably and the laboratory is generally able to recruit quality Laboratory Services
personnel.

Check Your Progress 4

1) Enumerate basic elements of laboratory administration.

2) Define accreditation. What are the advantages of accreditation'?

3) What is Total Quality Management (TQM)? Give important factors necessary for
consideration of TQM.

4) What role leadership and motivation play in laboratory management?

1.6 INFORMATION MANAGEMENT

Laboratory management is n complex process involving quality control, work flow
allocation etc. Information system within the laborntory and inter laboratory are order of
magnitude, more complex than the communications with outside world.

Day by day, there is addition to technology information nnd transaction to users. Data
transfer at much higher rate is in common use. A properly selected and installed laboratoh
information system, can provide valunble benefit in improved laboratory operation and
higher quality patient care.
Diagnostic and Therapeutic The following are benefits of laboratory information system:
Services
Reduces errors such as mix up specimen, calculation errors, transaction errors etc.
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Improved staff productivity.
i
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@ Rapid availability of results and improved turn around time.
Transformation of reports to patient. 11
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Improved patient reports legibility; duplicate reports, interpretive diagnosis, graphics 1
etc. I
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Improved management information. Ii

Quality assurance data record maintenance.

I
..!; i ; ~ t i $ . rill: i:;r;~,tc:s which ~.equirern1lr.i: attention in I:tborntory management?
r ~-n;~rl:igr;r.i:~l
1

3 1 WR;tr ;zr,tr iric pr.ol:~lernswhich affcct Ii~borntoryreports? Wow do ycru solve them'?

a& ..........................................................................................................................................
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Laboratory as you know exists for the sole purpose of providing diagnostic and
management information for the beating medical official, to aid in the care of patient.
During the past few years there has been a considerable increase in the clinical demand for
laboratory investigations both in number and spectrum of tests.

The following managerial issues are essential to consider:

1) In recent years, there has been an alarming increase in the error of judgement,
omissions'and commissigns on the part of technical staff, Pathologist/Microbi
Biochemists and other working laboratory staff in processing and reporting th
spectrum of routine and sophisticated investigations. .
2) Advances in early diagnosis, quick reporting, use of high sophisticated mi
based instruments, microtechniques are in practice without adequate quali
Maintenance programme methods"that identify and minimize sources of van
test system are. therefore, essehtial.
 3) For a good laboratory, appropriate planning, procurement and controlling of resources
will ensure efficient, quality operation in performances. Personnel policies, procedures
and records are vital to the efficient and cost effective operation of any laboratory. In
addition policy protocols and procedures are necessary to meet accreditation and
regulatory requirements.
4) Proper staffing and effective scheduling have more impact than any other management
tool in est3blishing good quality and cost effective laboratory services.

1.7.1 Problems of Management

The following are the problems which are major issues in day to day practice of laboratory
medicine:

i) Lack of technical knowledge amongst working personnel

ii) Non-availability of uptodate modern technology.
iii) Lack of resources.
iv) Inability to maintain an adequate staff.
v) Frequent rush orders for reports and work load beyond capacity.
vi) Low morale among the working laboratory staff.
vii) Irregular supply and increase lead time of material supply from stores and purchase
of substandard material.
viii) Lack of recognition of dignity i f work.
ix) Lack of job satisfaction.
x) Lack of work attitude, sincerity and devotion to work.
xi) Indifferent personnel behaviour
xii) Communication gap between officers and subordinate staff
xiii) Lack of Quality Control and standardisation of procedures; absence of protocols,
SOP and manuals.
xiv) Paucity of in service training programmes; CME and lack of technology transfer.
XV )Lack of norms of technical staff.
xvi) Lack of promotional avenues and revision of cadre at par with similar services.
xvii) Lack of laboratory information system.
xviii) Absence of rationalisation of reporting pattern.
xix) Absence of integrated approach of patient care system for laboratory management.
xx) Different kinds of malpractices.
xxi) Lack of medical audit.

1.7.2 Laboratory Hazards

Now you will learn about some of the laboratory hazards. Today a laboratory personnel is
exposed to various kind of infectious material which are of great risk to life. All can not be
described here and is beyond the scope of this unit. The following are some of the dangers
to a laboratory worker:

i) Handling of infectious material.

ii) Handling of broken glassware.
iii) Accidental spill over of corrosive reagents.
iv) Swallowing of cokosive material such as concentrated sulfuric acid, Hydrochloric
acid, sodium hydroxide; Trichloro acetic acid etc.
v) Inhalation innoculation, swallowing of infectious material -bacteria; viruses (HbsAg,
HIV etc.)
vi) Inhalation of poisonous fumes.
vii) Potential hazards in the form of inflammable chemicals and gas leakages.
1)i:lgnostic and Thcrapcutic
Services 1.7.3 Safety Precautions in the Laboratory
The infection as you know can occur through ingestion, inhalation, injections or aerosols.
In laboratory acquired infections the route could be any of the above. Bio-safety in a
laboratory is very essential and basically depends on three components:

a) Basic standard of laboratory design, operation and equipment.

b) Selection and use of essential bio-safety equipment.
c) Safe laboratory procedures.

1.7.4 Laboratory Waste Management

Laboratory waste can be classified into following main categories:

i) General waste
ii) Pathological waste
iii) Radioactive waste
iv) Chemical waste
v) Infectious and potentially infectious waste
vi) Sharps.

The management of laboratory waste involvcs following steps:

i) ~ b ~ l e c t i oand
n segregation at storage site
ii) Storage and pretreatment (disinfection)
iii) Transportation
iv) Disposal

The above steps could be applied to hazardous and non-hazardous waste. The bio-
medical waste handling rules are tabulated in Table 1.1 and various methods of the disposal
of blood and laboratory material are tabulated in Table 1.2.

Table 1.1: "Blo-Medical Wastes (Manngernent and Handling) Rules, 1995"

Colour of Containers
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1 Types of Wastes
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1
Yellow Clinical waste for incineration only
- 1
I

Yellow with black stripes Clinical waste which is suitable for landfill disposal
Light blue or transparent with Light Wastes forautoclavingor equivalent treatment before finnl
blue lettering d~sposal
Red Human aniltomical -wastes
Black Norlnal household waste
.
J
Table 1.2: Disposal of Blood and Laboratory Material
I
For your guidance minimum and more practical, easily achievable safe laboratory rules are
listed here:

i) Avoid mouth pipetting as far as possible.

ii) Avoid enting, drinking, smoking and storing eatables in the laboratory.
iii) Decontaminate the working area atleast once a day and more frequently after the
spillage of potentially infective material.
iv) Wash hands with soap and water after handling the infectious material.
v) Wear laboratory gownslcoats in the laboratory and these should not be taken outside
the working area.
vi) Use gloves for all those procedures that may involve accidental direct contact with
blood or infectious material.
vii) Decontaminate all liquid or solid waste materials as per the guidelines issued by
Environment Ministry and Directorate of Health Services for proper directed
disposal.
viii) Use of gloves for all those procedures that may involve accidental direct contact
with blood or infectious materials.
ix) Perform all technical procedures in a way that minimizes the aerosol formation.
X) Provide adequate training to staff in laboratory safety procedures.
xi) As far as possible, actively immunize the workers against the diseases, the materials
of which they are handling.
xii) Employ medically fit staff only to work in clinical laboratories and staff to be
subjected for regular health check LIPat least twice a year.
xiii) Provide ample space and illumination for safe conduction of laboratory procedures.
xiv) Ensure constant and adequate water supply for immediate washing and cleaning of
glasswares and premises for adequate safety from infectious materials.
Check Your Progress 6

1) Mention the infectious laboratory hazards which can be prevented?

......
....................................................................................................................................

2) Whnt steps should be taken for safety of laboratory in above infectious hazards'?

3) Mention the components on which biosafety of the laboratory is dependent?

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f ?z;i!li~ostic Thcr:~puulic -
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1.8 CONTROL AND EVALUATION
Perfection in the management of laboratory issues are essential. Every problem has its own
solution and control. Quality control and assessment is integral part of management.
Maintenance of services, material supply, equipment maintenance, personnel management
are components of evaluation in the procedures. A quality report and consumer satisfaction
is final goal of evaluation programme.

1.9 LET US SUMUP'

In this unit you have learnt that laboratory and laboratory services play an important role in
patient care services and also the types and functions of laboratory; the physical facilities
required for laboratory existence. You have also learnt the important'concepts o f planning
policy and procedure, information management in laboratory. Further you have learnt
various problems in management of laboratory system, quality control, assessment and
total quality management. The importance of trained qualified staff, laboratory
accreditation, performance appraisal and methods of evaluation has also been emphasized
in this unit.

1 . 1 ANSWERS TO CHECK YOUR PROGRESS

Check Your Progress 1

1) Laboratory is a place of work for testing patients sample for results in favour of
diagnosis and treatment.

2) T o provide diagnostic management information to treating physician.

To generate results of samples for investigations.
.e T o report ss!nples with accuracy, precision and reliability.

Check Your Progress 2

0 Histopathology
0 Clinical Pathology
Microbiology
* Haematology
0 Biochemistry
Research Laboratory

Check Your Progress 3

1) Adequate space provision, regular supply of water, electricity reagents, chemicals, kits
etc. and appropriate instruments, glasswares for use.
2) A) The clinical laboratory: as a work place.
I B) Staff: who performs the test
I C) The task: to be performed
' 1

3) Adequate functioning space of work for staff, space for wash room, store items, toilets,
reagent, preparation rooms etc.

, Check your' Progress 4

$1 i 1) There are four basic elements of laboratory administration:

'; i a) Objectives
I
,' I b) Guiding people

, ~!i C) Resources
, '1 l 111
d) Organisation
=

Ill ,
-1 , (ii i,
 Laboratory Services
2) Accreditation is a procedure by which an authoritative body gives formal recognition
of technical competence (including the quality system management) of testing and or
calibration laboratory to carry out specific test.

The advantages of accreditation are:

a) It maintains standard and quality which creates confidence of customer and

laboratory manager.
b) Mutual acceptance of reports between laboratory and the user.
C) Accredited laboratory is accepted in inter laboratory net work system.

3) This is the most promising managerial innovation which increases the efficiency and
effectiveness of health care session. The following important factors are considered in
quality management:

a) Top management leadership

b) Customer and process
C) Learning by practice and teaching
d) Quality measurement and statistical reports at every level
e) Recognition and reward.

4) Leadership and motivation are prime important factors in planning management

without which productivity is negligible.

Check Your Progress 5

1) Information management is essential component and high order of magnitude complex

communication system within and outside laboratories of the country and world. It
reduces errors, mix-up specimen, calculation errors etc., improves staff productivity,
quality assurance and interpretive diagnosis for the patients.

2) The following are the important managerial issues which require more attention in
laboratory management:

a) Quality control and management

' b) Technological updates

c) Human Resources
d) Staffing pattern and promotional avenues
e) Automation
f) Total Quality Management (TQM)

4) The following problems which affect the laboratory report are:

a) Unqualified staff functioning

b) Inadequate input and processing unit functioning
C) Lack of resoirces
d) Absence of Quality Control
e) Lack of work attitude, sincerity and devotion of work.

The above problems are definitely solved if the authorities concerned provide the
above and the laboratory workers attitudes are changed and they work with sincerity
and devotion.

Check Your Progress 6

I) a) Hospital acquired (nosocomial) infections

b) Hepatitis B infection
c) HIV infection
Diagnostic and Thcrapeutic
Services 2) a) Proper discard of laboratory waste as per the guidelines issued by Directorate
General of Health Services and Ministry from time to time.

b) Personal precautions such as washing of hands with soap and water before and
after for any sample handling in laboratory; use of gloves; use of Hypochlorite
solutions for discard etc. Wear Laboratory gown/coats in laboratory.

3) Bio-safety of the laboratory is dependent on the following components:

a) Basic standards of laboratory design. operation and equipment

b) Selection and use of essential bio-safety equipment
c) Safe laboratory procedures.

1.11 PURTHER READINGS

Burns, J.M., Leadersitip, New York, Harper and Row, 1978.

Chou, D., and McLendon, W.W., "Information Management", In Henry; J.B. (ed.),
Cli~licalDiagt!osis nrtd Matiogemertt by I~boratolyMet1torl.s. 17th ed., Philadelphia,
W.B. Saunders Company, 1984, pp. 1401-15,
College of American Pathologists (CAP), Selected Renclil~gsit1 Laborntory Mnnngenlent,
A loose-leaf binder available from the College of American Pathologists, Skokie, IL,
1982.
Feegel, J.R., k g a l Aspects of Laborntory Meclici~ze,Boston, Little, Brown and Co., 1973.
Rakich, J.S., Longest, B.B., Jr., andDarr, K., Ma~lngitlgHealtlz Ssrviccs Orgatzisations,
2nd ed. Philadelphia, W.B. Saunders Company, 1985.
Rappaport, A.E., "Laboratory Design", in Race, G.J. (ed.), &boratoly Medicine, Vol. IV
(rev.) Chapter 36, Hagerstown, MD, Harper and Row, 1979.
Rappoport, A.E., Gennaro, W.D., and Berquest, R.E., A Cot~iputerizc(1I~~ternatio~lal Audio
Resporlse Telephone Cotntnunicatiot~System Serviup: A Cetztralizccl, Cot~lprrtcr
Colrpled, Automated Clinicnl Loboratot-y, Can.J. Med. Tech., 37:150, 1975.
Snyder, J.R., Senhauser, D.A. (ed.), Adttiidstratiot~ntld Sripervision it1 Lnborcrrory
Mcclici~re,2nd ed., Philadelphia, J.B. Lippincott, 1989.
Talib, V.H., Essentinls of Laborntory Aedicke, Interprint Publication, Edn. 1999.