Introduction

Medical laboratory or clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.

• The primary function of laboratory department is to perform various tests and to provide timely information to the clinicians in arriving at correct diagnosis and treatment of diseases

Importance

• Physicians need laboratory support for accurate diagnosis and cost effective management of patients.

• -to provide correct & timely reports

• -to maintain a degree of quality in providing services.

• - to keep exact record of the tests being done & to inform govt. health agencies in case of HIV or any type of outbreak

• -to maintain patient confidentiality

Functions

• The haematology section analyses and tests blood

specimens and interprets test results to provide a basis for

treatment of diseases

• Whenever it exists the blood bank is usually a part of

haematology. It stores and preserves blood after

procuring it from donors.

• The biochemistry section performs quantitative and

qualitative analysis of blood fluids, secretions and

substances found in tissues.

Functions……..

• Other clinical pathology section perform a variety of studies

that include urine analysis, semen analysis etc

• The histopathology section prepares and examines tissues in

order to provide data on the cause and progress of diseases.

• The bacteriology section identifies micro organisms found in

body fluids, skin scrapings and surgical specimens. It tries to

identify, grow and perform sensitivity tests of organisms to

diff. antibiotics

Functions……..

• The cytology section examines body cells for

diagnosis of malignancy and other diseased

conditions, effects of hormones etc

• Autopsy is the responsibility of the pathology

section

• The clinical labs perform other functions such

as teaching and research programmes

Types of laboratories

Depending on the hospital

- Centralized

- Decentralized

Depending on the location of lab

1. OPD pathology laboratory

2. Ward laboratories

3. Central pathology laboratory

4. Emergency laboratory

• In many countries there are mainly three types of Medical Laboratories as per the types of investigations carried out.

1. Clinical Pathology

2. Clinical Microbiology

3. Clinical Biochemistry laboratories.

- Blood Bank

• 1. Clinical Pathology:

– Haematology, – Histopathology, – Cytology, – Routine Pathology

• 2. Clinical Microbiology:

– Bacteriology, –Mycology, – Virology, – Parasitology, – Immunology, – Serology

• 3. Clinical Biochemistry:

– Biochemical analysis, – Hormonal assays etc

Departments in the Laboratory

Hematology

Blood Banking

Microbiology

Chemistry

Serology

Department Review

Hematology

Is the study of cells in your blood. Your blood is made up of red blood cells, white blood cells and platelets. A Medical Laboratory Scientist working in this department will count how many of each type of cell you have and evaluate the size, shape and color.

A Medical Laboratory Scientist working in the Hematology department is trained in the physiological and physical aspects of every cell.

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Blood Banking

Is the practice of crossmatching blood components for healthy transfusions. A Medical Laboratory Scientist working in the Blood Bank department will identify blood types, perform accurate and safe crossmatches with various blood components, as well as identify unsuspected antibodies.

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Microbiology

Is the study of microorganisms. A Medical Laboratory Scientist working in the Microbiology department identifies bacteria, fungus and parasites. The Medical Laboratory Scientist must also tell the physician which antibiotics to use to kill the bacteria found.

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Chemistry

The chemistry department quantitates hormone, enzyme, electrolyte and drug levels in your blood stream, urine or body fluid. A Medical Laboratory Scientist working in the Chemistry department must be able to evaluate the results of these levels to determine if they are pathological or not.

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Specimen processing and work flow

• Sample processing will usually start with a set of samples and a request form.

• Typically a set of vacutainer tubes containing blood, or any other specimen, will arrive to the laboratory in a small plastic bag, along with the form.

• The form and the specimens are given a laboratory number.

• This label has a barcode that can be scanned by automated analyzers and test requests uploaded from the LIS.

• Entry of requests onto a laboratory management system involves typing, or scanning (where barcodes are used) in the laboratory number, and entering the patient identification, as well as any tests requested.

• This allows laboratory machines, computers and staff to know what tests are pending, and also gives a place (such as a hospital department, doctor or other customer) for results to go.

• For biochemistry samples, blood is usually centrifuged and serum is separated. If the serum needs to go on more than one machine, it can be divided into separate tubes.

• Many specimens end up in one or more sophisticated automated analyzers, that process a fraction of the sample and return one or more "results". Some laboratories use robotic sample handlers (Laboratory automation) to optimize the workflow and reduce contamination risk and sample handling of the staff.

Policies and Procedure

• There should be laid down policy• The standard operative procedure (SOP)

should be in its place and be followed properly• Strict control on documentation• Strict recruitment policy and training policy

for staff for leadership and motivation, job enrichment and rules and procedures be clearly laid down

• Information management system should be in its place

• Policy for recording and reporting in case of diseases under surveillance or in case of diseases of public health importance

• Policy and procedures in case of laboratory accidents in respect of blood borne infection particularly HIV/AIDS or HBV infection

• Policy for prevention of laboratory hazards

• Laid down procedure for hospital waste management especially for Bio Medical waste

• Role of labs in prevention and control of Nosocomial infection

• Policy and procedure for quality assurance of lab procedures

• Policies and procedures regarding role of pathology lab in research works

• Policy for role of pathology lab in disaster management and investigation of the epidemics

• All lab requests should be in well prepared request forms

• Specimen should be sent to the laboratory in properly labeled containers

• Nurses should be familiar with proper time for taking specimens (fasting, non-fasting), minimum volume necessary and the proper container to be used

• The test requests and the results should be promptly recorded

• Dispatching report should be done according to the hospital policy

• Scheduling the laboratories will facilitate lab operations

• Investigation request received from critical care areas of the hospital like Emergency, ICU, ICCU, OT etc would be given priority

QUALITY CONTROL

Laboratory adheres to the following steps to ensure analytical quality of the test results produced:

 • Head of Laboratory Services will are

involved in the procurement of all chemicals and reagents required by the laboratory.

• Calibration of equipments are done strictly as per the recommendations of the equipment manufacturer.

• Products recognized and certified by appropriate national and international are only used in laboratory.

QC…………….

QC…………….

• Wherever possible, third party control materials are used as internal and external controls

• Validation of the examination procedure technically and clinically will be done by qualified, well trained pathologists.

Quality assurance program in the Laboratory

• Quality control policy• Quality control tests• Accreditation: National Accreditation Board

for Laboratories (NABL)• Total Quality Control• Six - Sigma

LOCATION:

• The laboratory should be located on the ground floor to serve(easily accessible) the OP patients, Emergency and admitting department.

REQUIREMENTS

• Lighting • Work station: work benches• Sanitary fitting• Ventilation• Air – conditioning• Water supply• Electricity• Fire fighting• Communication system

Space Requirements

Layout-1

LAYOUT-2

Equipments and Reagents

Basic equipment/instruments must be provided in all laboratories.

• Calorimeter • Centrifuge: separates serum from other

components of blood• Water bath• Hot air oven

• Microscope: Preferably binocular with electric lamp as a source of light

• Autoclave

• Incubator: sample at a particular temp.

• Refrigerator: Storing prothrombin time samples before being analyzed

• Ph meter • ELISA reader: to perform antinuclear

antibody• ELISA washer/analyzer : to perform HbsAg,

HCV test• Micrometer • Wax melting box• Hot plates

• Electrolyte machine: to perform pH of K, Na, Cl etc.

• Auto analyzer: Hb, RBC,WBC absolute values and platelets counts, chemical analysis, biochemistry tests

Staffing

• Pathologist • Microbiologist/ Biochemist• Laboratory Manager/ laboratory Incharge • Department Supervisor • Medical Laboratory Technician/ technologist,• Medical Assistant (Lab Aide), • Transcriptionist• Clerical staff

Personnel • LAB DIRECTOR :

• He/She must be a physician or a doctoral scientist qualified to assume professional , scientific , consultative , organizational , administrative , and educational responsibility for the services offered by the lab .

• If a non-pathologist physician or doctoral scientist service as director , he/she must be qualified by virtue of documented training ,expertise , and experience in areas of analytic testing offered by the lab .

• He/She must have sufficient training and experience in clinical medicine , sciences basic to medicine , clinical lab sciences

Personnel• The following directorial functions are :

1- interpretation , correlation , and communication of lab data

2- interaction with physicians and/or medical staff , patient , administration .

3- monitoring of standard of performance , QC , QI. 4- provision of education programs , planning , research.5- ensuring sufficient personnel with adequate documented training and experience to meet the needs of the lab .6- he/she must be decision-maker in the selection of all lab

equipments and supplies .

• GENERAL SUPERVISOR :

• Bachelor degree in chemical or clinical lab / medical technology science with at least one year experience .

• Is responsible for day-to-day supervision of the lab operation , as well as personnel performing testing and reporting test results .

Personnel

• ALL PERSONNEL :

• There must be an organizational chart for the lab .

• Personnel policies must be documented and available to all employees

• The lab should have a complete , functional in-service continuing clinical laboratory education program .

• Personnel files must be maintained on all current employees , the ideal location of personnel files in the lab .

Personnel

• Technical personnel records must include of all of the following :

1- summary of training and experience . 2- description of duties . 3- records of continuing education . 4- health record . 5- incident records .The lab must conduct an annual performance review of all

employees.• New employees must be reviewed within 6 months of

employment .

Personnel

• Some elements of competency assessment of each person :

1- Direct observation of routine patient test performance , including patient preparation , specimen handling , processing and testing ;

2- Monitoring the recording and reporting of test results ;

3- Review of intermediate test results or worksheet , QC results records ; PT results ; and preventive maintenance .

Personnel

4- Direct observation of performance of instrument maintenance and function checks ;

5- Assessment of test performance through testing previously analyzed specimens , internal blind testing samples or external PT samples .

6- Evaluation of problem solving skills .

Personnel

• The lab must participate in an approved program of graded

interlaboratory comparison testing appropriate to the scope of

the lab.

• External surveys samples should be run within the routine lab

workload , and are analyzed by personnel who routinely test

patient samples using the same primarily method systems as

for patient samples.

• Replicate analysis of surveys samples is acceptable only if

patient samples are routinely analyzed in the same manner.

Personnel

ORGANISATION: comes under department of Pathology

HEAD OF LABORATORY DEPARTMENT

INCHARGE LABORATORY

HEAMATOLOGY LAB TECHNICIAN

MICROBIOLOGY LAB TECHNICIAN

BIOCHEMISTRY LAB TECHNICIAN BLOOD BANK

The requirement of the staff is calculated on the basis of number of investigation performed.

The formula are used to determine the investigation/day/technical staff

Standard time = total basic time × time allowanceAvg working day functioning technical staff= 6½ hrs of

duty (36 hrs per week)

Observed work/day/technician = 60-70investigation/day

OPD / Outside Patients IN Patients

Billing/ Receipt

Reception Counter

Sample collected in collection room

Sample collected in Wards

Central collection Room

Different laboratories

Testing the samples

Reporting

Dispatch counter Respective wardRespective consultant

PATIENT FLOW CHART

DOCUMENTSPatients Report Records

Procedure Manual

Standard Operating procedure

QC Data

Quality audit report and review Reports

Employee Job description

Blood Bank Records

Patients Test Requisition Form

Outsource report copies

Patients tests value observation record

Calibration reports

Instrument manuals

COMMUNICATION

Communications and other interactions with patients, health professionals, referral laboratories and supplies.

• No reports is communicated to the patients or others directly on the phone or verbally except in emergency cases or critical results where the results are intimate verbally or over phone as referred in the laboratory procedure manual.

• All communications to the referral laboratories pertaining to patient details is done by Pathologists, or by the laboratory technician.

• Communication with laboratory suppliers is done by Head of Laboratory Services, in his absence by Sr. lab technician.

Coordination

• The laboratory works in coordination with

– OPD– IN patient Wards– Billing– Emergency– ICUs/OT–Medical record department & Etc…….

References

• Hospital Administration - DC Joshi, Mamta Joshi

• Hospitals: facilities planning and management - G. D. Kunders

• http://en.wikipedia.org/wiki/Medical_laboratory• NABH Policies http://uphealth.up.nic.in/nabh.htm• Mgt of Super Speciality hospital

- Dr. M.F. Khan, Dr. H. Khan