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					Government of India
Ministry of Science and Technology
Technology Bhawan , New Mehrauli Road
New Delhi


FORE WORD
In the twentieth century, science and technology has started permeating of all spheres of life. World of
health, medicine and surgery is no exception. In spice of the excellent development in medicine and surgical
techniques as well as modern concepts of hospital management, there is vast scope for improvement in the
quality of operation of the clinical laboratories in India. This view is shared equally by the hospital owners,
professionals and users.
Accreditation is a formal recognition of the technical competence of a laboratory including quality system
management based on third- party assessment and following latest national and international guidelines.
This is excepted to give a high degree of credibility to the test results. The laboratories are excepted to the
follow the ISO/IEC Guide-25, while the accreditation body is required to follow ISO/IEC Guide –58. This
document is excepted to be an essential reference documents for the clinical laboratories, the assessors as
well as the accreditation body itself.
I sincerely hope that the publication of this document will go a long way towards establishing a system of
accreditation of clinical laboratories and make the same operational. I am happy to extend the services of
the department of Science and Technology under its NABL programme to the cause of clinical laboratories
and their users in the country.
                                                                                      V.S. Rama
murthy
                                                                            Chairman NABL
 New Delhi                                                                  Secretary DST
Dated 23rd February 1998




SPECIFIC GUIDELINES FOR ACCREDITATION
OF CLINICAL LABORATORIES
SECTION 1: GUIDELINES FOR CLINICAL LABORATORY ASSESSMENT
1. Introduction                                      5
2. Description and Type of laboratory                 6
3. Staff and Education                              7
4. Facilities                                      8
5. Safety and Environment                           9
6. Sample Collection, Handling and Pre- Analytical Storage 10
7. Internal Quality control and External Quality Assessment 11
8. Disposal of Samples and Related Materials               13
9. Laboratory Records                                      14
10. Ethical Practices                                      15
11. Guidelines on Equipment calibration                     16

SECTION II: CHECKLIST FOR CLINICAL LABORATORY ASSESSMENT
12. General Requirements             21
13. Blood Bank and Transfusion Techniques  30
14. Clinical Biochemistry                 47
15. Clinical Pathology                    50
16. Cytogenetics                              53
17. Cytopathology                              59
18. Haematology                                64
19. Histopathology (Anatomical Pathology)       68
20. Immunology                                75
21. Microbiology and Serology                  80
22. Nuclear Medicine                           87
23. References                                88
24. Members and Special Invitees of the Technical Committee on Accreditation of Clinical
Laboratories 89



SPECIFIC GUIDELINES FORACCREDITATION OF CLINICAL
LABORATORIES AND CHECKLIST
FORASSESSORS.


                                        INTRODUCTION:


Laboratory accreditation activities are administered under the direction of the
National Accredictation Board for Testing and Calibration Laboratories
(NABL),involving Technical Committee and Evaluation Panel as recommending
bodies.

"Specific Criteria for Clinical Laboratories" described in this booklet is one
of a series of supplementary documents to NABL 101. "General Criteria for
Laboratory Accreditation". These specific criteria are in compliance with clause
No.1.1 of ISO/IEC Guide-25(1990) and are based on the recommendations of
the
Technical Committee on clinic Laboratories.

The scope of the accreditation is applicable to the following clinical
laboratory services:

1.        Blood Bank and Transfusion Services*.

2.        Clinical Biochemistry.

3.        Clinical Pathology.

4.        Cytogenetics

5.        Cytopathology

6.        Haematology

7.        Histopathology
8.        Immunology

9.        Microbiology and Serology

10        Nuclear Medicine




     02 Description and Type of Laboratory


The guidelines are applicable to all clinical laboratories regardless of the
level (small/medium/large/super-speciality/village/district/city laboratory) at
which they function and whether they areprivate/government/quasi-government.

The laboratory may be comprehensive,performing tests related to several
laboratory disciplines such as clinical biochemistry,
clinicalpathology,microbiology and serology,histopathology( anatomical
pathology), haematology,cytopathology,cytogenetics, immunology,nuclear
medicine
and blood bank and transfusion services or may be limited in its scope to
fewerdisciplines.

Small Laboratory

A laboratory performing routine tests in haematology,clinical pathology and
biochemistry upto 50 tests per day manual or semiautomated techniques.


Medium Laboratory

A laboratory performing the above mentioned tests and special tests in the
above
mentioned specialities or others laboratory disciplines (such as histopathology,
cytopathology,etc) and doing 51-500 tests per day.

Large Laboratory

A laboratory performing the above mentioned tests with a higher load than 500
tests                          per day and/ or using
sophisticated instruments such as automated analysis,ELISA readers,
fluorescent
microscopes etc.

Super-Speciality Laboratory

A Laboratory restricting its activity to one or two disciplines of laboratory
medicine.


       03               STAFF AND EDUCATION

Supervisory Personnel

The large and super-speciality laboratory shall be mentioned be a medical
person
with post-graduate qualification in pathology or microbiology or
biochemistry/Ph.D in the respective discipline. The small and medium laboratory
may be manned by an MBBS or an MSc with at least five years experience in
laboratory medicine.

Any laboratory that performs histopathological,cytopathological and special
haematological tests must be manned by an MD in pathology or in the speciality.

Multi-disciplinary laboratories shall identify qa group leader, with specific
qualifications, for each area.

Technical Personnel

The technical person performing the tests and reporting the results should have
one of the following qualifications:

         Science graduate with one year experience in an established medium-
sized
laboratory.
         Graduate in Medical laboratory Technology.
         Diploma in Medical Laboratory Technology (with a course of at least of
one year
duration) awarded by a University,State Government,Central Technical Board,or
Indian Medical Association with two years experience inn an established
medium-sized laboratory.
         A laboratory may employ upto 25 percent of the staff without experience
but
with requisite qualifications or with more than ten years or laboratory
experience with at least matriculation with science.
The laboratory shall have a system for imparting necessary training to technical
staff at various levels. There shall be a system so that a technical person
receives adequate training in the operating of a new analytical equipment and
performance of a new test before he/she is assigned to such work.


04    FACILITIES

The space required by a laboratory shall be commensurate with the number,type
and range of tests performed,the level of automation available,degree of
computerization,workload and manpower. Adequate space should be provided to
enable efficient maintenance of equipment and ensure safety of personnel.

Each laboratory,however,must ensure adequate provision of space for the
following:

Sample collection*
Sample analysis*
storage of samples,reagents, chemicals,spares,stationery and records*
Washing*
Media preparation and autoclaving (application to microbiology laboratory)
Storaqge of slides,tissue blocks, grossing (applicable to histopathology
laboratory)
Reporting room (applicable to
microbiology,histopathology,cytopathology,haematology)
Seminar room and Library
Staff room
Toilets*
Fire safety*

----------------------------------------------------------------------------------------------




Laboratory must be well-lit and ventilated to provide a healthy environment.Many
tests and equyipment require regulated temperature and therefore,wherever
necessary effective airconditioning and uninterrupted power supply must be
available.

It is,howerver, understood that the laboratory performing simple tests need not
have all the facilities. However,the facilities marked with an asterisk (*) are
essential for any laboratory seeking accreditation.

NOTE: The laboratory shall limit and restrict entry to authorized personnel to
testing areas to ensure confidentiality and safety of patients and visitors.
05 SAFETY AND ENVIRONMENT


The safety measures,including effective fire fighting systems and fire
extinguishers must be extended to be laboratory.

The laboratory shall maintain first-aid facilities to take cure of any accident.
It is desirable to provide emergency showers asnd eye-washfacilities so that in
the event of accidental exposure to potentiality infectious,toxic,corrosive or
radioactivematerial,immediate action can be taken.The laboratory shall have
safety instructions written in simplelanguage and well displayed so that in the
event of any accidents such as exposure to infectious or bio-hazardous material
or toxic chemicals,appropriate immediate action is taken.

As a safety measure alllaboratory personnel are recommended to wear
laboratory
coats and gloves. Technicalstaff should be trained to avoid needle-stick
injuries. Safety instructions should be available for the action to be taken in
the event of a needle-stick injury.

_________________________________________________________


06 SAMPLE COLLECTION,HANDLING AND PRE-ANALYTICAL STORAGE


The testresults aremarkedly influenced by the quality of sample. Therefore,the
samplecollection labelling,transport,handling and storage shall be documented
procedures laid down for the type of specimen and the nature of the test to be
carried out. Written instructions about the same should be made available to
physicians,nursing staff and all other persons who send specimens to be
laboratory for testing.

All specimens recieved by the laboratory should be treatedaspotentially
infectious or hazardous.

Universal precautions should,therefore,be observed in handling and transport of
these specimens in conformity with national and international guidelines.

_________________________________________________________
07 INTERNAL QUALITY CONTROL AND EXTERNAL QUALITY
ASSESSMENT


Quality Assurance (QA) is a comprehensive term that refers to all
aspectsdofoperation from preparation of the patient to sample
collection,sampleanalysis,recording of the result and its despatch.

The results of analysis must be available within a reasonable period so as to be
useful for patient management.

All QA procedures shall be documented. Stages of QA include pre-analytical and
post analytical.


Pre-Analytical

The pre-analytical system shall take care of the following aspects as each can
have amajor effect on the accuracy of the result:

Patient preparation
Request forms
Specimens collection,containers,labelling and phlebotomy equipment and
procedure
Specimen transport.
Specimen preparation
Specimen storage


Analytical


`The following aspectsshall be monitored,evaluted,implemented and maintained
to
ensure,accuracy,precision and reliability of the tests carried out:


Quality if distilled water
Calibration of measuring and testing instruments including baslances,
thermometers,incubators,water baths,autoclaves,centrifuges,semi-automatic
pipettes,laminar flow cabinets,etc.


It is essential to use standard/calibrator which is traceable to
national/international material. The laboratory shall obtain evidence of
traceability of the same to the reference material. Precision can be maintained
through use of a suitable QC material either commercial or prepared in-house.
QC
material should be analyzed atpredetermined intervalsalong with patient samples
to monitorsystematic and random errors. Such QC material shall be traceable to
a national/internal certified reference material so that accurace of
measurements can be mentioned.

Microbiology laboratories shall run biological standards regularly to maintain
checks on materials and methods such as media,antibiotic discs,autoclaves and
gas sterilization.


Microbiological work environment must be fumigated periodically and total plate
count recorded. The laboratory shall participate regularly in external quality
assessment programmes approved by respective professional
bodies/stategovernments/central Government/NABL or an international agency.

All data relating to the laboratory's internal quality control prqactices and
performance in external quality assessment schemes (scoring,ranks,etc.) shall
be
recorded,reviewed snd corrective action implemented.

Post-Analytical

In order to avoid transcriptional errors in the results of the test,the
reporting/signatory technician shall verify the results entered manually or
through on-line instrument interfaces before the results are reported or
despatched.

________________________________________________________



08   DISPOSALOF SAMPLESAND RELATED MATERIALS

The laboratory shall dispose contaminated waste such as microbiological
caltures,organs and tissues,blood and body fluids,contaminated swabs, tissue
papers,towels,pipette tips,storage vials,glasssware,needles and other sharps by
disinfection with chemicals or autoclaving before appropriate disposal, i.e.
through incineration,or removal to orby an authorized waste disposal agency or
secire land fills. Local environmentalregulations in force shall be complied
with. Reusables shall be disinfected by chemicals,autoclaving or irradiation
before washing.


Chemical disinfection is carried out in a suitable receptacle kept at the work
station. Commonly used disinfectants aresodium
hypochlorite,formaldehyde,glutaraldehyde,phenol and hydrogen peroxide.

_________________________________________________________



09   LABORATORY RECORDS


The laboratory shall maintain a comprehensive record of allpatient results for a
minimum period of three months.


_________________________________________________________



10 ETHICAL PRACTICES


The laboratory shall maintain the highest standards of integrity in all its
operations. The laboratory should ensure that the staff is kind and courteous
in dealing with patients. Patients exploitation should be avoided and if a
problem has occured in the laboratory, the sample should be reprocessed or test
done on a fresh sample without additional charge.

The laboratory shall display the following either visually or through a brochure
for information of all clients:


List of tests performed by the laboratory
Names of the test methods used
Minimum time required for each test from sampling to reporting.
List of major instruments and facilities
Personnel and their qualifications
Procedure for complaint.


Transparency should be maintained in reporting of the results. Iif there is an
additional finding which may have a bearing on the patient's treatment or
diagnosis, it should be reported even if this has not been requested by the
physician in charge.

The laboratory shall maintain utmost confidentiality with regard to the findings
on the specimens sent to the laboratory.
The head of the laboratory will take all steps to minimize the occupational
hazards to the staff working in the laboratory.

***********************                           *********************




11 Guidelines for equipment caliberation
This sections details equipment calibration for any laboratory registered or seeking registration.
Section 1
The normal maximum periods between successive calibrations of general equipment are illustrated in
Table 1.
It must be stressed that these calibration intervals depend upon:
A Ruggedness of the equipment
B Frequency of use
C Life of the equipment
D Quality and periodicity of maintenance, etc.
Where more stringent requirements are dictated by the methods for which a laboratory is
registered, then appropriately shorter intervals will be necessary.




     ITEMS             MAXIMUM PERIOD BETWEEN SUCCESSIVE CALIBRATION
CALIBRATION PROCEDURES
                         OF CHECKS
AND COMMENTS
     Autoclaves      *Monthly check on effectiveness of sterilization



      Balance and Scales           Yearly calibration                              Checks
include calibration of balances, repeatability
                                                                                        Checks
and one point check using a known mass
                                                                                        Close to
balance capacity.

      Biological Safety Cabinets             one year                                            ---
----------------




          Items               Maximum period between successive calibration of checks
calibration procedures and comments
       Centrifuges              Every six months (where operating speed is specified)
Tachometer (mechanical stroboscope or
                                                                                                  Light cell
type)

                                                                                                  Calibration
of the timing device and, where

                                                                                                   Appropria
te, the temperature measurement
                                                                                                   Device
will be required. In addition, per-
                                                                                                   Formance
testing is recommended for
                                                                                                   Specific
applications:Technical Mannual,
                                                                                                   American
Association of Blood Banks,
                                                                                                   10th
edition, 1990(or later).



          Manometers
        Reference                                              Five years
Check fluid every three years
        Working                                                one years
check against reference


         Masses
         Reference, of integral stainless steel or nickel chromium alloy       Three years initial ,six years
subsequent
         Working stainless steel or nickel chromium alloy                    * Three years intial, six years
subsequent    ASTM E617
          Working , other                                                                 One years
ASTM E617


           Piston – operated Volumetric Apparatus
AS 4163
          Pipettes and Dispensers                                  Initial and every six months           For
gravimetric checks, volume dilivery
                                                                                                   And
weighing under specified

                                                                                                   Condition
s must be repeated at least
                                                                                                   Ten (10)
times. For adjustable devices
                                                                                                   Check
volume delivered at several settings
                                                                                                   Delivery
of volumes less than 100 ul may
                                                                                                    Be
verified by spectrometry using a dye
                                                                                                    Solution.
                                                         Three months
Check volume delivered at settings in use
                                                                                                    Check
sample and duluent volumes or
                                                                                                    Dilution
ratio and total volume
    Diluters                                                    Six months
Check sample and diluent volumes or
                                                                                                    Dilution
ratio and total volumes.


             Thermometers                                 Five years ( complete)
             Reference                                  *Check ice – point before use or at least every six
months


                                                                                                    Continue
d on following page




         Items                   Maximum period between successive calibrations of checks
Calibration procedures and comment




         Working                  Initial check at sufficient points to cover the expected       Check
against a calibrated reference
                                 Working range follow by six monthly checks at ice - point
                                 With in the working range two years ( complete)

        Electronic                     * six monthly ice – point checks                       checks
automatic cold junction
                                                                                              compensation

         Timing devices                * three months



         ·     Calibrations commonly performed by laboratory staff




         Section 2
         The following ia list of major analytical instrumentation that can be calibrated primarily in house
by use of reference materials of known composition.
         PH Meters
          Checks on use with at least two (2) standard buffer solutions appropriate to the expected ph of the
sample being tested. A records of the checks must be kept.
          Spectrophotometers
          Calibration checks on all spectrophotometers or automated devices employing spectrophotometers
or colorimeters shall be performed on a regular basis. A new calibration curve, where appropriate, must be
drawn at least three months.
          Such calibrations shall include checks on wavelength accuracy, absorbance , linearity, stray light,
matching of cells and must be carried ouu in accordance with the manufacturer’s instructions and/ot
intervals appropriate to the test procedures and the physical enviroment within which the instrumentation is
used (but at least every three months).
          All instruments shall be checked on use against appropriate reference materials. A bank and ideally
at least two points on the calibrations curve must also be checked . these calibrations should be compared
over time to detect any system deterioration.
          Chromatographs
          A Gas chromatographs . Performance shall be routinely monitored during use with standard
reference materials.
          B Liquid chromatography . including high performance ( or high pressure) liquid chromatographs
(HPLC) and ion chromatography.
          The total system must be monitored during use with reference standards. Loss of efficiency may be
detected by chronological comparison of reference materials measurements.
          System components (e.g. pumping system and detectors shall be subject to periodic checks and
details shall be recorded.
          Section 3
          The following section details general checks and maintenance requirements for requirements for
equipments and instrumentation in Medical Testing laboratories.
          DNA – sizing equipment
          Instruments performance shall be routinely monitored during use with control samples.
          Electrophoresis
          Instruments performance shall be routinely monitored during use with standard reference materials.
          System components (e.g. electrodes , tank and power supply ), must be checked periodically.
          Microscopes
          Regular cleaning and maintenance of microscopes is essential for satisfactory operation. The stage
and lenses shall be cleaned after use and maintenance and servicing shall be carried out by component
personnel.
          Temperature –controlled equipment
          The performance of waterbaths, incubators, ovens and refrigerators shall be monitored routinely to
ensure compliance with the temperature requirements of test methods.
          Accordingly, daily recorded checks of the temperature with in the load space of these items of
equipment shall be maintained. The use of continuous temperature monitors is strongly recommended
where temperature control is critical.
          The thermometers use to monitor the performance or temperature- controlled equipment shall be of
sufficient accuracy to ensure that this equipment complies with the temperature tolerances specified in the
test methods.
          The spatial distribution of temperatures throughout the load space of temperature controlled
equipment shall be checked following installation of equipment and at appropriate intervals thereafter.
          Temperature recording devices shall be checked at six (6) monthly intervals against a reference
thermometers and the results recorded.
12 General Requirements
5.  Areas of activity for which accreditation is sought
     Clinical biochemistry       YES       NO     N/A
     * Clinical Pathology          YES       NO     N/A
    * Haematology                  YES      NO      N/A
   * Microbiology and Serology YES           NO N/A
   * Histropathology                YES      NO     N/A
   * Cytopathology                 YES      NO      N/A
   * Cytogenetics                   YES      NO      N/A
   * Immunology                     YES      NO      N/A
   * Nuclear Medicine               YES      NO      N/A
   * Blood Bank and Transfusion Techniques YES NO            N/A
6. What are the working hours of the laboratory
6.1 Specify
    * Normal
    *Emergency
     * Weekend
     Holidays

7. Staff
3.1 Head of the laboratory :
    Name -------------------------------------------
    Qualifications --------------------------------
    Experience -----------------------------------

7.1.1       Does the laboratory incharge work :
        * full time                YES     NO          N/A
      * part time                 YES       NO      N/A
3.1.2 The laboratory incharge / director :
is accessible for cunsultations and for sorting
          unexpected problems in laboratory        YES       NO       N/A
     * decide the test methodology                  YES      NO       N/A
     * participates in misroscope examination of
       slides requiring expert opinion               YES      NO      N/A
    * does a random quality assurance /programmes YES NO                 N/A
7.1.2     Is the work looked after by the section head or another
          Qualified staff when the laboratory incharge /diretor is absent    YES    NO      N/A

7.2 Section heads for each area of activity
       NAME             Qualification         Working hours




3.3 Number of supervisory staff                 full time --------part time---------
3.3.1 Does any of the supervisory staff regularly perform
        or take over the functions stated under 3.1.2 and 3.1.3           YES NO N/A
3.4 Number of technical staff                Full time ----- part time-----
3.4.1 With regard to technical personnel :
    * are regular positions defined and filled               YES NO           N/A
    * does an hierarchy exist                   YES NO N/A
    * are responsibilities / duties assigned      YES NO N/A
    * is employment record maintained             YES NO N/A
3.4.2 Is the technical staff
     * examined for any disability that may
       affect his/ her performance                     YES NO N/A
     * offered necessary care if injured during work YES NO N/A
4 EDUCATIONAL AND TRANING PROGRAMMES
4.1 Does the laboratory provide regular in – service training to
      technical staff           YES       NO        N/A
      Explanatory Note :
      Some large hospital/ institutions may have regular medical laboratory technology (MLT ) Courses
leading to award of a degree, diploma or certificate.
The purpose of in – service training is to :
   * train new technicians in the laboratory
   * revise the existing knowledge
   * update knowledge
     train in new producers/ skills as and when introduced

4.1.2 Does the newly recruited staff undergo orientation programme in procedures followed in the
laboratory by the senior technical staff before the test
is assigned to the technicians         YES        NO     N/A

4.1.2 Has the laboratory got a written/ regular schedule of continuing medical education (CME) for
technicians by way of
   * formal lectures            YES       NO        N/A
   * seminars                   YES NO             N/A
   * hands- on training           YES NO           N/A
4.1.3 If no formal CME programme exists, does the laboratory depute its technicians to other institutions
and / or national meetings            YES       NO     N/A
5. Space and Enviroment
5.1 Is the laboratory adequate in respect of :
   * ventilation           YES     NO     N/A
   * work- bench space YES NO            N/A
   * space for equipment YES NO N/A
   * lighting                 YES NO N/A
   * power plugs ( minimal use of extension cables )    YES NO N/A
   * storage space           YES     NO     N/A
   * refrigerated            YES     NO      N/A
   * non- refrigerated        YES     NO      N/A
   * maintenance of optimum room temperature           YES     NO       N/A
5.1 Is the laboratory provided with :
   * emergency power supply e.g. UPS or generators for essential equipment yes NO N/A
   * Stabilizers               YES    NO    N/A
   * Computers                YES     NO N/A
   * telephones                YES     NO N/A
5.3 Has the laboratory got a disposal system in accordance with rrequirements of the NANL ‘Specific
criteria for clinical laboratory    YES    NO       N/A

6. SAFETY
6.1 Are safety measures, esp. fire extinguishers installed        YES NO N/A
6.2 Is the staff trained to use safety measures          YES     NO       N/A
6.3 Are there specific instructions to handle injuries to the staff during work YES NO N/A
6.4 In addition to first aid box, are facilities for emergency measures provided YES NO N/A
6.5 Has the laboratory made arrangement with physicians for treatment of work---- related injuries
YES      NO       N/A
6.6 Do the electrical installations meet the safety requirements ( earthing, etc.) YES NO N/A
6.7 Are precautions for storage of volatiles and flammables abhered to ( seprate from the main work area )
YES         NO        N/A
6.8 Are fume cypboards/ exhausts available where required           YES NO        N/A
6.9 Are written instructions available and practised handle potentially infectious material ( e.g. patient
specimens, pipettes tips and other glassware ) YES NO              N/A
6.10 Are written instructions available and practised to handle corrosives, poisons, flammables and
radioactive materials             YES         NO       N/A
6.11 Is mouth pipetting of potentially infectious materials and
corrosives prohibited               YES       NO      N/A
6.12 Are written instructions provided and practised for disposal of :
   * needles           YES     NO      N/A
   * potentially infectious waste      YES NO N/A
   * radioactive           YES       NO        N/A
6.13 Id the laboratory licensed by BARC for use of radioactive materials YES NO N/A
6.14 Are the safety instructions laid by BARC complied with          YES     NO      N/A
6.15 Are no- smoking instructions followed             YES     NO       N/A
6.16 Are eating and drinking prohibited in the work place         YES      NO      N/A
6.17 Is eye wash facility provided           YES       NO        N/A
6.18 Is the staff vaccinated against infectious agents, viz. Hepatitis B virus YES NO N/A

7. SPECIMENS
7.1 Are written instructions available for patient preparing and collection of specimens for all types of tests
performed by the laboratory             YES        NO        N/A
7.2 Are written instructions available for transport of specimens to avoid YES NO N/A
   * deterioration of sample          YES      NO         N/A
   * leakage of potentially hazardous materials        YES NO         N/A
7.3 In keeping with the range and a number of tests performed by the laboratory, are collections facilities
adequate of optimum in respect of
   * space to prevent avercrowding and chances of labelling errors         YES NO N/A
   * availability of sterile containers        YES      NO      N/A
         availability of sterile needles, syringes or evacuated tubes for collection
          of blood              YES        NO       N/A
   * facility for collections of specimens of urine and feces       YES      NO        N/A
7.4 Does the laboratory accept specimens collected out side the laboratory YES NO N/A
7.4.1 If so , are the specimens checked for their suitability viz. Labelling contaimers and conditions
YES        NO        N/A
7.4.2 Are improperly collected specimens rejected           YES       NO        N/A
7.5 Do specimens at collection and/ or after having been received in the laboratory carry a unique
identification number             YES         NO       N/A
7.5.1 Do the request forms carry the same identification number as that
       on the specimens          YES      NO      N/A
5.1 If different identification number are given for different tests, is a system followed to ensure that no
     mix up occurs in the identification or transcription of results YES NO N/A
5.2 Does the request form has the following information :
           * Name of the patient        YES      NO N/A
           * Age or date of birth          YES     NO     N/A
          * Sex                           YES       NO     N/A
          * Address                      YES NO          N/A
          * Telephone number              YES       NO N/A
          * Hospital                     YES      NO       N/A
     Referring physician / doctor’s address and
          Phone number                   YES      NO N/A
          * Nature of specimens           YES      NO      N/A
          * Date and time of collection YES             NO     N/A
        * Date and time of receipt of specimen         YES      NO N/A
5.3 Are the specimens properly stored with regard to temperature and light, till analysed YES NO
     N/A

5. EQUIPMENT
8.1 Automated equipment                      YES      NO    N/A
8.1.1 Is the equipment maintained according to the checklist recommended
by the manufacturers                         YES       NO    N/A
8.1.2 Has the laboratory got a maintenance contract with
local distributor             YES        NO        N/A
8.1.3 If not, has the laboratory got an in-house maintenance facility YES NO N/A
8.1.4 Are the QC checks using ‘ control material’ processed every day or with batch ( where necessary )
YES       NO        N/A
8.1.5 Is the equipment calibrated against a reference material/ laboratory control with assigned value
YES          NO         N/A
8.1.6 Is the equipment attached to the UPS/ generator and stabilizers YES NO N/A
8.1.7 Is the equipment adequately earthed             YES    NO      N/A
8.1.8 Are the operating manuals accessible              YES    NO      N/A
8.1.9 Is the staff properly trained in the use of equipment    YES       NO     N/A

8.2 Are the other equipment ( photometer, water baths, centrifuges, volumetric pipettes, refrigerators,
freezers, etc.) checked for accuracy and tolerance limits YES NO N/A

6. METHODS
6.1 Are the SOPs made accessible to all staff members imvolved in testing YES NO N/A
9.1.1 Are written down procedures for specific tests available at the
work--- bench                YES     NO        N/A
9.1.2 Does the SOP cover all procedures carried out in the laboratory including patient preparation, sample
collection, test procedure, etc.  YES       NO       N/A
9.3 Is the SOP approved by the head of the laboratory YES            NO    N/A
9.4 Is the SOP revised with necessary         YES       NO        N/A
9.5 Are the methods used validated and accepted internationally or nationally YES NO N/A

5. Quality Assurance Programme ( QAP )
10.1 Who is responsible for quality assurance ?
   * head of the laboratory         YES       NO       N/A
   * division head                  YES       NO       N/A
   * administration of the hospital     YES NO           N/A
10.2 Is written document on QAP available         YES NO N/A
10.3 Does it contain procedures for                   YES NO N/A
     * internal quality control ( IQC)        YES       NO N/A
     * external quality assessment (EQA)         YES NO          N/A
     * standardization               YES        NO        N/A
5.1.1     Which EQA programme the laboratory participates in
10.4 Are the items mentioned in item 10.3 practised         YES NO N/A
10.5 Is a written record available to verify the results of 10.3 and 10.3.1 YES NO N/A
10.6 Is corrective action taken if QC results are out of control YES NO N/A

6. REPORTING
11.1 Are the report verified by the head of the laboratory or authorized persons YES NO N/A
11.2 Is confidentiality of report maintained        YES NO         N/A
11.3 Are the results reported in appropriate units (SI units are preferred but some laboratories may still
report in conventional units YES        NO     N/A
11.4 Are the reference ranges based on :
      * In – house data              YES     NO       N/A
      * Primary reference as mentioned in the method        YES NO           N//A
      * Other established sources         YES      NO       N/A
11.4.2 Are reference ranges for different physiological states where applicable given YES NO N/A
11.5 Are the results of some urgent tests or life- threatening conditions ( such as direction of Plasmodium
falciparum infection ) communicated urgently or telephonically YES NO N/A
11.6 Is the staff trained to check the name, age, sex, ward number and patient’s registration Number with
the person making telephonic inquiry before communications the report YES NO                  N/A
11.7 Are the telephonic communications followed by a formal report YES NO N/A
11.8 Are the reports positive for specific diseases e.g. Plasmodium falciparum infection, seropositivity for
HIV infection, HBs – Ag. Positivity, HCV seropositivity conveyed to the appropriate authority as required
under law             YES       NO       N/A




Blood Transfusion Services


Organization of Blood Transfusion Centre
1.1 Premises
5.1.1     Is the area of Blood Transfusion centre within the Drug and Cosmetic Act regulation YES NO
          N/A
5.1.2     Do the premises consist of following designated areas for :
      * Donor reception             YES    NO       N/A
      * Registration and medical examination YES NO N/A
      * Blood collection            YES     NO     N/A
      * Post donation             YES NO       N/A
      * Compatibility laboratory YES          NO     N/A
      * Red cell serology laboratory YES           NO   N/A
      * Transfusion microbiology           YES      NO N/A
      * Blood component preparation YES NO N/A
      * Library                 YES      NO       N/A
      * Store and record room             YES NO       N/A
      * Sterilization, distillation and washing room YES NO N/A
5.2 STAFF
1.2.1 Does the centre have adequate medical manpower is the staff well trained YES NO N/A
1.2.2 Does the centre have adequate nursing staff is the staff well trained YES NO N/A
1.2.3 Does the centre have adquate technical manpower is the staff well trained YES NO N/A
1.2.4 Is adequate and trained staff available for conducting outdoor blood donation camps YES NO N/A

6. Donor Motivation and Recruitment
2.1 Are procedures development for motivation of voluntary blood donors YES NO N/A
2.2 Are trained donor recruitors available    YES      NO    N/A
2.3 Is donor counselling provided
         * pre-donation                 YES      NO     N/A
         * post-donation                 YES NO         N/A
2.4 Is medical support available during blood donation YES           NO        N/A
2.5 Is a comprehensive blood donor list available          YES      NO          N/A
2.6 Are procedures developed for retention of blood donors YES          NO      N/A
2.7 Is a rare donor panel available        YES        NO       N/A
2.8 Is sufficient donor educational/ motivational/ promotional publicity material available for recruitment
and retention blood donors               YES       NO N/A
2.9 Are the voluntary blood donors recognized by certificates, badges etc. YES          NO      N/A

7. Donor Selection
3.1 Is the blood collected from :
    * Voluntary donors only         YES     NO       N/A
    * Voluntary and replacement donors YES NO                N/A
3.2 Does the donor selection procedure include details of
   * Present and past relevant illness      YES        NO      N/A
   * Physical examination          YES NO           N/A
   * Preliminary laboratory testing       YES        NO     N/A
3.2.1 Medical History :
whether the following information is collected, and the donors deferred based on the information :
     * Age                      YES     NO N/A
     * Date of last blood donation     YES NO          N/A
     * Date of last pregnancy/ delivery/ abortion / lactation YES NO N/A
     * Date of any previous blood transfusion         YES      NO     N/A
     * Date and nature of immunization           YES       NO     N/A
     * H / o recent drug intake     YES     NO       N/A
     * H / o major surgery          YES      NO       N/A
     * H / o malaria                   YES NO N/A
     * H / o jaundice               YES     NO       N/A
     * H / o other viral infections YES NO           N/A
     * H / o fever and common cold YES NO N/A
      H / o tuberculosis, diabetes, convulsions, cancer or any other infectious disease YES NO N/A
      * H / o drug addiction         YES NO N/A
      * H / o alcohol intake       YES NO          N/A
      * H / o any circulatory disorder       YES NO         N/A
      * Signs and symptoms of AIDS           YES NO         N/A
      * High risk behaviour                 YES NO        N/A
      * H / o Sexually Transmitted Disease YES          NO N/A
      * Are donors with high risk behaviour , i.e. with H/o STDs / AIDS
        deferred permanently             YES       NO N/A
3.2.2 Physical Examination :
Is the following physical examination carried out for each donor before venepuncture :
    * Weight                     YES NO N/A
    * Pulse                     YES NO N/A
    * B.P.                       YES NO N/A
    * Temperature                YES NO N/A
    * Venepuncture site examination                YES NO N/A
    * Respiratory system examination                   YES NO N/A
    * Cardiovascular system examination YES NO N/A
    * Per – abdomen examination         YES      NO N/A
3.2.3 Preliminary laboratory testing:
 * Is donor Hb checked routinely before venepuncture                   YES NO N/A
 * Whether disposable lancets or needles are used for finger prick YES NO N/A
8. Blood collection
4.11 Are adequate aseptic precautions followed during blood collection YES NO N/A
4.1.2 Is the blood collected in plastic blood collection bags     YES NO        N/A
4.1.3 Is the blood bag inspected each time before blood collection for leaks or breaks in the bag and clarity
of anticoagulant                   YES      NO      N/A
4.1.4 Are identification numbers placed on pilot tubes, blood collection bags and related records before
venepuncture                    YES        NO        N/A
4.1.5 Are disposable needles and syringes used for local anaesthesia        YES       NO        N/A
4.1.6 Is a trained medical staff available during and after blood collection YES NO         N/A
4.1.7 Is proper mixing of blood and anticoagulants done during blood collection YES            NO N/A
4.1.8 Is the total time taken for collection of blood monitored YES         NO      N/A
4.1.9 Is the volume of blood collected monitored using a weighing scale each time        YES NO N/A
4.1.10 Are adequate quality control measures taken for donor weighing scale and blood weighing balance
YES             NO        N/A
4.1.11 Are there written standard operating procedures available for donor selection and blood collection
YES         NO         N/A
4.1.12 Is the donor clinic staff trained in handling serious donor reactions    YES      NO       N/A
4.1.13 Are there written instructions available for management of donor reactions      YES NO N/A
4.1.14 Are emergency kits available for management of donor reactions YES              NO       N/A
4.1.15 If a second venepuncture is required, is a new plastic blood collection bag used YES NO N/A
4.1.16 Are the reagents used for cleaning the venepuncture site sent for periodic bacterial examination YES
NO        N/A
4.1.17 Is the anticoagulant solution used in blood collection bags sent for periodic bacterial examination
YES              NO          N/A
4.1.18 Is the following information recorded on the blood unit label :
     * donation no . or donor identification for autologous blood         YES NO N/A
     * Name of the blood component         YES      NO     N/A
     * ABO and RH group          YES NO          N/A
     * Dates of collection and expiry      YES NO         N/A
     * Volume of blood           YES NO          N/A
     * Type and volume of anticoagulant         YES       NO      N/A
     * Storage temperature service/ centre                YES NO N/A
     * Licence No.              YES        NO        N/A
4.1.19 Are necessary medical supplies and equipment readily available for donor selection and blood
collection              YES          NO        N/A
4.1.20 Are refreshment facilities available for donors    YES NO           N/A

5.1 Blood storage and transportation
4.2.1 Is the blood stored in blood bank refrigerators with uniform temperature control YES NO N/A
4.2.2 Does the blood bank refrigerator have the following facilities :       YES      NO    N/A
      * Recording thermometer            YES      NO N/A
      * Weekly thermograph               YES        NO N/A
      * Alarm device ( visual and audible ) YES            NO    N/A
4.2.3 Is uninterrupted power – supply maintained for blood storage equipment YES NO              N/A
4.2.4 Is backup electric supply / generators available for of the transfusion centre YES NO N/A
4.2.5 Is the refrigeration space adequate for the needs of the transfusion centre        YES NO N/A
4.2.6 Is adequate documentation maintained for temperature control of refrigerators YES        NO     N/A
4.2.7 Is the alarm device check off and on           YES        NO       N/A
4.2.8 Are there written standard operating procedures available for action to be a taken in case of power
failure                      YES        NO          N/A
4.2.9 Are the refrigerators free of materials other than blood or blood component YES NO N/A
4.2.10 Are the temperature recorded records checked           YES       NO       N/A
4.2.11 Is the whole blood and red cell concentrate stored always between 4---6 0 C YES NO N/A
4.2.12 Are the plasma products ( Frozen plasma and cryoprecipitate ) stored in deep freezer YES NO N/A
4.2.13 Are the platelets stored under conditions of constant agitation        YES      NO    N/A
4.2.15 Are the blood stock control procedures performed daily to ensure efficient use of blood and reduce
discarding                  YES           NO               N/A
4.2.16 Is the blood stock arranged according to :
          * Blood groups ( ABO and RH {D} ) YES NO                 N/A
          * Date of collection ( to use oldest units first)      YES NO         N/A
4.2.17 Is segregated blood storage space available for
      * Unscreened / unprocessed blood           YES        NO    N/A
      * Blood suitable for cross- matching           YES       NO    N/A
      * Cross matched blood           YES       NO         N/A
      * Rejected blood                YES       NO          N/A
      * Autologous                     YES      NO          N/A
      * Outdated / expired blood        YES NO               N/A
4.2.18 Is the blood /blood components transported in temperature controlled conditions to YES NO N/A
       * Hospital wards          YES     NO       N/A
       * Outside the hospital / blood bank     YES NO N/A
4.2.19 Are the returned blood bags taken back into blood stock         YES NO          N/A
4.2.20 Is there a policy to resume the returned blood units          YES        NO     N/A
5.2 Blood collection in outdoor camps
4.3.1 Does the transfusion centre hold outdoor blood donation camps          YES       NO    N/A
4.3.2 Is the blood collection done under hygienic conditions in the outdoor camps YES NO N/A
4.3.3 Is a separate vehicle available in blood transfusion centre for outdoor camps       YES NO N/A
4.3.4 Is the blood stored properly in the camps till transported to the transfusion center YES NO N/A
4.3.5 Is the blood collected in camps transported in temperature controlled environment YES NO N/A
4.3.6 Are all procedures for donor selection and blood collection followed in outdoor camps YES NO N/A
4.3.7 Are adequate supplies available for conducting outdoor blood donation camps YES NO N/A

5. Blood Component Preparation
5.1 Mention the blood component prepared by laboratory
    * Red cell concentrate ( packed red cell )    YES NO N/A
     * Leucocyte poor red cells          YES NO N/A
    * Fresh frozen plasma              YES        NO N/A
    * Cryoprecipitate         YES NO N/A
    * Frozen red cells        YES NO           N/A
    * Plasma                 YES     NO        N/A
    * Random red cells       YES      NO       N/A
    * Single donor platelet concentrate YES           NO N/A
    * Single donor platelet concentrate YES NO               N/A
     Others ( please specify )---------------------------------------------------

5.2 Are adequate number of double/ triple bags available for component preparation YES NO N/S
5.3 Are bags with additive solutions used during component preparation YES             NO N/A
5.4 Is a separate premises with adequate area provided for component preparation YES NO                N/A
5.1 Are the following equipment available in the blood component preparation laboratory
     * refrigerated centrifuge         YES        NO        N/A
     * deep freezers                    YES      NO          N/A
     * platelet incubator ----shaker YES         NO         N/A
5.6 Are there written procedures available for processing and storage of all components YES NO N/A
5.7 Are all the components properly labelled                YES NO           N/A
5.8 Are adequate quality control measures for preparation of blood components observed YES NO N/A
5.9 Are the centrifuge temperature and speed protocols defined for component preparation YES NO N/A
5.10 Is sterile docking device available for aseptic tubing connections       YES      NO     N/A
5.11 Is the final haematocrit of red cell concentrate in the acceptable range     YES NO N/A
5.12 Are quality control procedures used to monitor PH, platelet count, RBC count, WBC count and
volume of platelet preparation                  YES       NO        N/A
5.13 Are the procedures for preeparing components designed to ensure sterility YES            NO N/A
5.14 Are the units carefully handled during processing           YES      NO        N/A
5.15 Are the plasma and platelets separated from whole blood with in validated time        YES       NO N/A
5.16 Is the plasma frozen with in 6---8 hrs/ cryoprecipitate adequately monitored       YES NO N/A
5.17 Are the thawing facilities for FFP/ cryoprecipitate adequately monitored         YES NO N/A
5.18 Is proper temperature control maintained in plasma thawing bath          YES NO          N/A
5.19 Is water in the plasma thawing bath regularly changed             YES     NO       N/A
5.20 Are thawed units used with in 6 hrs             YES        NO N/A
5.21 Are water samples sent for periodic bacterial culture from plasma thawing bath YES NO N/A
5.22 Is the FFP thawed between 2-8 0 C for cryoprecipitate preparation         YES       NO     N/A
5.23 Is the concentrated cryoprecipitate refrozen within 4 hours           YES     NO      N/A
5.24 Are blood bags for extended platelet shelf- life ( within 5 days) used     YES      NO      N/A
5.25 Is thefate of each unit traceable               YES         NO        N/A
6.APHERESIS
6.1 Are donors adequately selected for apheresis procedure             YES NO          N/A
6.2 Are the donors with H/o aspirin intake deferred for seven days before platelet apheresis YES NO N/A
6.3 Is trained medical staff available at all times during the apheresis procedures YES NO           N/A
6.4 Are the personnel involved in apheresis trained to identify the side effects and manage the reactions
during apheresis               YES       NO      N/A
6.5 Is HB checked before each donation               YES       NO      N/A
6.6 Are serum proteins checked 6 monthly on apheresis donor             YES NO         N/A
6.7 Are complete blood counts done regularly          YES      NO       N/A
6.8 Is the apheresis procedure designed to ensure sterility         YES       NO         N/A
6.9 Are the personnel involved trained in trouble – shooting of apheresis machine         YES      NO N/A
6.10 Are the units properly labelled to identify the blood group, type of component, time and date of
preparation and expiry date                YES        NO        N/A
7. LABORATORY TESTING
7.1 Sample collection in wards
7.1.1 Is recipient clearly identified before collecting the sample     YES      NO      N/A
7.1.2 Is there a written protocol available to identify recipients who cannot identify themselves like
unconscious patients and children                YES       NO       N/A
7.1.3 Are the instructions for collection and hanling of specimens followed, for example YES NO N/A
     * Type and amount of specimen               YES NO         N/A
     * Time of collection                         YES      NO N/A
     * Adequate labelling                         YES NO N/A
     * Specified anticoagulant                    YES NO N/A
7.2 Pre-transfusion testing
7.2.1 Are proper requisition forms used for blood request           YES      NO       N/A
7.2.2 Are specimen clearly labelled at all times to ensure correct recipient/ specimen idenfification YES NO
N/A
7.2.3 Are request forms and recipient blood samples checked to confirm identification before pre-
transfusion testing                     YES       NO      N/A
7.2.4 Is complete and adequate information provided on blood requisition form YES NO N/A
7.2.5 Is refrigerator available for storing specimens          YES     NO        N/A
7.2.6 Are suitable long term storage facilities available for specimens needing retesting YES NO N/A
7.2.7 Are all recipient specimens stored for a minimum of 7 days at 4 –8 0 C YES NO N/A
7.2.8 Are written guidelines available for rejection of unacceptable specimens; eg. Haemolyzed samples,
improper labelling or delayed receipts              YES      NO       N/A
7.2.9 Are blood bank records checked for previous transfusion and /or reactions          YES     NO N/A
7.2.10 Does the routine grouping procedure include :
   * Anti-A ( cell grouping )          YES NO N/A
   * Anti- B ( cell grouping )         YES     NO N/A
   * Anti-AB (cell grouping )           YES NO        N/A
   * Anti-D ( from two different firms ) YES NO N/A
   * Any other control system to check RH negative         YES NO       N/A
   * Pooled A-cells ( serum grouping )          YES NO         N/A
   * Pooled B-cells ( serum grouping )           YES NO N/A
   * Pooled O-cells ( serum grouping )           YES NO         N/A
   * Screening for unexpected antibodies          YES NO N/A
7.2.11 Is a defined grading system used for agglutination        YES NO          N/A
7.2.12 Is the grade of reaction recorded for each stage of grouping       YES NO          N/A
7.2.13 Are standard ( tube / microplate ) techniques used for ABO and RH grouping YES NO N/A
7.2.14 Are quality reagents used for testing         YES NO          N/A
7.2.15 Are tests for auto-antibodies done            YES       NO     N/A
7.2.16 Are standard methods used for cross- matching ( saline, antiglobulin test, albumin; major and minor )
YES       NO         N/A
7.2.17 Are the red cells sensitized with IgC used as control for antiglobulin test YES NO N/A
7.2.18 Is the inventory control of reagants done properly to use the oldest reagents first YES NO N/A
7.2.19 Is the ABO and RH group confirmed on all blood units before issue          YES         NO      N/A
7.2.20 Is each unit checked just prior to crossmatching for colour, smell, appearance of blood and expiry
date                 YES        NO      N/A
7.2.21 Is the patient identity, unit and crossnmatch label checked and signed at the time of issue of blood
YES             NO            N/A
7.2.22 Is there a separate protocol for issue of blood in emergency situations and neonatal transfusions
YES NO           N/A
7.2.23 Is a compatibility label carrying complete details attached to each unit after pre-transfusion testing
YES         NO          N/A
7.2.24 Does the label contain information on :
       * Patient’s complete      YES NO N/A
       * Patient’s registration no. YES NO N/A
       * Age             YES NO          N/A
       * ABO and RH group             YES      NO    N/A
      * Results of test of HTV, syphills and HbsAg           YES NO N/A
      * Donation No.              YES       NO      N/A
      * Compatibility report       YES      NO     N/A
      * Date of cross matching       YES NO         N/A
      * Date and time of issue       YES      NO N/A
      * Name of issuing blood bank         YES NO         N/A
7.2.25 Is the label colour coded         YES NO         N/A
7.2.26 For patients requiring repeat transfusion :
     * Is a fresh specimen collected after 72 hrs        YES NO         N/A
     * Is a new specimen regrouped                      YES      NO     N/A
     * Is a new specimen screened for unexpected antibodies         YES NO        N/A
7.2.27 Are patients record properly maintained            YES      NO     N/A
7.2.28 Are records of all cross- matching kept             YES       NO    N/A
5.1 Are the following performed in the ward/OT before transfusion :
7.3.1 Check on recipient’s identity            YES     NO      N/A
7.3.2 Check on unit and compatibility label         YES      NO     N/A
7.3.3 Signatures of the authorized person before starting the transfusion       YES     NO N/A
7.3.4 Are the vital parameters maintained for a minimum of 30 minutes after starting transfusion      YES
NO            N/A
5.2 Donor Screening
7.4.1 Is ABO group tested by cell and serum grouping               YES NO        N/A
7.4.2 Is RH (D) group checked with standard anti-D from two firms YES NO                  N/A
7.4.3 Is the sample of blood from each donation tested for HBSAG, HIV-I and II and syphilis YES NO N/A
7.4.4 Is the donor blood tested for red cell antibodies           YES       NO      N/A
7.4.5 Are adequate controls set up with each technique to prevent false reactions YES NO N/A
7.4.6 Are highly sensitive test- kits used for screening of infection markers     YES NO           N/A
7.4.7 Are laboratory worksheets used for test results          YES      NO      N/A
7.4.8 Are the results of infection markers confirmed using supplemental tests         YES      NO N/A
7.4.9 Are the results of infection marker tests informed to donor         YES      NO       N/A
5.3 Transfusion Reaction
7.5.1 Is the laboratory and hospital staff aware of the procedure to be followed in case of haemolytic
transfusion reaction                     YES       NO        N/A
7.5.2 Is the Standard Operating procedures available to describe the test done in case of haemolytic
transfusion reaction                    YES       NO         N/A
7.5.3 Is there an audit process for transfusion reaction        YES     NO     N/A
7.5.4 Is the transfusion reaction from given with blood at the time of issue     YES NO        N/A
7.5.5 Are all transfusion reactions reported immediately to the laboratory       YES     NO N/A
7.5.6 Are all blood units kept for examination after the reaction          YES     NO       N/A
7.5.7 Does the investigation of suspected haemolytic reaction include :
      * Full documentation             YES      NO N/A
      * Regrouping and antibody screening on pre-and post- transfusion samples YES NO N/A
      * Direct antiglobulin Test on patiens pre- and post – transfusion samples YES NO N/A
      * Culture and smear examination to loot for bacterial contamination        YES       NO     N/A
8. Quality Assurance Documentation and Biosafety
8.1 Quality Assurance
8.1.1 Does the institution have a hospital transfusion committee                 YES       NO      N/A
8.1.2 Are there written policies for blood transfusion practice      YES     NO      N/A
8.1.3 Do the policies include :
   * Indication for transfusion of blood and blood components         YES     NO N/A
     * Standard operating procedures for sample collection and transfusion of blood in the ward YES NO
     N/A
    * Maximum surgical blood ordering schedule             YES NO        N/A
  * Procedures for handling blood outside the blood bank ( transportation, details of administration of blood
such as blood warming, need for filters etc.)         YES NO         N/A
8.14 Are proper internal and external quality control measures taken YES         NO N/A
8,1.5 Are the personnel proficiency tests carried out         YES      NO      N/A
8.1.6 Is the staff sent for refresher training            YES       NO       N/A
8.1.7 Is the staff encouraged to attend training programmes         YES    NO      N/A
8.1 8 Are the reagents used comply with the standards               YES      NO      N/A
8.1.9 Is the newly recruited staff given initial orientation         YES    NO      N/A
8.1.10 Are steps taken for quality assurance of all reagents         YES     NO N/A
8.1.12 Is maintenance contract obtained for important equipment YES            NO N/A
8.2 Documentation
8.2.1 Are the records computerized                 YES      NO       N/A
8.2.2 Whether records of all activities in the blood bank are properly maintained         YES NO N/A
8.2.3 Are following records available :
    * donor deferral       YES NO N/A
    * Adverse donor reaction       YES NO N/A
    * Cross- match records          YES       NO     N/A
    * Issue registers               YES       NO      N/A
    * Transfusion           YES      NO       N/A
    * Inventory of blood and components        YES NO         N/A
    * Inventory of reagents and other material YES         NO      N/A
8.2.4 Are records of discarded blood units maintained       YES      NO      N/A
8.2.5 Are standard operating procedures available for all the activities in the blood bank YES NO N/A
8.2.6 Are laboratory records maintained for a maximum of five years          YES      NO    N/A
8.3 Bio --- Safety
8.3.1 Are universal safety precautions followed        YES        NO       N/A
8.3.2 Are there written procedures for safe handling and disposal of specimens          YES      NO N/A
8.3.3 Is handling regularly done         YES       NO      N/A
8.3.4 Are barrier protection methods such as gloves and aprons used regularly YES           NO N/A
8.3.5 Are bench tops and centrifuge (s) decotaminated daily        YES       NO      N/A
8.3.6 Are suitable methods used for disinfection of infectious wastes        YES      NO      N/A
8.3.7 Are suitable methods ( autoclaving / incineration) used for disposal of infected blood and other wastes
YES                     NO                   N/A
8.3.8 Are the infected sharps, needles and broken glassware handled carefully         YES     NO     N/A




CLINICAL BIOCHEMISTRY
SPECIMENS
1.1 Is the list of test available         YES       NO     N/A
5.1 Do written instructions mention
     * Whether fasting is required       YES       NO N/A
     * The time of collection of a specimen for hormones, glucose , etc.     YES NO       N/A
     * The volume and type of specimen           YES       NO     N/A
     * The need for immediate separation and processing        YES       NO N/A
     * Special instructions for blood gases, lactate, ammonia and other special tests YES NO N/A
2. Equipment
2.1 Is there a list major equipment such as
      * balance           YES     NO N/A
     * inclubators       YES       NO    N/A
     * PH meter           YES     NO      N/A
     * photometers        YES NO        N/A
     * semiautoanalyzers           YES    NO       N/A
     * ELISA reader            YES   NO      N/A
     * blood gas analyzer            YES NO            N/A
     * electrophoresis system         YES NO          N/A
     *densitometer                   YES      NO       N/A
2.2 Does the log book include frequency of calibration, routine maintenance and daily calibration checks of
instruments setting                 YES       NO        N/A
3. METHODS
3.1 Is there a record of tests performed, methods used, reference ranges and their sources including special
tests like boemones, tumour markers and therapeutic drugs         YES        NO    N/A
3.2 Are there written instructions for each test performed         YES       NO    N/A
3.3 Are these instructions available at the workplace               YES      NO N/A
3.4 Do the instructions cover all the aspects mentioned in the SOP        YES     NO     N/A
3.5 Are calibrators/ controls to national/international reference materials      YES    NO      N/A
3.6 Do the methods for hormone measuresments include the analytical specificity and limits of
determination mentioned                        YES NO           N/A
3.7 Are storage conditions for samples and reagents specified and adhered to       YES      NO     N/A
3.8 Is care taken for strict adherence and reagents specified and adhered to      YES     NO      N/A
3.9 Is the wavelength used appropriate for each measurement            YES        NO      N/A
4 REPORTING
4.1 Are the results obtained, reviewed by head of the laboratory or authorised persons before they are
released             YES        NO      N/A
4.2 Are the workbooks maintained regularly                 YES        NO N/A
4.3 Are the reports released with out delay         YES       NO     N/A
4.4 Is there a procedure documented for handling urgently requested tests         YES     NO      N/A
2. QUALITY CONTROL
Does the quality control programme include :
   * a responsible person for monitoring QC            YES      NO     N/A
   * documentation of internal quality control data       YES      NO     N/A
   * participation in appropriate EQA programmes              YES NO N/A
   * maintenance of all quality control results           YES     NO        N/A
   * updating and periodic review of QC charts            YES     NO       N/A
   * reasons for acceptance / reaction of QC results         YES NO          N/A
   * Evidence of corrective measures taken                   YES     NO       N/A




CLINICAL PATHOLOGY
5. WORKLOAD AND STAFF
5.1 Number of specimens ( annual figures )
   * Urine
   faeces
   Semen
1.2 Are relevant atlases and books available           YES      NO        N/A
6. Specimens
     Are there written instuctions available for
     * collections of specimens          YES        NO      N/A
     * appropriate preservatives         YES         NO      N/A
7. Equipment
7.1 Microscope
     * Is microscope with oil immersion lens available         YES      NO      N/A
     * Is polarzing light attachment available for identification of crystals    YES     NO      N/A
8. METHODS
4.1 Are SOPS made accessible to all staff members involved in testing           YES      NO    N/A
4.2 Are written down procedures for specific tests available at the work- bench          YES NO N/A
4.3 Does SOP cover all procedures carried out in the laboratory including patient preparation sample
collection, test procedure , etc.         YES        NO       N/A
4.4 Is the SOP revised when necessary            YES      NO     N/A
4.5 Urine
4.6 Is complete examination of urine done by
   * dipsticks             YES     NO      N/A
   * manual methods          YES NO          N/A
4.5.2 If done by dipsticks is a random check done by
    * chemical tests         YES NO N/A
    * PH meter for PH           YES NO         N/A
    * urinometer for specific gravity          YES      NO      N/A
    * microscopy for cells                YES NO              N/A
4.5.3 Is sediment examined routinely in all urine sample             YES       NO        N/A
4.5.4 Is Bence 0 jones protein detected by
    * heat test        YES     NO      N/A
    * electrophoresis       YES      NO       N/A
    * other                 YES       NO      N/A
4.5.5 Are non – glucose reducing substances in urine detected by
    * chemical methods          YES      NO      N/A
    * ozasone preparation                  YES NO N/A
    * chromatography                 YES         NO        N/A
8.1 Faeces
8.1.1     Is test for ova and cysts done
      * without staining        YES      NO       N/A
      * after staining with iodine      YES        NO     N/A
      * concentration method              YES NO           N/A
4.6.2 Are adequate instructions given to the patient before a sample of faces is brought for occult blood
YES                   NO            NO
8.2 Semen
8.2.1     Are instructions available and given tin the patient regarding
     * collection ( abstinence for 3 days )         YES        NO       N/A
     * time for transport to the laboratory if collected in the house ( with in 15 minutes ) YES NO N/A
8.2.2     Are the counts done by
     * direct counting by chamber          YES       NO       N/A
     * dilution methods           YES       NO      N/A
4.7.3 Is the analysis done without delay          YES      NO      N/A
9. Quality Control
9.1 Does the quality control programme include :
     * a responsible person for monitoring QC            YES NO         N/A
     * documentation of internal quality control data         YES     NO      N/A
     * participation in appropriate EQA programmes            YES      NO      N/A
     * maintenance of all quality control results              YES      NO      N/A
10. REPORTING
6.1 Are the results obtained, reviewed by head of the laboratory or authorized persons before they are
released                YES         NO             N/A
6.2 Are workbooks maintained regularly            YES       NO       N/A
6.3 Are reports released without delay              YES NO           N/A
CYTOGENETICS
5.    Particulars of the laboratory
5.1   Name---------------------------------------------------------
5.2   In – charge of the speciality-----------------------------------------
5.3    Qualifications-------------------------------------------------------------------
6.    Staff
6.1   Medical--------------------------------------------------------------
6.2   Full time------------------------------------------------------------
6.3   Part time ( specify working hours )-------------------------------
6.4   Technical ( specify level and numbers)------------------------------
6.4.1     Technical assistant----------------------------------------------------
6.4.2     Technicians --------------------------------------------------------
6.4.3     Others -------------------------------------------------------------
2.5 Is employment record of the above staff available YES                    NO      N/A
7. Space
7.1 Is the laboratory provided with the following space
3.1.1 Darkroom                         YES           NO          N/A
3.1.2 If darkroom not provided, does laboratory have a video camera, a monitor and printer? YES NO N/A
3.1.3 In – house sterilization room and equipment                      YES      NO          N/A
3.1.4 Tissue culture room                      YES           NO         N/A
8. Scope of the laboratory
8.1 Is karyotyping done on
4.1.1 bone marrow cultures                    YES           NO          N/A
4.1.2 peripheral blood lymphocytes              YES        NO           N/A
4.1.3 amniotic fluid            YES         NO         N/A
4.1.4 chorion villus specimens            ( CVS )            YES       NO        N/A
   * % by direct analysis                  YES          NO           N/A
   * % by culture                           YES          NO           N/A
4.1.5 skin specimens                      YES          NO             N/A
4.1.6 body effusions                      YES         NO              N/A
4.1.7 products of conception                 YES        NO          N/A
4.1.8 Others ( specify ) ------------------------------------------
8.2 Number of specimens processed per years
8.2.1     total----------------------------------------------------
8.2.2     X- chromosomes for fragile site ----------------------------------
8.2.3     For haematological malignancies ----------------------------
8.2.4     For inherited disorders –-----------------------------------------
8.3 Number of cells counted in each specimen ----------------------------------
8.4 Number of cells karyotyped -----------------------------------------------
8.5 Banding techniques used -----------------------------------------------
4.5.1 Giemsa                                    YES           NO        N/A
4.5.2 Giemsa trypsin                YES          NO        N/A
4.5.3       C                        YES         NO         N/A
4.5.4 NOR                            YES          NO        N/A
4.5.5 Others ( specify ) ------------------------------------------------------------------------------
4.5.6 Are more than one techniques used when required                     YES         NO           N/A
8.6 If so, what percentage of specimens ------------------------------------
4.8 Are the following techniques used
4.8.1 Sister chromosome exchange                             YES          NO          N/A
4.8.2 Late replication                       YES            NO             N./A
4.8.3 Pro – metaphase study                     YES          NO           N/A
4.8.4 Others ( specify )----------------------------------------------------
4.9 Is FISH technique used
4.9.1 If used, which probes are used
9. Clinical Facility
5.1 Does the in – charge of the laboratory also provide genetic counselling                       YES   NO N/A
5.2 I If not , does the hospital have a separate counselling service                   YES         NO N/A
10. Equipment
10.1 Microscope: Are the following microscopes available and are they adequate for the workload
6.1.1 Binocular microscope                 YES            NO         N/A
6.1.2 Multi – head microscopes               YES          NO       N/A
6.1.3 Fluorescence microscopes                  YES        NO N/A
6.1.4 Photomicroscope                 YES        NO         N/A
6.1.5 Are the microscope preperly maintained                   YES       NO       N/A
10.2 Centrifuge: Are the following centrifuges available and are they adequate for workload
6.2.1 Refrigerated centrifuges            YES        NO          N/A
6.2.2 Routine centrifuges                   YES        NO         N/A
10.3 Laboratory refrigerators and deep freezers
6.3.1 Are they on maintenance contract               YES       NO       N/A
6.3.2 Are they adequate for workload                 YES       NO         N/A
6.3.3 Are they filled with temperature recorders              YES NO N/A
6.3.4 Are they temperature recorders checked                  YES         NO     N/A
10.4 Incubators: Are the following incubators available and are they adequate for workload
6.4.1 Incubator with CO2 gas supply                YES        NO        N/A
6.4.2 Incubator with cooling facility                YES       NO N/A
6.4.3 BOD incubator              YES NO             N/A
6.4.4 Is an alarm provided to control temperature variations                   YES     NO    N/A
6.4.5 Are temperature connected to generators or UPS system                      YES   NO     N/A
6.4.6 Are temperature checked and records maintained                        YES      NO        N/A
6.4.7 Are these in working order                   YES          NO         N/A
6.4.8 Are they on maintenance contract                  YES        NO        N/A
10.5 Biosafety cabinets : type of biosafety cabinets in the laboratory
      ----------------------------------------------------------------------
          --------------------------------------------------------------
      ----------------------------------------------------------------------
6.5.1 Are these in working condition ?                   YES           NO        N/A
6.5.2 Are the y on maintenance contract ?                   YES         NO         N/A
11. METHODS
7.1 Are SOP provided                YES          NO        N/A
7.2 Are these revised periodically               YES        NO        N/A
7.3 Does the SOP include procedures related to
7.3.1 Collection of specimen              YES         NO        N/A
7.3.2 Preparation of reagents                    YES NO N/A
7.3.3 Dates of preparation and expiry of reagents                  YES       NO N/A
7.3.4 Maintenance of media                YES NO            N/A
7.4 Are new technicians give in house training before work is assigned                  YES NO N/A
7.5 Are written procedures provided at the workbench                     YES     NO    N/A
7.6 Is glassware properly washed                       YES         NO       N/A
7.7 Is sterility of media and cultures well maintained               YES        NO   N/A
7.8 Are tissue culture properly maintained                 YES        NO       N/A
7.9 Are reagents and media of standard quality                   YES        NO     N/A
7.10 Are precautions taken to avoid contamination                  YES NO          N/A
12. Biosafety
8.1 Are all steps written in the SOP abhered to                       YES            NO      N/A
8.2 Is procedure for internal quality control established                YES     NO       N/A
9. Quality Control
9.1 Are all steps written in the SOP adhered to                YES         NO    N/A
9.2 Is procedure for internal quality control established                YES     NO     N/A
9.3 Does the laboratory participate in any EQA programme                        YES    NO     N/A
9.4 Is specimen identity maintained in steps of analysis
9.4.1 collection            YES       NO        N/A
9.4.2 culture             YES        NO        N/A
9.4.3 cell preparation           YES        NO        N/A
9.4.4 photographic negatives                        YES NO              N/A
9.4.5 Photographic prints               YES         NO          N/A
9.4.6 records of cell counts           YES         NO N/A
9.4.7 karyotypes              YES        NO        N/A
9.4.8 recording of results           YES        NO          N/A
9.5 What is the turn around time for each specimen
     bone marrow --------------------------------
     blood --------------------------------------
     chorion villus --------------------------------
     amniotic fluid --------------------------------
10 Records
10.1 Which nomenclature is used for reporting------------------------
10.2 Are records retrievable        YES         NO       N/A
10.3 Does the maintenance of records include
10.3.1 date of receipt of specimen         YES        NO      N/A
10.3.2 date of reporting           YES           NO      N/A
10.3.3 accession numbers                YES         NO     N/A
10.3.4 name of the patient               YES        NO     N/A
10.3.5 Clinical diagnosis       YES         NO      N/A
10.3.6 type of specimen          YES        NO        N/A
10.3.7 investigation requested         YES         NO      N/A
10.3.8 result reporting         YES        NO N/A
10.3.9 copy of the photographs          YES        NO      N/A
10.3.10 karyotype                      YES         NO     N/A
10.4 Are the records maintained for at least 5 years       YES        NO   N/A




CYTOPATHOLOGY
1.STAFF
1.1 Category of staff                   Full time            part time
   Pathologists                       ----------             ----------
 Cytotechnicians                         -----------        -----------
Technicians                              ---------------           ----------------
Laboratory assistant                              ------------------          ---------------
Secretarial staff                            ---------------         ------------------
Others ( specify )                        ----------------           ---------------
1.2 Are the responsibilites of staff at different levels defined               YES         NO      N/A
5. Workload
5.1 No of specimens ( annual figures )
Gynaecological --------------------------------
General cytology --------------------------------
Fine needle aspiration ( FNA )          -------------------
2.2 Are all specimens screened in the laboratory              YES                 NO         N/A
5.2 How frequently is the pathologist present at the FNACS------------%
5.3 How frequently does the pathologist perform FNACS__________%
5.4 What proportion of aspirations are attended by the cytologist technical staff -----------------%
6. Continuing medical education ( CME )
3.1 Does the laboratory staff participate in CME programme                    YES        NO      N/A
3.2 Are standard textbooks accessible to the staff              YES          NO         N/A
7. METHODS AND PROCEDURES
4.1 Is the SOP readily available to the technical staff              YES       NO        N/A
4.2 Are the written methods provided at the work place               YES NO              N/A
4.3 Are instrucrtions for performing FNAC provided in the collections room YES NO N/A
4.4 Is the collections for equipped with UV light               YES        NO N/A]
4.5 Does the methods mannual contain package inserts when commercial kits are used                     YES NO N/A
4.6 Are written instructions included in the SOP for :
   * handling contaninated materials spill              YES NO N/A
   * disposal of sharps             YES          NO        N/A
   * disposal of infected material            YES NO              N/A
   * disposal of toxic chemical              YES        NO       N/A
   * cleaning of laboratory benches and equipment               YES        NO        N/A
4.7 Does SOP contain information on procedures to :
    * asses quality of all techniques          YES NO             N/A
    * follow special requirements for type of specimen tested               YES NO             N/A
    * validate new methods         YES        NO          N/A
4.8 Are the smears properly spread anf fixed              YES        NO N/A
4.9 Are adequate measures taken to avoid cross contamination                    YES NO N/A
8. Documentation and reporting
8.1 GENERALL
5.1.1 Are the specimens numbered as soon as they are received in the laboratory YES NO N/A
5.1.2 Does the request from include:
    * lab number                YES      NO        N/A
    * name and address of the patient YES NO N/A
    * date of birth/ age          YES       NO N/A
    * nature of specimen          YES NO             N/A
    * site from where specimen is taken                 YES NO               N/A
    * date and time              YES      NO         N/A
    * relevant clinical information                   YES NO N/A
    * previous reference number             YES        NO        N/A
5.1.3 Are the cytology reports and slides kept for a minimum of five years                    YES NO     N/A
or
Are the cytology slides handed over to patients with instructions that these should be maintained for at least
five years as it is a valuable piece of record                  YES         NO       N/A
5.1.4 Can patient’s previous reports and slides be retrieved               YES         NO      N/A
5.1.5 Are patient’s previous reports provided to screener                    YES          NO       N/A
5.1.6 Is the name of the person who reports on the slide recorded                    YES       NO N/A
5.1.7 Is specimen assessed for adequacy                  YES        NO          N/A
       IF , inadequate, are the reasons stated       YES NO          N/A
5.1.8 How many slides does a screener screen per day --------------------------
5.1.9 Are the slides and the file which are borrowed maintained and are they filed back after review
YES                   NO                 N/A
5.1.10 Do the reports contain suggestions for futher investigations when indicated           YES NO N/A
8.2 Non – gynaecological cytology
5.2.1 Is gross desription included in thereport, if required      YES        NO      N/A
5.2.2 Are all the exfoliative cytology slides stained with pap stains       YES      NO N/A
5.2.3 Are the routine samples reported within 3 working days           YES NO N/A
5.2.4 What stains are used for aspirartion cytology
    * Pap           YES NO N/A
    * Giemsa / Romanowsky                    YES NO N/A
    * H& E                      YES       NO N/A
    * Others                YES         NO       N/A
5.2.5 Are the reports which are cummunicated telepohonically followed by a written report YES NO N/A
5.2.6 Are all specimens reviewed and authenticated by a pathologist           YES NO N/A
5.2.7 Are the smears properly prepared and stained          YES NO             N/A
8.3 Gymaecological cytology
8.3.1      Do request forms provide additional relevant patient details such as
      * last menstrual period       YES      NO     N/A
      * hormonal status / therapy / contraception        YES         NO       N/A
5.3.2 Is Pap stain used routinely           YES     NO       N/A
8.3.2      Is reporting terminology uniform
           ( e.g. CIN, dysplastic, etc.)       YES     NO      N/A
5.3.4 Are the reports on sample having malignancy or suspected to have malignancy, conveyed
telephonically and are followed by a written report           YES       NO N/A
5.3.5 Are all positive reports checked by a pathologist       YES NO N/A
5.3.6 What percentage of negative reports are checked by a pathologist           YES NO         N/A
9. EQUIPMENT
6.1 Is the equipment appropriate for the tests being performed         YES       NO N/A
6.2 Are operation manuals placed along with the specific equipment          YES NO N/A
6.3 Are 10x and 40x objectives provided on screening microscopes              YES NO N/A
6.4 Are the small volume specimens processed on a cytocentrifuge              YES NO N/A
6.5 Are biological safety cabinets provided ( applicable to speciality labs )        YES NO N/A
6.6 Are all equipment regularly serviced         YES      NO     N/A
7 Quality Control
7.1 Are instructions provided for talking smears        YES NO            N/A
7.2 Are proper spatulas provided to take smears          YES     NO        N/A
7.3 Are endocervical cells present in the cervical smears If yes, in what proportion are they absent    yes
NO                 N/A
7.4 Is the laboratory attached to an external QAP                YES       NO     N/A
7.5 Are the records of corrective action taken maintained         YES       NO      N/A
8. FOLLOW - UP
8.1 Does the laboratory compare cytology with the result of follow – up histology or colposcopy as a part of
quality assurance                        YES     NO         N/A
8.2 If discrepancies are found, are both cytology and histology slides reviewed and compared with the
clinical profile of the patient            YES      NO       N/A
8.3 Is the laboratory attached to a cancer registry and if so does it regularly send information on all
malignancies               YES        NO       N/A
8.4 Are clinical details obtained when results are unusual or discrepant        YES       NO      N/A
HEMATOLOGY
Range of Tests Available
                  Does the range of tests provided cover

      only routine haematological                            yes            no         N/A

       routine and specialized haematological tests           yes            NO             N/A

Specimens
                 Are clearly written instructions available for collection
     Blood with regard to

        Patient preparation                                    yes            NO             N/A

        Finger – stick and venepuncture technique               yes           NO              N/A

        Anticoagulant to be used                                yes               NO          N/A

        Blood to anticoagulant ratio                            yes               NO              N/A


                   Does a procedure exist for adequate identification of
     Samples till the test is completed and report released       yes              NO             N/A



5.   Equipment

5.1 Is the equipment adequate to provide results in
    Reasonable time for the type and number of tests                yes                NO          N/A


3.2 Is the equipment

       Checked for precision                                     yes                   NO           N/A

       Calibrated for accuracy                                   yes                   NO           N/A

      Checked for background
      ( applicable to haematology autoanalyzers only)            yes                    NO              N/A

      Regularly maintained/ serviced                                yes                 NO              N/A
5.2 Are the operating and maintenance manuals
    Available for automated instruments                               yes                     NO         N/A


6.     Methods

4.1 Is SOP available                                                   yes                     NO         N/A

6.1 Is procedure for the specific tests available at
    Work – bench                                                           yes                 NO          N/A


4.3      Is the CBC performed

             manually                                                      yes                     NO          N/A

             by automated cell center                                       yes                     NO           N/A

6.1.1        Is the ‘ standard for manual haemoglobin traceable to
             National / international reference material                    YES                    NO          N/A


4..3.2       Are the methods validated in the laboratory                         yes               NO           N/A

     4.3.3    Are the methods followed by the laboratory
             As per recommendations of the international
             Council for standardization in hematology
             Or are the accepted internationally                             yes                    NO          N/A

6.1.2        Has the minimum time of centrifugation established
             To achieve maximum packing of cell for determination
             Of haematocrit/ packed cell volume                                  yes          NO         N/A


4.3.5        Are the counting chambers clean and marking intact                   yes         NO          N/A

6.1.3        Are the diluting fluids for platelet count and reticulocyte
             Count filtered each day                                               yes         NO         N/A

4.3.7        Are platelet counts performed

                  Manually                                                        YES              NO      N/A

                  By automated counters                                            yes             NO      N/A

6.1.4        Do values of platelet count correspond to the
             Estimate made by examination of blood film                            yes              NO         N/A

4.3.9        Is a manual check on specimen performed when
             flagged by the automated counter                                           yes        NO      N/A

4.3.10       Are the abnormal or flagged differential leucocyte
             counts (DLC) verified by examination of blood films                        yes        NO      N/A
6.2       Blood films

6.2.1     Are the blood films

            Prepared directly from non – anticoagulated blood or prepared
            With in one hour of collection of anticoagulated blood           yes           NO          N/A

            Identified by a unique number                                    yes            NO          N/A

            Properly spread                                                  yes            NO          N/A

            Properly stained                                                  yes               NO          N/A

4.4.2 Is screening for malarial parasites done both
          on thick and thin film using appropriate stains                     yes               NO      N/A

6.3       Haemostasis

6.3.1     Is bleeding time performed by Ivy’s or template method_______________________________
6.3.2     Are coagulation tests performed
              Manually                                                      yes      no    N/A

             By semiautomated or automated instruments                             yes     NO         N/A

4.5.3 Is thromboplastin for prothrombin time (PT)
        Prepared in – house                                                        yes      NO         N/A
         Procured commercially                                                     yes      NO         N/ A

6.3.3     Is the international Sensitivity Index (ISI) of the
          In - house preparation determined                                         yes         NO     N/A

4.5.5 Are the results of PT reported in INR                                         yes         NO      N/A

6.3.4     Are the reference ranges for PT, APTT
          Determined when alternative reagents are used                        yes               NO         N/A

6.4     Bone marrow

4.6.1 Is the bone marrow aspiration and / or trephine
         biopsy carried out by the laboratory
          haematologist / pathologist                                  yes           NO         N/A

4.6.2 Do bone marrow slides have unique number                         yes          NO      N/A

6.4.1     Are bone marrow smears stained to assess
          Iron stores where indicated                            yes                NO      N/A

6.4.2     Are slides labelled with diamond pencil
          And / or indelible ink                                   yes         NO          N/A

4.6.5    Does not reporting haematologist / pathologist
          participate in internal quality control programme
          and / or external quality assessment programme            yes       NO          N/A
6.5     Blood grouping and antiglobulin test

4.7.1 Is the blood grouping performed with
          monoclonal antiserum                                  yes             NO    N/A

          Polyclonal antiserum                                  yes         NO       N/A

6.5.1     In addition to ABO grouping is the Rh (D)
          Group determined                                     yes          NO        N/A

6.5.2     Is suitable control used to ensure accuracy of
          Grouping for Rh (D)                                        YES        NO    N/A


6.5.3     Are, A or B cells used on random specimens to
          Check accuracy of results                              yes            NO    N/A

6.5.4     Is the laboratory getting random samples
          Verified by blood transfusion centre                       yes        NO    N./A


6.6     Are procedures such as Ham acid test, sucrose lysis
        Test, asmotic fragility, hacmoglobin electrophoresis, etc
        Performed (specify)                                   ________________________________

4.8.1 Are these tests performed according to
      standard methods                                          yes             NO         N/A

4.8.2 Are these subjected to quality control                   yes         NO        N/A


7.    Reports

7.1 Are the results on the routine test provided
    Within 12 hours                                            yes         NO        N/A

5.2 Is there a procedure available for handling
    urgent samples                                             yes          NO       N/A

5.3 Are there random check to eliminate
    transcription errors                                       yes              NO     N /A

5.4 Do reports include appropriate units and
    reference ranges                                            yes             NO     N /A




HISTOPATHOLOGY
          Workload
5.1 Number of specimens received per year
5.2 Type of specimens ( 5 common)
5.3 Percentage of specimens

        Neurological                             ___________________%
        Orthopaedic / maxillo facial             ____________________%
        Ontological                             ______________________%

1.4 Are all specimens procured at your laboratory         yes     NO          N/A

      If not, are you satisfied with the quality system
      In the subcontracted laboratory                      yes     NO         N/A

6.    Eligiblity Criteria

6.1 Number of specimens per year ] 300
6.2 Personnel Technicians with it least one year
    Work experience in a histology laboratory. The
     Workload per technician should not exceed 50
    Block per day. A stand be technician with appropriate
    Training and skill should be available.

6.3 Neurological specimens to be accepted only in
    Super – speciality / dedicated laboratories

5.    Grossing of Specimens

3.1 Do request forms contain relevant clinical infor-
    mation , provisional diagnosis and operative findings              yes           NO         N/A

3.2 Is the space adequate for receipt, examination and
    storage of specimens                                                yes           NO         N/A

3.3 Is refrigerated storage facility available                   yes           NO               N/A
3.4 Is the lighting adequate                                           yes           NO           N/A
3.5 Is the water supply adequate and close to work place               yes           NO           N/A
3.6 Is grossing area separate from main laboratory                      yes           NO          N/A
3.7 Is grossing area adequately ventilated by means of an
    exhaust fan or fume hood                                            yes               NO     N/A
3.8 Is the area clean and maintained in an orderly manner               yes               NO     N/A
3.9 Is the work bench surface smooth                                     yes               NO     N/A
3.10 Are instruments clean, sharp and well maintained                    yes               NO     N/A
3.11 Is identity of specimens maintained from receipt
    till reported                                                            yes           NO         N/A
3.12 Are gross specimens retained till the report is
    reviewed by the referring physician                                      yes            NO        N/A
3.13 Are safety precautions ( e. g. use of gloves, gowns
    and masks) taken during handling fresh
      and fixed tissue                                                       yes            NO         N /A
3.14 Are the specimens disposed safely                                       yes            NO         N/A
5.1 Is a clean area available to record gross description
     By hand or by dictaphone                                                 yes               NO      N/A
3.16 Is bone – cutting equipment available ( applicable to
     orthopaedic / other bone work )                                           yes              NO       N/A
6.   Equipment

4.1 Is the equipment cleaned and well maintained               yes           NO        N/A
4.2 Is it serviced regularly                                    yes          NO        N/A
5.1 Is the electrical equipment properly connected
    And earthed                                                 yes          NO         N/A
5.2 Tissue processor

    Are the solutions changed regularly                         yes           NO         N/A
    Is there a regular removed click on wax bath temperature     yes           NO        N/A
    Are the fumes removed adequately
    ( by hood or ventilation                                     yes          NO         N/A
5.3 Wax dispenser

1. Is the temperature checked regularly                          yes          NO         N/A
2. Is the temperature appropriate for the type of wax used        yes         NO        N/A
3. Is the dispenser located at an adequate distance from
    exposed volatile solvent ( e. g. tissue processor)               yes          NO     N/A


5.4 Microtomes

1.   Are they well maintained ( e.g. no play in advance
     Mechanism) and lubricated.                                        Yes        NO         N/A
2. Are the microtomes knives sharp, without
     Scraches, and safely stored.                                Yes           NO         N/A
3. Is the knife sharpener shielded when is use                   yes          NO         N/A
3. If disposable knives are used, are they changed to
     Maintain quality of sections                               yes               NO     N/A

5.5 Tissue baths

1. Is the water in the tissue bath changed daily               yes            NO        N/A
5. Are tissue floaters removed before the next block is
     Cut to avoid contamination                                yes            NO        N/A
6. Are automated stainers available and if so
     Are they regularly checked and maintained                  yes           NO        N/A

7.   Methods

5.1 Is the SOP available to the staff                              yes      NO    N/A
5.2 Is it updated when required                                    yes     NO      N/A
7.1 Is the identity of specimens maintained throughout
      Processing, cutting and staining                              yes     NO   N/A
7.2 Are slides labelled by indelible system e.g. diamond
      Pencil or permanent marker                                    yes   NO   N/A
7.3 Is the section and the staining of optimal quality              yes   NO   N/A
7.4 Are position controls run with special stains                   yes    NO   N/A
7.5 Does laboratory perform immunohistochemistry                     yes   NO     N/A
7.6 If so, what antibodies are available                              yes NO    N/A
5.8.1 Are positive and negative controls set up with each antibody    yes  NO    N/A
t is the monthly workload       __________________________________________

8.   Frozen Sections
5.1 Is the slide ready for examination with in 20 minutes
    From the recipt of specimen                                          yes              NO         N/A
6.2 Are the sections of optimal quality                        yes       NO                N/A
5.2 Are the verbal reports directly communicated to one of the
    Surgeons in the operating team                             yes       NO               N/A
6.4 Is patient identity reconfirmed before verbal report is communicated yes             NO          N/A
6.5 Is the verbal report followed by a written report                     yes             NO          N/A
6.6 Is the frozen section report compared with the section report           yes           NO           N/A

6. Reporting
7.1 Are the slides examined and reporting by a pathologist                      yes          NO         N/A
5.1 Are routine report normally completed within 48 hours
    For both small biopsies and 72 hours for non- bony
    Large specimens and 5 days for bony specimens
    Requiring de – calicification                                               yes         NO    N/A
7.3 Are gross descriptions unambiguous                                 yes                NO     N/A
7.4 Are microscopic descriptions given when necessary                    yes             NO   N/A
7.5 Does the laboratory participate in EQA, if available              yes              NO     N/A
7.6 Does the laboratory have an internal QC                          yes              NO    N/A

5.    Records

5.1 Are the blocks field, usable and accessible ( stored in cool
    Area, not melted and properly identified)                        yes               NO           N/A
8.2 Are the slides field and accessible                            yes                NO          N/A
5.2 Is an index or cross reference system in use to
    Allow retrieval of information by :

    1. patient name                      yes      NO    N/A
    2. registration number               yes        NO N/A
    3. diagnosis                         yes       NO     N/A
8.4 Are slides and blocks returned to the patient                     YES                   NO        N/A
    If not, are they kept for at least five years                     yes                   NO        N/A
8.5 Are report kept for a minimum period of five years                 yes                   NO       N/A
8.6 Are gross specimens retained for at least three weeks              yes                   NO        N/A

6.    Autopsies

9.1 Are autopsies performed                                         yes                         NO         N/A
9.2 Is the space adequate                                                 yes                   NO         N/A
6.1 Is the autopsy room :

      1. clean                                                           yes                       NO      N/A
      2. ventilated                              yes       NO      N/A
      3. well lighted                            yes       NO      N/A
      4. airconditioned                           yes      NO      N/A
6.2   Is the autopsy room provided with
      1. clean and sharp instruments            yes        NO      N/A
      2. balance and weighing machines           yes       NO      N/A
      3. gloves masks, gowns and shoes            yes      NO      N/A
9.5   Is there refrigeration to store bodies      yes       NO       N/A
9.6   Is facility for recording of gross findings provided yes     NO    N/A
9.7   Is photographic facility available          yes       NO      N/A
9.8   Are locker and shower rooms provided yes               NO     N/A
9.9 Are viewing facilities available for students/ clinicians yes      NO     N/A
9.10 Is a written perliminary report of gross diagnosis available with in 48 hours   yes        NO   N/A
9.11 Are gross and microscopic description unambiguous             yes       NO N/A
9.12 Are autopsy reports discussed with clinicians               yes      NO     N/A
9.13 Does an idexing system exist to retrieve slides by
     name or diagnosis or registration number               yes        NO     N/A
9.14 Are autopsy reports filed and accessible               yes          NO N/A
9.15 Are organs stored till reports is completed            yes         NO     N/A
9.16 Are block field, usable and accessible                  yes        NO      N/A

7.   Electron Microscopy

7.1 Is space sufficient for
    1. processing and section cutting                  yes         NO       N/A
    2. electron microscope                             yes         NO       N/A
    3. photography                                     yes         NO       N/A
    4. storage of spares                                yes        NO         N/A
    5. storage of grids, records and photographs        yes        NO        N/A

7.2 Are safety producers followed ( e.g., goggles and
     Gloves for liquid nitrogen and safety hoods
     For toxic chemicals)                                  yes          NO       N/A
7.3 Are manufacturers’ instructions for operation and
        Safety followed                                     yes         NO       N/A
7.4 Does laboratory provide clear instruments for collection of
     Specimens to concerned persons                           yes       NO      N/A
7.5 Does the request from include relevant clinical
        Details and source of specimen                      yes         NO     N/A
7.6 Does the laboratory provide EM fixatives to
        Operating room, OPD autopsy room, etc               yes          NO     N/A
7.7 Is the EM
     1. routinely serviced as per manufacturer’s checklist      yes        NO N/A
     2. calibrated                                               yes        NO N/A
     3. maintained through a service contract                     yes        NO N/A
10.8 Is SOP available                                            yes         NO     N/A
7.8 Is the SOP updated when required                             yes         NO     N/A
7.9 Is identity of specimen maintained throughout
     The process                                                    yes         NO N/A
7.10 Is the quality of slides and electron micrographs
           Optimal for interpretation of ultrastrutural changes        Yes       NO     N/A
7.11 Are light microscopic and EM findings co – related            yes        NO     N/A
7.12 Are grids, photographs and report labelled , indexed
              And filed and are accessible                                yes     NO      N/A
10.14 Are gross specimens kept till the report is finalized            yes     NO     N/A




                  IMMUNOLOGY
5.   Specimens

5.1 Are the request forms appropriate for investigations available            yes      NO    N/A
5.2 Are instructions available for :

     6.   time and type of sample collection                               yes          NO   N/A
     7.   immediate separation                                              yes          NO    N/A
     8.   processing and storage                                           yes           NO    N/A
     9.   transportation                                                   yes            NO   N/A

9.1 Are there written criteria for rejection of unacceptable
    Specimens ( gross external contamination, dried swabs,
    Lack of transport media )                                               yes        NO     N/A
9.2 Are there special instructions for collections
    And transportation of infectious materials                   yes          NO       N/A
1.5 Are there suitable facilities for storage of
    specimens that may need retesting                                Yes          NO        N/A
1.6 Are all the specimens handled as a potentially infections        Yes          NO        N/A
1.7 Are emergency laboratory services available                      Yes          NO         N/A

10. EQUIPMENT

2.1 Is a list of major equipment available                   yes         NO      N/A
2.2 Is the laboratory equipped with water purification       Yes         NO      N/A
2.3 Is there a system for backup electricity                  Yes         NO      N/A
2.4 Is calibration and verification of equipment carried out yes          NO      N/A
2.5 Are log books for equipment maintained                    Yes          NO      N/A
2.6 Are equipment decontaminated after use                   Yes             NO     N/A
2.7 Are there annual maintenance contracts                    Yes            NO       N/A
2.8 Is there is a list of equipment which have service contracts     Yes     NO N/A
2.9 Is water bath and incubator temperature checked
    and recorded regularly                                       yes       NO        N/A
2.10 Are incubators available for:
        1. different temperatures                             yes        NO      N/A
         2. controlled CO, atmosphere                         Yes         NO     N/A
2.11 Are calibrated thermometers used to check temperature Yes            NO     N/A
2.12 In the ELISA system
          1. are the filters of the ELISA reader              Yes         NO     N/A
           2. is dual wavelength facility available          Yes            NO N/A
          3. is the washing system automatic or semiautomatic      Yes       NO     N/A
          4. is the washing system decontaminated regularly          Yes      NO     N/A
2.13 AUTOCLAVES
     1. is the autoclave indicator used             yes       NO      N/A
     2. is the temperature and pressure checked
      frequently and logged                         Yes           NO      N/A
    3. are spore strips used to check
        performance of autoclave                    Yes           NO      N/A
     4. are all the persons using autoclave
          trained to operate it                      Yes          NO      N/A
2.14 Are the pipettes calibrated frequently          Yes          NO        N/A
2.15 Microscope

     11. are the microscopes with oil immersion
         objective available                    yes             NO         N/A
     2. is fluorescence microscope available     Yes            NO         N/A
     3. is UV light source properly shielded to protect the personnel       Yes     NO   N/A
     4. in phase contrast microscope available          Yes            NO   N/A
     5. are the objectives and eyepieces checked regularly         Yes    NO    N/A
2.16 Are freezers available at :
          1. –20 C                  yes      NO     N/A
          2. –40 C                  Yes          NO   N/A
          3. –70 C                   Yes          NO N/A
2.17 Is liquid nitrogen storage facility available               Yes     NO   N/A
2.18 Biological safety cabinets
          1. to what class does the safety cabinet belong          Yes    NO N/A
          2. are personnel aware of the proper use of the cabinet Yes      NO N/A
          3. are the filters serviced according to regular schedule Yes     NO N/A
          4. are the cabinets monitored regularly for microbial
             contamination, efficiency and safety.                   Yes     NO N/A
2.19 Is there a flow cytometer in the laboratory             Yes    NO N/A
          1. If yes , is it calibrated regularly              Yes    NO N/A
     12. Is there a quality assessment programme
          For the flow cytometer                                Yes    NO N/A
     13. METHODS

3.1 Are the SOPs made accesible to all staff members
         involved in testing                                    Yes    NO     N/A
3.2 Are the written down producers for specific tests available
         at the work bench                                     Yes      NO   N/A
3.2 Are the SOPs revised necessary                          yes        NO    N/A

3.4 For C3 and C4 complement and IgM and IgM assays, what
     methods are used                                    yes NO N/A
    1. RID
14.       2. nephelimetry                  YES NO N/A
    3. immunotubidometry              YES NO N/A
    4. Other ( specify)              YES      NO       N/A
    5. If by nepelometry, are all diluents filtered to
           remove particulate matter       YES NO        N/A
     6. If by RID, is it carried out at a
          constant temperature             YES    NO N/A
3.5 Is IgM assay carried out by :
      1. ELISA                YES         NO      N/A
      2. RIA                   YES         NO      N/A
3.6     Arehe calibrators traceable to national/
         international reference materials      YES     NO     N/A
3.7 Method used for Rheumatiod factor:
     1. nephelometry            YES         NO     N/A
     2. latex kit                YES        NO      N/A
     3. conventional test is carried YES         NO      N/A
     4. others                    YES       NO      N/A
14.1 If haemagglutination test is carried out :
     15. are precautions taken to avoid interference
           from haterophilic antibodies         YES NO        N/A
     16. are reactive and non- reactive controls
           used for cell preparation            YES      NO     N/A
3.9 If lymphocyte enumeration carried out YES             NO     N/A
3.9.1 If yes, method used for cell preparation
       1. haemolysis for whole blood             YES       NO    N/A
     2. ficoll hypaque                         YES     NO    N/A
     3. are the cells tested for viability     YES       NO N/A
    17. if cytometry is used for lymphocyte enumeration are
        precautions taken for maximum stability of cells   YES NO      N/A
    17.1.1 Lymphocyte enumeration done by :
             1. ordinary microscopy            YES     NO     N/A
             2. fluorescence microscopy         YES      NO    N/S
18.           3. if by fluorescence microscopy,
19.                    is illumination checked   YES      NO     N/A

    19.1 If immuno – fixation and immuno – electrophoresisand carried out
         1. is voltage checked during each run     YES     NO    N/A
         2. are the buffer solutions in the chamber changed as
                    per manufacturer’s recommendation YES      NO      N/A

    20. SAFETY

4.1 Are safety measures documented and followed           YES NO    N/A
4.2 Are personal protective devices like gloves,
    gowns and masks used                                   YES  NO     N/A
4.3 Is there a system for reporting accidents             YES   NO      N/A
    20.1 Are instructions for disposal of specimens, used
         Glassware, disposable and biological media
        Available and followed                             YES   NO     N/A
    20.2 Are the protocols documented and followed for
         Handling spills of contaminated material           YES   NO     N/A




                  MICROBIOLOGY AND SEROLOGY

5. SPECIMENS
1.1 Are request forms appropriate for investigations available     YES  NO     N/A
1.2 Are instructions available for :
    1. time and type of sample collection          YES     NO    N/A
    2. immediate separation                         YES     NO   N/A
    3. processing and storage                       YES      NO N/A
    4. transportation of specimens                   YES      NO N/A
5.1 Are three written criteria for rejection of unacceptable
     Specimens (gross external contaminations, dried
     Swabs, lack of transport media )                YES NO N/A
1.4 Are there special instruments for collections
     and transportation of infectious materials      YES NO N/A
1.5 Are there suitable facilities for storage of
     specimens that may need retesting                 YES     NO N/A
1.6 Are all specimens handled as potentially infections YES NO N/A
1.7 Are emergency laboratory services available           YES    NO N/A

6. EQUIPMENT
2.1 Are major equipments listed       YES   NO   N/A
2.2 Is the laboratory equipped with water
    purification system                     YES NO N/A
2.3 Is there a system for backup electricity YES NO N/A
2.4 Is calibration and performance verification
                of equipment carried out         YES NO N/A
2.5 Are log books for equipment maintained YES NO N/A
2.6 Is equipment decontaminated after use          YES NO N/A
2.7 Are there annual maintenance contracts         YES NO N/A
2.8 Is there a list of equipment which have
     service contract                               YES NO N/A
2.9 Is water bath and inclubator terperature checked
     and recorded regularly                       YES NO N/A
2.10 Are inclubators available for
     1. different temperature                     YES NO           N/A
      2. controlled CO 2 atmosphere               YES      NO      N/A
2.11 Are calibrated thermometers used to check temperature YES            NO N/A
2.12 In the ELISA system
       1. Are the filters of the reader checked periodically YES NO N/A
       2. is dual wavelength facility available            YES      NO     N/A
       3. is the washing system automatic or semiautomatic YES NO          N/A
       4. is the washing system decontaminated regularly        YES NO N/A
2.13 AUTOCLAVES
      1. are autoclave indicators used        YES     NO       N/A
      2. are temperature and pressure checked frequently and logged      YES NO N/A
      3. are spore strips used to check performance of autoclave     YES NO        N/A
      4. are all persons using autoclave trained to operate it         YES NO N/A
2.14 Are the pipettes calibrated frequently                            YES     NO N/A
5.1 MICROSCOPE
      1. are microscope with oil immersion objective available          YES    NO N/A
       2. is phase contrast microscope available                       YES     NO     N/A
       3. is flourescence microscope available                         YES     NO     N/A
       4. is UV light source properly shielded to protect the personnel YES NO         N/A
       5. are objectives and eyepieces checked regularly                 YES NO        N/A
5.2 Are freezers available at
      1. –20 C                YES NO         N/A
       2. – 40 C               YES NO        N/A
       3. –70 C                  YES NO       N/A
2.17 Is liquid nitrogen storage facility available     YES NO N/A
5.3 Biological safety cabinets
      1. to what class does the safety cabinet belong YES NO           N/A
      2. are the personnel aware of the proper use of the cabinet     YES NO       N/A
      3. are filters serviced according to regular schedule      YES NO N/A
      4. are the cabinets monitored regularly for microbial
             contamination, efficiency and safety                 YES NO       N/A

3. LABORATORY SPACE
3.1 Is there space designated for :
    1. specimen receipt               YES     NO      N/A
    2. processing                     YES      NO     N/A
    3. packing and sterilization      YES      NO N/A
    4. media preparation              YES       NO N/A
    5. serological tests               YES NO         N/A
    6. decontamination and washing YES NO                 N/A
3.2 Are the surfaces of walls, ceiling, floors and benches smooth   YES      NO     N/A
3.3 Are dust – filtered air ventilation systems available           YES       NO     N/A
5.1 Is the cleaning programme to address the work area
      Documented and enforced                                               YES     NO        N/A
3.5   Are disposable labware used        YES NO     N/A
3.7   Are the disposable labware reused YES NO N/A
3.8   Is regular fumigation done and documented YES NO N/A
3.9   Are colony counts of air recorded regularly YES NO N/A

6. DOCUMENTATION
4.1 Are there SOPs for the tests performed by the lab YES NO N/A
4.2 Are written down procedures for specific tests available
    at the work bench                                    YES NO N/A
4.3 Are SOPs revised when necessary                YES NO     N/A

5. QUALITY CHECK
5.1 Does the quality control programme include:
    1. a responsible person for monitoring QC         YES NO N/A
    2. documentation of internal quality control data YES   NO N/A
    3. participation in appropriate EQA programme YES NO       N/A
    4. maintenance of all quality control result        YES NO N/A
    5. reasons for acceptance / rejection of QC results YES NO N/A
    6. evidence for necessary corrective measures taken YES NO    N/A

5.2 MEDIA
    1. Is the data of receipt , expiry date, opening date recorded  YES           NO    N/A
    2. Is quality check for media growth carried out with reference strain        YES   NO     N/A
    3. Is the PH of media checked           YES     NO N/A
    4. Is the sterility of media checked      YES NO N/A

5.3 Anti- microbial sensitivity testing:
    1. Is the quality of media for sensitivity checked      YES     NO      N/A
    2. Is quality check of sensitivity discs with
        reference strains carried out                       YES      NO      N/A

5.4 Is quality check out for stains          YES NO   N/A
5.5 Is a stock reference of strains maintained YES  NO    N/A

6. BACTERIOLOGY
6.1 Is isolation, identification and sensitivity of the following carried out :
    1. common bacteria         YES      NO      N/A
    2. fastidious organisms YES NO               N/A
    3. anaerobic organisms YES            NO      N/A
7. PARASITOLOGY
7.1 Is identification of parasites carried out     YES       NO N/A

8.    VIROLOGY
8.1   Are services provided for diagnosis of viral disease     YES    NO   N/A
8.2   Are cell cultures and viral isolation services available YES NO       N/A
8.3   If yes, are biosafety measures documents YES NO            N/A
8.4   Is the level of biosafety compatible with the services provided   YES NO           N/A

9. MYCOLOGY
9.1 Is the work area demarcated           YES      NO   N/A
9.2 Is a biosafety cabinet used           YES      NO    N/A
9.3 Is isolation, identification of fungus carried out YES   NO   N/A
9.4 Is sensitivity for fungus carried out          YES NO     N/A
10 MYCOBACTERIOLOGY
10.1 Is there a separate room for mycobacteriology                YES   NO    N/A
10.2 Is there a safety cabinet            YES         NO        N/A
10.3 Are the safety rules documented and carried out          YES    NO    N/A
10.4 Is mycobacterial isolation carried out                YES       NO    N/A
10.5 Is identification and anti- tubercular sensitivity testing done    YES NO            N/A

11 REPORTING
11.1 Are the final reports normally available with in 48 hours         YES       NO    N/A
11.2 Are preliminary reports issued if final reports are not available with in 48 hours YES NO N/A
11.3 Are reports reviewed by the need of the department of authorized persons          YES NO N/A
11.4 Are the reports computerized           YES      NO      N/A

12. SEROLOGY
12.1 Does the lab do routine serology        YES      NO      N/A
12.2 Does the lab do special tests            YES NO           N/A
12.3 Is the staff adequately trained to work in this area YES NO N/A
12.4 Are quality checks for serological tests carried out     YES NO N/A
12.5 Are reagents stored properly         YES      NO      N/A
12.6 Are controls run routinely            YES      NO      N/A
12.7 Is a record of date of receipt, date of expiry and date of opening maintained  YES NO                N/A
12.8 Does the lab run internal quality checks regularly       YES     NO N/A
12.9 Does the lab take part in external quality assessment programme YES         NO  N/A

13. SAFETY
13.1 Are safety measures documents and followed           YES NO       N/A
13.2 Are personal protective equipment like gloves, gowns and masks used   YES  NO                   N/A
13.3 Is there a system for accident reporting     YES      NO      N/A
13.4 Are instructions for disposal of specimens, used glassware,
      disposable and biological media available and followed      YES   NO  N/A
13.5 Are the protocols documents and followed for
      handling spills of contaminated material                 YES     NO   N/A
13.6 Are baseline sera of staff available                        YES   NO   N/A




NUCLEAR MEDICINE AND REFERENCES


The checklist for this section is under preparation. It will be available later as a supplement to this
document.



REFERENCE
1.   EAL documents on ‘ Accreditation for Medical Laboratories’ ( Edition- 1, january 1997)
     [ EALG25 ECLM- 1 ]
2.   ‘A Quality Manual for the Clinical Laboratory including the Elements of a Quality System’, published
     by NORDTEST, Finland [ NT Technical Report 187, 1992].
3.   NATA document on ‘ Accreditation of Medical Laboratories’.
4.   The Guideline Documents published by National pathology Accreditation Advisory Council,
     Australian Government Published Service, Canberra.
5.   NATA / RCPA Medical testing Requirements, 1996.

MEMBERS AND SPECIAL INVITEES OF THE TECHNICAL COMMITTEE ON
ACCREDITATION OF CLINICAL LABORATORIES
1. Dr. A.S Kanagasabapathy, Deputy Director and Secretary, Centenary project Professor of Clinical
Biochemistry, Christian Medical college and Hospital , Vellore 632 004 (Tamilnadu) Chairman.
2. Dr. A.K. Chakrabarty, chief executive , convener, NABL.
3. Dr. S.K. Sood , consultant haematologist ,Sir Ganga Ram Hospital, ganga ram hospital marg, New
    Delhi.
4. Dr. ( Mrs) Ira Ray, Director, National Institute of biologicals, Nirman Bhavan, New Delhi
5. Dr. Sita Devi, CDR Hospital Ltd; 3-6-287, hyderguda ,hyderabad- 500 029
6. Dr. Anita Borges, Head, Department of pathology, Tata memorial hospital, parel, mumbai.
7. Dr. U.M. Donde Deputy Directoer, Institute for Research in Reproduction, Jahangir.
8. Dr. Nilam Dhingra Kumar, Reader in pathology, Guru Tegh Bahadur Hospital, Shandara.
9. Dr. D. P. Srivastava, Medical Superintendent and Head, Clinical Biochemistry, Guru Tegh bahadur
    hospital , shahdara, new delhi.
10. Dr. Ratna Rao, department of microbiology, apollo hospital, jubilee hills,
11. Dr. Geeta Krishnamurthy, sion hospital, LTM medical college, Sion , Mumbai- 400 022
12. Dr. S.P. Vasireddi, Managing Director, Vimta labs Ltd; 142, IDA cherlapally, Hyderabad
13. Dr. K.L. Mukherjee professor of biochemistry, vivekanand institute of medical sciences, calcutta.
14. Mr. B. Bhattacharya, D-1 /206, Jumbo Darshan, anadheri (E) Mumbai – 400 069.
15. Dr. T. Verghese, Department of biochemistry, school of medical education, mahatma Gandhi
    University, Kottayam, Kerala.

				
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