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 New Delhi

Dated 23rd February 1998

Chairman NABL Secretary DST

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. 2. 3. 4. 5. 6. 7. 8. 9. Blood Bank and Transfusion Services*. Clinical Biochemistry. Clinical Pathology. Cytogenetics Cytopathology Haematology Histopathology Immunology 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 mediumsized 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 CALIBRATION AND COMMENTS Autoclaves

MAXIMUM PERIOD BETWEEN SUCCESSIVE CALIBRATION PROCEDURES OF CHECKS *Monthly check on effectiveness of sterilization

Balance and Scales Yearly calibration include calibration of balances, repeatability s and one point check using a known mass to balance capacity. Biological Safety Cabinets ------------------one year

Checks Check Close

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 type) Calibration of the timing device and, where Appropriate, the temperature measurement will be required. In addition, pertesting is recommended for applications:Technical Mannual, Association of Blood Banks, edition, 1990(or later).

Light cell

Device Formance Specific American 10th

Manometers Reference Check fluid every three years Working check against reference

Five years one years

Masses Reference, of integral stainless steel or nickel chromium alloy years subsequent Working stainless steel or nickel chromium alloy years subsequent ASTM E617 Working , other ASTM E617 Piston operated Volumetric Apparatus

Three years initial ,six * Three years intial, six One years

AS 4163

Pipettes and Dispensers For gravimetric checks, volume dilivery weighing under specified Conditions must be repeated at least times. For adjustable devices volume delivered at several settings of volumes less than 100 ul may verified by spectrometry using a dye Check volume delivered at settings in use sample and duluent volumes or ratio and total volume Diluters Check sample and diluent volumes or ratio and total volumes. Thermometers Reference six months

Initial and every six months And

Ten (10) Check Delivery Be Solution. Three months Check Dilution Six months Dilution

Five years ( complete) *Check ice point before use or at least every

Continued on following page

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

Working against a calibrated reference

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

Check

Electronic automatic cold junction Timing devices

checks compensation

* 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 manufacturers 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 6.What are the working hours of the laboratory 6.1Specify * Normal *Emergency * Weekend Holidays 5.Staff 3.1 Head of the laboratory : Name ------------------------------------------Qualifications -------------------------------Experience -----------------------------------

N/A

5.1.1Does 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 5.1.1Is the work looked after by the section head or another Qualified staff when the laboratory incharge /diretor is absent YES 5.2Section heads for each area of activity NAME Qualification Working hours

NO

N/A

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 5.1Is 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 5.1If 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 5.2Does 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 / doctors 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 5.1Are 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 6.1Are 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 5.1.1Which 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 patients 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 5.1.1Is the area of Blood Transfusion centre within the Drug and Cosmetic Act regulation YES NO N/A 5.1.2Do 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 5.2STAFF 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 5.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 5.1Blood 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 5.2Blood 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 5.1Mention 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 5.1Are 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 pretransfusion 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 : * Patients complete YES NO N/A * Patients 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 5.1Are the following performed in the ward/OT before transfusion : 7.3.1 Check on recipients 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 5.2Donor 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 5.3Transfusion 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 5.1Do 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 5.1Number of specimens ( annual figures ) * Urine faeces Semen 1.2 Are relevant atlases and books available YES NO N/A 5.Specimens Are there written instuctions available for * collections of specimens YES NO N/A * appropriate preservatives YES NO N/A 6.Equipment 6.1Microscope * Is microscope with oil immersion lens available YES NO N/A * Is polarzing light attachment available for identification of crystals YES NO N/A 7.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 7.1Faeces 7.1.1Is 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 7.2Semen 7.2.1Are 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 7.2.1Are 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 8.Quality Control 8.1Does 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 9.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 5.1Name--------------------------------------------------------5.2In charge of the speciality----------------------------------------5.3 Qualifications------------------------------------------------------------------6.Staff 6.1Medical-------------------------------------------------------------6.2Full time-----------------------------------------------------------6.3Part time ( specify working hours )------------------------------6.4Technical ( specify level and numbers)-----------------------------6.4.1Technical assistant---------------------------------------------------6.4.2Technicians -------------------------------------------------------6.4.3Others ------------------------------------------------------------2.5 Is employment record of the above staff available YES NO N/A 7.Space 7.1Is 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 8.1Is 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 ) -----------------------------------------8.2Number of specimens processed per years 8.2.1total---------------------------------------------------8.2.2X- chromosomes for fragile site ---------------------------------8.2.3For haematological malignancies ---------------------------8.2.4For inherited disorders ----------------------------------------8.3Number of cells counted in each specimen ---------------------------------8.4Number of cells karyotyped ----------------------------------------------8.5Banding 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 8.6If 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 5.2 I If not , does the hospital have a separate counselling service YES NO N/A 10.Equipment 10.1Microscope: 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 10.2Centrifuge: 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 10.3Laboratory 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 10.4Incubators: 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

N/A

10.5Biosafety 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 5.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 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 6.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

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 5.1No of specimens ( annual figures ) Gynaecological -------------------------------General cytology -------------------------------Fine needle aspiration ( FNA ) ------------------2.2 Are all specimens screened in the laboratory YES NO N/A 5.2How frequently is the pathologist present at the FNACS------------% 5.3How frequently does the pathologist perform FNACS__________% 5.4What 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 8.1GENERALL 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 patients previous reports and slides be retrieved YES NO N/A 5.1.5 Are patients 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 8.2Non 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 8.3Gymaecological cytology 8.3.1Do 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 8.3.1Is 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 routine and specialized haematological tests yes yes no NO N/A N/A

Specimens
Are clearly written instructions available for collection Blood with regard to Patient preparation Finger stick and venepuncture technique Anticoagulant to be used Blood to anticoagulant ratio yes yes yes yes NO NO NO NO N/A N/A N/A 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 5.1Is the equipment adequate to provide results in Reasonable time for the type and number of tests 3.2 Is the equipment Checked for precision Calibrated for accuracy Checked for background ( applicable to haematology autoanalyzers only) Regularly maintained/ serviced 5.2Are the operating and maintenance manuals Available for automated instruments 6.Methods 4.1 Is SOP available 6.1Is procedure for the specific tests available at Work bench 4.3 Is the CBC performed manually N/A by automated cell center N/A 6.1.1Is the standard for manual haemoglobin traceable to National / international reference material N/A 4..3.2 N/A 4.3.3 Are the methods validated in the laboratory Are the methods followed by the laboratory As per recommendations of the international Council for standardization in hematology Or are the accepted internationally N/A yes yes NO NO yes yes NO NO N/A N/A yes yes yes yes NO NO NO NO N/A N/A N/A N/A yes NO N/A

yes

NO

N/A

YES

NO

yes

NO

yes

NO

6.1.1Has the minimum time of centrifugation established To achieve maximum packing of cell for determination Of haematocrit/ packed cell volume 4.3.5 Are the counting chambers clean and marking intact

yes yes yes

NO NO NO

N/A N/A N/A

6.1.1Are the diluting fluids for platelet count and reticulocyte Count filtered each day 4.3.7 N/A By automated counters 6.1.1Do values of platelet count correspond to the Estimate made by examination of blood film N/A 4.3.9 4.3.10 Is a manual check on specimen performed when flagged by the automated counter Are the abnormal or flagged differential leucocyte counts (DLC) verified by examination of blood films Are platelet counts performed Manually

YES yes yes

NO NO NO N/A

yes yes

NO NO

N/A N/A

6.2Blood films 6.2.1Are the blood films Prepared directly from non anticoagulated blood or prepared With in one hour of collection of anticoagulated blood N/A N/A Properly stained N/A 4.4.2 Is screening for malarial parasites done both on thick and thin film using appropriate stains N/A 6.3Haemostasis 6.3.1Is bleeding time performed by Ivys or template method_______________________________ 6.3.2Are coagulation tests performed Manually yes no N/A By semiautomated or automated instruments 4.5.3 Is thromboplastin for prothrombin time (PT) yes NO N/A yes NO Identified by a unique number Properly spread yes yes yes NO NO NO N/A

yes

NO

Prepared in house N/A Procured commercially N/A 6.3.1Is the international Sensitivity Index (ISI) of the In - house preparation determined N/A 4.5.5 Are the results of PT reported in INR N/A 6.3.1Are the reference ranges for PT, APTT Determined when alternative reagents are used N/A 6.4Bone marrow 4.6.1 Is the bone marrow aspiration and / or trephine biopsy carried out by the laboratory haematologist / pathologist 4.6.2 Do bone marrow slides have unique number 6.4.1Are bone marrow smears stained to assess Iron stores where indicated 6.4.1Are slides labelled with diamond pencil And / or indelible ink 4.6.5 Does not reporting haematologist / pathologist participate in internal quality control programme and / or external quality assessment programme yes yes

yes yes

NO NO

yes yes

NO NO

yes

NO

yes yes

NO NO NO NO

N/A N/A N/A N/A

yes

NO

N/A

6.5Blood grouping and antiglobulin test 4.7.1 Is the blood grouping performed with monoclonal antiserum Polyclonal antiserum 6.5.1In addition to ABO grouping is the Rh (D) Group determined 6.5.1Is suitable control used to ensure accuracy of Grouping for Rh (D) 6.5.1Are, A or B cells used on random specimens to Check accuracy of results 6.5.1Is the laboratory getting random samples Verified by blood transfusion centre yes yes yes YES NO NO NO NO N/A N/A N/A N/A

yes yes

NO NO

N/A N./A

6.6Are 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 4.8.2 Are these subjected to quality control 7.Reports 7.1Are the results on the routine test provided Within 12 hours 5.2 Is there a procedure available for handling urgent samples 5.3 Are there random check to eliminate transcription errors 5.4 Do reports include appropriate units and reference ranges

yes yes NO

NO N/A

N/A

yes yes yes yes

NO NO NO NO

N/A N/A N/A N/A

HISTOPATHOLOGY
Workload 5.1Number of specimens received per year 5.2Type of specimens ( 5 common) 5.3Percentage of specimens Neurological Orthopaedic / maxillo facial Ontological ___________________% ____________________% ______________________% yes yes NO NO N/A N/A

1.4 Are all specimens procured at your laboratory If not, are you satisfied with the quality system In the subcontracted laboratory 6.Eligiblity Criteria

6.1Number of specimens per year ] 300 6.2Personnel 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. 6.3Neurological specimens to be accepted only in Super speciality / dedicated laboratories 5.Grossing of Specimens

3.1 Do request forms contain relevant clinical information , provisional diagnosis and operative findings 3.2 Is the space adequate for receipt, examination and storage of specimens 3.3 3.4 3.5 3.6 3.7 Is refrigerated storage facility available Is the lighting adequate Is the water supply adequate and close to work place Is grossing area separate from main laboratory Is grossing area adequately ventilated by means of an exhaust fan or fume hood 3.8 Is the area clean and maintained in an orderly manner 3.9 Is the work bench surface smooth 3.10 Are instruments clean, sharp and well maintained 3.11 Is identity of specimens maintained from receipt till reported 3.12 Are gross specimens retained till the report is reviewed by the referring physician 3.13 Are safety precautions ( e. g. use of gloves, gowns and masks) taken during handling fresh and fixed tissue 3.14 Are the specimens disposed safely 5.1Is a clean area available to record gross description By hand or by dictaphone 3.16 Is bone cutting equipment available ( applicable to orthopaedic / other bone work ) 6.Equipment 4.1 Is the equipment cleaned and well maintained 4.2 Is it serviced regularly 5.1Is the electrical equipment properly connected And earthed 5.2Tissue processor Are the solutions changed regularly Is there a regular removed click on wax bath temperature Are the fumes removed adequately ( by hood or ventilation 5.3Wax dispenser 1. Is the temperature checked regularly 2. Is the temperature appropriate for the type of wax used 3. Is the dispenser located at an adequate distance from exposed volatile solvent ( e. g. tissue processor) 5.4Microtomes 1. 2. Are they well maintained ( e.g. no play in advance Mechanism) and lubricated. N/A Are the microtomes knives sharp, without Scraches, and safely stored. N/A 3. Is the knife sharpener shielded when is use N/A yes

yes yes NO yes yes yes yes yes yes yes yes yes yes yes yes yes

NO NO NO NO NO

N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A

NO NO NO NO NO NO

NO NO NO NO

yes yes yes yes yes yes yes yes yes

NO NO NO NO NO NO NO NO NO

N/A N/A N/A N/A N/A N/A N/A N/A N/A

Yes Yes yes

NO NO NO

3.

If disposable knives are used, are they changed to Maintain quality of sections N/A

yes

NO

5.5Tissue baths 1. Is the water in the tissue bath changed daily 5.Are tissue floaters removed before the next block is Cut to avoid contamination 6.Are automated stainers available and if so Are they regularly checked and maintained 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 7.1Is the identity of specimens maintained throughout Processing, cutting and staining yes NO N/A 7.2Are slides labelled by indelible system e.g. diamond Pencil or permanent marker yes NO N/A 7.3Is the section and the staining of optimal quality yes NO N/A 7.4Are position controls run with special stains yes NO N/A 7.5Does laboratory perform immunohistochemistry yes NO N/A 7.6If 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 5.1Is the slide ready for examination with in 20 minutes From the recipt of specimen 6.2 Are the sections of optimal quality yes 5.2Are the verbal reports directly communicated to one of the Surgeons in the operating team yes 6.4 Is patient identity reconfirmed before verbal report is communicated 6.5 Is the verbal report followed by a written report 6.6 Is the frozen section report compared with the section report 6.Reporting 7.1 Are the slides examined and reporting by a pathologist 5.1Are 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 7.3 Are gross descriptions unambiguous 7.4 Are microscopic descriptions given when necessary 7.5 Does the laboratory participate in EQA, if available 7.6 Does the laboratory have an internal QC 5.Records 5.1Are the blocks field, usable and accessible ( stored in cool Area, not melted and properly identified) 8.2 Are the slides field and accessible 5.2Is an index or cross reference system in use to Allow retrieval of information by : 1. patient name yes NO N/A yes yes NO NO N/A N/A yes NO NO yes yes yes yes NO N/A N/A NO NO NO NO N/A yes yes yes NO NO NO N/A N/A N/A

N/A N/A N/A N/A

yes yes yes yes

yes

NO N/A NO N/A NO N/A NO N/A 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 If not, are they kept for at least five years 8.5 Are report kept for a minimum period of five years 8.6 Are gross specimens retained for at least three weeks 6.Autopsies 9.1 Are autopsies performed 9.2 Is the space adequate 6.1Is the autopsy room :

YES yes yes yes

NO NO NO NO

N/A N/A N/A N/A

yes

yes

NO NO NO

N/A N/A

1. clean yes N/A 2. ventilated yes NO N/A 3. well lighted yes NO N/A 4. airconditioned yes NO N/A 6.2Is 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 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 7.1Is space sufficient for 1. processing and section cutting 2. electron microscope 3. photography 4. storage of spares 5. storage of grids, records and photographs yes yes yes yes yes NO NO NO NO NO N/A N/A N/A N/A N/A

NO

N/A

7.2Are safety producers followed ( e.g., goggles and Gloves for liquid nitrogen and safety hoods For toxic chemicals) yes 7.3Are manufacturers instructions for operation and Safety followed yes 7.4Does laboratory provide clear instruments for collection of Specimens to concerned persons yes 7.5Does the request from include relevant clinical Details and source of specimen yes 7.6Does the laboratory provide EM fixatives to Operating room, OPD autopsy room, etc yes 7.7Is the EM 1. routinely serviced as per manufacturers checklist yes

NO NO NO NO NO NO

N/A N/A N/A N/A N/A 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 7.8Is the SOP updated when required yes NO N/A 7.9Is identity of specimen maintained throughout The process yes NO N/A 7.10Is the quality of slides and electron micrographs Optimal for interpretation of ultrastrutural changes Yes NO N/A 7.11Are light microscopic and EM findings co related yes NO N/A 7.12Are 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 5.1Are the request forms appropriate for investigations available 5.2Are instructions available for : 6.time and type of sample collection 7.immediate separation 8.processing and storage 9.transportation 9.1Are there written criteria for rejection of unacceptable Specimens ( gross external contamination, dried swabs, Lack of transport media ) 9.2Are there special instructions for collections And transportation of infectious materials 1.5 Are there suitable facilities for storage of specimens that may need retesting 1.6 Are all the specimens handled as a potentially infections 1.7 Are emergency laboratory services available 10.EQUIPMENT 2.1 Is a list of major equipment available yes 2.2 Is the laboratory equipped with water purification Yes 2.3 Is there a system for backup electricity Yes 2.4 Is calibration and verification of equipment carried out yes 2.5 Are log books for equipment maintained Yes 2.6 Are equipment decontaminated after use Yes 2.7 Are there annual maintenance contracts Yes 2.8 Is there is a list of equipment which have service contracts Yes 2.9 Is water bath and incubator temperature checked and recorded regularly yes 2.10 Are incubators available for: 1. different temperatures yes 2. controlled CO, atmosphere Yes 2.11 Are calibrated thermometers used to check temperature Yes NO N/A NO N/A NO N/A NO N/A NO N/A NO N/A NO N/A NO N/A NO NO NO NO N/A N/A N/A N/A yes yes yes yes yes NO N/A NO N/A NO N/A NO N/A NO N/A

yes yes Yes Yes Yes NO NO NO NO

NO N/A

N/A

N/A N/A 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 2. is fluorescence microscope available yes Yes NO NO N/A N/A N/A

3. is UV light source properly shielded to protect the personnel Yes NO 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 3.2 Are the written down producers for specific tests available at the work bench Yes 3.2 Are the SOPs revised necessary yes NO NO NO N/A N/A 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 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 14.1If 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 17.1.1Lymphocyte 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 3.6

N/A

19.1If 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 manufacturers 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 20.1Are instructions for disposal of specimens, used Glassware, disposable and biological media Available and followed YES NO N/A 20.2Are 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 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 NO N/A

5.1Are 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 5.1MICROSCOPE 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 5.2Are 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 5.3Biological 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 5.1Is 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 5.1Does 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 5.2MEDIA 1. Is the data of receipt , expiry date, opening date recorded YES 2. Is quality check for media growth carried out with reference strain 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 2. Is quality check of sensitivity discs with reference strains carried out YES YES NO NO NO YES N/A NO

N/A

N/A 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 6.1Is 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 9.2 Is a biosafety cabinet used YES 9.3 Is isolation, identification of fungus carried 9.4 Is sensitivity for fungus carried out

NO N/A NO N/A out YES NO N/A 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 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

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. 3. 4. 5.

A Quality Manual for the Clinical Laboratory including the Elements of a Quality System, published by NORDTEST, Finland [ NT Technical Report 187, 1992]. NATA document on Accreditation of Medical Laboratories. The Guideline Documents published by National pathology Accreditation Advisory Council, Australian Government Published Service, Canberra. 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.