ACCREDITATION

1. Test request forms - Completion of TRF, random audit of TRF for adequacy

2. All department wise scope of service Displayed and hard copy

3. All staff are aware about the scope of service, and TAT (routine and STAT)

4. Master list of IQC and EQAS, IQC register for all items in the scope and LJ charts wherever applicable), if no IQC split sample reports.

5. EQAS reports of all parameters under scope, if no EQAS, ILC reports with evaluation.

6. All staff is knows and can be responded when asked about the structure of QMS, BCMCH vision and mission, Lab quality policy and objectives, about any activities in their concerned working area (equipment operation, spill management, dos and don'ts in lab, safety (fire, use of PPE, BMW segregation ,physical harassment, incident (needle stick )reporting etc) and CODES (blue, white, red, yellow and pink and its announcement)

7. All relevant rooms are tested for the room temperature and humidity and is updated

8. All equipment using temperature regulation are monitored for the same and is updated

9. All test calibrated to be verified for acceptance and to be recorded with reason for calibration and this should tally with the inventory register lots.

10. All new lots to be verified for lot verification procedure and to be validated before use as per protocol

11. All internal training conducted to be scheduled in the department wise annual calendar, notified, conducted, evaluated using pretest and post testing and trainer feedback and the summary sheet created to be filed with necessary RCA CAPA

12. All tests repeated should be recorded in the repeat register, how many times it may be, what other techniques used, and all the values and the reported values to be recorded in the register.

13. All reagents prepared in house should be labelled legibly with name, date of preparation, vial number, expiry date, etc. There should not be any container or bottle inside the laboratory area without appropriate labels.

14. All columns in the records to be filled, do not leave any area blank.

15. All documents and records should to be accessible to all department & QMS staff and to be retrieved in less than 5 minutes time.

16. All departments have to create test SOPs in the departmental manual with following items

    1. purpose of the examination;

    2. principle and method of the procedure used for examinations;

    3. performance characteristics (see 5.5.1.2 and 5.5.1.3);

    4. type of sample (e.g. plasma, serum, urine);

    5. patient preparation;

    6. type of container and additives;

    7. required equipment and reagents;

    8. environmental and safety controls;

    9. calibration procedures (metrological traceability);

    10. procedural steps;

    11. quality control procedures;

    12. interferences (e.g. lipaemia, haemolysis, bilirubinemia, drugs) and cross reactions;

    13. principle of procedure for calculating

    14. biological reference intervals or clinical decision values;

    15. reportable interval of examination results;

    16. instructions for determining quantitative results when a result is not within the measurement interval;

    17. alert/critical values, where appropriate;

    18. laboratory clinical interpretation;

    19. potential sources of variation;

    20. references.

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Records to be Completed

1. Scope of service

2. List of reference materials with the tractability certificates (Stds, strains, QC, EQAS, calibrators etc)

3. IQC records with LJ Chart

4. EQAS & ILC reports with evaluation RCA and CAPA

5. List of critical regents and its inventory

6. Internal department training records ( annual plan, notification, attendance, pre test,post test, summary sheet.

7. Internal department communication record

8. Internal meeting and discussions minutes

9. Critical values display and uptodate communication record hard copy and in LIS

10. Repeat test register uptodate

11. Test calibration register with reason for calibrations

12. New lot verification report against the inventory register for each new lot

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1. Presentation about the laboaratory -

2. Updated list of all External documents

3. Certificated displayed and copy filed - Hospital Registration, IMAGE, Pollution, Fire,

4. Department wise and common scope of service verified.

5. Document understood sign in all documents (QSM, QSP & Dept manuals by concerned staff)

6. All QMS documents are apprriately signed sealed as controlled and issued

7. ALL QMS documents are reviewed appropritely and marked reviewed

8. Obsolete area identified and obsoleted documents are sealed OBSOLETE

9. Archive area is identified and archives are under control or sequentially identified.

10. Policy and procedure for handwriten docments or amendments exists

11. Policy and procedure regarding outsourced tests reports - attachment no reentry

12. System for advisory sevices - Discussion minutes with the clinicians

13. Interdepartmental meeting minutes - department meeting minutes

14. The complaint register - verbal, written, telephonic and clinician as OVRs

15. NC policy and procedure

16. Procedure and process flow for IQC rejections & EQAS out

17. Vertical and horizontal internal audit plan

18. Quality indicators and its monitoring report

19. Management review - every six months and reports

Records to be Completed

1. Quality Policy and objectives with displays at appropriate areas

2. Quality manual

3. Quality system procedures

4. Master lists ( scope, staff, equipment, records with retention, Documents, displays, materials, health status, key personnel and deputies, referral laboratories, approved vendors)

5. General and department wise Detailed Organogram

6. Document control register with details of all documents with amendments and review updated.

7. Review of contract/service agreement amendment register

8. Patient feedback analysis and Clinician feedback analysis report

9. Referral laboratory evaluation records - site visit report

10. Outsourced report register & master list of outsourced tests with tat and critical values

11. Materials acceptance rejection register

12. NC register- RCA and CAPA

13. Internal audit report

14. Quality indicator file

15. Management review report and action plans

16. Floor diagram with fire diagram and ergonomic process flow

17. Room and equipment temperature record.

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