Basic Requirements for NABL Accreditation of Biochemistry Laboratory

 

BIOCHEMISTRY LABORATORY

NABL ACCREDITATION BASIC REQUIREMENTS

(Small Sized Laboratory, Less than 100 Patients Per day)

 

1.     Designate/Appointment of Lab Director, Quality Manager, Technical Manager.

2.  Quality Manager should obtain internal Auditor Certification for standard ISO 15189:2012.

3.  Appointment of Authorized Signatory for signing of patient test reports (MD Biochemistry/MD Pathology/ PhD Biochemistry)

4.  Minimum three DMLT / B.Sc (Lifescience - Biochemistry/Biotechnology/Microbiology) qualified staff with experience in biochemistry sample testing & reporting.

5.  Daily minimum 2 Levels of IQC Material Testing before patient sample testing. Records to be maintained.

6.  Deep Freezer (-20 degree Celsius) for storage of reconstituted IQC Materials.

7.  Before submission of NABL Application, At least Two cycles of EQAS participation reports required for the scope of  tests applied. Suggested EQAS program in india are  CMC (Vellore)/RML EQAS/Metropolis EQAS Plus Program/Biorad EQAS/Randox- RIQAS etc.,). https://mindemits.blogspot.com/2021/01/pt-eqa-providers-medical-testing-in.html

8.     Fully Automated Analyser with necessary backup analyser (or) MoU with nearby NABL Accredited lab (with scope of Biochemistry) in case of breakdown/reagent un-availability. Automated Analyser required IQ/OQ/PQ & Calibration Certificate.

9.   Separate Refrigerator for storage of patient samples for 24 hours. 

10.  For All scope of tests required test method verification (at yearly basis) – Precision (Within Day & Between Day) /Accuracy Comparison /Carry-over testing.

11.  Reporting the critical alert results and record the results in critical alert record.

12.  One round of Internal Audit (as per ISO 15189:2012 & NABL 112) & Management Review should be conducted before submitting NABL Application.

13.  Monitor the room temperature & humidity by using Digital Thermo hygrometer.

14.  Reagent Grade Distilled Water for Automated Analyser/QC Reconstitution

    15.  Separate Area for Sample Collection Facility (with privacy & proper arm rest chair for phlebotomy) & Patient Waiting Area.

16.  Equipment Calibration frequency :

• Centrifuges - Every 12 months with NABL Accredited Calibration lab.  
• Micropipettes – Initial manufacturer certificate and calibration checks for every 12 months with NABL Accredited Calibration Service Provider
• Temperature monitoring devices – Every 12 months with NABL Accredited Calibration Service Provider.
• Refrigerator/Freezers - Every 12 months with NABL Accredited Calibration Service Provider
• Automated Analyser – Every 12 months/ Recommended by manufacturer.

17.   Documents/SOPs Requirement.

• Quality Manual (as per ISO 15189:2012) 
• Quality System Procedures (as per ISO 15189:2012) 
• Primary Sample Collection Manual (with addressing Blood sample collection procedure for Biochemistry) 
• Lab Safety Manual 
• Test SOPs for the NABL scope of Accreditation (as per clause 5.5 of ISO 15189:2012) 
• Risk Assessment Report (on annual basis) 
• Quality Indicators Report (on Monthly basis) 
• Laboratory Contingency Plan 
• List of Approved Suppliers & Supplier Evaluation (on annual basis)

 

18. Following are key records with update of minimum of 3 to 6 months patient data.

·         Test Request Form

·         Sample Receiving Record / can be captured in LIS.

·         Sample Rejection Record

·         Analyte Calibration Log

·         IQC Record

·         IQC Corrective Action Record

·         EQAS File

·         Critical Results/Alert Reporting Record

·         Repeat Testing Record

·         Advisory Service Record

·         Revised Reports file

·         Reagent Lot Verification

·         Stock Record

·         Equipment Maintenance Log

·         Daily Temperature Log (Room, Refrigerator, Deep Freezer)

·         Process Non-conformance Record

·         Sample Storage & Discard Record

·         Incident / Accident Record

·    Personal Records (Appointment Letter, Job Description, Educational Certificates, Training record, Competency Evaluation, Vaccination) 

                            .        Record of Customer complaints and Feed backs 

PREPARED BY

V.SELVAM, M.Sc

Mobile : 9940014466

Email : selvamqms@gmail.com

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