Benefits of NABL Accreditation vs certification Process of NABL 
Consultants in Chennai NCs in Biochem Lab Terms used in accredited lab

            NC EXAMPLES(Raised by veterans) 

                             ISO 15189:2007

 1.Expired kits found in the department refrigerator.

 2.MU not determined for the month of november 2008 for all  parameters in the scope of testing.

 3.Root cause analysis not done for Eqas for the month of Jan 08.

 4.Records not easily retriveble.

 5.Internal Qc for immulite system : suggested to run atleast one level (Positive or negative control) with each batch of patient samples in addition to running the calibrator while calabrating the the instrument with every new lot of reagent.

 6.Internal qc for hba1c is run once in 7 days at present.Suggested to run Iqc daily using previous tested patient sample and record it.

 7.Quality control values are not recorded for hb electrophoresis.

 8.Flame photometer is not calibrated .All equipments used for testing shall be calibrated before put into service.

 9.Advia machine was maintained in RT instead of 18 - 25 deg c which is temperature it should be maintained.

 10.Calibration details to be maintained for each parameters incuding the details of reagent and calibrator lot ,expiry , ,source in the calibration file.

 11.Date of kit opened to be marked on the packs.

 12.kit inserts / brochures  do not bear -- Document of external orgin seal.and no controlled copy seal and effective date in kit inserts.

 13.Body surface area and height not included in the creatinine clearance calculation.

 14.The date and time of receipt of primary samples as well as the identity of the receiving officer shall be recorded.

 15.None of the micropipettes are calibrated.There is no facility for in house calibration.

 16.Machine printouts of calibration of D10 -HbA1c analyser are not signed by the technician and no approval signature of HOD.

 17.Standardisation / calibration details for some of the manual test not available.

 18.The laboratory performs special biochemical test by manual method but not using certified glasswares which quality of test results.

 19.The software used to plot L J graph is not validated.

 20.The primary collection manual is not prepared in accordance with Iso 15189:2007.

 21.The processed samples were not stored in the refrigerator but discarded the same evening.

 22.Performance specification for each parameter has not been established.

 23.Transport of primary sample from nearby hospitals / labs not being monitored with respect to time.

 24.Laboratory has not established TAT for each parameters listed in the scope of testing.

 25.The laboratory has not established policies and procedures for release of reports by telephone and mail service.

 26.There is no external qc or ILC for LDL cholesterol.

 27.The balance which is used by the biochemistry department is placed in the CP department is not calibrated nor tracebel to NABL standard.

 28.No fire extinguisher is available in the department were the acids and chemicals and inflammable chemicals has been stored.

 29.Processed  urine and serum samples and kits are stored in the same refrigerator.

 30.Bicarbonate is quantatively derived from the parameters fron ABG analyser which is not calibrated nor included in the list of equipments and arterial blood parameters is not included in the scope of test.

 31.The waste disposal and segregation pattern are not displayed in the department were it is generated.

 32.Equas results there are many outliers for same parameters (Chloride) .The lab has failed to monitor EQAS results.

 33.In night duty reports being generated when authorised signatory is not available and signed by technician who is not authorised signatory.

 34.Kone lab instrument do not have identy nor location details or calibration details label on the instrument.

 35.Frequency of Qc run on olympus analyser is not according to NABL 112 document.






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