blog.valueadded.inblog.valueadded.in/.../2014/01/NABL-feedback-on-112-.docx · Web viewIf it is still desired by NABL, A number in terms of number requests received per month or per

Serial No.

Line No. Page No.

Existing Text Submission Modified Text Reference for Modification

11 174 & 175 9 Laboratories shall not

include tests which areperformed too infrequently as it does not permit calculation of imprecision

1.Inability to calculate imprecision cannot be a reason for not including a test in the accreditation scope It still can be calculated. Just that it needs 20 data points with a Reference Material or a QC material which can be generated over a period of time when it can be included in scope2.Also if it is qualitative or interpretative test, the question of calculation of imprecision does not arise Hence it is suggested to include any test irrespective of number of requests received for a day or month as quality needs to be maintained by a lab even if it is a single test result issued to a patient This requirement can be removed even for HP,CP & BM studiesIf it is still desired by NABL, A number in terms of number requests received per month or per day can be given to define a test as being “performed infrequently” as it is g given for HP,CP & BM in the line 176 & 177

Nil

2 141 to 145 8 When a Contract It is not clear whether routine tests

Serial No.

Line No. Page No.


Research Organisation (CRO) is involved in bioavailability & bioequivalence141 studies, it can apply under ISO/IEC 17025 accreditation. The organisations involved in clinical 142 diagnosis will be included under ISO 15189 accreditation. 143 The tests performed on the human tissues in the blood bank, tissue bank, stem cell harvesting 144 and manufacturing activity will not be covered under ISO 15189

done in a stem cell harvesting centre as part of stem cell harvesting like blood culture, CD counts, HIV antibody testing, CBC, etc can be covered under ISO 15189:2012 More clarity in terms of drafting is needed

It can be clearly stated whether tests done in blood bank of a hospital as part of screening blood for infectious disease & patient testing can be included in the scope of accreditation if the lab of the same hospital applies for accreditation

2 174 & 175 10 It is unethical for a laboratory accredited for a particular discipline to continue to perform tests that do not meet the quality requirements It is desirable that those tests which do not fulfil the

Although it is said as ‘desirable’ This line is contradictory to what is said in line 192,193,194Hence this may be removedIn such cases it is not possible for labs to continually improve its quality system by bring all tests in scope over a period of time Accreditation is all about continual improvement An Accredited lab is

The following sentence may be deleted and rephrased as “It is unethical for a laboratory accredited for a particular discipline / test(s)to claim

Nil

Serial No.

Line No. Page No.


requirements anywhere from a pass mark to a centum and is never 100% at any time Quality is a never ending journey Also as long as the laboratory does not claim accreditation for those tests not accredited it is not ‘Unethical’ Hence the question of ethics never arises and it is suggested to remove the this sentence and rephrase it accordingly Also a laboratory may still continue to do some tests as part of clinical work and for patient care following good clinical lab practices which cannot be discontinued even if not accredited as it may include them under scope at a later date as part CQI

accreditation for test(s) or discipline(s) not accredited by NABL .Appropriate & suitable action as per NABL bye laws will be taken against such laboratory management “ “If the laboratory wants to continue non accredited tests as part of clinical work or patient care it can still continue to perform them provided they follow Good Clinical Laboratory Processes and Internal and External Quality Control practices

3 157 9 Microbiology & infectious diseases serology

Tests relating to Non-infectious diseases serology (tests like CRP,ASO ANA done by

Serial No.

Line No. Page No.


immunoassay) are not addressed Does it still come under this department ?More clarity is needed

3 376 18 TABLE 2: Qualification norms for authorized signatories

1.MBBS with 3 years of experience in a clinical lab, MSc with 5 or 7 years of experience were allowed as authorised signatories for some discipline and for specific tests in earlier issue of NABL 112 document But It has been removed from this documentThe same can be continued Also Suggested to include M.Sc MLT with 5 or 7 years experience as authorised signatory for specific fieldsAnd to include MD pathology for Molecular Diagnostics 2.Also the PhD qualification addresses only Medical Microbiology or Medical BiochemistryHowever there are medical universities who confer PhD degrees in medical field but their PhD degree certificates mentions the degree as Basic Medical Sciences or Biomedical sciences Hence to include those PhD degrees also as signatories

NABL 112 earlier Document

Serial No.

Line No. Page No.


MD(Path) who have competency to handle the Infectious and Non-infectious Molecular diagnostics have to be considered with appropriate experience in the Authorised signatory

376 18 TABLE 2: Qualification norms for authorized signatories

The document does not address Post Graduate degree given by American Board and others such as Royal College (England, Australia) which are considered atleast equal to MD or DNB

3 263 to 265 13 Director/ Chairman/ Head (howsoever named) shall have basic Medical academic and postgraduate qualifications with continuous medical education and five years of experience in medical laboratory

It is not clear whether chairman / head of a hospital need to have Medical Qualification at all or Medical Degree with a PG qualification in Laboratory field or any medical field if the hospital has a Lab Qualified person designated as Lab DirectorMore clarity in this sentence is needed

Nil Nil

4 277 to 278 13 NABL also allows referral to eminent individuals who have extensively published in indexed scientific journals. Referral is also allowed to some central laboratories

A lot of subjectivity on the part of labs and assessors will arise in deciding “eminent individuals” & “Reputed Institutions”

5

Serial No.

Line No. Page No.


(NCDC New Delhi, NIV 278 Pune, CCMB Hyderabad etc.) or other reputed institutions.

4 170,171 9 For POCTs, the tests can be applied for accreditation under respective discipline of Medical testing

A separate ISO standard is available for POCT testing ISO 22870: 2006 Hence It is suggested thatPOCT tests should not and cannot be included under scope of accreditation under the respective discipline

4. 170 9 Only trained & authorised persons shall perform POCT

POCT testing is meant to be done at or near bed side and not in central lab Hence It may be mentioned “non laboratory staff namely nursing staff, clinicians, physician assistant can perform such tests if they are trained in performing the particular POCT

NA NA

5 2421 101 The results must be concordant with those from central lab and ....

Many a time a concordant value will not be obtained with central lab method as regular venous blood sample / another specimen is never taken simultaneously to be done in central labAlso it becomes ‘subjective’ to say what is concordant both by the lab personnel and by assessors Hence may be deleted

Serial No.

Line No. Page No.


6 351,352 17 Large /Very Large Laboratory shall have atleast one full time authorised signatory in each discipline

It is not clear if an authorised signatory is required for each discipline even when the person is authorised to sign reports for more than one discipline as per the table 2. For example if a lab has Histopathology, Cytopathology, Biochemistry, Hematology, Clinical Pathology Can One MD pathology sign for all departments or one authorised signatory is required for each department in such labs?

NA NA

7 335 16 Turn Around Time Definition for Turn Around Time may be given whether it is from the time of collection or from the time of receipt esp for samples received from outside labs or collected outside the lab premises in collection centres

NA NA

8 526,527 26 The temperature in all chambers of refrigerator and deep freezer shall be checked and records maintained till next assessment

Monitoring the temperature of all chambers of all refrigerators daily requires more thermometers and is expensive and time consuming If the lab can show evidence of monitoring all chambers and maintaining temperature within specified range it would be sufficient monitor different chambers can be monitored on different days and show

Nil Nil

Serial No.

Line No. Page No.


maintenance of temperature within acceptable range

9 531,532 26 Refrigerators and Deep freezers requiring critical and continuous temperature control shall be fitted with 24x 7 temperature recorders

In a medical lab all refrigerators are critical as reagents, chemicals, samples, reference materials QC samples are stored The document can mention “when a refrigerator is considered critical”or specify those freezers where Temperature recorders are required For example refrigerators where extracted DNA /RNA or reagents of molecular diagnostic tests, cytogenetics can be considered critical, Sub stock cultures of Reference Organisms

Nil Nil

10 716 33 The Laboratory shall establish and display critical limits for tests in consultation with the clinicians

1. It may not be possible for stand alone labs to establish critical alert levels in consultation with clinicians

2.This requirement was addressed in ISO 15189: 2007 but has been removed ( not given as a requirement) from the 15189: 2012 version

Clause 5.9.1 a & b of ISO standard 15189:2012 and ISO 15189:2007 Sub Clause 5.8.8

11 1166,1167 49 Anti HIV Ab testing Written informed consent of the individual must be taken before the blood

In a hospital attached lab Consent for Anti HIV testing is taken by the referring physician and the consent goes into the medical record of the patient .In such a

Evidence of counselling and consent shall be shown by the laboratory

Serial No.

Line No. Page No.


sample is collected. Evidence of counselling and consent shall be retained by the laboratory

case it will be difficult for the lab to maintain the consent forms for Anti HIV testing within the lab However evidence of having taken consent can be produced at the time of audit. Hence the draft can be modified accordingly

12 1043 to 1045

45 Incompatible activities shall be performed in separate areas, e.g., the area for media preparation shall be different from that of sample processing in Microbiology.

It is not clear whether a separate area or separate room is required for media preparation in view of space constraints for a lab in a hospital attached lab or a small lab carrying out basic C & S tests

13 44 Clinical Pathology Clause 5.5

The document does not address automation in urine microscopy, Automation in Seminal fluid analysis &Body fluid analysis as automation is increasingly used in these tests Suggested to include and address the requirements for automated seminal fluid counts and microscopy, urine & body fluid microscopy

Nil

14 681-684 31 If the laboratory uses more than one measuring system where the

It is not clear if method comparison needs to be undertaken if 2 similar instruments from the same manufacturer using

Can be changed :”shall be conducted atleast once a year”

Serial No.

Line No. Page No.


measurements are not traceable to the same reference material / reference method, or the biological reference interval are different, it is essential to perform a comparability study between the systems and prove that there is agreement in performance throughout appropriate clinical intervals

the same reagents, and calibrators and controls are usedAlso it is time consuming and costly to perform twice a year

1433,1434 58 Volume of workload for each screener shall be recorded. The laboratory shall avoid overloading the screener

It desirable that the workload can be specified in terms of No of slides per hour

CLSI Standard says 12.5 slides per working hour for full manual review (FMR) )if slides are manually prepared which works out to 100 slides / 8-hour day

CLSI standard and www.fda.org/medicaldevices/safety/alertsandnotices

1270 53 The examined specimens shall be stored for re-examination and/ or additional tests for a minimumperiod as

In view of space constraints in a lab especially hospital attached lab it is difficult to retain block and slides for 10 years Hence suggested to retain the older requirement of 5 years for HP

Earlier version of NABL 112 document

Serial No.

Line No. Page No.


specified below: Specimens – 30 days Slides/ Blocks – 10 years

slides and blocks and specimens for 15 days

1200 50 Sensitivity for those antibiotics e.g. vancomycin for S. aureus, and colistin, that cannot be reported on the basis of disc diffusion method shall be reported on the basis of MIC testing based on broth/ agar dilution or automated systems, or an E- test or equivalent.

Difficult to perform Disc Diffusion Method for Vancomycin & Colistin Sensitivity by medium and small labs Hence may be deleted

Nil

992-995 43 Biological Reference Intervals (BRI) show significant differences with each lot of reagent, type of reagent, technique and the instrument used and should be determined for each of the situations if the laboratory uses more than one system. The BRIstated in the

Determination of BRI with each lot of reagent is difficult as it requires an elaborate study with a minimum of 120 individuals (each males and females) But Reference Intervals given in product insert can be verified for each new lot Verification of reference intervals using 20 apparently healthy subjects is an accepted guideline as per CLSI C28-A3 Third Edition “Defining, Verifying, Establishing Reference Intervals in a Clinical

“ Should be determined or Verified”

CLSI Document ““Defining, Verifying, Establishing Reference Intervals in a Clinical Laboratory-Approved Guideline C28 - A23-third edition

Serial No.

Line No. Page No.


literature is unsuitable for reporting the prothrombin time results.

Laboratory-Approved GuidelineIt can be carried out for any analyte

1458 to 1685

59-67

Flow Cytometry The document does not address the requirements for Flow Crossmatch offered by some Transplantation Immunology LabsAlso the document does not address HLA MultiplexMethod PRA,DSA detection although it is being done in some centres

656 - 672 30 - 31

Inter Laboratory Comparison - Scheme

The Term Reference Lab to be defined more clearly

Documents

blog.valueadded.inblog.valueadded.in/.../2014/01/NABL-feedback-on-112-.docx · Web viewIf it is still desired by NABL, A number in terms of number requests received per month or per