NABL 111

National Accreditation Board for Testing

and Calibration Laboratories (NABL)

Procedure for Recognition of Sample Collection Centre/ Facility

declared by Medical Laboratories (CABs)

ISSUE NO. : 01 AMENDMENT NO. : 00

ISSUE DATE : 20-Jun-2018 AMENDMENT DATE : 00
 AMENDMENT SHEET

Sl. Page Clause Date of Amendment Reasons Signature Signature

No. No. Amendment QM CEO

10

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 111 Procedure for recognition of Sample Collection Centre/Facility declared by Medical Laboratories

Issue No: 01 Issue Date: 20-Jun-2018 Amend No: 00 Amend Date: 00 Page No: 1 of 7
 CONTENTS

Sl. Title Page

Amendment Sheet 1

Content 2

1. Procedure 3

2. Flow-diagram (Applicant CABs-FA/RA) 5

3. Flow-diagram (Accredited CABs) 6

4. Procedure for Adverse decision 7

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 111 Procedure for recognition of Sample Collection Centre/Facility declared by Medical Laboratories

Issue No: 01 Issue Date: 20-Jun-2018 Amend No: 00 Amend Date: 00 Page No: 2 of 7
 1. PROCEDURE

NABL recognizes sample collection centres/ facility(ies) declared by its associated medical CABs.
Assessment process of SCFs shall be an ongoing activity for the entire accreditation cycle. Each
declared sample collection centre/ facility (SCF) of a medical CAB shall be assessed once in its
accreditation cycle.

SCFs of applicant CABs

SCFs shall be assessed on sample basis (at least 5%) initially on or before the schedule of final or
renewal assessment and decision shall be taken for all declared SCFs with the assessment report of
CAB declaring these SCFs. All declared SCFs shall be considered recognised SCFs of CAB.
(Refer Flow-diagram).
SCFs of accredited CABs
All declared SCFs not assessed during initial assessment shall be assessed in subsequent months
of accreditation cycle. At all time, the SCFs shall maintain compliance to requirements and
recognition is co-terminus with accreditation cycle of CAB. (Refer Flow-diagram).

Digitalisation of Process
Mobile & Web based Applications has been developed for automation of application process and
processes of assessment, corrective action, and recognition. These applications have provision for
CABs to upload details of sample collection centres/facilities for which recognition is to be done,
provision for assessor and for NABL users to assign assessors to these SCFs and review the
assessment report. The mobile application will facilitate field assessment, marking location of
assessors and laboratories/SCFs. Further, it will involve geo-tagging of sample collection centres/
facilities which will help the CAB user/ patients to find these facilities to get quality services. The web
based application can be accessed from NABL website.

Till this above process becomes operational, NABL will be starting process as per current
procedure.

Web based Application: Key features

 Manage lab, Sample collection centre/facility details and Assessor Data.
 Map based and Dashboard based view of Data of different entities.
 Review of Assessment data of sample collection centres.
 Upload of corrective action and follow-up action.
 User Management to provide access to different modules.

Mobile application for on-site assessment of collection centres: Key features:

 Facility for Collection centre and Assessors to update their profile and mark their location.
 Questionnaire-based Assessment of collection centres along with pictorial evidence.
 Mark NC’s for non-compliances.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 111 Procedure for recognition of Sample Collection Centre/Facility declared by Medical Laboratories

Issue No: 01 Issue Date: 20-Jun-2018 Amend No: 00 Amend Date: 00 Page No: 3 of 7
Recognition of Sample Collection Centre/ Facility

NABL shall issue an annexure to the accreditation certificate containing ‘Recognised sample
collection centres/ facilities’ with the following details –

ID of Sample Collection Name of Sample Collection Address of Sample Collection

Centre/ Facility Centre/ Facility Centre/ Facility

Based on this annexure, the accredited medical CAB may issue certificate of recognition to its
declared SCFs as stated follows –

To be printed on the CAB Letter head

MC-XXXX
CERTIFICATE OF RECOGNITION
ABC SCF, ADDRESS is a recognized Sample Collection centre/ Facility of XYZ laboratory with
certificate no. MC-XXXX and validity (Issue date 00/00/0000 - Valid date 00/00/0000) and is
authorized to collect, prepare, handle, transport patient sample collected for this laboratory.

Name and Signature Date

(Signature of Laboratory Director)

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 111 Procedure for recognition of Sample Collection Centre/Facility declared by Medical Laboratories

Issue No: 01 Issue Date: 20-Jun-2018 Amend No: 00 Amend Date: 00 Page No: 4 of 7
 2. Flow-diagram (Applicant CABs-Final Assessment/ Reassessment)

Receipt of application. Information on Sample Collection Centre / Facility (SCF) will be

taken in 1.9, Annexure to Application NABL 153

Initially at least 5% of declared SCF will be assessed (on sample basis) either before the FA/
RA or during FA/ RA either by different or same assessment team appointed for CAB.

Decision will be informed to CAB,

Records will be updated; Invoices will be
Is centre/facility
generated for respective SCFs. CAB can
recommended? re-apply for such SCF along with
No
applicable fee
at that time
Yes
30 Days time will be given to address
the NCs, if any.

Decision will be informed to CAB,

Is centre/facility No Records will be updated; CAB can re-
recommended ? apply for such SCF along with applicable
fee

Yes

Assessment report will be evaluated by NABL for further decision

Recommendation/Decision on Sample collection centres / facilities shall be informed along

with decision on the accreditation of CAB

Invoices (AAFEE and other Charges) will Annexure to Certificate shall be issued to
be generated CAB

On decision, CAB will claim to have recognized sample collection centres/ facilities declared by
CAB as per application. It will have list of such recognized centres / facilities either on their
website or display board for its end-users.

Further, CAB will issue a ‘CERTIFICATE OF RECOGNITION’ to authorize its centres /facilities
to claim recognition (as per controlled template of CERTIFICATE) Enclosed

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 111 Procedure for recognition of Sample Collection Centre/Facility declared by Medical Laboratories

Issue No: 01 Issue Date: 20-Jun-2018 Amend No: 00 Amend Date: 00 Page No: 5 of 7
 3. Flow-diagram (Accredited CABs)

Rest of centres / facilities shall be assessed according to due activities or

otherwise. Each Centre/facility shall be assessed once during accreditation cycle
of the CAB

Is centre/facility Decision will be informed to CAB,

recommended? No Records will be updated; Invoices will be
generated for respective SCFs. CAB can
re-apply for such SCF along with
applicable fee
Yes

30 Days time will be given to address the NCs, if any. Assessment report will be
evaluated by NABL for further decision

Yes
Is centre/facility Decision will be informed to CAB,
recommended? Records will be updated; Invoices will
be generated for respective SCFs
No

Decision shall be informed & concerned centre/facility will be Derecognised and

delisted.

CAB will stop all claims related to concerned SCF; de-list the concerned
centre/facility. However CAB can re-apply for its SCF along with applicable fee

CAB will ask concerned centre/facility to remove certificate of recognition from all
places, to avoid inadvertent claim by its centre, till its re-enrolment and re-
assessment.

If CAB continues to claim or fails to stop claim of recognition by centre, adverse

decision will be initiated against the CAB

Adverse decision shall be taken as per NABL 216 for ABEYANCE

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 111 Procedure for recognition of Sample Collection Centre/Facility declared by Medical Laboratories

Issue No: 01 Issue Date: 20-Jun-2018 Amend No: 00 Amend Date: 00 Page No: 6 of 7
 4. Procedure for Adverse decision
When lab is not able to close the issues of complaints pertaining to SCFs and not taking corrective
action on the NCs after initial recognition, the CAB shall stop NABL claim or use of NABL symbol for
concerned SCFs and return its original annexure. NABL shall issue revised annexure to the medical
CAB for others SCFs. Lab shall de-list such concerned centre/ facility from all places, to avoid
inadvertent claim. Similarly lab will ask its centre/ facility to stop claiming recognition, till its re-
enrolment by re-application and assessment.

CAB will address complaints from patients/ users of centre/

facility as per its procedure

Negative recommendation in
Assessment report If lab fails to resolve the complaint received by them

NABL will provide 30 Days time for resolution, then

30 Days time to CAB for Corrective recommendation will be given to CABs according to outcome
action

Yes
Is centre/facility No Adverse decision
recommended?

No

No satisfactory Corrective Action or inadequate Corrective Action

CAB will delist such concerned centre/facility from all places, to avoid
inadvertent claim. Similarly CAB will ask its centre/ facility to stop claiming
recognition, till its re-enrolment by re-application and assessment

Failure to do so will call for adverse decision against the CAB (Abeyance)

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 111 Procedure for recognition of Sample Collection Centre/Facility declared by Medical Laboratories

Issue No: 01 Issue Date: 20-Jun-2018 Amend No: 00 Amend Date: 00 Page No: 7 of 7
National Accreditation Board for Testing and Calibration Laboratories (NABL)

NABL House
Plot No. 45, Sector 44,
Gurugram -122002, Haryana
Tel. no.: 91-124-4679700 (30 lines)
Fax: 91-124-4679799
Website: www.nabl-india.org