MINUTES OF THE MEETING OF THE NRL ON EXTERNAL QUALITY ASSESSMENT OF HIV LABORATORIES, NOIDA
23-24 SEPTEMBER 2008

A meeting of the National Reference Laboratories was held under the chairpersonship of Dr Jotna Sokhey, Additional DGHS and Director i/c NIB to discuss the report of the external assessment carried out jointly by CDC and WHO of the HIV testing laboratories in July 2008.  The assessment was coordinated by NACO to document current status and take up follow action to fill gaps identified as a result of the assessment.  The objective is to maintain high quality of services at the NRLs, ultimately leading to NABL accreditation. The meeting was held at the National Institute of Biologicals and attended by the officers in charge of the NRLs, external assessors and concerned officials from CDC, NACO and NIB. The list of the participants is given below.
Dr Jotna Sokhey, Additional DGHS & Director NIB, Ministry of Health and Family Welfare welcomed the participants and said that the external assessment was a very useful exercise and corrective action must be taken on the gaps identified in a time bound manner.  She said that some of the areas for follow-up action were common to most institutions.  Institution wise reports had also been circulated to enable specific action.  She said that some of the assessors had been invited to the meeting to give first hand feed back.  Officers from WHO had also been invited but they were unable to participate to due prior engagements.  She said that the Institutes with relatively high scores should aim at NABL accreditation within the next six to nine months.  Topics related to the essential quality systems would be covered during the course of the meeting and procedures for NABL accreditation would also be discussed.

Dr. Sandhya Kabra, Joint Director (Laboratory Services), NACO gave a brief on the background of the assessments done in collaboration with CDC and WHO.  She said that the assessment tools, designed by CDC, Atlanta were discussed with WHO and experts from India and modified to meet our requirements.  These were field tested in the three laboratories in Delhi prior to the assessment in the other NRLs.  She said that the NRLs should aim to achieve NABL accreditation in a time bound manner and NACO would facilitate if needed.

Dr. Sudhakar CDC said that high quality of services was not only imperative but that periodic external assessments were important to document the status of the essential quality systems.  He said that CDC was pleased to participate in this exercise and would also collaborate in the future.  He said that CDC would also provided technical support, if needed, for filling up the gaps identified during the assessment.  He said that the expertise developed would help in carrying out similar assessments of selected SRLs in the future.

Dr. Keenlyside, CDC said that pre analytical-analytical and post analytical components were as important as the testing itself. He said that experience has shown that most lab result errors were due to either pre-analytical or post-analytical errors.

Dr Deepanjan Roy, from CDC gave an overview of the methods used for assessments and results (scores of each NRL) obtained, of the exercise of assessment undertaken in July, 08.  A checklist using 12 QSE (Quality System Essentials), developed originally in Atlanta, adapted by NACO to suit the Indian context was used. Various assessors gave talks on each of the 12 QSE to make the delegates understand what is required to be done to meet the standard of each QSE.

Dr. S. Arora, Prof. of Microbiology and NABL assessor discussed the main findings of assessment.  He said that in most laboratories documentation was incomplete or missing; SOPs were either not available or not updated.  Quality manual was a mandatory requirement for application to NABL. He also briefed the NRLs on NABL requirements of assessment and procedures for application. He informed that detailed documents were available on the NABL website and could be downloaded free.  He informed that NABL also organized training programme on assessment on payment of fees.  Each batch of trainees was about 20 persons.  NACO could consider organizing such a course for selected microbiologists from the NRLs

Dr Arora discussed the various components of the standard 15189 2007 version at length, confirmation to all the various clauses is a must to qualify for accreditation. He stressed that each NRL has to purchase/procure the standard 15189 and fulfill all the requirements laid down in various clauses of this standard (including space, personnel, equipment, documentation, training, inventory management, etc).

Dr Reba Kanungo Professor of Microbiology, JIPMER described the requirements for customer services, personnel and process control.  Dr Vikas Gautam, Assistant Professor, PGI, Chandigarh gave a presentation of the accommodation & environment, facilities and safety and biological waste management.

Following detailed discussions, the NRLs were divided into three groups to work out action plans and time lines for NABL accreditation.  Each NRL made a presentation on the second day of their assessment of their readiness to apply for NABL accreditation.  It was noted that a major gap in the assessment was resources for comprehensive maintenance contracts of equipment used for testing and storage and also resources for application for NABL accreditation. Dr Kabra explained that NACO would arrange for the funds which would be limited to HIV serology and CD4 testing. It was suggested by Dr Arora that a thermometer, tachometer, weight box and pressure gauge calibrated only by an NABL accredited lab. could be used for the calibration of other equipment in the laboratory and it was not necessary that all the items are calibrated by an external NABL accredited laboratory.  It was estimated that approximately Rs 2 lakhs would need to be provided to each NRL for calibration and purchase of tachometer.

Action Points: NACO

1. Arrange meeting of trainers through NABL ( fee of each participant is Rs 7,500 and standard is free of cost for these).
2. To procure standard for NRLs of 15189 (2007) @ Rs 500 per lab as it has copyright
3. Resources for NABL accreditation ( Fee per lab for assessment – including application and actual process)
4. Maintenance and calibration of equipment.

The meeting ended with a vote of thanks to the Chair.

LIST OF PARTICIPANTS