Laboratory systems and practices in India in the context of Public Health and Public Health programs have been less prioritized historically and the role has been largely limited to providing periodic, need-based assistance to programs as well as primary and secondary health facilities, rather than providing ongoing technical assistance (TA) and leadership. Though over the last two decades, India has invested in establishing more than 5,000 HIV/Opportunistic Infection (OI) diagnostic facilities including integrated counseling and testing centers (ICTCs), CD4 and ART centers and Community Care Centers (CCCs). However, the laboratory services at these centers range from non-existent to functional with minimal or no quality assurance.

In the National AIDS Control Program third phase (NACP-III), the Government of India (GOI) aims to establish quality laboratory diagnostic systems providing ongoing quality assurance to peripheral institutions, strengthening the lab data management systems and emphasizing the establishment of minimum quality standards in the public and the private health care delivery system. In this regard, NACP-III has designated 1 Apex laboratory, 12 National Reference Laboratories (NRLs) and117 State Reference Laboratories (SRLs) to strengthen the laboratories at the service delivery points.

To expand and strengthen TA and collaboration at national, state and district levels to more effectively design, implement, and monitor HIV/AIDS programs through the strengthening of government-initiated laboratory systems in India, CDC has signed a new Cooperative Agreement (Co-Ag) with Project Concern International (PCI). Through this Co-Ag, PCI will initiate a project named PRATIBHA (Project for Accelerated Technical Assistance and Integrated Capacity Building for HIV/AIDS). The overall purpose of PRATIBHA is to strengthen laboratory services in India by focusing on the NACP-III priorities designed to increase effectiveness, efficiency and accountability with regards to HIV testing. The objectives of the project are to provide:

1. Training to improve skills and knowledge of laboratory workers and the upgrading of public and private laboratories at all levels

2. Implementation of quality assurance mechanisms at all NRLs, select SRLs and ICTCs

3. Strengthening of supervisory mechanisms to ensure laboratory adherence to quality standards, such as proficiency testing and a nationwide accreditation system

4. Recommendations for implementation of cutting-edge specimen collection technologies for HIV testing

Project PRATIBHA's proposed set of activities draws significantly from findings and the recommendations from the NRL assessment exercise, facilitated by PCI for all NRLs conducted in year 2008 by the CDC in collaboration with WHO and NACO. The exercise highlighted challenges related to various issues such as technical, operational, human resource, capacity building and equipment. Based on the findings related to the direction and strategic vision for laboratory systems strengthening reflected through the NRL assessment, PCI proposes to undertake eight main activities for all 13 NRLs, 40 SRLs (all across India) and 20 ICTCs (10 each in Andhra Pradesh and Tamil Nadu) for the period starting from September 30, 2009 till September 29, 2010. These activities are:

1. Human capacity development of laboratory program managers and staff

a. At NRL level

b. At SRL level

c. At SACS level (Blood safety and Laboratory team/s)

2. Technical assistance in developing qualitative standardized manuals, standard operating procedures (SOPs) and documentation at the NRL and SRL levels.

3. Regional consultancy and technical assistance through placement of consultants as lab advisors-cum-coordinators for strengthening the NRLs primarily and SRLs and acting as a bridge between laboratories.

4. South-to-South collaborations for exchange of lab- related experience and expertise by senior level laboratory persons at NACO and NRLs.

5. Setting up model NRLs and SRLs

6. Follow-up of NRLs assessments as a field review of action taken

7. Follow-up of SRLs assessments as a field review of action taken

8. Training of laboratory personnel in Laboratory Management Information Systems (LMIS)

Background

CDC has singed a new Cooperative Agreement (Co-Ag) with Project Concern International (PCI). Through this Co-Ag, PCI will initiate project named PRATIBHA (Project for Accelerated Technical Assistance and Integrated Capacity Building for HIV/AIDS). The overall purpose of PRATIBHA is to strengthen laboratory services in India by focusing on the NACP-III priorities designed to increase effectiveness, efficiency and accountability with regard to HIV testing

ACTIVITY 1: TECHNICAL ASSISTANCE IN DEVELOPING QUALITY MANUALS, SOPS AND DOCUMENTATION AT THE NRL AND SRL LEVEL.

This activity will include following initiatives: 1. A Prototype Quality Manual preparation: A PCI team composed of the representatives of NRLs, a senior level lab assessor and a program person will be assigned the responsibility of drafting the "A Prototype Quality Manual". This manual will address both management and technical issues and will have clear mention of the quality policy of the laboratory. The draft manual will be peer reviewed by certified assessors and the finalized document will be handed over to NACO for wider dissemination.

2. Supply of NABL Base documents to NRLs: The base documents and templates will be procured from CDC and NACO. In addition, PCI will procure the NABL standard documents (ISO-15189, NABL-112 and NABL-160), and supply copies of these to all NRLs.

3. Drafting of Standard Operating Procedures and Job-aids: In the first year, PCI will initiate work on development of SOPs and Job-aids on various topics such as specimen collection and transportation, and accept /rejection criteria etc. In addition, standardizing recording and reporting forms for common processes will be done. Since the testing kits are often changing, PCI will initiate work towards development of prototype SOP for some well-known and widely used test kits. Additionally, PCI will prepare guidelines on how labs can prepare SOPs in anticipation of a new HIV test kit.

By the year-end, PCI will equip 13 NRLs, 40 SRLs and 20 ICTCs with the select manuals, job-aids and SOPs and will train a total of 216 personnel from 13 NRLs, 40 SRLs, and 20 ICTC on use of these documents.

ACTIVITY 2: REGIONAL CONSULTANCY AND TECHNICAL ASSISTANCE

In year one, consultants will be placed at the regional sites (one at Pune to support the Apex NRL, another at eastern region/ North-eastern states, and third one at Chennai (to support south India labs) for continued support to NRLs/ SRLs. Preferably, PCI will aim at hiring consultants who are NABL trained. The expected roles of these consultants will be to: 1. Assist PCI Delhi team in writing of the quality manuals/ documentation 2. To conduct regional training for SRLs 3. Ensure implementation of the procedures (on which staff is trained) 4. Help NRLs and SRLs to write QM, and other documents for accreditation/ other proposes 5. Help NRLs and SRLs to assure quality on regular basis 6. Address any other technical issues, emerging with the SRLs or NRLs 7. Conduct internal audits of different NRLs/ SRLs

ACTIVITY 3: SOUTH- TO SOUTH COLLABORATION

South-to-South partnerships create an effective platform for building sustainable institutional and human-resource capacity through open exchange of knowledge, information, and professional experience. A regional collaboration will add an important dimension into training programs; an international problem oriented perspective, to enable training of specialists in a multidisciplinary fashion with a broader target oriented framework.

PCI will assist the state and national-level public health workforce in sharing experiences at the international level preferably with other USG partners in the South focusing on areas of laboratory and health systems strengthening. In this year, PCI will work to explore options of establishing south-to-south faculty and student exchange programs between India and other countries. In addition, PCI will encourage public health experts to experience study tours, meetings, conferences, and other relevant short-term trainings.

ACTIVITY 4: SETTING UP OF MODEL NRLS AND SRLS

PCI's aim is to set up one NRL and one SRL as model laboratories. The model SRL/NRL will have following: - Standardized recording and reporting forms - Job Aids in place - A manual on quality standards - Customer satisfaction survey - Proper number of well trained staff - All equipment in place - And Accredited to NABL

ACTIVITY 5: FOLLOW UP OF THE NRLS ASSESSMENTS

PCI will procure the NRL assessment report from NACO, and will prepare a baseline document, which will be used to review the progress made on lab strengthening in year 2 and/or later. PCI seeks facilitation from CDC in procurement of the reports from NACO.

ACTIVITY 6: FOLLOW UP OF THE SRLS ASSESSMENTS

PCI will procure the SRL assessment report from NACO, and will prepare a baseline document, which will be used to review the progress made on lab strengthening. PCI seeks facilitation from CDC in procurement of the reports from NACO.

Background

CDC has singed a new Cooperative Agreement (Co-Ag) with Project Concern International (PCI). Through this Co-Ag, PCI will initiate project named PRATIBHA (Project for Accelerated Technical Assistance and Integrated Capacity Building for HIV/AIDS). The overall purpose of PRATIBHA is to strengthen laboratory services in India by focusing on the NACP-III priorities designed to increase effectiveness, efficiency and accountability with regard to HIV testing.

ACTIVITY 1: HUMAN CAPACITY DEVELOPMENT (HCD) OF LABORATORY PROGRAM MANAGERS AND LAB STAFF

This activity would be undertaken at three different levels, namely:

(1) At the NRL level: The HCD initiative will be undertaken for staff from all 13 NRLs. At each NRL, trainings will be provided to the Laboratory-in-Charge, the Medical Officer, the Lab Technician and the Lab Assistant. The HCD initiatives at this level will comprise of a three-day national training program for NRL Labs-in-Charge from all NRLs. An expert group involving NRL team leaders on technical, managerial and quality aspects will conduct this training. In addition, two bench trainings of the technical staff and one training program for medical officers from all NRLs will be held.

(2) At the SRL level: PCI will conduct four regional trainings for 40 selected SRLs. This will include two training programs for SRL Laboratories-in-Charge and two regional training programs for Lab Technicians and Lab Assistants.

(3) At the SACS level: An assessment of training needs will be conducted for select teams from Andhra Pradesh and Tamil Nadu SACS on the issues of blood safety and laboratory-related procedures. This assessment would identify training needs and capacity gaps that are crucial for quality improvement of the lab services in the state. Secondly, select staff from the 20 ICTCs (10 from AP and 10 from TN) will be trained on the issues mentioned above. This training would be conducted in close collaboration with the CDC partner agencies located in these states, for example PHMI in AP and I-TECH in TN.

By the year's end, through these initiatives on HCD, PCI will train a total of 216 personnel from 13 NRLs, 40 SRLs, and 20 ICTCs. The training topics will include technical information on HIV/AIDS, HIV prevention, blood safety, testing procedures, interpretation of results, reporting and proper disposal of waste, personal safety, post exposure prophylaxis, quality control and quality assurance. The topics will be finalized after consultation with CDC and NACO. For training purposes, PCI will procure training manuals from NACO, adapting its content for relevance and technical updates before implementation.

ACTIVITY 2: TECHNICAL ASSISTANCE IN DEVELOPING QUALITY MANUALS, SOPS AND DOCUMENTATION AT THE NRL AND SRL LEVEL.

This activity will include following initiatives:

1. A Prototype Quality Manual preparation: PCI will convene a team of experts comprising of NRL representatives, a senior level lab assessor and a program person to draft the "A Prototype Quality Manual". This manual will address both management and technical issues and will have clear mention of the quality policy of the laboratory. The draft manual will be peer reviewed by certified assessors and the finalized document will be handed over to NACO for wider dissemination.

2. Supply of National Accreditation Board of Laboratories (NABL) Base Documents to NRLs: The base documents and templates will be procured from CDC and NACO. In addition, PCI will procure the NABL standard documents (ISO-15189, NABL-112 and NABL-160), and supply copies of these to all NRLs.

3. Drafting of Standard Operating Procedures (SOP) and Job-aids: In the first year, PCI will initiate work on development of SOPs and job-aids on various topics such as specimen collection and transportation, and acceptation /rejection criteria, etc. In addition, standardizing recording and reporting forms for common processes will be done. Also, due to confusion over the changing contents of test kits, PCI will initiate work towards the development of prototype SOPs for some well-known and widely used test kits and will prepare guidelines on how labs can prepare SOPs for a new HIV test kit.

By the end of the year, PCI will equip 13 NRLs, 40 SRLs and 20 ICTCs with the select manuals, job-aids and SOPs, and will train a total of 216 personnel from 13 NRLs, 40 SRLs, and 20 ICTC on effective use of these documents.

ACTIVITY 3: REGIONAL CONSULTANCY AND TECHNICAL ASSISTANCE

In year one, consultants will be placed at the regional sites (one at Pune to support the Apex NRL, another at eastern region/North-eastern states, and the third in Chennai to support south India labs) for continued support to NRLs/ SRLs. PCI will aim to hire consultants who are NABL-trained. The expected roles of these consultants will be to:

1. Assist PCI Delhi team in writing of manuals/ documentation

2. Conduct regional training for SRLs

3. Ensure implementation of the procedures (on which staff is trained)

4. Assist in strengthening the capacity of the NRLs and SRLs to write quality manuals, and other documents for accreditation/ other proposes

5. Help NRLs and SRLs to assure quality on regular basis

6. Address any other technical issues, emerging with the SRLs or NRLs

7. Conduct internal audits of different NRLs/ SRLs

ACTIVITY 4: SETTING UP OF MODEL NRLs AND SRLs

PCI will establish one NRL and one SRL as model laboratories. The model SRL/NRL will have following:

1. Standardized recording and reporting forms

2. Job Aids in place

3. A manual on quality standards

4. Customer satisfaction survey

5. Proper number of well-trained staff

6. All equipment in place

7. And Accredited to NABL

.

ACTIVITY 5: FOLLOW UP OF THE NRL ASSESSMENTS

PCI will procure the NRL assessment report from NACO and prepare a baseline document, which will be used to review the progress made on lab strengthening in year 2 and/or later. PCI will seek facilitation from CDC in procurement of the reports from NACO.

ACTIVITY 6: FOLLOW UP OF THE SRL ASSESSMENTS

PCI will procure the SRL assessment report from NACO and will prepare a baseline document, which will be used to review the progress made on lab strengthening. PCI will seek facilitation from CDC in procurement of the reports from NACO.

ACTIVITY 7: LAB MANAGEMENT INFORMATION SYSTEMS (LMIS)

PCI will work to strengthen labs on data access security, data transfer integrity, management of incoming and outgoing information, systems for creating and archiving documentation and compliance with international guidelines. For this, PCI will undertake following activities:

1. Information technology needs assessments for select NRLs and SRLs

2. Development of LMIS and its implementation in select NRLs and SRLs on pilot basis

3. Development of LMIS manual and training of the lab staff on use of LMIS

PCI will hire an expert to undertake the above mentioned activities. This expert will be drawn from the list of experts mentioned in the proposal.