# Presentation: 321334

## PT Program Development for Resource-Limited Countries and Regions

**Dr. Robert Martin**

**Workgroup 6**

- Wkgp 6 -- Subgp 1

- Feb 26, 2002

## WHAT ARE SOME OF THE ORGANIZATIONAL STRUCTURES FOR PT/EQA IN RESOURCE-LIMITED COUNTRIES OR REGIONS? ARE THERE SUCCESSFUL PROGRAMS RUN BY THE GOVERNMENT, ACADEMIC, COMMERCIAL, OR MIXED RESOURCE? 

-     Need financial support from government or other source
- Institutions or laboratories specializing in one type of PT sample should produce samples for other laboratories.
-     Regional coordinating body – re-distribution of samples within country or state
-  Provision of SOPs for materials production for in-	country laboratories preparing samples/slides for PT purposes
- Need standard guidelines accessing/available; ISO, NCCLS, CAP, CDC
-  Distribution of multiple sets of samples/slides to district level for further distribution to health centers
-  Re-cycling sample sets from district level to health centers
-     Re-checking of slides, however, issues such as re-blinding, results, and sample size to assure adequate confidence must be considered

- Wkgp 6 -- Subgp 1

- Feb 26, 2002

**Notes:**
6-1q1

## WHAT FACTORS HAVE MADE THESE PROGRAMS SUCCESSFUL?

-    Strong in-country government support
- Measure impact of program, e.g., improvement in performance over time
-    Constant communication, troubleshooting, support to 	  participating labs
-    Start small with laboratories that are likely to succeed
-    Pilot new analytes, in consultation
- Transfer of leadership

- Wkgp 6 -- Subgp 1

- Feb 26, 2002

**Notes:**
6-1q1

## IS THERE AN OPTIMAL MODEL FOR SAMPLE ACQUISITION BY PROGRAMS FOR RESOURCE-LIMITED COUNTRIES OR REGIONS?

- Regionally produced materials according to CAP specifications and re-distribution within countries
- Engage CAP in discussions for preparation/distribution of samples to developing countries in which infrastructure is now or will be present
- Donor support for sustainability is required over a number of years

- Wkgp 6 -- Subgp 1

- Feb 26, 2002

**Notes:**
6-1q1

## DO SUCCESSFUL PROGRAMS PURCHASE AN OUTSIDE PROGRAM OR CREATE THEIR OWN WITH ASSISTANCE, OR SOME MIXED?

- Create own specimens because of costs
- Alternative – digital images
- Develop Mentoring Programs  - training for developing quality EQA materials

- Wkgp 6 -- Subgp 1

- Feb 26, 2002

**Notes:**
6-1q1

## WHAT ARE THE BASIC REQUIREMENTS FOR DEVELOPING A PT/EQA PROGRAM, IN A RESOURCE-LIMITED COUNTRY OR REGION?

-  People (Champion, Administrator, Collaborating partner)
- Infrastructure (Quality Management System, Advisory Group, Facilities, Information Technology, Policy, Political Will)
- Planning (Assessment of scope of testing, Implementation Plan)
- Financial Resources (Identification of sustainable sources, vertical programs)

- Wkgp 6 -- Subgp 2

- Feb 26, 2002

**Notes:**
6-1q1

## Centralized vs. Decentralized Model

- The choice of a specific model should be made on the basis of the requirements of each specific program

- Wkgp 6 -- Subgp 2

- Feb 26, 2002

## WHAT ARE THE ADVANTAGES OR DISADVANTAGES OF A DISTRIBUTED NETWORK OF SAMPLE CREATION FACILITIES?

_**Advantages**_
- More local benefits (increased ownership, EQA customized to local requirements)
- Simpler logistics (provider redundancy, shipping, language, more sources of PT materials)
_**Disadvantages**_
- Lose economy of scale (more difficult to manage, replication of resources, availability of experts)
- Loss in comparability (more difficult to quality control, harmonization barriers)

- Wkgp 6 -- Subgp 2

- Feb 26, 2002

**Notes:**
6-1q1

## WHAT ARE THE ADVANTAGES AND DISADVANTAGES OF USING A SINGLE CENTRALIZED FACILITY TO PREPARE, DISTRIBUTE, AND ANALYZE DATA?

_**Advantages**_
- Standardization, Traceability, Comparability
- Economy of scale (expert needs are easier met, larger database)
- Organization benefits (Management, Accreditation, Training, added core business value)
_**Disadvantages**_
- Remote to local needs and more institution-dependent
- Vulnerability due to lack of back-up/ redundancy

- Wkgp 6 -- Subgp 2

- Feb 26, 2002

**Notes:**
6-1q1

## WHAT IF ANY, ETHICAL ISSUES NEED TO BE  CONSIDERED BEFORE DEVELOPING AND INTER-PROGRAM MENTORING INITIATIVE?

- 	Establish qualifications and commitment of the mentor to a sustained long-term relationship.
- 	Full disclosure by the mentor of conflicts of interest.
- 	Ethical issues with respect to sample acquisition should be dictated by local policy/regulations [and the mentor’s country].  Mentor has a responsibility to educate the host country on ethical issues.

- Wkgp 6 -- Subgp 3

- Feb 26, 2002

**Notes:**
6-1q1

## WHAT IS THE ROLE OF A MENTOR IN ESTABLISHING STANDARDS THAT FACILITATE THE DEVELOPMENT OF AN INTER-PROGRAM MENTORING INITIATIVE?

- Mentor should identify local champion [leader]
- Mentor should then enter into a dialog with host country to define the host’s expectations for the relationship.
- Mentor and the host country define the milestones and evaluation steps for the project with the long-term objective being to decrease the direct involvement of the mentor in the project. The long-term mentor/host relationship is maintained.
-  WHO should be encouraged to develop guidelines that define the mentor/host relationship.

- Wkgp 6 -- Subgp 3

- Feb 26, 2002

**Notes:**
6-1q1

## WHAT ARE THE QUALITY INDICATORS TO MONITOR THE SUCCESS OR FAILURE OF AN INTER-PROGRAM MENTORING INITIATIVE?

- The mentor/host should develop a strategic plan for the project
- Key elements to be included:
- Define goals, timelines and identify outcome indicators that can be objectively measured.  The plan should reflect the expectations as mutually agreed.   The long-term performance goal should be consistent with international standards.
- Indicators of success should be predicated upon the timely achievement of the measurable milestones as defined in the strategic plan.  Such milestones might include: enrollment, safety plans, continuing educational programs, measures of analytical variance, independence/self-reliance, availability of PT samples, data handling/processing, etc.

- Wkgp 6 -- Subgp 3

- Feb 26, 2002

**Notes:**
6-1q1

## HOW COULD AN INTER-PROGRAM MENTORING INITIATIVE HELP TOWARDS DEVELOPMENT OF SUSTAINABLE PT/EQA PROGRAMS IN RESOURCE-LIMITED COUNTRIES OR REGIONS?

- Raising awareness/visibility/advocacy for PT
- Support using data in order to gain resources, etc.
- Extension of PT effort into overall lab quality (i.e. improvement          leading to cost reduction, etc.)
- Mentoring –  collaboration/partnering  (in-country and between countries)
- Can benefit from cost reduction/sharing
- Can develop regional PT/EQA Programs
- Less developed programs learning from more developed and from one another
- Standardization of laboratory practice
- Provision of technical and materials support (data management, tools, etc.)
- Direct inter-comparability of data

- Wkgp 6 -- Subgp 4

- Feb 26, 2002

**Notes:**
6-1q1

## WHAT ARE THE FACTORS THAT CONTRIBUTE TO THE SUSTAINABILITY OF A PT/EQA PROGRAM?

**Ensure trainees implement PT programmes in-country**
**Reference lab development (transfer of expertise to ****	****      peripheral labs)**
**Standardization of program & laboratory practice**
**Ongoing resources**
** ****Monitoring of standards (accreditation)**
**Government mandated PT programs .**
** ****Maintenance of equipment (mentoring needed)**

- Wkgp 6 -- Subgp 4

- Feb 26, 2002

**Notes:**
6-1q1

## WHAT ARE SOME OF THE INTERNATIONAL AGENCIES, INSTITUTES, OR PRIVATE SECTOR GROUPS THAT COULD FACILITATE FUNDING FOR DEVELOPING INTER-PROGRAM MENTORING INITIATIVES IN RESOURCE-LIMITED COUNTRIES OR REGIONS?

**Financial support**
**U.S. based organizations (CDC, NIH, USAID, etc.)**
**International organizations/country organizations (WHO/PAHO, World Bank, DANIDA, European Union, etc.)**
**Foundations (Gates, Ford, etc.)**
** ****Private ISO Registrars (e.g.British Standards Institute)**

- Wkgp 6 -- Subgp 4

- Feb 26, 2002

**Notes:**
6-1q1

## Continued....

- Non-financial support
- Govt/non-govt PT/EQA providers (CDC, CAP, etc.)
- Associations (IFCC, CAP APHL, etc.)
- Independent Consultants
- Centers of excellence
- Regional mentors (link to sustainability)

- Wkgp 6 -- Subgp 4

- Feb 26, 2002

## Continued....

- Marketing of PT to agencies for financial support
- Access to internet vital (provides agency        background, what they are looking for, etc.)
- Development of PT brochure (providing justification) for private or public sector funding
-  Factors affecting funding
- Political situation in country may cause agencies to withdraw
- Funneling mechanisms in-country (do funds reach correct groups?)

- Wkgp 6 -- Subgp 4

- Feb 26, 2002

## Summary

- Long term funding support
- Long term partnerships
- Regional resource sharing
- Standardization
- Country infrastructure
- Overall quality management

- WORKGROUP 6

- Feb 26, 2002

## SUBGROUP LEADERS AND RECORDERS

- Jane Carter
- Jose Campione
- Grace Kahenya
- Valerie Wilson
- Eve Gadzikwa

- Stacy Howard
- Thomas Hearn
- Roger Taylor
- Bhavna Lall
- Erlo Roth

- WORKGROUP 6

- Feb 26, 2002