# Presentation: 009409

## -Policy Development-A Key Component in Achieving HIV Testing Technical Solutions to Program Questions

**Thomas L. Hearn, PhD**
**Deputy Director**
**Division of Laboratory Systems**
**Centers for Disease Control and Prevention**

**-****Policy Development-****A Key Component in Achieving HIV Testing Technical Solutions to Program Questions**

## When a fire is raging, throw water on it!  

## HIV Program Activities

**Voluntary counseling & testing**
**Prevention of mother-to-child transmission**
**Blood safety**
**Surveillance**
**Care & treatment**

## In order to prevent fires, that is build a sustainable system, more than throwing water is required. 

## When you are preparing to fight fires, build a system to assure that:

**the community authorities support fire prevention**
**agreements are in place assigning responsibilities**
**sufficient fire “stations” are strategically placed**
**there are firefighters who know what to do**
**the necessary equipment is ready**
**the supply of water is available **
**alarms are in place and work**
**fire drills are run to assure preparedness**** **

## Laboratory Path of Workflow (Reference NCCLS and ISO) 
		Pre-analytic 
				Analytic
						Post Analytic

Quality System Essentials
		        Organization			Documents/Records
Personnel			Internal assessment
Equipment			Process improvement
Purchasing & Inventory		Process control
Occurrence Management		Service & Satisfaction

Policies, Processes, and Procedures

**	****	****Pre-analytic **
**	****	****	****	****Analytic**
**	****	****	****	****	****	****Post Analytic**
**Quality System Essentials**
***	******	******        ******Organization******	******	******	******Documents/Records***
***Personnel******	******	******	******Internal assessment***
***Equipment******	******	******	******Process improvement***
***Purchasing & Inventory******	******	******Process control***
***Occurrence Management******	******	******Service & Satisfaction***
**Policies, Processes, and Procedures**

**Frames of Reference for Successful (Laboratory) Systems**

## Quality System

**Policies**

**Processes**

**Procedures**

**Quality System**

- “what to do”

- “how it happens”

- “how to do it” -  (SOPs)

## HIV Program Activities

**Voluntary counseling & testing**
**Prevention of mother-to-child transmission**
**Blood safety**
**Surveillance**
**Care & treatment**

## Critical Steps in Policy Development 

**Don’t assume the U.S. model**
**Determine who makes policy**
**Determine how policy is made**
**Determine what drives policy development?**
- law,
- financial leverage,
- culture,
- data supporting best practices...
- politics
**If policies exist, are they followed?**

## Slide 10

## Using Quality ControlReduces Error Rate

**  ****Sample HIV****	**** Number****	**** ****	****     ------------Errors-------------****	****    ****	****	**
**  **_**Ab Reactivity**_**	**** **_**Correct**__**	**__**	**__**With QC**__**	**__**	**__**Without QC**__**	**__**p-value**_
**  ****Negative****	****    6168****	****	****      3****	****   ****	****     19****	****	****  *****0.014***
**	**
**  ****Strong****	****   ****	****    4896****	****	****      4****	****     ****	****       3****	****	****  0.830**
**  ****Positive**
** **
**  ****Weak****	****	****    7021****	****	****  152****	****  ****	****   307****	****	****  *****0.0067***
**  ****Positive**
**  ****--------------------------------------------------------------------------------------------------------------------**
**  ****Total****	****	****  18085****	****	****   159****	****  ****	****   329****	****	****  *****0.0023***
**	****                ****(97.37%)****	****	****(2.20%)****	**** ****	****( 2.90%)**

**Using Quality Control****Reduces Error Rate**

## Critical Partners in HIV Policy Development

**High Level Appointees in the Ministries of Health and Boards created by MOHs**
**International Health and Standards Organizations (e.g., WHO, PAHO, CAREC, EU)**
**National AIDS Control Boards**
**Bilateral donors (e.g., DIFID, AMREF, USAID, CDC, GDZ, JICA, World Bank)**
**Medical and laboratory scientists/leaders**
**HIV counselors**
**Nurses and midwives**
**Hospital authorities**
**Clients**

## HIV Testing Policy Questions

**In each of the programs, who will be tested?**
**What is the primary purpose for testing and are there ethical issues?**
**What will be done as an outcome of testing?**
**How will testing be funded?**
**What happens if financial and other program resources wane?**

## HIV Testing Policy Questions

**continued--**
**Who can do the testing?**
**Will training be provided?**
**Which tests can be used?**
**Who is responsibility for purchase and inventory control?**
**How will testing be audited?**

## HIV Testing Policy Questions

**continued--**
**At the national level, who has authority & responsibility for QA?**
**What is the role of laboratory directors (national, provincial, and district) in QA?**
**Who makes, and will review, testing policies?**

## Policy Is Needed for Every Step in the Testing Process

**Analytic**
- Specimen processing
- Specimen storage
- Reagent preparation
- Preventive Maintenance
- Quality Control
- Method Validation / Evaluation
- Test performance
- Proficiency Testing / EQA
- Safety

**Post-Analytic**
- Results review
- Quality control review
- Report test results
- Results interpretation
- Records

**Pre-Analytic**
- Competency of Personnel
- Test selection
- Patient /client preparation
- Test requisition
- Collect, label, transport specimen
- Safety

## Zimbabwe HIV Rapid Testing Committee

## Views from LeadersInternational AIDS Conference, Barcelona Spain: 10 July 2002

**Dr. Patrick Osewe - USAID, Zimbabwe**
- Importance of Coalition Building for Implementing Rapid HIV Testing in VCT
**Dr. Roland Swai - NACP, Tanzania**
- Importance of Broad Input into Evaluation of HIV Rapd Tests and Policy for Use
**Dr. James Hospedales - Caribbean Region Epidemiology Center**
- Role that can be played by major health organizations

## Consequences of Jumping Past Policy Development

**Lack of buy-in with critical partners / players (e.g., gov’t officials, medical staff, laboratory scientists, procurement officers**
**Without Clear Policy, processes and procedures can follow a hazardous path**
**Loss of invested resources, time, and credibility**

## In Conclusion

**In Conclusion**

**Policy development is a critical step in implementation of lab testing strategies**
**Policy development requires technical expertise, negotiation skills, listening skills, thick skin, and patience**
**Reaching agreement on critical policy issues paves a path for sustainable laboratory systems to support programs**