# Presentation: 663323

## Expansion of Laboratory Capacity The Quality Systems Approach 

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

**16 December 2003**

## Slide 2

## The Laboratory from 30,000 feet

- Where is the oversight of laboratories within the government’s health system?
- How are policies and priorities established for laboratories?
- What are the relationships among public laboratories and others (e.g., private, university, research)
- Are structures in place to support  quality assurance, training, personnel, inventory & supplies, test validation, budget, etc?
- What bilateral agreements support laboratory activities?

## Slide 4

## Local laboratory services --where the rubber meets the road

- What services are offered at what levels (central or national, provincial, district, health center)?
- Who is doing the work (extent of training, number of persons)?
- How much work is being done?
- Is there a quality assurance program and who monitors it?
- How are samples obtained, collected, stored?
- How are results reported and records maintained?

## Total Testing Process

**Action**

**Question**

**Test Solution**

**Ordering**

**Identification**

**Collection**

**Transportation**

**Preparation**

**Analysis**

**Reporting**

**Interpretation**

** ****Care provider**

**Patient and Family**

**Laboratory**

**Post-analytic**

**Pre-analytic**

**Analytic**

**Notes:**
This slide refers back to Dr. Laposata’s introduction.  The multiple steps in the testing cycle provide many opportunities for error that are outside the traditional analytic domain of laboratory quality improvement activities.  Well over 80% of the errors in laboratory medicine occur outside traditional analytic domain.

## Slide 7

## George Santayana (1863-1952), American philosopher:

** **
**“****Those who cannot remember the past are condemned to repeat it”.**

## Quality System

**Quality System**

**Quality Assurance**

**Quality Control**

## Quality System Essentials

## All elements of a quality system are executed by...

**Policies**

**Processes**

**Procedures**

**All elements of a quality system are executed by...**

## Quality System Essentials

## Organization

## Personnel

## Purchasing and inventory

- Role and relationship of central medical stores
- Purchase regulations, requirements, customs
- Best price versus customer requirements
- Staking and delivery
- Maintenance agreements

## Equipment

**Space, equipment, organization**
**of the laboratory, power supply,**
**reagents, instructional aids,**
**disposable supplies are all part**
**of the system**

## Process control

**CD4 and viral load EQA training - Thailand**

## Information Management & Documents, Records

## Assessment

**Laboratory Certified by Guyana MOH National Bureau of Standards**

## Facilities and safety

- Zimbabwe NMRL

- Kasane, Botswana

## So what have we learned?

## CDC is but one partner

**CDC is but one partner**

## Money can initiate action...but by itself cannot 

- Money can initiate action...but by itself cannot
- determine the pace for achieving success

**May 2001****	****    Sept 2001****	****          Jan 2002****	****May-Nov 2002****	****Nov 2002****	****	****Feb 2003**
**Assessment****	****    Review Plan       Start construct****	****Train techs****	****	****QA training****	****	****Finish lab**

**Timeline for implementing **
**CD4 and viral load testing**
** ****at a new laboratory facility**

## Models exist

**Models exist**

## International References

**International References**

- The Guidelines are an outcome of a Consensus Workgroup Meeting
- Harare, Zimbabwe
-  (20) CDC, WHO, APHL, Regional 	Participants
-   Currently in CDC/WHO Clearance

**Protocols and Guidelines Serve as the Foundation for Processes & Procedures**** **
***CDC and WHO-AFRO led development of Guidelines for Appropriate Evaluation of HIV Testing Technologies***

## Lessons from the TB Prevention Program

**Lessons from the TB Prevention Program**

## Again, it’s about people and systems!

**Again, it’s about people and systems!**

## It’s about people laughing, learning, standing side-by-side, and becoming colleagues

**It’s about people laughing, learning, standing side-by-side, and becoming colleagues**

## And at the end of the day, it is about skilled, motivated

- health scientists stepping up to the plate and being willing
- to look at problems and solutions through unique lenses to
- find the way.

## Thank you...and welcome to the team!