# Presentation: 376148

## Thailand Experiences on Implementation of Quality Assurance and Quality System

- _[Wilai](slide2.xml)__[ ](slide2.xml)__[Chalermchan](slide2.xml)_, MSc
- Laboratory Chief, Quality Assurance of HIV Testing Section
- National Institute of Health
- Department of Medical Sciences, Thailand

**Notes:**
As you have heard during this workshop about “How to assess your quality” and EQAS is the one of the effective method to do so. 
The organizer of this workshop would like to encourage you to implement the NEQAS in your country and expect the Thai experience may give you an idea of how to implement it. 

## Presentation Outline

- From QC to QMS
- Implementation of QMS in Thailand
- Model Development of Comprehensive QA program for HIV Testing

## A Long Way From QC to QMS

- 1975: Implementation of QC program in Clinical Chemistry
- 1982: First exercise of EQA for Clinical Chemistry
- 1985: Establishment of Division of Laboratory Quality Control
- External Quality Assessment
- In-service Training for Clinical Chemistry, Hematology, Bacteriology, Microscopy, Immunology and Blood Banks
- 1994: Implementation ISO guide 25 to clinical laboratory
- 1998: Establishment of National Accreditation Body for  Clinical Laboratory
- 2000: Implementation of Hospital Accreditation Program

## Implementation of QMS into Clinical Laboratory

- National Accreditation Body was designated
- Since 1994, nation-wide continuation intensive training program for
- ISO guide 25 and certain technical requirements such as
- Equipment calibration
- Method validation
- Auditing

## Clinical Laboratory Accreditation Programs 

- Laboratory Accreditation by National Accreditation Body
- ISO 17025 and ISO 15189
- Laboratory Certification by Association of Medical Technologists of Thailand (AMTT)
- Medical Technology Standard
- Using 100 item-checklist
- Hospital Accreditation Institute by Institute of Healthcare System Development
- Developed guideline for Lab survey

## Model: Development of a Comprehensive Program for QA-HIV

## The first AIDS case in Thailand was reported in 1984.
Trend on HIV prevalence among risk groups, 1989-2001.

- Trend on HIV prevalence among risk groups, 1989-2001.

- THE THAI HIV EPIDEMIC

**• ****Male conscript**
**x Blood donor**
**• ****ANC**

**Source: AIDS Division,Thai MOPH**

**percent**

**Male conscript**

**ANC**

**Blood Donor**

**Notes:**
 While the first HIV case in Thailand was report  in 1984, it was only 2 years after the first report in USA. He was infected oversea and came back home. 
 Progressive numbers of AIDS cases as well as people living with HIV were reported throughout the following year, and reach to the peak in 1993 at 4% in men conscript which represent young men age 20 to 21.
The peak of general population peak at 2.3 in 1995 and 1% in blood donor in 1993 to 1993. 
It was evident that with a strong national response, we have seen a large decline in new HIV infections. In year 2001 the prevalence drop to 0.3% in blood donor and this year down to 0.2%. 

 Thailand was the first country in Asia to document HIV epidemics among IDUs and female sex workers and their clients. After a brief period of denial, the country organized a national program, supervised from the highest levels of government, to respond to the epidemic.

## QA Support Laboratory Process

## NIH QA Program for HIV/AIDS

- 1994  Kit Evaluation (HIV test)
- 1997  EQA for anti-HIV
- 2000  Re-evaluation
- 2001  Reference Testing
- 2002  Quality Control
- 2003  EQA p24
- 2003  EQA viral load
- 2004  Information Network
- 2005  Kit batch testing

## Implementation of National External Quality Assessment Scheme (NEQAS) for HIV Testing

## How National EQA for HIV Serology was Established in Thailand 

- Skill building of organizer
- A pilot program was initiated in 1998 to 1999
- It was expanded to the nation-wide program by year 2000
- Plan and propose to get approval.
- Select co-organizer to run sub-scheme in the regions.

**Notes:**
When the Thai anti HIV NEQAS was initiated in 1997, the needs for quality laboratory services was recognized as an essential measure of HIV/AIDS prevention and care 
With the developed kit evaluation program, it had brought me an opportunity of  
Skill building from participating NRL workshop
In 1998, the  pilot program of EQAS was initiated with the small group of laboratory which were regional and provincial hospital. The pilot program helping us gained the experience on scheme in operation.  The program was accept very well by the participants. More than 95% of public hospitals were voluntary member.  
 In year 2000, the national program was proposed to the department to get approval to expand the scheme to the nation-wide program. 
According to a large number of laboratory expecting participate the scheme, then it was decided to operate scheme as a cascade fashion. Then the meeting with 12 regional medical sciences centers (RMSc)was held up to discuss the appropriate site that the scheme could be run in the different region. 

## Selection Criteria for EQAS Co-organizer Laboratory

- Technical competence (on particular test)
- Resources e.g. staff, data management equipment etc....
- Representative of the country region
- Technical consultant (university) available  in the local area.

## Slide 13

**Notes:**
With consensus agreement in the meeting 4 RMSCs were select to run the regional scheme under technical supervision and supporting from central scheme.
 The selected site should take care participants both public and private in the area. 

## Preparation steps

- Research (e.g. information required, stability of test item)
- Training workshop for co-organizer
- Develop harmonized protocol
- Sample preparation
- Data analysis
- Performance evaluation
- Provide feedback
- Funding support for scheme operation
- Sharing the required materials

**Notes:**
Therefore, the training workshop was organized in my laboratory. 
WHO guideline of organizing EQAS was bring into practicing.
The harmonized protocol is developed for all 5 regional schemes
The sample preparation, Data management and analysis and performance evaluation are demonstrated. 
We also some required material such as preservative, some test kit, lab ware and computer supplies. 
Then, the program were started step by step with technical supervision from the central scheme. 

## Slide 15

**Notes:**
 This diagram may explain the quality tractability of the scheme. 
 Each  EQA panel preparing in the region have been sent to the central to check integrity of the sample. They are also participate as a participant of the central scheme. 
 Up to now, 12 panels had been sent as schedule and over 926 laboratories participate to all 5 scheme. 

## Quality Assurance of Scheme in Operation

- Homogeneity check of EQA sample
- Recheck stability of returned sample
- Data input and processing will be verified sufficiently
- Participate to other EQA program
- Apply QMS and Auditing by
- ISO 17025 for sample preparation and laboratory testing
- ISO/guide 43 for scheme management

## Outcome 1999-2003: Discrepant Rate of Various Assay within 13 trials

- Outcome 1999-2003: Discrepant Rate of Various Assay within 13 trials

**No. of test varies from 4****549 ****to**** 9725 ****tests**

- % discrepant results

## Common problems identified in NEQAS

- False negative on weakly positive GPA sample
- Testing strategy not follow
- All sample tested on all assay
- Non-reactive results were not reported as negative
- Reactive sample was not confirmed
- Incorrectly complete result forms.
- Kit name
- Kit lot
- Not record absorbent value or S/Co ratio for EIA

**Notes:**
Error made in transcription
 Incorrect kit name
 incomplete/incorrect result form 
 receive date
 not give test value

## Follow up activities on participants

- Provide consultative visit
- Organize training workshop.
- Quality Assurance
- HIV testing.
- Provide Quality Control program

**Notes:**
The observations from EQA program, some follow up activities were operated.  At the beginning of the year 2001, the QA workshop were organized 5 times in each region through the country. There were more than 800 laboratory personals participated the workshops. 
By the end of this year, anti HIV testing workshop will be organized to improve laboratory practice which focus on GPA and rapid testing practice and testing strategy. 
The third activity is  to support laboratory QC program, by prepared and standardized QC sample including software to facilitate laboratory QC program and subsequently kit monitoring program. 

## Pitfalls of our system

- Re-organization of the department did not facilitate the implement of QA program
- Re-engineering of the government organization made program under staffed
- There is no central organization to actually coordinate the QA program

## Next Steps 

- Apply for accreditation on ISO 17025 and ISO guide 43 by year 2004
- Expanded the activities to other blood safety screening markers

**Notes:**
What is need in the future?
 Establishment of NRL for serology in Thailand
 Implementation of Quality System and to be Accreditation

## Acknowledgement

- Technical consultant
- NRL Australia
- Funding agency
- Global AIDS Program
- The network
- Advisory group
- The 4 Sub-scheme organizers, Chiang Mai, Udorn Thani, Songkla and Chonburi RMSc
- Staff members of QA-HIV Laboratory, National Institute of Health

## Thank you 

- Thank you

## Thank you 

- Thank you

## Key Element of Success

- Basic Infrastructure
- Government support, e.g. policy
- Facilities
- Dedicate people
- Collaboration
- the network including National advisory group
- linkage to the international scheme and experts
- Start with small group of lab that are likely to succeed
- Responsible institute is assigned
- Independent body to laboratory being assess is essential