# Presentation: 294355

## Workgroup 3 International Aspects of PT Programs

- Dr. David Bullock

- Workgroup 3

- Feb 26, 2002

## WHAT ARE SOME OF THE DIFFICULTIES IN PROVIDING RELEVANT PT/EQA SAMPLES ACROSS INTERNATIONAL OR INTERCONTINENTAL BOUNDARIES?

- Transportation issues:
- Specimen integrity
- Border barriers
- Time lag
- Suggest reverse PT cycle, where participant sends sample to PT provider?

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-1q1

- Transport into and within countries is hampered by policies and regulations (IATA, etc)
- difficulties clearing borders - customs, health officer
- Need:
- Endorsement from top levels of government
- International Organization (WHO) to develop a standardized system for transporting specimens, eg:
- diplomatic pouch
- obtaining a special exemption from the Ministries of Health within countries
- suggest labeling specimens as EQA, not diagnostic, specimens
- address to hospital/research institute (non-commercial sites)
- No customs duty (EQA specimens, not IVDs)
- Suggest approaching WHO simultaneously through regional organizations and international meetings

- Workgroup 3

- Feb 26, 2002

- Communication:
- Different reporting units
- Language - use UN official languages
- Notification - of specimen despatch & receipt
- Motivation - plaques/certificates
- Need multiple communication channels:
- Internet, email, listserv, fax, telephone, PDA
- Lack of SOPs for transportation and communication
- Regional or international organizations develop standard distribution procedures.
- Focal person to handle communication and specimens
- Fees:
- Developing country funding from international NGOs

- Workgroup 3

- Feb 26, 2002

## IN WHAT CONTRIES OR REGIONS ARE NATIONAL REGULATIONS CREATING NON-TARIFF BARRIERS THAT INHIBIT INTERNATIONAL COOPERATION ON PT/EQA PROGRAMS? 

- Industrialised countries
- Less likely to cooperate
- National regulations hinder or prevent:
- legal, licensing, accreditation
- commercial, market
- autonomy
- Bring PT providers together to establish consensus (?funding needed)

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-1q2

- Developing countries
- More enthusiastic to collaborate
- Lack infrastructure
- need for workforce development
- develop core leadership nucleus for EQA
- Lack of (appropriate) standards
- Standards must be appropriate to country's situation
- Establish ideal and minimum standards
- How do we translate these ideals into a practical action plan?

- Workgroup 3

- Feb 26, 2002

## WHAT ARE SOME OF THE TRANSPORT ISSUES INFLUENCING INTERCONTINENTAL USE OF PT/EQA PROGAMS AND MATERIALS? 

- Due to time and temperature issues it is _essential_ that the samples be transported efficiently

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-2q1

## How Might These Issues Be Resolved?

- Selection of courier / distributor
- work with regional couriers, establish relationships with individuals
- consider shipment to one point, for distribution throughout an individual country
- Proper training of shipping personnel
- includes correct classification of product that is to be shipped
- Endorsement that specimens tested to transfusion standard are biological materials, exempt from dangerous goods' labelling & packaging rules
- International organization to work as advocate
- WHO; this conference; any other international group

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-2q1

## CAN INTERNATIONAL PEER GROUPS OF PT/EQA PROGRAMS BE DEFINED?  If SO, HOW? 

- In some cases peer groups would be appropriate.  They might be defined according to:
- Purpose (Educational vs. Regulatory)
- very important distinction
- must be defined up-front
- Type of testing
- Clusters of similar lab type:
- reference labs; rural labs; out-post labs

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-2q2

## WHAT FACTORS NEED TO BE DEFINED TO ALLOW PT/EQA INFORMATION TO BE EXCHANGED IN A COMPARABLE MANNER BETWEEN INTERNATIONAL LABORATORY GROUPS?

- Each provider needs to define:
- The question they ask the participant
- The data they require
- How the data is processed
- Formulation of the specimen
- Assessment model
- The purpose of the scheme
- Licencing
- Accreditation
- Education

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-3q1

## WHAT FACTORS NEED TO BE DEFINED TO ALLOW PT/EQA INFORMATION TO BE EXCHANGED IN A COMPARABLE MANNER BETWEEN INTERNATIONAL LABORATORY GROUPS?

- International exchange of EQA information should be at the level of transfer between:
-  EQA providers
- Reference laboratories (should also be participants)
- Manufacturers (should also be participants)
- Regulatory bodies
- Licensing bodies

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-3q1

## WHAT FACTORS NEED TO BE DEFINED TO ALLOW PT/EQA INFORMATION TO BE EXCHANGED IN A COMPARABLE MANNER BETWEEN INTERNATIONAL LABORATORY GROUPS?

- Report format as provided to participant
- Language
- Detail
- Format of report (use of tables, histograms etc)
- Personalised advice (small schemes)

- Workgroup 3

- Feb 26, 2002

## WHAT PROCEDURES EXIST THAT CAN FACILITATE INTERNATIONAL COOPERATION BETWEEN PT/EQA PROGRAMS? 

- 	Priority setting
- 	Advocacy
- 	Financial justification
- Meetings
- Publication (Newsletters of EQA providers, Product         	specification Discipline specific)
- Ongoing assessment of programs (scheme by scheme and outcome of benefits to participants)
- Training
- Internet
- Exchange of written and material standards
- Marketing
- Workshops
- Exchange programs
- Mentoring
- Network information (inventory of EQA scheme providers, comparable databases)

- Collaborative Activities

- Communication

**Coalition**

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-3q2

## WHAT PROCESSES ARE IN PLACE TO FACILITATE PT/EQA FOR LOW VOLUME OR “ORPHAN” ASSAYS?  WHAT NEW PROCESSES WILL NEED TO BE DEVELOPED?

- Information sharing and education
- Assay providers (DORA, AssayFinder) _and_ schemes
- Enhance existing websites
- Create new websites (?'meta-sites')
- Methods of coordination
- Professional societies
- Industry
- Government
- Validation of methods
- Availability of global guidelines
- Round Robins
- Performance criteria
- Accreditation

- Workgroup 3

- Feb 26, 2002

**Notes:**
3-4q1

## WHAT CRITERIA SHOULD BE USED FOR SELECTION AND PROVISION OF PT/EQA PROGRAMS INTERNATIONALLY? 

- Voluntary EQA
- Follow ISO Guide 43-1 requirements
- Review WHO guidance against ISO 43-1
- Regulated EQA
- Accreditation to requirements such as ILAC G13, CPA

- Workgroup 3

- Feb 26, 2002

## FOR WHAT TYPES OF LABORATORY TESTING WOULD IT BE BETTER TO RE-ANALYZE PATIENT SPECIMENS RATHER THAN SENDING OUT SAMPLES TO DETECT POOR LABORATORY PERFORMANCE? WOULD THIS BE A BETTER INDICATION OF ACTUAL LABORATORY PERFORMANCE?

- No tests could be better evaluated by reanalysis on an international PT scope
- This may be an approach to standardization, but not reasonable for inter-laboratory evaluation on an international scale

- Workgroup 3

- Feb 26, 2002

- Other mechanisms may be useful, such as:
- “virtual lab”/ “clone lab” – laboratorians travel to central laboratory and test specimens – this would be mechanism for education rather than PT
- “virtual” challenges: use of the internet to send pictures or raw data for analysis, for example
- questionnaires – could evaluate pre- and post-analytic processes as well as analytic
- use of manufacturers’ QC programs on a regional or international scope

- Workgroup 3

- Feb 26, 2002

- Reanalysis may be valuable on a regional scope or through a hierarchical process
- Tests for which accuracy is more important than precision, would be better for re-analysis (e.g. serology, histopathology, microscopic urinanalysis) than tests for which precision is more important than accuracy (e.g., chemistry, hematology)
- On regional level, could send specimens to a central laboratory with accepted credibility; adds element of traceablility
- Could use multi-layer approach from laboratories, to regional level to international level

- Workgroup 3

- Feb 26, 2002

## HOW WOULD THE COST COMPARE WITH TRADITIONAL PT/EQA AND WHAT WOULD BE THE LOGISTICAL CONCERNS ABOUT ESTABLISHING A RE-EXAMINATION OF PATIENT SPECIMENS? 

- Re-examination would cost more than traditional PT
- Alternative mechanisms described above may cost less
- Logistical concerns include:
- Language
- Population variance and incidence of abnormals
- Access to internet
- Ethics/laws/cultural issues
- Shipping

- Workgroup 3

- Feb 26, 2002

## Summary

- Specimen transport is a major concern
- without specimens, all else is irrelevant!
- individual schemes (or coalition) insufficient influence
- WHO & international level support needed
- Need to define scheme purpose
- otherwise, cannot know if fit for purpose
- Enhanced communcation required
- variety of means must be used
- Schemes shold comply with recommendations and accreditation
- Novel means of EQA should be explored

- Workgroup 3

- Feb 26, 2002

**Notes:**
Determine the best close for your audience and your presentation.  Close with a summary; offer options; recommend a strategy; suggest a plan; set a goal.  Keep your focus throughout your presentation, and you will more likely achieve your purpose.

## SUBGROUP LEADERS AND RECORDERS

- Austin Demby
- Carlyn Collins
- Roongrasamee Soisangwan
- Gary Myers
- Harry Hannon

- Louise Barden
- Sue Empson
- Vivienne James
- Chantal Maurice
- Devery Howerton

- and many thanks to _all_ Workgroup members . . .

- Workgroup 3

- Feb 26, 2002