# Presentation: 373536

## Workgroup 2 Innovative Approaches to Evaluate Performance

- Dr. Harry Richardson

- Wkgp 2 -- Subgp 1

- Feb 26, 2002

## WHAT ARE THE WAYS BY WHICH PT/EQA PROGRAMS COULD EVALUATE SPECIFIC PRE-ANALYTIC STEPS IN THE MEDICAL LABORATORY’S TESTING PROCESS?

- Evaluate information on the Collection of Specimens (Samples)
-  Patient Preparation
-  Correct identification of the patient
- Requirements for collectiLabelingen container
- Labeling
- Volume
- Special requirements
- Requisition document

- Wkgp 2 -- Subgp 1

- Feb 26, 2002

**Notes:**
2-1q1

## Evaluate the transport of specimens
Time in transit
Packaging
Temperature of storage
Precautions to preserve the integrity of the target analyte during transport
Use duplicate PT/EQA samples to check effect of pre-analytical processing

- Time in transit
- Packaging
- Temperature of storage
- Precautions to preserve the integrity of the target analyte during transport
- Use duplicate PT/EQA samples to check effect of pre-analytical processing

**WHAT ARE THE WAYS BY WHICH PT/EQA PROGRAMS COULD EVALUATE SPECIFIC PRE-ANALYTIC STEPS IN THE MEDICAL LABORATORY’S TESTING PROCESS?**

- Wkgp 2 -- Subgp 1

- Feb 26, 2002

## WHAT ARE THE WAYS BY WHICH PT/EQA PROGRAMS COULD EVALUATE SPECIFIC PRE-ANALYTIC STEPS IN THE MEDICAL LABORATORY’S TESTING PROCESS?

- Evaluate the  laboratory reception and accessioning process
- Criteria for acceptance and rejection
- Re-labeling
- Secondary sample preparation
- Check process and procedures for traceability
- Primary sample to the patient
- Secondary samples to primary samples

- Wkgp 2 -- Subgp 1

- Feb 26, 2002

## WHAT ARE THE WAYS BY WHICH A PT/EQA PROGRAM COULD EVALUATE SPECIFIC POST-ANALYTIC STEPS IN THE MEDICAL LABORATORY’S TESTING PROCESS?  

- Evaluate the report generation process
- Result review and acceptance
- Verification of calculations
- Fitness for purpose of the format of the report
- Appropriateness of the reference intervals
- Interpretive components
- Amendment of reports
- Examine the integrity and security of the Laboratory Information System and the linkage with the HIS

- Wkgp 2 -- Subgp 1

- Feb 26, 2002

**Notes:**
2-1q2

## WHAT ARE THE WAYS BY WHICH A PT/EQA PROGRAM COULD EVALUATE SPECIFIC POST-ANALYTIC STEPS IN THE MEDICAL LABORATORY’S TESTING PROCESS?

- Assess the report distribution process
- Authority for release
- Distribution mechanisms
- Confidentiality
- Turn around time
- Critical value reporting

- Wkgp 2 -- Subgp 1

- Feb 26, 2002

## WHAT ARE SOME OF THE WAYS THAT POINT-OF-CARE TESTING AND OTHER NEAR PATIENT TESTING CAN BE EVALUATED? 

- Regular internal audits
- Regular testing of QC materials with appropriate values especially for qualitative testing (+10% above cut-off)
- Use of 3rd party QC materials where available
- Protocols for education and training
- Defined oversight and/or responsibility for testing
- POC device manufacturers role in product QA (recommendations/materials)

- Wkgp 2 -- Subgp 2

- Feb 26, 2002

**Notes:**
2-2q1

## WHAT CAN BE DONE TO EVALUATE PERFORMANCE FOR ANALYTES/TESTS FOR WHICH TRADITIONAL PT/EQA IS NOT AVAILABLE? 

- Split sample testing
- Blind sample testing
- Repeat sample testing with time
- Sharing samples
- Referral of previously tested material to a reference or reference method laboratory

- Wkgp 2 -- Subgp 2

- Feb 26, 2002

**Notes:**
2-2q2

## WHAT CAN BE DONE TO EVALUATE PERFORMANCE FOR ANALYTES/TESTS FOR WHICH TRADITIONAL PT/EQA IS NOT AVAILABLE?

- Manufacturers provide appropriate QC materials
- Assistance from WHO, IFCC, CDC
- An intra- or inter-facility QC program
- Use of artificial challenge samples

- Wkgp 2 -- Subgp 2

- Feb 26, 2002

## HOW COULD THE INTERNET, FAX, TELEPHONE, OR OTHER MEANS BE USED TO PROVIDE PT/EQA RESULTS MORE RAPIDLY? 

- Aggregate information from PT/EQA should be made public
- for educational purposes and
- for assessing information used to determine the performance of the assays in the field.
- web based programs will provide more rapid access than traditional mail-outs
- benefits may not be readily achievable at the moment.
- use internet to receive and report proficiency test results.

- Wkgp 2 -- Subgp 3

- Feb 26, 2002

**Notes:**
2-3q1

## HOW COULD THE INTERNET, FAX, TELEPHONE, OR OTHER MEANS BE USED TO PROVIDE PT/EQA RESULTS MORE RAPIDLY?

- List-servers for PT/EQA participants and organizers could be used to share information such as the poor performance of an assay.
- Data mining issues; standardization of formats to access critical information.
- Education

- Wkgp 2 -- Subgp 3

- Feb 26, 2002

## IN WHAT WAYS CAN THE INTERNET, FAX, TELEPHONE OR OTHER TECHNOLOGIES BE USED TO MEET THE NEEDS FOR PT/EQA PROGRAMS IN RESOURCE-LIMITED COUNTRIES? 

- There is insufficient infrastructure currently available
- Assist resource limited countries to determine their needs
- Call on agencies such as CDC, PAHO, WHO and others to lobby organizations to assist financially.
- Develop a standard approach which takes into account different levels of resources
- If available, internet would provide access to training and education in IT and quality management procedures.

- Wkgp 2 -- Subgp 3

- Feb 26, 2002

**Notes:**
2-3q1

## WHAT CONCEPTS IN PT/EQA PROGRAMS COULD BE INTRODUCED IN A RESOURCE-LIMITED COUNTRY BEFORE A TRADITIONAL PROGRAM IS DEVELOPED? 

- External quality assessment audit—external review of laboratory operational structure
- Testing menu
- SOP’s
- QA/QC practices
- Educational qualifications and training of personnel
- Inter-laboratory cv’s to detect gross analytical errors or bias
- Offer recommendation on best practices

- Wkgp 2 -- Subgp 4

- Feb 26, 2002

**Notes:**
3-2q2

## WHAT CONCEPTS IN PT/EQA PROGRAMS COULD BE INTRODUCED IN A RESOURCE-LIMITED COUNTRY BEFORE A TRADITIONAL PROGRAM IS DEVELOPED?

- Random re-testing of patient samples
- Performed by “mentor” laboratory
- Intra-laboratory review—“round-robin” review
- Use to establish standardized protocols
- Use less costly EQA challenge materials
- Share control material among laboratories
- Use simplified panels with a limited analyte range
- Use materials donated by PT providers
- Simplified matrix/photographs, dry challenges

- Wkgp 2 -- Subgp 4

- Feb 26, 2002

## FOR WHICH LABORATORY DISCIPLINES MIGHT SUCH APPROACHES BE UCCESSFUL? 

- All disciplines
- Microbiology smears, hematology smears, other tests that have a stable specimen
- Clinical chemistry (selected analytes), immunology/serology, antigen detection

- Wkgp 2 -- Subgp 4

- Feb 26, 2002

**Notes:**
2-4q1

## 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?

- Advantages and disadvantages of both
- Internal re-examination advantageous when specimen integrity may be compromised
- External re-examination depends on an established network
- Both can evaluate specimen preparation, internal provides more rapid information

- Wkgp 2 -- Subgp 5

- Feb 26, 2002

**Notes:**
2-4q2

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

- Internal re-examination has less cost for “experts” and test fees but increases local labor costs
- Remote location of a laboratory is a factor regarding shipping costs
- Internal process likely will require a greater number of re-examinations than external for the same level of confidence

- Wkgp 2 -- Subgp 5

- Feb 26, 2002

**Notes:**
2-4q2

## SUBGROUP  LEADERS AND RECORDERS

- María Castillo-de-Sánchez
- William Cooper
- Wayne Dimech
- Mauri Keinanen
- Dennis Jay

- Marinda Logan
- Adam Mansterski
- Bereneice Madison
- Steven Glenn
- William Schalla

- WORKGROUP 2

- Feb 26, 2002