# Presentation: 485430

## Global Odyssey 2002Advances in PT/EQA for Clinical Microbiology 

- Michael A. Noble MD FRCPC
- Chair, Clinical Microbiology Proficiency Testing program,
- University of British Columbia, Vancouver Canada
- and
- Centers for Disease Control and Prevention, Division of Laboratory Systems
- Atlanta Georgia USA

## 3rd Workshop on Proficiency Testing in Analytical Chemistry,  Microbiology and Laboratory Medicine

**(24), 25 - 26, (27) September 2000, Boras/Gothenburg, Sweden**

## Microbiological proficiency testing:

- A personal perspective.
- Keith Jewell
**What makes microbiology different**
- 1: 	Microbiology samples are fundamentally 	non-uniform.
- 2: 	Microbiological taxonomy is fundamentally 	imprecise.
- 3: 	Microbiological samples are changing.
- 4: 	Traditional microbiological analysis 	depends upon behavior, not constitution.
- 5: 	Microbiology has many “right” answers.

- Accreditation and Quality Assurance
- V6 N4-5 2001
- 154-159

## Concerns expressed:

**Concerns expressed:**
- PT too concerned with procedures to recognize causative agents or correct identification rather than meaningful information.
- PT specimens did not represent reality.
- Pt ...not concerned enough with constructive approaches

## Advances in Microbiology PT/EQA

- Clinical realism
- Clinical relevancy
- Variety of challenge styles
-  New challenge targets

## ISO Guide 43-1

*As far as possible, provide clinically relevant challenges that mimic patient samples and check the entire examination process...*

- Similar text or concept found in:
- Clinical Laboratory Improvement Act: 1988
- WHO Requirements and Guidance for EQA

## PT/EQA

*PT/EQA*
*Specimens*
*Can be*
*Realistic*

## Clinically Realistic

- PT/EQA Microscopy

## Slide 9

## The Laboratory Cycle

- The Patient

- Report Interpretation

- Report Creation

- Report Transportation

- Test Selection

- Sample Collection

- Sample Transportation

- Traditional Microbiology PT

**Analysis**

**Accession**

## The Laboratory Cycle

- Report Interpretation

- Report Creation

- Report Transportation

- Test Selection

- Sample Collection

- Sample Transportation

- Achievable Microbiology EQA

**Analysis**

**Accession**

## Clinical Relevancy Reporting 

**Smear from male urethra**
**Gram: ****neutrophils and**
**	****	*****H. influenzae***
**Culture: *****H. influenzae***

- Challenge Results

| No N. gonorrhoeae | 55% |
| --- | --- |
| No N. gonorrhoeae; H. influenzae  | 28% |
| H. influenzae | 15% |
| Other | 2% |

- CMPT M013-3 November 2001

## Clinical Relevancy in Susceptibility Challenges

- 	Cephalosporin reporting and gram negative meningitis
- Do not report 1st generation agents
- 		M21-3: 2000  -  73/131 (55.7%)
- 		M011-2: 2001 - 85/141 (60.2%)
- Do report 3rd generation agents
- 		M21-3: 2000  -  36/131   (27.5%)
- 		M011-2: 2001 - 112/141 (79.4%)
-  CMPT, Department of Pathology and Laboratory Medicine, UBC

## Paper Challenge of Accessioning Practices

- A nasal swab is submitted to the laboratory with clinical information “possible anthrax”.  No other information provided.  What action would your laboratory undertake with this sample?

| A | Set-up and Culture.Read at 24 hours.   | 22% |
| --- | --- | --- |
| B | Do not process.  Destroy swab.  Report: “Do not perform this test”. | 0% |
| C | Do not process.  Contact physician. | 34% |
| D | Do not process. Seal for public health.  Contact Public Health. | 78% |

- CMPT M013; November 2001

## EQA of Packaging for Transportation of Infectious Agents

- Laboratories asked to submit a viable culture of *Escherichia coli* to the CMPT laboratory.
- Packaging assessed against prevailing Canadian regulations for domestic transport
- Education provided for those not in compliance with requirements.

## EQA of Packaging for Transportation of Infectious Agents

- Packaging over requirements:	19 (13.8%)
- Packaging acceptable		113 (81.6%)
- Packaging under requirements	6 (4.6%)

**RESULTS**

***Note: results affirmed by conjoint blinded study***

## PT/EQA of HIV testing

- CDC
- Human T-lymphotropic virus I and II antibodies
- T-lymphocyte immunophenotyping  by flow cytometry
- HIV-1 ribonucleic acid  determinations  (viral load)
- HIV-1 p24 antigen testing
- Acrometrix, US
- HIV-1 Resistance Proficiency Program

## Advances in Microbiology PT/EQA2002 and beyond

- More extensive challenges throughout the laboratory cycle.
- More thorough examination of issues that are critically important:
- Integrity of sample
- Appropriateness of investigation
- Clinical quality of reports
- Turn-around time
- PT/EQA for point of care testing

## The future of  Microbiology PT/EQA

- Continuation of current trends
- 		Antiviral susceptibility
- 		Antifungal susceptibility

- Application of nucleic acid technologies
- 	Bacterial identification
- 	Bacterial susceptibility testing

- Point-of-care Testing
- 	Antigen detection
- 	Antibody detection
- 	Gene product detection

## In Summary

- Traditional assessment has laid a solid foundation for external assessment.
- Advances in making EQA less artificial and introduced a sense of clinical realism and relevancy.