2.6.1.Enrolments

The regulatory requirement for laboratories to be enrolled in external quality control is outlined in the NPAAC document, ‘Requirements for participation in External Quality Assessment (2009)’3. This is the only regulatory framework, that currently exists, within which the performance monitoring project may operate. It should be noted that the requirement is for laboratories and not individual pathologists.

S1.1 Laboratories must be enrolled, participate and demonstrate acceptable performance continually in appropriate external quality assessment programs.

C1.1 Submission of results must be in a timely manner.

S1.2 Participation must cover all test methods performed in the laboratory.

S1.3 The laboratory must review in a timely manner participation and performance, investigate any aberrant result(s), and document any corrective actions taken to allow assessment of performance.

S1.4 All laboratory staff involved in patient testing must participate in these quality assessment programs.

S4.1 Quality assessment program material must be treated in a manner similar to patient specimen process. Alternative quality assessment, such as virtual microscopy, must be carried out in a manner that is as close as possible to patient testing.

C4.1 It is not always possible to treat the quality assessment samples in exactly the same way as a patient sample e.g. morphology, histopathology quality assessment.

Current practice of what and how laboratories are enrolled in external quality assurance appears to vary substantially across Australia. Participants enrolling in the RCPA QAP can enrol as a laboratory participant or as an individual participant. Laboratory enrolment is a requirement for accreditation purposes. Individual enrolment has been seen to be a requirement by some organisations for review of individual competency or for education and interest by some pathologists, particularly in the specialist modules. There is widespread misperception that for the specialist modules (e.g. Breast module) enrolment may only be by individual enrolment. Currently:

• A laboratory enrols in a module but there are no individual enrolments.
• A laboratory enrols in a module and its pathologists also enrol individually.
• Pathologists enrol individually but there is no laboratory enrolment.
• A single pathologist laboratory in one instance may be enrolled as a laboratory enrolment but in another as an individual enrolment.
• A large laboratory with many pathologists enrols as a laboratory in the General module only.
• A large laboratory with many pathologists may enrol as a laboratory in the General module but pathologists enrol as individuals in one or more specialist modules.

Stakeholder feedback also indicates that how QAP surveys are performed in the laboratory is also variable. E.g.

• Pathologists review the QAP separately, each submitting their own answers. One pathologist would have the laboratory enrolment number.
• In a large laboratory QAP samples are distributed to different pathologists. Each pathologist only does 1 – 2 cases per year.
• A laboratory coordinator randomly distributes cases. A pathologist may not receive cases that they would ordinarily report.
• Small laboratories do all of the QAP even if they would not ordinarily report those cases on patients.
• Where there is a requirement by an organisation for pathologists to be enrolled individually, pathologists still get together to discuss cases and then submit a consensus answer.
• A laboratory submits a consensus answer.

Due to the inconsistencies in enrolment the implications for the performance monitoring project are as follows:

• Single pathologist laboratories are effectively undergoing individual assessment.
• Small laboratories with only a few pathologists are being compared with large laboratories.
• Those laboratories, which have been enrolled using only individual enrolments, are excluded from monitoring performance of external quality assurance.

This makes comparing performance across laboratories very difficult.