ACCREDITATION STATUS:

Accredited UKAS 7872.

CLINICAL APPLICATION:

Prenatal Genetic Diagnosis - FISH analysis.

PURPOSE OF PROGRAMME:

To establish the cytogenetic analytical and interpretative capabilities of the participating laboratory specific to the testing of Blastomere samples.

ANALYTES:

PROGRAMME OF ANALYSIS:

The EQA consists of two parts: Part 1 involves a work-up for two cases given the clinical information and the referral information on the genetic abnormality; For part 1 all laboratories are expected to explain their probe strategy. Part 2 involves the online analysis of the blastomeres from IVF embryos of these patients. Participants report their findings for part 1 and 2 online. Both parts are open for four weeks each with a short break between the closing of part 1 and the availability of the part 2 images. Results for the relevant part can be entered at any time during this period. Any non-submitting labs will be contacted and given 24 hours to submit a late result.

DATA ANALYSIS:

All EQA cases are validated prior to release.  Results are assessed by a panel of experts against set marking criteria based upon professional guidelines. There are three marking categories, Analytical, Interpretation and Clerical Accuracy. Each category carries two points. Deductions are made in accordance with the severity of the omission.  A “critical error” is an error made in either the analytical or interpretive category that could lead to serious clinical consequences or imply a significant lack of diagnostic skill or scientific knowledge on the part of the participating laboratory. All critical errors are given a zero score and are designated as poor performance.  A critical error in one category may result in the remaining categories being left unmarked. Any poor performance is ratified by the PGD Specialist Advisory Group.

PERFORMANCE SCORING:

Satisfactory/Poor. A non-submission is also given a poor performance.

PERFORMANCE MONITORING:

Yes.

PERSISTENT POOR PERFORMANCE:

This is defined as:

1. a) Two poor performances in any PGD Blastomere FISH EQA in which the laboratory participates, over three or more distributions of material, within a 36 month rolling period;
2. b) A poor performance within one year following a previous persistent poor performance designation.