ACCREDITATION STATUS:

Exploratory Pilot EQA – not accredited.

CLINICAL APPLICATION:

Non-invasive prenatal testing for aneuploidies.

PURPOSE OF PROGRAMME:

To establish the analytical and interpretative capabilities of the participating laboratory.

ANALYTES:

PROGRAMME OF ANALYSIS:

DNA samples are sent to the laboratory, together with a case scenario to mimic a routine diagnostic case.  and a user guide are available on the website. The scheme is not prescriptive as to the technique used provided the limitations of the test used are stated in the report (ISO15189). The participant analyses the sample, interprets the results and reports via the CEQAS website. The EQA is open for 4 weeks. Results 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 Rapid Prenatal Specialist Advisory Group.

PERFORMANCE SCORING:

Pilot EQA – no performance designation.

PERFORMANCE MONITORING:

Pilot EQA – no performance designation.