IBTS DIAG GDE 0001 - Irish Blood Transfusion Service

IBTS/DIAG/GDE/0001 Ver. 2 Page 18 of 417.0 EXTERNAL AND INTERNAL QUALITY ASSESSMENT PROGRAMMES7.1 External Quality Assessment Programmes ( EQA)The Laboratories participate in relevant available external third party assessment schemes.This includes schemes operated by:-NEQAS (UK National External Quality Assurance Scheme) for Blood Transfusion LaboratoryPractice (NBC/ MRTC)UK AQQAS Scheme for Anti-D/c quantification (NBC)Lab Quality (Finnish External Quality Assurance Scheme) (NBC/MRTC)External proficiency testing is performed by all staff working in the diagnostics / compatibilitylaboratories on an annual frequencyThe laboratories are committed to participating in other schemes as they become available and arerequired to ensure comprehensive assessment of the test repertoire.7.2 Internal Quality Assessment Programmes.The IBTS diagnostic /compatibility laboratories are part of the IBTS quality management system,which is covered by GMP (Good Manufacturing Practice) and is regularly inspected by the IMB(Irish Medicines Board), the Blood Establishment Licensing Authority. The IBTS BloodEstablishment is licensed under BE Number 0002Internal controls are included in all tests: no tests can be accepted or reported unless controlresults are acceptable.All test procedures are covered by Standard Operating Procedures and only trained andauthorised staff may perform procedures. Staff competency is also assured before a staff membermay perform a procedure. All procedures are regularly reviewed.7.3 Outcome of a Major Non-ConformanceWhere the diagnostics laboratories may fail an external EQA scheme, or where internal systemsmay have failed resulting in a major non conformance, all users of the service will be informedofficially.Major non-conformances are managed by controlled procedures with investigation, correctiveand preventative actions and review of practices, taken as appropriate. The diagnosticslaboratories (MRTC/NBC) may be audited at any time provided that the director of quality andcompliance and the directors of the laboratories are notified in advance and that the time is agreedby all parties.