An industry Study Day at Girton College, Cambridge, staged by Tutela Medical, revealed that moves are being made towards the common assessment of temperature monitoring, audits, quality management systems and both documents and controls.
The speaker, Gwen Guthrie, regional assessment manager of CPA (UK), said that areas of common assessment included validation and verification, calibration, assuring quality and the retention and archiving of records, clinical material, data and information. Mrs. Guthrie said that the CPA started in 1992 with its own standards and, in 2003, ISO 15189 was adopted, it having been based on CPA standards for clinical laboratories. These were revised five years later when CPA moved under the umbrella of the UK Accreditation Service (UKAS). CPA standards are now divided into eight sections which are subdivided into 149 clauses. They cover organisation and quality management systems, personnel, premises and environment, equipment, information systems and materials, both pre-examination phase, evaluation and quality assurance. The essence of the CPA standards, was to objectively assess whether the clinical laboratory provides a service which responds to the needs and requirements of its users. Is safe, fit for purpose and commits to an on-going cycle of improvement through self evaluation and audit? “Major themes for assessment are the quality management system, document control, audit and evaluation, record keeping, chain of custody and the integrity of analytical and measuring systems,” said Mrs Guthrie. Stressing that CPA assessors sought evidence – whether written, verbal, witnessed, recorded or anecdotal – Mrs Guthrie said guiding legislation included the European Working Time Regulations, the European Blood Directive and health and safety rules. Added to these were guidelines for the RCPath staffing of pathology laboratories, skills mix, blood transfusion collaborations and andrology guidelines. “We are looking at amalgamating some systems. There will be increasing pressure to look at rationalising matters as in some areas the same assessors are being used. We will have a common purpose to establish and maintain a safe and responsive service,” she concluded.
