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Quality Control in a BioMedical Laboratory |
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Pathology Department Accreditation In the past decade, there is a movement towards the accreditation of medical testing laboratories worldwide. In the UK, pathology department accreditation is carried out by an independent non-profit making company known as CPA (Clinical Pathology Accreditation) which is jointly owned by several bodies including the Royal College of Pathologists. There are similar bodies for laboratory accreditation in other countries such as the that operated by the Colloege of American Pathologists in the US and NATA in Australia. In the past, the standards of these accreditation bodies varied. There is now a trend towards accepting ISO 15189 as the standard for all accreditation bodies in order to provide uniformity of standards and cross-recognition. Accreditation is an external audit of an applicant department’s organization and quality assurance program. The CPA defines standards for organization and performance of clinical pathology. Applicant departments assess themselves against those standards and fill in a form to indicate compliance with or, exemption from them and send this, together with details of their facilities and repertoire to CPA. At this stage, provisional accreditation is awarded if all seems to be in order. Some time later, the department is subjected to an on-site inspection. If all seems to be well, full accreditation is granted at this stage. Should the inspectors identify problems, full accreditation is withheld until the problems have been solved to the satisfaction of the CPA. If that is not achieved within a reasonable time, provisional accreditation lapses. The refusal of accreditation may be appealed by the applicant department, the CPA board’s decision will be binding. Fully and provisionally accredited departments will be put on the CPA register. Those with full accreditation will be reinspected at regular intervals, probably every 4 years. CPA inspectors will usually visit each department in pairs, each team consisting of a consultant or clinical scientist and a senior MLSO. This means that for an "average" NHS hospital with four pathology departments, eight inspectors will visit for one full day. In addition to on-site inspection of the laboratory, service users and hospital managers will be interviewed.
Standards of the UK CPA There are 44 standards grouped under 6 headings, most of which are applicable to all pathology departments. A. Organization and Administration There is a document to describe the organization and appropriate overall scope of the laboratory service and a documented line of managerial accountability. There are formal meetings between senior laboratory staff and management to review the service, set objectives and make financial arrangements B. Staffing and Direction Each discipline is directed by a consultant pathologist or clinical scientist there are appropriate numbers of staff with the required training. There is a documented line of accountability for all staff to the head of department - all unqualified staff must be supervised. Job descriptions must be available for all staff and all staff must have a contract of employment Regular staff meetings should be held and all new staff are given a comprehensive induction program C. Facilities and Equipment There are a total of 10 standards under this heading. This include appropriate laboratory and office space, staff facilities, space for specimen reception and handling and specimen storage. There should be adequate lighting, heating, ventilation, gas and water drainage. A safe working environment must be available for which he safety officer is responsible. There are appropriate data storage, retrieval and communication facilities. There is appropriate properly maintained scientific equipment that should be properly maintained. D. Policies and Protocols There should be a user manual to help clinicians to provide the right sample, to use the service to the best effect and what help and advice is available. Laboratory forms should include unique patient identity and supporting information. Reports should be accurate, comprehensive and clinically relevant and should include adequate patient identity, time and date of collection, testing and reporting. A written record of all reagents, calibration and quality control material. There must be written protocols for the performance of each test including the appropriate preparation of equipment, sample reagents, calculation of results and interpretation of internal quality control performance. There is a written protocol for the normal reporting and oral reporting of results. There should also be protocols for the regular maintenance as well as the decontamination of all items of equipment and working space. A policy describing any out of hours service must be instituted. In hospitals, a nominated consultant microbiologists is responsible for institutional infection control. E. Staff Development and Education There is a written program of training for all members of staff, appropriately sited facilities, resources and facilities to attend external seminars, meetings and conferences, and a continuing education program. In addition there should be an established staff appraisal scheme. F. Evaluation The department must participate in all appropriate external quality assessment programs which should be widely publicized in the department. Clinical audit of the service should be continually carried and senior staff should regularly participate in the audit activities of other clinical specialties. |
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