Accreditation is the procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. In the laboratory, whilst accreditation is no guarantee of acceptable performance at every level, it does serves as confirmation that a laboratory is performing to a given set of standards and provides assurance to the users of the laboratory’s commitment to quality.
As part of the Modernisation of Pathology Strategy, the Department of Health in England requires that all medical laboratories enrol with an accreditation programme. This is as has been recommended by the latest Carter report. All UK laboratories, including those in the independent and private sector, are now required to be registered with the Care Quality Commission (CQC) who are the new regulators of all Health and Social services. The CQC are working with Clinical Pathology Accreditation (CPA) who currently accredits medical labotarories in the UK.
Accreditation of Histocompatibility and Immunogenetics laboratories in the UK usually means accreditation by both CPA and by the European Federation for Immunogenetics (EFI). CPA ltd. is a ‘not-for-profit’ organisation, whose main shareholders are the major pathology professional bodies, including the Royal College of Pathologists. CPA assesses pathology laboratories against the ‘CPA standard for the medical laboratory’ which incorporates ISO 15189. CPA is in turn owned by United Kingdom Accreditation Services (UKAS) which is the sole National Accreditation Body for the UK under EU regulations and carries out accreditation activities beyond the medical laboratory including in business. Whilst CPA is UK based, EFI is pan European (and beyond). The aims of EFI include the development of Histocompatibility and Immunogenetics in Europe as a discipline of medicine and the development of standards of techniques, quality control and criteria for accreditation in the provision of Histocompatibility and Immunogenetics services. Stem cell transplant services who seek accreditation to Joint Accreditation Committee of the ISCT & EBMT (JACIE) standards must use an EFI accredited H&I laboratory for their H&I services.
The benefits of accreditation by CPA or EFI include helping to ensure staff are fully trained and supported to carry out all activities for the services offered by the laboratory, helping to ensure that procedures are in place and are followed, helping to ensure good documentation of all processes and procedures and helping to ensure a continuous cycle of improvement in the services offered.
To become accredited by CPA or EFI, a laboratory must be able to demonstrate compliance with the standards published by those accreditation bodies. The processes involved in attaining laboratory accreditation in Histocompatibility and Immunogenetics include gathering of information, preparing and submitting the application including payment of any fees, preparing for and undergoing an the inspection, receiving the report and putting in place any corrective actions identified and receiving the accreditation.
The first process is to gather the relevant information required for accreditation. This includes information on the laboratory, its personnel, test repertoire and workload, evidence of participation in external quality assurance (EQA) schemes, information on Policies and SOPs and evidence of having undertaken internal audits. Laboratory information includes its address and contact numbers and its relationship to any parent organisation. Information on personnel includes covers non technical and technical staff, including the Director of the laboratory and may be presented as an organogram showing the levels of staff within the laboratory. Details required on Personnel include qualifications, duties and responsibilities. For senior staff a CV may be required. Evidence of participation of staff in continued professional development (CPD) may also be required. Information that should be gathered also includes the types of services provided by the laboratory, its test repertoire and annual workload. This may need to be presented both as number of requests for various investigations as well as number of actual tests. In addition, evidence will be needed on the laboratories participation in external quality assurance (EQA) schemes covering all services offered by the laboratory. The evidence will constitute results obtained in EQA schemes and evidence that completion of the tests is rotated between staff. Accreditation will require proof that the laboratory has documented its processes in standard operating procedures (SOPs) and will require that a master list of SOPs be provided on application. Some SOPs may also need to be provided on application for accreditation. Another key piece of information which will need to be gathered for accreditation is evidence of participation in a program of internal audits.
Once all the required information is gathered, the next process is the completion of the application form. CPA has a dedicated ‘Application for Accreditation’ form that needs to be filled. A new application form is submitted every four years. EFI have a ‘Packet A’ form for first time accreditation application, a ‘Packet B’ for self inspection at the end of years 1 and 2 for an accredited laboratory and ‘Packet C’ for re-inspection in the third year. Several additional documents need to be provided with the application. For CPA, this includes the Quality Manual. For EFI, this includes copies of CV’s for senior staff, evidence of participation in CPD, lists of SOPs and copies of SOPs used for internal quality control, print outs from analysers, copies of laboratory worksheets and reports and printouts of some computer screens.
Once an application is processed and accepted, an inspection is scheduled. CPA use two UK based inspectors. One is a professional inspector and the other is a specialist inspector who must be a senior scientist working in the H& field. EFI also use two inspectors but both are scientists working in the H&I field. One is from the same country as the laboratory being inspected and the other is from a laboratory in a different country which has a similar test repertoire to the laboratory being inspected. CPA and EFI inspect to their own standards. The CPA standards have a number of clauses which ‘Shall’ be complied with, meaning they are mandatory and a number of clauses which ‘Should’ be complied with which means they are non mandatory recommendations. The EFI standards have a number of clauses which ‘Must’ be complied with, meaning they are mandatory and a number of clauses which ‘Should’ be complied with which means they are non mandatory recommendations. The inspection starts with an opening meeting in which the schedule of the inspection is discussed. Key personnel such as the Director and quality manager or deputies must be present for the inspection. The inspection reviews laboratory practices and does include questioning of laboratory staff about the laboratory processes. CPA inspection includes meetings with senior management of the parent organisation of the laboratory as well as meetings with clinical user groups.
The inspection concludes with a closing meeting in which the inspectors present key findings to the senior laboratory staff. There is an opportunity to discuss these findings in this meeting and some items may be closed as a result of the meeting.
The next process is for the inspectors to prepare a report for the accrediting body. The report includes general comments on the inspection together with a list of non conformances with mandatory requirements and observations as well as in the case of EFI, suggested corrective actions. CPA has two categories of non conformances, critical for systematic non conformances and non critical for other non conformances. Where non conformances are raised, the applicant would be given time to correct them. This would require evidence of corrective action to be submitted. Depending on the nature of the non conformance, a re-inspection may be required. If there are no corrective actions required or where the corrective actions have been completed, accreditation can be granted. The nature of the accreditation granted could be full accreditation, provisional accreditation, awaiting accreditation or accreditation withheld. EFI may grant accreditation but with reduced categories than were either applied for or was previously held.
CPA and EFI have large areas of similarities in their accreditation requirements but do also have significant differences which reflect the heritage of the two bodies. CPA accreditation standards are generic and can be applied to all UK pathology laboratories irrespective of discipline. CPA accreditation is based on a Quality Management Systems centred approach which does not set standards for individual tests and techniques. A Quality Management System is a set of interrelated and interacting elements that organisations can use to direct and control how quality policies are implemented and quality objectives are achieved. A good quality management system helps organisations to consistently meet the needs and requirements of their users. EFI accreditation standards are however very specific for H&I laboratories. Like CPA accreditation, EFI accreditation does also require most elements of a good quality management system, with requirements for personnel, facilities, quality assurance, handling of process and quality records and use of SOPs. Unlike CPA, however, EFI accreditation does include H&I specific service and technical requirements.
Both schemes require that the laboratory be directed by a qualified individual who takes responsibility for the clinical, scientific, consultative, advisory, organisational, administrative and educational activities of the laboratory. However whilst CPA are not prescriptive about the qualifications of the laboratory Director, EFI do require the person to hold a PhD, MD or equivalent and have 4 or 5 year laboratory experience two of which must have been in H&I. Both schemes similarly require that the laboratory be sufficiently staffed for the services provided. Again EFI is prescriptive in requiring supervisors to have a minimum qualification of BSc or equivalent plus three to five years experience.
Both CPA and EFI have similarities in the quality management system needs of their accreditation requirements. Both require that the premises are adequate for the activities undertaken, with sufficient storage of material, reagents and documents and that there be adequate separation of incompatible activities. EFI specifically mentions pre and post PCR activities in this regard. Both schemes require that laboratory procedures be documented in SOPs and that personnel are trained against those SOPs before undertaking any of those activities. Both schemes require that process and quality records are collected and stored and that result reports are controlled and stored securely. Both schemes are similar in requiring that laboratories participate in external proficiency testing programmes.
Both CPA and EFI have similarities in accreditation requirements for specimen handling and labelling pre test, for quality control during testing and for handling of results and reports post testing. EFI has specific requirements for the actual tests used and how the results are reported. In addition, both CPA and EFI require that the needs of the users be taken into account and that processes are in place that allow for continuous evaluation and improvement.
The key difference between the accreditation requirements of CPA and EFI is the emphasis CPA places on the quality management system itself versus the emphasis EFI places on standards for services and techniques. CPA uses a system of vertical, horizontal and examination audits to assess compliance with these quality management system requirements without being prescription about the techniques. EFI on the other hand defines standards for the various services offered by H&I laboratories including organ transplantation, haematopoietic progenitor cell transplantation, disease association and transfusion as well as for various techniques including serological and DNA based typing, antibody screening and identification and crossmatching. These service and techniques are not covered by CPA accreditation requirements.
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