Accreditation Requirements for Medical Laboratory

The medical laboratory is the place where biological samples are analyzed for the purpose of screening, diagnosis, prognosis, treatment or prevention of diseases. Therefore a quality medical laboratory services are essential for patient care. This quality services should fulfill the needs of all patients and clinical personnel responsible for the care of such patients.

ISO: 15189:2007 standards explain the requirements need to establish a quality and competent medical laboratory. When a laboratory implements its requirements under ISO: 15189:2007 standards, the accreditation board gives formal recognition that the laboratory is competent to carry out specific task. The ISO: 15189:2007 standards consist of two main requirements; Management requirements and technical requirements.

Management requirements

A laboratory shall be legally identifiable and it shall meet the relevant requirements of International Standards when currying out routine laboratory practices. The responsibilities of personnel in the laboratory with involvement or influence on the examination of primary samples shall be defined in order to identify conflict of interest. Financial or political considerations should not influence the testing. The laboratory management shall have the responsibility for the design, implementation and maintenance of the quality management system and shall ensure that appropriate communication processes are established within the laboratory. To establish a quality management system; policies, process, programs, procedures and instructions shall be documented and communicated to all relevant personnel. The quality management system shall include the internal quality control as well as external quality assessment schemes. The laboratory shall have quality policy statement documented in quality manual. A quality manual shall describe the quality management system and structure of documentation used in the quality management system. All laboratory personnel shall be instructed on use and application of quality manual. The laboratory management regularly monitors and demonstrates the proper calibration and function of instruments, reagents and analytical systems.

Each document in the laboratory should be maintained according to the quality documentation where a copy of each document should be archived for future references and these documents should be approved by authorized personnel. They should be periodically reviewed and revised. The invalid and suppressed documents should be promptly removed from all points of use. At regular intervals, the laboratory must review any contract to provide services to ensure that it can meet the contractual requirements. The records of reviews shall be maintained. The laboratory shall have an effective documented procedure for evaluating and selecting referral laboratories and consultants. The referral laboratory shall be reviewed periodically to ensure that it operates under an accredited quality system. The laboratory shall maintain register of all referral laboratories it uses and register of all tests referred and results reported. The laboratory management shall define and document its policies and procedures for selection and use of purchased external services, equipment and consumable supplies. The purchased equipment and consumable supplies shall not be used until they have been verified by examining quality control samples and the regents, supplies and services affecting the quality of examination shall be evaluated and recorded. The laboratory shall have policy and procedure for the resolution of complains or other feedback received from clients.

If a non-conformance is identified, the testing must be stopped and the result must be hold until it is resolved. Results reported during the critical natured non-conformance should be retested. Non-conformance must be recorded the root cause of them should be investigated as well as corrective actions should be taken and documented. If preventive action is required, action plan shall be developed, implemented and monitored to reduce of the non-conformances. The laboratory shall monitor the effectiveness of the corrective and preventive action and shall ensure the appropriate areas of activity are audited according to ISO standards. All laboratory procedures shall be systematically reviewed by laboratory management at regular intervals. A quality indicator shall be implemented to systematically monitoring and evaluating the laboratory’s contribution to the patient care. The laboratory management shall provide access to suitable educational and training opportunities for all laboratory personnel and relevant users of laboratory services. The laboratory shall establish and implement procedures for identification, collection, indexing, access, storage, maintenance and safe disposal of quality and technical records. The main elements of the quality management system should normally be subjected to internal audit annually. The internal audit shall be formally organized and carried out by quality manager or qualified laboratory personnel. The laboratory management must review the quality management system and all of it medical services at regular intervals usually annually but if the quality management system is being established, the intervals between reviews should be shorten.

Technical requirements

The laboratory management shall have an organizational plan, personnel policies and job descriptions that define qualifications and duties for all personnel. The responsibility of the laboratory director shall include professional, scientific, consultative or advisory organizational, administrative and educational matters. There shall be adequate staff to undertake the routine laboratory work and there shall be a continuing educational program to all staff. The competency of each person shall be accessed periodically. The laboratory shall have space allocated and monitor, control and record environmental condition where they may influence the quality of result. Work area shall be clean and well maintained. The laboratory shall be furnished with all equipment required for provision of services. They should be operated by authorized personnel only and maintained in a safe working condition. Records should be maintained for equipment.  Specific instructions for proper collection and handling of primary samples shall be documented and implemented by laboratory management. These instructions shall be contained in a specimen collection manual which shall be a part of document control system. All received primary samples shall be recorded in an accession book. Criteria shall be developed for acceptance or rejection of these samples. All examination procedures shall be documented and be available at the workstation for relevant staff in a language commonly understood. The laboratory management shall have the responsible for formatting reports which shall indicate the quality of primary sample received. The results shall be legible without mistakes in transcription and reported to persons authorized receive. Copies of reported results shall be retained by the laboratory.

References

Medical laboratories-Particular requirements for quality and competence; SLS ISO 15189: 2007; Sri Lanka Standards institution.