Point of care testing: regulation and accreditation.Clin Lab Sci. 1996 Sep-Oct; 9(5):298-302; quiz 303-4.CL
To provide an overview of point of care testing (POCT) regulatory and accrediting agencies and their requirements.
Current literature and the author's experience.
To develop and successfully run a POCT program that meets the federally mandated standards evaluated by accrediting agencies with Health Care Financing Administration (HCFA) status, requires that participants are aware of CLIA '88 requirements. Joint Commission on Accreditation of Healthcare Organizations (JCAHO), College of American Pathologists (CAP) and Commission on Office Laboratory Accreditation (CQLA) are the 3 principal organizations currently inspecting and accrediting POCT programs. They have included all CLIA '88 requirements on their inspection checklists. This paper covers requirements of JCAHO and CAP. In order to successfully meet the accreditation requirements of HFCA and their deeming agencies, JCAHO and CAP, these issues must be addressed: direction and supervision of the program, procedures performed, proficiency testing, quality assurance, quality control, procedure manuals, specimen handling, results reporting, reagents, calibration and standards, instrument selection and maintenance, personnel training and competence, and safety.
CLIA '88 states that all testing is site neutral, therefore the same regulations apply regardless of where the test is performed. All POCT programs must apply for a CLIA certificate and choose an appropriate accreditation agency for their needs. All accreditation agencies must follow the requirements listed in the federal register; some agencies are more stringent than others.