Clinical and laboratory standards exist to ensure the quality of laboratory testing procedures and clinical diagnostics in health care. Laboratory testing regulatory bodies seek to ensure that diagnostic tests and procedures are performed based on current evidence supported by trusted research bodies like the Centers for Disease Control and Prevention, as well as expert peer review by large pools of volunteer medical professionals. Clinical and laboratory standards in health care help to guarantee that patients receive the best in laboratory testing and diagnostic treatment, thereby optimizing their quality of medical care and, ultimately, their overall health and well-being.
Multiple regulatory bodies oversee the quality of laboratory and clinical testing. Many of them exist on a state or national level throughout the country and the world; hospitals and research institutes may also have their own private quality assurance teams. One of the largest regulatory bodies overseeing clinical and laboratory standards is the Clinical and Laboratory Standards Institute, or CLSI. Since its incorporation in 1968, it has earned accreditation from the American National Standards Institute, and contracts from the National Institutes of Health, the National Institute for Allergies and Infectious Diseases, and the World Health Organization. More than 1,900 clinical laboratories in 70 countries around the world belong to CLSI. More than 30 international lab and clinical standards regulatory bodies belong to CLSI, including:
- The Chinese Committee for Clinical Laboratory Standards
- The Ministry of Health and Social Welfare — Tanzania
- The Brazilian Society of Clinical Analysis
- The European Society of Clinical Microbiology and Infectious Diseases
- National Health Laboratory Services — South Africa
CLSI provides its members with some of the most respected current research and guidelines regarding laboratory and clinical standards.
Clinical and laboratory standards regulatory bodies audit clinics using a number of quality management assessment processes. Peer reviews by groups of established professionals allow regulatory bodies to determine the quality of clinic services, including general patient care, continuity of care, quality of health maintenance, diligence in keeping medical records, and so on. Access surveys allow regulatory bodies to understand patients’ ease of access to clinical health services. Patient surveys seek to collect assessment data on several aspects of a clinic’s functioning, including wait times; ease of access; quality of care from doctors, nurses, and other employees; treatment of confidential health information; level of facility maintenance and ease of access to the facility.
Access audits and quality assurance audits are generally performed by reviewers affiliated with the CLSI or another accredited regulatory body. They collect data from individual clinics and laboratories, analyzing it not just for quality of care in these clinics, but also for across-the-board trends in the quality of clinical and diagnostic health care. Audits are crucial for maintaining high standards for ease of access, quality of facilities and quality of care; they also help individual clinics and diagnostic providers learn how they might better serve their patient communities.
Issues addressed on a quality assurance audit include the efficiency of patient appointment and staff scheduling; the length of weight times for standard and emergency appointments; the cleanliness of medical equipment and treatment areas, as well as laboratory diagnostic facilities; secure storage of controlled substances; access to emergency medical services from the clinic; and respect for the privacy of the clinic’s patients. Clinical and laboratory standards audits even look at the ease of finding the clinic, to ensure the best possible ease of access for patients. By examining all aspects of a clinic’s functioning, from the organization of the waiting room to the sanitation practices of the staff, laboratory and clinical standards auditors hope to secure the best in health care for all those served by a clinic or diagnostic lab.
- The Centers for Medicare & Medicaid Services (CMS) regulates US laboratory testing via the Clinical Laboratory Improvement Amendments (CLIA)
- Quality control highlights from the CMS
- “Clinical Laboratory Standard Setting,” a presentation by Sue Richards, PhD, FACMG, Professor of Medical and Molecular Genetics at OHSU
- Community Clinics Health Network, Council of Community Clinics, San Diego, CA, database of quality management documents
- Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories, recommendations by a CDC Biosafety Blue Ribbon Panel
- DAIDS Guidelines for Good Clinical Laboratory Practice Standards