Follow-up studies of cases identified through laboratory diagnostics provide additional epidemiological data, including information on possible sources of the infection and on whether the cases are sporadic or associated with other cases. However, laboratory-based surveillance is dependent on an infrastructure of competent laboratories that provide routine diagnostic services, and often it also requires a central reference laboratory that can confirm the identity of unusual isolates and provide quality assurance. The regular reporting of the isolation of specific pathogens provides an important source of surveillance data. Notermans, in Encyclopedia of Food Microbiology (Second Edition), 2014 Surveillance of Foodborne InfectionsĬlinical laboratories routinely identify pathogenic organisms that may be foodborne by testing clinical specimens, such as blood or stool, from patients. Requirements can vary depending on the state in which the personnel practice and their discipline such as transfusion medicine which has additional requirements.ī. The most common organization providing certification for testing personnel is the American Society of Clinical Pathology (ASCP). There are no personnel requirements for waived testing however, there are very specific requirements for labs performing moderate or high complexity testing. These qualifications are based on the level of testing complexity performed. Qualifications are specified for personnel, including the Lab director, technical consultant, clinical consultant, and testing personnel. Their inspection typically use a tracer process which follows a laboratory test through the process of collection, transport, testing, and observing the integration of laboratory processes throughout the hospital. Although a hospital laboratory is inspected by the CAP, the hospital inspection by TJC can involve the laboratory.
TJC accredits hospitals and usually performs an unannounced inspection every 3 years. CAP inspection process surveys all areas of the laboratory and is a peer review process. In order to assess laboratories compliance with these regulations laboratories must be inspected every 2 years by either CMS or an organization approved by CMS most commonly CAP or The Joint Commission (TJC). These laboratories receive no routine inspections although a small percentage will be subjected to a random inspection to assure quality.Īll laboratories that perform moderate or high complexity testing must meet certain standards for proficiency testing (PT), QC, quality assurance (QA), and personnel qualifications. Laboratories that only perform waived testing are eligible for a certificate of waiver under CLIA. Complexity varies from waived testing which includes rapid strep and other antigen testing to moderate complex tests for example the Gram stain and urine culture to high complexity tests which includes most other testing in the microbiology laboratory. The requirements vary depending on the complexity of testing performed by the laboratory. The CLIA’88 Law, in effect since 1992, requires all clinical laboratories doing testing on human specimens to be certified by CMS. Amitava Dasgupta, in Microbiology and Molecular Diagnosis in Pathology, 2017 Clinical Laboratory Improvement Amendments/College of American Pathologists and Clinical LaboratoriesĬlinical laboratories are regulated by Center for Medicare and Medicaid Services (CMS) through the CLIA, whose objective is to assure a standard of quality in laboratory testing. Only liquid and gas-chromatography mass spectrometry are discussed in this chapter.Īudrey Wanger. We also discuss proposals for new FDA regulations regarding laboratory-developed tests (LDTs) that may have dramatic impact on clinical laboratories that utilize mass spectrometry. Here we review multiple guidelines and sources of information regarding this process: from federal requirements of the Clinical Laboratory Improvement Act (CLIA), accreditation requirements of the College of American Pathologists (CAP), Food and Drug Administration (FDA) guidance related to the pharmaceutical industry, and recommendations/reviews from the literature.
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Careful attention must therefore be given to both regulatory requirements and standards of professional practice regarding the validation, quality control, and competency/compliance aspects of offering, such assays.
Garg, in Mass Spectrometry for the Clinical Laboratory, 2017 AbstractĬlinical laboratory assays using mass spectrometry are invariably developed in-house.