Laboratory accreditation and inspection

Clin Lab Med. 2007 Dec;27(4):845-58, vii. doi: 10.1016/j.cll.2007.07.012.

Abstract

Clinical laboratories perform diagnostic testing in a highly regulated environment in which federal, state, and private accreditation agencies monitor the quality of testing processes. These agencies vary in the focus and stringency of their requirements, and differences exist among states. Continued accreditation requires regular inspection to assure quality of test results for physicians, insurers, and, ultimately, the patients being tested. Preparation for inspection requires understanding of the unique accreditation requirements for each institution, establishment of quality assurance and quality improvement oversight, and communication of each staff member's role in delivering quality test results for patient care.

MeSH terms

  • Accreditation*
  • Clinical Laboratory Techniques
  • Diagnostic Tests, Routine / standards*
  • Humans
  • Laboratories, Hospital / legislation & jurisprudence
  • Laboratories, Hospital / standards*
  • Medicaid
  • Medicare
  • Pathology, Clinical / legislation & jurisprudence
  • Pathology, Clinical / standards*
  • Quality Assurance, Health Care
  • United States