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Laboratory Accreditation

  • The Joint Commission began evaluating and accrediting hospital laboratory services in 1979 and freestanding laboratories in1995.
  • Accredits about 1,500 organizations that provide laboratory services, and these organizations represent nearly 2,000 laboratories with Clinical Laboratory Improvement Amendment certification.

Laboratories eligible for accreditation include:

  • Hospital laboratories
  • Reference and stand-alone laboratories
  • Point-of-care testing sites
  • In vitro fertilization (IVF) laboratories
  • Physician office laboratories
  • Ambulatory care laboratories
  • Anatomic pathology laboratories
  • Toxicology laboratories

Standards

Requirements for laboratory accreditation are contained in the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing. The standards emphasize the results a laboratory should achieve, not the specific methods of compliance, and were developed with input from professional laboratory organizations. In compliance with CLIA regulations, Joint Commission standards address processes that follow specimens through the laboratory from the time of collection to the time of result reporting, focusing on the provision of high quality, safe laboratory services.

Accreditation Process

The Joint Commission’s accreditation process concentrates on operational systems critical to the safety and quality of patient care. Surveys are conducted by Joint Commission-employed medical technologists. Surveyors must have a master’s degree, certification from the American Society for Clinical Pathology (ASCP), clinical work experience in three or more technical specialty areas of laboratory medicine, and five years of laboratory management experience. Full-time surveyors conduct up to 70 laboratory surveys annually. Pathologist surveyors are available by request.

Deemed Status

The Centers for Medicare & Medicaid Services (CMS) officially recognizes The Joint Commission Laboratory Accreditation program as meeting the requirements of CLIA. CLIA regulations require that all laboratories be surveyed on a two-year cycle. CLIA regulations also require an on-site survey or inspection by an approved agency such as The Joint Commission, for all tests of moderate or high complexity. The main categories of laboratory testing, as defined by CLIA regulation, are:

  • Waived tests – simple procedures with little chance of negative outcomes if performed inaccurately (surveyed only if nonwaived testing is being performed).
  • Moderately complex tests – more complex than waived tests but usually automated, such as blood counts or routine chemistry tests.
  • Provider-performed microscopy procedures (PPMP) – a subset of moderately complex tests performed by licensed mid-level providers or physicians.
  • Highly complex tests – usually non-automated or complicated tests requiring considerable clinical judgment, such as microbiology tests or cross-matching of blood.

Proficiency Testing

Joint Commission standards and CLIA regulations require that a laboratory be enrolled in a CMS-approved proficiency testing program for all regulated tests conducted by the laboratory. Annually, laboratories must report verification of annual enrollment in a proficiency testing program to The Joint Commission. CLIA requires that a laboratory’s proficiency testing results be monitored on an ongoing basis by The Joint Commission.

Cost of Accreditation

The on-site survey fee is paid at the end of the on-site survey and covers survey-related direct costs. The on-site survey fee starts at $2,500 for one surveyor per day. The additional annual fee, which is based on an organization’s volume and type of services provided, is due every January and covers Joint Commission accreditation-related services. The annual fee starts at $1,700 and increases based on the number of CLIA specialties, subspecialties, and locations for which testing is performed.

For More Information

  • Questions about The Joint Commission Laboratory Accreditation process and pricing, email us at .
  • Questions about unsuccessful proficiency testing and corrective plans of action: Eileen Stawczyk, Laboratory Specialist, 630-792-5248 or .
  • Joint Commission-accredited organizations: For questions about your organization’s accreditation, contact your assigned account executive at his or her extension or by calling 630-792-3007.

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