Which Laboratories Are Eligible for a JCI Accreditation Survey for ISO 15189:2022
Any laboratory may apply for this Joint Commission International (JCI) accreditation if it meets all the following criteria:
- The laboratory is located outside of the United States and its territories.
- If required by law, the laboratory has a facility license or registration to conduct its scope of services.
- The laboratory provides services addressed by the current JCI accreditation standards for laboratories.
- The laboratory accurately identifies in its application for survey the services it currently provides, indicating which services it provides directly, under contract, or through some other arrangement. (Those services that are planned and thus not identified in the electronic application for survey [E-App], and begin operations after an initial survey occurs, may require a separate extension survey to evaluate the services.)
- The laboratory is open and in full operation at the time of the accreditation survey. (See the sidebar “Defining Full Operation.”)
- Consistent with JCI’s normal survey process for the size and type of organization as described in this survey process guide, laboratory services identified by the organization in the survey application are immediately available for a comprehensive evaluation against all relevant standards such as through the following activities:
- Tracer activities
- Quality control process review and proficiency testing validation
- Staff qualifications and competency assessment
- Review of laboratory equipment and reagents
- Review of contract and referral laboratories
- Review of information management
- Direct observation of laboratory processes, collection stations, and off-site laboratory services
- The laboratory assumes, or is willing to assume, responsibility for improving the quality of its services.