For purposes of CLIA certification, laboratory testing is defined as analyzing a substance removed from the body and using this information for the diagnosis, prevention, or treatment of any disease, impairment, or assessment of the health of human beings.
Laboratory testing is divided into three categories (The final rules of CLIA enacted in April 2003 combine many requirements for moderate and high complexity and refer to them as “non-waived”):
- waived tests – simple procedures with little chance of negative outcomes if performed inaccurately.
- moderately complex tests – more complex than waived testing but usually automated, such as blood counts.
- highly complex tests – usually non-automated or complicated tests requiring considerable judgment, such as cross matching of blood.
For all tests not waived, CLIA requires an on-site survey or inspection by an approved agency, such as the Joint Commission.
CLIA regulations require that laboratory surveys be conducted every two years. This means that, if your laboratory is part of another Joint Commission accredited health care organization, your survey will not ordinarily take place at the same time as your health care organization’s triennial survey.
Laboratories that are part of larger health care organizations need to keep in mind that, just like any other department within a health care organization, your laboratory will be reviewed under the leadership, improving organization performance and other standards contained in the applicable Joint Commission manual that serves as the basis for the triennial survey process.
A laboratory that is seeking Joint Commission accreditation for the first time or that has not been unaccredited by the Joint Commission during the previous 6 months is eligible for an initial survey. The full scope of applicable standards is reviewed during the survey. The evaluation of the standards is based on a 4 - month track record of compliance (prior to the survey) rather than the 12 – 24 month track record of compliance required for re-surveys. If a laboratory is seeking Joint Commission accreditation for the first time, but has been accredited by another Laboratory Accrediting Organization up until that time, must demonstrate not only a 4 month track record of compliance with Joint Commission Standards but must also demonstrate a 24 month track record of proficiency testing.
If a laboratory is in compliance with all standards at the time of the on-site survey, it will be accredited at that time. If the laboratory is not compliant with one or more standards at the time of survey, it is required to submit an acceptable Evidence of Standards Compliance (ESC) Report within 45 days. If the ESC is acceptable, the laboratory’s accreditation decision is retroactive to the day after the last day of the survey, unless the laboratory is undergoing its first Joint Commission survey. In that case, the effective date for accreditation is the date on which the acceptable ESC is submitted.
An advantage of the laboratory survey process is that all laboratories within an organization can be reviewed during the course of one survey. For example, freestanding ambulatory care centers, surgicenters, psychiatric and long term care facilities, as well as hospitals, are often part of the same health care organization. Many have their own laboratory services, each with a CLIA certificate number. The Joint Commission survey covers not only laboratories in the hospital, but also laboratories serving different organizational elements, even if services are provided off-campus or in a neighboring state. A separate survey request for each laboratory is not required.
In addition, if any of the laboratory services in your organization are inspected and accredited by the College of American Pathologists (CAP) or any other accrediting agency recognized by the Joint Commission, the Joint Commission will continue to accept these findings and incorporate them into the accreditation decision of the larger health care organization.