This regulation requires skilled nursing facilities (SNFs) and nursing facilities to provide or obtain laboratory services that meet residents' needs, ensuring quality and timeliness. Facilities that perform their own laboratory testing must hold a current CLIA certificate appropriate to the level of testing performed. Facilities that only collect or prepare specimens without performing tests are exempt from CLIA requirements. Surveyors verify CLIA certificate currency but defer detailed CLIA compliance review to dedicated CLIA surveyors.
View official sourceF770 (Rev. 225; Issued: 08-08-24; Effective: 08-08-24; Implementation: 08-08-24) §483.50(a) Laboratory Services. §483.50(a)(1) The facility must provide or obtain laboratory services to meet the needs of its residents. The facility is responsible for the quality and timeliness of the services. (i) If the facility provides its own laboratory services, the services must meet the applicable requirements for laboratories specified in part 493 of this chapter. DEFINITIONS §483.50(a)(1)(i) “Laboratory service ” as referenced in §493.2, is any examination of materials derived from the human body for purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings. GUIDANCE §483.50(a)(1)(i) If a facility provides its own laboratory services or performs any laboratory tests directly (e.g., blood glucose monitoring, etc.) the provisions of 42 CFR Part §493 apply and the facility must have a current Clinical Laboratory Improvement Amendment (CLIA) certificate appropriate for the level of testing performed within the facility. Facilities collecting and/or preparing specimens and not performing testing are not considered to be providing laboratory services and do not need to meet the requirements of 42 CFR Part §493. Surveyors should only verify that the facility has a current CLIA certificate and not attempt to determine compliance with the requirements in 42 CFR part 493; rather, refer questions or concerns to CLIA surveyors. POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION If noncompliance with §483.50(a)(1)(i) has been identified, the surveyor may have identified concerns with related structure, process, and/or outcome requirements. If an additional concern has been identified, the surveyor must investigate the identified concern. Do not cite any related or associated requirements before first conducting an investigation to determine compliance or non-compliance with the related or associated requirement. Examples include, but are not limited to, the following: • §483.30 - Physician Services • §483.35 - Nursing Services • §483.70(f) - Use of Outside Resources • §483.70(g) - Medical Director • §483.75 - Quality Assessment and Performance Improvement KEY ELEMENTS OF NONCOMPLIANCE To cite deficient practice at F770, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following: • Have a current CLIA certificate appropriate for the level of testing it performs; OR • Meet the needs of residents with regard to the quality and/or timeliness of providing laboratory services and reporting laboratory results: OR • Provide or obtain laboratory services, to meet the needs of its residents.