Nursing facilities must provide or obtain laboratory services that meet residents' needs and are responsible for the quality and timeliness of those services. If laboratory services are not provided on-site, the facility must have a written agreement with a laboratory that meets the requirements of 42 CFR Part 493 (CLIA). Surveyors should refer CLIA compliance concerns to the State Agency or CMS rather than making independent determinations.
View official sourceF772 (Rev. 229; Issued: 04-25-25; Effective: 04-25-25; Implementation: 04-28-25) §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. (iv) If the facility does not provide laboratory services on site, it must have an agreement to obtain these services from a laboratory that meets the applicable requirements of part 493 of this chapter. GUIDANCE §483.50(a)(1)(iv) If the facility does not provide laboratory services on site, it must have a written agreement to provide services from a laboratory which meets the requirements of 42 CFR part §493. Nursing home surveyors should not attempt to determine compliance with the requirements in 42 CFR part §493 but should refer questions or concerns to the State Agency or CMS Location for appropriate follow-up by CLIA surveyors. If verified by CLIA surveyors that requirements in part §493 were not met cite a deficiency under this Tag, F772.