Nursing homes must provide or obtain laboratory services to meet the needs of their residents and are responsible for the quality and timeliness of the services. If they do not provide laboratory services on-site, they must have an agreement to obtain services from a laboratory that 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 Regional Office for appropriate follow-up by CLIA surveyors. If it is verified that requirements in part 493 were not met, a deficiency under Tag F772 should be cited. This letter will impact nursing homes and healthcare facilities by requiring them to obtain laboratory services from a laboratory that meets the requirements of 42 CFR part 493. If they do not meet this requirement, they will be cited with a deficiency. Nursing homes and healthcare facilities must be aware of this requirement and ensure that they are providing services from a laboratory that meets the requirements.

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