CMS Manual System - Louisiana Department of Health and Hospitals

§483.75(j)(1)(ii) If the facility provides blood bank and transfusion services, it
must meet the applicable requirements for laboratories specified in Part 493 of
this chapter.
§483.75(j)(1)(iii) If the laboratory chooses to refer specimens for testing to
another laboratory, the referral laboratory must be certified in the appropriate
specialties and subspecialties of services in accordance with the requirements of
part 493 of this chapter.
§483.75(j)(1)(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.
Intent: §483.75(j)(1)(i) - (iv)
The intent of this regulation is to assure that laboratory services, blood bank and
transfusion services are obtained from an entity that meets the requirements of 42 CFR
Part 493 in order to provide a standard of quality for laboratory and transfusion services.
If the long term care facility does not provide laboratory services on site, there must be an
agreement to obtain these services from a laboratory that meets the same requirements.
Interpretive Guidelines: §483.75(j)(1)(i) - (iv)
If a facility provides its own laboratory services, the provisions of 42 CFR Part 493
apply.
The facility must have a Clinical Laboratory Improvement Amendments (CLIA)
certificate appropriate for the level of testing performed. An application for a certificate
of waiver may be made if the facility performs only those tests categorized as waived
under CLIA.
Direct questions concerning the application of these requirements to your State laboratory
consultant or the CMS RO.
Procedures: §483.75(j)(1)(i) - (iv)
Determine if all laboratory services provided for the facility are provided by a laboratory
that meets the requirements of 42 CFR Part 493.
The surveyor should determine if the facility has an arrangement in writing to assume
responsibility for (a) obtaining services that meet professional standards and principles
that apply to professionals providing services in such a facility; and (b) the timeliness of
the services.