CMS SOM App. H, Tag V676

than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any

laboratory services, including tissue pathology and histocompatibility must be furnished by

or obtained from, a facility that meets the requirements for laboratory services specified in

part 493 of this chapter.

Interpretive Guidance § 494.130

Under Clinical Laboratory Improvement Amendments of 1988 (CLIA), laboratory services can

only be provided by an appropriately certified laboratory. Arrangements with these providers

must be in writing and signed and should specify: the types of laboratory tests to be performed;

methods for collection and handling the specimen(s); and, delivering results, including a

timeline for reporting of “alert” (sometimes called “panic”) values to a responsible person.

Page 260 of 420

Many facilities have agreements with distant laboratories for routine services; there should also

be a provision for service from a local laboratory for time-sensitive testing.

The dialysis facility may provide some testing directly. Generally, this is limited to CLIA-waived

tests, such as for blood glucose determinations obtained by blood glucose monitoring devices

cleared by FDA specifically for home use, and for stool testing for occult blood.

HLA Laboratories performing Panel Reactive Antibody (PRA) testing for patients on the

transplant waitlist must have a “regular” CLIA certificate of compliance or certificate of

accreditation which allows the laboratory to perform high-complexity testing.

Laboratory reports should be included in facility records and should include the patient’s name

and identifier, the date and time the specimen was taken, and the name and address of the

laboratory performing the test. Facility policies should address methods for specimen collection,

especially pertaining to post-dialysis samples for dialysis adequacy testing to ensure accurate

results.

Subpart D- Administration