CMS SOM App. L, Tag Q-0201

If the ASC performs laboratory services, it must meet the requirements of part 493

of this chapter. If the ASC does not provide its own laboratory services, it must

have procedures for obtaining routine and emergency laboratory services from a

certified laboratory in accordance with Part 493 of this chapter. The referral

laboratory must be certified in the appropriate specialties and subspecialties of

service to perform the referred tests in accordance with the requirements of Part

493 of this chapter.

Interpretive Guidelines: §416.49(a)

ASC policies and procedures should list the kinds of laboratory services that are provided

directly by the facility, and services that are provided through a contractual agreement.

Review the contractual agreements and determine if the referral laboratory is a CLIA-approved laboratory. The ASC procedures must include the following:

• A well-defined arrangement (need not be contractual) with outside services;

• Laboratory services that are provided by the ASC;

• Routine procedures for requesting lab tests; and

• Language that requires the incorporation of lab/radiological reports into patient

records.

When laboratory tests are performed prior to admission, the results should be readily

available to the attending physician in the ASC.