CMS SOM App. W, Tag C-1038

or more providers or suppliers participating under Medicare to furnish other services

to its patients, including—]

(ii) Additional or specialized diagnostic and clinical laboratory services that

are not available at the CAH; and

§485.635(c)(2) If the agreements or arrangements are not in writing, the CAH is

able to present evidence that patients referred by the CAH are being accepted and

treated.

Interpretive Guidelines §485.635(c)(1)(ii) & §485.635(c)(2)

In accordance with §485.635(b)(2), the CAH is required to furnish, either directly by the

CAH staff, under arrangement or agreement, or through a combination of CAH staff and

a laboratory under arrangement basic laboratory services essential to the immediate

diagnosis and treatment of the patient that meet the standards imposed under section 353

of the Public Health Service Act (42 U.S.C. 236a). These services must be provided on-site at the CAH and may be provided either by CAH staff or under an arrangement with a

laboratory. The CAH is also free to provide additional laboratory services on-site,

beyond the minimum required services. The provision at §485.635(c)(1)(ii) does not

apply to laboratory services provided on-site.

Instead, this provision addresses the requirement for the CAH to have an arrangement or

agreement, as appropriate, with a laboratory that can provide additional or specialized

clinical laboratory services that are not available at the CAH. The arrangement or

agreement may provide either for the CAH to draw the specimens to be examined and

send them to the outside laboratory. The CAH is not required to have a written

agreement or arrangement, but if it does not, it is expected to be able to document that an

outside laboratory to which it sends specimens provides the CAH with test results.

Laboratories that provide additional diagnostic and clinical laboratory services to a CAH

under agreement or arrangement must have a current Clinical Laboratory Improvement

Act (CLIA) certificate or waiver for all tests performed and meet the laboratory

requirements specified in Part 493 of this chapter. The CAH is expected to have

evidence of the outside laboratory to which it refers patients holding a current CLIA

certificate or waiver.

The CAH must have policies and procedures for additional or specialized laboratory

services provided under arrangement or agreement which address at least the following:

the specific laboratory services provided under arrangement; and the collection,

preservation, transportation, receipt, and reporting of tissue specimen results.

Likewise, although the CAH is expected to provide radiology services in accordance with

§485.635(b)(3), it is also expected to have an arrangement or agreement, as appropriate,

with other providers or suppliers of diagnostic imaging services, including advanced

diagnostic imaging services, such as magnetic resonance imaging, computed tomography,

etc. The CAH is not required to have a written agreement or arrangement, but if it does

not, it is expected to be able to document that an outside diagnostic imaging facility to

which it sends patients provides the CAH with the resulting studies and reports.

Patient diagnostic imaging studies and reports, laboratory results and all other laboratory

clinical patient records must be included in the patient’s medical record and meet all

requirements at §485.638(a)(4)(ii).

Survey Procedures §485.635(c)(1)(ii) & §485.635(c)(2)

• Verify that the CAH has an agreement or arrangement with an outside laboratory

and an outside diagnostic imaging facility for services not provided in the CAH.

• Ask the CAH how it ensures that the laboratory with which it has an agreement or

arrangement holds the necessary CLIA certification.

• If the agreement or arrangement is not in writing, can the CAH document that it is

sending specimens to an outside laboratory and patients to an outside diagnostic

imaging facility when needed, and that it is receiving test results?

• Do policies and procedures address which imaging and lab services are provided

under arrangement, as well as, for lab services, collection, preservation,

transportation, receipt, and reporting of tissue specimen results?