CMS SOM App. W, Tag C-1028

The CAH provides 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). (See the laboratory requirements

specified in part 493 of this chapter.) The services provided include the following:

(i) Chemical examination of urine by stick or tablet method or both (including

urine ketones).

(ii) Hemoglobin or hematocrit.

(iii) Blood glucose.

(iv) Examination of stool specimens for occult blood.

(v) Pregnancy tests.

(vi) Primary culturing for transmittal to a certified laboratory.

Interpretive Guidelines §485.635(b)(2)

Laboratory services that must be provided on-site at the CAH’s main campus are the tests

specified in the regulation, which would be considered the minimum necessary for

diagnosis and treatment of a patient:

• Chemical examination of urine by stick or tablet method or both (including urine

ketones);

• Hemoglobin or hematocrit;

• Blood glucose;

• Examination of stool specimens for occult blood;

• Pregnancy tests; and

• Primary culturing for transmittal to a certified laboratory.

These services may be provided by CAH staff or under arrangement or agreement with a

laboratory, or through a combination of CAH staff and a laboratory under arrangement.

Laboratory services, whether provided directly by the CAH or under an arrangement with

a laboratory contractor, 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. Compliance with Part 493 is not assessed by CAH

surveyors evaluating compliance with the CAH conditions of participation, but surveyors

are expected to refer potential issues they may identify to the program responsible for

CLIA certification.

Given that the CAH must provide emergency services 24 hours a day, 7 days a week, the

CAH must determine which laboratory services are to be immediately available to meet

the emergency needs of patients and how the services are to be provided. The emergency

laboratory services available should reflect the scope and complexity of the CAH’s

emergency services operations.

The provision of laboratory services that exceed the minimum tests specified is optional.

The scope and complexity of the CAH’s laboratory service must be adequate to support

the clinical services the CAH offers to patients. Additional laboratory services may be

offered directly or through arrangement. The CAH should have a written description of

all the laboratory services that it provides, including those delivered on routine and stat

basis.

The laboratory must have written policies and procedures for the collection, preservation,

transportation, receipt, and reporting of tissue specimen results.

Patient laboratory results and all other laboratory clinical patient records are considered

patient medical records and the CAH must comply with the requirements of the clinical

records CoP at §485.638(a)(4)(ii).

Survey Procedures §485.635(b)(2)

• Ask the CAH to identify which laboratory services it offers. Are the required lab

services provided at the CAH’s main campus?

• Does the CAH have a CLIA certificate or waiver, as applicable, for all laboratory

tests performed in CAH facilities?

• Verify that the CAH has a procedure in place for obtaining tests that are needed

but unavailable at the CAH laboratory.

• If the CAH refers specimens to another laboratory for testing, does the CAH have

documentation that the referral laboratory is CLIA certified for the appropriate

tests?

• Has the CAH identified laboratory services that must be available to support the

emergency services the CAH provides? Ask the staff who furnish emergency

services whether these laboratory services are available whenever they provide

emergency services.