CMS SOM App. A, Tag A-0576

The hospital must maintain, or have available, adequate laboratory services to meet the

needs of its patients. The hospital must ensure that all laboratory services provided to its

patients are performed in a facility certified in accordance with Part 493 of this chapter.

Interpretive Guidelines §482.27

The hospital must maintain or have available laboratory services whenever its patients need

those services. The hospital may make laboratory services available directly, through contractual

agreements, or through a combination of direct and contractual services. The scope and

complexity of the hospital laboratory service must be adequate to meet the needs of its patients.

The hospital must maintain, or have available, adequate laboratory services to meet the needs of

its patients at each campus or off-campus location of the hospital. All laboratory services,

whether direct or contractual, whether conducted in a lab or in another location, must be

provided in accordance with Clinical Laboratory Improvement Act (CLIA) requirements. Every

hospital laboratory service must be operating under a current CLIA certificate appropriate to the

level of services performed.

The hospital’s laboratory services, including any contracted services, must be integrated into its

hospital-wide QAPI program.

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

medical records and the hospital must comply with the requirements of the Medical Records

CoP.

Survey Procedures §482.27

• Determine the total number of laboratories, the location of each laboratory, and every

location where laboratory procedures are performed.

• Verify that the laboratory service and all laboratory locations are integrated into the

hospital-wide QAPI program.

• If laboratory services are contracted, verify that the review of the quality of those

services is integrated into the hospital-wide QAPI program.