CMS SOM App. H, Tag V101

applicable Federal, State, and local laws and regulations pertaining to licensure and any

other relevant health and safety requirements.

Interpretive Guidelines §494.20

This tag is intended for use in citing standard-level noncompliance.

Applicable laws and regulations of other Federal agencies which could be a basis for

noncompliance with §494.20 include the Department of Health & Human Services’ Office of

Civil Rights (HHS OCR) for the privacy provisions of the Health Insurance Portability and

Accountability Act (HIPAA), the Department of Justice Civil Rights Division for Title III

related to public accommodations under the Americans with Disabilities Act (ADA); the

Occupational Safety and Health Administration (OSHA) for regulations related to employee

safety; and the Food and Drug Administration (FDA) for regulations related to the safety of

drugs and medical devices. If a drug or device may have caused or contributed to a serious

injury or illness, the facility must notify the manufacturer and the FDA using FDA’s User

Facility reporting requirements. Clusters of adverse events (infectious or non- infectious)

should also be reported to the appropriate State or local public health department, as required

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by those authorities. Because these other Federal laws are complex, surveyors are not expected

to be their enforcement mechanism. If noncompliance with the laws or rules of another Federal

agency is suspected or noted, contact your CMS Location for guidance.

The Condition for Infection Control at V-145 addresses compliance with reporting

communicable diseases. The Condition for Reuse at V-383 addresses compliance with FDA

reporting requirements related to dialyzer/bloodline reuse. The Condition for Personnel

Qualifications at V-681 addresses compliance with licensure and certification of facility staff.

Subpart B—Patient Safety