42 CFR 484.100 — Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients

What this rule requires your agency to do

• 1If the HHA engages in laboratory testing (beyond assisting self-administration of an FDA-cleared appliance test), the testing must comply with all applicable requirements of part 493, and the HHA may not substitute its equipment for a patient's when assisting with self-administered tests (subd. c(1)).(42 CFR 484.100 — Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients)
• 2The HHA must disclose the name and business address of any corporation, association, or other company responsible for the management of the HHA, and the names and addresses of that management entity's chief executive officer and chairperson of the board (subd. a(3)).(42 CFR 484.100 — Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients)
• 3The HHA, its branches, and all persons furnishing services to patients must be licensed, certified, or registered as applicable in accordance with the state licensing authority (subd. b).(42 CFR 484.100 — Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients)
• 4If the HHA refers specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties in accordance with part 493 (subd. c(2)).(42 CFR 484.100 — Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients)
• 5The HHA must disclose the name and address of each officer, director, agent, or managing employee of the HHA as defined in §§ 420.201, 420.202, and 420.206 (subd. a(2)).(42 CFR 484.100 — Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients)
• 6The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients, and must be licensed if state or local law provides for licensing of HHAs (introductory paragraph).(42 CFR 484.100 — Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients)
• 7The HHA must comply with part 420 subpart C and disclose to the state survey agency, at initial certification, at each survey, and at any change in ownership or management, the names and addresses of all persons with an ownership or controlling interest as defined in §§ 420.201, 420.202, and 420.206 (subd. a(1)).(42 CFR 484.100 — Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations Related to the Health and Safety of Patients)