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42 C.F.R. § 124.511

Investigation and determination of compliance.

§ 124.511 Investigation and determination of compliance.

(a) Complaints. A complaint that a facility is out of compliance with the requirements of this subpart may be filed with the Secretary by any person.

(1) A complaint is considered to be filed with the Secretary on the date the following information is received in the Office of the HHS Regional Health Administrator for the Region in which the facility is located:

(i) The name and address of the person making the complaint or on whose behalf the complaint is made;

(ii) The name and location of the facility;

(iii) The date or approximate date on which the event occurred; and

(iv) A statement of what actions the complainant considers to violate the requirements of this subpart.

(2) The Secretary promptly provides a copy of the complaint to the facility named in the complaint.

(3) When the Secretary investigates a facility, the facility, including a facility certified under § 124.513, § 124.514, § 124.515, § 124.516, or § 124.517, shall provide to the Secretary on request any documents, records and other information concerning its operation that relate to the requirements of this subpart. A facility will be presumed to be out of compliance with its assurance unless it supplies documentation sufficient to show compliance with the applicable provisions of this subpart.

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The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

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