Conditions of Participation · 42 CFR Part 484
§484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients.
The regulation text and CMS’s interpretive guidelines for every survey tag under this condition, quoted from the State Operations Manual, Appendix B (Rev. 245).
§484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients.
On the 2567: Compliance With Federal, State, Local Law
The 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. If state or local law provides licensing of HHAs, the HHA must be licensed.
CMS’s guidance for this tag
Interpretive Guidelines §484.100
Non-compliance with this condition includes: 1) the agency is not currently licensed per State requirements; or 2) the HHA has been cited by a Federal program (other than CMS), or a State or local authority for a non-compliance with licensing requirements. The Federal, State or local authority has made a final determination after all administrative procedures have been completed; all appeals have been finalized; and the findings of the noncompliance with the laws/regulations were upheld and enforced.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.100(a) Standard: Disclosure of ownership and management information.
On the 2567: Disclosure Of Ownership And Management Info.
The HHA must comply with the requirements of part 420 subpart C, of this chapter. The HHA also must disclose the following information to the state survey agency at the time of the HHA's initial request for certification, for each survey, and at the time of any change in ownership or management:
(1) The names and addresses of all persons with an ownership or controlling interest in the HHA as defined in §420.201, §420.202, and §420.206 of this chapter.
(2) The name and address of each person who is an officer, a director, an agent, or a managing employee of the HHA as defined in §420.20l, §420.202, and §420.206 of this chapter.
(3) The name and business address of the corporation, association, or other company that is responsible for the management of the HHA, and the names and addresses of the chief executive officer and the chairperson of the board of directors of that corporation, association, or other company responsible for the management of the HHA.
- The CFR reads: “§ 420.201, § 420.202, and § 420.206”
Logicly’s note, not CMS text
typo in the manual: the letter "l" for the digit 1 in "420.201"
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.100(b) Standard: Licensing.
On the 2567: Licensing
The 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 as meeting those requirements.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.100(c) Standard: Laboratory services.
On the 2567: Laboratory Services/Clia Waivers
(1) If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient’s equipment when assisting with self- administered tests.
CMS’s guidance for this tag
Interpretive Guidelines §484.100(c)(1)
If an HHA nurse or other HHA employee only assists a patient who has her or his own glucose meter, then a Clinical Laboratory Improvement Amendment (CLIA) certificate is not required. If the HHA nurse or HHA employee conducts the test, regardless of whether the patient’s equipment or the HHA’s equipment is used, then a CLIA certificate (specifically a Certificate of Waiver) is required.
The HHA may not substitute its equipment for a patient’s equipment when assisting with self-administered tests, except that an HHA may allow a patient to use HHA testing equipment for a short, defined period of time until the patient has obtained his or her own testing equipment. As a part of the care planning process, HHAs are expected to help patients identify and obtain resources to secure the equipment needed for self-testing.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.100(c)(2)
On the 2567: Referral Laboratory Must Be Certified
§484.100(c)(2) If the HHA refers specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter.
CMS’s guidance for this tag
Interpretive Guidelines §484.100(c)(2)
HHAs may refer to Appendix C of the CMS State Operations Manual for regulations and interpretive guidelines for Part 493 (Laboratory Requirements).
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
Current CFR text, 42 CFR 484.100 as revised 2025-10-01 (govinfo)
§ 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients.
The 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. If state or local law provides licensing of HHAs, the HHA must be licensed.
(a) Standard: Disclosure of ownership and management information. The HHA must comply with the requirements of part 420 subpart C, of this chapter. The HHA also must disclose the following information to the state survey agency at the time of the HHA's initial request for certification, for each survey, and at the time of any change in ownership or management:
(1) The names and addresses of all persons with an ownership or controlling interest in the HHA as defined in § 420.201, § 420.202, and § 420.206 of this chapter.
(2) The name and address of each person who is an officer, a director, an agent, or a managing employee of the HHA as defined in § 420.201, § 420.202, and § 420.206 of this chapter.
(3) The name and business address of the corporation, association, or other company that is responsible for the management of the HHA, and the names and addresses of the chief executive officer and the chairperson of the board of directors of that corporation, association, or other company responsible for the management of the HHA.
(b) Standard: Licensing. The 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 as meeting those requirements.
(c) Standard: Laboratory services. (1) If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests.
(2) If the HHA refers specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter.
Read with this
Source: State Operations Manual, Appendix B - Guidance to Surveyors: Home Health Agencies (Rev. 245, issued 08-05-26), text extracted from the PDF with pdftotext, retrieved 2026-10-09, and 42 CFR Part 484, annual edition revised as of October 1, 2025 (govinfo XML granules). Works of the US Government are in the public domain.
The monthly home health regs digest
What CMS changed, what's due next, and what to do about it — one email a month, no fluff. Read the first issue