Conditions of Participation · 42 CFR Part 484
§484.110 Condition of participation: Clinical records.
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).
CMS lists these tags as Level 1 standards (SOM Appendix B, Part I.C, Table 1):
A partial extended survey is conducted when noncompliance is identified in any Level 1 standard.
§484.110 Condition of participation: Clinical records.
On the 2567: Clinical Records
The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically.
CMS’s guidance for this tag
Interpretive Guidelines §484.110
The HHA must use the information contained in each medical record to assure that safe care is delivered to each HHA patient. In accordance with the provisions of the Patient rights Condition at §484.50(c)(6), the HHA must ensure the confidentiality of each patient’s clinical record.
The manner and degree of noncompliance identified in relation to the standard level tags for §484.110 may result in substantial noncompliance with this CoP, requiring citation at the condition level.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.110(a) Standard: Contents of clinical record. The record must include:
On the 2567: Required Items In Clinical Record
(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders;
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.110(a) Standard: Contents of clinical record. The record must include:]
On the 2567: Interventions And Patient Response
(2) All interventions, including medication administration, treatments, and services, and responses to those interventions;
CMS’s guidance for this tag
Interpretive Guidelines §484.110(a)(2)
“All interventions” refers to those interventions performed by the HHA.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.110(a) Standard: Contents of clinical record. The record must include:]
On the 2567: Goals In The Patient'S Plans Of Care
(3) Goals in the patient's plans of care and the patient’s progress toward achieving them;
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.110(a) Standard: Contents of clinical record. The record must include:]
On the 2567: Contact Information For The Patient
(4) Contact information for the patient, the patient’s representative (if any), and the patient’s primary caregiver(s);
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.110(a) Standard: Contents of clinical record. The record must include:]
On the 2567: Contact Info For Primary Care Practitioner
(5) Contact information for the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA; and
CMS’s guidance for this tag
Interpretive Guidelines §484.110(a)(5)
If the patient identifies an attending physician (whether it is the responsible HHA physician or another physician) who will resume their care after the HHA episode, the contact information of the physician should be included in the clinical record.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.110(a) Standard: Contents of clinical record. The record must include:]
On the 2567: Discharge And Transfer Summaries
(6)(i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or
(ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or
(iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer.
CMS’s guidance for this tag
Interpretive Guidelines §484.110(a)(6)
Discharge summaries typically contain the following items:
• Admission and discharge dates; • Physician responsible for the home health plan of care; • Reason for admission to home health; • Type of services provided and frequency of services; • Laboratory data; • Medications the patient is on at the time of discharge; • Patient’s discharge condition; • Patient outcomes in meeting the goals in the plan of care; and • Patient and family post-discharge instructions.
A discharge summary must be sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within five (5) business days of the date of the order for discharge from the responsible physician.
The contents of a transfer summary typically contain the same components as a discharge summary.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.110(b) Standard: Authentication.
On the 2567: Authentication
All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.110(c) Standard: Retention of records.
On the 2567: Retention Of Records
(1) Clinical records must be retained for 5 years after the discharge of the patient, unless state law stipulates a longer period of time.
(2) The HHA’s policies must provide for retention of clinical records even if it discontinues operation. When an HHA discontinues operation, it must inform the state agency where clinical records will be maintained.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.110(d) Standard: Protection of records.
On the 2567: Protection Of Records
The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding personal health information set out at 45 CFR parts 160 and 164.
- The CFR reads: “rules regarding protected health information”
Logicly’s note, not CMS text
the manual says "personal health information"; the CFR says "protected health information"
CMS’s guidance for this tag
Interpretive Guidelines §484.110(d)
HHA staff (whether employed directly or under arrangement) who carry documents and/or electronic devices containing Protected Health Information from patient’s homes to the HHA office, or to and from the HHA staff member’s home, create additional confidentiality/protection concerns with patient records.
Section 45 CFR Parts 160 and 164, generally known as the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security rules, establish standards for health care providers and suppliers that conduct covered electronic transactions, such as HHAs, among others, for the privacy of protected health information (PHI), as well as for the security of electronic phi (ePHI).
In accordance with 45 CFR 164.530, all HHA staff must receive comprehensive and periodic training on the protection of patient clinical records. HHAs must also establish policies and procedures to ensure the security of clinical records and the privacy of information contained within such records to prevent loss or unauthorized use in the patient’s home, in transit, in the office setting, or any other location.
Survey Procedures §484.110(d)
During the home visit, observe how agency staff maintain the confidentiality of protected health information that they transport and use for patient care encounters as well as safeguard it against loss or unauthorized use.
CMS does not interpret or enforce the HIPAA Privacy and Security Rules, which fall under the jurisdiction of the Office for Civil Rights (OCR). Because there are a number of scenarios that allow for using or disclosing PHI in full compliance with the HIPAA Privacy and Security Rules, surveyors must defer to OCR on whether the manner in which the HHA uses, discloses, maintains or destroys PHI is consistent with these requirements. Information on how to file a HIPAA Privacy or Security complaint with OCR may be found at http://www.hhs.gov/ocr/privacy/hipaa/complaints/index.html.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.110(e) Standard: Retrieval of clinical records.
On the 2567: Retrieval Of Records
A patient’s clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first).
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
Current CFR text, 42 CFR 484.110 as revised 2025-10-01 (govinfo)
§ 484.110 Condition of participation: Clinical records.
The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically.
(a) Standard: Contents of clinical record. The record must include:
(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders;
(2) All interventions, including medication administration, treatments, and services, and responses to those interventions;
(3) Goals in the patient's plans of care and the patient's progress toward achieving them;
(4) Contact information for the patient, the patient's representative (if any), and the patient's primary caregiver(s);
(5) Contact information for the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA; and
(6)(i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or
(ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or
(iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer.
(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry.
(c) Standard: Retention of records. (1) Clinical records must be retained for 5 years after the discharge of the patient, unless state law stipulates a longer period of time.
(2) The HHA's policies must provide for retention of clinical records even if it discontinues operation. When an HHA discontinues operation, it must inform the state agency where clinical records will be maintained.
(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164.
(e) Standard: Retrieval of clinical records. A patient's clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first).
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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.
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