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§ 484.60 Condition of participation: Care planning, coordination of services, and quality of care.
Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice.
(a) Standard: Plan of care.
(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician is consulted to approve additions or modifications to the original plan.
(2) The individualized plan of care must include the following:
(i) All pertinent diagnoses;
(ii) The patient's mental, psychosocial, and cognitive status;
(iii) The types of services, supplies, and equipment required;
(iv) The frequency and duration of visits to be made;
(v) Prognosis;
(vi) Rehabilitation potential;
(vii) Functional limitations;
(viii) Activities permitted;
(ix) Nutritional requirements;
(x) All medications and treatments;
(xi) Safety measures to protect against injury;
(xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors;
(xiii) Patient and caregiver education and training to facilitate timely discharge;
(xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient;
(xv) Information related to any advanced directives; and
(xvi) Any additional items the HHA or physician may choose to include.
(3) All patient care orders, including verbal orders, must be recorded in the plan of care.
(b) Standard: Conformance with physician orders.
(1) Drugs, services, and treatments are administered only as ordered by a physician.
(2) Influenza and pneumococcal vaccines may be administered per agency policy developed in consultation with a physician, and after an assessment of the patient to determine for contraindications.
(3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies.
(4) When services are provided on the basis of a physician's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician in accordance with applicable state laws and regulations, as well as the HHA's internal policies.
(c) Standard: Review and revision of the plan of care.
(1) The individualized plan of care must be reviewed and revised by the physician who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. The HHA must promptly alert the relevant physician(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered.
(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care.
(3) Revisions to the plan of care must be communicated as follows:
(i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians issuing orders for the HHA plan of care.
(ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians issuing orders for the HHA plan of care, and the patient's 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).
(d) Standard: Coordination of care. The HHA must:
(1) Assure communication with all physicians involved in the plan of care.
(2) Integrate orders from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient.
(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines.
(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities.
(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge.
(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining:
(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA.
(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA.
(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services.
(4) Any other pertinent instruction related to the patient's care and treatments that the HHA will provide, specific to the patient's care needs.
(5) Name and contact information of the HHA clinical manager.
§ 484.80 Condition of participation: Home health aide services
All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section.
(a) Standard: Home health aide qualifications.
(1) A qualified home health aide is a person who has successfully completed:
(i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or
(ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or
(iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of § 483.151 through § 483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or
(iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section.
(2) A home health aide or nurse aide is not considered to have completed a program, as specified in paragraph (a)(1) of this section, if, since the individual's most recent completion of the program(s), there has been a continuous period of 24 consecutive months during which none of the services furnished by the individual as described in § 409.40 of this chapter were for compensation. If there has been a 24-month lapse in furnishing services for compensation, the individual must complete another program, as specified in paragraph (a)(1) of this section, before providing services.
(b) Standard: Content and duration of home health aide classroom and supervised practical training.
(1) Home health aide training must include classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. Classroom and supervised practical training must total at least 75 hours.
(2) A minimum of 16 hours of classroom training must precede a minimum of 16 hours of supervised practical training as part of the 75 hours.
(3) A home health aide training program must address each of the following subject areas:
(i) Communication skills, including the ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff.
(ii) Observation, reporting, and documentation of patient status and the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection prevention and control procedures.
(v) Basic elements of body functioning and changes in body function that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and the knowledge of instituting emergency procedures and their application.
(viii) The physical, emotional, and developmental needs of and ways to work with the populations served by the HHA, including the need for respect for the patient, his or her privacy, and his or her property.
(ix) Appropriate and safe techniques in performing personal hygiene and grooming tasks that include—
(A) Bed bath;
(B) Sponge, tub, and shower bath;
(C) Hair shampooing in sink, tub, and bed;
(D) Nail and skin care;
(E) Oral hygiene;
(F) Toileting and elimination;
(x) Safe transfer techniques and ambulation;
(xi) Normal range of motion and positioning;
(xii) Adequate nutrition and fluid intake;
(xiii) Recognizing and reporting changes in skin condition;
(xiv) Any other task that the HHA may choose to have an aide perform as permitted under state law; and
(xv) The HHA is responsible for training home health aides, as needed, for skills not covered in the basic checklist, as described in paragraph (b)(3)(ix) of this section.
(4) The HHA must maintain documentation that demonstrates that the requirements of this standard have been met.
(c) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section.
(1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient.
(2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section.
(3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate.
(4) A home health aide is not considered competent in any task for which he or she is evaluated as unsatisfactory. An aide must not perform that task without direct supervision by a registered nurse until after he or she has received training in the task for which he or she was evaluated as “unsatisfactory,” and has successfully completed a subsequent evaluation. A home health aide is not considered to have successfully passed a competency evaluation if the aide has an “unsatisfactory” rating in more than one of the required areas.
(5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met.
(d) Standard: In-service training. A home health aide must receive at least 12 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient.
(1) In-service training may be offered by any organization and must be supervised by a registered nurse.
(2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met.
(e) Standard: Qualifications for instructors conducting classroom and supervised practical training. Classroom and supervised practical training must be performed by a registered nurse who possesses a minimum of 2 years nursing experience, at least 1 year of which must be in home health care, or by other individuals under the general supervision of the registered nurse.
(f) Standard: Eligible training and competency evaluation organizations. A home health aide training program and competency evaluation program may be offered by any organization except by an HHA that, within the previous 2 years:
(1) Was out of compliance with the requirements of paragraphs (b), (c), (d), or (e) of this section; or
(2) Permitted an individual who does not meet the definition of a “qualified home health aide” as specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); or
(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or
(4) Was assessed a civil monetary penalty of $5,000 or more as an intermediate sanction; or
(5) Was found to have compliance deficiencies that endangered the health and safety of the HHA's patients, and had temporary management appointed to oversee the management of the HHA; or
(6) Had all or part of its Medicare payments suspended; or
(7) Was found under any federal or state law to have:
(i) Had its participation in the Medicare program terminated; or
(ii) Been assessed a penalty of $5,000 or more for deficiencies in federal or state standards for HHAs; or
(iii) Been subjected to a suspension of Medicare payments to which it otherwise would have been entitled; or
(iv) Operated under temporary management that was appointed to oversee the operation of the HHA and to ensure the health and safety of the HHA's patients; or
(v) Been closed, or had its patients transferred by the state; or
(vi) Been excluded from participating in federal health care programs or debarred from participating in any government program.
(g) Standard: Home health aide assignments and duties.
(1) Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist).
(2) A home health aide provides services that are:
(i) Ordered by the physician;
(ii) Included in the plan of care;
(iii) Permitted to be performed under state law; and
(iv) Consistent with the home health aide training.
(3) The duties of a home health aide include:
(i) The provision of hands-on personal care;
(ii) The performance of simple procedures as an extension of therapy or nursing services;
(iii) Assistance in ambulation or exercises; and
(iv) Assistance in administering medications ordinarily self-administered.
(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures.
(h) Standard: Supervision of home health aides.
(1)
(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in § 484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit.
(ii) If an area of concern in aide services is noted by the supervising registered nurse or other appropriate skilled professional, then the supervising individual must make an on-site visit to the location where the patient is receiving care in order to observe and assess the aide while he or she is performing care.
(iii) A registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care.
(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care.
(3) If a deficiency in aide services is verified by the registered nurse or other appropriate skilled professional during an on-site visit, then the agency must conduct, and the home health aide must complete a competency evaluation in accordance with paragraph (c) of this section.
(4) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements:
(i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional;
(ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family;
(iii) Demonstrating competency with assigned tasks;
(iv) Complying with infection prevention and control policies and procedures;
(v) Reporting changes in the patient's condition; and
(vi) Honoring patient rights.
(5) If the home health agency chooses to provide home health aide services under arrangements, as defined in section 1861(w)(1) of the Act, the HHA's responsibilities also include, but are not limited to:
(i) Ensuring the overall quality of care provided by an aide;
(ii) Supervising aide services as described in paragraphs (h)(1) and (2) of this section; and
(iii) Ensuring that home health aides who provide services under arrangement have met the training or competency evaluation requirements, or both, of this part.
(i) Standard: Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit. An individual may furnish personal care services, as defined in § 440.167 of this chapter, on behalf of an HHA. Before the individual may furnish personal care services, the individual must meet all qualification standards established by the state. The individual only needs to demonstrate competency in the services the individual is required to furnish.
§ 484.110 Condition of participation: Clinical records.
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) 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 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).
§ 484.75 Condition of participation: Skilled professional services.
Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in § 409.44 of this chapter, and physician and medical social work services as specified in § 409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care.
(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under § 484.115 and who practice according to the HHA's policies and procedures.
(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following:
(1) Ongoing interdisciplinary assessment of the patient;
(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s);
(3) Providing services that are ordered by the physician as indicated in the plan of care;
(4) Patient, caregiver, and family counseling;
(5) Patient and caregiver education;
(6) Preparing clinical notes;
(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care;
(8) Participation in the HHA's QAPI program; and
(9) Participation in HHA-sponsored in-service training.
(c) Supervision of skilled professional assistants.
(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of § 484.115(k).
(2) Rehabilitative therapy services are provided under the supervision of an occupational therapist or physical therapist that meets the requirements of § 484.115(f) or (h), respectively.
(3) Medical social services are provided under the supervision of a social worker that meets the requirements of § 484.115(m).
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