§484.80 Condition of participation: Home health aide services.

Interpretive Guidelines §484.80

The manner and degree of noncompliance identified in relation to the standard level tags for §484.80 may result in substantial noncompliance with this CoP, requiring citation at the condition level.

Interpretive Guidelines §484.80(a)(1)

The regulation describes four methods by which a home health aide may become qualified:

• The candidate may successfully complete a training and competency evaluation program offered by an HHA (except by an HHA specified in §484.80(f)).

• The candidate may successfully complete a competency evaluation program only. The competency evaluation program must address all requirements in §484.80(c).

• A nurse aide who successfully completes a nurse aide training and competency evaluation program, and is found to be in good standing in the state nurse aide registry, is considered to have met the training and competency requirements for an HHA aide. See also 42 CFR Part 483, Subpart D for requirements for states and state agencies on Nurse Aide Training and Competency Evaluation.

• The candidate may successfully complete a State administered program that licenses or certifies HHA aides and that meets or exceeds the requirements under paragraphs (b) and (c) of this section.

The HHA is responsible for ensuring that any HHA aide (whether employed directly or under arrangement) who provides home health aide services for the HHA meets the provisions of this regulation.

Any state requirement regarding aide education, training, competency evaluations, or certification and supervision that is more stringent that the corresponding federal requirement takes precedence over the federal requirement. Likewise, any federal requirement that is more stringent than a corresponding state requirement takes precedence over the more lenient state requirement

Interpretive Guidelines §484.80(a)(2)

If an individual has a 24 consecutive month lapse in furnishing aide services for compensation, regardless of the circumstances surrounding the lapse, the aide will be required to complete a new training and competency evaluation program, or a competency evaluation program, prior to providing aide services on behalf of the HHA. Compensation as it relates to home health aide means monetary compensation, as set forth in section 1891(a)(3)(A) of the Act (as noted in 82 FR 4545 preamble discussion).

Interpretive Guidelines §484.80(b)(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. Alternative formats for classroom training, such as online course material or internet based interactive formats are acceptable delivery methods for the classroom training. These alternative formats should also provide an interactive component that permits students to ask questions and receive responses related to the training.

Interpretive Guidelines §484.80(b)(3)

Two requirements were added to 484.80(b)(3) in 2017 (82 FR 4504) that must be included in HHA training beginning on January 13, 2018:

1. Communication skills in regard to the aide’s ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff; and 2. Recognizing and reporting changes in skin condition.

For individuals who met the qualification requirements for HHA aides prior to January 13, 2018, new training content in these requirements may be completed via in-service training.

Survey Procedures §484.80(b)(4)

When aide services are observed during the surveyor home visit, or are included in the patient sample, review documentation of the HHA aide competency testing for those home health aides to confirm that it was completed. The competency evaluation consists of those subject areas specified in §484.80(b)(3).

Interpretive Guidelines §484.80(c)

The HHA may not allow an aide to provide services to patients independently until they have successfully completed competency testing either at that HHA or at another training facility and successful completion is verified through documentation provided by the applicant or the training facility.

Interpretive Guidelines §484.80(c)(1)

The following skills must be evaluated by observing the aide’s performance while carrying out the task with a patient or pseudo-patient. (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; (iii) Reading and recording temperature, pulse, and respiration; (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.

In accordance with §484.80(c)(3), a registered nurse, in consultation with other skilled professionals (as appropriate), must observe the HHA aide candidate perform each of the tasks above in its entirety to confirm the competence of the candidate.

HHA aides who successfully completed a competency evaluation prior to January 13, 2018, do not need to repeat the portions of the competency evaluation required to be done while providing services to a patient under §§484.80 (b) (i), (iii), (ix), (x), and (xi). For all HHA aides who receive a competency evaluation after January 13, 2018, however, these skills must be tested while the aide is providing care to a patient or pseudo-patient. A pseudo-patient is a person who is trained to participate in a role-play situation, or a computer-based mannequin device. A pseudo-patient must be capable of responding to and interacting with the home health aide trainee, and must be similar in characteristics to the primary patient population served by the HHA in key areas such as age, frailty, functional status, and cognitive status.

When pseudo-patients are used to test home health aide competency, the simulated environment must mimic the reality of the homecare environment, including environmental distractions and constraints that evoke or replicate substantial aspects of the real world in a fully interactive fashion, to assess proficiency in performing skills.

Interpretive Guidelines §484.80(c)(5)

Documentation of competency must: • Include a description of the competency evaluation program, including the qualifications of the instructors; • Confirm that competency was determined by direct observation and the results of those observations; • Distinguish between skills evaluated during patient care and those taught in a laboratory, e.g., skills evaluated through use of a volunteer or direct observation of patient care versus a skill lab demonstration; and • Describe how additional skills beyond the basic skills listed at §484.80(b)(3) were taught and tested.

An HHA aide that is unable to provide the above documentation will be required to successfully complete a competency evaluation before providing care to patients (§484.80(c)(4)).

Interpretive Guidelines §484.80(d)

The annual 12 hours of in-service training is met for the 12 months following successful completion of an HHA aide training and competency evaluation, unless the HHA introduces a new procedure that would indicate the need for further HHA aide in-service training.

When conducting in-service training during patient care, the patient must first be informed of and consent to the training and be informed of how the training will be conducted; patient rights, respect for the patient’s preferences, and potential for care disruption must always guide such training.

Interpretive Guidelines §484.80(d)(1)

RN supervision means that the RN approves the content of and attends the in- service training to ensure the content is consistent with the HHA’s policies and procedures. It would be permissible for HHAs to use in-service education through another organization, if it is under the supervision of an RN (82 FR 4545).

Survey Procedures §484.80(d)(2)

Review a sample of HHA personnel and training records to verify compliance.

Interpretive Guidelines §484.80(e)

The required 2 years of nursing experience for the RN instructor should be “hands on” clinical experience such as providing care and/or supervising nursing services or teaching nursing skills in an organized curriculum or in-service program. At least 1 year of experience must be in home health care.

“Other individuals” who may help with home health aide training would include health care professionals such as:

• Physicians; • Physical therapists; • Occupational therapists; • Speech-language pathologists; • Medical social workers, • LPN/LVNs; and • Nutritionists.

Interpretive Guidelines §484.80(f)

The home health aide training and competency evaluation program may be offered by any HHA, except an HHA that falls under one of the exceptions specified in the regulation. These exceptions include, but are not limited to, agencies that have been found out of compliance with the home health aide requirements any time in the last 2 years, agencies that permitted an unqualified individual to function as a home health aide, and agencies that have been found to have compliance deficiencies that endangered patient health and safety. The full list of exceptions is included in the regulatory text.

“Substandard care” is defined as care that is noncompliant with federal HHA regulations at a condition-level.

If an HHA chooses to use volunteers to provide patient care services, the volunteer must either: (1) be licensed by the State to provide the service (RN/LPN/LVN/physical therapist, occupational therapist or speech therapist); or (2) have successfully completed any training and competency requirements applicable to the service performed.

The most reliable source of information to assure that an HHA has not been excluded from participating in federal health care programs is the List of Excluded Individuals and Entities on the HHS Office of Inspector General (OIG) website: https://oig.hhs.gov/exclusions/. In addition, a reliable source to confirm whether an HHA has been debarred (in accordance with the debarment regulations at 2 CFR 180.300) is the System for Award Management (SAM), an official website of the U.S. government: https://www.sam.gov/portal/SAM/##11#1.

Prohibition/Loss of Home Health Aide Training and Competency Evaluation Program

If a partially extended survey is conducted, but no condition-level deficiency is found, then the HHA would not be precluded from offering its own aide training and/or competency evaluation program. If a condition-level deficiency is found during a partially extended or extended survey, then the HHA may complete any training course and competency evaluation program that is in progress; however, the HHA may not: (1) accept new candidates into the program; or (2) begin a new program for two years after receipt of written notice from the CMS Regional Office of such condition-level deficiency. Correction of the condition-level deficiency does not lift the two-year restriction identified in this standard.

If an HHA loses the authority to operate a home health aide training and competency evaluation program, that does not preclude the HHA from using a contractor to acquire training (see 54 FR 33354, 33358 (Aug. 14, 1989)). If the HHA has its own training and competency lab onsite, it may be permissible for a contractor to conduct the training on the HHA premises. However, the HHA must have no influence or role in the conduct of the training and competency evaluation. The program must be independent of the HHA in all other regards.

Interpretive Guidelines §484.80(g)(1)

The act of assigning a “specific patient” to a HH aide should be an intentional and deliberate decision that takes into consideration the skills of the aide, the availability of the aide for patient care continuity, patient preference (when possible), and other considerations as determined by the patient’s care needs.

Most generally, HH aide services are provided in conjunction with, and as an adjunct to, a skilled nursing service. When both nursing and therapy services are involved, either skilled professional may assign home health aides and develop written patient care instructions.

Interpretive Guidelines §484.80(g)(3)

“Self-administration of medications” means that the patient (or the patient’s caregiver, if applicable) can manage all aspects of taking her or his medication, including safe medication storage, removing the correct dose of medication from the container, taking the medication at the correct time, and knowing how to contact the pharmacy for refills or other questions.

“Assistance in administering medications,” as referenced in this requirement, means that the HH aide may take only a passive role in this activity. Assistance may include items such as: • Bringing a medication to the patient either in a pill organizer or a medication container as requested by the patient or caregiver; • Providing fluids to take with the medication; • Reminding the patient to take a medication; • Applying a topical product, such as a non-prescription cream, to intact skin per home health aide instructions in how to apply it.

Interpretive Guidelines §484.80(g)(4)

As noted in 82 FR 4532, interdisciplinary teams work together, each member contributing their knowledge and skills, interacting with and building upon each other, to enhance patient care. The interdisciplinary team model is the foundation of care in other health care providers, such as hospices and complex chronic care management practices. HHAs may choose to develop interdisciplinary team models based on the experiences and knowledge developed by these similar care providers, or may develop their own strategies and structures to create effective interdisciplinary teams. The term “interdisciplinary” refers to an approach to healthcare that includes a range of health service workers, which may include but is not limited to, MDs, RNs, LPN/LVN, PT & Physical Therapy Assistant (PTA), OT & Occupational Therapy Assistant (OTA), SLP, MSW, and HH aides.

During interdisciplinary team meetings, all HHA staff involved in the patient’s care must be present for, and, where appropriate, should contribute to, any discussion regarding the patient’s care. Since home health aides play an integral role in the delivery of HHA services and have frequent and/or prolonged encounters with patients, their input as members of the interdisciplinary team is important for information sharing and their participation in the team should be reflected in the visit notes of the clinical record. The HHA aide may participate in person, electronically or via telephone.

Interpretive Guidelines §484.80(h)(1)(i)

An occupational therapist may conduct a home health initial assessment visit and complete a comprehensive assessment under the Medicare program, but only when occupational therapy is on the home health plan of care, with either physical therapy or speech therapy, and when skilled nursing services are not initially in the plan of care (86 FR 62242).

Interpretive Guidelines §484.80(h)(1)(iv)

In addition to the regularly-scheduled 14-day supervisory assessment and as-needed observation visits for aides providing care to patients receiving skilled services, HHAs are required to make an annual on-site, in person, visit to a patient's home to directly observe and assess each home health aide while he or she is performing patient care activities. The HHA is required to observe each home health aide annually with at least one patient (86 FR 62347). The skilled professional who supervises aide services should be familiar with the patient, the patient’s plan of care, and the written patient care instructions.

If, during a supervisory visit described in §484.80(h)(1)(iii), a concern is identified at a patient’s home, but the aide is not present, then the skilled professional must go on-site with the aide at the next scheduled visit to observe and assess the aide while he or she is performing care.

Interpretive Guidelines §484.80(h)(4)

During each supervisory visit the supervising registered nurse, or other appropriate skilled professional, should document his or her evaluation of the HH aide regarding each of the elements of this standard.

§484.80(h)(4)(ii) “Maintaining an open communication process” means that the aide can explain what they are going to do with the patient, ask the patient open-ended questions, seek feedback from the patient, and respond to the needs and requests of the patient, representative (if any), caregivers, and family.