§484.60 Condition of participation: Care planning, coordination of services, and quality of care.

Interpretive Guidelines §484.60

“Reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence” means that, in consideration of the patient’s level of acuity, the HHA can effectively and safely provide the patient with the skilled services that the patient needs within the patient’s home.

“Accepted standards of practice” include guidelines and recommendations issued by nationally recognized organizations with expertise in the relevant field. The Agency for Healthcare Research and Quality (AHRQ) maintains a National Guideline Clearinghouse as a public resource for summaries of evidence-based clinical practice guidelines.

See §484.60(e) for written information that must be provided to the patient.

Interpretive Guidelines §484.60(a)(1)

“Patient-specific measurable outcome” is a change in health status, functional status, or knowledge, which occurs over time in response to a health care intervention that provides end-result functional and physical health improvement/stabilization.

Patient-specific goals must be individualized to the patient based on the patient’s medical diagnosis, physician or allowed practitioner orders, comprehensive assessment and patient input. Progress/non-progress toward achieving the goals is evaluated through measurable outcomes. The HHA must include goals for the patient, as well as patient preferences and service schedules, as a part of the plan of care (See §484.60(a)(2) below).

“Periodically reviewed” means every 60 days or more frequently when indicated by changes in the patient’s condition (see §484.60(c)(1)).

The patient’s physician or allowed practitioner orders for treatments and services are the foundation of the plan of care. If the HHA misses a visit or a treatment or service as required by the plan of care, the HHA should make every attempt to reschedule the missed visit. If the visit cannot be rescheduled, the responsible physician or allowed practitioner should be notified, and the HHA should document the potential clinical impact of missed treatments or services. The HHA should advise and educate the patient on the potential impacts of missed visits.

If the patient or the patient’s representative refuses care that could impact the patient’s clinical wellbeing (such as dressing changes or essential medication) on more than one occasion, then the HHA must attempt to identify the reason for the refusal. If the HHA is unable to identify and address the reason for the refusal, then the HHA must communicate with the patient’s responsible physician or allowed practitioner to discuss how to proceed with patient care.

The physician or allowed practitioner should not be approached to reduce the frequency of services based solely on the availability of HHA staff.

In instances where the HHA receives a general referral from a physician or allowed practitioner that requests HHA services but does not provide the actual plan of care components (i.e., treatments and observations) for the patient, the HHA will not be able to create a comprehensive plan of care to include goals and services until a home visit is done and sufficient information is obtained to communicate with and receive approval from the physician or allowed practitioner.

Interpretive Guidelines §484.60(a)(2)

A detailed, individualized plan of care is critical to both the quality and safety of patient care and therefore each of the required elements must be included.

• In general, pertinent diagnoses include, but are not limited to, the chief reason the patient is receiving home care and the diagnosis most related to the current home health plan of care. Additionally, comorbid conditions that exist at the time of the assessment, that are actively addressed in the patient’s Plan of Care, or that have the potential to affect the patient’s responsiveness to treatment and rehabilitative prognosis should be considered and documented.

• Mental status is generally screened by asking the patient questions on orientation to time, place and person.

• Psychosocial status, as relevant to the patient’s plan of care, may include but is not limited to, interpersonal relationships in the immediate family, financial status, homemaker/household needs, vocational rehabilitation needs, family social problems and transportation needs.

• In general, the plan of care should list the required supplies and equipment which are non-routine and medically necessary for the patient’s care. Examples include, but are not limited to, shower chairs, catheters, tube feeding supplies, and ostomy bags.

Interpretive Guidelines §484.60(a)(3)

All patient care orders, including verbal orders are part of the plan of care. The plan of care may include orders for treatment or services received from physicians other than the responsible physician. The plan should be revised to reflect any verbal order received during the 60-day certification period so that all HHA staff are working from a current plan. It is not necessary for the physician or allowed practitioner to sign an updated plan of care until the patient is recertified to continue care and the plan of care is updated to reflect all current ongoing orders including any verbal orders received during the 60-day period.

NOTE: Pulse oximetry is a ubiquitous assessment tool, often used as a part of routine vital signs across health care providers. Routine monitoring of vital signs, including pulse oximetry, do not require a physician order.

Interpretive Guidelines §484.60(b)(1)

Drugs, services and treatments must be administered in accordance with the orders of a physician or allowed practitioner that establishes and periodically reviews the plan of care. See also §484.60(a)(1).

Interpretive Guidelines §484.60(b)(2)

The HHA, in consultation with a physician, physician assistant, nurse practitioner, or clinical nurse specialist must develop a written policy that addresses vaccination screening for safety exclusions and assessing contraindications prior to administration of a vaccine, as well as written policies and procedures that address vaccine administration, including managing adverse reactions. No individual physician or allowed practitioner order is required for a vaccine. The administration of these vaccines is an exception to §484.60(b)(1).

Interpretive Guidelines §484.60(b)(4)

When services are furnished based on a physician or allowed practitioner's verbal order, the order must be put into writing by personnel authorized to do so by applicable state laws as well as by the HHA's internal policies. The orders must be signed and dated with the date of receipt by the nurse or qualified therapist (i.e., physical therapist, speech-language pathologist, occupational therapist, or medical social worker) responsible for furnishing or supervising the ordered services.

In the absence of a state requirement, the HHA should establish a timeframe for physician or allowed practitioner authentication, i.e. for obtaining a physician or allowed practitioner signature for verbal/telephone orders received. The signature may be written or in electronic form following the requirements of the particular system. A method must be established to identify the signer.

When verbal orders are added to the plan of care, it is not necessary for the physician or allowed practitioner to sign an updated plan of care until the patient is recertified. However, all verbal orders must be authenticated and dated by the physician or allowed practitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies.

Interpretive Guidelines §484.60(c)(1)

See Tag G590 for Interpretive Guidelines for §484.60(c)(1).

Interpretive Guidelines §484.60(c)(1) (Tags G588 and G590)

For “responsible physician” see §484.60(a)(1).

The signature and date of the review by the responsible physician or allowed practitioner verifies the interval between plan of care reviews. In the event of a change in patient condition or needs that suggest outcomes are not being achieved and/or that the patient’s plan of care should be altered, the HHA should notify both the responsible physician or allowed practitioner and the physician(s) or allowed practitioner(s) associated with the relevant aspect of care. Changes in physician or allowed practitioner orders during the plan of care certification period do not automatically restart the timeframe for physician or allowed practitioner review of the plan of care.

Survey Procedures §484.60(c)(2)

The clinical record should demonstrate that patients are assessed throughout the episode of care to assure that HHA services meet the needs of the patient; changes in a patient’s status are consistently communicated; and the plan of care is updated as needed.

Survey Procedures §484.60(c)(3) Ask the HHA to explain how changes to the plan of care are consistently communicated and verify through record review that communications occur.

Interpretive Guidelines §484.60(c)(3)(i)

There must be evidence in the clinical record that the HHA explained to the patient that a change to the plan of care has occurred and how the change will impact the care delivered by the HHA. The clinical record must also document that the revised plan of care was shared with all relevant physicians or allowed practitioners providing care to the patient.

Interpretive Guidelines §484.60(c)(3)(ii)

Discharge planning begins early in the provision of care and must be revised as the patient’s condition or life circumstances change. There must be evidence in the clinical record that the HHA discussed any such changes with the patient, his or her representative (if any) and the responsible physician or allowed practitioner. Other physicians or allowed practitioner(s) who contributed orders to the patient’s plan of care must also be notified of changes to the patient’s discharge plan

Interpretive Guidelines §484.60(d)(1)

The physician or allowed practitioner who initiated home health care is responsible for the ongoing plan of care; however, to assure the development and implementation of a coordinated plan of care, HHA communication with all physicians or allowed practitioner involved in the patient’s care is often necessary. While a patient may see several physicians or allowed practitioner(s) for various medical problems, not all the physicians or allowed practitioner(s) would necessarily be involved in the skilled services defined in the patient’s home health plan of care. Regarding this requirement, “physicians or allowed practitioners involved in the plan of care” means those physicians or allowed practitioners who give orders that are directly related to home health skilled services.

Interpretive Guidelines §484.60(d)(2)

The clinical manager or other staff designated by the HHA is responsible for integrating orders from all relevant physicians or allowed practitioners involved into the HHA plan of care and ensuring the orders are approved by the responsible physician or allowed practitioner.

Interpretive Guidelines §484.60(d)(3)

The HHA must integrate services provided by various disciplines by:

• Managing the scheduling of patients, taking into consideration the type of services that are being provided on a given day. For example, a patient may become fatigued after a HH aide visit assisting with a bath, thus making a physical therapy session scheduled for directly after the HH aide visit less effective. • Managing pain during physical therapy or physical care (i.e. dressing changes or wound care) to minimize patient discomfort while maximizing the effectiveness of the therapy session. • Working with the patient to recommend and make safety modifications in the home. • Assuring that staff who provide care are communicating any patient concerns and patient progress toward the goals identified in the plan of care with others involved in the patient’s care.

Survey Procedures §484.60(d)(4)

Determine through interview if the patient, representative, and caregiver, as applicable and appropriate, are involved in care coordination. For example, were individual schedules considered and accommodated as able?

Interpretive Guidelines §484.60(d)(5)

The comprehensive assessment, patient-centered plan of care and the goals identified therein inform the training and education objectives for each patient. The goals of the HHA episode are established at admission and revised as indicated by the patient’s condition. With the discharge plan clearly identified, patient education and documentation of the patient response to the education begins upon admission and continues throughout the provision of HHA services. The HHA must monitor patient and caregiver responses to and comprehension of any training provided.

Survey Procedures §484.60(d)(5)

If education was conducted, did the HHA staff provide education and training to the patient and any caregivers, when appropriate, and according to the plan of care? Look for evidence that the education was conducted by reviewing the written information in the patient’s home and/or interviewing the patient and HHA staff.

Interpretive Guidelines §484.60(e)

The documents listed in (e)(1)-(5) must be provided to the patient and/or their his/her caregiver and representative (if any) no later than the next visit after the plan of care has been approved by the physician or allowed practitioner. The written information should be updated as the plan of care changes. Clear written communication between the HHA and the patient and the patient’s caregiver and representative (if any) helps ensure that patients and families understand what services to expect from the HHA, the purpose of each service and when to expect the services.

Interpretive Guidelines §484.60(e)(1)

The HHA must ensure that the written visit schedule provided to the patient is consistent with the patient’s most current plan of care.

Interpretive Guidelines §484.60(e)(2)

The HHA must prepare, and provide to the patient and his or her caregiver (if any) written information regarding the patient’s medication regimen as based on the results of the medication review conducted at §484.55(c)(5). The medication administration instructions must be written in plain language that does not use medical abbreviations.

The HHA must provide this information to the patient regardless of whether the patient is receiving only rehabilitation therapy services. See §484.55(c)(5) for communication between the therapist and the HHA nurse regarding medications.

Survey Procedures §484.60(e)(2)

Review the most current medication list that the HHA personnel provided to the patient. Determine if the medications match those listed in the comprehensive assessment, the plan of care, and the written information to the patient. Investigate any discrepancies for additions or deletions to the medications since the information was last updated by the HHA.

Interpretive Guidelines §484.60(e)(5)

The name and contact information of the HHA’s clinical manager, including the clinical manager’s telephone number and, if the patient prefers electronic communication, e-mail, must be provided to the patient. The HHA explains to the patient when the clinical manager should be contacted for discussion about their services.