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HOSPICE

SURVEY PROCEDURES

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INTERPRETIVE GUIDELINES

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Appendix M

Interpretive Guidelines - Hospice

Conditions of Participation

418.50............................ General Provisions

418.52............................ Governing Body

418.54............................ Medical Director

418.56............................ Professional Management

418.58............................ Plan of Care

418.60............................ Continuation of Care

418.62............................ Informed Consent

418.64............................ Inservice Training

418.66............................ Quality Assurance

418.68............................ Interdisciplinary Group

418.70............................ Volunteers

418.72............................ Licensure

418.74............................ Central Clinical Records

418.80............................ Furnishing of Core Services

418.82............................ Nursing Services

418.83............................ Nursing Services - Waiver

418.84............................ Medical Social Services

418.86............................ Physician Services

418.88............................ Counseling Services

418.90............................ Furnishing of Other Services

418.92............................ Physical Therapy

Occupational Therapy and

Speech-Language Pathology

418.94............................ Home Health Aide and

Homemaker Services

418.96............................ Medical Supplies

418.98............................ Short Term Inpatient Care

418.100........................... Hospices That Provide Inpatient Care Directly

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§418.3 Definitions.

For purposes of this part--

Attending physician means a physician

who--

(a) Is a doctor of medicine or osteopathy;

and

(b) Is identified by the individual, at the

time he or she elects to receive hospice

care, as having the most significant role in

the determination and delivery of the

individual's medical care.

Bereavement counseling means

counseling services provided to the

individual's family after the individual's

death.

Employee means an employee (defined by

section 210(j) of the Act) of the hospice

or, if the hospice is a subdivision of an

agency or organization, an employee of

the agency or organization who is

appropriately trained and assigned to the

hospice unit. "Employee" also refers to a

volunteer under the jurisdiction of the

hospice.

Hospice means a public agency or private

organization or subdivision of either of

these that--is primarily engaged in

providing care to terminally ill individuals.

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Physician means physician as defined in

§410.20 of this chapter.

Representative means an individual who

has been authorized under State law to

terminate medical care or to elect or revoke

the election of hospice care on behalf of a

terminally ill individual who is mentally or

physically incapacitated.

Social worker means a person who has at

least a bachelor's degree from a school

accredited or approved by the Council on

Social Work Education.

Terminally ill means that the individual

has a medical prognosis that his or her life

expectancy is 6 months or less if the

illness runs its normal course.

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L100 418.50 Condition of Participation - General

Provisions.

418.50(a) Guidelines:

The hospice Conditions of Participation apply to all patients of the hospice (Medicare and non-

Medicare) with the exception of the following regulations (which apply only to Medicare

beneficiaries):

§418.60 - The continuation of care requirement; and

§418.98(c) - The 80-20 inpatient care limitation.

418.50(b) Guidelines:

The hospice must be primarily engaged in providing services to hospice patients as specified

below. A hospice cannot serve as a brokerage agent by contracting or administratively arranging

for all hospice services.

As required by §418.202, hospice services include, but are not limited to, the following:

o Nursing services;

o Physical therapy, occupational therapy, speech-language pathology services;

o Medical social services;

o Home health aide and homemaker services;

o Physician services;

o Counseling services (dietary, pastoral and other);

o Short-term inpatient care; and

o Medical appliances and supplies, including drugs and biologicals.

In addition, the hospice must provide bereavement counseling to the patient's family/caregiver

after the patient's death.

L101 418.50(a) Standard: Compliance.

A hospice must maintain compliance with

the conditions of this subpart and

subparts D and E of this part.

418.50(b) Standard: Required Services.

L102 A hospice must be primarily engaged in

providing the care and services described

in §418.202, must provide bereavement

counseling and must-

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L103 (1) Make nursing services, physician 418.50(b)(1) Probes:

services, and drugs and biologicals

routinely available on a 24-hour basis; How does the hospice arrange staffing to meet the varied and changing needs of its patients 24

hours a day?

What evidence is there that the on-call system of the hospice is in place and operational?

418.50(b)(3) Guidelines: consistent with accepted standards of

Accepted standards of practice are typically developed by professional associations such as

nurses, therapists, and social workers, to establish the standards of practice for competent

persons serving in a particular professional role. The accepted professional standards and

principles that the hospice and its staff must comply with include, but are not limited to, the

hospice Federal regulations, State practice acts, and commonly accepted health standards

established by national organizations, boards, and councils (i.e., American Nurses' Association,

Centers for Disease Control and Prevention (CDC)) and the hospice's own policies and

procedures.

Any deficiency cited as a violation of accepted standards and principles must have a copy of the

applicable standard provided to the hospice along with the statement of deficiencies. A hospice

may also be surveyed for compliance with State practice acts for each relevant discipline. Any

deficiency cited as a violation of a State practice act must reference the applicable section of the

State practice act allegedly violated, and a copy of that section of the act must be provided to the

hospice along with the statement of deficiencies.

If a hospice has developed or adopted professional practice standards and principles for its staff,

there should be information available which demonstrates that the hospice monitors its staff for

compliance with these standards and principles, and takes corrective action as needed.

The regulations do not impose specific standards of practice. Do not impose your own preferred

standards of practice.

L104 (2) Make all other covered services

available on a 24-hour basis to the extent

necessary to meet the needs of

individuals for care that is reasonable and

necessary for the palliation and

management of terminal illness and related

conditions; and

L105 (3) Provide these services in a manner

practice.

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418.50(b)(3) Probes:

How does the hospice ensure that its employees and personnel serving the hospice under

arrangement or contract provide services to patients that are within the context of accepted

professional standards of practice and that, in fact, meet patient needs?

418.50(c) Guidelines:

This requirement refers to the disclosure of financial interest and business ownership. The State

agency should have the necessary information in its files to determine compliance with this

requirement. Review this information in the State files prior to the survey and compare it with the

data obtained during the onsite visit.

418.52 Guidelines:

The designated governing body, individual, group, or corporation must have the ultimate

responsibility and authority specified in writing for setting and monitoring hospice policies.

418.52 Probe:

What evidence is there that the governing body's records reflect direct involvement in hospice

policy development and oversight?

L106 418.50(c) Standard: Disclosure of

information.

The hospice must meet the disclosure of

information requirements at §420.206 of

this chapter.

L107 418.52 Condition of participation-

Governing body.

L108 A hospice must have a governing body

that assumes full legal responsibility for

determining, implementing and monitoring

policies governing the hospice's total

operation.

L109 The governing body must designate an

individual who is responsible for the day

to day management of the hospice

program.

L110 The governing body must also ensure

that all services provided are consistent

with accepted standards of practice.

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L111 418.54 Condition of participation-Medical 418.54 Guidelines:

director.

The medical director may be employed full-time or part-time by the hospice, although he/she need

not be a paid employee. If the medical director is not a paid employee, he/she is considered a

volunteer under the control of the hospice. Volunteers are defined at 42 CFR 418.3 as hospice

employees to facilitate compliance with the hospice core services requirement.

For Medicare certification purposes, an individual is considered a hospice employee only in the

following circumstances:

o The individual is a volunteer under the jurisdiction of the hospice;

o The individual is an employee of the hospice, as the term employee is defined by §210(j) of the

Act. In such a case, the hospice is responsible for paying the individual directly for services

performed either through a salary or on an hourly or per visit basis, and the hospice is required

to issue a form W-2 on his/her behalf; or

o The individual is an appropriately trained employee of the agency or organization of which the

hospice is a sub-division and the individual is assigned to the hospice unit. If the individual

divides work time between the parent organization and the hospice, the hospice must maintain

a record of the individual's assigned time to the hospice which is distinctly identifiable as

hospice time.

Volunteers are defined at 42 CFR 418.3 as hospice employees to facilitate compliance with the

hospice core services requirement.

The medical director may also be the physician representative of the interdisciplinary group (IDG)

and/or an attending physician. Responsibilities of the medical director or physician member of the

hospice IDG include, but are not limited to:

o Certifying (in conjunction with the attending physician if applicable) that the patient is

terminally ill. Terminally ill is defined by the statute to mean that the medical prognosis of life

expectancy is 6 months or less if the terminal illness runs its normal course; and

o Recertifying eligibility for hospice care for subsequent election periods. All certifications of

terminal illness must be written, even if a single election continues in effect for two or three

periods.

L112 The medical director must be a hospice

employee

L113 who is a doctor of medicine or osteopathy

L114 who assumes overall responsibility for the

medical component of the hospice's

patient care program.

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L115 418.56 Condition of participation- 418.56 Guidelines:

Professional management.

Subject to the conditions of participation responsibility for the professional management of the hospice patient's care related to the terminal

pertaining to services in §§418.80 and illness. It is the responsibility of the hospice to ensure that all services are provided in accordance

418.90, a hospice may arrange for another with the plan of care at all times and in all settings.

individual or entity to furnish services to

the hospice's patients. If services are

provided under arrangement, the hospice

must meet the following standards:

When an individual elects to receive services under the hospice benefit, the hospice assumes full

418.56(a) Probes:

What evidence exists in the clinical record or other documentation that indicates that there is

adequate ongoing communication between the hospice and a contract provider?

How does the hospice ensure that the plan of care is being followed in all settings?

418.56(b) Probes:

How does the hospice monitor and exercise control over services provided by personnel under

arrangements or contracts?

How and when does communication occur between the hospice and contracted facilities?

What evidence is there that all services provided by the contract facility are authorized by the

hospice?

L116 418.56(a) Standard: Continuity of care.

The hospice program assures the

continuity of patient/family care in home,

outpatient, and inpatient settings.

418.56(b) Standard: Written agreement.

L117 The hospice has a legally binding written

agreement for the provision of arranged

services.

L118 The agreement includes at least the

following:

(1) Identification of the services to be

provided.

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L119 (2) A stipulation that services may be

provided only with the express

authorization of the hospice.

418.56(c) Guidelines

It is the responsibility of the IDG to provide information concerning the care of the hospice

patient, to monitor this care, and to ensure that all care rendered follows the hospice plan of care.

L120 (3) The manner in which the contracted

services are coordinated, supervised, and

evaluated by the hospice.

L121 (4) The delineation of the role(s) of the

hospice and the contractor in the

admission process, patient/family

assessment, and the interdisciplinary

group care conferences.

L122 (5) Requirements for documenting that

services are furnished in accordance with

the agreement.

L123 (6) The qualifications of the personnel

providing the services.

L124 418.56(c) Standard: Professional

management responsibility.

The hospice retains professional

management responsibility for those

services and ensures that they are

furnished in a safe and effective manner

by persons

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meeting the qualifications of this part, and What evidence is there that the hospice maintains professional management responsibility for all

in accordance with the patient's plan of care, including inpatient care, rendered to the patient?

care and the other requirements of this

part. What evidence is there that the hospice maintains and documents communication between the

418.56(c) Probe:

contract provider and hospice staff?

418.56(e) Guidelines:

Short-term inpatient care may be provided in a Medicare participating hospice inpatient unit, or in

a Medicare participating hospital, SNF, or NF that meets the special hospice standards regarding

staffing and patient areas. (See §418.100(a) and (e).) The Medicare conditions for each of these

providers of service apply, as conditions always do, to all patients regardless of payment source,

unless a specific exception is provided in the regulations. It is the responsibility of the hospice to

establish a cooperative arrangement with the provider of inpatient care to assure that the patient's

plan of care can be developed, with the consent of the patient, in a manner that is consistent with

the requirements governing both the hospice and the inpatient provider.

There is no limit on the number of hospitals or facilities that a hospice may have agreements with

to provide inpatient care. Services provided in an inpatient setting must conform to the hospice

patient's written plan of care and must be reasonable and necessary for the palliation of symptoms

or management of the terminal illness. General inpatient care may be required to adjust and

monitor the patient's pain control or manage acute or chronic symptoms which cannot be provided

in another setting. Inpatient admission may also be furnished to provide respite for the

individual's family or other persons caring for the individual at home. Respite care is the only type

of inpatient care that may be furnished in a NF. However, in order to provide respite care, the NF

must meet the standards specified in §§418.100(a) and (e)

regarding 24 hour nursing service and patient areas. The hospice is accountable for all hospice

services provided under arrangement at the above facilities.

L125 The hospice retains responsibility for

418.56(d) Standard: Financial

responsibility.

payment for services.

418.56(e) Standard: Inpatient care.

L126 The hospice ensures that inpatient care is

furnished only in a facility which meets

the requirements in §418.98 and its

arrangement for inpatient care is described

in a legally binding written agreement that

meets the requirements of paragraph (b)

and that also specifies at a minimum-

L127 (1) That the hospice furnishes to the

inpatient provider a copy of the patient's

plan of care and specifies the inpatient

services to be furnished;

L128 (2) That the inpatient provider has

established policies

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consistent with those of the hospice and If a hospice is hospital-based, it is not necessary for the hospice to develop a formal contract with

agrees to abide by the patient care the parent hospital for the provision of inpatient care. However, a hospital-based hospice should

protocols established by the hospice for document, either in its bylaws or in other official documents, that the hospital will be used to

its patients; furnish inpatient services to hospice patients.

The adequacy of the hospice care training of personnel who provide care under arrangement is

measured by the demonstrated competencies of the staff in implementing the plan of care.

Although Medicare regulations do not require a hospice to maintain documentation in the clinical

record of the inpatient facility with which it has a contract, the hospice must ensure that the care

provided in the inpatient setting is in accordance with the hospice philosophy.

418.56(e) Probes:

How does the hospice monitor the inpatient provider for conformance with the established plan of

care?

How does the hospice ensure that a member of the IDG is available to the inpatient staff for

consultation concerning implementation of the patient's plan of care?

418.58 Guidelines:

Standardized plans of care are not acceptable unless each plan is individualized to meet the

specific needs of the patient and caregiver. Plans of care must be established according to

§418.58(a).

L129 (3) That the medical record includes a

record of all inpatient services and events

and that a copy of the discharge summary

and, if requested, a copy of the medical

record are provided to the hospice;

L130 (4) The party responsible for the

implementation of the provisions of the

agreement; and

L131 (5) That the hospice retains responsibility

for appropriate hospice care training of

the personnel who provide the care under

the agreement.

L132 418.58 Condition of participation-Plan of

care.

L133 A written plan of care must be established

and maintained for each individual

admitted to a hospice program, and the

care provided to an individual must be in

accordance with the plan.

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L134 418.58(a) Standard: Establishment of plan. 418.58(a) Guideline:

The plan must be established by the The physician designee must be a physician and may be the physician member of the IDG.

attending physician, the medical director

or physician designee and

interdisciplinary group prior to providing 418.58(a) Probes:

care.

How does coordination of care occur among staff providing services to the patient?

418.58(b) Probes:

How does the hospice ensure that the plan of care is revised and updated, as needed, when the

patient's condition changes?

418.58(c) Guidelines:

Hospice care focuses on palliative care rather than curative care. The goal of the plan of care is to

help the patient live as comfortably as possible, with emphasis on eliminating or decreasing pain

and/or other uncomfortable symptoms.

418.58 (c) Probes:

What criteria does the hospice use to assess the needs of the patient and caregiver?

Who is involved in this process?

How does the IDG decide what services the patient will receive?

How does the hospice evaluate if the services provided are continuing to meet the patients' and

caregivers' needs?

Is there any indication that the patient needs hospice services that he/she is not receiving?

L135 418.58 (b) Standard: Review of plan.

The plan must be reviewed and updated,

at intervals specified in the plan, by the

attending physician, the medical director

or physician designee and

interdisciplinary group. These reviews

must be documented.

418.58(c) Standard: Content of plan.

L136 The plan must include an assessment of

the individual's needs and identification

of services including the management of

discomfort and symptom relief.

L137 It must state in detail the scope and

frequency of services needed to meet the

patient's and family's needs.

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L138 418.60 Condition of participation- 418.60 Guidelines:

Continuation of care.

A hospice may not discontinue or

diminish care provided to a Medicare

beneficiary because of the beneficiary's

inability to pay for that care.

How does the hospice monitor the delivery of services, including those provided under

arrangement or contract, to ensure compliance with the hospice philosophy?

This condition applies to Medicare beneficiaries only.

418.62 Guidelines:

Informed consent implies that the consenting individual is competent to evaluate the decision

requiring consent (i.e., is able to evaluate the implications of choosing to receive hospice care.)

The patient, or representative, must sign or mark the consent form. The representative must be

permitted by State law to elect or revoke hospice care or terminate medical care on behalf of a

terminally ill individual. With respect to an individual granted the power of attorney for the

patient, State law determines the extent to which the individual may act on the patient's behalf.

Hospice admission criteria should clearly define primary caregiver requirements or decisionmaking

policies related to patients without caregivers. If the hospice requires a primary caregiver

for each patient, the policy must be specified in writing in the admission criteria and discussed

with the patient and family/caregiver during the initial assessment.

418.62 Probes:

How does the hospice communicate to the family/caregiver the role that it expects them to play in

providing care to the patient?

What evidence of informed consent related to care and services is documented in the patient's

chart?

What documentation indicates that the hospice advised the patient of all the services available to

the patient?

L139 418.62 Condition of Participation-Informed

Consent.

A hospice must demonstrate respect for

an individual's rights by ensuring that an

informed consent form that specifies the

type of care and services that may be

provided as hospice care during the

course of the illness has been obtained

for every individual, either from the

individual or representative as defined in

§418.3.

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L140 418.64 Condition of participation- 418.64 Guidelines:

Inservice training.

The adequacy of the in-service training program is measured in the demonstrated competencies of the

A hospice must provide an ongoing patient/caregiver.

program for the training of its

employees. The training may be done directly by the hospice or by other relevant outside organizations.

hospice staff in consistently applying the interventions necessary to meet the needs of the

418.64 Probes:

What evidence demonstrates that the hospice has developed a system to disseminate its policies,

procedures, and training materials to all its staff?

What evidence is there that all employees have been properly oriented to the tasks they are expected to

perform, that they are kept informed of the latest changes in techniques, philosophies, pharmaceuticals,

etc., and that they demonstrate these skills, when needed, in practice?

How does the hospice ensure that staff can demonstrate the skills and techniques needed to do their

jobs?

418.66 Guidelines:

This self-assessment should include all services that were provided, and the patients' and caregivers'

response to those services. It should also include those services that might have been provided but

were omitted. Special attention should be given to the ability of the hospice to deal with symptom

management, pain control, stress management, continuity of care, and inpatient care. Suggestions for

improving care and any problems identified in providing hospice care should receive the appropriate

consideration from the hospice management or governing body.

418.66 Probes:

What type of system does the hospice use to monitor and evaluate the care and services it provides to

its patients and their caregivers/families?

How does the hospice receive, record, investigate and resolve patient grievances or complaints?

Who has the overall responsibility for the development and implementation of the quality assurance

program?

L141 418.66 Condition of Participation-

Quality Assurance.

L142 A hospice must conduct an ongoing,

comprehensive, integrated, selfassessment

of the quality and

appropriateness of care provided,

including inpatient care, home care

and care provided under arrangements.

The findings are used by the hospice

to correct identified problems and to

revise hospice policies if necessary.

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L143 Those responsible for the quality How do the medical director and IDG implement procedures to monitor quality which include at

assurance program must- least the following:

(a) Implement and report on activities and

mechanisms for monitoring the quality of o Problem identification, assessment, correction, monitoring and documentation;

patient care;

o Policy implementation evaluations and monitoring of staff performance;

o Recommendations to the administrator and governing body for improving patient care;

and

o Implementation of recommendations resulting from evaluations and studies?

418.68 Guidelines:

Members of the IDG must be hospice employees or employees of the agency or organization of

which the hospice is a sub-division (e.g., a hospital) who are appropriately trained and assigned to

the hospice unit. All IDG members have the same responsibilities regardless of whether they are

employed directly, assigned, or volunteer employees of the hospice. An employee is one who

meets the common law definition of employee as found in title II of the Social Security Act, or one

who is a volunteer under the control of the hospice. (See §418.3, Definitions.)

The hospice may involve other members of the care team in the IDG's activities. A hospice with

more than one IDG group must designate a specific group to establish policies governing care and

services.

The IDG should conduct an ongoing assessment of each patient's and caregiver's or family's

needs.

"Supervision" of care may be accomplished by conferences, evaluations, discussions and general

oversight, as well as by direct over-the-shoulder observations.

418.68 Probe:

How does the hospice ensure that all individuals on the IDG have been trained and are competent

to perform in the area(s) assigned?

L144 (b) Identify and resolve problems;

and

L145 (c) Make suggestions for improving

patient care.

L146 418.68 Condition of participation-

Interdisciplinary group.

L147 The hospice must designate an

interdisciplinary group or groups

composed of individuals who provide or

supervise the care and services offered by

the hospice.

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418.68(a) Standard: Composition 418.68(a) Guidelines:

of group.

The number of individuals on the IDG is not as important as their qualifications and abilities. For

example, if a group member is licensed as a registered nurse and also meets the Medicare criteria to be

considered a social worker under the hospice benefit, he/she would be qualified to serve on the IDG as

both a nurse and a social worker.

418.68(a) Probes:

Who are the members of the IDG?

How are their responsibilities to provide or supervise patient care and services implemented?

How do the members of the IDG document the supervision of staff providing services under the plan

of care?

418.68(b) Guidelines:

As required by §418.58(a), the IDG participates in establishing the plan of care for each patient prior to

providing care. This plan is reviewed regularly and revised as needed. The plan should note each

contributor as well as those persons assigned to provide the care.

418.68(b) Probes:

What is the IDG's policy related to:

o Developing and revising patient care objectives;

o Facilitating exchange of information among staff and patient/caregiver; and

o Developing a mechanism whereby a continual flow of information regarding patients' and their

caregivers'/families' needs is made available to the IDG staff?

L148 The hospice must have an

interdisciplinary group or groups that

include at least the following

individuals who are employees of the

hospice:

L149 (1) A doctor of medicine or osteopathy.

L150 (2) A registered nurse.

L151 (3) A social worker.

L152 (4) A pastoral or other counselor.

418.68(b) Standard: Role of group.

L153 The interdisciplinary group is

responsible for-

(1) Participation in the establishment of

the plan of care;

L154 (2) Provision or supervision of hospice

care and services;

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L155 (3) Periodic review and updating of the

plan of care for each individual receiving

hospice care; and

418.68(d) Guidelines:

What evidence exists in the clinical record that a designated registered nurse coordinates the

implementation of the patient's plan of care?

418.70 Guidelines:

Volunteers are defined at §418.3 as hospice employees to facilitate compliance with the core

services requirement.

L156 (4) Establishment of policies governing

the day-to-day provision of hospice care

and services.

L157 418.68(c)

If a hospice has more than one

interdisciplinary group, it must designate

in advance the group it chooses to

execute the functions described in

paragraph (b)(4) of this section.

L158 418.68(d) Standard: Coordinator.

The hospice must designate a registered

nurse to coordinate the implementation of

the plan of care for each patient.

L159 418.70 Condition of participation-

Volunteers.

L160 The hospice in accordance with the

numerical standards specified in

paragraph (e) of this section, uses

volunteers, in defined roles, under the

supervision of a designed hospice

employee.

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L161 418.70(a) Standard: Training. 418.70 (a) Guidelines:

The hospice must provide appropriate All required volunteer training should be consistent with the specific tasks that volunteers

orientation and training that is consistent perform.

with acceptable standards of hospice

practice. 418.70(a) Probes:

What evidence is there that the volunteers are aware of:

o Their duties and responsibilities;

o The persons to whom they report;

o The person(s) to contact if they need assistance and instructions regarding the performance

of their of their duties and responsibilities;

o Hospice goals, services and philosophy;

o Confidentiality and protection of the patient's and family's rights;

o Family dynamics, coping mechanisms and psychological issues surrounding terminal illness,

death and bereavement;

o Procedures to be followed in an emergency, or following the death of the patient; and

o Guidance related specifically to individual responsibilities?

How does the hospice supervise the volunteers?

Is there evidence that all the volunteers have received training or orientation before being

assigned to a patient/family?

418.70(b) Guidelines:

Volunteers who are qualified to provide professional services should meet all standards

associated with their specialty area. If licensure or registration is required by the State, the

volunteer must be licensed or registered.

The hospice may use volunteers to provide assistance in the hospice's ancillary and office

activities as well as in direct patient care services, and/or help patients and families with

household chores, shopping, transportation, and companionship.

418.70(b) Probe:

What evidence exists that the IDG conducts an assessment of the patient/caregiver's need for a

volunteer?

What evidence is there documenting the roles assigned to that hospices' volunteers?

L162 418.70 (b) Standard: Role.

Volunteers must be used in administrative

or direct patient care roles.

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L163 418.70(c) Standard: Recruiting and 418.70 (c) Guidelines:

retaining.

The hospice must document active and flyers, or medica announcements.

ongoing efforts to recruit and retain

volunteers.

This documentation could include evidence such as advertisements in local newspapers, bulletins,

418.70(d) Guidelines:

It is anticipated that the hospice will use volunteers to supplement the care being provided by the

paid staff who work directly with patients and their family members, both in the patients' home and

the inpatient setting.

418.70(d) Standard: Cost saving.

L164 The hospice must document the cost

savings achieved through the use of

volunteers.

L165 Documentation must include-(1) The

identification of necessary positions

which are occupied by volunteers;

L166 (2) The work time spent by volunteers

occupying those positions; and

L167 (3) Estimates of the dollar costs which the

hospice would have incurred if paid

employees occupied the positions

identified in paragraph (d)(1) for the

amount of time specified in paragraph

(d)(2).

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418.70(e) Standard: Level of activity.. 418.70 (e) Guidelines:

Administrative support in this context means support of the patient care activities of the hospice

(i.e., clerical duties in the office) rather than general support activities (i.e., fund raising).

A hospice may fluctuate the volume of care provided by volunteers after the hospice meets the

required 5% minimum.

418.70(f) Probes:

What relationship does the hospice have with the clergy in the community?

How does the hospice ensure that all patients are at least offered the services of clergy?

L168 A hospice must document and maintain a

volunteer staff sufficient to provide

administrative or direct patient care in an

amount that, at a minimum, equals 5

percent of the total patient care hours of

all paid hospice employees and contract

staff.

L169 The hospice must document a continuing

level of volunteer activity.

L170 Expansion of care and services achieved

through the use of volunteers including

the types of services and the time worked,

must be recorded.

L171 418.70(f) Standard: Availability of clergy.

The hospice must make reasonable efforts

to arrange for visits of clergy and other

members of religious organizations in the

community to patients who request such

visits and must advise patients of this

opportunity.

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L172 418.72 Condition of participation-Licensure. 418.72 Guidelines:

The hospice and all hospice employees must be All professional and State licenses must be available upon request. Notify the regional office

licensed in accordance with applicable Federal, (RO) if you observe non-compliance with the laws of other Federal agencies relating to the

State and local laws and regulations. hospice program. The RO will notify the Federal agency of the observations.

418.72 Probe:

How does the hospice assure that all professional employees and personnel have current

licenses and/or registration?

418.72(a) Guidelines:

Be aware of all State and local laws covering the licensure of hospices. In order for §418.72 to

be determined NOT MET, the State or local agency must have completed action to revoke the

hospice's license or the hospice must have failed to apply for a license. If a State or local

agency has a licensure law, but does not revoke the hospice's license when the requirements are

not met, the hospice will be considered to be in conformance with State and local laws until such

time as the State license is revoked.

418.72(b) Guidelines:

The hospice must have a procedure for verifying the validity of a hospice employee's license or

registration. Professional and paraprofessional volunteers must meet all necessary standards,

registration and licensure requirements associated with their specialty area(s) the same as if they

were salaried employees.

418.74 Guidelines:

The clinical record must contain sufficient information to show that the hospice is aware of the

current status of the patient/caregiver, accurate documentation of the care/services provided to

the patient/caregiver and the results of the care provided.

A hospice which has created the option for an individual's record to be maintained

electronically, rather than in hard copy, may use electronic signatures as long as there is a

process for reconstruction of the information, and there are safeguards to prevent unauthorized

access to the records. The following guidelines must be in place and operational before such a

system would be acceptable:

L173 418.72(a) Standard: Licensure of program.

If State or local law provides for licensing of

hospices, the hospice must be licensed.

L174 418.72(b) Standard: Licensure of employees.

Employees who provide services must be

licensed, certified or registered in accordance

with applicable Federal or State laws.

L175 418.74 Condition of participation-Central clinical

records.

L176 In accordance with accepted principles of

practice, the hospice must establish and

maintain a clinical record for every individual

receiving care and services. The record must

be complete, promptly and accurately

documented, readily accessible and

systematically organized to facilitate retrieval.

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418.74(a) Standard: Content. 418.74(a) Guidelines:

o The hospice has a written policy describing the authentication policy(ies) in force at the facility;

o The computer has built-in safeguards to minimize the possibility of fraud;

o Each person responsible for an entry has an individualized identifier;

o The hospice has the responsibility to demonstrate that the identifier is used under safeguards to

assure that no one but the person assigned the code uses the code.

o A secret password known only to the user is to be employed to maintain confidentiality.

o The date and time is recorded from the computer's internal clock at the time of entry;

o An entry is not to be changed after it has been recorded;

o The computer program controls what sections/areas any individual can access or enter data,

based on the individual's personal identifier (and, therefore, his/her level of professional

qualifications).

A hospice is not precluded by the statute or regulations from providing services at locations other than

the site to which a provider number has been assigned. However, all hospice patients' clinical records

must be available to the surveyor at the time of the survey. If you have concerns about the provision of

services at any outlying hospice location, home visits should be made to beneficiaries receiving services

from those locations.

418.74 Probe:

How does the hospice ensure that the records of all patients, including those who live in outlying areas,

are accurately documented, readily accessible, and systematically organized?

The use of initials is acceptable provided the record identifies the initials with the signer's signature and

title. Entries are made for care, services, observations, and assessments, and are signed by the person

who provided the care, service, observations, and assessment. Signed physician orders which have

been sent to the hospice by facsimile (FAX) machines are acceptable. However, the hospice is

responsible for obtaining original signatures if an issue surfaces that would require verification of an

original signature.

A hospice may store clinical and health insurance records on microfilm or optical disk imaging systems.

All material must be available for review by HCFA, the intermediary, DHHS audit, or other specially

designated components for bill review, audit, or other examination during the retention period.

All clinical records, along with any necessary equipment to read them, must be made available during the

survey.

L177 Each clinical record is a comprehensive

compilation of information.

L178 Entries are made for all services

provided.

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L179 Entries are made and signed by the person 418.74(a) Probes:

providing the services. The record includes all

services whether furnished directly or under How does coordination of services among the various staff members occur?

arrangements made by the hospice.

What documentation is there that indicates that the physician's orders in the plan of care are

being implemented both in the home and the inpatient setting?

418.74(b) Probes:

How are the clinical records stored to protect them from physical destruction and unauthorized

use?

What written policies and procedures govern the use, removal and release of clinical records?

L180 Each individual's record contains (1) The initial

and subsequent assessments;

L181 (2) The plan of care;

L182 (3) Identification data;

L183 (4) Consent and authorization and election

forms;

L184 (5) Pertinent medical history; and

L185 (6) Complete documentation of all services and

events (including evaluations, treatments,

progress notes, etc.).

L186 418.74(b) Standard: Protection of information.

The hospice must safeguard the clinical record

against loss, destruction and unauthorized

use.

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L187 418.80 Condition of participation-Furnishing of 418.80 Guidelines:

Core Services.

What measures does the hospice use to protect the patient's confidentiality?

For certification purposes, an individual is considered an employee of the hospice if the hospice

pays the individual directly for services performed on an hourly or per visit basis and the hospice

is required to issue a form W-2 on his/her behalf. If a contracting service or agency pays the

individual, and is required to issue a form W-2 on the individual's behalf, or if the individual is

self-employed, the individual is not considered a hospice employee.

A hospice employee may also be an appropriately trained employee of the agency of which the

hospice is a sub-division if the individual divides work time between the parent organization and

the hospice. However, the hospice must maintain a record of the individual's assigned time

which is distinctly identifiable as hospice time.

An individual is also considered a hospice employee if the individual is a volunteer under the

jurisdiction of the hospice. See §418.3.

The hospice must maintain coordination of all staff to ensure continuity of care.

418.80 Probes:

What evidence is there that the core staff employed by the hospice is able to provide all needed

services to hospice patients, including continuous home care, on an ongoing, routine basis?

How does the hospice ensure that the services provided are consistent with the established plan

of care?

What evidence is there that the hospice provides training in hospice philosophy and care to

contract providers?

418.82 Guidelines:

This individual may also be a member of the IDG and may be a coordinator. Supervision should

include clinical record review, written and/or verbal instructions, plan of care review, and

observations in the clinical area.

For guidelines on services provided in accordance with recognized standards of practice, see

§418.50(b)(3).

L188 Except as permitted in §418.83, a hospice must

ensure that substantially all the core services

described in this subpart are routinely

provided directly by hospice employees.

L189 A hospice may use contracted staff if

necessary to supplement hospice employees

in order to meet the needs of patients during

periods of peak patient loads or under

extraordinary circumstances. If contracting is

used, the hospice must maintain professional,

financial, and administrative responsibility for

the services and must assure that the

qualifications of staff and services provided

meet the requirements specified in this

subpart. (§§418.80-418.88)

L190 418.82 Condition of participation-Nursing

services.

L191

The hospice must provide nursing care and

services by or under the supervision of a

registered nurse.

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L192 (a) Nursing services must be directed and 418.82 Probe:

staffed to assure that the nursing needs of

patients are met. What evidence is there that nursing services are provided based on a nursing assessment and in

accordance with the plan of care?

418.83 Guidelines

If a hospice claims to have a waiver, there must be written evidence from HCFA to that effect. If

there is any question concerning a waiver, contact the RO.

L193 (b) Patient care responsibilities of nursing

personnel must be specified.

L194 (c) Services must be provided in

accordance with recognized standards of

practice.

418.83 Nursing services-Waiver of

requirement that substantially all nursing

services be routinely provided directly by

a hospice.

(a) HCFA may approve a waiver of the

requirement in §418.80 for nursing

services provided by a hospice which is

located in a non-urbanized area. The

location of a hospice that operates in

several areas is considered to be the

location of its central office. The hospice

must provide evidence that it was

operational on or before January 1, 1983,

and that it made a good faith effort to hire

a sufficient number of nurses to provide

services directly. HCFA bases its

decision as to whether to approve a

waiver application on the following:

(1) The current Bureau of the Census

designations for determining nonurbanized

areas.

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(2) Evidence that a hospice was

operational on or before January 1, 1983

including:

(i) Proof that the organization was

established to provide hospice services

on or before January 1, 1983;

(ii) Evidence that the hospice-type

services were furnished to patients on or

before January 1, 1983; and

(iii) Evidence that the hospice care was a

discrete activity rather than an aspect of

another type of provider's patient care

program on or before January 1, 1983.

(3) Evidence that a hospice made a good

faith effort to hire nurses, including:

(i) Copies of advertisements in local

newspapers that demonstrate recruitment

efforts;

(ii) Job descriptions for nurse employees;

(iii) Evidence that salary and benefits are

competitive for the area; and

(iv) Evidence of any other recruiting

activities (e.g., recruiting efforts at health

fairs and contacts with nurses at other

providers in the area);

(b) Any waiver request is deemed to be

granted unless it is denied within 60 days

after it is received.

(c) Waivers will remain effective for one

year at a time.

(d) HCFA may approve a maximum of two

one-year extensions for each initial

waiver. If a hospice wishes to receive a

one-year extension, the hospice must

submit a certification to HCFA, prior to

the expiration of the waiver

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period, that the employment market for

nurses has not changed significantly

since the time the initial waiver was

418.84 Guidelines:

A social worker is defined at §418.3 as a person who has at least a bachelor's degree from a school

accredited or approved by the Council on Social Work Education.

The social worker's services are provided in accordance with the plan of care. Because social work

services must be provided under the direction of a physician, physician approval of the plan of

care will satisfy the intent of this requirement.

418.84 Probe:

What evidence is there that each patient/family has received an assessment of their psychosocial

needs and that the plan of care has identified ways to meet the needs identified in this assessment

as required by §418.58(c)?

418.86 Guidelines:

The attending physician is the physician identified by the patient, at the time he/she elects to

receive hospice care, as the one who is primarily responsible for the individual's medical care. (See

§418.3.)

Oversight of physician services in the hospice is generally considered to be the responsibility of

the medical director. The medical director should complement the attending physician's care, act

as a medical resource to IDG members, and assure overall continuity of the hospice program's

medical services. These services, to meet general medical needs, must be provided by the hospice

to the extent that they are not met by others. The most important aspect of physician services is

that the individual receives appropriate measures to control uncomfortable symptoms.

418.86 Probes:

How does the hospice assure that each physician maintains a current license in the State in which

the physician is practicing?

What evidence is there in the clinical record of physician involvement with the patient and the

IDG?

L195 418.84 Condition of participation-Medical

social services.

Medical social services must be provided

by a qualified social worker, under the

direction of a physician.

L196 418.86 Condition of participation-

Physician services.

In addition to palliation and management

of terminal illness and related conditions,

physician employees of the hospice,

including the physician member(s) of the

interdisciplinary group, must also meet

the general medical needs of the patients

to the extent that these needs are not met

by the attending physician.

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What system is in place to ensure than any necessary medical orders are signed by a physician?

Signed physician's orders that are faxed are acceptable. See guidelines at §418.74(a).

418.88 Guidelines:

Counseling services are core services and must routinely be provided directly by hospice

employees. (See §418.80.) A hospice may use contracted staff for core services only under

extraordinary circumstances, similar to when nursing services are provided to supplement hospice

employees in order to meet patients' needs during periods of peak patient loads. If contracting is

used, the hospice must continue to maintain professional, financial, and administrative

responsibility for the services. If the hospice provides all of its overall counseling services

directly through hospice employees, it could, in a specific situation, provide a particular

counseling service entirely through a contract with an individual who is not a hospice employee or

a separate entity such as a hospital. In this situation, the hospice must document in detail the

extraordinary circumstances which warrant the use of contracted staff to provide core services.

418.88(a) Guidelines:

Bereavement counseling is provided based on an assessment of the family/caregiver's needs, the

presence of any risk factors associated with the patient's death, and the ability of the

family/caregiver to cope with grief. (See §418.3.)

The supervisor of bereavement services may be the IDG social worker or other professional with

documented evidence of training and experience in dealing with grief.

Documentation for bereavement counseling does not necessarily have to be contained in the

clinical record, but must be maintained by the hospice in some form in an organized, easily

retrievable manner.

418.88(a) Probes:

How does the hospice ensure that each patient/caregiver is assessed for the need for bereavement

counseling?

How does the hospice counsel those individuals who are at risk for pathological grief?

L197 418.88 Condition of participation-

Counseling services.

L198 Counseling services must be available to

both the individual and the family.

Counseling includes bereavement

counseling, provided after the patient's

death, as well as dietary, spiritual and any

other counseling services for the

individual and family provided while the

individual is enrolled in the hospice.

L199 418.88(a) Standard: Bereavement

counseling.

There must be an organized program for

the provision of bereavement services

under the supervision of a qualified

professional.

L200 The plan of care for these services should

reflect family needs, as well as a clear

delineation of services to be provided and

the frequency of service delivery (up to

one year following the death of the

patient). A special coverage provision for

bereavement counseling is specified

§418.204(c).

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L201 418.88(b) Standard: Dietary counseling. 418.88(b) Guidelines:

Dietary counseling, when required, must Dietary counseling must be available to the caregiver/family and patient, but must relate to the

be provided by a qualified individual. patient's needs rather than the personal needs of the caregiver/family. Dietary counseling may be

provided to family members to enable them to prepare food for the patient.

Dietary counseling should be planned by a person who has relevant education or training. The

actual counseling may be delegated to another individual. The dietician does not have to be a full

time employee of the hospice.

418.88(c) Guidelines:

At a minimum, the hospice should discuss the patient's religious preference, if any, and assist the

patient in evaluating his/her spiritual needs.

418.88(c) Probe:

How does the hospice address the spiritual needs/concerns of the patients?

What evidence is there in the clinical record that indicates that assistance has been offered to

provide the patient an opportunity for counseling with his/her choice of available clergy?

418.88(d) Probe:

What evidence is there that the counseling services are provided by persons whose skills and

training are appropriate for the counseling provided?

418.90 Probe:

How does the hospice decide what services at §§418.92-418.98 it will provide under contract and

what services it will provide directly?

Is there evidence that the hospice is able to provide patients with all the services described in

§§418.92 - 418.98?

L202 418.88(c) Standard: Spiritual Counseling.

Spiritual counseling must include notice

to patients as to the availability of clergy

as provided in §418.70(f).

L203 418.88(d) Standard: Additional

counseling.

Counseling may be provided by other

members of the interdisciplinary group as

well as by other qualified professionals as

determined by the hospice.

L204 418.90 Condition of participation-

Furnishing of other services.

A hospice must ensure that the services

described in this subpart are provided

directly by hospice employees or under

arrangements made by the hospice as

specified in §418.56.

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L205 418.92 Condition of participation- 418.92 Probe:

Physical therapy, occupational therapy,

and speech-language pathology. What evidence is there that these services are provided when needed, as determined in the plan of

care?

How does the hospice verify that the professionals providing these services are appropriately

trained and supervised?

418.92(b)(1) Guideline:

Determine if the hospice is providing laboratory testing as set forth at 42 CFR 493. If the hospice is

performing testing, request to see the CLIA certificate for the level of testing being performed, i.e., a

certificate of waiver, certificate for physician-performed microscopy procedures, certificate of

accreditation, certificate of registration or certificate for moderate or high complexity testing.

Hospices holding a certificate of waiver are limited to performing only those tests determined to be in

the waived category. These are:

o Dipstick/tablet reagent urinalysis non-automated (includes 10 analytes);

o Fecal occult blood;

o Ovulation test kits - Visual color comparison tests for human luteinizing hormone;

o Urine pregnancy test - visual color comparison tests;

o Erythrocyte sedimentation rate (non-automated);

o Hemoglobin - copper sulfate (non-automated);

o Blood glucose by glucose monitoring devices cleared by the Food and Drug Administration

(FDA) specifically for home use;

o Spun microhematocrit; and

o Hemoglobin by single analyte instruments with self-contained or component features to

perform specimen/reagent interaction, providing direct measurement and readout (e.g.,

HemaCue).

Hospices holding a certificate for physician-performed microscopy procedures are limited to

performing only those tests determined to be in the physician-performed microscopy procedure

category listed below or in combination with waived tests:

L206 (a) Physical therapy services,

occupational therapy services, and

speech-language pathology services

must be available, and when provided,

offered in a manner consistent with

accepted standards of practice.

L207 (b)(1) If the hospice 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 FDA, such testing must

be in compliance with all applicable

requirements of part 493 of this chapter.

(2) If the hospice chooses to refer

specimens for laboratory testing to

another laboratory, 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.

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o Wet mounts, including preparations of vaginal, cervical or skin specimens;

o All potassium hydroxide preparations;

o Pinworm examinations;

o Fern tests;

o Post-coital direct, qualitative examinations of vaginal or cervical mucous;

o Urine sediment examinations.

These tests must be performed by a physician on his or her own patients or the patients of the

medical group practice of which the physician is a member. If performed by anyone else, the

performance of these tests would require a registration certificate, certificate of accreditation or

certificate.

If the hospice performs any other testing procedures, it would require a laboratory registration

certificate.

For example, if you determine that the hospice staff is only assisting a patient to use his/her own

glucometer, CLIA regulations do not apply. However, if hospice staff are actually responsible for

measuring the blood glucose level of patients with an FDA approved glucometer, and no other

tests are being performed, request to see the facility's certificate of waiver, since glucose testing

with a glucometer (approved by the FDA specifically for home use) is a waived test under the

provisions at 42 CFR 493.15.

If the facility does not possess the appropriate CLIA certificate, inform the facility that it is in

violation of CLIA and that it must apply immediately to the HCFA for the appropriate certificate.

Also, refer this facility's non-compliance to the SA personnel responsible for CLIA laboratory

surveys.

418.94 Guidelines:

In accordance with §484.4, a home health aide must successfully complete a training and

competency evaluation program or a competency evaluation program.

In accordance with §484.36, the aide training program must address each of the following subject

areas through classroom and supervised practical training totalling at least 75 hours, with at least

16 hours devoted to supervised practical training. The individual being trained must complete at

least 16 hours of classroom training before beginning the supervised practical training.

"Supervised practical training" means training in a laboratory or other setting in which the trainee

demonstrates knowledge while performing tasks on an individual under the direct supervision of a

registered nurse or licensed practical nurse. A "pseudo-patient," not a mannequin may be used

for training.

L208 418.94 Condition of participation-Home

health aide and homemaker services.

L209 Home