[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR484.14]

[Page 576-578]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 484_HOME HEALTH SERVICES--Table of Contents
 
                        Subpart B_Administration
 
Sec. 484.14  Condition of participation: Organization, services, and 
administration.

    Organization, services furnished, administrative control, and lines 
of authority for the delegation of responsibility down to the patient 
care level are clearly set forth in writing and are readily 
identifiable. Administrative and supervisory functions are not delegated 
to another agency or organization and all services not furnished 
directly, including services provided through subunits are monitored and 
controlled by the parent agency. If an agency has subunits, appropriate 
administrative records are maintained for each subunit.
    (a) Standard: Services furnished. Part-time or intermittent skilled 
nursing services and at least one other therapeutic service (physical, 
speech, or occupational therapy; medical social services; or home health 
aide services) are made available on a visiting basis, in a place of 
residence used as a patient's home. An HHA must provide at

[[Page 577]]

least one of the qualifying services directly through agency employees, 
but may provide the second qualifying service and additional services 
under arrangements with another agency or organization.
    (b) Standard: Governing body. A governing body (or designated 
persons so functioning) assumes full legal authority and responsibility 
for the operation of the agency. The governing body appoints a qualified 
administrator, arranges for professional advice as required under Sec. 
484.16, adopts and periodically reviews written bylaws or an acceptable 
equivalent, and oversees the management and fiscal affairs of the 
agency.
    (c) Standard: Administrator. The administrator, who may also be the 
supervising physician or registered nurse required under paragraph (d) 
of this section, organizes and directs the agency's ongoing functions; 
maintains ongoing liaison among the governing body, the group of 
professional personnel, and the staff; employs qualified personnel and 
ensures adequate staff education and evaluations; ensures the accuracy 
of public information materials and activities; and implements an 
effective budgeting and accounting system. A qualified person is 
authorized in writing to act in the absence of the administrator.
    (d) Standard: Supervising physician or registered nurse. The skilled 
nursing and other therapeutic services furnished are under the 
supervision and direction of a physician or a registered nurse (who 
preferably has at least 1 year of nursing experience and is a public 
health nurse). This person, or similarly qualified alternate, is 
available at all times during operating hours and participates in all 
activities relevant to the professional services furnished, including 
the development of qualifications and the assignment of personnel.
    (e) Standard: Personnel policies. Personnel practices and patient 
care are supported by appropriate, written personnel policies. Personnel 
records include qualifications and licensure that are kept current.
    (f) Standard: Personnel under hourly or per visit contracts. If 
personnel under hourly or per visit contracts are used by the HHA, there 
is a written contract between those personnel and the agency that 
specifies the following:
    (1) Patients are accepted for care only by the primary HHA.
    (2) The services to be furnished.
    (3) The necessity to conform to all applicable agency policies, 
including personnel qualifications.
    (4) The responsibility for participating in developing plans of 
care.
    (5) The manner in which services will be controlled, coordinated, 
and evaluated by the primary HHA.
    (6) The procedures for submitting clinical and progress notes, 
scheduling of visits, periodic patient evaluation.
    (7) The procedures for payment for services furnished under the 
contract.
    (g) Standard: Coordination of patient services. All personnel 
furnishing services maintain liaison to ensure that their efforts are 
coordinated effectively and support the objectives outlined in the plan 
of care. The clinical record or minutes of case conferences establish 
that effective interchange, reporting, and coordination of patient care 
does occur. A written summary report for each patient is sent to the 
attending physician at least every 60 days.
    (h) Standard: Services under arrangements. Services furnished under 
arrangements are subject to a written contract conforming with the 
requirements specified in paragraph (f) of this section and with the 
requirements of section 1861(w) of the Act (42 U.S.C. 1495x(w)).
    (i) Standard: Institutional planning. The HHA, under the direction 
of the governing body, prepares an overall plan and a budget that 
includes an annual operating budget and capital expenditure plan.
    (1) Annual operating budget. There is an annual operating budget 
that includes all anticipated income and expenses related to items that 
would, under generally accepted accounting principles, be considered 
income and expense items. However, it is not required that there be 
prepared, in connection with any budget, an item by item identification 
of the components of each type of anticipated income or expense.
    (2) Capital expenditure plan. (i) There is a capital expenditure 
plan for at

[[Page 578]]

least a 3-year period, including the operating budget year. The plan 
includes and identifies in detail the anticipated sources of financing 
for, and the objectives of, each anticipated expenditure of more than 
$600,000 for items that would under generally accepted accounting 
principles, be considered capital items. In determining if a single 
capital expenditure exceeds $600,000, the cost of studies, surveys, 
designs, plans, working drawings, specifications, and other activities 
essential to the acquisition, improvement, modernization, expansion, or 
replacement of land, plant, building, and equipment are included. 
Expenditures directly or indirectly related to capital expenditures, 
such as grading, paving, broker commissions, taxes assessed during the 
construction period, and costs involved in demolishing or razing 
structures on land are also included. Transactions that are separated in 
time, but are components of an overall plan or patient care objective, 
are viewed in their entirety without regard to their timing. Other costs 
related to capital expenditures include title fees, permit and license 
fees, broker commissions, architect, legal, accounting, and appraisal 
fees; interest, finance, or carrying charges on bonds, notes and other 
costs incurred for borrowing funds.
    (ii) If the anticipated source of financing is, in any part, the 
anticipated payment from title V (Maternal and Child Health and Crippled 
Children's Services) or title XVIII (Medicare) or title XIX (Medicaid) 
of the Social Security Act, the plan specifies the following:
    (A) Whether the proposed capital expenditure is required to comform, 
or is likely to be required to conform, to current standards, criteria, 
or plans developed in accordance with the Public Health Service Act or 
the Mental Retardation Facilities and Community Mental Health Centers 
Construction Act of 1963.
    (B) Whether a capital expenditure proposal has been submitted to the 
designated planning agency for approval in accordance with section 1122 
of the Act (42 U.S.C. 1320a-1) and implementing regulations.
    (C) Whether the designated planning agency has approved or 
disapproved the proposed capital expenditure if it was presented to that 
agency.
    (3) Preparation of plan and budget. The overall plan and budget is 
prepared under the direction of the governing body of the HHA by a 
committee consisting of representatives of the governing body, the 
administrative staff, and the medical staff (if any) of the HHA.
    (4) Annual review of plan and budget. The overall plan and budget is 
reviewed and updated at least annually by the committee referred to in 
paragraph (i)(3) of this section under the direction of the governing 
body of the HHA.
    (j) Standard: Laboratory services. (1) If the HHA 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 HHA 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.

[54 FR 33367, August 14, 1989, as amended at 56 FR 32973, July 18, 1991; 
56 FR 51334, Oct. 11, 1991; 57 FR 7136, Feb. 28, 1992; 66 FR 32778, June 
18, 2001]