(a) There shall be an identified governing body responsible
for the organization, management, control, and operation of the facility,
including the appointment of the facility's medical director as defined
in §117.2(48) of this title (relating to Definitions).
(1) A qualified medical director is a physician who
is board certified in internal medicine by the American Board of Internal
Medicine or pediatrics by the American Board of Pediatrics or is board
certified in nephrology or pediatric nephrology, and has at least
12 months of experience providing care to patients receiving dialysis.
(2) A facility may request a waiver to appoint or retain
as medical director a physician who does not meet one or more of the
qualifications in paragraph (1) of this subsection. The waiver shall
explain why a physician meeting the board certification requirement
is not available and include a resume of the physician the facility
seeks to appoint or retain. A written request for waiver shall be
made through the Texas Department of State Health Services, Health
Facility Compliance Group, Mail Code 1979, P.O. Box 149347, Austin,
Texas, 78714-9347 for transmission to CMS.
(b) The governing body shall develop, implement, and
enforce policies and procedures for all services provided by the facility.
(c) The governing body shall ensure that the medical
staff has current bylaws, rules and regulations that are adopted,
implemented, and enforced.
(d) The governing body shall ensure that effective
administrative rules, regulations, and policies designed to protect
the health and safety of patients are implemented and reviewed annually.
(e) The governing body shall ensure that there is a
quality assessment and performance improvement (QAPI) program to evaluate
the provision of patient care. The governing body shall review and
monitor QAPI activities quarterly.
(f) The governing body shall ensure that all facility
staff are qualified (i.e., advanced practice registered nurse, physician
assistant, registered nurse, licensed vocational nurse, licensed master
social worker, registered dietitian, patient care technician, and
other technical staff) to serve the complex needs of dialysis patients
and deliver dialysis services. The registered nurse, licensed vocational
nurse, patient care technician and other technical staff must demonstrate
and sustain the skills needed to perform the specific duties of their
positions.
(g) The governing body shall ensure adequate numbers
of qualified personnel are present whenever patients are undergoing
dialysis so that the patient/staff ratio is appropriate to the level
of dialysis care given and meets the needs of patients.
(h) The governing body shall review and approve the
facility's training program for staff, patients, and/or patient's
caregiver.
(i) The governing body shall develop, implement, and
enforce policies and procedures relating to the facility's disaster
preparedness plan, to meet the requirements of §117.45(b) of
this title (relating to Provision and Coordination of Treatment and
Services). The plan shall address the continuity of essential building
systems including emergency power and water, or a contract with another
licensed ESRD facility to provide emergency contingency care to patients
to meet the requirements of §117.91(h) of this title (relating
to Fire Prevention, Protection, and Emergency Contingency Plan).
(j) The governing body shall ensure that all equipment
utilized by facility staff and/or patients is properly maintained
in accordance with the manufacturer's direction for use.
(k) The governing body shall ensure a physical environment
that protects the health and safety of patients, personnel, and the
public. The physical premises of the facility and those areas of the
facility's surrounding physical structure that are used by the patients
(including stairwells, corridors, and passageways) shall meet the
local building and fire safety codes as they relate to design and
space requirements for safe access and patient privacy.
(l) The governing body shall develop, implement, and
enforce policies and procedures regarding disruptive patients or family
members to ensure the health and safety of patients, personnel and
the public.
(m) The governing body shall ensure that personnel
shall be assigned to assist a social worker(s) with ancillary tasks
(e.g., assistance with financial services, transportation, administrative,
clerical, etc.), when the patient load, including all modalities,
exceeds 100 patients per facility. The maximum patient load, including
all modalities, per full-time equivalent qualified social worker,
with assigned personnel assistance, is 125 patients.
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