TITLE
8 SOCIAL SERVICES
CHAPTER
370 OVERSIGHT OF LICENSED HEALTHCARE
FACILITIES AND COMMUNITY BASED WAIVER PROGRAMS
PART
24 REQUIREMENTS FOR END STAGE
RENAL DISEASE FACILITIES
8.370.24.1 ISSUING AGENCY: New Mexico Health Care Authority.
[8.370.24.1
NMAC - N, 7/1/2024]
8.370.24.2 SCOPE: These regulations apply to:
A. public,
profit or nonprofit facilities or entities providing dialysis services as
outlined by these regulations;
B. any
facility providing services as outlined by these regulations which by federal
regulation must be licensed by the state of New Mexico to obtain or maintain
full or partial, permanent or temporary federal funding.
[8.370.24.2
NMAC - N, 7/1/2024]
8.370.24.3 STATUTORY AUTHORITY: The regulations set forth herein are
promulgated pursuant to the general authority granted under Subsection E of
Section 9-7-6 NMSA 1978; and the authority granted under Subsection D of
Section 24-1-2, Subsection I of Section 24-1-3, and Section 24-1-5 of the
Public Health Act, NMSA 1978, as amended. Section 9-8-1 et seq. NMSA 1978 establishes the health care
authority as a single, unified department to administer laws and exercise
functions relating to health care purchasing and regulation.
[8.370.24.3
NMAC - N, 7/1/2024]
8.370.24.4 DURATION: Permanent.
[8.370.24.4
NMAC - N, 7/1/2024]
8.370.24.5 EFFECTIVE DATE: July 1, 2024, unless a different date is
cited at the end of a section.
[8.370.24.5
NMAC - N, 7/1/2024]
8.370.24.6 OBJECTIVE:
A. Establish
minimum standards for end stage renal disease facilities in the state of New
Mexico.
B. Monitor
end stage renal disease facilities with these regulations through surveys to
identify any areas which could be dangerous or harmful to the patients or
staff.
C. Encourage
the maintenance of end stage renal disease facilities that will provide quality
services which maintain or improve the health and quality of life for the
patients.
[8.370.24.6
NMAC - N, 7/1/2024]
8.370.24.7 DEFINITIONS: For purposes of these regulations the
following shall apply:
A. “Applicant”
means the individual who, or organization which, applies for a license. If the applicant is an organization, then the
individual signing the application on behalf of the organization must have
authority from the organization. The
applicant must be the owner.
B. “Deficiency”
means a violation of or failure to comply with a provision(s) of these
regulations.
C. “License”
means the document issued by the licensing authority pursuant to these
regulations granting the legal right to operate for a specified period of time,
not to exceed one year.
D. “Licensee”
means the person(s) who, or organization which, has an ownership, leasehold or
similar interest in the end stage renal disease facility and in whose name a
license has been issued and who is legally responsible for compliance with
these regulations.
E. “Licensing authority”
means the New Mexico health care authority.
F. “NMSA”
means the New Mexico Statutes Annotated, 1978 compilation, and all the
revisions and compilations thereof.
G. “Plan of correction”
means the plan submitted by the licensee or representative of the licensee
addressing how and when deficiencies identified at time of a survey will be
corrected.
H. “Policy”
means a statement of principal that guides and determines present and future
decisions and actions.
I. “Procedure”
means the action(s) that must be taken in order to implement a policy.
J. “Variance”
means an act on the part of the licensing authority to refrain from pressing or
enforcing compliance with a portion or portions of these regulations for an
unspecified period of time where the granting of a variance will not create a
danger to the health, safety, or welfare of patients or staff of a facility,
and is at the sole discretion of the licensing authority.
K. “Waive/waiver”
means to refrain from pressing or enforcing compliance with a portion or
portions of these regulations for a limited period of time provided the health,
safety or welfare of the patients and staff are not in danger. Waivers are issued at the sole discretion of
the licensing authority.
[8.370.24.7
NMAC - N, 7/1/2024]
8.370.24.8 STANDARD OF COMPLIANCE: The degree of compliance required throughout
these regulations is designated by the use of the words “shall” or “must” or
“may.” “Shall” or “must” means
mandatory. “May” means permissive. The use of the words “adequate”, “proper”,
and other similar words means the degree of compliance that is generally
accepted throughout the professional field by those who provide dialysis
services as outlined in these regulations.
[5/7/1991;
Recompiled 7/1/2024]
8.370.24.9 TYPES OF END STAGE RENAL DISEASE
(ESRD) FACILITIES AND SCOPE OF SERVICES:
A. Renal
transplantation center: A hospital unit which is approved to
furnish directly, transplantation and other medical and surgical specialty
services required for the care of the ESRD transplant patients, including
inpatient dialysis furnished directly or under arrangement. A renal transplantation center may also be a
renal dialysis center.
B. Renal
dialysis center: A hospital unit which
is approved and licensed to furnish the full spectrum of diagnostic,
therapeutic, and rehabilitative services required for the care of ESRD dialysis
patients (including inpatient dialysis furnished directly or under
arrangement). A hospital need not
provide renal transplantation to qualify as a renal dialysis center.
C. Renal dialysis
facility: A unit which is located in a
building other than a hospital which is approved and licensed to furnish
dialysis services directly to ESRD patients.
D. Self dialysis
unit: A unit that is within a licensed
renal transplantation center, renal dialysis center, or a renal dialysis
facility, which provides self-dialysis service.
E. Special purpose
renal dialysis facility: A renal
dialysis facility which is approved and licensed pursuant to these regulations
to provide dialysis at special locations on a short term basis (not to exceed
eight months) to a group of dialysis patients otherwise unable to obtain
treatment in the geographical area. The
special locations must be either special rehabilitative (including vacation)
locations serving ESRD patients temporarily residing there, or locations in
need of ESRD facilities under emergency circumstances.
F. End stage renal
disease (ESRD) services: The types of
care or services furnished to an ESRD patient are:
(1) transplantation
service which is a process by which:
(a) a kidney is excised from a live or
cadaveric donor;
(b) that kidney is implanted in an ESRD
patient;
(c) supportive care is furnished to the
living donor and to the recipient following implantation;
(d) this service is only provided at an
approved and licensed transplantation center.
(2) inpatient dialysis which because of
medical necessity, is furnished to an ESRD patient on a temporary inpatient
basis in a hospital. This service may
only be provided by a transplantation center or renal dialysis center.
(3) outpatient
dialysis is dialysis furnished on an outpatient basis at a licensed
transplantation center, renal dialysis center, or renal dialysis facility and
includes:
(a) staff assisted dialysis which is
dialysis performed by the staff of the center or facility;
(b) self dialysis which is performed with
little or no professional assistance, by an ESRD patient who has completed an
appropriate course of training;
(c) home dialysis performed by an
appropriately trained patient at home.
(4) self
dialysis and home dialysis training in which the licensed ESRD transplantation
center, renal dialysis center, or renal dialysis facility provides a program
that trains ESRD patients to perform self-dialysis or home dialysis with little
or no professional assistance, and trains other individuals to assist patients
in performing self-dialysis or home dialysis.
[8.370.24.9
NMAC - N, 7/1/2024]
8.370.24.10 INITIAL LICENSURE PROCEDURES: To obtain an initial license for a end stage
renal disease facility pursuant to these regulations the following procedures
must be followed by the applicant:
A. Initial
phase: These regulations should be
thoroughly understood by the applicant and used as a reference for design of a
new building or renovation or addition to an existing building for licensure as
a ESRD facility pursuant to these regulations.
Prior to starting construction, renovations or additions to an existing
building the applicant of the proposed ESRD facility shall advise the licensing
authority of intention to open an ESRD facility pursuant to these regulations
and submit the following:
(1) Plans: Submit a complete set of construction
documents (blueprints) for the total building.
Plans should indicate if new construction, remodeled or alteration, or
an addition. If remodeled or an addition
the plans must indicate existing and new construction.
(2) Functional
program outline: The proposed end stage
renal disease facility must also submit to the licensing authority a functional
program outline that provides the following information:
(a) scope of services to be provided by
the proposed ESRD facility;
(b) projected number of patients to be
served daily;
(c) number of staff and duties to be
performed;
(d) services that will be provided under
agreement or arrangement with another facility;
(e) number of dialysis stations,
treatment rooms and other rooms for diagnostic use such as X-ray, laboratory,
etc.
B. Construction
phase:
During the construction of a new building or renovations or
additions to an existing building the applicant must coordinate with the
licensing authority and submit any changes to the blueprints or plans for
approval before making such changes.
C. Licensing
phase: Prior to completion of
construction, renovation or addition to an existing building the applicant will
submit to the licensing authority the following:
(1) Application
form:
(a) will be provided by the licensing
authority;
(b) all information requested on the
application must be provided;
(c) will be printed or typed;
(d) will be dated and signed;
(e) will be notarized.
(2) Fees: All applications for licensure must be
accompanied by the required fee.
(a) Current fee schedules will be
provided by the licensing authority.
(b) Fees must be in the form of a
certified check, money order, personal, or business check made payable to the
state of New Mexico.
(c) Fees are non-refundable.
(3) Zoning
and building approval:
(a) All initial applications must be
accompanied with written zoning approval from the appropriate authority (city,
county or municipality).
(b) All initial applications must be
accompanied with written building approval (certificate of occupancy) from the
appropriate authority (city, county, or municipality).
(4) Fire
authority approval: All initial
applications must be accompanied with written approval of the fire authority
having jurisdiction.
(5) New Mexico environment department
approval: All initial applications must
be accompanied by written approval of the dnvironmental department for the
following:
(a) private water supply, if applicable;
(b) private waste or sewage disposal, if
applicable;
(c) X-ray equipment, if applicable.
(6) Copy of appropriate drug permit
issued by the state board of pharmacy, if applicable.
(7) Initial
survey: Upon receipt of a properly
completed application with all supporting documentation as outlined above an
initial survey of the proposed end stage renal disease facility will be
scheduled by the licensing authority.
(8) Issuance
of license: Upon completion of the
initial survey and determination that the end stage renal disease facility is
in compliance with these regulations the licensing authority will issue a
license.
[8.370.24.10
NMAC - N, 7/1/2024]
8.370.24.11 LICENSES:
A. Annual
license: An annual license is issued for a one
year period to an end stage renal disease facility which has met all requirements
of these regulations.
B. Temporary
license: The licensing authority may, at its
sole discretion, issue a temporary license prior to the initial survey, or when
the licensing authority finds partial compliance with these regulations.
(1) A temporary license shall cover a
period of time, not to exceed 120 days, during which the facility must correct
all specified deficiencies.
(2) In accordance with Subsection D of Section
24-1-5 NMSA 1978, no more than two consecutive temporary licenses shall be
issued.
C. Amended license: A
licensee must apply to the licensing authority for an amended license when
there is a change of administrator/director, or when there is a change of name
for the facility.
(1) Application must be on a form
provided by the licensing authority.
(2) Application must be accompanied by
the required fee for an amended license.
(3) Application must be submitted within
10 working days of the change.
[8.370.24.11
NMAC - N, 7/1/2024]
8.370.24.12 LICENSE RENEWAL:
A. Licensee must
submit a renewal application on forms provided by the licensing authority,
along with the required fee at least 30 days prior to expiration of the current
license.
B. Upon receipt of
renewal application and required fee, the licensing authority will issue a new
license effective the day following the date of expiration of the current
license, if the facility is in substantial compliance with these regulations.
C. If a licensee
fails to submit a renewal application with the required fee and the current
license expires, the ESRD facility shall cease operations until it obtains a
new license through the initial licensure procedures. Subsection A of Section 24-1-5 NMSA 1978, as
amended, provides that no health facility shall be operated without a license.
[8.370.24.12
NMAC - N, 7/1/2024]
8.370.24.13 POSTING OF LICENSE: The ESRD facility’s license must be posted in
a conspicuous place in an area visible to the public.
[8.370.24.13
NMAC - N, 7/1/2024]
8.370.24.14 NON-TRANSFERABLE RESTRICTION ON
LICENSE: A license shall not
be transferred by assignment or otherwise to other persons or locations. The license shall be void and must be
returned to the licensing authority when any one of the following situations
occur:
A. ownership of the
facility changes;
B. the facility
changes location;
C. licensee of the
facility changes;
D. the facility
discontinues operation;
E. a facility wishing
to continue operation as a licensed end stage renal disease facility under
circumstances listed above must submit an application for initial licensure in
accordance with Section 10 of these regulations, at least 30 days prior to the
anticipated change.
[8.370.24.14
NMAC - N, 7/1/2024]
8.370.24.15 AUTOMATIC EXPIRATION OF LICENSE: A license will automatically expire at
midnight on the day indicated on the license as the expiration date, unless
sooner renewed, suspended or revoked, or:
A. on the day a
facility discontinues operation;
B. on the day a
facility is sold, leased, or otherwise changes ownership or licensee;
C. on the day a
facility changes location.
[8.370.24.15
NMAC - N, 7/1/2024]
8.370.24.16 SUSPENSION OF LICENSE WITHOUT PRIOR
HEARING: In accordance with Subsection
H of Section 24-1-5 NMSA 1978, if immediate action is required to protect human
health and safety, the licensing authority may suspend a license pending a
hearing, provided such hearing is held within five working days of the
suspension, unless waived by the licensee.
[8.370.24.16
NMAC - N, 7/1/2024]
8.370.24.17 GROUNDS FOR REVOCATION OR SUSPENSION
OF LICENSE, DENIAL OF INITIAL OR RENEWAL APPLICATION FOR LICENSE, OR IMPOSITION
OF INTERMEDIATE SANCTIONS OR CIVIL MONETARY PENALTIES: A license may be revoked or suspended, an
initial or renewal application for license may be denied, or intermediate
sanctions or civil monetary penalties may be imposed after notice and
opportunity for a hearing, for any of the following reasons:
A. Failure to comply
with any provision of these regulations.
B. Failure to allow
survey by authorized representatives of the licensing authority.
C. Any person active
in the operation of a facility licensed pursuant to these regulations shall not
be under the influence of alcohol or narcotics or convicted of a felony.
D. Misrepresentation
or falsification of any information on application forms or other documents
provided to the licensing authority.
E. Discovery of repeat
violations of these regulations during surveys.
F. Failure to provide
the required care and services as outlined by these regulations for the
patients receiving care at the facility.
[8.370.24.17
NMAC - N, 7/1/2024]
8.370.24.18 HEARING PROCEDURES:
A. Hearing procedures for an
administrative appeal of an adverse action taken by the licensing authority
against an ESRD facility license as outlined in Section 16 and 17 above will be
held in accordance with adjudicatory hearings, New Mexico health care authority,
8.370.2 NMAC.
B. A copy of the
adjudicatory hearing procedures will be furnished to an ESRD facility at the
time an adverse action is taken against its license by the licensing
authority. A copy may be requested at
any time by contacting the licensing authority.
[8.370.24.18
NMAC - N, 7/1/2024]
8.370.24.19 CURRENTLY LICENSED FACILITIES: Any ESRD facility currently licensed on the
date these regulations are promulgated and which provides the services
prescribed under these regulations, but which fails to meet all building
requirements, may continue to be licensed if:
A. variance may be
granted for those building requirements the ESRD facility cannot meet provided
the variances granted will not create a hazard to the health, safety and
welfare of the patients and staff, and are not in violation of current fire and
building codes;
B. the building
requirements for which variances are granted cannot be corrected without an
unreasonable expense to the ESRD facility; and
C. variances granted
will be recorded and made a permanent part of the end stage renal disease
facility file.
[8.370.24.19
NMAC - N, 7/1/2024]
8.370.24.20 NEW FACILITY: A new ESRD facility may be opened in an
existing building or a newly constructed building.
A. If opened in an
existing building a variance may be granted for those building requirements the
ESRD facility cannot meet under the same criteria outlined in 8.370.24.19 NMAC,
if not in conflict with existing building and fire codes. This is at the sole discretion of the
licensing authority.
B. A new ESRD
facility opened in a newly constructed building must meet all requirements of
these regulations.
[8.370.24.20
NMAC - N, 7/1/2024]
8.370.24.21 FACILITY SURVEYS:
A. Application for licensure, whether
initial or renewal shall constitute permission for entry into and survey of a
ESRD facility by authorized licensing authority representatives at reasonable
times during the pendency of the application and, if licensed, during the
licensure period.
B. The licensing
authority shall perform, as it deems necessary, unannounced on-site surveys to
determine compliance with these regulations, to investigate complaints, or to
investigate the appropriateness of licensure for any alleged unlicensed
facility.
C. Upon receipt of a
notice of deficiency from the licensing authority the licensee or their
representative will be required to submit a plan of correction to the licensing
authority within 10 working days, stating how the facility intends to correct
each violation noted and the expected date of completion.
D. The licensing
authority may, at its sole discretion, accept the plan of correction as written
or require modifications of the plan by the licensee.
[8.370.24.21
NMAC - N, 7/1/2024]
8.370.24.22 ADOPTION OF FEDERAL STANDARDS: The licensing authority hereby adopts the
federal standards for certification of end stage renal disease (ESRD) services,
as set out in 42 C.F.R. Sections 405.2100 through 405.2171, as amended from
time to time, as the standards for licensure of end stage renal disease
services in the state of New Mexico.
[8.370.24.22
NMAC - N, 7/1/2024]
8.370.24.23 RELATED REGULATIONS AND CODES: End stage renal disease facilities subject to
these regulations are also subject to other regulations, codes and standards as
the same may, from time to time, be amended as follows:
A. Health facility
licensure fees and procedures, New Mexico health care authority, 8.370.3 NMAC.
B. Health facility
sanctions and civil monetary penalties, New Mexico health care authority 8.370.4
NMAC.
C. Adjudicatory hearings,
New Mexico health care authority, 8.370.2 NMAC.
[8.370.24.23
NMAC - N, 7/1/2024]
HISTORY
OF 8.370.24 NMAC: [RESERVED]