Alabama Administrative Code
Title 420 - ALABAMA STATE BOARD OF HEALTH
Chapter 420-5-5 - END STAGE RENAL DISEASE TREATMENT AND TRANSPLANT CENTERS
Section 420-5-5-.01 - General
Universal Citation: AL Admin Code R 420-5-5-.01
Current through Register Vol. 42, No. 11, August 30, 2024
(1) Legal Authority.
(a) Adoption of Rules. Under and
by virtue of authority vested in it by the Legislature of Alabama,
Code of Ala. 1975, Sections
22-21-20, et. seq., the State
Board of Health does hereby adopt and promulgate the following Rules governing
the operation of End Stage Renal Disease Treatment and Transplant Centers in
the State of Alabama.
(b) End Stage
Renal Disease Treatment and Transplant Centers. For the purpose of these Rules
"End Stage Renal Disease Treatment and Transplant Centers" shall include
facilities that are intended to treat persons suffering permanent and
irreversible kidney failure, who require dialysis on a regular maintenance
basis, or who may be of suitable candidates for kidney transplantation. The
facilities that are classified under these Rules as "End Stage Renal Disease
Treatment and Transplant Centers" are further defined in these Rules as Renal
Dialysis Centers, Renal Dialysis Facilities and Renal Transplantation
Centers.
(2) Definition (A list of selected terms often used in connection with these Rules):
(a) "AAC Rule" means Alabama
Administrative Code Rule.
(b) "Anticoagulant" means a medication or
medical technique to prevent or slow down coagulation and clotting.
(c) "Anticoagulation" means the process of
inhibiting the blood clotting mechanism by the administration of certain
drugs.
(d) "Artificial Kidney"
means apparatus which removes metabolic wastes or other poisons from the body
when the natural kidneys are not functioning properly. This apparatus may be
referred to as a kidney dialysis unit.
(e) "Chief Executive Officer" means a person
who is delegated the responsibility for the interpretation, implementation and
proper application of policies and programs established by the governing
authority. The CEO must meet one of the following requirements to be qualified:
1. Holds at least a Baccalaureate Degree and
has at least 1 year of experience in a dialysis unit.
2. Is a qualified registered nurse or
qualified physician director.
(f) "Chronic Hemodialysis" means Hemodialysis
over a long period of time, usually to the extent of the patient's life or
organ transplant.
(g) "Dialysis"
means the diffusion of dissolved material through a semipermeable membrane; as
used in these Rules a cleansing process using dialyzing equipment (artificial
kidney) and appropriately recognized procedures.
(h) "Dietitian (Qualified)" means a person
who (a) is eligible for registration by the American Dietetic Association or
(b) has a baccalaureate degree with major studies in food and nutrition,
dietetics or food service management and has 1 year of supervisory experience
in the dietetic service of a health care institution and participates annually
in continuing dietetic education.
(i) "Governing Authority" means owner(s),
Hospital Association, County Hospital Board, Board of Governors, Board of
Trustees or any other comparable designation of a body duly organized and
constituted for the purpose of owning, acquiring, constructing, equipping,
operating and/or maintaining an End Stage Renal Treatment and/or Transplant
Center, either hospital or non-hospital based.
(j) "Hepatitis" means inflammation of the
liver, usually due to a viral infection, but can result from toxic agents or
medications.
(k) "Medical Staff"
means physicians, certified registered nurse practitioners, and physician
assistants who are privileged by agreement with the Renal Dialysis Center or
facility to attend patients within the institution.
(l) "Physician-Director (Qualified)" means
the physician responsible for planning, organizing, conducting and directing
the Renal Dialysis Services. The Physician-Director must meet one of the
following requirements to be considered qualified:
1. Is Board eligible or Board certified in
nephrology medicine by a professional Board and has had at least 12 months of
experience or training in the care of patients at Renal Dialysis
Facilities.
2. During the 5 year
period prior to the effective date of these Rules, served for at least 12
months as Director of a Dialysis Program.
(m) "Peritoneal Dialysis" means dialysis
using the peritoneum as a dialysis membrane.
(n) "Recipient Registry" means registry
maintained for dialysis patients who are awaiting donor
transplantation.
(o) "Registered
Professional Nurse - (Qualified)" means that person responsible for the nursing
services in the Renal Dialysis Center or Facility. The registered nurse must
meet one of the following requirements to be recognized as qualified:
1. A person who holds current licensure and
registration as a registered nurse by the State of Alabama Board of Nursing
and;
(i) Has at least 12 months experience in
clinical nursing and an additional 6 months of experience in nursing care of
the patient with permanent kidney failure or undergoing kidney transplantation,
including training in and experience with the dialysis process, or;
(ii) Has 18 months of experience in nursing
care of the patient or maintenance dialysis or in nursing care of the patient
with a kidney transplant, including training in and experience with the
dialysis process.
2. If
the qualified registered nurse responsible for the nursing service is in charge
of self-care dialysis training, this person must have at least 3 months of the
total required renal dialysis experience in training patients in
self-care.
(p) "Renal
Dialysis Center" means a hospital unit that does not perform renal transplant,
but is approved to furnish the full spectrum of diagnostic, therapeutic
(including inpatient dialysis furnished directly or under arrangement), and
rehabilitative services for the care of renal dialysis patients.
(q) "Renal Dialysis Facility" means:
1. A hospital based facility which furnishes
end stage renal dialysis treatment on inpatients or outpatients but do not
provide a full spectrum of diagnostic, therapeutic and rehabilitative
services.
2. A non-hospital based
facility which furnishes end stage renal dialysis treatment to non-hospitalized
patients but does not provide a full spectrum of diagnostic, therapeutic and
rehabilitative services.
(r) "Renal Transplantation Center" means a
hospital unit which is approved to furnish directly transplantation and other
medical and surgical specialty services required for the care of the End Stage
Renal Disease transplant patients including dialysis furnished directly or
under arrangements. A Renal Transplantation Center may also be a Renal Dialysis
Center.
(s) "Self-Care Dialysis
Training" means a program which trains renal disease patients or their helpers,
or both, to perform self-care dialysis either in the center/facility or at
home.
(t) "Social Worker -
(Qualified)" means that person who is responsible for providing social services
to renal disease patients on maintenance dialysis or self-care training in the
center/facility. The person to be considered qualified must meet one of the
following requirements:
1. Completion of a
course of study with specialization in clinical practice, and hold a masters
degree from a graduate school of social work accredited by the council on
social work education and meet the requirements of "the Alabama Social Work
Board of Examiners."
2. Has a
Bachelor's Degree and meets the requirements of "the Alabama Social Work Board
of Examiners" and has served for at least two years as a social worker, one
year of which was in a dialysis unit or transplantation program prior to the
effective date of these Rules.
(u) "These Rules" means Rules through
420-5-5-.04, Chapter 420-5-5, End
Stage Renal Disease Treatment and Transplant Centers, Alabama
Administrative Code.
(v)
"Water Treatment" means the process of treating water used for dialysis
purposes in order to maintain a continuous water supply that meets ASAIO-AAMI
(American Society of Artificial External Organs-Association for the Advancement
of Medical Instrumentation) 1977 Standards for water for
Hemodialysis.
(3) Types of License.
(a) Regular License. A regular
license may be granted by the State Board of Health after the Board has
determined that the End Stage Renal Disease Center is in substantial compliance
with the Rules herein adopted.
(b)
Temporary License.
1. At its discretion, the
State Board of Health may grant a license which indicates a temporary condition
of non-compliance with these Rules. A temporary license may be granted when the
Board is satisfied that preparations are being made to qualify for a regular
license or as provided below, and that notwithstanding the deficiencies,
appropriate measures have been taken to minimize any threat to the health and
safety of patients and personnel. A temporary license may be granted for a
calendar year, but not to exceed five successive one year terms.
2. An End Stage Renal Disease and Treatment
Center may be granted a temporary license prior to opening if in compliance
with the provision of these Rules relative to the physical plant and staffing.
The license granted under Alabama Administrative Code Rule (3)
(b) shall be valid until a regular license is granted or December 31 of the
year in which the license was issued. A temporary license may be re-granted
under Alabama Administrative Code Rule
420-5-5-.01(3)(b)
when it has been demonstrated to the Board
that specific efforts are being made to comply with these Rules.
3. End Stage Renal Disease and Transplant
Centers which are in existence on the effective date of these Rules may be
granted a temporary license under one or more of the following conditions:
(i) Where failure to qualify for a regular
license is due to higher requirements of these Rules.
(ii) Where the governing authority is making
specific plans to construct a new facility to establish an End Stage Renal
Disease and/or Transplant Center which meets the Rules or is actually in the
process of meeting these Rules.
(iii) Where a formal appeal of an
administrative decision is pending action by the State Board of
Health.
4. End Stage
Renal Disease and Transplant Centers which have been granted a temporary
license in lieu thereof when an official inspection shows that the maintenance
and operation of the center does not substantially meet the requirements for a
regular license.
(c)
Probational License. At its discretion, the State Board of Health may grant a
probational license under one or more of the following conditions, and then
only when the Board is satisfied notwithstanding the deficiency, appropriate
measures have been taken to minimize any threat to the health and safety of
patients and personnel. A probational license may be granted for a calendar
year not to exceed two successive one year terms.
1. When the Board has reason to believe the
operation is questionable.
2. When
the Board has reason to believe the facility is not making specific plans to
comply with these Rules or the End Stage Renal Disease Center's ability is
questionable.
3. Conduct or
practices not deemed by the Board to be in the patient's best interest for
example; unethical, fraud or abuse, aiding or abetting the commission of an
illegal act.
(4) Licensing.
(a) Application for License. All facilities
except those that are in and under the direct control of a license hospital
shall apply for licensure on a form designated by the State Board of Health.
The application will reflect all data required by the Code of Ala.
1975, Section
22-21-20 et. seq. and shall be
submitted with either a Certificate of Need (CON) or letter of
non-reviewability obtained from the State Health Planning Agency.
(b) Fee. See Code of Ala.
1975, Section
22-21-20 et. seq.
(c) Name of Facility. Every End Stage Renal
Disease Treatment and Transplant Center shall be designated by a permanent and
distinctive name which shall not be changed until an application has been
completed and approved. Words in the name of the center that may reflect a
different type of facility or service shall not be used.
(d) Separate Licenses. When more than one
facility is operated under the same operating entity, a separate license shall
be required for each facility. Separate licenses are not required for separate
buildings on the same grounds used by the same facility.
(e) Re-issuance of License Certificate. A new
license may be issued under certain circumstances:
1. The following changes in the status of the
facility will require issuance of a new license certificate, upon application
and payment of licensure fee (if applicable):
(i) Change in facility ownership or operating
entity (fee required).
(ii) Change
in name (no fee required).
(iii)
Physical Relocation.
(iv) Station
Increase (fee required).
2. The governing authority shall file with
the State Board of Health an application for license 30 days before any
proposed change requiring a new license certificate in order to permit
processing of the application and issuance of the license certificate prior to
the desired effective date of the change.
(f) Hospital Owned and Controlled Facilities.
1. An End Stage Renal Disease Treatment
and/or Transplant Center located within a licensed hospital and is controlled
and organized as a department of the hospital will not be licensed as a
separate entity of the hospital.
2.
A hospital owned and controlled End Stage Renal Disease Treatment and/or
Transplant Center located within the hospital will be subjected to these Rules
and will be applied as part of the Hospital Licensure Program.
(5) Right of Appeal. Any licensee dissatisfied with administrative decisions made in the application of these rules may appeal under the Alabama Administrative Procedures Act, Code of Ala. 1975, Sections 41-22-1 et.seq., and the State Board of Health Rules for the Hearing of Contested Cases, Alabama Administrative Code Chapter 420-1-3.
(6) Waivers. Waivers from these rules may be requested in accordance with the provisions of the Alabama Administrative Procedures Act, Code of Ala. 1975, Sections 41-22-1 et.seq., and the State Board of Health Rules for the Hearing of Contested Cases Alabama Administrative Code Chapter 420-1-3-.09.
(7) Unusual Occurrences. Unusual occurrences which threaten the welfare, safety and health of patients, personnel or visitors shall be reported by the ESRD facility within 24 hours, either by telephone (and confirmed in writing), or by facsimile to the Alabama Department of Public Health, Division of Health Care Facilities, and other agencies/authorities as required. Examples of unusual occurrences that must be reported include: include: misuse of medical devices or medications, defective devices, suspected cases of patient abuse or neglect, life threatening burns, fires or other catastrophic occurrences, medical conditions or deaths that occur as the result of unusual circumstances. Any acute event that results in a patient receiving emergency treatment must be reported. Emergency treatment includes unscheduled transportation to a hospital or receipt of cardiac life support from a hospital, ambulance service or rescue squad, or staff member. Also to be reported are outbreaks of infectious diseases or any condition in the facility, including the water treatment system, which would necessitate the temporary or long term closure of the dialysis facility (excluding inclement weather).
(8) Disclosure of Information. Official reports, such as Statements of Deficiencies generated by the State Board of Health as a result of on-site inspections, and plans of corrections submitted in response to those statements of deficiencies, are subject to public disclosure. Information received through other means and reports, other than statements of deficiencies, shall be deemed to be confidential and shall not be publicly disclosed except in response to a valid subpoena or court order or in proceedings involving the license of this facility or another facility operated by the same governing authority. Inspection reports will never contain the name or other identification of any patient or client in the inspected facility.
Author: Rick Harris
Statutory Authority: Code of Ala. 1975, §§ 22-21-20, et seq.
Disclaimer: These regulations may not be the most recent version. Alabama may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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