Ala. Admin. Code r. 420-5-5-.01

Current through Register Vol. 43, No. 02, November 27, 2024

Section 420-5-5-.01 - General

(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.

Ala. Admin. Code r. 420-5-5-.01

Filed September 1, 1982. Amended: Filed May 22, 1990. Amended: Filed September 20, 2001; effective October 25, 2001. Amended: Filed November 13, 2007; effective December 18, 2007.

Author: Rick Harris

Statutory Authority:Code of Ala. 1975, §§ 22-21-20, etseq.