Ala. Admin. Code r. 420-5-5-.02

Current through Register Vol. 43, No. 1, October 31, 2024

Section 420-5-5-.02 - Administration

(1) Governing Authority.

(a) Responsibility. The governing authority or the owner or the person or persons designated by the owner as the governing authority shall be the supreme authority of the facility, responsible for the management, control, and operation of the facility, including the appointment of a qualified medical staff (or in the absence of an organized medical staff) a medical director.

(b) Organization. The governing authority shall be formally organized in accordance with a written constitution and/or bylaws. In the event the governing authority consists of one person, this requirement must still be met. Such constitution and/or bylaws shall include:

1. Identification of the facility.

2. The purpose for which the facility is organized.

3. Length of tenure and mechanism for appointment of members of the governing body.

4. Appointments and duties of the chief executive officer.

5. Requirement that the medical staff (if such exists) be organized in accordance with bylaws approved by the governing authority.

6. Mechanism for appointment of medical staff members and a medical director.

7. Mechanism for approval of medical staff bylaws and policies governing activities of the medical director if an organized medical staff does not exist.

(c) Meetings. The governing authority shall meet regularly. A copy of the minutes of these meetings shall be kept as a permanent record of the facility.

(d) Notification of Chief Executive Officer. The State Board of Health shall be advised of the chief executive officer's name within 15 days of his appointment.

(2) The Chief Executive Officer.

(a) Responsibility. There shall be a competent, well-trained chief executive officer who shall have executive authority and be responsible for directing, coordinating, and supervising the overall activities of the facility. The chief executive officer and the medical director or other qualified employee of the facility may be one and the same person.

(b) Enforcement of Medical Staff Regulations. As the authorized representative of the governing authority, the chief executive officer shall have the authority to enforce medical staff rules and regulations with regard to patient care, after consultation with appropriate members of the medical staff.

(c) Policies and Procedures. The chief executive officer shall be responsible for assuring, either directly or through delegation of authority, that policies promulgated by the governing authority are carried out. Appropriate procedures to enforce these policies, assure proper patient care and safety, and meet requirements of these Rules, shall be developed in writing. Policies and procedures shall be developed to include the following areas:

1. Patient admission and discharge. These shall be for both in-facility care and self-care or home care.

2. Requirement for a complete history and physical examination on admission and at least annually.

3. Required diagnostic procedures.

4. Patients waiting for renal transplant must be typed initially for Human Leukocytes Antigens (HLA) and screened for antibodies to HLA. The facility must complete an Agreement or Arrangement with a State licensed and/or CLIA licensed Histocompatibility Laboratory which contains the provision for HLA typing and antibody screening, including the frequency of antibody screening.

(3) Self-Care Dialysis. Self-Care Dialysis Training Program. If the facility offers self-care dialysis training, a qualified registered nurse is in charge of the training. Appropriate records of this training shall be maintained in the patient's record.

(4) Use of Outside Resources. Contractual Service Agreements. There are written contractual agreements and arrangements for services which the facility or its employees do not provide directly. The agreement or arrangement delineates the responsibilities, functions, objectives, and services provided by the outside resource and is signed and dated by an authorized representative of the facility and the person or agency providing the service.

(5) Fire Evacuation Plan.

(a) Written Evacuation Plan. A written fire control and evacuation plan shall be maintained by each facility. In addition, necessary instruction and fire evacuation routes shall be posted in conspicuous places in the facility and shall be kept current.

(b) Fire Drills. Fire drills shall be conducted at least quarterly and written observations of the effectiveness of these rehearsals shall be filed and kept for at least three years.

(6) Communication Facilities.

(a) Personnel Paging Systems. Arrangements shall be provided within the facility to summon additional personnel or help when, or if needed, in the event of emergency conditions. In general, if all personnel (or occupants) are within hearing distance of any area of the facility, this would be deemed sufficient. Otherwise, there shall be a call system to all portions of the building normally occupied by personnel of the facility.

(b) Telephones. There shall be an adequate number of telephones to summon help in case of fire or other emergency, and these shall be located so as to be quickly accessible from all parts of the building.

(7) Records.

(a) Responsibility for Medical Records. There is a qualified member of the facility's staff designated to serve as supervisor of medical records.

(b) Maintenance and Content of Medical Records.

1. The facility maintains complete medical records on all patients, including those receiving care within the facility and those self-care or home dialysis patients for whom the facility has assumed responsibility. These medical records shall be maintained in accordance with acceptable professional standards and practices.

2. Each patient's record shall contain sufficient information to identify the patient clearly, to justify the diagnosis and treatment and to accurately document the rendition and results of treatment.

3. The medical record shall contain physicians' orders for all medications to be administered, treatments to be given and services to be rendered.

4. Nurses' notes records shall be maintained for each patient in the facility. In addition to regular entries concerning special diets and medications administered, personal services rendered and observations made, other notes, which may be of importance to the attending physician or other nursing personnel shall be annotated.

5. Nurses' notes and physician orders shall be kept at the nurses' station while current and shall be placed in the patient's file folder when completed.

6. All entries on all records and reports shall be legibly written in ink or typewritten.

7. A physician may use a rubber stamp signature to sign records and reports, if that physician has submitted a letter, kept on file in the facility, indicating that the rubber stamp is for his own use and will not be used by any other personnel within the facility.

(c) Completion and Organization of the Record.

1. Current medical records and those of discharged patients are completed promptly (not to exceed 15 days after discharge or death) and all clinical information pertaining to a patient is centralized in the patient's medical record.

2. The medical record shall be organized in such a manner as to retrieve information readily. If numerical indexing is used, an alphabetical cross-reference is utilized to facilitate retrieval.

(d) Confidentiality of Medical Records. When an individual enters an End Stage Renal Disease Treatment or Transplant Center, records and information regarding him are confidential. Information shall not be shared with visitors, other patients, or anyone not having responsibility for his care. Access to these records shall be limited to designated staff members, physicians and others having professional responsibility, and to representatives of the State Board of Health.

(e) Storage and Protection of Medical Records.

1. The facility maintains adequate facilities, equipment, and space conveniently located to provide efficient processing of medical records and other medical information.

2. The medical record shall be protected against loss, destruction (from water and fire damage) or unauthorized use. The facility has written policies and procedures which govern the use and release of information contained in the medical record. A medical record shall be maintained for six years after discharge of patient, or six years after patient reaches majority under State law, whichever is longer.

(f) Transfer of Medical Information. The facility provides for the interchange of medical and other information necessary or useful in the care and treatment of patients transferred between treating facilities.

(g) Personnel Records. A personnel record shall be maintained for each employee. The personnel record shall include application for employment, which contains information regarding education, training, experience, and if applicable, registration and/or licensure information of the applicant, and record of physical examinations. The names and qualification of all professional employees shall be kept on file for inspection by the State Board of Health.

(h) Disposition of Medical Records. When an End Stage Renal Disease Treatment or Transplant Center ceases to operate, either voluntarily or by revocation of its license, the governing body (licensee), at or prior to such action, shall develop a proposed plan for the disposition of its medical records. Such plans shall be submitted to the Alabama Department of Public Health for approval and shall contain provisions for the proper storage safeguarding and confidentiality, transfer and/or disposal of patient's medical records and x-ray files. Any center that fails to develop such plans of disposition of its records acceptable to the Alabama Department of Public Health shall dispose of its records as directed by a court of appropriate jurisdiction.

(8) Housekeeping Services.

(a) Personnel. Sufficient personnel are employed to maintain the facility clean and orderly. Personnel utilized in nursing and other activities may be utilized to perform routine housekeeping chores, however, specific written instructions to eliminate possible sources of cross-contamination must be developed. Primary patient care personnel shall not perform general decontamination and housekeeping chores during periods in which they are caring for patients.

(b) Techniques. Written procedures outlining techniques to be followed in routine housekeeping and decontamination are developed and maintained. Procedure rooms and areas must be cleaned, using appropriate disinfectants, between each procedure.

(c) Premises. The premises shall be kept neat and clean, and free of accumulation of rubbish, weeds, ponded water, or other conditions of similar nature which would have a tendency to create a health hazard.

(d) Control of Insects, Rodents, etc. The facility shall be kept free of ants, flies, roaches, rodents and other vermin. Proper methods of their eradication or control shall be utilized.

(e) Toilet Room Cleanliness. Floors, walls, ceilings, and fixtures of all toilet rooms shall be kept clean and free of objectionable odors. These rooms shall be kept free from an accumulation of rubbish, cleaning supplies, toilet articles, etc.

(f) Housekeeping Facilities and Services. Housekeeping facilities and services are required to be such that comfortable and sanitary conditions for patients and employees are constantly maintained.

(g) Equipment and Supplies. The facility shall maintain an adequate quantity of housekeeping and maintenance equipment and supplies.

(9) Infection Control.

(a) Policies and Procedures. There are written policies and procedures in effect for preventing and controlling hepatitis and other infections. The policies and procedures support sound patient care and promote good personal practices and include appropriate aseptic and isolation techniques to be used.

(b) Sterilization. Definitive written procedures governing sterilization techniques shall be developed. Pressurized steam sterilization is the preferred method; however, gas sterilization and soaking of some types of equipment or instruments in a bacteriocidal solution of approved efficacy may be permitted. Procedures are to include:

1. Technique to be used for a particular instrument or group of instruments.

2. Length of time to accomplish sterilization.

3. Prohibition against reuse of one-time use (disposable) items with the exception of renal dialyzers and dialyzer lines provided a written processing protocol for reuse is submitted to the Alabama Department of Public Health.

4. Temperature, time, and pressure for steam sterilization.

5. Proper methods of preparation of items for sterilization (cleaning, wrapping and dating).

6. Shelf storage time for sterile items.

7. Use of sterilizer indicators.

8. Methods of disposal of contaminated items such as needles, syringes, catheters, gloves, etc.

9. Use of routine (at least monthly) sterilizer culture controls.

(c) Investigation of Infections. Reports of infections such as abscesses, septicemia, hepatitis, or other communicable diseases observed during admission or follow-up (or return) visit of the patient shall be made and kept as a part of the administrative files. Efforts shall be made to determine the origin of any such infection and if the procedure was found to be related to acquiring the infection, remedial action shall be taken to prevent recurrence.

(d) Hepatitis Surveillance.

1. Routine surveillance of patients and staff for HBV infection is essential to determine if transmission is occurring in the unit. The HBsAg (anti-HBs) status of all patients and staff shall be known to identify those individuals who are;

(1) HBsAg-positive and therefore potential sources of infection to others;

(2) anti-HBs-positive and therefore, immune; and

(3) HBV-seronegative and therefore susceptible to HBV.

2. Patients for dialysis and new employees must be screened for HBsAg and anti-HBs before or at the time they enter the unit in order to determine their serologic status for surveillance purposes. HBsAg positivity in staff does not necessarily preclude employment in the dialysis center; these persons may be managed in the same manner as employees who seroconvert to HBsAg-positive status while working in the unit.

3. The HBsAg status of visiting and home patients must be known, if possible, at the time of admission to determine if they are potential sources of infection.

4. The most sensitive test methods available for HBsAg and anti-HBs detection must be employed.

5. Patients who are seronegative (HBsAg- and anti-HBs-negative) must be tested once a month for HBsAg, serum glutamic oxalacetic transaminase (SGOT), and/or serum glutamic pyruvic transaminase (SGPT) and at least once every three months for anti-HBs. Seronegative staff members must be tested at least once every six months for HBsAg and anti-HBs.

6. Patients and staff who have had hepatitis B as demonstrated by:

(1) a documented history of hepatitis B;

(2) HBsAg-positivity demonstrated on two occasions; or

(3) a positive HBsAb test in the absence of an injection of hepatitis B immune globin, need have only further HBsAb determinations on an annual basis for hepatitis surveillance purposes.

7. Patients and staff who have received a full course (3 injections over a six-month period) of Heptavax vaccine and have a positive HBsAb test need only further HBsAb determinations on an annual basis for hepatitis surveillance purposes.

(e) Cross-Contamination Prevention.

1. The facility must employ appropriate techniques to prevent cross-contamination between the dialysis unit and adjacent hospital or public areas.

2. There must be some type of protective covering, either plastic, disposable, or launderable, during the time when blood lines are opened or needles inserted or withdrawn in order to prevent the patient's street clothing from becoming contaminated.

3. All equipment utilized in dialysis must be changed or cleaned after each use.

4. Appropriate precautionary measures must be implemented to prevent facility personnel from contaminating shoes and clothing that will be worn outside the dialysis unit.

(f) Disposal of Infectious Material and Waste. Policies and procedures must be developed for the proper handling, cleaning and disposal of all infectious material and waste products. All dialysis waste must be contained in a closed sewage drain system.

(g) Isolation Facilities.

1. An isolation dialysis room must be provided for all Hepatitis B Antigen Positive Dialysis Patients; the room must be partitioned from treatment areas for Hepatitis B Antigen Negative Patients and provide separate facilities from toilet, handwashing, janitorial, drug storage, blood (Hematocrit and clotting time) handling and waste storage and disposal.

2. Facilities not equipped with a Hepatitis B Isolation Section as defined above may not accept for treatment any Hepatitis B Antigen Positive Patients but must complete an Agreement to transfer any Positive Patients to a facility so equipped.

(h) Infection Control Committee. A committee must be established and made up of at least a physician and the Director of Nurses to evaluate or monitor staff performance, review all policies and procedures at least annually, and review infectious cases. This committee shall meet at least monthly.

(i) Linens.

1. All reusable linens, including those used as sterilizing wrappers, must be laundered before reuse.

2. Linens are handled, stored, processed, and transported in such a manner as to prevent the spread of infection.

3. The facility has available at all times a quantity of linen essential for proper care and comfort of patients.

(j) Water Treatment. Water used for dialysis purposes must be analyzed at least monthly for bacteria and at least six months for chemicals. The water must be treated as necessary to maintain a continuous water supply that is biologically and chemically compatible with acceptable dialysis techniques. Records of test results and equipment maintenance are maintained at the facility.

Authors: Tigner Zorn, Carol Nason, Jim Prince, Rick Harris

Ala. Admin. Code r. 420-5-5-.02

Filed September 1, 1982. Amended: Filed November 19, 1987. Amended: Filed October 18, 1996; effective November 22, 1996. Amended: Filed September 20, 2001; effective October 25, 2001.

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