Section 0720-33-.04 - ADMINISTRATION(1) Renal dialysis clinics must have a governing body which is legally responsible for: (a) The overall operation and maintenance of the facility;(b) The provision of personnel, facilities, equipment, supplies, and services to patients and families;(c) Adopting administrative policies regarding patient care;(d) Appointing an administrator or director responsible for implementing the adopted policies;(e) Establishing and maintaining a written organizational plan;(f) Appointing a clinical staff and assuring its competence;(g) Adopting medical staff bylaws; and(h) Documenting all of the above.(2) When licensure is applicable for a particular job, a copy of the current license must be included as a part of the personnel file. Each personnel file shall contain accurate information as to the education, training, experience and personnel background of the employee. Adequate medical screenings to exclude communicable disease shall be required of each employee.(3) Whenever the rules and regulations of this chapter require that a licensee develop a written policy, plan, procedure, technique, or system concerning a subject, the licensee shall develop the required policy, maintain it and adhere to its provisions. A renal dialysis clinic which violates a required policy also violates the rule and regulation establishing the requirement.(4) Policies and procedures shall be consistent with professionally recognized standards of practice.(5) All renal dialysis clinics shall adopt appropriate policies that meet state and federal rules and regulations regarding the testing of patients and staff for human immunodeficiency virus (HIV) and other communicable diseases.(6) Each renal dialysis clinic utilizing students shall establish policies and procedures for their supervision.(7) No renal dialysis clinic shall retaliate against or, in any manner, discriminate against any person because of a complaint made in good faith and without malice to the board, the regional ESRD network, the department, the Adult Protective Services, or the Comptroller of the State Treasury. A renal dialysis clinic shall neither retaliate, nor discriminate, because of information lawfully provided to these authorities, because of a person's cooperation with them, or because a person is subpoenaed to testify at a hearing involving one of these authorities.(8) Infection Control. (a) The renal dialysis clinic must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.(b) The renal dialysis clinic must have an infection control program. Members of the medical staff, nursing staff and administrative staff shall develop guidelines and techniques for the prevention, surveillance, control and reporting of facility infections. Duties of the program shall include the establishment of: 1. Written infection control policies;2. Techniques and systems for identifying, reporting, investigating and controlling infections in the facility;3. Written procedures governing the use of aseptic techniques and procedures in the facility;4. Written procedures concerning laundry practices, disposal of environmental and patient wastes, traffic control and visiting rules, sources of air pollution, and routine culturing of autoclaves and sterilizers;5. A mechanism for tracking incidents related to infectious and communicable diseases;6. Formal provisions to educate and orient all appropriate personnel in the practice of aseptic techniques such as handwashing, proper grooming, masking, dressing care techniques, disinfecting and sterilizing techniques, and the handling and storage of patient care equipment and supplies; and7. Continuing education for all facility personnel on the cause, effect, transmission, prevention, and elimination of infections.(c) An End Stage Renal Dialysis Clinic shall have an annual influenza vaccination program which shall include at least: 1. The offer of influenza vaccination to all staff and independent practitioners at no cost to the person or acceptance of documented evidence of vaccination from another vaccine source or facility. The End Stage Renal Dialysis Clinic will encourage all staff and independent practitioners to obtain an influenza vaccination;2. A signed declination statement on record from all who refuse the influenza vaccination for reasons other than medical contraindications (a sample form is available at http://tennessee.gov/health/topic/hcf-provider);3. Education of all employees about the following:(ii) Non-vaccine control measures, and(iii) The diagnosis, transmission, and potential impact of influenza;4. An annual evaluation of the influenza vaccination program and reasons for nonparticipation; and5. A statement that the requirements to complete vaccinations or declination statements shall be suspended by the administrator in the event of a vaccine shortage as declared by the Commissioner or the Commissioner's designee.(d) The administrator, the medical staff and Nurse Manager must ensure that the facilitywide performance improvement program and training programs address problems identified by the infection control program and must be responsible for the implementation of successful corrective action plans in affected problem areas.(e) The facility shall develop policies and procedures for testing a patient's blood for the presence of the hepatitis B and C virus and the HIV virus in the event that an employee of the facility, a student studying at the facility, or health care provider rendering services at the facility is exposed to a patient's blood or other body fluid. The testing shall be performed at no charge to the patient, and the test results shall be confidential.(f) The facility and its employees shall adopt and utilize universal precautions of the Centers for Disease Control and Prevention (CDC) for preventing transmission of infections and communicable diseases.(g) Precautions shall be taken to prevent the contamination of sterile supplies by soiled supplies. Sterile supplies shall be packaged and stored in a manner that protects the sterility of the contents. Decontamination and preparation areas shall be separated.(9) Each renal dialysis clinic shall adopt safety policies for the protection of patients from accident and injury.(10) Documentation pertaining to the payment agreement between the renal dialysis clinic and the patient shall be completed prior to admission. A copy of the documentation shall be given to the patient and the original shall be maintained in the renal dialysis clinic records.(11) Dialysis Technicians and Trainees.(a) All dialysis technicians and renal dialysis clinics shall comply with federal laws and rules relative to patient care dialysis technician certification pursuant to 42 C.F.R. § 494.140(e).(b) An individual may not act as a dialysis technician unless that individual is trained and competent under these rules.(c) Trainees shall be identified as such during any time spent in the patient treatment areas.(d) Until the successful completion of the competency evaluation, the trainee may provide patient care only as part of the training program and under the immediate supervision of a registered nurse or an assigned preceptor. A preceptor shall be a licensed nurse. If a dialysis technician is deemed competent in one or more of the components outlined in 0720-33-.04(12), he/she may perform those duties prior to being deemed competent in all components of the training curriculum. A dialysis technician who has one year of experience in hemodialysis obtained within the last twenty-four (24) months, a recommendation by the supervising nurse to be a preceptor and a current competency skills checklist on file in the facility may be utilized in training as defined in the facility's policies and procedures.(12) Each training program for dialysis technicians shall develop a written curriculum with objectives and include at a minimum, the following components:(a) Introduction to dialysis therapies to include history and major issues;(b) Principles of hemodialysis;(c) Understanding the individual with kidney failure;(e) Hemodialysis devices;(f) Water treatment following current AAMI guidelines;(g) Reprocessing, utilizing current AAMI guidelines if the facility practices reuse;(i) Infection Control and safety 1. Universal precautions, aseptic technique, sterile technique, specimen handling;2. Risks to employees of blood and chemical exposure.(j) Principles of Quality Improvement and Role of the technician or nurse in QI activities;(k) Principles of peritoneal dialysis to include:1. Periotoneal dialysis delivery systems;2. Symptoms of peritonitis;3. Other complications of peritoneal dialysis.(l) If a dialysis technician is to cannulate access or administer normal saline or lidocaine during initiation or termination of dialysis, the following content must be included: 1. Access to the circulation to include: (i) Fistula creation, development, needle placement, and prevention of complications;(ii) Grafts; materials used, creation, needle placement, and prevention of complications; and(iii) Symptoms to report.2. Safe administration of medications listed above to include:(i) Identifying the right patient;(ii) Assuring the right medication;(iii) Measuring the right dose;(iv) Ascertaining the right route;(v) Checking the right time for administration;(vi) Reasons for administration;(vii) Potential complications;(viii) Administration limits; and(ix) Information to report and record.(13) The supervising nurse or registered nurse acting as training instructor shall complete a skills competency checklist to document each dialysis technician trainee's knowledge and skills listed in 0720-33-.04(11)-(12).(14) Performance Improvement. (a) The renal dialysis clinic must ensure that there is an effective, facility-wide performance improvement program to evaluate patient care and performance of the organization.(b) The facility must develop and implement plans for improvement to address deficiencies identified by the performance improvement program and must document the outcome of the remedial action.(c) The performance improvement program shall be ongoing and have a written plan of implementation which assures that:1. All organized services related to patient care, including services furnished by a contractor, are evaluated;2. Nosocomial infections and medication therapy are evaluated; and3. All services performed in the facility are evaluated as to the appropriateness of diagnosis and treatment.(d) Performance improvement program records are not disclosable, except when such disclosure is required to demonstrate compliance with this section.(e) Good faith attempts by the performance improvement program committed to identify and correct deficiencies will not be used as a basis for sanctions.(f) Written policies, procedures and practice guidelines for management of emergencies and discharge must be developed and implemented.(15) Personnel records. (a) A personnel record for each staff member of a facility shall include an application for employment and a record of any disciplinary action taken.(b) Wage and salary information, time records, an authorization and record of leave shall be maintained but may be kept in a separate location.(c) A job description shall be maintained which includes the employment requirements and the job responsibilities for each facility staff position.(d) A personnel record shall be maintained which verifies that each employee meets the respective employment requirements for the staff position held, including annual verification of basic skills and annual evaluation of personnel performance. This evaluation shall be in writing. There shall be documentation to verify that the employee has reviewed the evaluation and has had an opportunity to comment on it.(e) Training and development activities which are appropriate in assisting the staff in meeting the needs of the patients being served shall be provided for each staff member including HIV and other communicable disease education. The provision of such activities shall be evidenced by documentation in the facility records.(f) Direct-services staff members shall be competent persons aged eighteen (18) years of age or older.(g) All new employees, including volunteers, who have routine contact with patients shall have a current tuberculosis test prior to employment or service.(h) Employees shall have a tuberculin skin test annually and at the time of exposure to active TB and three months after exposure.(i) Employee records shall include date and type of tuberculin skin test used and date of tuberculin skin test results, date and results of chest x-ray, and any drug treatment for tuberculosis.(16) Water Treatment and Reuse. Compliance Required. A facility shall meet the requirements of this section. A facility may follow more stringent requirements for water treatment and reuse of hemodialyzers than the minimum standards required by this section.
(a) The physical space in which water treatment is located must be adequate to allow for maintenance, testing, and repair of equipment. If mixing of dialysate is performed in the same area, the physical space must also be adequate to house and allow for the maintenance, testing and repair of the mixing equipment and for performing the mixing procedures.(b) The water treatment system components shall be arranged and maintained so that bacterial and chemical contaminant levels in the product water do not exceed the standards for hemodialysis water quality as described in the current Association for the Advancement of Medical Instrumentation (AAMI) standards.(c) Facility records must include all test results and evidence that the medical director has reviewed the result of water quality testing and directed corrective action when indicated.(d) Only persons qualified by education or experience may repair or replace components of the water treatment system. Documentation of education or training which qualifies these persons must be maintained on file in the facility.(e) A facility that reuses hemodialyzers and other dialysis supplies shall meet current AAMI standards.(17) All health care facilities licensed pursuant to T.C.A. §§ 68-11-201, et seq. shall post the following in the main public entrance:(a) Contact information including statewide toll-free number of the division of adult protective services, and the number for the local district attorney's office;(b) A statement that a person of advanced age who may be the victim of abuse, neglect, or exploitation may seek assistance or file a complaint with the division concerning abuse, neglect and exploitation; and(c) A statement that any person, regardless of age, who may be the victim of domestic violence may call the nationwide domestic violence hotline, with that number printed in boldface type, for immediate assistance and posted on a sign no smaller than eight and one-half inches (81/2") in width and eleven inches (11") in height. Postings of (a) and (b) shall be on a sign no smaller than eleven inches (11") in width and seventeen inches (17") in height.
(18) "No smoking" signs or the international "No Smoking" symbol, consisting of a pictorial representation of a burning cigarette enclosed in a red circle with a red bar across it, shall be clearly and conspicuously posted at every entrance.(19) The facility shall develop a concise statement of its charity care policies and shall post such statement in a place accessible to the public.Tenn. Comp. R. & Regs. 0720-33-.04
Original rule filed April 22, 2003; effective July 6, 2003. Amendment filed April 20, 2006; effective July 4, 2006. Amendment filed July 18, 2007; effective October 1, 2007. Amendment filed December 9, 2010 to have been effective March 9, 2011 was stayed for 28 days by the Government Operations Committee; new effective date March 29, 2011. Amendments filed July 18, 2016; effective October 16, 2016. Transferred from chapter 1200-08-32 pursuant to Public Chapter 1119 of 2022 effective7/1/2022.Authority: T.C.A. §§ 4-5-202, 4-5-204, 39-17-1803, 39-17-1805, 68-11-201, 68-11-202, 68-11-204, 68-11-206, 68-11-209, 68-11-268, and 71-6-121.