Section 0720-20-.04 - ADMINISTRATION(1) The ASTC must have an effective governing body legally responsible for the conduct of the ASTC. If an ASTC does not have an organized governing body, the persons legally responsible for the conduct of the ASTC must carry out the functions specified in this chapter.(2) The governing body shall appoint a chief executive officer or administrator who is responsible for managing the ASTC. The chief executive officer or administrator shall designate an individual to act for him or her in his or her absence, in order to provide the ASTC with administrative direction at all times.(3) The governing body, whether it be that of the center alone or that of a parent organization, shall establish effective mechanisms to ensure the accountability of the center's medical staff and other professional personnel.(4) The governing body shall assure that the ASTC has the financial resources to provide the services essential to the operation of the facility.(5) Staffing shall be adequate to provide the services essential to the operation of the ASTC.(6) The ambulatory surgical treatment center shall ensure a framework for addressing issues related to care at the end of life.(7) The ambulatory surgical treatment center shall provide a process that assesses pain in all patients. There shall be an appropriate and effective pain management program.(8) The ASTC shall perform only those surgical procedures which can be safely and effectively carried out on an outpatient basis.(9) Each ASTC shall have at all times a designated Medical Director who shall be a licensed physician or dentist who shall be responsible for the direction and coordination of medical programs.(10) Staff education programs and training sessions shall include life safety, medical equipment, utility systems, infection control and hazardous waste practices. At least two (2) on duty members of the facility shall be trained in emergency resuscitation.(11) 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.(12) 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. An ASTC which violates a required policy also violates the rule and regulation establishing the requirement.(13) Policies and procedures shall be consistent with professionally recognized standards of practice.(14) No ASTC 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 department, the Adult Protective Services, or the Comptroller of the State Treasury. An ASTC 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.(15) When services such as dietary, laundry or therapy services are purchased from others, the governing body shall be responsible to assure the supplier(s) meet the same local and state standards the facility would have to meet if it were providing those services itself using its own staff.(16) The governing body shall provide for the appointment, reappointment or dismissal of members of the medical, dental, and other health professions and provide for the granting of clinical privileges.(17) The governing body shall ensure that there is a written facility agreement with one or more acute care general hospitals licensed by the state, which will admit any patient referral who requires continuing care.(18) Each ASTC shall specify the classification of services to be provided in the facility and list authorized surgical procedures.(19) Where the physician-owner-operator serves as the governing body, the articles of incorporation or other written organizational plan shall describe the manner in which the owner-operator executes the governing body responsibility.(20) Infection Control. (a) The ASTC must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active performance improvement program for the prevention, control, and investigation of infections and communicable diseases.(b) The physical environment of the ambulatory surgical treatment center shall be maintained in a safe, clean and sanitary manner.1. Any condition on the ambulatory surgical treatment center site conducive to the harboring or breeding of insects, rodents or other vermin shall be prohibited. Chemical substances of a poisonous nature used to control or eliminate vermin shall be properly identified. Such substances shall not be stored with or near food or medications.2. Cats, dogs or other animals shall not be allowed in any part of the ambulatory surgical treatment center except for specially trained animals for the handicapped and except as addressed by ambulatory surgical treatment center policy for pet therapy programs. The ambulatory surgical treatment center shall designate in its policies and procedures those areas where animals will be excluded. The areas designated shall be determined based upon an assessment of the ambulatory surgical treatment center performed by medically trained personnel.3. The layout of patient care areas of the ASTC, as well as the personal items offered to the patient, shall be outlined in the ASTC's policy and be based on the type of procedure performed on the patient.4. Bath basin water service, emesis basin, bedpan and urinal shall be individually provided.5. Water pitchers, glasses, thermometers, emesis basins, douche apparatus, enema apparatus, urinals, mouthwash cups, bedpans and similar items of equipment coming into intimate contact with patients shall be disinfected or sterilized after each use unless individual equipment for each is provided and then sterilized or disinfected between patients and as often as necessary to maintain them in a clean and sanitary condition. Single use, patient disposable items are acceptable but shall not be reused.(c) The chief executive officer or administrator shall assure that an infection control committee including members of the medical staff, nursing staff and administrative staff develops guidelines and techniques for the prevention, surveillance, control and reporting of facility infections. Duties of the committee 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 all areas of the facility, including adoption of a standardized central venous catheter insertion process which shall contain these key components: (i) Hand hygiene (as defined in 0720-20-.04(20)(g) );(ii) Maximal barrier precautions to include the use of sterile gowns, gloves, mask and hat, and large drape on patient;(iii) Chlorhexidine skin antisepsis;(iv) Optimal site selection;(v) Daily review of line necessity; and(vi) Development and utilization of a procedure checklist;4. Written procedures concerning food handling, laundry practices, disposal of environmental and patient wastes, traffic control and visiting rules in high risk areas, sources of air pollution, and routine culturing of autoclaves and sterilizers;5. A log of incidents related to infectious and communicable diseases;6. A method of control used in relation to the sterilization of supplies and water, and a written policy addressing reprocessing of sterile supplies;7. Formal provisions to educate and orient all appropriate personnel in the practice of aseptic techniques such as handwashing and scrubbing practices, proper grooming, masking and dressing care techniques, disinfecting and sterilizing techniques, and the handling and storage of patient care equipment and supplies; and,8. Continuing education provided for all facility personnel on the cause, effect, transmission, prevention, and elimination of infections, as evidenced by front line employees verbalizing understanding of basic techniques.(d) The chief executive officer, the medical staff and the chief nursing officer must ensure that the facility-wide performance improvement program and training programs address problems identified by the infection control committee 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 virus and the HIV (AIDS) virus in the event that an employee of the facility, a student studying at the facility, or other 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 shall have an annual influenza vaccination program which shall include at least: 1. The offer of influenza vaccination to all staff and independent practitioners or accept documented evidence of vaccination from another vaccine source or facility;2. A signed declination statement on record from all who refuse the influenza vaccination for other than medical contraindications;3. Education of all direct care personnel 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. The requirements to complete vaccinations or declination statements are suspended by the Medical Director in the event of a vaccine shortage.(g) The facility and its employees shall adopt and utilize standard precautions (per CDC) for preventing transmission of infections, HIV, and communicable diseases, including adherence to a hand hygiene program which shall include: 1. Use of alcohol-based hand rubs or use of non-antimicrobial or antimicrobial soap and water before and after each patient contact if hands are not visibly soiled;2. Use of gloves during each patient contact with blood or where other potentially infectious materials, mucous membranes, and non-intact skin could occur and gloves changed before and after each patient contact;3. Use of either a non-antimicrobial soap and water or an antimicrobial soap and water for visibly soiled hands; and4. Health care worker education programs which may include: (i) Types of patient care activities that can result in hand contamination;(ii) Advantages and disadvantages of various methods used to clean hands;(iii) Potential risks of health care workers' colonization or infection caused by organisms acquired from patients; and(iv) Morbidity, mortality, and costs associated with health care associated infections.(h) All ASTC's shall adopt appropriate policies regarding the testing of patients and staff for human immunodeficiency virus (HIV) and any other identified causative agent of acquired immune deficiency syndrome.(21) Performance Improvement. The ASTC shall have a planned, systematic, organization-wide approach to process design and redesign, performance measurement, assessment and improvement which is approved by the designated medical staff committee of the facility, the owner and/or the governing body. This plan shall address and/or include, but is not limited to: (a) Infection control, including post-operative surveillance;(b) Complications arising after the patient was admitted;(c) Documentation of periodic review of the data collected and follow-up actions;(d) A system which identifies appropriate plans of action to correct identified quality deficiencies;(e) Documentation that the above policies are being followed and that appropriate action is taken whenever indicated.(f) The facility shall develop and implement a system for measuring improvements in adherence to the hand hygiene program, central venous catheter insertion process, and influenza vaccination program.(22) The ASTC shall ensure a framework for addressing issues related to care at the end of life.(23) The ASTC shall provide a process that assesses pain in all patients. There shall be an appropriate and effective pain management program.(24) 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.
(25) "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.(26) The facility shall develop a concise statement of its charity care policies and shall post such statement in a place accessible to the public.(27) Informed Consent (a) Any ambulatory surgical treatment center in which abortions, other than abortions necessary to prevent the death of the pregnant female, are performed shall conspicuously post a sign in a location defined below so as to be clearly visible to patients, which reads: Notice: It is against the law for anyone, regardless of the person's relationship to you, to coerce you into having or to force you to have an abortion. By law, we cannot perform an abortion on you unless we have your freely given and voluntary consent. It is against the law to perform an abortion on you against your will. You have the right to contact any local or state law enforcement agency to receive protection from any actual or threatened criminal offense to coerce an abortion.
(b) The sign shall be printed in languages appropriate for the majority of clients of the facility with lettering that is legible and that is Arial font, at least 40-point bold-faced type.(c) A facility in which abortions are performed that is an ambulatory surgical treatment center shall post the required sign in each patient waiting room and patient consultation room used by patients on whom abortions are performed.(d) An ambulatory surgical treatment center shall be assessed a civil penalty by the board for licensing health care facilities of two thousand five hundred dollars ($2,500.00) for each day of violation in which:1. The sign required above was not posted during business hours when patients or prospective patients are present; and2. An abortion other than an abortion necessary to prevent the death of the pregnant female was performed in the ambulatory surgical treatment center.Tenn. Comp. R. & Regs. 0720-20-.04
Original rule filed July 22, 1977; effective August 22, 1977. Amendment filed September 10, 1991; effective October 25, 1991. Repeal and new rule filed June 30, 1992; effective August 14, 1992. Repeal and new rule filed March 21, 2000; effective June 4, 2000. Amendment filed June 18, 2002; effective September 1, 2002. Amendment filed June 16, 2003; effective August 30, 2003. Amendment filed September 9, 2005; effective November 23, 2005. Amendment filed April 20, 2006; effective July 4, 2006. Amendment filed July 18, 2007; effective October 1, 2007. Amendment filed October 11, 2007; effective December 25, 2007. Amendment filed February 22, 2010; effective May 23, 2010. Amendment filed December 16, 2013; effective March 16, 2014. Amendments filed July 10, 2018; effective October 8, 2018. Transferred from chapter 1200-08-10 pursuant to Public Chapter 1119 of 2022 effective 7/1/2022.Authority: T.C.A. §§ 4-5-202, 4-5-204, 39-15-202, 39-17-1803, 39-17-1805, 68-11-201, 68-11-202, 68-11-204, 68-11-206, 68-11-209, 68-11-216, 68-11-268, and 71-6-121.