1. (1) Surgical Services.

   1. (a) If the hospital provides surgical services, the services must be well-organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered, the services must be consistent in quality with inpatient care in accordance with the complexity of services offered.
   2. (b) The organization of the surgical services must be appropriate to the scope of the services offered.
   3. (c) The operating rooms must be supervised by an experienced registered nurse or a doctor of medicine or osteopathy.
   4. (d) A hospital may use scrub nurses in its operating rooms. For the purposes of this rule, a “scrub nurse” is defined as a registered nurse or either a licensed practical nurse (LPN) or a surgical technologist (operating room technician) supervised by a registered nurse who works directly with a surgeon within the sterile field, passing instruments, sponges, and other items needed during the procedure and who scrubs his or her hands and arms with special disinfecting soap and wears surgical gowns, caps, eyewear, and gloves, when appropriate.
   5. (e) Qualified registered nurses may perform circulating duties in the operating room. In accordance with applicable state laws and approved medical staff policies and procedures, LPNs and surgical technologists may assist in circulatory duties under the supervision of a qualified registered nurse who is immediately available to respond to emergencies.
   6. (f) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner.
   7. (g) Surgical services must be consistent with needs and resources. Policies covering surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care.

   8. (h) The Health Facilities Commission shall publish an approved list of accredited surgical technology programs.

      1. 1. Surgical technologists must meet one (1) or more of the following:
   9. (i) Successfully completed a nationally accredited surgical technology program, and holds and maintains certification as a surgical technologist from a national certifying body that certifies surgical technologists and is recognized by the Health Facilities Commission;

   10. (ii) Successfully completed an accredited surgical technologist program;

       1. (I) Has not, as of the date of hire, obtained certification as a surgical technologist from a national certifying body that certifies surgical technologists and is recognized by the Health Facilities Commission; and
       2. (II) Obtains such certification no later than eighteen (18) months after completion of the program.
   11. (iii) Successfully completed a training program for surgical technology in the armed forces of the United States, the national guard, or the United States public health service; or

   12. (iv) Performed surgical technology services as a surgical technologist in a healthcare facility on or before May 21, 2007, and has been designated by the healthcare facility as being competent to perform surgical technology services based on prior experience or specialized training validated by competency in current practice. The healthcare facility employing or retaining such person as a surgical technologist under this subsection (a) obtains proof of such person’s prior experience, specialized training, and current continuing competency as a surgical technologist and makes the proof available to the Health Facilities Commission upon request of the Commission.

       1. 2. This section does not prohibit a person from performing surgical technology services if the person is acting within the scope of the person’s license, certification, registration, permit, or designation, or is a student or intern under the direct supervision of a healthcare provider.
   13. (i) A hospital can petition the Commission for a waiver from the provisions of 0720-14- .07(1)(h) if they are unable to employ a sufficient number of surgical technologists who meet the requirements. The facility shall demonstrate to the Commission that a diligent and thorough effort has been made to employ surgical technologist who meet the requirements. The Commission shall refuse to grant a waiver upon finding that a diligent and thorough effort has not been made. A waiver shall exempt a facility from meeting the requirements for not more than nine (9) months. Additional waivers may be granted, but all exemptions greater than twelve (12) months shall be approved by the Commission.
   14. (j) Surgical technologists shall demonstrate continued competence in order to perform their professional duties in surgical technology. The employer shall maintain evidence of the continued competence of such individuals. Continued competence activities may include but are not limited to continuing education, in-service training, or certification renewal. Persons qualified to be employed as surgical technologists shall complete fifteen (15) hours of continuing education or contact hours annually. Current certification by the National Board of Surgical Technology and Surgical Assisting shall satisfy this requirement.
   15. (k) There must be a complete history and physical work-up in the chart of every patient prior to surgery, except in emergencies. If the history has been dictated, but not yet recorded in the patient’s chart, there must be a statement to that effect and an admission note in the chart by the practitioner who admitted the patient.
   16. (l) Properly executed informed consent, advance directive, and organ donation forms, when applicable, must be in the patient’s chart before surgery, except in emergencies.

   17. (m) The following equipment must be available to the operating room suites:

       1. 1. Call-in system;
       2. 2. Cardiac monitor;
       3. 3. Resuscitator;
       4. 4. Defibrillator;
       5. 5. Aspirator; and
       6. 6. Tracheotomy set.
   18. (n) There must be adequate provisions for immediate pre- and post-operative care.
   19. (o) The operating room register must be complete and up-to-date.
   20. (p) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon.

2. (2) Anesthesia Services.

   1. (a) If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital.

   2. (b) The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by:

      1. 1. A qualified anesthesiologist;
      2. 2. A doctor of medicine or osteopathy (other than an anesthesiologist);
      3. 3. A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under state law;
      4. 4. A certified registered nurse anesthetist (CRNA); or
      5. 5. A graduate registered nurse anesthetist under the supervision of an anesthesiologist who is immediately available if needed.

   3. (c) Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of pre-anesthesia and post- anesthesia responsibilities. The policies must ensure that the following are provided for each patient:

      1. 1. A pre-anesthesia evaluation or evaluation update conducted within forty-eight

3. (48) hours prior to surgery by an individual qualified to administer anesthesia;

   1. 2. An intraoperative anesthesia record;
   2. 3. For each inpatient, a written post-anesthesia follow-up report prepared within forty-eight (48) hours following surgery by an individual qualified to administer anesthesia or by the person who administered the anesthesia and submits the report by telephone; and
   3. 4. For each outpatient, a post-anesthesia evaluation of anesthesia recovery prepared in accordance with policies and procedures approved by the medical staff.

4. (3) Nuclear Medicine Services.

   1. (a) If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice.
   2. (b) The organization of the nuclear medicine service must be appropriate to the scope and complexity of the services offered.
   3. (c) There must be a director who is a doctor of medicine or osteopathy qualified in nuclear medicine.
   4. (d) The qualifications, training, functions, and responsibilities of nuclear medicine personnel must be specified by the service director and approved by the medical staff.
   5. (e) Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice.
   6. (f) In-house preparation of radiopharmaceuticals is by, or under, the direct supervision of an appropriately trained registered pharmacist or a doctor of medicine or osteopathy.
   7. (g) If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirements for laboratory services as specified in TCA §§ 68-29-101, et seq.

   8. (h) Equipment and supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for safe and efficient performance. The equipment must be:

      1. 1. Maintained in safe operating condition; and,
      2. 2. Inspected, tested, and calibrated at least annually by qualified personnel.
   9. (i) The hospital must maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures. Copies of nuclear medicine reports must be maintained for at least ten (10) years.
   10. (j) The practitioner approved by the medical staff to interpret diagnostic procedures must sign and date the interpretation of these tests.
   11. (k) The hospital must maintain records of the receipt and disposition of radiopharmaceuticals.
   12. (l) Nuclear medicine services must be ordered only by a practitioner whose scope of federal or state licensure and whose defined staff privileges allow such referrals.
   13. (m) Patients are not left unattended in pre- and post-procedure areas.

5. (4) Outpatient Services.

   1. (a) If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice.
   2. (b) Outpatient services must be appropriately organized and integrated with inpatient services.
   3. (c) The hospital must have appropriate professional and non-professional personnel available to provide outpatient services.
   4. (d) Patient’s rights, including a phone number to call regarding questions or concerns, shall be made readily available to outpatients.

   5. (e) Outpatient laboratory testing in Tennessee hospitals may be ordered by the following:

      1. 1. Any licensed Tennessee practitioner who is authorized to do so by T.C.A. § 68- 29-121;
      2. 2. Any out-of-state practitioner who has a Tennessee telemedicine license issued pursuant to Rule 0880-02-.16; or
      3. 3. Any duly licensed out-of-state health care professional as listed in T.C.A. § 68- 29-121 who is authorized by his or her state board to order outpatient laboratory testing in hospitals for individuals with whom that practitioner has an existing face-to-face patient relationship as outlined in Rule 0880-02-.14(7)(a)1., 2., and
      4. 3.

   6. (f) Outpatient diagnostic testing in Tennessee hospitals may be ordered by the following:

      1. 1. Any Tennessee practitioner licensed under Title 63 who is authorized to do so by his or her practice act;
      2. 2. Any out-of-state practitioner who has a Tennessee telemedicine license issued pursuant to Rule 0880-02-.16; or
      3. 3. Any duly licensed out-of-state health care professional who is authorized by his or her state board to order outpatient diagnostic testing in hospitals for individuals with whom that practitioner has an existing face-to-face patient relationship as outlined in Rule 0880-02-.14(7)(a)1., 2., and 3.

6. (5) Emergency Services.

   1. (a) Hospitals that elect to provide surgical services, other than in a separately licensed Ambulatory Surgical Treatment Center, must maintain and operate an emergency room.

   2. (b) If emergency services are provided, the hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. Each hospital must have a policy which assures that all patients who present to the emergency department, are screened/triaged to determine if a medical emergency exists and stabilized when a medical emergency does exist. A hospital may deny access to patients when it is on diversionary status only because it does not have the staff or facilities in the emergency department to accept any additional emergency patients at that time. If an ambulance disregards the hospital’s instructions and brings an individual on to the hospital grounds, the individual has arrived on hospital property and cannot be denied access to hospital services. Hospital property, for the purpose of this subparagraph, is considered to be:

      1. 1. The hospital’s physical geographic boundaries; or
      2. 2. Ambulances owned and operated by the hospital, whenever in operation, whether or not on hospital grounds.
   3. (c) A hospital may not delay provision of an appropriate medical screening examination in order to inquire about the individual’s method of payment or insurance status.

   4. (d) If emergency services are provided at the hospital:

      1. 1. The services must be organized under the direction of a qualified member of the medical staff;
      2. 2. The services must be integrated with other departments of the hospital; and
      3. 3. The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. These policies and procedures must define how the hospital will assess, stabilize, treat and/or transfer patients.
   5. (e) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility.
   6. (f) There shall be a sufficient number of emergency rooms and adequate equipment and supplies to accommodate the caseload of the emergency services.
   7. (g) The entrance to the emergency department shall be clearly marked.
   8. (h) Legend drugs in emergency rooms shall be stored in locked cabinets, except as otherwise provided for emergency drugs by the written policies and procedures of the hospital. Discharge medications may be dispensed to out-patients upon written physician orders provided that they have been packaged in containers by the pharmacist in amounts not to exceed twelve (12) hours dosage and labeled in accordance with Pharmacy Board rules.

   9. (i) Emergency room medical records shall include the following:

      1. 1. Identification data;
      2. 2. Information concerning the time of arrival, means and by whom transported;
      3. 3. Pertinent history of the injury or illness to include chief complaint and onset of injuries or illness;
      4. 4. Significant physical findings;
      5. 5. Description of laboratory, x-ray and EKG findings;
      6. 6. Treatment rendered;
      7. 7. Condition of the patient on discharge or transfer;
      8. 8. Diagnosis on discharge;
      9. 9. Instructions given to the patient or his family; and
      10. 10. A control register listing chronologically the patient visits to the emergency room. The record shall contain at least the patient’s name, date and time of arrival and record number. The name of those dead on arrival shall be entered in the register.
   10. (j) Emergency patients and their families are made aware of their rights, including a number to call regarding concerns or questions.

7. (6) Rehabilitation Services.

   1. (a) If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients. These disciplines should document their contribution to the plan for patient care.
   2. (b) The organization of the service must be appropriate to the scope of the services offered.
   3. (c) The director of the service must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services.
   4. (d) Physical therapy, occupational therapy, speech therapy, or audiology services, if provided, must be provided by staff who meet the qualifications specified by hospital policy, consistent with state law.
   5. (e) Services must be furnished in accordance with a written plan of treatment in accordance with the practice acts of the practitioners who are authorized by medical staff to provide the services. The written plan of treatment must be incorporated in the patient’s record.

8. (7) Obstetrical Services.

   1. (a) If a hospital provides obstetrical services it shall have space, facilities, equipment and qualified personnel to assure appropriate treatment of all maternity patients and newborns.
   2. (b) The hospital must have written policies and procedures governing medical care provided in the obstetrical service which are established by and are a continuing responsibility of the medical staff.
   3. (c) Provisions must be made for care of the patient during labor and delivery, either in the patient’s room or in a designated room.
   4. (d) Designated delivery rooms shall be segregated from patient areas and be located so as not to be used as a passageway between or subject to contamination from other parts of the hospital.

   5. (e) A delivery record shall be kept that must indicate:

      1. 1. The name of the patient;
      2. 2. Her maiden name;
      3. 3. Date of delivery;
      4. 4. Sex of infant;
      5. 5. Name of physician;
      6. 6. Names of persons assisting;
      7. 7. What complications, if any, occurred;
      8. 8. Type of anesthesia used;
      9. 9. Name of person administering anesthesia; and
      10. 10. Other persons present.

9. (8) Pediatric Services.

   1. (a) If the hospital provides pediatric services, it shall provide appropriate pediatric equipment and supplies.
   2. (b) Pediatric services must be appropriate to the scope and complexity of the services offered and must meet the needs of the patients in accordance with acceptable standards of practice.
   3. (c) The hospital must have appropriate professional and non-professional personnel available to provide pediatric services.

10. (9) Respiratory Care Services.

    1. (a) If the hospital provides respiratory care services, the hospital must meet the needs of the patients in accordance with acceptable standards of practice.
    2. (b) The organization of the respiratory care services must be appropriate to the scope and complexity of the services offered.
    3. (c) There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge, experience, and capabilities to supervise and administer the service properly.
    4. (d) There must be adequate numbers of certified respiratory therapists, certified respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with state law.
    5. (e) Services must be delivered in accordance with medical staff directives.
    6. (f) Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures must be designated in writing.
    7. (g) If blood gases or other laboratory tests are performed in the respiratory care unit, the unit must meet the applicable requirements for clinical laboratory services specified in the Tennessee Medical Laboratory Act.

11. (10) Social Work Services.

    1. (a) If the hospital provides social work services, the services must be available to the patient, the patient’s family and other persons significant to the patient, in order to facilitate adjustment of these individuals to the impact of illness and to promote maximum benefits from the health care services provided.
    2. (b) Social work services shall include psychosocial assessment, counseling, coordination of discharge planning, community liaison services, financial assistance and consultation.
    3. (c) Social work services shall be provided by personnel who satisfy applicable accreditation standards and who are in compliance with Tennessee State Law governing social work practices. Social work personnel employed by the hospital prior to the effective date of these regulations shall be deemed to meet this requirement.
    4. (d) Facilities for social work services shall be readily accessible and shall permit privacy for interviews and counseling.

12. (11) Psychiatric Services.

    1. (a) If a hospital provides psychiatric services, a psychiatric unit devoted exclusively for the care and treatment of psychiatric patients and professional personnel qualified in the diagnosis and treatment of patients with psychiatric illnesses shall be provided. Adequate protection shall be provided for patients and the staff against any physical injury resulting from a patient becoming violent. A psychiatric unit shall meet the requirements as needed to care for patients admitted, either through direct care or by contractual arrangements.
    2. (b) A hospital licensed by the Commission as a satellite hospital whose primary purpose is the provision of mental health or substance abuse services, must verify to the Commission that Standards of the Department of Mental Health and Substance Abuse Services are satisfied.

13. (12) Alcohol and Drug Services.

    1. (a) If a hospital provides alcohol and drug services, the service shall be devoted exclusively to the care and treatment of alcohol and drug dependent patients and have on staff physicians and other professional personnel qualified in the diagnosis and treatment of alcoholism and drug addiction.
    2. (b) Adequate protection shall be provided for the patients and staff against any physical injury resulting from a patient becoming disturbed or violent. Alcohol and drug services shall meet the requirements as needed to care for patients admitted, either through direct care or by contractual arrangements.

14. (13) Perinatal and/or Neonatal Care Services. Any hospital providing perinatal and/or neonatal care services shall comply with the Tennessee Perinatal Care System Guidelines for Regionalization, Hospital Care Levels, Staffing and Facilities developed by the Tennessee Department of Health’s Perinatal Advisory Committee, the Ninth Edition effective October 14,

    1. 2020.

15. (14) Burn Unit Services.

    1. (a) If a hospital provides burn unit services, the following licensing requirements apply:

       1. 1. The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Commission. Patients shall not be admitted to the burn unit until a license has been issued. Applicants shall not hold themselves out to the public as being a burn unit until the license has been issued.
    2. (i) The applicant shall allow the burn unit to be inspected by Commission staff. In the event that deficiencies are noted, the applicant shall submit a plan of corrective action within ten (10) calendar days to the Commission that must be accepted by the Commission. Once the deficiencies have been corrected, then the Commission shall consider the application for licensure.
    3. (ii) A provisional license shall be issued upon administrative approval of the initial application.

    4. (iii) A provisional licensee must achieve American Burn Association (ABA) verification within five (5) years of obtaining a provisional license. A provisional licensee must comply with the following requirements:

       1. (I) Provide the Commission with annual progress reports demonstrating engagement and measurable efforts toward obtaining verification.
       2. (II) Provide data to the Burn Care Quality Platform (BCQP) and provide reports formatted in accordance with Commission reporting requirements.

       3. (III) Participate in annual on-site visits conducted by Commission staff, consultant burn surgeons and burn nurses until ABA verification is achieved.

          1. I. Site visits must be scheduled by within twelve (12) months of provisional licensure. II. Costs associated with site visits shall be assessed to the provisional licensee by the Commission through the issuance of an Assessment of Costs.

             1. 2. A full license shall not be issued until the facility is ABA verified and written confirmation verification has been achieved is submitted to the Commission.
             2. 3. A fully licensed burn unit must maintain ABA verification. Loss of ABA verification will cause the full license to be reverted to a provisional license until re- verification is achieved

             3. (b) If a hospital provides burn unit services, the following administrative requirements apply:

                1. 1. The burn unit must have a Burn Unit Director who is responsible for the following:
             4. (i) All burn unit administrative functions.
             5. (ii) Creation of policies and procedures regarding burn unit care.
             6. (iii) Ensure burn unit staff are properly credentialed through the general hospital’s medical staff credentialing process.

             7. (iv) Ensure burn unit physicians, advanced practice providers, and registered nurses obtain and maintain Advanced Burn Life Support (ABLS) certification.

                1. 2. The burn unit must have a Burn Nurse Leader who is responsible for the following:
             8. (i) All burn unit nursing functions.
             9. (ii) Ensure burn unit nurses obtain, within six (6) months of hiring, and continuously maintain Advanced Burn Life Support (ABLS) certification.
             10. (iii) Participate in burn unit quality improvement meetings.

             11. (15) MRI Services

                 1. (a) If a hospital provides MRI services, the following licensing requirements apply to each unit:

                    1. 1. Must become accredited within two years of licensure per machine and per diagnostic type.
                    2. 2. Must adhere to all federal and state regulations, as well as the Nuclear Regulatory Commission Requirements.
                    3. 3. For Pediatric MRI Units, a person who initiates magnetic resonance imaging services shall notify the commission in writing that imaging services are being initiated and shall indicate whether magnetic resonance imaging services will be provided to a patient who is fourteen (14) years of age or younger on more than five (5) occasions per year.
                    4. 4. A facility who provides MRI services and/or PET services shall file with the commission an annual report no later than thirty (30) days following the end of each state fiscal year that details the mix of payers by percentage of cases for the prior calendar year, charity care, Medicare, and Medicaid.

             12. (16) NICU Services

                 1. (a) If a qualifying hospital provides NICU services, the following licensing requirements apply:

                    1. 1. The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Commission. Patients shall not be admitted to the NICU until a license has been issued. Applicants shall not hold themselves out to the public as being a NICU unit until the license has been issued.
                 2. (i) The applicant shall allow the NICU to receive an initial inspection by Commission staff. In the event that deficiencies are noted, the applicant shall submit a plan of corrective action within ten (10) calendar days to the Commission that must be accepted by the Commission. Once the deficiencies have been corrected, then the Commission shall consider the application for licensure.
                 3. (ii) A provisional license shall be issued upon administrative approval of the initial application.

                 4. (iii) Within three (3) years of obtaining a provisional license, licensee must achieve either:

                    1. (I) State level verification; or
                    2. (II) Verification through the American Academy of Pediatrics (AAP).

                 5. (iv) Upon application, applicant will self-designate. At verification, licensee must comply with the corresponding requirements based upon level of designation (for Levels II–IV) as illustrated in the referenced levels of care;

                    1. (I) The verification process shall be based upon the standards established by and referenced within the Tennessee Perinatal Care System, Guidelines for Regionalization, Hospital Care Levels, Staffing and Facility as published by the Tennessee Department of Health, Division of Family Health and Wellness. The Tennessee Perinatal Care System, Guidelines for Regionalization, Hospital Care Levels, Staffing and Facility shall be published by reference on the Health Facilities Commission website.

                 6. (b) Levels of Care – Neonatal Intensive Care Units II–IV Requirements:

                    1. 1. Facility Capacity Requirements IV III II
                 7. (i) Level II units provide care for infants born at >or= to 32 weeks’ gestation and E weighing >or= to 1500 grams who have physiologic immaturity or who are moderately ill with problems that are expected to resolve rapidly and are not anticipated to need subspecialty services on an urgent basis.
                 8. (ii) Level III units have the capabilities of Level II NICUs and provide comprehensive E care for infants born <32 weeks gestation and weighing <1500 grams and infants born at all gestational ages birth weights with critical illness. Provide prompt and readily available access to a full range of pediatric medical subspecialists, pediatric surgical specialists, pediatric anesthesiologists, and pediatric ophthalmologists.
                 9. (iii) Level IV units have Level III capabilities plus are located within an institution with E the capability to provide surgical repair of complex congenital or acquired conditions and maintain a full range of pediatric medical subspecialists, pediatric surgical subspecialists, and pediatric anesthesiologists at the site.
                 10. (iv) Provide mechanical ventilation for brief duration (<24 hours) and provide E E E continuous positive airway pressure (CPAP).
                 11. (v) Stabilize infants born at <32 weeks’ gestation and weighing <1500 grams until E E E transfer to a neonatal intensive care facility.
                 12. (vi) Provide care for infants who are convalescing after intensive care. E E E

                 13. (vii) Provide sustained life support. E E

                     1. (viii) Provide prompt and readily available access to a full range of pediatric medical E E subspecialists, pediatric surgical specialists, pediatric anesthesiologists, and pediatric ophthalmologists.
                 14. (ix) Provide a full range of respiratory support that may include conventional and/or E E high-frequency ventilation and inhaled nitric oxide.
                 15. (x) Perform advanced imaging with interpretation on an urgent basis, including E E computed tomography, MRI, and echocardiography.
                 16. (xi) Located within an institution with the capability to provide surgical repair of E complex congenital or acquired conditions.
                 17. (xii) Maintain a full range of pediatric medical subspecialists, pediatric surgical E subspecialists, and pediatric anesthesiologists at the site.

                 18. (xii) Facilitate transport. E E E

                     1. 2. Education Services Requirement IV III II
                 19. (i) Educational services should include the following: All neonatal care providers shall maintain both current NRP and S.T.A.B.L.E. E E E provider status. The S.T.A.B.L.E. Cardiac Module is also recommended.
                 20. (ii) Parent Education Ongoing perinatal education programs for parents. E E E
                 21. (iii) Nurses’ Education Required to provide ongoing educational programs for their nurses that conform E to the latest edition of the Tennessee Perinatal Care System Educational Objectives for Nurses, Level IV, for neonatal nurses, published by the Tennessee Department of Health. Outreach educational activities are not required. Required to provide ongoing educational programs for their nurses that conform E to the latest edition of the Tennessee Perinatal Care System Educational Objectives for Nurses, Level III, for neonatal nurses, published by the Tennessee Department of Health. Outreach educational activities are not required. Programs for nurses that conform to the latest edition of the Tennessee Perinatal E Care System Educational Objectives for Nurses, Level II, for neonatal nurses, published by the Tennessee Department of Health. These neonatal courses should be made available periodically at Level II facilities by instructors on the staff of that institution and/or the staff from a Regional Perinatal Center. Courses may also transpire at a Regional Perinatal Center or at another site remote from the Level II hospital, thus requiring that the hospital provide nurses with educational leave for attendance. Level II hospitals are responsible for the necessary arrangements for nurse education.

                 22. (iv) Physicians’ Education NICUs are required to provide ongoing educational programs for physicians E E E practicing in that institution. Outreach educational activities are not required. Educational opportunities for physicians should be available upon request, E provided by the qualified individuals on the staff of the Level II institution.

                     1. 3. Neonatal Care Requirement IV III II
                 23. (i) Resuscitation Provision must be made for resuscitation of infants immediately after birth. E E E Resuscitation capabilities should include assisted ventilation with blended oxygen administered by bag or T-piece resuscitator with mask or endotracheal tube, chest compression, and appropriate intravascular therapy. Refer to the most recent edition of the American Heart Association and American Academy of Pediatrics Neonatal Resuscitation Program Guidelines for a complete list of resuscitation equipment and supplies.
                 24. (ii) Transport from Delivery Room to the NICU Transport to a NICU requires a capacity for uninterrupted support. An E E E appropriately equipped pre-warmed transport incubator, with blended oxygen, should be used for this purpose.
                 25. (iii) Transitional Care Recurrent observation of the neonate should be performed by personnel who can E E E identify and respond to the early manifestations of neonatal disorders.

                 26. (iv) Care of Sick Neonates

                     1. (I) The care of moderately and severely ill infants entails the following essentials: Continuous cardiorespiratory monitoring. E E E Serial blood gas determinations and non-invasive blood gas monitoring. E E E Periodic blood pressure determinations (intra-arterial when necessary). E E E Portable diagnostic imaging for bedside interpretation. E E E Availability of electrocardiograms and echocardiograms with rapid interpretation. E E Laboratory Services: Clinical laboratory services must be available to fully E E E support clinical neonatal functions. Fluid and electrolyte management and administration of blood and blood E E E components. Phototherapy. E Phototherapy and exchange transfusion. E E Administration of parenteral nutrition through peripheral or central vessels. E E Provision of appropriate enteral nutrition and lactation support. E E E

                 27. (v) Mechanical Ventilatory Support

                     1. (I) Unit must be qualified to provide mechanical ventilatory support. The essential qualifications are as follows: Continuous in-house presence of personnel experienced in airway management, E E E endotracheal intubation, and diagnosis and treatment of air leak syndromes. A staff of nurses (R.N.) and respiratory therapists (R.T.) who are specifically E E E educated in the management of neonatal respiratory disorders. Blood gas determinations and other data essential to treatment must be E E E available 24 hours a day, 7 days a week. NICUs should be able to provide a full range of respiratory support, including E E sustained conventional and/or high frequency ventilation and inhaled nitric oxide.
                 28. (vi) Diagnostic Imaging Perform advanced imaging, with interpretation on an urgent basis, including CT, E E MRI, and echocardiography.

                 29. (vii) Transfusion Services Transfusion services must be maintained at all times. E E E An appropriately trained technician should be available in-house 24 hours a day, 7 E E E days a week. All blood components must be obtainable on an emergency basis from within the E facility. All blood components must be obtainable on an emergency basis, either on the E E premises or by pre-arrangement with another facility.

                     1. 4. Ancillary Services Requirement IV III II

                 30. (i) Laboratory Services: Clinical laboratory services must be available to fully support clinical neonatal E E E functions.

                     1. (I) Laboratory capabilities should include but not be limited to the following:

                        1. I. Routine Availability Clotting factors E E E Serum total protein E E E Serum total protein E E E Serum albumin E E E Serum IgM E E E Serum triglycerides (for parenteral nutrition) E E E Metabolic screen E E E Liver function tests E E E Serologic test for syphilis E E E Serology for hepatitis E E E Screening for HIV E E E TORCH titers E E E Viral cultures E E E II. Available 24 Hours – 7 Days a Week Hematocrit E E E Hemoglobin E E E Complete blood count E E E Reticulocyte count E E E Blood typing: major groups and Rh E E E Cross match E E E Minor blood group antibody screen E E E Coombs’ test E E E Prothrombin time E E E Partial thromboplastin time E E E Platelet count E E E Fibrinogen concentration E E E Serum sodium, potassium, chloride E E E Serum calcium E E E Serum phosphorus E E E Serum magnesium E E E Serum blood glucose E E E Therapeutic drug levels E E E Serum bilirubin, total and direct E E E Blood gases/Ph E E E Blood urea nitrogen E E E Serum creatinine E E E Serum/urine osmolality’s E E E Urinalysis E E E Cerebrospinal fluid: cells, chemistry E E E Bacterial cultures and sensitivities E E E C-reactive protein (CRP) E E E Gram stain E E E Toxicology E E E Group B strep screening E E E

                           1. 5. Consultation and Transfer Requirement IV III II

                           2. (i) Neonatal Transport: The facility that operates a transport service is required to maintain E E E equipment and a trained team of personnel for the transport of newborn patients. The team and equipment must be available at all times. The facility is responsible for transport of referred infants with its own equipment, or alternatively, with equipment from a commercial source. The facility that operates a transport service should originate a protocol that E E E describes procedures, staffing patterns, and equipment for the transport of referred infants. The protocol should conform to the most recent edition of the Tennessee Perinatal Care System Guidelines for Transportation, published by the Tennessee Department of Health. The facility that operates a transport service is required to maintain records of its E E E activities. (See the most recent edition of the Tennessee Perinatal Care System Guidelines for Transportation.) The Level II facility should maintain an active relationship with a Level III or Level E IV facility in the region for consultation and transfer. Protocols for transport should conform to the most recent edition of the Tennessee Perinatal Care System Guidelines for Transportation, published by the Tennessee Department of Health. Neonatal Consultation and Transport: When the severity of an illness requires a E level of care that exceeds the capacity of the Level II facility, the infant should be transferred to a Level III or Level IV institution capable of providing required care. Transfer of these infants should be provided after consultation with the receiving Level III or Level IV unit. Refer to the most recent edition of the Tennessee Perinatal Care System Guidelines for Transportation, published by the Tennessee Department of Health, for more information.

                              1. 6. Maintenance of Data Requirement IV III II

                           3. (i) Maintenance of Data and Assessment of Quality Measures

                              1. (I) The following items represent the minimum information that should be in medical records maintained at all facilities: Name, gender, hospital medical record number E E E Date of birth E E E Birthweight E E E Gestational age E E E Apgar scores E E E Maternal complications (test results relevant to neonatal care; maternal illness E E E potentially affecting the fetus; history of illicit substance use or any other known socially high-risk circumstances; complications of pregnancy associated with abnormal fetal growth, fetal anomalies, or abnormal results from tests of fetal well-being; information regarding labor and delivery; and situations in which lactation may be compromised) Discharge diagnoses E E E Special care administered (specify) E E E Documentation of newborn metabolic, hearing and critical congenital heart E E E disease (CCHD) screens, and immunizations and medications given Bilirubin screen (according to American Academy of Pediatrics guidelines) E E E Disposition E E E -Discharged home -Transferred to a higher level of care/Receiving hospital/Transport service -Expired
                              2. (II) A systematic ongoing compilation of data should be maintained to reflect the care E E E of sick patients, in addition to the listing of minimal data that is specified for Level I, Level II, and Level III facilities. All Level III & IV programs should participate in a state or national continuous quality initiative that includes ongoing data collection and review for benchmarking and evaluation of outcomes. Examples of continuous quality initiatives available in Tennessee are those provided by TIPQC and THA.
                              3. 7. Personnel Qualifications and Functions Requirement IV III II

                           4. (i) Physicians

                              1. (I) Director The director of the newborn intensive care unit must be a full-time, board-certified E E pediatrician with subspecialty certification in neonatal-perinatal medicine. The director is responsible for maintaining practice guidelines and, in cooperation with nursing and hospital administration, is responsible for developing the operating budget; evaluating and purchasing equipment; planning, developing, and coordinating in-hospital and outreach educational programs; and participating in the evaluation of perinatal care. In a Level II (UNIT), a board-certified pediatrician with subspecialty certification in E neonatal-perinatal medicine should be chief of the neonatal care service. The chief should assure that appropriate trained and adequate staff are available at all times
                              2. (II) Neonatologists The attending physician for neonates must be fellowship-trained and board- E E certified or eligible to take the board certification exam in neonatal-perinatal medicine. The co-directors of perinatal services should coordinate the hospital’s perinatal E care services and, in conjunction with other medical, anesthesia, nursing, respiratory therapy, and hospital administration staff, develop policies concerning staffing, procedures, equipment, and supplies. The medical directors of obstetrics and neonatology are responsible for setting the hospital’s standard of perinatal care by working together to incorporate evidence-based practice patterns and nationally recognized care standards.

                              3. (III) Pediatricians A board-certified neonatologist must have primary and ultimate responsibility for E E infants who receive intensive care. Board-certified pediatricians, whose qualifications and appointments have been approved by the appropriate hospital committee, can care for infants who need more than routine care as long as they are under the supervision of a neonatologist.

                                 1. (IV) In-House Coverage In-house physician consultation and coverage should be provided 24 hours a day, E E 7 days a week by a board-certified neonatologist or a board-certified neonatal nurse practitioner. However, when in-house coverage does not include a board-certified neonatologist, he/she must be on-call and available to be on-site within 30 minutes of request.
                                 2. (V) Deliveries E E E Deliveries of high-risk fetuses should be attended by an obstetrician and at least two other persons qualified in neonatal resuscitation whose only responsibility is the neonate. With multiple gestations, each newborn should have his or her own dedicated team of care providers who are capable of performing neonatal resuscitation according to the American Heart Association and American Academy of Pediatrics Neonatal Resuscitation Program guidelines. Every delivery should be attended by at least one person whose primary E E E responsibility is for the newborn and who is capable of performing neonatal resuscitation according to the American Heart Association and American Academy of Pediatrics Neonatal Resuscitation Program guidelines. Either that person or someone else who is immediately available should have the skills required to perform a complete resuscitation, including endotracheal intubation and administration of medications.
                                 3. (VI) Anesthesiologists Pediatric anesthesia services should be directed by a board-certified E E anesthesiologist who has a special interest and an expertise in pediatric anesthesia.
                              4. (VII) Radiologists A radiologist must be available on-call at all times. E E
                              5. (VIII) Sub-Specialty Consultants Should have pediatric surgical sub-specialists on call and readily available for E consultation and continuous patient management. Should be available on-site or at a closely related institution by prearranged E consultative agreement, ideally in close geographic proximity. Pediatric medical subspecialists E E Pediatric surgical specialists E E Pediatric anesthesiologists E E Pediatric ophthalmologists E E

                           5. (ii) Nurses

                              1. (I) The Nurse Manager Of the Level IV NICU should have completed education according to the E most recent edition of the Tennessee Perinatal Care System Educational Objectives for Nurses, Level IV, Neonatal, published by the Tennessee Department of Health. A baccalaureate degree is required. Of the Level III NICU should have completed education according to the most E recent edition of the Tennessee Perinatal Care System Educational Objectives for Nurses, Level III, Neonatal, published by the Tennessee Department of Health. A baccalaureate degree is required. The nurse manager (R.N.) is responsible for all nursing activities in the nurseries E of Level II facilities. The nurse manager in a hospital with a Level II ICU must complete the Level II neonatal courses prescribed for staff nurses in the most recent edition of the Tennessee Perinatal Care System Educational Objectives for Nurses, Level II, published by the Tennessee Department of Health.
                              2. (II) Staff Nurses (R.N.) Must have received courses as outlined in the most recent edition of the E Tennessee Perinatal Care System Educational Objectives for Nurses, Level IV, for neonatal nurses, published by the Tennessee Department of Health. Nurses should maintain institutional unit-specific competencies. In addition, all nurses should be current NRP and S.T.A.B.L.E. providers. Must have received courses as outlined in the most recent edition of the E Tennessee Perinatal Care System Educational Objectives for Nurses, Level III, for neonatal nurses, published by the Tennessee Department of Health. Nurses should maintain institutional unit-specific competencies. In addition, all nurses should be current NRP and S.T.A.B.L.E. providers. Must be skilled in the observation and treatment of sick infants. For Level II E facilities, they must complete the Level II neonatal course for nurses outlined in the most recent edition of the Tennessee Perinatal Care System Educational Objectives for Nurses, published by the Tennessee Department of Health. Nurses should maintain institutional unit-specific competencies. In addition, all nurses should be current NRP and S.T.A.B.L.E. providers.

                              3. (III) Nurse Educator Should have at least one neonatal nurse on its full-time staff who is responsible E E for staff education. This nurse should either be masters’ prepared or actively pursuing an advanced degree.

                                 1. (IV) Recommended Registered Nurse (R.N.)/Patient Ratios for Newborn Care (Association of Women’s Health, Obstetric, and Neonatal Nurses Guidelines for Professional Registered Nurse Staffing for Perinatal Units, 2010): 1:5–6 Newborns requiring only routine care E 1:3–4 Newborns requiring continuing care E 1:2–3 Newborns requiring intermediate care E E E 1:1–2 Newborns requiring intensive care E E E 1:1 Newborns requiring multisystem support E E E 1 or more :1 Unstable newborns requiring complex critical care E E E
                           6. (iii) Social Workers The services of social workers should be made available by the hospital 24 hours E E a day, 7 days a week. These services should be provided by a staff that is qualified in perinatal social work. This requires that social workers be educated according to the most recent edition of the Tennessee Perinatal Care System Educational Objectives in Medicine for Perinatal Social Workers, published by the Tennessee Department of Health.
                           7. (iv) Case Manager/Discharge Coordinator Personnel experienced in dealing with discharge planning and education, follow- E E E up and referral, and home care planning should be available to neonatal intensive care unit staff members and families. Personnel experienced in dealing with perinatal issues, discharge planning and E E E education, follow-up and referral, home care planning, and bereavement support should be available to intermediate and intensive care unit staff members and families.
                           8. (v) Respiratory Therapists Respiratory therapists who can provide supplemental oxygen, assisted ventilation E and continuous positive pressure ventilation (including high flow nasal cannula) of neonates with cardiopulmonary disease should be continuously available on-site to provide ongoing care as well as to address emergencies. Dedicated respiratory therapists who can provide the assisted ventilation of E E neonates with cardiopulmonary disease must be available. The NICU’s respiratory therapy director must be a registered respiratory therapist (R.R.T.).
                           9. (vi) Dietitian/Lactation Consultant The staff must include at least one dietitian who has special training in perinatal E nutrition and can plan diets that meet the special needs of high-risk neonates. Availability of lactation consultants 7 days a week is recommended to assist with complex breastfeeding issues. 1.6 full-time equivalent lactation consultants are recommended for every 1,000 births based on annual birth volume in Level II perinatal facilities (Association of Women’s Health, Obstetric, and Neonatal Nurses Guidelines for Professional Registered Nurse Staffing for Perinatal Units, 2010). The staff must include at least one dietitian who is knowledgeable in the E E management of parenteral and enteral nutrition of low birthweight and other high- risk infants. Availability of lactation consultants 7 days a week is recommended to assist with complex breastfeeding issues. 1.9 full-time equivalent lactation consultants are recommended for every 1,000 births based on annual birth volume in Level III (also applies to Level IV) perinatal facilities (Association of Women’s Health, Obstetric, and Neonatal Nurses Guidelines for Professional Registered Nurse Staffing for Perinatal Units, 2010).

                           10. (vii) Pharmacist A registered pharmacist with expertise in compounding and dispensing E medications, including total parenteral nutrition (TPN) for neonates must be available 24 hours a day, 7 days a week. A registered pharmacist with expertise in compounding and dispensing E E medications for neonates must be included on staff. Registered pharmacists with expertise in dispensing neonatal medications, including total parenteral nutrition (TPN), must be available 24 hours a day, 7 days a week.

                               1. (viii) Occupational Therapist/Physical Therapist/Speech Therapist At least one occupational therapist or physical therapist and one speech therapist E E with neonatal expertise must be included on staff. These disciplines will work collaboratively with the medical and nursing staffs to provide developmentally appropriate care.

                           11. (ix) Neonatal Follow-Up Services E E Neonatal intensive care unit graduates who are considered high risk and those with birthweights <1500 grams should be enrolled in an organized follow-up program that tracks and records medical and neurodevelopmental outcomes to allow later analysis.

                               1. 8. Space and Equipment for Level II Facilities Requirement IV III II
                           12. (i) Physical Facilities and Equipment Physical facilities and equipment should meet criteria published in the latest E edition of the Guidelines for Perinatal Care, jointly published by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Equipment of a Level III or IV NICU should be adequate for the care of moderately E E and severely ill infants in accordance with contemporary standards. The quantities of all items of equipment should be sufficient to support the management of the maximum number of infants that are anticipated at times of peak census loads. An in-house Bioengineering Department should have an active program for preventive maintenance and rapid repair.
                           13. (ii) Equipment Necessary for NICU Units A platform scale, preferably with metric indicators. E E E A controlled source of continuous and/or intermittent suction. E E E Incubators and/or radiant warmers for adequate thermal support. E E E Equipment for determination of blood glucose at the bedside. E E E Ability to provide intensive phototherapy. E E E A device for the external measurement of blood pressure from the infant’s arm or E E E thigh. Oxygen flow meters, tubing, binasal cannulas for short-term administration of E E E oxygen. An oxygen blending device, and warming nebulizer for short-term administration of E E E oxygen. An oxygen analyzer that displays the ambient concentration of oxygen. E E E A newborn pulse oximeter for non-invasive blood oxygen monitoring. E E E An infusion pump that can deliver appropriate volumes of continuous fluids and/or E E E medications for newborns. A fully equipped neonatal resuscitation cart. E E E Positive pressure ventilation equipment and masks; endotracheal tubes in all the E E E appropriate sizes for neonates. A laryngoscope with premature and infant size blades. E E E A CO2 detector. E E E Laryngeal mask airway (LMA, size 1) E E E A servo-controlled incubator or heated open bed for each infant who requires a E E E controlled thermal environment. Cardiorespiratory monitors that include pressure and waveform monitoring. E E E Oxygen analyzers, blenders, heaters, and humidifiers sufficient for anticipated E E E census. Modes of respiratory support: binasal cannulas, conventional mechanical E E E ventilator, mechanism to deliver nasal CPAP. A bag or T-piece resuscitator and mask for each infant. E E E An adequate supply of endotracheal tubes and other intubation supplies and LMA. E E E A device for viewing x-rays in the infant area. E E E

                           14. (c) If a hospital provides NICU services the following administrative requirements apply:

                               1. 1. The NICU must have a NICU Director who is responsible for the following:
                           15. (i) All NICU administrative functions;
                           16. (ii) Creation of policies and procedures regarding NICU care;
                           17. (iii) Ensure NICU staff are properly credentialed through the general hospital’s medical staff credentialing process; and

                           18. (iv) Any other requirements in 0720-14-.07(16)(a).

                               1. 2. The NICU must have a Nurse Manager who is responsible for all NICU nursing functions.

                           19. (d) Quality Initiative Program Participation- Each licensed NICU shall annually participate in a neo-natal quality initiative program approved by the Commission.

                               1. 1. Approval of Quality Initiative Programs- Each program seeking approval by the Commission shall submit the following in writing:
                           20. (i) Curriculum Vitae of each presenter or program leader.
                           21. (ii) Copies of programmatic material to be used during the program.
                           22. (iii) Information concerning the neonatal subject to be covered by the program, as well as the anticipated length of the program.

                           23. (iv) Information on how annual participation and/or completion shall be documented by the program, which shall include a blank copy of any certificate to be used.

                               1. 2. The Commission shall maintain a list of approved Quality Initiative Programs, as informed by the Perinatal Advisory Committee.
                               2. 3. Each licensed NICU must maintain, and make readily available for inspection by Commission staff, participation or completion certificates for the preceding three

                           24. (3) years.

                               1. 4. If no Quality Initiative Program has been approved by the Commission for any calendar year, this requirement shall be automatically waived.

                           25. (17) PET Services

                               1. (a) If a hospital provides PET services, the following licensing requirements apply:

                                  1. 1. Must become accredited within two years of licensure per machine per diagnostic type.
                                  2. 2. Must adhere to all federal and state regulations, as well as the Nuclear Regulatory Commission requirements.
                                  3. 3. A facility who provides MRI services and/or PET services shall file with the commission an annual report no later than thirty (30) days following the end of each state fiscal year that details the mix of payers by percentage of cases for the prior calendar year, charity care, Medicare, and Medicaid.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-3-511, 68-11-202, 68-11-204, 68-11-209, 68-57-101, 68-57- 102, 68-57-104, and 68-57-105. Administrative History: Original rule filed March 18, 2000; effective May 30, 2000. Amendment filed April 17, 2000; effective July 1, 2000. Amendment filed June 12, 2003; effective August 26, 2003. Amendment filed July 27, 2005; effective October 10, 2005. Amendment filed February 23, 2006; effective May 9, 2006. Amendment filed February 23, 2007; effective May 9, 2007. Amendment filed February 22, 2010; effective May 23, 2010. Amendment filed January 3, 2012; effective April 2, 2012. Amendment filed March 27, 2015; effective June 25, 2015. Amendments filed July 10, 2018; effective October 8, 2018. Transferred from chapter 1200-08-01 pursuant to Public Chapter 1119 of 2022 effective July 1, 2022. Amendments filed February 25, 2025; effective May 26, 2025. Amendments filed January 8, 2026; effective April 8, 2026.