(a) Facilities restricted in
services they provide, e.g. those that restrict services to radiation therapy
or use of local anesthetics only, may be exempted from all or part of the
requirements of this rule pertaining to laboratory services, food and dietetic
services, surgical services, and anesthesia services.
(b) If the facility 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.
(c) A hospital may choose to separately
license a portion of the facility as an Ambulatory Surgical Treatment Center;
the licensure fee for such is not required.
(d) The organization of the surgical services
must be appropriate to the scope of the services offered.
(e) The operating rooms must be supervised by
an experienced registered nurse or a doctor of medicine or
(f) An ASTC 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
(L.P.N.) 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.
(g) 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
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
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.
Surgical technologists must:
1. Hold current national certification
established by the Liaison Council on Certification for the Surgical
Technologist (LCC-ST); or
completed a program for surgical technology accredited by the Commission on
Accreditation of Allied Health Education Programs (CAAHEP); or
3. Have completed an appropriate training
program for surgical technologists in the armed forces or at a CAAHEP
accredited hospital or CAAHEP accredited ambulatory surgical treatment center;
4. Successfully complete the
surgical technologists LCC-ST certifying exam; or
5. Provide sufficient evidence that, prior to
May 21, 2007, the person was at any time employed as a surgical technologist
for not less than eighteen (18) months in the three (3) years preceding May 21,
2007 in a hospital, medical office, surgery center, or an accredited school of
surgical technology; or has begun the appropriate training to be a surgical
technologist prior to May 21, 2007, provided that such training is completed
within three (3) years of May 21, 2007.
(k) An ASTC can petition the director of
health care facilities of the department for a waiver from the provisions of
1200-08-10-.06(1)(j) if they are unable to employ a sufficient number of
surgical technologists who meet the requirements. The facility shall
demonstrate to the director that a diligent and thorough effort has been made
to employ surgical technologist who meet the requirements. The director 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 Board for
Licensing Health Care Facilities.
(l) 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.
(m) 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.
(n) Properly executed informed consent,
advance directive, if available, and organ donation forms, if available, must
be in the patient's chart before surgery, except in emergencies. The patient is
not required to sign advance directive and organ donation forms.
(o) Adequate equipment and supplies must be
available as determined by the governing body and the medical staff, and must
meet the current acceptable standards of practice in the ASTC industry. In
conjunction with their governing body and the medical staff, the facility shall
develop policies and procedures specifying the types of emergency equipment
that are appropriate for the facility's patient population, and shall make the
items immediately available at the ASTC to handle inter- or post-operative
(p) At least one
registered nurse shall be in the recovery area during the patient's recovery
(q) The operating room
register must be complete and up-to-date.
(r) An operative report describing
techniques, findings, and tissues removed or altered must be written or
dictated immediately following surgery and signed by the surgeon.
(s) The ASTC shall provide one or more
surgical suites which shall be constructed, equipped, and maintained to assure
the safety of patients and personnel.
(t) Surgical suites are required to meet the
same standards as hospital operating rooms, including those using general
(u) The ASTC shall have
separate areas for waiting rooms, recovery rooms, treatment and/or examining
Anesthesiology Services. Anesthesia shall be administered by:
(a) A qualified anesthesiologist;
(b) A doctor of medicine or osteopathy (other
than an anesthesiologist);
dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia
under State law;
(d) A certified
registered nurse anesthetist (CRNA); or
(e) A graduate registered nurse anesthetist
under the supervision of an anesthesiologist who is immediately available if
(f) After the completion of
anesthesia, patients shall be constantly attended by competent personnel until
responsive and able to summon aid. Each center shall maintain a log of the
inspections made prior to each day's use of the anesthesia equipment. A record
of all service and maintenance performed on all anesthesia machines, vaporizers
and ventilators shall also be on file.
(g) When inhaled general anesthesia known to
trigger malignant hyperthermia and/or succinylcholine are maintained in the
facility, there shall be thirty-six (36) ampules of Dantrolene for injection
onsite. This requirement applies to anesthesia agents, current or future, that
are shown to cause malignant hyperthermia. If Dantrolene is administered,
appropriate monitoring must be provided post-operatively.
(h) Written policies and procedures relative
to the administration of anesthesia shall be developed and approved by the
Medical Staff and governing body.
Any patient receiving conscious sedation
1. Continuous EKG
2. Continuous oxygen
3. Serial BP
monitoring at intervals no less than every 5 minutes; and
Supplemental oxygen therapy and
(iii) Endotracheal tube; and
(iv) Crash cart.
The ASTC shall have a medical staff
organized under written by-laws that are approved by the governing body. The
medical staff of the ASTC shall define a mechanism to:
1. Assure that an optimal level of
professional performance is maintained;
2. Appoint independent practitioners through
a defined credentialing process;
Apply credentialing criteria uniformly;
4. Utilize the current license, relevant
training and experience, current competence and the ability to perform
requested privileges in the credentialing process; and
5. Provide for participation in required
committees of the facility to ensure that quality medical care is provided to
licensed independent practitioner shall provide care under the auspices of the
facility in accordance with approved privileges.
(c) Clinical privileges shall be granted
based on the practitioners' qualifications and the services provided by the
facility, and shall be reviewed and/or revised at least every two (2)
Service. A licensed registered nurse (R.N.) shall be on duty at all times.
Additional appropriately trained staff shall be provided as needed to ensure
that the medical needs of the patients are fully met.
(a) The ASTC shall be organized under written
policies and procedures relating to patient care, establishment of standards
for nursing care and mechanisms for evaluating such care and nursing
(b) A qualified
registered nurse designated by the administrator shall be responsible for
coordinating and supervising all nursing services.
(c) There shall be a sufficient staffing
pattern of registered nurses to provide quality nursing care to each surgical
patient from admission through discharge. Additional staff shall be on duty and
available to assist the professional staff to adequately handle routine and
emergency patient needs.
ASTC shall establish written procedures for emergency services which will
ensure that professional staff members who have been trained in emergency
resuscitation procedures shall be on duty at all times when there is a patient
in the ASTC and until the patient has been discharged.
(e) Nursing care policies and procedures
shall be consistent with professionally recognized standards of nursing
practice and shall be in accordance with the Nurse Practice Act of the State of
Tennessee and the Association of Operating Room Nurses Standards of
(f) Staff development and
training shall be provided to the nursing staff and other ancillary staff in
order to maintain and improve knowledge and skills. The educational/training
program shall be planned, documented and conducted on a continuing basis. There
shall be at least appropriate training on equipment, safety concerns, infection
control and emergency care on an annual basis.
(5) Pharmaceutical Services. The ASTC must
provide drugs and biologicals in a safe and effective manner in accordance with
accepted standards of practice. Such drugs and biologicals must be stored in a
separate room or cabinet which shall be kept locked at all times.
(6) Ancillary Services. All ancillary or
supportive health or medical services, including but not limited to,
radiological, pharmaceutical, or medical laboratory services shall be provided
in accordance with all applicable state and federal laws and
Services. The ASTC shall provide within the facility, or through arrangement,
diagnostic radiological services commensurate with the needs of the ambulatory
surgical treatment center.
(a) If radiological
services are provided by facility staff, the services shall be maintained free
of hazards for patients and personnel.
(b) New installations of radiological
equipment, and subsequent inspections for the identification of radiation
hazards shall be made as specified in state and federal requirements.
Personnel monitoring shall be maintained
for each individual working in the area of radiation. Readings shall be on at
least a monthly basis and reports kept on file and available for review.
1. Personnel - The ASTC shall have a
radiologist either full-time or part-time on a consulting basis, both to
supervise the service and to discharge professional radiological
2. The use of all
radiological apparatus shall be limited to personnel designated as qualified by
the radiologist; and use of fluoroscopes shall be limited to
provided under arrangement with an outside provider, the radiological services
must be directed by a qualified radiologist and meet state and federal
(a) The ASTC shall
provide on the premises or by written agreement with a laboratory licensed
under T.C.A. §
a clinical laboratory to provide those services commensurate with the needs and
services of the ASTC.
patient terminating pregnancy in an ASTC shall have an Rh type, documented
prior to the procedure, performed on her blood. In addition, she shall be given
the opportunity to receive Rh immune globulin after an appropriate crossmatch
procedure is performed within a licensed laboratory.
(9) Food and Dietetic Services. If a patient
will be in the facility for more than four (4) hours postop, an appropriate
diet shall be provided.
(a) The facility
shall provide a safe, accessible, effective and efficient environment of care
consistent with its mission, service, law and regulation.
The facility shall develop policies and
procedures that address:
3. Control of hazardous materials and
6. Medical equipment;
7. Utility systems.
(c) Staff shall have been oriented
to and educated about the environment of care and possess knowledge and skills
to perform responsibilities under the environment of care policies and
(d) Utility systems,
medical equipment, life safety elements, and safety elements of the environment
of care shall be maintained, tested and inspected.
(e) Safety issues shall be addressed and
(f) Appropriate staff
shall participate in implementing safety recommendations and monitoring their
(g) The building and
grounds shall be suitable to services provided and patients served.
Infection Control. An
Ambulatory Surgical Treatment Center shall have an annual influenza vaccination
program which shall include at least:
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 Ambulatory Surgical Treatment Center
will encourage all staff and independent practitioners to obtain an influenza
Education of all employees about the
1. Flu vaccination,
2. Non-vaccine control measures,
3. The diagnosis, transmission,
and potential impact of influenza;
(d) An annual evaluation of the influenza
vaccination program and reasons for non-participation; and
(e) 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.
(a) The ASTC shall comply with the Medical
Records Act of 1974, T.C.A. §§
A medical record shall
be maintained for each person receiving medical care provided by the ASTC and
2. Name of nearest
relative or other responsible agent;
3. Identification of primary source of
4. Dates and times of
5. Signed informed
6. Pertinent medical
8. Physician examination report;
9. Anesthesia records of pertinent
preoperative and postoperative reports including preanesthesia evaluation, type
of anesthesia, technique and dosage used;
10. Operative report;
11. Discharge summary, including instructions
for self care and instructions for obtaining postoperative emergency
12. Reports of all laboratory
and diagnostic procedures along with tests performed and the results
authenticated by the appropriate personnel; and,
13. X-ray reports.
(c) Medical records shall be current and
confidential. Medical records and copies thereof shall be made available when
requested by an authorized representative of the board or the
For purposes of
interventional pain management, only a medical doctor, licensed pursuant to
et seq., or an osteopathic physician, licensed pursuant to T.C.A. §§
et seq., who meets the following qualifications will be permitted to perform
invasive procedures of the spine, spinal cord, sympathetic nerves of the spine
or block of major peripheral nerves of the spine.
Board certified through the American Board
of Medical Specialties (ABMS) or the American Osteopathic Association (AOA) or
the American Board of Physician Specialties (ABPS)/American Association of
Physician Specialists (AAPS) in one of the following medical specialties:
(ii) Neurological surgery, or
(iii) Orthopedic surgery;
(iv) Physical medicine and
(vi) Any other board certified
physician who had completed an ABMS subspecialty board in pain medicine or
completed an ACGME accredited pain fellowship;
2. A recent graduate in a medical specialty
listed in part 1 not yet eligible to apply for ABMS, AOA, or ABPS/AAPS board
certification; provided, there is a practice relationship with a medical doctor
or an osteopathic physician who meets the requirements of part 1.;
3. A licensee who is not board certified in
one of the specialties listed in part 1, but is board certified in a different
ABMS, AOA, or ABPS/AAPS specialty and has completed a post-graduate training
program in interventional pain management approved by the board;
4. A licensee who serves as a clinical
instructor in pain medicine at an accredited Tennessee medical training
5. A licensee who has
an active pain management practice in a clinic accredited in outpatient
interdisciplinary pain rehabilitation by the Commission on Accreditation of
Rehabilitation Facilities or any successor organizations.
6. This subparagraph (13)(a) shall not apply
to a medical doctor, licensed pursuant to T.C.A. §§
et seq., or an osteopathic physician, licensed pursuant to T.C.A. §§
et seq., in the placement of medical devices used in the treatment of
conditions not primarily related to pain.
(b) An advanced practice nurse or physician
assistant shall only perform invasive procedures involving any portion of the
spine, spinal cord, sympathetic nerves of the spine or block of major
peripheral nerves of the spine under the direct supervision of a medical doctor
or an osteopathic physician who meets the qualifications of Rule
1200-08-10-.06(12)(a) 1. or 3. Direct supervision is defined as being
physically present in the center at the time the invasive procedure is
Tenn. Comp. R. &
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 16, 2003; effective August 30, 2003.
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 December 16, 2013; effective March 16, 2014. Amendments
filed March 27, 2015; effective June 25, 2015. Amendment filed October 20,
2015; effective January 18, 2016. Amendments filed July 18, 2016; effective
October 16, 2016. Amendments filed January 7, 2019; to have become effective
April 7, 2019. However, the Government Operations Committee filed a 60-day stay
of the effective date of the rules; new effective date
Authority: T.C.A. §§
68, 68-11-209, 68-11-216, 68-57-101, 68-57-102, 68-57-104, and