Tennessee Code Annotated

Title 63: Professions of the Healing Arts

Chapter 6: Medicine and Surgery

Part 2: General Provisions

TCA 63-6-221: Office-based surgeries.

(a) For the purposes of this section, unless the context otherwise requires:

(1) "Board" means the board of medical examiners;

(2) "Level II office-based surgery" means Level II surgery, as defined by the board of medical examiners in its rules and regulations, that is performed outside of a hospital, an ambulatory surgical treatment center or other medical facility licensed by the department of health;

(3) "Office-based surgery" or "Level III office-based surgery" means Level III surgery requiring a level of sedation beyond the level of sedation defined by the board of medical examiners as Level II surgery that is performed outside a hospital, an ambulatory surgical treatment center or other medical facility licensed by the department of health;

(4) "Physician" means any person licensed under this chapter; and

(5) "Surgical suite" means both the operating and recovery room or rooms located in a physician's office where Level III office-based surgery is to be performed.

(b) The board shall have the duty and responsibility to regulate the practice of office-based surgery, including the promulgation of rules necessary to promote patient health and safety in such practices, including, but not limited to, a mechanism by which all office-based surgical suites are surveyed and certified by the board.

(c) The board shall specifically identify in rules the parameters to be used in determining Level III surgical procedures and multiple procedures that may be performed in an office-based setting pursuant to the level of anesthesia involved in the procedures. In addition, the board shall promulgate age and risk classification criteria of patients eligible for Level III office-based surgical procedures.

(d) By December 30, 2007, the board shall adopt rules establishing a specific list of approved Level III surgical procedures that can be performed in a physician's office in this state. The ambulatory surgical center covered procedures list promulgated by the centers of medicare and medicaid shall be used as a guide. No physician shall perform any Level III surgical procedures that are not included on the list promulgated by the board. The board may modify the list as the board deems necessary. The board shall also promulgate rules addressing the minimum requirements deemed necessary by the board for the safe performance of office-based surgery.

(e) Using the rules established for ambulatory surgical treatment centers as guidelines, the board shall promulgate rules relative to infection control, life safety, patient rights, hazardous waste and equipment and supplies necessary to assure the safety of patients undergoing office-based surgery. Any provision in the ambulatory surgical treatment center rules addressing infection control, life safety, patient rights, hazardous waste and equipment and supplies that is not adopted by the board shall require a statement entered into the official minutes from the board justifying the board's decision.

(f) No more than three (3) patients undergoing Level III office-based surgery in a physician's office may be incapable of self-preservation at the same time. The board shall promulgate rules requiring physician offices that perform office-based surgery to adopt bylaws that put in place a management system and documentation that will ensure that no more than three (3) patients that are in surgery or recovery are incapable of self-preservation at the same time. The bylaws and documentation of the management system shall be included in the application for surgical suite certification.

(g) Except for emergencies, a surgical suite certified for office-based surgery may be utilized only by physician employees of the practice in which the surgical suite is located. Surgical suites may not be shared with other practices or other physicians.

(h) The board shall enter into a memorandum of understanding, contract or other written arrangement with the department of health such that the department:

(1) Provides a site survey of the surgical suites sought to be certified to perform office-based surgery. A physician office at which office-based surgeries are being performed as of October 1, 2007, shall submit both a request for a site survey on an application form developed by the board and remit payment of the office-based surgery fee to the department by October 1, 2007. If the office makes a timely filing in accordance with this subdivision (h)(1), the physician's office may continue to be a site for office-based surgeries pending completion of a survey confirming compliance with board rules and subsequent issuance of a certification of the surgical suite or suites. A physician office at which office-based surgeries are not being performed as of October 1, 2007, shall not perform any such procedures until an application form and payment of the office-based surgery fee is submitted to the board and a site survey is completed by the department and a certification of the surgical suite is issued by the board;

(2) Is authorized to require plans of correction and to verify that the plans of correction have been implemented;

(3) Is authorized to initiate subsequent, unannounced site surveys during regular business hours as long as the physician office continues to be used to perform office-based surgeries, but no more frequently than once every twelve (12) months; and

(4) Is authorized to respond to any complaints made by patients or the public against a physician who performs office-based surgery or a physician's office at which office-based surgery is being performed at the request of the office of investigations.

(i) The results of all site surveys shall be transmitted by the department to the board. The results shall include any requirement for plans of correction, the department's determination of the acceptability of the submitted plans of correction and the department's verification that the plans of correction have been implemented. The board shall make a final determination on certifying the surgical suite for performance of office-based surgeries. The results of site surveys and board determinations shall be shared on a routine basis with the board for licensing health care facilities.

(j) The results of all complaint investigations by department staff shall be transmitted to the board for resolution; however, that information shall at all times be maintained as confidential and not available to the public except to the extent SC 63-1-117(g) applies.

(k) Any physician office that desires to be certified to perform office-based surgery shall pay to the department an annual office-based surgery fee as set by the board.

(l) A physician office at which office-based surgery is being performed shall ensure that claims data is reported to the commissioner of health on a form approved by the department of health. The data shall be submitted through a third party approved by the department of health for the purpose of editing the data according to rules and regulations established by the commissioner. The physician office shall be responsible for the costs associated with processing of the data by the approved vendors. The claims data shall be reported at least quarterly to the commissioner. No information shall be made available to the public by the commissioner that reasonably could be expected to reveal the identity of any patient. The claims data reported to the commissioner under this section are confidential and not available to the public until the commissioner processes and verifies the data. The commissioner shall prescribe conditions under which the processed and verified data are available to the public.

(m) (1) Except as provided in subdivision (h)(1), a physician office surgical suite is required to be certified by the board in order to perform office-based surgery. A physician office that proposes to perform office-based surgery shall submit to the board, on an application form provided by the board, at least the following:

(A) Level III procedures expected to be performed by each physician;

(B) The specialty board certification or board eligibility of the physician or physicians performing Level III procedures, if any;

(C) Verification of health care liability coverage for all physicians performing Level III procedures;

(D) Verification of hospital staff privileges for all physicians performing Level III procedures;

(E) The name of a responsible physician in whose name the surgical suite certification shall be issued for that office and a list of the physicians with the practice who are going to be performing Level III office-based surgeries; and

(F) The documentation required by subsection (f) regarding incapacitated patient limits.

(2) The form required by subdivision (m)(1) shall serve as an application form, but the information on the form shall be updated as appropriate when any information on it has changed.

(n) The board shall notify all physicians of the office-based surgery certification requirements. Failure of a physician performing office-based surgery or a physician office at which office-based surgery is being performed to abide by this section, any rules promulgated pursuant to this section or of SC 68-11-211 may be grounds for disciplinary action or termination of either the rights of the physician to perform office-based surgery or the surgical suite's certification by the physician's licensing board, or both disciplinary action and termination. For purposes of SC 4-5-320(c), the public health, safety and welfare imperatively require emergency action at any time that a previously authorized surgical suite fails to maintain the standards set by the board.

(o) Applicants for initial licensure or reinstatement of a previously issued license shall indicate to the board on the appropriate licensure application if they intend to perform Level II office-based surgery procedures as defined by the rules of the board of medical examiners and that are integral to a planned treatment regimen and not performed on an urgent or emergent basis.

(p) Licensed physicians who perform Level II office-based surgery at the time of licensure renewal shall indicate to the board on the licensure renewal application if the licensee currently performs Level II office-based surgery procedures as defined in the rules of the board of medical examiners and that are integral to a planned treatment regimen and not performed on an urgent or emergent basis.

(q) In order for health care providers and the board to work together to collect meaningful health care data, so as to minimize the frequency and severity of certain unexpected events and improve the delivery of health care services, each physician who performs any Level II office-based surgery or Level III office-based surgery that results in any of the following unanticipated events shall notify the board in writing within fifteen (15) calendar days following the physician's discovery of the event:

(1) The death of a patient during any Level II office-based surgery or Level III office-based surgery or within seventy-two (72) hours thereafter;

(2) The transport of a patient to a hospital emergency department except those related to a natural course of the patient's illness or underlying condition;

(3) The unplanned admission of a patient to a hospital within seventy-two (72) hours of discharge, only if the admission is related to the Level II office-based surgery or Level III office-based surgery, except those related to a natural course of the patient's illness or underlying condition;

(4) The discovery of a foreign object erroneously remaining in a patient from a Level II office-based surgery or Level III office-based surgery at that office; or

(5) The performance of the wrong surgical procedure, surgery on the wrong site or surgery on the wrong patient.

(r) Records of reportable events should be in writing and should include at a minimum the following:

(1) The physician's name and license number;

(2) The date and time of the occurrence or discovery of the incident;

(3) The office and address where the incident took place;

(4) The name and address of the patient;

(5) The type of Level II office-based surgery or Level III office-based surgery that was performed;

(6) The type and dosage of sedation or anesthesia utilized during the procedure;

(7) The circumstances surrounding the incident; and

(8) The type or types of events required to be reported as provided in subsection (q).

(s) The filing of a report as required by subsection (q) does not, in and of itself, constitute an acknowledgement or admission of health care liability, error or omission. Upon receipt of the report, the board may, in its discretion, obtain patient and other records pursuant to authority granted to it in SC 63-1-117. The reporting form and any supporting documentation reviewed or obtained by the board pursuant to this section and any amendments to the reports shall be confidential and not subject to discovery, subpoena or legal compulsion for release to any person or entity; nor shall they be admissible in any civil or administrative proceeding, other than a disciplinary proceeding by the board; nor shall they be subject to any open records request made pursuant to title 10, chapter 7, part 5 or any other law. This section shall not affect any of the provisions of or limit the protections provided by SCSC 63-6-219 [repealed] and 63-9-114.

(t) Failure to comply with the requirements of subsections (o)-(s) constitutes grounds for disciplinary action by the board in its discretion pursuant to SC 63-6-214.

History: Acts 2007, ch. 373, SC 1; 2008, ch. 927, SCSC 1, 2; 2010, ch. 637, SCSC 1-6; 2012, ch. 798, SCSC 38, 39