By: Carona S.B. No. 1340 A BILL TO BE ENTITLED AN ACT 1-1 relating to the regulation of anesthesia in certain outpatient 1-2 settings. 1-3 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-4 SECTION 1. (a) The legislature finds that it is necessary 1-5 to regulate the provision of anesthesia services in outpatient 1-6 surgical settings that are not part of a licensed hospital or a 1-7 licensed ambulatory surgical center to protect the health, safety, 1-8 and welfare of the public. The legislature further finds that the 1-9 provision of anesthesia services in these settings is appropriately 1-10 regulated by the professional licensing boards of the licensed 1-11 professionals who provide anesthesia services. 1-12 (b) It is the purpose of this Act to require the Texas State 1-13 Board of Medical Examiners and the Board of Nurse Examiners to 1-14 adopt rules for their respective license holders that will regulate 1-15 the provision of anesthesia services in outpatient surgical 1-16 settings that are not a part of a licensed hospital or licensed 1-17 ambulatory surgical center. 1-18 SECTION 2. The Medical Practice Act (Article 4495b, Vernon's 1-19 Texas Civil Statutes) is amended by adding Subchapter G to read as 1-20 follows: 1-21 SUBCHAPTER G. ANESTHESIA IN OUTPATIENT SETTING 1-22 Sec. 7.01. DEFINITION. In this subchapter, "outpatient 1-23 setting" means any facility, clinic, center, office, or other 1-24 setting that is not part of a licensed hospital or a licensed 2-1 ambulatory surgical center. 2-2 Sec. 7.02. RULES. (a) The board shall establish by rule 2-3 the minimum standards for the provision of anesthesia services in 2-4 outpatient settings by persons licensed by the board. 2-5 (b) The rules must be designed to protect the health, 2-6 safety, and welfare of the public and must include requirements 2-7 relating to: 2-8 (1) general anesthesia, regional anesthesia, and 2-9 monitored anesthesia care; 2-10 (2) patient evaluation, diagnosis, counseling, and 2-11 preparation; 2-12 (3) patient monitoring to be performed and equipment 2-13 to be used during a procedure and during post-procedure monitoring; 2-14 (4) emergency procedures, drugs, and equipment, 2-15 including education, training, and certification of personnel, as 2-16 appropriate, and including protocols for transfers to a hospital; 2-17 (5) the documentation necessary to demonstrate 2-18 compliance with this subchapter; and 2-19 (6) the period in which protocols or procedures 2-20 covered by rules of the board shall be reviewed, updated, or 2-21 amended. 2-22 (c) The board shall cooperate with the Board of Nurse 2-23 Examiners in the adoption of rules under this subchapter to 2-24 eliminate to the extent possible conflicts between the rules 2-25 adopted by each board. 2-26 Sec. 7.03. APPLICABILITY. Rules adopted by the board under 3-1 this subchapter do not apply to: 3-2 (1) an outpatient setting in which only local 3-3 anesthesia, peripheral nerve blocks, or both are used; 3-4 (2) an outpatient setting in which only anxiolytics 3-5 and analgesics are used and only in doses that do not have the 3-6 probability of placing the patient at risk for loss of the 3-7 patient's life-preserving protective reflexes; 3-8 (3) a licensed hospital; 3-9 (4) a licensed ambulatory surgical center; 3-10 (5) a clinic located on land recognized as tribal land 3-11 by the federal government and maintained or operated by a federally 3-12 recognized Indian tribe or tribal organization as listed by the 3-13 United States secretary of the interior under 25 U.S.C. Section 3-14 479a-1 or as listed under a successor federal statute or 3-15 regulation; 3-16 (6) a clinic directly maintained or operated by the 3-17 United States or by any of its departments, officers, or agencies; 3-18 or 3-19 (7) an outpatient setting accredited by: 3-20 (A) the Joint Commission on Accreditation of 3-21 Healthcare Organizations relating to ambulatory surgical centers; 3-22 (B) the American Association for the 3-23 Accreditation of Ambulatory Surgery Facilities; or 3-24 (C) the Accreditation Association for Ambulatory 3-25 Health Care. 3-26 Sec. 7.04. COMPLIANCE WITH ANESTHESIA RULES. (a) On or 4-1 after August 31, 2000, a physician who practices medicine in this 4-2 state and who administers anesthesia or performs a surgical 4-3 procedure for which anesthesia services are provided in an 4-4 outpatient setting shall comply with the rules adopted under this 4-5 subchapter. 4-6 (b) The board may require a physician to submit and comply 4-7 with a corrective action plan to remedy or address any current or 4-8 potential deficiencies with the physician's provision of anesthesia 4-9 in an outpatient setting in accordance with this Act or rules of 4-10 the board. 4-11 Sec. 7.05. ANNUAL REGISTRATION. (a) Beginning September 1, 4-12 2000, the board shall require each physician who administers 4-13 anesthesia or performs a surgical procedure for which anesthesia 4-14 services are provided in an outpatient setting to annually register 4-15 with the board on a form prescribed by the board and to pay a fee 4-16 to the board in an amount established by the board. 4-17 (b) The board shall coordinate the registration required 4-18 under this section with the registration required under Section 4-19 3.01 of this Act so that the times of registration, payment, 4-20 notice, and imposition of penalties for late payment are similar 4-21 and provide a minimum of administrative burden to the board and to 4-22 physicians. 4-23 Sec. 7.06. INSPECTIONS. (a) The board may conduct 4-24 inspections to enforce this subchapter, including inspections of an 4-25 office site and of documents of a physician's practice that relate 4-26 to the provision of anesthesia in an outpatient setting. The board 5-1 may contract with another state agency or qualified person to 5-2 conduct these inspections. 5-3 (b) Unless it would jeopardize an ongoing investigation, the 5-4 board shall provide at least five business days' notice before 5-5 conducting an on-site inspection under this section. 5-6 (c) This section does not require the board to make an 5-7 on-site inspection of a physician's office. 5-8 Sec. 7.07. REQUESTS FOR INSPECTION AND ADVISORY OPINION. 5-9 (a) The board may consider a request by a physician for an on-site 5-10 inspection. The board may, in its discretion and on payment of a 5-11 fee in an amount established by the board, conduct the inspection 5-12 and issue an advisory opinion. 5-13 (b) An advisory opinion issued by the board under this 5-14 section is not binding on the board, and the board, except as 5-15 provided by Subsection (c) of this section, may take any action 5-16 under this Act in relation to the situation addressed by the 5-17 advisory opinion that the board considers appropriate. 5-18 (c) A physician who requests and relies on an advisory 5-19 opinion of the board may use the opinion as mitigating evidence in 5-20 an action or proceeding to impose an administrative or civil 5-21 penalty under this Act. The board or court, as appropriate, shall 5-22 take proof of reliance on an advisory opinion into consideration 5-23 and mitigate the imposition of administrative or civil penalties 5-24 accordingly. 5-25 SECTION 3. Subsection (b), Section 3.10, Medical Practice 5-26 Act (Article 4495b, Vernon's Texas Civil Statutes), as amended by 6-1 Chapter 214, Acts of the 73rd Legislature, Regular Session, 1993, 6-2 is amended to read as follows: 6-3 (b) The board may not set, charge, collect, receive, or 6-4 deposit any of the following fees in excess of: 6-5 (1) for processing and granting a license by 6-6 reciprocity to a licensee of another 6-7 state ..................................... $700 6-8 (2) for processing an application and administration 6-9 of a partial examination for licensure .... $700 6-10 (3) for processing an application and administration 6-11 of a complete examination for licensure ... $700 6-12 (4) for processing an application and issuance of a 6-13 temporary license ......................... $200 6-14 (5) for processing an application and issuance of a 6-15 duplicate license ......................... $200 6-16 (6) for processing an application and issuance of a 6-17 license of reinstatement after a lapse or 6-18 cancellation of a license ................. $700 6-19 (7) for processing an application and issuance of an 6-20 annual registration of a licensee ......... $200 6-21 (8) for processing and issuance of an institutional 6-22 permit for interns, residents, and others in 6-23 approved medical training programs ..... $200 6-24 (9) for processing an application and issuance of an 6-25 endorsement to other state medical 6-26 boards .................................... $200 7-1 (10) for processing and issuance of a license or 7-2 temporary license to a physician 7-3 assistant ................................ $200 7-4 (11) for processing and issuance of a permit to a 7-5 physician who supervises an 7-6 acupuncturist ............................ $200 7-7 (12) for processing an application and issuance of an 7-8 annual registration for anesthesia in an 7-9 outpatient setting ..................... $300. 7-10 SECTION 4. Chapter 7, Title 71, Revised Statutes, is amended 7-11 by adding Article 4527e to read as follows: 7-12 Art. 4527e. ANESTHESIA IN OUTPATIENT SETTING 7-13 Sec. 1. DEFINITION. In this article, "outpatient setting" 7-14 means any facility, clinic, center, office, or other setting that 7-15 is not part of a licensed hospital or a licensed ambulatory 7-16 surgical center. 7-17 Sec. 2. RULES. (a) The board shall establish by rule the 7-18 minimum standards for the provision of anesthesia services in 7-19 outpatient settings by persons licensed by the board. 7-20 (b) The rules must be designed to protect the health, 7-21 safety, and welfare of the public and must include requirements 7-22 relating to: 7-23 (1) general anesthesia, regional anesthesia, and 7-24 monitored anesthesia care; 7-25 (2) patient assessment, counseling, and preparation; 7-26 (3) patient monitoring to be performed and equipment 8-1 to be used during a procedure and during post-procedure monitoring; 8-2 (4) emergency procedures, drugs, and equipment, 8-3 including education, training, and certification of personnel, as 8-4 appropriate, and including protocols for transfers to a hospital; 8-5 (5) the documentation necessary to demonstrate 8-6 compliance with this article; and 8-7 (6) the period in which protocols or procedures 8-8 covered by rules of the board shall be reviewed, updated, or 8-9 amended. 8-10 (c) The board shall cooperate with the Texas State Board of 8-11 Medical Examiners in the adoption of rules under this article to 8-12 eliminate to the extent possible conflicts between the rules 8-13 adopted by each board. 8-14 Sec. 3. APPLICABILITY. Rules adopted by the board under 8-15 this article do not apply to: 8-16 (1) an outpatient setting in which only local 8-17 anesthesia, peripheral nerve blocks, or both are used; 8-18 (2) an outpatient setting in which only anxiolytics 8-19 and analgesics are used and only in doses that do not have the 8-20 probability of placing the patient at risk for loss of the 8-21 patient's life-preserving protective reflexes; 8-22 (3) a licensed hospital; 8-23 (4) a licensed ambulatory surgical center; 8-24 (5) a clinic located on land recognized as tribal land 8-25 by the federal government and maintained or operated by a federally 8-26 recognized Indian tribe or tribal organization as listed by the 9-1 United States secretary of the interior under 25 U.S.C. Section 9-2 479a-1 or as listed under a successor federal statute or 9-3 regulation; 9-4 (6) a clinic directly maintained or operated by the 9-5 United States or by any of its departments, officers, or agencies; 9-6 or 9-7 (7) an outpatient setting accredited by: 9-8 (A) the Joint Commission on Accreditation of 9-9 Healthcare Organizations relating to ambulatory surgical centers; 9-10 (B) the American Association for the 9-11 Accreditation of Ambulatory Surgery Facilities; or 9-12 (C) the Accreditation Association for Ambulatory 9-13 Health Care. 9-14 Sec. 4. COMPLIANCE WITH ANESTHESIA RULES. (a) On or after 9-15 August 31, 2000, a certified registered nurse anesthetist providing 9-16 anesthesia services in an outpatient setting shall comply with the 9-17 rules adopted by the board under this article. 9-18 (b) The board may require a certified registered nurse 9-19 anesthetist to submit and comply with a corrective action plan to 9-20 remedy or address any current or potential deficiencies with the 9-21 nurse anesthetist's provision of anesthesia in an outpatient 9-22 setting in accordance with this chapter or rules of the board. 9-23 Sec. 5. BIENNIAL REGISTRATION. (a) Beginning September 1, 9-24 2000, the board shall require each certified registered nurse 9-25 anesthetist who provides anesthesia services in an outpatient 9-26 setting to biennially register with the board on a form prescribed 10-1 by the board and to pay a fee to the board in an amount established 10-2 by the board. 10-3 (b) The board shall coordinate the registration required 10-4 under this article with the license renewal provisions under 10-5 Article 4526, Revised Statutes, so that the times of registration, 10-6 payment, notice, and imposition of penalties for late payment are 10-7 similar and provide a minimum of administrative burden to the board 10-8 and to certified registered nurse anesthetists. 10-9 Sec. 6. INSPECTIONS. (a) The board may conduct inspections 10-10 to enforce this article, including inspections of the equipment 10-11 owned or leased by a certified registered nurse anesthetist and of 10-12 documents of a certified registered nurse anesthetist's practice 10-13 that relate to the provision of anesthesia in an outpatient 10-14 setting. The board may contract with another state agency or 10-15 qualified person to conduct these inspections. 10-16 (b) Unless it would jeopardize an ongoing investigation, the 10-17 board shall provide at least five business days' notice before 10-18 conducting an on-site inspection under this section. 10-19 (c) This section does not require the board to make an 10-20 on-site inspection of an outpatient setting where a certified 10-21 registered nurse anesthetist provides anesthesia. 10-22 Sec. 7. REQUESTS FOR INSPECTION AND ADVISORY OPINION. 10-23 (a) The board may consider a request by a certified registered 10-24 nurse anesthetist for an inspection of equipment owned or leased by 10-25 the nurse anesthetist and of documents of the nurse anesthetist's 10-26 practice that relate to the provision of anesthesia in an 11-1 outpatient setting. The board may, in its discretion and on 11-2 payment of a fee in an amount established by the board, conduct the 11-3 inspection and issue an advisory opinion. 11-4 (b) An advisory opinion issued by the board under this 11-5 section is not binding on the board and the board, except as 11-6 provided by Subsection (c) of this section, may take any action 11-7 under this chapter in relation to the situation addressed by the 11-8 advisory opinion that the board considers appropriate. 11-9 (c) A certified registered nurse anesthetist who requests 11-10 and relies on an advisory opinion of the board may use the opinion 11-11 as mitigating evidence in an action or proceeding by the board to 11-12 impose an administrative penalty or assess a monetary fine under 11-13 this chapter. The board shall take proof of reliance on an 11-14 advisory opinion into consideration and mitigate the imposition of 11-15 administrative penalties or the assessment of a monetary fine 11-16 accordingly. 11-17 SECTION 5. The Texas State Board of Medical Examiners and 11-18 Board of Nurse Examiners may permit the registration requirements 11-19 imposed under Subchapter G, Medical Practice Act (Article 4495b, 11-20 Vernon's Texas Civil Statutes), as added by this Act, and under 11-21 Article 4527e, Revised Statutes, as added by this Act, to be 11-22 staggered and phased in so that not later than September 1, 2002, 11-23 all physicians and certified registered nurse anesthetists required 11-24 to register under those laws will be in compliance. 11-25 SECTION 6. (a) The rules required under Subchapter G, 11-26 Medical Practice Act (Article 4495b, Vernon's Texas Civil 12-1 Statutes), as added by this Act, and under Article 4527e, Revised 12-2 Statutes, as added by this Act, must be adopted by the Texas State 12-3 Board of Medical Examiners and Board of Nurse Examiners, as 12-4 appropriate, not later than January 7, 2000. 12-5 (b) The Texas State Board of Medical Examiners and the Board 12-6 of Nurse Examiners shall report to the speaker of the house of 12-7 representatives and the lieutenant governor on the implementation 12-8 and enforcement of those rules and of the laws added by this Act 12-9 not later than January 1, 2001. The report must include any 12-10 suggested amendments or changes to the laws added by this Act to 12-11 make those laws more effective or efficient. 12-12 SECTION 7. This Act takes effect September 1, 1999. 12-13 SECTION 8. The importance of this legislation and the 12-14 crowded condition of the calendars in both houses create an 12-15 emergency and an imperative public necessity that the 12-16 constitutional rule requiring bills to be read on three several 12-17 days in each house be suspended, and this rule is hereby suspended. 12-18 COMMITTEE AMENDMENT NO. 1 12-19 Amend S.B. 1340 as follows: 12-20 (1) In SECTION 2 of the bill, in added Section 7.03(3), 12-21 Medical Practice Act, insert the following between "licensed 12-22 hospital" and the semicolon (engrossed version, page 3, line 8): 12-23 ", including an outpatient facility of the hospital that is 12-24 separately located apart from the hospital". 12-25 (2) In SECTION 2 of the bill, in added Section 7.03, Medical 12-26 Practice Act, insert the following as a new Subdivision (6) of 13-1 Section 7.03 (engrossed version, page 3, between lines 15 and 16) 13-2 and renumber the existing Subdivisions (6) and (7) of Section 7.03 13-3 appropriately (engrossed version, page 3, lines 16 and 19): 13-4 "(6) a facility maintained or operated by a state or 13-5 local governmental entity;". 13-6 (3) In SECTION 4 of the bill, in added Section 3(3), Article 13-7 4527e, Revised Statutes, insert the following between "licensed 13-8 hospital" and the semicolon (engrossed version, page 8, line 22): 13-9 ", including an outpatient facility of the hospital that is 13-10 separately located apart from the hospital". 13-11 (4) In SECTION 4 of the bill, in added Section 3, Article 13-12 4527e, Revised Statutes, insert the following as a new Subdivision 13-13 (6) of Section 3 (engrossed version, page 9, between lines 3 and 4) 13-14 and renumber the existing Subdivisions (6) and (7) of Section 3 13-15 appropriately (engrossed version, page 9, lines 4 and 7): 13-16 "(6) a facility maintained or operated by 13-17 a state or local governmental entity;". 13-18 76R13503 JRD-F Maxey