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