S.F. 275 Section 1. NEW SECTION . 135Q.1 Definitions. 1 As used in this chapter, unless the context otherwise 2 requires: 3 1. “Ambulatory surgical center” means a distinct facility 4 that operates exclusively for the purpose of providing surgical 5 services to patients not requiring hospitalization and in which 6 the expected duration of services does not exceed twenty-four 7 hours following an admission. “Ambulatory surgical center” 8 includes a facility that otherwise meets the definition of an 9 ambulatory surgical center whether or not licensed, certified, 10 or accredited as an ambulatory surgical center and which may 11 or may not operate on a partially cash-only or completely 12 cash-only basis. “Ambulatory surgical center” does not include 13 individual or group practice offices of private physicians 14 or podiatrists that do not contain a distinct area used for 15 outpatient surgical treatment on a regular basis, or that 16 only provide surgery routinely provided in a physician’s 17 or podiatrist’s office using local anesthesia or conscious 18 sedation; individual or group practice offices of private 19 dentists; or a portion of a licensed hospital designated for 20 outpatient surgical treatment. 21 2. “Department” means the department of inspections and 22 appeals. 23 Sec. 2. NEW SECTION . 135Q.2 Purpose. 24 The purposes of this chapter is to protect the public 25 health, safety, and welfare by providing for the licensing and 26 regulation of ambulatory surgical centers. 27 Sec. 3. NEW SECTION . 135Q.3 Licenses —— application —— fees 28 —— expiration and renewal. 29 1. A person, acting severally or jointly with any other 30 person shall not establish, operate, or maintain an ambulatory 31 surgical center in this state without first meeting the 32 requirements and obtaining a license as provided in this 33 chapter. 34 2. a. An application for a license shall be on a form 35 -1- LSB 2074XS (2) 89 pf/rh 1/ 9

S.F. 275 prescribed by the department and shall require information the 1 department deems necessary. An application for an initial 2 license for an ambulatory surgical center shall be accompanied 3 by a nonrefundable fee of fifty dollars. The fees collected 4 under this section shall be considered repayment receipts as 5 defined in section 8.2 and shall be used by the department to 6 administer this chapter. 7 b. The ambulatory surgical center shall meet the criteria 8 adopted by rule of the department pursuant to section 135Q.5 9 before a license is issued. The department is responsible 10 to provide the necessary personnel to inspect the ambulatory 11 surgical center to determine if the ambulatory surgical center 12 complies with necessary standards before a license is issued. 13 3. An ambulatory surgical center certified under the 14 Medicare program or accredited by an accrediting organization 15 authorized by the centers for Medicare and Medicaid services 16 with deeming authority, shall be licensed without inspection by 17 the department as provided in section 135Q.6. 18 4. A license shall be issued only for the premises and 19 persons named in the application. 20 5. A license is not transferable or assignable except with 21 the written approval of the department. 22 6. A license shall be posted in a conspicuous place on the 23 licensed premises as prescribed by rule of the department. 24 7. Separate licenses are not required for ambulatory 25 surgical center facilities that are maintained on the same 26 physical site and that have the same ownership or control. 27 Multiple buildings located on the same physical site under the 28 same ownership or control shall be considered one ambulatory 29 surgical center and may operate under one license. 30 8. A license, unless sooner suspended or revoked, shall 31 expire on June 30 of each year and shall be renewed annually. 32 The department shall renew a license upon payment of a fifty 33 dollar annual license renewal fee and filing of an application 34 for renewal at least thirty days prior to the expiration of the 35 -2- LSB 2074XS (2) 89 pf/rh 2/ 9

S.F. 275 existing license. The annual licensure fee shall be considered 1 a repayment receipt as defined in section 8.2 and dedicated to 2 support the staffing necessary to conduct the inspections and 3 investigations provided in section 135Q.6. 4 Sec. 4. NEW SECTION . 135Q.4 Denial, suspension, or 5 revocation of license —— hearings and review. 6 1. The department may deny, suspend, or revoke a license in 7 any case where it finds there has been a substantial failure 8 to comply with this chapter or the rules and standards adopted 9 under this chapter. 10 2. The denial, suspension, or revocation of a license by 11 the department and appeal from that action are governed by the 12 procedures for a contested case hearing under chapter 17A. 13 3. a. If the department finds, after providing notice of 14 noncompliance and a reasonable time for corrective action, that 15 an ambulatory surgical center is in repeated noncompliance with 16 this chapter or the department’s rules but that noncompliance 17 does not endanger public health or safety, the department may 18 issue a conditional license to the ambulatory surgical center 19 as an alternative to suspending or revoking the ambulatory 20 surgical center’s license. 21 b. The department shall provide notice of its intent to 22 issue a conditional license to the ambulatory surgical center 23 and of the items of noncompliance not less than ten days before 24 the date the conditional license is issued. 25 c. The department shall designate a period of not more 26 than one year during which the ambulatory surgical center may 27 operate under a conditional license. 28 d. During the period an ambulatory surgical center is 29 operating under a conditional license, the ambulatory surgical 30 center shall correct the items that are in noncompliance and 31 report the corrections to the department for approval. 32 4. The department may suspend or revoke the license of an 33 ambulatory surgical center that does not correct items that 34 are in noncompliance or that does not comply with this chapter 35 -3- LSB 2074XS (2) 89 pf/rh 3/ 9

S.F. 275 or the rules adopted under this chapter within the applicable 1 period. 2 5. The department may issue an emergency order to suspend 3 a license issued under this chapter if the department has 4 reasonable cause to believe that the conduct of the ambulatory 5 surgical center creates an immediate danger to the public 6 health and safety. An emergency suspension is effective 7 immediately without a hearing or notice to the licensee. On 8 written request of the licensee, the department shall conduct 9 a hearing not earlier than the tenth day or later than the 10 thirtieth day after the date the hearing request is received 11 to determine if the emergency suspension is to be continued, 12 modified, or rescinded. The hearing and any appeal are 13 governed by the department’s rules for a contested case hearing 14 and chapter 17A. 15 Sec. 5. NEW SECTION . 135Q.5 Rules. 16 1. The department, with the advice and approval of the state 17 board of health, shall adopt rules specifying the standards 18 for ambulatory surgical centers to be licensed under this 19 chapter. The rules and standards shall be consistent with the 20 requirements of this chapter and the conditions for coverage 21 in the federal Medicare program for ambulatory surgical 22 centers under 42 C.F.R. pt. 416 including those related to 23 the administration of anesthesia and to a safe and sanitary 24 environment in which to perform surgical procedures. 25 2. The department shall adopt rules as the department deems 26 necessary to implement the provisions of this chapter relating 27 to the issuance, renewal, denial, suspension, and revocation 28 of a license to establish, operate, and maintain an ambulatory 29 surgical center. 30 3. An ambulatory surgical center which is in operation at 31 the time of adoption of any applicable rules or standards under 32 this chapter shall be given a reasonable time, not to exceed 33 one year from the date of adoption, within which to comply with 34 such rules and standards. 35 -4- LSB 2074XS (2) 89 pf/rh 4/ 9

S.F. 275 Sec. 6. NEW SECTION . 135Q.6 Inspections or investigations. 1 1. The department shall make or cause to be made inspections 2 or investigations of ambulatory surgical centers to determine 3 compliance with this chapter and applicable rules and 4 standards. The department shall perform inspections on a 5 schedule that is of the same frequency required for inspections 6 of Medicare-certified ambulatory surgical centers. 7 2. The department shall recognize, in lieu of its own 8 licensure inspection, the comparable inspection and inspection 9 findings of a Medicare conditions for coverage survey completed 10 by the department, or an accrediting organization authorized by 11 the centers for Medicare and Medicaid services of the United 12 States department of health and human services. 13 3. A department inspector shall not participate in an 14 inspection or investigation of an ambulatory surgical center in 15 which the inspector or a member of the inspector’s immediate 16 family works or has worked within the last two years or in 17 which the inspector or the inspector’s immediate family has 18 a financial ownership interest. For the purposes of this 19 section, “immediate family member” means a spouse, natural or 20 adoptive parent or grandparent, child, grandchild, sibling, 21 stepparent, stepchild, or stepsibling. 22 Sec. 7. NEW SECTION . 135Q.7 Ambulatory surgical center 23 employees —— criminal history and abuse record checks. 24 The department shall adopt rules pursuant to chapter 17A 25 to provide for the performance of criminal record checks and 26 founded child abuse or dependent adult abuse record checks 27 applicable to prospective employees of an ambulatory surgical 28 center in substantial conformance with the provisions of 29 section 135B.34 and section 135C.33. 30 Sec. 8. NEW SECTION . 135Q.8 Confidentiality. 31 The department’s final findings with respect to compliance 32 by an ambulatory surgical center with requirements for 33 licensing shall be made available to the public in a readily 34 available form and place. Other information relating to 35 -5- LSB 2074XS (2) 89 pf/rh 5/ 9

S.F. 275 an ambulatory surgical center obtained by the department 1 which does not constitute the department’s findings from an 2 inspection of the ambulatory surgical center shall not be made 3 available to the public, except in proceedings involving the 4 denial, suspension, or revocation of a license under this 5 chapter. The name of a person who files a complaint with the 6 department shall remain confidential and shall not be subject 7 to discovery, subpoena, or other means of legal compulsion for 8 its release to a person other than department employees or 9 agents involved in the investigation of the complaint. 10 Sec. 9. NEW SECTION . 135Q.9 Injunction. 11 Notwithstanding the existence or pursuit of any other 12 remedy, the department may, in the manner provided by law, 13 maintain an action in the name of the state for injunction 14 or other process against any person to restrain or prevent 15 the establishment, operation, or maintenance of an ambulatory 16 surgical center without a license. 17 Sec. 10. NEW SECTION . 135Q.10 Judicial review. 18 Judicial review of an action of the department may be sought 19 in accordance with chapter 17A. Notwithstanding the provisions 20 of chapter 17A, petitions for judicial review may be filed 21 in the district court of the county in which the ambulatory 22 surgical center is located or is to be located and the status 23 quo of the petitioner or licensee shall be preserved pending 24 final disposition of the judicial review matter. 25 Sec. 11. NEW SECTION . 135Q.11 Penalties. 26 Any person establishing, operating, or maintaining any 27 ambulatory surgical center without a license commits a serious 28 misdemeanor, and each day of continuing violation after 29 conviction shall be considered a separate offense. 30 EXPLANATION 31 The inclusion of this explanation does not constitute agreement with 32 the explanation’s substance by the members of the general assembly. 33 This bill creates a new Code chapter to provide for the 34 licensing and regulation of ambulatory surgical centers. 35 -6- LSB 2074XS (2) 89 pf/rh 6/ 9

S.F. 275 The bill defines “ambulatory surgical center” as a distinct 1 facility that operates exclusively for the purpose of providing 2 surgical services to patients not requiring hospitalization 3 and in which the expected duration of services does not exceed 4 24 hours following an admission. “Ambulatory surgical center” 5 includes a facility that otherwise meets the definition of an 6 ambulatory surgical center whether or not licensed, certified, 7 or accredited as an ambulatory surgical center and which may 8 or may not operate on a partially cash-only or completely 9 cash-only basis. “Ambulatory surgical center” does not include 10 individual or group practice offices of private physicians 11 or podiatrists that do not contain a distinct area used for 12 outpatient surgical treatment on a regular basis, or that 13 only provide surgery routinely provided in a physician’s 14 or podiatrist’s office using local anesthesia or conscious 15 sedation; individual or group practice offices of dentists; 16 or a portion of a licensed hospital designated for outpatient 17 surgical treatment. 18 The bill prohibits the establishment, operation, or 19 maintenance of an ambulatory surgical center in the state 20 without meeting the requirements of the new Code chapter and 21 obtaining a license. 22 The bill provides for the application for licensure, the 23 issuance and renewal of a license, and the denial, suspension, 24 or revocation of a license, and the associated processes, and 25 for the imposition and payment of associated fees. 26 The bill directs the department of inspections and appeals 27 (DIA) to adopt rules with the advice and approval of the 28 state board of health to specify the standards for ambulatory 29 surgical centers. The rules and standards are required to be 30 consistent with the requirements of the Code chapter and the 31 conditions for coverage in the federal Medicare program for 32 ambulatory surgical centers. DIA is also directed to adopt 33 rules relating to the issuance, renewal, denial, suspension, 34 and revocation of a license to establish, operate, and 35 -7- LSB 2074XS (2) 89 pf/rh 7/ 9

S.F. 275 maintain an ambulatory surgical center. If an ambulatory 1 surgical center is in operation at the time of adoption of 2 any applicable rules or standards, the center is to be given 3 a reasonable time, not to exceed one year from the date of 4 adoption, within which to comply with such rules and standards. 5 The bill provides for inspections or investigations of 6 ambulatory surgical centers, and directs that the DIA shall 7 perform inspections on a schedule that is of the same frequency 8 required for inspections of Medicare-certified ambulatory 9 surgical centers. The bill also requires the DIA to recognize, 10 in lieu of its own licensure inspection, the comparable 11 inspection and inspection findings of a Medicare conditions 12 for coverage survey completed by the department or a national 13 accreditation agency authorized by the centers for Medicare and 14 Medicaid services of the United States department of health and 15 human services. 16 The bill prohibits a DIA inspector from participating in an 17 inspection or investigation of an ambulatory surgical center in 18 which the inspector or a member of the inspector’s immediate 19 family works or has worked within the last two years or in 20 which the inspector or the inspector’s immediate family has a 21 financial ownership interest. 22 The bill requires DIA to adopt administrative rules to 23 provide for the performance of criminal record checks and 24 founded child abuse or dependent adult abuse record checks 25 applicable to employees of an ambulatory surgical center in 26 substantial conformance with the record checks applicable to 27 facilities and providers under Code sections 135B.34 (hospital 28 employees —— criminal history and abuse record checks —— 29 penalty) and 135C.33 (employees and certified nurse aide 30 trainees —— child or dependent adult abuse information and 31 criminal record checks —— evaluations —— application to other 32 providers —— penalty). 33 The bill provides confidentiality provisions relating to 34 ambulatory surgical center information. The final findings 35 -8- LSB 2074XS (2) 89 pf/rh 8/ 9

S.F. 275 with respect to compliance by an ambulatory surgical center 1 are to be made available to the public in a readily available 2 form and place. Other information relating to an ambulatory 3 surgical center shall not be made available to the public, 4 except in proceedings involving the denial, suspension, or 5 revocation of a license. The name of a person who files a 6 complaint with the DIA is required to remain confidential and 7 not be subject to discovery, subpoena, or other means of legal 8 compulsion. 9 The bill provides for injunctive relief and judicial review. 10 The bill provides that any person establishing, operating, 11 or maintaining an ambulatory surgical center without a license 12 commits a serious misdemeanor, and each day of continuing 13 violation after conviction shall be considered a separate 14 offense. A serious misdemeanor is punishable by confinement 15 for no more than one year and a fine of at least $430 but not 16 more than $2,560. 17 -9- LSB 2074XS (2) 89 pf/rh 9/ 9