S.F. _____ Section 1. NEW SECTION . 135P.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” does 8 not include individual or group practice offices of private 9 physicians, podiatrists, or dentists that do not contain a 10 distinct area used for outpatient surgical treatment on a 11 regular basis, or that only provide surgery routinely provided 12 in a physician’s, podiatrist’s, or dentist’s office using local 13 anesthesia or conscious sedation; or a portion of a licensed 14 hospital designated for outpatient surgical treatment. 15 2. “Department” means the department of inspections and 16 appeals. 17 Sec. 2. NEW SECTION . 135P.2 Purpose. 18 The purpose of this chapter is to protect the public 19 health, safety, and welfare by providing for the licensing and 20 regulation of ambulatory surgical centers. 21 Sec. 3. NEW SECTION . 135P.3 Licensure. 22 A person, acting severally or jointly with any other person, 23 shall not establish, operate, or maintain an ambulatory 24 surgical center in this state without obtaining a license as 25 provided under this chapter. 26 Sec. 4. NEW SECTION . 135P.4 Application for license —— fee. 27 1. An applicant for an ambulatory surgical center license 28 shall submit an application to the department. Applications 29 shall be upon such forms and shall include such information 30 as the department may reasonably require, which may include 31 affirmative evidence of ability to comply with reasonable rules 32 and standards prescribed under this chapter. 33 2. a. An application for an initial license for 34 an ambulatory surgical center that is in existence and 35 -1- LSB 1649XC (2) 85 pf/nh 1/ 12

S.F. _____ Medicare-certified prior to July 1, 2014, shall be accompanied 1 by a fee of fifty dollars. 2 b. An application for an initial license for an ambulatory 3 surgical center established on or after July 1, 2014, shall 4 be accompanied by a fee sufficient to cover the costs of 5 performing the inspection required in section 135P.8 in an 6 amount as provided in rules adopted by the department. 7 Sec. 5. NEW SECTION . 135P.5 Issuance and renewal of 8 license. 9 1. Upon receipt of an application for license and the 10 license fee, the department shall issue a license if the 11 applicant and the ambulatory surgical center meet the 12 requirements of this chapter and the rules adopted by the 13 department. 14 2. A license shall be issued only for the premises and 15 persons named in the application. 16 3. A license is not transferable or assignable except with 17 the written approval of the department. 18 4. A license shall be posted in a conspicuous place on the 19 licensed premises as prescribed by rule of the department. 20 5. Separate licenses are not required for ambulatory 21 surgical center facilities that are maintained on the same 22 physical site and that have the same ownership or control. 23 Multiple buildings located on the same physical site under the 24 same ownership or control shall be considered one ambulatory 25 surgical center facility for purposes of this chapter and 26 section 135.61, subsection 21, and may operate under one 27 license. 28 6. A license, unless sooner suspended or revoked, shall 29 expire on December 31 of each year and shall be renewed 30 annually. The department shall renew a license upon payment of 31 a five hundred dollar annual license renewal fee and filing of 32 an application for renewal at least thirty days prior to the 33 expiration of the existing license. The annual licensure fee 34 shall be dedicated to support the staffing necessary to conduct 35 -2- LSB 1649XC (2) 85 pf/nh 2/ 12

S.F. _____ the inspections and investigations provided in section 135P.8. 1 Sec. 6. NEW SECTION . 135P.6 Denial, suspension, or 2 revocation of license —— hearings and review. 3 1. The department may deny, suspend, or revoke a license in 4 any case where it finds there has been a substantial failure 5 to comply with this chapter or the rules and standards adopted 6 under this chapter. 7 2. The denial, suspension, or revocation of a license by 8 the department and appeal from that action are governed by the 9 procedures for a contested case hearing under chapter 17A. 10 3. a. If the department finds, after providing notice of 11 noncompliance and a reasonable time for corrective action, that 12 an ambulatory surgical center is in repeated noncompliance with 13 this chapter or the department’s rules but that noncompliance 14 does not endanger public health or safety, the department may 15 issue a conditional license to the ambulatory surgical center 16 as an alternative to suspending or revoking the ambulatory 17 surgical center’s license. 18 b. The department shall provide notice of its intent to 19 issue a conditional license to the ambulatory surgical center 20 and of the items of noncompliance not less than ten days before 21 the date the conditional license is issued. 22 c. The department shall designate a period of not more 23 than one year during which the ambulatory surgical center may 24 operate under a conditional license. 25 d. During the period an ambulatory surgical center is 26 operating under a conditional license, the ambulatory surgical 27 center shall correct the items that are in noncompliance and 28 report the corrections to the department for approval. 29 4. The department may suspend or revoke the license of an 30 ambulatory surgical center that does not correct items that 31 are in noncompliance or that does not comply with this chapter 32 or the rules adopted under this chapter within the applicable 33 period. 34 5. The department may issue an emergency order to suspend 35 -3- LSB 1649XC (2) 85 pf/nh 3/ 12

S.F. _____ a license issued under this chapter if the department has 1 reasonable cause to believe that the conduct of the ambulatory 2 surgical center creates an immediate danger to the public 3 health and safety. An emergency suspension is effective 4 immediately without a hearing or notice to the licensee. On 5 written request of the licensee, the department shall conduct 6 a hearing not earlier than the tenth day or later than the 7 thirtieth day after the date the hearing request is received 8 to determine if the emergency suspension is to be continued, 9 modified, or rescinded. The hearing and any appeal are 10 governed by the department’s rules for a contested case hearing 11 and chapter 17A. 12 Sec. 7. NEW SECTION . 135P.7 Rules. 13 1. The department, with the advice and approval of the state 14 board of health, shall adopt rules specifying the standards for 15 ambulatory surgical centers to be licensed under this chapter. 16 The rules shall be consistent with and shall not exceed the 17 requirements of this chapter and the conditions for coverage in 18 the federal Medicare program for ambulatory surgical centers 19 under 42 C.F.R. pt. 416. 20 2. The department shall adopt rules as the department deems 21 necessary to implement the provisions of this chapter relating 22 to the issuance, renewal, denial, suspension, and revocation 23 of a license to establish, operate, and maintain an ambulatory 24 surgical center. 25 3. An ambulatory surgical center which is in operation at 26 the time of adoption of any applicable rules or standards under 27 this chapter shall be given a reasonable time, not to exceed 28 one year from the date of adoption, within which to comply with 29 such rules and standards. 30 4. The department shall enforce the rules. 31 Sec. 8. NEW SECTION . 135P.8 Inspections. 32 1. The department shall make or cause to be made inspections 33 or investigations of ambulatory surgical centers to determine 34 compliance with this chapter and applicable rules and 35 -4- LSB 1649XC (2) 85 pf/nh 4/ 12

S.F. _____ standards. The department shall perform inspections on a 1 schedule that is of the same frequency required for inspections 2 of Medicare-certified ambulatory surgical centers. 3 2. The department shall recognize, in lieu of its own 4 licensure inspection, the comparable inspection and inspection 5 findings of a Medicare conditions for coverage survey. 6 3. A department inspector shall not participate in an 7 inspection or investigation of an ambulatory surgical center in 8 which the inspector or a member of the inspector’s immediate 9 family works or has worked within the last two years or in 10 which the inspector or the inspector’s immediate family has 11 a financial ownership interest. For the purposes of this 12 section, “immediate family member” means a spouse, natural or 13 adoptive parent or grandparent, child, grandchild, sibling, 14 stepparent, stepchild, or stepsibling. 15 Sec. 9. NEW SECTION . 135P.9 Employee background checks. 16 1. An ambulatory surgical center shall comply with child and 17 dependent adult abuse information and criminal record checks 18 and evaluations in the same manner as provided in section 19 135B.34, except that the authorization of an exemption under 20 section 135B.34, subsection 4, paragraph “b” , from requirements 21 for reevaluation of the latest record checks by the department 22 of human services relative to a person being considered for 23 employment in an ambulatory surgical center is subject to all 24 of the following provisions: 25 a. The position with the ambulatory surgical center is 26 substantially the same or has the same job responsibilities as 27 the position for which the previous evaluation was performed. 28 b. Any restrictions placed on the person’s employment in the 29 previous evaluation by the department of human services shall 30 remain applicable in the person’s employment in the ambulatory 31 surgical center. 32 c. The person subject to the record checks has maintained 33 a copy of the previous evaluation and provides the evaluation 34 to the ambulatory surgical center or the previous employer 35 -5- LSB 1649XC (2) 85 pf/nh 5/ 12

S.F. _____ provides the previous evaluation from the person’s personnel 1 file pursuant to the person’s authorization. If a physical 2 copy of the previous evaluation is not provided to the 3 ambulatory surgical center, the record checks shall be 4 reevaluated. 5 d. Although an exemption may be authorized, the ambulatory 6 surgical center may instead request a reevaluation of the 7 record checks and may employ the person while the reevaluation 8 is being performed. 9 2. An ambulatory surgical center licensed in this state 10 may access the single contact repository established by the 11 department pursuant to section 135C.33 as necessary for the 12 ambulatory surgical center to perform record checks of persons 13 employed or being considered for employment by the ambulatory 14 surgical center. 15 Sec. 10. NEW SECTION . 135P.10 Confidentiality. 16 The department’s final findings or the final survey findings 17 of an accrediting body with respect to compliance by an 18 ambulatory surgical center with requirements for licensing 19 or accreditation shall be made available to the public in a 20 readily available form and place. Other information relating 21 to an ambulatory surgical center obtained by the department 22 which does not constitute the department’s findings from an 23 inspection of the ambulatory surgical center or the final 24 survey findings of the accrediting body shall not be made 25 available to the public, except in proceedings involving the 26 denial, suspension, or revocation of a license under this 27 chapter. The name of a person who files a complaint with the 28 department shall remain confidential and shall not be subject 29 to discovery, subpoena, or other means of legal compulsion for 30 its release to a person other than department employees or 31 agents involved in the investigation of the complaint. 32 Sec. 11. NEW SECTION . 135P.11 Injunction. 33 Notwithstanding the existence or pursuit of any other 34 remedy, the department may, in the manner provided by law, 35 -6- LSB 1649XC (2) 85 pf/nh 6/ 12

S.F. _____ maintain an action in the name of the state for injunction 1 or other process against any person to restrain or prevent 2 the establishment, operation, or maintenance of an ambulatory 3 surgical center without a license. 4 Sec. 12. NEW SECTION . 135P.12 Judicial review. 5 Judicial review of an action of the department may be sought 6 in accordance with chapter 17A. Notwithstanding the provisions 7 of chapter 17A, petitions for judicial review may be filed 8 in the district court of the county in which the ambulatory 9 surgical center is located or is to be located and the status 10 quo of the petitioner or licensee shall be preserved pending 11 final disposition of the judicial review matter. 12 Sec. 13. NEW SECTION . 135P.13 Penalties. 13 Any person establishing, operating, or maintaining any 14 ambulatory surgical center without a license commits a serious 15 misdemeanor, and each day of continuing violation after 16 conviction shall be considered a separate offense. 17 Sec. 14. Section 135.11, Code 2013, is amended by adding the 18 following new subsection: 19 NEW SUBSECTION . 32. Adopt rules requiring ambulatory 20 surgical centers to report quality data to the department of 21 public health that is consistent with the data required to be 22 reported to the centers for Medicare and Medicaid services 23 of the United States department of health and human services 24 as authorized by the Medicare Improvements and Extension Act 25 of 2006 under Title I of the Tax Relief and Health Care Act 26 of 2006, Pub. L. No. 109-432, and the regulations adopted 27 under such Acts. Notwithstanding any provision of law to 28 the contrary, nothing in this subsection shall require an 29 ambulatory surgical center to provide health data to the 30 department of public health or any other public or private 31 entity that is in addition to, different than, or exceeds 32 the quality data required to be reported to the centers for 33 Medicare and Medicaid services of the United States department 34 of health and human services. 35 -7- LSB 1649XC (2) 85 pf/nh 7/ 12

S.F. _____ Sec. 15. EFFECTIVE DATE. This Act takes effect July 1, 1 2014. 2 EXPLANATION 3 This bill creates a new Code chapter to provide for the 4 licensing and regulation of ambulatory surgical centers. 5 The bill defines “ambulatory surgical center” as a distinct 6 facility that operates exclusively for the purpose of providing 7 surgical services to patients not requiring hospitalization 8 and in which the expected duration of services does not 9 exceed 24 hours following an admission. “Ambulatory surgical 10 center” does not include individual or group practice offices 11 of private physicians, podiatrists, or dentists that do not 12 contain a distinct area used for outpatient surgical treatment 13 on a regular basis, or that only provide surgery routinely 14 provided in a physician’s, podiatrist’s, or dentist’s office 15 using local anesthesia or conscious sedation; or a portion of a 16 licensed hospital designated for outpatient surgical treatment. 17 The department of inspections and appeals is designated to 18 enforce the regulations. 19 The bill provides that the purpose of the new Code chapter is 20 to protect the public health, safety, and welfare by providing 21 for the licensing and regulation of ambulatory surgical 22 centers. The bill prohibits the establishment, operation, 23 or maintenance of an ambulatory surgical center in the state 24 without obtaining a license. 25 The bill provides the process for application for licensure. 26 An application for an initial license for an ambulatory 27 surgical center that is in existence and Medicare-certified 28 prior to July 1, 2014, is required to be accompanied by a fee of 29 $50. An application for an initial license for an ambulatory 30 surgical center established on or after July 1, 2014, is 31 required to be accompanied by a fee sufficient to cover the 32 costs of performing the required inspection in an amount 33 provided in rules adopted by the department. 34 The bill provides for the issuance and renewal of licenses. 35 -8- LSB 1649XC (2) 85 pf/nh 8/ 12

S.F. _____ A license is to be issued only for the premises and persons 1 named in the application; is not transferable or assignable 2 except with the written approval of the department; and is 3 required to be posted in a conspicuous place on the licensed 4 premises as prescribed by rule of the department. The bill 5 provides that separate licenses are not required for ambulatory 6 surgical center facilities that are maintained on the same 7 physical site and that have the same ownership or control. 8 Multiple buildings located on the same physical site under the 9 same ownership or control shall be considered one ambulatory 10 surgical center facility for purposes of the new Code chapter 11 and Code chapter 135, division VI, relating to the health 12 facilities council and certificate of need provisions, and are 13 to be permitted to operate under one license. Licenses expire 14 on December 31 of each year and are required to be renewed 15 annually. The bill directs the department to renew a license 16 upon payment of a $500 annual license renewal fee and filing 17 of an application for renewal at least 30 days prior to the 18 expiration of the existing license. The annual licensure fee 19 is to be dedicated to support the staffing necessary to conduct 20 the inspections and investigations under the Code chapter. 21 The bill provides for denial, suspension, or revocation of 22 licenses. A license may be denied, suspended, or revoked if 23 the department finds there has been a substantial failure to 24 comply with the Code chapter or the rules and standards adopted 25 under the Code chapter. The denial, suspension, or revocation 26 of a license by the department and appeal from that action are 27 governed by the procedures for a contested case hearing under 28 Code chapter 17A. The bill authorizes the department, after 29 providing notice of noncompliance and a reasonable time for 30 corrective action, and if the noncompliance does not endanger 31 public health or safety, to issue a conditional license to the 32 ambulatory surgical center as an alternative to suspending or 33 revoking its license. 34 The bill also authorizes the department to issue an 35 -9- LSB 1649XC (2) 85 pf/nh 9/ 12

S.F. _____ emergency order to suspend a license if the department has 1 reasonable cause to believe that the conduct of the ambulatory 2 surgical center creates an immediate danger to the public 3 health or safety. On written request of the licensee, the 4 department is required to conduct a hearing to determine if 5 the emergency suspension is to be continued, modified, or 6 rescinded. The hearing and any appeal are governed by the 7 department’s rules for a contested case hearing and Code 8 chapter 17A. 9 The bill directs the department to adopt rules with the 10 advice and approval of the state board of health to specify 11 the standards for ambulatory surgical centers. The rules are 12 required to be consistent with and not exceed the requirements 13 of the Code chapter and the conditions for coverage in the 14 federal Medicare program for ambulatory surgical centers. 15 The department is also directed to adopt rules relating to 16 provisions of the Code chapter relating to the issuance, 17 renewal, denial, suspension, and revocation of a license to 18 establish, operate, and maintain an ambulatory surgical center. 19 If an ambulatory surgical center is in operation at the time of 20 adoption of any applicable rules or standards, the center is 21 to be given a reasonable time, not to exceed one year from the 22 date of adoption, within which to comply with such rules and 23 standards. 24 The bill provides for inspections or investigations of 25 ambulatory surgical centers, and directs that the department 26 shall perform inspections on a schedule that is of the same 27 frequency required for inspections of Medicare-certified 28 ambulatory surgical centers. The bill also requires the 29 department to recognize, in lieu of its own licensure 30 inspection, the comparable inspection and inspection findings 31 of a Medicare conditions for coverage survey. 32 The bill prohibits a department inspector from participating 33 in an inspection or investigation of an ambulatory surgical 34 center in which the inspector or a member of the inspector’s 35 -10- LSB 1649XC (2) 85 pf/nh 10/ 12

S.F. _____ immediate family works or has worked within the last two years 1 or in which the inspector or the inspector’s immediate family 2 has a financial ownership interest. 3 The bill requires an ambulatory surgical center to comply 4 with child and dependent adult abuse information and criminal 5 record checks and evaluations in the same manner as provided 6 for hospitals, but specifically provides that the authorization 7 of an exemption from a reevaluation of the person’s criminal 8 or abuse record prior to commencing employment is subject to 9 specific provisions. The bill also authorizes an ambulatory 10 surgical center to access the single contact repository 11 established by the department as necessary for the ambulatory 12 surgical center to perform record checks of persons employed 13 or being considered for employment by the ambulatory surgical 14 center. 15 The bill provides confidentiality provisions relating to 16 ambulatory surgical center information. The final findings or 17 the final survey findings of an accrediting body with respect 18 to compliance by an ambulatory surgical center are to be 19 made available to the public in a readily available form and 20 place. Other information relating to an ambulatory surgical 21 center shall not be made available to the public, except in 22 proceedings involving the denial, suspension, or revocation of 23 a license. The name of a person who files a complaint with 24 the department is required to remain confidential and not 25 be subject to discovery, subpoena, or other means of legal 26 compulsion. 27 The bill provides for injunctive relief and judicial review. 28 The bill provides that any person establishing, operating, 29 or maintaining an ambulatory surgical center without a license 30 commits a serious misdemeanor, and each day of continuing 31 violation after conviction shall be considered a separate 32 offense. A serious misdemeanor is punishable by confinement 33 for no more than one year and a fine of at least $315 but not 34 more than $1,875. 35 -11- LSB 1649XC (2) 85 pf/nh 11/ 12

S.F. _____ The bill also directs the department of public health 1 to adopt rules requiring ambulatory surgical centers to 2 report quality data to the department of public health that 3 is consistent with the data required to be reported to the 4 centers for Medicare and Medicaid services of the United States 5 department of health and human services. However, the rules 6 are not to require an ambulatory surgical center to provide 7 health data to the department of public health or any other 8 public or private entity that is in addition to, different 9 than, or exceeds the quality data required to be reported to 10 the centers for Medicare and Medicaid services of the United 11 States department of health and human services. 12 The bill takes effect July 1, 2014. 13 -12- LSB 1649XC (2) 85 pf/nh 12/ 12