1. Indiana Federation of Ambulatory Surgical Centers September 27, 2013 To promote and provide essential public health services

2. Indiana Ambulatory Surgery Centers

3. Average Number of Deficiencies Deficiencies per Certification Survey 2008 – 1.0 2009 – 7.1 2010 – 7.7 2011 – 7.1 2012 – 5.1 2013 – 4.8 Source: Indiana data from CMS PDQ

4. S&C 13-58.2000 2000 Edition National Fire Protection Association (NFPA) 101® Life Safety Code (LSC) Waivers

5. Categorical Waivers for: Medical Gas Alarms Opening Exit Enclosures Emergency Generator & Standby Power Doors Suites Extinguishing Requirements Clear Waste & Patient Record Recycling Containers

6. S&C 13-25 LAC & ASC Relative Humidity (RH): Waiver of Life Safety Code (LSC) Anesthetizing Location Requirements; Discussion of Ambulatory Surgical Center (ASC) Operating Room Requirements

7. Categorical Waiver for: Relative humidity: Minimum: ≥ 20% Maximum: ≤ 60% Cannot affect ventilation system performance.

8. REGULATIONS AND COMPLIANCE

9. ASC Physician Requirement Definition of Ambulatory Surgery Center: IC 16-18-2-14(a)(2) –Is operated under the supervision of at least one (1) licensed physician or under the supervision of the governing board of the hospital if the center is affiliated with a hospital

10. ASC Physician Requirement 410 IAC 15-2.5-4(b)(3)(r): Medical Staff –A physician shall be available to the center during the period any patient is present in the center. –The interpretive guidelines for surveyors include verification that there is a physician immediately available by phone, during the period a patient is in the center, to respond to patients requiring emergency care and then available on the premises within an acceptable period of time, if necessary, and in accordance with medical staff policies.

11. ASC Anesthesiologist Requirement 410 IAC 15-2.1-2(c)(1((a): Medical Staff –Requires that a physician with specialized training or experience in the administration of an anesthetic supervise the administration of the anesthetic to a patient and remain present in the facility during the surgical procedure, except when only a local infiltration anesthetic is administered.

12. Hospital Physician Requirement 410 IAC 15-1.4-1(d)(3): Governing Board –(A) In hospitals with at least 100 acute care staffed beds, provide a licensed physician on the premises at all times who has the responsibility to respond to patients requiring emergency care –(B) In hospitals of less than 100 beds, a minimum of a licensed physician who has the responsibility to respond to patients requiring emergency care and who is on call at all times and immediately available by phone and then available on the premises with 30 minutes

13. Question Our ASC was built in the late 1980s. We would like to remove the hopper that was originally installed. The center is ophthalmology and we do not use the hopper. Can we remove it? Do we need to obtain a waiver for this? Who do we contact?

14. Response Contact Todd Hite, Health Care Engineering Program: Thite@isdh.in.gov Thite@isdh.in.gov 317-233-7166 for assistance in determining required components for an ASC per the AIA guidelines and/or the possibility for waiver, if the component is required.

15. Question Review the new Medicare rule regarding advanced directives and not having a blanket statement that living wills are not honored. Although our recent survey was not a federal survey, the surveyors did not know about this rule when we asked their opinion on the rule.

16. Response Surveyor opinion about the regulation is irrelevant. Staff have been provided the update. Rule: no blanket statement. Centers: consult with counsel.

17. Question The local hospital completes the biomedical safety checks on our equipment. The print out for each piece of equipment documents a pass/fail grade. The last surveyor said this was not acceptable because it did not include the ground current leakage results on the form. The hospital has criteria that if not met, the equipment is taken out of circulation. This is the same report that has been given to us for over 20 years and now this surveyor states it is not sufficient. The director at the hospital even mentioned a previous ISDH surveyor said their policy meet the standard. Also the surveyor said a triennial electrical current leakage report was required. What rule is this?

18. Response Rule: 410 IAC 15-2.5-7(b) Specifically: 15-2.5-7(b)(4)(B)(iii) Waiver? Was a citation given?

19. Question The surveyor mentioned if the generator battery is not enclosed, we need to complete a yearly hygrometer testing of the specific acid in the battery. Where is this rule located?

20. Response: “Buried” in the LSC, Code 110, Appendix as a ‘should’. Maintenance free: not allowed. Cited??

21. Question Please let the membership know where the 2008 rules with the guidance to surveyors are located. Is there any document that denotes the changes from the 2000 edition compared to the 2008 edition?

22. Response http://www.in.gov/isdh/files/410_iac_15-2.pdf No cross-walk from 2000 to 2008

23. Question The surveyor reviewed the pest control report and mentioned it should include not only the product that was used but also what bugs they were looking for. What rule is this?

24. Response No rule; but…..

25. Question Part 2 Infection Control and Related Practices Page 10 Letter K "Multidose medications used for more than one patient are not stored or accessed in the immediate areas where direct patient contact occurs" 1-Does this include enclosed and locked anesthesia carts located in the OR's? 2-If so, what are acceptable storage and access methods if multidose medications are used in order to meet this regulation?

26. Response Yes: 2. B.11 If multi ‐ dose vials are used for more than one patient, they do not enter the immediate patient treatment area (e.g., operating room, patient room, anesthesia carts). Note: if multi ‐ dose vials are found in the patient care area they must be dedicated for single patient use and discarded after use. If using multi-dose vials, store them somewhere besides ORs, patient rooms or anesthesia carts.

27. Question Ask if an endoscopy center can get a waiver for the scrub sink or at the very least put it in the locker room. Also want to know if you can call any sink a scrub sink or does it technically have to be a ‘scrub sink’?

28. Response Scrub sinks are a defined type of sink. Not any sink can be a ‘scrub’ sink. No scrub sinks in locker rooms. A waiver request may be submitted for good cause shown.

31. Indiana State Department of Health Mission To promote and provide essential public health services