State Survey Agency Training ASC Survey Process

1. State Survey Agency TrainingASC Survey Process May 14, 2009

2. Training Overview • Introduction • Overview of CfC Changes • Case Tracer Methodology • New Infection Control Requirements • Infection Control Instrument • Questions

3. Training Faculty • CMS • Thomas Hamilton, Director, Survey & Certification Group • Marilyn Dahl, Director, Division of Acute Care Services, S&C Group • Angela Mason-Elbert, MS, JD, Technical Lead, ASCs, Division of Acute Care Services

4. Training Faculty • CDC • Melissa Schaefer, MD, Medical Epidemiologist • Michael Jhung, MD, MPH, Medical Epidemiologist

5. Training Faculty • MD SA Surveyors from 2008 Pilot • Barbara Hall, Health Facilities Nurse Surveyor II • Luke Reich, Health Facilities Nurse Surveyor II

6. Introduction Thomas Hamilton

7. ASC Focus • Rapid Growth • 5,175 Ambulatory Surgical Centers (ASCs) currently participate in Medicare • 61% increase from CY 2000 – CY 2009

8. ASC Focus • Site for 43% (15 M) of all same day surgeries • 15% of FY 08 surveys had condition-level problems (4% for hospitals) • Only 10% resurveyed each year

9. Nevada ASC Problems • January, 2008 identification of hepatitis C cluster caused by poor infection control practices in a Nevada ASC heightened concern • Over 50,000 former patients were notified of potential exposure to infectious diseases

10. Nevada 2008 ASC Surveys • Federal surveys conducted in 28 of the 51 Nevada ASCs • CDC developed infection control survey tool to assist surveyors • 64% had condition-level problems • 18% (5 ASCs) terminated

11. FY 2008 ASC Pilot • Goals • Determine prevalence of ASC noncompliance in representative sample • Evaluate revised survey process

12. FY 2008 ASC Pilot • Maryland, North Carolina, Oklahoma • Total of 68 ASCs surveyed • Identified widespread deficiencies, particularly in infection control

13. Changes in ASC Oversight Marilyn Dahl

14. Changes in ASC Oversight • New Conditions for Coverage, effective May 18, 2009 • New guidance to be released shortly

15. Changes in ASC Oversight • New survey process : • Case tracer methodology • Infection control survey tool • Team approach to health surveys for medium & large ASCs

16. Changes in ASC Oversight • More surveys • Volunteers sought for FY 2009 • 30% of non-deemed ASCs to be surveyed in FY 2010 • Also increasing FY 2010 ASC validation surveys

17. GAO Report • GAO-09-13, 2/25/08, Health-care-Associated Infections – HHS Action Needed to Obtain Nationally Representative Data on Risks in ASCs

18. GAO Report • Findings: • No nationwide source of data on HAIs in ASCs • Process data more feasible for ASCs than outcomes data • Positive view of CMS ASC Pilot

19. GAO Report • Recommendation: • HHS should use ASC infection control surveyor worksheet developed for pilot to conduct periodic studies of randomly selected ASCs to assess infection control practices in ASCs • CMS considering how to implement

20. ARRA Initiative • $50 M to States for HAI control • Great timing: • CMS pilot shows ASC infection control problems • GAO endorses CMS pilot approach • CMS requested $10 M to enhance ASC oversight

21. ARRA Initiative • FY 09 $ available to volunteers • FY 10 new survey process mandatory • ARRA $ may be requested for added costs • Application details distributed to SAs

22. CfC Changes • New ASC definition • Ambulatory surgical center or ASC means any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization

23. CfC Changes • New ASC definition con’t. (changes in italics) • and in which the expected duration of services would not exceed 24 hours following an admission. The entity must have an agreement with CMS to participate in Medicare and must meet the conditions set forth in Subpart B and C of this part.

24. CfC Changes New Conditions: • Quality Assessment/Performance Improvement • Patients’ Rights • Infection Control • Patient Admission, Assessment & Discharge

25. CfC Changes • Revised Conditions: • Governing Body (Contract Services, Hospitalization & Disaster Preparedness Plan)

26. CfC Changes • Revised Conditions: • Surgical Services (Anesthetic Risk & Evaluation) • Laboratory & Radiologic Services

27. Guidance to CfCs • Infection Control - Today • New SOM Appendix L – coming soon • In-person Training, all CfCs, October 2009

28. Case Tracer Methodology Angela Mason-Elbert, MS, JD

29. Case Tracer Methodology • Surveyors required to follow at least one patient from admission, through surgery, recovery, to discharge • Observe for compliance with multiple CfCs throughout, particularly at transition points

30. Case Tracer Methodology • Facilitates assessing multiple CfCs: • Infection control • Patient pre-op assessments • Informed consent • Discharge requirements • Medication administration • Easier with two health surveyors

31. Case Selection • Schedule survey to occur when ASC is operating • Check website, other available sources to check operating hours

32. Case Selection • Type of modality • Consent • Length of case – generally < 90 minutes operative time

33. Case Selection • Many multi-specialty ASCs have block scheduling • A different type of procedure each day • Consider partial observations of other types • If possible, observe a case on first day to see typical practices

34. Patient Consent • Usually provider obtains consent after surveyor selects a case • Surveyor approaches patient after consent obtained • Consent to observation must be documented in medical record

35. Surgeon Consent • Surgeon is responsible for patient’s care; surveyors to seek consent to observe part or all of procedure • ASC management may be able to assist if surgeon(s) issue blanket refusal • Make clear that goal of observation is to assess CfC compliance, not surgical skill

36. Case Observation Typically begin case observation in the pre-operative area

37. Pre-Operative Area • Focal points: • Required assessments: prior H&P, update, pre-op assessment of anesthetic/procedural risk • Infection control practices • Informed consent

38. Pre-Operative Area Focal points: • Patient ID, site marking • Medication administration • Medical records

39. Operating Room • Must the surveyor remain continuously in the OR? • Opinions of pilot surveyors differ • At a minimum, must observe patient arrival in OR, prep, start of procedure, end of procedure and transfer to recovery

40. Operating Room • Multiple options with 2 surveyors: • Both in the OR; one observes set-up and clean-up of OR; one follows patient out of OR; or • One follows case up to OR and upon leaving OR; other observes arrival in OR, procedure, and OR clean-up

41. Operating Room • If only one health surveyor (for smaller/low volume ASCs): • Let the ASC know you want to see the procedure start, so that they allow time for surveyor gowning • Follow patient out of OR; seek other case to observe OR clean-up and set-up for another case

42. Operating Room • Focal points: • Time out for patient and site ID • Medication administration • Patient preparation – e.g., alcohol-based skin prep

43. Operating Room • Focal points: • Physical environment • Design • Equipment • Sterilization/high-level disinfection

44. Operating Room • Observe the breakdown of the OR and the set up for the next procedure • Look for: • High level disinfection & cleaning • Flash sterilization

45. Recovery Room • Focal points: • Recovery process (monitoring, assessment, pain management) • Medication administration

46. Recovery Room • Focal points: • Medical records • Discharge instructions • Discharge

47. Infection Control CfC Marilyn Dahl

48. Infection Control CfC • §416.51 consists of: • Condition statement • 2 Standards • §416.44(a)(3) also retained

49. Condition • §416.51: The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases.

50. ASC Infection Control Challenges • Patients in common areas • Surgical prep, recovery rooms and ORs turned around quickly for multiple patients