Meeting CMS Requirements for Infection Prevention in Ambulatory Surgery Centers

1. Meeting CMS Requirements for Infection Prevention in Ambulatory Surgery Centers September 18, 2012 APIC Badger Chapter Madison, WI Presenter: Judy Hintzman RN MS CIC

2. Objectives • Understand the elements of infection prevention and control in ambulatory settings surveyed by CMS. • Describe how to perform a facility risk assessment. • Identify the initial steps in implementing change in your organization.

3. Centers for Medicare and Medicaid Services (CMS) • Federal agency that administers: • Medicare and Medicaid • HIPAA • Enforces federal quality standards for various healthcare settings • Maintains oversight of ASC’s, long term care facilities, home health agencies, intermediate care facilities, mental health facilities and hospitals • Administers Quality Improvement Organizations at state level

4. What Led to the Focus on Infection Control in ASCs? • Cluster of Hepatitis C virus infections (Nevada) related to endoscopy procedures • Survey of that ASC identified unsafe injection practices resulting in 40,000+ patients notified of potential exposure. • Nevada also identified other ASCs with deficient infection control practices. • CDC has reported other outbreaks related to bloodborne infectious diseases in other states.

5. CMS Conditions for CoverageInfection Control Requirements 5/18/09 • 416.51 Infection Control The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases. • Standard A :Sanitary Environment “The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.”

6. CMS Conditions for CoverageInfection Control Requirements 5/18/09 Standard B: Infection control program. “The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.

7. CMS Conditions for CoverageInfection Control Requirements 5/18/09 The program is (1) Under the direction of a designated and qualified professional who has training in infection control (2) An integral part of the ASC’s quality assessment and performance improvement program

8. CMS Conditions for CoverageInfection Control Requirements 5/18/09 The program Is (3) Responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement.

9. What is an Ambulatory Surgical Center or ASC (per CMS)? • Any entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization • Duration of services not expected to exceed 24 hours

10. What is Surgery per CMS? • Procedure performed for purpose of structurally altering the human body by incision or destruction of tissues. • Diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which includes lasers, ultrasound, ionizing radiation, scalpels, probes and needles. Endoscopy is included in definition. • Injections of substances into body cavities, internal organs, joints, sensory organs, and the central nervous system.

11. The ASC Survey Process for CMS • Certification accomplished through • Observations and tours • Interviews • Document and record reviews

12. Survey ProcessNo more “drive by” CMS surveys October 2009 - first training in 10 years • Focus on staff that do procedures • Case tracer methodology • Surveyors required to follow at least one patient from admission, through surgery and recovery, to discharge. • Infection control surveyor worksheet is used to collect information (16 pages)

13. Accreditation StandardsMust be met to receive accreditation • Government regulations- CMS - OSHA • ASC accrediting agencies • AAAHC Accreditation Association for Ambulatory Health Care • AAAASF American Association for Accreditation for Ambulatory Surgery Facilities • AOA American Osteopathic Association • Best practices – may become standard of care • Guidance documents • CDC, DHQPA,NHSN,NIOSH,HICPAC, AAMI, APIC • Environmental Infection control • Terminal cleaning of OR room • Prevention of Surgical Site Infection • Have you read CDC document? • How is information shared when SSI’s are identified? • Hand Hygiene • Have you read the CDC document? • Have you done observation studies on compliance?

14. Infection Prevention Program Required Elements • Written plan • Risk assessment • Qualified licensed professional to direct the program • Education in Infection Prevention is documented • Can be certified but not required • Selection of nationally recognized guidelines • Available to staff and current • Evidence of compliance with guidelines • Surveillance system including notifiable disease reporting to State • Staff education and training • Must have an annual plan • Documented training

15. CMS ASCInfection Control Worksheet (ICWS) • Initial tool developed by CDC as part of Nevada Outbreak investigation • $10 million funding made it possible to increase ASC’s surveys and implement process nation wide • Some accreditation organizations are also using the ICWS • Original goal: collect ICWS from 1500 ASCs

16. CMS Survey Outcomes • No Deficiency • Standard Level • Condition Level • Immediate Jeopardy

17. Focus on Specific Infection Prevention Practices • Hand Hygiene (including glove use) • Safe injection practices (including use of medication vials) • Disinfection and sterilization • Environmental infection control • Safe use and handling of point of care devices

18. ASCs Characteristics Sample Questions 1) ASC name: 2) Address: 3) 10-digit CMS Certification Number: 4) What year did the ASC open for operation?

19. ASCs Characteristics Sample Questions What is the primary procedure performed at the ASC (i.e.,what procedure type reflects the majority of procedures performed at the ASC). Check only ONE:  Dental  Orthopedic  Endoscopy  Pain  Ear/Nose/Throat  Plastic/reconstructive  OB/GYN  Podiatry  Ophthalmologic Other

20. ASCs Characteristics Sample Questions What additional procedures are performed at the ASC (Check all that apply)? Dental  Orthopedic  Endoscopy  Pain  Ear/Nose/Throat  Plastic/reconstructive  OB/GYN  Podiatry  Ophthalmologic  Other ____________

21. ASCs Characteristics Sample Questions Who does the ASC perform procedures on? (Check only ONE):  Pediatric patients only  Adult patients only  Both pediatric and adult patients

22. ASCs Characteristics Sample Questions What is the average number of procedures performed at the ASC per month? How many Operating Rooms (including procedure rooms) does the ASC have? # of rooms # actively maintained

23. ASCs Characteristics Sample Questions Please indicate how the following services are provided (check all that apply): Anesthesia Contract  Employee  Other____ Environmental Cleaning Contract  Employee  Other ____ Linen Contract  Employee  Other ____ Nursing Contract  Employee  Other ____ Pharmacy Contract  Employee  Other ____ Sterilization/Reprocessing Contract  Employee  Other ____ Waste Management Contract  Employee  Other ____

24. Worksheet Standard Assessment Does the ASC have an explicit infection control program?  YES  NO NOTE! If the ASC does not have an explicit infection control program, a condition-level deficiency related to 42 CFR 416.51 must be cited.

25. Worksheet Standard Assessment Does the ASC’s infection control program follow nationally recognized infection control guidelines?  YES  NO NOTE! If the ASC does not follow nationally recognized infection control guidelines, a deficiency related to 42 CFR 416.51(b) must be cited. Depending on the scope of the lack of compliance with national guidelines, a condition-level citation may also be appropriate.

26. Worksheet Standard Assessment Is there documentation that the ASC considered and selected nationally-recognized infection control guidelines for its program?  YES  NO

27. Worksheet Standard Assessment Which nationally-recognized infection control guidelines has the ASC selected for its program (Check all that apply)? NOTE! If the ASC cannot document that it considered and selected specific guidelines for use in its infection control program, a deficiency related to 42 CFR 416.51(b) must be cited. This is the case even if the ASC’s infection control practices comply with generally accepted standards of practice/national guidelines. If the ASC neither selected any nationally recognized guidelines nor complies with generally accepted infection control standards of practice, then the ASC should be cited for a condition-level deficiency related to 42 CFR 416.51

28. Worksheet Standard Assessment Does the ASC have a licensed health care professional qualified through training in infection control and designated to direct the ASC’s infection control program?  YES  NO is this person an: (check only ONE):  ASC employee  ASC contractor

29. Worksheet Standard Assessment Is this person certified in infection control (i.e., CIC) (Note: §416.50(b)(1) does not require that the individual be certified in infection control.)  YES  NO If this person is NOT certified in infection control, what type of infection control training has this person received?

30. Worksheet Standard Assessment On average how many hours per week does this person spend in the ASC directing the infection control program? Note: §416.51(b)(1) does not specify the amount of time the person must spend in the ASC directing the infection control program, but it is expected that the designated individual spends sufficient time directing the program, taking into consideration the size of the ASC and the volume of its surgical activity.)

31. How Many IC Hours per Week? • Does not specify • The amount of time needed to direct the program is relative to the size and scope of service • Judy’s thoughts - at least 3 times a week- 4 hours per day until the program is established. There is lots to do!

32. Worksheet Standard Assessment Does the ASC have a system to actively identify infections that may have been related to procedures performed at the ASC?  YES  NO If YES, how does the ASC obtain this information? • Sends e-mails to patients' after discharge. • Follows up with patients’ primary provider after discharge. • Relies on the surgeon at a follow up visit to report • Other

33. Worksheet Standard Assessment Is there supporting documentation confirming this tracking activity?  YES  NO

34. Worksheet Standard Assessment Does the ASC have a policy/procedure in place to comply with State notifiable disease reporting requirements?  YES  NO

35. Worksheet Standard Assessment Do staff members receive infection control training?  YES  NO If YES, How do they receive infection control training (check all that apply)?  In-service  Computer-based training  Other (specify)

36. Worksheet Standard Assessment Which staff members receive infection control training? (check all that apply):  Medical staff  Nursing staff  Other staff providing direct patient care • Staff responsible for on-site sterilization/high- level disinfection  Cleaning staff  Other (specify):

37. Worksheet Standard Assessment • Is training: • The same for all categories of staff ? • Different for different categories of staff ?

38. Worksheet Standard Assessment Indicate frequency of staff infection control training (check all that apply):  Upon hire  Annually  Periodically/as needed • Other (specify)

39. Survey Process • Tracer methodology • Focus on staff who perform procedures • Injection practices: nurses & physicians • Instrument reprocessing: reprocessing technicians

40. Hand Hygiene • Challenging to assess • Observations in patient-care areas • Pre-operative area • Post-operative area • Focus on: • Nurses • Physicians

41. Hand Hygiene • Soap and water available • Alcohol-based hand rubs available and installed as required • Staff perform hand hygiene correctly • After removing gloves • After direct patient contact • Before performing invasive procedure

42. Glove Use • Healthcare providers should wear (non-sterile) gloves: • For procedures that might involve contact with blood or body fluids • When handling potentially contaminated patient equipment • Healthcare providers should remove gloves (and immediately perform hand hygiene) before moving to the next task and/or patient

43. Gloves: Common Mistakes Seen • Failure to clean hands after gloves removed. • Moving from patient to patient without cleaning hands and changing gloves • Using alcohol based hand rub on gloves • Thinking double gloving protects against puncture injury • Not having gloves accessible in locations where they are needed/ and used.

44. Injection SafetyInjectable medications, saline, other infusates • Observations in patient care and medication preparation areas • Pre-operative area • Operating/Procedure rooms • Anesthesia cart • Focus on: • Nurses (e.g., RN, CRNA) • Physicians (e.g., anesthesiologists)

45. Injection Practices

46. Needles are used for only one patient Syringes are used for only one patient Medication vials are always entered with: New needle New syringe Injection Safety

47. Single-dose medication vials Manufacturer-prefilled syringes Bags of IV solution Medication administration tubing and connectors Handling of Single-dose Medications and Supplies

48. Handling of Multi-dose Medications • Rubber diaphragm is disinfected with alcohol prior to each entry. • Vials are dated when opened and discarded within 28 days or according to manufacturer instructions, whichever comes first • Vials are not stored or accessed in the immediate areas where direct patient contact occurs (e.g., at patient bedside)

49. Label Requirements are Strictly Enforced • Medications that are pre drawn are labeled with the time of draw, initials of the person drawing, medication name, strength and expiration date or time. • There are NO acceptable “work arounds” or substitute practices to avoid using a label.

50. Inspection Of Multi-Dose VialsNeed a policy and assure practice • Multi-dose vials used on >1 patient • Vial septum disinfected with alcohol before entry • New needle and syringe for each access • Vials are dated when opened and discarded in 28 days or manufacturer’s expiration date, which ever comes first. • Reminder: single dose and multi-dose vials are not interchangeable. • Drug cost/availability does not justify doing so.