CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2016 Part 4 of 4 What PPS Hospitals Need to Know

1. CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2016Part 4 of 4What PPS Hospitals Need to Know

2. Speaker Sue Dill Calloway RN, Esq. CPHRM, CCMSCP AD, BA, BSN, MSN, JD President of Patient Safety and Education Consulting 5447 Fawnbrook Lane Dublin, Ohio 43017 614 791-1468 (Call with Questions, No emails) sdill1@columbus.rr.com Questions to CMS at hospitalscg@cms.hhs.gov 2 2

3. Subscribe to the Federal Register http://listserv.access.gpo.gov/cgi-bin/wa.exe?SUBED1=FEDREGTOC-L&A=1

4. Location of CMS Hospital CoP Manual Questions to hospitalscg@cms.hhs.gov New website www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf

5. Physical Environment 700 • Hospital must be constructed, arranged, and maintained to ensure the safety of patient • And to provide diagnosis and treatment and for services appropriate for the community • This CoP applies to all locations of the hospital, all campuses, all satellites

6. Physical Environment • Hospital’s maintenance and hospital departments responsible for the buildings and equipment must be incorporated into the QAPI program • Must also be in compliance with the QAPI requirements • Survey of physical environment should be conducted by one surveyor • LIFE SAFETY CODE survey may be conducted by specially trained surveyor • LS code very important and being hit hard in the surveys

8. Buildings 701 • Condition of physical plant and overall hospital environment must be developed and maintained for the safety and well being of patients • Making sure that a routine and PM activities are done, as manufacturer requires and by state and federal law • Conduct ongoing maintenance inspections • Routine and PM and testing activities should be incorporated into hospital QAPI plan

9. Buildings Emergency Preparedness 701 • Includes developing and implementing emergency preparedness plans and capabilities • Must coordinate with federal, state, and local emergency preparedness and health authority (Department of Health) • To identify risks for their area (natural disasters, bio-terrorism threats, disruption of utilities like water, sewer, electrical, communication, fuel, nuclear accident) • Lists 14 things to consider in developing this

10. Proposed Changes to Emergency Preparedness

11. Emergency Preparedness Resources • There are many other organizations that have resources on emergency preparedness: • The Joint Commission • National Incident Management System (NIMS) • Hospital Incident Command Systems (HICS)

12. Emergency Preparedness Checklist Updated

13. Emergency Preparedness • Transfer of hospital equipment to another facility • Transfer or discharge of patients to home or other hospitals • Security of patients and walk in patients and supplies from misappropriation • Pharmacy, food, and other supplies and equipment that may be needed • Communication among staff • Training needed to implement emergency procedure

14. Emergency Gas and Water • Must be facilities for emergency gas and water supply (703) • To provide care to inpatients • Includes making arrangements with local utility company for emergency sources of gas/water • One source of water is Federal Emergency Management Agency (FEMA) • Gas includes propane, natural gas, fuel oil, as well as gases used such as oxygen, nitrous oxide, nitrogen

15. Trash 713 • Proper storage and disposal of trash • Trash includes bio-hazardous waste • Storage of trash must be in accordance with state and federal law (EPA, CDC, OSHA, state environmental health and safety regulations) • Need policies for storage and disposal of trash

16. Fire Control Plan 715 • Need fire control plan • Must contain section on prompt reporting of fires, extinguishing fires, protection of patients and guests, evacuation and cooperation with fire fighting authorities • Surveyor will review fire plan • Verify all fires are reported to state officials • Will interview staff to make sure they know what to do during a fire • Amended for alcohol based hand dispensers

17. Facilities 722 • Keep written evidence of regular inspections and approval by state or local fire control agencies • Maintain adequate facilities for its service - designed and maintained in accordance with federal, state, and local laws • Toilets, sinks, and equipment should be accessible • Make sure water acceptable for its intended use such as drinking, lab water, irrigation • Review water quality monitoring

18. Facilities 724 2-21-2014 • Standard: Facilities, supplies, and equipment must be maintained to ensure an acceptable level of quality and safety • Must make sure condition of hospital is maintained in a manner to provide for acceptable level of safety for patients, visitors, and staff • Need supplies to meet patient needs • Ensure against theft or contamination of supplies • Need emergency supplies such as when a disaster occurs

19. Facilities 724 • Need equipment when needed for patient care, emergency use, or if there is a disaster • Includes elevators, generators, air compressors, medical equipment, vacuum, etc. • Equipment inspected and tested before use • Maintain records of who is competent to do preventive maintenance • Need equipment maintenance policies and inventories of equipment • Follow manufacturers recommendations and see alternative equipment management program (AEM)

20. Ventilation, Light, Temperature • There must be proper ventilation, light, and temperature controls in pharmacy, food preparation and other appropriate areas • Proper ventilation in areas using ethylene oxide, nitrous oxide, xylene, pentamidine, glutaraldehyde, or other hazardous substances • Temperature controls in pharmacy and food preparation • Amended 1-31-2014

21. Ventilation, Light, Temperature • Ventilation where O2 is transferred from one container to another • In isolation rooms and lab locations • Adequate lighting in patient rooms and food and medication preparation areas (shown to reduce medication errors) • Anesthetizing locations where nonflammable inhalation anesthetic agents are used • Will review temp monitoring records

22. Ventilation, Light, Temperature 726 • Temperature, humidity, and airflow in OR within acceptable standards to inhibit microbial growth • Remember 2 CMS memos and effect of lowering the humidity to 20% • Each OR room should have a separate temperature control - have temp and humidity tracking logs • Incorporate AORN – American Association of periOperative Registered Nurses should be incorporated into hospital policy along with Facilities Guidelines Institute (FGI)

23. CMS Memo April 19, 2013 • CMS issues memo related to the relative humidity (RH) • AORN use to say temperature maintained between 68-73 degrees and humidity between 30-60% in OR, PACU, cath lab, endoscopy rooms and instrument processing areas • CMS says if no state law can write policy or procedure or process to implement the waiver • Waiver allows RH between 20-60% • In anesthetizing locations- see definition in memo

24. Humidity in Anesthetizing Areas

25. Impact of Lowering the Humidity • Lowering humidity can impact some equipment and supplies • Can affect shelf life and product integrity of some sterile supplies including EKG electrodes • Some electro-medical equipment may be affected by electrostatic discharge especially older equipment • Can cause erratic behavior of software and premature failure of the equipment • It can affect calibration of the equipment • Follow the manufacturers instructions for use that explains any RH requirements

26. CMS Memo on Low Relative Humidity

27. Impact of Lowering the Humidity

28. Lowering Humidity Can Have Other Effects

29. Infection Control 747 • Updated to reflect changing infectious and communicable disease threats • Including current knowledge and best practices • Very important in today’s healthcare environment • CDC estimates there are 1.7 million HAI in hospitals every year and 75,000 deaths • CMS gets $50 million dollar grant to enforce and HHS 1 billion dollars to reduce HAI • Interpretive guidelines are 12 pages long 1www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

30. Remember the Final Infection Control Worksheet

31. Safe Injection Practices Brief www.empsf.org

32. Insulin Pens CMS Memo

33. CMS Memo on Insulin Pens • Regurgitation of blood into the insulin cartridge after injection can occur creating a risk if used on more than one patient • Hospital needs to have a policy and procedure • Staff should be educated regarding the safe use of insulin pens • More than 2,000 patients were notified in 2011 because an insulin pen was used on more than one patient • CDC issues reminder on same and has free flier

34. CDC Reminder on Insulin Pens www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html

35. CDC Has Flier for Hospitals on Insulin Pens

36. Insulin Pen Posters and Brochures Available www.oneandonlycampaign.org/content/insulin-pen-safety

38. Infection Control • TJC has chapter on Infection Prevention and Control • APIC and CMS now calls infection preventionists (IPs) • Hospital must have sanitary environment to avoid sources and transmission of infection and communicable diseases (750) • Active IC program for prevention, control, and investigation of infections and communicable diseases

39. Infection Control (IC) • Standards apply to all departments of hospitals both on and off campus • Infection prevention must include monitoring of housekeeping and maintenance including construction activities • Areas to monitor include food storage preparation, serving and dish rooms, refrigerators, ice machines, air handlers, autoclave rooms, venting systems, inpatient rooms, supply storage and equipment cleaning

40. Infection Control (IC) 747 • Must follow all standards of care and practice (APIC (Association for Professionals in Infection Control and Epidemiology), CDC, SHEA (Society for Healthcare Epidemiology of America), OSHA, etc. • Need to investigate infections and communicable diseases for inpatients and from personnel working in hospitals including volunteers • Must have active surveillance program that includes specific measures for infection detection, data collection, analysis monitoring, and evaluations of preventive interventions

41. Infection Control • Must have sampling or other mechanism in place to identify and monitor infections and communicable diseases • Infection control must be integrated in QAPI • Surveillance activities should be conducted in accordance with recognized surveillance practices such as those used by CDC NHSN (National Healthcare Safety Net) • Requirement for hospitals to report certain central line or CaUTI infections to NHSN

42. IC Officer’s Responsibilities • Many have added these to their job descriptions • Maintain sanitary hospital environment (ventilation and water controls, construction - make sure safe environment, safe air handling in areas of special ventilations such as the OR and isolation rooms, techniques for food sanitation, cleaning and disinfecting surfaces, carpeting and furniture, how is pest control done, and disposal of trash along with non-regulated waste)

43. IC Officer’s Responsibilities • Develop and implement IC measures (hospital staff, contract workers, volunteers) • Mitigation of risks associated with patient infections present upon admission and risks contributing to HAI • Active surveillance • Hospital must identify and track the following categories • HAI selected by IC program targeted strategies based on national guidelines and periodic risk assessments • Patients or staff with reportable communicable diseases

44. IC Officer’s Responsibilities • Active surveillance (continued) • Culture of patient colonized with MDRO • Isolation patients • Staff or patients with signs in which local, state, or feds request • Staff or patients infected with significant pathogens • Recommend use of automated surveillance technology • Monitoring compliance with all P&Ps, protocols and other infection control program requirements

45. Blue Box Use Automated Surveillance

46. IC Officer’s Responsibilities • Program evaluation and revision of the program, when indicated • Coordination as required by law with federal, state, and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism and outbreaks • Complying with the reportable disease requirements of the local health authority • Make sure IC program is integrated into hospital wide QAPI (now stands for quality assessment and performance improvement)

47. Infection Control (IC) • Long list of IC policies that hospitals must have • Maintain a sanitary physical environment • Hospital staff related measures (evaluate hospital staff immunization status for infectious diseases as per CDC and APIC, how you screen hospital staff for infections likely to cause significant infectious disease to others, policy on when staff are restricted from working)

48. IC Policies to Include: • New employees and what they need in orientation including hand hygiene • P&P to mitigate risk when patient admitted with infection - must be consistent with the CDC isolation guidelines, staff knowledge of PPE • Mitigate risk that cause or contribute to HAI such as SCIP measures, appropriate hair removal, timely antibiotics in OR, DC in 24 hours except 48 hours for cardiac patients, beta blockers during perioperative periods for select cardiac patients, proper sterilization of equipment, etc.

49. Immediate Use Steam Sterilization IUSS

50. Medical Equipment and Supplies Resources • Multi-Society Guidelines for Reprocessing Flexible Gastrointestinal Endoscopes by APIC at www.apic.org/AM/Template.cfm?Section=Guidelines_and_Standards&template=/CM/ContentDisplay.cfm&section=Topics1&ContentID=6381 • Cleaning of scopes is hit hard • Disinfection of Healthcare Equipment Chapter in Guidelines for Disinfection and Sterilization in Healthcare Facilities Nov 2008 at www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf • Single Use Device Reprocessing athttp://cms.h2e-online.org/ee/waste-reduction/waste-minimization/