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CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2014 All Day Program What PPS Hospitals Need to Know. Speaker. Sue Dill Calloway RN, Esq. CPHRM, CCMSCP AD, BA, BSN, MSN, JD President of Patient Safety and Education Consulting

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  1. CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2014All Day ProgramWhat 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 Board Member Emergency Medicine Patient Safety Foundation www.empsf.org 614 791-1468 sdill1@columbus.rr.com 2 2

  3. You Don’t Want One of These

  4. The Conditions of Participation (CoPs) • Many revisions since manual published in 1986 • Manual updated more frequently now • Many changes June 7, 2013, July 11, 2014, and Medication in June 6, 2014 • First regulations are published in the Federal Register thenCMS publishes the Interpretive Guidelines and some have survey procedures 2 • Hospitals should check this website once a month for changes 1 http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR 2www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

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

  6. CMS Survey and Certification Website www.cms.gov/SurveyCertificationGenInfo/PMSR/list.asp#TopOfPage Click on Policy & Memos

  7. Example of a CMS Survey Memo

  8. CMS Changes July 11, 2014 • In final rule, CMS estimates cost safety to be nearly $660 million annually or $3.2 billion over five years • The name of the federal rule was “Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Part II” • The final rule is 201 pages long and effective July 11, 2014 and not in current manual • The final changes at located at the end of the document • CMS will issue interpretive guidelines • The rule explains the decision making process and addresses comments sent

  9. Changes to Hospital Sections • Governing Body (§ 482.12) • Medical Staff (§ 482.22) • Food and Dietetic Services (§ 482.28) • Nuclear Medicine Services (§ 482.53) • Outpatient Services (§ 482.54) • Special Requirements for Hospital Providers of Long-term Care Services (“swing-beds”) (§ 482.66)

  10. Summary of Changes • Medical Staff (MS) can grant hospital privileges for RD or nutrition specialist to write diet orders • Includes diet orders, TPN, or supplemental feeding • Board must consult with and individual responsible for the MS for each individual hospital regarding quality of medical care provided in the hospital and suggest at least twice a year • Such as the chief medical officer or MS president • Each hospital can have separate medical staff or shared which CMS calls a unified integrated medical staff with specific rules in a multi hospital system

  11. Summary of Changes • CMS revised the definition of physician in the rural health center (RHC)/federally qualified health center (FQHC) regulations to conform to the definition of a “physician” to be the same as the term used for M/M payments • Medical Staff can include PharmD, registered dieticians, PA, NP, dentist, podiatrist, speech pathologist, etc. • Must be consistent with state scope of practice and state law

  12. Summary of Changes • No requirement for board to include MD/DO • Allow in-house preparation of radiopharmaceuticals by trained nuclear medicine technicians in hospitals on off hours without a physician or a pharmacist being present • Removed the wording of direct supervision but still under their supervision • Changes for hospitals that are transplant centers by eliminating a redundant data submission requirement and an unnecessary survey process while maintaining strong federal oversight

  13. Summary of Changes • Allow practitioners not on MS to order outpatient services • Must have policy to specify which tests can be ordered • Must be licensed in state where care is provided • Must be acting within scope of practice under state law • Must be allowed by the MS • Confirms its prior interpretation regarding who can order outpatient orders under tag 1079 and 1080

  14. Summary of Changes • Made a change to the CLIA law regarding proficiency testing referrals • Swing beds move to Part D so accreditation organizations can survey CAH • TJC, AOA HCFA, DNV Healthcare or CIHQ • Questions contact Lauren Oviatt at 410 786-4683 at CMS

  15. How to Keep Up with Changes • First, periodically check to see you have the most current CoP manual1 • Once a month go out and check the survey and certification website 2 • Once a month check the CMS transmittal page 3 • Have one person in your facility who has this responsibility • 1 http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf • 2 http://www.cms.gov/SurveyCertificationGenInfo/PMSR/list.asp#TopOfPage • 3 http://www.cms.gov/Transmittals

  16. Location of CMS Hospital CoP Manual New website www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf

  17. Transmittals www.cms.gov/Transmittals/

  18. CMS Survey Memos Issued • Survey memo issued March 15, 2013 with changes • Privacy and confidentiality memo on March 2, 2012 • Complaint manual updated April 19, 2013 • Access to hospital deficiency data March 22, 2013 • Use of insulin pens issue May 18, 2012 • Single dose June 15, 2012, Humidity in OR 2013 • Discharge planning rewritten May 17, 2013 • Reporting to internal PI March 15, 2013 • Luer Misconnections March 8, 2013, Equipment Dec12, 2013, Medication and Safe Opioid Use March 2014

  19. Luer Misconnections Memo • CMS issues memo March 8, 2013 • This has been a patient safety issues for many years • Staff can connect two things together that do not belong together because the ends match • For example, a patient had the blood pressure cuff connected to the IV and died of an air embolism • Luer connections easily link many medical components, accessories and delivery devices

  20. Luer Misconnections

  21. PA Patient Safety Authority Article

  22. June 2010 Pa Patient Safety Authority

  23. ISMP Tubing Misconnections www.ismp.org

  24. TJC Sentinel Event Alert #36 www,jointcommission.org http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misconnections—a_persistent_and_potentially_deadly_occurrence/ http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misconnections—a_persistent_and_potentially_deadly_occurrence/ http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misconnections—a_persistent_and_potentially_deadly_occurrence/ http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misconnections—a_persistent_and_potentially_deadly_occurrence/ http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misconnections—a_persistent_and_potentially_deadly_occurrence/

  25. New Standards Prevent Tubing Misconnections • New and unique international standards being developed in 2014 for connectors for gas and liquid delivery systems • To make it impossible to connect unrelated systems • Includes new connectors for enteral, respiratory, limb cuff inflation neuraxial, and intravascular systems • Phase in period for product development, market release and implementation guided by the FDA and national organizations and state legislatures • FAQ on small bore connector initiative

  26. www.premierinc.com/tubingmisconnections/

  27. CMS Hospital Worksheets Third Revision • October 14, 2011 CMS issues a 137 page memo in the survey and certification section • Memo discusses surveyor worksheets for hospitals by CMS during a hospital survey • Addresses discharge planning, infection control, and QAPI • It was pilot tested in hospitals in 11 states and on May 18, 2012 CMS published a second revised edition • Piloted test each of the 3 in every state over summer 2012 • November 9, 2012 CMS issued the third revised worksheet which is now 88 pages

  28. CMS Hospital Worksheets • Third pilot is non-punitive and will not require action plans unless immediate jeopardy is found • This is the third and most likely final pilot • In spring 2015 will make some revisions to PI and Infection Control and CMS will use whenever a validation survey or certification survey is done at a hospital by CMS • Revisions made in 2014 to Discharge Planning worksheet • Hospitals should be familiar with the three worksheets

  29. Current QAPI and Infection Control WS www.cms.gov/SurveyCertificationGenInfo/PMSR/list.asp#TopOfPage

  30. CMS Hospital Worksheets • The regulations are the basis for any deficiencies that may be cited and not the worksheet per se • The worksheets are designed to assist the surveyors and the hospital staff to identify when they are in compliance • Will not affect critical access hospitals (CAHs) but CAH would want to look over the one on PI and especially infection control • Questions or concerns should be addressed to PFP.SCG@cms.hhs.gov

  31. Access to Hospital Complaint Data • CMS issued Survey and Certification memo on March 22, 2013 regarding access to hospital complaint data • Includes acute care and CAH hospitals • Does not include the plan of correction but can request • Questions to bettercare@cms.hhs.com • This is the CMS 2567 deficiency data and lists the tag numbers • Updating quarterly • Available under downloads on the hospital website at www.cms.gov

  32. Access to Hospital Complaint Data

  33. Updated Deficiency Data Reports www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Hospitals.html

  34. Can Count the Deficiencies by Tag Number

  35. Lists by State and Names Hospitals

  36. Complaint Manual Update • CMS issues memo on April 19, 2013 • CMS updates the Complaint Manual • Hospital found to be in immediate jeopardy could have a full validation survey if the RO requests it • Regional office has discretion • Hospital can be placed on 23 or 90 days termination track depending on if IJ removed • GAO emphasized need to share complaint information and SA survey finding with the applicable accreditation agency and CMS agrees • TJC, DNV,AOA, or CIHQ

  37. Complaint Manual Update

  38. TJC Revised Requirements • TJC has published many changes over the past two years • Many of the changes reflected in their standards is to be in compliance with the CMS CoP • Standards are for hospitals that use them to get deemed status to allow payment for M/M patients • This means hospitals do not have to have a survey by CMS every 3 years • Can still get a complaint or validation survey • So now TJC standards crosswalk closer to the CMS CoPs • Not called JCAHO any more

  39. Mandatory Compliance • Hospitals that participate in Medicare or Medicaid must meet the COPs for all patients in the facilities and not just those patients who are Medicare or Medicaid • Hospitals accredited by TJC, AOA, CIHQ, or DNV Healthcare have what is called deemed status • These are the only 4 that CMS has given deemed status to for hospitals and possible 5th one called AAHHS • This means you can get reimbursed without going through a state agency survey • States can still institute a survey and be more restrictive

  40. CMS Hospital CoPs • All Interpretative guidelines are in the state operations manual and are found at this website1 • Appendix A, Tag A-0001 to A-1164 and471 pages long • You can look up any tag number under this manual • Manuals • Manuals are now being updated more frequently • Still need to check survey and certification website once a month and transmittals to keep up on new changes 2 1http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf 2 http://www.cms.gov/Transmittals/01_overview.asp

  41. Location of CMS Hospital CoP Manual All the manuals are at www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf

  42. Conditions of Participation (CoPs) • Important interpretive guidelines for hospitals and to keep handy • A- Hospitals and C-Critical Access Hospitals • C-Labs • V-EMTALA (Rewritten May 29, 2009 and amended July 2010 and proposed changes 2014) • Q-Determining Immediate Jeopardy • I-Life Safety Code Violations • All CMS forms are on their website

  43. Contact for Questions • Resource is your state department of health or regional CMS office • The American Hospital Association or state hospital association may be of assistance • Note that when changes are published in the Federal Register or CMS Survey Memo there is always the name and phone number of a contact person at CMS to contact for questions

  44. Compliance Recommendation • Assign each section of the hospital CoPs to the manager of that department • Do a side by side gap analysis like the TJC PPR for each section • Have standard on left side and go line by line and document compliance on the right side • Keep a hard copy of CoP and analysis • Designate someone in charge if a validation, complaint, or unannounced survey occurs • Commonly referred to as the CoP king or queen

  45. CMS Required Education • These will be discussed throughout presentation: • Restraint and seclusion (annual) • Abuse, neglect and harassment (annual) • Infection control, Advance directive • Medication errors, drug incompatibility and ADR • Organ donation, Standing orders & protocols • IVs and blood and blood products P&P, Medication timing, safe opioid use • ED common emergencies, IVs and blood and blood products for ED

  46. What’s Really Important • Life Safety Code Compliance • Infection Control and CMS received $50 million grant to enforce and HHS gets 1 billion • Patient Rights especially R&S and grievances • EMTALA • Performance Improvement (CMS calls it QAPI) • Medication Management • Dietary and cleanliness of dietary • Infection control issues in dietary is big!

  47. What’s Really Important • Verbal orders, Policies and procedures • History and physicals • Need order for respiratory and rehab (such as physical therapy) • Need order for diet, medications, and radiology • Anesthesia (updated four times) • Standing orders and protocols • Medications, safe opioid use and blood transfusions • Note the CMS quarterly Deficiency Memos

  48. Survey Protocol • First 37 pages list the survey protocol, including sections on: • Off-survey preparation • Entrance activities • Information gathering/investigation • Exit conference • Post survey activities

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