CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2011 What PPS Hospitals Need to Know

1. CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2011What PPS Hospitals Need to Know

2. Speaker Sue Dill Calloway RN, Esq. CPHRM AD, BA, BSN, MSN, JD President Patient Safety and Healthcare Education 5447 Fawnbrook Lane Dublin, Ohio 43017 614791-1468 sdill1@columbus.rr.com

4. The Conditions of Participation • Regulations first published in 1966 • Many revisions since with final interpretive guidelines June 5, 2009 (Tag 450 Medical Record) and anesthesia (December 11, 2009, February 5, 2010, May 21, 2010 and February 14, 2011) and Respiratory and Rehab Orders August 16, 2010 and Visitation 2011 • First regulations are published in the Federal Register first-42 CFR Part 4821 • CMS then publishes Interpretive Guidelines2 • Hospitals should check this website once a month for changes 1www.gpoaccess.gov/fr/index.html 2www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

6. Respiratory and Rehab Orders • Published in the August 16, 2010 Federal Register • Allows a qualified licensed practitioner who is responsible for the care of the patient (such as a PA or NP) • Who is acting within their scope of practice under state law • Can order respiratory or rehab order (physical therapy, occupational therapy, speech) • Must be privileged (authorized) by the MS • Must have hospital P&P to allow also

7. Visitation • Effective January 19, 2011 • Must rewrite policy on visitation including visiting hours in ICU • Must inform each patient of their visitation rights • Must include any restrictions on those rights • Can not restrict or deny visitation privileges on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity or disability • For example same sex partner may present visitation advance directive

8. Federal Register Visitation Changes

9. CMS Proposed New Rule • CMS proposed new rule for notifying beneficiaries of their right to file a quality of care complaint • Give beneficiaries written notice of their right to contact their state QIO or Quality Improvement Organization • Also include • Currently, only hospital inpatients receive this information • Includes 10 facilities such as clinics, CAH, LTC, hospices, home health agencies, ASCs, comprehensive outpatient rehab facilities, portable X-ray services and rural health clinics

10. Medicare Patients, Complaints and the QIO • The proposed rule was published in the Federal Register on February 2, 2011 • at http://www.gpo.gov/fdsys/pkg/FR-2011-02-02/pdf/2011-2275.pdf • QIOs must conduct a review of all written complaints about the quality of care for Medicare patients only • Current hospital CoP includes a requirement that the grievance process must include a mechanism for timely referral to the QIO of beneficiary concerns regarding quality of care • Must also give Medicare patients a copy of their IM Notice

11. Medicare Patients, Complaints and the QIO • Since 9th scope of work started August 1, 2008, QIOs have received 6,379 inpatient and 4,1116 outpatient requests • Feel number is inadequate because Medicare patients do not know they can complain to their QIO • Expanding now that Medicare patients, or their representative, will receive written notice at the start of their care,of their right that they can complain about quality of care issues to the QIO in other settings • Such as time of admission or in advance of furnishing care

12. Medicare Patients, Complaints and the QIO • Medicare patient who is competent can also decide to have the written notice given to their surrogate such as a friend or family member • Remember if need to use an interpreter for limited English proficiency (LEP) or deaf/hard of hearing patients • Unless patient signs a waiver declining interpreter • Remember the 2011 TJC patient centered communication standards • Also 7 of the 10 providers must include information to contact the state agency • Hospitals, HH, RHC, CORF, FQHCs, Hospices, clinics

13. Specific Requirements • For example an ASC, hospice, hospitals, home health, hospice etc. would have to do the following; • Give the patient a written notice of their right to notify the QIO • Must include at the time of admission or in advance of furnishing care • Must include name, telephone number, email address, and mailing address • Must document in the medical record that the notice was given

14. Proposed FR February 2, 2011

15. 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)

16. http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdfhttp://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf

17. 4th Anesthesia Changes February 14, 2011

18. Respiratory and Rehab Changes

19. 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, or DNV Healthcare have what is called deemed status • These are the only 3 that CMS has given deemed status to for hospitals • This means you can get reimbursed without going through a state agency survey • States can still institute a survey and be more restrictive

20. 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-1163 and370 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

21. http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdfhttp://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf

24. 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) • Q-Determining Immediate Jeopardy • I-Life Safety Code Violations • All CMS forms are on their website

25. 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 there is always the name and phone number of a contact person at CMS

26. Survey Procedure • Step one is publication in Federal Register • Step two is where CMS publishes the interpretive guidelines • The interpretive guidelines provide instructions to the surveyors on how to survey the CoPs • These are called survey procedure • Not all the standards have survey procedures • Questions such as “Ask patients to tell you if the hospital told them about their rights”

27. Interpretive Guidelines • Surveyors use the information contained in the interpretive guidelines • They do not replace or supersede the law • Should not be used as basis for citation • They do contain authoritative interpretations and clarifications which can assist surveyors in making determinations of compliance

28. 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

29. CMS Required Education • These will be discussed throughout presentation: • Restraint and seclusion (annual) • Abuse, neglect and harassment (annual) • Infection control • Advance directive • Organ donation • IVs and blood and blood products • ED common emergencies, IVs and blood and blood products for ED

30. What’s Really Important • Life Safety Code Compliance • Infection Control and CMS gets $50 million grant to enforce in 2011 • Patient Rights especially R&S and grievances • EMTALA • Performance Improvement (CMS calls it QAPI) • Medication Management • Dietary and cleanliness of dietary

31. What’s Really Important • Verbal orders • 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 within 30 minute time frame • Outpatient under one person (Tag 1078)

32. 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

33. Survey Protocol • Survey done through observation, interviews, and document review • Usually surveys are done Monday - Friday but can come on weekends or evenings • Federal law allows CMS or department of health surveyors access to your facility • CAH rehab or psych (behavioral health) is surveyed under this section even though CAH has separate manual

34. Survey Team • Mid-sized hospital with a full survey • Two to four surveyors for three or more days and at least one RN with hospital survey experience • Team based on complexity of services offered • SA (state agency) decides or RO (regional office) for federal teams • Have an organized plan for an unannounced survey with designated persons to accompany surveyors • Include education of security or those who attend to the front desk where surveyors could enter in the morning

35. Task 1 – Off Site Survey Prep • Team coordinator gathers information about provider (ownership, types of services offered, locations) • Determines if provider based, remote locations, PPS-exempt services offered • Information collected from CMS database such as previous surveys and findings, size of facility, and average daily census • Team should enter together and usually goes to administration

36. Task 2 – Entrance Activities • Team will explains purpose and scope of survey • ENTRANCE CONFERENCE – sets the tone for entire survey • Give surveyors conference room, telephone • Give names of department heads, their location and phone numbers • CMS has a list of documents they may ask for so be ready and know what is on this list • Provide organizational chart

37. Task 2 – Entrance Activities • Provide additional information • Infection control plan • Names and addresses of all off-site locations and provider numbers • List of employees • Medical staff bylaws, rules and regulations • List of contracted services • Copy of floor plan • List of current patients with room numbers, doctors • Give preliminary date and time for exit conference

38. Task 3 – Information Gathering • Purpose is to determine compliance with CoPs thru observation, interviews, and document review • Will visit patient care areas including ED and outpatient, Imaging, rehab, and remote locations • Observe actual care (IV, tube feeding, wound dressing changes) • May observe a nurse pass medications • Review copies of materials • Use interpretive guidelines to guide survey

39. Task 3 – Information Gathering • Use Appendix Q if Immediate Jeopardy is suspected • Surveyor has discretion whether to allow staff to accompany the surveyor • All significant adverse events should be brought to the team coordinator’s attention immediately • Surveyors must respect patient privacy and confidentiality • Work with surveyor so they do not take peer-review protected documents with them

40. Task 4 Analysis of Finding • If surveyor makes copies of documents ask to make one for the hospital • No federal review law but if in PSO surveyor can not see • Review and analyze all information gathered • Determine if CoPs are met and if PPS exclusionary criteria (42 CFR Part 412, subpart B) or swing bed (42 CFR 482.66) • Prepare exit conference report • If noncompliance with CoP then determine if at standard or condition level and how dangerous it is

41. Deficiency • Condition level- (NOT GOOD) due to noncompliance with requirement in a single standard or several standards within the condition or single tag but represents a severe or critical health breach, (need to have conversation) • Standard level- noncompliance as above but not of such a character to limit facility’s capacity to furnish adequate care - no jeopardy or adverse effect to health or safety of patient • Try and work with the surveyor to resolve the issue before CMS leaves the building

42. Task 5 Exit Conference • Objective - inform facility of preliminary findings • Policy is to do exit conference • Can refuse if hostile environment or • Counsel tries to turn into evidentiary hearing • If recorded, must provide two tapes and tape recorders • Tape at same time and give surveyor one • Official findings are provided in writing on Form CMS 2567 (all forms on CMS website now)

43. Task 5 Exit Conference • Surveyor can set ground rules • Present findings of noncompliance • Statement of deficiencies will be mailed and have 10 working days to fix (Form 2567) • This form is made public no later than 90 days after survey • So try and fix before the surveyor leaves • List deficiencies, plans for correction, timelines and opportunity to refute findings

44. Task 6 Post-Survey Activities • Objective is to complete the survey and certification requirements and notify staff regarding survey results • Complete hospital restraint/seclusion death reporting worksheet as appropriate • Enter information into hospital Medicare database • Certification of providers with deficiencies if acceptable plan of correction

45. Interpretive Guidelines • Starts with a tag number, example A-0001 • “A” refers to the hospital CoPs • Goes from 0001 to 1163 • The three sections from Federal Register (CFR) include the regulation, interpretive guidelines and survey procedure • Survey procedure • Not in every section • Explains survey process, policies that will be reviewed, questions that will be asked and documents reviewed

47. Compliance with Laws A-0020 • The hospital must be in compliance with all federal, state, and local laws • Survey procedure tells surveyor to interview CEO or other designated by hospital • Refer non-compliance to proper agency with jurisdiction such as OSHA (TB, blood borne pathogen, universal precautions, EPA (haz mat or waste issues), or Rehabilitation Act of 1973 • Will ask if cited for any violation since last visit

48. Compliance with Laws 0023, 0022 • Hospital must be licensed or approved for meeting standards for licensure, as applicable • Personnel must be licensedor certified if required by state (doctors, nurses, PT, PA, etc.) • If telemedicine used must be licensed in state patient located and where practitioner is located • See proposed changes on telemedicine • Verify that staff and personnel meet all standards (such as CE’s) required by state law • Review sample of personnel files to be sure credentials and licensure is up to date

49. Governing Body (Board) A-0043 • Hospital must have an effective governing body responsible for the conduct of the hospital as an institution • Written documentation identifies an individual as being responsible for conduct of hospital operations • Board makes sure MS requirements are met • Board must determine which categories of practitioners are eligible for appointment to medical staff (MS), as allowed by your state law (CRNA, NP, PA’s, nurse midwives, chiropractors, podiatrists, dentists, etc.)

50. Medical Staff and Board • Board appoints individuals to the MS with the advice and recommendation of the MS (0046) • Will review board minutes to make sure they are involved in appointment of MS • Board must assure MS has bylaws and they comply with the CoPs (0047) • Board must make sure they have approved the MS bylaws and rules and regulations (0048) and any changes • TJC MS.01.01.01 as to what goes into a bylaw or R/R