CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2014 PI Standards and PI Worksheet 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 at www.empsf.org 614 791-1468 sdill1@columbus.rr.com 2 You Don’t Want One of These 3 The Conditions of Participation (CoPs) Regulations first published in 1986 Manual updated January 31, 2014 and 456 pages Tag number 0001 through 1164 and PI starts at tag 263 First regulations are published in the Federal Register then CMS publishes the Interpretive Guidelines and some have Survey Procedures 2 Hospitals should check this website once a month for changes 1www.gpoaccess.gov/fr/index.html 2www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp 4 az Location of CMS Hospital CoP Manuals CMS Hospital CoP Manuals new address www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf 5 CMS Hospital CoP Manual June 7, 2013 6 CMS Hospital CoP Manual 7 CMS Survey and Certification Website www.cms.gov/SurveyCertific ationGenInfo/PMSR/list.asp# TopOfPage 8 9 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 Will update quarterly Available under downloads on the hospital website at www.cms.gov 10 Number of Deficiencies for PI CMS issued its first deficiency report in March of 2013 CMS plans to update quarterly Issued reports in June and November of 2013 Issues report in January of 2014 Reports lists the name and address of all hospitals receiving deficiencies 11 Access to Hospital Complaint Data 12 Deficiency Data January 2014 Tag Number Section Number 263 QAPI 77 270 Provision of Services 13 271 & 272 Patient Care Policies 22 273 Data Collection and Analysis 142 274 Policy Emergency Services 4 13 Deficiency Data January 2014 Tag Number Section Number 276 Policies Drug Management 6 277 Policies Med Errors & ADR 2 278 Policies Infection Control 11 279 Policies Nutrition 3 280 Patient Care Policies 6 14 Deficiency Data January 2014 Tag Number Section Number 280 Patient Care Policies 6 281-282 Patient Services 9 283 QI Activities 145 284 Patient Services 1 286 Patient Safety 191 15 Hospital CoPs for QAPI CMS issued new hospital COPs memo for QA and Performance Improvement (QAPI) CMS issues Memo March 15, 2013 on AHRQ Common Formats Hospitals are required to track adverse events for PI Starts with tag number 0263 Short section because the hospital compare program is not part of the CMS CoP Hospital compare is the indicators that must be sent to CMS to receive full reimbursement rates 16 Report Adverse Events to PI 17 Adverse Event Reporting Hospitals are required to track AE (adverse events) Several reports show that nurses and others were not reporting adverse events and not getting into the PI system OIG recommends using the AHRQ common formats to help with the tracking States could help hospitals improve the reporting process Encouraged all surveyors to develop an understanding of this tool 18 Adverse Event Reporting IOM report discussed the need for comprehensive patient safety reporting to address the alarming high incidence of AE occurring in hospitals (Pg. 2) OIG report November, 2010 “AE in Hospitals: National Incidence Among Medicare Beneficiaries” encouraged internal reporting of all AE, whether preventable or not OIG issues report in January 2012 “Hospital Incident Reporting Systems Do Not Capture Most Patient Harm” 86% of AE are never reported to the PI program 44% are considered preventable 19 http://oig.hhs.gov/oei/reports/oei-0609-00091.asp 20 http://oig.hhs.gov/oei/reports/oei-0609-00090.pdf 21 Adverse Event Reporting CMS PI section requires hospital to track AEs and analyze the causes and implement actions to prevent in the future Need to include near misses The internal hospital reporting system represents a foundational capability to determine if the hospital can maintain compliance with the CoPs The AHRQ Common Formats are evidenced based Common Formats allow for identification and reporting of any AE even if rare and includes NQF 29 never events such as falls and medication errors 22 Events That Should be Reported 23 9 Modules in the Common Formats 1. Blood or Blood Product 2. Device or Medical/Surgical Supply, including Health Information Technology (HIT) 3. Fall 4. Healthcare-associated Infection 5. Medication or Other Substance 6. Perinatal 7. Pressure Ulcer 8. Surgery or Anesthesia 9. Venous Thromboembolism 10. Other (allows collection of information on all other types of events) 24 https://psoppc.org/web/patientsafety 25 Hospital Common Formats 26 The Conditions of Participation (CoPs) The manual is known as the conditions of participation or the CoPs for short The CoP sections are called tag numbers When IG are final they are printed in a transmittal All the sections contain a tag number so it is easy to go back and look up that section if you want to read more about it There are currently 456 pages in the current manual There were many changes in the manual effective June 7, 2013 but none to the PI section 27 Transmittals www.cms.gov/Transmittals/01_overview.asp 28 Feb 4, 2013 Proposed Changes CMS issues 114 pages related to proposed changes to the CMS CoP but none in PI section Hospital privileges for RD to write diet orders Board must consult with chief medical officer for each individual hospital regarding quality of medical care provided in the hospital Confirmed each hospital must have separate medical staff MS can include PharmD, dieticians, PA, NP, etc. No requirement for board to include MD/DO 29 Feb 4, 2013 Proposed Changes Allow practitioners not on MS to order outpatient services Allow in-house preparation of radiopharmaceuticals on off hours without a physician or a pharmacist being present 3 changes for hospitals that are transplant centers ASC change for radiology services incident to the surgery Swing beds move to Part D so accreditation organizations can survey CAH P&P committee deleted requirement for non staff member requirement 30 Feb 4, 2013 Proposed Changes www.ofr.gov/inspection.aspx 31 CMS Worksheets Infection Control, Discharge Planning and PI 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 (performance improvement) 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 33 CMS Hospital Worksheets This is the third and final pilot and in 2014 will be slightly revised Will use whenever a validation survey or certification survey is done at a hospital by CMS Third pilot is non-punitive and will not require action plans unless immediate jeopardy is found Hospitals should be familiar with the three worksheets Already assigned the number of hospitals to do in 2014 Has money in the budget for states that want to do more 34 Third Revised Worksheets www.cms.gov/SurveyCertificationGe nInfo/PMSR/list.asp#TopOfPage 35 36 CMS Hospital Worksheets Goal is to reduce hospital acquired conditions (HACs) including healthcare associated infections Goal to prevent unnecessary readmission and currently 1 out of every 5 Medicare patients is readmitted within 30 days Many hospitals (66%) financially penalized after October 1, 2013 because they had a higher than average rate of readmissions Forfeited 280 million dollars in 2013 and 216 million in2014 The underlying CoPs on which the worksheet is based did not change 37 CMS Hospital Worksheets However, some of the questions asked might not be apparent from a reading of the CoPs A worksheet is a good communication device It will help clearly communicate to hospitals what is going to be asked in these 3 important areas Hospitals might want to consider putting together a team to review the 3 worksheets and complete the form in advance as a self assessment Hospitals should consider attaching the documentation and P&P to the worksheet 38 CMS Hospital Worksheets This would impress the surveyor when they came to the hospital The worksheet is used in new hospitals undergoing an initial review and hospitals that are not accredited by TJC, DNV, CIHQ, or AOA who have a CMS survey every three or so years The Joint Commission (TJC), American Osteopathic Association (AOA) Healthcare Facility Accreditation Program, CIHQ, (Center for Improvement in Healthcare Quality) or DNV Healthcare It would also be used for hospitals undergoing a validation survey by CMS 39 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 Mary Ellen Palowitch at PFP.SCG@cms.hhs.gov 40 CMS Hospital Worksheets First part of the pilot program draft version included identification information Name of the state survey agency which in most states is the department of health under contract by CMS In Kentucky it is the OIG or Office of Inspector General It will ask for the name and address of the hospital, CCN number, number of surveyors, time spent on completing the tool, date of survey etc. 41 CMS Hospital Worksheets Questions or concerns should be addressed to PFP.SCG@cms.hhs.gov First part of the pilot program draft version included identification information Name of the state survey agency which in most states is the department of health under contract by CMS In Kentucky it is the OIG or Office of Inspector General It will ask for the name and address of the hospital, CCN number, number of surveyors, time spent on completing the tool, date of survey etc. 42 CMS Worksheet QAPI 44 CMS Hospital Worksheets CMS uses the term “tracers” for the first time The first worksheet is on QAPI which stands for Quality Assessment Performance Improvement CMS previously called it Quality Assurance Performance Improvement and changed June 7, 2013 The worksheet is a document that the surveyor will sit down with the hospital and fill out The first column includes the elements to be assessed and there are boxes to fill in 45 Quality Indicator Tracers 46 PI Tracer Data Collection & Analysis This section is 21 pages long First select three quality indicators related to PI activities or projects An example might be the timing of medications and PI data to show medication was given on time and number of medication errors or missed or omitted doses Number of catheter associated UTIs Write the quality indicator at the top and answer the following questions for each one 47 PI Tracer Data Collection & Analysis Hospitals collect all kind of data TJC requires data to be collected in a number of areas Data on medication management (ADR, medication errors), FMEA, patient flow, staff compliance with employee health screening requirements, patient satisfaction, pediatric asthma, ED measures, infection control surveillance data Data on R&S use, patient perception of care, organ donation, blood transfusion reactions, ORYX data, medical record deficiency data, staffing, data on how patient communication needs are met, race and ethnicity etc. 48 PI Tracer Data Collection & Analysis CMS has hospital compare with data on number of MI patients who get thrombolytics timely or pneumonia patients who get their antibiotics timely Measure patient experience or patient satisfaction data Measure some or all of the AHRQ patient safety indicators National Quality Forum includes lists of quality indicators that are evidence based that hospital may measure 49 PI Tracer Data Collection & Analysis Can you show evidence that each quality indicator is related to improved health outcomes? Based on QIO, national guidelines, evidence based studies etc. Is the scope of data collection appropriate to the indicator Hand hygiene would require data from multiple parts of the hospital ED or L&D might be specific to date from that area such as the average LOS in the ED or the number of elective C-sections performed with premature infants 50 PI Tracer Data Collection & Analysis Is the method and frequency of data collection specified? Such as chart reviews or monthly observations Is the data collected in the manner specified and it is done as often as specified such as will do 30 charts per month for ED documentation criteria If unit staff play a role in data collection then is the data collection consistent with the specifications Example OR staff complete a data collection tool with number of cases time out is taken and documented, H&P and consent on chart before surgery, etc. 51 PI Tracer Data Collection & Analysis Are data collected aggregated in accordance with hospital methodology specified for this indicators Is the data analyzed? If indicator is type that measures rate are the rates calculated for points in time and compared to benchmark data set out by national organizations when available? Pneumonia patients should get their first dose of antibiotics within 6 hours or MI patients thrombolytics in 30 minutes 52 PI Tracer Data Collection & Analysis Is data broken down into subsets that allow for comparison among hospital units Such as hand hygiene or the fall rate If data identified area that needs improvement then is there evidence the issue was addressed Such as an infant abduction risk, high fall rate, high medication error rate Are the interventions evaluated for success? If not, what did the hospital do? 53 PI Tracer Data Collection & Analysis Does PI focus on high risk, high volume, or problem prone areas? Orthropedic hospital does lots of Orthropedic projects or hospital that does CABG do PI on these Can hospital prove it conducts distinct PI projects? Should of course be reflected in the PI minutes Every department should participate in PI process Is number of projects proportional to the scope and complexity of the hospital’s service and operations Larger hospital expected to do more projects 54 PI Tracer Data Collection & Analysis Can hospital show evidence of why each project was selected? CMS then has a section on patient safety that discusses adverse events (AE) and medical error This part is to evaluate the hospital’s leadership expectation for patient safety Is there staff training or communications related to expectation for patient safety to all staff? Is there a P&P on non-punitive approach to staff reporting medical errors which includes near misses? 55 PI Patient Safety AE and Medical Errors Can staff on each unit explain hospital’s expectation for their role in promoting patient safety? Is there a systematic process to identify medical errors which include near misses and AEs On every unit, can the staff describe what is a medical error? Can they explain how to report? Does hospital employ other methods to find medical errors such as trigger tools, chart reviews, review of claims, patient grievances, interview patients etc. 56 Patient Safety LD, AE and Medical Error 57 PI Patient Safety AE and Medical Errors Can hospital provide evidence of medical errors and AEs identified through staff reports? Is there a PI program with the infection preventionist (IP) to track avoidable HAI? IC section requires this and starts at tag 747 Are problems identified by the IP addressed through PI? Does the PI program track medication errors and ADE and drug incompatibilities Tag 508 revised May 20, 2011 to require this 58 PI Patient Safety AE and Medical Errors Is there a process to report blood transfusion reaction and determine if due to medical error? Did the survey team have prior knowledge of any serious AE that the hospital failed to identify? Were any identified by the surveyors? Has a RCA been done on all serious preventable AEs? 59 PI Causal Analysis Tracers Part 5 The next question discuss the causal analysis tracers Causal analysis searches for the cause and effect or causes of the particular event or adverse outcome More commonly referred to as a RCA or root cause analysis The surveyor will select three causal analysis done for single event or near miss Were underlying causes identified? 60 Causal Analysis Tracers 61 PI Causal Analysis Tracers Was preventive actions developed based on the RCA? TJC has a matrix which contains elements that must be included in a reviewable sentinel event Has the hospital evaluated the impact of the preventable actions including tracking a reoccurrences or near misses? Has the hospital implemented the preventable actions found to be effective unless there is a documented reason for not doing so? 62 TJC Framework for Conducting RCA www.jointcommission.org/sentinel_eve nt.aspx 63 TJC Sentinel Event Policy with Matrix www.jointcommission.org/Sentine l_Event_Policy_and_Procedures/ 64 65 Broad PI Requirements & Leadership Part 6 addresses broad PI requirements and leadership responsibilities Does the hospital have a formal PI program? Most hospitals have a PI plan that discusses the PI program Is there a written P&P on the PI program? Is there budgeted resources so staff can attend education programs and data can be collected? Is there responsible staff to do PI Is the PI program approved by MS, CEO, and the board? 66 Broad PI Requirements and Leadership 67 Broad PI Requirements and Leadership Is there evidence of PI review for contracted services? Is there evidence that the board, CEO, MS leadership and senior leaders have a role in PI planning and implementation? Is there evidence of PI review in the board minutes? Does the board approve the PI program quality indicators and how often the data is collected? Determine how many projects for next year? Does board hold CEO accountable for effectiveness of PI program? CMS Board section starts at tag 38 68 CMS HOSPITAL CONDITIONS OF PARTICIPATION (COPS) 2014 What PPS Hospitals Need to Know About the QAPI Section CMS CoP PI Section Starts at Tag 263 70 Hospital CoPs for PI 263 QAPI stands for quality assessment performance improvement Use to stand for Quality Assurance and Performance Improvement but changed June 7, 2013 Referred to in short as PI Must have PI program that is ongoing, hospitalwide, data driven, and effective The board must make sure the program reflects the complexity of the hospital’s services 71 Hospital CoPs for PI Includes all departments even if contracted services Must focus on indicators related to improve health outcomes How do you improve outcomes in the patient with hyponatremia? How to improve outcomes in the diabetic patient admitted with hyperosmolar syndrome? Must focus on the prevention and reduction of medical errors What do you to prevent medical errors such as medication errors which is the most common type? 72 Program Scope 264 Standard: The hospital must ensure that the program scope requirements are met So what is the scope of activities of your PI program? Is the scope your PI program to include an overall assessment of the efficacy of the PI activities with a focus on continually improving the care provided at your hospital? Does it look at indicators for both process and outcome? Are the indicators objective, measurable, and based on current knowledge and experience? 73 What is the Scope of Your PI Program? Threats to patient safety –Eg. falls, patient identification, injuries Medication therapy/medication use –Includes medication reconciliation –Includes the use of dangerous abbreviations Infection control system, including healthcare associated infections (HAI) Utilization Management System Patient experience or satisfaction 74 What is the Scope of Your PI Program? Discrepant pathology reports Unanticipated deaths, adverse and/or sentinel events Adverse event/near miss Physical Environment Management Systems Operative and invasive procedures – Including wrong site/wrong patient/wrong procedure surgery Anesthesia/moderate sedation Blood and blood components Restraint use/seclusion 75 What is the Scope of Your PI Program? Effectiveness of pain management system Patient flow issues, to include reporting of patients held in the Emergency Department in excess of four hours Other adverse events Critical and/or pertinent processes, both clinical and supportive Medical record delinquency Other aspects of performance that assess process of care, hospital service and operation 76 What’s in Your PI Plan? 77 78 79 Scope of Activities of the PI Plan 80 81 Scope of PI Plan and Program 82 Board is Responsible for Quality of Care 83 Role of MEC in PI Plan and Program 84 Hospital Uses PDCA and FOCUS 85 Focus on High Risk and High Volume 86 Collect Data and Monitor 87 Identify Change and Implement 88 Ongoing Program 265 Standard: The PI program must include an ongoing program The program must show measurable improvements in indicators for which there is evidence that it will improve health outcomes Hospitals has improved patient flow and admitted patients now get to their bed in four hours or less Patients get their antibiotics timely in the OR now Patients with pneumonia now get their antibiotics within the six hour window 89 Identify and Reduce Medical Errors 266 Standard: The PI program needs to identify and reduce medical errors First, the hospital need to identify that there is a medical error – It needs to be reported into the PI system – Risk management and hospital staff cannot fix a problem they do not know exists Second, the hospital evaluates it to determine what processes can be put in place to prevent it from occurring RCA and FMEA are two tools that can be used 90 Identify and Reduce Medical Errors 266 Medical errors may be difficult to detect in hospitals and are under reported Make sure incident reports filled out for errors and near misses Are there any diagnostic errors, equipment failures, blood transfusion injuries, or medication errors Trigger tools by IHI can assist in finding medical errors and opportunities for improvement Classen DC, Resar R, Griffin F, et al. Global Trigger Tool shows that adverse events in hospitals may be ten times greater than previously measured. Health Affairs. 2011 Apr;30(4):581-589. 91 IHI Global Trigger Tool wwww.ihi.org 92 Trigger Tool for Adverse Drug Events 93 Resources Griffin FA, Classen DC. Detection of adverse events in surgical patients using the Trigger Tool approach. Quality and Safety in Health Care. 2008 Aug;17(4):253258. Classen DC, Lloyd RC, Provost L, Griffin FA, Resar R. Development and evaluation of the Institute for Healthcare Improvement Global Trigger Tool. Journal of Patient Safety. 2008 Sep;4(3):169-177. Resar RK, Rozich JD, Simmonds T, Haraden CR. A trigger tool to identify adverse events in the intensive care unit. Joint Commission Journal on Quality and Patient Safety. Oct 2006;32(10):585-590. 94 Track Quality Indicators 267 Standard: the hospital must measure, analyze, and track quality indicators, including adverse events This includes adverse patient events This includes other aspects of performance that assess processes of care, hospital service, and operation Want to focus on aspects and processes that related to the health and safety of patient care services Look at what could result in a sentinel event if not properly managed TJC has a sentinel event policy and lists reviewable SE 95 TJC Revised Sentinel Event Policy www.jointcommission.o rg/Sentinel_Event_Polic y_and_Procedures/ 96 Reviewable Sentinel Events 97 98 QAPI Standards Standard: Program Data (Tag 273) Hospital must ensure that the program data requirements are met Standard: The PI program must incorporate quality indicator data including patient care data (Tag 274) For example, information submitted or received from the QIO QIO stands for Quality Improvement Organization and every state has one under contract by CMS 99 CMS QIO Website www.cms.gov/Medica re/Quality-InitiativesPatient-AssessmentInstruments/QualityI mprovementOrgs/ind ex.html?redirect=/qua lityimprovementorgs 100 List of QIOs http://www.qualitynet.org/dcs/ContentS erver?c=Page&pagename=QnetPublic %2FPage%2FQnetTier2&cid=1144767 874793 101 Outpatient Data Collection 102 CMS Hospital CoPs QAPI Hospital uses data to monitor the effectiveness and safety of services and quality of care (275) Hospital identify opportunities for improvement (276) Board determines frequency and detail of data collection (277) Hospital ensures that the program activities are met (283) Hospital sets priorities and focuses on high risk, high volume, or problem prone (285) Considers incidence and severity of problems 103 QAPI Must not only track medical errors and adverse events but also analyze their causes (287, 288) RCA is one tool to analyze causes Includes preventive actions and learning throughout Hospital must take action based on data (289) and measure its success (290) Example; process hospitals took to get MI patient timely thrombolytics and timely antibiotics and blood culture for pneumonia patients TJC has accountability measures and CMS has value based purchasing (VBP) 104 CMS VBP Website www.cms.gov/Medicare/ Quality-InitiativesPatient-AssessmentInstruments/hospitalvalue-basedpurchasing/index.html?re direct=/hospital-value- / based-purchasing 105 VBP Fact Sheet 106 VBP Clinical Process of Care Measures 107 108 CMS Hospital Compare www.cms.gov/Medicare/Quality-Initiatives-PatientAssessmentInstruments/HospitalQualityInits/HospitalCompare.html 109 CMS Outcome Measure Hospital Compare 110 QAPI Hospital needs to document and track performance to make sure improvements are sustained (291) Continue to track antibiotics given timely in the OR before surgical procedure and prophylactic treatment to prevent DVT/PE in major surgery patients Number of PI projects depends on scope and complexity of hospital services so large hospital doing CABG would measure indicators on this (298) Hospital may want to develop and implement IT system to improve patient safety and the quality of care (299) 111 QAPI Hospital must document what PI projects are being done (300) and the reason for doing them (301) and progress on it (302) The hospital is not required to participate in the QIO projects but its own projects are required to be of comparable effort (303) Board, MS, and administration are responsible for and accountable for ongoing program (309) These 3 must make sure the following are done That an ongoing program for PI is defined, implemented and maintained (310) 112 QAPI That there is an ongoing program for patient safety that includes reduction of medical errors Decide which are priorities and that all improvement actions are evaluated (312) Hospital must address issues to improve patient safety (313) Clear expectations for patient safety are established (314) Need adequate resources for PI and patient safety (315, 316) and number of projects is conducted annually (317) 113 QAPI Patient Safety This means people who can attend meetings, data so analysis can be made and other resources Safer IV pumps, new anticoagulant program, implement central line bundle, sepsis, and VAP bundle, preventing inpatient suicides, wrong site surgery, retained FB, new processes for neuromuscular blocker agents, implement policy on Phenergan administration and Fentanyl patches So what’s in your PI and Safety Plans? 114 National Quality Forum NQF NQF is an excellent resource Has the ABCs of measurement A list of NQF endorsed standards A list of consensus projects Resources Can do a search of measures such as AAA repair mortality rate, accidental puncture or laceration rate, 30 day post hospital MI discharge care transition rate, stroke mortality rate, adherence to medication for diabetic patients, etc. 115 AHRQ Has Excellent Resources 116 Quality Indicator Toolkit www.ahrq.gov/legacy/qual/qitoolkit/ 117 Patient Safety Indicators 118 Types of Indicators; Inpatient, PS, Peds, 119 List of NQF Measures 120 National Quality Forum NQF www.qualityforum.org/Home.aspx 121 TJC Performance Measurement www.jointcommission.org/performance http://www.jointcommission.org/perfor mance_measurement.aspx _measurement.aspx 122 Hospital Quality Alliance www.hospitalqualityalliance.org/hospitalqualityalliance/index.html 123 The End! Questions?? 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 at www.empsf.org 614 791-1468 sdill1@columbus.rr.com Call with questions, No emails, Thanks 124