W-35. Speaker Information Diane M. Bonifas BSN, C-NE, RN-BS Senior Clinical Support for Trilogy Health Services

4/9/2014 W-35 Simplify the survey experience by knowing the Interpreted Guidelines Speaker Information Diane M. Bonifas BSN, C-NE, RN-BS Senior Clinical Support for Trilogy Health Services Dominic Lombardo RN Clinical Support Nurse Trilogy Health Services Objectives: Identify what the interpreted guidelines are and how to use them during the survey process Discuss F-221, F222, F-279, F-309, F-314, F-323, F-329, F-441 and others Analyze the guidelines and how surveyors are to assign scope and severity Discuss components of an acceptable plan of correction 1

4/9/2014 Survey Process Helpful Hints Entrance- information gathering and forms to complete Survey readiness book Nursing staff aware of interview questions Suggest asking residents the interview questions so prepared for some answers. At least the missing items and staff treatment questions When able to go into Phase II Discharged records have 6 months of weights available for requested discharge records Know when your survey window is open- could be for 6 months Survey Readiness Key staff and locations Alphabetical listing of residents Indicate if facility utilized paid feeding assistance Schedule of meal times and medication pass Influenza/Pneumococcal policy CMS 20045 (3/2013) EIDC information Make sure you have access for survey information, also for self reportable https://odhgateway.odh.ohio.gov/ Review who receives emails/notices Website to request access http://publicapps.odh.ohio.gov/eid/useraccountr equest/useraccountrequest.aspx 2

4/9/2014 CMS Manuals Appendix p is survey process manual http://www.cms.gov/regulations-and- Guidance/Guidance/Manuals/downloads/som107ap_p_ltcf.pdf Appendix pp is the State Operations Manual (SOM) http://www.cms.gov/regulations-and- Guidance/Guidance/Manuals/downloads/som107ap_pp_guidel ines_ltcf.pdf This is the regulations, so all F-tags and the interpreted guidelines Interpreted Guidelines The SOM provides guidance to surveyors regarding the interpretation of the applicable regulations. 3

4/9/2014 Interpreted Guidelines and Nursing Process From guidelines Identifying hazards and risks Evaluating and analyzing hazards and risks Implementing interventions to reduce hazards and risks; and Monitoring for effectiveness and modifying interventions as indicated. Nursing Process Assessment Diagnosis Planning Implementing Evaluating Survey Tasks 9 tasks for QIS Off site preparation On site preparation and Entrance conference Initial tour Stage I Non-stage survey tasks Transition from Stage I to Stage II Stage II Analysis and Decision-Making Exit conference F-221, F-222 Restraints The resident has the right to be free from chemical or physical restraints imposed for purposes of discipline or convenience, and not required to treat the residents medical symptoms. SOM pages 55-61 4

4/9/2014 F-221, F-222 Side rails to keep a resident in bed Placing a resident in a chair so he/she cannot rise Alarms Use of sedatives for staff convenience Seatbelts that cannot be released on command Bed bolsters not assessed F-221, F-222 Investigation Care planning Initial assessment, F/U assessments Care givers understanding of devices ADL decline, contractures, loss of autonomy, depression, withdrawal Cannot use on solely on legal surrogates approval Increase in falls, pressure sores Exploring other options prior to restraint F-221, F-222 severity levels 1. (J) Side rail entrapment, sliding under tray tables, able to left a waist restraint 2. (G) Any harm resulting from physical or chemical device 3. (D) Device not appropriately assessed or re-assessed at least quarterly 5

4/9/2014 F-279 Comprehensive Care Plans The facility must develop a comprehensive care plan for each resident that has measureable objectives and time tables to meet the residents needs that are identified in the comprehensive assessment. Problem, interventions, goal, with review date SOM pages 136-140 F-279 Care Plans The facility must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. F-279 Investigation Do objectives have measureable outcomes If resident refuses Tx, does facility find alternatives Does care plan address needs Is the care plan current and followed Does the care plan have a problem, interventions, goal, review date 6

4/9/2014 F-279 Severity Levels (D) frequently cited related to intervention on care plan and not in place, care plan not updated, goal not specific, this list goes on and on. Not cited higher then D related to can not cause harm from not having a care plan F-309 Quality of Care The Facility must provide the necessary care and services to attain or maintain the highest physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. The Catch all tag SOM pages 146-183 Citation under F-309 Pain not being accurately assessed Fluid restrictions not being followed Hospice services Dialysis services Non-pressure-related skin ulcers, pain, or fecal impaction. Deficiency categories SOM pg. 180 7

4/9/2014 Updates coming F-309 F309 includes, but is not limited to, care such as care of a resident with dementia, end-of-life, diabetes, renal disease, fractures, congestive heart failure, nonpressure related skin ulcers, pain, and fecal impaction. F-309 Resident s record reflect A. Recognition and Assessment; Definitions for Dementia and Delirium B. Cause Identification and Diagnosis; Staff make on-going effort to identify and document C. Development of Care Plan; Specific for resident D. Individualized Approaches and Treatment; Staff training E. Monitoring, Follow-up and Oversight; and F. Quality Assessment and Assurance (QAA). F- 314 Pressure Sores (1) A resident who enters facility without pressure sores does not develop pressure sores unless clinically unavoidable (2) A resident having pressure sores receives treatment to promote healing, prevent infection and prevent new sores. SOM pages 195-232 8

4/9/2014 Avoidable VS. Unavoidable Avoidable The resident developed a pressure ulcer and the facility did not: Evaluate clinical condition, define and implement interventions that are consistent with the residents goals/needs. Monitor and evaluate interventions or revise as appropriate. Avoidable VS. Unavoidable Unavoidable Resident develops a Pressure sore even though the facility had evaluated risk factors and condition, defined and implemented interventions consistent with needs and goals. Monitored and evaluated interventions and revised as appropriate. F-314 Prevention ASSESSMENT- Identifying risk factors Pressure points and tissue tolerance Nutrition and hydration Moisture Repositioning Support surfaces and pressure Redistribution 9

4/9/2014 Investigative Protocol 1. Observation 2. Resident and Staff Interviews 3. Record review 4. Interviews Deficiency Categorization 1. Presence of harm or negative outcome 2. Degree of harm(actual or Potential) 3. The immediacy of correction required F-314 Severity Level 1. (J) development of avoidable stage 4 2. (G) Stage 3 develops, multiple stage 2s, No comprehensive care plan and were determined to be avoidable. 3. (D) Stage 2, stage1, failure to recognize or address potential for breakdown SOM page 229 10

4/9/2014 F-323 Accidents The facility must ensure that The resident environment remains as free of accident hazards as is possible and each resident receives adequate supervision and assistance devices to prevent accidents. SOM pages 276-306 F-323 Falls Elopement Burns Resident to resident Smoking Environmental hazards Equipment failure Shower Temps F-323 Investigative Protocol Staff and response times Equipment in good repair Staff aware of interventions Care plan addressing safety hazards Intervention outcomes and reassessment Behavior Documentations Interventions are in place and effective 11

4/9/2014 F-323 Noncompliance Monitor for defective or disabled equipment Assess, develop interventions, revise care plans for those at risk for falls/elopement Adequate supervision Safe storage of harmful substances F-323 Severity Level 1. (J) Requires immediate action by facility Fx with decline, 3 rd degree burns, falls that caused serious harm or potential with significant decline, resident leaves locked unit or facility. 2. (G) short term disability, Fx without decline, Falls and elopement with harm and facility has a ineffective practice in place, 2 nd degree burns, pain. Out to hospital and was admitted 3. (D) Bruising, rashes, pain that does not impair normal activities, out to hospital only requiring first aide. SOM pages 302-306 F-329 Unnecessary Drugs Each resident must be free of unnecessary drugs. Excessive dose, excessive duration, without monitoring, without adequate indications for use, presence of adverse consequences which indicate the dose should be reduced or discontinued. SOM pages 344-427 12

4/9/2014 F-329 GDR Coumadin monitoring Pharmacy reviews Non pharmacological interventions prior to medicating (esp. PRN medication) Prolonged ATB therapy Duplicate treatments F-329 Investigative Protocol Only use meds that are clinically indicated. Review conditions associated with meds and how facility manages meds for the resident. MRR by a pharmacist Determine if approaches other than medications were discussed. F-329 Noncompliance No clinical rationale Lack of monitoring(coumadin) Give a drug despite an allergy Antipsychotic med without GDRs Giving meds exceeding manufacturers recommendations. 13

4/9/2014 F-329 Severity Level 1. (J) INR of 9 or greater W/O assessment or F/U, No PT/INR, GI bleed R/T NSAIDs, COX-2 inhibitors 2. (G) no GDR resulting in functional decline, Coumadin admin leading to transfusion/hosp 3. (D) Failure to change or suspend Coumadin dose PT/INR 4-9 with no bleeding, missed INR, minor allergic response SOM pages 425-429 Updates for F-329 The facility failed to evaluate for the ongoing indication of use of the antipsychotic after symptoms were no longer present, had not monitored for the presence of adverse consequences, had not attempted gradual dose reductions nor implemented any behavioral interventions. This in in conjunction with updates to F-309 F-441 Infection Control The facility must establish and maintain an infection control program designed to provide a safe, sanitary, comfortable environment and to help prevent the development and transmission of disease and infection. SOM pages 560-598 14

4/9/2014 Hand washing Infection tracking TB protocol C-DIFF protocol F-441 Staff education in infection control Correct technique for nursing procedures. F-441 Investigative protocol Surveyors will ask for infection tracking tool. Watch hand-washing, isolation precautions. Glucometer cleaning. Vaccine records F-441 Severity Levels 1. (J) Glucometer not sanitized between residents with one having a bloodbourne pathogen, witnessed possible C-DIFF spread(failure to clean with bleach and/or appropriate disinfectant, using hand sanitizer) 2. (D) Related to hand-hygiene techniques, ice scoop left in ice chest, linen barrels, isloation practices. SOM pages 594-598 15

4/9/2014 Hot Button Tags F-223, F-225, and F-226 related to abuse and reporting SOM pages 61-69 F-325 Nutrition related to diets pgs 306-339 F-332, F-333 Medication errors and significant error SOM pages 427-436 F-353 Nursing services SOM pages 450 F-278 Accuracy of assessments SOM133-136 Immediate Jeopardy The 14 IJ deficiencies cited during CY - Qtr 4 2013 were under the following 7 tags: F221 Right to be free from physical restraints = 1 F223 - Free from abuse/involuntary seclusion = 2 F225 Investiate/report allegations /individuals = 1 F226 Develop/implement abuse/neglect policies = 1 F309 - Provide care/services for highest well being = 3 F323 Free of accident hazards/supervision/devices = 5 F329 - Drug regimen is free from unnecessary drugs = 1 Utilize OHCA Immediate Jeopardy Bulletins Helpful Hints at Exit Record exit conference 2567 within 10 working days Facility has 10 calendar days to write POC and upload to EIDC 50 days from date of exit must reach substantial compliance 16

4/9/2014 2567 Review scope and severity for each citation- left hand column of 2567 Read Notice letter carefully, pay attention to dates Samples of Notice letter Opening paragraph- survey exit date of March 7, 2014 On the date noted above, we completed an annual survey of your facility for the purpose of determining whether it meets Federal requirements for skilled nursing facilities (SNF) and nursing facilities (NF) participating in the Medicare or Medicare/Medicaid programs. This survey found the most serious deficiencies in your facility to be widespread in scope, constituting no actual harm with potential for more than minimal harm that is not immediate jeopardy, as evidenced by the enclosed Statement of Deficiencies and Plan of Correction FORM CMS-2567 whereby corrections are required. 17

4/9/2014 Found usually on page 2 of notice letter Enforcement Remedies Based upon the deficiencies cited during this survey, unless your facility corrects its deficiencies and is in substantial compliance with the requirements set forth in 42 CFR Part 483 Subpart B, by April 11, 2014, we will recommend that CMS Regional Office and/or the Director of Health impose the following remedies: Mandatory denial of payment, as provided by 42 CFR Sections 488.408 and 488.417 (b), for new Medicare and Medicaid eligible admissions effective May 20, 2014. We have determined that the remedy recommended is in the best interest of the facility residents. In recommending this remedy, we have considered the factors under 42 CFR Section 488.404 and Section 488.438, as may be appropriate. We are also recommending to the CMS Regional Office and/or Ohio Department of Job and Family Services, as may be appropriate, that your provider agreement be terminated on August 20, 2014, if substantial compliance has not been achieved and maintained. Notice Letters Note who signs the letter Karen Gingery, R.D.,L.D., Regional Manager Division of Quality Assurance Bureau of Long Term Care Quality Western Region Or Carol Todd, R.N., Regional Manager Division of Quality Assurance Bureau of Long Term Care Quality Eastern Region Do not want to see Suzanne L. Murphy RN, B-C, Supervisor Bureau Regulatory Compliance 2567 continued 18

4/9/2014 Writing acceptable Plan of Correction (POC) Must cover 5 elements How the facility will correct the deficiency and resident affected How the facility will protect resident in similar situations (how will identify) Must include measure the facility will take or systems it will alter to ensure that the problem does not recur Describe in detail the ongoing monitoring and improvement process to be used Date by which the deficiency will be corrected Additional Information for Harm or IJ Detailed analysis of the facts and circumstances of the finding including identification of its cause Detailed explanation of how the corrected actions described in the plan relate to identified cause of the finding A detailed explanation of the relationship between the ongoing monitoring and improvement process and the identified cause of the findings Note letter will come from Bureau of Regulatory Compliance (BRC) Upload to EIDC 19

4/9/2014 Helpful Websites http://www.cms.gov/regulations-and- Guidance/Guidance/Manuals/downloads/som107ap_pp_guideline s_ltcf.pdf SOM on CMS website http://www.odh.ohio.gov/odhprograms/ltc/nurhome/annc/nhann1. aspx ODH announcement page/memos http://www.aging.ks.gov/manuals/qismanual.htm QIS forms 20

TO DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C2-21-16 Baltimore, Maryland 21244-1850 Center for Clinical Standards and Quality /Survey & Certification Group DATE: May 24, 2013 Ref: S&C: 13-35-NH TO: FROM: SUBJECT: State Survey Agency Directors Director Survey and Certification Group Advanced Copy: Dementia Care in Nursing Homes: Clarification to Appendix P State Operations Manual (SOM) and Appendix PP in the SOM for F309 Quality of Care and F329 Unnecessary Drugs Memorandum Summary Guidance This memo conveys clarification to Appendices P and PP related to nursing home residents with dementia and unnecessary drug use. Training - Mandatory surveyor trainings are available online at http://surveyortraining.cms.hhs.gov. National Partnership On March 29, 2012, the Centers for Medicare & Medicaid Services (CMS) launched the National Partnership to Improve Dementia Care and Reduce Unnecessary Antipsychotic Drug Use in Nursing Homes (this is now referred to as the Partnership to Improve Dementia Care in Nursing Homes). The goal of this Partnership is to optimize the quality of life and function of residents in America s nursing homes by improving approaches to meeting the health, psychosocial and behavioral health needs of all residents, especially those with dementia. The CMS has joined with various stakeholders to improve dementia care in nursing homes. We are doing several things to support this work, including producing surveyor training videos as well as updating Appendix P and Appendix PP of the State Operations Manual (SOM). Individualized, person-centered approaches may help reduce potentially distressing or harmful behaviors and promote improved functional abilities and quality of life for residents. It has been a common practice to use various types of psychopharmacological medications in nursing homes to try to address behaviors without first determining whether there is a medical, physical, functional, psychological, emotional, psychiatric, social or environmental cause of the behaviors. Medications may be effective when they are used appropriately to address significant, specific underlying medical or psychiatric causes, or new or worsening behavioral symptoms. However, medications may be ineffective and are likely to cause harm -if given

Page 2 State Survey Agency Directors without a clinical indication. All interventions, including medications, need to be monitored for efficacy, risks, benefits and harm. The problematic use of medications, such as antipsychotics, is part of a larger, growing concern. This concern is that nursing homes and other settings (i.e. hospitals, ambulatory care) may use medications as a quick fix for behavioral symptoms or as a substitute for a holistic approach that involves a thorough assessment of underlying causes of behaviors and individualized, person-centered interventions. Antipsychotic medications are frequently prescribed for residents with dementia who have behavioral or psychological symptoms of dementia (BPSD). 1,2 The term BPSD is used to describe behavior or other symptoms in individuals with dementia that cannot be attributed to a specific medical or psychiatric cause. When antipsychotic medications are used without an adequate rationale, or for the purpose of limiting or controlling behavior of an unidentified cause, there is little chance that they will be effective. In addition, they commonly cause complications such as movement disorders, falls, hip fractures, cerebrovascular adverse events (cerebrovascular accidents and transient ischemic events) and increased risk of death. 3,4,5,6 The Food & Drug Administration (FDA) Black Box Warnings Regarding Atypical Antipsychotics in Dementia provides, Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. 7 Dementia Care Principles Fundamental principles of care for a resident with dementia include an interdisciplinary approach that focuses on the needs of the resident as well as the needs of the other residents in the nursing home. Sections 1819 and 1919 of the Social Security Act (the Act) and current regulations already require a number of essential elements to be in place in order for facilities to be in compliance with federal requirements on quality of care and quality of life. This revised CMS guidance and surveyor training highlight and re-emphasize a number of those key principles, including: 1. Person Centered Care. CMS requires nursing homes to provide a supportive environment that promotes comfort and recognizes individual needs and preferences. 2. Quality and Quantity of Staff. The nursing home must provide staff, both in terms of quantity (direct care as well as supervisory staff) and quality to meet the needs of the residents as determined by resident assessments and individual plans of care. 3. Thorough Evaluation of New or Worsening Behaviors. Residents who exhibit new or worsening BPSD should have an evaluation by the interdisciplinary team, including the physician, in order to identify and address treatable medical, physical, emotional, psychiatric, psychological, functional, social, and environmental factors that may be contributing to behaviors.

Page 3 State Survey Agency Directors 4. Individualized Approaches to Care. Current guidelines from the United States, United Kingdom, Canada and other countries recommend use of individualized approaches as a first line intervention (except in documented emergency situations or if clinically contraindicated) for BPSD. 8-10 Utilizing a consistent process that focuses on a resident s individual needs and tries to understand behavior as a form of communication may help to reduce behavioral expressions of distress in some residents. 5. Critical Thinking Related to Antipsychotic Drug Use. In certain cases, residents may benefit from the use of medications. The resident should only be given medication if clinically indicated and as necessary to treat a specific condition and target symptoms as diagnosed and documented in the record. Residents who use antipsychotic drugs must receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort discontinue these drugs. NOTE: If during a survey, the team identifies a concern that an antipsychotic medication may potentially be administered for discipline, convenience and not being used to treat a medical symptom, the survey team should review F222-483.13(a) Right to be Free From Chemical Restraints. 6. Interviews with Prescribers. None of the guidance to surveyors should be construed as evaluating the practice of medicine. Surveyors are instructed to evaluate the process of care. Surveyors interview the attending physician or other primary care provider (NP, PA), behavioral health specialist, pharmacist and other team members to better understand the reasons for using a psychopharmacological agent or any other interventions for a specific resident. 7. Engagement of Resident and/or Representative in Decision-Making. In order to ensure judicious use of psychopharmacological medications, residents (to the extent possible) and/or family or resident representatives must be involved in the discussion of potential approaches to address behavioral symptoms. These discussions with the resident and/or family or representative should be documented in the medical record. Guidance Updates and Surveyor Training 1. Surveyor training videos Through work with our partners, CMS has developed a series of interactive training sessions around behavioral health and dementia care. Materials currently available to surveyors may be accessed on the surveyor training website at: http://surveyortraining.cms.hhs.gov/index.aspx. We have made available three mandatory surveyor trainings (see S&C memo 13-34-ALL). The first training provides an overview of dementia care and potential approaches to addressing behavioral distress. The second training walks surveyors through portions of an annual survey and focuses on the evaluation of one resident with dementia. These two trainings are currently available on the surveyor training website. A third training video is under development that will provide a review of the revised interpretive guidance at F309 and changes to Table 1 for antipsychotic medications at F329. This final training will present case studies and discuss how

Page 4 State Survey Agency Directors to identify potential F Tags and determine severity for non-compliance related to care of a resident with dementia. 2. Updates to Appendix P (Attachment A) include: Changes to the resident sampling process for the traditional survey (changes to QIS were included in the recent 10.1.3 release). The change is intended to ensure that the survey sample includes an adequate number of residents with dementia who are receiving an antipsychotic medication. See Attachment A. 3. Updates to Appendix PP (Attachment B) include: A new section of interpretive guidance at F309 related to the review of care and services for a resident with dementia; Revisions to the antipsychotic medication section of Table 1 at F329; New severity example at the end of the interpretive guidance at F329 (Unnecessary drugs); A surveyor checklist that may be used in either the traditional or QIS process (modeled after the CE pathways) is also provided (Attachment C). This checklist is not part of the SOM. References: 1. Briesacher BA, Limcangco MR, Simoni-Wastila L et al. The quality of antipsychotic drug prescribing in nursing homes. Arch Intern Med 2005;165(June):1280-1285. 2. Levinson DR. Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents. Department of Health and Human Services Office of Inspector General Report (OEI- 07-08-00150)05-04-2011 accessed at https://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf 3. Schneider L, Tariot P, Dagerman K. Effectiveness of atypical antipsychotic drugs in residents with Alzheimer's disease. N Engl J Med 2006;355:1525-1538. 4. Ray WA, Chung CP, Murray KT, et al: Atypical antipsychotic drugs and the risk of sudden cardiac death. N Engl J Med 2009;360:225 235. 5. Schneider LS, Dagerman K, Insel PS: Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. American Journal of Geriatric Psychiatry 2006 14:191 210. 6. Rochon P, Normand S, Gomes T et al. Antipsychotic therapy and short-term serious events in older adults with dementia. Arch Intern Med 2008;168:1090-1096. 7.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProvid ers/drugsafetyinformationforheathcareprofessionals/publichealthadvisories/ucm053171.htm

Page 5 State Survey Agency Directors 8. The American Geriatrics Society. (2012). American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Journal of American Geriatrics Society. New York. The American Geriatrics Society. 9. 3 rd Canadian Consensus Conference on Diagnosis & Treatment of Dementia. (2007). Approved Recommendations. Montreal. 10. Scottish Intercollegiate Guidelines Network. (2006). Management of Patients with Dementia: A National Clinical Guideline. Scott Intercollegiate Guidelines Network. Attachments: 3 Attachment A SOM Appendix P Revision to Sample Selection for the Traditional Survey Attachment B SOM Appendix PP F309 Interpretive Guidance for Care and Services of a Resident with Dementia; F329 Interpretive Guidance for Drug Regimen Free from Unnecessary Drugs (includes only revised sections of F329, including Table 1, section on antipsychotic medications and the new severity example) Attachment C Surveyor Checklist for Review of Care and Services for a Resident with Dementia (This document is not considered a SOM revision or addition.) For questions on this memorandum, please contact Michele Laughman at dnh_behavioralhealth@cms.hhs.gov. Effective Date: This policy is in effect immediately. This policy should be communicated with all survey and certification staff, their managers and the State/Regional Office training coordinators within 30 days of this memorandum. Training: This policy should be shared with all appropriate survey and certification staff, their managers and the State/Regional Office training coordinators. /s/ Thomas E. Hamilton cc: Survey and Certification Regional Office Management

CMS Manual System Pub. 100-04 Medicare Claims Processing Transmittal: Advanced Copy Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Date: CHANGE REQUEST: SUBJECT: National Partnership to Improve Dementia Care in Nursing Homes; Interim Changes to Appendix P State Operations Manual (SOM) I. SUMMARY OF CHANGES: We are providing interim guidance related to surveyors assessment for compliance with requirements related to nursing home residents with dementia and unnecessary drug use. These updates include sampling for the traditional survey process in Appendix P. In Appendix P, we have made changes to the resident sampling process for the traditional survey (changes to QIS were included in the recent 10.1.3 release). The change is intended to ensure that the survey sample includes an adequate number of residents with dementia who are receiving an antipsychotic medication. NEW/REVISED MATERIAL - EFFECTIVE DATE*: Upon Issuance IMPLEMENTATION DATE: Upon Issuance Disclaimer for manual changes only: The revision date and transmittal number apply to the red italicized material only. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents. II. CHANGES IN MANUAL INSTRUCTIONS: (R = REVISED, N = NEW, D = DELETED) R/N/D R R R CHAPTER/SECTION/SUBSECTION/TITLE App P/Revision to Sample Selection for the Traditional Survey/Task1/Off Site Preparation App P/Revision to Sample Selection for the Traditional Survey/Task2/Entrance Conference/Onsite Preparatory Activities/A/Entrance Conference/3/The team coordinator should App P/Revision to Sample Selection for the Traditional Survey/Task4/Revision to Sample Selection for Traditional Survey/D/Protocol/1/Phase 1 Sample Selection III. FUNDING: No additional funding will be provided by CMS; contractor activities are to be carried out within their operating budgets. IV. ATTACHMENTS:

Business Requirements X Manual Instruction Confidential Requirements One-Time Notification One-Time Notification -Confidential Recurring Update Notification *Unless otherwise specified, the effective date is the date of service

Appendix P - Revision to Sample Selection for the Traditional Survey* Task 1 Off Site Preparation Use the Facility QM Report to pre-select concerns for any QM that is flagged at the 75 th (or greater) national percentile. NOTE: If either of the QM s for residents on antipsychotic medications are flagged, include the questions related to dementia care and antipsychotic medication use during the entrance conference (see Task 2 below). Use the instructions identified in Task 2 and Task 4 in order to include a resident with dementia who is receiving an antipsychotic medication in the sample. Task 2 Entrance Conference/Onsite Preparatory Activities: A. Entrance Conference 3. The team coordinator should: Request a list of the names of residents who have a diagnosis of dementia and who are receiving, have received, or presently have PRN orders for antipsychotic medications over the past 30 days. If the facility population includes residents with dementia, ask the administrator or director of nursing to describe how the facility provides individualized care and services for residents with dementia and to provide policies related to the use of antipsychotic medications in residents with dementia. Task 4 Sample Selection for Traditional Survey Phase 1 - Sample Selection Use the list of names of residents, who over the past 30 days, received, are presently receiving or have PRN orders for antipsychotic medications and have a diagnosis of dementia: Compare this list to the off-site Phase 1 resident sample and determine if a resident from this list is already included in the Phase 1 sample; and Ensure that, at a minimum, at least one of the residents on the list who is receiving an antipsychotic medication is in the Phase 1 sample for a comprehensive or focused record review.

If the Phase 1 sample does not identify at least one resident that is on the facility provided list, the team should consider either replacing one resident from the Phase 1 sample with one resident from the facility provided list or adding a resident from the list to the sample. Consider the following: 1. If selecting a replacement resident, attempt to select a resident from the facility provided list that was noted to be included in the same QM conditions as the resident who was removed. 2. When considering the addition of a resident from this list, attempt to select a resident who is representative of areas of concern, such as triggering QM s at or above the 75% percentile or other special factors. Reference the Review of Care and Services for a Resident with Dementia Checklist while conducting this review. Appendix P - Sample Selection for the Quality Indicator Survey (QIS) For the QIS, surveyors will not have to make an adjustment to the sample selection as the software will automatically identify the required sample. NOTE: An electronic version of the CMS Review of Care and Services for a Resident with Dementia Checklist is available and may be used either electronically or the surveyor may print a copy of the checklist to guide the Phase 2 investigation of care provided to a resident with dementia. *This is revised guidance for portions of Tasks 1, 2 and 4 it does not replace existing guidance in Appendix P for other aspects of those tasks.

CMS Manual System Pub. 100-04 Medicare Claims Processing Transmittal: Advanced Copy Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Date: CHANGE REQUEST: SUBJECT: National Partnership to Improve Dementia Care in Nursing Homes; Interim Changes to Appendix PP in the State Operations Manual (SOM) for F309 Quality of Care and F329 Unnecessary Drugs I. SUMMARY OF CHANGES: We are providing interim guidance related to surveyors assessment for compliance with requirements related to nursing home residents with dementia and unnecessary drug use. These updates include Appendix PP F329 Table 1 and severity examples, as well as F309. In Appendix PP, a new section of interpretative guidance at F309 related to the review of care and services for a resident with dementia has been added. At F329, new severity examples have been added at the end of the interpretative guidance and revisions to the antipsychotic medication section have been made to Table 1. NEW/REVISED MATERIAL - EFFECTIVE DATE*: Upon Issuance IMPLEMENTATION DATE: Upon Issuance Disclaimer for manual changes only: The revision date and transmittal number apply to the red italicized material only. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents. II. CHANGES IN MANUAL INSTRUCTIONS: (R = REVISED, N = NEW, D = DELETED) R/N/D R R R CHAPTER/SECTION/SUBSECTION/TITLE App PP/ 483.25/F309/Quality of Care App PP/ 483.25/F329/Table 1/Medication Issues of Particular Relevance/Antipsychotic Medications App PP/ 483.25/F329/Additional Example III. FUNDING: No additional funding will be provided by CMS; contractor activities are to be carried out within their operating budgets. IV. ATTACHMENTS: Business Requirements X Manual Instruction Confidential Requirements

One-Time Notification One-Time Notification -Confidential Recurring Update Notification *Unless otherwise specified, the effective date is the date of service.

F309

F309 483.25 Quality of Care Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. Intent: 483.25 The facility must ensure that the resident obtains optimal improvement or does not deteriorate within the limits of a resident s right to refuse treatment, and within the limits of recognized pathology and the normal aging process. NOTE: Use guidance at F309 for review of quality of care not specifically covered by 42 CFR 483.25 (a)-(m). Tag F309 includes, but is not limited to, care such as care of a resident with dementia, end-of-life, diabetes, renal disease, fractures, congestive heart failure, non-pressure related skin ulcers, pain, and fecal impaction. Review of Care and Services for a Resident with Dementia Use this guidance for a resident with dementia. If the resident is receiving one or more psychopharmacological agents, also review the guidance at F329, Unnecessary Drugs. There is no specific investigative protocol for care of a resident with dementia. For the traditional survey, the surveyor may use the surveyor checklist titled, Review of Care and Services for a Resident with Dementia to assist in investigating the care and services provided to a resident with a diagnosis of dementia. For the QIS survey, the surveyor will use the general CE pathway and may use the checklist as a guide to completing that pathway. Definitions Related to Recognition and Management of Dementia Behavioral interventions are individualized approaches (including direct care and activities) that are provided as part of a supportive physical and psychosocial environment, and are directed toward understanding, preventing, relieving, and/or accommodating a resident s distress or loss of abilities. Person-Centered or Person-Appropriate Care is care that is individualized by being tailored to all relevant considerations for that individual, including physical, functional, and psychosocial aspects. For example, activities should be relevant to the specific needs, interests, culture, background, etc. of the individual for whom they are developed and medical treatment should be tailored to an individual s risk factors, current conditions, past history, and details of any present symptoms. Behavioral or Psychological Symptoms of Dementia (BPSD) is a term used to describe behavior or other symptoms in individuals with dementia that cannot be attributed to a specific medical or psychiatric cause. The term behaviors is more

general and may encompass BPSD or responses by individuals to a situation, the environment or efforts to communicate an unmet need. Overview of Dementia and Behavioral Health What is Behavior? Human behavior is the response of an individual to a wide variety of factors. Behavior is generated through brain function, which is in turn influenced by input from the rest of the body. Specific behavioral responses depends on many factors, including personal experience and past learning, inborn tendencies and genetic traits, the environment and response to the actions and reactions of other people. A condition (such as dementia) that affects the brain and the body may affect behavior. What is Dementia? Dementia is not a specific disease. It is a descriptive term for a collection of symptoms that can be caused by a number of disorders that affect the brain. People with dementia have significantly impaired intellectual functioning that interferes with normal activities and relationships. They also lose their ability to solve problems and maintain emotional control, and they may experience personality changes and behavioral problems, such as agitation, delusions, and hallucinations. While memory loss is a common symptom of dementia, memory loss by itself does not mean that a person has dementia. Doctors diagnose dementia only if two or more brain functions - such as memory and language skills -- are significantly impaired without loss of consciousness. Some of the diseases that can cause symptoms of dementia are Alzheimer s disease, vascular dementia, Lewy body dementia, fronto-temporal dementia, Huntington s disease, and Creutzfeldt-Jakob disease. Doctors have identified other conditions that can cause dementia or dementia-like symptoms including reactions to medications, metabolic problems and endocrine abnormalities, nutritional deficiencies, infections, poisoning, brain tumors, anoxia or hypoxia (conditions in which the brain s oxygen supply is either reduced or cut off entirely), and heart and lung problems. Although it is common in very elderly individuals, dementia is not a normal part of the aging process. 1 Some individuals with dementia may have coexisting symptoms or psychiatric conditions such as depression or bipolar affective disorder, paranoia, delusions or hallucinations. Progressive dementia may exacerbate these and other symptoms. Behavioral or psychological symptoms are often related to the brain disease in dementia; however behavior and other symptoms may also be caused or exacerbated by environmental triggers. Behavior often represents a person s attempt to communicate an unmet need, discomfort or thoughts that they can no longer articulate. Knowing detailed cultural, medical and psychosocial information about a person can help caregivers identify potential environmental or other triggers in order to prevent or reduce, to the extent possible, behavior or

other expressions of distress. 2 Because behavioral symptoms may be caused by medical conditions such as delirium, medication side effects, and psychiatric symptoms such as delusions or hallucinations, these should be considered as possible causes in addition to environmental triggers. What is Delirium? A resident may have undiagnosed delirium, which is an acute confusional state that includes symptoms very similar to those of dementia and psychiatric disorders. The diagnostic criteria for delirium include a fluctuating course throughout the day, inattention as evidenced by being easily distracted, cognitive changes, and perceptual disturbances 3. Delirium develops rapidly over a short time period, such as hours or days, and is associated with an altered level of consciousness. Delirium has an underlying physiologic cause that can generally be identified through a diagnostic evaluation. Potential causes include, but are not limited to, infection, fluid/electrolyte imbalance, medication, or multiple factors. Specific diagnostic criteria are outlined in the DSM IV-TR or the Confusion Assessment Method 3,4. Classic delirium is often characterized as hyperactive (e.g., extreme restlessness, climbing out of bed); but more commonly delirium is hypoactive often leading to the misdiagnosis of dementia or a psychiatric disorder. Delirium is particularly common post-hospitalization; signs and symptoms may be subtle and therefore are often missed. Although generally thought to be short lived, delirium can persist for months. Delirium and dementia are now recognized as being related. Individuals with dementia are at higher risk for developing delirium and it now appears that delirium increases the risk of developing dementia over time 5. Recognizing delirium is critical, as failure to act quickly to identify and treat the underlying causes may result in poor health outcomes, hospitalization or even death 6. Therapeutic Interventions or Approaches The use of any approach must be based on a careful, detailed assessment of physical, psychological and behavioral symptoms and underlying causes as well as potential situational or environmental reasons for the behaviors. Caregivers and practitioners are expected to understand or explain the rationale for interventions/approaches, to monitor the effectiveness of those interventions/approaches, and to provide ongoing assessment as to whether they are improving or stabilizing the resident s status or causing adverse consequences. Describing the details and possible consequences of resident behaviors helps to distinguish expressions such as restlessness or continual verbalization from potentially harmful actions such as kicking, biting or striking out at others. This description alone does not suggest that a specific intervention is or is not indicated; however, it is important information that may assist the care team (including the resident and/or family or representative) in decision-making and in matching selected interventions to the individual needs of each resident.

Identifying the frequency, intensity, duration and impact of behaviors, as well as the location, surroundings or situation in which they occur may help staff and practitioners identify individualized interventions or approaches to prevent or address the behaviors. Individualized, person-centered interventions must be implemented to address behavioral expressions of distress in persons with dementia. In many situations, medications may not be necessary; staff/practitioners should not automatically assume that medications are an appropriate treatment without a systematic evaluation of the resident. Examples of techniques or environmental modifications that may prevent certain behavior related to dementia may include (but are not limited to): Arranging staffing to optimize familiarity with the resident (e.g., consistent caregiver assignment); Identifying, to the extent possible, factors that may underlie the resident s expressions of distress, as well as applying knowledge of lifelong patterns, preferences, and interests for daily activities to enhance quality of life and individualize routine care. Understanding that the resident with dementia may be responding predictably given the situation or surroundings. For example, being awakened at night in his/her bedroom by staff and not recognizing the staff could elicit an aggressive response; and Matching activities for a resident with dementia to his/her individual cognitive and other abilities and the specific behaviors in that individual based on the assessment. Medication Use in Dementia (see also F329) It has been a common practice to use various types of psychopharmacological medications in nursing homes to try to address behavioral or psychological symptoms of dementia (BPSD) 7,8 without first determining whether there is an underlying medical, physical, functional, psychosocial, emotional, psychiatric, or environmental cause of the behaviors. Medications may be effective when they are used appropriately to address significant, specific underlying medical and psychiatric causes or new or worsening behavioral symptoms. However, medications may be ineffective and are likely to cause harm when given without a clinical indication, at too high a dose or for too long after symptoms have resolved and if the medications are not monitored. All interventions including medications need to be monitored for efficacy, risks, benefits and harm. These agents must only be used if the steps in the care process below and as outlined in F329 have been followed. When antipsychotic medications are used without an adequate rationale, or for the sole purpose of limiting or controlling behavior of an unidentified cause, there is little chance that they will be effective, and they commonly cause complications such as movement disorders, falls, hip fractures, cerebrovascular adverse events (cerebrovascular accidents and transient ischemic events) and increased risk of death. 9,10,11,12 The FDA Black Box

Warning Regarding Atypical Antipsychotics in Dementia states, Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. The FDA issued a similar Black Box Warning for conventional antipsychotic drugs. (Additional information on the FDA black box warning is available at http://www.fda.gov/drugs/default.htm.) Recent studies suggest that certain antipsychotic medications may have greater risks than others in that same class of medications 13,14. Other classes of psychopharmacological agents may carry significant risks as well. NOTE: If a concern is identified during a survey that an antipsychotic medication may potentially be administered for discipline, convenience and/or is not being used to treat a medical symptom, consider reviewing F222-483.13(a) Restraints, for the right to be free from any chemical restraints. Resident and/or Family/Representative Involvement: CMS expects that the resident and family/representatives, to the extent possible, are involved in helping staff to understand the potential underlying causes of behavioral distress and to participate in the development and implementation of the resident s care plan. Residents have the right to be informed about their medical condition, care and treatment; they have the right to refuse treatment and the right to participate in the care plan process (See F154, F155, F242, F279, F280). Facilities should be able to identify how they have involved residents/families/representatives in discussions about potential approaches to address behaviors and about the potential risks and benefits of a psychopharmacological medication (e.g., FDA black box warnings), the proposed course of treatment, expected duration of use of the medication, use of individualized approaches, plans to evaluate the effects of the treatment, and pertinent alternatives. The discussion should be documented in the resident s record (See F154). NOTE: some states have specific laws/licensing rules regarding the provision of informed consent. The State Agency determines and directs the surveyors regarding the review for those provisions under their State licensing authority. If non-compliance with the State regulation is identified, the surveyors may only cite this non-compliance at F492 when the Federal, State or local authority having jurisdiction has both made a determination of non-compliance AND has taken a final adverse action. The facility should document attempts to include the family/representative, to the extent possible, in the decision-making process. If the family/representative is unable to participate in person, were further attempts made to include the family/representative in the discussions/development of the care planning through alternative methods, such as by phone or electronic methods?