IDR Preparation and Abuse Reporting Requirements Rick E. Harris Of Counsel Starnes Davis Florie LLP Birmingham, AL November 18, 2014 What We Are Going to Discuss Risk Management aka Survey Preparation Survey Rebuttal (pre 2567) IDR/IIDR Abuse Reporting Requirements Risk Management/Survey Preparation IDR Preparation Begins with Survey Preparation! 1
Risk Management/Survey Preparation Identifying and correcting problems before they become a matter of regulatory agency attention. This is not unlike liability risk management. Two important (but not all inclusive) components: Ongoing review of policies and procedures. Thoroughly investigating incidents. Risk Management/Survey Preparation Review Policies &Procedures Why is this important? Risk Management/Survey Preparation Review Policies &Procedures Do staff know where to find P&Ps that are applicable to them? Have facility practices evolved? Do staff know what P&Ps require? Is it time for inservicing on P&Ps? 2
Risk Management/Survey Preparation Review Policies &Procedures Goals: P&Ps are useful, handy, and reflect actual facility practice. This starts at Administrator/ED/DON/DNS level. If leaders are not following P&Ps, why would other staff? Risk Management/Survey Preparation Review Policies &Procedures Bottom line is the facility actually following these? If not, evaluate whether to change current practice or change P&Ps to do this communication between corporate leadership and facility leadership, as well as between facility leadership and facility staff is essential. Survey Rebuttal (pre 2567) This involves sending in additional material, supportive documentation, and written arguments based on the exit conference citations. Available in Alabama survey team should tell you at exit the deadline for submission. If they don t say ASK! This submission can also give you a head start on IDR/IIDR submissions. 3
Survey Rebuttal (pre 2567) Important that several facility staff members attend exit conference and take extensive notes (many nurses are good at this). Survey Rebuttal (pre 2567) Regardless of deadlines, the goal should be to submit the material before the surveyors get too far along in writing up their deficiencies and certainly before there has been any supervisory review. For a Thursday Friday exit, first thing Monday morning is the optimal time for this submission. Survey Rebuttal (pre 2567) When deciding whether to submit survey rebuttal documents, as in submitting investigatory reports, consider quality assurance privilege issues, and be aware that you may be locking yourselves into a particular position very early in the process. 4
Survey Rebuttal (pre 2567) Consider Quality Assurance issues. What happens to documents submitted to or gathered by a state survey agency? What is and what is not publicly releasable by a survey agency? Touhy rule and FOIA issues. Survey Rebuttal (pre 2567) Consider Quality Assurance issues. NOTE: THIS IS A QUALITY ASSURANCE DOCUMENT. Despite the legal quality assurance privilege available under the laws of the State of Alabama, this document is being provided to the Alabama Department of Public Health pursuant to its police power and because federal regulations require that the facility provide the results of investigations such as this one to the State survey agency. It is being provided for the official use only of the Alabama Department of Public Health and the United States Centers for Medicare and Medicaid Services. By providing this document for such official use, the facility does not waive the quality assurance privilege provided by state law with respect to its use in legal proceedings unrelated to licensure and certification matters. IDR/IIDR Informal Dispute Resolution (IDR) Must be offered by the SA (or CMS for federal surveys) once facility receives 2567 must be included in transmittal letter with deadline for request Does not delay enforcement action Not a formal legal proceeding 5
IDR/IIDR IDR requirements: May not be used to challenge: s/s of deficiencies, except SSQ/IJ remedies imposed or proposed failure of surveyors to follow process inconsistency of SA in citing deficiencies inadequacy of IDR process IDR/IIDR IDR requirements: SA s process must be in writing and provided to facilities for review on request May not be used to re review a previous IDR decision IDR/IIDR Informal Dispute Resolution procedures vary widely by state. In Alabama, the present system utilizes a three person panel consisting of one attorney who hears CNA abuse cases, and two nurses who teach at AUM School of Nursing. Dr. Geary often attends IDR sessions. 6
IDR/IIDR Independent Informal Dispute Resolution (IIDR) Available only when CMPs are imposed by CMS and are subject to escrow (more on this later), generally this occurs only for tags cited at G and above. Information about availability of IIDR provided in CMS Imposition Notice IDR/IIDR IIDR not available if IDR process previously used unless IDR process completed before imposition notice sent IIDR process must be approved by CMS Must be conducted by an entity with an understanding of Medicare and Medicaid program requirements, but independent of the State Survey Agency IDR/IIDR IIDR process Must allow affected resident(s), family members, and state LTC ombudsman to provide comment. Must be completed within 60 days of facility request. Must generate a written record. 7
IDR/IIDR IIDR most of the same restrictions apply as in IDR does not delay enforcement action, can t challenge s/s (except IJ/SSQ), doesn t delay enforcement, can t challenge failure to follow survey process, citation inconsistency, inadequacy of IIDR process. IDR/IIDR Both IDR and IIDR meetings are an informal administrative process and are in no way to be construed as formal administrative hearings. Not required to perfect appeal rights. Cannot be appealed. SA/RO can override an IDR/IIDR decision with some limitations. In Alabama, a request for an IDR is due at the same time as the POC. Instructions for making an IDR request are included in the letter transmitting the 2567. An IDR request must state which tags are disputed, and give a brief basis for the dispute. It does not need to be exhaustive a two or three sentence statement is what is being asked for. 8
BAD: We disagree with the citation of F 323. GOOD: We disagree with the citation of F323 because the resident in question was adequately assessed and care planned. In addition, her care plan was followed, her progress was monitored, and ineffective interventions were changed. Once the IDR request is received, you will be sent an acknowledgement that the request is received, and be given a date for the IDR meeting. You will also be asked to submit a thorough explanation of your dispute along with all documents you want the panel to consider. If you disputed the tag ahead of the 2567, start from that submission. In all events, it is very important to be thorough and to do all the intellectual heavy lifting. Don t just send voluminous records and charts. Make it easy for those reviewing your information to find in your favor. 9
Thinking through your response it s always a good idea to start with the language of the proposed tag and the interpretive guidance. These can be found in Appendix PP of the State Operations Manual. If you don t have a copy of Appendix PP, you need one. AHCA s Watermelon Book (Long Term Care Survey Binder) includes this, or a pdf file can be downloaded free from CMS. Type SOM & Appendix PP into a search engine. Note: Electronic versions are notoriously difficult to navigate. There are no page numbers and the table of contents is not very helpful. For example, let s look at F 323 Accidents. This is a commonly cited tag at G and higher levels when there has been a fall with injuries. 10
F323 483.25(h) Accidents. The facility must ensure that (1) The resident environment remains as free from accident hazards as is possible; and (2) Each resident receives adequate supervision and assistance devices to prevent accidents. Interpretive Guidelines 483.25(h) Accidents. For various reasons, residents are exposed to some potential for harm. Although hazards should not be ignored, there are varying degrees of potential for harm. It is reasonable to accept some risks as a trade off for the potential benefits, such as maintaining dignity, self determination, and control over one s daily life. The facility s challenge is to balance protecting the resident s right to make choices and the facility s responsibility to comply with all regulations. Interpretive Guidelines 483.25(h) Accidents. The responsibility to respect a resident s choices is balanced by considering the potential impact of these choices on other individuals and on the facility s obligation to protect the residents from harm. The facility has a responsibility to educate a resident, family, and staff regarding significant risks related to a resident s choices. Incorporating a resident s choices into the plan of care can help the facility balance interventions to reduce the risk of an accident, while honoring the resident s autonomy. 11
Interpretive Guidelines 483.25(h) Accidents. Consent by resident or responsible party alone does not relieve the provider of its responsibility to assure the health, safety, and welfare of its residents, including protecting them from avoidable accidents. While Federal regulations affirm the resident s right to participate in care planning and to refuse treatment, the regulations do not create the right for a resident, legal surrogate, or representative to demand the facility use specific medical interventions or treatments that the facility deems inappropriate. The regulations hold the facility ultimately accountable for the resident s care and safety. Verbal consent or signed consent forms do not eliminate a facility s responsibility to protect a resident from an avoidable accident. Interpretive Guidelines 483.25(h) Accidents. Supervision is an intervention and a means of mitigating accident risk. Facilities are obligated to provide adequate supervision to prevent accidents. Adequacy of supervision is defined by type and frequency, based on the individual resident s assessed needs, and identified hazards in the resident environment. Adequate supervision may vary from resident to resident and from time to time for the same resident. Tools or items such as personal alarms can help to monitor a resident s activities, but do not eliminate the need for adequate supervision. Interpretive Guidelines 483.25(h) Accidents. NOTE: It is important to remember that not all accidents in a facility, regardless of outcome to a resident, are necessarily due to facility noncompliance. A resident can sustain bodily injury as a result of an accident over which the facility had no control (i.e., an unavoidable accident). The survey team needs to review the situation that led to the injury or potential for injury, as well as the facility practices, and resident s rights, preferences, and choices, to determine if the potential or negative outcome was avoidable or unavoidable. 12
How should surveyors determine avoidability? Interpretive Guidelines 483.25(h) Accidents. For the resident who has had an accident or was assessed at risk for an avoidable accident, the facility is in compliance with this requirement, if staff have: Identified hazards and risk of an avoidable accident based on the facility s assessment of the resident environment and the resident, including the need for supervision and/or assistive devices; Evaluated/analyzed the hazards and risks; Implemented interventions, including adequate supervision and/or assistive devices, to reduce the risks of an accident that were consistent with a resident s needs, goals, plan of care, and current standards of practice; How should surveyors determine avoidability? Interpretive Guidelines 483.25(h) Accidents. For the resident who has had an accident or was assessed at risk for an avoidable accident, the facility is in compliance with this requirement, if staff have: Provided assistive devices consistent with a resident s needs; Properly deployed and maintained resident specific equipment (e.g., lifts, canes, wheelchairs, walkers); Provided a safe environment, such as by monitoring chemicals, wet floors, cords and other equipment; Operated equipment in accordance with manufacturer s recommendations and resident need; How should surveyors determine avoidability? Interpretive Guidelines 483.25(h) Accidents. For the resident who has had an accident or was assessed at risk for an avoidable accident, the facility is in compliance with this requirement, if staff have: Provided and maintain a secure environment (e.g., resident room, unit, common use areas, stairs and windows, facility grounds, etc.) to prevent negative outcomes (e.g., prevent falling/tumbling down stairs or jumping from windows or eloping through exit doors) for residents who exhibit unsafe wandering and/or elopement behavior (regardless of whether ambulatory, in wheelchair or using walker); and Monitored the effectiveness of the interventions and modified the interventions as necessary, in accordance with current standards of practice. 13
Interpretive Guidelines 483.25(h) Accidents. (from beginning of F323 IGs) The intent of this requirement is to ensure the facility provides an environment that is free from accident hazards over which the facility has control and provides supervision and assistive devices to each resident to prevent avoidable accidents. This includes: Identifying hazard(s) and risk(s); Evaluating and analyzing hazard(s) and risk(s); Implementing interventions to reduce hazard(s) and risk(s); and Monitoring for effectiveness and modifying interventions when necessary. The elements of unavoidability: Assessment Care Planning Implementing the Care Plan Monitoring the Effectiveness of the Care Plan Modifying Ineffective Interventions For falls and most other adverse outcomes, we will want to argue that the outcome was unavoidable. The elements of unavoidability form the core of our argument and the evidence we submit, quoting liberally from the interpretive guidance. 14
Note that the elements of unavoidability (facility must assess, care plan, faithfully execute the care plan, monitor, and change ineffective interventions) more or less constitute something analogous to, in a liability case, a breach. It is of course another matter whether this actually constitutes a breach under state law. We often finding ourselves defending both civil and regulatory liability. Because of the structure of the severity and scope grid, however, when there is an adverse outcome, and the facility has failed any of the five elements of unavoidability, causation is assumed for regulatory purposes. (This is one good argument for keeping G and higher level citations out of evidence in a liability case.) Read the regulatory language, the interpretive guidance, and, if possible the DAB cases that cover this tag. http://www.hhs.gov/dab/search.html See what CMS says the gist of this tag really is. 15
http://www.hhs.gov/dab/decisions/index.html http://www.hhs.gov/dab/decisions/index.html http://www.hhs.gov/dab/decisions/index.html 16
. Construct your argument based on the actual regulatory language and guidance. Attached records should be indexed, highlighted, and quoted directly. ENSURE RECORDS SENT DO NOT DIFFER FROM RECORDS GIVEN TO SURVEYORS, OR BE PREPARED TO EXPLAIN WHY THEY WERE CHANGED LATER. Questions to answer Why facility actions were appropriate given the circumstances. How records show that facility actions were as you claim they were. 17
Questions to answer Why regulatory requirement as written or interpreted means facility actions were appropriate. Be thorough in your explanations. Do not expect the panel to pore through your records to find what you need them to find. Your best opportunity to prevail at IDR is to construct a strong and clear written submission. A notebook with tabbed exhibits is easiest to follow. Explaining why records were not considered by surveyors. Weak argument surveyors asked for records, you could not find. 18
Explaining why records were not considered by surveyors. Better surveyors never asked for records. Explaining why records were not considered by surveyors. Better yet records offered to surveyors, surveyors didn t want them. Explaining why records were not considered by surveyors. Best surveyors have records and didn t credit them, ignored them, or did not understand their significance. 19
In general, facilities opportunity to prevail in these situations is improved if they are willing to work harder and think harder than the surveyors did. Details matter. IDR/IIDR Meeting IDR/IIDRs are very informal, but face to face preparation and face to face rehearsal are absolutely critical. At least two preparation sessions are recommended, one a week or so before the meeting, and the other the morning of the meeting or the afternoon before. IDR/IIDR Meeting It would be unusual for the survey staff who will be sitting on the other side of the IDR/IIDR table to have spent extensive preparation time. The survey agency has many advantages going into the process this is one area where we can have an advantage over them if we are willing and able to spend the time to do it. 20
IDR/IIDR Meeting The panel will almost certainly have read your submission. If they were not convinced by what you said in that submission, they are unlikely to be convinced by anything you say at the meeting. The goal for the meeting is to hold on to the momentum created by an excellent written submission, and to answer or clarify any issues that confuse the panel. Abuse Reporting Requirements Exercise CNA on 7 3 shift, shortly after report goes to room to help two residents out of bed. First resident is moderately cognitively impaired female (BIMS=9, short term and long term memory loss). She appears to be sound asleep when CNA arrives, but is writhing and moaning. 21
Exercise Resident says to her, Thank God you re here. There was a man in here a minute ago. He slapped me in the face, twisted my arm, and pulled my hair. I thought he was going to pull my arm off. I screamed and he ran away. Exercise CNA believes the resident must have been having a bad dream, but notifies Charge Nurse. There were no male staff on the outgoing or incoming shifts for that wing. A quick check reveals no one saw any men on the wing at any time. Exercise Only description resident can provide is that he was a big white man wearing a mask. Resident s room mate says she heard no commotion. Charge nurse reports incident to DON. 22
Exercise Describe the next steps that should be taken by management of the facility. Federal Regulatory Requirements Self Investigations F225 42 CFR 483.13(c)(2) The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source and misappropriation of resident property are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency). Federal Regulatory Requirements Self Investigations F225 42 CFR 483.13(c)(3) The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress. 23
Federal Regulatory Requirements Self Investigations F225 42 CFR 483.13(c)(4) The results of all investigations must be reported to the administrator or his designated representative and to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken. State Regulatory Requirements Self Investigations 420 5 10.07(1)(d) The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including suspicious injuries of an unknown source and misappropriation of resident property are reported immediately to the administrator of the facility. Alleged violations that would constitute violations of criminal statutes, such as murders, rapes, and assaults must also be reported to the appropriate local law enforcement agency. State Regulatory Requirements Self Investigations 420 5 10.03(1)(j) Unusual Occurrences. Occurrences such as catastrophes and unusual occurrences which threaten the welfare, safety or health of residents, personnel, or visitors shall be documented within 24 hours of the incident or occurrence. This documentation shall be retained in the facility for at least 2 years. All records required by this subsection shall be, upon request, made immediately available to surveyors employed by the Alabama Department of Public Health. Copies of such records shall be forwarded to the Alabama Department of Public Health promptly upon request. The term, Unusual occurrences includes life threatening burns, and deaths under unusual circumstances. 24
State Regulatory Requirements Self Investigations 420 5 10.07(1)(e) The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress. State Regulatory Requirements Self Investigations 420 5 10.07(1)(f) The results of all investigations must be reported to the administrator or his designated representative and to the Alabama Department of Public Health within 5 working days of the incident, and if the alleged violation is verified, appropriate corrective action must be taken. Regulatory Requirements Self Investigations The 24 hour requirement means within 24 clock hours after any staff member becomes aware of the allegation. This is for the report to ADPH. This is independent of the obligation to notify the attending physician and the family or sponsor, which should always be done as soon as possible. This means all staff must be aware of this obligation! 25
Regulatory Requirements Self Investigations The 24 hour requirement means within 24 clock hours after any staff member becomes aware of the allegation. This is for the report to ADPH. This is independent of the obligation to notify the family, which should always be done as soon as possible. Do the staff know who to report to? Regulatory Requirements Self Investigations The 24 hour requirement means within 24 clock hours after any staff member becomes aware of the allegation. This is for the report to ADPH. This is independent of the obligation to notify the family, which should always be done as soon as possible. Do all staff know what should be reported? Exercise DON reports to work at 7 a.m., is met by CNA who pulls her into resident s room. Resident has black eye, multiple bruises on arms bilaterally. They ask resident what happened to her, she says she doesn t remember. She denies being in pain. 26
Exercise A review of nurses notes for the resident shows that on previous Saturday morning, a CNA had notified the charge nurse that she had a knot on her head. The resident denied knowing what happened. Exercise Weekend staff say they thought she fell. There is no incident report and no report of a fall or resident found on floor. Resident has a known history of being combative during baths. ADL records show resident was given a bath Saturday morning. Exercise CNA who bathed resident continued to work the entire weekend. She states that the resident became combative during her bath and she stopped bathing her. 27
Exercise Describe the next steps that should be taken by management of the facility. Regulatory Requirements Self Investigations Any allegation of abuse is reportable. Allegations may come from residents themselves ( I was abused or I saw another resident being abused ), family members, other visitors, or staff. Once the allegation is made known to any staff member, the clock is ticking. Regulatory Requirements Self Investigations Suspicious injury of unknown origin means any injury a) When staff cannot be absolutely positive what the cause of the injury is; and b) That is of a nature that abuse cannot be ruled out, such as injury to or near a private area of the body, an injury to the face or neck, an injury that is consistent with finger marks, or an injury requiring medical attention or evaluation. 28
Regulatory Requirements Self Investigations Suspicious injury of unknown origin means any injury a) When staff cannot be absolutely positive what the cause of the injury is this means that if staff believe the resident fell, the fall should be documented consistently with the facility s policy for reporting and documenting falls. If staff think the resident may have fallen, and the resident is injured, this is a suspicious injury of unknown origin. Regulatory Requirements Self Investigations Failure of staff to respond appropriately to allegations of abuse or suspicious injuries of unknown origin can result in severe regulatory liability as well as civil liability. Any allegation of abuse and any suspicious injury or unknown origin requires the facility s abuse protocol to be immediately invoked. This includes removing any alleged or suspected perpetrators from resident contact, notifying the facility administrator, notifying the survey agency within 24 hours, and beginning a thorough investigation. Regulatory Requirements Self Investigations Failure of staff to respond appropriately to allegations of abuse or suspicious injuries of unknown origin can result in severe regulatory liability as well as civil liability. Failure to immediately invoke the abuse protocol and relieve any suspected or alleged perpetrators from resident care duties can be grounds for an immediate jeopardy citation. Reluctance often caused by not wanting to believe that abuse has occurred is fatal. 29
Exercise Resident tells DON that CNA Jones murdered a neighboring resident last year. She didn t think I saw her, but I did. She went into the room and pulled out all the tubes going into her. Then she died. Exercise The DON checks the records and finds that this resident has been in the facility for two years. Nobody living in her vicinity, including her room mate, had a feeding tube nor were there any devices attached to tubes going to the body. Exercise Describe the next steps that should be taken by management of the facility. 30
Abuse Protocol Three elements, non negotiable 1. Protect victim and other residents from abuse while investigation is underway 2. Notify state survey agency as soon as possible, but not later than 24 hours after allegation is made or situation discovered 3. Conduct thorough investigation, report due in five days Minimum Requirements for Incident Investigation Documentation Circumstances under which the incident occurred. When the incident occurred (date and time). Where the incident occurred (for example, bathroom, bedroom, street, or lawn). Immediate treatment rendered. Minimum Requirements for Incident Investigation Documentation Names, telephone numbers, and addresses of witnesses. Date and time relatives or sponsor were notified. Out of facility treatment. 31
Minimum Requirements for Incident Investigation Documentation Symptoms of pain and injury discussed with the physician, and the date and time the physician was notified. The extent of injury, if any, to the affected resident or residents. Minimum Requirements for Incident Investigation Documentation For interviews: Provenance of the interview, including date/time, name of person conducting interview, name of person being interviewed, brief statement of reason for interview. Minimum Requirements for Incident Investigation Documentation Follow up care and outcome resolution. The action taken by the facility to prevent the occurrence of similar incidents in the future. This is a systems question. Anything else specified in facility s own P&Ps. 32
Minimum Requirements for Incident Investigation Documentation GOALS: Report shows a thorough, competent investigation. Conclusions make sense to the reader. Facility has already identified and corrected any problems by the time the report is read by outside entities. Don t worry if you can t remember all this... Total non retention has kept my education from being a burden to me. Flannery O Connor, The Habit of Being: Letters of Flannery O Connor. Questions? Comments? 33