PHYSICAL AND CHEMICAL RESTRAINTS AFH COMPLAINT/INCIDENT INVESTIGATION PROTOCOL

PURPOSE To guide investigation of allegations of inappropriate use of physical and/or chemical restraints to determine if failed facility practice relative to a statute(s) or regulation(s) has occurred and if the failed practice(s) had, or has, the potential to contribute to negative resident(s) outcome(s). IMPORTANT CONSIDERATIONS Residents have the right to be free from restraints used for convenience or discipline. Investigators may find restraining devices/practices used to allegedly limit falls, prevent exit seeking and/or deal with behavioral or other issues. The use of any type of restraint had, or has, the potential to contribute to negative physical or mental outcomes and/or to violate resident rights. Any physical/medical device used on or near a residents body should be assessed for safety, regardless of its intended purpose or its identified need for its use. Refer to RCS Management Bulletin R05-086 Medical Device Safety for updated information on safety risks associated with the use of devices. Focus your investigation on whether the device or practice is for restraining purposes, when and how it is used, and the providers efforts to use other approaches or measures prior to using the restraining device or practice. If it is identified that the AFH is using a device/practice as a physical restraint, the RCS staff investigator is to determine if there is a documented medical reason for its use, a safety assessment of the device in use, and if there is immediate supervision by appropriate professionals available whenever the restraining device or practice is used. The term chemical restraint means a psychopharmacologic drug that is used for discipline or convenience and not required to treat the residents medical symptoms. With regard to chemical restraints:

Discipline can be considered an action taken by the provider and/or caregiver for the purpose of punishing or penalizing residents. Convenience can be considered as an action taken by the provider and/or caregiver to control or manage a residents behavior with a lesser amount of effort by the staff and not in the residents best interest. Medical symptom can be defined as an indication or characteristic of a physical and/or psychological condition.

For investigation of allegations of the inappropriate use of chemical restraints, RCS staff is to determine if there is a documented medical reason for the drug(s) use, if the drug(s) are used only as ordered, and if the sole use of such drug(s) is not for staff convenience or resident discipline.

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AUTHORITY The following is a list of rules and regulations that pertain to the use of physical or chemical restraints. Review these rules and regulations and others that may apply. Chapter 70.128 RCW Adult Family Homes Chapter 70.129 RCW Long-Term Care Resident Rights Chapter 74.34. RCW Abuse of Vulnerable Adults WAC 388-76-540 Definitions WAC 388-76-60070 Other Resident Rights WAC 388-76-605 Restraints WAC 388-76-61000 through 61080 Resident Assessment WAC 388-76-61500 through 61560 - Negotiated Care Plan WAC 388-76-620(1)(4)(a)(b)(c)(5) Provision of Services and Care WAC 388-76-64010 Resident Medications WAC 388-76-655 General Management and Administration WAC 388-76-660 Training WAC 388-76-675 Reporting Requirements WAC 388-76-770 Safety and Maintenance I. OFF-SITE PREPARATION Review pertinent section(s) of RCS C/I Guidance. This protocol has two sections: I. Physical Restraints; and II. Chemical Restraints For allegations related to abuse or neglect, refer to the AFH Abuse or Neglect Protocols for sections relevant to Off-Site Preparation. SECTION I PHYSICAL RESTRAINTS A. Identify/Clarify Issues If information reveals the concern is not within RCS statutory jurisdiction, refer to MB R07-010 Operational Principle and Procedure for CRU Complaint/Incident Referral Processing in Field Offices, for guidance and actions to take. When working this protocol, remember the continued potential dangers that the use of physical/medical devices pose to certain residents. While medical devices should not be automatically considered restraints, neither should they be used as restraints. Complainant Interview What type of physical device(s) are you concerned about? Have you see it used? How recently? Did the provider/caregiver explain why/when the device is used? Do you know if the resident is able to self-release/get out of any device adjacent to their body? How does the resident act when the device is used? How does the provider/caregiver monitor the devices use and address the residents needs when it is used?

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Is there a nurse or doctor in the home when the device is in use? How do you know this (for fact) regardless of whether answer is Yes/No?

B. Preliminary RCW/WAC Selection: As part of the off-site investigation plan, determine the number of allegation(s) to be investigated, as identified on the Complaint Intake Routing Form from CRU and from any additional information obtained prior to going on-site. Identify in advance the likely applicable statutes and/or regulations that address the allegation(s) to be investigated. If the investigation determines additional unalleged failed facility practice(s), go back and determine additional RCW/WACs applicable for these citations, as well. C. Review History Review RCS C/I Guidance, Section II. D. Plan Approach to Investigation 1. Special Considerations Review pertinent section(s) of RCS C/I Guidance. In addition: Consider that vulnerable adults/residents at risk for entrapment in the bed environment are often those who are frail or aged and those with conditions, such as agitation, delirium, confusion, pain, uncontrolled body movement, hypoxia, bowel impaction, and urinary retention. Remember that the resident always has the right to refuse to use any/all physical device(s) and/or any/all medications. If there are allegations of insufficient staffing, refer to the AFH Insufficient Staff Protocol for sections relevant to planning the investigation. 2. Observation Planning Review pertinent section(s) of RCS C/I Guidance. In addition, observe resident(s) and the environment for any kind of use of a physical device/provider restraining practice(s). Environment (Sample list is not meant to be all-inclusive) Light levels? Resident(s) Staff Observe staff interactions with resident and how they apply/use physical/medical devices: * When/why do they use them? * How do they monitor use of device(s)? * Do they release it if the resident requests it?

Type of Physical/Medical Device & Resident Response: * Beds lowered/on floor? Temperature? * Soft waist/wrist bands/ties? Monitoring devices/intercoms? * Seat belts (able to release?) lap tables/ recliners/Velcro gates? Amount of time spent in bed? * Personal alarms/ Wander Guard band?

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Environment (Sample list is not meant to be all-inclusive) Proximity to toilet within view and accessible

Resident(s)

Staff

Side rails * , , full? * Spacing between mattress and rail? * Entrapment potential? * Have resident demonstrate how/when the side rail is used? * How applied, how often/when released and repositioned? Can the resident: * Release the device? * Summon on-duty staff assistance and make needs known? * Become entrapped/injured by it? Are residents toileting, repositioning, skin, hydration, behavioral needs addressed? Does the resident appear distressed when the physical/medical device is in use? If yes, document behaviors.

Do they release restraint as scheduled for toileting, repositioning, ambulating, etc.?

Bed safety height, mattress/overlay, spacing between mattress and device in use, bed against wall, side rails of any type, transfer pole

Safety and maintenance

Chair safety and mobility recliner chair, wheelchair, merry walker, lap belt If fall(s) were the justification for using a physical/medical device, observe where fall(s) occurred and ask for a demonstration/explanation of how fall(s) occurred.

3. Interview Planning If the physical/medical device is determined by assessment/observation to be a restraint, ask sufficient questions to support these findings. Routinely plan to interview the resident, caregiver and provider separately.

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Physical/Medical Device(s) as Possible Restraints:

Resident(s)/Family/Representative(s) What is this device? Providers/Caregiver/Staff Why and when is this physical/medical device used? Does the AFH provider consider this physical/medical device a restraint? Why or why not? When do you use it? How long have you had it? Why? Did you okay its use? Did you sign any papers giving consent? Did the provider discuss the risks to your safety with you? Does the resident/family/representative(s) understand the level/significance of the risks to safety posed by this device or practice? Are you able to remove/release it yourself? Can you show me (have staff present)? Or, does staff remove it when you ask them to? If no, tell me more about that. Do you get the help you request/need when this device is on? Were other measures tried prior to using this device? Were the risks and benefits explained? Tell me more about this please. How does the resident act when the device is being used? How does the resident ask/indicate they need assistance? How do you monitor the use of this device and for its safety with this particular resident? Can the resident self-release it? Can/does the resident ask to have it removed? How often do you release it? How do you meet the residents hydration, skin and toileting needs when this device is used? What type of training does AFH staff receive regarding physical/medical device(s) as restraints? If the AFH provider considers the device a restraint, is qualified staff on-site and immediately available (around-the-clock) to supervise the use of this specific physical/ medical device?

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4. Record Review Planning Make preliminary decisions regarding which records need to be reviewed and adjust/expand as needed, based on information obtained on-site. SECTION II CHEMICAL RESTRAINTS I. OFF-SITE PREPARATION A. Identify/Clarify Issues If information reveals the concern is not within RCS statutory jurisdiction, refer to MB R07-010 Operational Principle and Procedure for CRU Complaint/Incident Referral Processing in Field Offices, for guidance and actions to take. For investigation of allegations of the inappropriate use of chemical restraints, RCS staff is to determine if there is a documented medical reason for the drug(s) use, if the drug(s) are used only as ordered and if the sole use of such drug(s) is not for staff convenience or resident discipline. Complainant Interview: What is your concern about the residents psychopharmacological medication(s)? What specific medication/substances are you concerned about? When and how did you become aware of this problem? Why do you think the resident is being given these medication(s)? Have you talked with the residents physician to understand why s/he ordered these medication(s)? Tell me about that. B. Preliminary RCW/WAC Selection As part of the off-site investigation plan, determine the number of allegation(s) to be investigated, as identified on the Complaint Intake Routing Form from CRU and from any additional information obtained prior to going on-site. Identify in advance the likely applicable statutes and/or regulations that address the allegation(s) to be investigated. If the investigation determines additional unalleged failed facility practice(s), go back and determine additional RCW/WACs applicable for these citations, as well. C. Review History Review RCS C/I Guidance, Section II. D. Plan Approach to Investigation 1. Special Considerations Review pertinent section(s) of RCS C/I Guidance. In addition: Make arrangements for access to a current medication reference source to aid you in your investigative work. Consult with your Field Manager on the best timing of your initial visit on-site. Depending on information obtained from the Complainant, consider contacting the pharmacy source providing medications for the named resident for additional information and/or a current medication profile.

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2. Observation Planning Review pertinent section(s) of RCS C/I Guidance. In addition: Observe resident(s) ability to maintain cognitive and physical skills and a general interest in the ongoing activities in the home. Observe resident(s) for potential evidence of sedation, i.e. slurred speech, slow responses, excessive sleepiness, unsteady/wobbly gait, etc. Observe if there is sufficient staff to meet resident(s) needs? 3. Interview Planning Interview a number of residents to gather sufficient information to rule in or rule out failed facility practice. Resident(s)/Family/Representative(s) How are you feeling today? Is this how you usually feel? I notice you are taking (medications of concern). What can you tell me about it? Why are you taking it? Does it seem to help you? Does it give you any problems? Staff/Supervisory Staff What types of medications does the resident take and why? Are any of them taken for anxiety, sleep or difficult behaviors? What other approaches do you use prior to giving these medications? Who decides when the resident needs these medications? How do you know when to give them to the resident? If you have a choice of doses, how do you decide which dose to give? Do they help? Tell me more about that.

Can you refuse to take any/all of your medications? If no, have you told anyone about this? If not, why not? What does staff do/say when you dont want to take your medications?

Have you noticed any changes in the residents cognition or behaviors after the medication was started? Have there been recent changes in the amount of medication used or when it is used?

4. Record Review Planning Make preliminary decisions regarding which records need to be reviewed and make adjustments based on information obtained on-site.

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II. ON-SITE ACTIVITIES Follow your on-site investigation plan as written. Based on information obtained during the on-site investigation, expand observations and interviews, as needed. In addition, conduct the Record Reviews as follows:

I. Physical Restraints
Record Reviews Resident Records What is the purpose of the device, such as special mattress, side rails, seatbelt, Gerichair, or transfer pole? Why is the device or intervention being used with, on, or for the resident? When was the device initiated? By whom? Provider/Staff Records If insufficient staffing concerns, review staffing records and the AFH Insufficient Staff Protocol. Review providers behavior monitoring policy/procedures/practices. Verify orientation, basic/modified training, ongoing continuing education and specialty training, as applicable for all staff based on the resident(s) pertinent diagnoses/needs for care. Review evidence of follow-up for falls and/or other accidents/injuries that may have precipitated the use of a physical/ medical device. Determine if evidence of follow-up by AFH provider led to logical conclusions and prompt/timely revisions to the negotiated care plan. Are there current assessment documents addressing safety issues and medical indications for use of the device? Was assessment done by a qualified person? How recently? Evidence that risks/benefits were explained/alternatives tried and failed? Is there evidence that the benefit of the device outweighs the risks to this particular residents safety, given their physical, cognitive and functional abilities? Determine if AFH caregivers were informed of the above revisions to the negotiated care plan in a timely manner. Determine if AFH provider/caregivers followed the revised negotiated care plan to minimize/avoid the use of devices used as physical restraints with the named resident(s), if at all possible.

Does it enhance or restrict the residents current mobility capabilities?

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Resident Records Negotiated care plan reflects: * Environmental/behavioral strategies/ modifications when indicated * Addresses the residents care needs and safety issues related to the restraining device/practice?

Provider/Staff Records

Intentionally left blank.

Resident has the right to refuse to use the device?

If falls involved: * Fall prevention used as justification for use of the device? * Cause of fall determined and resident evaluated for contributing factors? * Other methods used and proven to fail prior to using the device? Environmental/behavioral strategies/ modifications when indicated? Addresses the residents care needs and safety issues while device in use? Resident given opportunity to make informed decision about use of device to the best of their capabilities? Directions to staff regarding use of device, i.e., circumstances/behaviors/alternate approaches, monitoring, etc.? II. Chemical Restraints
Resident Records When was the medication(s) initiated? Provider/Staff Records If insufficient staffing concerns, review staffing records, if available, and refer to the AFH Insufficient Staff Protocol. Personnel file conduct file review as indicated to verify orientation, basic/ modified training, ongoing continuing education, and specialty training based on the residents diagnoses/needs for care, as applicable.

Why were the medication(s) added for this resident?

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Resident Records Did the resident take any medications prior to admission for sedation, anxiety, or other behaviors?

Provider/Staff Records If your investigation raises the issue of potential medication mismanagement and/or problems with medication assistance/administration, refer to the AFH Medication Management/Administration Protocol for additional provider/staff records to consider for possible review.

Do health care providers orders exist for prescribed medication(s) of all types? Current resident assessment documents a medical reason for use of medication(s)? Current assessment by a qualified person? Current assessment indicates need for medication(s) resident is taking (prescription and over-the counter)? Consent documented? Evidence present that risks/benefits discussed and informed consent given by appropriate decision maker? Negotiated care plan reflects: * Environmental/behavioral strategies/ modifications? * Alternate approaches to try prior to administering medication? * Directions to staff regarding use of the medications, such as circumstances/ behaviors/alternate approaches, monitoring? Daily Medication Log: * Correct medication(s) dose(s) and times given per prescribers orders? * Is medication given PRN (as needed) or routinely given? * Are trends and patterns evident and evaluated? * Frequency and timing of medication(s)? * Symptoms medication(s) given for? * Who administers the medication(s)? * Concerns medication(s) used for staff convenience?

Intentionally left blank.

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Resident Records Nurse delegation? If yes, are the provider/caregivers in compliance with these regulations? Is there evidence that the residents responses to the medication(s) and/or their behaviors are monitored?

Provider/Staff Records

Intentionally left blank.

Review and Analyze Data Determine if sufficient information has been obtained to answer key questions about failed facility practice and negative resident(s) outcomes. Is the device/medication being used as a restraint? Is the device/medication being used for staff convenience or resident discipline? Is this practice specific to certain staff? Is there any evidence that lack of staffing or lack of qualified staff was a factor in the use of the physical and/or chemical restraint? Does this practice affect more than one resident and/or involve more than one type of device/medication? Does the provider demonstrate understanding of the residents rights and the regulatory requirements related to the use of a restraining device or a chemical restraint? Do a brief review of the Key Triggers documents. Talk to your Field Manager when applicable prior to leaving the facility to determine if any additional data may need to be collected and analyzed. Remember: It is NOT the medical device and/or the psychopharmacological medication that is a physical and/or chemical restraint, it is the effect that the device or medication has on restricting or limiting the resident(s) function. In addition, lack of a written assessment does not automatically mean that use of a device/medication makes it a physical or chemical restraint. For failed facility practice regarding Physical Restraints WAC 388-76-61020(4)(5)(9) What Must be Included in the Resident Assessment? To cite facility practice that failed to ensure that the residents assessment included known behaviors and symptoms requiring special care, cognitive status and/or functional abilities that supported the use of a specific medical device. Then, identify if the failure had, or has, resulted in specific negative resident(s) outcomes. For failed facility practice regarding Chemical Restraints Refer to the most relevant AFH Assessment and Outcome regulations to fit the casespecific facts.

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For failed facility practice regarding Physical Restraints WAC 388-76-770(2) Safety and Maintenance. This requires the provider shall ensure that the AFH is maintained internally and externally in good repair and condition, and free of hazards. Use this regulation to cite facility practice that failed to ensure the residents environment was free of hazards and if this failure had, or has, resulted in specific negative resident(s) outcomes.

For failed facility practice regarding Chemical Restraints Consult with your Field Manager and/or the RCS Assistant Director for additional direction.

Status Report/Exit Conference: Use this opportunity to explain preliminary findings and identified deficiencies to the provider or provider representative to provide them with an opportunity to ask questions and present additional information. Ensure provider or provider representative is aware of resident issues that need immediate attention. See page 21 of RCS C/I Guidance for details of this last task to be done prior to exit from the home or the last day of on-site data collection. III. OFF-SITE ACTIVITIES & FINAL DETERMINATION Review pertinent section(s) of RCS C/I Guidance. In addition, complete the following tasks: 1. Final determination of failed facility practice with regulation(s). 2. Inform provider of final outcome of investigation. 3. Complete a Statement of Deficiency and related enforcement activities (if applicable). 4. Make necessary follow-up referrals to the CRU if/as applicable.

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