IRIS 40-Hour Health and Safety Assurance Policy

4.0 Health and Safety

Ensuring the health and safety of IRIS (Include, Respect, I Self-Direct) program participants is one of the six assurance areas in the approved 1915(c) Home and Community-Based Services waiver. The Centers for Medicare and Medicaid Services (CMS) requires states to document in the waiver application how the state will ensure the health and safety of program participants, including performance measures that measure compliance with the approved 1915(c) Home and Community-Based Services waiver.  IRIS participants may elect to exercise employer authority over their caregivers or workers (1915(c) Appendix E-1: 2 of 13). Under employer authority, the participant hires, schedules, and manages his or her own caregivers who are known as participant-hired workers (PHWs). DHS policy prevents a single PHW from providing more than 40 hours per week of paid caregiving to an individual participant, regardless of their employer. These hours may be any combination of supportive home care, IRIS self-directed personal care (SDPC), respite, daily living skills training, or other services paid at an hourly rate. The goal of this policy is to mitigate safety risks to both the participant and the PHW, while still allowing participants to exercise their employer and budget authority. This policy does not limit the total number of hours in a participant’s care plan; it merely limits the number of hours that a single PHW can provide. Any exceptions to this policy are noted in the IRIS Work Instructions in Section 4.0A Participants choosing to exercise their employer authority are required to be compliant with all U.S. Department of Labor regulations, including the Fair Labor Standards Act (FLSA).


4.1 Assessing Risk


The approved 1915 (c) Home and Community-Based Services waiver states the following about how the IRIS program assesses, monitors, and mitigates risk in Appendix D-1-e: 


“Participation in a self-directed waiver provides participants with new opportunities, responsibilities, and risks. Finding the right balance between the participants’ right to make choices with OIM’s (Office of IRIS Management) obligation to ensure participant safety requires special consideration and careful planning. 

ICAs are required to collaborate with participants to identify potential risks and to help identify and implement strategies to mitigate identified risks. ICAs [IRIS consultant agencies] are able to define their own practices for assessing risks to participants during the ISSP [Individual Support and Service Plan] development process. 

OIM monitors the health and safety of participants through the record review process, which has indicators in place that ensure the ICA addressed all health and safety risks. Health and safety issues must be addressed in the ISSP based on the participant’s needs and preferences.


As part of risk mitigation, participants are required to have comprehensive emergency backup plans in the event that needed services are for any reason not accessible. Emergency backup plans must contain the following components:

  • Medical needs
  • Behavior needs
  • Medication and medical equipment needs
  • General overview of the participant’s daily schedule
  • Contact information for emergency backup providers
  • Contact information for service providers including medical providers and the IRIS consultant

Other pertinent participant-specific information 

ICAs may implement their own emergency backup plan format approved by OIM. All formats must provide sufficient information to ensure a backup caregiver can provide the participant with needed care to ensure the participant’s health and safety in the absence of the participant’s primary caregiver. 

The participant and IRIS consultant collaborate to develop the emergency backup plan as part of the ISSP development process. The participant and the IRIS consultant review the accuracy and effectiveness of the emergency backup plan during every face-to-face visit and every phone contact. The participant is responsible for notifying the IRIS Consultant of any changes to their emergency backup plan.” 


4.2 Behavior Support


IRIS consultants are required to administer a behavior assessment for all participants for whom behaviors have been identified on an annual basis. 

The approved 1915 (c) Home and Community-Based Services waiver describes the following requirements about the annual assessment of participant needs in Appendix G-2-i: 

“On an annual basis, participants and IRIS consultants reassess the needs and long-term care outcomes of the participant by evaluating the results of the annual LTC FS (Long Term Care Functional Screen), the behaviorassessment (when required), and the participant’s progress on the outcomes identified on the previous year’s ISSP. The participant and IRIS consultant collaborate to ensure the new ISSP is an accurate and current reflection of the participant’s needs and the ISSP adequately supports the participant’s long-term care outcomes with IRIS-funded services used as a last resort.”


4.3 Restrictive Measures


The term “restrictive measures” refers to specific behavior support techniques that restrict a participant’s ability to move. Because of the risk of injury to either the participant or the caregiver when using restrictive measures, the use of restrictive measures must be approved by the Department of Health Services (DHS). 

The approved 1915 (c) Home and Community-Based Services waiver states the following regarding the required approval process for the use of restrictive measures in Appendix G-2-i:

 “The Office of IRIS Management (OIM) permits the use of restraints in limited situations as stated in Wisconsin Administrative Code § DHS 94.10, “For a community placement, the use of isolation, seclusion, or physical restraint shall be specifically approved by the department on a case-by-case basis and by the county department if the county department has authorized the community placement. In granting approval, a determination shall be made that use is necessary for continued community placement of the individual and that supports and safeguards necessary for the individual are in place.”


The approved 1915 (c) Home and Community-Based Services waiver defines “restraints” or restrictive measures in Appendix G-2-i: 

“The OIM defines “restraints” as any device, garment, or physical hold that restricts the voluntary movement of a person’s body, or access to any part of the body, and cannot be easily removed by the individual. (All long-term care programs in Wisconsin define restraints in this manner.) Examples include, but are not limited to: 

  •  Manual restraint
  •  Holding limbs or body contingent upon behavior
  •  Restricting or preventing movement
  •  Applying devices to any part of a person’s body contingent upon behavior
  •  Restricting or preventing movement or normal use or functioning of the body part that cannot be easily removed by the individual

The State of Wisconsin does not permit the use of medications to manage behaviors (chemical restraints) in the IRIS program unless the participant is in a licensed nursing facility under the direct supervision of the attending physician. The DHS Division of Quality Assurance (DQA) provides oversight and monitoring of the use of chemical restraints in licensed nursing facilities. Licensed nursing facilities are not eligible living settings in the IRIS program except for stays of 90 days or less for respite or rehabilitation purposes.” 

The approved 1915 (c) Home and Community-Based Services waiver describes the following requirements about the emergency use of restrictive measures in Appendix G-2-i: 

“The use of restraints requires written approval by the Department of Health Services (DHS) prior to implementation. OIM permits exceptions to this rule as an emergency response to a crisis. The participant, legal representative, and/or provider must report emergency use of restraints using the form “Incident Report – Medicaid Waiver Programs” (F-22541) in accordance with the critical incident reporting process. The IRIS consultant must work with the participant, legal representative, and/or provider to determine if the crisis was an isolated incident, or if there is a need to submit a request for approval to use restrictive measures.” 

The approved 1915 (c) Home and Community-Based Services waiver describes the following process for obtaining approval for the use of restrictive measures in Appendix G-2-i: 

“The IRIS consultant and participant must submit the appropriate request for approval. For restraints to be used as part of a Behavior Support Plan (BSP), the form “Requests for Use of Restraints, Isolation, and Protective Equipment as Part of a Behavior Support Plan” (F-62607) is required. For restraints to be used as a medical restraint, the form ‘Request for Use of Medical Restraints’ (F-62608) is required. Both request forms collect information that thoroughly demonstrates the need for the restraint, including the other least restrictive options that were attempted. Specific content includes:

  • Demographic information
  • Summary of the participant’s strengths and needs
  • Health considerations
  • Prescribed medications
  • Detailed description of challenging behavior(s)
  • Previous attempted intensive behavior supports, including outcomes
  • Current behavior supports (attach behavior support plan)
  • Description of why the restraint is being requested
  • Plan for monitoring, documenting, and reviewing the progress
  • Plan for training caregivers
  • Signatures of physician and behavioral support team

The ICAs are required to submit the completed request forms, including supplementary documentation, such as the participant’s behavior support plan, to the OIM for a pre-review via the DHS Restrictive Measures SharePoint site. The OIM ensures that the request is complete and all required documentation is attached. The OIM follows up with the ICA to obtain any missing or incomplete information through the DHS Restrictive Measures SharePoint site. The OIM routes completed requests to the appropriate reviewing party via the DHS Restrictive Measures SharePoint site. 

The Division of Long Term Care (DLTC) Restrictive Measures lead chairs a committee, which includes OIM representation, which reviews requests for the use of restraints from participants with developmental disabilities. DQA reviews requests for the use of restraints from participants who are elderly and/or have physical disabilities who reside in facilities regulated by DQA. The OIM reviews requests for the use of restraints, under guidance from the DLTC Restrictive Measures lead, from participants who are elderly and/or have physical disabilities, but do not reside in facilities regulated by DQA. 

All three reviewing entities deny applications when there is an option available that is less restrictive. Each reviewing entity provides written notification to the participant of the committee’s decision within 15 working days of the committee’s receipt of the application following a successful pre-review unless other arrangements are made. Complex cases may require additional time.”


4.4 Critical Incident Reporting


Ensuring the immediate and ongoing health and safety of the participants is one of the most important, and at times most difficult, aspects of a self-directed program such as IRIS. Incident reporting is an important way the IRIS consultant agencies (ICAs) and the DHS OIM help to ensure the participants’ health and safety. 

The approved 1915 (c) Home and Community-Based Services waiver states the following about the IRIS program’s critical incident reporting process in Appendix G-1-b: 

“The Department of Health Services (DHS) defines a critical incident as an event or situation that poses an immediate or serious risk to the participant’s physical or mental health, safety, and well-being. DHS also includes the misappropriation of the participant’s property and violation of the participant’s rights. Examples of critical incidents include:

  • Any alleged or confirmed abuse (mental/emotional, physical, sexual, verbal) or neglect, including self-neglect
  • Death of the participant, including accidents and suicide
  • Medical errors or medication administration errors that require medical attention
  • Illnesses, injuries, or hospitalizations that require emergency medical treatment, including accidents, suicide attempts, and mental/behavioral health emergencies
  • Law enforcement investigation when the participant is the alleged victim or the alleged perpetrator
  • Damage to a participant’s residence due to fire, natural disaster, or other cause
  • Misappropriation of a participant’s funds or property, including theft, damage, and exploitation
  • Unexpected significant behavior that is not addressed through a behavior support plan
  • Unapproved use of restrictive measures, including isolation and seclusion

ICAs are required to report critical incidents to the OIM using the form “Incident Report – Medicaid Waiver Programs” (F-22541). All Wisconsin Medicaid Waiver programs use this form for critical incident reporting in accordance with “Incident Reporting – Medicaid Waiver Programs – Instructions” (F-22541i). OIM divides the critical incident reporting process into four components: The IRIS consultant (IC) learns of the critical incident through the participant’s self-report or other means—participants should report incidents within 24 hours to their IRIS consultant. Participants receive education about what is considered reportable and how to report critical incidents during orientation and annually.

  •  The IC notifies the state agency contact via phone within three business days. High-profile cases require notification of OIM within 24 hours. “High-profile” is defined as a case that involved serious and immediate consequences to the participant. Incident types that fall into this category and require a 24-hour report to the Department include deaths, including suicides, as well as injuries sustained as a result of suspected abuse or neglect. (There is a slight variation from the instructions for the IRIS program in that notification takes place through the DHS-owned Critical Incident Reporting SharePoint site instead of by phone.)
  • The IC completes the form Incident Report – Medicaid Waiver Programs (F-22541) within seven calendar days, demonstrating assurance of the participant’s immediate and ongoing health and safety. The ICA attaches the form in the participant’s record in the IRIS centralized information technology system known as the Wisconsin IRIS Self-Directed Information Technology System (WISITS) and copies and pastes the required information into the participant’s record in the DHS Critical Incident Reporting SharePoint site. 
  • The ICA completes and documents all activities related to the participant’s immediate and ongoing health and welfare in both the case notes in WISITS and the DHS Critical Incident Reporting SharePoint site within 30 calendar days.

Fiscal employer agents have the responsibility to report all critical incidents identified in the course of interaction with participants and participant-hired workers. 

IM facilitates the initial review of each critical incident through the DHS Critical Incident Reporting SharePoint site using the following procedure:

  • ICAs enter each critical incident;
  • OIM reviews each critical incident validating that the participant’s immediate and ongoing health and welfare have been ensured;
  • OIM communicates required remediation tasks for individual negative findings;
  • ICAs complete the required individual remediation activities;
  • OIM validates the remediation activities and closes the incident when appropriate;
  • OIM runs aggregate data reports each month that OIM shares and discusses with the ICAs.

The DHS Critical Incident Reporting SharePoint site provides several advantages including centralizing the communication and documentation of the remediation of individual negative findings. The DHS Critical Incident Reporting SharePoint site serves as the IRIS program’s system of record for critical incident reporting data. The DHS Critical Incident Reporting SharePoint site will inform the future module within WISITS. At present, each ICA has its own SharePoint site to ensure compliance with the Health Information Portability and Accountability Act (HIPAA). 

The OIM meets monthly with each ICA to share the data from the DHS Critical Incident Reporting SharePoint site, and discuss identified trends and develop prevention strategies. During this meeting, the team also reviews each death. In previous waivers, the review of participant deaths was a performance measure that consistently achieved
100 percent compliance. Per CMS’ request, OIM has discontinued this performance measure, though the practice of reviewing each death will continue. In addition to reviewing each participant death, the team also reviews each case of alleged or actual abuse and neglect, such that OIM can provide greater oversight to the resolution of these incidents.”


4.5 Emergency Backup Plan


Each IRIS participant is required to maintain an emergency backup plan that meets the unique needs of the participant in the event of needing a backup caregiver in all situations, including those where there may be little or no notice. Each ICA is responsible for developing a DHS-approved emergency backup plan format. 

The approved 1915 (c) Home and Community-Based Services waiver states the following regarding emergency backup plans in Appendix D-1-e: 

“OIM monitors the health and safety of participants through the record review process, which has indicators in place that ensure the ICA addressed all health and safety risks. Health and safety issues must be addressed in the ISSP based on the participant’s needs and preferences. 

As part of risk mitigation, participants are required to have comprehensive emergency backup plans in the event that needed services are for any reason not accessible. Emergency backup plans must contain the following components:

  • Medical needs
  • Behavior needs
  • Medication and medical equipment needs
  • General overview of the participant’s daily schedule
  • Contact information for emergency backup providers
  • Contact information for service providers including medical providers and the IRIS Consultant
  • Other pertinent participant-specific information

ICAs may implement their own emergency backup plan format approved by OIM. All formats must provide sufficient information to ensure a backup caregiver can provide the participant with needed care to ensure the participant’s health and safety in the absence of the participant’s primary caregiver. The participant and IRIS consultant collaborate to develop the emergency backup plan as part of the ISSP development process. The participant and the IC review the accuracy and effectiveness of the emergency backup plan during every face-to-face visit and every phone contact. The participant is responsible for notifying the IC of any changes to their emergency backup plan.”

Last Revised: March 2, 2017