Incident Reporting and Improvement System (IRIS)

2. Incident Reporting and Improvement System (IRIS) • A program of the N.C. Department of Health and Human Services (DHHS) and N.C. Division of Mental Health/ Developmental Disabilities/Substance Abuse Services (DMH/DD/SAS) • Helps ensure serious adverse events involving people receiving publicly funded mental health, developmental disabilities and/or substance abuse (MH/DD/SA) services are: • Addressed quickly • Used to analyze trends to prevent future occurrences/improve the service system • Providers of publicly funded services are required to report incidents involving members (consumers) receiving MH/DD/SA services. Failure to do so may result in DHHS taking administrative action against the provider’s license or authorization to provide services. • Providers should also notify all other appropriate agencies as required by law.

3. Vaya Health Incident Report Team (IRT) • The IRT reviews IRIS reports to monitor provider responses to incidents, ensure necessary steps are taken to protect the individuals involved and to minimize the occurrence of future incidents. • Incident reports assist Vaya in our monitoring responsibilities. • IRIS reports must include: • Details of the incident • A summary of the activities undertaken by the provider to respond to the incident • Any corrective measures implemented as a result of the incident • Preventive measures being put into place to avoid similar events in the future If the submission is incomplete or unsatisfactory, Vaya is authorized to request additional information as needed.

4. What is an incident? • An incident is an event that is not consistent with the routine operation of a facility or service or the routine care of a member and that is likely to lead to adverse effects for a member. • For reporting purposes, incidents are divided into three levels, based on the potential or actual severity of the event:

5. Who reviews incident reports? • DHHS • DMH/DD/SAS • Vaya Health • Incident Report Team • Care coordinators • Provider Monitoring staff • Critical Incident Review Committee: Reviews Level IIIs and some Level IIs for further assessment of the provider’s response to the incident and to ensure appropriate steps have been taken. • Other contracted LME/MCOs

6. Confidentiality • All incident reports are confidential quality assurance documents and protected from disclosure by: • 10A NCAC Subchapter 26B • N.C. Gen. Stat. § 122C-30(2) • N.C. Gen. Stat. § 122C-31(e) • N.C. Gen. Stat. § 122C-52 • N.C. Gen. Stat. § 122C-191(e) • Incident reports are not referred to or filed in a member’s individual service records.

7. Level I incidents • Level I incidents are events that, in isolated numbers, do not significantly threaten the health or safety of an individual but could indicate systematic problems if they were to occur frequently. • These incidents do not need to be reported outside of the provider agency. Providers must: • Maintain documentation of the incident internally • Report to other authorities as required by law • Require provider staff to evaluate and consider any trends or areas of concern. It is the responsibility of the provider agency to create an internal system to track and find trends in Level I incidents. Documentation should be available to Vaya upon request. (10A NCAC 27G.0602-0604)

8. Level II incidents • Level II incidents are events that involve a threat to the health or safety of the member or another person due to the member's behaviorormember deaths caused by terminal illness or natural cause (when official documentation is provided). • All deaths are considered to be due from “unknown causes” until officially determined otherwise by a death certificate or the medical examiner’s report. • Level II incident require documentation to be reported in IRIS and to other authorities as required by law.

9. Level III incidents • Level III incidents are events that result in death (or pose a substantial risk of death) or sexual assault or that cause permanent physical or psychological impairment; or incidents that are perceived to be a significant danger to, or concern of, the community. • 10A NCAC 27G .0602 • Examples of Level III incidents include: • Death • Substantial risk of death • Sexual assault • Critical consumer behaviors (e.g. rape, homicide, Amber or Silver alerts, etc.)

10. Level III incidents: Guidelines • Level III incidents require documentation of the incident and a report to Vaya, DHHS and other authorities as required by law. “Concern for community” incidents are events that are: • Perceived as a significant danger to the community • Likely to encounter media coverage • Involve a member whose behavior poses an eminent concern to the community • Answering yes to any of the questions above will automatically upgrade the incident to a Level III. • Level III incidents should be immediately reported to: • DMH/DD/SAS Customer Service • Community Rights Team • Vaya or other host LME/MCO

11. Level III incidents: Internal reviews • A level III incident triggers an Internal Team Review process by the provider. Vaya will also review the provider’s response. • The provider must initiate a formal internal team review process within 24 hours of the incident. • A written preliminary findings of fact must be issued within five working days of the incident. • The final written report should be submitted within three months of the incident. • The internal review is required only if the incident occurred while the member was receiving a service or if the incident occurred on the provider’s premises.

12. Timelines for reporting A provider must submit an initial incident report within 72 hours of learning about an incident, even if the provider does not yet have all of the facts about the incident. * PLEASE NOTE: A death occurring within seven days of restrictive intervention must be reported in IRIS immediately. A death that occurs while member is receiving opioid treatment must be reported in IRIS, regardless of the insurance type or self-pay status.

13. Reporting guidelines • Report even if the incident occurred while the individual was not under your active care. “Under your care” means the member received a service within the last 90 days prior to the incident. • Complete all required sections for the Level II and III incidents. • Always give as much information as is known about an incident. • Use the “Five Ws Rule”: Who, what, where, when and why (and sometimes how) • Other considerations: • Residential or ACT services are considered under your care 24 hours a day. • Day services or periodic services are considered under your care while staff is providing services. • Crisis providers are expected to report incidents that occur during provision of crisis services.

14. Submitting to IRIS: The basics • Physical address should be the address of the local site (facility, unit, group home, etc.) • “Host LME” is based on the county in which the service is provided. • “Home LME” is based on the county where the member (consumer) legally resides (county of Medicaid eligibility). • The city of the physical address should match with the appropriate Host LME county. • Asheville = Buncombe County • Lenoir = Caldwell County • Waynesville = Haywood County

15. Submitting to IRIS: Other people involved • Providers sometimes forget to indicate whether anyone else was involved in the incident. Be sure to complete this section as required. • Allegations against a facility: If the incident includes an allegation against a staff member, you must select “Yes” for this question.

16. Submitting to IRIS: Tabs • Many sections contain multiple tabs. • Failing to complete each tab can result in the incident report missing some information and/or cause errors when trying to submit.

17. Submitting to IRIS: Member information • Even though IRIS does not require these fields, Vaya expects all fields be completed fully before submitting the report. Answer “Yes” or “No.” Do not select “Unknown.”

18. Submitting to IRIS: Service type • At least one service must be selected to show which service the member is receiving to continue through the report. • For service types that do not apply, the provider will need to go through each tab and select NO. ✔

19. Submitting to IRIS: Incident type • This section should always have a category selected for the type of incident. • IRIS will direct the reporter to complete required information based on the chosen category.

20. Incident category types • Death • Restrictive intervention • Consumer injury • Allegations • Medication error • Consumer behavior • Suspension/expulsion • Fire • Other incident type

21. Deaths • Providers must report all member deaths when they become aware of it, even if the death occurred while the individual was not under the provider’s care. • The 24-hour notifications can be done by phone call, voicemail or email and to either one of the Incident Report Team members or to the team’s shared inbox: IncidentReport@vayahealth.com. • It is important to note that ALL deaths are considered Level IIIs until the manner of death has been confirmed by one of two official documents: • Medical examiner’s report • Death certificate

22. Deaths: Level criteria • Level II • Terminal illness • Natural causes • The Incident Report Team will downgrade these to a Level II once the medical examiner’s report has been attached to the IRIS Report. • Level III • Accident • Motor vehicle • Drowning • Choking • Suicide • Homicide/violence • Assault • Gunshot • Drug overdose • Unknown cause

23. Restrictive intervention • Restrictive intervention incidents are recorded by type and duration. • They are described in detail to include purpose, pre-attempts, debriefing, staff involved, plan of action and member status (initial, ending and follow-up).

24. Restrictive intervention SECLUSION, ISOLATION TIME OUT AND/OR RESTRAINT • Level II • Emergency or unplanned use • Planned use that exceeds authorized limits • Administered by an unauthorized person • Resulted in discomfort or complaint • Requires treatment • Level III • Results in permanent physical or psychological impairment • Is perceived to be a significant danger to concern of the community

25. Injury DUE TO/CAUSE • Assault • Behavioral outburst • Fall • Motor vehicle accident • Seizure • Self-injurious behavior • Etc. DESCRIPTION • Ache/pain • Broken bone • Burn • Cut/laceration • Indication of pain • Sprain, strain or twist • Etc. Any injury that fits criteria from OSHA’s First Aid List (https://www.osha.gov/recordkeeping/tutorial/first-aid-list.pdf) should be considered a Level I incident.

26. Injury: Level criteria A visit to the emergency department (in and of itself) is not considered a reportable incident. Level III • Injury that results in permanent physical or psychological impairment • Perceived to be a significant danger to or concern of the community Level II • Does not include diagnostic tests (blood work, x-rays or MRI) • Goes beyond first aid (as defined by OSHA guidelines) NOTE: Medical Illness of a member is not reportable unless it results in injury or death or is believed to be caused by abuse/neglect or a medication error.

27. Allegations of abuse, neglect and/or exploitation Verbal and mental abuse • Harassment • Belittling • Insulting • Teasing/mocking • Scaring/threatening • Berating • Cursing/swearing Physical and sexual abuse • Scratching, hitting, punching, biting, strangling or kicking • Throwing something at a member, such as a phone, book, shoe or plate • Grabbing, pushing or pulling the member • Pulling hair • Using or threatening with a gun, knife, or other weapon • Forcing a member to have sex or perform a sexual act

28. Allegations of abuse, neglect and/or exploitation Exploitation • Using a person/belongings for another’s gain • Cashing checks without permission • Forging signatures • Stealing money or belongings • Unauthorized cash withdrawals • Changes in wills without permission Neglect • Failure to supervise or protect (abandonment) • Failure to assist with daily care • Failure to provide basic necessities (food, water, medication, clothing, etc.) • Unsanitary living conditions • Self-neglect

29. Allegations of abuse, neglect and/or exploitation Level II • Any allegation • Can be against: • A caretaker • Friend • Relative • Staff • Stranger • Anyone else Level III • Allegation of an act that has resulted in permanent physical or psychological impairment • Incident perceived to be a significant danger to or concern of the community

30. Medication errors • All medication errors must be evaluated by a physician, pharmacist, physician’s assistant or nurse practitioner. • This professional should be notified immediately. Include his or her determination on IRIS submission form. • A physician and/or pharmacist will indicate the level of threat to the member’s health and determine treatment required, if any.

31. Medication errors: Examples • Missed dose • Wrong dose • Refusal • Wrong time • Wrong medication • Wrong member • Wrong administrative technique • Loss or spillage of medication • Dose preparation error • Other

32. Medication errors: Level criteria • Level I: • No threat to the member’s health or safety as determined by a physician or pharmacist • Level II: • If the medication error shows any side effects or distress • If medical attention was needed • Include self-administration errors even if it did not happen while actively engaged in providing services • Level III • Any medication error that causes permanent or psychological impairment

33. Member behavior • Report any behavior that is potentially a serious threat to the health or safety of self or others • Report any sexual, aggressive or destructive behavior that involves a report to law enforcement or a complaint to an oversight agency, including an LME, DSS, DHSR or DMH/DD/SAS. • Providers of Day and Periodic Services must report any member acts that are reported to law enforcement in IRIS.

34. Member behavior: Examples • Aggressive behavior • Destructive behavior • Illegal act • Inappropriate sexual behavior • Suicide attempt • Unplanned absence greater than three hours or involves police • Diversion of drugs • Other

35. Member behavior: Suicidal • Level I • Any suicidal threat or verbalization that indicates a new or different behavior or an increase in the number of these behaviors • Level II • Any suicidal behavior that does not result in death • Level III • Any suicidal behavior that result in permanent physical or psychological impairment, or, the incident is perceived to be a significant danger to or concern of the community

36. Member behavior: Inappropriate Sexual Behavior • Level I: Inappropriate sexual behavior that is not a potentially serious threat to others and does not involve a report to Law Enforcement or complaint to an oversight agency. • Level II: Any sexual behavior that involves a potentially serious threat to others (or is a threat to the safety of others); or involves a report to Law Enforcement or complaint to an oversight agency, including DSS. • Level III: Any sexual behavior that results in death, permanent physical or psychological impairment caused by the consumer; or if the incident is perceived to be a significant danger to or concern of the community. • Level 1 examples: Masturbation, consensual sex • Level II examples:Unwanted touching, kissing, or physically injurious masturbation • Level III examples:Rape, sexual assault, including unwanted touching/kissing, physical injurious masturbation, coercing someone to perform sexual behaviors that he/she would not ordinarily do

37. Member behavior: Absence • Level I • Any absence of up to three hours that is not specified in the Service Plan, if police contact is not required. • Level II • Any absence greater than three hours over the time specified in the individual’s Service Plan and/or any absence that requires police contact. • Level III • Amber Alerts • Silver Alerts Be sure to provide us with an update if and when the individual is located.

38. Member behavior: Member act • Level I: Any aggressive or destructive act that does not involve a report to law enforcement or an oversight agency. • Level II: Any aggressive or destructive act or illegal behavior that involves a report to law enforcement or oversight agency or is a potentially serious threat to health or safety of self or others. • Level III: Any member act that results in death, permanent physical or psychological impairment caused by the member or if the incident is perceived to be a significant danger to or concern of the community. • Level 1 examples: • Throwing a chair or destruction of their own property. • Level II examples: • Hitting someone, destroy public or private property, stealing, diverting drugs, injuring someone, taking illegal or non-prescribed drugs (for him/herself), starting a fire • Level III examples: • Member act will be under public scrutiny

39. Fire • Level I: Any fire that poses no threat to the health or safety of the member or others • Level II: Any fire that threatens the health or safety of the member or others • Level III: Any fire that results in permanent physical or psychological impairment, or, the incident is perceived to be a significant danger to or concern of the community

40. Other incident categories • Suspension • Level 1: Any provider withdrawal of services for less than one day due to member misconduct • Level II: Any provider withdrawal of services for more than one day due to member misconduct • Expulsion: • Level II: Any permanent provider withdrawal of services due to member misconduct (discharge). If an expulsion occurs, indicate if the member has been referred to another agency for continued care.) If suspension or expulsion is due to lack of following rules of the agency, please specify the rule when reporting. • Search and seizure • Level I: The search of the member’s living area/ seizure of member’s property, in the member’s possession • Confidentiality breaches • Level I: Any breach of a member’s confidentiality

41. Submitting to IRIS: Supervisor actions • Supervisor Actions tabs: • Level of Incident (automatically filled) • Cause of Incident • Incident Prevention • Incident Submission • The ‘save’ button (red arrow) does not submit – it only allows the provider to save progress made. • Saved incident reports cannot be viewed by the LME/MCO. The only way to correctly submit is to click “Submit Incident Report” (green arrow). • NOTE: MANY incident reports go unreceived when providers save a report but do not actually submit it!

42. Submitting to IRIS: Completion • A provider will still receive an incident number even without successful submission of the report. • An incident is successfully submitted when you have reached the page showing a “Thumbs Up” graphic. • Keep a record of the incident number to access the report at a later time (NOT TO BE SHARED WITH THE LME/MCO). TIP: There are no letter “Os” in incident numbers.

43. Retrieve an IRIS report • If you need to retrieve an incident report, enter the incident number and member’s last name into the fields located toward the top of the main page on the IRIS website. • Or, contact Vaya’s Incident Report Team (IRT) and request that we trigger IRIS to email the incident number to the person who entered the report and/or his/her supervisor.

44. IRIS unavailable? • If IRIS is unavailable at any time, providers still must meet the required timeframes for submission of an incident. • Complete the paper forms found at https://www.ncdhhs.gov/document/incident-response-improvement-system-iris-forms. • Fax to appropriate agencies within required timeframes. • Vaya fax number: 828-398-4407, Attn: Incident Report Team • DHHS fax number: 919-508-0986 The report must still be submitted into IRIS once the system becomes available again.

45. Updating incident reports Vaya may request resubmission due to: • Missing information • Member identifying factors, such as date of birth, Home-LME Client Record No., Medicaid number, etc. • Incident Category Type not indicated • Incomplete information • Details of incident are lacking • Prevention section does not include preventive measures • HCPR not completed when allegation of abuse is made against the provider • Inaccurate information • Updates requested by DMH • Other inquiries The resubmission request will be sent to the employee who submitted the original incident via email. Vaya should receive the requested information within 10 days.

46. Online resources IRIS RESOURCES ONLINE • DHHS: https://www.ncdhhs.gov/document/iris-resources • Vaya Health: www.vayahealth.com IRIS Website LIVE-SITE (NC Incident Response Improvement System) https://iris.dhhs.state.nc.us/ IRIS Practice (User Acceptance Testing Site) https://irisuat.dhhs.state.nc.us/

47. Questions? Vaya Health Incident Report Team (IRT): • Phone: 1-800-893-6246 (toll-free) • Email: IncidentReport@vayahealth.com • Ayofemi Powell: ext. 1104, Ayofemi.Powell@vayahealth.com • Tashia Shamwell: ext. 5094, Tashia.Shamwell@vayahealth.com If you are in doubt, please get in touch with us. We are happy to help!