Administrative Rules of the State of Montana

BEFORE THE Department of Public

health and human services of the

STATE OF MONTANA

In the matter of the amendment of ARM 37.34.1501 and the repeal of 37.34.1502, 37.34.1506, 37.34.1507, 37.34.1511, 37.34.1512, and 37.34.1513 pertaining to incident reporting

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NOTICE OF AMENDMENT AND REPEAL

TO: All Concerned Persons

1. On October 11, 2012, the Department of Public Health and Human Services published MAR Notice No. 37-608 pertaining to the public hearing on the proposed amendment and repeal of the above-stated rules at page 1994 of the 2012 Montana Administrative Register, Issue Number 19.

2. The department has repealed ARM 37.34.1502, 37.34.1506, 37.34.1507, 37.34.1511, 37.34.1512, and 37.34.1513 as proposed.

3. The department has amended the following rule as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:

37.34.1501 INCIDENT REPORTING AND HANDLING, PURPOSE

(1) remains as proposed.

(a) The Developmental Disabilities Program Incident Management Procedures Manual, dated ~~August 8, 2012~~ February 1, 2013, sets forth further requirements and criteria that govern the incident management system for the developmental disabilities program of the department.

(b) The department ~~hereby~~ adopts and incorporates by reference the Developmental Disabilities Program Incident Management Procedures Manual, dated ~~August 8, 2012~~ February 1, 2013.

AUTH: 53-6-402, 53-20-204, MCA

IMP: 53-6-402, 53-20-205, MCA

4. The department has thoroughly considered the comments and testimony received. A summary of the comments received and the department's responses are as follows:

All comments received pertain to the Developmental Disabilities Program Incident Management Procedures Manual (hereafter referred to as the "manual"), dated February 1, 2013. The effective date of the manual was changed from August 8, 2012 due to comments made to this rule and to coincide with the publication date of this MAR notice. The manual with the added changes may be viewed at the following web site: http://www.dphhs.mt.gov/dsd/admnrules.shtml.

COMMENT #1: One commenter stated that the definition of abuse includes "the infliction of physical or mental injury," but on page 6 of the manual there are separate categories for physical injury and mental injury. Does this not serve to confuse people?

RESPONSE #1: The department does not agree with this comment. Abuse is a cause of physical and mental injury. The data management system prompts the question of abuse as a cause of the physical or mental injury.

COMMENT #2: A commenter asked why not use the "other" event section in "Therap" and enter in physical abuse. They stated that when reports are run on "Therap," these incidents will show as injury and not abuse, which makes it harder to pick out which clients should be reviewed during high risk.

RESPONSE #2: The department is removing the choice of "other" as it skews the data based on inconsistent use of language and misspellings. The department also wants providers to report on causes.

COMMENT #3: One commenter asked if self-neglect on page 6 of the manual should have a Montana Code Annotated (MCA) definition as the other categories do and asked if self-injurious behavior that results in injury constitute self-neglect.

RESPONSE #3: There is currently no definition for self-neglect in MCA. The department has changed the language of this definition to make it less confusing to the reader.

COMMENT #4: One commenter asked if "civil-rights violation" on page 7 of the manual should have a bolded heading and MCA as the other categories do. In addition, this commenter asked for specification of what is a civil-rights violation.

RESPONSE #4: Civil rights encompass both federal and state laws establishing certain rights or prohibiting certain types of discrimination. The rule and manual cannot comprehensively provide a listing of all possible applicable laws. It is expected that those persons involved in the reporting and review of incidents will have common knowledge of actions that may constitute violations and will proceed to report those possible incidents. The Developmental Disabilities (DD) Program in carrying out the administration of the incident report system can obtain further advice as to the nature of such incidents for the purpose of further processing them.

COMMENT #5: One commenter stated that "reportable injuries" under the incident definitions section is very vague and that doctors do a lot more than first aid. The commenter also states that the definition for "critical" is only if they are admitted to a hospital which leaves everything else as reportable.

RESPONSE #5: The department reviewed this comment and will keep the language that events classified with a severity of reportable injuries are those that require treatment of staff or medical personnel; however, the department will remove the examples in the proposed language of the manual to avoid the confusion expressed by this commenter.

The intent of the critical events language is to encompass emergency room treatment or a physician treatment that results in a hospital admission or any injury from suspected abuse and neglect.

COMMENT #6: One commenter asked about the medication error section on page 9 of the manual, asking what do with medication if it is dropped on the floor.

RESPONSE #6: The department will add a section to the "other" category and include medications that are located or found in a place not specifically indicated for medicine storage.

COMMENT #7: One commenter asked about the section of the manual on page 11, "restraints other." This commenter requested we supply examples rather than refer to the Administrative Rules of Montana (ARM) that address restraints.

RESPONSE #7: The department will leave the reference to the ARM which address restraints. Though this requires an additional resource, it ensures that the rules remain consistent and are not repetitive.

COMMENT #8: One commenter asked if catching someone when they are falling to prevent them from falling or assist them to the floor is considered a restraint.

RESPONSE #8: Physical restraint is restricting a person's movement by holding or applying physical pressure to bring the person's behavior under control in order to avoid the risk of serious harm to the person, other person(s), or the environment. Further information regarding restraints can be found in ARM Title 37, chapter 34, subchapter 14. If the incident results in an injury, it must be reported as an injury.

COMMENT #9: One commenter questioned "Other incidents as listed in the data management system" section on page 12, if someone is attacked by a staff member or member of the community, why it isn't considered physical abuse. They suggest the "other" category be selected in "Therap" and then type in physical abuse.

RESPONSE #9: The department agrees, in part, with the commenter that it is physical abuse but will keep this listed under assault. Physical abuse is not an event; it is the result of an event, which in this situation is the assault. This will help keep the data cleaner.

COMMENT #10: One commenter asked if a person is considered "AWOL/missing" if the person's whereabouts is unknown and it is not due to suspected abuse, neglect, or exploitation.

RESPONSE #10: In addition to suspected abuse, neglect, or exploitation, the definition of "AWOL/Missing" person also states if a person whose whereabouts is unknown and whose supervision needs, or pattern of behavior, is cause for concern for reasons of safety and wellbeing, the person would be considered "AWOL/Missing." The department reviewed this section and has changed the wording to make the department's intent more evident.

COMMENT #11: One commenter would like to know why the behavioral issue option is not available to use as a category for an incident. They state that it is a highly used category by staff.

RESPONSE #11: The department determined that the general event record is not meant to record behavioral data, unless the behavior leads to an incident, which would then be recorded as the incident for the purpose of this policy.

COMMENT #12: One commenter asked why events identified in "Therap" that are not approved for use are not removed from the drop down list. The commenter stated that if they are available on the list then staff will use them.

RESPONSE #12: The department is an end user of the "Therap" system and therefore cannot make the modifications requested. The department will provide training on this manual and it is the responsibility of the incident management coordinators to ensure proper coding in compliance with this policy.

COMMENT #13: One commenter asked if law enforcement involvement would include motor vehicle accidents.

RESPONSE #13: The department has reviewed this comment and the definition of "law enforcement" on page 13 of the manual and has decided to remove the list of examples from the manual since it is not all inclusive and might cause confusion. The definition of law enforcement involvement is any incident involving a person where law enforcement has been contacted; therefore, if the motor vehicle accident results in law enforcement involvement, then yes, it is included.

COMMENT #14: One commenter requested to use the event of "hospital without admission" for an unscheduled medical issue rather than serious illness as that is the way it has been done in the past and the commenter would like to know why it must change.

RESPONSE #14: The feedback the department received prior to this manual update from users was that using "hospital without admission" was unclear.

COMMENT #15: One commenter asked if the P.R.N. protocol must be signed by the doctor or is the presence of a script sufficient.

RESPONSE #15: The protocol must be signed by the physician; the department added the language in the manual to specify this requirement.

COMMENT #16: One commenter asked when there is law enforcement involvement if the incident management coordinators interview witnesses.

RESPONSE #16: When law enforcement is involved, they direct the process regarding interviewing witnesses. Providers must also follow the procedures provided in the investigator's manual.

COMMENT #17: One commenter asked if it should be an agency decision removing an employee, who is an alleged perpetrator, from contact during an investigation.

RESPONSE #17: The department disagrees with this comment. This is one of the performance measures required for a federal program and is not a change from past department policies.

COMMENT #18: One commenter expressed concern about the requirement to supply a copy of the administrative review (AR) to the person or legal representative. They stated they are concerned about the confidentiality of the document and that others working in the home may have access to the material contained in the document. The commenter would like a requirement to "sanitize" the document. The commenter also questioned an appeal process in the event the person or legal representatives disagree with the outcome of the AR.

RESPONSE #18: The department has considered the comment and has determined that the redaction of certain information must occur before release of the report to the person or their legal representative. While a report may contain reference to the information concerning the incident received from other residents or persons receiving services, personal information about health status and other personal matters of those other residents or persons receiving services that may appear in a report must also be redacted. In addition, employment related actions taken by a provider in relation to an employee who is alleged to be responsible for the harm to the person must also be redacted from a report.

COMMENT #19: One commenter asked why the "trends" information is only provided to the case management supervisor rather than all case managers.

RESPONSE #19: The department reviewed the process and determined that all case managers do not need all "trends" information; therefore, the case management supervisor can determine who needs the information and provide it to the appropriate case managers.

COMMENT #20: One commenter stated that the requirement for the incident management coordinator to be responsible for calling team meetings to discuss patterns or trends of incidents should be the responsibility of the team. Alternatively, the incident management committee makes recommendations that are not already addressed by the team.

RESPONSE #20: The department determined it is important to have one person responsible for monitoring trends and calling meetings when appropriate. By assigning the responsibility of this to one person, it provides a safeguard to assure it happens.

COMMENT #21: One commenter stated that listing the shifts in which injuries and other incidents occur isn't necessary because the time is already entered.

RESPONSE #21: The department has reviewed this comment and will remove the reference to the shift and leave time of incident as the sole requirement.

COMMENT #22: One commenter asked why there is a requirement for the incident management committee to determine who to do a high-risk review (HRR) on. The commenter stated it is a waste of time for the incident management coordinator to pull this information and bring it to the committee when they could determine who meets the criteria and schedule the review.

RESPONSE #22: The department agrees that there is a clear cut criterion for when a high-risk review is needed. Therefore, the department will amend the language in the manual to reflect that the incident management coordinator will bring only those that do not clearly meet the criteria to the incident management committee. However, the committee also has the discretion to recommend an HRR when someone doesn't meet the criteria and it is valuable to get a wide range of input in a team environment rather than having one person make that determination independently.

COMMENT #23: A commenter asked if the "triage report and process" should be added to Appendix A and requested the term "if applicable" be added regarding the investigator arriving at the scene.

RESPONSE #23: Appendix A lists the stages to conducting a full investigation; therefore, triage is not a part of this process and is located in a separate section of the manual. As Appendix A refers to full investigations, it will always be applicable and required for the investigator to arrive at the scene.

COMMENT #24: One commenter asked what is "reconciliation of evidence."

RESPONSE #24: The act of reconciling something is to resolve the issue at hand and to check it for accuracy. Beginning on page 30, stage 3, in the incident management procedures manual there is a list of the core rules (guidelines) associated with reconciliation of evidence provided to assist with the process.

COMMENT #25: One commenter asked if in Appendix B, other staff involved should be identified by name or initials in the general event report.

RESPONSE #25: Yes, other staff involved in an incident should be identified by name. The department added clarifying language to this section.

COMMENT #26: One commenter stated that on page 38 of the procedure manual it would be good to have column headings on the top of each page of the appendix.

RESPONSE #26: The department agrees with this suggestion and will add column headings at the top of each page.

COMMENT #27: One commenter asked if the quality improvement specialist (QIS) should be notified of law enforcement involvement, med errors, and other reportable and all internal incidents.

RESPONSE #27: Per the chart in Appendix C, the QIS is still notified in the above referenced events via the incident reports in the data management system. It is not a telephonic notification.

COMMENT #28: One commenter had multiple concerns about the two charts in Appendix D.

RESPONSE #28: The department has reviewed appendix D and had determined to remove it from the manual. Appendix D was intended to be a tool for providers to use and the information found in the manual is available in the manual.

COMMENT #29: One commenter had multiple comments regarding the final investigation report form as follows:

a) there is not a place for case number on the final investigation report form and only one space for provider notification;

b) does the question regarding injuries resulting in hospitalization also include those that result in medical treatment;

c) requested page numbers for the report;

d) should the "investigator recommendations/provider agency follow-up actions" actually be committee recommendations; and

e) stated there is no space for the investigator to sign.

RESPONSE #29: The department responds as follows:

a) The department removed the place for case number because the person's name is now referenced.

b) Injuries resulting in hospitalization do not include those that result in medical treatment.

c) Page numbers will be placed in the documents when the electronic versions are posted, the department did not add them for the purpose of this notification.

d) The form is correct as proposed; the provider is responsible for the investigation and the recommendations as a result of the investigation. The committee may have input on the provider recommendations through the incident management review process.

e) The department will add a signature line for those forms filled out manually; however, the department expects the majority of the forms will be electronic.

COMMENT #30: One commenter asked if there is a place on the form for committee recommendations, how providers will know what actions were taken based on the investigations, and why there is not more room for signatures on the administrative review so that the agency, the QIS, and the case managers can all sign in agreement.

RESPONSE #30: The forms attached to this document will be available in electronic formats; the boxes expand as they are filled in allowing for room to make the committee recommendations. In the new policy, the administrative review form is completed by the agency's administration or the regional manager, depending on who completed the investigation. The committee will monitor and follow up on the recommendation at the committee meetings to ensure they are implemented. The person filling out the form is the only signature required on the new form.

COMMENT #31: One commenter asked why there isn't a place for case numbers on the triage form and why is there only one place for signature.

RESPONSE #31: The department removed the place for case number because the person's name is now referenced. The director or the coordinator is the only signature required on the new form.

COMMENT #32: One commenter asked why there is not a signature block on the witness form.

RESPONSE #32: The witness must sign directly under their completed statement to prevent additional statements from being added after the witness has signed the document.

/s/ Cary B. Lund /s/ Richard H. Opper

Rule Reviewer Richard H. Opper, Director

Public Health and Human Services

Certified to the Secretary of State January 22, 2013.