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STATEMENTS OF POLICY

Title 55--PUBLIC WELFARE

DEPARTMENT OF PUBLIC WELFARE

[55 PA. CODE CH. 6000]

Incident Management

[34 Pa.B. 1234]

Scope

   Individuals who are registered with a county mental retardation program or who receive supports and services from facilities licensed by the Department of Public Welfare's Office of Mental Retardation (OMR), or both, are afforded the protections detailed in this statement of policy.

   Providers who receive funds from the mental retardation system, either directly or indirectly, to provide or secure supports or services for individuals authorized to receive services from a county mental retardation program and providers licensed by the OMR are reporters and are to file incident reports as specified in this statement of policy.

   County mental retardation programs and their designated support coordination entities are reporters and are to file incident reports as specified in this statement of policy.

   Following the processes outlined in this statement of policy will satisfy the incident reporting requirements of 55 Pa. Code (relating to public welfare) for the following regulation chapters:

   *  Chapter 20--Relating to Licensure or Approval of Facilities and Agencies

   *  Chapter 2380--Relating to Adult Training Facilities

   *  Chapter 2390--Relating to Vocational Facilities

   *  Chapter 6400--Relating to Community Homes for Individuals with Mental Retardation

   *  Chapter 6500--Family Living Homes

   *  Chapter 6600--Intermediate Care Facilities for the Mentally Retarded

Purpose

   The purpose of this statement of policy is to specify the guidelines and procedures for the incident management process. The incident management process is a subset of a larger risk management process. Incident policies, procedures, training, response and reporting are all important aspects of the incident management process. Combined with other areas of risk assessment such as, but not limited to, employee injuries, complaints, satisfaction surveys and hiring practices, incident management is an essential component of a comprehensive quality management process.

   Providers and counties establish incident management and risk management related policies, procedures, orientation and training that address the items identified in Appendix E (relating to incident management components).

   This statement of policy establishes processes that will ensure the health and safety, enhance the dignity and protect the rights of individuals receiving supports and services. The processes include uniform practices for:

   *  Building organizational policies and structures to support incident management.

   *  Taking timely and appropriate action in response to incidents.

   *  Reporting of incidents.

   *  Investigating of incidents.

   *  Taking corrective action in response to incidents.

   *  Implementing quality improvement, risk management and incident management processes for the analysis and interpretation of individual and aggregate incident data.

Background

   All providers of mental retardation services and supports, including private and State-operated intermediate care facilities for persons with mental retardation (ICFs/MR), county mental health/mental retardation programs and the OMR are partners in the effort to ensure the health, safety and rights of persons receiving supports and services. Each entity reports certain incidents, collects information about those incidents and takes action based on those reports. The development and expansion of community-based supports and services and the increasing flexibility people enjoy to choose a wide variety of both traditional and nontraditional supports have increased the need to establish consistent Statewide processes for safeguarding individuals. To this end, the OMR promulgated Subchapter D (relating to incident management), published at 32 Pa.B. 2117 (April 27, 2002). Following the implementation period, the OMR systematically collected and evaluated feedback from a variety of sources. As part of a continuous quality improvement effort, opportunities for improvement were identified in the feedback, which resulted in the revisions contained in this statement of policy.

Discussion

   The primary goal of an incident management system is to ensure that when an incident occurs, the response will be adequate to protect the health, safety and rights of the individual. This statement of policy communicates clear and specific methodologies to ensure appropriate responses at the provider, county and State levels. The standardization of the reporting format, the time frames for reporting and the investigation protocol are key to conducting individual, provider, countywide and Statewide analysis of incidents. The continuous review and analysis of reported incidents at the provider, county and State levels is to enhance risk management processes and to formulate actions to prevent the recurrence of incidents.

   All reportable incidents are to be submitted electronically by means of the Home and Community Services Information System (HCSIS), a web-based system developed by the Department of Public Welfare. If HCSIS is unavailable, the submission of incidents is to occur by following the directions in the Incident Management Contingency Plan. See Appendix J (relating to incident management contingency plan).

   The incident management processes described in this statement of policy expect that investigations at the provider, county and State levels be conducted by certified investigators. This will ensure that all incidents that require investigation receive a systematic investigation that meets established standards. A training program and certification process has been established by the OMR and communicated by Mental Retardation Bulletin 00-01-06, Announcement of Certified Investigator Training, dated September 6, 2001.

   In addition to the OMR reporting processes described in this statement of policy, reporting requirements of other laws, regulations and policies must be followed. See Appendix F (relating to related laws, regulations and policies). Providers, supports coordination entities, counties and OMR must be vigilant to report any incident when there is a suspected crime to law enforcement. When an individual is allegedly abused, neglected or the victim of a crime, the individual is to be offered the support of a Victim's Assistance Program. See Appendix G (relating to victim's assistance programs).

   Facilities must comply with Chapters 2380, 2390, 6400, 6500 and 6600. To the extent that this statement of policy exceeds the requirements of Chapters 2380, 2390, 6400, 6500 and 6600, the use of this subchapter is optional for facilities. Because this statement of policy meets or exceeds the regulatory requirements in Chapters 2380, 2390, 6400, 6500 and 6600 compliance with the reporting procedures in this statement of policy will be accepted by the Department as meeting the regulatory requirements of §§ 2380.17, 2390.18, 6400.18 and 6500.20.

   The intention of the OMR is to develop an effective incident management system that applies an elevated standard concerning the health, safety and rights of individuals receiving services. Complying with this statement of policy will provide the opportunity to test and revise the policy before regulations related to incident management are revised or initiated. Therefore, it is in everyone's best interest that all providers adhere to the reporting specified in Annex A.

Obsolete Bulletins

   Mental Retardation Bulletin 00-01-05, Incident Management, issued August 27, 2001

   Mental Retardation Bulletin 00-02-02, Announcement of the Incident Management Implementation Schedule and Contingency Plan, issued March 1, 2002

   Mental Retardation Bulletin 00-02-14, Incident Management Interpretive Guideline, issued October 29, 2002

   Mental Retardation Bulletin 00-02-15, Incident Management Interpretive Guideline--Hospital Discharge Instructions, issued November 27, 2002

Obsolete Statement of Policy

   Sections 6000.461--6000.474 (relating to incident management)

Effective Date

   This statement of policy is effective February 21, 2004.

   (Editor's Note:  The regulations of the Department, 55 Pa. Code Chapter 6000, are amended by deleting a statement of policy in §§ 6000.461--6000.474 and by adding a statement of policy in §§ 6000.901--6000.904, 6000.911--6000.913, 6000.921--6000.925, 6000.931, 6000.941, 6000.951--6000.959, 6000.961, 6000.962, 6000.971, 6000.972, 6000.981--6000.985 and Appendices E--K to read as set forth in Annex A.)

ESTELLE B. RICHMAN,   
Secretary

   Fiscal Note:  14-BUL-065. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 55.  PUBLIC WELFARE

PART VIII.  MENTAL RETARDATION MANUAL

Subpart A.  STATEMENTS OF POLICY

CHAPTER 6000.  STATEMENTS OF POLICY

Subchapter D.  (Reserved)

§§ 6000.461--6000.474.  (Reserved).

Subchapter Q.  INCIDENT MANAGEMENT

GENERAL PROVISIONS

Sec.

6000.901.Scope.
6000.902.Purpose.
6000.903.Licensing applicability.
6000.904.Definitions.

RESPONSIBILITY FOR REPORTING/INVESTIGATING

6000.911.Providers.
6000.912.Individuals and families.
6000.913.County mental health/mental retardation programs.

REPORTABLE INCIDENTS

6000.921.Categories of incidents.
6000.922.Incidents to be reported within 24 hours.
6000.923.Incidents to be reported within 72 hours.
6000.924.Incident management contingency plan.
6000.925.Categories of incidents to be investigated.

SEQUENCE OF REPORTING

6000.931.Multiple categories and sequences.

INCIDENT MANAGEMENT PROCESS

6000.941.Administrative structure.

ROLES

6000.951.Initial reporter.
6000.952.Point person.
6000.953.Incident management representative.
6000.954.Certified investigator.
6000.955.Supports coordinator.
6000.956.Supports coordinator supervisor/unit manager.
6000.957.County incident manager.
6000.958.Regional incident manager.
6000.959.Bureau of State Operated Facilities (BSOF) incident manager.

TYPES OF INCIDENT REPORTS

6000.961.Standardized incident report.
6000.962.Abbreviated incident report.

REVIEW PROCESS

6000.971.County review process.
6000.972.OMR regional office review process.

QUALITY MANAGEMENT

6000.981.Support to quality management.
6000.982.Purpose of quality management.
6000.983.Use of incident data.
6000.984.Provider incident management quarterly reports.
6000.985.County incident management reports.

GENERAL PROVISIONS

§ 6000.901.  Scope.

   (a)  Individuals who are registered with a county mental retardation program or who receive supports and services from facilities licensed by the OMR are afforded the protections detailed in this subchapter.

   (b)  Providers who receive funds from the mental retardation system, either directly or indirectly, to provide or secure supports or services for individuals authorized to receive services from a county mental retardation program and providers licensed by the OMR are reporters and are to file incident reports as specified in this subchapter.

   (c)  County mental retardation programs and their designated support coordination entities are reporters and are to file incident reports as specified in this subchapter.

§ 6000.902.  Purpose.

   The purpose of this subchapter is to specify the guidelines and procedures for the incident management process. The incident management process is a subset of a larger risk management process. Incident policies, procedures, training, response and reporting are all important components of the incident management process. Combined with other areas of risk assessment such as employee injuries, complaints, satisfaction surveys and hiring practices, incident management is an essential component of a comprehensive quality management process. See Appendix E (relating to incident management components).

§ 6000.903.  Licensing applicability.

   A facility must comply with Chapters 2380, 2390, 6400, 6500 and 6600. To the extent that this subchapter exceeds the requirements of Chapters 2380, 2390, 6400, 6500 and 6600, the use of this subchapter is optional for facilities. Because this subchapter meets or exceeds the regulatory requirements in Chapters 2380, 2390, 6400, 6500 and 6600, compliance with the reporting procedures in this subchapter will be accepted by the Department as meeting the regulatory requirements of §§ 2380.17, 2390.18, 6400.18 and 6500.20.

§ 6000.904.  Definitions.

   The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

   Department--The Department of Public Welfare of the Commonwealth.

   HCSIS--The Home and Community Services Information System.

   OMR--The Office of Mental Retardation of the Department.

RESPONSIBILITY FOR REPORTING/INVESTIGATING

§ 6000.911.  Providers.

   (a)  Employees, contracted agents and volunteers of providers covered within the scope of this subchapter are to respond to events that are defined as an incident in this subchapter. When an incident is recognized or discovered by a provider, prompt action is to be taken to protect the individual's health, safety and rights. The responsibility for this protective action is assigned to the provider initial reporter and point person. The protection may include dialing 911, escorting to medical care, separating the perpetrator, calling ChildLine, arranging for counseling and referring to a victim assistance program. Unless otherwise indicated in the individual support plan, the provider point person or designee is to inform the individual's family within 24 hours, or within 72 hours for medication error and restraint, of the occurrence of an incident and to also inform the family of the outcome of any investigation.

   (b)  After taking all appropriate actions following an incident to protect the individual, the provider is to report all categories of incidents and complete an investigation as necessary whenever services or supports are:

   (1)  Rendered at the provider's site.

   (2)  Provided in a community environment, other than an individual's home, while the individual is the responsibility of an employee, contracted agent or volunteer.

   (3)  Provided in an individual's own home or the home of his family, while an employee, contracted agent or volunteer is providing services in the home.

   (c)  In situations when multiple providers learn of an incident, the provider responsible for the individual at the time the incident occurred is to report the incident and conduct any required investigation. If it cannot reasonably be determined which provider had responsibility at the time of the incident, all providers who are aware of the incident are to report the incident and investigate.

   (d)  If, during an investigation, the certified investigator assigned by the provider determines that an alleged perpetrator is not an employee, a volunteer or an individual receiving services from the provider, the certified investigator is to complete the investigation summary in the HCSIS incident management application stating the reason why the investigation could not be concluded. The certified investigator is to review the protective action taken by the agency and ensure communication with county staff occurs, outside HCSIS, to alert the county that appropriate interventions may be needed to protect the individual.

   (e)  In addition, employees, contracted agents or volunteers of provider agencies are to report deaths, alleged abuse or neglect when they become aware of such incidents regardless of where or when these incidents occur. If the death, alleged abuse or neglect occurred beyond the provider's responsibility as specified in subsection (b)(1)--(3), the provider is not to report the incident in HCSIS, but instead should give notice of the incident, outside of HCSIS, to the individual's supports coordinator.

   (f)  Any person, including the victim, shall be free from intimidation, discriminatory, retaliatory or disciplinary actions exclusively for the reporting or cooperating with a certified investigation. These individuals have specific rights as defined by the Whistleblower Law (43 P. S. §§ 1421--1428) and the Older Adults Protective Services Act (35 P. S. § 10225.101--10225.5102). See Appendix F (relating to related laws, regulations and policies).

§ 6000.912.  Individuals and families.

   (a)  Individuals and families are to notify the provider, when they feel it is appropriate, or their supports coordinator regarding any health and safety concerns they may have related to a service or support that they are receiving. If an individual or family member observes or suspects abuse, neglect or any inappropriate conduct, whether occurring in the home or out of the home, they should contact the provider or their supports coordinator, or both, and they may also contact the Office of Mental Retardation directly at 1 (888) 565-9435. As specified in this subchapter, the supports coordinator will either inform the involved provider of the incident or file an incident report. Once informed by the supports coordinator, the provider is subsequently responsible to take prompt action to protect the individual, complete an investigation as necessary and file an incident report. In the event of the death of an individual, the family is requested to notify the supports coordinator.

   (b)  When an individual or the individual's representative arrange his own supports through a payment agent or intermediary service organization and an incident occurs, the individual, the individual's family or his representative is to inform the provider, when it is appropriate, or the supports coordinator that an incident has occurred. The provider or supports coordinator will take prompt action to protect the individual, ensure a certified investigator is assigned as necessary and file an incident report in HCSIS.

§ 6000.913.  County mental health/mental retardation programs.

   (a)  When an individual or family informs his supports coordinator that an event has occurred that can be defined as an incident and there is a relationship as specified in § 6000.911(b)(1)--(3) (relating to providers) the supports coordinator is to immediately notify the provider rendering the support or service. The provider is responsible for taking prompt action to protect the individual, completing an investigation as necessary and filing an incident report in HCSIS.

   (b)  When an individual or a family member informs the supports coordinator of an event that can be categorized as abuse or neglect as defined in this subchapter and there is no relationship as specified in § 6000.911(b)(1)--(3), the supports coordinator will take prompt action to protect the individual. Once the individual's health and safety are assured, the supports coordinator will ensure a certified investigator is assigned as necessary and file an incident report in HCSIS.

   (c)  When a family member of an individual informs the individual's supports coordinator of the death of the individual, the supports coordinator will determine if a report has been filed by a provider. If a provider is not required to file the report, the supports coordinator will file an incident report in HCSIS.

   (d)  In some circumstances, county mental retardation program staff may be required to report incidents. County staff are to report deaths and incidents of alleged abuse or neglect when a provider or supports coordinator relationship does not currently exist, or in circumstances when the process for reporting or investigating incidents, described in this subchapter, for providers or support coordination entities compromises objectivity.

   (e)  If a county incident manager or designee is informed that a provider's certified investigator suspects that abuse or neglect is occurring beyond the authority of the provider to investigate, the county is to take all available action to protect the health and safety of the individual. The county may need to employ the resources of law enforcement, ChildLine, area agency on aging, counselors or other protective service agencies to protect the individual.

REPORTABLE INCIDENTS

§ 6000.921.  Categories of incidents.

   (a)  The following are the categories of incidents to be responded to by staff who are knowledgeable about incident management processes and protecting individuals. After the immediate health and safety assurances have been met, these incidents are to be reported in HCSIS. The categories are divided into those that must be reported within 24 hours of discovery or recognition and those that are to be reported within 72 hours.

   (b)  For the incidents that require reporting within 24 hours, the first section of the incident report must be completed in HCSIS within 24 hours. The first section includes a minimum data set (individual and provider demographics, action taken to protect the individual and description of the incident and the category of incident). The final section of the incident report includes additional information about the incident, any required investigation and corrective actions. The final section is to be completed within 30 days of recognition or discovery of the incident.

   (c)  The second set of incidents requires reporting within 72 hours of recognition or discovery. These incidents are reported using abbreviated data entry screens in HCSIS.

   (d)  When multiple individuals associated with a provider/entity are involved in certain primary categories or secondary categories, or both, of incidents, the incident can be reported using a site report. Only those events designated in the list of reportable incidents as a site report may be filed in this manner. An individual who is part of a group involved in a site report and is injured must have a separate individual report completed using the proper classification.

   (e)  Providers, supports coordination entities, counties and OMR must be vigilant to report any incident when there is a suspected crime to law enforcement. When an individual is allegedly abused, neglected or the victim of a crime, the individual is to be offered the support of avictim's assistance program. See Appendix G (relating to victim's assistance programs).

§ 6000.922.  Incidents to be reported within 24 hours.

   (a)  The following are categories of incidents to be reported within 24 hours after the occurrence of the incident:

   (1)  Abuse. The allegation or actual occurrence of the infliction of injury, unreasonable confinement, intimidation, punishment, mental anguish, sexual abuse or exploitation. Abuse is reported on from the victim's perspective, not on the person committing the abuse.

   (i)  Physical abuse. An intentional physical act by staff or other person which causes or may cause physical injury to an individual, such as striking or kicking, applying noxious or potentially harmful substances or conditions to an individual.

   (ii)  Psychological abuse. An act, other than verbal, which may inflict emotional harm, invoke fear or humiliate, intimidate, degrade or demean an individual.

   (iii)  Sexual abuse. An act or attempted acts such as rape, incest, sexual molestation, sexual exploitation or sexual harassment and inappropriate or unwanted touching of an individual by another. Any sexual contact between a staff person and an individual is abuse.

   (iv)  Verbal abuse. A verbalization that inflicts or may inflict emotional harm, invoke fear or humiliate, intimidate, degrade or demean an individual.

   (v)  Improper or unauthorized use of restraint. A restraint not approved in the individual support plan or one that is not a part of an agency's emergency restraint procedure is considered unauthorized. A restraint that is intentionally applied incorrectly is considered an improper use of restraint.

   (2)  Death. All deaths are reportable.

   (3)  Disease reportable to the Department of Health. An occurrence of a disease on the Pennsylvania Department of Health List of Reportable Diseases. The current list can be found at the Department of Health's website, www.health.state.pa.us. An incident report is required only when the reportable disease is initially diagnosed.

   (4)  Emergency closure. An unplanned situation that results in the closure of a home or program facility for 1 or more days. This category does not apply to individuals who reside in their own home or the home of a family member. This may be reported as a site report.

   (5)  Emergency room visit. The use of a hospital emergency room. This includes situations that are clearly ''emergencies'' as well as those when an individual is directed to an emergency room in lieu of a visit to the Primary Care Physician (PCP) or as the result of a visit to the PCP. The use of an emergency room by an individual's PCP, in place of the physician's office, is not reportable.

   (6)  Fire. A situation that requires the active involvement of fire personnel, that is, extinguishing a fire, clearing smoke from the premises, responding to a false alarm, and the like. Situations which require the evacuation of a facility in response to suspected or actual gas leaks or carbon monoxide alarms, or both, are reportable. Situations in which staff extinguish small fires without the involvement of fire personnel are reportable. This may be reported as a site report.

   (7)  Hospitalization. An inpatient admission to an acute care facility for purposes of treatment. Scheduled treatment of medical conditions on an outpatient basis is not reportable.

   (8)  Individual-to-individual abuse. An interaction between one individual receiving services and another individual receiving services resulting in an allegation or actual occurrence of the infliction of injury, unreasonable confinement, intimidation, punishment, mental anguish, sexual abuse or exploitation. Individual-to-individual abuse is reported on from the victim's perspective, not on the person committing the abuse.

   (i)  Physical abuse. An intentional physical act that causes or may cause physical injury to an individual, such as striking or kicking, or applying noxious or potentially harmful substances or conditions to an individual.

   (ii)  Psychological abuse. An act, other than verbal, which may inflict emotional harm, invoke fear or humiliate, intimidate, degrade or demean an individual.

   (iii)  Sexual abuse. An act or attempted act such as rape, incest, sexual molestation, sexual exploitation or sexual harassment and inappropriate or unwanted touching of an individual by another. Nonconsensual sex between individuals receiving services is abuse.

   (iv)  Verbal abuse. A verbalization that inflicts or may inflict emotional harm, invoke fear or humiliate, intimidate, degrade or demean an individual.

   (9)  Injury requiring treatment beyond first aid. Any injury that requires the provision of medical treatment beyond that traditionally considered first aid. First aid includes assessing a condition, cleaning an injury, applying topical medications, applying a Band-Aid, and the like. Treatment beyond first aid includes lifesaving interventions such as CPR or use of the Heimlich maneuver, wound closure by a medical professional, casting or otherwise immobilizing a limb. Evaluation/assessment of an injury by emergency personnel in response to a ''911'' call is reportable even if the individual is not transported to an emergency room.

   (10)   Law enforcement activity. The involvement of law enforcement personnel is reportable in the following situations:

   (i)   An individual is charged with a crime or is the subject of a police investigation that may lead to criminal charges.

   (ii)  An individual is the victim of a crime, including crimes against the person or his property.

   (iii)  A crime such as vandalism or break-in that occurs at a provider site. This may be reported as a site report.

   (iv)  An on-duty employee or an employee who is volunteering during off duty time, who is charged with an offense, a crime or is the subject of an investigation while on duty or volunteering. This is reported as a site report.

   (v)  A volunteer who is charged with an offense, a crime or is the subject of an investigation resulting from actions or behaviors that occurred while volunteering. This is reported as a site report.

   (vi)  A crisis intervention involving police/law enforcement personnel.

   (vii)  A citation given to an agency staff person for a moving violation while operating an agency vehicle, or while transporting individuals in a private vehicle, is reported as a site report.

   (11)  Missing person. A person is considered missing when they are out of contact with staff for more than 24 hours without prior arrangement or if they are in immediate jeopardy when missing for any period of time. A person may be considered in ''immediate jeopardy'' based on the person's personal history and may be considered ''missing'' before 24 hours elapse. Additionally, it is considered a reportable incident whenever the police are contacted about an individual or the police independently find and return the individual, or both, regardless of the amount of time the person was missing.

   (12)  Misuse of funds. An intentional act or course of conduct, which results in the loss or misuse of an individual's money or personal property. Requiring an individual to pay for an item or service that is normally provided as part of the individual support plan is considered financial exploitation and is reportable as a misuse of funds. Requiring an individual to pay for items that are intended for use by several individuals is also considered financial exploitation. Individuals may voluntarily make joint purchases with other individuals of items that benefit the household.

   (13)  Neglect. The failure to obtain or provide the needed services and supports defined as necessary or otherwise required by law or regulation. This includes the failure to provide needed care such as shelter, food, clothing, personal hygiene, medical care, protection from health and safety hazards, attention and supervision, including leaving individuals unattended and other basic treatment and necessities needed for development of physical, intellectual and emotional capacity and well being. This includes acts that are intentional or unintentional regardless of the obvious occurrence of harm.

   (14)  Psychiatric hospitalization. An inpatient admission to a psychiatric facility, including crisis facilities and the psychiatric departments of acute care hospitals, for the purpose of evaluation or treatment, or both, whether voluntary or involuntary. This includes admissions for ''23 hour'' observation and those for the review or adjustment, or both, of medications prescribed for the treatment of psychiatric symptoms or for the control of challenging behaviors.

   (15)  Rights violation. An act which is intended to improperly restrict or deny the human or civil rights of an individual including those rights which are specifically mandated under applicable regulations. Examples include the unauthorized removal of personal property, refusal of access to the telephone, privacy violations and breach of confidentiality. This does not include restrictions that are imposed by court order or consistent with a waiver of licensing regulations.

   (16)  Suicide attempt. The intentional and voluntary attempt to take one's own life. A suicide attempt is limited to the actual occurrence of an act and does not include suicidal threats.

§ 6000.923.  Incidents to be reported within 72 hours.

   (a)  The following are categories of incidents to be reported within 72 hours after the occurrence of the incident:

   (1)  Medication error. Any nonconforming practice with the ''Rights of Medication Administration'' as described in the OMR Medication Administration Training Course. This includes omission, wrong dose, wrong time, wrong person, wrong medication, wrong route, wrong position, wrong technique/method and wrong form. Over the counter medication is excluded. Treatment procedures (for example, skin creams, shampoo, eye drops, and the like) that do not contain a prescription medication are excluded. A medication error occurring during a home visit, when the family is responsible for the administration, is not reportable. An individual's refusal to take medication is not reportable. See Appendix H (relating to abbreviated incident report, medication error).

   (2)  Restraints. Any physical, chemical or mechanical intervention used to control acute, episodic behavior that restricts the movement or function of the individual or portion of the individual's body, including those that are approved as part of an individual support plan or those used on an emergency basis. Improper or unauthorized use of restraint is considered abuse and is to be reported under the abuse category. See Appendix I (relating to abbreviated incident report, restraint).

   (i)  Physical. A physical or manual restraint is a physical hands-on technique that lasts 30 seconds or more, used to control acute, episodic behavior that restricts the movement or function of an individual or portion of an individual's body such as a basket hold and prone or supine containment.

   (ii)  Mechanical. A mechanical restraint is a device used to control acute, episodic behavior that restricts the movement or function of an individual or portion of an individual's body. Examples of mechanical restraints include anklets, wristlets, camisoles, helmets with fasteners, muffs and mitts with fasteners, poseys, waist straps, head straps, restraining sheets and similar devices. A device used to provide support for functional body position or proper balance and a device used for medical treatment, such as a wheelchair belt or helmet for prevention of injury during seizure activity, are not considered mechanical restraints.

   (iii)  Chemical. A chemical restraint is a drug used to control acute, episodic behavior that restricts the movement or function of an individual. A drug ordered by a licensed practitioner as part of an on-going treatment program or pretreatment prior to medical or dental examination or treatment is not a chemical restraint. Medications prescribed on a Pro Re Nata (PRN) basis for the treatment of episodically occurring and well-defined symptoms of an underlying disorder (such as an anxiety disorder, auditory hallucinations, and the like) and not simply for behavior control, are not considered chemical restraints. For further clarification see Mental Retardation Bulletin 00-02-09, issued July 11, 2002, titled Pro Re Nata Medication Usage for Psychiatric Treatment--Clarification of Interpretation.

§ 6000.924.  Incident management contingency plan.

   Reportable incidents are to be submitted electronically by means of the HCSIS, a web-based system developed by the Department. In the event that HCSIS is unavailable, the submission of incidents is to occur by following the directions in the Incident Management Contingency Plan. See Appendix J (relating to incident management contingency plan).

§ 6000.925.  Categories of incidents to be investigated.

   The following chart indicates those incidents to be investigated by the provider, the county and OMR. The investigation process does not preclude investigations by law enforcement or other agencies responsible to investigate.

Primary Category Secondary Category Entity Responsible for
Investigation
Abuse All Provider
Improper or unauthorized use of restraint Provider and County
Neglect All Provider
Rights Violation All Provider
Misuse of Funds All Provider
Death When an individual is receiving services from a provider/entity. (See § 6000.911(b)(1)--(3).) Provider and OMR or Department of Health (county participation as requested by OMR)
Hospitalization Accidental Injury
Unexplained Injury
Staff to Individual Injury
Injury Resulting from Individual to Individual Abuse
Provider
Provider
Provider
Provider
Injury Resulting from Restraint Provider and County
Emergency Room Visit Unexplained Injury
Staff to Individual Injury
Injury Resulting from Individual to Individual Abuse
Provider
Provider
Provider
Injury Resulting from Restraint Provider and County
Injury requiring treatment beyond first aid Staff to Individual Injury
Resulting from Individual to Individual Abuse
Provider
Provider
Injury Resulting from Restraint Provider and County
Individual to Individual Abuse Sexual Abuse Provider

SEQUENCE OF REPORTING

§ 6000.931.  Multiple categories and sequences.

   (a)  Many real life occurrences may result in events that may be classified under multiple categories of incidents. In an attempt to assist the point person in identifying an appropriate order for reporting incidents that may be classified under multiple categories, the following sequence is suggested. This sequence may not be appropriate in all situations, but should be used as a guide in selecting the most appropriate category.

   (1)  24-Hour Reporting Primary Incident Category.

   (i)  Death.

   (ii)  Suicide attempt.

   (iii)  Hospitalization.

   (iv)  Psychiatric hospitalization.

   (v)  Emergency room visit.

   (vi)  Abuse.

   (vii)  Individual to individual abuse.

   (viii)  Neglect.

   (ix)  Missing person.

   (x)  Injury requiring treatment beyond first aid.

   (xi)  Disease reportable to the Department of Health.

   (xii)  Fire.

   (xiii)  Misuse of funds.

   (xiv)  Rights violation.

   (xv)  Law enforcement activity.

   (xvi)  Emergency closure.

   (2)  72-Hour Reporting Primary Incident Category.

   (i)  Medication error.

   (ii)  Restraint.

   (b)  If a death, hospitalization, psychiatric hospitalization, emergency room visit or injury requiring treatment beyond first aid is the result of a medication error or the use of a restraint, a report is to be initiated within 24 hours using the corresponding primary category. Data about the medication error or the restraint is also to be recorded within 72 hours in the abbreviated HCSIS data entry screens for medication error or restraint.

INCIDENT MANAGEMENT PROCESS

§ 6000.941.  Administrative structure.

   Providers, supports coordination entities and counties are to create an administrative structure that is sufficient to implement the requirements of this subchapter. Specifically, they shall:

   (1)  Assign an individual with overall responsibility for incident management.

   (2)  Develop a policy for incident management.

   (3)  Ensure that staff, individuals and families are trained on incident management policies and procedures.

   (4)  Assign roles within their organization for reporting and investigation of incidents.

   (5)  Assure corrective action to individual incidents.

   (6)  Conduct analysis of data on incidents and the quality of investigations.

   (7)  Identify and implement individual and systemic changes based on risk management analysis.

ROLES

§ 6000.951.  Initial reporter.

   The initial reporter is any person who witnesses the incident or is the first to discover or be made aware of the signs of an incident. The initial reporter first responds to the situation by taking prompt action to protect the individual's health, safety and rights. The protection may include dialing 911, escorting to medical care or calling ChildLine. As soon as the immediate needs of the person have been met, the initial reporter notifies the provider point person of the incident and receives instructions on next steps to take. The initial reporter documents his observations in a narrative report which is kept in the provider/entity's files. In cases of alleged abuse or neglect, the initial reporter will comply with the applicable laws and regulations. See Appendix F (relating to related laws, regulations and policies).

§ 6000.952.  Point person.

   A point person is assigned and authorized to perform specific duties as described in provider/entity or county policy. In general, a point person is to receive verbal or other reports or allegations of incidents from individuals, families and initial reporters. They are to safeguard the individual, ensure that HCSIS Incident Reports are submitted, communicate with others involved in investigations, follow-up and review of incidents. This role is pivotal in the incident management process. When an incident is reported, the point person, as a representative of the agency, is to:

   (1)  First confirm that appropriate actions have been taken or order additional actions to secure the safety of the individual involved in the incident.

   (2)  Separate the individual from the target when the individual's health and safety may be jeopardized.

   (3)  Ensure notification requirements of the Older Adults Protective Services Act (35 P. S. §§ 10225.101--10225.5102) and 23 Pa.C.S. §§ 6301--6384 (relating to Child Protective Services Law) are met.

   (4)  Determine whether an investigation or other follow-up is needed.

   (5)  Secure the scene of an incident when an investigation may be required.

   (6)  Ensure that, when needed, a certified investigator is promptly assigned.

   (7)  Notify appropriate supervisory/management personnel within 24 hours of the incident, as specified in provider/entity or county policies.

   (8)  Initiate a HCSIS Incident Report within 24 or 72 hours as described in the Reportable Incident section of this bulletin.

   (9)  Notify the family within 24 hours (72 hours for medication error and restraint) unless otherwise indicated in the individual support plan.

§ 6000.953.  Incident management representative.

   The incident management (IM) representative is the person designated by the provider with overall responsibility for incident management. This includes the assurance that the activities of the initial reporter and point person have been completed. In addition, the IM representative is responsible for the finalization of the incident report within 30 days of the incident. The IM representative is responsible to evaluate the quality of incident investigations as described in the Pennsylvania Certified Investigators Manual, Labor Relations Alternatives, Inc.

§ 6000.954.  Certified investigator.

   A certified investigator is a person who has been trained and received a certificate in investigation from OMR as communicated via Mental Retardation Bulletin 00-01-06, issued September 6, 2001, titled Announcement of Certified Investigator Training. Certified investigators are to promptly begin an investigation, when assigned, and are to enter a summary of their investigation findings in the HCSIS Incident Report.

§ 6000.955.  Supports coordinator.

   (a)  A support coordinator is a person who is responsible for the coordination of services for an individual and who receives reports from an individual or family. When an individual or a family member informs the supports coordinator of an event that can be categorized as abuse or neglect as defined in this subchapter and there is no relationship as specified in § 6000.911(b)(1)--(3) (relating to providers), the supports coordinator functioning in the point person role is to take prompt action to protect the individual. Once the individual's health and safety are assured, the supports coordinator will ensure a certified investigator is assigned, as necessary, and file a HCSIS Incident Report.

   (b)  When a family informs their supports coordinator of the death of a relative, the supports coordinator will determine if a report has been filed by a provider. If no provider is required to file the report, the supports coordinator will file a HCSIS Incident Report.

§ 6000.956.  Supports coordinator supervisor/unit manager.

   The supports coordinator supervisor and the supports coordinator unit manager are responsible for the finalizing of HCSIS Incident Reports filed by the supports coordinator.

§ 6000.957.  County incident manager.

   The county incident manager is the person designated by the county with overall responsibility for incident management within his county program. This responsibility includes a review to ensure that incidents are managed and reported in accordance with the process described in this statement of policy and to approve or not approve HCSIS Incident Reports submitted by the provider or supports coordination entity. In addition, the county incident manager is responsible for the final submission of HCSIS Incident Reports filed by the county point person.

§ 6000.958.  Regional incident manager.

   The regional incident manager is the person designated by OMR with overall responsibility for incident management within his region. This responsibility includes a review to ensure that incidents are managed and reported in accordance with the process described in this subchapter and to approve or not approve HCSIS Incident Reports.

§ 6000.959.  Bureau of State Operated Facilities (BSOF) incident manager.

   The BSOF incident manager is the person designated by OMR with overall responsibility for incident management for incidents filed by State-operated facilities. This responsibility includes a review to ensure that incidents are managed and reported in accordance with the process described in this subchapter and to approve or not approve HCSIS Incident Reports.

TYPES OF INCIDENT REPORTS

§ 6000.961.  Standardized incident report.

   The following process applies to the primary incident category to be reported within 24 hours.

   (1)  The first section of the incident report is to include individual and provider demographics, incident categorization, actions taken to protect the health and safety of the individual, and a description of the incident. See Appendix K (relating to standardized incident report). The first section is to be submitted through HCSIS within 24 hours of the incident being recognized or discovered.

   (2)  The certified investigator is responsible for conducting certified investigations, completing investigation records and for entering the summary of the investigator's findings into HCSIS. The summary is the compilation of the analysis and findings section of the investigation report. For more information on the analysis and findings section, see the Pennsylvania Certified Investigation Manual. The final section of the incident report will retain all of the information

   (3)  The final section of the incident report will retain all of the information from the first section and will add additional information relevant to the incident. See Appendix K. The final section is to be submitted through HCSIS within 30 days of the incident being recognized or discovered. If the provider agency determines it will not be able to meet the 30-day reporting timeframes for completion of the final section, notification of an extension is to be made to the county and the regional office of OMR by means of HCSIS prior to the expiration of the 30-day period.

   (4)  When multiple individuals associated with a provider or entity are involved in certain primary categories and secondary categories of incidents, the incident can be reported using a site report. Only those events designated in the list of reportable incidents as a site report may be filed in this manner.

§ 6000.962.  Abbreviated incident report.

   (a)  The following process applies to the primary incident categories requiring reporting within 72 hours. These incidents are not individually approved by the county, OMR regional office or Bureau of State Operated Facilities, but are to have a 30-day analysis completed and maintained by the provider/entity. Analysis of these incidents is to be included in the quarterly report.

   (b)  Medication errors and the use of restraints are to be reported using the abbreviated HCSIS incident management data entry screens, designed to gather relevant data about these incidents. Data is to be input within 72 hours of the recognition or discovery of the event.

REVIEW PROCESS

§ 6000.971.  County review process.

   (a)  Within 24 hours of the submission of the first section of the incident report, designated county staff are to review the incident to determine that appropriate actions to protect the individual's health, safety and rights occurred. If the appropriate actions have not taken place, the county staff should immediately communicate their concerns to the appropriate provider/entity staff.

   (b)  After the provider or entity submits the final section of the HCSIS Incident Report, county staff are to perform a management review within 30 days. Counties will conduct the management review process so that at least 90% of the submitted incident reports are approved or not approved within 30 days of finalization by the provider or supports coordination entity. The management review process is to review the full report and approve or not approve the incident report. This process will include a determination that:

   (1)  The appropriate action to protect the individual's health, safety and rights occurred.

   (2)  The incident categorization is correct.

   (3)  A certified investigation occurred when needed.

   (4)  Proper safeguards are in place.

   (5)  Corrective action in response to the incident has, or will, take place.

§ 6000.972.  OMR regional office review process.

   (a)  Within 24 hours of the submission of the first section of the incident report, designated OMR regional office staff are to review the incident to determine that appropriate action to protect the individual's health, safety and rights occurred. If the appropriate actions have not taken place the OMR regional office staff should immediately communicate their concerns to the appropriate provider/entity and county staff.

   (b)  After the county approves the incident report, regional OMR staff are to perform a management review within 30 days. The OMR regional office will conduct the management review process so that at least 90% of the county approved incident reports are approved or not approved within 30 days. The management review process is to review the full report, including the county's response, and approve or not approve the incident report. This process will include a determination that:

   (1)  The appropriate action to protect the individual's health, safety and rights occurred.

   (2)  The incident categorization is correct.

   (3)  A certified investigation occurred when needed.

   (4)  Proper safeguards are in place.

   (5)  Corrective action in response to the incident has, or will, take place.

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