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PA Bulletin, Doc. No. 04-330a

[34 Pa.B. 1234]

[Continued from previous Web Page]

QUALITY MANAGEMENT

§ 6000.981.  Support to quality management.

   The incident management policy described in this subchapter is designed to support provider/entity, county and OMR quality management and risk management structures and practices. As a part of OMR's quality initiatives, the incident management policy is a key component of the OMR Quality Framework and is integral to maintaining OMR's assurance to the Federal Centers for Medicare and Medicaid Services that the health and safety of individuals receiving services will be protected.

§ 6000.982.  Purpose of quality management.

   The purpose of quality management within the mental retardation system is to advance the quality of life of people served and supported. OMR assures that through the application of standardized incident management processes, systematic safeguards are in place to protect persons from events that place them at risk. Therefore, each provider and entity covered under the scope of this subchapter is to develop specific policy and procedures to implement a continuous quality improvement process, which includes a risk management and an incident management component. Since there is a wide diversity of agencies/entities responsible for the protection of individuals, the approach to quality management must be tailored to the unique structure of the organization. Agencies should employ standardized approaches to quality management and incident management.

§ 6000.983.  Use of incident data.

   (a)  HCSIS produces a set of standardized online reports that are available to providers/entities, counties and OMR. In addition to the online reports, providers and counties may request an electronic extract of incident management data through HCSIS.

   (b)  To assure effective quality and risk management processes, data is collected, aggregated, analyzed and utilized to make improvement decisions. Data and information in HCSIS are to be continuously, as well as systemically, assessed and analyzed by those individuals responsible for risk management, a risk management group or a risk management committee. The responsibility is to review a representative sample of individual incidents for information about the events, the response to the incident including timeliness, thoroughness and the appropriateness of the corrective actions. This responsibility also includes analysis of data and information using standardized methodology and processes. There are a variety of quality management tools for analysis and trending. These tools assist in either defining, analyzing and preventing incidents or in sustaining improvements already implemented. OMR has begun to conduct training introducing some of these quality management tools and to demonstrate how to use them effectively. The outcome of this assessment and analysis process is to identify strategies for prevention.

§ 6000.984.  Provider incident management quarterly reports.

   (a)  Within 60 days following the end of a calendar quarter, a provider/entity is to submit to each county with whom the provider contracts, a qualitative report that describes the analysis of incidents and the systemic interventions implemented to improve the health and safety protections afforded to the individuals served. Supporting data is to be included with the report.

   (b)  OMR recognizes that providers desire a uniform format for quarterly reporting. A general template will be disseminated by OMR which will give structure to the design of the provider's qualitative quarterly report. This template will be flexible enough to accommodate the wide diversity of agencies/entities involved in the incident management process. Training on this template will occur prior to the first quarterly report due date.

§ 6000.985.  County incident management reports.

   (a)  The county MH/MR program is to submit to his respective regional office a semiannual qualitative report on June 1 and December 1 of each year. A general template will be disseminated by OMR which will give structure to the design of the county's qualitative semi-annual report. The report is to describe the analysis of all incidents for individuals registered with the county mental retardation program. The county is to explain the systemic interventions implemented and document instructions to providers that will improve the health and safety protections afforded to the individuals served. Supporting data is to be included with the report. Training on this template will occur prior to the first semi-annual report due date.

   (b)  OMR will review data on all reported incidents at least semiannually to determine what trends may be developing Statewide, or by county, and take appropriate administrative steps to intervene. OMR will issue an annual report reviewing statewide incident trends.

   (c)  The following is a review schedule for quality incident management reporting:

Report Period Provider Report Due to County County Report Due to OMR Region
July 1--September 30 November 30 June 1
October 1--December 31 February 28
January 1--March 31 May 31 December 1
April 1--June 30 August 31

APPENDIX E

INCIDENT MANAGEMENT COMPONENTS

PROVIDERS/ENTITIES ARE TO:

   *   Promote the health, safety, rights and enhance the dignity of individuals receiving services.

   *   Develop provider-specific policy/procedures for incident management.

   *   Ensure that staff and others associated with the individual have proper orientation and training to respond to, report and prevent incidents.

   *  Provide ongoing training to individuals and families on the recognition of abuse and neglect.

   *  Ensure when incidents occur that affect a person's health, safety or rights, that the people who are present:

   --  Take prompt action to protect the person's health, safety and rights. This includes separation of the target when the individual's health and safety are jeopardized. This separation shall continue until an investigation is completed. In addition, the target shall not be permitted to work directly with any other service recipient during the investigation process. When the target is another individual receiving supports or services, and complete separation is not possible, the provider shall institute additional protections.

   --  Notify the responsible person designated in provider policy.

   *  Assign trained individual(s) Point Person(s) to whom incidents are reported when they occur and who will make certain that all immediate steps to assure health and safety have been implemented and follow the incident through closure.

   *  Contact appropriate law enforcement agencies when there is suspicion that a crime has occurred.

   *  Comply with all applicable laws, regulations and policies.

   *  Conduct certified investigations.

   *  Analyze the quality of investigations.

   *  Respond to concerns from individuals/family about the reporting and investigation processes.

   *  Inform the family of the incident unless otherwise indicated in the individual's plan.

   *  Notify the family of the findings of any investigation unless otherwise indicated in the individual's plan.

   *  Maintain an investigation file within the agency.

   *  Create an incident management process which:

   --  Designates an individual with overall responsibility for incident management.

   --  Considers possible immediate and long-term effects to the individual resulting from an incident or multiple incidents.

   --  Uses trend analyses to identify systemic issues.

   --  Analyzes and shares information with relevant staff, including direct care staff.

   --  Periodically assesses the effectiveness of the incident management process.

   --  Monitors quality and responsiveness of all ancillary services (such as health, therapies, etc.) and acts to change vendors or subcontractors, or assists the individual to file available grievances or appeals procedures to secure appropriate services.

COUNTIES ARE TO:

   *  Promote the health, safety, rights and dignity of individuals receiving services.

   *  Develop county policies and procedures necessary to implement this bulletin.

   *  Have an administrative structure sufficient to meet mandates of this bulletin:

   --  Designate an individual with overall responsibility for incident management.

   --  Train staff in incident management procedures.

   --  Assure that supports coordinators have proper orientation and training to respond to, document and prevent incidents.

   --  Support providers with appropriate training and resources to meet the mandates of the bulletin.

   *  Provide ongoing training to individuals, families, guardians, and advocates regarding their rights, roles and responsibilities that are outlined in this bulletin.

   *  Provide training to individuals and families on the recognition of abuse and neglect.

   *  Have the Incident Management Processes in this bulletin referenced in county/provider contracts.

   *  Maintain an investigation file within the county.

   *  Create an incident management process which:

   --  Assures accuracy of incident reports.

   --  Reviews and closes all provider generated incidents.

   --  Reviews and analyzes data.

   --  Identifies and implements individual and systemic changes based on data analysis.

   --  Analyzes and shares information with relevant staff.

   --  Regularly reviews trend and occurrence data compiled by providers.

   --  Assesses provider's incident management and investigative processes.

   --  Assures provider compliance with plans of correction resulting from incidents and investigations.

   *  Conduct certified investigations.

   *  Analyze the quality of investigations.

   *  Respond to concerns from individuals/family about the reporting and investigation processes.

   *  In collaboration with the individual's planning team, revise the individual's plan as needed in response to issues identified through the incident management process.

   *  Comply with all applicable laws, regulations and policies.

   *  Coordinate with other agencies as necessary.

   *  In those instances where the county is the initial reporter of the incident, the county will assume the responsibility of the point person.

THE OFFICE OF MENTAL RETARDATION IS TO:

   *  Promote the health, safety, rights and dignity of individuals receiving services.

   *  Create an incident management review process which:

   --  Maintains the statewide data system.

   --  Analyzes data for statewide trends and issues.

   --  Identifies issues and initiates systemic changes and provides periodic feedback.

   --  Evaluates county and provider reports and analysis of trends.

   *  Monitor implementation of this bulletin.

   *  Support providers and counties with appropriate training to meet the mandate of the bulletin.

   *  Certify investigators.

   *  Provide support and technical assistance to counties to implement the incident reporting system.

   *  Conduct certified investigations.

   *  Analyze the quality of investigations.

   *  Respond to concerns from individuals/families about the reporting and investigation processes.

   *  Review and revise this bulletin as needed.

   *  Ensure compliance with all applicable laws, regulations and policies.

   *  Coordinate with other agencies as necessary.

APPENDIX F

RELATED LAWS, REGULATIONS AND POLICIES

   The incident management and reporting detailed in this subchapter are related to a variety of laws, regulations and policies. The applicable licensing regulations (and facilities licensed under those regulations) include:

   Related Laws:

   *  The Mental Health and Mental Retardation Act of 1966 (50 P. S. §§ 4101--4704)

   *  Title XIX Social Security Act (42 U.S.C.A. §§ 1396--1396v)

   *  18 Pa.C.S. § 2713 (relating to the neglect of care-dependent person)

   *  The Child Protective Services Law (23 Pa.C.S. §§ 6301--6385)

   *  The Older Adults Protective Services Act (35 P. S. §§ 10225.101--10225.5102)

   *  Elder Care Payment Restitution Act (35 P. S. §§ 10226.101--10226.107)

   *  Early Intervention Services System Act (11 P. S. §§ 875.101--875.503)

   *  The Whistleblower Law (43 P. S. §§ 1422--1428)

Title 55 of the Pennsylvania Code.

   *  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 3490--Relating to Child Protective Services

   *  Chapter 3800--Relating to Child Residential and Day Treatment Facilities

   *  Chapter 5310--Relating to Community Residential Rehabilitation Services for the Mentally Ill

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

   *  Chapter 6500--Relating to Family Living Homes

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

Title 6 of the Pennsylvania Code (Aging).

   *  Chapter 11--Relating to Older Adult Daily Living Centers

Related Policy Guidelines:

   *  Medical Assistance Bulletin--Revised Medical and Treatment Self-Directive Statement:  Your Rights As a Patient In Pennsylvania:  Making Decisions About Your Care and Treatment (effective June 19, 1998)

   *  Mental Retardation Bulletin 00-98-08--Procedures for Substitute Health Care Decision Making (effective November 30, 1998)

   *  Mental Retardation Bulletin 00-94-32--Assessments: Lifetime Medical History (effective December 6, 1994)

   *  Mental Retardation Bulletin 00-03-01--Passage of Act 171 relating to the Older Adults Protective Services Act (OAPSA)

ADDITIONAL REPORTING:

   In addition to the reporting methodologies described in this statement of policy, the following is provided as a guide to assist in identifying additional reporting. This does not fully define, nor is it intended to substitute for, the applicable statutes and regulations.

   Reportable incidents involving individuals who reside in facilities licensed as ICF/MRs (both state and privately-operated), are to be reported to the appropriate Regional Field Office of the Pennsylvania Department of Health, Division of Intermediate Care Facilities.

   Reportable incidents that occur in facilities licensed by OMR, involving individuals whose support needs are not funded through the Commonwealth or county mental retardation systems, are to be reported to whomever funds the individual's support and to the Commonwealth/Regional Office of Mental Retardation. This includes individuals from other states, individuals who are funded by agencies not part of the mental retardation system and individuals whose support needs are privately funded.

Neglect of care-dependent person (18 Pa.C.S. § 2713)

   The neglect of care-dependent person 18 Pa.C.S. § 2713 covers any adult who, due to physical or cognitive disability or impairment, requires assistance to meet his needs for food, shelter, clothing, personal care or health care. 18 Pa.C.S. § 2713 extends to certain listed facilities and to home health services provided to care-dependent persons in their residence. The statute criminalizes intentional, knowing or reckless conduct by a caregiver which results in bodily injury or serious bodily injury to a care-dependent person by the failure to provide treatment, care, goods or services necessary to preserve the health, safety or welfare of a care-dependent person for whom the caregiver is responsible to provide care. A caregiver may also be prosecuted if he intentionally or knowingly uses a physical restraint, a chemical restraint or medication on a care-dependent person, or isolates that person, contrary to law or regulation, such that bodily or serious bodily injury results.

   Anyone aware of possible violations of this may make a report to the appropriate law enforcement authorities. The reporting requirements of this bulletin are to be followed even if a report of a possible violation of this statute is made to law enforcement authorities. Copies of the statute were distributed via Mental Retardation Bulletin 00-95-25, issued December 26, 1995 and Mental Retardation Bulletin 00-97-06, issued August 29, 1997.

The Child Protective Services Law (23 Pa.C.S. §§ 6301--6385)

   The Child Protective Services Law (CPSL) establishes procedures for the reporting and investigation of suspected child abuse. Certain types of suspected child abuse must be reported to law enforcement officials for investigation of criminal offenses. Children under the age of 18 are covered by the act including those who receive supports and services from the mental retardation system. Providers covered within the scope of this bulletin are required to report suspected child abuse in accordance with the procedures established in the CPSL and the Protective services Regulations. The CPSL defines child abuse as any of the following when committed upon a child under 18 years of age by a parent, person responsible for a child's welfare, an individual residing in the same home as a child or a paramour of a child's parent.

   *  Any recent act or failure to act that causes non-accidental serious physical injury.

   *  Any act or failure to act that causes nonaccidental serious mental injury or sexual abuse or sexual exploitation.

   *  Any recent act or series of such acts or failures to act that creates an imminent risk of serious physical injury or sexual abuse or sexual exploitation.

   *  Serious physical neglect constituting prolonged or repeated lack of supervision or the failure to provide essentials of life including adequate medical care which endangers a child's life or development or impairs the child's functioning.

   Reports of suspected abuse are received by the Department of Public Welfare's (DPW) ChildLine and Abuse Registry (800) 932-0313, which is the central register for all investigated reports of abuse. Individuals who come into contact with children in the course of practicing theirprofession are required to report when they have reasonable cause to suspect on the basis of their medical, professional or other training or experience, that a child is an abused child. Every facility or agency is required by the CPSL to funnel reports to the director or a designee to be promptly reported to ChildLine. The reporting, investigation and documentation requirements of this statement of policy must also be followed when a report of suspected child abuse is made. It must be noted that the definition of abuse found in the CPSL differs greatly from the definition promulgated in this statement. Because of this difference it is possible that an allegation may be ''unconfirmed'' in terms of the CPSL but still substantiated with reference to these guidelines. Likewise, the scope of reports subject to investigation differs so it is important to be familiar with the requirements of the CPSL.

The Older Adults Protective Services Act (35 P. S. §§ 10225.101--10225.5102)

   The Older Adults Protective Services Act (OAPSA) of 1987 was enacted to protect all Pennsylvanians age 60 and older. The OAPSA established a detailed system for reporting and investigating suspected abuse, neglect, exploitation, and abandonment for care-dependent individuals. Act 13 was signed into law in 1997 as an amendment to the OAPSA. Unlike the other provisions of OAPSA that applied only to adults age 60 and above, Act 13 applied to adults age 18 and above who were considered ''care-dependent'' individuals and to ''care-dependent'' individuals under age 18 if they resided in a facility serving individuals over 18. Employees or administrators of a covered entity reported suspected abuse incidents to the local Area Agency on Aging, where indicated, to the Pennsylvania Department of Aging and to local law enforcement pursuant to Chapter 7 of the OAPSA. These requirements existed in addition to the reporting procedures contained in this Bulletin. In 2002, the OAPSA was further amended by the Elder Care Payment Restitution Act.

The Elder Care Payment Restitution Act (35 P. S. §§ 10226.101--10226.107)

   The Elder Care Payment Restitution Act eliminated the requirements of Act 13 for which suspected abuse of individuals with mental retardation under the age of 60 was reported to the Area Agency on Aging and in some cases, to the Department of Aging. This act became effective February 9, 2003.

Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Public Law 104-191)

   HIPAA and the applicable regulations at 45 CFR Parts 160 and 164 (Privacy Rule) established a set of National standards for the protection of personal health information. The Privacy Rule addresses the use and disclosure of individuals' health information or ''protected health information'' by organizations subject to the Privacy Rule or ''covered entities.'' The Privacy Rule establishes standards for individuals' rights to understand and control how their personal health information is used. The U. S. Department of Health and Human Services, Office of Civil Rights is responsible to implement and enforce the Privacy Rule.

REPORTING MATRIX

   The following is provided as a guide to assist in identifying additional reporting. This does not fully define, nor is it intended to substitute for, the applicable statutes and regulations.

Reportable Incident Report
to
OMR
Report
to
County1
Report to
AAA2 If 60 or
older
Report to
ChildLine if
under 18
PA Department of Aging3
If 60 or older
DOH Local Law Enforcement Acts 28/264
Death X X If suspicious If suspicious If suspicious If ICF/MR If suspicious If the result of neglect
Disease Reportable to the Department of Health X XX
Emergency Closure X XIf ICF/MR
Emergency Room Visit X XIf ICF/MR
Fire X XIf ICF/MR
Hospitalization X XIf ICF/MR
Individual to Individual Abuse X XIf ICF/MR
Injury requiring treatment beyond first aid X XIf ICF/MR
Law Enforcement Activity X XIf ICF/MR
Medication Error X XIf ICF/MR
Missing Person X XIf ICF/MR If person is at risk
Misuse of Funds X X If exploitationIf ICF/MR If it appears that a crime has occurred
Neglect X X X X If serious bodily injury or serious physical injury If ICF/MR If serious bodily injury or serious physical injury If serious bodily injury
Physical Abuse X X X X If serious bodily injury If ICF/MR If serious bodily injury or serious physical injury
Psychiatric Hospitalization X XIf ICF/MR
Psychological Abuse X X X XIf ICF/MR
Restraint X XIf ICF/MRIf serious bodily injury
Rights Violation X XIf ICF/MR
Sexual Abuse X X X X X If ICF/MR X
Suicide Attempt X XIf ICF/MR
Verbal Abuse X X XIf ICF/MR

______

1 If an individual is not funded by OMR or by County MR services a report should be made to the funding agent.
2 Allegations of abuse or neglect involving children under 18 who reside in a facility that primarily serves adults must be reported to Child Line.
3 Allegations of abuse or neglect involving children under 18 who reside in a facility that primarily serves adults must be reported to Child Line.
4 Reporting under Acts 28/26 is only mandated for Commonwealth employees.

APPENDIX G

VICTIM'S ASSISTANCE PROGRAMS

   When individuals are abused, neglected, injured or victims of crimes, there are resources to assist them physically, emotionally, financially and legally. Organizations have been developed based on the need to support victims through the criminal justice system, recognizing that victim's needs are oftentimes overlooked. Individuals with disabilities who fall victim to crimes, especially physical violence and sexual assaults, should be encouraged and assisted to access these resources. It is suggested that providers develop relationships with local entities and assist individuals in accessing such services when appropriate.

   There are two main types of victim assistance programs:  system and community-based organizations. System-based programs that generally operate out of a District Attorney's office provide notification to victims/witnesses of court proceedings. Community based programs are designed to provide support and assistance to victims. Usually, the programs fall under the categories of:

   *  Rape Crisis/Sexual Assault programs providing services to victims and their family/supporters. Domestic Violence programs provide counseling and temporary housing to victims, as needed.

   *  Crime Victim Services provide supports and assistance to victims of crimes excluding sexual assaults and domestic violence.

   There are domestic violence centers, rape crisis centers and victim assistance offices throughout the Commonwealth. In order to locate the most appropriate resource for individuals, you may contact the following statewide organizations. Additional information regarding local resources is available through these organizations:

PA Commission on Crime and Delinquency (PCCD)
(717) 787-2040

PA Coalition Against Rape (PCAR)
(800) 692-7445
(717) 728-9740

PA Coalition Against Domestic Violence (PCADV)
(800) 932-4632

Office of Victim Advocate (crime victim compensation)
(717) 783-7501

Pennsylvania Protection and Advocacy (PP&A)
(800) 692-7443

APPENDIX H

ABBREVIATED INCIDENT REPORT

Medication Error

   The data entry screen is to include the following information:

   *  DEMOGRAPHICS (pre-populated from HCSIS demographics)

   Name of the individual for whom the Medication Error is being reported.

   Individual's Base Service Unit (BSU) number.1

   *  CATEGORIZATION

   Secondary category of Medication Error.

   Date and time when the incident was recognized/discovered.

   *  MEDICATION ERROR INCIDENT INFORMATION

   Staff position of the person giving medication.

   Name of medication(s).

   Indication if the error occurred over multiple consecutive administrations.

   The reason(s) why the Medication Error occurred.

   The response(s) to the Medication Error.

   The agency system response to prevent this type of error from occurring in the future.

   Any additional comments.

   Indication if another Incident Report was filed as a result of the Medication Error.

   If another Incident Report was filed, the Incident ID number.

   In addition to the required information, providers may choose to include optional information to further analyze their medication errors.

   *  OPTIONAL MEDICATION ERROR INFORMATION

   The name or unique identifier of person making the Medication Error.

   Indication if the person making the Medication Error was working longer than their regular work hours at the time of the Medication Error.

   The length of time the staff person who made the Medication Error has been giving medications.

   The number of medications supposed to be given to this person at the same time as the Medication Error was made including the medication when the Medication Error was made.

   The number of medications this person receives on a daily basis.

   The number of people that the staff person who made the Medication Error has to give medications to around the same time as the Medication Error occurred.

APPENDIX I

ABBREVIATED INCIDENT REPORT

Restraint

   The data entry screen is to include the following information:

   *  DEMOGRAPHICS (prepopulated from HCSIS demographics)

   Name of the individual for whom the Restraint was used.

   Individual's Base Service Unit (BSU) number.1

   *  CATEGORIZATION

   Secondary category of Restraint.

   Date of the Restraint.

   Time in Restraint.

   Time out of Restraint.

   *  RESTRAINT INCIDENT INFORMATION

   Restraint agent.

   Antecedent to the Restraint.

   Reason for the Restraint.

   Indication if the Restraint was used on a planned or emergency basis.

   Authorizing Staff.

   Indication if Prone (face down) Restraint was used.

   Indication if another Incident Report was filed as a result of the Restraint.

   If another Incident Report was filed the Incident ID number.

APPENDIX J

INCIDENT MANAGEMENT CONTINGENCY PLAN

   In the event that a provider or county or entity is unable to report a 24-hour incident through the Home and Community Services Information System (HCSIS), faxed contingency reporting is to be utilized.

   Incidents that are reported via fax are to be recorded on a copy of the attached Incident Management Contingency Form. This reporting method will satisfy regulatory requirements to report an incident. In the event of a serious incident (such as abuse with injury, suspicious death), a provider should also call its OMR Regional Office and County MH/MR Program to alert OMR and the county of the incident.

   Once complete, the Incident Management Contingency Form is to be faxed to the appropriate OMR Regional Office and to the County MH/MR Program. The form should have a fax cover sheet that identifies the fax as a reportable incident and states the reason that the report needed to be faxed. Faxing the Incident Management Contingency Form is a short-term solution for meeting regulatory requirements for reporting incidents; however, once access to HCSIS can be established, the incident must be entered into HCSIS.

CONTACT INFORMATION:

   OMR Regional Office Fax Numbers:

   *  Northeast Region (570) 963-3177

   *  Southeast Region (215) 560-3043

   *  Central Region (717) 772-6483

   *  Western Region (412) 565-5479

   OMR Regional Office Phone Numbers:

   *  Northeast Region (570) 963-4391

   *  Southeast Region (215) 560-2242

   *  Central Region (717) 772-6507

   *  Western Region (412) 565-5144

APPENDIX K

STANDARDIZED INCIDENT REPORT

FIRST SECTION (completed within 24 hours)

   The First Section is to include the following information:

   *  DEMOGRAPHICS (pre-populated from HCSIS demographics)

   Name of the individual involved/affected by the incident.

   Individual's Base Service Unit (BSU) number.1

   County of Registration.

   Gender.

   Individual's date of birth.

   MR Diagnosis.

   Home address of the individual.

   Living Arrangement of the individual.

   Name and address of the reporting entity.

   Location where the incident occurred.

   Name of the point person.

   *  CATEGORIZATION

   Date and time when the incident was recognized/discovered.

   Primary and secondary category of the incident.

   Determination if an investigation is required or desired.

   Name of the Certified Investigator assigned, if the incident requires investigation.

   *  HEALTH AND SAFETY ASSURANCE

   Description of the immediate and subsequent steps taken by the point person or other representatives of the provider to ensure the individual's health, safety and response to the incident, including date, time and by whom those steps were taken.

   *  INCIDENT DESCRIPTION

   Narrative description of the incident completed by staff or other person(s) who were present when the incident occurred or who discovered that an incident had occurred.2

FINAL SECTION (completed within 30 days)

   The reporting entity will complete the Final Section of the incident report within 30 days from the date of the incident or of the date the provider learns of the incident (unless an extension has been made). The Final Section will retain all of the preceding information from the First Section and will add:

   Name of the initial reporter.

   Name of the individual's supports coordinator (pre-populated).

   Whether CPR was administered.

   Weather the Heimlich was administered.

   If 911 was called, the time, date and person who called.

   If the incident involves an illness or injury, the name of the practitioner/facility by whom the individual was treated initially, the date and time of the initial contact with a health-care/medical practitioner, the nature/content of the initial treatment/evaluation, and the nature of, date of, time of, and practitioner involved in any subsequent treatments, evaluations.

   In the event of a death, indication if the individual was in hospice care, had a diagnosis of terminal illness, if a ''Do Not Resuscitate'' order was in effect, if the coroner was contacted, if an autopsy has been or will be performed.

   Identification of all persons to whom the incident notification has been (or will be) submitted (i.e., family, law enforcement agency), the date the notification has been made, and the person who has/will notify the necessary parties.

   Update of incident description, as needed.

   Specific description of any injury received by the individual.

   Present status of the individual in reference to the incident.

   Identification of other persons who may have witnessed or been directly involved in the incident.

   Specific signs and symptoms of any illness (acute or chronic) which may be contributory to the incident.

   Any relevant background information on the individual, including medical history and diagnoses.

   Date on which the investigation began, if required.

   Summary of the investigator's findings and conclusions, if required.

   If the incident involves an allegation of abuse or neglect, the conclusion reached on the basis of the investigation (i.e., the allegation is confirmed, not confirmed, inconclusive) and the status of the target.

   Description of the steps taken by the provider in response to the conclusions reached as a result of the investigation.

   If the incident involves an injury of unknown origin, confirmation of the cause (if one has been identified) and steps taken to prevent recurrence.

   Description of any changes in the individual's plan of support necessitated by or in response to the incident.

   Verification by the provider that all necessary corrective actions have been identified.

   If any corrective action cannot/has not been completed by the time the Final Section is submitted, the expected date of completion must be provided along with the identity of the person responsible for carrying the extended action through to completion.

   If the nature of the incident requires contact with local law enforcement, the name and department/office of the person(s) contacted, the date of the contact, the name of the person who initiated the contact, and a description of any steps taken by law enforcement officials.

   If the individual has been hospitalized, the date of admission, name of the hospital, the admitting diagnosis(es), indication if the admission was from the emergency room, what occurred during the hospitalization, change in voluntary/involuntary status, the date of discharge, the discharge diagnosis(es), an indication that the Hospital Discharge Instructions were provided, what changed after discharge, current status and any plans for subsequent medical follow-up.

   If the individual is deceased, the Final Section is to be supplemented by a hard copy of the following:3

   --  Lifetime medical history.

   --  Copy of the Death Certificate.

   --  Autopsy Report, if one has been completed.

   --  Discharge Summary from the final hospitalization, if the individual died while hospitalized.

   --  Results of the most recent physical examination.

   --  Most recent Health and Medical assessments.

   Name of the family member notified of the results of the investigation, if required.

   The incident classification the provider believes is most appropriate.

   The date and time the provider believes is most appropriate.

   After final submission by the provider, the county and OMR will perform a management review and close the incident.

______

1 If the individual is not registered with a County MH/MR Program, the report is to list the county or state where the person is/was a resident.

______

1 If the individual is not registered with a County MH/MR Program, the report is to list the county or state where the person is/was a resident.

______

1 If the individual is not registered with a County MH/MR Program, the report is to list the county or state where the person is/was a resident.

2 Providers may summarize the narrative description, but the written statements of the person(s) directly involved are to be available for review, if needed.

3 Documents, which are not immediately available, must be forwarded to the appropriate parties (county and/or OMR Regional Office) as they become available. If, after attempting to acquire the document, it is determined to be unobtainable, the expecting party will be notified.

[Pa.B. Doc. No. 04-330. Filed for public inspection February 27, 2004, 9:00 a.m.]



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