Regulations. The regulations which require and govern reports to DBHDS which could be reported in the CHRIS system are:

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CHRIS Reporting: There are a number of issues and concerns which have been raised about the requirements of the CHRIS reporting system. We are not going to attempt to address the technical issues with access to the system, etc. The list below is designed to give providers some information about the areas of concern shared by multiple providers and which issues are still being addressed: Regulations The regulations which require and govern reports to DBHDS which could be reported in the CHRIS system are: 12VAC35-115-230. Provider requirements for reporting to the department, and 12VAC35-115-50. Dignity A. Providers shall collect, maintain and report the following information concerning abuse, neglect, and exploitation: 1. The director of a facility operated by the department shall report allegations of abuse and neglect in accordance with all applicable operating instructions issued by the commissioner or his designee. 2. The director of a service licensed or funded by the department shall report each allegation of abuse or neglect to the assigned human rights advocate within 24 hours from the receipt of the allegation (see 12VAC35-115-50). 3. The investigating authority shall provide a written report of the results of the investigation of abuse or neglect to the director and human rights advocate within 10 working days from the date the investigation began unless an exemption has been granted by the department (see 12VAC35-115-50). This report shall include: a. Whether abuse, neglect, or exploitation occurred; b. The type of abuse; and c. Whether the act resulted in physical or psychological injury. B. Providers shall collect, maintain, and report the following information concerning deaths and serious injuries: 1. The director of a facility operated by the department shall report to the department deaths and serious injuries in accordance with all applicable operating instructions issued by the commissioner or his designee. 2. The director of a service licensed or funded by the department shall report deaths and serious injuries in writing to the department within 24 hours of discovery and by telephone to the authorized representative within 24 hours. 3. All reports of death and serious injuries shall include: VNPP, Inc 1 of 6

a. Date and place of the death or serious injury; b. Nature of the injuries and treatment required; and c. Circumstances of the death or serious injury. C. Section on reporting of seclusion & restraint omitted here. D. The director shall provide to the human rights advocate and the LHRC information on the type, resolution level, and findings of each complaint of a human rights violation and implementation of variances in accordance with the LHRC meeting schedule or as requested by the advocate. E. Reports required under this section shall be submitted to the department on forms or in an automated format or both developed by the department. F. The department shall compile all data reported under this section and make this data available to the public and the inspector general upon request. 1. The department shall provide the compiled data in writing or by electronic means. 2. The department shall remove all provider-identifying information and all information that could be used to identify a person as an individual receiving services. G I. Sections omitted here. 12VAC35-115-50. Dignity D. The provider's duties. 1 & 2 Sections omitted here. 3. Providers shall assure the following relative to abuse, neglect, and exploitation: a d Sections omitted here. e. The director shall initiate an impartial investigation within 24 hours of receiving a report of potential abuse or neglect. The investigation shall be conducted by a person trained to do investigations and who is not involved in the issues under investigation. (1) The investigator shall make a final report to the director or the investigating authority and to the human rights advocate within 10 working days of appointment. Exceptions to this timeframe may be requested and approved by the department if submitted prior to the close of the sixth day. (2) The director or investigating authority shall, based on the investigator's report and any other available information, decide whether the abuse, neglect or exploitation occurred. Unless otherwise provided by law, the standard for deciding whether abuse, neglect, or exploitation has occurred is preponderance of the evidence. VNPP, Inc 2 of 6

(3) If abuse, neglect or exploitation occurred, the director shall take any action required to protect the individual and other individuals. All actions must be documented and reported as required by 12VAC35-115-230. (4) In all cases, the director shall provide his written decision, including actions taken as a result of the investigation, within seven working days following the completion of the investigation to the individual or the individual's authorized representative, the human rights advocate, the investigating authority, and the involved employee or employees. The decision shall be in writing and in the manner, format, and language that is most easily understood by the individual. (5) If the individual affected by the alleged abuse, neglect, or exploitation or his authorized representative is not satisfied with the director's actions, he or his authorized representative, or anyone acting on his behalf, may file a petition for an LHRC hearing under 12VAC35-115-180. f h Sections omitted here 4 Section omitted here 12VAC35-115-30 Definitions (Human Rights): "Abuse" means any act or failure to act by an employee or other person responsible for the care of an individual in a facility or program operated, licensed, or funded by the department, excluding those operated by the Department of Corrections, that was performed or was failed to be performed knowingly, recklessly, or intentionally, and that caused or might have caused physical or psychological harm, injury, or death to a person receiving care or treatment for mental illness, mental retardation, or substance abuse. Examples of abuse include acts such as: 1. Rape, sexual assault, or other criminal sexual behavior; 2. Assault or battery; 3. Use of language that demeans, threatens, intimidates or humiliates the person; 4. Misuse or misappropriation of the person's assets, goods or property; 5. Use of excessive force when placing a person in physical or mechanical restraint; 6. Use of physical or mechanical restraints on a person that is not in compliance with federal and state laws, regulations, and policies, professionally accepted standards of practice, or the person's individualized services plan; and 7. Use of more restrictive or intensive services or denial of services to punish the person or that is not consistent with his individualized services plan. See 37.2-100 of the Code of Virginia. "Complaint" means an allegation of a violation of these regulations or a provider's policies and procedures related to these regulations. VNPP, Inc 3 of 6

Exploitation means the misuse or misappropriation of the individual s assets, goods, or property. Exploitation is a type of abuse. (See 37.2-100 of the Code of Virginia.) Exploitation also includes the use of a position of authority to extract personal gain from an individual. Exploitation includes violations of 12VAC35-115-120 (Work) and 12VAC35-115-130 (Research). Exploitation does not include the billing of an individual s third party payer for services. Exploitation also does not include instances of use or appropriation of an individual s assets, goods or property when permission is given by the individual or his authorized representative: 1. With full knowledge of the consequences; 2. With no inducements; and 3. Without force, misrepresentation, fraud, deceit, duress of any form, constraint, or coercion. Neglect means failure by a person, program, or facility operated, licensed, or funded by the department, excluding those operated by the Department of Corrections, responsible for providing services to do so, including nourishment, treatment, care, goods, or services necessary to the health, safety, or welfare of a person receiving care or treatment for mental illness, mental retardation, or substance abuse. See 37.2-100 of the Code of Virginia. Peer-on-peer aggression means a physical act, verbal threat or demeaning expression by an individual against or to another individual that causes physical or emotional harm to that individual. Examples include hitting, kicking, scratching, and other threatening behavior. Such instances may constitute potential neglect. Serious injury means any injury resulting in bodily hurt, damage, harm, or loss that requires medical attention by a licensed physician. 12VAC35-105-20. Definitions (Licensing) Medication error means an error in administering a medication to an individual and includes when any of the following occur: (i) the wrong medication is given to an individual, (ii) the wrong individual is given the medication, (iii) the wrong dosage is given to an individual, (iv) medication is given to an individual at the wrong time or not at all, or (v) the wrong method is used to give the medication to the individual. [see note below] Serious injury means any injury resulting in bodily damage, harm, or loss that requires medical attention by a licensed physician, doctor of osteopathic medicine, physician assistant, or nurse practitioner while the individual is supervised by or involved in services, such as attempted suicides, medication overdoses, or reactions from medications administered or prescribed by the service. Note: The interpretation which leads to a medication error being possible neglect is the literal interpretation of the definition of neglect; i.e., failure by a person, VNPP, Inc 4 of 6

program or facility... responsible for providing services to do so... Some areas of the state (because of the interpretation by some human rights staff) have required the reporting of all medication errors as possible neglect for a number of years. Other regulations ( 780) outline the steps to be taken including prompt notification of an appropriate health professional though frequently there is neither an adverse reaction nor any treatment ordered. 12VAC35-105-780. Medication errors and drug reactions. In the event of a medication error or adverse drug reaction: 1. First aid shall be administered if indicated. 2. Employees or contractors shall promptly contact a poison control center, pharmacist, nurse or physician and shall take actions as directed. 3. The individual s physician shall be notified as soon as possible unless the situation is addressed in standing orders. 4. Actions taken by employees or contractors shall be documented. 5. The provider shall review medication errors at least quarterly as part of the quality assurance in 12VAC35-105-620. 6. Medication errors and adverse drug reactions shall be recorded in the individual s medication log. Issues to be Resolved The decision has been made by DBHDS that names of staff alleged to have abused, neglected or exploited an individual must be entered but only if the case is founded. DBHDS claims to have an opinion from the Office of the Attorney General that they can ask for the name of the alleged abuser; many entities have opinions from their attorneys which direct them to not provide that information. There is no regulation which requires the name to be provided as part of the report. They also request the date of birth for that individual if the name is provided. As we do not obtain the dates of birth directly from staff (it is a question prohibited federal law); providers should seek the advice of their attorney prior to providing that information, if available, in the CHRIS system. That particular field is not required. We will continue to work with the Department to have the CHRIS system modified to provide security for the provider s data; as the system is currently configured, the information entered by the provider can be altered, modified, amended or changed by DBHDS staff after it is entered by the provider. DBHDS staff have been instructed to not change any information entered by the provider; event logs in the IT system may identify who made an entry, but they are not retained for any significant period of time. Training which has been offered suggests a much broader interpretation of what is required to be reported. The regulations which describe the elements required are printed above and have not changed. VNPP, Inc 5 of 6

Data entry into the CHRIS system is controlled by each provider to allow limited access and security. Regulations require reporting abuse, neglect, serious injuries or deaths within 24 hours; discussion of the CHRIS system have suggested that this will be a data element to track and to cite providers if the timeframe is exceeded. The CHRIS system may not be accessible to a provider entity outside of regular business hours; inability to access CHRIS should not deter a provider from taking the appropriate action to provider for the safety and welfare of the individuals VNPP, Inc 6 of 6