OVERALL COMMENTS:
Overall concern that the complexity and intensity of the proposed Risk Management Plan expectations are such that they may be beyond many small organization's ability to meet without the hiring of a separate "Compliance Officer" or "Risk Manager".  Administrative expectations and burden for DD Waiver providers is already extensive and expensive.  Because of the historically low DD Waiver provider rates, the continued addition of administrative burden presents providers from providing "living wages" to DSPs as well as other supports that provide value to the individuals we serve.

Based on recent OL audits of providers, there seems to be confusion that arises when the OL staff looks at some of the proposed items in the Risk Management Plan "in a vacuum".  For example, OL staff has asked to see quarterly Level 1 reviews - but, without looking at the individual's record where there is person-centered context.  Level 1 incidents are most often part of a person's baseline and/or are very personalized.  These would not be addressed in an "organizational" Risk Management Plan with the except that the treatment team would follow-up when there are increased frequencies and/or patterns.

12VAC35-105-520. A.
Suggested Language:
A. The provider shall designate a person(s) responsible for the risk management function who has completed department approved training or equivalent experience, which shall include training related to risk management, understanding of individual risk screening, conducting investigations, root cause analysis, and the use of data to identify risk patterns and trends.

COMMENT:
The purpose for the addition of (s) in 12VAC35-105-520.A is to allow for multiple individuals to possess risk management functions within their position description as necessary depending on where they are the subject matter expert. Additionally, this allows for contract positions to provide a risk management analysis from data collection.

12VAC35-105-520.B
Suggested Language:
The provider shall identify individual person centered risks with the person-centered planning team for the individual receiving services through quarterly and annual reviews and as needed when multiple serious incidents occur to ensure best therapeutic support is able to be provided. The provider shall implement a written plan to identify, monitor, reduce, and minimize harms and risk of harm that are deemed systemic organizationally impacting two or more persons from a root cause analysis , including personal injury, infectious disease, property damage or loss, and other sources of potential liability.

COMMENT:
The purpose for this addition in 12VAC35-105-520.B is to allow for person-centered planning to address person-centered risk, and organizational risk management to address service provision areas as a whole should they be systemic from an organizational level.

12VAC35-105-520.C
The provider shall conduct systemic risk assessment reviews at least annually to identify and respond to practices, situations, and policies that could result in the risk of harm to individuals receiving services. The risk assessment review shall address at least the following:………

COMMENT:
Section C would support suggested language change to Section B as it outlines “harm to individuals” (plural) meaning two or more to be systemic. This will allow for a separation between one individual receiving services that needs a risk management review in their person-centered plan vs. systemic risk on the part of the organization.

12VAC35-105-520.F.
Current Language:The provider shall document serious injuries to employees, contractors, students, volunteers, and visitors that occur during the provision of a service “or on the provider's property”. Documentation shall be kept on file for three years. The provider shall evaluate serious injuries at least annually……

Suggested Language:
If a serious injury occurs during the provision of licensed services, the provider shall document and report to appropriate parties', serious injuries to employees, contractors, students, volunteers and visitors.  Documentation will be kept on file for three years.  Providers shall evaluate all serious injuries within the provision of licensed services annually and will document and determine areas for improvement as applicable.

COMMENT:

Major concern about the language included "or on the provider's property".  The purpose of our suggested language would help to ensure the provider is only reporting to DBHDS on licensed services.  Serious injuries outside the provision of licensed services do not fall under the jurisdiction of the department, and information as such should not be provided to ensure protection of HIPAA and PHI.