There are two related substantive changes in 12VAC35-105-170 and 620.D.3 that will have a significant impact on all providers. Both sections contain provider expectations of “prevent recurrence” which is an impossible standard to meet. Perfection is an unachievable standard. The “Indicators” agreed to between DBHDS and DOJ, and approved by the Court on January 14, 2020, state “prevent or mitigate future risks of harm” (page 36) and “prevent or substantially mitigate risks of harm (page 33). The proposed regulations including the absolute “prevent recurrence” are above and beyond the standard agreed to between DOJ, DBHDS and Judge Gibney. We recommend the deletion of Section 170H

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 prevents providers from providing “living wages” to DSPs as well as other supports that provide value to the individuals we serve. The Risk Management function can be carried out by multiple staff that have expertise in different subject matter, not just one. Recommend that providers be given the option of having a risk management team that would have a collective knowledge base of root cause analysis, investigations, risk management, etc.

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 Assessment Plan with the exception that the treatment team would follow-up when there are increased frequencies and/or patterns.

12VAC35-105-20 Definitions

Qualified developmental disability professional or QDDP
Experience option is needed in lieu of Bachelor’s Degree.  Many QDDPs have achieved a 5-year+ experience standard but do not have degrees. Definition needs to clearly state experience option.

ISP
Regulations are using the term Individual Service Plan. Person-centered language uses Individual “Support” Plan. “Service” is used throughout document as in “receives services” instead of “is provided supports”.

Level 1 Serious Incident
Clarity is needed between Level 1 and Level II and III. To ensure providers understand the Level 1 serious incident definition, the regulation should include a list of sample incidents that constitute a Level 1 serious incident (e.g. bruises, minor sprain, etc.) Adding this information will help reduce CHRIS serious incident reporting errors and increase the likelihood that providers address all Level 1 incidents in their quarterly review.

12VAC35-105-160 Reviews by Dept; Requests for Info; Required Reporting

B. Further clarity is needed that “all information requested” applies to the current inspection and/or investigation currently under review. As currently written, this language may be interpreted as a “blanket request”. Include specifics as to “x, y and z” etc.

12VAC35-105-170. Corrective Action Plan

170.C and 170.H. - While it is reasonable for a provider to develop a corrective action plan which includes a detailed description of the actions to be taken that will minimize the possibility that the violation will occur again and correct any systemic deficiencies (albeit not all cited violations are the result of systemic deficiencies), the standard is raised to an unattainable level in Section 170.H to “prevent recurrence”.  This is unreasonable. The “Indicators” agreed to between DBHDS and DOJ, and approved by the Court on January 14, 2020, state “prevent or mitigate future risks of harm” (page 36) and “prevent or substantially mitigate risks of harm (page 33). The proposed regulations including the absolute “prevent recurrence” are above and beyond the standard agreed to between DOJ, DBHDS and Judge Gibney. We recommend the deletion of Section 170H. This additional burden must not be placed upon providers.

What is considered a repeat and systemic citation for a provider that operates multiple services via multiple sites throughout multiple regions of the Commonwealth? Please define.

12VAC35-105-520 - Risk Management

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.

    Also states that the “designated person” for risk management will complete “department approved training”. We have concerns about the qualifying statement of “department approved training”. Will DBHDS be the designated provider of this training? Will there be a list of approved trainings? It would improve consistency across the state if DBHDS provided the training and the language read “complete training provided or approved by DBHDS”.

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 licenses 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 the 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.

12VAC35-105-530 - Emergency Preparedness and Response Plan

Section A.9. - States that "fire and evacuation drills shall be conducted at least monthly". We recommend that this language be deleted and regulatory language be inserted that reflects current requirements of "Providers shall implement a quarterly schedule for testing emergency preparedness plan and testing emergency drills".

12VAC35-105-620 - Monitoring and Evaluating Service Quality

Section 620.D. - The provider is required to include their plan for accomplishing the expectation to "prevent recurrence" as part of their Quality Improvement strategy.  For the reasons stated above in 12VAC35-105-170 and to be consistent with the level of requirement in the DOJ/DBHDS "Indicators", we object to this unreasonable and unattainable standard.  As one commenter said, "there are a multitude of actions, occurrences, circumstances and/or instances of human behavior that can interfere with any path to perfection".

Section 620.C.3. - Question regarding "statewide performance measure".  What are they? Where can they be found?

12VAC35-105-660 - ISP

Section D.1.b. and D.2. - Need clarity regarding language "alternative services that might be advantageous" and "documenting alternative services".  This reads as if the provider is responsible for researching alternative services and documenting steps taken to secure them.  If this means alternative to current services, we suggest that it be clarified as the responsibility of the Case Manager or Support Coordinator and belongs in Part 1 through Part 4 rather than expecting each provider to document in Part 5.

We also recommend changing the term "authorized representative" to "substitute decision-maker" in both of these sections.

12VAC35-105-665 - ISP Requirements

Section D - We have an objection to the requirement proposed in Section D. While we agree that it is appropriate for DSPs to demonstrate a "working knowledge of each individual's detailed health and safety protocols" that they work with, it is not reasonable to impose that requirement on our contractors who consult about services for multiple individuals.  It is also unreasonable for staff whose role is supervisory to have this requirement as they supervise a large number of individuals just because they may have an assigned role in ISP implementation.