General Statement:

Southside Community Service Board complies with regulatory requirements. As DBHDS expectations and requirements burgeon across all of its departments, it is increasingly challenging to meet requirements with current staff. Southside Community Service Board is requesting consideration of funding for additional administrative and/or quality assurance staff to meet expectations. Consideration is also requested for DBHDS to partner with providers in the drafting of future regulations and guidance documents prior to the public comment period to gather input on implementation impacts.

Regulation:

“12VAC35-105-520. Risk management. A. The provider shall designate a person responsible for the risk management function who has completed department approved training, 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:

Please clarify department-approved training? Is DBHDS going to provide this training? Until department-approved training is released what training would count towards meeting this regulation?

In addition, please allow for qualifications of the Risk Manager to include relevant or equivalent experience and not be based solely on DBHDS training; and I suggest broadening allowable sources of training.  I would like to know how each Risk Manager's qualifications and training will be reviewed/approved.

This position and its increasing responsibilities are good practice overall but are another significant unfunded requirement, that is not covered by reimbursement rates or state funding. Funding will have to be taken away from positions that provide direct care to clients in order to fund these regulations. How are smaller providers going to be able to provide quality services to their clients while also attempting to meet the demands of DBHDS?

Regulation:

“12VAC35-105-520.F 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.”

Comment:

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 the protection of HIPAA and PHI.

Regulation:

“12VAC35-105-520.A All providers are required to have a qualified designated person with risk management responsibilities. Qualifications for this position may be obtained through the completion of department approved training in these enumerated areas of risk management responsibility:

1. Individual risk screening;

2. Conducting investigations;

3. Root cause analysis; and

4. The use of data to identify risk patterns and trends.”

Comment:

Please clarify the meaning of "individual risk screenings”.  The guidance appears to indicate the risk manager will have a clinical responsibility.  While a risk manager would be looking for issues, they would not necessarily have the clinical expertise needed to conduct individual risk screenings.

Regulation:

“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:

1. The environment of care;

2. Clinical assessment or reassessment processes;

3. Staff competence and adequacy of staffing;

4. Use of high risk procedures, including seclusion and restraint; and

5. A review of serious incidents.”

Comment:

Regarding Section C(4): Use of High-Risk Procedures, I am seeking clarity as to what besides seclusion and restraint is perceived as a high-risk procedure. I ask that DBHDS provide in the guidance some examples of the ‘other high-risk procedures’ they would consider applicable to this section.

Regulation:

“12VAC35-105-520.D The systemic risk assessment review process shall incorporate uniform risk triggers and thresholds as defined by the department.”

Comment:

When will the risk triggers and thresholds be defined?