Overall, this document continues to make changes to regulations that require additional administrative burden to agencies currently experiencing increased demand and stress related to the intentions to keep individuals safe in their current environment.  Having regulatory documents that have been on hold for months to be open for comment during this time of a national emergency related to COVID-19 is not only challenging but also additionally burdensome.

I seek increased consistency within these regulations and decreased overlapping information.  Regulations should be stated once and not in multiple places to cause confusion and hinder a providers ability to meet the criteria outlined.  When stringent guidelines are placed causing increased requirements and financial/administrative burdens on agencies this will ultimately impact those for which the regulations are there to protect.

12VAC35-105-160 E. 2.

This section is re-stating requirements that already exist within the Quality Improvement Program Regulation.  Providers are already required to have a policy regarding reporting and review of incidents as well as systemic concerns.  Any incident noted within this section already requires a root cause analysis as well as quarterly review as noted within the current regulations related to serious incident reporting and should not be restated with an additional requirement in this section.

With regards to the additional policy requirement related to root cause analysis, it is recommended that E. 2. is removed and the wording from E.1. c. remains with an addition as noted below.

A more detailed root cause analysis, including convening a team, collecting and analyzing data, mapping processes, and charting causal factors should be considered based upon the circumstances of the incident at the discretion of the agency.

12VAC35-105-170. Corrective action plan

H. The provider shall monitor implementation and effectiveness of approved corrective actions as part of its quality improvement program required by 12VAC35-105-620. If the provider determines that an approved corrective action was fully implemented, but did not prevent the recurrence of a regulatory violation or correct any systemic deficiencies, the provider shall:

1. Continue implementing the corrective action plan and put into place additional measures to prevent the recurrence of the cited violation and address identified systemic deficiencies; or

2. Submit a revised corrective action plan to the department for approval. ]

12VAC35-105-620. Monitoring and evaluating service quality.

3. Submit revised corrective action plans to the department for approval or continue implementing the corrective action plan and put into place additional measures to prevent the recurrence of the cited violation and address identified systemic deficiencies when reviews determine that a corrective action was fully implemented but did not prevent the recurrence of the cited regulatory violation or correct a systemic deficiency pursuant to 12VAC35-105-170.

These requirements make it impossible to provide services.  We work in a system where we are working with people and there is no way to prevent actions rather we mitigate the occurrence or attempt to minimize the risk.  It is recommended that this wording be changed to mitigate as noted in another section of this document.  In the section regarding Reviews by the department; requests for information; required reporting within this regulatory document the following is noted and here is an example of the inconsistency:

12VAC35-105-160

C. The provider shall collect, maintain, and review at least quarterly all serious incidents, including Level I serious incidents, as part of the quality improvement program in accordance with 12VAC35-105-620 to include an analysis of trends, potential systemic issues or causes, indicated remediation, and documentation of steps taken to mitigate the potential for future incidents.

12VAC35-105-530

A. 9.Fire and evacuation drills shall be conducted at least monthly.

This is not only burdensome to agency personnel but can be traumatizing to some individuals.  In addition, studies have shown with fire and intruder drills that this can have an impact in desensitizing individuals to true emergencies when/if they occur because this becomes a form of routine as opposed to truly a drill to practice for when a true emergency occurs.  The current requirement of quarterly drills allows agencies to ensure the individuals and staff are responsive in an emergency but also maintain the emergent nature of the alarm.