Re: Objection to the addition of 12VAC35-105-170 H and 12VAC35-105-620.D.3

As a provider in the Commonwealth, I would like to share my concerns with the following proposed regulations:

12VAC35-105-170 H

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.D.3

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.

While we agree with the continued need for providers to implement, monitor and re-evaluate their quality improvement plans and to create action steps to reduce the likelihood of future recurrence of violations cited in an approved corrective action plan, we do not agree with the addition 170 H and 620.D.3.

The language used in this section, specifically the use of “prevent the recurrence”, sets up unreasonable expectations for providers to meet, but especially large providers who have multiple lines of services and multiple locations around the Commonwealth.  For larger organizations, there are several factors that could lead to a recurrence of a cited violation at different service sites.

Further, the language “prevent the recurrence” contradicts the language used in section C1 “will minimize the possibility that the violation will occur again…”

The language in 170 H also leaves a subjective measure of interpretation to the specialist who may determine that more than one occurrence following a CAP would be considered “systemic” which could result in a provisional license status.

Given all of the variables involved in providing care to the vulnerable populations we serve, it is unreasonable to assume that a provider will be able to completely “prevent” the recurrence of a cited violation.

Therefore, we recommend that the final regulations either remove the term “prevent” or do not include 12VAC35-105-620.D.3 or 12VAC35-105-170 H in their entirety.