Comments regarding draft guidance document re: 

12VAC35-105 Incident Reporting Requirements

General Comments:

1. Prince William County CS continues to comply with all DBHDS regulatory requirements.  However, as DBHDS has consistently added expectations, measures, and requirements, as well as reducing timelines for completion, meeting these obligations have become significantly more challenging at our current staffing levels. Prince William CS encourages DBHDS to consider funding for additional administrative, IT and QA staff for CSBs in order to meet current and future regulations.  The ever-expanding regulations have resulted in unfunded mandates from the state and impose a significant economic burden on providers that is certainly not being recouped in our current funding.
2. It is recommended that the department figure out a way for providers entering incidents that meet both “serious incidents” and potential human rights violations to do it one time.  Requiring providers to enter the same information twice is a waste of resources on the providers end.

Guidance Document

“When the provider must update an incident report in CHRIS after the initial submission, the provider must do so within 48 hours from the initial submission of the incident report, or from the time that the provider is informed by the IMU of the need to update the report, whichever is later. Failure to update a serious incident report in CHRIS within 48 hours from the initial submission of the report, or from the time that the provider is informed by the IMU of the need to update the report, will be cited as a regulatory violation of 12VAC35-105-160.F. or 12VAC35-46-230.A., as applicable.”

1. It is recommended that the department change both the reporting requirements for the initial incident at 24 hours as well as the 48-hour follow up timeline.  There are a variety of reasons for agencies to not meet these rather subjective timeframes that are not related to just failure to do so.  For example, if an incident is discovered by a direct line staff at 4:00 pm on Friday it could certainly take several hours for it to get through the chain to a person with the authority to enter a CHRIS report.  So, if that report is entered after work hours by 9:00 pm on Friday by someone working overtime (with the agency accruing additional personnel costs) no one will be reading it at the department level until Monday AM.  Additionally, if the report is medical in nature, we would have to close the report by 4:00 pm on Sunday when we have gathered no additional medical information due to it being the weekend. It is suggested that the department revise their timelines to be COB on the next business day for incident reports and give the provider 3 business days to gather whatever medical information they can to close out the report.  This will provide DBHDS with more complete and accurate information and make the reviewer’s job easier.

Guidance Document:

“Progressive Actions for Repeat Citations: 

Beginning June 15, 2020, the Office of Licensing will implement progressive citation protocols to address repeat violations of serious incident documentation and reporting requirements. The purpose of these protocols is to ensure that providers who demonstrate regulatory noncompliance implement effective corrective actions and quality improvement activities to prevent future violations. When a provider has been previously cited for a regulatory violation, future violations of the same regulation will result in the following progressive actions: 

First Citation: When issued related to the reporting of serious incidents, deaths, or allegations of abuse or neglect within a two-year period, the provider will be issued a licensing report citing:  12VAC35-105-160D.2. or 12VAC35-46-1070. C., as applicable, for noncompliance with reporting requirements. 

Second Citation: When issued related to the reporting of serious incidents, deaths, or allegations of abuse or neglect within a two-year period, the provider will be issued a licensing report citing:  12VAC35-105-160. D.2. or 12VAC35-46-1070. C., as applicable, for systemic noncompliance with reporting requirements; AND  12VAC35-105-170. G. or 12VAC35-46-80. B., as applicable, for failure to implement the previously pledged CAP. 

Third Citation: When issued related to the reporting of serious incidents, deaths, or allegations of abuse or neglect within a two-year period, the provider will be issued a licensing report citing:  12VAC35-105-160. D.2. or 12VAC35-46-1070. C., as applicable, for systemic noncompliance with reporting requirements; AND  12VAC35-105-170. G. or 12VAC35-46-80. B., as applicable, for failure to implement the previously issued CAP. The Department of Medical Assistance Services (DMAS) will be copied on the licensing report when a third citation is sent out. In addition, the department may mandate serious incident reporting training for the provider’s employees, with costs borne by the provider, when it is determined that a lack of training caused or contributed to the licensing or human rights violations pursuant to Code of Virginia § 37.2-419 and 12VAC35-105-100.A. or 12VAC35-46-60.G.; or require the provider to submit a signed attestation verifying that the regulations and guidance pertaining to serious incident reporting were reviewed(Note: Memos from this office are guidance). 

Fourth Citation: When issued related to the reporting of serious incidents, deaths, or allegations of abuse or neglect within a two year period, in addition to the steps enumerated above for the third citation, the Office of Licensing may do any of the following:  Deny an application for a license or license renewal (Code of Virginia § 37.2-418 and 12VAC35- 105-110 or 12VAC35-46-120);  Issue a provisional license (Code of Virginia § 37.2-415 and 12VAC35-105-50A.2. or 12VAC35- 46-90. B.); or Revoke or suspend a full, conditional, or provisional license, due to the provider’s repeated failure to submit or implement an adequate CAP (Code of Virginia § 37.2-418 and 12VAC35- 105-110 or 12VAC35-46-1630).”

1. It is recommended that the Department revise the start date of this policy.  Having a start date of June 15, 2020, before the comment period even started and before any questions regarding the policy can be reviewed, is unreasonable and leaves providers with the impressions that the department is just going through the motions of following the statutory regulations and will not result in any real review and/or modification.  The department should also clearly define when the review period begins and ends.  Does it start with the first incident?  Is it rolling so it’s the last two fiscal years?  Is it FY21 and FY22 with a start over in FY23?
2. Nothing in this document addresses the realities of the size of an agency, location, and programs provided.  It places an unreasonable burden on larger organizations that is almost impossible to meet.  As an agency that provides services to over 8000 clients a year an expectation that there be less than four late incident reports in a 2-year period is unreasonable and ignores just basic human error.  For example, in FY20 we entered approximately 150 reports into CHRIS.  If you double that for a two year period (and that doesn’t even account for the fact that we are now required to enter all COVID-19 cases in addition to all other reports even if it doesn’t require a hospitalization) that would be 300 reports in a two year period.  If we had 4 late reports in that timeframe we would be at 99.8% compliance, but it could still be possible to have our license moved to provisional status and/or revoked.  It seems that the number of citations in the guidance document is completely arbitrary and does not take into the considerations a provider’s size.
3. It also seems that the department’s response to late incident reporting conflicts with what is a statewide compliance rate of 91%.  If agencies are already in compliance, why does the department need to threaten progressive action and potential financial action through notifications to DMAS?  We recommend that the expectation be in alignment with the PMI’s in the DOJ settlement agreement of at least 86%.
4. Additionally, this extremely punitive response to a late report has the inadvertent consequence of encouraging providers to not report incidents to the department in order to avoid potential consequences.  This is significantly more worrisome than reporting an incident at hour 36 especially when there is no one at the Department reviewing incidents outside standard business hours.  We recommend that actions taken by the department be in alignment with the severity of the infraction since when they are incongruent, they encourage providers to purposely ignore the standard.
5. The policy needs to clearly define how an agency that has either been put on provisional status or had their licensed revoked due to last incident reporting can get their status changed back.