Keeping in mind that Guidance Documents are interpretive of regulations and while they may bind regulators who are obligated to adhere to regulations, they do not bind the regulated entities.  Therefore:

• As the only “acceptable” method of reporting a serious incident or an allegation of abuse or neglect is the department’s web-based system (CHRIS); the threat of citation for any report outside the limited 24 hour time frame is unreasonable.  This is especially true because the only alternative method (email) is allowable only if the CHRIS portal is determined to be unavailable or another reason “not under the provider’s control.” There are a myriad of reasons why communication option(s) dependent on technology (up to and including a source of power) may be unavailable and, absent confidence that “not under the provider’s control” will be based on the judgement of the provider this is obviously problematic.  This Guidance might be manageable if there were DBHDS/DELTA support staff available 24/7 via telephonic means.
• Lacking 24/7 support, the insistence in the Guidance, under threat of citation, that providers must have sufficient authorized users to allow for incidents to be entered 24/7 is also unreasonable.  There are a myriad of reasons why an authorized user could not access the system or that even with multiple authorized users none would be available on a timely manner to do so.  It should be noted that the first duty for the provider is care not entering data in the DBHDS data bank.

For these two items – the issue is not to dispute the requirement for reporting within 24 hours, the issue is the interpretation (and apparent current practice) that the citation is to be issued based solely on the timestamp on the report  (data not available to the provider in the printed report); it is therefore, without any consideration of mitigating circumstance.  

Serious incidents may also be considered issues of possible abuse or neglect.  Therefore:

• Either the provider will make that determination and file both a serious incident report AND an allegation of abuse or neglect report for the same occurrence, OR the staff of the Incident Management Unit (IMU) will determine that, in their opinion, the incident warrants an investigation of possible abuse or neglect and will note that the provider has not filed on the OHR side of CHRIS.
• Allegations made by IMU must be communicated to the provider directly including the name of the individual making the allegation and the specific allegation.  The provider, who should note those details, can then initiate their internal process for complying with 12VAC35-115-230.  Making an assumption that this should have been done by the provider and communicating directly with staff of OHR should be viewed as negligence on the part of the IMU staff and treated accordingly.
• The issuance of a citation for late report by OHR without determination that the provider had been informed of an allegation of abuse or neglect (apparent current practice) is in itself an “abuse” of the regulatory authority.

12VAC35-105-160F is the generic provision that covers DBHDS’s right to ask and the provider’s responsibility to provide information:

• “D. F. The provider shall submit, or make available and, when requested, submit reports and information that the department requires to establish compliance with these regulations and applicable statutes.”   

• Requiring, under threat of citation for any violation, “follow-up” within a 48 hour time frame reinforces the perception that this Guidance is not designed to improve the quality of the services provided, but is instead designed to improve the data available to show to the Independent Reviewer for the DOJ Settlement Agreement – whether the data is of any value or not!
• There are any number of reasons why follow-up details and information may not be available within 48 hours – results of lab work not yet available to make a conclusive diagnosis,  or inability to discuss incident in more detail with staff who may not be on duty, are two that come quickly to mind.  If the provider adheres to the required timeframe, information will be inaccurate, incomplete or both. 
• If the request for follow-up is made by the IMU, they must be required to request the information in writing (via email) with a notation of when the email was read as the time to note for when the clock starts ticking! Entries in the CHRIS system are insufficient as a tool to communicate as there is not any reason why the provider should take the time to review the entries made by IMU, OL or OHR staff.

On the last issue of progressive discipline toward termination (and this ties directly to the concerns which will be noted separately about the new proposed language in 12VAC35-105-170H and the related Guidance), the threat of refusing to renew a license, to issue a provisional license or to revoke or suspend a license at the forth citation because the provider failed on three occasions to implement an adequate corrective action plan to “prevent recurrence” speaks directly to the earlier comment.  None of this “Guidance” is intended to improve the quality of the care or services, but to impress the Independent Reviewer for the DOJ Settlement Agreement that DBHDS can be very tough on its provider community.

Actions under §37.2-415 and §37.2-418 are appealable under the  Administrative Process Act (§ 2.2-4000 et seq.) and, therefore, should require a level of significant or serious concern, e.g., the health or welfare of the individuals  served.  Admittedly, with the system to be in place when the Guidance documents currently under review are fully implemented the first failure to report will result in a citation of 12VAC35-105-160 (unless of course there is follow-up submitted more than 48 hours after first report and then there will be two citations); for the second failure, there will be a citation as above, plus a citation of 12VAC35-105-170H for failure to implement the CAP which had to have said that the provider would “prevent recurrence;” for the third failure, there will be the same and DMAS will be notified.  At the fourth failure, the provider will be receiving their sixth and seventh citations for 160 and 170 and failure to “prevent recurrence.”  It becomes quickly an untenable position for the provider as failure to comply with the timeframes set is not always preventable and adds nothing to the value of the services provided.

For a large provider, this will be an ongoing battle – we strongly object to the Guidance being provided especially since the data suggest that currently there is approximately 90% compliance with the reporting timeframe.