Page 11-12 "Serious Incident" definition: The tiered system is a bit confusing. Tier 1 has no definition, so it is not clear what types of incidents would fall under that category. The tiers are not all-inclusive which makes it open to interpretation and open to corrective action if done improperly.

Page 12 (same category) Level III serious incident number 4. Should there be a clairifcation of a "medical" hosptialization?

Page 18D: Level III serious incidents to include consequences or risk of harm to be included in the reports. Not all consequences of an incident are known at the time of reporting and if a licensing specialist closes a CHRIS report, how is it to be documented?

page 18  Root Cause Analysis: To what extent are these required? Investigations are done, but not each incident requires the same level of inquiry. Will DBHDS require us to provide the root cause analysis for all incidents? How organizied/formal is this process?

page 28 D.3. what is the definition of "the team" shall meet to review.

12 VAC 35 – 105 – 20 – definitions

Group Home – specific proposed change insert “that provides 24-hour supervision by persons in direct care positions who do not live in the home”.

I)The proposed regulation is unjustified:

1. There is no logical nexus between the justifications provided in the Walker memorandum of 3/5/18 and this specific regulatory change. In that memo 3 rationales for the changes are identifiable; 2 to specifically address the DOJ concerns (inadequate requirements for submission of information and mandatory attendance at trainings) and the last a broad statement of goals to address health and safety concerns. Nothing in this specific provision would address either of the DOJ concerns and thus they provide no justification for this specific change. Additionally, it is difficult to imagine a scenario in which a live-in QDDP providing a portion of their services and continuous supervision of DSP services would have negative impact on health and safety that justifies this provision. In fact, even a cursory reading of the investigations and CAPs listed on your website indicate that a vast majority of the actual concerns occurred in traditional not live in group homes and there is no available evidence indicating that live in homes or more problematic on a percentage basis. Empirical evidence based on provider experience proves that the live-in model provides superior supports that reduce health and safety risk and thus better meets the goal (see below).

2. The proposed regulation is overly broad as written as it would require a person not living in the home to be in contact with all individuals served 24 hours a day; creating absurd dilemmas for providers that would reduce options, choice and the quality of services. Since supervising is listed as a direct care position, a fully qualified QDDP who lives in the home could be interpreted as incapable of supervising DSPs. Even without this interpretation other negative scenarios abound, 2 simple ones provide sufficient evidence to illustrate the point; 1st – a DSP who lives outside the home is providing services to 2 individuals, one wants to go to McDonald’s for lunch the other wants to stay home. Under this regulation the fully qualified QDDP who lives in the home would not be able to be home alone with the individual who desires to stay home while the other went to McDonald’s with the DSP; rather one would be denied their preferred choice. 2nd – when DSPs call out due to dangerous weather conditions or last-minute concerns, a fully qualified QDDP who lives in the home cannot under this regulation provide the services, but instead would either have to force staff into the dangerous condition (if possible) or be in noncompliance with the regulation.

3. The proposed regulation is overly restrictive and less restrictive approaches that would avoid its pitfalls and still achieve the supposed objective are available. If the purpose is to assure significant contact with persons who do not live in the home simply inserting the words “including staff” or “including direct care staff” between the word “positions” and the phrase “who do not live in the home” with additional qualifiers if necessary, would address this concern without the pitfalls of the current wording-assuming such a restriction is ever found justified. Without a clear objective or nexus between the specific regulation and the justifications provided it is difficult to pinpoint other less intrusive options; however, a host of alternatives such as regulating: staff ratios, contact hours, demonstration of outside contacts etc.; are all available to address specific concerns as they arise without incurring the negative impact of this specific regulation.

4. The burden of proof is on the department to provide a justification for a regulatory change and the only ones offered to date do not provide a justification for this specific proposed change and given the preceding analysis it is unclear how one would be generated. Simply the burden of proof is on the department to identify a unique scenario where any aspect of an individual’s well-being or services would be negatively impacted by allowing a fully qualified QDDP who lives in the home to provide some of their services and supervision of the DSPs who provide the bulk of their services.

II) This specific regulatory change is counterproductive and would undermine efforts to promote health and safety as a number of advantages of the live-in provider would be undermined or lost.

1. A live-in QDDP provides increased supervision of DSPs. A live-in provider has the opportunity to have more frequent observations, interactions and collaborative development across the staff and throughout their shift than is provided by a house manager on an 8 hour shift who is typically absent at least 2 days a week. If as other sections of the regulations suppose QDDP supervision is necessary and beneficial then this is clearly a superior model. Empirical evidence also demonstrates that this model has superior outcomes. Having operated under both models for several years medication errors have been significantly reduced under the live-in model.

2. A live-in QDDP provides for an improved emergency response. Even in their time off the live-in QDDP is able to spring into action when any type of emergency occurs in the home to provide additional support to the DSPs on duty and in a true emergency the more qualified actors the better. Additionally, it should be noted that the QDDP is assumed to be a better decision-maker under the regulations and the live-in model better assures that the QDDP would be available to make a more timely/qualified decision in directing the emergency response. Clearly, for promoting health and safety during an emergency the live-in model is superior.

3. A live-in QDDP provides for improved continuity of service. A live-in provider is engaged and available across all 3 shifts, typically on a daily basis, which provides the opportunity to relay information and instruction without repetition bias and allows for direct observation in real time of services provided which promotes continuity. This gives the live-in QDDP a unique ability to provide consistent feedback and follow-up on implementation to assure continuity of services in real time which can be vital in preserving/promoting an individual’s health and safety, making the live-in model superior for addressing health and safety concerns; among others.

III) This specific regulatory change is counterproductive to meeting the stated DOJ concern justifications for the change.

1. A live-in QDDP improves the provider reporting process. A live-in provider is much more likely to be available and engaged when an emergency, crisis and/or other reportable event occurs. This increased presence allows the live-in provider to more often experience the event 1st hand, begin the investigation immediately, actually observe the actions in question, collect testimony in real time and be less reliant on secondhand testimony; which would improve the content and reliability of any subsequent reports. Presence would also increase the likelihood of more timely/accurate reporting as the house manager wouldn’t have to type in information from telephone reports in 24-hour situations or wait until they return from their three-day weekend in other scenarios.

2. A live-in QDDP improves quality control and risk management. The improved quality control potential of this model is clear in the analysis on superior supervision, continuity of services, emergency response and providing preferred options (above) and will be further clarified in the section on disadvantages to this proposed change (below). The improved risk management potential of this model stems not only from the increased ability to intervene, investigate and respond to risk scenarios as they occur but also from the increased availability of the fully qualified QDDP to consistently implement risk control measures and respond immediately to potential risk as they arise. Finally, it should be noted that the ability to better employ ethnographic tools by the fully qualified QDDP in the home will greatly enhance any subsequent root cause analysis.

IV) This specific regulatory change would be disadvantageous from a policy perspective for individuals receiving services.

1. This change would undermine the right of individuals served to freely choose from a range of available service options in the community. The clear intent of the regulatory change is to discourage the live-in model, make it impractical and thus reduce the existence of live-in group homes. It is important to note that the individuals who currently live in those homes made an informed consent decision with numerous protections to do so because it was their preferred option. Empirical surveys of individuals we have served in group homes under both models unanimously indicate a preference for the live-in model. This regulation would also have a disproportionate impact on small group homes in rural areas as weather barriers and lengthy rides on cajoled outings (see above) would make this regulation much more problematic for rural providers, which demonstrates a clear cultural insensitivity to individuals who prefer a rural environment. This cultural insensitivity could be magnified for countryfolk from our area where multi-generational domiciles coupled with a clear head of household are familiar, comforting and consistent with traditional cultural norms. Thus, this specific regulation would have the exact opposite impact of the DOJ intent to increase the range of culturally appropriate community-based services that can be offered to individuals in Virginia.

2. This change would undermine individualization of services and free choice. The proposed regulation would have a disproportionate impact on small independent providers who have found this model the key to successful continuation of their services under the new reimbursement regime. Our organization for one would probably not be able to continue services under this definition. The reduction of small independent service providers would not only reduce the availability of a range of choices for community-based options; but also, would result in services increasingly being provided by organizations with a large bureaucratic model. In large bureaucratic models, blanket house rules and company procedures developed without regard to specific individuals are frequently encountered where staff feel constrained from making small nuances of difference to account for differences in and individual’s abilities and default to the blanket provision. In large bureaucratic models, decision-making authority is often far removed from or occasionally unavailable to the individual which reduces their ability to influence the decision and may limit their ability to exercise their preferred choice (i.e. we encounter situations where waiting for house manager approval for an activity with a peer in another group home have prevented the activity from occurring, even though the house manager was eventually agreeable). In short, large bureaucratic models tend to institutionalize the home. The increased presence of a live-in QDDP gives the individual more consistent direct access to the decision-maker, provides ethnographic tools to better develop individualized/nuanced services/rules application; coupled with increased supervision of implementing staff and continuity of services to promote more effective provision of individualized services and choice on a day-to-day basis. Again, this regulation would have the exact opposite impact of the DOJ intent.

12 VAC 35 – 105 – 20 – definitions

Missing – although the intent is laudable and link to the justifications clear the wording (particularly when reinforced by the reinclusion of the words “any period of time” on page 12) should be reconsidered. An individual who is exercising their freedom to move about the home and grounds freely may easily be somewhere staff did not expect them but well within their rights and creating no concern which would appear to make the word “supposed” operative in this example. Merriam-Webster’s dictionary indicates that supposed can be relevantly defined as “believed” or “understood” and/or “permitted” – if the pertinent indication is “believed” or “understood” it is virtually synonymous with expected in this context and if it is permitted it would appear to only apply in situations where restrictions have been placed on the freedom to move about the home and grounds freely. Depending on how this section is later interpreted it could have an adverse impact by appearing to require reports for a missing person who is not in bed during bed check (where they are supposed-“believed/understood” to be) and not located in the bathroom or other portion of the home for 30 or 40 seconds. Additionally, it would be unclear how to handle a common situation where logisticare is “supposed” to deliver a person at an “expected” time but the person is late and they are not where they are supposed to be or under another interpretation you have no way to make contact to see if they are where they’re supposed to be (in the cab) and have to report. An unfortunate side effect of this requirement may well be that supervision is increased in such a way as to reduce privacy and undermine their freedom to move about the home and grounds freely to reduce the burden of a multitude of frivolous occurrence reports.

12 VAC 35 – 105 – 20 – definitions

Medication administration – it is unclear how the phrase “in the presence of” a legally permitted administrator would apply if medications are packaged/administered from the med cabinet for an individual to attend a weekend home visit and/or other outing with natural supports.

12 VAC 35 – 105 – 20 – definitions

QDDP – the definition listed here is inconsistent with the definition published in the Virginia register 1/8/2018 issue 10 volume 34 action ID # 4928 – – is this a change back, which definition will be controlling going forward.

12 VAC 35 – 105 – 400 – criminal background checks and registry searches.

Although section B is clearly required by and reflects the intent of 37.2 – 416 which governs group homes, the inclusion in section E which establishes the requirement that registry results be reviewed prior to hiring the applicant, clearly exceeds the statutory intent and would create an onerous requirement which would have a negative impact on individuals served and is unnecessary given that less restrictive/intrusive provisions which would provide adequate safeguards are available.

1. The section E inclusion clearly adds an additional element which was not included in the statute, it is equally clear that awaiting the results of the registry search was not the intended in the statute; given the legislative history of the statute, the method of inclusion and the ease of making the requirement had it been intended.

2. Awaiting the results of the central registry search prior to making an employment decision would be an onerous burden. An empirical analysis of our last 5 most recent checks (going back almost 3 years) indicates that criminal history results can be received in as little as 8 days post them being mailed to BIU; however, central registry searches consistently require more than 30 days between the form being mailed in and an individual signing off on the approval and then involves additional days of delay as the approval was mailed back. This provision would prevent hiring the individual for training activities (even if they were held off-site) which would add an additional month before a hired individual could begin providing services. As a result, a provider who was faced with a sudden need (death, quit with no notice, immediate termination) would have to advertise the position, conduct interviews, wait over a month for the return of the registry search, then hire and begin training- leaving that position unfilled for almost 3 months.

3. Less restrictive provisions which would provide adequate protections to the individual served while reducing the burden and negative impacts of the proposed restriction are available. For example, in our agency no individual who has been hired (post criminal background check verification and OIG exclusion search) is permitted to have any independent contact with nor supply any services to individuals served until the results of the central registry search have been verified. This simple change would not only protect the individual but would also reduce the onerousness of the burden by permitting training activities which would prepare the individual for the provision of services and allow them to begin their duties as soon as they are cleared in the central registry search which would cut the delay in filling the position almost in half.

4. This specific proposed change as currently written would have a negative impact on the individual served.

5. The proposed change would reduce our ability to secure quality hires. If you can’t hire them even for training purposes you can’t pay them and we have few to no quality applicants who can afford to wait over a month and a half before they receive their next paycheck. Given the significant direct competition for the limited applicant pool which we face from assisted-living, nursing home and home health agencies who would not be required to have a similar delay, it is highly doubtful that any of the individuals we contacted a month after their interview would still be available for hire. While this may be a lesser concern in Richmond due to the focus on degreed professionals, it is certainly a significant concern for the DSP applicant pool currently available given the constraints of the current reimbursement regime. Even if a few of the individuals were available for hire it would often mean that we miss the opportunity to hire the best/preferred individual for the position and we would be stuck with people who were unable to find employment anywhere else; typically for reason.

6. This change would undermine individualization of services and free choice. The proposed regulation would have a disproportionate impact on small independent providers who are forced to staff to their needs with little excess personnel available due to the new reimbursement regime making the long-time lag even more problematic and their low turnover rates (we only have a new hire every 2 or 3 years) which reduces advertisements to generate new applicants and prevents them from developing a contemporary stockpile/backlog of screened applicants to draw on when a need arises. Both of these impacts would make continued operation of a small independent service much more difficult and unlikely. The reduction of small independent service providers would not only reduce the availability of a range of choices for community-based options; but also, would result in services increasingly being provided by organizations with a large bureaucratic model. In large bureaucratic models, blanket house rules and company procedures developed without regard to specific individuals are frequently encountered where staff feel constrained from making small nuances of difference to account for differences in and individual’s abilities and default to the blanket provision. In large bureaucratic models, decision-making authority is often far removed from and occasionally unavailable to the individual which reduces their ability to influence the decision and may limit their ability to exercise their preferred choice (i.e. we encounter situations where waiting for house manager approval for an activity with a peer in another group home have prevented the activity from occurring, even though the house manager was eventually agreeable). In short, large bureaucratic models tend to institutionalize the home. Thus, this regulation would have a net impact that is the exact opposite of the DOJ intent.

7. This change would undermine the right of individuals served to freely choose from a range of available service options in the community.This regulation would also have a disproportionate impact on providers in rural areas as individuals for hire in rural (less socioeconomically advantaged) locations are less likely to be able to accommodate the long lag time in receiving their 1st check (under these regulations would go for 2 weeks to 6 or more a 200% increase in the time lag between interview and payment); they need to eat and will simply look elsewhere. In addition to our perception, interviews with all of our current staff indicate that none of them would have waited nor accepted employment if this long lag time had been in place at the time they were hired. Jeopardizing rural placements demonstrates a clear cultural insensitivity to individuals who prefer a rural environment. Thus, this specific regulation would have the exact opposite impact of the DOJ intent to increase the range of culturally appropriate community-based services that can be offered to individuals in Virginia.

March 12, 2018

Emily Bowles                                                                                                                          

Legal Coordinator, QMD Division                                                                                         

Office of Licensing

Department of Behavioral Health and Developmental Disabilities

RE: Draft Amendments to the DBHDS Rules and Regulations for Licensing Facilities and Providers

Dear Ms. Bowles,

Thank you for the opportunity to provide public comment on the Draft Amendments to the DBHDS Rules and Regulations for Licensing Facilities and Providers. The disAbility Law Center of Virginia welcomes needed revisions to align the DBHDS provider licensing regulations with the goals of the U.S. v. Commonwealth Settlement Agreement.

The draft amendments establish requirements for the development of quality improvement programs and reporting processes, provide comprehensive definitions of serious incidents, and require routine root cause analysis. Other amendments go beyond the stated goal of aligning the regulations with the quality improvement requirements of the Settlement Agreement; many of those are positive.  For example, they align the regulations with Federal and state law and currently accepted terminology within the disability community.  dLCV is further encouraged by the enhanced staffing, employee screening and training requirements. However, to the extent that amendments seem to narrow protections or allow significant discretion to modify the licensing requirements, they demand further thoughtful deliberation.

dLCV welcomes the quality improvement requirements, including a comprehensive scheme of incident reporting and ongoing review of serious incidents.  An effective system for licensing and protection from harm must include ongoing review and require providers to respond to and proactively identify systemic risks.  The draft amendments could strengthen the system by requiring that recurring Level I serious incidents identified during quarterly review be reported to DBHDS along with Level II and Level III incidents.

An effective system should also capture critical information on serious incidents, regardless of where they take place or by whom they were caused.  For example, Level II incidents should include self-injurious behavior other than a suicide attempt to allow providers and DBHDS to identify and address patterns on severe self-injury. Limiting the definition of Level II serious incidents to those that occur while the provider is delivering services or on the provider’s premises could allow significant injuries to go unreported. We recommend instead that the regulations require providers to confirm reporting of any Level II incidents of which they are aware.

The addition of the informed choice provision to 12VAC35-105-660 reinforces the importance of person-centered planning.  However, the language requiring the provider to “explain to the individual or his authorized representative” should be changed to “the individual and his authorized representative.”  This is consistent with the definition found in 12VAC35-105-20 and reflects the importance of including individuals in the development of services plans to the greatest extent possible, regardless of incapacity.  Requiring providers to regularly review the ISP, evidence of progress or lack of progress, and the underlying barriers likewise reinforces these principles as well as the need for active treatment for individuals receiving services.

dLCV is concerned with the revisions to 12VAC35-105-120, pertaining to the Commissioner’s authority to grant variances to the licensing regulations.  Subsection 1 builds in additional requirements for providers seeking a variance.  However, Subsection 2 gives the Commissioner significant authority to grant variances to the regulations when “he determines necessary to facilitate the development of needed services to address emerging issues.”  While this authority is limited where a variance may “jeopardize the health, safety, or welfare of individuals,” this seems to be the only limitation to the authority to waive licensing requirements in a regulatory scheme where the Commissioner may, on his own initiative, grant variances to the licensing standards to expedite the development of services or induce providers to develop new services.  The licensing regulations should only be waived where they represent a significant burden to a provider and their purpose and effect can be accomplished by other means, without jeopardizing the health, safety and welfare of individuals receiving services.  DBHDS must to have the tools it needs to safely and deliberatively expand community services for people with disabilities.  Chief among those tools must be accountability.  As providers enter the market and expand, they must be held to the standards and expectations set forth in the licensing regulations.  The variance amendment is a departure from the current licensing variance scheme; we are concerned with lack of specific guidelines or review processes for this new and sweeping category of variance.

Finally, we note that without robust implementation by the Department and Office of Licensing, Virginia’s systems for quality improvement and protection from harm will continue to fall short of expectations.  As the Independent Reviewer noted in his most recent report, “OLS appears to have the necessary regulatory tools to force improvements among substandard  providers  and  to  eliminate  substandard  providers  who  have  demonstrated  a refusal or inability to improve their services. Interviews with OLS staff confirmed previous findings of a continued systemic reluctance by OLS to pursue use of these other tools, including provisional status,  because  of  the  due  process  burdens  on  Licensing  staff.”  In short, the regulations are only as effective as the Department and OLS’s ability and willingness to implement them.  We hope that the positive improvements to the licensing regulations will be supported by a robust licensing staff empowered to enforce them.

Sincerely,

Colleen Miller  

Executive Director                                                                               

I am so glad to see these changes/corrections.Also, glad to see the the verbage has changed and it is easier for people to read and understand. Hopefully, these changes will make it better for people who are seeking licensing to understand what they need to do to comply with the Licensing Rules and Regulations.

Hello,

As a citizen of Virginia and a Licensed Professional Counselor, I would like to submit these comments in regards to the Draft DBHDS Licensure Regulations.:

Definitions:  Missing; Current proposed definition:  “ a circumstance in which an individual is at any time not physically present where and where his is expected or supposed to be.  Requirement- Level II serous incident_ An individual who is missing for any period of time

The definition of "Missing" is too broad and extremely problematic.  It is not in line with an individual’s rights.  An adult with decision making capacity has the right to be where he or she chooses without a report to the being made to the State, even if he or she changes his mind about his schedule.  If an individual knows that, if he or she agrees to the provision of services for their substance use, mental illness or developmental disorder that a report will be made to the state if he is not physically at a location where he is expected to be, this may create a barrier to agreeing to services. Adults that have decision making capacity (unless another determination has been made)  and are not required to inform their provider if they change their mind about where they intend to be.  This would be an infringement on individual’s rights as it is written.  In addition, this requirement would be unreasonable to carry out in regards to outpatient services.  The definition proposed does not outline that this is only in relation to residential or inpatient services.  Therefore, anytime and adult misses an appointment or is even late, a notification would be required to the State.  This is not reasonalbe. It is recommended that this be amended to  "Missing means a circumstance of an individual in residential or inpatient programming who has been assessed to lack decision making capacity, has a guardian or authorized representative or who has been assessed to be a danger to himself/herself is not physically present when or where he is expected or supposed to be." (or other similar language)

Article 3 105-400 E: Criminal Background Checks:There is already difficulty throughout the State in hiring qualified applicants. While adding in wording to require that the criminal history and registry checks be reviewed before hiring seems reasonable at first glance, it will have a detrimental impact on services.  After interviewing for a position, applicants who have been selected for a position cannot be asked to complete the background check and then wait lengthy periods of time before  “being hired”   Qualified applicants will surely take another job while waiting.  This will further erode the ability of programs throughlut the State to hire skilled and credentialed staff.  The requirement of a review of the background check and registry search prior to hiring will delay an already long hiring process. It will result in unfilled positions and the loss of potential employees. Change to say review the criminal history and background check regulations before being released to provide direct services to individuals.  Staff may be hired and remain in a training capacity while awaiting results..

Definitions: Serious injury- The new definition takes out that an injury is defined as an occurrence while the individual is supervised or involved in services.  Individuals who agree to services for their disability are NOT agreeing to all aspects of their life being reportable to a State agency.  It could easily be seen as a violation of their rights as an individual that their medical information is required to be reported (even against their will) .  Just because someone signs up for services at the a program , that should not give the program the right (requirement)  to make reports to a State entity if he is in a car accident or accidently sprains his ankle if that has no association at all with a program or service. This is an over step regarding reporting that can easily be a barrier to an individual agreeing to services.

Definition Recovery- The section on substance use can be seen as discriminatory.  While recovery for individuals with mental illness is described as a "Journey of healing and transformation enabling an individual with a mental illness to live a meaningful life in the community or his choice", "Substance abuse recovery is “Incremental” leading to positive “social change” … As we continue to fight stigma in light of the opioid epidemic and want individuals to seek help and recovery, it is especially important that state documents and regulations  includes wording that is positive and cannot be seen as discriminatory. Recommend combining to say something similar to

“Recovery is a journey of healing and transformation enabling an individual to live a meaningful life in the community reflective of healthy functioning in accordance with his/her goals”

Thank you for your consideration of these important issues.

12VAC 35 105-160 - Root cause analysis for all serious incidents in all tiers for all DBHDS licensed will result in extraordinary administrative burden. Recommend defining root cause analysis for specific tiers

-320 is there a time expectation by which all individuals would need to be evacuated?  That would inform how to define "adequate staff"

- 400 - Wording of checks completed prior to hiring of staff - will result in bottleneck of waiting for background checks to return - vs. language that would indicate continued employment contingent upon...

- 520 - A.-Will there be specified curriculum or DBHDS training in order to qualify someone as an expert in all spheres?

- 520 - C- Definition of "adequacy of staffing"?  HIgh risk understandably points out seclusion and restraint - any other definition of "high risk"?

650 - F- 7 g - Definition of restrictive protocols and special supervision requirements?

660 - C - "alternative services" - does that include services not available  or affordable? 

675 A-  re: reassessments, includes language "or other" change in status.  Does that include housing?  Job?  Social?  How to apply across all service provision?

675 - 3 - define team members . Applying to all services is extraordinary.  Time frame of when team meeting would be expected to occur?

1245 - Would that require case managers to be assessing all Part Vs?

It is understood the intent of these emergency regulations are to respond to the SA.  For CSBs, it needs to be noted the regulations also effect all licensed services.

The proposed regs still have the old definition of a QMHP which requires 1 year of experience.  This needs to be changed to correspond with DHP that requires 1500 hours experience not 1 year (2080 hours).  The CHMRS Manual, DHP and Licensure needs to match.

1. With respect to the criteria defining "serious incident", please provide clarity regarding:

Item 3, "an individual who is missing for any period of time".  There are a variety of levels of accountability as it pertains to the whereabouts of an individual and staff may not always know where a person is (dignity of risk).  This provision needs clarification since we serve individuals who expect that their services will not infringe on their personal rights to move about their community freely.

Item 4 "Hospital Admission" Because hospital admission can take place as part of a routine or planned medical service, please qualify this provision as "Unplanned Hospital Admission".

2. Regarding section  12VAC35-105-160 section E, please confine the root cause analysis to Levels 2 and 3 incident reports.  Root cause analysis is not necessary for Level 1 reports since quarterly reviews of level 1 incidents are required and should suffice for this level.

3. Section 12VAC35-105-400, which requires a criminal background check prior to hiring, is an extremely problematic provision for providers and inhibits the hiring process. It is also an expensive provision (actual costs and man- hours) as criminal history checks would now be done on individuals who may not actually accept an offer of hire.  Also of note is the question of privacy invasion for individuals who have not yet entered into an employment agreement with the potential employer. 

4. Section 12VAC35-105-400, item B is also very problematic in its overall effect of slowing down the hiring process when responses can take well over 30 days.  Additionally, language in item B which requires the provider to obtain personal information prior to employment (such as age) in order to submit this form violates protections of applicants with respect to what personal information a perspective employer may or may not ask for.   Regarding item E of this section, this provision should be altered to "upon hire" and remove the "prior to hiring" requirements.  This item as written is extremely problematic to the hiring process.

Group Home Definition: Addition of the line, “that provides 24-hour supervision by persons in direct care positions who do not live in the home.” This line is problematic and will decrease service options and choice for individuals receiving Waiver Services. There are group home models in Waiver Services that utilize DSPs who live in the home and are currently licensed as group homes. Remove, “who do not live in the home” from the definition..

Licensed Behavior Analysts respectfully ask to be added to this list pursuant to HB762

"Licensed mental health professional (LMHP)" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, licensed behavior analyst, or certified psychiatric clinical nurse specialist.

We feel it is important to add the exemptions for behavior analysis in this paragraph:

"Provider" means any person, entity, or organization, excluding an agency of the federal government by whatever name or designation, that delivers (i) services to individuals with mental illness, mental retardation (intellectual disability) developmental disabilities, or substance abuse (substance use disorders), or (ii) services to individuals who receive day support, inhome support, or crisis stabilization services funded through the IFDDS Waiver, or (iii) residential services for individuals with brain injury. The person, entity, or organization shall include a hospital as defined in § 32.1-123 of the Code of Virginia, community services board, behavioral health authority, private provider, and any other similar or related person, entity, or organization. It shall not include any individual practitioner who holds a license issued by a health regulatory board of the Department of Health Professions or who is exempt from licensing pursuant to §§ 54.1-2901, 54.1-3001, 54.1-3501, 54.1-3601, 54.1-3701, and 54.1-2957.17 of the Code of Virginia. 

In addition, we believe that in all of the sections that reference behavior plans and assessments, it should indicate that they are only to be performed/created by licensed professionals acting within their scope of practice.

Thank you for the opportunity to comment.

12VAC35-105-20. Definitions.

“Missing” – This definition is concerning as providers would be required to report in CHRIS any time an individual is not physically present when and where he is expected or supposed to be. Under this definition; an individual could go to the restroom for 5 minutes and be considered “missing.” Individuals often do not show for therapy, would they then be considered “missing” if the clinician is unable to contact them to find their whereabouts because they are not answering their phone? This is not person-centered and does allow for a person’s right to be where he or she chooses to be.

“Neglect” – failure by a person… funded by the department. We operate programs that are “funded” from DBHDS (Prevention/Intervention), but individuals utilizing these services are not admitted and there is no way to report this into CHRIS, as CHRIS is built around licensed services.

 “Serious Incident” –

• Concerns with reporting an individual missing for any period of time (as noted above in “missing” definition.
• What are the requirements for reporting hospital admissions? There are concerns as this could include someone admitted for outpatient surgery. Does this include medical or mental health hospital admissions? Both? Mental health admissions are reported to DBHDS through other ways and are not currently reported through CHRIS.
• Diagnosis of decubitus ulcer, bowel obstructions, or aspiration pneumonia – this seems duplicative as this would be reported through submissions of hospital admission or ER/Urgent Care visit.

12VAC35-105-160. Reviews by the department; requests for information; required reporting.

C. How would this quarterly review of Level I serious incident be reported to DBHDS? What is the expectation? Why a quarterly review of only Level I incidents? How does this correspond with the root cause analysis as described below? There are expectations for providers to have corrective actions for every incident; however, not every incident warrants corrective actions. For example, air-borne illnesses are not something that a provider did incorrectly that needs to be corrected. Would like to see this defined further in the regulations.

D. 2. Reporting Level II and III serious incidents by phone to anyone designated by the individual to receive such notice and to the individual’s AR. There could be unintended 42 C.F.R. Part 2 and HIPAA consequences with this requirement. Providers will need to ensure that they have the required authorization to disclose this information.

E. A root cause analysis of each serious incident seems excessive. Many level I serious incidents include illnesses that an individual contracts just from being around other people (colds, flu, gastrointestinal viruses) and when solutions to mitigate its reoccurrence is unreasonable (we can’t keep individuals from going out in public all winter) or it will be the same for all similar incidents (proper hand washing; flu shots).

This will also increase administrative costs and time associated with completing a root cause analysis for every serious incident. What is the expectation for reporting these to DBHDS? What will be the expectation if we are already conducting a human rights investigation?

12VAC35-105-400. Criminal background checks and registry searches.

B. Concerns that providers must obtain written consent and personal information to search the registry prior to hiring. This would entail obtaining consent at the interview process. Providers would, therefore, have to obtain this information for applicants who providers end up not hiring. Interviewees may have concerns with providing this information prior to hiring an applicant, especially to an employer they may not end up working for.

E. Reviewing the criminal history background check and registry search results prior to hiring is of a concern for similar reasons as noted above. This will delay the hiring process; thus resulting in longer vacancy periods to fill valuable direct care positions. These background checks can take weeks or months to have back for review. Providers will be unable to provide valuable services and individuals will ultimately go without services.

There are also financial concerns; this will increase costs as more background checks will be completed on applicants, many of whom will not be hired on.

It is difficult to find qualified people who are willing to work in health and human services. This provision will make the hiring process even more cumbersome. This will deter people from considering employment with us and many applicants will find other employment while waiting for their background check to return. This has the potential to greatly affect services; programs will have to place a hold on new admissions, thus waitlists will increase and individuals will go without services.

12VAC35-105-520. Risk management.

C. What are the risk triggers and thresholds? It would be beneficial to have those defined within the regulations.

12VAC35-105-660. Individualized services plan (ISP).

C. What does “full participation” mean? Many individuals and their families (especially those in crisis and those who are very familiar with services) will not want to sit through and discuss all that is entailed in this section to document informed choice. Will there be a consideration if this is attempted, but the individual/AR does not want this information?

12VAC35-105-675. Reassessments and ISP reviews.

D. 3. This will require additional meetings and increased meeting frequency with the team and individual. Individual circumstances may make this difficult to accomplish.

12VAC35-105-691. Transition of individuals among service.

B. 2. What is the expectation of how informed choice will be documented? Will there be a required form?

12VAC35-105-1245. Case management direct assessments.

Specifically what risks are required to be assessed by the case managers? The previous sections of these regulations speak to having the individual provide informed choice and preferences; this section does not explicitly suggest that individuals are providing their feedback on how their services and supports are being implemented. 

Case management service definition added “or support coordination service” Support Coordinator is widely used in lieu of ID/DD Case Manager, yet there is not a definition for Support Coordinator. Will the current CM be grandfathered in to the QDDP positions

Direct care position means any position that includes responsibility for: (i) treatment, case management, health, safety, development, or well-being of an individual receiving services or (ii) immediately supervising a person in a position with this responsibility.   This contradicts DMAS’s definition (Ch. IV; page 68) that case management does not include the provision of direct clinical or treatment services

Background checks:105-400

Prior to hiring an applicant, the provider shall obtain the employee’s written consent and personal information necessary to obtain a search of the registry of founded complaints of child abuse and neglect maintained by the Virginia Department of Social Services. 

If the applicant hasn’t been hired yet, due to pending background check results, the word applicant or person should be used… otherwise, it’s confusing. The length of time it takes to get the results back may cause applicants to look for employment elsewhere.Average turnaround time for results from the registries is three (3) weeks.We have found turnaround times during July – September to be has high as 4 – 6 weeks.By then, the applicant has moved on to other job opportunities.

It would be most advantageous to be able to hire contingent on receipt of background and registry checks. During the waiting period, orientation and training can occur, so when results arrive, the employee can begin providing services.

105-620: who determines the staff ratio for evaucations, it is unclear how the determination is made

The Virginia Association of Community Services Boards has concerns with the proposed emergency regulations per the following:

§320 
Request that “The provider shall ensure adequate staff to safely evacuate all individuals during an emergency” 

§20 
Request insertion of “unplanned” before the phrase “hospital admission”; individuals are admitted to the hospital for procedures that, while they may be critical to an individual’s health, are not serious incidents.

Request that reporting of a “disaster, fire emergency or other condition that may jeopardize the health, safety or welfare,” be removed from these regulations as it is already required to be reported in 12VAC35-105-530 F and requiring it in this context would require, for example, a report for each individual in a group home.  

§160 E
Request the insertion of “level 2 or level 3” before the phrase “serious incident” to clarify that a root cause analysis is not necessary for level 1 critical incidents.

§400 E
A provider would realistically not be able to comply with these regulations as written.

Results of these background checks are not received prior to hiring nor are they received prior to the individual beginning his/her duties.  In addition, current code §19.2-389 designates the acceptance of employment as the driver for determining if the applicant has been convicted of a barrier crime.

Comments on proposed regulations

105-20 Definitions:

“Missing”- can we be more specific, too broad, clarification for reporting purposes.

“Serious Incidents”- Tier system is somewhat confusing, would welcome trainings and guidance documents.

“Social Detoxification Service”- should this be removed and changed to managed withdrawal?

105-60- Reviews by the department

E.- Requirement of a root cause analysis of each serious incident- does this include all 3 tiers? This seems excessive and hope only II and III would be required.

Finally, received today a statement from the DBHDS legal coordinator explaining the rationale behind the change in the group home definition: “the rationale for the change in the definition of group home was to assure that residents in the group home receive 24 hour supervision… If live in staff is tasked with supervising residents 24 hours a day, there is no way residents are receiving 24 hour supervision as the staff must sleep at some point.”

As expected, this rationale in no way provides a justification for the actual change that was included in the draft regulations.

1. Current regulations already provide the mechanism to accomplish this objective; as the current regulations clearly require 24 hour supervision in group homes and group homes that are not adequately staffed to provide 24 hour supervision (because the live in person must sleep) are already in violation. The licensing specialist who regularly reviews staffing plans would be able to include this rationale in their findings and present the offending home with a corrective action plan under the current system – that would resolve this concern without any changes whatsoever in the definition of group home.

2. The proposed change is extremely excessive given this rationale, as the proposed change would prevent live in staff from providing any of the services or supervision over the 24 hour period, which is clearly not warranted by the supposed rationale provided.

Clearly, the rationale provided does not warrant this proposed change and provides further evidence that the rationale is merely a pretext for efforts to undermine the live in group home model, which has been so valuable to small independent providers. DBHDS has repetitively demonstrated a clear hostility to this model as a part of their overall campaign to favor large bureaucratic providers and eliminate small independent providers, which will be detrimental to options and services. Ignoring that this change would be redundant in achieving the stated objective and deciding to try to sneak by language that goes way beyond the stated rationale to make live in group homes impractical either: demonstrates lax procedures and inadequate deliberation in making proposed changes are a conscious effort on the part of the department to disadvantage the live-in group home model. If they want to put us out of business they need a better reason than this and to be more forthright in their efforts.

Making us wait until background results are returned will make it virutualy impossible to hire staff.  With the shortage of qualified applicants, making them wait anywhere from 2 weeks and as long as 6 weeks, they will take other jobs.   How would you like to wait a month or 6 weeks to be hired and go without a pay check that long?     No one will wait that long.  I sincerely believe that this regulation will cause severe staff shortages making it impossible to provide the standard of care we all want for our individuals.

Under the definition of "serious incident", the statement "missing for any period of time" in #3 is too broad. There are numerous considerations here including the type of program, the individual's skills and abilties as they pertain to safety, the right to privacy, dignity of risk,etc., and other concerns. This regulation needs further clarification to balance the need to protect vulnerable persons with the rights of others to move freely in the community.

#4, a hospital admission is often planned as part of comprehensive medical care,e.g. sleep apnea study, observation duirng significant medication changes,etc. Scheudled or planned hospital admissions should not qualify as Level 2 Serious Incidents.

Please limit the requirement of root cause analysis to Level 2 and 3 Serious incidents. Suggest adding langauge that  Level 1 incidents be  reviewed and documented on a quarterly basis.

It is duplicative to require providers to report allegations of exploitation or theft to both Human Rights and Licensing. This is already covered and Licensure can access the CHRIS reports.

It is unreasonable to require providers to receive and review the resutls of criminal background checks prior to hire. This process currently takes weeks and even if expedited with the changes pending in the process,will not be quick enough. Prospective employees will just go elsewhere if expected to wait a month for hire.Additionally, the code of Virginia specifices that an offer of employment must be made and accepted prior to processing criminal background checks. Providers are able to discharge without legal consequence if the individual has a barrier crime based on language placed in the offer letter.Additionally, this requirment would place employers in legal jeopardy by requiring us to obtain information that legally we should not request until employment has been offered and accepted.

520C; include the "uniform risks,triggers and thresholds as defined by the Department' in the licensing regulaitons if providers are expected to comply with this. Providers will need more information and technical assistance or training from DBHDS on this. 

The L'Arche Metro Board has been working for almost a decade on its plan to bring a L'Arche Home to the Richmond Metro area.  If the definition of "group home" is changed to include the proposed words "supervision by persons in direct care  positions who do not live in the home" this will impact the work of our vision in perhaps an insurmountable way.  PLEASE reconsider this stipulation.  Our present model on which we have made substantial and exciting progress calls for a person (L'Arche names "Assistant") to live, family-like, in the home.  I appreciate your consideration of our earnest request.  

The current recommendation states that a "group home or community residential service" would be updated to be defined as  "a congregate service providing 24hour supervision in a community-based home having eight or fewer residents that provides 24hour supervision by persons in direct care positions who do not live in the home."

This proposed language change would have a significant impact on choice of service providers for individuals already receiving services in our communities. Should the chang be adopted, it will exclude agencies that use a blended staff model - employing direct care professionals that live in the home AND live out of the home"  in order to provide 24hr support and supervision - from providing services.

Please remove the language "who do not live in the home" from the proposed changes.

Horizon Behavioral Health Responses to Proposed Licensing Regulations Comments

Re: 12VAC35-105-520. Risk management. - The provider shall designate a person responsible for the risk management function who has training and expertise in conducting investigations, root cause analysis, and data analysis. Revise with more specific language, such as: The provider shall designate a CQI team to conduct investigations, root cause analysis, and data analysis instead of “a person”. Using the word “person” narrows the scope unnecessarily vice the full breadth of a CQI team.

Re: 12vac 35 105-160  - Requiring all serious incidents in all tiers for all DBHDS licensed organization is going to cause a hardship in administrative duties.  Root cause analysis should be for specific tiers only. 

Re: 12VAC35-105-400 - Concern about having to get background check results and review before hire. No problem with checking OIG before hire, but the other process, particularly DSS, can take weeks. Candidates won’t wait weeks for a job offer. 400 checks completed prior to hiring of staff will prevent us from getting staff hired in a timely manner.  Therefore, I would recommend changing the wording so we can hire them and make their continued employment be based on the findings of the background check. 

Conflict with VA Code: Also, it is important to note that the proposed revision of 12VAC35-105-400 appears to conflict with Code of Va 19.2-389A 29 that specifies that a criminal background check may be completed for applicant who accepts employment in any direct care position.  This revision appears to read that to process a criminal background check, the job offer of employment must have been made and accepted. 

Comments on ICF / Housing

Re: Typos

Page 1 5. “an individual” change to: “the individual” in physical or mechanical restraint. 6. “his individualized services plan” change to: “the individualized service plan” 7. “an individual” change to: “the individual” also later in this same sentence instead of: is not consistent with “his individualized services plan” change to “the individualized service plan”

Page 2 4th paragraph: and their family member “in assessing accessing needed services” change to: “and their family members in order to determine the needed services and supports that are responsive…”

Page 3 1st paragraph: “identified independently” change to: “identified independent of one another”

Page 4 2nd paragraph: toward the end…fullest potential to the greatest extent possible change to “for individual optimal health and wellness, self-esteem, and overall functioning.”

Page 7 3rd paragraph from bottom make “disabilities” singular to correspond with the others of which are singular change to: developmental disability Last paragraph: after family basis, take out the and change to: group, or family basis, usually in a clinic…

Re: Community  intermediate  care  facility/mental  retardation  (ICF/MR):

Removes the word “community” from the definition.  We provide ICF/ID services in the community.  Removing the word is appears to be a step towards treating the community based ICF/IDs as institutions. 

Re: Instrumental activities of daily living:

Meal preparation” change to “food and meal preparation and consumption” second to some clients also need to be fed in order to not just PREPARE but to consume food for adequate nutrition and wellness.

ALSO: HEALTH AND HYGEINE was left out IE: bathing, toileting. Why change the name and what is the advantage of adding the word “instrumental” to the phrase? 

Re: Medical evaluation:

The statement, “Within the scope of his license” should be changed to “within the scope of the practitioner’s stated license”.

Re: Neglect:

The definition does not include the peer to peer or other items we have been required to document in CHRIS

Re: Person-centered:

CHANGE ENTIRE DEFINITION TO READ: “means focusing on the needs and preferences of the individual, promoting self-determination, community involvement, and recovery in order to empower and support the directions of the individual’s life”.

Re: "Quality improvement plan":

The description lacks detail, who will complete it? How often? What will be required? the end of the last sentence defined add to the end “Quality improvement plan” and health status of the individual to promote or maintain optimal level of individual wellness and overall functioning.

Re: "Qualified Developmental Disability Professional (QDDP)" :

QIDP is still a CMS term and staff will have to maintain dual credentials

Re: Recovery:

In the sense that in reference to individuals with DD change to: “in the sense that while the supports may change, the individual will most likely need supports and services throughout their entire lifespan. The definition is wordy & not clear otherwise.

Re: Restraint:

Means change the term, “prevent change” to: “hands-on hold restricting the movement of the individual in order to prevent a behavior compromising safety to the individual and/or others.”

Re: "Root cause analysis" :

Description lacks detail, who will complete it? How often? What steps and elements will be required?

Re: Seclusion:

Actually  means the involuntary placement of solitude of an individual secured by a locked door, or held shut by a staff member, for safety precaution to prevent danger or harm to self or others.

Re: Serious incident:

The system of level 1, 2, 3 is confusing, what documentation will be required, by whom , and how often?  Assuming it will need to be recorded in the CHRIS system and it is a barely functioning software.  Hospital admissions are not always a crisis- Scheduled surgeries for example  will not meet the definition of a serious injury.  Less than reputable providers will delay/deny medical care to avoid completing documentation.  Level 2 does not include med errors, however we have a FAQ from years ago that suggests "several missed medications" might be neglect.  It would be great to get clarification.

Re: Service:

Planned individualized interventions and supports delivered to individuals with mental illness, developmental disabilities, or substance abuse. Services include (i) outpatient, intensive in-home, opioid treatment, inpatient psychiatric hospitalization, community gero-psychiatric residential, assertive community treatment, and/or other clinical services, day support, day treatment, partial hospitalization, psychosocial rehabilitation, and habilitation services, case management, supportive residential, special school, halfway house, in-home services, crisis stabilization, and other residential services; and (ii) planned individualized interventions intended to reduce or ameliorate the effects of brain injury through care, treatment, or other supports provided in residential services for persons with brain injury.

Re: 12VAC35-105-120. Variances.

As providers we do not have a way to contact DBHDS during non business hours to report emergencies or seek guidance if there was a need for a variance. An example would be if there was a need for an emergency relocation.  We can email and leave voice mail messages but there is no expectation of response on weekends or holidays

Re: 12VAC35-105-160:

The Depts. web based reporting system is not user friendly.  It locks us out before we can finish the reports.  It gives error messages that prevents information from being saved.  The 24 hour requirement to enter the information is unreasonable.  The support for the system is not open on weekends/ holidays and DBHDS staff are not there to read the reports if we manage to get the information entered.  We must report the information from the hospitals when providers are often not informed of treatment from them. Consent to share information with hospitals can be revoked.  Providers do not have any recourse if we disagree with the diagnosis.  It can be weeks before we get written discharge information, and often the verbal discharge information is inaccurate.

Re: 12VAC35-105-400:

1) A disclosure statement signed by applicant stating whether or not the applicant has ever been convicted of or is the subject of pending charges for any offense.

Re:115-230 C 4.:

Why would we complete a Root Cause analysis of a scheduled hospitalization?  What and who can complete the RCA and how will it be documented?  Is it a part of the client record?  What if it documents performance issues of staff? 

Re: 12VAC35-105-170. Corrective action plan.:

Can providers have a date to expect a CAP after a visit?  We have received CAP's several months after visits.  It is difficult to remember details when they come that far after a visit, and delay the improved service delivery.

Re: 12VAC35-105-320. Fire inspections

Where are we to document it?

Re: 12VAC35-105-520. Risk management

How will state define expertise?

How do state define serious injuries?

Re: 12VAC35-105-590. Provider staffing plan.  C #7

"Experience may be substituted for the education requirement"  How much experience and who will decide?  What type of experience?  Will we have to submit our managers and Q's to the DHP? 

Will the following requirement be billable or and be an unfunded mandate? A.     provider shall employ or contract with persons with appropriate training, as necessary, to meet the specialized needs of and to ensure the safety of individuals being served receiving services in residential services with medical or nursing needs; speech, language, or hearing problems; or other needs where specialized training is necessary. 

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

A quality improvement program, what are the credentials of the staff, how will it be documented, how often will DBHDS change the performance measures?  Will we have to document it in the CHRIS system?  Will there be training?  Who will indicate improvements are indicated?

Re: 12VAC35-105-650. Assessment policy:

Since the SIS audits have minimized the supports needed for individuals should we use them for the provider assessments or document the care required?

Re: 12VAC35-105-660. Individualized services plan C

How should we handle absent AR, or an AR that does not wish to participate in the assessments or in the development of the ISP?

Do you expect a full meeting monthly if a client has not met their outcomes?

Re: 12VAC35-105-830. Seclusion, restraint, and time out:

Needs to include:
-A “time-frame” the MD order stands for seclusion and or restraint?
-Assessment and circulation checks if restrained (for safety)
-How often client will be assessed for safety and thus release from seclusion or restraint.

Thank you for the opportunity to submit comments on behalf of Community Living Alternatives and the men and women we support.  We appreciate the work that has gone into improving overall safety, quality, and competence through these amended draft regulations.  

We do have concerns in the following areas:

Page 7:  The definition of "Missing".  Some of the adults we support do have the capacity to make decisions on where they would like to go and the manner in which they will go.  While we make every effort to help individuals communicate their plans with us and build a rapport where we are knowledgeable of a person's patterns, whims, and interests.  It may not be possible to know exactly where someone is 100% of the time when they have the ability and capacity to decide to walk home instead of take the bus or stop off at 7-11 delaying their arrival home by a "reasonable" amount of time.  Requiring a Level II incident be completed for anyone who is not where they are supposed to be at any time is not only unrealistic, but also not person centered or demonstrative of the dignity and respect that the individuals we support deserve.  We ask that you amend this definition.

Page 11:  Serious Incident, Level I is not clear.  

Page 18 160-e:  Requiring Root Cause Analysis of all Serious Incidents will be an excessive burden on a provider of CLA's size.  While we do applaud the effort to better assess how and why serious incidents occur in order to prevent them from re-occurring, some incidents are fairly obvious in their cause and accidental in nature with little that can be done systematically or personally to avoid them in the future.  Creating a report in addition to the current reporting standards for any serious incident will add an additional task to our already stretched Compliance team.  If this remains a requirement, we would ask that there be some consideration for additional funding to meet this mandate.

Page 20, 400:  Background Checks.  Our industry is in the midst of a significant shortage of DSP staff to provide adequate staffing.  Extending the length of time to hire a staff member will only increase this staffing crisis.  We are diligent about conducting background checks and acting immediately on any that come back as ineligible for hire (which has only been 1 in the past 14 months), but having to wait to offer a position until those checks are returned would surely result in potential employees securing employment elsewhere before we could hire them.

Thank you for your consideration.  

Susan Keenan

It would be beneficial if the DBHDs Licensure Regulations allowed for Nurse Practitioner for PACT/ICT as it is difficult to find psychiatrists for these positions.

We continue to have challenges in recruiting Support Coordinator's often due to the lack of the one year of documented experience with people with DD needs.  Would like to recommend consideration of a QDDP/QIDP Eligible opportunity similar to the QMHP-E option.  This would open the door to being able to hire and train and hopefully retain the nescessary SC positions.  Thank you for the consideration.

With respect to:

12VAC35-105-20 Definitions, Missing Person.  It is not clear how this broad definition might apply to any number of environments, including Day Support, Community Engagement, Residential, etc.  It is arguable that "missing" is quite different from an individual being "at any time not physically present when and where he is expected or is supposed to be."  By this definition, "missing" could refer to a person being in the restroom when expected in the kitchen.  Clarification needed.

Definitions, Serious incident.  The proposed system of 3 levels implies a three-tiered system of citations, although this is not expressed.  Examples of Level I incidents should be provided, although none are.  Level II incidents include the afore-mentioned "Missing" category, which requires definition.  Level III incidents are, by definition given, incidents which may have occurred outside of service hours and off provider premises: guidance is needed as to which entity bears the burden of recording such an incident.  Additionally, will these proposed levels be in addition to data already entered into the CHRIS system?

12VAC35-105-160.E, Root Cause Analysis.  This proposed regulation is burdensome and apparently duplicative of the data currently entered into CHRIS.  Additionally, Section 160.C requires the provider to "collect, maintain, and review at least quarterly all Level I serious incidents" without apparent regard to successful corrective action.  Under Section 160.D.2 instructions for Level II and III incidents include listing "the consequences or risk of harm that resulted..."  Risk of harm would be speculative and could be physical or emotional; additionally, Level III incidents are those incidents which may have occurred outside of the provider's service, making such speculation potentially harmful or libelous. Guidance needed.

\Good Afternoon.....below you will find questions and areas which I have specific questions concerning the draft regulations for the new Licensing regulation. Please let me know if you should have any additional questions.

    At the heading of the top of each licensing regulation page, the page notes “re: Settlement Agreement Compliance” What is the rationale behind noting this statement?

·         The credential for QMRP/QIDP has changed to QDDP. How does this effect the current staff who hold the QMRP/QIDP credential? Will there be a variance? When will the final guidance be issued? Will the Board of Counseling also be governing the process?

·         The definition between QMHP-A and QMHP-C is worded differently from the Board of Counseling registration requirements vs the licensing draft regulations. Could you please clarify both definitions?

·         The definition of Day Support does not define/include the youth population. This population needs to be added.

·         On page nine of the definitions, QMHP-C definition states” in section (v) “at least one year of clinical experience providing direct services to children and adolescents with a dx of mental illness”. We suggest language change to reflect “at least one year of clinical experience providing direct services to children at risk of serious emotional disturbance or children and adolescents with serious emotional disturbance”. The reason for the suggestion is due to the current definition does not allow experience with children 0-8 with at risk or serious emotional issues.

·         VAC105-665: could you clarify who is “others” the CSB is to offer the ISP?

·         On page 30, do the new CM face to face requirements apply to both MH and ID/DD CM services?  What is the difference between case management and enhanced case management and does this apply to all case management?

·         On page 14, TDT definition states under certain circumstances individuals can be served until age 21, however age 18 and older will meet SMI criteria not SED criteria.

ype over this text and enter your comments here. You are limited to approximately 3000 words.

Under Day Support definitions need to include youth population (page3).  Page 9 definitions of QMHP-A and QMHP-C are not consisitent with current definitons from Board of Counseling registration requirments. There is no longer a QMHP-E, but rather a "Trainee".  On page 14 in the definition of Therapeutic Day Treatment, youth 0 - 17 are potetntially SED, but at 18 the designation, if appropriate, should change to SMI. 

Page 4  - Please modify the proposed definition of Group Home to allow live-in assistants.

The proposed regulations defines a Group Home as “a congregate service in a community-based home having eight or fewer residents that provides 24-hour supervision by persons in direct care positions who do not live in the home.”

Please delete the phrase, “who do not live in the home.”

When a home is shared by assistants and persons with disabilities, the quality of life and the quality of the home  increases for several reasons. First, and most importantly, when sharing a home, assistants and persons with disabilities form meaningful relationships that enhance life for all. Second, assistants have an extra incentive to care for the home – it’s theirs too. Third, assistants who live in a home tend to stay longer, reducing the constant upheaval caused by frequent turnover.

10 years ago, 2 friends and I visited a L’Arche home with the question, “What will happen when I can no longer care for my daughter?” In L’Arche, we witnessed assistants (aides) accompanying and sharing a home with persons with disabilities. We were inspired by hope. We founded L’Arche Metro Richmond and have been working towards bringing L’Arche to our area for 10 years. Please delete the phrase "who do not live in the home" so the door to the L'Arche model and other models that include live-in assistants remains open.

L'Arche (French for The Ark) was founded in France in 1964. Today, there are 149 L'Arche communities around the globe, 18 in the USA. Metro Richmond needs L'Arche.

§20 Definitions – Serious Incident - Hospital Admission

Recommend this definition be changed to “Unplanned Hospital admission”. Hospital admissions can take place as part of a routine or planned medical service; these should be exempt from reporting as a serious incident.

§20 Definitions - QMHP

Recommend the definitions of QMHP-A, QMHP-C, QMHP-E and QMHPMH be revised. The Board of Counseling now defines these qualifications; the Licensing regs should match their definitions

§400 Criminal Registry Background Checks and Registry Searches

We are concerned about the proposed requirement for “the provider shall review the criminal history background check and registry search results prior to hiring the applicant.”

RRCS requests this information in a timely manner during the hiring process but obtaining the results are outside of our control. There are often significant delays with the agencies that process these background checks and criminal registry searches.

Requiring the results before an applicant is hired slows down the hiring process and inhibits our ability to recruit qualified staff.

§160  Reviews by the Department – Root Cause Analysis of Serious Incidents

Requiring a root cause analysis for each serious incident is burdensome to providers. We recommend the requirement for a root cause analysis be limited Level II and Level III incidents.

Thank you for the opportunity to comment on the Emergency Regulations.  

Definitions: Group Home "in a community-based home having eight or fewer residents that provides 24-hour supervision by persons in direct care positions who do not live in the home."  Most Group Homes have moved away from live-in staff members, but there may be incidences in which live-in supports would be appropriate.  

Serious Incidents--The use of missing using the term "any "in the definition is problematic.  Many individuals are capable of time away and have the freedom to leave their homes to access the community.    The definition should reflect a serious elopement so as to avoid reporting every time a staff member does not know the exact location of an individual.

---“All hospital admissions” should be clearly defined as an unplanned admission to differentiate it from planned surgeries, procedures, and medical care as prescribed by a doctor.

----A root-cause analysis should be required for Level II and III, but the quarterly review of the Level 1 should be adequate.   Adding a requirement for a quarterly report and review of level 1 incidents would assist the provider is determining any patterns which need to be addressed.

Under 400—The section indicates that the criminal background check report needs to be available prior to hiring.  Under the Code of Virginia, the background checks are to be submitted after a job has been offered and accepted.  If the job has not been offered and accepted prior to completing the fingerprinting and submission form, employers are being told to ask for information they are not yet legally entitled to request.   In addition, it often takes as much as 6 weeks for the report to be returned to the employer.  With the severe shortage of applicants and DSPs this is a huge deterrent to hiring and will worsen the staff shortages across agencies.   People applying for DSP and other positions in the IDD world will not be able to deter employment for 6 weeks.  Even if the time for the report’s return is shortened, the gap from hire to work will cause great damage to the employee and the agency and may risk the quality of support to the individuals.   

Under 520C---“This process shall incorporate uniform risk triggers and thresholds as defined by the department.”  This language is unclear and the expectations of the DBHDS need to be clearly defined and providers trained in expectations if this language stands in the final regulations.

12VAC35-105-20. Definitions.

“Direct care position” means any position that includes responsibility for: (i) treatment, case management, health, safety, development, or well-being of an individual receiving services or (ii) immediately supervising a person in a position with this responsibility.

Comment: The Case management role being defined as a component of  the definition of  Direct Care Position seems to contradict the CMS definition of Case Management. It is unclear how this new definition will be applied to service provision, and credential and training requirements across all disabilities.

CMS definition of case management

• Case management is a collaborative process of assessment, planning, facilitation, care coordination, evaluation, and advocacy for options and services to meet an individual’s and family’s comprehensive health needs through communication and available resources to promote quality, cost-effective outcomes.

"Level II serious incident"

5. A hospital admission;

9. Ingestion of any hazardous material.

Comment: Need additional clarification/ definition of Hospital admission – i.e. medical admission. And additional clarification of what constitutes a hazardous material i.e. ingestion of a material that warrants a call to poison control.

12VAC35-105-160. Reviews by the department; requests for information; required reporting

E. A root cause analysis of each serious incident shall be conducted by the provider within 30 days of discovery to include at least the following information: (i) a detailed description of what happened; (ii) an analysis of why it happened, including identification of all identifiable underlying causes of the incident that were under the control of the provider; and (iii) identified solutions to mitigate its reoccurrence.

Comment: This seems excessive, particularly for Serious Incident Level 1 if it is apparent staff followed agency’s policy and procedures. We do not have a designated position whose primary duties are Risk Management Activities and currently do not have anyone with a strong skill set for such activities. We would need and welcome well defined expectations and root cause analysis training from the department before this requirement goes into effect.

12VAC35-105-320. Fire inspections.

The provider shall ensure adequate staff to safely evacuate all individuals during an emergency

Comment: Supervised Residential sites may not be able to plan for and adequately staff a site for a fire event that may occur at night when most residents would be asleep. This is type of an event is out of the ordinary and cannot be planned for in advance.

12VAC35-105-400. Criminal registry background checks and registry searches.

B. Prior to hiring an applicant, the provider shall obtain the employee's written consent and personal information necessary to obtain a search of the registry of founded complaints of child abuse and neglect maintained by the Virginia Department of Social Services.

E. The provider shall review the criminal history background check and registry search results prior to hiring the applicant and shall maintain the following documentation:

Comment: The statements for pre-hire activities to obtain applicant written consent and personal information as well as the criminal check being completed prior to hire will place a burden on the agency’s ability to hire and retain the necessary man power to provide coverage for needed services to the individuals we serve. It is understandable and warranted for the protection of those we serve that new hires do not provide direct service prior to receiving results of the criminal background and registry checks. The time between hire and receipt of results is generally used by our agency to provide the necessary required trainings to the new hires.

12VAC35-105-660. Individualized services plan (ISP).

C. This ISP shall be developed based on the initial assessment with the full participation and informed choice of the individual receiving services. To ensure the individual’s participation and informed choice, the provider shall explain to the individual or his authorized representative, as applicable, in a reasonable and comprehensible manner, the proposed services to be delivered, alternative service or services that might be advantageous for the individual, and accompanying risks or benefits. The provider shall clearly document that this information was explained to the individual or his authorized representative and the reasons the individual or his authorized representative chose the option included in the ISP.

Comment: If the ISP is a person centered plan, completed with the individual/AR/Legal guardian then documenting the reason why an option is chosen in an ISP seems to be redundant documentation.

12VAC35-105-675. Reassessments and ISP reviews.

D. The provider shall review the ISP at least every three months from the date of the implementation of the ISP or whenever there is a revised assessment based upon the individual's changing needs or goals.

2. These reviews shall document evidence of progression towards or achievement of a specific targeted outcome for each goal and objective.

Comment: Reassessment and ISP reviews do not always result in progress. This line indicates there is always progress. It should end with an or …  this would lead into the next line of what to do if there is no progress.

3. For goals and objectives that were not accomplished by the identified target date, the team shall meet to review the reasons for lack of progress and provide the individual an opportunity to make an informed choice of how to proceed.

Comment: the line that states teams shall meet implies a face to face meeting with all parties working with the individual at every review / reassessment. This is not always possible for all cases and across all disabilities. Documenting care coordination on an ongoing basis and on an as needed basis should be sufficient.

12VAC-35-105-20

Group Home Definition:

The addition of the line, “that provides 24-hour supervision by persons in direct care positions who do not live in the home.” is problematic and will decrease service options and choice for individuals receiving Waiver Services. There are group home models in Waiver Services that utilize DSPs who live in the home. Remove, “who do not live in the home” from the definition.

Serious Incident Definition:

Level II, (3), "an individual who is missing for any period of time".  This is too broad of a statement and needs clarity. There should be different criteria depending on the level of supervision required, the environment or circumstances.

Level II, (4) "Hospital Admission" Hospital Admissions often take place as part of a routine or planned medical service, please qualify this provision as "Unplanned Hospital Admission".

12VAC35-105-160

Root Cause Analysis: Level I review, described in 160 C, is sufficient for a Level I incident.  Exempt Level I incidents from requiring root cause analysis and limit that to Level II and III incidents.

12VAC35-105-400 E

Requires a criminal background check prior to hiring. This is problematic for providers and inhibits the hiring process. Code of Virginia §19.2-389 A 29 specifies that a criminal background check may be completed for “applicant who accepts employment in any direct care position” – to process a criminal background check the offer of employment must have been made and accepted.

Comment: The draft amendment does not address any changes to the ISP requirements in lieu of the implementation of Same Day Access the CSBs are in the process of implementing. The regulation continues to have a description and process of an intial plus a comprehensive ISP.

Recommend having language with in the regulations that allows a Comprehensive ISP to meet the requirements of the initial and Comprehensive ISPs at the very start of services, following a comprehensive assessment.

Please see comments below related to the proposed Licensing regulations:

• At the heading of the top of each licensing regulation page, the page notes “re: Settlement Agreement Compliance” What is the rationale behind noting this statement?
• The credential for QMRP/QIDP has changed to QDDP. How does this effect the current staff who hold the QMRP/QIDP credential? Will there be a variance? When will the final guidance be issued? Will the Board of Counseling also be governing the process?
• The definition between QMHP-A and QMHP-C is worded differently from the Board of Counseling registration requirements vs the licensing draft regulations. Could you please clarify both definitions?
• The definition of Day Support does not define/include the youth population. This population needs to be added.
• On page nine of the definitions, QMHP-C definition states” in section (v) “at least one year of clinical experience providing direct services to children and adolescents with a dx of mental illness”. We suggest language change to reflect “at least one year of clinical experience providing direct services to children at risk of serious emotional disturbance or children and adolescents with serious emotional disturbance”. The reason for the suggestion is due to the current definition does not allow experience with children 0-8 with at risk or serious emotional issues.
• VAC105-665: could you clarify who is “others” the CSB is to offer the ISP?
• On page 30, do the new CM face to face requirements apply to both MH and ID/DD CM services?  What is the difference between case management and enhanced case management and does this apply to all case management?
• On page 14, TDT definition states under certain circumstances individuals can be served until age 21, however age 18 and older will meet SMI criteria not SED criteria.

Respectfully submitted

Shane Ashby

12VAC-35-105-20

Group Home Definition:

The addition of the line, “that provides 24-hour supervision by persons in direct care positions who do not live in the home.” is problematic and will decrease service options and choice for individuals receiving Waiver Services. There are group home models in Waiver Services that utilize DSPs who live in the home. Remove, “who do not live in the home” from the definition.  Individuals should have the option to decide if they prefer a "live-in" model. 

Serious Incident Definition:

Level II, (3), "an individual who is missing for any period of time".  This is too broad of a statement and needs clarity. There should be different criteria depending on the level of supervision required, the environment or circumstances.

Level II, (4) "Hospital Admission" Hospital Admissions often take place as part of a routine or planned medical service, please qualify this provision as "Unplanned Hospital Admission".

12VAC35-105-160

Root Cause Analysis: Level I review, described in 160 C, is sufficient for a Level I incident.  Exempt Level I incidents from requiring root cause analysis and limit that to Level II and III incidents.

12VAC35-105-400 E

Requires a criminal background check prior to hiring. This is problematic for providers and inhibits the hiring process. This could delay services for families by 6+ weeks.  Families need faster access to services.  Not more barriers.  Code of Virginia §19.2-389 A 29 specifies that a criminal background check may be completed for “applicant who accepts employment in any direct care position” – to process a criminal background check the offer of employment must have been made and accepted. 

12VAC35-105-20  Definitions

“Missing” means a circumstance in which an individual is at any time not physically present when and where he is expected or is supposed to be.     This definition is concerning as we have many individuals scheduled for appointments who are a “No Show”.   Individuals may change their mind about attending appointments and should not be labeled as “missing”. To place “missing” as a Level 2, Serious Incident and require reporting of all these “missing” people will increase administrative reporting duties.   It also seems excessive that a Root Cause Analysis would then have to be completed for every person deemed “missing” because they were not physically present when and where they were supposed to be.

"Serious incident" definition includes the description of a Level II serious incident to include:

5.  A hospital admission  -  is this an admission to any hospital -  State or general/medical hospital?

12VAC35-105-590  Provider staffing plan

5.  Adequate number of staff required to safely evacuate all individuals during an emergency.   The phrase "adequate number of staff" needs to be defined. What guidelines are used to determine what is "adequate"?

Comments on the DRAFT Licensing Regulation revisions:

§20 Definitions

1. Definition of “Case management service” or “support coordination service” - “Case Management Service” is a specific service requiring a DBHDS license, 16-001 through 005.“Support coordination service”, however, is often a component of another service as “care coordination” defined and required by DMAS which does not require separate licensing to provide. Please reference DMAS’ definition and description of “Care Coordination” in the CMHRS Provider Manual, Chapter 4, pages 13-14; the description of “care coordination” is the similar to the definition of “case management or support coordination service” defined here by DBHDS.Since “support” is synonymous with “care” in the definition immediately above in §20, including both terms in the same definition implies that “support coordination service” would require a separate license to provide.Was that the intention here?
2. Would recommend adding a definition for “counseling” to align with the DHP and DMAS definitions and regulations.
3. Definition of “Intensive in-home service” – recommend removing “case management” from the definition of IIH.“Case management” was removed as a component of the IIH service by DMAS in January 2015 and replaced with “care coordination”.See DMAS regulations at 12VAC30-50-130.5.b.
4. “Mental Health Community Support Service (MHCSS)” – Reviewing the most recent revision of the DBHDS Service Modification Provider Request form (12/2017), the license code 03-002 for Mental Health Community Support Service has been removed.A specific license/code for Mental Health Skill Building Service has been added, 03-001.Should this definition be replaced/updated to reflect “Mental Health Skill Building Service” now?
5. “Missing” – this definition needs further clarification as it applies to residential versus community-based services, especially now that it is included as a reportable Serious Incident.
6. Recommend providing specific examples of a “Level I Serious Incident”.
7. Definition of a “Level II Serious Incident” – “hospital admission” – needs to be more specifically defined to exclude routine or planned medical services.Maybe should be qualified as hospitalization due to a medical or psychiatric emergency/crisis?

§30. Licenses.

1. B.13 – Recommend changing MHCS to Mental Health Skill Building or adding Mental Health Skill Building since it is now listed separately as a licensed service, 03-001.

§160. Required reporting.

1. More clearly define “a person who is missing” as it relates to a community-based program.
2. More clearly define “hospital admission”.
3. Requiring a root cause analysis for all Serious Incident Levels will create additional administrative burdens on providers.Level I reports would already be reviewed on a quarterly basis and not necessarily require this level of analysis.

"Level II serious incidents" #4 includes E.R. and urgent care visits when not used in lieu of primary care physician visits. Does this mean that if an urgent care visit is used in lieu of a primary care visit, it should be considered a Level I incident? Clarification is needed. Further, examples are given for level II and Level III incidents. Examples should also be given for level I incidents.

Append Serious Incident definition to... "includes death, serious injury and may include serious illnesses" and further define types/nature of illnesses which are to be included and thus reported out.

"Level II serious incidents" #5 should be amended to say "unplanned" hospital admissions. 

On behalf of the Alexandria Community Services Board I submit the following comments:

Given the nationwide lack of available psychiatrist, we propose adding language to the Intensive Community Treatment (ICT) service and Program of Assertive Community Treatment (PACT) service definitions to allow for a Nurse Practitioner.  Specifically, where both definitions itemize the staffing of the teams we recommend “… a full- or part-time psychiatrist or a Nurse Practioner (NP)”

This wording would allow more flexibility in meeting the needs of individuals in the community.

We also would like to recommend adding the definition of the “Registered Peer Recovery Specialist”.  The definition should match the peer recovery specialist definition contained in 12VAC35-250-10. Definitions.  The definition as written is:  means a person who by education and experience is professionally qualified to provide collaborative services to assist individuals in achieving sustained recovery form the effects of mental illness, addition, or both.

The omission of this definition may lead to confusion regarding what standard within the Licensure guidelines best fit the peer recovery specialist.  The only comparable definition listed is the “Qualified Paraprofessional in Mental Health (QPPMH)" which requires education or a minimum of experience of providing services to individuals with a  mental illness. The peer recovery specialist lived life experiences with a serious mental illness is the criteria that we need.  The registration process with the Board of Professional Counselors ensures the minimum threshold of standardized education is obtained by the peer recovery specialist.  We want to ensure that the regulations clearly support the lived life experiences which peer recovery specialist bring to the support team without causing an undue burden of direct work experience in addition to the lived life experiences.

We appreciate your consideration of our recommendations.

Serious Incident definition - Tier 1 has no definition.  What is it?

Definition of Serious Incident:  Hospital admission should be "unplanned hospital admission."

Background and CPS Registry prior to hiring - our industry has a difficult time recruiting a qualified work force and to put this requirement on providers means that potential employees will be seeking work elsewhere.  

There are proposed regulations requiring additional time consuming administrative requirements.   Example root cause analysis for all tier levels. The current rate stucture for providers is poor enough - now we're being asked to have more costly admin oversight.

Thank you for our allowing comments.    

Why are you including the phrase "who do not live in the home" in the revised definition of group home? What is the rationale for this limitation? Is there something inherently wrong with the L'Arche Greater Washington D.C. group home model? Will this organization no longer be able to have "live-in" assistants who do not have a disability?  Thank you for your attention to this matter.

Definitions: Informed Choice.  "These options are developed through collaboration with ...the provider ....." and 660 C. "the provider shall explain to the individual ..... alternative service or services that might be advantageous for the individual......"  Discussion about what options an individual has in the community is incumbent on the CSB Support Coordinator prior to placement and then at least annually or when indicated.  If an individual has already been admitted by a provider and an ISP is being developed, decisions about supports have already been made.  If an individual is interested in alternative supports, it is more reasonable to expect a provider to discuss supports offered by the provider and then to refer the individual to the CSB Support Coordinator to discuss other providers.

400

Considering staffing is already a state-wide issue, requiring providers to obtain results of criminal background check and registry searches prior to hiring applicants will delay hiring and escalate the challenge of adequate staffing.  Additionally, due to 2-6 week return of results, most DSP level applicants will not be able to wait to secure the position.

520

A. "who has training and expertise in conducting investigations, root cause analysis, and data analysis"--by what criteria will this training be established?  

C. "Uniform risk triggers and thresholds as defined by the department" should be defined in the regulations.

"E. The provider shall review the criminal history background check and registry search results prior to hiring the applicant...”

This would create a significant hardship on the hiring process. The turnaround time for both the Criminal Background checks and the Child Protective Registry searches are lengthy. We have noticed that the turnaround time is normally 3 to 6 weeks. This does not count the people that have 3 non-classifiable/unreadable prints which could take months.  We wouldn't be able to give our potential employee a definite date of hire. If a potential employee were to wait that long without a paycheck, only then we would be able to begin the training process.  For the applicants that pursued other job opportunities in that waiting period, the provider would have spent $58.00 ($48.00 and $10.00) on an applicant not an employee. The lengthy time will not only delay the hiring and training processes but it will create longer openings in our direct care positions which are considerably needed. Industry wide, I think this amendment will make it substantially harder to attract and retain applicants.

Remove “who do not live in the home.” There are homes already in existence and homes which are proposed that have assistants who live in the home. By having an assistant living in the home, the home becomes theirs, they have a vested interest in the home and there is less disruption due to asssistants coming and going. All of these benefit the clients who live in the home. Please remove “who does not live in the home.”

12VAC35-105-20

• “Direct Care Position”: add “support” to the list of tasks.The current definition seems very clinical and not flexible to In-Home supports.

• ‘Missing’. Consider defining this related to an individual’s identified support needs documented in the ISP. If someone walks to the store for 5 minutes and then returns, this does not require reporting.

• ‘Residential service’. Remove the use of community twice.
• “Medication Administration”:Change this to include “assist with or administer” medications.Definition of Medication Aide should match this definition.

• ‘Serious Incident’. Stating that an incident is serious in nature when it is likely to lead to adverse effects is interpretable by each licensing specialist and does not allow providers to develop policy or consistent practice.

• Level I:

  • Stating that deaths must be reported is clear. Stating that injury caused by physical restraint is clear. These regulations have provided no definition or clarity regarding Level 1 incidents. Providers will be unable to develop policy or consistent practice to meet regulation.

• Level II:

  • The reportability of an individual missing for any period of time is problematic. Missing should be defined as related to an individual’s identified support needs documented in their ISP.

  • DBHDS wants to identify trends related to specific injuries and not the use of emergency rooms and urgent care facilities. The regulations should be written to require specific injuries to be reported, not use of the ER and urgent care centers.

  • Hospital admissions are already reported quarterly to case management utilizing the quarterly review. Remove this or state unplanned hospital visits require reporting to exclude care that is ordered by a physician and requires hospital admission.

  • Remove allegations of exploitation and theft as these are already required to be reported via CHRIS by the Human Rights Regulations.

  • Remove disaster, fire, emergency or other condition. Disaster and emergency is broad and interpretable across licensing specialists. This is already required to be reported with a focus on provider precautions and provision of care.

  • Remove the “diagnosis section #10.Those diagnoses should not be more reportable than others, especially in Supportive In-Home services.

• Level III:

  • Remove “whether or not the incident occurs while in the provision of service”.

  • 3. Who determines if a serious injury is likely to result in permanent physical or psychological impairment? This is interpretable across licensing specialists and does not allow providers to develop policy or consistent practice to meet regulation.

  • 4. This is covered in Level II #5.

• ‘Serious Injury’ Medical attention that was not required but sought as a precaution and resulted in no formal treatment or diagnosis is not necessary to report.

12VAC35-105-160

• D2. A provider would need to document this contact so requiring that the communication take place via phone should be removed. This should be communicated in writing to other parties if included here.

• E. A root cause analysis is conducted as part of an investigation and this is redundant. Remove this.

12VAC35-105-170

• E. A deadline should be included in regulation to specify DBHDS’s deadline to respond to a provider’s correction action plan.

12VAC35-105-400

• B. Consent should be obtained after hire and is not relevant to a hiring decision.

• E. The results of background checks takes several weeks and cannot be reviewed prior to hire. The Code of VA specifies that a criminal background check be completed for an applicant that accepts employment into a direct care position and therefore the offer of employment has to be made and accepted before processing can occur.

12VAC35-105-520

C. If this is to be required by DBHDS, the uniform risk triggers and thresholds should be defined in regulation. Otherwise, providers will be unable to develop policy and or consistent practice.

12VAC35-105-590

• A.5. Adequate number of staff required to safely evacuate all individuals during an emergency.This statement should say it does not apply to Supportive In-Home.

Throughout regulation the language distinguishing between the sections do not apply to in-home or non-centered based locations was removed and not struckthrough consistently. This clarification should be highlighted and applicable sections labeled accordingly.

Tiered Incident Reporting System:

• Does not help to streamline reporting and it is anticipated this will result in an increase in reporting requirements and demands. Providers currently report in most, if not all of these areas and frequently receive feedback from DBHDS regarding over reporting.
• Increases likelihood of Providers becoming responsible for reporting on issues the organization would otherwise not be responsible for reporting.
• Takes away the parameter of an individual requiring unscheduled medical attention as a perquisite for reporting.
• Reporting sexual assault: The regulation is unclear as to whether Providers would investigate (or even have the authority to) if the event did not occur during/on a program site, in a peer-to-peer instance or involving a Provider’s staff.

12VAC35-105-160 C:

• Quarterly reviews of all Level I serious incidents is superfluous. The initial review to determine its reporting value and level assignment is sufficient. Maintenance of these incidents for on-demand review by DBHDS is sufficient, given their low-level, sub-acute status.
• The requirement that a “root cause analysis” be completed of each serious incident is an unrealistic mandate. The proposed regulation provides no indication as to what Level of incident this applies, so it is assumed all would need to be done. Completing an analysis and subsequent report within 30-days of the incident, in addition to the currently required investigation and reporting requirements is not feasible. It is requested that the section be amended to remove this requirement from Level I serious incidents.
• It would be imperative that DBHDS provide ongoing support and training to providers on how to effectively complete the root cause analysis process to ensure fidelity of the system. However, DBHDS has often struggled with how to effectively offer training to Providers, in a timely and ongoing fashion, on best practices related to current mandates. It is unclear how additional support and technical assistance would be made available by DBHDS to Providers on this new mandate.

12VAC35-105-400:

• Requiring Providers to reserve hiring personnel until the receipt of background checks results is unreasonable and will significantly impact the ability for licensed Providers to attract and acquire qualified staff for critical positions.

12VAC35-105-520 C:

• This level of mandate would require a risk assessment tool, developed by DBHDS, to ensure accurate application and assessment across Providers. The requirement that the “process shall incorporate uniform risk triggers and thresholds as defined by the department” requires provision of an instrument by which to apply these measures.

12VAC35-105-20. Definitions.

"group home or community residential service" would be updated to be defined as  "a congregate service providing 24hour supervision in a community-based home having eight or fewer residents that provides 24hour supervision by persons in direct care positions who do not live in the home."

The proposed redefinition of Group Home, will adversely affect people with Developmental Disbailities. The changes porposed suggest that people in direct care positions can no longer live in the same home as people with Developmental Disabilities. This change would limit the personal choicesof people Developmental Disabilities. Furthermore, it risks isolating and confining people with Developmental Disabilities. It limits and restricts the role of people with Developmental disabilities from teaching and coaching direct support professionals.

This proposed language change would have a significant impact on choice of service providers for individuals already receiving services in our communities. Should the chang be adopted, it will exclude agencies that use a blended staff model - employing direct care professionals that live in the home AND live out of the home"  in order to provide 24hr support and supervision - from providing services. 

Please delete the phrase, “who do not live in the home.”

12VAC35-105-20. Definitions.

“Direct care position” means any position that includes responsibility for: (i) treatment, case management, health, safety, development, or well-being of an individual receiving services or (ii) immediately supervising a person in a position with this responsibility.

Comment: The Case management role being defined as a component of the definition of Direct Care Position seems to contradict the CMS definition of Case Management. It is unclear how this new definition will be applied to service provision, and credential and training requirements across all disabilities.

CMS definition of case management

•Case management is a collaborative process of assessment, planning, facilitation, care coordination, evaluation, and advocacy for options and services to meet an individual’s and family’s comprehensive health needs through communication and available resources to promote quality, cost-effective outcomes.

"Missing" means a circumstance in which an individual is at any time not physically present when and where he is expected or is supposed to be.

Comment: This definition is entirely too broad if applicable in all programs. Many individuals “no show” outpatient appointments and are not at any clinical risk. Submitting incident reports for these types of non-events would be unnecessarily burdensome.

"Qualified Mental Health Professional-Adult (QMHP-A)" means a person in the human services field who is trained and experienced in providing psychiatric or mental health services to individuals adults who have a mental illness; including (i) a doctor of medicine or osteopathy licensed in Virginia; (ii) a doctor of medicine or osteopathy, specializing in psychiatry and licensed in Virginia; (iii) an individual with a master's degree in psychology from an accredited college or university with at least one year of clinical experience; (iv) a social worker: an individual with at least a bachelor's degree in human services or related field (social work, psychology, psychiatric rehabilitation, sociology, counseling, vocational rehabilitation, human services counseling or other degree deemed equivalent to those described) from an accredited college and with at least one year of clinical experience providing direct services to individuals with a diagnosis of mental illness; (v) a person with at least a bachelor's degree from an accredited college in an unrelated field that includes at least 15 semester credits (or equivalent) in a human services field and who has at least three years of clinical experience; (vi) a Certified Psychiatric Rehabilitation Provider (CPRP) registered with the United States Psychiatric Rehabilitation Association (USPRA); (vii) a registered nurse licensed in Virginia with at least one year of clinical experience; or (viii) any other licensed mental health professional.

Comment:  This definition is contradictory with Emergency Regulations effective 12/17/2017 (see below)

"Qualified mental health professional" or "QMHP" means a person who by education and experience is professionally qualified and registered by the board to provide collaborative mental health services for adults or children. A QMHP shall not engage in independent or autonomous practice. A QMHP shall provide such services as an employee or independent contractor of the DBHDS or a provider licensed by the DBHDS.

"Qualified mental health professional-adult" or "QMHP-A" means a registered QMHP who is trained and experienced in providing mental health services to adults who have a mental illness. A QMHP-A shall provide such services as an employee or independent contractor of the DBHDS or a provider licensed by the DBHDS.

"Qualified Mental Health Professional-Child (QMHP-C)" means a person in the human services field who is trained and experienced in providing psychiatric or mental health services to children who have a mental illness. To qualify as a QMHP-C, the individual must have the designated clinical experience and must either (i) be a doctor of medicine or osteopathy licensed in Virginia; (ii) have a master's degree in psychology from an accredited college or university with at least one year of clinical experience with children and adolescents; (iii) have a social work bachelor's or master's degree from an accredited college or university with at least one year of documented clinical experience with children or adolescents; (iv) be a registered nurse with at least one year of clinical experience with children and adolescents; (v) have at least a bachelor's degree in a human services field or in special education from an accredited college with at least one year of clinical experience providing direct services to with children and adolescents with a diagnosis of mental illness, or (vi) be a licensed mental health professional.

Comment:  This definition is contradictory with Emergency Regulations effective 12/17/2017 (see below)

"Qualified mental health professional-child" or "QMHP-C" means a registered QMHP who is trained and experienced in providing mental health services to children or adolescents who have a mental illness. A QMHP-C shall provide such services as an employee or independent contractor of the DBHDS or a provider licensed by the DBHDS.

"Level III serious incident" means a serious incident whether or not the incident occurs while in the provision of a service or on the provider’s premises and results in:

1. Any death of an individual;

2. A sexual assault of an individual;

3. A serious injury of an individual that results in or likely will result in permanent physical or psychological impairment;

4. A suicide attempt by an individual admitted for services that results in a hospital admission.

Comment: While we would support the reporting of a sexual assault that occurs or originates during the provision of a service or on the premises of the provider or for individuals for whom we have 24-hour responsibility, we do not support the reporting of other types of sexual assault. Knowing these will be reported to DBHDS would inhibit victims and perpetrators from seeking needed treatment.

We would also support the reporting of a serious injury that occurs or originates during the provision of a service or on the premises of the provider or for individuals for whom we have 24-hour responsibility, we do not support the reporting of other types of serious injuries. Injuries that result from another source – like a motor vehicle accident – are outside our span of control and purview to investigate.

Please amend the proposed definition of Group Home to accommodate supervision by live-in assistants.  I write with a deep concern for programs like L’Arche, which nurture community that extends beyond supervision and services, and promotes shared life for all residents and an invaluable sense of mutual belonging. 

Programs that include live-in assistants encourages help from not only the hands but the heart.

Please remove the phrase “who do not live in the home” to allow for live-in assistants.

12VAC35-105-400. Criminal registry background checks and registry searches.

B. Prior to hiring an applicant, the provider shall obtain the employee's written consent and personal information necessary to obtain a search of the registry of founded complaints of child abuse and neglect maintained by the Virginia Department of Social Services.

C. The provider shall develop a written policy for criminal history background checks and registry searches. The policy shall require at a minimum a disclosure statement stating whether the person has ever been convicted of or is the subject of pending charges for any offense and shall address what actions the provider will take should it be discovered that person has a founded case of abuse or neglect or both, or a conviction or pending criminal charge.

D. The provider shall submit all information required by the department to complete the criminal history background checks and registry searches.

E. The provider shall review the criminal history background check and registry search results prior to hiring the applicant and shall maintain the following documentation:

1. The disclosure statement from the applicant stating whether he has ever been convicted of or is the subject of pending charges for any offense; and

2. Documentation that the provider submitted all information required by the department to complete the criminal history background checks and registry searches, memoranda from the department transmitting the results to the provider, and the results from the Child Protective Registry search.

Comment:  Are the changes to this section intended to now require these checks and searches only for employees? The removal of this requirement for contractors, students, and volunteers is concerning and seems contradictory to the intent of the regulation