There are two related substantive changes (12VAC35-105-170 H. and 620 D.3.) from the version of the regulations published at the proposed stage which will have a substantial impact on all providers.  Both contain the expectation that providers, if cited for any violation of any regulation, will produce and implement a corrective action plan that will prevent recurrence.

While in 12VAC35-105-170 C the provider is required to produce a corrective action plan which includes a detailed description of the actions to be taken that will minimize the possibility that the violation will occur again and correct any systemic deficiencies, the standard is raised to an unattainable level in 170 H where if the provider determines that a corrective action plan was fully implemented but did not prevent recurrence additional steps are required to meet the standard and are now expected to prevent recurrence.   In 620 D the provider is required to include their plan for accomplishing the expectation to prevent recurrence as part of their Quality Improvement strategy.

We object to the change in principle as it is an impossible standard to meet – the scope of the regulatory authority is very broad and deals with everything from physical plant standards and maintenance to the development and implementation of services plans, care for the health and welfare of a wide variety of ages and disability groups, monitoring and maintaining health, nutrition and personal care, and supporting all aspects of life in the community.  There are a multitude of actions, occurrences, circumstances and/or instances of human behavior that can interfere with any path to perfection. 

To expect a provider to develop a corrective action plan (CAP) which is formulated to ensure that no actions, occurrences, circumstances and/or instances of human behavior, which may have contributed to the original citation, will prevent recurrence is asking more than should be expected. To be accepted as a valid CAP also requires that it meets that standard in the judgement and interpretation of the Licensing Specialist.  Failure to meet the expectations in the CAP development can result in an additional citation.

To expect a provider to implement a CAP which is formulated to ensure that no actions, occurrences, circumstances and/or instances of human behavior, which may have contributed to the citation will prevent recurrence is also asking more than should be expected. There are a multitude of actions, occurrences, circumstances and/or instances of human behavior that can interfere with any path to perfection.  Failure to meet the expectations can result in an additional citation.

12VAC35-105-170 H. and 12VAC35-105-D.3. should be removed from the Final regulations.

170 H 

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

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

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

Also 620 D.3

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

Provider does not disagree with the idea of monitoring effectiveness of approved corrective action plans or submitting a revised corrective action plan should the corrective action plan not appear to be effective.  Provider’s issue lies with assumption that a fully implemented plan would always prevent the recurrence of a violation, and that failure to do so requires a systemic plan – some issues that are included on a corrective action plan may not be something that a provider can guarantee won’t occur again regardless of the plan of action put in place.  This seems an impossible standard to meet. 

280 F 

Adequate hot and cold running water of a safe and appropriate temperature shall be available.  Hot water accessible to Individuals being served shall be maintained within a range of 100-110°F.  If temperatures cannot be maintained within the specific range, the provider shall make provisions for protecting Individuals from injury due to scalding.

Provider takes issue with the temperature range allowed in these regulations.  A maximum water temperature of 110 degrees is not sufficient to kill bacteria (Legionella bacteria, for example, in fact thrives at this temperature).  Licensing has in the past recommended a master mixing valve placed at the water heater as a solution, but mixing valves typically only reduce the water temperature to 120 degrees, per ASSE guidelines (still above the maximum required temperature).  And again, water heated only to 110 degrees is not sufficient to kill bacteria.

1. 12VAC35-105-520. Risk management.

   1. Comment: What is the department approved training? Has this already been developed or is this task being placed on providers to develop and submit to the Department for approval?

2. 12VAC35-105-620. Monitoring and evaluating service quality

   1. Comment: Have the statewide performance measures been developed yet? If so, where are they kept?

3. 12VAC35-105-660. Individualized services plan (ISP).

   1. Comment: Can you please change the language to match provider and CSB language of Parts I – V? For B & C, please clarify the role of Support Coordination in the development of the ISP? 

4. 12VAC35-105-620. Monitoring and evaluating service quality.

   1. Comment:  Not all cited violations are the result of systemic deficiencies.  It is not possible to guarantee recurrence even with fully implemented corrective action.  Plans and additional measures are put in place to mitigate future incidents.

Initially, it is important to note that the risk management, requirements contained in these regulations were not included in the original Burns analysis for establishing the current reimbursement rate; thus, they represent a significant unfunded mandate. The state rightly considers this a major change; however, fails to recognize that it also generates a major expense in time, resources and payroll, both initially and ongoing. This unfunded mandate, like the litany of others imposed after the Burns rate setting analysis was conducted (2014), creates a unique hardship for small businesses, because the original Burns analysis excluded any provision for profit that would make additional funds (above 2013 operating cost) available for implementing changes, much less for inflation in cost and wages over the past 6 years. When asked about profit inclusions during the Burns call, they openly laughed and indicated with economies of scale you could probably “find some somewhere”; however, small businesses do not enjoy economies of scale and as a result are uniquely and seriously burdened by each additional unfunded mandate. The state should give serious consideration to providing some relief consistent with the provisions and requirements of section 2.2 – 4007.1 of the Administrative Process Act, for this and all other unfunded mandates implement since the Burns analysis was conducted.

105 – 520 – A – qualifications for risk manager –is too vague, overly restrictive, creates significant unfunded mandates and is a significant unique and unnecessary burden for small businesses. 1^st – too vague/costly, insertion of the phrase “ completed department approved training” – provides no indication of what the department is likely to approve which makes any meaningful comment on the burden, necessity and/or utility of such trainings impossible—This also creates an unknown but potentially huge cost as providers would be forced to sign up for whatever trainings were eventually approved and the vendor could charge any astronomical fee they desire knowing you lose your license if you don’t pay up; and this would only magnify the cost of the unfunded mandate and all of the negative impacts that entails. 2^nd – overly restrictive – as written it would require specific training in each of these areas when all of the knowledge, skills and abilities necessary to accomplish these functions can be obtained from a wide variety of other education, training and experiential sources – this creates the potential to disqualify individuals who have clearly and empirically demonstrated all of these abilities but cannot demonstrate that they’ve had these narrowly focused trainings and it creates a significant unfunded mandate as an already qualified individual has to take additional specific trainings just to meet the standard in the regulations. 3^rd – unnecessary small business burden – the requirement for training and expertise in data analysis, assumes some large data set, multiple inputs and a complicated interrelationship of variables that simply does not occur in small businesses. The data analysis for our current risk program only requires an individual to be able to analyze less than or greater than (thresholds) and calculate percentages (for some data), which does not require any more training and/or expertise in data than is typically found in an individual graduating elementary school.

Recommendations: 1^st – exempt small businesses from the requirement and/or utilize

other mechanisms contained in section 2.2 – 4007.1 of the Administrative Process Act to reduce the burden on small business or 2^nd – Include language that indicates the training and expertise required is relative to the size/complexity of the operations of the business and the data sets they develop or 3^rd – indicate in the regulation that completion of a state-sponsored training provided without charge in these areas (individually or in conjunction) is sufficient to meet the requirement and then provide that training to assure a standardized process that provides equal treatment across providers and reduces the onerous burden of the unfunded mandate.

105 – 59 – C7 – this section provides the QDDP definition and then adds “Experience may be substituted for the educational requirement.” This final sentence adds an entire class of individuals to the regulations without providing any clarity whatsoever as to their title, roles, rights and privileges. The guidance document for determining functional equivalency provided some standards but was wholly inadequate by itself for the effective identification, verification and use of this class of individuals – functional equivalents. Overreliance, on this single sentence in the regulations has had a negative impact on utilization of this class of individuals; in that it:

1. Devalues an entire class of individuals who have demonstrated exemplary professional performance in serving this role. The current regulation permits the existence of functionally equivalent individuals without any direct recognition (title) or inclusion in the regulatory rights/privileges implied for QDDP’s (holding a license, independently operating a home, training/supervision at upper levels etc.). Individuals in this class, who have clearly met the standard and are performing the function well, are reminded daily when they sign off on paperwork and are unable to know what letters to include after their name to meet the requirement/current vogue for establishing their bona fides on each document. These individuals also find themselves in a regulatory limbo as to what duties they can legitimately perform, as the areas required in the guidance document for establishing functional equivalency appear far broader than the regulatory inclusion (or maybe not, really no way to know). This regulatory limbo is destructive to the morale of individuals who fulfill this function, excessively limits their career advancement opportunities and represents a basic unfairness to the individual who has dedicated a lifetime of work to serving individuals in the population.
2. Disincentivizes the development and utilization of functional equivalents. The current regulation permits the existence of functional equivalent individuals but provides no verification process that would formalize the acceptability of an Individual in that role. Licensing agents will not review the material that establishes equivalency and/or provide written verification that an individual has been determined to meet the standard and neither they nor the department can point you to anyone who will verify that an individual meets the standard. As a result, the Individual and the provider can never be sure if the individuals work product will actually be acceptable to the state, since there are no objective standards nor verification process, any one individual can retroactively be declared unqualified by the state and all of the work/billing they’ve been responsible for disallowed. This regulatory limbo provides a clear barrier to providers investing in the development of functional equivalents. Additionally, this factor coupled with the regulatory limbo for acceptable roles for the functional equivalent incentivizes underutilization of individuals who have developed the knowledge, skills and abilities on their own through decades of experience, limiting the utility of a potentially significant staff resource.

Both individually and collectively these factors significantly hinder the interest in and development of this potentially valuable staff resource and makes the use of functional equivalents much less prevalent in the current service environment.

Reduced utilization of functional equivalents has negative impacts on the employee class, service quality and business operations, especially small businesses.

1. Individuals in the functional equivalency class of employees are treated unfairly. Remember here that we are talking about individuals who through decades of service, training and experience have empirically verified their ability to demonstrate and implement all of the knowledge, skills and abilities required of a QDDP in the provision of their services. However, the system devalues their contribution, creates barriers to professional growth and prohibits them from obtaining the recognition they duly deserve; seemingly dismissing all the hard work they endured to achieve the status and making it an apparent dead-end.
2. Exacerbates the staffing crisis reducing overall service quality. Service quality is impacted in 2 ways 1^st – the quality of the overall labor pool is reduced; by dis-incentivizing the use of functional equivalents these individuals are excluded from inclusion in the available supervisory labor pool up front and over the long-term quality employees will leave our services in search of employment that recognizes and rewards their empirical knowledge, skills and abilities (they have lots of options for this). Underutilization of functional equivalents also inflates the wages that have to be dedicated to supervisory staff, as a result of college graduates seeking/feeling entitled to a more significant wage, which directly draws from the overall allocation to wages in the organizational budget and results in lower wages for all DSPs making the direct service positions less attractive to quality individuals. 2^nd – overreliance on college graduates reduces service quality –individuals with college degrees who we can hire at the currently low pay rates are seldom if ever superior to the individual with decades of experience and given the wages that we can pay these positions are frequently filled by new graduates or existing graduates who exhibit frequent job hopping, both of which introduce significant turnover in these vital roles undermining the familiarity, stability and continuity of services for individuals served. The use of new graduates is particularly problematic when they are put in charge of DSPs with years of experience, generating resentment among seasoned DSPs who believe that you can’t lead the charge unless you’ve been in the trenches; resulting in decreased morale, supervisory dismissiveness and tensions, all of which impact negatively on service quality. Even more problematic is when the seasoned DSP has to perform roles/functions for the individual with the new or existing college degree, because they simply lack the understanding that can only be gained from years of experience with the population/services and all of these concerns become significantly exacerbated; decreasing service quality.
3. Business operations, particularly that of small businesses are significantly hampered by a labor shortage/crisis. At the simplest level, forcing reliance on college graduates significantly increases the labor cost for that position, which is a cost that will fall disproportionately on small businesses because they lack the economies of scale, double dipping and multiple career paths that are enjoyed by large bureaucratic businesses. Additionally, the inability to identify and hire qualified college graduates particularly in rural areas has become a significant constraint on our ability to maintain much less expand service provision in the Commonwealth. Reduction in the regulatory disincentives to the development of functional equivalent individuals to fill these vital roles would significantly increase the availability of qualified supervisory personnel who could help fill a significant labor shortage in our field. The refusal of the state to include cost-of-living adjustments and/or regularly scheduled rate refurbishments in the regulations, ensure that the labor crisis in our services will only get worse as inflation and more competitive wages elsewhere draw individuals away from our agencies and the state disincentivizing the development of this potential labor pool makes the crisis more acute; ignoring a potentially significant source of relief.

Recommendation: recognize these individuals formally in the regulation by providing them a title (suggest QDDP functional equivalent), provide a regulatory mechanism which permits verification of their status by DBHDS and recognize regulatory rights for the individual who has achieved that status (i.e. qualifies to hold a license, preform all QDDP functions explicit or implicit for that service and establishes equivalency by regulation).

Regardless of how it looks in Richmond or other NOVA rate areas, the labor crisis confronting our services in much of the Commonwealth is real, growing and exacerbated by these regulations which fail to justly recognize functional equivalents and implement additional unfunded mandates; where each and every individual unfunded mandate uniquely and linearly decreases the compensation we can provide to support staff. The unfunded mandates continue to increase and each  seemingly small cost of $2000 represents a dollar per hour for a single full time DSP or $.10 an hour for 10 full time DSPs for a year and more than double that impact for part-timers; given the limited line items in our budget these funds are subtracted directly from the available entry wage and our subsequent raises to individuals across service categories, which have made our employment offerings increasingly noncompetitive –the current average wage in Virginia is already below the average wage at fast food outlets – how can the state justify calling them professionals (but refuse to recognize the status officially, when it is earned), require we trained them up to professional standards but only make it possible to pay them unskilled labor rates. Change is needed before the crisis becomes a catastrophe for individuals in the population served.

105 – 170 – E – corrective action plans – should include a deadline (number of business days) for the DBHDS response and require the department response be in writing, this is necessary to prevent providers from being held in limbo and to provide the documentation they need to address licensing agent change (either personnel or evolving standard) and to prepare for implementation of the appeals process.

Concur with other writers that the prevention of reoccurrence is an impossible standard that is not realistic in all cases and should be amended as they suggest.

105-620-A9-Monthly Fire/Evac Drills- when we 1st begin providing services years ago we attempted to have monthly fire drills and it proved counterproductive creating a significant risk to the individual served. Simply, this frequent, repetitive and unnecessary intrusion into the daily lives of the individuals very quickly became recognized, resisted and eventually refused by majority of the individual served. They would literally just sit at the table and look at you and exclaim “it’s just another drill – I’m tired of these (expletive) things”. As a result, the drill failed to serve its intended purpose and actually increased the risk that the individuals would fail to respond in the event of an actual fire/emergency thus increasing the risk to their life.

We have since conducted quarterly fire/evacuation drills, which has not only largely eliminated this concern, but also has allowed the drill to serve its intended purpose thus reducing not increasing the risk to individuals. The empirical evidence from the quarterly fire drills, have also provided documentation that the skills/actions necessary for an appropriate response have been obtained and maintained by both individuals served and staff, as the vast majority of the time over the past 5 years all individuals have been evacuated in less than 1 minute and there was only one occasion in the past 5 years when the evacuation took over 2 minutes (because the individual objected that it was only a drill and no real reason to leave). This provides clear evidence that the skills/actions necessary to assure a safe evacuation can be obtained and maintained with a quarterly drill schedule making more frequent drills unnecessary.

Recommendation: 1st – the requirement should be reduced to only require a quarterly fire/evacuation drill, unless the drill demonstrated an inability for whatever reason to accomplish the evacuation within a specified time frame (2 – 3 minutes), which would then trigger the need for additional drills (perhaps monthly) until successful evacuation time frame is accomplished. 2nd – If the state is concerned about new individuals/staff in the home and the adequacy of skills/actions/supports to safely evacuate demonstrated by those individuals, they could include a requirement that a drill or evacuation demonstration be conducted within the 1st 30 days of an individual served moving into a home or for the 1st 30 days of service for a new staff member.

Requiring a monthly fire/evacuation drill will be counterproductive and will get someone killed when there is a real fire.

105-620-K- monthly smoke detector checks – while advisable and should be encouraged, inclusion is a regulatory requirement is unnecessary and onerous. Modern smoke alarms include built-in alarm devices to warn you if the battery is running low or the alarm is malfunctioning in some way, which coupled with the significant overlap of devices required by other regulations ensure that adequate warning will be provided even in the unlikely event that one of them is dysfunctional. Including this in the regulations creates another unfunded mandate, as now in addition to paying someone to go through the home and pushed 20+ buttons they will have to devise/implement/maintain a documentation system for license review that directly takes time away from quality services for little to no return. Recommendation: 1 – remove the requirement; 2 – exempt small businesses/homes

105-620 – L5 – evacuation postings – the requirement to include the location of fire extinguishers and flashlights on evacuation postings is both unnecessary and counterproductive, especially in smaller homes. The provision is unnecessary because the location and operation of all fire extinguishers in the home are included in the staff training for emergency preparedness as required by other regulations and neither the staff nor individual served are likely to consult the evacuation posting to search out these devices. The provision is counterproductive because it would add significant clutter to an otherwise simple posting that could create confusion and improper response in the event it was actually consulted during emergency. We live in a rural area where occasional electrical disruptions are to be expected and as a result, flashlights are ubiquitously placed throughout the home, including on the window sill and night tables of each individual’s room and multiple places throughout the common areas assuring ready access to anyone who has need of a flashlight. Again, staff are provided information on their location during emergency training, individuals served or trained on the location and neither the staff nor individual served are likely to consult the evacuation posting to search out these devices. Recommendation: 1 – remove the requirement; 2 – exempt small businesses/homes

105-520-D- the continued inclusion of risk triggers/thresholds developed by the department continues to be vague, undefined and potentially a significant concern – – as providers we are required to follow these regulations from the moment (and in this case even before) they are officially implemented; it would therefore appear to be incumbent upon the state to tell us what they actually are before their inclusion in a final draft of the proposed regulations.

105 – 620 – C3 – the continued inclusion of “state performance measures” suffer from the exact same concern is risk trigger/threshold until these are defined they should not be included in any final regulation applying the same analysis as above.

Under 12 VAC35-105-170 C, providers are required to submit a corrective action plan (CAP) outlining actions to be taken to minimize the possibility that the violation will occur again.  This requires correcting any systemic issues which might lead to the issue in another location operated by the provider.  Minimizing the possibility of violation is a reasonable goal.  Providers desire to provide the best supports possible to our individuals.

Under 12 VAC35-105-170 H, the provider is held to a standard that is unachievable by stating the corrective action plan would prevent recurrence.  The provider is expected to include the expectation to prevent recurrence as part of the Quality Improvement plan.  

The standard of preventing recurrence is an impossible standard to meet.  This is particularly difficult for providers with multiple locations.  During a review at one site, an issue such as a small maintenance need could be cited and then later a non-related issue that falls under the regulation at another location is cited.  If these are cited on different CAPs under the same regulation, multiple citations would be considered a "systemic" issue.  To have a CAP that can cover all contingencies and ensure no more violations is impossible and will lead to additional citations.  The purpose of a CAP should to to improve services and ensure that supports are best practice.   To expect perfection across numerous programs and situations when working with human beings is not realistic.  

12VAC35-105-170-H and 12VAC34-105-D-3 should be removed from the Final regulations.  

12VAC35-105-170.H. and 12VAC35-105-620.3. create a substantial negative impact on Behavioral Health providers, including those providing CMHRS services.  Though committed to implementing corrective action plans in any necessary instance, Lucid remains concerned about how any agency would be able to “prevent recurrence” of a future regulatory violation.  This regulatory change shifts the focus from standards of care to a limited view of the impossible prevention of violations such as late reporting.

With so many factors outside of provider control, the next similar violation may not be caused by the same factors. A report could be forced beyond the 24-hour period due to the day and time of the incident (for example, on a Saturday at 10pm), difficulty accessing caregivers, awaiting medical procedures, or obtaining information from parties restricted to traditional business hours. These various factors could delay reporting despite internal efforts to mitigate any future regulatory violations. Therefore, there are simply too many individualized circumstances across multiple locations and programs that prevent provider ability to “prevent recurrence” of a cited violation.

If the current language goes in effect, it is possible and perhaps inevitable that providers will receive additional citations when their CAP is regrettably unable to prevent a future delay of an incident report. In practice, faced with the likelihood of a similar citation, many incidents that would have been brought to the attention of supervising staff for consideration will go unreported. Ultimately, with the addition of this language, the Office of Licensing establishes an entirely different expectation for providers to not just mitigate risk of citation, as previously directed, but to prevent it.  When coupled with the ‘Guidance’ document, this effort to improve care becomes a punitive endeavor for the provider.

The progressive actions for citations in violation of 12VAC35-105-160D.2 or 12VAC35-45-1070.c are too punitive and do not take leave room for human error or even with possible corrective action plans in place from prior citations. The standard of no less than 4 occurrences in a two year period will be an impossible one to keep for providers and if enforced as written could have a negative effect on the provider availability for individuals with disabilities.  It is already difficulty enough to find and train staff as a provider in a field that is already struggling to pay the work force at a competitive rate without having to make no more than 4 honest errors in the course of two years without having to worry about your license being suspended.

Regarding 12VAC35-105-160D.2 or 12VAC35-45-1070.c, progressive punitive action will most likely be most difficult for smaller, rural providers to navigate. Progressive disciplinary actions sit on the negative side of engagement.  Trainings from DBHDS currently focus on and are centered around the urban areas of the state making access to small rural providers difficult.  Training provides a base that allows opportunity to improve.  Providers are guided by state regulations. We rely on the state to provide clear guidance and training.  Too often mandates are executed before there is clear understanding and subsequent training.  Make training easily accessible in all parts of the state. 

There is inherent risk to living in the greater community for all.  Providers are not only managing risks of staff providing support to people, we are obligated to mitigate the risk of people we support living their life in the community as well.  We all work in a human services field often tasked with providing support for the very basics of human need.  It is impossible to prevent human errors, it is a much more fathomable task to manage and reduce risks.  I believe all providers strive for reduction in errors. 

“Corrective Action Plan’ means the provider’s pledged corrective action in response to cited areas of noncompliance documented by the regulatory authority.

"Risk management" means an integrated system-wide program to ensure the safety of individuals, employees, visitors, and others through identification, mitigation, early detection, monitoring, evaluation, and control of risks.

The proposed language in these definitions and in 12VAC35-105-170 H. and 620 D.3 are substantive changes that would have significant impact on the providers of these services.

It is unrealistic to expect that providers could control risks (vs. minimizing or mitigating those risks), or, with absolute certainly, prevent a situation to occur, or ensure the safety of everyone at all times. To expect that a provider will develop and sign a corrective action plan pledging to these absolutes, creates a legal liability for the provider. Aside from the many issues that will result with citations and loss of a provider’s license should any of those things occur/reoccur (as already well outlined in others’ comments), I would think the providers’ insurance carriers and legal representatives would have a considerable objection with the provider committing themselves to this liability.

The new/revised language in regulation 12 VAC35-105-170 now states that providers, in their corrective action plans, must detail measures to prevent recurrences of a cited action/inaction. While providers can and must certainly develop and implement plans to reduce the likelihood of a recurrence of any event which resulted in a citation, there are entirely too many variables, including the fact that many providers operate multiple sites, for a provider to attest to being able to prevent a recurrence. The standard is simply unreasonable if not unattainable. 

COMMENTS ON PROPOSED OL REGULATORY LANGUAGE

1. Section 170 - Corrective Action Plan

Section H language has been added and we object to establishing an unachievable standard, which is inconsistent with proposed language of Section C. 

The proposed language in Section H introduces an unachievable measure; while it is reasonable for a provider to develop and implement risk mitigation efforts in an effort to “correct any systemic deficiencies” to eliminate risk by following the language proposed in Section C, it is totally unreasonable to “prevent the recurrence of a regulatory violation”. We also object to the stated requirement to repeatedly continue implementation of corrective action plans-full prevention is unreasonable regardless of the number of attempts.

We recommend eliminating 170 Section H completely

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

Continue implementing the corrective action plan and put into place additional measures to prevent the recurrence of the cited violation and address identified systemic deficiencies; or submit a revised corrective action plan to the department for approval. 

2. Section 520 - Risk management

We have concerns about the qualifying statement requiring “department approved training”. 

We suggest that DBHDS both provide the curriculum AND provide the training since this is the most effective way to ensure consistency.

3. Section 660 - Individualized Services Plan (ISP)

We are requesting clarity in the language of section 2

Section 2 states that:

4. 1. If no alternative services are available to the individual, it shall be clearly documented within the ISP, or within documentation attached to the ISP, that alternative services were not available as well as any steps taken to identify if alternative services were available       

We suggest clarity as to whether this is a responsibility of the Support Coordinator, and if it belongs in Parts 1 through 4 (which is reasonable) rather than expecting each provider to document in each Part 5.

Similarly, Section 3 b and c states that:

5. 2. The proposed and alternative services and their respective risks and benefits were explained to the individual or the individual's authorized representative, and;
   3. The reasons the individual or the individual's authorized representative chose the option included in the ISP.

We suggest clarity as to whether this is a responsibility of the Support Coordinator, and if it belongs in Parts 1 through 4 (which is reasonable) rather than expecting each provider to document in each Part 5 for each service.

We recommend changing the term “authorized representative” to “substitute decision maker” in both of these sections

4. Section 665 - ISP requirements

We object to the requirement proposed in section D.  While we agree that it is appropriate for DSPs to demonstrate a working knowledge of each individual’s detailed health and safety protocol, it is not reasonable to impose that requirement on our contractors who consult about services for a group of individuals.  It is also unreasonable for a staff whose role is supervisory to have this requirement for a large number of individuals, just because they may have an assigned role in ISP implementation.

D. Employees or contractors who are responsible for implementing the ISP shall demonstrate a working knowledge of the objectives and strategies contained in the individual's current ISP [, including an individual's detailed health and safety protocols].

The requirement for providers to identify measures that prevent a recurrence of certain outcomes (resulting in citations) is excessive.  Providers do (and should) take measures to reduce the probability of a similar event happening again; however, it is impossible for a provider to confirm/ ensure that it won't.  This standard is setting providers up for failure (and to receive repeated citations despite what corrective action or positive changes they implement).  

The proposed language change is excessive and will result in repeated citations.  All providers should (and do) take measures to try to prevent future occurrences of any violations, however with multiple variables, it may be hard to prevent the violation from occurring again.  The proposed language change sets providers up for failure; repeated citations and CAPs will only result in providers focusing on paperwork/policy changes and potentially reduce the provider's ability to provide quality services.  Providers are tasked with continued responsibilities but are extremely underfunded and any and all language changes result in more work for the provider with no additional resources.  Again, this proposed change is too risky and excessive.  

Paragraphs in Section 12VAC35-105-170 seem to not be in agreement.  Section C1 states that a detailed description for the corrective action to be taken that will minimize the possibility that the violations will occur again and correct any systemic deficiencies.

Section H reads that we must prevent the recurrence of a regulatory violation……

Minimize and prevent are not the same thing.  Furthermore, I agree that we should do what we can to minimize all violations but I don’t see how it’s possible to completely prevent a situation for occurring again. Section H should remove “prevent” or remove the section entirely.

Section 12VAC35-105-520 paragraph A states that the designated person responsible for risk management will “complete department approved training.”  Will DBHDS be providi8ng this training? Will there be a list of approved trainings submitted to providers or will you require pre-approval of all trainings? Vague statements like this could become problematic for providers.  We would be in favor if the statement read, “complete training provided by DBHDS.” This would ensure all providers receive the same training, same curriculum, from consistent trainers.

Section 12VAC35-105-620 part D.3. once gain states that we will include “additional measures to prevent the recurrence of the cited violation….”  Once again, this is an impossible standard to meet. Furthermore, not all cited violations are systemic deficiencies. Also, I’m not sure if I read this correctly but for providers with more than one home across multiple locations, this will be impossible to ensure. 

The regulation states that providers "put into place additional measures to prevent the recurrence of the cited violation."  CRi cannot be held responsible for "preventing" recurrence of incidents.  This is an unrealistic expectation and leaves no room for error for CRi.

The language needs to be revised.

Arthur M. Ginsberg, President/CEO, CRi

Definition of Level I Serious Incident- The regulation needs to be adjusted to include the list of incidents that constitute a Level I serious incident (ie bruises, minor sprains, etc.).  Including this additional information will assist in reducing the CHRIS serious reporting errors and increase the likelihood that providers address all Level I incidents in their quarterly review.  

Arthur M. Ginsberg, President/CEO, CRi

Updates to serious incident reports, we would like to that updates would be done withing 72 hours

Public comments for progressive discipline for repeat violations.

In the proposed draft of the serious incident reporting guidance, they note that the purpose of the corrective action plan is to prevent the reoccurrence of regulatory violations by addressing the underlying cause of the violation.   Yet the proposed draft of the serious incident reporting guidance and the progressive discipline for repeat violations go directly against the purpose of the CAP as so defined. 

It instead creates a culture of fear. It goes directly against the care drive culture that providers have pledged to adhere to. The proposed Progressive discipline policy if punitive, arbitrary, and subjective. 

Currently, the proposed draft is designed to retaliatory in nature, it does not create a collaborative culture to ensure that providers and license agents work together to ensure that the CAP put in place safeguards the individuals that they serve. 

For example, there is no enumeration of any type that speaks to what would prompt the first citation. We propose a different gauge be used to prompt the issue of a citation ( 1,2, lr 3) that if within 2 years and if 20% of the providers' current census of reporting serious incidents, deaths, or allegations of abuse of neglect the provider would be issued a First citation citing 12VAC35-105-160.D.2 or 12VAC35-46-1070.C as applicable for noncompliance with reporting requirements. 

An appeal process needs to be included. If a provider receives a 4th citation in which their license is in jeopardy, this should be an appealable issue. The case should be reviewed by a neutral party ( arbitrator, hearing officer or mediator) Providers should be permitted to request a formal change to an official decision; as appeals function both as a process for error correction as well as a process of clarifying and interpreting the law. 

I am writing to express my concern at substantial and significant changes which were made to the proposed Licensing regulations which were previously published. These changes are both inconsistent and unachievable in the real world. Under 12VAC35-105-170.C.1, it states that "The corrective action plan shall include a  detailed description of the corrective actions to be taken that will minimize the possibility that the violation will occur again and correct any system deficiencies."  All providers strive to provide consistent and quality care to individuals through the development of clear protocols, policies, and staff training. We work to minimize variance from expectations but we work in multiple locations with numerous employees, different clients, families, and the all the uncontrollable variables in the environment. We are not all powerful and thus cannot possibly prevent any recurrence of a cited violation. The requirement, in section 170.H.1, of the above referenced regulation, which states providers will "prevent recurrences"  is inconsistent with efforts to minimize and is unreasonable. Similarly, in 12VAC35-105-620.D.3, the statement about "preventing recurrence "of cited violations is a guarantee that providers will fail, despite their best efforts.We ask that the current language of 170 H and 620 D be removed from these regulations.

Objection to Regulatory Action

There are two related substantive changes (12VAC35-105-170 H. and 620 D.3.) from the version of the regulations published at the proposed stage which will have a substantial impact on all providers.  Both contain the expectation that providers, if cited for any violation of any regulation, will produce and implement a corrective action plan that will prevent recurrence.

While in 12VAC35-105-170 C the provider is required to produce a corrective action plan which includes a detailed description of the actions to be taken that will minimize the possibility that the violation will occur again and correct any systemic deficiencies, the standard is raised to an unattainable level in 170 H where if the provider determines that a corrective action plan was fully implemented but did not prevent recurrence additional steps are required to meet the standard and are now expected to prevent recurrence.   In 620 D the provider is required to include their plan for accomplishing the expectation to prevent recurrence as part of their Quality Improvement strategy.

We object to the change in principle as it is an impossible standard to meet – the scope of the regulatory authority is very broad and deals with everything from physical plant standards and maintenance to the development and implementation of services plans, care for the health and welfare of a wide variety of ages and disability groups, monitoring and maintaining health, nutrition and personal care, and supporting all aspects of life in the community.  There are a multitude of actions, occurrences, circumstances and/or instances of human behavior that can interfere with any path to perfection. 

To expect a provider to develop a corrective action plan (CAP) which is formulated to ensure that no actions, occurrences, circumstances and/or instances of human behavior, which may have contributed to the original citation, will prevent recurrence is asking more than should be expected. To be accepted as a valid CAP also requires that it meets that standard in the judgement and interpretation of the Licensing Specialist.  Failure to meet the expectations in the CAP development can result in an additional citation.

To expect a provider to implement a CAP which is formulated to ensure that no actions, occurrences, circumstances and/or instances of human behavior, which may have contributed to the citation will prevent recurrence is also asking more than should be expected. There are a multitude of actions, occurrences, circumstances and/or instances of human behavior that can interfere with any path to perfection.  Failure to meet the expectations can result in an additional citation.

12VAC35-105-170 H. and 12VAC35-105-D.3. should be removed from the Final regulations.

If a CAP  is returned o the provider a second time for failure to meet all requirements within 12VAC35-105-170.C, the licensing specialist ( remove will and add shall) have a phone call with the provider to provide technical assistance related to the criteria needed to create an acceptable CAP.

We submit that disagreement in how the provider has constructed their CAP should not prompt the 3rd citation. The provider may have submitted and implemented a CAP that effectively addresses the issue and the licensing specialist may not have agreed with the process even though it adequately mitigates the issue from reoccurring. 

Instead, we proposed the following:

1. The licensing specialist shall meet with the provider and their team. Discuss their concerns and develop a viable solution.
2. If the licensing specialist refuses to honor the CAP developed by the provider and their team an appeal process needs to be included. The case should be reviewed by a neutral party ( arbitrator, mediator, hearing officer) providers should be permitted to request a formal change to an official decision as appeals function both as a process for error correction as well as a process of clarifying and interpreting the law. 

The risk management function can be carried out by multiple staff, not just one.  As such, not one person should be required to have training in the areas of root cause analysis, investigations, risk management, risk screening, etc.  We support and recommend providers be given the option of establishing a risk management team that has the collective knowledge of root cause analysis, investigations, risk management, etc.

Arthur M. Ginsberg, President/CEO, CRi

General Statement:

Southside Community Service Board complies with regulatory requirements. As DBHDS expectations and requirements burgeon across all of its departments, it is increasingly challenging to meet requirements with current staff. Southside Community Service Board is requesting consideration of funding for additional administrative and/or quality assurance staff to meet expectations. Consideration is also requested for DBHDS to partner with providers in the drafting of future regulations and guidance documents prior to the public comment period to gather input on implementation impacts.

Regulation:

“12VAC35-105-520. Risk management. A. The provider shall designate a person responsible for the risk management function who has completed department approved training, which shall include training related to risk management, understanding of individual risk screening, conducting investigations, root cause analysis, and the use of data to identify risk patterns and trends.”

Comment:

Please clarify department-approved training? Is DBHDS going to provide this training? Until department-approved training is released what training would count towards meeting this regulation?

In addition, please allow for qualifications of the Risk Manager to include relevant or equivalent experience and not be based solely on DBHDS training; and I suggest broadening allowable sources of training.  I would like to know how each Risk Manager's qualifications and training will be reviewed/approved.

This position and its increasing responsibilities are good practice overall but are another significant unfunded requirement, that is not covered by reimbursement rates or state funding. Funding will have to be taken away from positions that provide direct care to clients in order to fund these regulations. How are smaller providers going to be able to provide quality services to their clients while also attempting to meet the demands of DBHDS?

Regulation:

“12VAC35-105-520.F The provider shall document serious injuries to employees, contractors, students, volunteers, and visitors that occur during the provision of a service “or on the provider's property”. Documentation shall be kept on file for three years. The provider shall evaluate serious injuries at least annually.”

Comment:

Serious injuries outside the provision of licensed services do not fall under the jurisdiction of the department and information as such should not be provided to ensure the protection of HIPAA and PHI.

Regulation:

“12VAC35-105-520.A All providers are required to have a qualified designated person with risk management responsibilities. Qualifications for this position may be obtained through the completion of department approved training in these enumerated areas of risk management responsibility:

1. Individual risk screening;

2. Conducting investigations;

3. Root cause analysis; and

4. The use of data to identify risk patterns and trends.”

Comment:

Please clarify the meaning of "individual risk screenings”.  The guidance appears to indicate the risk manager will have a clinical responsibility.  While a risk manager would be looking for issues, they would not necessarily have the clinical expertise needed to conduct individual risk screenings.

Regulation:

“12VAC35-105-520.C The provider shall conduct systemic risk assessment reviews at least annually to identify and respond to practices, situations, and policies that could result in the risk of harm to individuals receiving services. The risk assessment review shall address at least the following:

1. The environment of care;

2. Clinical assessment or reassessment processes;

3. Staff competence and adequacy of staffing;

4. Use of high risk procedures, including seclusion and restraint; and

5. A review of serious incidents.”

Comment:

Regarding Section C(4): Use of High-Risk Procedures, I am seeking clarity as to what besides seclusion and restraint is perceived as a high-risk procedure. I ask that DBHDS provide in the guidance some examples of the ‘other high-risk procedures’ they would consider applicable to this section.

Regulation:

“12VAC35-105-520.D The systemic risk assessment review process shall incorporate uniform risk triggers and thresholds as defined by the department.”

Comment:

When will the risk triggers and thresholds be defined?

In response to the proposed serious incident guidance and those regulations affected herein, we wish to convey the following concerns and or considerations: 

• Since the IMU service has not rolled out to all regions perhaps this should be delayed until such time that DBHDS is able to uniformly hold every provider to expectations.  Larger providers may serve several regions and keeping programs in congruence becomes increasingly difficult with the differing needs from DBHDS.
• Office of Human Rights and Office of Licensing have two separate timelines for CHRIS report entry.  Because a serious incident report requires the number of the Human Rights report, there is a possible confusion or breakdown.  Since no one responds to serious incident reports that are entered over weekends or holidays, perhaps it should be considered appropriate to adjust the Office of Licensing’s timeline to match that of the Office of Human Rights and require that all reports are entered in CHRIS on the next business day.  This will allow providers to focus more on addressing the incident rather than ensuring time is made for paperwork, which can be completed on the next business day without issue.  The guidance clearly states that the IMU pulls reports on business days – providers should have the same courtesy.
• The expectation that CHRIS reports will be updated within 48 hours is unreasonable.  There are times when 48 hours pass and the additional information needed is not yet available.  This creates additional burden on the provider to go in and indicate that no further updates are available yet.  One example of this is entering COVID-19 test results which can take up to 5 days to receive once the individual is able to be tested.
• The IMU has not been consistently following the protocols for reaching out to providers with questions – recently we’ve had reports issued without engaging with us.  One such report was generated because of a clerical error that we could have resolved very quickly.
• Providers should be alerted annually to the contact lists held in DBHDS systems to ensure that they are consistently updated. 
• Progressive Action for Repeat Citations should not be in effect as of June 15^th, since the review of the document is not yet complete.  This should not go into effect until the document has had a fair review and providers of varying sizes should be included in this review. The information was sent out on June 3rd, a 12 calendar day (7 business day) period is insufficient to prepare providers for such a significant change that threatens their license renewals or applications.
• The inconsistency with which licensing agents address situations and issue citations will need to be addressed.  This has long been a concern of many providers.  Larger providers bear the brunt of this inconsistency, as well, due to needing to work with, possibly, several different licensing agents who all focus in on different things and interpret the regulations differently.  We’ve been told by licensing that this is not the case – but it is; if you look at the larger providers that traverse several regions, you will find that some have citations for the same things over and over and others do not review that portion of the regulations. 

The proposed language in these definitions and in 12VAC35-105-170 H. and 620 D.3 are substantive changes that would have significant impact on the providers of these services.

It is unrealistic to expect that providers could control risks (vs. minimizing or mitigating those risks), or, with absolute certainly, prevent a situation to occur, or ensure the safety of everyone at all times. To expect that a provider will develop and sign a corrective action plan pledging to these absolutes, creates a legal liability for the provider. Aside from the many issues that will result with citations and loss of a provider’s license should any of those things occur/reoccur (as already well outlined in others’ comments), I would think the providers’ insurance carriers and legal representatives would have a considerable objection with the provider committing themselves to this liability.

Section H reads that we must prevent the recurrence of a regulatory violation……

Minimize and prevent are not the same thing.  Furthermore, I agree that we should do what we can to minimize all violations but I don’t see how it’s possible to completely prevent a situation for occurring again. Section H should remove “prevent” or remove the section entirely.

The standard that implementing a CAP should prevent any repeat recurrences of level II or III incidents is an unrealistic standard.  Any punitive actions associated with failing to meet these standards, including simply added administrative burdens, will only further discourage (reasonably so) providers from taking clients with higher medical or behavioral needs. 

The language within this document places additional burden upon the provider community. This document moves into regulating through guidance. This language punishes providers who continue to report knowing the risk of citation outside of the 24 or 48 hour time frame. The steps of Progressive Action for Repeat Citations does not take into account agency size including number of locations or programs and places an unreasonable burden on larger providers that is almost impossible to fulfill. If the document is not pulled, it needs rewritten with input from stakeholders and includes language that takes into account provider size in relation to Progressive Action

The regulation requires providers to include in their quality improvement plans statewide performance measures.  The regulation does not indicate what these measures are nor where they can be found.  CRi is recommending the regulation be revised to provide more clarity to providers.

Arthur M. Ginsberg, President/CEO, CRi

Way too punitive to the provider.  Feels like there is someone trying to blame people rather than actually be proactive with this.  Us. vs. Them

What about providers who have a lot of homes and a lot of administrative overhead versus a small provider.  Data would be skewed this way.

It is impossible to completely eliminate level 2 and level 3 incidents through the use of a CAP.

Concern should be made for trends and patterns, or systemic issues with providers, instead of this unrealistic measurement.

CHRIS reporting timelines are often difficult to meet, due to dealing with the serious incident.  Never-the-less, to expect updates to the reports within 48 hours is impractical as well.  When someone is seriously ill, it may take longer than this for blood work to come back, be analyzed, or a new diagnosis even.  This should be addressed by a licensing specialist through a CAP if they are struggling with getting updates from providers.  It is called communication.  By imposing these short time frames to respond with additional information, or in a rush to complete a CHRIS report by the 24 hours time frame, often times reports are left very generic, and more information will be needed by the licensing specialist anyway.

The addition of the new provision in Section H of 12VAC35-105 - 170 regarding Corrective Action Plans" is overly directive.  Section G already provides that "The provider shall monitor implementation of approved corrective action and include a plan for monitoring in its quality assurance activities  . . ."  There is a big difference between "minimizing" the risk of an occurrence of an identified problem and the complete "prevention"
of such an occurrence.  Monitoring compliance with a CAP is reasonable, but requiring complete prevention is a standard which can't be met.

 12VAC35-105-520 paragraph A states that the designated person responsible for risk management will “complete department approved training.”  DBHDS needs to clarify what qualifies as an approved training in order to assure consistency across all providers. It would be helpful if DBHDS provided the training to assure this consistency and to facilitate compliance.

The expectation that a recurrence will not happen, even when preventative measures have been instituted, is not realistic. Perhaps 100% perfection is not the intent of this regulation. If so, this reg needs to be rewritten for clarity. It seems that we are all interpreting this to mean that no recurrence is acceptable

The process of licensing citations and creation of corrective action plans already provide agencies with a vehicle to put in place safeguards against re-occurrence of licensing violations.  The reality is, however, that there is no way to completely ensure or prevent a re-occurrence of a violation.  Putting in place punitive measures in instances of re-occurrence of violations only threatens to harm good agencies who due to a variety of factors outside of their control may experience repeat violations.   

The description of identified implementation standards for a CAP to address violations start with the realistic standard of “minimize the possibility that the violation will occur again” in section 12VAC35-105-170 C1  to the unrealistic standard of “prevent the reoccurrence of a regulatory violation” listed in section 12VAC35-105-170 H and “prevent the reoccurrence of the cited violation” listed in section 12VAC35-105-170 H1. 

The increase in the standard diminishes what the regulation previously stated as the function of the CAP. This means an agency can, actually, be meeting the related standard (“minimize”) while also being cited for not meeting the CAP regulation (“prevent”). This causes a severe impact in understanding the correct development and implementation of any CAP. These regulations, at the very least, contradict themselves.

It is unreasonable to expect anyone to be able to develop a CAP that will “prevent” the reoccurrence. The realistic expectation is listed in section 12VAC35105-170 C1 to “minimize the possibility.”  With an expectation of “prevent” within the CAP, an agency will constantly be spinning wheels to provide revisions every time there is a perceived reoccurrence.  By definition, humans are not perfect; mistakes are made and plans for improvement are warranted. However, based on the logic of the revised/proposed regulation, humans (licensing specialists) will continually issue citations to humans (providers) because they are human, until the provider is cited out of their license. 

C.3 refers to “statewide performance measures" – can clarification be provided on what these measures are and where they are located

D.3. -this appears to operate on the assumption that all CAPs and violations are a result of systemic deficiencies and does not include other situations that may not reflect a systemic issue

- “prevention of recurrence” sounds like a good goal, but an unrealistic expectation to have of all providers – changing the language to better capture CAPS as mitigating and minimizing the likelihood of recurrence may be more accurate

Providers are constantly working towards mitigating the risk of regulatory violations.  The goal is always to eliminate risk and prevent recurrence. The reality is that it cannot be guaranteed.  It is not due to systemic failure. Providing person centered services that includes the dignity of risk is by nature unpredictable. It is unrealistic to expect providers to prevent recurrence of incidents. 

The language is strong when referring to developing CAPs that will "prevent" recurrence. It also relates both a citation and systemic deficiencies, which many times may not be the case. Providers put plans in place to help minimize the chance that a particular incident or occurrence doesn't happen again, however these settings can be very unpredictable and can set providers up for failure. 

The proposed regulation 12 VAC 35-105-170 C is to minimize the possibility that the violation will occur again. However, proposed regulations 12 VAC 35-105-170 H.1 and 12 VAC 35-620 D.3 should be removed.  Prevention of the violation from occurring again is unrealistic.  This language requires the provider to prevent recurrence of the citation.

The provider is committed to protect the health, safety, and welfare of the individual.  Proposed measures in the CAP by the provider is to minimize the systemic deficiencies, utilize best practice and implement in the Quality Improvement Plan.

The content of these regulations set the stage for punitive and adversarial relationships between licensing specialists and providers instead of the supportive and educational relationship that has been discussed and promised over the last several years. The threat of license loss is conflict and fear based. 

To require a CAP to "prevent the re-occurrence " of anything is beyond a reasonable expectation for any provider. 

Paragraphs in Section 12VAC35-105-170 do not apear to be in agreement with each other.  Section C1 explains a need for the corrective action to be taken that will Minimize the possibility that the violations will occur again and correct any systemic deficiencies. However as you move on to Section H it uses the phrasing that it must prevent the re-ocurrence of a regulatory violation. While I am in agreement that we should do  our best to minimize all violations  I don’t see how it’s possible to completely prevent a situation for occurring again. Section H should remove  the “prevent”  to come in line with section c1 or the section should be removed. 

Section 12VAC35-105-520 paragraph A sats that the designated person responsible for risk management will need to complete department approved training.  Will DBHDS be the designated provider of this training ?  Will there be a list of approved trainings/ trainers submitted to providers ?   It would be beneficial if the statement read, “complete training provided by DBHDS.” This would ensure all providers receive the same trainings with consistent curriuculms  across the state.

Section 12VAC35-105-620 part D.3. once gain focuses on prevention,  while a nice idea this is an impossible standard to meet as not all  violations resulting in a citation are systemic deficiencies. 

I have concerns regarding the DBHDS corrective action.  As licensed DBHDS providers, we serve individuals with unique and often challenging needs.  Most providers and their staff genuinely perform this work because they care and are often doing so with limited resources due to reimbursement rates and their ability to attract and retain quality staff.  Maintaining a positive and collaborative relationship between the provider and licensing specialist is in the best interest of those we serve.  We are concerned, based on the language in the proposed regulation, that this process could be perceived as adversarial and punitive and result in unnecessary adverse consequences for the provider.

Overall in review of the guidance documents and compliance updates to regulations, it is evident that the department is attempting to enforce standards that focus on data collection and follow up accountability that continues to increase and not account for the reality of service delivery, leading agencies away from the direct care and oversight that is necessary in truly maintaining the person centered quality community services that every individual within the state deserves. The increased punitive approach by the department does not allow for a supportive and truly partnering relationship among the Provider community and staff offices under DBHDS. The true intention of corrective action plans as well as reporting requirements center on the basis of safety protection for individuals which all providers from across the state want to ensure; however this stance from DBHDS does not truly address this but rather creates data that can be utilized versus remediation support and training that could truly help services as a whole.

The following is an outline of the areas of concern that have been pulled from the most recent final regulation document.

12VAC35-105;

160; Additional requirements outlined for a more detailed route cause analysis shall be simply noted as “a more detailed root cause analysis shall occur as determined by the agency and incident that occurs” The outlined minimum policy standards should be what is included within the routine incident reviewing process that occurs for all serious incidents as part of the risk management plan. It is recommended that the language reflected in the requirement outlined within the previous stage.

170; If a corrective action plan was implemented according to the noted action steps and deadline; however, did not prevent a recurrence then regulations suggest that this CAP be continued. Again, this does not account for an evaluation as to what may have occurred within each circumstance but rather indicates that if a CAP was implemented and actions steps were taken then another CAP would be issued if there were further issues that surfaced that warranted such a need. Regulation and guidance that does fully account for areas of service delivery to include location, service site, services, etc. This may be seen more in larger agencies than small agencies; however, all provider agencies must be viewed in the evaluation of ensuring that regulations are applicable across settings.  

320; It is appreciated that this section was updated to no apply to sponsored residential home services due to the nature of these types of service settings; however adding additional requirements to include monthly fire and evaluation drills within section 550 does not appear to be appropriate for all individuals within services. Having routine drills is important; however we also want to ensure that individuals are able to be prepared for emergencies that arise and not done so repetitively that individuals may become desensitized to responding appropriately thinking that it may be simply another drill that they are encouraged to participate in. This requirement should be based upon several factors to include services, settings, staffing, etc.

Thank you for your time and consideration of all comments that are noted within this town hall forum as the feedback and input from the whole provider community is imperative in order to move forward in a direction and focus that truly centers around the services and needs of the individuals across the state of Virginia.

Licensing Regulations - Compliance with VA Settlement Agreement with DOJ

OVERALL COMMENTS:

There are two related substantive changes in 12VAC35-105-170 and 620.D.3 that will have a significant impact on all providers. Both sections contain provider expectations of “prevent recurrence” which is an impossible standard to meet. Perfection is an unachievable standard. The “Indicators” agreed to between DBHDS and DOJ, and approved by the Court on January 14, 2020, state “prevent or mitigate future risks of harm” (page 36) and “prevent or substantially mitigate risks of harm (page 33). The proposed regulations including the absolute “prevent recurrence” are above and beyond the standard agreed to between DOJ, DBHDS and Judge Gibney. We recommend the deletion of Section 170H

Overall concern that the complexity and intensity of the proposed Risk Management Plan expectations are such that they may be beyond many small organization’s ability to meet without the hiring of a separate “Compliance Officer” or “Risk Manager”.  Administrative expectations and burden for DD Waiver providers is already extensive and expensive.  Because of the historically low DD Waiver provider rates, the continued addition of administrative burden prevents providers from providing “living wages” to DSPs as well as other supports that provide value to the individuals we serve.  The Risk Management function can be carried out by multiple staff that have expertise in different subject matter, not just one. Recommend that providers be given the option of having a risk management team that would have a collective knowledge base of root cause analysis, investigations, risk management, etc.

Based on recent OL audits of providers, there seems to be confusion that arises when the OL staff looks at some of the proposed items in the Risk Management Plan “in a vacuum”.  For example, OL staff has asked to see quarterly Level 1 reviews - but, without looking at the individual’s record where there is person-centered context. Level 1 incidents are most often part of a person’s baseline and/or are very personalized.  These would not be addressed in an “organizational” Risk Assessment Plan with the exception that the treatment team would follow-up when there are increased frequencies and/or patterns.

12VAC35-105-20 Definitions

Qualified developmental disability professional or QDDP
Experience option is needed in lieu of Bachelor’s Degree.  Many QDDPs have achieved a 5-year+ experience standard but do not have degrees. Definition needs to clearly state experience option.

ISP
Regulations are using the term Individual Service Plan.  Person-centered language uses Individual “Support” Plan. “Service” is used throughout document as in “receives services” instead of “is provided supports”.

Level 1 Serious Incident
Clarity is needed between Level 1 and Level II and III. To ensure providers understand the Level 1 serious incident definition, the regulation should include a list of sample incidents that constitute a Level 1 serious incident (e.g. bruises, minor sprain, etc.)  Adding this information will help reduce CHRIS serious incident reporting errors and increase the likelihood that providers address all Level 1 incidents in their quarterly review.

12VAC35-105-160 Reviews by Dept; Requests for Info; Required Reporting

B. Further clarity is needed that “all information requested” applies to the current inspection and/or investigation currently under review.  As currently written, this language may be interpreted as a “blanket request”. Include specifics as to “x, y and z” etc.

12VAC35-105-170. Corrective Action Plan

170.C and 170.H. - While it is reasonable for a provider to develop a corrective action plan which includes a detailed description of the actions to be taken that will minimize the possibility that the violation will occur again and correct any systemic deficiencies (albeit not all cited violations are the result of systemic deficiencies), the standard is raised to an unattainable level in Section 170.H to “prevent recurrence”.  This is unreasonable. The “Indicators” agreed to between DBHDS and DOJ, and approved by the Court on January 14, 2020, state “prevent or mitigate future risks of harm” (page 36) and “prevent or substantially mitigate risks of harm (page 33). The proposed regulations including the absolute “prevent recurrence” are above and beyond the standard agreed to between DOJ, DBHDS and Judge Gibney. We recommend the deletion of Section 170H.  This additional burden must not be placed upon providers.

What is considered a repeat and systemic citation for a provider that operates multiple services via multiple sites throughout multiple regions of the Commonwealth? Please define.

12VAC35-105-520 - Risk Management

Suggested Language:
A. The provider shall designate a person(s) responsible for the risk management function who has completed department approved training or equivalent experience, which shall include training related to risk management, understanding of individual risk screening, conducting investigations, root cause analysis, and the use of data to identify risk patterns and trends.

COMMENT:
The purpose for the addition of (s) in 12VAC35-105-520.A is to allow for multiple individuals to possess risk management functions within their position description as necessary depending on where they are the subject matter expert. Additionally, this allows for contract positions to provide a risk management analysis from data collection.

1. Also states that the “designated person” for risk management will complete “department approved training”. We have concerns about the qualifying statement of “department approved training”. Will DBHDS be the designated provider of this training? Will there be a list of approved trainings?  It would improve consistency across the state if DBHDS provided the training and the language read “complete training provided or approved by DBHDS”.

12VAC35-105-520.B
Suggested Language:
The provider shall identify individual person centered risks with the person-centered planning team for the individual receiving services through quarterly and annual reviews and as needed when multiple serious incidents occur to ensure best therapeutic support is able to be provided. The provider shall implement a written plan to identify, monitor, reduce, and minimize harms and risk of harm that are deemed systemic organizationally impacting two or more persons from a root cause analysis , including personal injury, infectious disease, property damage or loss, and other sources of potential liability.

COMMENT:
The purpose for this addition in 12VAC35-105-520.B is to allow for person-centered planning to address person-centered risk, and organizational risk management to address service provision areas as a whole should they be systemic from an organizational level.

12VAC35-105-520.C
The provider shall conduct systemic risk assessment reviews at least annually to identify and respond to practices, situations, and policies that could result in the risk of harm to individuals receiving services. The risk assessment review shall address at least the following:………

COMMENT:
Section C would support suggested language change to Section B as it outlines “harm to individuals” (plural) meaning two or more to be systemic. This will allow for a separation between one individual receiving services that needs a risk management review in their person-centered plan vs. systemic risk on the part of the organization.

12VAC35-105-520.F

The provider shall document serious injuries to employees, contractors, students, volunteers, and

visitors that occur during the provision of a service “or on the provider's property”. Documentation

shall be kept on file for three years. The provider shall evaluate serious injuries at least annually……

Suggested language: 

If a serious injury occurs during the provision of licensed services, the provider shall document and report to appropriate parties’, serious injuries to employees, contractors, students, volunteers and visitors.  Documentation will be kept on file for three years.  Providers shall evaluate all serious injuries within the provision of licensed services annually and will document and determine areas for improvement as applicable. 

COMMENT -  Major concern about the language included “or on the provider’s property”. The purpose of this suggested language would help to ensure the provider is only reporting to DBHDS on licensed services.  Serious injuries outside the provision of licensed services do not fall under the jurisdiction of the department, and information as such should not be provided to ensure protection of HIPAA and PHI.

12VAC35-105-530 - Emergency Preparedness and Response Plan

Section A.9 - States that “fire and evacuations drills shall be conducted at least monthly”.  We recommend that this language be deleted and regulatory language be inserted that reflects current requirements of “Providers shall implement a quarterly schedule for testing emergency preparedness plan and testing emergency drills”.

12VAC35-105-620 - Monitoring and Evaluating Service Quality

Section 620.D. - The provider is required to include their plan for accomplishing the expectation to “prevent recurrence” as part of their Quality Improvement strategy.  For the reasons stated above in 12VAC35-1-5-170 and to be consistent with the level of requirement in the DOJ/DBHDS “Indicators”,  we object to this unreasonable and unattainable standard. As one commenter said, “there are a multitude of actions, occurrences, circumstances and/or instances of human behavior that can interfere with any path to perfection.”

Section 620.C.3. - Question regarding “statewide performance measures”.  What are they? Where can they be found?

12VAC35-105-660 - ISP

Section D.1.b and D.2 - Need clarity regarding language “alternative services that might be advantageous” and “documenting alternative services”. This reads as if the provider is responsible for researching alternative services and documenting steps taken to secure them. If this means alternatives to current services, we suggest that it be clarified as the responsibility of the Case Manager or Support Coordinator and belongs in Part 1 through Part 4 rather than expecting each provider to document in Part 5.

We also recommend changing the term “authorized representative” to “substitute decision-maker” in both of these sections.

12VAC35-105-665 - ISP Requirements

Section D. We have an objection to the requirement proposed in Section D -  While we agree that it is appropriate for DSPs to demonstrate a “working knowledge of each individual’s detailed health and safety protocols” that they work with, it is not reasonable to impose that requirement on our contractors who consult about services for multiple individuals.  It is also unreasonable for staff whose role is supervisory to have this requirement as they supervise a large number of individuals -  just because they may have an assigned role in ISP implementation.

12VAC35-105-170 H. and 620 D.3 contain substantive changes from the version of the regulations published at the proposed stage which will have a substantial impact on all providers. Both contain the expectation that providers, if cited for any violation of any regulation, will develop and implement a corrective action plan that will prevent recurrence. Prevention of a recurrence is an impossible standard to meet. We can mitigate or minimize risks through plans, but it is not possible for an agency to attest that a plan will absolutely prevent a recurrence. 170 C uses "minimize the possibility" appropriately. Of additional concern is how the Guidance Document for Incident Reporting clearing indicates how the Department intends to enforce this standard through the Progressive Actions for repeat citations. 12VAC35-105-170 H and 12VAC35-105-620 D.3 should be removed from the final regulations.

12VAC35-105-160

2. The provider shall develop and implement a root cause analysis policy for determining when a more detailed root cause analysis, including convening a team, collecting and analyzing data, mapping processes, and charting causal factors, should be conducted. At a minimum, the policy shall require for the provider to conduct a more detailed root cause analysis when:

a. A threshold number, as specified in the provider's policy based on the provider's size, number of locations, service type, number of individuals served, and the unique needs of the individuals served by the provider, of similar Level II serious incidents occur to the same individual or at the same location within a six-month period;

Will there be guidance from DBHDS on determining a “threshold number” to ensure consistency among providers and DBHDS representatives?  Without appropriate guidance this “threshold number” is arbitrary.

12VAC35-105-170. Corrective action plan.

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

“Prevent the recurrence” is an impossible standard to meet and should be removed from regulations.  It indicates the presumption that all risk factors are under a provider’s control and removes any possible consequence due to external factors such as individual choice, acts of nature, deficits in available services, etc.  Providers should have a method to analyze effectiveness of a CAP, should be accountable for ensuring measures outlined in a CAP are enforced, but the end goal to “prevent the recurrence” is impossible.

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

D.1.      a. The ] proposed services to be delivered [ ,;

b. Any ] alternative services that might be advantageous for the individual [ ,; ] and

c. Any ] accompanying risks or benefits [ of the proposed and alternative services ].

2. If no alternative services are available to the individual, it shall be clearly documented within the ISP, or within documentation attached to the ISP, that alternative services were not available as well as any steps taken to identify if alternative services were available.

Additional clarification is necessary.  Who is responsible for the identification of and communication to the individual regarding alternative services?  The SC?  The provider?  This action is beyond the provider’s purview to be aware of services beyond their license in a manner sufficient to accurately describe availability, benefits, and risks.