22 comments
12VAC35-105-170:
Include the specific time frame the DBHDS staff person issuing the CAP has to respond to the provider when they submit their corrective action plan AND/OR any questions they have about it. DBHDS seemingly has no accountability for timely response to CAPs or questions despite the numerous deadlines imposed on providers.
12VAC35-105-170 C: “If a CAP is returned to the provider a second time for failure to meet all requirements within 12VAC35-105-170.C., the licensing specialist will offer to have a phone call with the provider to provide technical assistance related to the criteria needed to create an acceptable CAP.”
Will the department provide transcripts of these phone calls or will it be the responsibility of the provider to record the conversation to ensure continuity between licensing specialists?
12VAC35-105-170 C: “If a CAP is returned to the provider a third time for failure to meet all requirements within 12VAC35-105-170, the CAP will be returned with an additional citation for violating regulation 12VAC35-105-170.C. and the CAP dispute process will be initiated automatically as outlined in 12VAC35-105-170.F”
By issuing an additional citation to a provider for essentially not agreeing with or not fully understanding a licensing specialist, DBHDS is unnecessarily intimidating providers into making greater systemic changes than necessary simply to avoid having their CAP rejected enough times to cause yet another citation.
If after the one phone call the licensing specialist is required to offer, the provider and licensing specialist still aren’t able to resolve the CAP issue then the dispute process should be automatically initiated. The additional citation serves no other purpose than to be adversarial.
The dispute process is often one of the few ways a provider supporting multiple regions of Virginia can receive consistent guidance between multiple licensing specialists. And now with the addition of the incident management unit, investigators, etc., there will be even greater discrepancy between DBHDS staff.
However, now that DBHDS has so many new staff in place, they can afford the extra time to complete the dispute process as opposed to discouraging it with threat of citation.
It is also noted that the guidance document does not indicate whether the additional citation will be removed should the dispute process end in favor of the provider. This is another example of inequitable delegation of accountability. By not removing the additional citation after the dispute process ends in favor of the provider, per this guidance document, a licensing specialist can be wrong but the provider still gets punished for not going along with it (i.e. getting another citation that requires them to change policy and procedure and enact system changes that weren’t actually necessary).
Removing the additional citation voids that issue entirely.
Why is it that the provider has very specific time requirements when responding to CAPS, yet there are no time frames for DBHDS to issue, review or comment on these CAPs? If the issue is so serious as to require a citation on a provider, DBHDS should also be under specific time frames for their own accountability when issuing, reviewing or commenting on these citations.
Returned CAPs for “failure to meet all requirements within 12VAC35-105-170.C” adds a citation prior to beginning the dispute process outlined in 12VAC35-105-170.F, which is outside of the regulatory requirements in 12VAC35-105-170.E. Provider is concerned about the Department’s approach of adding citations as a way to address concerns or simply a provider not agreeing with a Licensing Specialist. This provider’s reading of the regulation this Guidance pertains to, does not have the adversarial feel this Guidance does. Citations are a part of this business – no provider likes to receive them, and Licensing Specialists should not enjoy issuing them. Again and again, providers are told that the Department and providers are intended to work together to provide quality services, yet there is a large discrepancy between statements like “work together” and a Guidance document that mandates outside of the regulatory requirements currently out for final comment up to 3 citations (and possibly a reduced License) for a CAP with a single citation that a provider disagreed with or a Licensing Specialist felt that the “systemic changes” did not go far enough and the CAP then went through the dispute process for.
Another commentor asked the question which I will repeat - if a CAP goes through the dispute process and the Supervisor agrees with the Provider, is the 2nd(? 3rd?) citation removed? Why would the provider be penalized if the Supervisor ultimately agrees with the CAP the provider submitted?
When providers should consider steps to writing a CAP, Department states to develop a “systemic plan of
action”, Provider can see instances where simpler solutions than “updating policies, procedures, forms, or
conducting training/retraining for staff” would resolve the issue. As this provider commented on the final
regulations now out for comment, provider’s issue lies with the 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. As
another commenter noted, issuing additional citations to a provider for essentially not agreeing with or not
fully understanding a licensing specialist, DBHDS is unnecessarily intimidating providers into making greater
systemic changes than necessary simply to avoid having their CAP rejected enough times to cause yet
another citation.
Please define what is considered a repeat and systemic citation for a provider that operates multiple services throughout multiple regions.
We appreciate efforts to standardize and publicize expectations regarding the content of CAPs and recommend revising the CAP form to promote successful fulfillment of the expectations, which benefits both the Office of Licensing and providers. While we understand the importance of including systemic corrections, the expectations allow no latitude for the reality that some events are idiosyncratic and do not require a systemic level correction. Please specify the timeframe allotted to Licensing Specialists to send a CAP to a provider and to review and follow up with providers after a CAP is submitted.
We are concerned regarding the plan to issue an additional citation “if a CAP is returned to the provider a third time for failure to meet all requirements”. While the guidance document recognizes the need to initiate the dispute process, the concurrent issuing of a citation presumes the issue at hand is one of noncompliance with 170.C vs. another factor and presumes an unwillingness to collaboratively problem solve. The additional citation under 170 C should only be issued, if indicated, after the dispute resolution process has completed.
Please be aware that there is a frequent disconnect between current practice and the regulation 170.C.3. It is not unusual for providers to be asked to defer signature on the CAP until it has been approved. To avoid unnecessary citations, please ensure all Licensing Specialists accept that providers will need to sign CAPs upon initial submission and after any revision.
Requiring CAPS to address systemic plan of action for problems identified does not take into account that there are individualized events that occur that do not require systemic level corrections.
The process to submit signed CAPS is not effective with the technology available to most agencies in collaboration with their licensing specialists. Signed CAPS have to be sent as PDF's. Licensing specialists request that the CAPS be submitted as word documents so they can identify if the action plans are approved. Once they are approved by licensing, a signed CAP can be sent back as a PDF. That system does not align with your guidance.
Guidance that an additional citation will be issued if a CAP is returned to a provider for a third time for failure to meet all requirements is concerning. Issuing a CAP during this process is punitive rather than collaborative.
It is a concern to providers that the provider has a time frame for responding to the CAP, but the department does not. Often, it is unclear what the status of a CAP that was submitted is because it has not been returned. We rarely receive a notification that it has been accepted. If the provider does not agree with the department and wishes to appeal, there is generally a time of conversation which includes resubmitting. It is a burden on the provider that during this process, and prior to appeal, another CAP would be issued. The CAP should be a tool for improvement of services, not a punishment. This guidance document makes the process punitive rather than cooperative. It appears that rather than helping the provider improve services, the approach is to add citations.
It is appropriate to cite issues during a review, such as a minor maintenance issue. For larger providers with multiple locations, the ability to ensure that at the exact moment a reviewer visits a program, something may have just happened and the staff members have not had the opportunity to repair it. Again, this is appropriate to note and even cite, but to call it "systemic" is not necessarily reasonable. The issue may not be that there is a need for new policy or retraining so much as just to fix that issue, such as perform a repair.
Under 12VAC35-105-170, the provider is being held to a standard that is impossible to meet. A CAP is written to improve services and ensure best practices. Expecting a provider to develop a CAP to prevent recurrences is more than should be expected and is punitive rather than cooperative. This standard should be removed from the Final regulations.
General Comment:
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.
Guidance Document:
12VAC35-105-170. Corrective action plan.
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.
Comment:
I do not disagree with the idea of monitoring the effectiveness of approved corrective action plans or submitting a revised corrective action plan should the corrective action plan not appear to be effective. My issue lies with the 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.
Comment on Guidance on Corrective Action Plan
It appears that the guidance document referencing corrective action plans continues to implement additions to the regulations in place, in what appears to be the implementation of additional regulatory requirements through a guidance document versus an update to the existing regulations. This causes some confusion in that the guidance document should be to elaborate on the regulations to aid in clarity and further understanding. The way in which these guidance documents are outlined results in additional confusion and misunderstanding regarding the regulations at hand. Having this guidance document outline the regulations in a usable manner would be recommended without additional information beyond the outlined regulation being referenced. This includes reference to details pertaining to additional citations being provided for failure to meet all requirements within regulation 12VAC35-105-170; however, the guidance outline offers additional requirements than referenced within the regulation.
Additional language utilized within the guidance document should be removed, as the wording remedying and preventing the recurrence of identified regulatory violations; however, the regulations define corrective action plan as the Provider’s pledged corrective action in response to areas of noncompliance. The wording within the guidance document is not a realistic expectation of Providers to prevent occurrences of violations. Providers from across the state would like to ensure the prevention of many occurrence that unfortunately take place; however, in working with the reality of service delivery this is not a standard that can be upheld.
Additionally, this guidance document continues to note the intent of the department to move forward with progressive action steps that continue to be outlined within the use of language such as the issuing of additional citations. There is also a notation that if the Provider reaches out to a Specialist’s supervisor that this would be referred back to the Specialist which does not provide a point of remedy for potential issues that may surface regarding interpretation of regulations and CAPs, as essentially there is no ability for the Provider to seek additional support to address areas of concern with the involvement of other staff members.
Thank you for your time and consideration.
In group homes and other care-settings for disabled individuals in Virginia, abuse, neglect, and other forms of substandard care occur far too often. The proposed Guidance on Corrective Action Plans is welcome, common sense regulation. It emphasizes the health, safety, and welfare (HSW) of the individual over the obfuscation and abdication of responsibility by providers.
My experience has been, as the parent of a disabled young adult in a community living group home, that providers run their operations to the allowable limits of state regulations. However, those regulations fail, in many areas, to protect the HSW of the disabled individual. This is inexcusable and unacceptable.
That “providers are required to conduct a root cause analysis (RCA) …” is common sense, but shockingly, it’s not common sense within the current regulations.
Requiring providers to develop a plan of action, monitoring the effectiveness of those plans, then documenting demonstrable compliance, is a no-brainer level of accountability.
The example for creating a CAP is excellent. Timelines for compliance and corrective action are essential (for both the licensee and the regulator) to the process.
Verification by the Office of Licensing that corrective action plans have been implemented is also critical, and, once again, just plain common sense.
I applaud and fully support the new regulations and what they are trying to accomplish.
I can understand that CAPs need to be monitored for effectiveness and possibly revised if they are not, but to assume that a CAP (or even a revised CAP) would prevent the recurrence of a violation is not realistic. There are too many variables, including human behavior. This statement in itself is proof that a systemic plan is not always required. No one can guarantee that a problem won't occur again, regardless of the plan put into action. Having to guarantee a CAP (or revised CAP) will prevent a problem from reoccurring seems to be an impossible standard to meet.
Prince William CS
Comments regarding draft guidance document related to 12VAC35-105
July 22, 2020
1A. Prince William CS appreciates the efforts to clarify the CAP process and agrees that providers should be in compliance with regulations and failure to meet a regulation requires that the agency determine why they were not in compliance and what can be done to remain in the compliance for the future. However, since regulations cover everything from lighting to paperwork to behavioral restrictions, for an agency our size (serving 8000+ people per year, 400+ staff, 50+ new staff each year, 10+ locations throughout the County) it is to be expected that there will be occasional individualized missteps that don’t always require a “systemic” plan of action. The regulations do not currently indicate individualized responses such as additional supervision/training for a single staff person is acceptable.
1C. How are providers to submit documentation for each part of the CAP to DBHDS? This is not clarified in the current policy and how often would that documentation need to be submitted (using your example of weekly chart reviews how long would the licensing specialist require to receive the reviews?)
Re: 2VAC35-105-170 C: “If a CAP is returned to the provider a third time for failure to meet all requirements within 12VAC35-105-170, the CAP will be returned with an additional citation for violating regulation 12VAC35-105-170.C and the CAP dispute process will be initiated automatically as outlined in 12VAC35-105-170.F”
This seems excessively punitive for a situation that is most likely a miscommunication or lack of clarity regarding what is needed/expected. This threat of an additional citation seems almost as if the department is trying to force providers to just accept what they are told and eliminates the collaborative process between the providers and the department. Additionally, there is no clarification if the additional citation would be removed if the dispute process ends in the favor of the provider. If it ends
D. Please clarify the guidance regarding requests for extensions, is it 10 days from the original due date or 10 days from the date of request for extension? A 10-day extension that is granted from the date of request instead of 10 days from the original due date penalizes organization for being proactive about requesting an extension.
E. Please specify the time frame in which the licensing specialist is required to respond to the submitted CAP.
F. Please provide time frames regarding the various stages of the CAP dispute resolution process. Please include that the DOL will provide a written response regarding the final resolution of the dispute process.
General Comments:
I understand CAPs need to be monitored but it is unrealistic to believe a CAP will prevent a recurrence of a violation. With the best CAP in place, many factors may come into play including the human factor. To guarantee a CAP will prevent a recurrence is impossible to achieve and sets the standards beyond reach.
Some CAPs do not require a systemic plan of correction but are only individualized in nature. Not all CAPs will require a systemic plan of correction. Please consider changing this language.
We are concerned about the requirement for CAPs to include systemic plans of actions to address problems.
Sometimes, after a review of an incident, we find there is not a systemic issue. An incident could be due to a staff member oversight / mistake; this should be addressed with the staff member. Allocating time and resources towards systemic solution when there is not a systemic issue creates unnecessary, additional work.
12VAC35-105-170. Corrective Action Plan (A)
The guidelines are silent regarding the timing of Department notification regarding both the issuing of a licensing report and the acceptance/need for modification of a CAP. We are seeking clarification regarding these timelines be included in the guidance and ask that the Department provide both the licensing reports and communicate acceptance or the need for modification of CAPs within 10 days of receipt and/or conclusion of a licensing audit or inspection. We believe doing so would be in keeping with the intent behind the CAP process and ensure the immediate and continued wellbeing of the individuals receiving services in a prompt and efficient manner.
12VAC35-105-170. Corrective Action Plan (C)
The draft Guidance indicates the provider should “develop a systemic plan of action to address each problem.” We object to this language as it makes an assumption that every violation cited by the Department will be systemic in nature and require a systemic solution. For providers with multiple programs the solution for the issue in one program may not be relevant to another program. To require a systemic plan for every problem has a potential to create new issues within programs that may not have the same structure as the program the plan of action is intending to address. Furthermore, some issues may have simple solutions that do not require policy, form, or procedure changes. DBHDS should consider modifying the language to reflect that not all issues identified are systemic and not all issues require complex solutions.
The regulations also indicate the provider will “[detail] actions taken that will minimize the possibility that the violation will occur again.” The guidance provided by DBHDS is silent as to what standard Department will utilize when measuring whether the corrective actions taken will minimize the possibility that the violation will occur again. We ask that a uniform standard be developed in order to ensure implementation of CAPs for providers across the state can be consistent. A communicated standards for “minimalizing risk” will not only provide for the safety and wellbeing of the individual served but provide ease of correction for each provider.
12VAC35-105-170. Corrective Action Plan (F)
While the guidance addresses situations which may arise during the 15 day CAP submission window, it is silent on situations in which the execution of the CAP uncovers further needs or concerns that may call for the modification of the CAP. The lack of guidance and procedures for these situations have the potential to negatively impact a provider’s ability to implement the MOST meaningful and effective corrective actions that benefit the individuals served. For that reason, we ask the Department to consider and provide guidance for situations that warrant the modification of a CAP post approval from the Department.
The guidance indicates that the dispute process may be initiated by the provider or the specialist in the event the two parties are not able to come to an agreement related to the citation. The guidance is silent though on the time or standard for which the two parties must attempt to reach an agreement prior to the initiation of dispute resolution. This provider would like clarification on how long after the request can the provider expect the resolution processes to take place.
The guidance on pages 2 and 3 also appear to contradict the guidance regarding dispute resolution. The guidance adds a citation prior to the initiation of any dispute process. This negatively impacts the provider in two ways. First, it prevents any dispute resolution from occurring in advance of the issuance of a citation. Second, should the dispute resolution come out in favor of the provider the guidance is silent as to what will become of the citation issued in advance of the dispute process. We ask that the Department provide clarity regarding this contradiction and amend the guidance to reflect that citations will not be issued until any disputes are resolved.
The guidance provides the Department 10 days following the resolution meeting to provide a final decision. We have a concern regarding this timeframe. Keeping in mind that the CAP process is a critical component of ensuring the safety of the individuals receiving services, we believe this timeframe has the potential to negatively impact the individuals served and ask that the timings associated with the resolution process be more immediate in nature.
The guidance indicates that “No decisions will be made at the time of [the dispute resolution] meeting and the information will be gathered from the meeting and discussed with the Office of Licensing Associate Director and Director to make a final decision.” We wish to express concern that the provider will not have a voice of representation when the information gathered from the dispute meeting is presented to the Associate Director and Director. This provision of the guidance creates a potential for a perceived risk of bias and misrepresentation during the dispute resolution process. Therefore, we ask DBHDS to amend this portion to include the Associate Director and/or Director in the information gathering meeting.
I am a parent of a child with DD, as well as a professional in this industry. Although, there have been numerous discussions between the State and Agency Stakeholders to address a crosswalk document to offer additional guidance on implementation of the regulations it is clearly noted in this document that there is increased regulatory oversight as opposed to clarification or guidance.
With the noted guidance, this will have an impact not only on service providers but on those receiving said services. As a parent I would rather see the current regulations enforced than additional regulations added to agencies to overburden them to the extent that the care of my child suffers.
12VAC35-105-170 Guidance:
When writing a CAP, to assume that all things that arise are related to a systemic concern and require a systemic plan unnecessarily burdens the system as it could be related to one staff or one maintenance item that could be easily remedied without updating policies or procedure manuals or retraining an entire agency of staff. The current procedure for corrective action plan development and implementation often remedies a particular situation.
As with the current regulations that are up for comment, the word prevent is noted within this guidance document and should be changed to mitigate or minimize risk as we are working with people and we cannot prevent something from occurring. Additionally, this document continues to reference progressive citations when a provider is seeking guidance to get an accepted corrective action plan if the provider does not meet the criteria after several attempts then an additional CAP will be implemented.
We begin by assuming that it is the expectation that any regulated entity will comply with the regulations, however, it is also true that regulations are developed to set a standard that the State can rely on to provide assurance to the public, to the legislative body that appropriates funds for the purpose of supporting the regulated service and, if appropriate, to the Federal Government who may also provide support that they adequately protect their interests and enhance their mission. If standards are so weak or enforced so poorly as to always be met, the latter function is not accomplished.
Therefore, citations for failure to meet a specific standard is the norm and not the exception.
It is the structure of the system that the regulated entity will produce a Corrective Action Plan (CAP) for each citation in accordance with 12VAC35-105-170 A - C. If the Licensing Specialist does not agree with the CAP, it is their responsibility to state clearly the reason for their disapproval. For example,
1) the corrective action does not comply with the standard cited, or
2) the citation is either one which has been made before, or is made about multiple incidents and the corrective action does not address the larger issue.
The provider has a wide range of options in developing a CAP and retains the right to a wide range of actions which may be taken as a part of exercising good judgement and best practice which may or may not be included in the CAP.
The Specialist also has a wide range of options including follow-up visits or visits to other locations where the same issue may be present to monitor the performance of the provider.
The Guidance offered suggests two things:
First, the Office of Licensing, DBHDS, views all regulations equally critical and therefore all citations equally serious. And,
Second, the Office of Licensing, DBHDS, will not accept the basic and rather obvious premise that the development and complete implementation of a corrective action plan will not prevent the recurrence of the occurrence of either human error or burned out light bulbs. A perfect example of human behavior is found in this regulation:
12VAC35-105-170 C states that:
"The corrective action plan shall include a:
12VAC35-105-170 H (added only for the final regulation) changes the meaning of the earlier section by adding that the corrective action is to "prevent recurrence of a regulatory violation" which is an entirely different construct.
The Guidance should be withdrawn.
The guidance in this document highlights the accuracy a provider has to ensure to mitigate risk and correct errors. How will accuracy across DBHDS be ensured? Historically there have been variances between the instruction given by advocates, specialists, and even the guidance documents provided by DBHDS. With the addition of another entity (the IMU) there is an increased chance of contradictions. Beyond the mitigation that can be requested with the specialist's supervisor what path is there for the provider if there are discrepancies between offices?
“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”
Again, the idea of total prevention is infeasible. The individuals and DSP who support them are all human. No CAP can account for all factors and eliminate all error. While providers strive for excellence and to meet all standards; prevention is an impossible standard.
The CAP should be a tool for improvement of services, not a punishment. This guidance document makes the process punitive rather than cooperative. It appears that rather than helping the provider improve services, the approach is to add citations.
I am also concerned that providers have a time frame for responding to a CAP, but the department does not. Often, the status of a submitted CAP is unclear because it has not been returned. Notifications that a CAP has been accepted do not often occur. If the provider does not agree with the department and wishes to appeal, there is generally a time of conversation which includes resubmitting. It is a burden on the provider that during this process, and prior to appeal, another CAP would be issued.
It is appropriate to cite issues during a review, such as a minor maintenance issue. For larger providers with multiple locations, the ability to ensure that at the exact moment a reviewer visits a program, something may have just happened and the staff members have not had the opportunity to repair it. Again, it is appropriate to note or cited the issue, but to call it "systemic" is not necessarily reasonable. The issue may not be that there is a need for new policy or retraining so much as just to fix that issue, such as perform a repair.