Re: Definition of a Level II Serious Incident

“Please note that residential providers are responsible for individuals 24 hours a day and, therefore, are required to report all incidents once notified”

While your example may be reasonable (a group home provider reporting based on information obtained from the individual’s AR of an incident which occurred while the individual was on a home visit), it is not reasonable nor efficient for the residential provider to report an incident which occur during the provision of service or on the premises of another licensed provider (which by regulation is required to report and conduct the appropriate investigation/quality review)

 While I understand your attempt to capture serious incidents which happen while the individual is with family or independently away from their program, this does not conform to the regulation which clearly states that a “’Level II serious incident’ means a serious incident that occurs or originates during the provision of a service or on the premises of the provider . . .”  You are attempting, by Guidance, to expand the regulatory requirement. We request that you remove the language and the explanatory example above.

 Re: Unplanned medical hospitalization

“If an individual is taken to the hospital after a qualifying event in the accordance with their medical protocol, and is not admitted following evaluation, then the provider does not have to report the incident. If it is determined that the individual should be admitted, then the incident shall be reported.”

 It may be a factor of ER capacity and not patient need that dictates if an individual is “admitted for observation.”  We request that you change the language  to include the following:

“If it is determined that the individual should be admitted for treatment, then the incident shall be reported.”

 Re: Ingestion of any hazardous material

Your example is so broad as to make this unmanageable, esp if the provider supports any individual with PICA behavior.  Replace the example with a suggestion that “if, following consultation with Poison Control or EMS, emergency medical care is sought, the incident shall be reported.”

 Re: Any death of an individual

The guidance does not address the previously identified issue of duplicative reporting.  We would suggest that once the Licensing Specialist receives the initial report in the CHRIS system, they identify the CM and notify other providers that a report has already been made.

Re: Root Cause Analysis

The definition of Root Cause Analysis (RCA) is clear and does not include a specific method or approach; while a “team approach” may be a good system to use, the regulatory requirement that the RCA be conducted within 30 days places constraints on the options providers may have.

The paragraph beginning “The best way . . . “ ends with a reference to a “requirement” which does not appear in the regulation and, thereby, you are attempting, by Guidance, to expand the regulatory requirement. We request that you remove the entire paragraph.

Item of Concern:

Page 4 under Level III Incidents: 

"2) A sexual assault of an individual; 

• Providers shall report to the department and other relevant authorities as required by law that an individual alleges they were sexually assaulted, whether or not the alleged assault occurred within the provision of the provider’s services or on their property"

The proposed change in its current form would have the potential to harm the therapeutic relationship when an alleged sexual assault is reported by an adult receiving or requesting outpatient counseling services and an adult does not wish to make a criminal report to law enforcement agencies. By reporting information about an adult's alleged sexual assault, this may cause concerns for the adult receiving services about confidentiality. Additionally, reporting information about an adult's alleged sexual assault when an adult does not want the information shared with anyone is in contradiction of person-centered and trauma-informed practices. 

This proposed change would be beneficial for minors or incapacitated adults to ensure that mandated reporting by law has occurred. 

Additionally, this proposed change would be helpful if it also specifically mandated that providers report to the department and other relevant authorities as required by law that an individual alleges they were sexually assaulted by any employee of a site licensed by DBHDS.

Level II  #3 An Emergency room or urgent care facility visit when not used in lieu of a PCP visit. Direct care staff who work on weekends and holidays often take clients to ED or urgent care when a medical condition / injury ocurs since they are not medically trained to discern if the injury or medical symptoms can wait till a work day to contact a PCP....To meet the requirement, these will always be reported in CHRIS  even if they likely should not have been. Is there any quidance as to what providers can do in such cases.. Cane the level in CHRIS be changed, if after the fact, it is determined the incident should not have been reported in CHRIS?

Level II #4. An unplanned psychiatric or unplanned medical hospital admission. For level II , these would be reported if the incident occurs or originates during the provision of a service or on the premises of the provider. The guidance to this requirement is not clear to me. I believe the intent is that any of our clients who are active clients, receiving any service, has an unplanned psychiatric event or an unplanned  medical admission ,we should report this as a level II incident. However, if one takes into account the parameters of Level II,  that if the individual is not on the premise or receiving services at the time, we would only report on individuals who received an unplanned psychiatric event of unplanned medical admission from our residential programs or if the incident occured during the provision of a service such as MHSS. If the intent is to complete a Level II Incident report and an RCA for all unplanned psychiatric eents and unplanned medical admissions for all active clients, this will most certainly be an unachievable requirement. Please provide clearer guidance.

Level III

• Providers shall report to the department and other relevant authorities as required by law that an individual alleges they were sexually assaulted, whether or not the alleged assault occurred within the provision of the provider’s services or on their property

Reporting all sexual assaults may affect the therapeutic relatioship between individual and therapist. The guidance should be more narrowly focused to require a report of sexaul assault by staff, or by a peer within the provision of a service . Agencies are already mandated reporters. Narrowing the focus of the requirement would provide better oversight to the licensed programs and how they are addressing this level of incident.

Page 13 (definitions)

Level 3 Serious Incident occurs is a serious incident whether or not the incident occurred while in the provision of service or on the provider’s premises.  What are the reporting requirements for a provider if the incident did not occur while in service?

12VAC35-105-650

While having a comprehensive assessment process is important, it should be noted that providers may not have access to the “required” historical documentation under F.  Some information listed may be out of the scope needed to provide appropriate service for some providers.  Is it possible to add "as available and applicable"?

Page 2: "...residential Providers are responsible for individuals 24 hours a day and therefore are reuqired to report all incidents once notified." This shifts the resposnbility of licensed non-residential providers, e.g. day support, etc.from reporting what has occurred under their supervision, which may also cause them to shift the repsosnbility of  seeking medical care for the individual. Obtaining  accurate infomration about an incident that occurred with another provider, especially if they didn't report it or take it seriously, can be challenging for the residential provider.

Page 3: Hosptial admissions: I agree with  comments of others that " admissions for the purpose of observation" should not require reporting.

Page 3: Ingestion of any hazardous material: I would suggest amending the language to indicate the incident is reportable as a Level II incident if the provider seeks emergency medical care for the individual after consulting Poison Control or EMS.

Pg.4 Providers should not be required o report Level III incidents that did not occur on their premises or under provision of their services.  DBHDS should notify all providers after receiving the first report to avoid duplication.

Page 7: Third paragraph in the box is too prescriptivr and expands the regulation.Sponosred residential providers should not be relieved of this duty. They are overseen by licensed agencies.

First, we would like to extend our thanks to DBHDS for issuing and seeking input regarding this draft guidance document.  In addition, we are appreciative of the consistent message that the majority of Serious Incidents occur during the actual moments of service delivery or while an individual in on a provider’s property and of the accompanying reduction in duplicate reporting and reduced focus on events generally unrelated to our role in individuals’ lives. 

The guidance related to Level II events raises some additional questions.  Regarding the requirement for residential providers to report all incidents will result in duplicate reporting.  Is there a means to ensure providers attest to notification to residential providers and case managers within CHRIS, e.g. by having to put in the date of notification?  If not, when an event occurs during a day program provided by the same agency that provides residential services, please confirm that the agency need only report this event once, in connection to the residential license, but identifying the day program as the specific location.

Please find ways to ensure consistency among Licensing Specialists regarding the interpretation of “serious injury”, as in recent years there has been some expectation of reporting any event that was treated by someone with the identified credentials, regardless of actual harm or potential for harm.  Along these lines, the recognition that emergency rooms and urgent care facilities are used when PCPs are unavailable is much appreciated. 

The additional guidance related to “unplanned psychiatric admissions” is appreciated, as is the recognition of the role of Emergency Services providers.  A focus on TDOs is, indeed, the most similar terminology to that used by pre-screeners.  As ECOs only enable a person to be brought for evaluation and may result in voluntary hospitalization (or even no hospitalization), please consider removal of that aspect of the guidance document.

For instances where an individual is taken to the hospital in accordance with their medical protocol and is admitted following the evaluation, please confirm that the 24 hour reporting period starts when the provider is notified of the decision to admit the individual.

In general, the events selected as Level III incidents are logical topics to be viewed as sentinel events.  Most questions relate to the expectation of conducting a root cause analysis for all events of “Sexual Assault”.  First, how is that term being defined and who is to determine that sexual assault occurred? Second, if an event occurs during service provision, it would be considered an Allegation of Abuse or of Neglect and should be reviewed under the Human Rights process, certainly with attention to systemic root causes that enabled any abusive actions to occur.  Similarly, if Provider A learns that this allegedly occurred during service delivery by Provider B, then mandated reporting, ensuring the Office of Human Rights is aware, and ensuring safety of the alleged victim would be the keys to a response.  When an event such as this occurs outside of any provider’s direct service provision and outside of any provider’s premises, there are concerns about how this review could impact the victim’s experience with a provider.  Considered from the perspective of the victim, having any number of staff members potentially unfamiliar with their treatment reviewing a highly personal event could feel like an additional violation.  Few facts could be obtained and the individual him/herself should not be interviewed for this purpose.

Finally, please provide some additional clarification regarding expectations for reviewing of incidents beyond initial information gathering and root cause analyses.  Specifically, Section 160 addresses reviewing Level I incidents as part of the Quality Improvement Program, referencing 105-620.  However, 105-620 does not specify review of incidents, whereas 105-520, Risk Management, clearly specifies “a review of serious incidents”.  Perhaps this is comment better suited for clarification within the regulations themselves, but what is the appropriate venue to review these events?  Three tiers of review (addressing the incidents immediately, via the QIP, and via the Risk Management Plan) seems likely to create additional work with little gain and to result in potentially conflicting messages and internal plans for correction actions.  We look forward to attending DBHDS sponsored training on root cause analysis and hope multiple sessions will be offered per region.

Loudoun County MHSADS Comments on DBHDS Office of Licensing Guidance for a Quality Improvement Program Document

1.  12VAC35-105620 
   1. The regulation was changed to indicate “develop and implement a quality improvement program…” The regulatory requirement to have quality improvement policies and procedures was specifically removed in the most recent update to regulations.  However, under the department’s guidance box it indicates “[t]he provider’s policies and procedures should include direction related to their quality improvement program.”  This goes beyond what the regulations indicate is required and should be removed.
   2. DBHDS’ examples of QI Plan key components go beyond what is stated in the regulations.  The specific examples that go beyond what the regulations require are, "a quality statement”, “Quality Infrastructure” and “Culture of Safety and Quality”.  These should be removed as the regulations do not require the information described to be included in a QI plan. 
2. “The program shall:  i. Include a quality improvement plan that is reviewed and updated at least annually.”    The information provided in guidance goes beyond what is stated in the regulations in the following two requirements:

“The annual review should also include an evaluation of the effectiveness of the quality improvement program and whether the provider seeks to change how quality improvement work is accomplished.”

“The quality Improvement plan shall be signed and dated by the person designated as responsible for the quality improvement program and shall be readily available upon request by DBHDS.”

Both of these stated requirements should be removed as they go beyond what is included in regulations.  The guidance document should not require elements that are not stated in the regulations.  

Loudoun County MHSADS Comments on DBHDS Office of Licensing Guidance on Serious Incident Guidance

1. On page 1, it states that level II incidents are only required to be reported if occurred, originated, or happened during the provision of service or on the premises of the provider. On page 3 under “Unplanned psychiatric or unplanned medical hospital admission”, it says that “any time that an individual is admitted to the hospital for unplanned medical it is required to be reported.” This reads that even if the individual is admitted to the hospital outside of the provision of services (i.e. an individual receiving only outpatient services goes to the hospital for an emergency appendectomy while at home) this would need to be reported; which is contradictory to the definition of a level II incident and should be revised.

1. On page 2, it states that residential providers are responsible for individuals 24 hours a day and are required to report all incidents once notified. This guidance contradicts the regulations which state that level II incidents are reported if occurring during the provision of service or on the premises. An individual may be with another provider, guardian, or with a community member during the incident. This goes beyond what is stated in the regulations and should be removed.

1. On page 2 under “An emergency room or urgent care facility visit…” it states that Emergency rooms and urgent care centers should not be routinely used in lieu of a primary care physician. We have individuals whose PCP is located at an urgent care center and often go to the urgent care center for walk-in appointments to visit with their PCP. In addition, the first bullet states unexpected ER or urgent care visits assume that the incident was serious enough to warrant ER or urgent care. Individuals may utilize these services because an appointment with their PCP cannot be made in a timely matter (e.g., after-hours, weekend, holiday). This is not an accurate statement and should be removed.

1. On page 3 and 4 under “bowel obstruction” and “aspiration pneumonia,” the diagnosis of a bowel obstruction is not always known at the time of the medical appointment and therefore, the reporting would need to occur within 24 hours of the diagnosis and not incident discovery. The guidance should be updated to clarify this information.

1. Page 5 under the quarterly review of Level I serious incidents; the guidance indicates to mandate for root cause analysis for all Level I serious incidents in the example provided regarding falls. This goes beyond what is stated in the regulations and should be removed.

1. On page 6  under Level II and III reporting, information should be included to indicate that discovery of incident may be when the diagnosis is made, and not necessarily at the initial discovery of the  “incident.”

1. Page 7 under root cause analysis, the guidance goes beyond the regulations. The regulations do not prescribe a way to complete a root cause analysis. While the guidance seems to make suggestions as to the best way to implement (e.g., team approach); there are instances in this section of the guidance where the word “requirement” is used. The regulations do not require a team approach with an uninvolved supervisor. The guidance may suggest or recommend this approach, but cannot make this a requirement. This goes beyond what is stated in the regulations and should be removed.

1. Pages 5 and 8 provide examples of non-compliance from a provider for not providing information to DBHDS. These examples do not address other legal reasons in which a provider may not disclose information to DBHDS.

1. Throughout the document, the use of “receiving services” is used. This terminology could be interpreted to mean “enrolled” in services as opposed to meaning “during the provision of services,” however; it is not always clear throughout the guidance document the intention of the meaning.

OVERALL - The guidance document should not require elements that are not stated in the regulations. 
Licensing Guidance on Serious Incident Guidance 

• Throughout the document, the use of “receiving services” is used. This terminology could be interpreted to mean “enrolled” in services as opposed to meaning “during the provision of services,” however; it is not always clear throughout the guidance document the intention of the meaning.

• On page 1, it states that level II incidents are only required to be reported if occurred, originated, or happened during the provision of service or on the premises of the provider. On page 3 under “Unplanned psychiatric or unplanned medical hospital admission”, it says that “any time that an individual is admitted to the hospital for unplanned medical it is required to be reported.” This reads that even if the individual is admitted to the hospital outside of the provision of services (i.e. an individual receiving only outpatient services goes to the hospital for an emergency appendectomy while at home) this would need to be reported; which is contradictory to the definition of a level II incident and should be revised. 

• On page 2, it states that residential providers are responsible for individuals 24 hours a day and are required to report all incidents once notified. This shifts the responsibility of licensed non-residential providers, e.g. group day/day support, etc. from reporting what has occurred under their supervision, which may also cause them to shift the responsibility of seeking medical care for the individuals.  Obtaining accurate information about an incident that occurred with another provider, especially if they didn’t report it or take it seriously, can be challenging for the residential provider.  This guidance contradicts the regulations which state that level II incidents are reported if occurring during the provision of service or on the premises. An individual may be with another provider, guardian, or with a community member during the incident.  Requiring a licensed residential provider to report on an incident that occurs within the confines of another licenses program/setting will also cause data regarding serious incidents to be inaccurate due to duplicate reporting of the same incident.  It is also inefficient for staff in both settings.  Remove the example at the top of page 2 related to this requirement and remove the language regarding residential providers being required to report all incidents. This goes beyond what is stated in the regulations and should be removed. 

• On page 2 under “An emergency room or urgent care facility visit…” it states that Emergency rooms and urgent care centers should not be routinely used in lieu of a primary care physician. We have individuals whose PCP is located at an urgent care center and often go to the urgent care center for walk-in appointments to visit with their PCP. In addition, the first bullet states unexpected ER or urgent care visits assume that the incident was serious enough to warrant ER or urgent care. Individuals may utilize these services because an appointment with their PCP cannot be made in a timely matter (e.g., after-hours, weekend, holiday). This is not an accurate statement and should be removed. 

• On page 3 regarding hospital admissions – “admissions for the purpose of observation” should not require reporting. 

• On page 3 and 4 under “bowel obstruction” and “aspiration pneumonia,” the diagnosis of a bowel obstruction is not always known at the time of the medical appointment and therefore, the reporting would need to occur within 24 hours of the diagnosis and not incident discovery. The guidance should be updated to clarify this information. 

• On page 4, Providers should not be required to report Level III incidents that did not occur on their premises or under their provision of services.  DBHDS should notify all providers after receiving the first report to avoid duplication.

• On page 5 under the quarterly review of Level I serious incidents; the guidance indicates to mandate for root cause analysis for all Level I serious incidents in the example provided regarding falls. This goes beyond what is stated in the regulations and should be removed. 

• On page 6 under Level II and III reporting, information should be included to indicate that discovery of incident may be when the diagnosis is made, and not necessarily at the initial discovery of the “incident.” 

• On page 7 under root cause analysis, the guidance goes beyond the regulations. The regulations do not prescribe a way to complete a root cause analysis. While the guidance seems to make suggestions as to the best way to implement (e.g., team approach); there are instances in this section of the guidance where the word “requirement” is used. The regulations do not require a team approach with an uninvolved supervisor. The guidance may suggest or recommend this approach but cannot make this a requirement. This goes beyond what is stated in the regulations and should be removed. 

• Pages 5 and 8 provide examples of non-compliance from a provider for not providing information to DBHDS. These examples do not address other legal reasons in which a provider may not disclose information to DBHDS.  

12VAC35-105620 –

Quality Improvement Program Document

• The regulation was changed to indicate “develop and implement a quality improvement program…” The regulatory requirement to have quality improvement policies and procedures was specifically removed in the most recent update to regulations. However, under the department’s guidance box it indicates “[t]he provider’s policies and procedures should include direction related to their quality improvement program.” This goes beyond what the regulations indicate is required and should be removed. 

• DBHDS’ examples of QI Plan key components go beyond what is stated in the regulations. The specific examples that go beyond what the regulations require are, "a quality statement”, “Quality Infrastructure” and “Culture of Safety and Quality”. These should be removed as the regulations do not require the information described to be included in a QI plan.  
“The program shall: i. Include a quality improvement plan that is reviewed and updated at least annually.” The information provided in guidance goes beyond what is stated in the regulations in the following two requirements:

• “The annual review should also include an evaluation of the effectiveness of the quality improvement program and whether the provider seeks to change how quality improvement work is accomplished.” 

• “The quality Improvement plan shall be signed and dated by the person designated as responsible for the quality improvement program and shall be readily available upon request by DBHDS.”  
 

The provider shall develop and implement a quality improvement program..... The guidance document seems to exceed the current regulation.  A guidance document should not exceed the refulatory standard and for that reason it should be removed.  

OVERALL - The guidance document should not require elements that are not stated in the regulations.

Licensing Guidance on Serious Incident Guidance

• Throughout the document, the use of “receiving services” is used. This terminology could be interpreted to mean “enrolled” in services as opposed to meaning “during the provision of services,” however; it is not always clear throughout the guidance document the intention of the meaning.
• On page 1, it states that level II incidents are only required to be reported if occurred, originated, or happened during the provision of service or on the premises of the provider. On page 3 under “Unplanned psychiatric or unplanned medical hospital admission”, it says that “any time that an individual is admitted to the hospital for unplanned medical it is required to be reported.” This reads that even if the individual is admitted to the hospital outside of the provision of services (i.e. an individual receiving only outpatient services goes to the hospital for an emergency appendectomy while at home) this would need to be reported; which is contradictory to the definition of a level II incident and should be revised.
• On page 2, it states that residential providers are responsible for individuals 24 hours a day and are required to report all incidents once notified. This shifts the responsibility of licensed non-residential providers, e.g. group day/day support, etc. from reporting what has occurred under their supervision, which may also cause them to shift the responsibility of seeking medical care for the individuals.  Obtaining accurate information about an incident that occurred with another provider, especially if they didn’t report it or take it seriously, can be challenging for the residential provider.  This guidance contradicts the regulations which state that level II incidents are reported if occurring during the provision of service or on the premises. An individual may be with another provider, guardian, or with a community member during the incident.  Requiring a licensed residential provider to report on an incident that occurs within the confines of another licenses program/setting will also cause data regarding serious incidents to be inaccurate due to duplicate reporting of the same incident.  It is also inefficient for staff in both settings.  Remove the example at the top of page 2 related to this requirement and remove the language regarding residential providers being required to report all incidents. This goes beyond what is stated in the regulations and should be removed.
• On page 2 under “An emergency room or urgent care facility visit…” it states that Emergency rooms and urgent care centers should not be routinely used in lieu of a primary care physician. We have individuals whose PCP is located at an urgent care center and often go to the urgent care center for walk-in appointments to visit with their PCP. In addition, the first bullet states unexpected ER or urgent care visits assume that the incident was serious enough to warrant ER or urgent care. Individuals may utilize these services because an appointment with their PCP cannot be made in a timely matter (e.g., after-hours, weekend, holiday). This is not an accurate statement and should be removed.
• On page 3 regarding hospital admissions – “admissions for the purpose of observation” should not require reporting.
• On page 3 and 4 under “bowel obstruction” and “aspiration pneumonia,” the diagnosis of a bowel obstruction is not always known at the time of the medical appointment and therefore, the reporting would need to occur within 24 hours of the diagnosis and not incident discovery. The guidance should be updated to clarify this information.
• On page 4, Providers should not be required to report Level III incidents that did not occur on their premises or under their provision of services.  DBHDS should notify all providers after receiving the first report to avoid duplication.
• On page 5 under the quarterly review of Level I serious incidents; the guidance indicates to mandate for root cause analysis for all Level I serious incidents in the example provided regarding falls. This goes beyond what is stated in the regulations and should be removed.
• On page 6 under Level II and III reporting, information should be included to indicate that discovery of incident may be when the diagnosis is made, and not necessarily at the initial discovery of the “incident.”
• On page 7 under root cause analysis, the guidance goes beyond the regulations. The regulations do not prescribe a way to complete a root cause analysis. While the guidance seems to make suggestions as to the best way to implement (e.g., team approach); there are instances in this section of the guidance where the word “requirement” is used. The regulations do not require a team approach with an uninvolved supervisor. The guidance may suggest or recommend this approach but cannot make this a requirement. This goes beyond what is stated in the regulations and should be removed.
• Pages 5 and 8 provide examples of non-compliance from a provider for not providing information to DBHDS. These examples do not address other legal reasons in which a provider may not disclose information to DBHDS.

12VAC35-105620 – Quality Improvement Program Document

• The regulation was changed to indicate “develop and implement a quality improvement program…” The regulatory requirement to have quality improvement policies and procedures was specifically removed in the most recent update to regulations. However, under the department’s guidance box it indicates “[t]he provider’s policies and procedures should include direction related to their quality improvement program.” This goes beyond what the regulations indicate is required and should be removed.
• DBHDS’ examples of QI Plan key components go beyond what is stated in the regulations. The specific examples that go beyond what the regulations require are, "a quality statement”, “Quality Infrastructure” and “Culture of Safety and Quality”. These should be removed as the regulations do not require the information described to be included in a QI plan.

“The program shall: i. Include a quality improvement plan that is reviewed and updated at least annually.” The information provided in guidance goes beyond what is stated in the regulations in the following two requirements:

• “The annual review should also include an evaluation of the effectiveness of the quality improvement program and whether the provider seeks to change how quality improvement work is accomplished.”
• “The quality Improvement plan shall be signed and dated by the person designated as responsible for the quality improvement program and shall be readily available upon request by DBHDS.”

QI plan components

The example of the QI plan components seems to exceed the regulatory standards and for that reason should not be explicit.  There are current concerns that providers are being exposed to interpretations that are broad and exceed the regulation standards. 

Level II reporting while in care of AR or licensed provider

A Level II incident language is clear in that it states that "serious incident that occurs or originates  during the provision of a service or on teh premises of a provider...." It feels that the guidance example is overreaching and outside of the regulatory standard when it suggests that a provider must report incidents that occur when an individual is not on the premises or in the care of an AR or other provider.  This should be removed. 

Unplanned Medical Visits

The language about unplanned medical visits is unclear in the guaidance document as individuals can be seen by a PCP, urgent care or ER and may not be admitted at that time. Please indicate clearer language so avoid broad interpretations of this requirement.  It may be more appropriate to indicate that level II should be initiated if an individual is admitted for treatment.  

Level III sexual assault

Level III incident of sexual assault reporting is not trauma informed and negates the sensitivity of the client/therapist relationship. 

Duplicate Death Reporting 

This guidance still does not address the requirement for duplicative reporting.  

Requirement for 24 hour reporting for bowel obstruction and aspiration pneumonia

Diagnosis of medical conditions are not immediately known at the time of medical intervention.  This should be clarified that there is a 24 hour requirement after receiving a diagnosis.   

• 12VAC35-105-20, Definitions of serious incidents – Level II definition #6, “Ingestion of any hazardous material”  which must be reported “If any individual drinks, swallows, or absorbs a material that is hazardous to their health…it shall be reported.” We serve many individuals who engage in PICA.  Calls to the Poison Control Center direct us on whether to seek emergency care, or if we can provide treatment and monitoring at our sites.  We request requiring reporting only when the individual is taken to receive emergency or urgent professional medical care after ingesting any material, rather than after each occurrence of ingesting by individuals who engage in  PICA.  (Responses to their PICA behavior are driven not only by the Poison Control Center, but by individual protocols, behavior plans, and/or physician’s orders.)

• 12VAC35-105-20, Definitions of serious incidents – Level II definition, “Level II serious incident means a serious incident that occurs or originates during the provision of a services or on the premises of the provider…,” then #3. “An emergency room or urgent care facility visit when not used in lieu of a primary care physician visit.”  These two sections of the definition are sometimes at odds.  It is not at all uncommon for one provider to transport an individual to the ER or to urgent care in response to an injury that occurred elsewhere – in a group home, in the family home, during a ride with a transportation provider, etc.  The regulation must clarify whether or not a provider categorizes transport to the ER or urgent care as a Level II incident, if the injury or illness did not originate during the provider’s services or on the provider’s premises. 

• 12VAC35-105-20, Definitions of serious incidents – “Level III serious incident means serious incidents whether or not the incident occurs on the provider’s premises or within the provision of services. All providers that are made aware of a level III serious incident are required to report even if this results in duplicative reporting.”  Level III, definition #1, “Any death of an individual” – When using the CHRIS system to report deaths of individuals who did not die while in our licensed program, the system requires providers to answer questions to which we lack answers.  After choosing “yes” or “no” as required, we can only explain in a random textbox within CHRIS that the answers are in fact unknown.  We ask that instead of using CHRIS, a provider be required to notify OL of all deaths via a documented phone call or encrypted email.  Only the provider in whose care the individual died should be required to enter the death into the CHRIS system. 

• 12VAC35-105-160, “Amend to require reporting of all level II and level III serious incidents to the department,” “A root cause analysis shall be conducted by the provider within 30 days of the discovery of Level II and Level III serious incidents,” and “The provider shall submit, or make available, reports and information that the department requires to establish compliance with these regulations and application statutes.”  We appreciate the importance of tracking, analyzing, and reporting data on serious incidents state-wide.  This is important to monitor services and to protect the safety of individuals served, not just for compliance with the Settlement Agreement.  We request that the Comprehensive Human Rights Information System (CHRIS) be updated, or that another “web-based reporting application” replace it.  The system used should be user-friendly and should require entry of all mandated information and only that information, specific to categories of serious incidents, so that only one reporting mechanism is used.  Providers appreciate the availability of OHR staff to train and re-train staff on the use of CHRIS; such training is not a substitute for resolving system issues that now use considerable staff hours due to technical difficulties.

• Sections 20 and 691 – These sections and probably others refer to the individual and/or the individual’s “authorized representative.”  “Authorized representative” has a specific definition in the Code of Virginia.  If the regulations intentionally reference that Code definition, then the term “legal guardian” should be added to these and other sections where only an authorized representative is mentioned.  If on the other hand, “authorized representative” is intended as a generic term, then perhaps “substitute decision-maker” should be used instead.  12VAC35-115-145 does use the generic term “substitute decision making.”

• 12VAC35-105-20, Definitions of serious incidents – Level II definition, “Level II serious incident means a serious incident that occurs or originates during the provision of a services or on the premises of the provider…,” then #3. “An emergency room or urgent care facility visit when not used in lieu of a primary care physician visit.”  These two sections of the definition are sometimes at odds.  It is not at all uncommon for one provider to transport an individual to the ER or to urgent care in response to an injury that occurred elsewhere – in a group home, in the family home, during a ride with a transportation provider, etc.  The regulation must clarify whether or not a provider categorizes transport to the ER or urgent care as a Level II incident, if the injury or illness did not originate during the provider’s services or on the provider’s premises. 

• Additional direction is needed regarding the use of the guidance document by the department.  Can a provider be cited because they have not developed and implemented their quality improvement plan as outlined in the guidance document? If their plan has all of the components listed in the regulations but do not have all of the key components listed in the guidance document could they receive a citation?  The guidance document should not add additional components that are not identified in the regulation 12VAC35-105620.
• 105.60 - The guidance document states the provider’s policies and procedures should include directions to the quality improvement plan. The regulations do not require written policies and procedures. The guidance documents should not be more prescriptive than the regulations and should be deleted.
• 105-620 – The regulations identify what should be in the quality improvement program (I – vi). The guidance document exceeds these requirements and adds; quality statement, infrastructure, participation of stakeholders, culture of safety and quality, data collections methods , sources of data all exceed what is stated in the regulation. The guidance documents should not be more prescriptive than the regulations and should be deleted or reworded as suggestions.

OVERALL - The guidance document should not require elements that are not stated in the regulations.
Licensing Guidance on Serious Incident Guidance  • Throughout the document, the use of “receiving services” is used. This terminology could be interpreted to mean “enrolled” in services as opposed to meaning “during the provision of services,” however; it is not always clear throughout the guidance document the intention of the meaning. • On page 1, it states that level II incidents are only required to be reported if occurred, originated, or happened during the provision of service or on the premises of the provider. On page 3 under “Unplanned psychiatric or unplanned medical hospital admission”, it says that “any time that an individual is admitted to the hospital for unplanned medical it is required to be reported.” This reads that even if the individual is admitted to the hospital outside of the provision of services (i.e. an individual receiving only outpatient services goes to the hospital for an emergency appendectomy while at home) this would need to be reported; which is contradictory to the definition of a level II incident and should be revised.  • On page 2, it states that residential providers are responsible for individuals 24 hours a day and are required to report all incidents once notified. This shifts the responsibility of licensed non-residential providers, e.g. group day/day support, etc. from reporting what has occurred under their supervision, which may also cause them to shift the responsibility of seeking medical care for the individuals.  Obtaining accurate information about an incident that occurred with another provider, especially if they didn’t report it or take it seriously, can be challenging for the residential provider.  This guidance contradicts the regulations which state that level II incidents are reported if occurring during the provision of service or on the premises. An individual may be with another provider, guardian, or with a community member during the incident.  Requiring a licensed residential provider to report on an incident that occurs within the confines of another licenses program/setting will also cause data regarding serious incidents to be inaccurate due to duplicate reporting of the same incident.  It is also inefficient for staff in both settings.  Remove the example at the top of page 2 related to this requirement and remove the language regarding residential providers being required to report all incidents. This goes beyond what is stated in the regulations and should be removed.  • On page 2 under “An emergency room or urgent care facility visit…” it states that Emergency rooms and urgent care centers should not be routinely used in lieu of a primary care physician. We have individuals whose PCP is located at an urgent care center and often go to the urgent care center for walk-in appointments to visit with their PCP. In addition, the first bullet states unexpected ER or urgent care visits assume that the incident was serious enough to warrant ER or urgent care. Individuals may utilize these services because an appointment with their PCP cannot be made in a timely matter (e.g., after-hours, weekend, holiday). This is not an accurate statement and should be removed.  • On page 3 regarding hospital admissions – “admissions for the purpose of observation” should not require reporting.  • On page 3 and 4 under “bowel obstruction” and “aspiration pneumonia,” the diagnosis of a bowel obstruction is not always known at the time of the medical appointment and therefore, the
reporting would need to occur within 24 hours of the diagnosis and not incident discovery. The guidance should be updated to clarify this information.  • On page 4, Providers should not be required to report Level III incidents that did not occur on their premises or under their provision of services.  DBHDS should notify all providers after receiving the first report to avoid duplication. • On page 5 under the quarterly review of Level I serious incidents; the guidance indicates to mandate for root cause analysis for all Level I serious incidents in the example provided regarding falls. This goes beyond what is stated in the regulations and should be removed.  • On page 6 under Level II and III reporting, information should be included to indicate that discovery of incident may be when the diagnosis is made, and not necessarily at the initial discovery of the “incident.”  • On page 7 under root cause analysis, the guidance goes beyond the regulations. The regulations do not prescribe a way to complete a root cause analysis. While the guidance seems to make suggestions as to the best way to implement (e.g., team approach); there are instances in this section of the guidance where the word “requirement” is used. The regulations do not require a team approach with an uninvolved supervisor. The guidance may suggest or recommend this approach but cannot make this a requirement. This goes beyond what is stated in the regulations and should be removed.  • Pages 5 and 8 provide examples of non-compliance from a provider for not providing information to DBHDS. These examples do not address other legal reasons in which a provider may not disclose information to DBHDS. 
12VAC35-105620 – Quality Improvement Program Document • The regulation was changed to indicate “develop and implement a quality improvement program…” The regulatory requirement to have quality improvement policies and procedures was specifically removed in the most recent update to regulations. However, under the department’s guidance box it indicates “[t]he provider’s policies and procedures should include direction related to their quality improvement program.” This goes beyond what the regulations indicate is required and should be removed.  • DBHDS’ examples of QI Plan key components go beyond what is stated in the regulations. The specific examples that go beyond what the regulations require are, "a quality statement”, “Quality Infrastructure” and “Culture of Safety and Quality”. These should be removed as the regulations do not require the information described to be included in a QI plan. 
“The program shall: i. Include a quality improvement plan that is reviewed and updated at least annually.” The information provided in guidance goes beyond what is stated in the regulations in the following two requirements: • “The annual review should also include an evaluation of the effectiveness of the quality improvement program and whether the provider seeks to change how quality improvement work is accomplished.”  • “The quality Improvement plan shall be signed and dated by the person designated as responsible for the quality improvement program and shall be readily available upon request by DBHDS.” over this text and enter your comments here. You are limited to approximately 3000 words.

• Additional direction is needed regarding the use of the guidance document by the department.  Can a provider be cited because they have not implemented their root cause analysis as outlined in the guidance document  yet includes the elements listed in the regulations 12 VAC35-105-160.E.?
• Level II states reporting occurs for incident that occurs or originates during the provision of service or on the premises of the provider. In the guidance document it exceeds this requirement for residential services and states residential providers are responsible 24 hours a day for an individual.  The provider may not be with the person 24 hours a day as they attend a day program, employed , with family and can only be held accountable for the time the person is with them.  This exceeds the regulations and should be changed.
• Level II serious injuries include an individual who is missing. The focus should be narrowed to residential and day programs as it becomes difficult to assess in other services that have less contact.
• Level II emergency room visits - How would we know if the ER was being used in lieu of a primary care visit? Does this include urgent care visits in lieu of seeing the PCP, even when the PCP offices are closed?
• Level II unplanned psychiatric or unplanned medical hospital admissions - If a client comes to the CSB to see a nurse and it is recommended to go to the ER is that reportable? Is that planned or unplanned? How do we handle voluntary hospitalizations, are they considered unplanned? Are they reportable? Considerations should be made to remove psychiatric hospitalizations as a reportable requirement.
• Diagnosis of decubitus ulcer, bowel obstruction or aspiration pneumonia is stated in the guidance documents as typically reported by residential services. Should be clearer to state that it only applies to residential services.
• Level III reporting - Level III. For level three reporting does the individual have the right to know what is being reporting to the state regarding what is shared with the provider?
• Level III. 2. Sexual assault of an individual - In an outpatient service this has serious impacts on the therapeutic relationship and the individual may feel additionally victimized by the reporting, and a root cause analysis completed. This should be moved to level II.

September 5, 2018

Emily Bowles, Legal Coordinator

Dept. of Behavioral Health & Developmental Services

PO Box 1797

Richmond, VA 23218-1797

Re: Comment on DBHDS Office of Licensing Guidance for Serious Incident Reporting

Dear Ms. Bowles,

The disAbility Law Center of Virginia (dLCV), the Commonwealth’s federally mandated protection and advocacy system, thanks you for the opportunity to comment on the proposed guidance document that the Department of Behavioral Health and Developmental Services has created for providers regarding the requirements for Serious Incident Reporting.  dLCV maintains that many providers are confused by reporting requirements, and that this confusion results in inconsistencies and errors.  The proposed guidelines will help alleviate confusion in some respects, but as proposed, may create more confusion.

For example, the proposed guidelines could be read to exempt providers from reporting certain Emergency Room visits. You provide some language on page two of the document “evaluating how to use the emergency room,” but it is not cast as a mandate. We recommend that you clarify as mandate the appropriate use of the emergency room and that there is no exemption for reporting ER visits.

On pages two and three of the document, concerning Item 4, unplanned psychiatric or unplanned medical hospital admission, it states that “Any time that an individual is admitted to the hospital due to an unplanned medical issue […] shall be reported.” The document should clarify every entity that is responsible for making that report.  

Item 4 also states, “If an individual is taken to the hospital after a qualifying event in accordance with their medical protocol, and is not admitted following evaluation, then the provider does not have to report the incident. If it is determined that the individual should be admitted, then the incident shall be reported.” We disagree with this distinction and recommend removing it.  CHRIS reports speak to provider action. The fact that the provider believes the individual should go to the hospital is more relevant than the hospital’s determination not to admit.  

Another concern relates to Item 7, which speculates that decubitus ulcers, bowel obstructions, and aspiration pneumonia will “generally be reported by a provider of residential services.”  We recommend revising this requirement so that all providers who discover such an issue will report it, not just residential providers.

Regarding review of incidents, part C on page five says that the provider must “collect, maintain and review” Level 1 serious incidents that are not reported to the Department. While dLCV believes this is a necessary step, we suggest that providers’ data analysis should also include Level 2 and 3 incidents to fully identify trends.

Of greater concern is that, under the proposed guidance document, the information required for collection and review by the provider does not have to be reported to DBHDS. The Department should require some level of reporting of those reviews, including identified trends and remedial actions, as part of its quality assurance efforts.

Our final concerns relate to sections D and E on pages six and seven of the document. In part D-2, providers are only required to report deaths if the individual was not yet discharged from services.  This is inconsistent with the reporting requirements established for state operated facilities.  State operated facilities must report all known deaths that occurred within 21 days of discharge. This standard is the proper measure for community based providers as well.

Also in this section, Part D-3 requires reporting seclusion and restraint (that is improper). Improper use of seclusion and restraint is abuse, under the Human Rights regulations. For consistency, dLCV suggests merging this section with D-1. (“1. Each allegation of abuse or neglect shall be reported to the department as provided in 12VAC35-115-230 A.”) and emphasizing that seclusion and restraint is abuse, except for very narrow circumstances. dLCV also suggests providing guidance to providers to clearly report when an injury is connected to an episode of seclusion and restraint.

The section on Root Cause Analysis states that sponsored residential providers are not required to include an “uninvolved superior” in the analysis. We disagree. In order to ensure the integrity of the analysis, there should always be an additional level of objectivity and accountability.

Thank you for your thoughtful consideration of dLCV’s comment and concerns.

Sincerely,

Colleen Miller

Executive Director

The comments to follow are being submitted by Community Residences, Inc.

Guidance for Serious Incident Reporting

As stated in other public comments, the Office of Licensing is attempting, by guidance, to expand regulatory requirements and dictate the method or approach that providers will use to satisfy the regulation(s) including:

• Reporting serious incident that occurred when the individual was NOT receiving services from the provider

• Defining the “best way” to conduct a root cause analysis and the use of the word “requirement” in the guidance language

• Mandating a root cause analysis for Level I incidents

It would be helpful to consistently use the term “serious incident”. Currently, CHRIS uses the term “serious injury” which causes confusion to users.

Will CHRIS be enhanced to include a Level II and Level III indicator? Will CHRIS be enhanced to provide a field or fields to capture the results of provider’s RCA?

To clarify reporting responsibility, it would be helpful to consistently define reportable serious incidents as incidents occurring during “the provision of their (provider’s) service or on the premises of the provider” in all guidance text. Requiring a provider to report serious incidents which occurred outside of their direct provision of services is unreasonable. ALL licensed providers are required to report Level II and Level III serious incidents, including day support, in-home supports, etc.

The definition of Level I serious incident is very broad - Level I “serious incidents" do not result in significant harm to individuals, but may include events that result in minor injuries that do not require medical attention, or events that have the potential to cause serious injury, even when no injury occurs. A plethora of events have the potential to cause serious injury. A succinct definition, with examples, would be helpful to clarify your intent.

The following guidance is contradictory and open to interpretation concerning the severity of the medical concern. If the intent is to say that Level I serious incidents are NOT required to be reported, the guidance should clearly state that. The first statement appears to mean that any incident where an individual is unexpectedly taken to the ER or Urgent Care must be reported. However, the second statement appears to be an exception to this rule.  The second statement appears to mean that if the individual was taken to the ER in accordance to a protocol and not admitted then no reporting is required. Please clarify.

3. An emergency room or urgent care facility visit when not used in lieu of a primary care physician visit;

The guidance below for Level II serious incidents is confusing and contradictory. Additionally, the guidance indicates that providers ae required to report “serious incident” even if they occurred during the provision of service by another provider or when an individual is visiting family.

• Providers are required to report Level II serious incidents that occurred, originated, or happened during the provision of service or on the premises of the provider.

• Residential Providers are responsible for individuals 24 hours, therefore required to report all incidents once notified.

Level II serious incident includes “allegation of financial exploitation”. All allegations – abuse, neglect, or exploitation - are required to be reported to the Office of Human Rights in CHRIS as “abuse” cases.  All allegations must be investigated as defined in the Human Rights regulations. Reporting allegations of exploitation as “serious injury” cases in CHRIS is redundant.

Level III serious incidents include “serious injury of an individual that results in or likely will result in permanent physical or psychological impairment”. Determining the likelihood of future impairment is highly subjective. To meet the 24-hour reporting requirement providers will need to make a decision regarding future impairment in the moment and most likely will not have facts or diagnosis to support their reporting decision.

Mandatory reporting of allegations of sexual assault without the consent of an adult individual receiving services would be considered a violation of their human rights and confidentiality. Additionally, reporting allegations of sexual assault, without consent, is contradiction of person-centered and trauma-informed practices. I do not believe this is the intent of the guidance. Adults have the right to choose reporting a criminal report to law enforcement agencies. However, citing mandated reporting law, licensed providers have a legal and moral responsibility to report all known allegations of abuse, sexual or otherwise, for “minors or incapacitated adults”. We suggest revising the language used to better define the intent of this guidance and the population(s) included. All allegations of sexual abuse by an employee of a licensed provider must be reported to CPS/APS and the Office of Human Rights in CHRIS as “abuse” cases. Reporting allegations of sexual assault as “serious injury” cases in CHRIS is redundant.

Guidance for a Quality Improvement Program:

As stated in other public comments, the Office of Licensing is attempting, by guidance, to expand regulatory requirements and dictate the method or approach that providers will use to satisfy the regulation(s) including:

• Referencing quality improvement policies and procedures when this language was specifically removed from the regulations

• Defining specific components/requirements for a provider’s annual review of their quality improvement program

• Requiring that the quality improvement plan be signed and dated by the person designated as responsible

OVERALL - The guidance document should not require elements that are not stated in the regulations.

Licensing Guidance on Serious Incident Guidance

• Throughout the document, the use of “receiving services” is used. This terminology could be interpreted to mean “enrolled” in services as opposed to meaning “during the provision of services,” however; it is not always clear throughout the guidance document the intention of the meaning.
• On page 1, it states that level II incidents are only required to be reported if occurred, originated, or happened during the provision of service or on the premises of the provider. On page 3 under “Unplanned psychiatric or unplanned medical hospital admission”, it says that “any time that an individual is admitted to the hospital for unplanned medical it is required to be reported.” This reads that even if the individual is admitted to the hospital outside of the provision of services (i.e. an individual receiving only outpatient services goes to the hospital for an emergency appendectomy while at home) this would need to be reported; which is contradictory to the definition of a level II incident and should be revised.
• On page 2, it states that residential providers are responsible for individuals 24 hours a day and are required to report all incidents once notified. This shifts the responsibility of licensed non-residential providers, e.g. group day/day support, etc. from reporting what has occurred under their supervision, which may also cause them to shift the responsibility of seeking medical care for the individuals.  Obtaining accurate information about an incident that occurred with another provider, especially if they didn’t report it or take it seriously, can be challenging for the residential provider.  This guidance contradicts the regulations which state that level II incidents are reported if occurring during the provision of service or on the premises. An individual may be with another provider, guardian, or with a community member during the incident.  Requiring a licensed residential provider to report on an incident that occurs within the confines of another licenses program/setting will also cause data regarding serious incidents to be inaccurate due to duplicate reporting of the same incident.  It is also inefficient for staff in both settings.  Remove the example at the top of page 2 related to this requirement and remove the language regarding residential providers being required to report all incidents. This goes beyond what is stated in the regulations and should be removed.
• On page 2 under “An emergency room or urgent care facility visit…” it states that Emergency rooms and urgent care centers should not be routinely used in lieu of a primary care physician. We have individuals whose PCP is located at an urgent care center and often go to the urgent care center for walk-in appointments to visit with their PCP. In addition, the first bullet states unexpected ER or urgent care visits assume that the incident was serious enough to warrant ER or urgent care. Individuals may utilize these services because an appointment with their PCP cannot be made in a timely matter (e.g., after-hours, weekend, holiday). This is not an accurate statement and should be removed.
• On page 3 regarding hospital admissions – “admissions for the purpose of observation” should not require reporting.
• On page 3 and 4 under “bowel obstruction” and “aspiration pneumonia,” the diagnosis of a bowel obstruction is not always known at the time of the medical appointment and therefore, the reporting would need to occur within 24 hours of the diagnosis and not incident discovery. The guidance should be updated to clarify this information.
• On page 4, Providers should not be required to report Level III incidents that did not occur on their premises or under their provision of services.  DBHDS should notify all providers after receiving the first report to avoid duplication.
• On page 5 under the quarterly review of Level I serious incidents; the guidance indicates to mandate for root cause analysis for all Level I serious incidents in the example provided regarding falls. This goes beyond what is stated in the regulations and should be removed.
• On page 6 under Level II and III reporting, information should be included to indicate that discovery of incident may be when the diagnosis is made, and not necessarily at the initial discovery of the “incident.”
• On page 7 under root cause analysis, the guidance goes beyond the regulations. The regulations do not prescribe a way to complete a root cause analysis. While the guidance seems to make suggestions as to the best way to implement (e.g., team approach); there are instances in this section of the guidance where the word “requirement” is used. The regulations do not require a team approach with an uninvolved supervisor. The guidance may suggest or recommend this approach but cannot make this a requirement. This goes beyond what is stated in the regulations and should be removed.
• Pages 5 and 8 provide examples of non-compliance from a provider for not providing information to DBHDS. These examples do not address other legal reasons in which a provider may not disclose information to DBHDS.

12VAC35-105620 – Quality Improvement Program Document

• The regulation was changed to indicate “develop and implement a quality improvement program…” The regulatory requirement to have quality improvement policies and procedures was specifically removed in the most recent update to regulations. However, under the department’s guidance box it indicates “[t]he provider’s policies and procedures should include direction related to their quality improvement program.” This goes beyond what the regulations indicate is required and should be removed.
• DBHDS’ examples of QI Plan key components go beyond what is stated in the regulations. The specific examples that go beyond what the regulations require are, "a quality statement”, “Quality Infrastructure” and “Culture of Safety and Quality”. These should be removed as the regulations do not require the information described to be included in a QI plan.

“The program shall: i. Include a quality improvement plan that is reviewed and updated at least annually.” The information provided in guidance goes beyond what is stated in the regulations in the following two requirements:

• “The annual review should also include an evaluation of the effectiveness of the quality improvement program and whether the provider seeks to change how quality improvement work is accomplished.”
• “The quality Improvement plan shall be signed and dated by the person designated as responsible for the quality improvement program and shall be readily available upon request by DBHDS.”

OVERALL - The guidance document should not require elements that are not stated in the regulations. Licensing Guidance on Serious Incident Guidance

• Throughout the document, the use of “receiving services” is used. This terminology could be interpreted to mean “enrolled” in services as opposed to meaning “during the provision of services,” however; it is not always clear throughout the guidance document the intention of the meaning.
• On page 1, it states that level II incidents are only required to be reported if occurred, originated, or happened during the provision of service or on the premises of the provider. On page 3 under “Unplanned psychiatric or unplanned medical hospital admission”, it says that “any time that an individual is admitted to the hospital for unplanned medical it is required to be reported.” This reads that even if the individual is admitted to the hospital outside of the provision of services (i.e. an individual receiving only outpatient services goes to the hospital for an emergency appendectomy while at home) this would need to be reported; which is contradictory to the definition of a level II incident and should be revised.
• On page 2, it states that residential providers are responsible for individuals 24 hours a day and are required to report all incidents once notified. This shifts the responsibility of licensed non-residential providers, e.g. group day/day support, etc. from reporting what has occurred under their supervision, which may also cause them to shift the responsibility of seeking medical care for the individuals. Obtaining accurate information about an incident that occurred with another provider, especially if they didn’t report it or take it seriously, can be challenging for the residential provider. This guidance contradicts the regulations which state that level II incidents are reported if occurring during the provision of service or on the premises. An individual may be with another provider, guardian, or with a community member during the incident. Requiring a licensed residential provider to report on an incident that occurs within the confines of another licensed program/setting will also cause data regarding serious incidents to be inaccurate due to duplicate reporting of the same incident. It is also inefficient for staff in both settings.  Remove the example at the top of page 2 related to this requirement and remove the language regarding residential providers being required to report all incidents. This goes beyond what is stated in the regulations and should be removed.
• On page 2 under “An emergency room or urgent care facility visit…” it states that Emergency rooms and urgent care centers should not be routinely used in lieu of a primary care physician. We have individuals whose PCP is located at an urgent care center and often go to the urgent care center for walk-in appointments to visit with their PCP. In addition, the first bullet states unexpected ER or urgent care visits assume that the incident was serious enough to warrant ER or urgent care. Individuals may utilize these services because an appointment with their PCP cannot be made in a timely matter (e.g., after-hours, weekend, holiday). This is not an accurate statement and should be removed.
• On page 3 regarding hospital admissions – “admissions for the purpose of observation” should not require reporting.
• On page 3 and 4 under “bowel obstruction” and “aspiration pneumonia,” the diagnosis of a bowel obstruction is not always known at the time of the medical appointment and therefore, the reporting would need to occur within 24 hours of the diagnosis and not incident discovery. The guidance should be updated to clarify this information.
• On page 4, Providers should not be required to report Level III incidents that did not occur on their premises or under their provision of services. DBHDS should notify all providers after receiving the first report to avoid duplication.
• On page 5 under the quarterly review of Level I serious incidents; the guidance indicates to mandate for root cause analysis for all Level I serious incidents in the example provided regarding falls. This goes beyond what is stated in the regulations and should be removed.
• On page 6 under Level II and III reporting, information should be included to indicate that discovery of incident may be when the diagnosis is made, and not necessarily at the initial discovery of the “incident.”
• On page 7 under root cause analysis, the guidance goes beyond the regulations. The regulations do not prescribe a way to complete a root cause analysis. While the guidance seems to make suggestions as to the best way to implement (e.g., team approach); there are instances in this section of the guidance where the word “requirement” is used. The regulations do not require a team approach with an uninvolved supervisor. The guidance may suggest or recommend this approach but cannot make this a requirement. This goes beyond what is stated in the regulations and should be removed.
• Pages 5 and 8 provide examples of non-compliance from a provider for not providing information to DBHDS. These examples do not address other legal reasons in which a provider may not disclose information to DBHDS.

12VAC35-105620 – Quality Improvement Program Document

• The regulation was changed to indicate “develop and implement a quality improvement program…” The regulatory requirement to have quality improvement policies and procedures was specifically removed in the most recent update to regulations. However, under the department’s guidance box it indicates “[t]he provider’s policies and procedures should include direction related to their quality improvement program.” This goes beyond what the regulations indicate is required and should be removed.
• DBHDS’ examples of QI Plan key components go beyond what is stated in the regulations. Thespecific examples that go beyond what the regulations require are, "a quality statement”, “Quality Infrastructure” and “Culture of Safety and Quality”. These should be removed as the regulations do not require the information described to be included in a QI plan.

“The program shall: i. Include a quality improvement plan that is reviewed and updated at least annually.” The information provided in guidance goes beyond what is stated in the regulations in the following two requirements:

• “The annual review should also include an evaluation of the effectiveness of the quality improvement program and whether the provider seeks to change how quality improvement work is accomplished.”
• “The quality Improvement plan shall be signed and dated by the person designated as responsible for the quality improvement program and shall be readily available upon request by DBHDS.”