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.”