“Even though the root cause analysis has not been required in the past, DBHDS indicates that the facilities would readily have many elements for such analysis and the analysis would not take more than 15 minutes in most cases. Thus, some administrative costs may be imposed on regulated facilities. However, the root cause analysis is also expected to improve quality and risk management at the regulated facilities.”

12VAC35-105-160. Reviews by the department; requests for information; required reporting. The root cause analysis shall include at least the following information: (i) a detailed description of what happened; (ii) an analysis of why it happened, including identification of all identifiable underlying causes of the incident that were under the control of the provider; and (iii) identified solutions to mitigate its reoccurrence when applicable. A more detailed root cause analysis, including convening a team, collecting and analyzing data, mapping processes, and charting causal factors should be considered based upon the circumstances of the incident.

Comment: The administrative work required to complete a root cause analysis with the minimal elements far exceeds 15 minutes.  Additionally, it is unclear when the provider would be required to assemble a team in order to complete additional analysis. Many serious incidents already require supplementary investigation in order to determine if a client’s Human Rights were violated which already includes many of the elements outlined above.

12VAC35-105-160. Reviews by the department; requests for information; required reporting 2. Level II and Level III serious incidents shall be reported using the department's web-based reporting application and by telephone [ or email ] to anyone designated by the individual to receive such notice and to the individual's authorized representative within 24 hours of discovery.

Comment: The 24-hour requirement is unrealistic for providers to complete on the weekends and holidays.  Many smaller organizations only have one or two individuals that are permitted to input information into the web-based reporting application.  Imposing a 24-hour requirement (not 24 business hours) makes it so individuals responsible for these reports are not able to have time off. In addition, Licensing requires updates to the reports 24 to 48 hours after discovery forcing the provider to log back into the system in a short period of time.

"Missing" means a circumstance in which an individual is not physically present when and where he should be and his absence cannot be accounted for or explained by his supervision needs or pattern of behavior

Comment: Many advocates and specialists disagree on the interpretation of a missing individual.  In the proposed language, “his absence cannot be accounted for or explained by his supervision needs or pattern of behavior” implies that an elopement should not be characterized as a Level II serious incident if the client has a history of running or has several instances of elopement.  The department should provider more clear guidance on elopements including a timeframe for when an individual should be considered missing.   

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

E. A root cause analysis shall be conducted by the provider within 30 days of discovery of Level II serious incidents and any Level III serious incidents that occur during the provision of a service or on the provider's premises.

Comment: Many events that fall under the criteria for a Level II incident are unavoidable for a program to encounter; particularly when the age, trauma history, and population of clients served is accounted for. For example, a client twists his ankle when playing basketball (an injury that requires medical attention by a physician) or a client experiencing suicidal ideation is admitted to psychiatric acute (an unplanned psychiatric hospital admission).  Additionally, the program provided appropriate care and followed all procedures.  In these situations, completing a root cause analysis in addition to all other documentation to meet reporting requirements is excessive given the nature of the events.  Similarly, completing a root cause analysis implies the provider has control in order to eliminate these events from occurring in the future.  I propose that a root cause analysis only be required for Level III serious incidents.

12VAC35-105-170. Corrective action plan.

A. If there is noncompliance with any applicable regulation during an initial or ongoing review, inspection, or investigation, the department shall issue a licensing report describing the noncompliance and requesting the provider to submit a corrective action plan for each violation cited.

Comment: The department should establish a timeline for issuance of a corrective action plan to a provider after a review, inspection or investigation.  There have been multiple instances when a CAP was issued several months after an inspection.  Additionally, the department should further define a timeline for the acceptance of a CAP by a specialist.

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

D. The initial ISP and the comprehensive ISP shall be developed based on the respective assessment with the participation and informed choice of the individual receiving services. To ensure the individual's participation and Regulations Volume 36, Issue 6 Virginia Register of Regulations November 11, 2019 876 informed choice, the provider shall explain to the individual or the individual's authorized representative, as applicable, in a reasonable and comprehensible manner the proposed services to be delivered, alternative services that might be advantageous for the individual, and accompanying risks or benefits.

Comment: it is unclear if the provider should document the informed choice at the onset of services, throughout, or during discharge planning.