Comments regarding draft guidance document re:
12VAC35-105 Incident Reporting Requirements
General Comments:
Guidance Document
“When the provider must update an incident report in CHRIS after the initial submission, the provider must do so within 48 hours from the initial submission of the incident report, or from the time that the provider is informed by the IMU of the need to update the report, whichever is later. Failure to update a serious incident report in CHRIS within 48 hours from the initial submission of the report, or from the time that the provider is informed by the IMU of the need to update the report, will be cited as a regulatory violation of 12VAC35-105-160.F. or 12VAC35-46-230.A., as applicable.”
Guidance Document:
“Progressive Actions for Repeat Citations:
Beginning June 15, 2020, the Office of Licensing will implement progressive citation protocols to address repeat violations of serious incident documentation and reporting requirements. The purpose of these protocols is to ensure that providers who demonstrate regulatory noncompliance implement effective corrective actions and quality improvement activities to prevent future violations. When a provider has been previously cited for a regulatory violation, future violations of the same regulation will result in the following progressive actions:
First Citation: When issued related to the reporting of serious incidents, deaths, or allegations of abuse or neglect within a two-year period, the provider will be issued a licensing report citing: 12VAC35-105-160D.2. or 12VAC35-46-1070. C., as applicable, for noncompliance with reporting requirements.
Second Citation: When issued related to the reporting of serious incidents, deaths, or allegations of abuse or neglect within a two-year period, the provider will be issued a licensing report citing: 12VAC35-105-160. D.2. or 12VAC35-46-1070. C., as applicable, for systemic noncompliance with reporting requirements; AND 12VAC35-105-170. G. or 12VAC35-46-80. B., as applicable, for failure to implement the previously pledged CAP.
Third Citation: When issued related to the reporting of serious incidents, deaths, or allegations of abuse or neglect within a two-year period, the provider will be issued a licensing report citing: 12VAC35-105-160. D.2. or 12VAC35-46-1070. C., as applicable, for systemic noncompliance with reporting requirements; AND 12VAC35-105-170. G. or 12VAC35-46-80. B., as applicable, for failure to implement the previously issued CAP. The Department of Medical Assistance Services (DMAS) will be copied on the licensing report when a third citation is sent out. In addition, the department may mandate serious incident reporting training for the provider’s employees, with costs borne by the provider, when it is determined that a lack of training caused or contributed to the licensing or human rights violations pursuant to Code of Virginia § 37.2-419 and 12VAC35-105-100.A. or 12VAC35-46-60.G.; or require the provider to submit a signed attestation verifying that the regulations and guidance pertaining to serious incident reporting were reviewed(Note: Memos from this office are guidance).
Fourth Citation: When issued related to the reporting of serious incidents, deaths, or allegations of abuse or neglect within a two year period, in addition to the steps enumerated above for the third citation, the Office of Licensing may do any of the following: Deny an application for a license or license renewal (Code of Virginia § 37.2-418 and 12VAC35- 105-110 or 12VAC35-46-120); Issue a provisional license (Code of Virginia § 37.2-415 and 12VAC35-105-50A.2. or 12VAC35- 46-90. B.); or Revoke or suspend a full, conditional, or provisional license, due to the provider’s repeated failure to submit or implement an adequate CAP (Code of Virginia § 37.2-418 and 12VAC35- 105-110 or 12VAC35-46-1630).”