14- 197 C.M.R. ch. 12, § 3

Current through 2024-51, December 18, 2024

Section 197-12-3 - REPORTABLE EVENTREVIEW AND FOLLOW-UP

1.Provider Reportable Event Internal Review and Remediation

A. When a Provider becomes aware that a Reportable Event has been reported involving an Individual Receiving Services under the Provider's care (whether through the Reportable Event Database or otherwise), the Provider shall conduct an Internal Review into the circumstances surrounding the Reportable Event.

i. The Internal Review may involve, but is not limited to, the following:

1. Communication with the Individual Receiving Services, if appropriate;

2. Communication with any witnesses to the Reportable Event , if appropriate;

3. Survey of the area where the Reportable Event occurred, if appropriate.

B. The Provider and the Individual Receiving Services' Case Manager or Care Coordinator shall communicate as part of the Internal Review process and work cooperatively to determine the cause of the Reportable Event and to identify potential Remediation Action Steps.

C. Following the Internal Review, the Provider shall determine what, if any, Remediation Action Steps would decrease the likelihood that such an incident will reoccur.

D. Reporting Reportable Event and conducting Internal Review and remediation of Reportable Event does not preclude Providers from conducting reviews and identifying Remediation Action Steps related to other events, incidents, or observations that are not identified within the categories of Reportable Event listed in Section 2(2)(A)(1) -(16).

2.Provider Reportable Event Follow-Up

A.Provider Follow-Up Report

i. Following the Provider Internal Review, the Provider shall submit a Follow-Up Report to the Department through the Reportable Event Database outlining the following:

1. The date and time of the Reportable Event and, if the Reportable Event is reported in the Reportable Event Database more than one business day from the time of the Reportable Event, an explanation for the delay in reporting;

2. A summary of the circumstances that resulted in the Reportable Event ;

3. An outline of any Remediation Action Steps that were taken following the Reportable Event to decrease the likelihood that the same or a similar incident will reoccur, including the date(s) of implementation and the party or parties responsible for implementing each Remediation Action Step;

4. An outline of any future Remediation Action Steps that will be taken to decrease the likelihood that such an incident will reoccur, including the planned dates of implementation, if applicable, and the party or parties responsible for implementing each Remediation Action Step;

5. If no Remediation Action Steps have been or will be taken in response to the incident, an explanation as to why Remediation Action Steps are not necessary.

ii. The Provider Follow-Up Report on a Reportable Event shall be submitted into the Reportable Event Database no later than thirty (30) calendar days from the date of the Reportable Event.

3.Case Manager and Care Coordinator Reportable Event Follow-Up

A. The Case Manager or Care Coordinator shall review the Reportable Event Database to determine whether Provider Reportable Event Follow-Up has taken place and ensure that Remediation Action Steps are reflected in the person-centered plan of the Individual Receiving Services, as necessary.

B. The Case Manager or Care Coordinator shall consult with the Individual Receiving Services on the Remediation Action Steps taken or to be taken by the Provider in a manner that demonstrates inclusion and informed consent of the Individual Receiving Services and his or her legal guardian as appropriate.

4.Additional Follow-Up on Reportable Event that involve the Death of an Individual Receiving Services

A.Mortality Review Form

i. Following any Reportable Event that involves the death of an Individual Receiving Services, the Individual Receiving Services' Case Manager or Care Coordinator shall complete the Mortality Review Form within the Reportable Event Database.

ii. The Mortality Review Form shall be submitted into the Reportable Event Database no later than ten (10) business days from the date of the Reportable Event involving the death of an Individual Receiving Services.

iii. In the event that the Case Manager or Care Coordinator is not available at the time of death, a supervisor of the Case Manager or Care Coordinator shall complete the Mortality Review Form within the required timeframe.

B.Mortality Review Committee

i. The Mortality Review Committee will conduct trend analysis based on completed Mortality Review Form aggregate data.

ii. The Mortality Review Committee will meet quarterly to review any identifiable patterns and trends related to the deaths of Individuals Receiving Services.

iii. The Mortality Review Committee will produce an annual report to the Commissioner that outlines trend analysis findings and makes recommendations to improve care for Individuals Receiving Services.

5.Additional Follow-Up on Reportable Events Involving Rights Violations

A. The Protection and Advocacy Agency shall have access within the Reportable Event Database to Reportable Events that involve one or more alleged Rights Violations.

B. The Protection and Advocacy Agency may investigate any Reportable Event that involves one or more alleged Rights Violations.

C. Providers must cooperate fully with the Protection and Advocacy Agency during any investigation of a Reportable Event involving one or more Rights Violations.

D. Requirements within this Rule related to Provider Reportable Event Internal Review, Remediation, and Follow-Up Reports are not impacted by whether the Protection and Advocacy Agency investigates a Reportable Event involving one or more alleged Rights Violations. Provider requirements following a Reportable Event involving one or more alleged Rights Violations are governed by Section 3.

6.Department and Provider Aggregate Reportable Event Review

A. Providers shall conduct trend analysis of Reportable Event data on an ongoing basis, at least quarterly, in order to identify areas where services may be improved to ensure the health and safety of Individuals Receiving Services.

B. The Department will meet quarterly with every Provider required to report Reportable Event in accordance with this Rule to discuss Reportable Event data collected during the previous quarter, including, but not limited to:

i. The total number of Reportable Event involving Individuals Receiving Services under the Provider's care during the quarter;

ii. Any identified trends and patterns associated with Reportable Events;

1. Examples of data sets that may be identified and discussed are:

a. Aggregate Reportable Events per quarter per Individual Receiving Services by Reportable Event type;

b. Aggregate Reportable Events per quarter by Provider site by Reportable Event type;

c. Increases and decreases in the number of Reportable Events reported from the previous quarter or previous year;

d. Increases and decreases in the number of Reportable Event types from previous quarters or previous years.

iii. The adequacy and effectiveness of the Provider's Reportable Event Reviews, Remediation Action Steps, and Follow-Up Reports and the timeliness of same;

iv. Comparison of any trend analysis performed by the Department with trend analysis performed by the Provider.

14- 197 C.M.R. ch. 12, § 3