105 CMR, § 130.332

Current through Register 1533, October 25, 2024

Section 130.332 - Serious Reportable Events (SREs) and Serious Adverse Drug Events (SADE)

(A)Definitions Applicable to 105 CMR 130.332.

National Quality Forum (NQF). The not-for-profit membership organization created to lead national collaboration to improve health and measurement and reporting.

Preventable. An event that could have been anticipated and prepared for, but that occurs because of an error or other system failure, including, but not limited to lack of adherence to best practices, patient safety guidelines or established policies and procedures.

Serious Adverse Drug Event (SADE). Any untoward, preventable medical occurrence associated with the use of a controlled substance, as defined in M.G.L. c. 94C, § 1, in humans that results in any of the following outcomes:

(1) death;

(2) a life-threatening outcome;

(c) inpatient hospitalization or prolongation of existing hospitalization;

(d) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or

(e) a congenital anomaly or birth defect; provided, however, that adverse medical occurrences directly associated with the use of a controlled substance in humans that may not immediately result in one of the outcomes listed in 105 CMR 130.332: Serious Adverse Drug Event (SADE) (a) through (e) may be considered a serious adverse drug event when they develop into or result in any of the outcomes listed in 105 CMR 130.332: Serious Adverse Drug Event (SADE) (a) through (e).

Serious Reportable Event (SRE). An event that occurs on premises covered by a hospital's license that results in an adverse patient outcome, is clearly identifiable and measurable, has been identified to be in a class of events that are largely preventable and harmful, and of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the hospital. The Department will issue a list of SREs based on those events included on the NQF table of reportable events to which 105 CMR 130.332 applies.

Unambiguously the Result of a System Failure. Events determined by the hospital to result from:

(1) a failure to follow the hospital's policies and procedures;

(2) inadequate or non-existent hospital policies and procedures; or

(3) inadequate system design.

(B)Reporting of SREs.

(1) Within seven calendar days of the date of discovery of an SRE, a hospital shall:

(a) file a written report with the Department of an SRE (SRE report) as specified in guidelines of the Department;

(b) inform the patient or the patient's representative orally or in writing or both about:

1. the occurrence of the SRE including unanticipated outcomes of care, treatment and services provided as the result of an SRE;

2. the hospital's policies and procedures and documented review process for making a preventability determination as required by 105 CMR 130.332(C); and

3. the option to receive a copy of the SRE report filed with the Department; and

(c) affirm on the SRE report that the hospital has complied with the patient notification requirements of 105 CMR 130.332(B)(1)(b).

(2) A hospital that provides services resulting from an SRE that did not occur on its premises shall file a written report with the Department within seven calendar days of the date of discovery of the SRE. The reporting hospital shall comply with the requirements of 105 CMR 130.332(B)(1), but need not make a preventability determination for the SRE.

(3) If a SRE is also a SADE, the hospital shall also comply with the requirements of 130.332(E).

(C)Preventability Determination.

(1) A hospital shall establish policies and procedures for a documented review process to determine whether an SRE was:

(a) preventable; and

(b) unambiguously the result of a system failure. A hospital shall make a preventability determination for all SREs occurring on premises covered by its license.

(2) No later than 30 days after the date of reporting of the SRE to the Department the hospital shall:

(a) make the preventability determination required by 105 CMR 130.332(C)(1);

(b) file an updated SRE report with the Department describing the hospital's preventability determination including, at a minimum, the following:

1. narrative description of the SRE;

2. analysis and identification of the root cause of the SRE;

3. analysis of the preventability criteria required by 105 CMR 130.332(C)(1);

4. description of the corrective actions developed, implemented and to be monitored by the hospital following discovery of the SRE; and

5. whether the hospital intends to charge or seek reimbursement for services provided by the hospital as a result of the SRE; and

(c) provide a copy of the updated SRE report to the Department, the patient and any responsible third-party payer.

(D)Reimbursement for SREs.

(1) A hospital may not charge or seek reimbursement from a patient or responsible third-party payer for services provided as a result of an SRE occurring on premises covered by the hospital's license if the hospital determines that the SRE was:

(a) preventable; and

(b) unambiguously the result of a system failure, as required by 105 CMR 130.332(B) and (C).

(2) A hospital shall immediately suspend or rescind any claims to any patient or responsible third-party payer pending the preventability determination and notification requirements of 105 CMR 130.332(C).

(3) A hospital may charge or seek reimbursement for services it provides that result from an SRE that did not occur on its premises; however a hospital that provides services (treating facility) resulting from an SRE occurring on premises of a separately licensed hospital or an ambulatory surgery center licensed pursuant to 105 CMR 140.000: Licensure of Clinics (responsible facility), may not charge or seek reimbursement for those services, if the treating facility and the responsible facility have common ownership or a common corporate parent.

(4) Any dispute(s) arising between the hospital and any responsible third-party payer resulting from a charge or claim for reimbursement for services provided by the hospital as a result of an SRE shall be addressed through the third-party payer's provider claims appeals process.

(5) The provisions of 105 CMR 130.332(D) shall not be construed to prohibit a Medicare provider from submitting a claim for reimbursement to the Medicare program.

(6) For services to MassHealth members, the hospital shall perform the documented review process solely for purposes of reporting, not for purposes of determining reimbursement.

(E)Serious Adverse Drug Events.

(1) Within seven days of the date of discovery of a medication error that occurs or occurred on the premises of the hospital and that meets the definition of a SADE, a hospital shall report the SADE to the Department as specified in guidelines of the Department.

(2) If a SADE also is an SRE, the hospital shall also comply with the requirements of 105 CMR 130.332(B), (C) and (D).

(3) Upon first discovering, through diagnostic evaluation and assessment of an individual patient, that a SADE has resulted from a patient's use, consumption or interaction with any pharmaceutical or drug preparation, a hospital must report the event to the federal MedWatch Program, as well as the pharmacy from which the drug was produced or compounded in addition to all other reporting requirements.

(4) Any facility failing to comply with 105 CMR 130.332(E) may:

(a) be fined up to $1,000 per day per violation;

(b) have its license revoked or suspended by the Department; or

(c) be fined up to $1,000 per day per violation and have its license revoked or suspended by the Department.