Current through Register 1531, September 27, 2024
(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.
