Massachusetts Coalition for the Prevention of Medical Errors

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500 District Avenue ● Burlington, MA 01803 781-262-6080 ● www.macoalition.org The Massachusetts Coalition for the Prevention of Medical Errors is a 501(c)3 organization. October 28, 2016

Catrice C. Williams Office of the General Counsel Department of Public Health 250 Washington Street Boston, Massachusetts 02108

Re: Hospital Licensure Regulations

Dear Ms. Williams,

Thank you for this opportunity to submit comments on the proposed changes to regulation 105 CMR 130.000 on behalf of the Board of the Massachusetts Coalition for the Prevention of Medical Errors (the Coalition).

(We note that Eric Sheehan, an ex officio member of our Board, did not participate in the discussions since we are commenting about the regulations of the Bureau of Health Care Safety and Quality.)

In our review, the Coalition has sought to represent the concerns of our multi-stakeholder membership, who continue to advocate that patient safety oversight programs and agency reporting requirements should be built on a core set of safety principles, and should be coordinated to ensure not only accountability but also maximal improvements in patient safety without undue regulatory burden. The principles include: - Grounding in safety science including systems thinking and Just Culture - Deep learning from adverse events, and strong corrective strategies within a healthcare organization - Shared learning across healthcare organizations - Reducing regulatory redundancy and burden that produces no benefit

1. Overall recommendation: Thorough consultation among all parties, including interagency discussion

The Coalition strongly support the administration’s intent of reviewing existing regulations to assess that there is a clearly identified need, that regulations are clear and concise, and to consider if they create an excessive burden . We have a concern that issuing large numbers of proposed regulations for public comment over a short period of time risks the effective achievement of these goals.

We recommend that there be substantial consultation with all parties after the public comment period to ensure that the intent of regulatory changes can be clarified, communication about impacts is clear, complete, and well understood, and opportunities for approaches that meet shared goals among the interested parties are pursued and achieved as much as possible.

We would also strongly recommend that there be interagency discussions, in consultation with stakeholders, since there are regulations across agencies which are related and should be coordinated to reduce redundancy and unnecessary burden. We recommend these discussions include the Department of Public Health through the Bureau of Health Care Safety and Quality and the Bureau of Health Professions Licensure, together with the Board of Registration in Medicine, including its Division of Quality and Patient Safety. We would additionally recommend that the Betsy Lehman Center for Patient Safety be included in these discussions, given their recent work creating a Navigator tool for events to be reported to state agencies.

500 District Avenue ● Burlington, MA 01803 781-262-6080 ● www.macoalition.org The Massachusetts Coalition for the Prevention of Medical Errors is a 501(c)3 organization. 2. Related to the addition to 130.331 Serious Incident and Accident reports – “ (7) Reports on surgery-related and anesthesia-related complications that result in serious morbidity or death of a patient”

We acknowledge that we did not understand the intent of adding this section, as currently worded, and its value for improving patient safety. It seems so broad that it will create a substantial burden of reporting, without focusing on cases that represent preventable complications. It also seems to overlap a more narrowly defined set of events which are currently reported to the Quality and Patient Safety Division of the BORIM, those called Type 4, resulting in “Death or major or permanent impairment of bodily function that was not ordinarily expected as a result of the patient’s condition or presentation.”

We do not support this language in its current form, and recommend consultation with stakeholders, including patient safety experts, hospitals, consumers, and Quality and Patient Safety Division of Board of Registration in Medicine, to consider whether there are incidents that represent an imminent risk that are not adequately addressed by the current reporting to DPH/BORIM, and if so, how could they be addressed in a more narrow and specific definition of incidents.

3. Related to 130.332 Serious Adverse Drug Event ( SADE) Sections (E) (1) and (2)

Again, we acknowledge that we may not understand the intent of adding these two sections, as currently worded, and their value in improving patient safety. It seems possible under this wording that hospitals would be required to report adverse drug events beyond those that would be considered medical errors. It also appears that redundant reporting is intended by section (2).

We would recommend consultation with the stakeholders to clarify the intent of reporting, and to design an approach and definition that would meet that intent without redundant or unduly burdensome reporting.

4. Related to 130.332 (B) and (C): the seven and 30 day letters to patients and insurers after a Serious Reportable Event

Our Board supports the simplification of the process, to eliminate the 7 day letter to the third party payer, and now require only one letter to be sent at 30 days.

While we also appreciated the effort to simplify communications with the patient, upon consultation with our consumer members, we did not reach agreement to eliminate the requirement for written communication at seven days following the event. We strongly recommend engaging in further consultation with Patient and Family Advisory Councils, other consumer representatives, and with patient safety experts and hospitals, about the elements and process of communication to ensure that they are patient –centered and appropriate for patients and families at this extremely difficult time.

Again, we deeply appreciate the Department of Public Health taking on this significant task of reviewing all existing regulations, and the goals of this review, but would strongly recommend further consultation with the stakeholders, as part of interagency discussions, to ensure an effective outcome for patient safety and reducing undue regulatory burden. If you have any questions on our comments, please contact me at 781-262-6081 or [email protected]

Sincerely,

Paula Griswold Executive Director

500 District Avenue ● Burlington, MA 01803 781-262-6080 ● www.macoalition.org The Massachusetts Coalition for the Prevention of Medical Errors is a 501(c)3 organization.