Reporting of serious reportable events may impact peer review

By Mario Motta, M.D.
For some time, state regulations on hospital licensure have required hospitals to report serious incidents that affect patient health and safety to the Department of Public Health (DPH). In 2007, DPH revised its rules to require the identification and reporting of incidents that meet the National Quality Forum’s (NQF) definitions of serious reportable events.

NQF is a national nonprofit group of health care organizations dedicated to improving health care quality measurement and reporting.

In 2002, it developed a list of 28 events it considers serious reportable events (SREs), grouped into the following six categories:

•    Surgical, such as an instrument left in a patient,
•    Product or device, such as contaminated drugs or a malfunctioning device,
•    Patient protection, such as if an infant is discharged to the wrong person,
•     Care management, such as a medication error,
•    Environment, such as a fall in a health care facility, or
•    Criminal event, such as an abduction or sexual assault of a patient.

“By creating a clear, unambiguous and standardized list,” the agency wrote, “NQF aims to bring greater transparency to health care and an opportunity to learn from mistakes and take swift actions to improve patient safety.”

“The errors are of concern to the public and health care providers and warrant careful investigation that should be targeted for mandatory public reporting,” NQF said.

More than half the states, including Massachusetts, now require reporting of SREs, with many others considering such a system.

Here in the Commonwealth, DPH, following a legislative mandate in last year’s cost containment reforms, has added amendments to its original requirements that compel a hospital to “make a preventability determination” following a documented review process for all SREs.

Hospitals must determine if the event was (1) preventable, (2) within the hospital’s control and (3) unambiguously the result of a system failure based on the hospital’s policies and procedures.
DPH states that the “revised amendments promote quality improvement and accountability through internal review and assessment and public reporting, and by prohibiting payment for SRE-related costs (i.e., payment for the original error and the costs of correcting the error).”

DPH also requires hospitals to include a “root cause analysis” as part of the preventability determination, which will be reported to DPH, third-party payers and the patient.

No one questions the necessity, professional importance or ethics of discovering the cause of an error. The patient deserves no less, and such findings invariably lead to improved patient safety efforts and systems.
But the new regulations do raise questions and concerns (putting aside the financial issue of SRE-related costs).

By requiring hospitals and physicians to conduct and report root cause analyses of SREs, DPH is essentially mandating a peer review process for such acts. Recognizing that peer review proceedings are protected under state law, will such actions change the nature of peer review? Will they improve the process or lead to reduced participation? Will hospitals have to change their by-laws on peer review to ensure protection of these new reports? And how will the new reporting affect facilities such as ambulatory surgery centers, where peer review is not an established part of the legal system?

Another concern is the confidentiality of the DPH reports. While peer review is protected, will
the DPH reports have the same safeguards?

This is a new reporting process, untested in the courts. Will it be subject to disclosure by subpoenas or requests under the Freedom of Information Act?  And will it lead to more medical malpractice cases?

Initial DPH responses to these questions indicate that the reports will not need to include patient-specific or provider-specific information. However, the identity of the parties in many cases will be well known and may be established by other means. The courts have found in prior cases that even if material is publicly disclosed, it is not admissible in court.

At the heart of the NQF’s actions in compiling the list of SREs is the idea that transparency and accountability are critical to reducing medical errors. No one disputes that notion.

But reporting procedures without adequate safeguards for confidentiality have the potential to weaken the reporting and review process, making parties less likely to be frank and open.

A sound course of action would be for DPH to issue ironclad assurances that such reporting will not compromise peer review processes. Absent that, legislative action may be needed, just as it was to protect the peer review process.

Mario Motta, M.D. is president of the Massachusetts Medical Society.