By Greg Freeman
EXECUTIVE SUMMARY
State laws on privilege for quality assurance processes vary from state to state. Some states offer more protection than others.
- A recent New York court ruling undermined the privilege afforded to morbidity and mortality conferences.
- Anonymous minutes of a meeting backfired on one hospital.
- The scope of the privilege always is limited.
Risk managers and clinicians depend on the ability to investigate adverse outcomes or errors without fear their words will be used against them in court, most notably in morbidity and mortality conferences and peer review sessions. The degree of protection varies from state to state — and there is some concern this privilege has been eroded.
A recent report from New York illustrates the dangers posed by court interpretations and how healthcare organizations’ fear of liability can be problematic, says lead author Vikas Mehta, MD, MPH, FACS, vice chair and associate professor of otorhinolaryngology, head and neck surgery at Montefiore Medical Center in Bronx, NY.
The report by Mehta and his co-author explains a case from November 2015. A man suffered a head injury and died after he was removed from life support. The case was discussed at the trauma peer review committee with two physicians involved in his care. In 2016, the family filed a malpractice suit and requested the patient’s hospital records, including the minutes of the trauma peer review meeting.1
The defendants tried to limit the full disclosure of the peer review meeting minutes to statements made by the named defendants in accordance with New York laws. A court ruled the peer review minutes were not protected because of exceptions for the discovery of statements made by a party to the lawsuit. The hospital appealed, arguing many of the comments during the peer review meeting could not be attributed to individuals.
The hospital lost the appeal. “By failing to properly identify each speaker, the defendants have failed to establish its entitlement to the quality-assurance privilege as they have not met their burden of demonstrating that the statements were not made by a party,” the court concluded. The hospital had to turn over the minutes of the peer review meeting.
By keeping the peer review records anonymous, the hospital had to release much more information from the peer review minutes than if it had been able to specify only the comments made by involved parties, Mehta explains.
The experience prompted the entire multihospital health system to change its policy on quality assurance conferences. They now discuss only theoretical cases rather than actual adverse events or complications.
“The issue is that now there is precedent out there for the minutes to be obtained. That’s what makes me the most concerned. I think it’s an overreaction on the part of the health system,” Mehta says. “But I can see where they’re coming from.”
Mehta acknowledges the plaintiff’s legal team maneuvered the hospital into a potentially damaging situation. But once the precedent has been set, the door is open for it to happen again.
The court’s ruling does not affect the peer review process as much as department morbidity and mortality conferences, Mehta notes. Parties to a lawsuit participate in the morbidity and mortality conferences, making their comments discoverable, according to the court ruling.
“You could argue that those meetings are a much more important aspect of patient safety culture because it includes the people who are actually involved with the problem,” Mehta says. “Getting their input on what happened and why and having them look into it is very important — oftentimes more salient to fixing the issues.”
New Jersey Addresses Pharmacy Safety
Although the ruling applies only in New York, Mehta notes every state has enacted its own laws regarding privilege. The exact formulation could make some states vulnerable to the same loophole. Mehta is working with other concerned healthcare leaders to contact the state medical society and urge action by the state legislature to restore the privilege of these meetings.
“This is something that people should hear about, because it’s not a small, isolated thing,” Mehta notes. “It’s a major hospital system in New York.”
Recently, New Jersey introduced the Continuous Quality Improvement Program, which requires pharmacy incidents to be recorded and investigated for learning purposes, says Satish V. Poondi, JD, partner with Trenk Isabel Siddiqi & Shahdanian in Livingston, NJ. Other states have enacted similar regulations.
The intent of the regulation is good, Poondi says, but it does raise questions for practitioners about what is discoverable. When a pharmacy error is involved in an adverse event, plaintiffs’ attorneys will want access to the information the state requires to be reported.
“There is a concern that as a practitioner, you might be unwittingly or unknowingly putting out a roadmap for the plaintiff, making their case a lot easier and shifting that burden,” Poondi says.
The regulation is relatively new, so there has not been much chance to see how those concerns will play out. Most pharmacies are implementing the required policies and procedures, but Poondi says it is likely a test case will arise soon.
“Then, you get to the second step as to how you implement it, abiding by the spirit and the letter of the law but at the same time protecting your practice from inadvertent disclosures,” Poondi explains “That might be something as simple as how you’re documenting something, maybe using the wrong language. You suspect something may have happened, but you put it down as that it happened.”
Limited Privilege
It is important to understand that the peer review privilege is limited and does not afford blanket protection of all documents relating to peer review, says Peter Lehr, JD, an attorney with Norris McLaughlin in Allentown, PA. The language of a state’s peer review act limits application, and a common example would be that the privilege attends to “proceedings” of the medical review committee conducting peer review, he says.
The decisions of state courts that involve whether peer review documents are admissible further limit the scope of the privilege and often focus on what constitutes proceedings, Lehr says. Risk managers should closely review these state court decisions. The supreme court of one state ruled the peer review privilege applies to the substantive exchanges that transpire during a peer review meeting, but not for any knowledge gained by a committee member independent of the meeting.
“It is also key to recognize the risk that even if discussions enjoy protection against disclosure under the peer review privilege, if they are divulged or disclosed beyond the committee, the privilege may be lost, and the matters will be subject to discovery and admission into evidence in a civil suit,” Lehr explains. “It is recommended that reports or referrals of matters should be done directly to the peer review committee. The peer review committee should ensure that its analysis and discussions are not disclosed or shared with individuals outside the committee context. Email communication of peer review matters should be avoided to preserve the privilege and prevent inadvertent disclosures.”
While all states have enacted some legislation to protect the peer review process, these statutes vary from state to state in terms of the level of protection, says Khaled John Klele, JD, partner with Riker Danzig in Morristown, NJ. In most states, the privilege is limited to certain committees that are formed in hospitals or for certain topics, such as adverse events.
For example, the applicable New Jersey statute provides a privilege limited to only documents submitted to the Department of Health in connection with certain adverse events and documents used “exclusively” during self-critical analysis, which is further limited to three scenarios. Like New Jersey, the courts in Pennsylvania have held that Pennsylvania’s Peer Review Protection Act only applies to documents that were generated and used exclusively by a peer review committee, Klele says. New Jersey also provides immunity for utilization review committees. A party challenging the privilege can demand the court review the subject documents in camera for purposes of making privilege determinations.
“Unlike some privileges, such as the attorney-client privilege, many courts tend to narrowly construe the privilege governing the peer review process,” Klele explains. “Indeed, courts tend to reject the privilege for a number of reasons, including, among others, if the facility did not follow the statutory requirements for invoking the privilege, such as having members on the peer review committee that did not have certain qualifications, the facility did not follow its policies and procedures regarding the committee that was established to conduct the peer review, confidentiality was not maintained, or the process was used to retaliate against a physician.”
This is played out more often in the context of sham peer reviews, where a healthcare provider argues the peer review privilege should not apply because the hospital used the process to restrict or terminate the physician’s privileges to retaliate against the physician for raising concerns about the hospital, Klele explains.
It is critically important to understand the laws that govern privilege in the state in which you operate, Klele says. If the privilege is limited to certain committees and staff, then you must properly structure the committee or appoint the appropriate staff members. If the hospital hires a third party to investigate, results may not be covered by the privilege depending on the laws of the state in question.
The policies and procedures of the committee should be established and revised to match state law and should be strictly followed. The facility should periodically review those policies and procedures, especially if a court in the state issues a precedential opinion on the privilege.
“Anyone participating in the process should maintain the confidentiality of the process to prevent disclosure to third parties,” Klele says. “The peer review process should be used for its intended purpose, and not to shield nefarious conduct or to retaliate against the healthcare provider.”
REFERENCE
- Mehta V, Sharkey MS. Erosion of peer review and quality assurance privilege. JAMA Surg 2023; Jun 14. doi: 10.1001/jamasurg.2023.1583. [Online ahead of print].
SOURCES
- Khaled John Klele, JD, Partner, Riker Danzig, Morristown, NJ. Phone: (973) 451-8451. Email: [email protected].
- Peter Lehr, JD, Norris McLaughlin, Allentown, PA. Phone: (484) 765-2283. Email: [email protected].
- Vikas Mehta, MD, MPH, FACS, Vice Chair and Associate Professor of Otorhinolaryngology - Head and Neck Surgery, Montefiore Medical Center, Bronx, NY. Phone: (718) 920-8488. Email: [email protected].
- Satish V. Poondi, JD, Partner, Trenk Isabel Siddiqi & Shahdanian, Livingston, NJ. Phone: (973) 533-1000. Email: [email protected].
Risk managers and clinicians depend on the ability to investigate adverse outcomes or errors without fear their words will be used against them in court, most notably in morbidity and mortality conferences and peer review sessions. The degree of protection varies from state to state — and there is some concern this privilege has been eroded.
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