PA Superior Court Decision Provides Hope and Guidance on Peer Review/Patient Safety Privilege, in the Wake of Reginelli v. Boggs ● January 6, 2020

Case Review and Analysis: Smith v. Schaff, 2019 Pa. Super. Unpub. LEXIS 3923, 2019 WL 5295409 (Pa. Super. Oct. 18, 2019)

January 6, 2020
By Joshua T. Calo, Esquire

Post & Post obtained a significant victory before the Superior Court of Pennsylvania, in a discovery dispute involving assertions that reports of “serious events” are confidential, and privileged under Pennsylvania’s MCARE Act and Peer Review Protection Act.

In Smith v. Schaff, decided October 18, 2019, the Superior Court reversed and vacated a trial court’s discovery order, which would have required a medical facility to produce three years of serious event reports that it submitted to the Pennsylvania Department of Health and Patient Safety Authority pursuant to the MCARE Act’s mandatory reporting requirements.

In 2018, the Pennsylvania Supreme Court’s decision in Reginelli v. Boggs, 181 A.3d 293 (Pa. 2018), significantly limited the scope of protection for peer review materials, under Pennsylvania’s Peer Review Protection Act. Since Reginelli, lower courts have increasingly ordered medical facilities to produce confidential information, related to peer review and patient safety activities.

Smith is an important decision for medical providers in Pennsylvania. In this case, the Superior Court provides guidance for protecting confidential and privileged information. In particular, the Court recognized several significant restrictions on discovery, which are wholly independent from the Peer Review Protection Act.

In the following article, I will summarize the Smith decision, and describe how it provides a roadmap for protecting peer review and patient safety materials in the wake of Reginelli.

 

Key Takeaways

  • A plaintiff may not obtain medical information about non-party patients, without a compelling justification for such discovery.
  • The MCARE Act precludes discovery of patient safety compliance and reporting materials, independent of the Peer Review Protection Act. However, Pennsylvania’s appellate courts have not defined the scope of the MCARE Act privilege.
  • A defendant is entitled to develop an appropriate record, through in camera review and evidentiary submissions, to support assertions of a statutory privilege.
  • In litigation, it is crucial to develop a thorough and strategic factual record in the trial court, in order to avoid certain pitfalls of Reginelli.
  • Outside of litigation, healthcare facilities should delineate formal policies and procedures for peer review, and patient safety reporting, which track current interpretations of the MCARE Act and Peer Review Protection Act.

I. Case Background

The underlying lawsuit, in Smith v. Schaff, involves allegations of medical professional liability, arising from a surgical abortion performed at Allentown Women’s Center (“AWC”), on March 21, 2015. In December 2016, Plaintiffs, Megan and Jordan Smith, brought suit against AWC and Eric Schaff, M.D., in the Northampton County Pennsylvania Court of Common Pleas.

Generally, Plaintiffs claim that Mrs. Smith’s uterus was perforated during the March 21, 2015 abortion. Several weeks later, on April 8, 2015, Mrs. Smith suffered a uterine hemorrhage, requiring an emergency hysterectomy that was performed at Lehigh Valley Hospital. The Defendants deny all allegations of liability.

The Superior Court’s decision arises from a discovery dispute, over Plaintiffs’ request for production of “serious event” reports that AWC submitted to the Pennsylvania Department of Health and Patient Safety Authority.

By way of relevant background, Chapter 3 of the Medical Care Availability and Reduction of Error (“MCARE”) Act, imposes a number of reporting and compliance requirements, for medical facilities and practitioners, related to patient safety. See 40 P.S. §§ 1303.301-313.

These requirements include the reporting of “serious events,” as defined by the statute, to the Department of Health and Patient Safety Authority. See 40 P.S. §§ 1303.308(a), 1303.313(a). Additionally, medical facilities must provide affected patients with “written notification” of serious events, “within seven days of the occurrence or discovery of a serious event.” See 40 P.S. § 1303.308(b).

The MCARE Act defines “serious event,” as:

“An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident.”

40 P.S. § 1303.302.

In our case, discovery revealed that, on April 14, 2015, AWC sent a notification letter to Mrs. Smith, which stated, in relevant part, that:

“in compliance [with the] MCARE Act, a report of a serious event has been made by Allentown Women’s Center to the Pennsylvania Department of Health and the Patient Safety Authority . . . . This report does not contain any information that could identify you.”

Early in this litigation, the “serious event report,” pertaining to Mrs. Smith, was identified on the Defendants’ privilege log, which explained how the report was submitted through the Patient Safety Authority’s “Patient Safety Reporting System” (known as “PA-PSRS”), solely for purposes of compliance with MCARE reporting requirements. As such, the privilege log asserted that the report is confidential, and privileged, under Section 311 of the MCARE Act. See 40 P.S. § 1303.311 (a) & (d).

Subsequently, Plaintiffs served a supplemental request for production of documents, which included a request for the following items:

“Please produce all reports of all serious events Allentown Women’s Center made to the Pennsylvania Department of Health and the Patient Safety Authority between January 1, 2014, and December 31, 2016. Any patient identity information contained in these documents may be redacted, with or without the production of a ‘privilege log.'”

In response, the Defendants filed a Motion for Protective Order, asserting that all of the requested serious event reports are privileged, and precluded from discovery, under both the MCARE Act, 40 P.S. § 1303.311; and the Peer Review Protection Act (“PRPA”), 63 P.S. §§ 425.1-425.4. Defendants further asserted that the reports pertaining to non-party patients are precluded from discovery, because they are irrelevant, and contain confidential health information.

The trial court denied the Defendants’ Motion for Protective Order, which meant that Defendants were required to disclose all serious event reports, from AWC, for a three-year time period. The trial court also denied a Motion for Reconsideration, in which the Defendants provided additional information, and documentation, to support their assertions of privilege.

The Defendants took an immediate collateral appeal to the Superior Court of Pennsylvania, from the trial court’s denial of the Motion for Protective Order.

II. The Superior Court Reverses and Vacates the Trial Court’s Discovery Order

On October 18, 2019, the Superior Court reversed, and vacated, the trial court’s discovery order. Specifically, the Superior Court held, on appeal, that the trial court erred by ordering AWC to respond to Plaintiffs’ request for production of serious event reports.

As detailed below, the Superior Court directly precluded Plaintiffs from obtaining any reports pertaining to non-party patients. Furthermore, regarding the report about Plaintiff’s care and treatment, the Superior Court reversed, vacated, and remanded for the trial court to properly consider and rule on the Defendants’ assertions of privilege.

a. Plaintiffs are precluded from obtaining reports of serious events pertaining to non-party patients.

First, the Superior Court addressed Plaintiffs’ request for three years of serious event reports from AWC. As indicated, Plaintiffs’ request, for “all reports of all serious events,” encompassed documents regarding medical care provided to non-parties who have no connection to this litigation.

On appeal, we argued that, in addition to being privileged, reports pertaining to non-parties are confidential, irrelevant, and implicate the privacy rights of unrepresented, non-party patients. The Superior Court agreed, holding that Plaintiffs may not obtain any non-party serious event reports.

The Superior Court relied on its 2012 decision in Buckman v. Verazin, 54 A.3d 956 (Pa. Super. 2012). In Buckman, the Superior Court held that a plaintiff could not obtain medical records for prior surgeries performed by the defendant physician, on grounds that “information relating to third parties that have not given their consent is confidential and is not relevant to the instant negligence claim[.]” See Buckman, 54 A.3d at 964.

In our case, the Court recognized that serious event reports “undoubtedly” contain “sensitive medical information” about non-party patients. Thus, in light of Buckman, “the trial court erred by not taking into account the privacy and confidentiality of medical information related to non-parties[.]”

The Court further held that, in order to obtain medical information about non-parties, without their consent, a plaintiff must establish a “compelling reason for needing it.” As applied to this case, the Court observed, “[t]he Smiths primarily focus their argument on the need for information about [Plaintiff’s] medical condition, not about why they need three years worth of medical information related to other patients at AWC.”

Thus, the Court concluded that “the Smiths have utterly failed to satisfy us that they need the information they requested.” Accordingly, the Court reversed the trial court’s ruling, and precluded discovery of any reports pertaining to non-party patients.

b. The trial court failed to properly determine whether the serious event report, pertaining to Plaintiff, is privileged.

Second, the Superior Court held that the trial court erred, by ordering production of the serious event report pertaining to Plaintiff’s care at AWC.

We first argued that a serious event report, submitted to the Department of Health and/or the Patient Safety Authority, is, on its face, privileged, under both the MCARE Act and the PRPA.

Our primary argument focused on Section 311 of the MCARE Act. That provision states that “documents, materials or information solely prepared or created for the purpose of compliance . . . or of reporting,” pursuant to various sections of the statute, “are confidential and shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding.” See 40 P.S. § 1303.311(a) & (d).

Section 311 specifically references the sections of the statute, 40 P.S. § 1303.308(a) and 40 P.S. § 1303.313(a), which require medical facilities and practitioners to file reports of “serious events,” in defining the scope of materials which are privileged under Section 311.

In the alternative, we argued that the trial court erred, by refusing to conduct in camera review of the serious event report pertaining to Plaintiff, before concluding that it was not privileged under the MCARE Act or PRPA.

The Superior Court agreed with our alternative argument. Specifically, the Court concluded that “the trial court abused its discretion by not determining in the first instance whether [the Defendants] have appropriately asserted a privilege related to the MCARE Act or PRPA.”

The trial court, in its opinion, claimed that the Defendants did not “sustain their burden” of proving that the document was privileged, through their initial Motion for Protective Order. Nevertheless, the Superior Court held that the trial court failed to properly consider, and rule upon, the Defendants’ assertions of privilege.

In particular, the Superior Court noted how the Defendants requested in camera review of the serious event report, in our original Motion for Protective Order. Furthermore, we filed a Motion for Reconsideration, which “provided additional information, including a privilege log specifically setting forth the privilege, as well as additional information about the report and reporting system.” However, the trial court did not conduct in camera review, and did not consider the additional information we submitted, before ordering production of the Plaintiffs’ serious event report.

For these reasons, the Superior Court reversed, and vacated, the order requiring production of the serious event report pertaining to Plaintiff. The Court instructed that, on remand, the trial court should “take any actions it deems appropriate,” to rule on the assertions of privilege “in the first instance.” The Superior Court’s opinion did not comment on the actual interpretation, or application, of the MCARE Act and PRPA privileges.

This issue is presently pending before the trial court, on remand. At an initial hearing, after the appeal, the trial court indicated that it would conduct in camera review of the serious event report, and related documents from the Defendants’ privilege log.

III. Case Analysis and Implications

Smith v. Schaff is a significant decision for healthcare providers in Pennsylvania.

In the wake of Reginelli, lower courts have increasingly ordered the production of confidential materials related to peer-review, performance evaluations, and the improvement of patient safety. Likewise, plaintiffs’ lawyers have aggressively pursued new categories of peer-review documentation which, prior to Reginelli, were unquestionably protected from discovery.

For instance, in May 2019, the Superior Court held that the PRPA did not protect records of a hospital’s credentialing committee, even though the credentialing file included “peer evaluations [and] performance appraisals . . . generated for quality improvement purposes[.]” Krappa v. Lyons, 211 A.3d 869, 872, 875 (Pa. Super. 2019), appeal denied 2019 Pa. LEXIS 7019 (Pa. Dec. 19, 2019). Compare Troescher v. Grody, 869 A.2d 1014 (Pa. Super. 2005) (holding, pre-Reginelli, that PRPA protects documents generated for use by a hospital’s credentialing committee).

For healthcare providers, the Reginelli Court’s narrow construction of the PRPA is a troubling precedent. However, I strongly believe that, in many circumstances, Reginelli can be acknowledged, but distinguished.

With appropriate strategies, before and during litigation, Pennsylvania law provides ample protections for candid peer-review, patient safety, and quality improvement activities.

The Superior Court’s decision, in Smith v. Schaff, highlights several strategies to thwart a plaintiff’s efforts to obtain privileged documentation. Additionally, while the Court did not specifically interpret or apply the statutory privileges, Smith provides a roadmap for avoiding several pitfalls of Reginelli, both before and during litigation.

a. Restrictions on peer-review pertaining to care of non-party patients

First, Smith confirms that a plaintiff must satisfy a heavy burden, to obtain any information about medical care provided to non-party patients. This basis for restricting discovery is completely independent from any assertion of privilege.

Prior to Smith, Pennsylvania appellate courts frequently prohibited discovery of non-parties’ medical records, based largely on the constitutional right to privacy. See, e.g., Lykes v. Yates, 77 A.3d 27 (Pa. Super. 2013); Buckman v. Verazin, 54 A.3d 956 (Pa. Super. 2012); Jones v. Faust, 852 A.2d 1201 (Pa. Super. 2004).

However, in Smith, the Superior Court held that the same restrictions apply to event reports, and other peer-review materials, which contain medical information about non-party patients-even if the patients’ names are redacted. The Smith Court indicated that such discovery should be prohibited, unless the plaintiff can demonstrate “a compelling reason for needing it.”

Thus, in response to any request for documents concerning treatment of non-parties, defendants can raise strong objections, based on the right to privacy, and the lack of relevance, regardless of whether the documents are protected under the PRPA.

b. The MCARE Act provides an independent basis for protecting patient safety information

Second, the Smith litigation is positioned to be the first case to squarely address the scope, and applicability, of the MCARE Act’s evidentiary privilege.

Section 311 of the MCARE Act protects numerous categories of materials-which are analogous to “peer review” activities, as defined in the PRPA-related to the MCARE Act’s patient safety reporting and compliance requirements. Therefore, Section 311 provides a strong basis for protecting broad categories of peer review, and patient safety, documentation, independent of the PRPA.

In light of Reginelli, the MCARE Act privilege is potentially broader, and more protective, than the PRPA. In addition to event reporting, Section 311 applies to numerous types of patient safety activities and committees, while the PRPA privilege is limited to proceedings and records of formal “peer review committees.” However, no appellate court has discussed, interpreted, or applied Section 311, in a published decision. As such, the scope, and requirements for invoking Section 311, are not well defined.

Based on the plain language of MCARE Sections 311(a) & (d), we maintain that all reports submitted through the Patient Safety Authority’s reporting system (PA-PSRS) are confidential, and protected from discovery. Nevertheless, it is important for medical facilities to recognize that this interpretation has never been confirmed by a Pennsylvania appellate court.

In our case, the Plaintiffs have vigorously argued that Section 311(a) contains numerous requirements, and limitations on the scope of confidentiality. In fact, in our case, the trial court’s initial opinion indicated that a serious event report is only privileged, when the following requirements are proven:

“[The] serious event reports (1) were solely created in order to comply with reporting requirements, (2) arise from a matter reviewed by a patient safety committee, and (3) were not otherwise available from an original source.”

The Superior Court did not endorse, or comment on, the trial court’s statutory interpretation.

In future cases, defendants should develop privilege arguments, based specifically on the MCARE Act, in appropriate circumstances.

c. It is essential to develop a comprehensive, and strategic, trial court record, to support claims of privilege

Third, Smith v. Schaff highlights the importance of developing a meticulous trial court record, to support arguments that statutory privileges apply to the requested documents.

The Superior Court indicated that trial courts must allow a defendant to develop an appropriate record-such as creating a privilege log; conducting in camera review; and submitting information about the documents-before ordering the production of potentially privileged documents. However, the Court emphasized how, in our case, the Defendants specifically requested in camera review, and submitted information, which the trial court did not consider.

In the wake of Reginelli, peer-review privilege issues are highly fact and context specific. Strong legal arguments can easily be waived, or deemed inapplicable, when they are not anticipated or developed in the trial court record. In point of fact, the Supreme Court, in Reginelli, refused to consider a strong legal argument, because a relevant staffing contract was not introduced during the trial court proceedings.

For these reasons, when preparing to litigate an assertion of privilege, it is critical to identify all of the potential legal arguments, and develop the factual basis needed to support those arguments, early in the trial court proceedings.

Our Smith case demonstrates the challenges in anticipating how courts will interpret and apply the PRPA, or the MCARE Act, to a particular document-particularly when the appellate courts have not defined the precise requirements for invoking the privilege. Thus, defendants should err on the side of being “over-inclusive,” but strategic, in developing the trial court record.

d. Outside of litigation, medical facilities should delineate clear procedures for peer review activities, based on the current state of Pennsylvania law

The most important takeaway is that, outside of litigation, medical facilities should proactively review, and update, their procedures for peer-review and patient safety activities, to ensure they are protected under the current state of Pennsylvania law.

Without question, Reginelli narrowed the scope of the PRPA’s evidentiary privilege. However, Reginelli does not preclude medical providers from engaging in confidential, and protected, peer review.

The primary effect of Reginelli is procedural. In short, Reginelli requires medical facilities to have, and utilize, formal procedures and committees for conducting true “peer review,” in order to ensure that such activities are protected under the PRPA. By contrast, other types of peer review, through less formal channels, may fall outside the scope of the PRPA’s protections.

In litigation, Reginelli may create challenges for protecting some documentation, which was previously generated with an expectation of confidentiality. However, facilities can implement policies and procedures, based on current interpretations of the PRPA and MCARE Act, to maximize the protection for future peer review and patient safety activities.

Reginelli provides a fairly clear roadmap for the types of information that are likely to be protected by the PRPA. With this information, facilities should review and update their peer review policies, to identify formal “peer review committees,” and delineate clear procedures conducting, and documenting, peer review activities.

Additionally, facilities should promulgate internal policies and procedures, based on the MCARE Act’s requirements, for patient safety reporting and compliance. Facilities should carefully define, in writing, how each requirement is to be implemented, and documented. For example, effective policies might delineate (1) guidance for uniformly identifying reportable incidents and serious events; (2) the person(s) responsible for filing reports on behalf of the facility; and (3) procedures for the Patient Safety Committee to review, and properly utilize, reports of serious events, in connection with patient safety activities.

In the event of litigation, these types of written policies, and documentation, will establish a strong record, to support claims of privilege under the PRPA and MCARE Act.

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