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C.A., A Minor, By Her Mother v. Eric Bentolila

August 9, 2012

C.A., A MINOR, BY HER MOTHER AND GUARDIAN AD LITEM, ESTHER APPLEGRAD, ESTHER APPLEGRAD, INDIVIDUALLY, AND GEDALIA APPLEGRAD, INDIVIDUALLY, APPROVED FOR PUBLICATION PLAINTIFFS-APPELLANTS/ CROSS-RESPONDENTS,
v.
ERIC BENTOLILA, M.D., AND GITA PATEL, R.N., DEFENDANTS, AND THE VALLEY HOSPITAL, KOURTNEY KACZMARSKI, R.N., MARY BROWN, R.T., AND YIE-HSIEN CHU, M.D., DEFENDANTS-RESPONDENTS/ CROSS-APPELLANTS.



On appeal from an interlocutory order of the Superior Court of New Jersey, Law Division, Passaic County, Docket No. L-0908-08.

RECORD IMPOUNDED

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION

Argued April 30, 2012

Before Judges Sabatino, Ashrafi, and Fasciale.

The opinion of the court was delivered by SABATINO, J.A.D.

In this case of first impression, we ascertain the dimensions of the confidentiality provisions contained within the Patient Safety Act (the "PSA" or the "Act"), N.J.S.A. 26:2H-12.23 to -12.25. We also examine their interplay with other laws and procedures, including the qualified common-law privilege for self-critical analysis of medical peer review documents, as set forth in Christy v. Salem, 366 N.J. Super. 535 (App. Div. 2004).

The Legislature adopted the PSA in 2004 in an effort to promote within health care facilities the candid exploration of what may have caused, or nearly caused, an adverse event to a patient, in order to better understand how such risks may be prevented in the future. We consider that policy objective in the context of this medical malpractice case, in which it is alleged that an infant was negligently deprived of oxygen at birth, resulting in her brain damage. Plaintiffs have sought to obtain certain documents that were internally generated within the hospital after an investigation of the care provided to the newborn and her mother. Defendants contend that those documents are privileged from disclosure under the PSA.

For the reasons that follow, we hold that post-event investigatory and analytic documents exclusively created in compliance with the PSA and its associated regulations, and not created for some other statutory or licensure purpose, are absolutely privileged from disclosure under the PSA. The PSA's confidentiality provisions insulate such documents from outside access. They do so regardless of a plaintiff's asserted need for disclosure and regardless of whether the documents contain factual information in addition to subjective opinions.

However, if the specified procedures of the PSA and the related regulations have not been observed, or if the documents have been generated for additional non-PSA purposes, then the PSA's absolute privilege does not apply. Instead, other legal principles govern, such as those expressed in Christy, depending upon the kind of document involved.

Applying these principles, we affirm in part the trial court's application of the PSA to the contested documents, and reverse it in part.

I.

Before delving into the facts and procedural history of this litigation, we first provide, by way of context, an introductory overview of the PSA and of our decision in Christy, both of which were key aspects of the trial court proceedings.

A.

The PSA was signed into law on April 27, 2004 and took effect six months later. L. 2004, c. 9, § 4. In enacting the PSA, the Legislature observed in its codified findings that "the health care literature demonstrates that the great majority of medical errors result from systems problems, not individual incompetence[.]" N.J.S.A. 26:2H-12.24(a). The Legislature further recognized that "[w]ell-designed systems" within health care facilities "have processes built in to minimize the occurrence of errors, as well as to detect those that do occur[.]" N.J.S.A. 26:2H-12.24(b). Such optimal systems "incorporate mechanisms to continually improve their performance[.]" Ibid. Hence, "[t]o enhance patient safety, the [legislative] goal is to craft a health care delivery system that minimizes, to the greatest extent feasible, the harm to patients that results from the delivery system itself[.]" N.J.S.A. 26:2H-12.24(c). More specifically, "[a]n important component of a successful patient safety strategy is a feedback mechanism that allows detection and analysis not only of adverse events, but also of 'near-misses[.]'" N.J.S.A. 26:2H-12.24(d).

The Legislature was manifestly concerned that such after-the-fact detection and analysis were not occurring within New Jersey health care facilities to an extent desired to promote future patient safety. In that vein, the PSA appears to have been sparked, at least in part, by a series of notorious patient homicides committed by a nurse at various New Jersey hospitals. Hearing on S. 557 Before the S. Comm. on Health, Human Services and Senior Citizens, 211th Leg. 1-2 (Jan. 26, 2004) (statement of Joseph F. Vitale, Comm. Chair). The Legislature was concerned that professionals and staff within health care facilities can feel inhibited in reporting or criticizing unsafe practices within the institution. Such inhibition may stem from fear of repercussions, inertia, and other factors that can lead to under-reporting and the institution's failure to take prospective corrective measures.

Based upon these concerns, the Legislature resolved in the PSA to promote disclosure and reporting:

To encourage disclosure of these [adverse or near-miss] events so that they can be analyzed and used for improvement, it is critical to create a non-punitive culture that focuses on improving processes rather than assigning blame. Health care facilities and professionals must be held accountable for serious preventable adverse events; however, punitive environments are not particularly effective in promoting accountability and increasing patient safety, and may be a deterrent to the exchange of information required to reduce the opportunity for errors to occur in the complex systems of care delivery. Fear of sanctions induces health care professionals and organizations to be silent about adverse events, resulting in serious under-reporting[.] [N.J.S.A. 26:2H-12.24(e).]

The Legislature sought to address these described problems

[b]y establishing an environment that both mandates the confidential disclosure of the most serious, preventable adverse events, and also encourages the voluntary, anonymous and confidential disclosure of less serious adverse events, as well as preventable events and near misses[.] [N.J.S.A. 26:2H-12.24(f) (emphasis added).]

By establishing such confidential processes, the State seeks to increase the amount of information on systems failures, analyze the sources of these failures and disseminate information on effective practices for reducing systems failures and improving the safety of patients. [Ibid.]

There are two vital parts to the PSA reporting system: (1) the framework within the medical facility for implementing it, and (2) the confidential treatment of communications made pursuant to the PSA, in order to encourage reporting and self-critical analysis. We first describe the framework components.

In its definitional section, the PSA distinguishes between several terms describing the nature and relative severity of various patient events. Specifically, an "adverse event" under the Act "means an event that is a negative consequence of care that [actually] results in unintended injury or illness, which may or may not have been preventable." N.J.S.A. 26:2H-12.25(a). By contrast, a "near-miss" refers to "an occurrence that could have resulted in an adverse event but [where] the adverse event was prevented." Ibid. A "preventable event," meanwhile, is defined as "an event that could have been anticipated and prepared against, but occurs because of an error or other system failure." Ibid. Finally, a "serious preventable adverse event" -- the most extreme category -- consists of "an adverse event that is a preventable event and results in death or loss of a body part, or disability or loss of bodily function lasting more than seven days or still present at the time of discharge from a health care facility." Ibid.

Subsection (c) of N.J.S.A. 26:2H-12.25 mandates the reporting to the State of all "serious preventable adverse events" within a facility. It states that "[a] health care facility shall report to the [D]department [of Health*fn1 ] or, in the case of a State psychiatric hospital, to the Department of Human Services, in a form and manner established by the commissioner, every serious preventable adverse event that occurs in that facility." N.J.S.A. 26:2H-12.25(c) (emphasis added).

In addition, the PSA calls for certain measures to encourage the disclosure and analysis of non-serious or non-preventable adverse events, as well as near-misses. The statutory framework requires each health care facility to "develop and implement a patient safety plan for the purpose of improving the health and safety of patients at the facility." N.J.S.A. 26:2H-12.25(b). The prescribed patient safety plan must, at a minimum, include:

(1) a patient safety committee, as prescribed by regulation;

(2) a process for teams of facility staff, which teams are comprised of personnel who are representative of the facility's various disciplines and have appropriate competencies, to conduct ongoing analysis and application of evidence-based patient safety practices in order to reduce the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures;

(3) a process for teams of facility staff, which teams are comprised of personnel who are representative of the facility's various disciplines and have appropriate competencies, to conduct analyses of near-misses, with particular attention to serious preventable adverse events and adverse events; and

(4) a process for the provision of ongoing patient safety training for facility personnel. [Ibid. (emphasis added).]

The statute clarifies that these required elements of a patient safety plan do not "eliminate or lessen a hospital's obligation under current law or regulation to have a continuous quality improvement program."*fn2 Ibid.

The PSA further provides that patients or their family members affected by either a serious preventable adverse event, or an adverse event relating to an allergic reaction, must be informed about such matters in a timely fashion, unless such disclosure would be detrimental to the patient's health. N.J.S.A. 26:2H-12.25(d). In addition, the Act encourages health care professionals and other employees to make anonymous reports to the State of near-misses, preventable events, and adverse events that are not subject to the Act's mandatory reporting requirements. N.J.S.A. 26:2H-12.25(e). The statute has several other structural facets that need not be discussed here.

Within this described framework, the PSA also contains several important confidentiality provisions. Those provisions are designed to achieve the statute's objective to establish "an environment that both mandates the confidential disclosure of the most serious, preventable adverse events, and . . . encourages the voluntary, anonymous and confidential disclosure of less serious adverse events, as well as preventable events and near-misses[.]" N.J.S.A. 26:2H-12.24(f) (emphasis added).

Subject to certain exceptions for access by the Attorney General and the pertinent regulatory agencies, or for use as evidence in certain disciplinary actions, the PSA provides:

f. Any documents, materials, or information received by the [D]department [of Health] or the Department of Human Services, as applicable, pursuant to the provisions of subsections c. and e. of this section concerning serious preventable adverse events, near-misses, preventable events, and adverse events that are otherwise not subject to mandatory reporting pursuant to subsection c. of this section, shall not be:

(1) subject to discovery or admissible as evidence or otherwise disclosed in any civil, criminal, or administrative action or proceeding;

(2) considered a public record under P.L.1963, c.73 (C.47:1A-1 et seq.) or P.L.2001, c.404 (C.47:1A-5 et al.); or

(3) used in an adverse employment action or in the evaluation of decisions made in relation to accreditation, certification, credentialing, or licensing of an individual, which is based on the individual's participation in the development, collection, reporting or storage of information in accordance with this section. [N.J.S.A. 26:2H-12.25(f) (emphasis added).]

Likewise, subsection (g) of N.J.S.A. 26:2H-12.25 extends similar confidentiality protection to documents, materials, or information that have not been reported to State regulators, if such items have nevertheless been "developed" by the health care facility "as part of a process of self-critical analysis conducted pursuant to [a patient safety plan in accordance with N.J.S.A. 26:2H-12.25(b).]" In particular, except for certain disciplinary matters described in subsection (g)(2), N.J.S.A. 26:2H-12.25(g) prescribes:

Any documents, materials, or information developed by a health care facility as part of a process of self-critical analysis conducted pursuant to subsection b. of this section concerning preventable events, near-misses, and adverse events, including serious preventable adverse events, and any document or oral statement that constitutes the disclosure provided to a patient or the patient's family member or guardian pursuant to subsection d. of this section, shall not be:

(1) subject to discovery or admissible as evidence or otherwise disclosed in any civil, criminal, or administrative action or proceeding; or

(2) used in an adverse employment action or in the evaluation of decisions made in relation to accreditation, certification, credentialing, or licensing of an individual, which is based on the individual's participation in the development, collection, reporting, or storage of information in accordance with subsection b. of this section. [Emphasis added.]

Thus, the PSA's umbrella of confidentiality extends beyond the mandatory reports that health care facilities must make to the State for "serious preventable adverse events." The statute also is designed to foster internal self-critical analysis on certain matters that do not rise to the severity of a "serious preventable adverse event."

After reciting these confidentiality protections in subsections (f) and (g) of N.J.S.A. 26:2H-12.25, the PSA thereafter references, in subsection (k), this court's published opinion in Christy. That opinion had been coincidentally issued in February 2004, two months before the PSA was signed into law. Subsection (k) declares:

k. Nothing in this act shall be construed to increase or decrease the discoverability, in accordance with Christy

v. Salem, [366 N.J. Super. 535 (App. Div. 2004),] of any documents, materials or information if obtained from any source or context other than those specified in this act. [N.J.S.A. 26:2H-12.25(k).]

The intended meaning of subsection (k), and its impact upon the confidentiality provisions within the PSA, are at the crux of the parties' legal disagreement in the present appeal and cross-appeal.*fn3

B.

In Christy, a medical negligence case, the plaintiff sought discovery of a report issued by the defendant hospital's "peer review committee" that had investigated the plaintiff's care and treatment. Christy, supra, 366 N.J. Super. at 538. On appeal from the trial court's order to disclose the committee's report to the plaintiff, we balanced the opposing interests involved, drawing a distinction between the factual and evaluative portions of the report. Id. at 543-44.

Applying common-law principles, we held in Christy that the plaintiffs were entitled to disclosure of "purely factual material," because they have "a right to discover the location of critical information, which would logically be expected to be in the possession of an adversary but is missing for some unexplained reason." Id. at 541, 543-44. A hospital, by contrast, should be presumptively entitled to preserve the confidentiality of its "opinions, analysis and findings of fact[.]" Id. at 544. However, a plaintiff may obtain discovery of evaluative material upon a showing of a "compelling need." Ibid. Thus, the extent that peer review reports are discoverable under the criteria of Christy depends upon: (1) whether the contents of the reports are factual in nature, and

(2) whether a plaintiff can show a compelling need to obtain discovery of the evaluative, non-factual portions within those reports. Id. at 543-44.

II.

We now detail the chronology of events that led to the present appeal. Because this matter is before us on interlocutory review of the trial court's disposition of a discovery motion, the actual facts underlying plaintiffs' medical malpractice claim have not been conclusively determined. We thus summarize the relevant allegations from plaintiffs' submissions and their expert's opinions as described in their brief, with the caveat that these allegations have not yet been proven in the underlying action.

On May 26, 2007, plaintiff Esther Applegrad was admitted to the maternity ward at defendant The Valley Hospital ("the Hospital"). She gave birth to C.A. that same day.

Plaintiffs contend that prior to C.A.'s delivery, a nurse employed at the Hospital, defendant Kourtney Kaczmarski, R.N., failed to timely discover or alert the attending obstetrician, defendant Eric Bentolila, M.D., that C.A. was in a breech position. Dr. Bentolila elected not to deliver C.A. through a Caesarean section, but to deliver her vaginally, a decision which allegedly resulted in birth complications for C.A. The record contains allegations that, after the birth, he attempted to destroy a medical document in connection with C.A.'s delivery.*fn4

After Dr. Bentolila delivered C.A., a pediatrician, defendant Yie-Hsien Chu, M.D., assumed her care. Plaintiffs claim that Dr. Chu negligently resuscitated C.A., and did not timely notify the anesthesiologist of C.A.'s malfunctioning intubation tube, resulting in C.A. suffering anoxic brain injury.

Based upon the expert opinion of a pediatric neurologist, plaintiffs assert that non-negligent care by defendants would have either prevented or limited the scope of C.A.'s injury. Conversely, defendants maintain that C.A.'s hospital records establish that the infant was resuscitated in the immediate post-birth period, and that her brain injury had proximately resulted from ...


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