SYLLABUS
(This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the Clerk for the
convenience of the reader. It has been neither reviewed nor approved by the Supreme Court. Please note that, in the
interest of brevity, portions of any opinion may not have been summarized.)
C.A. v. Eric Bentolila, M.D. (A-32-12) (071702)
Argued February 3, 2014 -- Decided September 29, 2014
PATTERSON, J., writing for a majority of the Court.
In this appeal, the Court considers whether a memorandum memorializing a round-table discussion by
hospital staff investigating an adverse event is shielded from discovery under the Patient Safety Act, N.J.S.A.
26:2H-12.23 to -12.25.
The Patient Safety Act was enacted in 2004 to reduce the incidence of medical errors that may endanger
patients in health care facilities. The Act imposed new requirements for evaluating and reporting adverse medical
events, and created a statutory privilege shielding specific communications from discovery in litigation. The Act
sought to encourage health care workers to candidly disclose their observations and concerns, and to promote self-
critical evaluation by professional and administrative staff. Regulations detailing the requirements for complying
with the Act were not promulgated until 2008.
Plaintiff Esther Applegrad was admitted to The Valley Hospital (Hospital) on May 26, 2007, in her forty-
first week of pregnancy. Her daughter, C.A., was born later that same day. Plaintiffs contend that C.A. suffers from
a serious brain injury that was caused by the negligent medical care she received at the Hospital during and after the
birth. Defendants maintain that C.A.’s brain injury resulted from unpreventable birth complications.
Plaintiffs filed suit against the Hospital and the doctors and nurses involved in C.A.’s birth and care. They
moved to compel production of the Hospital’s investigative and peer review records relating to C.A.’s birth.
Defendants urged the trial court to find that several of the Hospital’s documents were privileged. Among those was
the document at issue in this appeal, a memorandum dated June 1, 2007, and entitled “Director of Patient Safety
Post-Incident Analysis,” which was created following a “round-table” discussion among Hospital staff as part of an
investigation of C.A.’s delivery and neonatal care. The document was designated for discovery purposes as “DV2.”
According to defendants, DV2 and other documents were absolutely privileged under the Patient Safety Act.
The trial court ultimately determined that although the Hospital did not strictly follow the requirements of
the Patient Safety Act when it created DV2, it had substantially complied with the Act. It ruled that DV2 was
privileged under the Patient Safety Act, and accordingly denied plaintiffs’ motion to compel discovery of the
document.
Plaintiffs filed a motion for leave to appeal with the Appellate Division. The Appellate Division granted
the motion and held that the statutory privilege does not attach to documents created in a process in which “the
specified procedures of the [Act] and the related regulations have not been observed.” C.A. v. Bentolila, 428 N.J.
Super. 115, 122 (App. Div. 2012). Applying the regulations adopted in 2008, after the creation of DV2, the panel
concluded that DV2 was not created in full compliance with the processes and procedures of the Patient Safety Act,
and ordered its disclosure. The judgment was stayed pending defendants’ motion for leave to appeal to this Court.
The Court granted the motion for leave to appeal. 213 N.J. 47 (2012).
HELD: The Hospital’s evaluative process in this case conformed to the Patient Safety Act’s requirements. The
memorandum at issue is privileged, not subject to discovery, and should not be used for any purpose in this case.
1. New Jersey hospitals have been required to engage in self-evaluation and to maintain quality improvement
programs since 1990. The Patient Safety Act was not intended to replace preexisting evaluative processes for
hospitals. Instead, the Act pursues a distinct goal: to minimize adverse events deriving from system failures in a
hospital or other health care facility. To that end, the Act mandates that health care facilities establish a patient
1
safety plan “for the purpose of improving the health and safety of patients at the facility.” One of the plan’s
components is the establishment of “a patient safety committee.” The Patient Safety Act did not specify the
composition or operation of the patient safety committee, but left those details to be determined by regulation. The
regulatory process was not completed until 2008, nearly four years after the Patient Safety Act became law. Thus,
the structure and mission of the patient safety committee, now comprehensively prescribed by regulation, had yet to
be specified when the Hospital prepared the document disputed in this case. (pp. 13-21)
2. The Legislature included in the Patient Safety Act a provision creating an absolute privilege. It reasoned that
health care professionals and other facility staff are more likely to effectively assess adverse events in a confidential
setting, in which an employee need not fear recrimination for disclosing his or her own medical error, or that of a
colleague. Like its process requirements, the Patient Safety Act’s privilege provisions were explained and refined
by the regulations that followed. In the regulations that became effective in 2008, the standard for determining
applicability of the privilege was expanded in two significant respects: first, to require that the documents, materials
and information at issue be “exclusively” prepared in the setting of a qualifying self-critical analysis process, and
second, to mandate that the self-critical analysis be conducted in accordance with one of three accompanying
regulations. (pp. 21-28)
3. When DV2 was prepared on June 1, 2007, the only guidance to the Hospital and its staff was found in the Patient
Safety Act. The discoverability of DV2 must therefore be determined in accordance with the Patient Safety Act
itself, without imposing requirements that appeared for the first time in subsequent regulations. The Act shields
from discovery documents, materials or information developed “as part of a process of self-critical analysis” and
requires a safety plan that includes, at a minimum, four components: establishment of a patient safety committee; a
process for teams of facility staff to conduct ongoing analysis and application of evidence-based patient safety
practices; a process for teams of facility staff to conduct analyses of near-misses; and a process for the provision of
ongoing patient safety training for facility personnel. (pp. 28-29)
4. The record supports the trial court’s determination that the Hospital established all four of the components of the
patient safety plan that are required by the statute. In addition, the record also supports the trial court’s finding that
DV2 was prepared “as part of a process of self-critical analysis” pursuant to the statute. Regardless of whether the
Hospital’s process would have satisfied the regulations that became effective at a later time, the Hospital met the
only standard that governed it in 2007, the mandate of the Patient Safety Act itself. Health care facilities were not
compelled to anticipate later regulations as a condition of the statutory privilege. (pp. 30-36)
The judgment of the Appellate Division is REVERSED, and the matter is REMANDED for proceedings
consistent with this opinion.
CUFF, P.J.A.D. (temporarily assigned), DISSENTING, joined by CHIEF JUSTICE RABNER and
JUSTICE ALBIN, expresses the view that the personnel involved in the Hospital’s self-evaluation process were not
representative of the facility’s various disciplines and did not have the appropriate competencies as required under
the Patient Safety Act. Therefore, that process did not comply with the Act and the memorandum should not be
shielded from discovery.
JUSTICES LaVECCHIA and FERNANDEZ-VINA and JUDGE RODRÍGUEZ (temporarily
assigned) join in JUSTICE PATTERSON’s opinion. JUDGE CUFF (temporarily assigned) filed a dissenting
opinion in which CHIEF JUSTICE RABNER and JUSTICE ALBIN join.
2
SUPREME COURT OF NEW JERSEY
A-32 September Term 2012
071702
C.A., a Minor, by Her Mother
and Guardian ad Litem, ESTHER
APPLEGRAD, ESTHER APPLEGRAD,
Individually, and GEDALIA
APPLEGRAD, Individually,
Plaintiffs-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-Appellants.
Argued November 6, 2013
Reargued February 3, 2014 – Decided September 29, 2014
On appeal from the Superior Court, Appellate
Division, whose opinion is reported at 428
N.J. Super. 115 (2012).
Douglas S. Eakeley argued the cause for
appellants (Lowenstein Sandler, Vasios,
Kelly & Strollo, and Buckley Theroux Kline &
Petraske, attorneys; Mr. Eakeley and Rowena
M. Duran, of counsel; Mr. Eakeley, Ms.
Duran, Natalie J. Kraner, Liad Levinson,
Linda S. Fulop-Slaughter, Karla M. Donovan,
and William G. Theroux, on the briefs).
1
Cynthia A. Walters argued the cause for
respondents (Budd Larner, attorneys; Ms.
Walters, Justin P. Van Dyke, and Donald P.
Jacobs, on the briefs).
Ross A. Lewin argued the cause for amicus
curiae New Jersey Hospital Association
(Drinker Biddle & Reath, attorneys).
E. Drew Britcher argued the cause for amicus
curiae New Jersey Association for Justice
(Britcher, Leone & Roth, attorneys; Mr.
Britcher and Kristen B. Miller, on the
brief).
Susan J. Dougherty, Deputy Attorney General,
submitted a letter in lieu of brief on
behalf of amicus curiae Attorney General of
New Jersey (John J. Hoffman, Acting Attorney
General, attorney).
JUSTICE PATTERSON delivered the opinion of the Court.
In 2004, the Legislature enacted the Patient Safety Act to
reduce the incidence of medical errors that may endanger
patients in health care facilities. N.J.S.A. 26:2H-12.23 to -
12.25. The Act imposed new requirements for evaluating and
reporting of adverse events, and created a statutory privilege
shielding specific communications from discovery in litigation.
N.J.S.A. 26:2H-12.25(b), (c), (e), (g). The Act sought to
encourage health care workers to candidly disclose their
observations and concerns, and promote self-critical evaluation
by professional and administrative staff.
The interlocutory appeal before the Court involves an early
application of the Patient Safety Act. In the underlying
2
medical malpractice litigation, plaintiffs claim that the infant
plaintiff, C.A., is permanently disabled because of injuries
sustained during her birth on May 26, 2007, at The Valley
Hospital (Hospital). Shortly after C.A.’s birth, a “round-
table” discussion among Hospital staff was conducted as part of
an investigation of her delivery and neonatal care. A hospital
administrator prepared a memorandum memorializing the
discussion. The parties dispute the discoverability of this
document.
The trial court determined that because the Hospital had
substantially complied with the Patient Safety Act in its
investigation, the memorandum was subject to the Act’s absolute
privilege. The Appellate Division reversed the trial court’s
determination. C.A. v. Bentolila, 428 N.J. Super. 115, 122
(App. Div. 2012). It concluded that the process used by the
Hospital and its staff in creating the memorandum did not meet
the statute’s requirements to shield the document from
discovery. In its holding, the panel retroactively applied
regulations that were adopted by the Department of Health and
Senior Services (Department) after the preparation of the
contested memorandum. It thus ordered the Hospital to produce
the document in discovery.
We reverse. We construe the Patient Safety Act in light of
its purpose to encourage health care workers to freely report
3
their observations and concerns related to patient safety in a
confidential setting. Today, health care facilities are guided
by detailed regulations that supplement the requirements of the
Patient Safety Act. See N.J.A.C. 8:43E-10.1 to -10.11. Those
regulations, however, did not exist when the document at issue
was prepared. At the relevant time, the only prerequisite to
the privilege was compliance with the terms of the Patient
Safety Act itself. We hold that the Hospital’s evaluative
process in this case conformed to the Patient Safety Act’s
requirements, and that the memorandum at issue is therefore
privileged.
Accordingly, we reverse the order requiring the Hospital to
produce the disputed document.
I.
On May 26, 2007, plaintiff Esther Applegrad, in her forty-
first week of pregnancy, was admitted to the Hospital after
sustaining a spontaneous rupture of membranes the previous day.1
She was treated by Eric Bentolila, M.D., the attending
obstetrician. From the time that Applegrad arrived at the
Hospital to the conclusion of the day shift at 7:00 p.m., the
nurse primarily responsible for her care was Kourtney
1 At this pretrial stage, the record before the Court regarding
the medical care provided to Applegrad and the birth of C.A. is
limited, and it appears that the parties substantially dispute
many of the underlying facts.
4
Kaczmarski, R.N. Plaintiffs contend that Kaczmarski failed to
ascertain that C.A. was in a breech position, and that the
nurse’s failure to note this complication prompted Dr. Bentolila
to anticipate a vaginal delivery rather than a Caesarean
section. They further allege that although Dr. Bentolila
discovered C.A.’s breech presentation, he nonetheless decided to
proceed with a vaginal delivery, thereby deviating from the
applicable standard of care. Dr. Bentolila denied that he was
negligent, and contended that he fully discussed the risks and
benefits of both vaginal delivery and Caesarean section with
Applegrad.
Plaintiffs allege that Dr. Bentolila ordered that the
labor-inducing medication Pitocin be administered to Appelgrad,
and that he later attempted to destroy the medical record
indicating she was given Pitocin. They assert that in
accordance with Dr. Bentolila’s order, Kaczmarski began to
administer Pitocin at approximately noon on the day of C.A.’s
birth.
By evening, Applegrad was in the final stages of labor.
Dr. Bentolila delivered C.A. at approximately 8:45 p.m. The
newborn had an Apgar score of 2,2 and her heart rate was recorded
2 An Apgar score is an “evaluation of a newborn infant’s physical
status by assigning numerical values (0-2) to each of five
criteria: heart rate, respiratory effort, muscle tone, response
stimulation, and skin color; a score of 8-10 indicates the best
5
as faint. Following her birth, C.A. was intubated and
transferred to the care of Yie-Hsien Chu, M.D., a pediatrician.
Plaintiffs allege that Dr. Chu was negligent in her
resuscitation of C.A. and for failing to immediately notify the
attending anesthesiologist that the newborn’s intubation tube
was not functioning properly, which caused the infant to suffer
an anoxic brain injury.
Plaintiffs claim that C.A. currently suffers from Hypoxic-
Ischemic Encephalopathy and a seizure disorder resulting from
the medical care that she received at the Hospital during and
after her birth. Defendants maintain that C.A.’s brain injury
resulted from unpreventable birth complications, that Applegrad
received competent care during the birth, and that the infant
was properly resuscitated.
This medical malpractice action was filed by Applegrad and
her husband, Gedalia Applegrad, in the Law Division. Plaintiff
named as defendants the Hospital, Dr. Bentolila, Dr. Chu, Nurse
Kaczmarski, a second nurse, Gita Patel, R.N., and a respiratory
therapist, Mary Brown, R.T.3
possible condition.” Stedman’s Medical Dictionary 1735 (28th
ed. 2006).
3 The trial court dismissed plaintiffs’ claims against Dr.
Bentolila and Nurse Patel in 2009. The Hospital, Kaczmarski,
Brown and Dr. Chu remain defendants in the case and are parties
to this appeal.
6
The document dispute at the center of this case arose
during pretrial discovery in the medical malpractice litigation.
Plaintiffs moved to compel production of the Hospital’s
investigative and peer review records relating to C.A.’s birth.
In their initial response to the motion, defendants did not rely
upon the statutory privilege set forth in the Patient Safety
Act. Instead, they urged the trial court to conduct the
balancing test set forth by the Appellate Division in Christy v.
Salem, 366 N.J. Super. 535, 541-45 (App. Div. 2004), and to find
that several of the Hospital’s documents were privileged in
accordance with that standard.
Among the disputed documents that were the subject of
plaintiffs’ motion was a memorandum dated June 1, 2007, entitled
“Director of Patient Safety Post-Incident Analysis.” The
document was designated for discovery purposes as “DV2.” Along
with five other documents, DV2 was submitted to the trial court
for in camera review. The trial court initially proposed to
review the document in accordance with the balancing test set
forth by the Appellate Division in Christy. Notwithstanding its
initial reliance upon the Christy test, the Hospital objected to
the trial court’s proposal, and claimed for the first time that
the six documents at issue were absolutely privileged under
N.J.S.A. 26:2H-12.25(g) of the Patient Safety Act. Following a
further hearing, the trial court agreed with the Hospital’s
7
position that the documents were privileged under the Act, and
denied plaintiffs’ motion to compel production of the documents.
Plaintiffs sought leave to appeal. An Appellate Division
panel granted the motion, but later vacated its order and
remanded to the trial court for further development of the
record. On remand, defendants partly modified their position
with respect to the documents at issue. They contended that
only two documents, DV2 and a second memorandum, DV5, were
subject to the Patient Safety Act’s absolute privilege, and
asserted that the remaining four documents should remain
confidential on other grounds not at issue in this appeal.
The trial court conducted a seven-day evidentiary hearing.
The Hospital presented the testimony of three witnesses: Kim
Robles, the Hospital’s Director of Quality Assessment
Improvement and Regulatory Compliance; Michael Mutter, the
Hospital’s Director of Patient Safety and the author of DV2; and
Linda Malkin, the Hospital’s Director of Risk Management. The
parties also submitted documentary evidence to the trial court.
The trial court made factual findings with respect to the
Hospital’s compliance with the Patient Safety Act and the
process followed in the Hospital’s investigation of C.A.’s birth
and neonatal care. The trial court also made several
observations about the purpose and preparation of the contested
document, DV2. On the basis of those findings, the trial court
8
held that although the Hospital did not strictly follow the
requirements of the Patient Safety Act when it created DV2, it
had substantially complied with the Act. It ruled that DV2 was
privileged under the Patient Safety Act, and accordingly denied
plaintiffs’ motion to compel discovery of the document. The
court held, however, that the judge scheduled to preside over
the medical malpractice trial should have a copy of the document
in order to evaluate the credibility of witnesses who were
participants in the round-table discussion.4
Plaintiffs filed a second motion for leave to appeal.
After granting the motion, an Appellate Division panel affirmed
in part and reversed in part the trial court’s determination.
C.A., supra, 428 N.J. Super. at 159. The panel construed the
Act to confer an absolute privilege upon “post-event
investigatory and analytic documents exclusively created in
compliance with the [Act] and its associated regulations, and
not created for some other statutory or licensure purpose.” Id.
at 122. It held, however, that the statutory privilege does not
attach to documents created in a process in which “the specified
procedures of the [Act] and the related regulations have not
4 The trial court also made findings about the five other
contested documents, and ruled on the discoverability of those
documents in accordance with the standard set forth in Christy,
supra, 366 N.J. Super. 535. Those findings are not pertinent to
this appeal.
9
been observed,” or to documents “generated for additional non-
[Patient Safety Act] purposes.” Ibid.
Applying the “exclusivity test” prescribed by N.J.A.C.
8:43E-10.9(b), a regulation adopted by the Department after the
creation of DV2, the panel reasoned that a document must be
exclusively created to comply with the Patient Safety Act -- and
not for any other purpose -- in order to warrant the statutory
privilege. Id. at 148-49. The panel further held that
compliance with another regulation adopted after the preparation
of DV2, N.J.A.C. 8:43E-10.4(d)(7), was essential for the
application of the privilege. Id. at 153.
The panel concluded that DV2 was not created “in full
compliance with the processes and procedures of the [Patient
Safety Act].” Id. at 154. It noted that no physician
participated in the round-table discussion, and that the
findings recorded in the document were not presented to the
Patient Safety Committee. Id. at 152-55. The panel ordered the
disclosure of DV2, but stayed its judgment pending defendants’
filing of a motion for leave to appeal in this Court. Id. at
159.5
5 The panel also rejected plaintiffs’ constitutional challenge to
the Patient Safety Act, which was premised on the argument that
the Legislature violated principles of the separation of powers
doctrine when it created the evidentiary privilege under the
Patient Safety Act without the involvement of the judicial
10
We granted defendants’ motion for leave to appeal, which
sought review of the portion of the Appellate Division’s
judgment that ordered the disclosure of DV2. 213 N.J. 47
(2012).
II.
Defendants argue that the Appellate Division improperly
applied the administrative regulations adopted in 2008 to
determine the discoverability of DV2, a document prepared before
the regulations were adopted. They maintain that the Hospital
satisfied the statutory standard that governed when DV2 was
created. Defendants contend that the panel imposed requirements
that are not found in the Act, such as the presence of a
physician on the evaluating team and the involvement of the
Patient Safety Committee in the evaluative process at issue.
Defendants assert that the Appellate Division erred in holding
that a document for which protection is sought must be
exclusively created to comply with the Patient Safety Act. They
maintain that the confidentiality provisions of the Act are not
conditioned on strict adherence to every aspect of the statute.
Plaintiffs urge the Court to affirm the Appellate
Division’s determination. They argue that the panel properly
held that the confidentiality provisions of the Patient Safety
branch. C.A., supra, 428 N.J. Super. at 157-59. That
determination is not challenged in this appeal.
11
Act are only available to facilities that conduct their
investigations in strict compliance with the Act’s terms.
Plaintiffs contend that the panel correctly identified
deficiencies in the process by which the Hospital created DV2.
They maintain that although the “exclusivity test” invoked by
the panel was set forth in the regulations adopted in 2008, it
may also be inferred from the Act’s statutory text, and should
therefore provide the standard for this discovery dispute. In
the alternative, plaintiffs argue that any change in the law
that occurred with the adoption of the regulations was curative,
and that the regulations should therefore apply retroactively.
Amicus curiae New Jersey Association for Justice (NJAJ)
argues that the Legislature intended that any internal documents
or communications generated by a health care facility should be
protected only by the qualified privilege identified in Christy,
not by any absolute privilege. NJAJ contends that the Hospital
failed to comply with the Patient Safety Act’s mandatory
committee structure and that it violated the Act by failing to
refer C.A.’s case to the Patient Safety Committee.
Amicus curiae New Jersey Hospital Association (NJHA) argues
that the Patient Safety Act was intended to shield from
discovery internal analyses generated in accordance with the
Act, and that plaintiffs’ argument that Christy governs the
discoverability of such analyses would undermine the legislative
12
objective. It asserts that the panel improperly imposed
conditions that were not articulated in the Patient Safety Act,
and appeared only in regulations that had yet to take effect at
the relevant time.6
III.
An appellate court applies “an abuse of discretion standard
to decisions made by [the] trial courts relating to matters of
discovery.” Pomerantz Paper Corp. v. New Cmty. Corp., 207 N.J.
344, 371 (2011) (citing Bender v. Adelson, 187 N.J. 411, 428
(2006)). It “‘generally defer[s] to a trial court’s disposition
of discovery matters unless the court has abused its discretion
or its determination is based on a mistaken understanding of the
applicable law.’” Ibid. (quoting Rivers v. LSC P’ship, 378 N.J.
Super. 68, 80 (App. Div.), certif. denied, 185 N.J. 296 (2005)).
However, we conduct a de novo review of the trial court’s
construction of a statute. In re Liquidation of Integrity Ins.
Co., 193 N.J. 86, 94 (2007).
Our review of the trial court’s interpretation of the
Patient Safety Act is conducted in accordance with familiar
rules of statutory construction. “The Legislature’s intent is
6 Pursuant to Rule 4:28-4, the Attorney General appeared in the
trial court and the Appellate Division to defend the
constitutionality of the Patient Safety Act. Because the
constitutionality of the Act is not challenged before this
Court, the Attorney General has declined to participate in this
appeal.
13
the paramount goal when interpreting a statute and, generally,
the best indicator of that intent is the statutory language.”
DiProspero v. Penn, 183 N.J. 477, 492 (2005). “When
interpreting statutory language, the goal is to divine and
effectuate the Legislature’s intent.” State v. Shelley, 205
N.J. 320, 323 (2011). Accordingly, “[t]he plain language of the
statute is our starting point.” Patel v. N.J. Motor Vehicle
Comm’n, 200 N.J. 413, 418 (2009). In construing statutory
language, “words and phrases shall be given their generally
accepted meaning, unless that meaning is inconsistent with the
clear intent of the Legislature or unless the statute provides a
different meaning. Words in a statute should not be read in
isolation.” Shelton v. Restaurant.com, Inc., 214 N.J. 419, 440
(2013) (citing N.J.S.A. 1:1-1). “To accomplish that, we read
the statutes in their entirety and construe ‘each part or
section . . . in connection with every other part or section to
provide a harmonious whole.’” State v. Marquez, 202 N.J. 485,
499 (2010) (quoting Bedford v. Riello, 195 N.J. 210, 224 (2008)
(alteration in original)). We consider the statute at the
center of this case in accordance with these principles.
A.
The Patient Safety Act was not the first requirement
imposed on New Jersey health care facilities to evaluate their
practices in a confidential setting, and to report to regulatory
14
authorities. Since the adoption of N.J.A.C. 8:43G-27 in 1990,
hospitals have been required to maintain a continuous quality
improvement program. N.J.A.C. 8:43G-27.1 to -27.6.7 That
program must include a utilization review, a federally-mandated
process by which a hospital reviews the physicians’ practice of
admitting and discharging patients, and the resources used to
treat patients during hospital stays. 42 U.S.C.A. § 1395x et
seq.; 42 C.F.R. § 482.30; see also Todd v. S. Jersey Hosp. Sys.,
152 F.R.D. 676, 682 (D.N.J. 1993) (noting that utilization
review is requirement of hospital’s participation in Social
Security and in certain other federal and state programs).
In addition, prior to the enactment of the Patient Safety
Act, New Jersey hospitals were also permitted -- but not
required -- to evaluate adverse events in accordance with
7 Notably, N.J.A.C. 8:43G was enacted to replace N.J.A.C. 8:43B,
a regulation that specifically mandated a peer review process.
See N.J.A.C. 8:43B-6.1 et seq. (repealed 1990). That process
required a hospital’s medical staff to “identify problems that
may exist in patient care and suggest appropriate action to
correct those problems.” Bundy v. Sinopoli, 243 N.J. Super.
563, 566 (Law Div. 1990); see N.J.A.C. 8:43B-6.1, -6.2 (repealed
1990). Although the current regulatory framework does “not
specifically address[] the area of [p]eer [r]eview,” it
nevertheless “provide[s] a framework for the evaluation of the
type and quality of care given to patients at hospitals.”
Bundy, supra, 243 N.J. Super. at 566; see, e.g., N.J.A.C. 8:43G-
27.5(a) (obligating hospitals to engage in “an ongoing process
of monitoring patient care” through a “criteria-based”
evaluation “so that certain review actions are taken or
triggered when specific quantified, predetermined levels of
outcomes or potential problems are identified”).
15
guidelines promulgated by the Joint Commission, a national
accreditation body for health care organizations and programs.
See Reyes v. Meadowlands Hosp. Med. Ctr., 355 N.J. Super. 226,
229-31 (Law Div. 2001) (noting that, pursuant to guidelines
promulgated by Joint Commission, hospitals were asked to conduct
root cause analyses of certain medical errors, called “Sentinel
Events,” “voluntarily, without compulsion under the
accreditation process” and to report results to Joint
Commission). The Joint Commission guidelines thus present a
framework which a health care facility may use to investigate
adverse events.
The Patient Safety Act was not intended to replace those
preexisting evaluative processes in the health care setting; it
specifically provides that it does not “eliminate or lessen a
hospital’s obligation under current law or regulation” to
maintain “a continuous quality improvement program.” N.J.S.A.
26:2H-12.25(b). Instead, the Act pursues a distinct goal: to
minimize adverse events deriving from system failures in a
hospital or other health care facility.8 The sponsor’s statement
8 In enacting the Patient Safety Act, the Legislature responded
in part to the revelation that Charles Cullen, a former nurse on
staff at several New Jersey hospitals, “ha[d] professed to have
killed at least 40 individuals under his care.” Hearing on S.
557 Before the S. Health, Human Services and Senior Citizens
Comm., 211th Leg. 2 (N.J. 2004) (Statement of Sen. Joseph F.
Vitale, Chair). Following his April 29, 2004 guilty plea to the
“murder of hospital patients in New Jersey and Pennsylvania,”
16
attached to the original bill stated that the Act’s legislative
objective was to
[e]stablish[] a medical error reporting system
for health care facilities that seeks to
minimize the occurrence of errors, as well as
to detect those that do occur, and to
incorporate mechanisms to continually improve
the performance of facilities to enhance
patient safety by minimizing, to the greatest
extent feasible, the harm to patients that
results from the delivery system itself. In
this regard, the [bill] establishes a system
that both mandates the confidential disclosure
to [the Department] or the Department of Human
Services (DHS), in the case of State
psychiatric hospitals, of the most serious
preventable adverse events, and also
encourages the voluntary, anonymous and
confidential disclosure to the respective
departments of less serious adverse events, as
well as near-misses.
[S. 557 (Sponsor’s Statement), 211th Leg.
(2004).]
To that end, the Act mandates that health care facilities
establish 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). One of that plan’s components is the
establishment of “a patient safety committee.” N.J.S.A. 26:2H-
12.25(b)(1). The Patient Safety Act did not specify the
composition or operation of the Patient Safety Committee, but
Charles Cullen is serving a sentence of life imprisonment. Taub
v. Cullen, 373 N.J. Super. 435, 440 (Ch. Div. 2004).
17
left those details to be determined “by regulation.” N.J.S.A.
26:2H-12.25(b)(1).
The regulatory process was completed in 2008, nearly four
years after the Patient Safety Act became law.9 The mandated
composition and duties of a facility’s patient safety committee
were established with the adoption of N.J.A.C. 8:43E-10.4. That
regulation compelled hospitals to establish a patient safety
committee by June 1, 2008. N.J.A.C. 8:43E-10.4(a)(1). It
requires that the committee be chaired by an individual selected
by the facility’s chief executive officer or administrator, and
that individual committee members be assigned responsibilities
“based on the relevance of their job responsibilities and
professional experience.” N.J.A.C. 8:43E-10.4(c). The
regulation mandates that the patient safety committee report
directly to the facility’s chief executive officer and
administrative head, that it meet at least quarterly, that it
document its proceedings in minutes, and that it act
independently of other committees. N.J.A.C. 8:43E-10.4(c)(4)-
(7). Among other responsibilities, the committee must develop
and periodically review and revise a written patient safety plan
in accordance with N.J.A.C. 8:43E-10.5. N.J.A.C. 8:43E-10.4(d).
9 The regulations adopted pursuant to the Patient Safety Act,
N.J.A.C. 8:43E-10.1 to -10.11, became effective on March 3, 2008
as applied to general, special, psychiatric and rehabilitation
hospitals. N.J.A.C. 8:43E-10.2.
18
The patient safety committee must also “[f]oster attitudes,
beliefs and behaviors supporting open communication within the
facility” by means of information systems detailed in the
regulation, implement measures to minimize the risk of
preventable adverse events, ensure timely reporting to
regulators, and assemble an appropriate team to analyze root
cause analyses of certain adverse events. N.J.A.C. 8:43E-
10.4(d).
In short, the detailed requirements for the patient safety
committee’s composition, goals and process were not set forth in
the Patient Safety Act itself, but were established by the
regulations adopted nearly four years after the statute was
enacted. The structure and mission of the patient safety
committee, now comprehensively prescribed by regulation, had yet
to be specified when the Hospital prepared the document disputed
in this case.
A second important component of the Act is its mandate that
each facility implement a procedure for the collaborative review
of adverse events. As part of its patient safety plan, a
facility must designate “teams of facility staff . . . comprised
of personnel who are representative of the facility’s various
disciplines and have appropriate competencies,” to analyze and
apply “evidence-based patient safety practices,” and thereby
“reduce the probability of adverse events resulting from
19
exposure to the health care system.” N.J.S.A. 26:2H-
12.25(b)(2). Effective for general hospitals on March 3, 2008,
a corresponding regulation, N.J.A.C. 8:43E-10.4(b)(2),
supplemented the statutory requirement.
The Patient Safety Act also mandates that “serious
preventable adverse event[s]” must be reported by health care
facilities “in a form and manner established by the
[C]ommissioner [of the Department].” N.J.S.A. 26:2H-12.25(a),
(c).10 Effective on March 3, 2008, for general hospitals,
N.J.A.C. 8:43E-10.6 describes in detail the categories of events
that will trigger the reporting requirement. N.J.A.C. 8:43E-
10.6(e)-(j). That regulation specifies that a serious
preventable adverse event occurring in a hospital must be
disclosed to the Department within five business days of its
discovery using the appropriate form. N.J.A.C. 8:43E-10.6(b),
(c). It also gives detailed direction on the conduct and
reporting of analyses of serious preventable adverse events --
guidance that was not set forth in the Patient Safety Act
itself. N.J.A.C. 8:43E-10.6(k)-(m).11
10 The Act also encourages the anonymous reporting of adverse
events that are not subject to mandatory reporting. N.J.S.A.
26:2H-12.25(e)(1).
11 Other requirements that were set forth in general terms in the
Patient Safety Act were further explained by subsequent
regulations. The Patient Safety Act requires that teams of
facility staff, comprised of personnel “who are representative
of the facility’s various disciplines and have appropriate
20
To further the legislative goal of minimizing system
failures and enhancing patient care, the Patient Safety Act thus
provided the basic framework for the analysis and reporting of
serious adverse events occurring in health care facilities. The
subsequent adoption of N.J.A.C. 8:43E-10.1 to -10.11 provided
comprehensive guidance with respect to the necessary committee
structure, evaluation methodology and process for reporting such
events to regulators.
B.
The Legislature included in the Patient Safety Act a
provision creating an absolute privilege. N.J.S.A. 26:2H-
12.25(g). It reasoned that health care professionals and other
facility staff are more likely to effectively assess adverse
events in a confidential setting, in which an employee need not
fear recrimination for disclosing his or her own medical error,
or that of a colleague. As articulated in the statute’s
legislative findings,
[t]o encourage disclosure of [adverse events
and near-misses], . . . it is critical to
create a non-punitive culture that focuses on
competencies,” analyze events that constitute “near-misses” --
occurrences “that could have resulted in an adverse event but
the adverse event was prevented.” N.J.S.A. 26:2H-12.25(a),
(b)(3). That requirement was refined by N.J.A.C. 8:43E-
10.5(a)(3). The Patient Safety Act also requires “a process for
the provision of ongoing patient safety training for facility
personnel,” N.J.S.A. 26:2H-12.25(b)(4), and the details of that
process are prescribed in N.J.A.C. 8:43E-10.5(a)(5).
21
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 thus recognized the pivotal role of
confidentiality in promoting open and effective evaluation and
reporting.
The Patient Safety Act was drafted in a setting in which
other evaluative processes conducted by health care facilities
were completely or partially privileged from disclosure by
statute or case law. In New Jersey, the utilization review
process is subject to a statutory privilege against disclosure.
See N.J.S.A. 2A:84A-22.8 (stating that, subject to certain
exceptions, “[i]nformation and data secured by and in the
possession of utilization review committees established by any
certified hospital or extended care facility in the performance
of their duties shall not be revealed or disclosed in any manner
or under any circumstances by any member of such committee”).
22
In Christy, supra, the Appellate Division addressed the
privilege protecting documents memorializing a health care
facility’s peer review process. 366 N.J. Super. at 537. There,
a medical malpractice plaintiff sought discovery of a report
created by the defendant hospital’s “peer review committee”
regarding the plaintiff’s care. Id. at 538. Noting the absence
of a statutory privilege governing peer review materials, the
Appellate Division conducted a balancing test of the competing
interests at issue -- the “plaintiff’s right to discover
information concerning his care and treatment” for purposes of
his litigation and the “public interest to improve the quality
of care and help to ensure that inappropriate procedures, if
found, are not used on future patients.” Id. at 541. Relying
on Payton v. N.J. Turnpike Auth., 148 N.J. 524 (1997), the
Appellate Division ordered the disclosure of the “purely
factual” contents of the peer review report, but shielded from
discovery “evaluative and deliberative materials” within the
report that contained the hospital’s “opinions, analysis, and
findings of fact concerning the events that [were] the subject
matter of [the] plaintiff’s case.” Id. at 543-45. The panel
thus concluded that “peer review” materials should be evaluated
case by case to determine the existence and scope of a
privilege. Ibid. Like the statutory privilege that governs the
utilization review component of continuous improvement programs,
23
the common law privilege governing documents generated in a peer
review process exists to promote open discussion of medical
errors.
In enacting the Patient Safety Act, the Legislature
considered the extent to which the statute’s confidentiality
provisions would shield documents from disclosure in litigation
and other settings. As explained by Clifton R. Lacy, M.D., then
Commissioner of the Department, in his testimony before the
Senate Health, Human Services and Senior Citizens Committee in
support of Senate Bill 557, the proposed Act “strikes the right
balance between acknowledging and learning from errors, and also
holding people accountable. It shields self-critical analysis
from discovery, but maintains discoverable all that is now
discoverable.” Hearing on S. 557 Before the S. Health, Human
Services and Senior Citizens Comm., 211th Leg. 6 (N.J. 2004)
(Statement of Clifton R. Lacy, M.D.). Asked to elaborate on
that statement, Commissioner Lacy testified:
[W]hat I meant when I said that everything
that’s currently discoverable remains
discoverable -- [w]hat this shields is,
multidisciplinary teams get together and sit
and analyze and digest and try to find out
what are the root causes, why did this error
occur, and what safety precautions can we put
into place -- redundancy, scrutiny -- whatever
is necessary -- computerization. Find out the
causes, find the fix to prevent not just this
error, but every error like this kind in the
future. Everything that’s currently
discoverable -- the medical record, the test
24
results, deposition of witnesses -- all that
continues to be exactly as it is now. What
this legislation shields is that self-critical
analysis, the next step of analyzing -- of
getting the team of nurses, physicians,
pharmacists, these interdisciplinary groups -
- to digest and find those root causes. That’s
protected. And the reporting of those things
to our Department is protected.
[Hearing on S. 557 Before the S. Health, Human
Services and Senior Citizens Comm., 211th Leg.
12-13 (N.J. 2004) (Statement of Clifton R.
Lacy, M.D.).]12
The Act attaches a privilege to specific information
generated by health care facilities in two distinct processes:
the reporting of adverse events to regulators, and the
investigative process that may or may not lead to such
reporting. Pursuant to N.J.S.A. 26:2H-12.25(f), “[a]ny
documents, materials or information received by” the Department
from a health care facility pursuant to the statute’s two
reporting provisions, N.J.S.A. 26:2H-12.25(c) and -12.25(e),
“that are otherwise not subject to mandatory reporting pursuant
to [N.J.S.A. 26:2H-12.25(c)], shall not be . . . subject to
discovery or admissible as evidence or otherwise disclosed in
12Prior to the passage of the Patient Safety Act, the Senate
Bill was amended to confirm that the Act was not intended “to
increase or decrease the discoverability, in accordance with
Christy v. Salem . . . of any documents, materials or
information if obtained from any source or context other than
those specified in this act.” S. Bill No. 557 (Mar. 4, 2004).
25
any civil, criminal, or administrative action or proceeding.”
N.J.S.A. 26:2H-12.25(f)(1).13
Similarly, N.J.S.A. 26:2H-12.25(g)(1) protects
communications generated in the setting of self-critical
analysis:
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 . . . shall not be:
(1) subject to discovery or
admissible as evidence or otherwise
disclosed in any civil, criminal or
administrative action or
proceeding.
N.J.S.A. 26:2H-12.25(g) thus shields certain documents,
materials and information developed by a health care facility as
it investigates and evaluates adverse events.
Like its process requirements, the Patient Safety Act’s
privilege provisions were explained and refined by the
regulations that followed. Effective March 3, 2008, as applied
to the Hospital, N.J.A.C. 8:43E-10.9(b)(1) requires that a
13The same section of the Act provides that such reporting
documents, materials and information shall not be “considered a
public record under [N.J.S.A. 47:1A-1],” N.J.S.A. 26:2H-
12.25(f)(2), and addresses the use of such information in
adverse employment actions and in the evaluation of certain
“accreditation, certification, credentialing or licensing”
decisions, as defined in the statute. N.J.S.A. 26:2H-
12.25(f)(3).
26
document be “exclusively” developed in the setting of self-
critical analysis as defined by three other regulations,
N.J.A.C. 8:43E-10.4, 10.5 and 10.6, in order to warrant the
statutory privilege:
Documents, materials and information
(including [root cause analyses] and minutes
of meetings) developed by a health care
facility exclusively during the process of
self-critical analysis, in accordance with
[N.J.A.C.] 8:43E-10.4, 10.5 or 10.6 concerning
preventable events, near-misses and adverse
events, including serious preventable adverse
events . . . shall not be:
(1) Subject to discovery or
admissible as evidence or
otherwise disclosed in any civil,
criminal or administrative action
or proceeding.
[(emphasis added).]
Thus, pursuant to N.J.A.C. 8:43-10.9, which now governs New
Jersey health care facilities, the statutory privilege applies
only to documents, materials and information developed
exclusively during self-critical analysis conducted during one
of three specific processes: the operations of the patient or
resident safety committee pursuant to N.J.A.C. 8:43E-10.4, the
components of a patient or resident safety plan as prescribed by
N.J.A.C. 8:43E-10.5, or reporting to regulators under N.J.A.C.
8:43E-10.6. N.J.A.C. 8:43E-10.9(b). In the regulations that
became effective in 2008, the statutory standard was expanded
upon in two significant respects: first, to require that the
27
documents, materials and information at issue be “exclusively”
prepared in the setting of a qualifying self-critical analysis
process, and second, to mandate that the self-critical analysis
be conducted in accordance with one of three accompanying
regulations as a prerequisite for the privilege to attach,
N.J.A.C. 8:43E-10.4, -10.5 and -10.6. N.J.A.C. 8:43E-10.9(b).
Under the statutory and regulatory framework in place today,
medical and administrative professionals are on notice of the
exact procedures that they must follow in order to ensure the
confidentiality of information pursuant to the Patient Safety
Act.
IV.
This case did not arise in the setting of the detailed
regulatory scheme that now exists. Although the Patient Safety
Act had been passed when DV2 was written, the implementing
regulations had yet to be adopted at that time; they would not
govern the Hospital until March 3, 2008. N.J.A.C. 8:43E-
10.2(a)(9). Moreover, health care facilities were given an
additional 180 days from the regulations’ effective date to
“[d]evelop a written patient or resident safety plan for the
facility” in compliance with the regulations. N.J.A.C. 8:43E-
10.4(d)(1). When DV2 was prepared on June 1, 2007, the only
guidance to the Hospital and its staff was found in the Patient
Safety Act. The discoverability of DV2 must therefore be
28
determined in accordance with the Patient Safety Act itself,
without imposing requirements that appeared for the first time
in subsequent regulations.
The Act focuses upon the process that generated the
communication for which a health care facility claims privilege.
N.J.S.A. 26:2H-12.25(g) shields from discovery documents,
materials or information developed “as part of a process of
self-critical analysis conducted pursuant to” N.J.S.A. 26:2H-
12.25(b). N.J.S.A. 26:2H-12.25(b) requires that a patient
safety plan include, “at a minimum,” four components: the
establishment of “a patient safety committee,” N.J.S.A. 26:2H-
12.25(b)(1); “a process for teams of facility staff . . . to
conduct ongoing analysis and application of evidence-based
patient safety practices” to reduce the risk of adverse events,
N.J.S.A. 26:2H-12.25(b)(2); “a process for teams of facility
staff . . . to conduct analyses of near-misses,” N.J.S.A. 26:2H-
12.25(b)(3); and “a process for the provision of ongoing patient
safety training for facility personnel,” N.J.S.A. 26:2H-
12.25(b)(4). Accordingly, the discoverability of DV2 turns on
whether the document was developed in the setting of a “process
of self-critical analysis,” conducted as part of a patient
safety plan that meets the four components of N.J.S.A. 26:2H-
12.25(b). N.J.S.A. 26:2H-12.25(g).
29
The record supports the trial court’s determination that
the Hospital had established such a patient safety plan. It
confirms that the Hospital satisfied the first aspect of such a
plan, the establishment of a patient safety committee in
compliance with N.J.S.A. 26:2H-12.25(b)(1). As the trial court
found, the Hospital’s Patient Safety Committee consisted of
sixteen members and was chaired by Mitchell Rubenstein, M.D.,
the Chief Medical Officer of the Hospital. The Patient Safety
Committee was determined to be a “stand-alone, decision making
committee” with “independent decision-making” authority.
Nothing in N.J.S.A. 26:2H-12.25(b)(1) requires that the Patient
Safety Committee conduct every aspect of factfinding in
accordance with the Patient Safety Act. That Committee was in
operation when DV2 was prepared in June 2007. The Hospital
therefore met this component of the statutory mandate.
The Hospital also complied with N.J.S.A. 26:2H-12.25(b)(2)
and (3). Those provisions require facilities to establish
“teams of facility staff” that “are comprised of personnel who
are representative of the facility’s various disciplines and
have appropriate competencies” to analyze patient safety
practices and near-misses. The Patient Safety Act did not
require that physicians, nurses, administrators, or any other
category of facility staff play a role in a given committee, and
it did not specify the procedure for the meeting of a team
30
following a potentially reportable adverse event. Instead, the
statute requires only that each facility appoint teams of staff,
comprised of members with competencies representative of the
facility’s various disciplines. N.J.S.A. 26:2H-12.25(b)(2),
(3).
The Hospital met that standard. As the trial court
determined, after the Patient Safety Act became effective, it
was Mutter’s practice, as Director of Patient Safety, to conduct
round-table discussions with professionals from various
disciplines, as required by the Act. Mutter would commence each
round-table meeting by stating that the discussion was held as
an exercise in self-critical analysis, in accordance with the
Patient Safety Act.
Finally, as evidenced by its Performance Improvement Plan,
the Hospital had implemented “a process for the provision of
ongoing patient safety training for facility personnel,” in
compliance with N.J.S.A. 26:2H-12.25(b)(4). Consequently, the
Hospital’s patient safety plan satisfied all of the statutory
requirements of the Patient Safety Act.
As it establishes the Hospital’s general compliance with
the Patient Safety Act, the record also supports the trial
court’s finding that DV2 was prepared “as part of a process of
self-critical analysis” pursuant to N.J.S.A. 26:2H-12.25(b). As
the trial court noted, Mutter recorded in DV2 that the document
31
memorializing the meeting was created pursuant to the Patient
Safety Act. The team of facility staff that reviewed C.A.’s
case included Mutter, in his role as the Director of Patient
Safety, along with obstetrical nursing management and educators,
and the nurses involved in the care of Applegrad and her child.
As the trial court found, Mutter assured the participants in the
round-table discussion that their disclosures would be kept
confidential, and inquired about the medical treatment
administered to Applegrad and C.A. during and following the
birth. Following the meeting that was memorialized in DV2,
Mutter separately discussed C.A.’s case with Robles and Malkin.
All three individuals agreed that C.A.’s birth and neonatal care
did not give rise to a reportable event for purposes of N.J.S.A.
26:2H-25(c) of the Patient Safety Act, or a “Sentinel Event”
that would warrant a root cause analysis under the Joint
Commission standards. The round-table discussion that led to
the creation of DV2 was part of an investigation into whether
the incident under review was a serious preventable adverse
event that should be reported to the Department under N.J.S.A.
26:2H-12.25(c).
Moreover, the self-critical analysis required by N.J.S.A.
26:2H-12.25(b) entails not only the decision-making that leads
to the reporting of an adverse event, but also the development
and collection of information necessary for that determination.
32
See N.J.S.A. 26:2H-12.25(g)(2) (identifying “development,
collection, reporting or storage of information” as components
of process of self-critical analysis under N.J.S.A. 26:2H-
12.25(b)).
Notwithstanding the detailed requirements later implemented
by regulation, the “round-table” evaluative process initiated by
the Hospital under Mutter’s oversight satisfied the statutory
mandate.14 DV2 was “developed . . . as part of a process of
self-critical analysis conducted pursuant to [N.J.S.A. 26:2H-
12.25(b)],” as required by N.J.S.A. 26:2H-12.25(g). Regardless
of whether the Hospital’s process would have satisfied the
regulations that became effective at a later time, the Hospital
met the only standard that governed it in 2007, the mandate of
the Patient Safety Act itself.
Our dissenting colleagues do not share the Appellate
Division’s view that this case is governed by the regulatory
requirements of N.J.A.C. 8:43E-10.6, which were not yet in
effect when the Hospital prepared DV2. Nor do they contend that
14Contrary to the suggestion of the Appellate Division panel,
the Hospital’s conclusion that the event was not reportable does
not abrogate the statutory privilege. Nothing in N.J.S.A.
26:2H-12.25(g) limits the privilege to settings in which the
incident is ultimately determined to be subject to mandatory
reporting under N.J.S.A. 26:2H-12.25(c). The Patient Safety
Act’s privilege is not constrained to cases in which the
deliberative process concludes with a determination that the
case is reportable under N.J.S.A. 26:2H-12.25(c).
33
the Hospital’s Patient Safety Committee was not established in
accordance with N.J.S.A. 26:2H-12(b)(1). Instead, our
dissenting colleagues argue that the Hospital failed to comply
with the requirement of N.J.S.A. 26:2H-12(b)(2) and (3) that
“teams of facility staff . . . comprised of personnel who are
representative of the facility’s various disciplines and have
appropriate competencies,” analyze evidence-based safety
practices and near-misses. Post at ____ (slip op. at 1-2, 6-8,
11-12). Contrary to the suggestion of the dissent, however, the
round-table discussion that generated DV2 was not confined to
Mutter, Robles and Malkin. Instead, that discussion included a
broader team of Hospital staff, including the obstetrical nurses
directly involved in the care of C.A. and her mother, as well as
nursing managers and nursing educators. The Hospital complied
with the PSA’s mandate that this case be analyzed by a qualified
team of its staff.
Our dissenting colleagues further contend that the
Hospital’s process fell short of compliance with the PSA because
the record does not establish that the review conducted by
Mutter, Robles and Malkin was conducted with the knowledge of
the Patient Safety Committee of which the three administrators
were members. Post at ____ (slip op. at 7-8). However, nowhere
in the PSA did the Legislature define the relationship between
the Patient Safety Committee, which was generally mandated by
34
N.J.S.A. 26:2H-12.25(b)(1) with details to be “prescribed by
regulation,” and the teams envisioned by N.J.S.A. 26:2H-
12.25(b)(2) and (3). The Patient Safety Committee’s conduct of
its analytical function, and its reporting structure, would
later be set forth in detail in N.J.A.C. 8:43E-10.4, but the
regulatory requirements had yet to be imposed at the relevant
time.
In sum, the Patient Safety Act exists to promote thorough
and candid discussions of events occurring in health care
facilities, and thereby to protect the safety of patients. In
the interim period between the enactment of the Act and the
adoption of its implementing regulations, health care facilities
were required to follow the Patient Safety Act, which serves the
important public policy goal of promoting open discussions of
adverse events. Those facilities were not compelled to
anticipate later regulations as a condition of the statutory
privilege. In this case, the Hospital complied with the
requirements governing the application of that privilege. DV2
memorialized part of a confidential process of self-critical
analysis, as prescribed by N.J.S.A. 26:2H-12.25(b).
Accordingly, pursuant to N.J.S.A. 26:2H-12.25(g), DV2 is
not subject to discovery, and should not be used for any purpose
in this case, including its use as a resource for the judge
trying the case. N.J.S.A. 26:2H-12.25(g) shields only DV2,
35
consistent with the narrow construction generally afforded to
privileges under our law, and does not protect otherwise
discoverable information concerning C.A.’s birth and neonatal
treatment. See State v. J.G., 201 N.J. 369, 383 (2010);
Stempler v. Speidell, 100 N.J. 368, 375 (1985); State v. Dyal,
97 N.J. 229, 237 (1984).
V.
The judgment of the Appellate Division is reversed, and the
matter is remanded for further proceedings in accordance with
this opinion.
JUSTICES LaVECCHIA and FERNANDEZ-VINA and JUDGE RODRÍGUEZ
(temporarily assigned) join in JUSTICE PATTERSON’s opinion.
JUDGE CUFF (temporarily assigned) filed a separate, dissenting
opinion in which CHIEF JUSTICE RABNER and JUSTICE ALBIN join.
36
SUPREME COURT OF NEW JERSEY
A-32 September Term 2012
071702
C.A., a Minor, by Her Mother
and Guardian ad Litem, ESTHER
APPLEGRAD, ESTHER APPLEGRAD,
Individually, and GEDALIA
APPLEGRAD, Individually,
Plaintiffs-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-Appellants.
JUDGE CUFF (temporarily assigned), dissenting.
A newborn suffered catastrophic injuries during the
birthing process at The Valley Hospital (Hospital). The Patient
Safety Act, N.J.S.A. 26:2H-12.23 to -12.25(k), mandated that the
Hospital create a patient safety committee to investigate such
adverse events as occurred in this case. The composition of
that committee should have been “representative of the
facility’s various disciplines and have appropriate
competencies.” N.J.S.A. 26:2H-12.25(b). Yet the Hospital
1
committee that reviewed the tragic event was comprised of three
administrators, none of whom was a physician, much less one
specializing in obstetrics.
The Patient Safety Act guarantees that documents developed
during a patient safety committee inquiry, such as interview
notes, are privileged and not subject to discovery. This
interlocutory appeal presents a narrow issue concerning whether
information generated by Hospital personnel reviewing the events
preceding and immediately following this birth is subject to the
privilege conferred on any document or information generated as
part of a process of self-critical analysis conducted pursuant
to the Act. The majority holds that the evaluative process
utilized by the Hospital conformed to the requirements of the
Patient Safety Act and the memorandum at issue in this appeal is
privileged. The committee that conducted the inquiry here,
however, was not a patient safety committee as envisioned by the
Act. Having failed to satisfy the conditions established in the
Act, the Hospital cannot invoke the absolute privilege accorded
by the statute. For that reason, I part with the majority and
would hold that no privilege attaches to interview notes
generated by a committee not in compliance with the Patient
Safety Act.
It is not necessary to recount the facts and procedural
history recited by the majority. It is also unnecessary to
2
recount the events that precipitated enactment of the Patient
Safety Act and its relationship to other processes that
hospitals are permitted to utilize to evaluate adverse events.
The focus of this dissent is founded on the process employed in
this case and my conclusion that the process did not conform to
that contemplated by the Legislature as a pre-condition for
invocation of the statutory privilege.
N.J.S.A. 26:2H-12.25(g) provides that any documents or
information developed by a health care facility in accordance
with the process outlined by the Act shall not be subject to
discovery, or used in any civil, criminal or administrative
action or proceeding, an adverse employment action, or the
valuation of credentialing, accreditation, certification or
licensure of any individual. The statute provides:
Any documents, material, or information
developed by a health care facility as part of
a process of self-critical analysis conducted
pursuant to [N.J.S.A. 26:2H-12.25(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 [N.J.S.A. 26:2H-12.25(d)] of the 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
3
(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 [N.J.S.A. 26:2H-12.25(b)].
[N.J.S.A. 26:2H-12.25(g).]
In short, a hospital named as a defendant in a medical
negligence action may withhold possibly relevant and probative
information and documents developed during a Patient Safety Act
self-critical analysis pursuant to the privilege conferred by
that statute on such information and documents.
By the terms of the statute, the privilege does not attach
to the information and documents generated during a Patient
Safety Act self-critical analysis unless the hospital has
followed the procedure outlined in the statute. First, the
hospital must develop and implement a patient safety plan.
N.J.S.A. 26:2H-12.25(b). The purpose of the plan is to improve
the “health and safety of patients at the facility.” Ibid.
Then, the Act proceeds to outline the minimum features of the
patient safety plan requiring
(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
4
the health care system across a range of
diseases and procedures; [and]
(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.
[N.J.S.A. 26:2H-12.25(b)(2) and (3).]
The Act also contemplates the enactment of regulations,15
N.J.S.A. 26:2H-12.25(b)(1), and a process for ongoing patient
safety training for hospital personnel, N.J.S.A. 26:2H-
12.25(b)(4).
The majority asserts that the review conducted by the
Hospital complied with the Patient Safety Act. Ante at ____
(slip op. at 33). It notes that the Legislature enacted the Act
shortly before C.A.’s birth and that the review at issue
occurred long before the Department of Health issued its
regulations in 2008. Ante at ___ (slip op. at 28). It
concludes that the Hospital did no less than reasonably possible
given the lack of direction provided by the Legislature.
Accordingly, the majority determines that the Hospital’s efforts
permit it to invoke the statutory privilege afforded to self-
critical analysis of adverse events. Ante at ___ (slip op. at
30).
15 See N.J.A.C. 8:43E-10.1 to -10.10, effective March 3, 2008.
5
The Patient Safety Act, however, cannot be characterized as
a vague declaration of public policy with little or no guidance
to the administrative agency charged with its administration or
the health care facilities required to follow the law, which can
decide to invoke the privilege conferred by the statute. The
patient safety plan must outline a process to conduct an ongoing
analysis of patient safety practices and to apply those
practices such that adverse events “resulting from exposure to
the health care system across a range of diseases and
procedures” are reduced. N.J.S.A. 26:2H-12.25(b)(2). The
patient safety plan must also include a process to conduct
analyses of “near-misses, with particular attention to serious
preventable adverse events and adverse events.” N.J.S.A. 26:2H-
12.25(b)(3).
Importantly, the Patient Safety Act does more than
prescribe the development and implementation of a process.
Sections 12.25(b)(2) and (3) also prescribe the personnel who
are to be engaged in the process. The process to analyze and
implement patient safety practices and the process to analyze
near-misses and serious preventable adverse events and adverse
events are to be conducted by “teams of facility staff”
comprised of “personnel who are representative of the facility’s
various disciplines and have appropriate competencies” to
6
conduct the analyses required by the Act. N.J.S.A. 26:2H-
12.25(b)(2).
Here, the record reveals that at the time of C.A.’s birth,
the Hospital had a Patient Safety Committee (Committee)
comprised of sixteen members. The Chief Medical Officer, an
employee of the Hospital, chaired the Committee. Other non-
employee physicians with staff privileges at the Hospital were
members of the Committee. Michael Mutter, Director of Patient
Safety, was a member of this Committee.
Following C.A.’s birth, Kim Robles, Director of Quality
Assessment Improvement and Regulatory Compliance, received a
referral from the Quality Assurance Coordinator. She referred
the matter to Linda Malkin, Director of Risk Management, who
referred the matter to Mutter to conduct an investigation to
determine whether the circumstances of C.A.’s birth and her
condition were a preventable event that should be reported to
the Department of Health. Mutter convened a roundtable
discussion composed of persons designated by the manager of the
Labor and Delivery Unit. During this discussion, Mutter sought
to identify a process failure and led the discussion by posing
open-ended questions to the participants. All in attendance
were encouraged to participate. In the end, Mutter concluded
that the circumstances of the labor and delivery were
attributable to medical complications rather than a failure of
7
process. Therefore, he concluded that events attendant to
C.A.’s birth were not a reportable event and he forwarded his
recommendation to Malkin. She consulted Robles, who concurred.
The matter was not reviewed by the Committee. In fact, the
record does not reflect that the Committee was aware of the
Mutter roundtable discussion and report or the concurrence of
Robles and Malkin. The record also does not reveal whether the
Committee ever knew that a patient safety review of this
incident under its auspices ever occurred. In other words, the
purported Patient Safety Act review was conducted by one member
of the Committee, who reported his roundtable findings to
another member of the Committee, and a third member of the
Committee concurred.
Although relevant evidence is presumed to be discoverable,
it is well-established that the presumption can be overcome by
an applicable evidentiary privilege. Such a privilege excludes
relevant evidence from the factfinder’s consideration and
therefore “‘contravene[s] the fundamental principle that the
public . . . has a right to every man’s evidence.’” State v.
Szemple, 135 N.J. 406, 413 (1994) (quoting Trammel v. United
States, 445 U.S. 40, 50, 100 S. Ct. 906, 912, 63 L. Ed. 2d 186,
195 (1980) (internal quotation marks omitted)). As a result,
this Court has repeatedly instructed that any privilege must be
narrowly construed so as to protect the judicial system’s
8
fundamental goal of securing just results. See, e.g., State v.
J.G., 201 N.J. 369, 372 (2010) (“[C]ourts sensibly accommodate
privileges to the ‘aim of a just result[.]’” (quoting State v.
Briley, 53 N.J. 498, 506 (1969))); Kinsella v. Kinsella, 150
N.J. 276, 294 (1997) (noting that privileges are generally
construed narrowly in favor of admitting relevant evidence;
privilege against compelled disclosure “‘runs counter to the
fundamental theory of our judicial system that the fullest
disclosure of the facts will best lead to the truth.’” (quoting
In re Selser, 15 N.J. 393, 405 (1954))).
Privileges are disfavored as obstacles to this Court’s
“desire to attain truth through the adversarial process[.]”
Payton v. N.J. Tpk. Auth., 148 N.J. 524, 539 (1997); see also
State v. Mauti, 208 N.J. 519, 531 (2012). Despite a presumption
against the creation of new privileges, Payton, supra, 148 N.J.
at 546, the Legislature is free to do so in situations where the
social policy in support of nondisclosure is weightier than the
evidence it renders unavailable. In accordance with these
guiding principles, a statutory privilege will shield evidence
from compelled disclosure only when, “in the particular area
concerned, it serves a more important public interest than the
need for full disclosure.” State in Interest of C., 165 N.J.
Super. 131, 136 (App. Div. 1979) (citing Briley, supra, 53 N.J.
at 506).
9
Until today, cognizant of the disfavored status of
privileges, New Jersey has refused to recognize a broad
privilege for information generated by an organization engaged
in self-critical analysis. See Payton, supra, 148 N.J. at 547-
48 (holding employer’s internal investigation of sexual
harassment complaint akin to other confidential information and
therefore not privileged). The Patient Safety Act, which
affords an absolute privilege to information and documents
generated pursuant to a self-critical analysis conducted by a
healthcare facility in accordance with the requirements of that
statute, N.J.S.A. 26:2H-12.25(b), embodies a narrow exception to
this rule.
In drafting the Patient Safety Act, the Legislature devoted
a separate subsection to the policies and procedures a
healthcare facility must follow in order to claim a privilege
with regard to the results of a self-critical analysis. These
requirements include developing a patient safety plan, which
must include a patient safety committee, ongoing patient safety
training for facility personnel, and processes for conducting
ongoing analysis of “evidence-based patient safety practices”
and “near misses [or] serious preventable adverse events and
adverse events.” N.J.S.A. 26:2H-12:25(b). The presence of
these conditions clearly indicates that the Legislature did not
intend the Act’s privilege to apply universally to any self-
10
critical analysis conducted by a healthcare facility, but rather
to a carefully circumscribed self-critical analysis conducted in
accordance with the statute. Like all relevant evidence, such
information would be discoverable unless the healthcare facility
abided by the specific requirements to invoke the privilege.
The Legislature’s decision to carefully circumscribe the
circumstances under which this privilege may be invoked accords
with the disfavored status of privileges and the principles of
broad discovery envisioned by the New Jersey Rules of Evidence.
The Patient Safety Act requires more than the existence of a
hospital committee that bears the name “Patient Safety
Committee.” The committee must be “comprised of personnel who
are representative” of the hospital’s “various disciplines.”
N.J.S.A. 26:2H-12.25(b)(2) (emphasis added). Thus, the Act
requires more than a reference to one member of a committee and
consultation with two other members. Yet that is all this
record establishes. This record does not even permit a finding
that the Hospital’s existing Patient Safety Committee knew that
the so-called self-critical analysis contemplated by the Act and
purportedly conducted by Mutter, Malkin, and Noble was conducted
under its auspices. Furthermore, the focus of the Mutter,
Malkin, and Noble effort seems to have concentrated more on
whether the Hospital should report the birth event to the
Department of Health rather than identifying any internal
11
process that may have caused or contributed to the circumstances
surrounding C.A.’s birth. The record requires me to conclude
that the discussion led by Mutter falls well short of the
process envisioned by the Patient Safety Act. I, therefore,
respectfully disagree with the majority’s decision to shield the
document at issue from discovery. The privilege created by the
Act cannot apply when a healthcare organization fails to abide
by the requirements of that statute.
I would affirm the Appellate Division. Therefore, I
respectfully dissent.
CHIEF JUSTICE RABNER and JUSTICE ALBIN join in this
opinion.
12
SUPREME COURT OF NEW JERSEY
NO. A-32 SEPTEMBER TERM 2012
ON APPEAL FROM Appellate Division, Superior Court
C.A., a Minor, by Her Mother
And Guardian Ad Litem, ESTHER
APPLEGRAD, ESTHER APPLEGRAD,
Individually, and GEDALIA
APPLEGRAD, Individually,
Plaintiffs-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-Appellants.
DECIDED September 29, 2014
Chief Justice Rabner PRESIDING
OPINION BY Justice Patterson
CONCURRING/DISSENTING OPINION BY
DISSENTING OPINION BY Judge Cuff
CHECKLIST REVERSE/REMAN
AFFIRM
D
CHIEF JUSTICE RABNER X
JUSTICE LaVECCHIA X
JUSTICE ALBIN X
JUSTICE PATTERSON X
JUSTICE FERNANDEZ-VINA X
JUDGE RODRÍGUEZ (t/a) X
JUDGE CUFF (t/a) X
4 3
1
C.A. v. Eric Bentolila, M.D. (071702)
Court: Supreme Court of New Jersey
Date filed: 2014-09-29
Citations: 219 N.J. 449, 99 A.3d 317
Copy CitationsCombined Opinion