                                                      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



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