                      RECORD IMPOUNDED

                 NOT FOR PUBLICATION WITHOUT THE
                APPROVAL OF THE APPELLATE DIVISION

                                   SUPERIOR COURT OF NEW JERSEY
                                   APPELLATE DIVISION
                                   DOCKET NO. A-4342-15T1

JANELLE BRUGALETTA,
                                       APPROVED FOR PUBLICATION
      Plaintiff-Respondent,
                                          February 6, 2017
v.                                       APPELLATE DIVISION

CALIXTO GARCIA, D.O.,
STEVEN D. RICHMAN, M.D. and
PATRICK J. HINES, M.D.,

      Defendants,

and

CHILTON MEMORIAL HOSPITAL,

     Defendant-Appellant.
___________________________________

          Argued December 6, 2016 – Decided February 6, 2017

          Before Judges Fisher, Ostrer and Vernoia.

          On appeal from an interlocutory order of the
          Superior Court of New Jersey, Law Division,
          Passaic County, Docket No. L-112-15.

          Anthony Cocca argued the cause for appellant
          (Bubb, Grogan & Cocca, LLP, attorneys; Mr.
          Cocca, of counsel and on the briefs; Katelyn
          E. Cutinello, on the briefs).

          Ernest P. Fronzuto argued the cause for
          respondent (Fronzuto Law Group, attorneys;
          Mr. Fronzuto and Casey Anne Cordes, on the
          brief).

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

       This medical malpractice case involves the Patient Safety

Act (the Act), N.J.S.A. 26:2H-12.23 to -12.25, which creates an

absolute     privilege       over    certain     documents     that    a   hospital

develops as part of a self-critical analysis.                         See N.J.S.A.

26:2H-12.25(g).        The   trial    court    compelled      defendant    Chilton

Medical     Center    (Chilton)1     to   disclose       to   plaintiff,    Janelle

Brugaletta, a redacted report containing Chilton's self-critical

analysis of Brugaletta's care.                 The court ordered disclosure

because     it     found:    (1)    Brugaletta     had    suffered     a   "serious

preventable adverse event" (SPAE), see N.J.S.A. 26:2H-12.25(a);

and (2) Chilton failed to report the SPAE to the New Jersey

Department of Health (the Department) or to Brugaletta, as the

Act required.        See N.J.S.A. 26:2H-12.25(c), -12.25(d).

       By leave granted, Chilton appeals from the court's order.

Chilton disputes the court's finding that Brugaletta suffered a

SPAE and contends the court erred in compelling it to report the

SPAE   to    the     Department     and   Brugaletta.         More    importantly,

Chilton argues the Act's absolute privilege over a self-critical

analysis may not be pierced based on a failure to report a SPAE.


1
  Plaintiff denominated defendant as "Chilton Memorial Hospital"
in her complaint. Chilton answered the complaint in the name of
"AHS Hospital Corp./Children Medical Center."



                                          2                                A-4342-15T1
Rather, Chilton contends the privilege is conditioned solely on

compliance with statutory and regulatory mandates governing the

formation    of       a   patient     safety        plan      and   related     procedural

requirements.         See N.J.S.A. 26:2H-12.25(b).

       We agree the privilege does not depend on compliance with

the    requirement        to   report     a    SPAE     to    the    Department    or    the

patient.         We       therefore       reverse       the      trial   court's      order

compelling      partial        release    of    a   document        revealing   Chilton's

privileged self-critical analysis.                    We also reverse the finding

that there was a reportable SPAE because the finding lacked

sufficient credible evidence in the record.

                                               I.

       In the underlying malpractice action, Brugaletta alleges

she arrived at Chilton's emergency room on January 20, 2013,

complaining of abdominal pain and a fever that had persisted for

seven days.       A twenty-three-year-old college student, she also

complained of bodyaches, weakness, and a cough "productive of

. . .    thick    phlegm."          Her       initial      diagnosis     was    pneumonia.

After she was admitted, she continued to complain of abdominal

pain.    A CT scan of her abdomen and pelvis was performed the day

after she arrived at the hospital.                    It revealed a pelvic abscess

that    "most     probably"       resulted          from     a   perforated     appendix,

according to one physician's report.




                                               3                                   A-4342-15T1
     A large amount of purulent fluid2 was drained through the

right   ischial      fossa.3      Although      her    abdominal    symptoms   soon

improved, she developed fasciitis4 in the right thigh and right

buttock muscle.         One physician stated the fasciitis resulted

from "the leakage of the drainage around the [ischial] nerve."

Beginning    January        23,   2013,       Brugaletta    underwent     multiple

debridements5 of the thigh and buttock muscles.                    She also had an

appendectomy.         In    the   midst   of     those     repeated    procedures,

Brugaletta missed doses of a post-operation antibiotic despite a

physician's orders, which were recorded in his January 30, 2013

progress    note.6         When   Brugaletta     was     finally    discharged   on


2
  "Purulent fluid" is fluid that contains pus.                Stedman's Medical
Dictionary 1607 (28th ed. 2006).
3
  The "ischial fossa" refers to a space between muscle and skin
in the pelvic region. See Stedman's, supra, 765.
4
  "Fasciitis" refers to an inflammation of a particular kind of
tissue that covers the body below the skin.   Stedman's, supra,
700, 706.
5
  A "debridement" is a procedure whereby "devitalized tissue and
foreign matter" are removed from a wound.      Stedman's, supra,
496.   The post-operative notes of January 23, 2013 reported
"abundant dead fascia."
6
  We note that plaintiff does not address this oversight in her
complaint, nor is it clear from the limited record before us
that plaintiff is aware of it.    The oversight is documented in
the non-privileged chart.      Although Chilton disclosed the
document to the trial court as part of its ex parte submission,
Chilton recognized that the document is not privileged and was
included among its voluminous document production to Brugaletta.



                                          4                               A-4342-15T1
February 13, 2013, she was still suffering from severe pain; she

was instructed to use a walker or a person to assist her; and

she was prescribed pain medication and intravenous antibiotics

for administration at home.

       In her initial complaint, Brugaletta alleged that Chilton

and    various   providers        negligently          diagnosed     and   treated     her

condition.        In   particular,            she      highlighted     the    delay     in

diagnosing her "ruptured appendix and pelvic abscess."                           In her

first amended complaint, she added that physicians negligently

failed to detect a second abscess on her CT imaging.

       In   response      to    Brugaletta's           discovery    demands,    Chilton

identified but withheld as privileged the document at issue in

this   case.      Described       as     an   "Event     Detail     History    with    all

Tasks," Chilton asserted it was privileged pursuant to the Act

and    implementing       regulations,            as    well   as    other     grounds.7

Brugaletta sought to compel production, initially seeking the

court's     in   camera        review.        Chilton      opposed     and    sought     a

protective       order.           In     support,         Chilton     submitted        the

certification of Ebube Bakosi, M.D. the then-current chair of




7
  Chilton asserted privilege over another document pursuant to
the Act and the common law "conditional privilege" as set forth
in Christy v. Salem, 366 N.J. Super. 535, 540-42 (App. Div.
2004).   The court's order allowing Chilton to withhold that
document is not at issue in this appeal.



                                              5                                 A-4342-15T1
Chilton's Preventable Events Review Committee (PERC), formerly

known as the Patient Safety Committee.

     The trial court ordered the document's production for in

camera review.         The court also permitted Chilton to file an ex

parte   brief     to    present   document-specific          arguments    against

disclosure.     Upon review, the court found that Chilton prepared

the document, which the court marked as DCP-2, in accordance

with the procedural requirements of the Act and implementing

regulations.      However, the court concluded that the document

revealed   that      Brugaletta   had   suffered       a    separate     SPAE   and

Chilton failed to report that SPAE to the Department or disclose

to Brugaletta.8

     The court determined that when a hospital fails to report a

SPAE to the Department or a patient, the court is empowered to

compel it to do so.        The court also concluded if the hospital's

reporting failure was arbitrary or capricious, then the hospital

shall lose its privilege under the Act.                    The court held that

when the hospital has erred in failing to report without acting

arbitrarily     or      capriciously,       then   a       lesser      remedy    is

appropriate.      Applying those standards, the court found that

8
  Because we find DCP-2 is privileged and there is insufficient
evidence supporting the court's finding of a SPAE, we do not
detail the nature of the SPAE found by the court in order to
protect Chilton's privilege against disclosure of its self-
critical analysis.



                                        6                                 A-4342-15T1
Chilton       made    a    "clear      error    in     judgment,"        but   did    not   act

arbitrarily or capriciously.                    The court concluded under those

circumstances it was appropriate to release only the portion of

DCP-2    that    described        the     SPAE,      while       redacting     the   balance.

Nonetheless, the portion to be disclosed still revealed aspects

of Chilton's self-critical analysis.

       This appeal followed.              Chilton contends the court erred in

compelling       it       to   disclose       DCP-2,    albeit      redacted.          Chilton

argues        that    the       court     lacked        authority         to    review      its

determination that no SPAE occurred and to compel reporting;

and,     in    any    event,        neither      the    Act       nor    the   implementing

regulations authorize the partial or total loss of the privilege

when     a     hospital        fails     to     report       a    SPAE     when      required.

Brugaletta argues the trial court did not err, and its order

promotes compliance with the Act's reporting mandate.9


9
  Brugaletta also contends the trial court erred in finding that
Chilton complied with the privilege's procedural prerequisites.
As a result, she contends not even a limited privilege existed
under the Act, and the discoverability of DCP-2 should have been
analyzed under Christy, supra, 366 N.J. Super. at 540-42.
However, in order to challenge the trial court's order,
Brugaletta was required to file a cross-appeal.     See Franklin
Discount Co. v. Ford, 27 N.J. 473, 491 (1958) ("[A respondent],
in order to attack the actions below which were adverse to him,
must pursue a cross-appeal."); Pressler & Verniero, Current N.J.
Court Rules, comment 2 on R. 2:3-4 (2016) ("Ordinarily, a
respondent . . . must cross-appeal in order to obtain relief
from the judgment.").   We therefore shall not reach the issue.
For the same reason, we shall not address her argument that she
                                                     (continued)


                                                7                                     A-4342-15T1
                                        II.

      We review the trial court's discovery decision for an abuse

of   discretion,    but   we    shall   not    defer   to   the   trial   court's

decision if "based on a mistaken understanding of the applicable

law."     C.A. ex rel Applegrad v. Bentolila, 219 N.J. 449, 459

(2014)    (internal   quotation       marks    and   citation     omitted).      We

review    legal    issues      de   novo,     including     the   trial   court's

interpretation of the Act.           Ibid.

      In interpreting the Act and effectuating the Legislature's

intent, we look first to the plain language, reading it as an

integrated whole.         Id. at 459-60.         "If the plain language is

clear, the court's task is complete."                In re Kollman, 210 N.J.

557, 568 (2012).      If it is unclear or ambiguous, we may resort

to extrinsic aids.           Ibid.      "It is not the function of [a]

[c]ourt    to     'rewrite      a    plainly-written        enactment     of    the



(continued)
was entitled to access Chilton's ex parte brief, the hearing
transcripts "placed on a sealed record," and the judge's sealed
statement of reasons for its order.

     We also decline both parties' request that we endorse the
trial court's procedural measures for protecting the document's
confidentiality during its proceedings pending our review. The
court's thoughtfulness is evident.       We also appreciate the
parties' desire for guidance.      However, this aspect of the
matter is not disputed. It also is conceivable that in another
case and setting, a trial judge's exercise of discretion might
call for different measures.       We therefore believe it is
inappropriate for us to reach the issue.



                                         8                                A-4342-15T1
Legislature []or presume that the Legislature intended something

other   than   that      expressed   by       way   of    the   plain     language.'"

DiProspero v. Penn, 183 N.J. 477, 492 (2005) (quoting O'Connell

v. State, 171 N.J. 484, 488 (2002)).                     We respect, although we

are not bound by, an agency's statutory interpretation embodied

in its regulations.         See Hargrove v. Sleepy's, L.L.C., 220 N.J.

289, 301-02 (2015); see also Mayflower Sec. Co. v. Bureau of

Sec., 64 N.J. 85, 93 (1972) (stating an appellate court is "in

no way bound by the agency's interpretation of a statute").

    In this case, we do not write on a clean slate.                                  The

Supreme Court in C.A. reviewed in detail the purpose, structure,

and meaning of the Act and its implementing regulations.                          C.A.,

supra, 219 N.J. at 460-68; see also Conn v. Rebustillo, 445 N.J.

Super. 349, 354-57 (App. Div. 2016).                 We shall not repeat that

analysis here.

    We    focus     on   distinct    obligations         the    Act    imposes    on    a

hospital: self-critical analysis and reporting.                       With respect to

self-critical analysis, a hospital must create a safety plan

establishing    a   dedicated    patient        safety     committee.          N.J.S.A.

26:2H-12.25(b).       The purpose of such committees is, among other

things,   to   provide     processes      by    which     hospitals      can   conduct

analyses of harmful events and carry out root cause analyses for

all SPAEs.        Ibid.; N.J.A.C. 8:43E-10.4(d)(7).                    The reporting




                                          9                                    A-4342-15T1
obligation involves two recipients:                      regulators and patients.

See N.J.S.A. 26:2H-12.25(c) and N.J.A.C. 8:43E-10.6 (requiring

reporting      to   the     Department);10         N.J.S.A.         26:2H-12.25(d)       and

N.J.A.C. 8:43E-10.7 (requiring disclosure to patient).

       The definition of a "serious preventable adverse event" is

gleaned   from      the   definitions        of    its       constituent      terms.      An

"adverse event" is "a negative consequence of care that results

in    unintended     injury    or    illness."           N.J.S.A.          26:2H-12.25(a).

"Serious" means "result[ing] in death or loss of a body part, or

disability or loss of bodily function lasting more than seven

days or still present at the time of discharge from a health

care facility."           Ibid.      "Preventable" means "could have been

anticipated and prepared against, but occurs because of an error

or other system failure."            Ibid.

       To encourage compliance with the two obligations — self-

critical analysis and reporting — the Act creates a privilege.

"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 patients], and

the   investigative        process    that    may       or    may    not    lead   to   such


10
   The statute requires reporting to the Department of Human
Services in the case of State psychiatric hospitals.  N.J.S.A.
26:2H-12.25(b).  For simplicity's sake, we will refer only to
the Department.



                                         10                                        A-4342-15T1
reporting."           C.A., supra, 219 N.J. at 467.                  This evidentiary

privilege is broad:              The covered items "shall not be . . .

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(f)(1), -12.25(g)(1).

      The    Act       separately      defines     the      privilege       over      reports

depending        on    their    potential       recipient.           With       respect      to

reporting        to    regulators,         N.J.S.A.    26:2H-12.25(f)            creates       a

privilege over "documents, materials, or information received by

[the Department] . . . pursuant to the provisions of subsections

c[, which relates to mandatory reporting of SPAEs], and e[],"

which relates to the voluntary reporting of non-SPAEs, that is,

"near-misses, preventable events, and adverse events that are

otherwise        not    subject       to     mandatory      reporting       pursuant         to

subsection        c[] . . . ."             Regarding      reporting        to     patients,

N.J.S.A. 26:2H-12.25(g) creates a privilege over "any document

or oral statement that constitutes the disclosure provided to a

patient or the patient's family member or guardian pursuant to

subsection        d[]    of     this       section"      pertaining        to     mandatory

reporting of SPAEs to patients.

      At issue in this case is the privilege over self-critical

analysis.        In addition to creating a privilege over SPAE reports

to   patients,         subsection      (g)    extends       a    privilege       to    "[a]ny




                                              11                                      A-4342-15T1
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

[SPAEs]    .    .   .    ."    (Emphasis    added).      Subsection    (b)   compels

hospitals to "develop and implement a patient safety plan," and

to do so "[i]n accordance with the requirements established by

the commissioner by regulation."                  N.J.S.A. 26:2H-12.25(b).         The

subsection does not refer to the obligation to report SPAEs.

That reporting obligation is imposed by N.J.S.A. 26:24-12.25(c).

    Thus, the only statutory precondition of this self-critical

analysis privilege is compliance with subsection (b), pertaining

to safety plans.              The plain language of subsection (g) does not

condition       the       privilege        over    self-critical      analysis      on

compliance with the reporting obligation.                    In other words, so

long as the self-critical analysis is conducted according to the

proper procedures as set forth in the hospital's safety plan, it

is protected.

    Although            the    regulations    clarify     preconditions      of    the

privilege, they do not vary our conclusion that the privilege

over a self-critical analysis exists independent of compliance

with the reporting obligation.                    Specifically, N.J.A.C. 8:43E-

10.9(b)     defines           the   privilege      as    covering     "[d]ocuments,




                                             12                              A-4342-15T1
materials, and information (including RCAs [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        . . . ."       N.J.A.C.    8:43E-

10.9(b) (emphasis added); see also C.A., supra, 219 N.J. at 468.

Accordingly, the sole requirement for the privilege to apply

under subsection 10.9(b) is that the self-critical analysis be

undertaken according to the appropriate procedure.

       The fact that the privilege is conditioned upon procedural

(and    not   substantive)       concerns        is   further     established      by   an

examination of the regulations cited by subsection 10.9(b).                             The

first    of    the     three    cited    regulations,           N.J.A.C.     8:43E-10.4,

prescribes in greater detail than the Act the structure and

duties of a patient or resident safety committee.                            The second,

N.J.A.C.      8:43E-10.5,       specifies    in       detail    the   safety    planning

obligation.

       We recognize that the third, N.J.A.C. 8:43E-10.6, addresses

in detail the obligation to report SPAEs to the Department,

N.J.A.C. 8:43E-10.6(a)-(d), and specifies several categories of

SPAEs.     N.J.A.C. 8:43E-10.6(e)-(j).                However, we do not construe

section 10.9 to mean that the self-critical analysis privilege




                                            13                                   A-4342-15T1
depends     on   reporting         SPAEs     to    the    Department.       Notably,

subsection 10.6(l) addresses the required contents of a root

cause analysis.         We presume the reference in subsection 10.9(b)

to a self-critical analysis performed in accordance with section

10.6 was intended to require compliance with subsection 10.6(l).

    In short, the relevance of the three regulations, including

section    10.6,   is    their      impact    on    the   manner   in    which   self-

critical analyses are performed.                  They elaborate the "process of

self-critical analysis" cited in subsection 10.9(b).

    Furthermore, were reporting SPAEs a condition of the self-

critical    analysis     privilege,        N.J.A.C.       8:43E-10.9(b)     logically

would also have referred to a fourth regulation, N.J.A.C. 8:43E-

10.7, which details the obligation to report SPAEs to patients.

Omission of section 10.7 reflects the Department's view that

reporting    SPAEs      is   not    a   precondition        of   the    self-critical

analysis privilege.          We have found nothing in the Department's

rulemaking record that would support a contrary conclusion.                        See

39 N.J.R. 314(a) (Feb. 5, 2007) (proposed rulemaking); 40 N.J.R.

1094(a) (March 3, 2008) (final adoption).

    In C.A., the Court upheld a hospital's assertion of the

self-critical analysis privilege over a document pertaining to a

child born with anoxic brain injury.                     C.A., supra, 219 N.J. at

452-54.     The Court held that the hospital complied with the




                                           14                                A-4342-15T1
Act's broad prerequisites set forth in N.J.S.A. 26:2H-12.25(b).

Id. at 468-72.     Since the hospital prepared the document before

the Department adopted its regulations, compliance with them was

not required.     Id. at 468-69.

       The Court expressly rejected a connection between complying

with   the   reporting    obligation    and     the   self-critical   analysis

privilege.     The hospital had decided that the treatment did not

result in a SPAE.        Id. at 471.        Significantly, our court found

that decision "debatable," and concluded the newborn suffered a

"potential"    SPAE,     and   the   hospital    should   have   referred   the

matter to its patient safety committee to determine whether it

was reportable.        C.A. ex rel Applegrad v. Bentolila, 428 N.J.

Super. 115, 153-54 (App. Div. 2012), rev'd, 219 N.J. 449 (2014).

But the Supreme Court responded:

             Contrary 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).

             [C.A., supra, 219 N.J. at 471 n.14.]




                                       15                             A-4342-15T1
       In   Conn,      we    emphasized     the    dichotomy     between           the    two

obligations — reporting and self-critical analysis — and the

accompanying         privileges.      At    issue    was   the    privilege           under

N.J.S.A. 26:2H-12.25(f) governing reports to regulators.                                 Conn,

supra, 445 N.J. Super. at 350-51.                   We rejected the suggestion

that    the    privilege       depends     on     compliance     with        the    safety

planning mandates of subsection (b).                  Id. at 357.            Rather, the

privilege depended solely on whether the Department received the

documents pursuant to N.J.S.A. 26:2H-12.25(c) and (e), governing

mandatory       and     voluntary     reporting       to   regulators.                Ibid.

Applying this same dichotomy, Conn supports our conclusion that

the privilege over self-critical analysis as defined at N.J.S.A.

26:2H-12.25(g) does not depend on compliance with the mandatory

reporting requirement of N.J.S.A. 26:2H-12.25(c).

       Finally,       we     note   that    predicating        the      self-critical

analysis       privilege       on   complying       with   the        SPAE     reporting

obligation could lead to a result that we doubt the Legislature

intended.       We have in mind cases where a hospital denied that a

serious       adverse       event   was    preventable.          In     general,          the

proponent       of    an     evidentiary     privilege     must        establish          the

prerequisites of the privilege.                   See Horon Holding Corp. v.

McKenzie, 341 N.J. Super. 117, 125 (App. Div. 2001) (applying

attorney-client privilege).               Thus, to assert the self-critical




                                           16                                      A-4342-15T1
analysis privilege, the hospital would have to prove a serious

adverse result was not preventable if it did not report it.      The

proofs would likely overlap with those relevant to the alleged

negligence in the underlying case.        We doubt the Legislature

contemplated that a court would need to conduct such a mini-

trial in which the burdens are reversed in order to recognize

the self-critical analysis privilege.

     In sum, the trial court erred in predicating the privilege

over a self-critical analysis on the hospital's compliance with

its obligation to report a SPAE to regulators or the patient.

                               III.

     We must still consider whether the trial court erred in (1)

determining that Chilton violated its reporting obligation, and

(2) compelling it to report to the Department and Brugaletta.

The court predicated its order on its finding that Brugaletta

suffered a SPAE.   We conclude that the finding lacked support of

sufficient evidence in the record.      See Rova Farms Resort, Inc.

v. Investors Ins. Co. of Am., 65 N.J. 474, 484 (1974).            We

therefore reverse the trial court's order compelling Chilton to

report.11


11
   Given our disposition, we need not address three additional
questions that may be implicated by the court's order.   First,
we need not decide the standard of review of a hospital's
determinations as to whether a SPAE has occurred and whether to
                                                    (continued)


                                17                         A-4342-15T1
      We may presume for purposes of our analysis that Brugaletta

suffered an "adverse event" consisting of the fasciitis of her

right lower extremity, which was a "negative consequence of care

that result[ed] in unintended injury or illness . . . ."                    See

N.J.S.A.     26:2H-12.25(a);    N.J.A.C.      8:43E-10.3.       We   may   also

presume it was serious if she suffered a "loss of a body part

. . . or loss of bodily function" for at least one week or at

the   time    of   her    discharge.        See   N.J.S.A.    26:2H-12.25(a);

N.J.A.C. 8:43E-10.3.

      But the trial court did not identify record evidence for

the conclusion that this was a "preventable event" — that is, it

"could     have    been    anticipated      and    prepared    against,     but

occur[red] because of an error or other system failure."                    See


(continued)
report it. Second, we do not address whether a plaintiff has a
private right of action to compel a hospital to fulfill its
reporting obligation, particularly as it relates to reporting to
regulators. See R.J. Gaydos Ins. Agency, Inc. v. Nat'l Consumer
Ins. Co., 168 N.J. 255, 271, 272 (2001) (noting that we have
"been reluctant to infer a statutory private right of action
where the Legislature has not expressly provided for such
action" and setting forth a test for ascertaining whether a
private right of action is implied).    In this regard, we note
the Department is empowered to enforce the reporting requirement
by imposing penalties up to $100,000 on non-compliant general
hospitals.   N.J.A.C. 8:43E-3.4(a)(14)(i).    Third, we do not
reach the issue whether, based on principles of primary
jurisdiction, the agency, as opposed to the court, should decide
in the first instance whether a reportable SPAE has occurred.
See Smerling v. Harrah's Entm't, Inc., 389 N.J. Super. 181, 187
(App. Div. 2006); Muise v. GPU, Inc., 332 N.J. Super. 140, 158-
59 (App. Div. 2000).



                                       18                             A-4342-15T1
N.J.S.A. 26:2H-12.25(a); N.J.A.C. 8:43E-10.3.                      We emphasize one

of the three elements of a "preventable event" is the element of

causation.       Not only must the event be one that a hospital could

have "anticipated and prepared against", and not only must there

be "an error or other system failure", but the event must occur

"because    of"    the    error    or     system      failure.      N.J.S.A.      26:2H-

12.25(a); N.J.A.C. 8:43E-10.3.

      The evidence does not support a finding that the causation

element was satisfied.             The record clearly supports the trial

judge's finding there was an error in Brugaletta's care.                          We may

assume for argument's sake that the error could be "anticipated

and prepared against."            However, the trial court does not rely

on   an   expert    opinion       to    conclude      that     Brugaletta's      serious

adverse event occurred "because of" that error.                        Under the facts

of this case, an expert opinion was essential.                           See Kelly v.

Berlin,    300     N.J.   Super.        256,    268    (App.     Div.    1997)    ("[I]n

general, a jury should not be allowed to speculate without aid

of expert testimony in an area where laypersons could not be

expected to have sufficient knowledge or experience." (internal

quotation marks and citation omitted)).                        In its absence, the

court's    conclusion      that        Brugaletta     suffered     a    SPAE     was   not

supported by sufficient record evidence.




                                           19                                    A-4342-15T1
    In sum, the trial court erred in compelling Chilton to: (1)

disclose   the   redacted   memorandum   revealing   its   self-critical

analysis, and (2) report an alleged SPAE to the Department and

Brugaletta.

    Reversed.




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