Janelle Brugaletta v. Calixto Garcia, D.O. , 448 N.J. Super. 404 ( 2017 )


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  •                       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    NOT FOR PUBLICATION WITHOUT THE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.
    20                           A-4342-15T1