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NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION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,

(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

. However, in order to challenge the trial court's order, Brugaletta was required to file a cross-appeal. See Franklin Discount Co. v. Ford,

(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,

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

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

interpretation of the Act.

In interpreting the Act and effectuating the Legislature's

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

integrated whole.

. "If the plain language is

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

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

to extrinsic aids.

"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,

(2005) (quoting O'Connell

v. State,

(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.,

(2015); see also Mayflower Sec. Co. v. Bureau of

Sec.,

(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.

; see also Conn v. Rebustillo,

(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."

"Preventable" means "could have been

anticipated and prepared against, but occurs because of an error

or other system failure."

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."

. 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

.

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.

. 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).

. Since the hospital prepared the document before

the Department adopted its regulations, compliance with them was

not required.

.

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.

. 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,

(App. Div. 2012), rev'd,

(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,

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.

. We rejected the suggestion

that the privilege depends on compliance with the safety

planning mandates of subsection (b).

. 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.

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,

(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.,

(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.,

(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.,

(App. Div. 2006); Muise v. GPU, Inc.,

, 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,

(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