*1
Cynthia (Budd A. argued Walters respondents the cause for Lamer, attorneys; Walters, Ms. Dyke, Justin P. Van and Donald Jacobs, briefs). P. on the argued
Ross A. Lewin Jersey cause for amicus curiae New Hospital Reath, Association attorneys). {Drinker Biddle &
E. Drew argued Britcher the cause for amicus curiae New Jersey {Britcher, Roth, Association for Justice Leone attorneys; & Miller, brief). Mr. Britcher and Kristen B. on the Dougherty, Susan J. Deputy Attorney General, submitted a letter in lieu of brief on behalf of amicus Attorney curiae General Jersey of New Hoffman, Acting Attorney General, {John J. attorney).
Justice opinion PATTERSON delivered the of the Court. 2004, In Legislature enacted the Patient Act to reduce the incidence of medical may endanger errors that patients in health care facilities. N.J.S.A. 26:2H-12.23 to -12.25. The Act imposed requirements new evaluating for reporting of adverse events, statutory and created a privilege shielding specific commu- 26:2H-12.25(b), discovery litigation. in
nications from encourage care workers (c), (e), sought to health The Act (g). concerns, promote their observations candidly disclose staff. and administrative by professional evaluation self-critical early involves an interlocutory appeal the Court before The underlying In medical Safety Act. application of C.A., plaintiff, the infant plaintiffs claim that malpractice litigation, during her injuries sustained disabled because permanently is Shortly (Hospital). 26, 2007, Valley Hospital at The May on birth among Hospital staff birth, discussion a “round-table” after C.A.’s delivery and investigation of her part of an conducted as was prepared a memorandum hospital A administrator neonatal care. parties dispute the discovera- memorializing the discussion. bility of this document. Hospital had sub that because trial court determined investigation, in its Act
stantially complied with the Patient privilege. The absolute subject to the Act’s the memorandum C.A. the trial court’s determination. Division reversed Appellate Bentolila, (App.Div.2012). 51 A .3d 119 N.J.Super. v. staff and its process used It concluded that the not meet the statute’s creating memorandum did holding, panel discovery. In its from the document to shield Depart adopted by the that were retroactively applied regulations prepa (Department) after the of Health and Senior Services ment Hospi It thus ordered contested memorandum. ration of the discovery. produce the document tal to light of its construe the reverse. We We freely report their encourage health care workers purpose to *4 safety in a confiden- and concerns related observations guided by detailed facilities are setting. Today, health care tial Patient Safe- requirements of the supplement regulations regulations, Those to -10.11. ty 8:43E-10.1 Act. See N.J.A.C. prepared. at issue was however, the document did not exist when privilege was time, only prerequisite to the At the relevant Safety Act itself. We terms of the Patient compliance with the Hospital’s hold that the evaluative in this case conformed requirements, Act’s and that the memoran- dum at issue privileged. is therefore
Accordingly, we requiring reverse the order Hospital produce disputed document.
I. May On plaintiff Applegrad, Esther forty-first her week of pregnancy, was admitted to the sustaining after spontaneous rupture of previous membranes day.1 She was Bentolila, M.D., treated Eric attending obstetrician. From Applegrad time that arrived at the Hospital to the conclusion day of the shift p.m., at 7:00 primarily nurse responsible for Kaezmarski, her Kourtney care was R.N. Plaintiffs contend that Kaczmarski failed to ascertain that C.A. position, a breech and that the nurse’s failure to complication note this prompted Dr. anticipate vaginal Bentolila to delivery rather than a Caesarean They allege section. further that although Dr. Bentolila discover- presentation, ed C.A.’s breech he proceed nonetheless decided to vaginal delivery, with a thereby deviating applicable from the standard of care. Dr. Bentolila denied that negligent, he was and contended fully that he discussed the risks and benefits of both vaginal delivery and Caesarean Applegrad. section with allege
Plaintiffs that Dr. Bentolila ordered that the labor- inducing medication Pitocin be Applegrad, administered to that he attempted later destroy the medical indicating record given she was They Pitocin. assert that in accordance with Dr. order, Bentolila’s began Kaczmarski to administer Pitocin ap- proximately day noon on the of C.A.’sbirth.
By evening, Applegrad inwas stages final of labor. Dr. Bentolila delivered C.A. at approximately p.m. 8:45 The newborn pretrial stage, At this regarding the record before the Court the medical care provided Applegrad limited, appears the birth of C.A. is it that the parties substantially dispute many underlying facts.
454 2,2 was as faint. Apgar and her heart rate recorded
had an score birth, Following was intubated transferred her C.A. Chu, M.D., allege that pediatrician. Plaintiffs care Yie-Hsien failing in her of C.A. and for negligent Dr. resuscitation Chu anesthesiologist the new- immediately notify attending the caused functioning properly, which born’s intubation tube was injury. infant to an anoxic brain suffer Hypoxic-Is- currently C.A. suffers from Plaintiffs claim that resulting and a disorder from Encephalopathy chemic seizure after during care received medical that she injury brain maintain that C.A.’s resulted her birth. Defendants complications, unpreventable Applegrad received from birth birth, properly competent during the and that the infant was care resuscitated. by Applegrad filed and her malpractice
This medical action was husband, named Applegrad, the Law Division. Plaintiff Gedalia Bentolila, Chu, Hospital, Dr. Kacz- Dr. Nurse as defendants nurse, Patel, R.N., marski, respiratory Gita and a second Brown, R.T.3 therapist, Mary during of this arose dispute at the center case document litigation. discovery malpractice in the Plaintiffs
pretrial medical Hospital’s investigative and compel production moved relating initial review to C.A.’s birth. In their peer records motion, statutory rely upon response to defendants did not Instead, they urged set in the Patient Act. privilege forth balancing test forth the trial court to conduct set Salem, Christy N.J.Super. v. 366 541- Appellate Division 2 Apgar “evaluation infant's status An score is an of a newborn physical (0-2) assigning rate, criteria: values to each of five heart respiratory numerical color; 8-10 stimulation, and skin a score of effort, tone, muscle response (28th Medical 1735 condition." Stedman’s indicates best Dictionary possible 2006). ed. against Dr. Bentolila and Nurse The trial court dismissed claims plaintiffs' and Dr. defen- Kaczmarski, in 2009. Brown Chu remain Patel The Hospital, dants in the case and are this parties appeal. 45, 841 A .2d (App.Div.2004), and to find that several of the *6 Hospital’s privileged documents were in accordance with that standard.
Among disputed the subject documents that were the plain- of tiffs’ motion was a memorandum dated June entitled “Director of Safety Patient Analysis.” Post-Incident The docu- designated ment was for discovery purposes Along as “DV2.” with documents, five other DV2 was submitted to the trial court for in camera review. The trial initially proposed court to review the document balancing accordance with the test set forth the Appellate Christy. Division in Notwithstanding its initial reliance upon test, Christy the Hospital objected the to the trial court’s proposal, and claimed for the first time that the six documents at absolutely issue were privileged under N.J.S.A. 26:2H-12.25(g) of the Safety Patient Act. Following a hearing, further the trial court agreed Hospital’s with the position that the documents were privileged Act, under the plaintiffs’ and denied motion compel production of the documents. sought
Plaintiffs appeal. leave to Appellate An panel Division granted motion, the but later vacated its order and remanded to the trial court for development further remand, of the record. On partly defendants modified position respect their with They documents at issue. only documents, contended that two memorandum, DV5, DV2 and a second subject were to the Patient Safety Act’s privilege, absolute and remaining asserted that the four documents should remain grounds confidential on other not at appeal. issue in this
The trial court seven-day conducted a evidentiary hearing. The Hospital presented testimony the Robles, of three witnesses: Kim the Hospital’s Quality Director of Improvement Assessment Regulatory Compliance; Mutter, Hospital’s Michael the Director Safety DY2; Patient and the Malkin, author of and Linda the Hospital’s Director of Management. Risk parties The also sub- mitted documentary evidence to the trial court. Hospi- findings respect to the made factual with trial court Act and compliance
tal’s
with the
investigation
and neonatal
Hospital’s
of C.A.’sbirth
in the
followed
trial court also made several observations about
care. The
document,
DV2. On
purpose
preparation of
contested
although
findings,
trial court held
basis
those
of the Patient
strictly
follow the
did
DV2,
substantially complied
it had
when it created
privileged
under the Patient
It ruled
Act.
DV2
compel discovery
accordingly
plaintiffs’ motion to
denied
held, however,
judge
that the
sched-
of the
court
document.
malpractice
have a
medical
trial should
preside
uled to
over the
credibility
copy
document in order
evaluate
participants
round-table discussion.4
who were
witnesses
*7
appeal. After
a
motion for leave to
Plaintiffs filed
second
motion,
part
in
Appellate
panel
an
Division
affirmed
granting the
C.A, supra,
part
in
court’s determination.
and reversed
the trial
159,
panel
119.
the Act
N.J.Super. at
A.3d
The
construed
428
51
privilege upon “post-event investigatory and
to
absolute
confer an
exclusively
compliance
the
analytic
created
with
documents
some
regulations, and not created for
and its associated
[Act]
122,
It
statutory
purpose.” Id. at
Applying the
Department
the
10.9(b),
by the
after
creation
regulation adopted
exclusively
DV2,
panel
that a document must be
the
reasoned
any
comply
Patient
Act—and not for
with the
created
documents,
4
findings about the
other contested
The
court also made
five
trial
discoverability
accordance with the
of those documents in
and ruled on the
535,
N.J.Super.
supra,
Christy,
ance with
processes
procedures
the
of the [Patient
154,
Id.
physician
Act].”
at
A.3d 119.
It noted that no
discussion,
participated
findings
round-table
recorded in
presented
the document were not
152-55,
panel
Committee.
Id. at
51 A. 3d
119.
or
DV2,
dered
stayed
the disclosure of
judgment pending
but
its
filing
appeal
defendants’
of a motion
for leave
in this Court. Id.
II.
argue
Defendants
Appellate
improperly
Division
ap-
plied
regulations adopted
the administrative
determine
DV2,
discoverability
prepared
regu-
document
before the
adopted.
lations
They
were
maintain that the
satisfied
statutory
governed
standard that
when
DV2
created.
panel imposed
Defendants contend that
that are
presence
found in
such
physician
as the
of a
on the
*8
evaluating team and the
Safety
involvement of the Patient
Com-
mittee in
the evaluative
at issue. Defendants assert that
5
panel
rejected plaintiffs'
challenge
also
constitutional
to the Patient
Act,
Safety
premised
argument
Legislature
which was
on the
that the
violated
principles
separation
powers
of
evidentiary
the
doctrine when it created the
privilege
Safety
judicial
under
Patient
the
Act
the
without
involvement of the
C.A.,
157-59,
supra,
N.J.Super.
branch.
the Division erred exclusively comply sought be created protection is must confidentiality Safety They maintain that the the Act. Patient strict adherence to provisions the Act are not conditioned on every aspect of the statute. Appellate Division’s urge the to affirm the
Plaintiffs Court They panel properly the held that the argue that determination. Safety only Patient Act are avail- confidentiality provisions of the compli- in investigations their strict able to that conduct facilities panel that Act’s Plaintiffs contend the ance with the terms. process by Hospi- in the which the correctly deficiencies identified “exclusivity They although that the maintain tal created DV2. regulations adopted panel the set forth in the test” invoked text, statutory from Act’s may also be inferred it dispute. discovery this provide the standard for should therefore alternative, change in that plaintiffs argue any that the law In the curative, adoption regulations was of the occurred with retroactively. apply therefore regulations that the should (NJAJ) ar- Jersey New Association for Justice curiae Amicus or Legislature any that internal documents gues that the intended generated by a health care should be communications Christy, qualified privilege not protected only by the identified Hospital failed by any privilege. NJAJ contends that absolute Safety mandatory Act’s committee comply with the Patient by failing it to refer C.A.’s case that violated the structure and Safety Committee. Patient (NJHA) argues Jersey New Association Amicus curiae discovery from Act was intended to shield that the Patient Act, generated and that analyses internal in accordance with discoverability Christy governs the plaintiffs’ argument that objective. It as- legislative analyses such would undermine imposed panel improperly conditions were serts that the only regula- appeared in the Patient articulated yet at the time.6 tions had to take effect relevant 4:28-4, in the trial court and to Rule General Pursuant Attorney appeared Act. Division defend constitutionality Appellate
459
III.
of discretion stan
applies “an abuse
appellate
An
court
relating to matters of
courts
[the]
made
trial
dard to decisions
Cmty. Corp., 207
Corp. New
N.J.
discovery.”
Paper
v.
Pomerantz
Adelson,
(2011)
187 N.J.
344, 371,
(citing Bender v.
A. The Patient requirement imposed was not the first Jersey on New health practices care facilities to evaluate their in a setting, report regulatory confidential and to to authorities. Since adoption 1990, of N.J.AC. hospitals 8:43G-27 have been required quality improvement to maintain a continuous program. program N.J.AC. 8:43G-27.1 to -27.6.7 That must include a utiliza- review, federally-mandated tion process by hospital a a which physicians’ practice reviews the admitting discharging patients, patients and the during hospital resources used to treat stays. 482.30; § § 42 seq.; U.S.C.A 1395x et 42 C.F.R. see also (D.N.J.1993) Jersey Hosp. Sys., v. Todd S. 152 F.R.D. 682 (noting requirement that utilization review is hospital’s partic- ipation in Security Social and in certain other federal and state programs). addition, prior
In
to
the enactment of the Patient
Jersey hospitals
permitted
New
required
were also
—but
—to
7
regulation
N.J.A.C. 8:43G
8:43B,
was enacted to
N.J.A.C.
a
Notably,
replace
mandated a
review
See N.J.A.C. 8:43B-6.1 et
specifically
peer
process.
seq.
1990).
(repealed
That
a
medical staff to
process required
hospital’s
"identify
suggest
exist in
care and
action to correct
problems
may
patient
appropriate
those
v.
563, 566,
243
580 A.2d
problems." Bundy
1101
Sinopoli,
N.J.Super.
(Law Div.1990);
1990).
(repealed
Although
8:43B-6.1,
see N.J.A.C.
-6.2
regulatory
current
framework does "not
address[]
the area of
specifically
[p]eer
[r]eview," it nevertheless
a framework for the evaluation of the
"provide[s]
type
given
of care
to
at
243
quality
patients
hospitals." Bundy, supra,
N.J.Super.
8:43G-27.5(a)
e.g.,
(obligating
see,
In in the goals process were not forth composition, set mittee’s itself, by regulations Safety Act were established but nearly years the statute was enacted. adopted four after committee, safety com- patient now and mission of the structure regulation, yet specified had to be prescribed by prehensively disputed in this case. Hospital prepared the document when the component of the Act is its mandate important A second facility implement for the collaborative review procedure a each safety facility must part patient plan, As of its adverse events. comprised personnel ... who designate “teams of staff facility’s disciplines various and have representative are competencies,” analyze apply “evidence-based appropriate thereby probability of safety practices,” and “reduce the sys- resulting exposure to the health care events from adverse 26:2H-12.25(b)(2). general hospitals Effective for tem.” N.J.S.A. 3, 2008, corresponding regulation, N.JAC. 8:43E- March on 10.4(b)(2), statutory requirement. supplemented the preventable mandates that
The Patient Act also “serious “in a reported must health care facilities event[s]” be [C]ommissioner [of and manner form established (c).10 26:2H-12.25(a), Effective on March Department].” N.J.S.A. general N.JAC. 8:43E-10.6 describes hospitals, for reporting categories trigger that will of events detail 8:43E-10.6(e)-(j). regulation speci requirement. N.JAC. That occurring in a preventable that a serious adverse event fies Department within five business hospital must be disclosed discovery appropriate form. N.JAC. 8:43E- days using of its subject The Act also mandatory encourages reporting. anonymous reporting 26:2H-12.25(e)(1). of adverse events that are *13 (c). 10.6(b), gives It also detailed direction on the conduct and reporting analyses of preventable of serious adverse events— guidance that was not set forth in Safety the Patient Act itself. N.J.AC. 8:43E-10.6(k)-(m).11 legislative goal
To further the minimizing system of failures and care, enhancing patient Safety provided Act thus analysis basic framework for reporting and of serious adverse occurring events in health subsequent care facilities. The adop- tion of N.J.AC. provided 8:43E-10.1 to -10.11 comprehensive guidance respect necessary structure, committee evalu- methodology ation process for reporting regu- such events to lators.
B. Legislature included in the provision Act a N.J.S.A. creating privilege. an absolute 26:2H-12.25(g). It rea- professionals soned that health care facility and other staff are likely effectively more assess adverse events in a confidential setting, employee in which an need not fear recrimination for disclosing error, his or her own medical colleague. or that of a As articulated in legislative findings, the statute’s encourage [t]o [adverse disclosure of events and ... it is critical near-misses], improving create a culture that focuses on non-punitive rather than processes assigning blame. Health care facilities and must be held accountable professionals
for serious preventable events; however, environments are not punitive promoting increasing effective in particularly accountability patient safety, general Other that were set forth terms in the Patient Safety regulations. Act were further explained by The Patient subsequent that teams staff, requires "who are comprised personnel representa tive of the various and have facility’s disciplines appropriate competencies," events that constitute analyze "near-misses” —occurrences "that could have resulted in an adverse event but the adverse event was N.J.S.A. prevented." 26:2H-12.25(a), (b)(3). That was refined N.J.A.C. requirement 8:43E- 10.5(a)(3). The Patient Act also "a for the requires process provision ongoing training for safety 26:2H- facility personnel," 12.25(b)(4), and the details of that are in N.J.A.C. 8:43E- prescribed 10.5(a)(5). *14 exchange the to reduce of information a deterrent the required be may Bear in care delivery. for errors occur the complex systems opportunity organizations silent about to be health care induces professionals sanctions resulting under-reporting. in serious events, 26:2H-12.24(e).] [NJ.S.A. confidentiality pivotal recognized thus the role Legislature reporting. open and evaluation promoting effective setting in other in a which Act was drafted The Patient com- by health care facilities were processes conducted evaluative or case privileged by from disclosure statute partially pletely or process subject to a Jersey, review is In the utilization law. New against See 2A:84A-22.8 statutory privilege disclosure. “[ijnformation that, and data subject exceptions, (stating certain committees possession in the of utilization review by and secured facility in by any hospital or extended care certified established or disclosed of their shall not be revealed duties performance the of such any any under member any manner or circumstances committee”). privi Christy, supra, Appellate Division addressed
In
facility’s
memorializing a health care
lege protecting documents
There,
537,
N.J.Super. at
In enacting Legislature considered the extent to which the confidentiality statute’s provisions would shield documents from in litigation disclosure settings. and other explained by M.D., As Lacy, Clifton R. then Commissioner of the Department, testimony Health, his before the Senate Human Services and Senior Citizens support Committee in of Senate Bill *15 proposed right “strikes the balance between acknowl- edging learning errors, and from holding and also people account- able. It shields self-critical analysis from discovery, but maintains discoverable all that is now Hearing discoverable.” on S. 557 Health, the S. Human Services and Senior Citizens Before Comm., (N.J. 2004) (Statement Leg. 211th 6 Lacy, Clifton R. M.D.). Asked to statement, elaborate on that Lacy Commissioner testified: everything [W]hat I meant when I said that that’s currently discoverable remains get [w]hat together this shields is, teams multidisciplinary discoverable — and sit digest and analyze to find out what tiy are the root causes, did this why error occur-, and what can we safety precautions into put place redundancy, — is scrutiny Find out the necessary computerization. find the causes, —whatever — just fix to this but prevent error, error like every this kind in the future. Everything that’s discoverable —the currently medical record, the test results, of witnesses —all that deposition continues to be it as is now. exactly What this
legislation shields is that analyzing self-critical the next analysis, step —of getting the team of nurses, physicians, these pharmacists, interdisciplinary groups digest and reporting find those root causes. That’s And the protected. —to things of those to our is Department protected. [Hearing on S. 557 the S. Health, Human Services and Senior Citizens Before (N.J. 2004) (Statement Leg. Comm., M.D.).] 211th 12-13 of Clifton R. Lacy, passage Prior to the the Senate Bill was amended to confirm that the Act was not intended “to increase or decrease the discovera- privilege specific generated The Act attaches to information by health processes: reporting care facilities two distinct regulators, investigative process to events and the may may reporting. or not lead to such Pursuant to N.J.S.A. 26:2H-12.25(f), documents, “[a]ny or materials information re- by” Department facility pursuant ceived from a care health 26:2H-12.25(c) reporting provisions, the statute’s two N.J.S.A. -12.25(e), subject mandatory “that are otherwise not re- 26:2H-12.25(c) ], porting pursuant shall ... [N.J.S.A. not be subject discovery or admissible as evidence or otherwise dis- civil, criminal, any closed in proceed- or administrative action or 26:2H-12.25(f)(l).13 ing.” N.J.S.A.
Similarly, 26:2H-12.25(g)(l) protects N.J.S.A. communications generated setting analysis: of self-critical materials or documents, information a health care as
Any developed by facility part of a of self-critical conducted to subsection b. of this process analysis pursuant concerning including section events, near-misses and adverse preventable events, serious adverse events ... shall not be: preventable (1) subject to or admissible as evidence or otherwise disclosed in discovery any proceeding. criminal or civil, administrative action or 26:2H-12.25(g) documents, thus shields certain materials developed by and information a health care it as investi- gates and evaluates adverse events.
Like requirements, its privilege Act’s provisions explained regulations were and refined 3, 2008, followed. Effective March applied Hospital, as 8:43E-10.9(b)(l) requires N.J.A.C. that a document be “exclusive- *16 in accordance documents, with v. Salem ... of bility, materials or Christy any if information obtained from or source context other than those in any specified (Mar. 2004). this act." S. Bill No. reporting The same section of the Act that such documents, provides materials and information shall not be "considered a record under public 26:2H-12.25(f)(2), [N.J.S.A. 47:1A-1]," N.J.S.A. and addresses the use of such information in adverse actions and in the evaluation of certain employment credentialing licensing” "accreditation, certification, or decisions, as defined in 26:2H-12.25(f)(3). the statute. N.J.S.A. analysis as defined setting in of self-critical
ly” developed the 10.6, 8:43E-10.4, in regulations, N.J.AC. 10.5 and three other statutory privilege: the order to warrant (including minutes [root cause and information Documents, analyses] materials during meetings) the process a health care facility exclusively developed by or [N.J.AC.] 8:43E-10.4,10.5 10.6 concern- in accordance self-critical analysis, including ing serious events, preventa- near-misses and events, preventable events ... shall not be: ble adverse (1) Subject in as evidence or otherwise disclosed any or admissible discovery proceeding. action or criminal or administrative civil, added).] (emphasis [ 8:43-10.9, governs to N.J.AC. Thus, which now New pursuant facilities, only statutory privilege applies Jersey care health exclusively documents, developed dur- materials and information during specific analysis one of three ing self-critical conducted safety patient or commit- processes: operations of the resident 8:43E-10.4, pursuant to N.J.AC. components tee 8:43E-10.5, N.J.A.C. or safety plan prescribed as or resident N.J.AC. regulators under N.J.AC. 8:43E-10.6. reporting to 8:43E-10.9(b). in regulations that became effective In the significant expanded upon in two statutory standard was documents, first, materials and require that respects: “exclusively” setting of a prepared information at issue be second, to mandate analysis process, qualifying self-critical one analysis conducted in accordance with self-critical be privi- regulations prerequisite for the accompanying as of three -10.6. N.J.AC. 8:43E-10.4, attach, N.J AC. -10.5 and lege to 8:43E-10.9(b). regulatory statutory and framework Under the professionals are on notice today, administrative place medical and to ensure they must follow order procedures of the exact pursuant to the Patient confidentiality of information Act.
IV. setting detailed arise in the This case did not Although the Patient that now exists. regulatory scheme written, implementing passed when DV2 was Act had been time; they adopted at that would regulations yet had to be *17 8:43E- govern Hospital until March 2008. N.J.A.C. the 10.2(a)(9). Moreover, given care facilities were an addition- health “[djevelop regulations’ date to days al 180 from the effective compli- safety plan facility” in patient or for the written resident 8:43E-10.4(d)(l). regulations. N.J.A.C. When DV2 ance with the 1, 2007, Hospital only guidance the prepared on June Safety Act. The discoverabil- and its staff was found in the Patient ity determined accordance with the of DV2 must therefore be itself, imposing requirements that Act without subsequent regulations. appeared for the first time upon process generated the communi- focuses the facility privilege. cation for which a care claims N.J.S.A. health documents, 26:2H-12.25(g) discovery shields from materials or analysis developed part process information of a of self-critical “as 26:2H-12.25(b). pursuant conducted to” N.J.S.A N.J.S.A 26:2H- 12.25(b) include, requires safety plan that a “at a mini- mum,” components: patient safety four of “a the establishment committee,” 26:2H-12.25(b)(l); process N.J.S.A. “a for teams of facility ongoing analysis application ... staff to conduct of patient safety practices” to evidence-based reduce the risk of events, 26:2H-12.25(b)(2); process “a N.J.S.A for teams near-misses,” analyses of ... staff to conduct of N.J.S.A. 26:2H-12.25(b)(3); provision ongoing for and “a patient safety training facility personnel,” for 26:2H- N.J.S.A. 12.25(b)(4). Accordingly, discoverability of DY2 turns on developed setting “process whether the document was analysis,” part patient safety plan of self-critical as conducted of a 26:2H-12.25(b). components that meets four N.J.S.A 26:2H-12.25(g). N.J.S.A. supports
The record the trial court’s determination that Hospital patient safety plan. It had established such a confirms aspect plan, of such a satisfied the first patient safety compliance establishment of a committee in 26:2H-12.25(b)(l). found, Hospi- As trial court tal’s Patient Committee consisted of sixteen members and M.D., Rubenstein, was chaired Mitchell the Chief Medical *18 Hospital. Safety Officer of the The Patient Committee was “stand-alone, making a decision committee” with determined be N.J.S.A. authority. Nothing in “independent decision-making” 26:2H-12.25(b)(l) Safety requires that the Patient Committee every aspect factfinding in Patient conduct of accordance with the Safety operation Act. That was in when DV2 was Committee prepared Hospital compo- in met this June 2007. The therefore statutory nent of the mandate. 12.25(b)(2) N.J.S.A Hospital complied with also and 26:2H —
(3). require “teams of provisions Those facilities establish facility comprised personnel represen- staff’ that “are of who are facility’s disciplines appropriate tative of the various and have competencies” analyze patient safety practices and near-misses. nurses, Safety require physicians, The Patient Act did not administrators, any category facility play in or other of staff a role committee, given specify procedure it for the did meeting following potentially reportable of a team adverse event. Instead, only facility appoint requires the statute that each teams staff, comprised competencies representative with members (3). 26:2H-12.25(b)(2), N.J.S.A. facility’s disciplines. of the various determined, Hospital met that standard. As the trial court effective, Safety after the Act became it was Mutter’s Patient practice, Safety, of Patient to conduct as Director round-table disciplines, required professionals discussions with from various as by meeting Act. Mutter would commence each round-table an in stating that the discussion was held as exercise self-critical analysis, Safety in Act. accordance with Plan,
Finally, Improvement as evidenced its Performance implemented process provision ongoing “a for the had safety facility personnel,” compliance in training for with 26:2H-12.25(b)(4). Consequently, N.J.S.A. Hospital’s patient statutory safety plan satisfied all of the Patient Act. Hospital’s general compliance it with the
As establishes the supports the record also the trial court’s finding prepared part “as of a of self-critical DV2 26:2H-12.25(b). analysis” pursuant to As trial court noted, memorializing Mutter recorded DV2 that the document meeting pursuant was created to the Patient Act. The Mutter, team of staff that reviewed C.A.’s case included Safety, along his role as the Director of Patient with obstetrical educators, nursing management and and the nurses involved in found, Applegrad the care of and her child. As trial court participants in Mutter assured the the round-table discussion that confidential, kept inquired their disclosures would be about Applegrad during the medical treatment administered to and C.A. following Following meeting the birth. that was memori- DV2, separately alized Mutter discussed C.A.’s case Robles agreed and Malkin. All three individuals that C.A.’s birth and *19 give reportable purposes neonatal care did not to a rise event for 26:2H-25(c) of N.J.S.A. of the a Patient or “Sentinel analysis Event” that would warrant a root cause under the Joint Commission standards. The round-table discussion that led to the of part investigation creation DV2 was of an into whether the preventable incident under was a review serious adverse event reported that Department should be to the under N.J.S.A. 26:2H- .12.25(c).
Moreover, analysis required the self-critical 26:2H- N.J.S.A. 12.25(b) only decision-making entails not the that leads to the event, reporting of an development but also the necessary collection of information for that determination. See 26:2H-12.25(g)(2) (identifying “development, collection, N.J.S.A. reporting storage components or of process information” as of of 26:2H-12.25(b)). analysis self-critical under N.J.S.A Notwithstanding the implemented detailed later by regulation, the process “round-table” evaluative initiated Hospital oversight statutory under Mutter’s satisfied the man- date.14 “developed part DV2 was ... as of a of self- 26:2H-12.25(b) analysis pursuant ],” critical conducted to [N.J.S.A suggestion of the Division Contrary Appellate panel, Hospital's abrogate conclusion that the event was not does not reportable statutory 26:2H-12.25(g). Regardless of whether required by
as N.J.S.A. regulations that would have satisfied the Hospital’s process time, only Hospital met at a later became effective of the Patient governed it in the mandate standard that Safety Act itself. Appellate Division’s dissenting colleagues do not share the
Our regulatory requirements of governed by the view that this case is 8:43E-10.6, yet were not effect when N.J.A.C. which Hospital’s they contend that the Hospital prepared DV2. Nor do in accordance with was not established Committee 26:2H-12(b)(l). Instead, colleagues argue dissenting our N.J.S.A. requirement comply with the Hospital that failed (3) 26:2H-12(b)(2) facility staff ... that “teams of facility’s representative who are comprised personnel analyze appropriate competencies,” disciplines and have various at safety practices and near-misses. Post evidence-based 332, 334-35, 476-78, 479-81, Contrary to the A 335-36. 99 .3d dissent, however, the round-table discussion suggestion of the Mutter, and Malkin. not confined to Robles generated DV2 was staff, Instead, team of that discussion included broader directly involved the care of including the nurses obstetrical mother, nursing nursing managers and as well as C.A. and her Act’s mandate that Hospital complied with the educators. The analyzed by qualified team its staff. this case be Hospital’s dissenting colleagues further contend Our *20 Act because the record process compliance of with the fell short Mutter, by Robles establish that the review conducted does not knowledge of the Patient with the and Malkin was conducted were mem- Safety which the three administrators Committee of settings 26:2H-12.25(g) privilege Nothing to privilege. limits the in NJ.S.A. subject reporting to is determined to be mandatory which the incident ultimately 26:2H-12.25(c). privilege is not con- The Patient Act's under NJ.S.A. Safety with a determina- deliberative concludes strained to cases in which the process 26:2H-12.25(c). case is under N.J.S.A. tion that the reportable However, bers. Post at 99 A .3d at 334. nowhere the Act Legislature did the define the relationship between the Patient Committee, Safety which generally by mandated N.J.S.A. 26:2H-12.25(b)(l) with “prescribed by details to be regulation,” 26:2H-12.25(b)(2) and the teams (3). envisioned N.J.S.A. Committee’s analytical function, conduct of its reporting structure, and its would later be set forth in detail in 8:43E-10.4, N.J.A.C. but regulatory requirements yet had imposed be at the relevant time. sum,
In
the Patient
promote
thorough
exists to
candid discussions of
occurring
facilities,
events
in health care
thereby
protect
safety
patients.
of
In the
period
interim
between the enactment of the
adoption
Act and the
imple-
of its
menting regulations, health
required
care facilities were
to follow
which
important
serves
public
policy
goal
promoting
open discussions of adverse events. Those
facilities were
compelled
anticipate
regulations
later
as a
condition of
statutory privilege.
case,
In this
complied
with the
governing
application
of that
privilege. DV2
part
memorialized
a confidential
of self-
analysis,
prescribed
critical
26:2H-12.25(b).
as
Accordingly, pursuant
to N.J.S.A. 26:2H-12.25(g), DV2 is not
subject to discovery, and should not be
any purpose
used for
case,
this
including its use as a
judge
resource for the
trying the
case. N.J.S.A. 26:2H-12.25(g)
DV2,
only
shields
consistent with
the narrow construction generally afforded
privileges
under our
law, and
protect
does not
otherwise discoverable information
concerning C.A.’sbirth and neonatal
J.G.,
treatment. See State v.
369, 383,
(2010);
N.J.
V. judgment Appellate reversed, Division is and the matter is remanded for further proceedings in accordance with opinion. this *21 assigned), dissenting.
Judge (temporarily CUFF injuries during birthing catastrophic the A newborn suffered Safety (Hospital). Patient Valley Hospital The The process at -12.25(k), Hospital Act, that the 26:2H-12.23 to mandated investigate adverse patient safety to such create a committee composition The of that commit- as occurred in case. events this facility’s various “representative should have been tee competencies.” N.J.S.A. 26:2H- disciplines appropriate and have 12.25(b). tragic Hospital committee that reviewed Yet administrators, a comprised none of whom was of three event specializing much less obstetrics. physician, one developed that guarantees documents The Patient Act notes, inquiry, as interview during patient safety a committee such interlocutory subject discovery. privileged and This are information concerning whether appeal presents narrow issue reviewing Hospital preceding the events by personnel generated subject privilege immediately following this birth is to the and part of a any generated information as on document or conferred pursuant the Act. The analysis conducted process of self-critical Hospital by the majority that utilized holds the evaluative Safety Act and of the Patient conformed committee appeal privileged. is at issue in this memorandum however, here, safety inquiry was not that conducted satisfy the Having the Act. failed to committee as envisioned cannot invoke in the conditions established reason, I privilege by the statute. For that absolute accorded that attaches to majority privilege would hold no part with the compliance generated by a committee not interview notes Act. history procedural the facts necessary It is not to recount unnecessary to recount majority. It is also recited precipitated enactment events permitted are relationship processes hospitals its other is this dissent evaluate events. focus of utilize to my in this conclusion process employed on the case and founded *22 process contemplated by did not conform to that Legislature pre-condition statutory as a for invocation of the privilege. 26:2H-12.25(g) provides any
N.J.S.A. documents or infor- developed by mation facility a health care in accordance with the process by subject discovery, outlined the Act shall to not be or civil, any used in proceeding, criminal or action or administrative action, employment an adverse credentialing, or the valuation of accreditation, any certification or licensure of individual. The provides: statute documents, material, or information a health care
Any as developed by facility part of a of self-critical [N.J.S.A. conducted to 26:2H- process analysis pursuant 12.25(b) concerning ] of this section and preventable events, near-misses, adverse including serious events, adverse and document or oral preventable events, any statement that constitutes the disclosure to a or the provided patient’s 26:2H-12.25(d) guardian [N.J.S.A. member or ] of the family pursuant section, shall not be: (1) subject or admissible as evidence or otherwise in discovery disclosed any proceeding; or civil, criminal, administrative action or or (2) used an adverse action inor the evaluation of decisions made in employment credentialing, licensing relation to accreditation, or of an certification, individual, which is on based the individual’s in the participation development, collection, reporting, 26:2H-12.25(b) storage [N.J.S.A. or of information in ]. accordance with 26:2H-12.25(g).] [N.J.S.A. short, hospital
In a named as a negligence defendant a medical may action possibly withhold probative relevant and information developed during and documents a Patient Act self-critical analysis pursuant privilege conferred that statute on such information and documents. statute,
By the privilege terms of the does not attach to the generated information during and documents a Patient analysis self-critical hospital procedure unless the has followed the First, outlined the statute. hospital develop must 26:2H-12.25(b). implement patient safety plan. a N.J.S.A. purpose plan improve of the is to safety the “health and of patients facility.” Then, proceeds Ibid. the Act to outline the minimum patient safety plan requiring features of the (2) are staff, for teams of which teams comprised personnel process various and have of the facility’s disciplines appropriate
who are representative ongoing of evidence-based patient to conduct analysis application competencies, resulting events from in order to reduce the of adverse safety probability practices range across a of diseases and procedures; to the health care system exposure [and] (3) which teams are staff, personnel for teams of facility comprised process and have various disciplines appropriate who are facility’s representative attention near-misses, to conduct analyses particular competencies, adverse events and events. serious preventable 12.25(b)(2) (3).] [N.J.S.A 26:2H— regulations,15 N.J.S.A. contemplates the enactment of The Act also 26:2H-12.25(b)(l), safety ongoing patient for train- and a 26:2H-12.25(b)(4). hospital personnel, ing for majority that the review conducted asserts *23 471-72, Act. Ante at 99 A .3d at complied with the Patient shortly Legislature enacted the Act before It notes that the 331. long at issue occurred before birth and that the review C.A.’s Ante at 468- regulations in its 2008. Department of Health issued Hospital no less than It that the did 99 A .3dat 329. concludes by provided reasonably possible given the lack of direction majority that the Hos Accordingly, the determines Legislature. statutory privilege afforded permit it to invoke the pital’s efforts 469-70, Ante at analysis 99 A.3d of adverse events. to self-critical at 329-30. Act, however, cannot characterized as a be
The guidance to the public policy of with little or no vague declaration charged its administration or the agency with administrative law, can decide required to follow the which health care facilities patient The privilege conferred the statute. to invoke the analysis ongoing an safety plan process outline a to conduct must apply practices to those such that patient safety practices and of system exposure to the health care “resulting from adverse events procedures” are reduced. N.J.S.A. range of diseases and across 26:2H-12.25(b)(2). include a patient safety plan must also -10.10, effective March 2008. N.J.A.C. 8:43E-10.1 to See “near-misses, particular atten- analyses of process to conduct adverse events.” preventable adverse events and tion to serious 26:2H-12.25(b)(3). prescribe than Safety Act does more Importantly, the Patient process. Sections development implementation of a and (3) 12.25(b)(2) personnel who are to be prescribe the also analyze implement process. process engaged analyze near-misses safety practices and the and adverse events are to preventable adverse events and serious comprised “personnel staff’ be conducted “teams facility’s disciplines various and have representative who are analyses required by the appropriate competencies” to conduct the 26:2H-12.25(b)(2). Act. N.J.S.A birth,
Here, the record reveals that at the time of C.A.’s (Committee) comprised Hospital had a Patient Committee Officer, employee of members. The Chief Medical an sixteen non-employee physi- Hospital, chaired the Committee. Other privileges members of the cians with staff were Mutter, Safety, Michael Director of Patient was a Committee. member of this Committee. birth, Robles,
Following Quality Kim C.A’s Director of Assess- Regulatory Improvement Compliance, ment received a refer- Quality ral from Assurance She referred the Coordinator. Malkin, Management, matter to Linda Director of Risk who investigation to conduct an referred the matter Mutter *24 determine whether the circumstances of C.A.’s birth and her preventable reported the condition were a event that should be to Department a of Health. Mutter convened roundtable discussion manager composed persons designated by of the Labor and discussion, Delivery During sought identify to Unit. this Mutter by posing open-ended ques- process failure and led the discussion participants. encouraged All in tions to the attendance were end, participate. In that the circumstances Mutter concluded delivery complica- to medical of the labor and were attributable Therefore, process. concluded tions rather than a failure of he 478 reportable
that events attendant to birth were not a event C.A.’s his and he forwarded recommendation Malkin. She consulted Robles, who concurred. fact, by
The matter was not reviewed In Committee. does not reflect that was aware of the record Committee report Mutter roundtable discussion and or the concurrence of Robles and Malkin. The record also does not reveal whether the patient safety ever knew that a review of this incident Committee words, auspices purported under its ever occurred. In other Act review was conducted one member of the Committee, reported findings his to another mem- who roundtable Committee, ber of the and a third member of the Committee concurred. discoverable,
Although
presumed
it
relevant evidence is
to be
is
presumption
that
can
an
well-established
be overcome
evidentiary
applicable
privilege.
privilege
Such a
excludes rele
vant evidence from the factfinder’s consideration and therefore
“
principle
”
public
...
‘contravene^] the fundamental
has
every
right
Szemple,
man’s evidence.’ State v.
135 N.J.
(1994)
States,
(quoting
v.
479 “desire to to this Court’s as obstacles Privileges are disfavored Payton v. N.J. process[.]” through the adversarial attain truth (1997); 524, 539, also State Auth, A .2d321 see 691 Tpk. 148 N.J. (2012). 531, Despite a 519, 1216 33 A.3d 208 N.J. v. Mauti Payton, supra, privileges, of new against the creation presumption 321, free to do so Legislature is at 691 A.2d 148 N.J. support of nondisclosure is policy in where the social situations In accordance it renders unavailable. weightier than evidence privilege will shield principles, statutory guiding a with these when, only particular “in the compelled from disclosure evidence concerned, public interest than important a more it serves area C., 165 N.J.Su in Interest need for full disclosure.” State Briley, supra, 131, 136, (citing (App.Div.1979) A.2d 1092 per. 442). at 251 A.2d 53 N.J. privileges, cognizant status of today, of the disfavored
Until for recognize privilege a broad infor Jersey has refused to New analy engaged in self-critical organization an generated mation 547-48, (holding Payton, supra, 691 A.2d 148 N.J. sis. See complaint investigation of harassment employer’s internal sexual privi and therefore not confidential information akin to other Act, privilege an absolute leged). which affords generated pursuant to self-critical to information and documents facility in accordance with the analysis a healthcare conducted 26:2H-12.25(b), statute, embodies a requirements of that N.J.S.A exception to this rule. narrow Legislature devoted a drafting
In procedures a healthcare policies to the separate subsection privilege regard follow in order to claim a must analysis. include of a self-critical These results patient patient safety plan, which must include developing a committee, training facility per- ongoing safety for safety sonnel, conducting ongoing analysis of “evi- processes for patient safety practices” [or] and “near misses seri- dence-based events.” N.J.S.A. preventable adverse events ous 26:2H-12:25(b). clearly indicates presence of these conditions *26 Legislature
that did not intend privilege apply the Act’s universally any analysis by self-critical conducted healthcare facility, carefully but analy- rather to a circumscribed self-critical sis conducted accordance with the statute. Like all relevant evidence, such information would be discoverable unless the by specific healthcare requirements abided to invoke privilege. Legislature’s carefully decision to circumscribe the circum- privilege may stances under which this be invoked accords with privileges the disfavored status of principles and the of broad discovery by Jersey envisioned the New Rules of Evidence. The Safety requires Patient hospital more than the existence of a committee that bears name “Patient Committee.” The “comprised personnel committee must be representa- who are tive” of hospital’s disciplines.” “various N.J.S.A. 26:2H- 12.25(b)(2) added). Thus, (emphasis requires the Act more than a reference to one member of a committee and consultation with two other members. Yet that is all this record establishes. This permit finding record does not even Hospital’s existing that the Committee knew that the so-called self-critical analysis contemplated by the Act purportedly by and conducted Mutter, Malkin, and Noble was auspices. conducted under its Furthermore, Mutter, Malkin, the focus of the and Noble effort seems to have concentrated more on whether the should report Department the birth event of Health rather than identifying any process may internal have caused or contrib- surrounding uted to the circumstances C.A.’s birth. The record requires by me to conclude that the discussion led Mutter falls by I, well short of the envisioned Act. therefore, respectfully disagree majority’s with the decision to discovery. shield the document at from privilege issue creat- apply organization ed the Act cannot when a healthcare fails to abide of that statute. Appellate Therefore,
I would affirm respectfully Division. I dissent. join opinion. ALBIN in this Justice Justice RABNER
Chief LaVECCHIA, For reversal/remandment—Justices FERNANDEZ-VINA, Judge PATTERSON, RODRÍGUEZ assigned) (temporarily —4. ALBIN, RABNER, Justice Justice
For affirmance—Chief assigned) Judge (temporarily CUFF —3.