Madeline Keyworth v. CareOne at Madison Avenue Suzanne Bender v. Harmony Village at CareOne Paramus
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Opinion
SYLLABUS
This syllabus is not part of the Court’s opinion. It has been prepared by the Office of the Clerk for the convenience of the reader. It has been neither reviewed nor approved by the Court and may not summarize all portions of the opinion.
Madeline Keyworth v. CareOne at Madison Avenue (A-17/18-23) (088410)
Argued May 2, 2024 -- Decided August 5, 2024
PIERRE-LOUIS, J., writing for the Court.
In this consolidated appeal, the Court considers whether internal reports and documents created after alleged adverse events occurred at the defendant nursing and assisted living facilities are discoverable or are instead privileged under the New Jersey Patient Safety Act (PSA), N.J.S.A. 26:2H-12.23 to -12.25.
In the first appeal, Keyworth v. CareOne at Madison Avenue, plaintiff Madeline Keyworth claims that she sustained injuries from two falls at a skilled nursing facility and seeks the facility’s internal incident reports and associated documents relating to those falls. In the second appeal, Bender v. Harmony Village at CareOne Paramus, plaintiffs Suzanne and Jonathan Bender, as co-executors of decedent Diane Bender’s estate, seek an incident report and associated documents regarding an alleged attack committed against decedent by another resident during her stay at an assisted living facility. In both appeals, the defendant institutions and caregivers asserted that the requested materials are not discoverable pursuant to the PSA’s self-critical-analysis privilege, which shields certain internal communications from discovery in litigation. See N.J.S.A. 26:2H-12.25(b), (c), (f), (g).
The trial courts in both matters found that the self-critical-analysis privilege did not apply and ordered defendants to disclose the materials. The Appellate Division reversed, concluding that defendants procedurally complied with the PSA and that the documents at issue are therefore privileged. 476 N.J. Super. 86, 107-09 (App. Div. 2023). The Court granted leave to appeal. 256 N.J. 126 (2024).
HELD: The only precondition to applying “the PSA’s privilege is whether the hospital performed its self-critical analysis in procedural compliance with N.J.S.A. 26:2H-12.25(b) and its implementing regulations.” Brugaletta v. Garcia, 234 N.J. 225, 247 (2018). One of those regulations requires that a facility’s patient safety committee operate independently from any other committee within the facility. See N.J.A.C. 8:43E-10.4(c)(4). The facilities in these consolidated appeals did not comply with that procedural requirement, and the disputed documents are therefore not privileged.
1 1. Enacted in 2004, the PSA and its implementing regulations set out a detailed procedural plan to minimize adverse events caused by patient-safety system failures in a hospital or other health care facility. N.J.S.A. 26:2H-12.24(b) and (c). Through the PSA’s multi-faceted framework, the Legislature aimed to encourage self-critical analysis related to adverse events and near misses by fostering a non-punitive, confidential environment in which health care facilities can review internal practices and policies and report problems without fear of recrimination while simultaneously being held accountable. The statute requires facilities to “develop and implement a patient safety plan for the purpose of improving the health and safety of patients at the facility” and sets minimum requirements for those plans, including the creation of “a patient safety committee, as prescribed by regulation.” N.J.S.A. 26:2H- 12.25(b). The PSA’s corresponding regulations outline the requirements for a patient safety committee in significant detail. Relevant here, the regulation directs that the “patient or resident safety committee shall not constitute a subcommittee of any other committee within a facility or health care system.” N.J.A.C. 8:43E- 10.4(c)(4). That exclusivity requirement is significant because other statutes, both federal and state, impose additional requirements on health care facilities including nursing homes. (pp. 6-9)
2. Normally, parties may “obtain discovery regarding any matter, not privileged, which is relevant to the subject matter involved in the pending action.” R. 4:10-2(a). The PSA, however, confers an absolute privilege on documents, materials, and information developed as part of a health care facility’s self-critical analysis. See N.J.S.A. 26:2H-12.25(g)(1). But investigations that are undertaken pursuant to other laws are not shielded by the PSA privilege, and the PSA does not affect the discoverability of material that “may have been considered in the process of self- critical analysis . . . if obtained from any source or context other than those specified in [the PSA].” See N.J.S.A. 26:2H-12.25(h). (pp. 28-30)
3. The Court reviews in detail Brugaletta, in which it recently addressed the PSA’s self-critical-analysis privilege. 234 N.J. at 241-45. There, the plaintiff sued her treating physicians and the hospital for medical malpractice. Id. at 232. During pre- trial discovery, the plaintiff issued an interrogatory seeking “statement[s] regarding this lawsuit” and identifying information about the individuals involved. Id. at 233. In its decision, the Court noted that “[t]he Legislature inserted no role for a trial court to play in reviewing the” substance of the patient safety committee’s determination about an adverse event in determining whether related documents were privileged. Id. at 246. Rather, “the only precondition to application of the PSA’s privilege is whether the hospital performed its self-critical analysis in procedural compliance with N.J.S.A. 26:2H-12.25(b) and its implementing regulations.” Id. at 247. Interpreting N.J.S.A. 26:2H-12.25(b) and (g)’s plain language, the Court concluded that “the PSA leave[s] no reasonable doubt about the 2 legislative intent regarding the self-critical-analysis privilege it authorizes.” Ibid. That intent “encase[s] the entire self-critical-analysis process in a privilege, shielding a health care facility’s deliberations and determinations from discovery or admission into evidence.” Ibid. In sum, Brugaletta establishes procedural compliance with the PSA’s requirements as the single metric for evaluating a health care facility’s invocation of the PSA privilege. (pp. 31-34)
4. One of the PSA’s implementing regulations expressly provides that the patient safety committee “shall not constitute a subcommittee of any other committee within a facility or health care system.” N.J.A.C. 8:43E-10.4(c)(4). That regulation mandates that the patient safety committee act independently of other committees. Here, defendants’ certifications demonstrate that the evaluative processes within their facilities did not adhere to the PSA’s procedural scheme because they were created for the dual purpose of complying with federal and state law. Therefore, defendants’ own admissions that they treated their committees related to quality assurance and improvement as patient safety committees to comply with both the requirements of the PSA and their federal obligations shows that they did not follow “the only precondition to application of the PSA’s privilege.” Brugaletta, 234 N.J. at 247. Moreover, the institutions’ investigations were not undertaken “exclusively during the process of self-critical analysis in accordance with N.J.A.C. 8:43E-10.4, 10.5 or 10.6” as mandated by another implementing regulation. See N.J.A.C. 8:43E- 10.9(b). Accordingly, the incident reports and associated documents at issue are not privileged and thus subject to discovery. (pp. 35-37)
5. The Court recognizes the important competing interests involved between patients and their right to know what occurred, and health care facilities and their interest in ensuring effective self-critical analysis to promote optimal patient-safety practices.
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SYLLABUS
This syllabus is not part of the Court’s opinion. It has been prepared by the Office of the Clerk for the convenience of the reader. It has been neither reviewed nor approved by the Court and may not summarize all portions of the opinion.
Madeline Keyworth v. CareOne at Madison Avenue (A-17/18-23) (088410)
Argued May 2, 2024 -- Decided August 5, 2024
PIERRE-LOUIS, J., writing for the Court.
In this consolidated appeal, the Court considers whether internal reports and documents created after alleged adverse events occurred at the defendant nursing and assisted living facilities are discoverable or are instead privileged under the New Jersey Patient Safety Act (PSA), N.J.S.A. 26:2H-12.23 to -12.25.
In the first appeal, Keyworth v. CareOne at Madison Avenue, plaintiff Madeline Keyworth claims that she sustained injuries from two falls at a skilled nursing facility and seeks the facility’s internal incident reports and associated documents relating to those falls. In the second appeal, Bender v. Harmony Village at CareOne Paramus, plaintiffs Suzanne and Jonathan Bender, as co-executors of decedent Diane Bender’s estate, seek an incident report and associated documents regarding an alleged attack committed against decedent by another resident during her stay at an assisted living facility. In both appeals, the defendant institutions and caregivers asserted that the requested materials are not discoverable pursuant to the PSA’s self-critical-analysis privilege, which shields certain internal communications from discovery in litigation. See N.J.S.A. 26:2H-12.25(b), (c), (f), (g).
The trial courts in both matters found that the self-critical-analysis privilege did not apply and ordered defendants to disclose the materials. The Appellate Division reversed, concluding that defendants procedurally complied with the PSA and that the documents at issue are therefore privileged. 476 N.J. Super. 86, 107-09 (App. Div. 2023). The Court granted leave to appeal. 256 N.J. 126 (2024).
HELD: The only precondition to applying “the PSA’s privilege is whether the hospital performed its self-critical analysis in procedural compliance with N.J.S.A. 26:2H-12.25(b) and its implementing regulations.” Brugaletta v. Garcia, 234 N.J. 225, 247 (2018). One of those regulations requires that a facility’s patient safety committee operate independently from any other committee within the facility. See N.J.A.C. 8:43E-10.4(c)(4). The facilities in these consolidated appeals did not comply with that procedural requirement, and the disputed documents are therefore not privileged.
1 1. Enacted in 2004, the PSA and its implementing regulations set out a detailed procedural plan to minimize adverse events caused by patient-safety system failures in a hospital or other health care facility. N.J.S.A. 26:2H-12.24(b) and (c). Through the PSA’s multi-faceted framework, the Legislature aimed to encourage self-critical analysis related to adverse events and near misses by fostering a non-punitive, confidential environment in which health care facilities can review internal practices and policies and report problems without fear of recrimination while simultaneously being held accountable. The statute requires facilities to “develop and implement a patient safety plan for the purpose of improving the health and safety of patients at the facility” and sets minimum requirements for those plans, including the creation of “a patient safety committee, as prescribed by regulation.” N.J.S.A. 26:2H- 12.25(b). The PSA’s corresponding regulations outline the requirements for a patient safety committee in significant detail. Relevant here, the regulation directs that the “patient or resident safety committee shall not constitute a subcommittee of any other committee within a facility or health care system.” N.J.A.C. 8:43E- 10.4(c)(4). That exclusivity requirement is significant because other statutes, both federal and state, impose additional requirements on health care facilities including nursing homes. (pp. 6-9)
2. Normally, parties may “obtain discovery regarding any matter, not privileged, which is relevant to the subject matter involved in the pending action.” R. 4:10-2(a). The PSA, however, confers an absolute privilege on documents, materials, and information developed as part of a health care facility’s self-critical analysis. See N.J.S.A. 26:2H-12.25(g)(1). But investigations that are undertaken pursuant to other laws are not shielded by the PSA privilege, and the PSA does not affect the discoverability of material that “may have been considered in the process of self- critical analysis . . . if obtained from any source or context other than those specified in [the PSA].” See N.J.S.A. 26:2H-12.25(h). (pp. 28-30)
3. The Court reviews in detail Brugaletta, in which it recently addressed the PSA’s self-critical-analysis privilege. 234 N.J. at 241-45. There, the plaintiff sued her treating physicians and the hospital for medical malpractice. Id. at 232. During pre- trial discovery, the plaintiff issued an interrogatory seeking “statement[s] regarding this lawsuit” and identifying information about the individuals involved. Id. at 233. In its decision, the Court noted that “[t]he Legislature inserted no role for a trial court to play in reviewing the” substance of the patient safety committee’s determination about an adverse event in determining whether related documents were privileged. Id. at 246. Rather, “the only precondition to application of the PSA’s privilege is whether the hospital performed its self-critical analysis in procedural compliance with N.J.S.A. 26:2H-12.25(b) and its implementing regulations.” Id. at 247. Interpreting N.J.S.A. 26:2H-12.25(b) and (g)’s plain language, the Court concluded that “the PSA leave[s] no reasonable doubt about the 2 legislative intent regarding the self-critical-analysis privilege it authorizes.” Ibid. That intent “encase[s] the entire self-critical-analysis process in a privilege, shielding a health care facility’s deliberations and determinations from discovery or admission into evidence.” Ibid. In sum, Brugaletta establishes procedural compliance with the PSA’s requirements as the single metric for evaluating a health care facility’s invocation of the PSA privilege. (pp. 31-34)
4. One of the PSA’s implementing regulations expressly provides that the patient safety committee “shall not constitute a subcommittee of any other committee within a facility or health care system.” N.J.A.C. 8:43E-10.4(c)(4). That regulation mandates that the patient safety committee act independently of other committees. Here, defendants’ certifications demonstrate that the evaluative processes within their facilities did not adhere to the PSA’s procedural scheme because they were created for the dual purpose of complying with federal and state law. Therefore, defendants’ own admissions that they treated their committees related to quality assurance and improvement as patient safety committees to comply with both the requirements of the PSA and their federal obligations shows that they did not follow “the only precondition to application of the PSA’s privilege.” Brugaletta, 234 N.J. at 247. Moreover, the institutions’ investigations were not undertaken “exclusively during the process of self-critical analysis in accordance with N.J.A.C. 8:43E-10.4, 10.5 or 10.6” as mandated by another implementing regulation. See N.J.A.C. 8:43E- 10.9(b). Accordingly, the incident reports and associated documents at issue are not privileged and thus subject to discovery. (pp. 35-37)
5. The Court recognizes the important competing interests involved between patients and their right to know what occurred, and health care facilities and their interest in ensuring effective self-critical analysis to promote optimal patient-safety practices. The PSA acknowledges it will unlikely be the case that everything is privileged, which is consistent with the competing interests involved. (pp. 37-39)
REVERSED. REMANDED to the trial court.
CHIEF JUSTICE RABNER and JUSTICES PATTERSON, SOLOMON, WAINER APTER, FASCIALE, and NORIEGA join in JUSTICE PIERRE- LOUIS’s opinion.
3 SUPREME COURT OF NEW JERSEY A-17/18 September Term 2023 088410
Madeline Keyworth,
Plaintiff-Appellant,
v.
CareOne at Madison Avenue, Ann Duran, RN, and Donald Gelin, LPN,
Defendants-Respondents,
and
Dalia Tadros, MD,
Defendant.
Suzanne Bender and Jonathan Bender, Co-Executors for the Estate of Diane Bender, and on behalf of the heirs of Diane Bender,
Plaintiffs-Appellants,
Harmony Village at CareOne Paramus, Olga Romaine, RN, Risa Kory, RN, Gelacio Ramirez, RN, and Cecilia Ugwu, RN,
Defendants-Respondents.
1 On appeal from the Superior Court, Appellate Division, whose opinion is reported at 476 N.J. Super. 86 (App. Div. 2023).
Argued Decided May 2, 2024 August 5, 2024
E. Drew Britcher argued the cause for appellants (Britcher, Leone & Sergio, attorneys; E. Drew Britcher, of counsel and on the briefs, and Jessica E. Choper, on the briefs).
Anthony Cocca argued the cause for respondents (Cocca & Cutinello, attorneys; Anthony Cocca and Katelyn E. Cutinello, of counsel and on the briefs).
Jonathan F. Lauri argued the cause for amicus curiae New Jersey Association for Justice (Stark & Stark, attorneys; Jonathan F. Lauri, of counsel and on the brief, and Denise Mariani, on the brief).
Ross A. Lewin argued the cause for amicus curiae New Jersey Hospital Association (Faegre Drinker Biddle & Reath, attorneys; Ross A. Lewin, of counsel and on the brief).
Ryan A. Notarangelo submitted a brief on behalf of amicus curiae New Jersey Defense Association (Dughi, Hewit & Domalewski, attorneys; Ryan A. Notarangelo and Herbert Kruttschnitt, III, of counsel and on the brief).
Michael A. Moroney submitted a brief on behalf of amici curiae Medical Society of New Jersey and American Medical Association (Flynn Watts, attorneys; Michael A. Moroney, of counsel, and Catherine J. Flynn, on the brief).
2 JUSTICE PIERRE-LOUIS delivered the opinion of the Court.
In this consolidated appeal, we consider whether incident reports and
associated documents at issue are privileged under the New Jersey Patient
Safety Act (PSA), N.J.S.A. 26:2H-12.23 to -12.25.
In 2004, the Legislature enacted the PSA to minimize medical errors that
could harm patients in hospitals and other health care facilities. The law
imposed new obligations on those facilities for assessing and reporting adverse
events and near-misses, and it created an absolute privilege -- the self-critical-
analysis privilege -- to shield certain internal communications from discovery
in litigation. N.J.S.A. 26:2H-12.25(b), (c), (f), (g). In enacting the PSA, the
Legislature aimed to encourage health care workers to openly disclose their
observations and concerns and to facilitate professional and administrative
staff’s self-critical evaluation. At the same time, however, the statute did not
impact a plaintiff’s ability to discover factual information regarding alleged
adverse events through other non-privileged means.
The matters before us involve the discoverability of disputed internal
documents created after alleged adverse events occurred at facilities subject to
the PSA’s procedural requirements.
3 In the first appeal, Keyworth v. CareOne at Madison Avenue, plaintiff
Madeline Keyworth claims that she sustained injuries from two falls at a
skilled nursing facility and seeks the facility’s internal incident reports and
associated documents relating to those falls. During pre-trial discovery, the
CareOne defendants 1 refused to produce those materials, asserting that they are
not discoverable pursuant to the PSA’s self-critical-analysis privilege.
In the second appeal, Bender v. Harmony Village at CareOne Paramus,
plaintiffs Suzanne and Jonathan Bender (the Benders), as co-executors of
decedent Diane Bender’s estate, seek an incident report and associated
documents regarding an alleged attack committed against decedent by another
resident during her stay at an assisted living facility. Like the defendants in
Keyworth, the Harmony Village defendants 2 claimed that those materials are
privileged under the PSA and refused to disclose them during pre-trial
discovery.
1 The named defendants in the first matter are CareOne at Madison Avenue, LLC d/b/a CareOne at Madison Avenue; Ann Duran, RN; Donald Gelin, LPN; and Dalia Tadros, MD. We collectively refer to all defendants as CareOne. 2 The named defendants in the second matter are Harmony Village at CareOne Paramus; Olga Romaine, RN; Risa Kory, RN; Gelacio Ramirez, RN; and Cecelia Ugwu, RN. We collectively refer to all defendants as Harmony Village. 4 After reviewing the disputed documents in camera, the trial courts in
both matters found that the self-critical-analysis privilege did not apply and
ordered defendants to disclose the materials. Defendants sought leave to
appeal, to seal portions of the records, and to stay the trial court proceedings.
Harmony Village also moved to consolidate their cases. The Appellate
Division granted all of those motions. In a published opinion, the appellate
court reversed the trial courts’ orders in both matters, concluding that
defendants procedurally complied with the PSA and that the documents at
issue are therefore privileged and not discoverable. Keyworth v. CareOne at
Madison Ave., 476 N.J. Super. 86, 107-09 (App. Div. 2023).
We granted plaintiffs’ motion for leave to appeal and now reverse. The
facilities in these consolidated appeals did not comply with the procedural
requirements of the PSA, and, therefore, the disputed documents are not
privileged under that statute. Defendants’ certifications, which avow that their
quality assurance and improvement committees also operated as patient safety
committees to comply with the PSA, defeat their claims for the self-critical-
analysis privilege. In order to invoke the privilege, the PSA and its
implementing regulations require that a facility’s patient safety committee
operate independently from any other committee within the facility. See
N.J.A.C. 8:43E-10.4(c)(4).
5 As we noted in Brugaletta v. Garcia, the only precondition to applying
“the PSA’s privilege is whether the hospital performed its self-critical analysis
in procedural compliance with N.J.S.A. 26:2H-12.25(b) and its implementing
regulations.” 234 N.J. 225, 247 (2018). Because that did not occur in either
case, we reverse the Appellate Division’s judgment and remand to the trial
courts for further proceedings consistent with this opinion.
I.
Before turning to the facts of these appeals, we provide the following
summary of the requirements for patient-safety review processes at hospitals
and other health care facilities.
Enacted in 2004, the PSA and its implementing regulations set out a
detailed procedural plan to minimize adverse events caused by patient-safety
system failures in a hospital or other health care facility. N.J.S.A. 26:2H-
12.24(b) and (c). Through the PSA’s multi-faceted framework, the Legislature
aimed to “encourage self-critical analysis related to adverse events and near
misses by fostering a non-punitive, confidential environment in which health
care facilities can review internal practices and policies and report problems
without fear of recrimination while simultaneously being held accountable.”
Brugaletta, 234 N.J. at 241; see N.J.S.A. 26:2H-12.24(e).
6 Then-New Jersey Department of Health (DOH) Commissioner Clifton R.
Lacy, MD, echoed this intent in his testimony before the Senate Health,
Human Services and Senior Citizens Committee, stating that the PSA “strikes
the right balance between acknowledging and learning from errors, and also
holding people accountable. It shields self-critical analysis from discovery,
but maintains discoverable all that is now discoverable.” Hearing on S. 557
Before the S. Health, Hum. Servs. & Senior Citizens Comm., 211th Leg. 6
(2004) (statement of Clifton R. Lacy, MD).
Although the Legislature did not intend for the PSA to replace
preexisting evaluative processes in the health care setting, C.A. ex rel.
Applegrad v. Bentolila, 219 N.J. 449, 461 (2014), the statute requires facilities
to “develop and implement a patient safety plan for the purpose of improving
the health and safety of patients at the facility,” N.J.S.A. 26:2H-12.25(b); see
N.J.A.C. 8:43E-10.4(a). At a minimum, patient safety plans must include:
(1) a patient safety committee, as prescribed by regulation;
(2) a process for teams of facility staff, which teams are comprised of personnel who are representative of the facility’s various disciplines and have appropriate competencies, to conduct ongoing analysis and application of evidence-based patient safety practices in order to reduce the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures;
7 (3) a process for teams of facility staff, which teams are comprised of personnel who are representative of the facility’s various disciplines and have appropriate competencies, to conduct analyses of near-misses, with particular attention to serious preventable adverse events and adverse events; and
(4) a process for the provision of ongoing patient safety training for facility personnel.
[N.J.S.A. 26:2H-12.25(b).]
The statute immediately adds: “The provisions of this subsection shall not be
construed to eliminate or lessen a hospital’s 3 obligation under current law or
regulation to have a continuous quality improvement program.” Ibid.
The PSA’s corresponding regulations outline the requirements for a
patient safety committee in significant detail, including, for example, direction
as to how to appoint the chairperson and members; meeting frequency;
documentation; regular review protocols; and data analysis of the committee’s
findings. See N.J.A.C. 8:43E-10.4(c) and (d). Relevant here, the regulation
directs that the “patient or resident safety committee shall not constitute a
subcommittee of any other committee within a facility or health care system.”
N.J.A.C. 8:43E-10.4(c)(4) (emphasis added); see C.A., 219 N.J. at 462 (“The
3 Although the statute uses the term “hospital,” N.J.A.C. 8:43E-10.5(b)(1) specifies that this requirement applies to any “facility” that is required to “implement and maintain a continuous quality improvement program” under Title 8. 8 regulation mandates that the patient safety committee . . . act independently of
other committees.”).
That exclusivity requirement is significant because other statutes, both
federal and state, impose additional requirements on health care facilities
including nursing homes. Nursing homes, for example, must comply with the
Federal Nursing Home Reform Act (FNHRA), 42 U.S.C. §§ 1396r(b)(1)(B),
1395i-3(b)(1)(B), which requires nursing homes to maintain a Quality
Assessment and Assurance Committee (QAAC). And federal regulations
require health care facilities to maintain a Quality Assurance and Performance
Improvement (QAPI) program that focuses on “indicators of the outcomes of
care and quality of life,” 42 C.F.R. § 483.75(a), and set forth an identical
structure and purpose for the facility’s QAAC to those found in the FNHRA,
see 42 C.F.R. § 483.75(g)(2)(i) to (ii). New Jersey separately requires assisted
living facilities to have Quality Improvement (QI) programs under N.J.A.C.
8:36-21.1, including written plans for resident care and ongoing monitoring of
resident services.
II.
This appeal involves two separate cases consolidated by the Appellate
Division. Because this matter involves confidential records and comes before
us on interlocutory appeal from the trial courts’ discovery rulings, we briefly
9 recite each case’s alleged facts and relevant procedural history, but make no
factual findings.
A. Keyworth v. CareOne at Madison Avenue
Plaintiff Madeline Keyworth was an eighty-year-old patient at skilled
nursing facility CareOne at Madison Avenue (CareOne) from November 16 to
18, 2016. Keyworth alleges that on November 18, 2016, she suffered two falls
-- the first at approximately 12:45 a.m. in her room, and the second later that
morning in front of the nurses’ station. Her treating nurses documented the
events surrounding both falls in her medical chart. 4 Regarding the first fall, an
entry in Keyworth’s chart at 3:27 a.m. reported that
at 1245am was call[ed] by aid to room that they noted [patient] stumbling against closet door to floor. [Patient] noted on the floor sit[t]ing . . . . When asked what happen[ed], [patient] stated she woke up and came [out] of bed to[o] fast and was mildly disoriented and wasn’t aware of the room, while walk[ing] around in the room . . . grab[bed] on to roommate[’]s [wheelchair] and [wheelchair] was locked and stumbles along the closet door with [wheelchair] hit her right shoulder.
At 5:21 p.m., another chart entry reported that Keyworth had fallen
earlier and complained of “pain to hip and pelvis, [right] shoulder and
4 Keyworth’s medical chart, however, does not appear to contain all facts relevant to her two falls; it does not state, for example, who witnessed the incidents; whether Keyworth’s roommate provided any factual statements; whether Keyworth’s bed had side rails; or whether staff were at the nurses’ station when Keyworth’s second fall occurred. 10 humerus.” Regarding the second fall, the entry continued that later the same
morning, while “sitting in front of nursing station . . . for closer observation,
resident attempted to stand and slid to floor, seen and examine[d] by 8am.”
The entry concluded by noting that “pain management was in progress” and
“bed and chair alarm in place, call light within [reach].”
Keyworth alleges that she fractured her right hip as a result of the falls.
CareOne did not report the falls to the DOH, but it developed two internal
incident reports, one shortly after each fall. The information contained in
those incident reports is in CareOne’s confidential appendix, which Keyworth
has not seen, and we do not disclose those facts here.
On November 16, 2018, Keyworth filed an eight-count complaint against
CareOne, alleging common law negligence, breach of contract, and violations
of several statutes. Keyworth propounded Form C interrogatories, to which
CareOne responded on April 16, 2020, producing several requested
documents, including Keyworth’s medical chart during her residency at
defendants’ facility.
Interrogatory five asked CareOne to state
(a) the name and address of any person who has made a statement regarding this lawsuit;
(b) whether the statement was oral or in writing;
(c) the date the statement was made; 11 (d) the name and address of the person to whom the statement was made;
(e) the name and address of each person present when the statement was made; and
(f) [t]he name and address of each person who has knowledge of the statement.
CareOne did not substantively respond to inquiries (a) through (f).
Instead, CareOne objected, asserting in relevant part that the request “seeks
information that is protected by . . . the [PSA’s] privilege of self-critical
analysis.” CareOne maintained that “[t]hose documents, and the information
contained therein, are strictly confidential, and may not be disclosed or
distributed to any person or entity outside of the review process, except as
otherwise provided by law.” CareOne confirmed that it possessed two incident
reports dated November 18, 2016, listing them in an attached privilege log, but
refused to produce them.
Between October 2020 and September 2021, Keyworth’s counsel
deposed three of CareOne’s nurses, but all three testified that they could not
independently recall any details about Keyworth or the alleged falls beyond
the minimal information they documented in her medical chart. For example,
the nurses testified that they could not state with certainty whether they
witnessed Keyworth’s alleged falls or whether they were on the premises when
12 the falls occurred; whether the side rails on Keyworth’s bed were raised at the
time of the falls; or whether the attending nurses discussed the falls afterwards.
On March 31, 2022, after deposing the parties and fact witnesses and
exchanging expert reports, Keyworth moved to compel production of the
incident reports for in camera review and all factual information contained
therein. Keyworth argued that she could not obtain certain factual data that
may exist only in the reports because her medical chart lacked key information
and “the defendants and fact witnesses largely lack any recollection of the
events of this case and have relied upon the records and their habits and
practices to provide testimony concerning relevant facts.”
CareOne cross-moved for a protective order, arguing that the reports
were not discoverable under the PSA’s self-critical-analysis privilege.
CareOne submitted a certification by Michael Shipley, licensed nursing home
administrator and chair of the facility’s QAAC, asserting that the QAAC
created the incident reports and associated documents “for the sole purpose” of
complying with the PSA and 42 C.F.R. § 483.75, a federal regulation that
governs federal QAPI plans. Shipley stated that CareOne’s “QAPI plan
comports with the requirements of N.J.S.A. 26:2H-12.25(b),” because, among
other things, CareOne has a “Quality Assessment and Assurance Committee or
‘QAAC,’ which performs the functions of a Resident Safety Committee.”
13 The trial court ordered CareOne to provide the incident reports and
associated documents to the court for in camera review to resolve the privilege
dispute. On June 22, 2022, after reviewing the materials in camera, the court
issued an order along with a brief statement of reasons, finding the documents
were “not privileged” because they “were directly related and relevant to the
matter at issue.”
B. Bender v. Harmony Village at CareOne Paramus
On September 4, 2018, then eighty-three-year-old decedent Diane
Bender was admitted to Harmony Village at CareOne Paramus (Harmony
Village), a memory care assisted living facility housing patients with dementia
and other conditions. Her estate’s co-executors, the Benders, allege that on
June 8, 2019, another resident “attacked” Bender in her room. As a result of
the attack, Bender allegedly suffered multiple rib fractures, head trauma, spinal
contusion, and pneumothorax.
Bender’s medical chart includes entries at 1:31 p.m. and 2:44 p.m. on the
day of the alleged attack. 5 According to the entries, she called for help around
12:00 p.m., at which point a nurse found her “sitting on the floor leaning by
the head side of the bed and another resident was sitting by the foot of her
5 Like Keyworth’s medical chart, Bender’s chart provides few details surrounding the alleged incident. 14 bed.” The entries also noted that Bender was “very anxious” and complained
of “pain on her right upper back,” but did not display “visible signs of pain”
other than a small bruise on her abdomen.
The chart also indicated that Bender herself called 9-1-1 because she
was in pain and did not believe the staff was helping her. According to the
police report created on the day of the alleged incident, when officers arrived
on scene, defendant Risa Kory, R.N., told them that Bender did not need their
assistance. Later, Bender’s medical team determined that she needed to be
seen at the hospital, and she was admitted at around 5:43 p.m. the same day.
Bender eventually returned to Harmony Village and died five weeks later.
Harmony Village created an incident report related to the alleged attack
on June 9. The “Investigation Report” is addressed to the “QAA Committee,”
or QAAC, from Kory, in her capacity as chair of the facility’s QAPI
Committee. The incident summary within the report states that a nurse found
Bender on the floor towards the head of her bed with “[the other resident]
sitting calmly on the foot of her bed,” and Bender claiming that “[h]e pushed
me,” which the other resident denied. According to the report, the other
resident “is known to walk into open doors, but [there was] no prior concern”
about his behavior.
15 The report includes a “Summary of Critical Information Obtained
During Investigation,” which discusses Bender’s and the other resident’s
histories while residents at the assisted living facility. According to the
summary, Bender “ha[d] a history of long standing psychiatric diagnoses
including anxiety,” and “ha[d] a history prior to admission of agitation and
verbal aggression towards others which has lessened over her stay at Harmony
[Village].” The summary described the other resident as an eighty-seven-year-
old man with dementia whose “behavioral patterns include repeatedly walking
around the neighborhood[,] . . . history of mild irritable mood, and impaired
judgment. When an apartment door is open, he has been observed entering
apartments believing it is his. When asked, he will leave apartments of other
residents without difficulty.” The report concluded that “there was no
apparent/witnessed resident to resident incident. [The other resident] entered
[Bender’s] apartment and at some point she fell, it is not clear how . . . . Both
residents will have service care plans reviewed and revised upon their return to
the community.”
The report also identified three staff members whom Kory interviewed
about the alleged attack within two days of the incident. Kiswaan Smith
reported “hear[ing] screams from [Bender’s] room” around 12:30 p.m., and
that when he entered the room, Bender was lying on the floor and said to him,
16 “that man pushed me down and my back and shoulder are broken.” Maxine
Morgan reported that following the incident, she was asked to “keep a close
eye” on the other resident, after which he told her to “leave me alone get the
f*** away from [m]e.” She added that as she continued to walk with him, he
“was somewhat resisting [her] verbal redirection, and grabbed [her] neck.”
The final witness statement from Gillacio Ramirez restated the information in
Bender’s medical chart.
The materials also contain a standardized “Incident/Accident Report,”
reporting the same information in Bender’s medical chart and observing that
she had no apparent injury. Kory reported the incident by telephone to the
DOH on June 9, and faxed the report and associated documents to the agency
in the following days.
On February 11, 2021, the Benders filed a complaint against Harmony
Village, alleging the same eight counts as did the plaintiff in Keyworth, as well
as a ninth count for Bender’s severe pain and suffering. The Benders also
issued the same Form C interrogatories as in Keyworth and received a nearly
identical response from Harmony Village to interrogatory number five.
Harmony Village did not identify the individuals involved and asserted the
self-critical-analysis privilege over the June 8, 2019 incident report.
17 Additionally, Harmony Village asserted the “federal quality assurance
privilege” pursuant to 42 U.S.C. §§ 1396r, 1395i-3, and 42 C.F.R. § 483.75.
Harmony Village objected on the same grounds to supplemental
interrogatory number four, which asked “whether a resident with the first name
of . . . was present on the floor where [Bender] resided at Care One Harmony
Village at Paramus and, specifically, whether such person was involved with
an unwanted touching or assault of [Bender] on or about June 8, 2019.”
Harmony Village did not substantively respond to the question but provided
over five hundred pages of Bender’s medical records.
The Benders scheduled depositions of the defendant nurses for
November and December 2021, but those were adjourned until after defense
counsel deposed the Benders. Thereafter, the Benders moved to compel
production of the following, among other things: (1) the incident report and
associated documents; (2) Harmony Village’s response to supplemental
interrogatory number four; (3) the other resident’s full name and last known
address; and (4) the depositions of all defendants within thirty days of the
court’s ruling.
Harmony Village filed a cross-motion for a protective order, attaching a
certification from Kory that closely mirrors Shipley’s certification in
Keyworth. Kory attested to being chair of the facility’s QAPI committee, that
18 the “QAPI plan comports with the requirements of N.J.S.A. 26:2H-12.25(b),”
and that Harmony Village’s QAPI committee “performs the functions of a
Resident Safety Committee” under the PSA. Similar to Shipley, Kory certified
that the facility’s QAPI committee generated the incident report “for the sole
purpose of compliance with the requirements of N.J.A.C. 8:36-21 et seq. and
the PSA.” She affirmed that “[a]t all relevant times, Care One Harmony
Village at Paramus had in place a QAPI Plan as required by N.J.S.A. 26:2H-
12.25(b).” Harmony Village therefore argued that the documents were entitled
to the self-critical-analysis privilege. Kory later provided a supplemental
certification confirming that she reported the incident to the DOH by phone the
same day it occurred and later submitted the disputed materials in writing.
The trial court, which did not hear oral argument on the competing
motions, granted the Benders’ proposed order requiring, among other things,
that Harmony Village (1) provide the incident report for in camera review; (2)
disclose the requested information about the other resident; and (3) complete
defendant depositions within thirty days after the court resolved the privilege
issue. The court denied Harmony Village’s cross-motion. In compliance with
the court’s order, Harmony Village provided the documents for in camera
review, disclosed the other resident’s full name, and disclosed that he is
deceased.
19 On August 10, 2022, after reviewing the materials in camera, the court
sent a letter to the Benders’ counsel, copying defense counsel, and held that
the June 8 incident report was not privileged. In the letter, the trial court
explained that
[w]hile the records include an Investigation Report, the Report is only a narrative that includes witness statements of a purported altercation between two patients. Nothing concerning deviation of protocols or self critical statements are included.
Thus, the information is freely discoverable. See Brugaletta v. Garcia, 234 N.J. 225 (2018). These reports are therefore not privileged pursuant to N.J.S.A. 26:2H-12.24(e) and are discoverable.
Thereafter, the Benders’ counsel filed a notice on eCourts seeking to compel
the deposition of the other resident’s doctor during his stay at the facility,
attaching the contested documents as exhibits, which the trial court had
released following its letter to the parties.
Harmony Village responded that its counsel had never received the
court’s letter and that it was not posted on eCourts. As a result, it claimed that
it did not know the court granted the Benders’ motion to compel or that the
disputed materials had been released, and therefore lacked an opportunity to
20 appeal before the Benders accessed the allegedly privileged documents. 6
Accordingly, Harmony Village moved to immediately delete the Benders’
motion from eCourts, to return the documents at issue to them, and to destroy
any copies in the Benders’ possession.
The trial court denied Harmony Village’s motion, reasoning that public
policy justified disclosure of the requested information despite the traditional
physician-patient privilege. The court also rejected Harmony Village’s
HIPAA claims as moot because the other resident is deceased.
C.
CareOne and Harmony Village each moved for leave to appeal the
respective trial court rulings, to seal portions of the records, and to stay the
trial court proceedings. Harmony Village also moved to consolidate their
cases. The Appellate Division granted those motions. In a published opinion,
the Appellate Division reversed the trial courts’ discovery orders. Keyworth,
476 N.J. Super. at 107-09.
The appellate court initially noted that the PSA attaches a privilege to
specific information generated by health care facilities in two distinct
6 In addition to raising the PSA’s self-critical-analysis privilege, Harmony Village claimed that the released documents were protected under HIPAA, the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§ 1320d-1 to -9, and the associated “Privacy Rule,” see 45 C.F.R. §§ 160, 162, and 164. Those claims are not before the Court. 21 processes: (1) the reporting of adverse events to regulators and (2) the
investigative process that may or may not lead to such reporting. Id. at 103.
In Keyworth, the court determined that CareOne developed the two
incident reports and associated documents during a self-critical analysis
process as part of a patient safety plan that complied with N.J.S.A. 26:2H-
12.25(b)’s requirements but did not report them to the DOH. Id. at 107. Thus,
per N.J.S.A. 26:2H-12.25(g), the appellate court held that the materials are
privileged and not discoverable. Id. at 107-08. Accordingly, the Appellate
Division reversed the trial court’s judgment and ordered the court to issue a
protective order shielding the documents from disclosure. Id. at 108.
In Bender’s matter, the Appellate Division similarly concluded that
Harmony Village created the June 9 incident report concerning Bender’s
alleged injuries as part of its self-critical analysis under the PSA. Ibid.
Specifically, the court reasoned that Harmony Village prepared the documents
pursuant to its QAPI plan and to comply with the PSA’s requirements and
N.J.A.C. 8:36-21.1. Ibid. Further, the appellate court explained that Harmony
Village developed the documents’ contents as part of a patient safety plan that
met N.J.S.A. 26:2H-12.25(b)’s requirements and noted that they submitted the
incident report to the DOH. Ibid. For those reasons, the Appellate Division
held that the disputed documents are privileged under the PSA. Ibid.
22 We granted plaintiffs’ motions for leave to appeal, 256 N.J. 126 (2024),
and granted amicus curiae status to the New Jersey Association for Justice
(NJAJ), the New Jersey Hospital Association (NJHA), the Medical Society of
New Jersey and American Medical Association (collectively, MSNJ), and the
New Jersey Defense Association (NJDA). We also granted defendants’ cross-
motions to seal the confidential appendices but denied their motions to strike
certain portions of plaintiffs’ appendices and references to the same in their
filings.
III.
A.
Keyworth asks this Court to reverse the Appellate Division’s decision
and remand this matter to the trial court to conduct an in-camera review of the
disputed materials and to compel CareOne to provide her with the factual data
contained therein, or, alternatively, to identify other non-privileged sources
from which she can learn those facts. She contends that the PSA protects only
a health care facility’s analyses and opinions related to adverse events, not the
facts underlying those deliberations. Keyworth asserts that the Appellate
Division’s decision limits her knowledge of the alleged incidents to those
minimal facts which she can glean from CareOne’s evasive interrogatory
responses, her medical chart, and witnesses’ imperfect recollections during
23 depositions. Consequently, she claims it is “impossible” for her to know what
facts CareOne concealed and how those facts impact her case.
The Benders, on behalf of decedent’s estate, seek the same relief as
Keyworth and echo her contentions regarding the underlying facts’
discoverability. They emphasize that the factual information contained in the
incident report and associated documents “is not available from any other
document,” including Bender’s medical chart. Further, they identify specific
facts that they cannot obtain without access to the confidential appendix,
including the attacking resident’s full name and records demonstrating his
purported history of aggression, “propensity for violence,” and attempts to
enter other residents’ rooms. The Benders contend that those underlying facts
are essential to enable them to prove their case, but the Appellate Division’s
decision denies them access to that information.
NJAJ supports plaintiffs’ positions and contends that defendants failed
to procedurally comply with the PSA, thus rendering the self-critical-analysis
privilege unavailable. NJAJ submits that the Appellate Division improperly
conflated the federal QAPI program, 42 C.F.R. § 483.75, with a health care
facility’s independent requirements under the PSA, an argument with which
plaintiffs agreed in later briefing. NJAJ also argues that the QAPI program
affords a narrow privilege that extends only to the QAAC’s internal minutes,
24 working papers, and conclusions, but not to incident reports or investigations
created outside of that distinct committee.
B.
CareOne urges this Court to affirm the Appellate Division’s decision,
arguing that Keyworth’s distinction between facts and opinions is immaterial
because the PSA affords the documents an absolute privilege. CareOne further
submits that Brugaletta and the PSA protect the materials from discovery for
“any purpose” because they were “undoubtedly” developed as part of a self-
critical analysis under N.J.S.A. 26:2H-12.25(g). CareOne relies on the
certification from its QAAC’s chairperson to establish that it created the
documents solely to comply with the PSA and that any information contained
therein is therefore absolutely privileged.
Harmony Village asks this Court to affirm the Appellate Division’s
decision and relies on CareOne’s brief in Keyworth to the extent that it raises
the same arguments. Harmony Village additionally argues that because the
incident was reported to the DOH pursuant to N.J.S.A. 26:2H-12.25(c) and (e),
the disputed documents are “automatically privileged under N.J.S.A. 26:2H-
12.25(f).” Harmony Village also raises privilege claims over the attacking
resident’s identity and medical records pursuant to HIPAA, the associated
25 “Privacy Rule,” and New Jersey’s physician-patient privilege, codified at
N.J.S.A. 2A:84A-22.1 to -22.7.
Defendants collectively argue that this Court should not consider NJAJ’s
arguments because they introduce new issues at a delayed time that plaintiffs
have not raised throughout this litigation. On the merits, defendants repeat the
language from their respective certifications and insist that they are entitled to
the PSA’s self-critical-analysis privilege even though their committees
simultaneously fulfilled functions relating to patient safety and quality
assurance.
Several amici support defendants’ positions and caution that reversing
the Appellate Division’s decision would chill health care facilities’
investigative processes and contravene legislative intent. Amici contend that
our case law, as well as the PSA’s plain language and legislative history, make
clear that the absolute privilege extends to facts uncovered during a facility’s
self-critical analysis. NJDA adds that trial courts cannot balance competing
interests when determining the discoverability of facts contained in
purportedly PSA-protected documents because doing so would lead to
inconsistent discovery rulings and frustrate the statute’s legislative purpose.
26 IV.
We generally review the trial court’s disposition of a discovery dispute
for an abuse of discretion. Brugaletta, 234 N.J. at 240. However, to the extent
that the court’s decision involves a question of statutory interpretation, we
review the determination de novo. Id. at 240-41.
When interpreting a statute, we aim to effectuate the Legislature’s intent,
W.S. v. Hildreth, 252 N.J. 506, 518 (2023), which is best indicated by the
statutory text, State v. Lane, 251 N.J. 84, 94 (2022). In construing statutory
text, “words and phrases shall be given their generally accepted meaning,
unless that meaning is inconsistent with the clear intent of the Legislature or
unless the statute provides a different meaning. Words in a statute should not
be read in isolation.” Shelton v. Restaurant.com, Inc., 214 N.J. 419, 440
(2013).
Thus, “we read the statutes in their entirety and construe each part or
section . . . in connection with every other part or section to provide a
harmonious whole.” C.A., 219 N.J. at 459-60 (quoting State v. Marquez, 202
N.J. 485, 499 (2010)). If the text’s plain meaning is clear and unambiguous,
“we ‘apply the law as written.’” State v. J.V., 242 N.J. 432, 443 (2020)
(quoting Murray v. Plainfield Rescue Squad, 210 N.J. 581, 592 (2012)).
27 Conversely, if the text is ambiguous, “we may turn to extrinsic evidence,
including legislative history to aid our inquiry.” Hildreth, 252 N.J. at 518.
Normally, parties may “obtain discovery regarding any matter, not
privileged, which is relevant to the subject matter involved in the pending
action.” R. 4:10-2(a). Rule 4:17-1(a) provides that “[a]ny party may serve
upon any other party written interrogatories relating to any matters which may
be inquired into under Rule 4:10-2.” However, “[p]rivileged information need
not be disclosed provided the claim of privilege is made pursuant to Rule 4:10-
2(e). Nor need information be disclosed if it is the subject of an identified
protective order issued pursuant to Rule 4:10-3.” R. 4:17-1(b)(3). “When a
requesting party challenges an assertion of privilege, the court must undertake
an in camera review of the purportedly privileged document or information
and make specific rulings as to the applicability of the claimed privilege.”
Brugaletta, 234 N.J. at 245.
Furthermore, under Rule 4:17-4(a), a responding party must “furnish all
information available to the [responding] party,” and “if the source of the
information is documentary,” the responding party must provide “a full
description including the location thereof.” However, “[a] party upon whom
interrogatories are served who objects to any questions propounded therein”
28 may respond accordingly, after which the requesting party may “serve a notice
of motion to compel an answer to the question” within twenty days of being
served with the answers. R. 4:17-5(a). Finally, an evasive or incomplete
answer in response to a discovery request, including an interrogatory, is treated
as a failure to answer. R. 4:23-1(b).
The PSA confers an absolute privilege on documents, materials, and
information developed as part of a health care facility’s self-critical analysis:
Any documents, materials, or information developed by a health care facility as part of a self-critical analysis conducted pursuant to subsection b. of this section concerning preventable events, near-misses, and adverse events, including serious preventable adverse events . . . shall not be subject to discovery or admissible as evidence or otherwise disclosed in any civil, criminal, or administrative action or proceeding.
[N.J.S.A. 26:2H-12.25(g)(1) (emphasis added); see N.J.S.A. 26:2H-12.25(b) (listing minimum requirements for patient safety plans).]
The corresponding regulation clarifies that the absolute privilege covers
“[d]ocuments, materials, and information . . . 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.” N.J.A.C. 8:43E-10.9(b) (emphasis
added).
29 Thus, the PSA shields specific documents, materials, or information that
a health care facility develops as it investigates and evaluates adverse events
only during one of three specific processes: “the operations of the patient or
resident safety committee pursuant to N.J.A.C. 8:43E-10.4, the components of
a patient or resident safety plan as prescribed by N.J.A.C. 8:43E-10.5, or
reporting to regulators under N.J.A.C. 8:43E-10.6.” C.A., 219 N.J. at 468.
Investigations that are undertaken pursuant to other laws are not shielded by
the PSA privilege.
In addition, despite the absolute privilege afforded by the PSA to certain
materials, the PSA does not affect the discoverability of material that “may
have been considered in the process of self-critical analysis . . . if obtained
from any source or context other than those specified in [the PSA].” N.J.S.A.
26:2H-12.25(h). Stated differently, the PSA’s self-critical-analysis privilege
does “not bar the discovery . . . of information that would otherwise be
discoverable.” Brugaletta, 234 N.J. at 244. Relatedly, the statute clarifies that
it likewise does not alter the discoverability of material obtained from other
sources, or in other contexts, as provided in Christy v. Salem, 366 N.J. Super.
30 535, 544-45 (App. Div. 2004), 7 which the Appellate Division decided before
the PSA’s enactment. N.J.S.A. 26:2H-12.25(k); Brugaletta, 234 N.J. at 244.
This Court most recently addressed the PSA’s self-critical-analysis
privilege in Brugaletta, 234 N.J. at 241-45. There, the plaintiff sued her
treating physicians and the hospital for medical malpractice during her stay,
alleging that they failed to administer doses of a prescribed antibiotic and to
detect a second abscess in her body. Id. at 232. During pre-trial discovery, the
plaintiff issued an interrogatory seeking “statement[s] regarding this lawsuit”
and identifying information about the individuals involved. Id. at 233. The
defendants responded that they possessed two relevant incident reports but
objected to producing them under the PSA’s absolute privilege, attaching a
certification from a physician asserting that the reports were prepared “for the
sole purpose of complying with the requirements of the PSA” and that they
were forwarded only to the hospital’s patient safety committee. Id. at 233-34.
7 In Christy, the Appellate Division held that despite the defendant hospital’s claim of privilege, the plaintiff was entitled to “purely factual” content from the hospital’s peer-review report but not to deliberative material. 366 N.J. Super. at 544-45. In making this decision, the appellate court balanced the “plaintiff’s right to discover information concerning his care and treatment” against the “public interest to improve the quality of care and help to ensure that inappropriate procedures, if found, are not used on future patients.” Id. at 541.
31 After the plaintiff moved to compel production of the requested
documents, the trial court reviewed the report 8 in camera and ordered
defendants to release a redacted version “in an attempt to honor the self-
critical-analysis privilege while revealing the facts of the [serious preventable
adverse event (SPAE)] to [the] plaintiff.” Id. at 234-35. The court also
analyzed the report’s contents to determine whether the plaintiff suffered
SPAE. Ibid. The court determined that the defendants had to disclose the
redacted document and report the SPAE to the DOH because the PSA required
such reporting to both regulators and the patient. Id. at 235. Further, the court
concluded that if a hospital’s decision not to report was “arbitrary and
capricious,” it loses its self-critical-analysis privilege. Ibid.
After granting the defendants leave to appeal, the Appellate Division
reversed the trial court’s order, finding (1) the entire report was absolutely
privileged under the PSA, (2) the trial court’s SPAE finding was “unsupported
by the record,” and (3) the self-critical-analysis privilege does not depend on a
court’s SPAE finding or the hospital reporting to the DOH. Id. at 236-37. The
appellate court determined that the only precondition to applying the PSA’s
self-critical-analysis privilege is whether the hospital performed the self-
8 By the time the appeal reached this Court, only one report was at issue. Brugaletta, 234 N.J. at 234 n.4. 32 critical analysis in compliance with the PSA and its implementing regulations.
Id. at 236.
After granting the plaintiff leave to appeal from the Appellate Division’s
decision, this Court first determined that “[t]he Legislature inserted no role for
a trial court to play in reviewing the SPAE determination made by a patient
safety committee,” and that courts should not become “entangle[d]” in that
“essentially administrative function.” Id. at 246. Notably, we agreed with the
appellate court that “the only precondition to application of the PSA’s
privilege is whether the hospital performed its self-critical analysis in
procedural compliance with N.J.S.A. 26:2H-12.25(b) and its implementing
regulations.” Id. at 247 (emphasis added). Interpreting N.J.S.A. 26:2H-
12.25(b) and (g)’s plain language, we concluded that “the PSA leave[s] no
reasonable doubt about the legislative intent regarding the self-critical-analysis
privilege it authorizes.” Ibid. That intent “encase[s] the entire self-critical-
analysis process in a privilege, shielding a health care facility’s deliberations
and determinations from discovery or admission into evidence.” Ibid.
In Brugaletta, we made clear that the self-critical-analysis privilege is
“broad, provided procedural compliance is present. The privilege otherwise
unconditionally protects the process of self-critical analysis, the analysis’s
results, and the resulting reports developed by a facility in its compliance with
33 the PSA.” Ibid. (emphasis added). We further held “the finding that an event
is not reportable does not abrogate the self-critical-analysis privilege” because
the privilege covers the entire decision-making process, including one that
results in finding a reportable SPAE did not occur. Id. at 248. Therefore, we
instructed that a trial “court may not order the release of documents prepared
during the process of self-critical analysis,” even if redacted. Id. at 249.
The underscored language from Brugaletta quoted above establishes
procedural compliance with the PSA’s requirements as the single metric for
evaluating a health care facility’s invocation of the PSA privilege. In the
earlier case of C.A., this Court explored in detail whether the defendant
hospital had complied with the procedures prescribed by the PSA at the
relevant time. See 219 N.J. at 468-70. Finding that the hospital complied with
the relevant statutes and regulations in place at the time, we concluded that the
requested discovery was privileged. Id. at 470-72. Compliance with the then-
current PSA requirements set forth in the statute itself and its implementing
regulations was our sole focus in determining whether the PSA privilege
applied. See id. at 468-72.
34 V.
Guided by those legal principles, we hold that defendants did not comply
with the PSA’s procedural scheme and therefore the disputed documents in
these consolidated appeals are not privileged under that statute.
To be clear, as we stated in Brugaletta, the only precondition to applying
“the PSA’s privilege is whether the hospital performed its self-critical analysis
in procedural compliance with N.J.S.A. 26:2H-12.25(b) and its implementing
regulations.” 234 N.J. at 247. And one of the PSA’s implementing regulations
expressly provides that the patient safety committee “shall not constitute a
subcommittee of any other committee within a facility or health care system.”
N.J.A.C. 8:43E-10.4(c)(4) (emphasis added); see C.A., 219 N.J. at 462 (“The
regulation mandates that the patient safety committee . . . act independently of
Here, defendants’ certifications demonstrate that the evaluative
processes within their facilities did not adhere to the PSA’s procedural scheme.
In Keyworth, CareOne’s certification asserted that the facility’s QAAC created
the incident reports and associated documents “for the sole purpose” of
complying with the PSA and 42 C.F.R. § 483.75, which governs federal QAPI
plans. Further, CareOne’s QAAC chairperson attested that the facility’s
“QAPI plan comports with the requirements of N.J.S.A. 26:2H-12.25(b),”
35 because, among other things, CareOne has a QAAC, “which performs the
functions of a Resident Safety Committee.”
Similarly, in Bender’s matter, Harmony Village presented a nearly
identical certification from the facility’s QAPI committee chairperson,
avowing that the facility’s “QAPI plan comports with the requirements of
N.J.S.A. 26:2H-12.25(b),” and that the QAPI committee “performs the
functions of a Resident Safety Committee” under the PSA. The certification
added that the facility’s QAPI committee generated the June 9 incident report
“for the sole purpose of compliance with the requirements of N.J.A.C. 8:36-21
et seq. and the PSA,” affirming that “[a]t all relevant times, Care One
Harmony Village at Paramus had in place a QAPI Plan as required by N.J.S.A.
26:2H-12.25(b).”
N.J.A.C. 8:43E-10.4(c)(4), however, explicitly requires a health care
facility’s patient safety committee to operate independently from any other
committee within the facility. See C.A., 219 N.J. at 462. Therefore,
defendants’ own admissions that they treated their committees related to
quality assurance and improvement as patient safety committees to comply
with both the requirements of the PSA and their QAPI obligations shows that
they did not follow “the only precondition to application of the PSA’s
privilege.” Brugaletta, 234 N.J. at 247.
36 In addition, the PSA expressly provides that it “shall not be construed to
eliminate or lessen a [health care facility’s] obligation under current law or
regulation to have a continuous quality improvement program.” N.J.S.A.
26:2H-12.25(b). Here, the defendants’ certifications admit that they undertook
their investigations pursuant to federal laws governing QAAC and QAPI plans.
They were not undertaken “exclusively during the process of self-critical
analysis in accordance with N.J.A.C. 8:43E-10.4, 10.5 or 10.6.” N.J.A.C.
8:43E-10.9(b) (emphasis added).
Accordingly, we conclude that the incident reports and associated
documents at issue are not privileged and thus subject to discovery. 9
VI.
Although we resolve this matter on the basis of defendants’ procedural
non-compliance, we recognize the important competing interests involved
between patients and their right to know what occurred, and health care
9 We decline to overlook defendants’ non-compliance with the PSA on the ground that it was first asserted by NJAJ as amicus. We find that the interests of fairness dictate that defendants not be accorded a privilege without satisfying the requirements for that privilege. See, e.g., State Farm Mut. Auto. Ins. Co. v. Zurich Am. Ins. Co., 62 N.J. 155, 165 (1973) (assessing a second insurance policy when the petition for certification challenged only a judgment as to a different policy “in the interests of a fair resolution of the entire controversy”); see also R. 2:12-11 (providing that, upon a grant of certification, “the petitioner’s entire case shall be before the Supreme Court for review unless the Supreme Court otherwise orders”). 37 facilities and their interest in ensuring effective self-critical analysis to
promote optimal patient-safety practices. See Jenkins v. Rainner, 69 N.J. 50,
56 (1976) (“Our court system has long been committed to the view that
essential justice is better achieved when there has been full disclosure so that
the parties are conversant with all the available facts.”); Hearing on S. 557
(statement of Clifton R. Lacy, MD) (testifying that the PSA “strikes the right
balance between acknowledging and learning from errors, and also holding
people accountable. It shields self-critical analysis from discovery, but
maintains discoverable all that is now discoverable”).
Defense counsel suggested at oral argument that documents and
information are privileged under the PSA when the health care facility self-
declares that the sought-after information was part of the facility’s self-critical
analysis process, but counsel was unable to explain when the PSA process
begins and who makes that determination. The PSA’s plain language,
however, makes clear that it cannot be used as a shield to shut out all possible
discovery. Indeed, we do not deal here with a case in which a health care
facility sought to shut down all avenues of discovery by implementing the self-
critical-analysis process within moments of an adverse event. The PSA
acknowledges it will unlikely be the case that everything is privileged, which
is consistent with the competing interests involved. See Brugaletta, 234 N.J. at
38 244-45 (“The Legislature’s express acknowledgment of [Christy], as well as its
nod to documents obtained through sources other than the PSA’s process of
self-critical analysis, leaves no doubt of [the Legislature’s] respect for the
importance of discovery in ensuring the fair resolution of litigation brought
before courts.”); see also N.J.S.A. 26:2H-12.25(h) (“[I]f obtained from any
source or context other than those specified in [the PSA],” the law preserves
the discoverability of material that “may have been considered in the process
of self-critical analysis.”).
VII.
For the foregoing reasons, we reverse the judgment of the Appellate
Division and remand both matters to the trial court for further proceedings
consistent with this opinion.
CHIEF JUSTICE RABNER and JUSTICES PATTERSON, SOLOMON, WAINER APTER, FASCIALE, and NORIEGA join in JUSTICE PIERRE- LOUIS’s opinion.
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Cite This Page — Counsel Stack
Madeline Keyworth v. CareOne at Madison Avenue Suzanne Bender v. Harmony Village at CareOne Paramus, Counsel Stack Legal Research, https://law.counselstack.com/opinion/madeline-keyworth-v-careone-at-madison-avenue-suzanne-bender-v-harmony-nj-2024.