IN THE SUPREME COURT OF THE STATE OF RHODE ISLANDAND PROVIDENCE PLANTATIONS

KATHERINE CARRON and RYAN CARRON, Individually and as Co-Administrators of the ESTATE OF KENNETH H. CARRON

Plaintiffs- Appellees

v.

RANDALL ROSENTHAL, M.D.; NEWPORT OB-GYN ASSOCIATES, LTD. AND NEWPORT HOSPITAL

Defendants- Appellant

No. SU2015-0212 (C.A. No. NC2013-0479)

PETITIONER NEWPORT HOSPITAL’S BRIEF IN SUPPORT OF ITS REQUEST FOR THE ISSUANCE FOR A WRIT OF CERTIORARI TO THE

NEWPORT COUNTY SUPERIOR COURT

Petitioner,NEWPORT HOSPITALBy Its Attorneys,

Jason C. Preciphs (#6727)ROBERTS, CARROLL, FELDSTEIN & PEIRCE10 Weybosset Street, 8th FloorProvidence, RI 02903-2808(401) 521-7000 (FAX) (401) 521-1328jpreciphs@rcfp.com

TABLE OF CONTENTS

Table of Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-iii

Questions Presented . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Statement of the Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17

Specification of Error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Standard of Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17-18

Argument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18- 49

I. The Superior Court erred in ordering the production of two Newport Hospital reports which qualify as privileged Patient Safety Work Product under the federal Patient Safety and Quality Improvement Act of 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . .18-38

a. The Patient Safety And Quality Improvement Act of 2005 and the federal privilege for Patient Safety Work Product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-20

b. The Privilege for Patient Safety Work Product under PSQIA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-23

c. Limitations on the definition of Patient Safety Work Product and the Patient Safety Work Product Privilege under the PSQIA. . . . . . . . . . . . . . . . . . . . . . . . . . 23-29

d. The MERS Reports are “Patient Safety Work Product” under the PSQIA and, accordingly, not subject to discovery in connection with a state civil proceeding. . . . . . . . . . . . 29-30

e. The MERS Reports are NOT Mandated By State Law or otherwise excluded from qualification as “Patient Safety Work Product” under the PSQIA. . . . . . . . . . . . .31-36

f. The Superior Court Committed an Error of Law in Ordering Production of Newport Hospital’s MERS Reports and Erred in Failing to Analyze Newport Hospital’s Assertion of Privilege. . . . . . . . . . . . . . . . . . . . .36-38

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II. The Superior Court Committed an Error of Law in Ordering Production of Newport Hospital’s MERS Reports and Erred in Failing to Analyze Newport Hospital’s Assertion of Privilege under the Rhode Island Patient Safety Act of 2008.. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38-49

a. Background: The Rhode Island Patient Safety Actof 2008. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 38-41.

1. RIPSA’s Broader Definition of “Patient SafetyWork Product” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 41-42

2. RIPSA’s Broader Definition of “Patient Safety Work Product” reflects the General Assembly’s legislative intent that RIPSA capture each Patient Safety Event. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43-45

3. In this case, the MERS Reports are “Patient Safety Work Product” under RIPSA and, accordinglyare not “subject to discovery in connection with a federal, state, or local civil, criminal, or administrative proceeding.” . . . . . . . . . . . . . . . . . . . . . . . . 45-47

4.. The Department of Health’s PSO Regulations do not constrain RIPSA’s definition of “patient safety work product” and the DHHS Guidance for the PSQIA has no application under RIPSA. . . . . . . . . . . . . . . . . 47-48

b. The Superior Court committed reversible error in ordering the production of the MERS Reports in contravention of RIPSA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48-49

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

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TABLE OF AUTHORITIES

CASES

State v. Ahmadjian, 438 A.2d 1070, 1081 (R.I. 1981)…………………………………………. 43Baptist Health Richmond, Inc. v. Clouse, 497 S.W.3d 759, 766 (Ky. 2016)…………………... 27Brennan v. Kirby, 529 A.2d 633, 637 (R.I. 1987)……………………………………………… 38Brown v. State, 841 A.2d 1116, 1121 (R.I. 2004)……………………………………………… 17 Bruglaletta v. Garcia, 2017 WL 476219 (N.J. App. Div., Feb. 6, 2017)………………………. 46Caminetti v. United States, 242 U.S. 470, 485, 37 S.Ct. 192, 61 L.Ed. 442 (1917)……………..30Chambers v. Ormiston, 935 A.2d 956, 959–60 (R.I. 2007)………………………………… 40, 41Charles v Southern Baptist of Florida Inc., No. SC15-2180, 2017 WL 411333 (Fla. Jan. 31, 2017)……………………………………………………………………………... 27Curtis v. State, 996 A.2d 601, 604 (R.I. 2010)…………………………………………………. 41In re Denisewich, 643 A.2d 1194, 1197 (R.I. 1994)……………………………………………..41Dept. of Financial and Professional Regulation v. Walgreen Company, 970 N.E.2d 552 (Ill.App.2012)……………………………………………………………………………27, 28, 29State v. DiCicco, 707 A.2d 251, 253 (R.I. 1998)………………………………………………...41In re Estate of Gervais, 770 A.2d 877, 880 (R.I. 2001)………………………………………… 40Gooden v. CVS Caremark Corp., No. 11CVA-10885 (Ct. Com. Pl., Franklin Co., Ohio, Nov. 20, 2012)…………………………………………………………………………… 27State v. Greenberg, 951 A.2d 481, 489 (R.I. 2008)…………………………………………….. 17 Herbert v. Lando, 441 U.S. 153, 175, 99 S. Ct. 1635, 1648, 60 L. Ed. 2d 115 (1979)……….... 36Horn v. S. Union Co., 927 A.2d 292, 300 (R.I. 2007).…………………………………………. 42Howard v. Lyons, 360 U.S. 593, 597, 79 S. Ct. 1331, 1334, 3 L. Ed. 2d 1454 (1959)………… 29KD ex. rel. Dieffenbach v. United States, 715 F.Supp.2d 587, 595 (D.Del. 2010)…………….. 21Klein v. Republic Steel Corp., 435 F.2d 762, 765–66 (3rd Cir. 1970)………………………….. 42Kelly v. Marcantonio, 678 A.2d 873, 876 (R.I. 1996)………………………………………….. 49Local 400, International Federation of Technical and Professional Engineers v. Rhode Island State Labor Relations Board, 747 A.2d 1002, 1005 (R.I. 2000)………………….43 Moretti v. Lowe, 592 A.2d 855, 857 (R.I. 1991)…………………………………………………47Narragansett Food Services, Inc. v. Rhode Island Department of Labor, 420 A.2d 805, 808 (R.I. 1980)…………………………………………………………………...44State v. O’Brien, 774 A.2d 89, 96 (R.I. 2001)…………………………………………………...42Park’N Fly, Inc. v. Dollar Park & Fly, Inc., 469 U.S. 189, 194 (1985)…………………………30Pastore v. Samson, 900 A.2d 1067 (R.I. 2006)………………………………………………….47Pierce v. Providence Retirement Board, 15 A.3d 957, 961 (R.I. 2011)…………………………17State v. Poulin, 66 A.3d 419, 423 (R.I. 2013)……………………………………………………17Providence Journal Co. v. Rodgers, 711 A.2d 1131, 1134 (R.I. 1998)……………………..44, 49Ret. Bd. of Employees’ Ret. Sys. of State v. DiPrete, 845 A.2d 270, 287 (R.I. 2004)……….43, 44Rhode Island Department of Mental Health, Retardation, and Hospitals v. R.B., 549 A.2d 1028, 1030 (R.I. 1988)……………………………………….. 43State v. Santos, 870 A.2d 1029, 1032 (R.I. 2005)………………………………………………..41Shelter Harbor Fire Dist. v. Vacca, 835 A.2d 446, 449 (R.I. 2003)…………………………….44 Simeone v. Charron, 762 A.2d 442, 446 (R.I. 2000)…………………………………………….44

iv

Smith v. Retirement Board of the Employees’ Retirement System, 656 A.2d 186, 189 (R.I. 1995)…………………………………………………………………...44 State v. Smyth, R.I., 397 A.2d 497 (1979)……………………………………………………….43Swidler & Berlin v. United States, 524 U.S. 399, 412, 118 S. Ct. 2081, 2088, 141 L. Ed. 2d 379 (1998)………………………………………………………………….37Taylor v. Hy-Vee, Inc., 2016 WL 7405669 (D. Kan. 2016)………………………………….27, 29Tibbs v. Bunnell, 448 S.W.3d 769 (Ky. 2014) cert. denied 136 S.Ct. 2504, U.S. (2016)……25-26Tinal v. Norton Healthcare, Inc., No. 3:11-CV-596-S (W.D. Ky. 2014)………………………..20Trammel v. United States, 445 U.S. 40, 50, 100 S.Ct. 906, 63 L.Ed.2d 186 (1980)…………….47Univ. Med. Ctr., Inc. v. Beglin, 375 S.W.3d 783, 787 (Ky. 2011)………………………………26

STATUTES

42 U.S.C. § 299b-21……………………………………………………………………………. 2242 U.S.C. § 299b-21(8)………………………………………………………………………… 2242 U.S.C. § 299b-21(5) ………………………………………………………………………… 2342 U.S.C. 299b-21(7)(A) ……………………………………………………………………20, 2342 U.S.C. 299b-21(7)(B) ……………………………………………………………………20, 2342 U.S.C. § 299b-22…………………………………………………………………………… 2142 U.S.C. § 299b-22(f)(1) ……………………………………………………………………… 23R.I. Gen. Laws §23-17-40………………………………………………………………………. 32R.I. Gen. Laws §23-17-40(i) ……………………………………………………………… 35, 48R.I. Gen. Laws §23-17.21-2……………………………………………………………...39, 43, 44R.I. Gen. Laws §§23-17.21-3. ……………………………………………………………… 44R.I. Gen. Laws §23-17.21-4(e). …………………………………………………………… 44, 45R.I. Gen. Laws §23-17.21-4(f). ………………………………………………………………… 39R.I. Gen. Laws §23-17.21-4(h) ………………………………………………………… 39, 41, 42R.I. Gen. Laws §23-17.21-4(h)(2) …………………………………………………………… 42 R.I. Gen. Laws § 23-17.21-8(a) …………………………………………………………… 40, 45

REGULATIONS

42 C.F.R. §3.20………………………………………………………………………20, 23, 30, 4142 C.F.R. §3.204(a)(2) ………………………………………………………………………22, 3073 Fed. Reg. 81132 (November 21, 2008) ………………………………………………… 19-2073 Fed. Reg. 8113 (November 21, 2008) ……………………………………………… 19-20, 2973 Fed. Reg. 70732 (November 21, 2008) ………………………………………………………2073 Fed. Reg. 70739 (November 21, 2008) ………………………………………………… 23, 2473 Fed. Reg. 70741 (November 21, 2008) …………………………………………………… 2081 Fed. Reg. 32657 (May 24, 2016) …………………………………………………………… 24R23-17-HOSP § 1.5…………………………………………………………………………31 - 32R23-17-HOSP § 34.3…………………………………………………………………………… 36R. 23-17-HOSP §34.6………………………………………………………………………..31, 33R23-17.21-PSO………………………………………………………………………………35, 47R23-17.21-PSO §3.1(b)………………………………………………………………………… 48R23-17.21-PSO §1.16……………………………………………………………………………48

v

902 KAR 20:016 § 3(3)(a)……………………………………………………………………… 26LEGISLATIVE MATERIALS

H.R. Rep. No. 109-197, 14 (2005)…………………………………………………………… 24S.Rep. No. 108-196 (2003)………………………………………………………………...20, 21

OTHER AUTHORITIESBarrett, Britta, at al., GE Listed as National Patient Safety Organization by HHS, AHRQ, ME News Wire, February 13, 2011………………………………………………9Dooley, Joanne, RN, et al., Event Reporting: How Rhode Island is Leading a Revolution in Patient Safety. Patient Safety & Quality Healthcare, January/February 2011…………………………………………………………………………..9Institute of Medicine: “To Err is Human: Building a Safer Health System,” Nat’l Acad. Press, 1999……………………………………………………………………..18-19Ross, Julie R., PSO Transforms Smallest State Into Patient Safety Giant. Health Exec, July 05, 2011………………………………………………………………………9

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QUESTIONS PRESENTED

I. Did not the Superior Court err in ordering the production of two Newport Hospital

reports which qualify as privileged Patient Safety Work Product under the federal Patient Safety

and Quality Improvement Act of 2005 because they: (a) were authored to improve patient safety;

(b) were assembled by Newport Hospital for reporting to its Patient Safety Organization; (c)

were reported to the Hospital’s Patient Safety Organization; (d) were not “a patient’s medical

record, billing and discharge information, or any other original patient or provider record”; (e)

were not generated for another purpose; (f) were not “information that is collected, maintained or

developed separately, or existing separately from a patient safety evaluation system”; and (f) no

statutory exceptions from the federal privilege for Patient Safety Work Product exist?

II. Does not the privilege for “patient safety work product” set forth in the Rhode Island

Patient Safety Act of 2008 prohibit a party’s discovery in a civil action of two privileged reports

that a health care facility/provider: (a) prepared for the purpose of disclosing a patient safety

event; (b) disclosed to a patient safety organization; or (c) were received by a Rhode Island

patient safety organization.

STATEMENT OF THE FACTS AND THE PRIOR PROCEEDINGS

a. Summary of the Case

In this civil action, Respondents-Plaintiffs, (“The Carrons”), contend that obstetrical

medical negligence occurred in relation to the labor, emergency delivery and tragic death of

Baby Boy Kenneth Carron at 7 days of life. On June 22, 2013, Katherine Carron was admitted at

8:00 a.m. to Petitioner-Defendant Newport Hospital for a scheduled induction of her labor. Dr.

Randall Rosenthal, an employee of Newport Hospital, was the admitting obstetrician.

Mrs. Carron’s labor progressed during the day while on Pitocin, an agent to progress

labor. At 7:52 p.m., Dr. Rosenthal artificially ruptured Mrs. Carron’s membranes in an effort to

augment the labor process. Dr. Rosenthal subsequently departed and Mrs. Carron remained in in

the care of a supervised clinical team that included Colleen Savage, RN, an employee of

Newport Hospital who monitored Mrs. Carron’s labor. Mrs. Carron continued to experience

some vaginal bleeding over the next hour. Plfs’ Mot. to Compel, pp. 1-2; App. 6, pp. 61-63.

The fetal heart monitor was removed at 8:56 p.m. and Nurse Savage assisted Mrs. Carron

out of bed so that she could go into the bathroom. It has been asserted that, after walking a few

steps, blood splattered onto the floor and that additional blood and blood clots fell to the floor

and into the toilet. Nurse Savage assisted Mrs. Carron back into her bed and re-attached the fetal

heart monitor at approximately 9:04 p.m. No fetal heartbeat could be detected. Id.

The Charge Nurse, Sharon Ryan, RN, was summoned to the patient’s bedside and Dr.

Rosenthal was contacted. (Ryan Dep. at 30-33; App. 1, pp. 12-15; Savage Dep at. 175-76; App.

2, pp. 29-30.) Nurse Ryan also spoke briefly, for a period of seconds, with Dr. Rosenthal to

report the absence of fetal heartbeat and her action plan to open the operating room for a C-

Section. Required personnel were contacted and Nurse Ryan opened the operating room and

waited there until she was relieved by an OR staff member prior to Cesarean Section. Assisted

by another nurse, she moved on to set up the nursery for resuscitation. (Ryan Dep. at 68; App. 1,

p. 16.)

Dr. Rosenthal arrived from off site and Cesarean section occurred with Nurse Savage

present, along with an OR team involving approximately four other nurses, an anesthesiologist

and a pediatrician. (Savage Dep. at 110-12; 117; App. 2, pp. 20-22.) After his birth the infant

was brought to the nursery; Nurse Ryan later assisted there in pediatric code activities. (Ryan

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Dep at 70; App. 1, p. 17.) Following resuscitation and a blood transfusion, Baby Boy Carron

was transferred to Women & Infants Hospital for further treatment and care. At 10:44 pm on

June 22, 2013, Dr. Rosenthal notified the Hospital’s Risk Manager of the events. (Chandler Aff.

at ¶ 9; App. 3, p. 33.)

b. Factual Background of the Events Relating to the Petition

By protocol, Newport Hospital utilizes a patient safety evaluation system to collect

information regarding any issue that may be a “Patient Safety Event”, as defined by federal

and/or state law. This is done to further Newport Hospital’s efforts to improve patient safety and

the quality of health care delivered to its patients by collecting information regarding each and

every Patient Safety Event for evaluation, the conduct of patient safety activities and submission

to the Hospital’s certified Patient Safety Organization. (Chandler Aff. at ¶3; App. 3, p. 32.)

In 2013 Newport Hospital utilized a Patient Safety Evaluation System known as “MERS”

(Medical Event Reporting System), to compile and store information regarding Patient Safety

Events, as they are defined under state and federal law, as part of the Hospital’s voluntary

participation with the GE-MERS National Patient Safety Organization, a Patient Safety

Organization (“PSO”) that, in 2013, was both federally certified and certified by the Rhode

Island Department of Health as GE-Rhode Island PSO. (Chandler Aff. at ¶2; App. 3, p. 32.)

Each MERS Report is evaluated by the Hospital’s Risk Manager, acting in her capacity

as a member of the institution’s Patient Safety Committee. If, upon review, it is determined that

the report relates to a Patient Safety Event, as defined by law, the report is submitted to the

Hospital’s Patient Safety Organization. (Chandler Aff. at ¶¶4, 5; App. 3, pp. 32-33.)

In this instance, Nurse Colleen Savage authored a MERS Report at 6:23 am. on June 23,

2013. Nurse Sharon Ryan also authored a MERS Report at 8:24 am. on June 23, 2013. Both

3

MERS Reports were submitted to the Hospital’s PSO as part of the Hospital’s routine practice

whereby all reports relating to every Patient Safety Event are submitted to the PSO. (Chandler

Aff. at ¶¶5, 6; App. 3, p. 33.)

Additionally, the Hospital is required to notify the Department of Health regarding every

“reportable incident”, defined by General Laws §23-17-40 to include any event where a “birth

injury” occurs. In recognition that patient safety work product cannot be used to comply with

state reporting obligations, Newport Hospital has, from the inception of its patient safety

program, utilized independent sources of information to gather the information required to

submit the Rhode Island Department of Health Hospital Incident Reporting Form. (Aff. C.

Chandler, ¶7; App. 3, p. 33.)

Specifically, Newport Hospital’s policy is to conduct an independent and separate

investigation to gather all information that is required to comply with state reporting protocols.

Id. Accordingly, at Newport Hospital, any legally required reporting is accomplished using an

investigation and sources of information that are separate and independent from information

contained in the Hospital’s Patient Safety Evaluation System, MERS. Id.

Newport Hospital’s Administrative Manual, Section 1386, states that the Hospital’s

mandatory state law reporting requirement is separate from the information gathering pathway

for the collection of information regarding incidents reportable to external agencies.

Specifically, Newport Hospital’s policy states, “Reporting through MERS does not replace the

manager’s requirement to notify Risk Management of events and incidents reportable to the

Department of Health (DOH) or other external agencies as delineated in Administrative Manual

Policy #1385.” App. 13, p. 159. The Hospital’s Administrative Manual Policy #1385, “Event

Reporting, Management and Analysis Policy”, provides, “Any unexpected patient safety event

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that may constitute a serious problem or serious harm to a patient must be reported immediately

to the appropriate department Director or Administrative Coordinator who will immediately call

the Risk Manager and the responsible Vice President or Administrator on Call.” Administrative

Manual Policy #1386 at p. 5; App. 13, p. 158.

In this instance, Dr. Rosenthal contacted Newport Hospital’s Risk Manager, Ms.

Cheryl Chandler, at 10:44 pm on the evening of June 22, 2013, informing her “of the

existence of the event in question, as well as [of] certain details and [the identities of] other

individuals who had involvement in the case.” (Chandler Aff. at ¶ 9a; App. 3, p. 33.)

Because the birth injury triggered an obligation to report the incident to the Department

of Health, Ms. Chandler then completed her investigative work to complete the Rhode Island

Department of Health Hospital Incident Reporting Form, which form requires: (1) the patient’s

medical record number; (2) the patient’s gender; (3) the patient’s admission date; (4) a checkbox

indication for the type of incident (e.g., birth injury); and (5) a “brief description of incident”.

App. 5, p. 60. Ms. Chandler spoke with Nurse Ryan on Monday morning, June 24, 2013, at or

around 7:30 am. (Chandler Aff. at ¶9b; App. 3, p. 33) Next, Ms. Chandler spoke with Nurse

Savage by telephone the same afternoon, around 12:30 pm. Id. Finally, Ms. Chandler completed

her investigation to gather information required to report the incident to the Department of

Health with a review of the medical record. Id. Each step required to gather information for

reporting to the Department of Health was completed before Ms. Chandler reviewed either

Nurse’s MERS Report. (Chandler Aff. at ¶10; App. 3, p. 33.) Finally, Ms. Chandler submitted

the Rhode Island Department of Health Hospital Incident Reporting Form to the Department of

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Health identifying the birth injury at issue in conformity with General Laws 23-17-40(e) within

the requisite seventy-two (72) hours on June 25, 2013.1

The incident involving Baby Carron, separate and apart from its status as a reportable

incident to the Department of Health, triggered an obligation for Newport Hospital to conduct

patient safety activities in conformity with its Patient Safety Policy and Program. Ms. Chandler,

as a member of the Patient Safety Committee, was a designated recipient of all MERS Reports

and it was her duty to review each Patient Safety Event report as the first step in the process of

Newport Hospital’s Patient Safety Policy and Program. (Chandler Aff. at ¶¶ 11, 12; App 3, pp.

33-34.)

Specifically, here, after gathering the necessary information for reporting to the

Department of Health, Ms. Chandler accessed the MERS Report authored by Nurse Savage at

4:46 pm. on June 24, 2013. (Chandler Aff. at ¶ 13; App. 3, p. 34.) She accessed the MERS

Report authored by Nurse Ryan one minute later at 4:47 pm. Id.

All reports of a Patient Safety Event are submitted to the PSO following the conclusion

of the Patient Safety Activities that relate to the associated Patient Safety Event. (Chandler Aff.

at ¶15; App. 3, p. 34.) The Hospital does not edit, alter or change the content of the information

in its Patient Safety Evaluation System. Reports relating to a Patient Safety Event are submitted

in their entirety, as existing in the system, to the PSO. (Chandler Aff. at ¶16; App. 3, p. 34.)

Here, Ms. Chandler submitted Nurse Savage’s MERS Report to the PSO on September 15, 2013,

1 See Defendant Newport Hospital’s Privilege Log, cited at page 4 of Plaintiffs’ Motion to Compel (App. 8, p. 100), particularizing:

DATE AUTHOR TITLE RECIPIENT PRIVILEGE6/25/13 Cheryl

Chandler, Risk Manager

Hospital IncidentReporting Form

Rhode Island Department of Health

R.I.G.L. §23-17-40

6

at 7:47 am., and Nurse Ryan’s report three minutes later at 7:50 am. (Chandler Aff. at ¶¶ 17-18;

App. 3, p. 34.)

Meanwhile, the peer review process mandated by General Laws §23-17-40(e) occurred.2

This culminated with Ms. Chandler’s authorship and submission of the Department of Health’s

Follow-Up Report for Incidents on October 18, 2013, which document reports the outcome of

the Hospital’s internal peer review. 3

Tragically, the baby sustained permanent irreversible brain damage; life support was

terminated on June 29, 2013 at 7 days of life. Subsequently, the Carrons instituted the present

lawsuit.

c. Newport Hospital’s Patient Safety Organization and its Patient Safety Evaluation System, “MERS”

Information regarding the Medical Event Reporting System and its role as the statewide

“safe-harbor” PSO reporting system is summarized in a number of published articles. In Rhode

Island, all thirteen (13) private hospitals began working with a PSO sponsored by GE Healthcare.

Subsequently, the United States Secretary of Health and Human Services (HHS) listed the GE-

MERS National Patient Safety Organization (“GE PSO”) as part of the Agency for Healthcare

2 In relevant part, General Laws 23-17-40 provides that where a reportable incident occurs:

The hospital shall require the appropriate committee within the hospital to carry out a peer-review process to determine whether the incident was within the normal range of outcomes, given the patient's condition. The hospital shall notify the department of the outcome of the internal review …. R.I. Gen. Laws 23-17-40(e).

3 See Defendant Newport Hospital’s Privilege Log, cited at page 4 of Plaintiffs’ Motion to Compel (App. 8, p. 100), listing:

DATE AUTHOR TITLE RECIPIENT PRIVILEGE10/18/13 Cheryl

Chandler, Risk Manager

Follow-Up Report for Incidents

Rhode IslandDepartment of Health

R.I.G.L. §23-17-40

7

Research and Quality’s (“AHRQ”) Patient Safety Organization program and the GE-MERS

National Patient Safety Organization joined a list of 80 federally certified PSOs.

The GE PSO had 16 founding members, 13 of which were hospitals in Rhode Island,

making Rhode Island the only state in which all the hospitals were working with and sending

their data to one PSO. As one author described the state’s groundbreaking PSO system:

Rhode Island has played a leadership role in a number of revolutions throughout history…. Today, Rhode Island continues that trailblazing tradition by leading efforts in another critical area: patient safety. Thanks to a statewide initiative to standardize the reporting and analysis of both adverse and near-miss medical events, Rhode Island will unite its private acute care hospitals—technologically and culturally—in a common effort to reduce medical errors.* * *Implementation of the standardized reporting tool is well underway, with hospitals reporting a significant increase in reported events, including near-miss events that did not result in injury or patient harm but had the potential to do so (no-harm events)…

A critical component in achieving transparency on a statewide scale was to have all hospitals implement the same medical event-reporting technology and standardize their reporting criteria….. [Prior to standardization] the hospitals used a variety of manual and electronic methods to track events.Having a standardized reporting platform was important for another reason.  Rhode Island was in the process of creating a state-certified patient safety organization (PSO).  A PSO is a protected central repository that enables healthcare providers to report data on adverse and near-miss events without fear of discovery.  This “safe harbor” environment encourages the sharing of information within the PSO so institutions can uncover and correct the systemic factors that undermine patient safety.  In order for the PSO to be effective, a standardized event-reporting system that could be used by all hospitals to populate the repository was needed. 

The executive steering committee assessed a number of vendors and associated event-reporting systems and selected the Medical Event Reporting System (MERS) from GE Healthcare. This web-based system met three key criteria: it is easy to use so hospital personnel would be more likely to enter and analyze data, improving compliance based on a variety of criteria, its routing function sends reports immediately and automatically to managers and administrators, improving accountability and speed of follow-up; and its color-coded, real-time dashboard gives managers clear visibility into the status of each event inquiry, improving communication.

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* * *The first hurdle for the statewide steering committee was to gain consensus on standardization of the inputs to MERS and definitions of patient safety terms. Successful implementation of the MERS technology depended on getting all of the hospitals to agree on hundreds of standardized definitions for event-reporting categories, from pharmacy services and medication safety to falls, infection control, and general patient care events.

Dooley, Joanne, RN, et al., Event Reporting: How Rhode Island is Leading a Revolution in

Patient Safety. Patient Safety & Quality Healthcare, January/February 2011 (emphasis added).

See also Ross, Julie R., PSO Transforms Smallest State Into Patient Safety Giant. Health Exec,

July 05, 2011 (“[A]ll 13 of Rhode Island’s private hospitals [entered] in the GE-MERS National

Patient Safety Organization (PSO) sponsored by GE Healthcare. The “MERS” stands for

“medical event reporting system,” GE Healthcare’s technology tool, which the hospitals are

using to report and send event and related data to the PSO.”).

Ultimately, information submitted to the Hospital’s PSO is compiled, analyzed and

utilized to make practical improvements in the quality of health care delivered to patients in

Rhode Island and across the nation.4 As Rhode Island’s Director of the Department of Health

was quoted regarding the Hospital’s PSO:

“We are pleased that the GE PSO has earned this designation,” said Director of Health, Rhode Island, David R. Gifford, MD, MPH. “As one of the founding members of the GE PSO, Rhode Island hospitals have shown tireless dedication to patient safety and quality improvement. This designation will allow our hospitals to collect information, while continuously reviewing and evaluating policies and standards, and as a result, improve patient care in the state.”5

4 Newport Hospital, along with its partners and affiliate hospitals of Lifespan, all of which support the within Petition, Bradley Hospital, Rhode Island Hospital, The Miriam Hospital and Hasbro Children’s Hospital, make numerous reports of patient safety events to a PSO and have effectively utilized PSO analysis and reports to improve patient safety care and avoid medical errors.

5 Barrett, Britta, at al., GE Listed as National Patient Safety Organization by HHS, AHRQ, ME News Wire, February 13, 2011.

9

d. The MERS Reports at Issue

At issue in this dispute are two documents: (1) the MERS Report authored by Nurse

Sharon Ryan at 8:24 am. on June 23, 2013; and (2) the MERS Report authored by Nurse Colleen

Savage at 6:23 am. on June 23, 2013. The MERS Reports pertaining to the birth of Baby Carron

were described by way of a privilege log in response to Respondents’ Fifth Request for

Production of Documents.

Respondents conducted the depositions of the two authors, Nurse Sharon Ryan and

Colleen Savage, RN (collectively, the “Nurses”). The Nurses gave extensive testimony

regarding the events and circumstances surrounding Baby Carron’s birth and his mother’s labor.

The Nurses were questioned regarding their MERS Reports and each author provided testimony

that explains why the MERS Reports are patient safety work product.

First, on October 17, 2014, the following testimony was elicited from Nurse Savage:

Q. We have received information through discovery that you prepared what is called an event registration report; have you ever heard of such a report?

A. Yes.Q. Tell me what an event registration report is?A. It is something – if any event occurred that is harmful to a patient, it is a

report we do.***Q. Did someone ask you to prepare that report?A. It is generally the nurse who is caring for the patient’s responsibility to

generate the report, but in that case, I don’t recall if I did, or Sharon did, or another nurse did it.

***Q. Can you tell me, generally tell me, what you understand is in such a

report?A. It usually asks what were the events that led up to whatever happened,

describe the event. What else? Ways that we could have prevented the event from happening again in the future. A checklist, has the family been notified, has the nursing supervisor been notified, the chain of command. Things like that.

Q. Is it like a preprinted form, and you just fill in the answers to the already-printed questions?

10

A. Yes.Q. And do you do this, is it a paper report, or is it on-line?A. It is on-line.Q. Have you prepared such reports before – A. Yes.Q. -- this event?A. Yes.Q. How often, how many times have you filled out such reports?A. Often. We have to fill them for any – if a lightbulb is out.Ms. Boisclair: I am sorry, I didn’t hear you.A. We have to do them even if a lightbulb is out, so I have done – it is a

common report.Q. So it details with all issues, not just –A. Patient safety.Q. -- not just – Mr. Wakeman: You have to wait until she is finished.The Witness: Thanks for reminding me.Q. So this report , as you understand it, has just to do with patient safety, as

you view it at the hospital; yes ? A. That’s always the way I do the report.Q. It can range from anything to there is a lightbulb out in Room 12 to

medical care issues with a patient, yes?A. Yes.Q. And do you get a feedback, do you get anything back after you file such a

report?A. I get a confirmation E-mail that the risk manager accepted it.Q. Does it always go to risk management?A. Yes. That’s my understanding.Q. Is there anywhere you can go as to what type of events need to be reported

in the event registration reporting system?A. There is a checkoff list, and it will say describe the nature of your incident,

was it environmental, did somebody fall, was it a visitor, a patient. There is a checklist.

Q. And you understand that this is part of your nursing duties to fill out this, the event registration report, when you deem the event falls within one of the checkoff lists; yes?

A. Yes.***Q. The specific reason you file such a report in this case was why?A. In an event like this, I would normally constitute that as a complication of

care.Q. And so it is not my definition of an event like this, tell me what about an

event like this, how do you describe it?The Witness: How do I normally describe?Ms. Boisclair: Yes.

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A. I would type down the events, as I remember them, how they occurred in a concise manner to give the risk manager an idea of what happened.

(Savage Dep. at 118-22; App. 2, pp. 24-28.)(emphasis added).* * *Q. When you filled out the registration reporting form, did you review the

chart before doing that?A. No.Q. When you filled out the registration report, is that based on your memory,

of just your memory of what had occurred during the labor and delivery?A. That's what I usually do. I just go by my memory.(Savage Dep. at 189; App 2, p. 31.)

Thereafter, Nurse Ryan testified at deposition on November 10, 2014, as follows:

Q. Now, I understand that you completed an event registration report following the delivery of Baby Boy Carron?

A. I don’t recall, but I would have as the charge nurse.Q. And as you are sitting here, you have no recollection of actually

completing an event registration report? A. That would be my standard practice to do that as the charge nurse and

being involved in an event like that, but I don't have recollection of filling it out.

Q. Okay. Why is it your testimony that, as a charge nurse, you would have, standard operating procedure, filled out such an event registration report in this matter?

A. Usually the charge nurse fills out events, and as I was involved in the event, I would be the one to fill it out.

Q. And is it your testimony that the charge nurse would, versus the nurse caring for the patient?

A. Not necessarily.Q. When you use the term “event” as something, in this case, you would have

filled out an event registration, what is your definition of event?A. An emergency C-section and the resuscitation of the baby.Q. What is your understanding as to what an event registration report is? A. You’re documenting an event occurred in order for you to learn from

something that happened or to learn from, I guess, learn from it. We have criteria that are listed, and those are, that is the criteria for it. If there’s an emergency C-section, you have to do a safety net, is what it’s called right now. And a resuscitation of a newborn is considered an eventto be documented in the safety net, also.

Q. And when you fill out the report, is it an online report, or is it a handwritten report by you?

A. It’s online. Q. And is it a preprinted form, where it asks you information, and you just fill

in?

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A. You start at one point, and depending on what department you’re in, it will give specifics to that department on what's required to be an event documentation.

Q. Prior to filling the event registration report out, did you have a conversation with Nurse Colleen Savage?

A. It would have been brief. Yes.Q. Tell me as best you can recall that conversation that you had with Nurse

Savage prior to filling out the event registration report.A. I believe we discussed what had occurred. I don’t recall specifics.Q. You certainly know that if -- strike that. Was it your standard operating

practice to speak to the nurse who was assigned to the patient when you asthe charge nurse were filling out the event registration report?

A. Yes.Q. And you did that because you were trying to get information so that you

could enter it into the system if the ultimate goal was to learn from what had happened; true?

A. Yes. Q. And I just need you to, for the record, as best you can recall, tell us what

she said to you about what had happened. A. I remember her talking about the tracing, the tracing had been fine before

she got out of bed to the bathroom. That’s when she had told me about theblood.

(Ryan Dep. at pp. 22-29; App. 1, pp.4-11.)

***Q. How long is the document?A. As long as need be. It can be pages. They want you to be brief and

concise, though. It doesn’t print, it’s electronically, so I don’t know how many pages. It gets sent to risk management.

Q. I was going to ask you, did you print a copy of the report that you filled out?

A. No.Q. Do you know if you’re even able to do that?A. I don’t believe so.Q. But there is a narrative section that you fill out?A. Yes.(Ryan Dep. at 22-25, App. 1, pp. 4-7.)

e. The Superior Court’s consideration of Plaintiffs’ Motion to Compel production of the MERS Reports over Newport Hospital’s objection.

The parties initially appeared before the Newport County Superior Court, Mr. Justice

13

Stone presiding, on April 6, 2015, to argue Plaintiffs’ Motion to Compel and Newport Hospital’s

Objection thereto. At the initial hearing the Superior Court misapprehended the cited privileges

and ordered that the documents either be: (a) provided to the Nurses to refresh their recollections

of what they wrote in MERS to obtain their testimony about the documents; or (b) produced.

The following excerpts encapsulate the Court’s misapprehension at the April 6, 2015,

hearing:

THE COURT: * * * If the nurses, when you [the plaintiffs] take a deposition, had a chance to review the documents to refresh their memory, then I say fine, they don’t need them. But you can’t say, ‘Well, we don’t remember,’ and you know you’ve got the documents that they prepared. Okay. When you want to take their depositions, again, if for the limited purposes of the deposition, [the Hospital’s] counsel brings those documents so they can review them and say, ‘Yes, now I remember.’ Or ‘I can’t recall.’ Or they say: ‘This refreshes my memory,’ without ever offering the documents.MS. BONNET-EBERT: Well –THE COURT: I’m trying to think if there’s something in between here.MS. BONNET-EBERT: That is not something that we had considered as an option, your Honor. You know, if they’ve relied on something in preparing for the deposition, usually that makes it discoverable as well because it is a report that they have reused for that purpose.THE COURT: It is my understanding they didn’t rely on it.MS. BONNET-EBERT: They didn’t – in their initial deposition, they didn’t remember what they had include in this report….THE COURT: So is that an issue where they can take their depositions again? You [Hospital Counsel] can be there. And based on asking them questions, if they don’t recall it, you [Hospital Counsel] say: “Here are your notes from that”; and then without actually giving them [the Plaintiffs’] the notes, “Does this refresh your memory?”MR. PRECIPHS: I believe under both federal and state law there was a new privilege created, that is 42 C.F.R.[…]THE COURT: It’s not being offered for that. You’d only offer it to refresh the memory. They’re not asking to be introduced is what I’m suggesting here.MR. PRECIPHS: Your Honor, what the law says: “Notwithstanding any other provision of federal, state, or local law to the contrary. Patient safety workproduct and a document log shall be privileged and shall not be: 1) subject to a federal, state, or local civil, criminal, or administrative subpoena or order; 2) subject to discovery in connection with a federal, state, or civil proceeding.” And I believe that the proposed course of action really would invade that privilege. This is absolute privilege. This is patient safety work product regarding a patient

14

safety event. It was intended to be submitted to the Rhode Island Patient Safety Organization and it was in fact submitted to the Patient Safety Organization. THE COURT: They didn’t go anywhere else?MR. PRECIPHS: It didn’t go anywhere else other than the Patient Safety Committee.THE COURT: Okay. But it is not being offered, in terms of deposition, for the truth of the subject or as it relates to federal and state law, just as to whether or not those are the notes she wrote and does that refresh the memory; right?

(Tr. 4/6/15 at pp. 10-12; App. 9, pp. 113-15.)

After further colloquy and arguments about the directed course of action being untenable,

the following exchange occurred:

THE COURT: You’ve got a doctor that is not there, you’ve got a nurse that has made notes, and neither one recalls what they wrote down.MR. PRECIPHS: But they testified at length regarding the incidents.THE COURT: Which makes it even worse.MR. FRIEDEMANN: Everything is in the chart, everything that they reported that they remember should be in the patient chart, your Honor.THE COURT: What information did you get from the patient chart?MS. BONNET-EBERT: We did get information from the patient chart but our concern is the nurses consider this as part of the chart…* * *THE COURT: Okay. It’s 11:45, and what I was hoping, I didn’t want the lawyers to have to come back in the afternoon, so I was hoping that we could get through all of the cases before lunch. I’m prepared to say that if you want to depose him (sic) again, you bring those documents there so they can look at them to see if that refreshes their memory. You can note your objection on the record.MR. PRECIPHS: So noted.THE COURT: But given the seriousness of this case, I just find it hard to believe that this is the only limitation that these matters could be used for, and neither nurse remembers anything that happened. MR. PRECIPHS: It is very specific, you Honor, there is an absolute privilege for these reports…THE COURT: I’m not asking that you waive privilege. I’m asking that the nurses be allowed to review those documents to see if that refreshes their memory. (Tr. 4/6/15 at pp. 15-16; App. 9, pp. 128-29.)* * *MR. FRIEDEMANN: Your Honor, that privilege is so significant to the doctors and nurses because without it we wouldn’t be able to improve safety. If doctors and nurses fell (sic), this Court would order the production of records. Even for the nurses to look at before depositions, it would have a very chilling effect on the ability to improve safety issues in the hospital. The federal law and the state law

15

was enacted to improve safety of patient care. It was intended to stop malpractice from occurring. THE COURT: Oh –MR. FRIEDEMANN: That is what it was intended for.MR. PRECIPHS: That is what it is about.THE COURT: On the other side of the coin, this is a medical malpractice case involving the birth of a child. Some serious issues have been raised in the notes, that were spontaneous with the event, and seem to be quite relevant.MR. PRECIPHS: Except our General Assembly has made (sic) [negated] their relevance either by [en]do[w]ing it with the absolute privilege, they did that in the Rhode Island Patient Safety Act of ’08, which followed the Federal Act in ’05, and both legislatures talked very candidly and very openly about this balancing test. (Tr. 4/6/15 at pp. 18-19; App. 9, pp. 132-33.)

The April 6, 2015 hearing ended with the Court ruling as follows:

THE COURT: You understand what I’m suggesting and what my order is? You can either give them the documents or she can take the depositions again of the nurses and you can offer them the documents for limited purposes of refreshing their memory. But, again, make it part of the record. (Tr. 4/6/15 at p. 22; App. 9., p. 136.)

The Hospital filed a Motion for Reconsideration or, in the Alternative, for Issuance of

Stay of Proceedings in accordance with Rule 8(a). The Superior Court considered the motion,

along with the parties’ disagreement regarding appropriate Order language to reflect Judge

Stone’s April 6, 2105 ruling, on June 1, 2015. On motion for reconsideration, the Superior Court

eliminated the previously suggested deposition to discover the content of the MERS Reports and

ordered their production. At the June hearing, the Superior Court explained its decision as

follows:

THE COURT: …I certainly think that they’re entitled to the records here. This is not a situation as serious as where we’re going to hide the ball. If at all possible, I’d like to see as much open discovery as possible. To say, well, there is a federal statute or state statute, how that applies in this particular case gives me great concern. And I don’t like the idea of the hospital using these kinds of statutes to avoid discovery for something that is this traumatic to the mother and child. I will stay any action on this matter and give you an opportunity to file a petition for Cert. (Tr. 6/1/15 at 5-6; App. 10, pp. 144-45.)

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Newport Hospital filed its Petition for Certiorari on June 30, 2015. This Court issued its

Writ of Certiorari on January 21, 2016.

SPECIFICATION OF ERROR

Before this Court on Writ of Certiorari, Newport Hospital asserts that the Superior Court,

Mr. Justice Stone presiding, committed a clear error of law that amounts to an abuse of discretion

in issuing the Order entered on June 8, 2015 (App. 11, pp. 146-47) based on hearings that

occurred before the Honorable Court on April 6, 2105 (App. 9, pp. 102-37) and June 1, 2015

(App. 10, pp. 138-45) collectively failing to recognize that two documents sought by Plaintiffs’

are expressly privileged and not subject to discovery in connection with a state civil proceeding,

pursuant to 42 C.F.R. §3.204 and R.I. Gen. Laws § 23-17.21-8(a).

Standard of Review

As this Court has explained, “[R]eview of a case on certiorari is limited to an

examination of ‘the record to determine if an error of law has been committed.’” State v. Poulin,

66 A.3d 419, 423 (R.I. 2013) (quoting State v. Greenberg, 951 A.2d 481, 489 (R.I. 2008)). “In

addition to examining the record for judicial error, the Court will ‘inspect the record to discern if

there is any legally competent evidence to support the findings of the hearing justice below.’” Id.

(quoting Brown v. State, 841 A.2d 1116, 1121 (R.I. 2004)). “When [the Court] evaluate[s]

questions of law, [the] review is de novo.” Pierce v. Providence Retirement Board, 15 A.3d 957,

961 (R.I. 2011).

Here, the Superior Court ordered production of privileged documentation making no

express findings or clear determination that either statutory privilege was inapplicable. The

Superior Court initially recognized the privilege and attempted to enable reconciliation. On

Reconsideration, the Superior Court stated that it had “great concern” about how the federal or

17

state law applied in this particular case, and articulated the basis for its ruling, stating that it did

not “like the idea of the hospital using these kinds of statutes to avoid discovery for something

that is this traumatic…” (Tr. 6/1/15 at p. 6; App. 10, p. 145.) As explained below, the decision

was a clear error of law because the documentation at issue is Patient Safety Work Product

shielded from discovery by both federal and state law.

ARGUMENT

I. The Superior Court erred in ordering the production of two Newport Hospital reports which qualify as privileged Patient Safety Work Product under the federal Patient Safety and Quality Improvement Act of 2005

a. The Patient Safety And Quality Improvement Act of 2005 and the federal privilege for Patient Safety Work Product

The concept for a federal patient safety system was based on the November 29, 1999,

publication by the Institute of Medicine, “To Err is Human: Building a Safer Health System,”

Nat’l Acad. Press, 1999 (the “Report”).6 The Report specifically recommended the creation of a

nationwide public reporting system, with mandatory and voluntary components, for the reporting

of adverse medical events that result in harm to patients. Id. at 3.

In making this recommendation, the Report recognized litigation as a significant barrier

to such a system in that, “Providers also perceive the medical liability system as a serious

impediment to systemic efforts to uncover and learn from errors”. Id. More specifically, the

Report recognized, “Health care organizations are concerned that sharing information about

medical errors will expose them to litigation. The unwillingness to share such information means

that errors remain hidden and the same errors may be repeated in different organizations.” Id. at

23. Accordingly, the Report’s recommendation was for, “Congress to enact protective federal

legislation.” Id. at 128. Specifically, the Report advocated that, “Congress should pass

6 See Patient Safety and Quality Improvement Act: Notice of Proposed Rulemaking, 73 Fed. Reg. 8112- 8113 (Feb. 12, 2008).

18

legislation to extend peer review protections to data related to patient safety and quality

improvement that are collected and analyzed by health care organizations for internal use or

shared with others solely for purposes of improving safety and quality.” Id. at 10. The

understanding was that, “This nonpunitive environment will foster the sharing of medical error

information that is a significant step in a process to improve the safety, quality, and outcomes of

medical care.” Id. at 5.

To implement the Institute’s recommendations from the Report, Congress enacted the

Patient Safety and Quality Improvement Act in 2005, seeking to “move … to a ‘culture of

safety’ that focuses on information sharing, improved patient safety and quality and the

prevention of future medical errors.” 73 Fed. Reg. 8112- 13. Among other concerns, the federal

government noted, “Traditional state-based legal protections for such health care quality

improvement activities, collectively known as peer review protections are limited in scope…”

Id. at 8113. To address and eliminate this “impediment,” the federal government attached

“confidentiality and privilege protections… to ‘patient safety work product,’” using “strong

Federal confidentiality and privilege protections for information that is patient safety work

product under the Patient Safety Act.” Id. (emphasis added).

As the goal was explained, “The protections will enable all health care providers,

including multi-facility health care systems, to share data within a protected legal environment,

both within and across states, without the threat of information being used against the subject

providers.” Id.

Meanwhile, the Act facilitated the creation of a new entity, the Patient Safety

Organization (“PSO”), whose function would be to “collect data from medical providers in order

to identify common causes of medical errors”. See id. PSOs include all organizations that

19

collect and analyze patient safety work product and provide feedback to providers on strategies

to improve patient safety and quality of care, and that have been listed by the Department of

Health and Human Services (“DHHS”) as such. S.Rep. No. 108-196, at *5 (2003).

In accordance with Congressional directives, the DHHS regulations establish a

“framework by which . . . providers may voluntarily report information to [a PSO], on a

privileged and confidential basis, for the aggregation and analysis of patient safety events.” 73

Fed. Reg. at 70732. DHHS expressed that the PSQIA’s confidentiality protections “enable all

health care providers . . . to share data within a protected legal environment. . . without the threat

that the information will be used against the subject providers.” Id. at 70732.

Under the DHHS regulations, the privileges afforded to patient safety work product

attach immediately upon collection of information in a patient safety evaluation system. 73 Fed.

Reg. at 70741.7 However, only documentation developed by a provider for reporting to a [PSO]

are protected. 42 U.S.C. § 299b-21(7)(A)(i)(I). See also Tinal v. Norton Healthcare, Inc., No.

3:11-CV-596-S (W.D. Ky. 2014)(holding that incident reports of alleged medication errors were

protected patient safety work product in the context of a federal discrimination suit where they

were reported to a PSO). Moreover, under the PSQIA, the very definition of patient safety work

product does not include, “a patient’s medical record, billing and discharge information, or any

other original patient or provider record.” 42 U.S.C. §299b-21(7)(B)(i). This is consistent with

the understanding that the PSQIA “recognizes that the original [discoverable] records underlying

patient safety work product remain available in most instances for the providers to meet . . . other

reporting requirements.” 73 Fed. Red. 70732 (Nov. 21, 2008).

b. The Privilege for Patient Safety Work Product under PSQIA

7 See also 42 C.F.R. §3.20 (defining patient safety work product to “ include[] information that is documented as within a patient safety evaluation system for reporting to a PSO…” )

20

The PSQIA was designed to promote an open atmosphere for reporting and addressing

safety risks that moved “beyond the existing culture of blame and punishment that suppresses

information about health care errors to a ‘culture of safety’ that focuses on information sharing,

improved patient safety and quality and the prevention of future medical errors.” S.Rep. No.

108-196, at 2 (2003). To that end, the PSQIA “announces a more general approval of the

medical peer review process and more sweeping evidentiary protections for materials used

therein.” KD ex. rel. Dieffenbach v. United States, 715 F.Supp.2d 587, 595 (D.Del. 2010). \

Specifically, the PSQIA affords a privilege to all documents, communications, and other

information that meet the statutory definition of “patient safety work product.” 42 U.S.C. §

299b-22. Under the PSQIA, the privilege for patient safety work product is enshrined as follows:

(a) Privilege. Notwithstanding any other provision of Federal, State, local, or Tribal law and subject to paragraph (b) of this section and § 3.208 of this subpart, patient safety work product shall be privileged and shall not be:(1) Subject to a Federal, State, local, or Tribal civil, criminal, or administrative subpoena or order, including in a Federal, State, local, or Tribal civil or administrative disciplinary proceeding against a provider;(2) Subject to discovery in connection with a Federal, State, local, or Tribal civil, criminal, or administrative proceeding, including in a Federal, State, local, or Tribal civil or administrative disciplinary proceeding against a provider;(3) Subject to disclosure pursuant to section 552 of Title 5, United States Code (commonly known as the Freedom of Information Act) or any other similar Federal, State, local, or Tribal law;(4) Admitted as evidence in any Federal, State, local, or Tribal governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or(5) Admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.

42 C.F.R. §3.204 (“Privilege of patient safety work product”)(emphasis added); 42 U.S.C.

§299b-21. Exceptions to privilege exist in subpart (b) of the Section 21 of the statute, none of

which apply or have been asserted to exist.

21

As covered by the privilege quoted above, the PSQIA protects all “patient safety work

product,” (“PSWP”), a term defined expansively to include:

any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material) (i) Which could improve patient safety, health care quality, or health care outcomes; and

(A) Which are assembled or developed by a provider8 for reporting to a PSO and are reported to a PSO, which includes information that is documented as within a patient safety evaluation system for reporting to a PSO, and such documentation includes the date the information entered the patient safety evaluation system; or (B) Are developed by a PSO for the conduct of patient safety activities; or

(ii) Which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system. 42 C.F.R. §3.20 (“Definitions – Patient safety work product”) (emphasis added).

DHHS explains “patient safety work product” as follows:

Three provisions identified how information becomes patient safety work product. First, information may become patient safety work product if it is assembled or developed by a provider for the purpose of reporting to a PSO and is reported to a PSO. Second, patient safety work product is information developed by a PSO for the conduct of patient safety activities. Third, patient safety work product is information that constitutes the deliberations or analysis of, or identifies the fact of reporting pursuant to, a patient safety evaluation system. Fed. Reg. Vol. 73, No. 226, commentary, p 70739.

8 PSQIA defines “Provider” as follows:

The term “provider” means—(A) an individual or entity licensed or otherwise authorized under State law to provide health care services, including—(i) a hospital…; or(ii) a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner; or(B) any other individual or entity specified in regulations promulgated by the Secretary. 42 U.S.C §299b-21(a)(8).

22

Again, the PSQIA proceeds to define a “patient safety evaluation system” as a system for

“the collection, management, or analysis of information for reporting to or by a patient safety

organization.” 42 C.F.R. § 3.20.9

Finally, “Patient safety activities”, as referenced by DHHS above, are defined to include,

inter alia: (1) efforts to improve patient safety and the quality of health care delivery; (2) the

collection and analysis of patient safety work product; (3) the development and dissemination of

information with respect to improving patient safety, such as recommendations, protocols, or

information regarding best practices; and (4) the utilization of patient safety work product for the

purposes of encouraging a culture of safety and of providing feedback and assistance to

effectively minimize patient risk. 42 U.S.C. § 299b-21(5)(emphasis added). Notably, “[A]

person who discloses identifiable patient safety work product in knowing or reckless violation of

[of the PSQIA] shall be subject to a civil monetary penalty of not more than $10,000 for each act

constituting such violation.” 42 U.S.C. § 299b-22(f)(1).

c. Limitations on the definition of Patient Safety Work Product and the Patient Safety Work Product Privilege under the PSQIA

Subparagraph (7)(B) of the definition of PSWP excludes, “a patient’s medical record,

billing and discharge information, or any other original patient or provider record,” as well as

“information that is collected, maintained or developed separately, or existing separately from a

patient safety evaluation system” even if collected by such a system and reported to a patient

safety organization from being patient safety work product. 42 U.S.C. 299b-21(7)(B).

9 For example, a Patient Safety Evaluation System may independently compile data and generate documents such as statistical compilations, charts and indicators that events are related. These documents are also protected and privileged as Patient Safety Work Product.

23

The U.S. House Report concerning the PSQIA explains Congressional intent that original

documents and primary sources of information are excluded from the definition of “Patient

Safety Work Product” under the PSQIA. As the House Report states:

[T]here may be documents or communications that are part of traditional health care operations or record keeping (including but not limited to medical records, billing records, guidance on procedures, physician notes, hospital policies, logs of operations, records of drug deliveries, and primary information at the time of events). Such information may be in communications or copies of documents sent to a patient safety organization. Originals or copies of such documents are both original provider records and separate information that is developed, collected, maintained or exist separately from any patient safety evaluation system. Both these original documents and ordinary information about health care operations may be relevant to a patient safety evaluation system but are not themselves patient safety work product.

H.R. Rep. No. 109-197, 14 (2005). Overall, “the Patient Safety Act and the final rule have

carefully assured that information generally available today remains available, such as medical

records, original provider documents, and business records. Providers must fulfill external

reporting obligations with information that is not patient safety work product.” 73 Fed. Reg.

70739 (Nov. 21, 2008).

The need to fulfill external reporting obligations with information that is not patient

safety work product was reiterated by DHHS in its Guidance published on May 24, 2016. 81

Fed. Reg. at 32657 (May 24, 2016). For example, as restated in the May 2016 Guidance,

“written reports of witness accounts of what they observed at the time of a patient incident”, if

not required for another purpose and “originally prepare[d]… for reporting to the PSO so that the

richness of the narrative can be mined for contributing factors”, can be PSWP. 81 Fed. Reg. at

32657. (May 24, 2016). On the other hand, if prepared for “claims and liability purposes”, such

a report would not be PSWP. Id.

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Respondents rested their argument in chief below on a single, distinguishable case: Tibbs

v. Bunnell, 448 S.W.3d 769 (Ky. 2014) cert. denied 136 S.Ct. 2504, U.S. (2016), where the

salient issue was the use of a provider’s PSES to store a report required by the State of Kentucky

that had no patient safety analysis. Quite simply, in contrast to Newport Hospital, items that

would otherwise constitute patient safety work product held to have no protection in Tibbs

because the Kentucky hospital took a report that was both required and otherwise discoverable

under state law and placed it in the Hospital’s PSES to assert patient safety work product

privilege for the document. What distinguishes Newport Hospital’s program from the system

used in Tibbs is that Newport Hospital does not and never has utilized its Patient Safety

Evaluation System to comply with any state or other legally imposed reporting requirement.

Rather, it is the practice of Newport Hospital and all Lifespan-affiliated institutions to use a

separate and independent pathway to gather all information that is required to comply with state

and any other applicable reporting protocols and its reports required by legally imposed reporting

obligations is not stored in the Hospital’s Patient Safety Evaluation System.

In Tibbs, a discovery dispute arose in a medical malpractice action regarding a post-

incident or event report generated by a hospital nurse in the hospital’s patient safety evaluation

system. 448 S.W.3d at 798. The Supreme Court of Kentucky upheld a trial court’s order that the

report be produced based on two factors: (1) its analysis and specific findings that the hospital

utilized its patient safety evaluation system to comply with Kentucky’s state incident reporting

obligations; and (2) case law that renders incident reports in Kentucky both mandatory to

generate and discoverable. Id. at 809. Thus, the Tibbs court held that an otherwise mandatory

and discoverable incident report was not privileged where the sole basis for the assertion of

privilege was its residence in the hospital’s patient safety evaluation system. See id.

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The Tibbs court explained that, under Kentucky law, “Occurrence or incident reports are

‘to be used by employees in the ordinary course of business when significant events occur to

document their experience and observations for subsequent review by the hospital's risk

management staff in assessing legal liability issues.’” 448 S.W.3d 796 at fn. 10. (citing Univ.

Med. Ctr., Inc. v. Beglin, 375 S.W.3d 783, 787 (Ky. 2011)). The court also noted that, under a

specific Kentucky law, occurrence or incident reports are “not a patient record, but, rather, a

hospital record.”  Id. (citing 902 KAR 20:016 § 3(3)(a)). Thus, the Tibbs court surveyed the

situation it confronted as follows:

Here, we have incident information reported by a hospital surgical nurse that normally would be found in an incident report which is required by Kentucky regulations to be “established, maintained and utilized as necessary to guide the operation ... of the facility.” 902 KAR 20:016 § 3(3)(a). Yet, it appears the information has not been completed or maintained separately as a hospital record (in a normal incident report), but was filed and stored in a database ostensibly dedicated to the Hospital's Patient Safety Evaluation System operated by its Risk Management Department and to which the hospital's PSO has access. For this reason, it is claimed to be privileged under the Act.

Yet, while the incident information may be relevant to its endeavors under the Act, it is not, nor can it be, patient safety work product, since its collection, creation, maintenance, and utilization is mandated by the Commonwealth of Kentucky as part of its regulatory oversight of its healthcare facilities. As evidenced by its recognition of dual reporting requirements, Congress never intended the Act to deprive the states of state-mandated information relevant to their regulatory duties. 42 U.S.C.A. § 299b–21(7)(B); H.R. Rep. 109–197, 14 (“Both these original documents and ordinary information about health care operations may be relevant to a patient safety evaluation system but are not themselves patient safety work product.”). Thus, Congress did not intend for separately-mandated incident information sources to be able to acquire a federal privilege by virtue of the healthcare provider's act of putting them solely into a PSES repository system (here, “Patient Safety Net®”) for the use of the healthcare provider's PSES and its PSO. Thus, information normally contained in an incident report is not privileged under the Act and may be discovered, following an in camera review, and its information compelled. Id. at 809 (emphasis added).

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See also Baptist Health Richmond, Inc. v. Clouse, 497 S.W.3d 759, 766 (Ky. 2016) (holding that

Patient Safety Act privilege did not cover information that should have been collected and

maintained pursuant to a state obligation); Charles v Southern Baptist of Florida Inc., No. SC15-

2180, 2017 WL 411333 (Fla. Jan. 31, 2017) (holding that the privilege for PSWP did not cover a

report that a provider was obligated to disclose under state law).

In contrast, courts have held that the Patient Safety Work Product Privilege applies to

incident reports when they are created for patient safety purposes. See Taylor v. Hy-Vee, Inc.,

2016 WL 7405669 at *3 (D. Kan. 2016); Dept. of Financial and Professional Regulation v.

Walgreen Company, 970 N.E.2d 552 (Ill. App. 2012); Gooden v. CVS Caremark Corp., No.

11CVA-10885 (Ct. Com. Pl., Franklin Co., Ohio, Nov. 20, 2012)(“This Court finds that the

incident report at issue marked ‘confidential- patient safety work product – PSES …’ is protected

by the statutory privilege and need not be produced.”). For example, in Dept. of Financial and

Professional Regulation v. Walgreen Company, (“Walgreens”), the Appellate Court of Illinois

upheld use of the patient safety work product privilege for incident reports sought by the state

where Walgreens established by affidavit that it collected incident reports in an electronic patient

safety evaluation system and reported them to a patient safety organization. 970 N.E.2d at 557-

58.

The Walgreens dispute arose in July 2010 when the Illinois Department of Financial and

Professional Regulation, (the “Department”), served Walgreens with subpoenas requesting “all

incident reports of medication errors” pertaining to three pharmacists as part of a Pharmacy

Board investigation. Id. at 555. The pharmacy objected leading the Department to file its

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petition for enforcement of its administrative subpoenas. Id. In response, the pharmacy filed a

motion to dismiss the petition, asserting privilege under the Patient Safety Act. Id.

In support of its assertion of patient safety work product privilege, Walgreens explained,

“when a medication error occurs, its pharmacists are required to complete a report in

[Walgreens’] own ‘STARS’ system… Each STARS report is transmitted to … a federally

certified patient safety organization (PSO).” Id. In addition, Walgreens supported its position

with affidavits of its vice president of pharmacy services. As the stated by affidavit:

Walgreens does not create, maintain, or otherwise have in its possession incident reports pertaining to medication error other than the STARS reports referenced in my original affidavit. There are no other incident reports pertaining to medication error that are collected or maintained separately from the STARS reporting system. Id. at 556.

In reply, the Department argued that the PSWP privilege applied only to documents created

exclusively for the purpose of being transmitted to a PSO. Id. at 555-56.

Following hearing, the circuit court granted Walgreens’ motion to dismiss, holding,

“‘[T]he… incident reports of medication error… are … patient safety work product…under 42

USC, Section 299 B-22. They’re privileged….” Id. at 556. The Department appealed the

decision, arguing that the record did “not establish that every incident report of medication error

maintained by [Walgreens] is privileged patient safety work product under the Patient Safety

Act.” Id.

In its analysis on review, the court construed the pleadings and supporting documents in a

light most favorable to the Department and upheld the assertion of the patient safety work

product privilege. Id. at 556-57. The court relied, in part, on Walgreens’ affidavit, which

explained that there were no other incident reports and “that the STARS reports were transmitted

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to a PSO”, and, accordingly, held that Walgreens “established that its STARS reports were

privileged pursuant to section 299b-21(7) of the Patient Safety Act.” Id. at 558.

Likewise, following the May 2016 DHHS Guidance, a District Court evaluated an

assertion of PSWP privilege in Taylor, where a terminated pharmacist sought records contained

within a PSES. In support of her argument, the Plaintiff pointed out that Kansas law requires

pharmacies to maintain a record of medication errors and an Error Log Book was used to contain

the incident reports at issue to comply with the state mandate while the errors listed on the

incident reports therein were also reported in the pharmacy’s PSES and to its PSO. In addition,

the errors listed on the incident reports were also reported on the pharmacy’s internal record-

keeping website. 2016 WL 7405669, at *3.

The argument was unavailing. In its decision upholding the assertion of privilege,

the Court explained:

The evidence in the record makes clear that all the data on the incident reports is gathered for reporting to a PSO and that it then was reported to a PSO when Ms. Newton entered it into PQC [the PSES]. It is true that the incident reports were then saved by defendant in the Error Log Book to comply with Kansas law requiring pharmacies to maintain records of medication errors. It is also true that at least some of the information was logged into Hy-Vee Connect. But what a pharmacy ultimately does with data collected and reported to a PSO is not relevant. 2016 WL 7405669 at *3 (emphasis added).

d. The MERS Reports are “Patient Safety Work Product” under the PSQIA and, accordingly, not subject to discovery in connection with a state civil proceeding.

Given the expressed determination that the PSQIA should be enacted, in part, because,

“Traditional state-based legal protections for such health care quality improvement activities,

collectively known as peer review protections are limited in scope…,” 73 Fed. Reg. 8113, its

application should be analyzed in light of this clear Congressional intent. See, e.g., Howard v.

Lyons, 360 U.S. 593, 597, 79 S. Ct. 1331, 1334, 3 L. Ed. 2d 1454 (1959). “Statutory

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construction must begin with the language employed by Congress and the assumption that the

ordinary meaning of that language accurately expresses the legislative purpose.” Park’N Fly,

Inc. v. Dollar Park & Fly, Inc., 469 U.S. 189, 194 (1985). “It is elementary that the meaning of

a statute must, in the first instance, be sought in the language in which the act is framed, and if

that is plain, * * * the sole function of the courts is to enforce it according to its terms.”

Caminetti v. United States, 242 U.S. 470, 485, 37 S.Ct. 192, 61 L.Ed. 442 (1917). Here, under

the ordinary meaning of the language in the PSQIA, the MERS Reports are privileged “Patient

Safety Work Product”. Moreover, based on the evidence in the record, they are not excluded

from the definition as original source records, information created separately or records created

for purposes other than patient safety.

Under the federal PSQIA, PSWP is,

any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material) (i) Which could improve patient safety, health care quality, or health care outcomes; and (A) Which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO, which includes information that is documented as within a patient safety evaluation system for reporting to a PSO…. 42 C.F.R. § 3.20.

Here, the MERS Reports, which, inter alia, address, “Ways that we could have prevented

the event from happening again in the future,”10 prepared under a scheme where, “You’re

documenting an event occurred in order for you to learn from something that happened…,”11

could improve patient safety, health care quality, or health care outcomes. They were assembled

by the Hospital for reporting to the PSO and they were reported to the Hospital’s PSO.

Accordingly, the MERS Reports are not, “Subject to discovery in connection with a …State…

civil, criminal, or administrative proceeding….” 45 C.F.R. 3.204(a)(2).

10 Savage Dep. at p. 119, App. 2, p. 25.11 Ryan Dep. at 24; App. 1, p. 6.

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e. The MERS Reports are NOT Mandated By State Law or otherwise excluded from qualification as “Patient Safety Work Product” under the PSQIA.

In support of their argument against the MERS Reports’ qualification for the federal

privilege for Patient Safety Work Product, the Carrons assert that the MERS Reports were

prepared to meet mandatory state reporting requirements. Specifically, in a bid to analogize to

Tibbs, the Plaintiffs cite a Department of Heath regulation, RI R. 23-17-HOSP § 34.6, (the

“Regulation”), to base an unsupported assertion that the MERS Reports were created to comply

with a state reporting obligation. However, this argument is without merit based on: (1) analysis

of the cited and relied upon Department of Health regulation; (2) the testimony of the MERS

Reports’ Authors; and (3) the Department of Health’s regulatory framework for the

implementation of the RIPSA.

i. The Regulation

The Regulation, in its entirety, reads as follows:

34.6 The hospital shall ensure that any employee who has reasonable cause to believe a reportable incident, as defined in section 1.50 herein, has occurred reports such information to a high managerial agent within twenty-four (24) hours of receipt of such information on a form and in a manner specified by the Department. RI R. 23-17-HOSP § 34.6 (2009)(emphasis added).

The cross-referenced “Reportable incidents” are defined in RI R. 23-17-HOSP as:

those which result in patient injury as defined in a) though j) or which involve matters described in k) through o):

a) brain injury; b) mental impairment; c) paraplegia; d) quadriplegia; e) any paralysis; f) loss of use of limb or organ; g) any serious or unforeseen complication, that is not expected or probable, resulting in an extended hospital stay or death of the patient; h) birth injury; i) impairment of sight or hearing; j) surgery on the wrong patient; k) subjecting a patient to a procedure/treatment not ordered or intended by the patient’s attending physician, excluding procedures not requiring a physician’s order, medication errors, and collection of specimen, for laboratory study, obtained by noninvasive means or routine phlebotomy; l) suicide of a patient during treatment or within five (5) days of discharge from inpatient

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or outpatient units (if known); m) blood transfusion error; n) medication error that necessitates a clinical intervention other than monitoring; or o) any other incident reported to the malpractice insurance carrier or self insurance program. RI R. 23-17-HOSP § 1.5 (2009)(emphasis added)12.

Here, as set forth in the Regulation and General Laws §23-17-40, “birth injury” is a

“reportable event”.

ii. The testimony of the MERS Reports’ authors shows the Regulation’s inapplicability.

Key distinctions between the Regulation and the MERS system lie in the purpose for the

MERS Report’s creation, underpinned by the motivation for which the reports are made. Here,

based on the Nurses’ testimony, the argument that MERS Reports are state-mandated reporting

of “a reportable incident, as defined in section 1.50… to a high managerial agent” under RI R.

23-17-HOSP § 34.6, fails.

As Nurse Savage testified, the MERS Report, “just has to do with patient safety” as

“That’s always the way I do the report.” (Savage Dep. at 120; App. 2, p. 26.) The MERS Report

is a document that asks, “Ways that we could have prevented the event from happening again in

the future….” Id. at 119; App. 2, p. 25.

Meanwhile, Nurse Ryan explained the same motivation, a hallmark patient safety

activity, for documenting this patient safety event. Again, her testimony was that a MERS

Report is for, “documenting an event occurred in order for you to learn from something that

happened or to … learn from it….” (Ryan Dep. at 24; App. 1, p. 6.)

Neither Nurse testified that the purpose of authoring her MERS Report was to notify a

Risk Manager or any other “high managerial agent” of a reportable incident under state law or,

otherwise, to meet any state –mandated reporting obligation. The MERS Reports were not

12 These definitions mirror those contained in R.I. Gen. Laws § 23-17-40 (“Hospital and freestanding, emergency-care facility events reporting.”).

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intended, by their authors own testimony, to comply with state reporting obligations and are not

- a mere report” by of an employee that has reasonable cause to believe a reportable incident, as

defined in section 1.50 herein, has occurred.” RI R. 23-17-HOSP § 34.6.

Furthermore, any argument that the MERS Reports are intended to serve as reports to a

High Managerial Agent under the Regulation fails based on additional testimony of the Nurse

authors. As Nurse Savage explained the MERS Patient Safety Event Registration Report, “if any

event occurred that is harmful to a patient, it is a report we do.” (Savage Dep at 118; App. 2, p

24.) “We have to fill them for any -- if a lightbulb is out.” Id. at 119; App. 2, p. 25. Indeed, she

explained, “[I]t is a common report.” Id. at 120; App. 2, p. 26. In contrast, the types of events

that qualify as “Reportable Events” under both the Regulation and General Laws §23-17-40 are

limited to the enumerated incidents, not “any event that is harmful to a patient,” (i.e. the

definition of a patient safety event).13

Additionally, the testimony of Nurse Savage establishes that the types and categories of

events that need to be reported in the Hospital’s Patient Safety Evaluation System, MERS is not

guided by the Regulation. She testified that MERS contains, “a checkoff list and it will say

describe the nature of your incident, was it environmental, did somebody fall, was it a visitor,

was it a patient[?]” (Savage Dep. at 120-21; App. 2. Pp. 26-27.)

Again, based on the above-quoted testimony, the failure of the argument that the MERS

Reports are those required under RI R. 23-17-HOSP § 34.6 is illuminated. The list of

“Reportable Events” in the Regulation pertain exclusively to issues “which result in patient

13 The National Quality Forum, (“NQF”), issued a set of definitions in December 2009 that define “patient safety event” as, “A process or act of omission or commission that resulted in hazardous health care conditions and/or unintended harm….” NQF defined “Near Miss” as, “An event or a situation that did not produce patient harm, but only because of intervening factors, such as patient health or timely intervention.” See http://www.qualityforum.org/topics/ safety_definitions.aspx (accessed February 24, 2017).

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injury” Id. In contrast, as explained by Nurse Savage, the list of issues that qualify for the

patient safety event reporting system include, e.g., environmental incidents and events involving

visitors.14

What the Carrons do rely on in the Nurses’ testimony is their statements that the reports

go “to the Risk Manager”. However, this is neither dispositive nor illuminating.

In preparing to work with PSO, providers were instructed to designate someone within the

organization to be responsible for understanding PSQIA and, for many providers, this would be a

patient safety officer or risk manager.15

Overall, the Carrons’ misapplication of Tibbs is apparent when the evidence is examined.

Had the Nurses, for example, stated that the purpose of authoring the MERS Reports was to

notify the hospital of a reportable incident to comply with a state reporting obligation, the

Respondents’ argument might find support in the record; no such support exists. Likewise, were

there any indication that the documents contained within the Hospital’s PSES, MERS, were

simply the “form…specified by the Department [of Health]” under the Regulation, completed

and inserted in the Hospital’s PSES instead of being routed to the Hospital’s file for reporting

under §23-17-40, Respondents’ arguments might draw upon a basis to conclude that the forms

14 A “Near Miss” may, for example, not involve a patient because the event impacted, unfortunately, a visitor.15 See, e.g., Carroll, Roberta, Management Handbook for Health Care Organizations, American Society for Healthcare Risk Management (ASHRM), 2011.

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may not qualify as “patient safety work product” under federal law.16 Yet again, this is not borne

out.

iii. The Department of Health’s regulatory framework for the implementation of the RIPSA shows that the MERS Reports are distinct from the Regulation.

In addition to the Regulation, the Rhode Island Department of Health also issued

regulations regarding patient safety organizations and the privilege pertaining to their records.

Specifically, the Rhode Island Department of Health, in implementing the Rhode Island Patient

Safety Act of 2008, issued Rules and Regulations Pertaining to Certification of Patient Safety

Organizations in January 2009. See R23-17.21-PSO (the “DOH PSO Regulations”).

Initially, the DOH PSO Regulations specify:

(b) Certification Regarding PSO Criteria.(1) An entity seeking initial certification as a PSO shall attest that it will comply with each of the following seven (7) criteria: * * *

(vi) To the extent practical and appropriate, the PSO shall collect patient safety work product from reporting entities in a standardized manner that permits valid comparisons of similar cases among similar reporting entities.” R23-17.21-PSO §6.2(b)(1)(vi)(emphasis added).

In furtherance of the standardization urged by the Rhode Island PSO Regulations, the format

utilized for the “MERS-TH Event Registration Report” that Respondents characterize as an

“incident report” was designed, not by Newport Hospital or its parent corporation, but in a

standardized format by the Rhode Island Patient Safety Organization and implemented in a

16 If this example were true, Respondents would still need a satisfactory argument to overcome the Hospital’s assertion of privilege under §23-17-40 to obtain reporting under the statute. The Hospital did properly assert privilege pursuant to §23-17-40 for the two (2) documents that are reports that were generated under §23-17-40, which statute specifies that, “all reports under this section, together with the peer-review records and proceedings related to events and incidents so reported and the participants in the proceedings, shall be deemed entitled to all the privileges and immunities for peer-review records set forth in § 23-17-25.” R.I. Gen. Laws § 23-17-40(i).

35

standardized manner by all of the private hospitals in the state. 17 See MERS-TH Event

Registration Report Exemplar (App. 12, pp. 148-53.)

Again, this evidences that the “MERS-TH Event Registration Report” is not the “form”

or “manner specified by the Department [of Health]”, as suggested by Plaintiffs. Moreover,

there is no basis to argue that Newport Hospital has placed the “form… specified by the

Department” in its PSES to attempt an inappropriate assertion of the PSWP. Finally, if the

Hospital failed, in any way, to comply with its reporting obligations with the Department of

Health, no basis exists to eviscerate the privilege for its PSWP. Any remedy for such a failure,

were one to exist would lie with the regulatory authority, our Department of Health and not with

the Carrons.

At the outset, Respondents ignore the prescribed “form” and “manner specified by the

Department” to conflate the reports at issue with this Regulation. Clearly, the MERS form is not

the prescribed “form” or “manner specified” for such reporting to the Department.18 Notably,

again, the Superior Court made no specific findings, including no finding in regard to the

Carrons’ assertion that the MERS Reports are state mandated. As explained above, any such

finding would be a clear error of law.

f. The Superior Court Committed an Error of Law in Ordering Production of Newport Hospital’s MERS Reports and Erred in Failing to Analyze Newport Hospital’s Assertion of Privilege.

17 Again, our Department of Health certified the GE Rhode Island PSO, which designed MERS, on January 13, 2010. A copy of the PSO certification was filed with the Superior Court within “Exhibit B” to Defendant, Newport Hospital’s, Memorandum of Law In Support of Defendant’s Objection to Plaintiffs’ Motion to Compel Production of Patient Safety Work Product.

18 The same set of regulations speaks to a prescribed “form” and “manner” for hospital reporting of “reportable events” to the Department of Health. RI R. 23-17-HOSP § 34.3. It, likewise, is entirely separate from the MERS Event Registration Report and the patient safety evaluation system.

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The Supreme Court of the United States has stated that, “[E]xceptions to the demand for

every man’s evidence are not lightly created nor expansively construed, for they are in

derogation of the search for truth.” Herbert v. Lando, 441 U.S. 153, 175, 99 S. Ct. 1635, 1648,

60 L. Ed. 2d 115 (1979). Here, Congress has created a broad, explicit and necessary privilege

for patient safety work product by its enaction of the PSQIA.

The statute, not lightly created, was the topic of extensive legislative activity and

Newport Hospital, requesting an appropriate construction of the federal law and the application

of the law to its reports, received a decision contrary to the law with no statutory analysis,

significantly based on the Superior Court’s concern that it did not “like the idea of the hospital

using these kinds of statutes to avoid discovery for something that is this traumatic to the mother

and the child.”19 By enacting the PSQIA, Congress, in fact, has determined and stated which

factors are relevant and should be evaluated; these nowhere include the degree of trauma, real or

perceived, to a patient involved in a patient safety event. Moreover, Congress, in enacting the

PSQIA, in the first instance, weighed and balanced the impact of the privilege for Patient Safety

Work Product and its effect, i.e., the Hospital’s ability to “avoid discovery”, against the inability

of a malpractice plaintiff to obtain discovery of PSWP. Congress’s enaction of the law embodies

its determination that systemic benefits of this privilege outweigh the harm caused by excluding

what, in a range of matters, may be critical evidence.

A privilege, properly invoked, is to be upheld under such a circumstance. See Swidler &

Berlin v. United States, 524 U.S. 399, 412, 118 S. Ct. 2081, 2088, 141 L. Ed. 2d 379 (1998)

(upholding attorney-client privilege noting, in part, “The systemic benefits of the privilege are

commonly understood to outweigh the harm caused by excluding critical evidence.”)

Congressional determination that a public good exists in shielding Patient Safety Work Product,

19 Tr. 6/1/15 at pp. 4-5; App. 10, pp. 143-44.

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accordingly, transcends the need for discovery in a broad range of legal actions, including civil

suits. Giving the motion justice proper deference, he erred in ordering the production of the

MERS Reports both as a matter of law and also absent findings or analysis of the relevant

statutory considerations set forth in the PSQIA. It is not the prerogative of the court to read into

a statutory privilege an exception that does not exist.

II. The Superior Court Committed an Error of Law in Ordering Production of Newport Hospital’s MERS Reports and Erred in Failing to Analyze Newport Hospital’s Assertion of Privilege under the Rhode Island Patient Safety Act of 2008.

a. Background: The Rhode Island Patient Safety Act of 2008

Separate and apart from the PSQIA, our General Assembly enacted a statutory legal

framework for Patient Safety Activities under state law: The Rhode Island Patient Safety Act of

2008, (“RIPSA”). Notably, the PSQIA and RIPSA are not identical. First, when compared, the

two statutory schemes contain a marked departure from each other’s definition of “patient safety

work product”. Second, when analyzed, RIPSA’s broader definition of PSWP is directly tied to

the General Assembly’s stated legislative intent. Accordingly, a separate analysis of Newport

Hospital’s assertion of privilege for its MERS Reports is required under RIPSA. Under RIPSA,

again, the Superior Court made a clear error of law in ordering production of the MERS Reports.

When construing statutes, this Court’s role is “to determine and effectuate the

Legislature’s intent and to attribute to the enactment the meaning most consistent with its

policies or obvious purposes.”  Brennan v. Kirby, 529 A.2d 633, 637 (R.I. 1987). Here, the basis

and rationale for RIPSA is set forth within the law’s statutory enactment as follows:

The general assembly finds:

(a) There are an unacceptable high number of preventable patient safety events in the health care system;

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(b) Current solutions that focus on reporting, discipline and retraining of individuals have proven inadequate alone to address this systemic problem. 

R.I. Gen. Laws § 23-17.21-2 (“Legislative findings”)(emphases added).20 Following this, the

General Assembly set forth RIPSA’s legislative purpose and intent in the statute, stating:

The general assembly proposes a Rhode Island patient safety organization that:(a) Works with hospitals, nursing facilities, and freestanding ambulatory surgical centers for both the reporting of patient safety events including situations in which a patient safety event was averted (near misses) and evaluating the root causes of the patient safety event; (b) Recommends to health care providers changes to improve their patient safety through investigating system causes related to the patient safety events and, on at least an annual basis, to the department for statewide changes and policies that will advance patient safety and quality improvement; (c) Facilitates the creation and maintenance of a non-identifiable patient safety database. The database shall have the capacity to accept, aggregate, and analyze non-identifiable patient safety work product and data reported by entities and provide this to the national network of patient safety databases.  R.I. Gen. Laws §23-17.21-3 (“Legislative purpose and intent”).

  Under RIPSA:

“Patient safety work product” means all reports, records, memoranda, analyses, statements, root cause analyses, or written or oral statements, that:

(1) a health care facility or provider prepares for the purpose of disclosing a patient safety event, or is disclosed, to a patient safety organization; (2) is received from a reporting entity, or is created or analyzed by a patient safety organization; or (3) directly or indirectly contains deliberations, analytical process, recommendations, conclusions, or other communications of a patient safety organization or between a patient safety organization and health care providers or facilities. R.I. Gen. Laws § 23-17.21-4(h)(emphasis added).

20 Under RIPSA, “‘Patient safety event’ means those events as defined by the national quality forum, institute of medicine, center for Medicare and Medicaid Services (CMS), and as further defined by the quality of care advisory committee, as established herein, and shall include near misses.” R.I. Gen. Laws § 23-17.3-4(f). The National Quality Forum, (“NQF”), defines “patient safety event” as, “A process or act of omission or commission that resulted in hazardous health care conditions and/or unintended harm….” See http://www.qualityforum.org/topics/ safety_definitions.aspx (last accessed February 24, 2017).

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RIPSA provides that, “‘Reporting entities’ means all hospitals, nursing facilities, and

freestanding ambulatory surgical centers licensed under chapter 23-17.’” R.I. Gen. Laws § 23-

17.21-4(h)(“Definitions”).

Finally, RIPSA enshrines a new privilege for “Patient Safety Work Product” whereby:

Notwithstanding any other provision of federal, state, or local law to the contrary . . . patient safety work product and a document log shall be privileged and shall not be: (1) subject to a federal, state, or local civil, criminal, or administrative subpoena or order, including in a federal, state, or local civil or administrative disciplinary proceeding against a provider; (2) subject to discovery in connection with a federal, state, or local civil, criminal, or administrative proceeding, including in a federal, state, or local civil or administrative disciplinary proceeding against a provider; (3) subject to disclosure pursuant to § 552 of title 5, United States Code (commonly known as the Freedom of Information Act), Title 38, chapter 2 of the general laws (commonly known as the Access to Public Records Law), or any other similar federal, state, or local law; (4) admitted as evidence in any federal, state, or local governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or (5) admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under state law.

 R.I. Gen. Laws §23-17.21-8(a)(“Privilege and confidentiality protections”)(emphasis added).

RIPSA’s privilege and confidentiality protections include a provision whereby:

Subject to subsection (3) herein, a person who discloses identifiable patient safety work product and/or document log in a knowing or reckless violation of subsection (b) herein shall be subject to a civil monetary penalty of not more than ten thousand dollars ($10,000) for each act constituting such violation. R.I. Gen. Laws §23-17.21-8(f)(1)(“ Privilege and confidentiality protections – Enforcement - Civil monetary penalty”).21

The Most Honorable Court “is the final arbiter with respect to questions of statutory

construction.”  In carrying out that responsibility, the Court has written that it will determine the

intent of the General Assembly by looking to “the language, nature, and object” of the

21 Were Newport Hospital to mishandle and disclose the two MERS Reports at issue, it could potentially be subject to combined state and federal civil monetary penalties in the sum of up to $40,000.

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enactments of that body.  Chambers v. Ormiston, 935 A.2d 956, 959–60 (R.I. 2007)(citing In re

Estate of Gervais, 770 A.2d 877, 880 (R.I. 2001).

In construing the meaning of a statute, this Court has explained that it will “first attempt

to see whether or not the statute in question has a plain meaning and therefore is unambiguous;

in that situation, we simply apply that plain meaning to the case at hand.” Chambers, 935 A.2d

at 960. See also, e.g., State v. DiCicco, 707 A.2d 251, 253 (R.I. 1998). When addressing an

unambiguous statute, the Court “simply must determine what the words in this statute were

intended to mean. Once we have done so, our interpretive task is at an end and our role is simply

to apply the statute as written.” Chambers 935 A.2d at 961 (citing State v. Santos, 870 A.2d

1029, 1032 (R.I. 2005); DiCicco, 707 A.2d at 253; In re Denisewich, 643 A.2d 1194, 1197 (R.I.

1994). “It is generally presumed that the General Assembly intended every word of a statute to

have a useful purpose and to have some force and effect.” Curtis v. State, 996 A.2d 601, 604

(R.I. 2010).

1. RIPSA’s Broader Definition of “Patient Safety Work Product”

To begin with, a comparison of the two definitions of PSWP reveals that under the

federal PSQIA, a prerequisite (“which could improve patient safety, health care quality, or health

care outcomes”) is followed by a proviso that documents qualify if they are, “assembled or

developed by a provider for reporting to a PSO and are reported to a PSO, which includes

information that is documented as within a patient safety evaluation system for reporting to a

PSO…” 42 C.F.R. §3.20 (emphases added). In contrast, RIPSA’s definition of PSWP is written

in a manner that broadens “patient safety event” disclosure.

First, in contrast to Congress’s use of the conjunctive “and” in the PSQIA’s definition of

PSWP, our General Assembly drafted RIPSA’s definition of patient safety work product using

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the disjunctive “or” in Section 23-17.21-4(h)(1). Specifically, under RIPSA, a report qualifies

as patient safety work product when, “a health care facility or provider prepares [it] for the

purpose of disclosing a patient safety event, or [it] is disclosed, to a patient safety

organization…” R.I. Gen. Laws §23-17.21-4(h)(1). Additionally, RIPSA’s definition of

“patient safety work product” materially differs from the PSQIA in other regards.

Notably, under RIPSA, reports, records, memoranda, analyses, statements, root cause

analyses, or written or oral statements that are “received [by a PSO] from a reporting entity” are

also patient safety work product. R.I. Gen. Laws § 23-17.21-4(h)(2). The effect of this variation

evidences the General Assembly’s deliberate decision to broaden the definition of PSWP under

RIPSA beyond the federal definition of PSWP under the PSQIA.

Where Rhode Island law touches upon topics where Congress has enacted analogous or

similar laws, a distinction within our state’s law must be given effect in recognition of our

General Assembly’s decision to chart its own course. See, e.g., Horn v. S. Union Co., 927 A.2d

292, 300 (R.I. 2007) (reflecting that departures from a parallel federal statute are a relevant

guidepost for the interpretation of a state statute); State v. O’Brien, 774 A.2d 89, 96 [n.6.] (R.I.

2001)(declining to apply a federal statutory definition to Rhode Island’s statute addressing the

same topic where Congress enacted a change to the analogous federal statute in 1986 but “The

General Assembly, however, declined to follow the federal amendment in 1999…”); Klein v.

Republic Steel Corp., 435 F.2d 762, 765–66 (3rd Cir. 1970) (“It is a canon of statutory

construction that where as here the words of a later statute differ from those of a previous one on

the same or a related subject, the legislature must have intended them to have a different

meaning.”).

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2. RIPSA’s Broader Definition of “Patient Safety Work Product” reflects the General Assembly’s legislative intent that RIPSA capture each Patient Safety Event.

The Court has stated, “When the legislative intent behind a statute is clear, we are obliged

to interpret statutes consistently with such intent.” State v. Ahmadjian, 438 A.2d 1070, 1081

(R.I. 1981)(citing State v. Smyth, R.I., 397 A.2d 497 (1979)). In addition, “[t]his [C]ourt has

long applied a canon of statutory interpretation which gives effect to all of a statute’s provisions,

with no sentence, clause or word construed as unmeaning or surplusage.”  Local 400,

International Federation of Technical and Professional Engineers v. Rhode Island State Labor

Relations Board, 747 A.2d 1002, 1005 (R.I. 2000) (quoting Rhode Island Department of Mental

Health, Retardation, and Hospitals v. R.B., 549 A.2d 1028, 1030 (R.I. 1988)). Here, the plain

language of RIPSA’s definition of “patient safety work product” combined with the PSWP

privilege accomplishes the General Assembly’s legislative intent to arm the PSOs created by

RIPSA with detailed event reports, authored by providers who are unburdened by a concern that

their reporting will be subject to disclosure, dissemination or, as threatened in the case at bar,

discovery in a malpractice action.

Specifically, RIPSA’s expanded definition of “patient safety work product” furthers our

General Assembly’s intent for RIPSA to create a patient safety organization that, “Works with

hospitals…for both the reporting of patient safety events including situations in which a patient

safety event was averted (near misses) and evaluating the root causes of the patient safety

event….[to] [f]acilitate[] the creation and maintenance of a non-identifiable patient safety

database….” R.I. Gen. Laws §§23-17.21-2,3.

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As this Court has oft repeated, it is presumed that the General Assembly knows the

“‘state of existing relevant law when it enacts or amends a statute.’” Ret. Bd. of Employees’ Ret.

Sys. of State v. DiPrete, 845 A.2d 270, 287 (R.I. 2004)(quoting Smith v. Retirement Board of the

Employees’ Retirement System, 656 A.2d 186, 189 (R.I. 1995)). See also Shelter Harbor Fire

Dist. v. Vacca, 835 A.2d 446, 449 (R.I. 2003); Simeone v. Charron, 762 A.2d 442, 446 (R.I.

2000); Providence Journal Co. v. Rodgers, 711 A.2d 1131, 1134 (R.I. 1998)); Narragansett

Food Services, Inc. v. Rhode Island Department of Labor, 420 A.2d 805, 808 (R.I. 1980) (“The

legislature is presumed to know the state of existing relevant law when it enacts…a statute.”).

Here, in contrast to the PSQIA, RIPSA’s broader definition of PSWP works in

conjunction with the PSWP privilege to extend an umbrella of protection over an expanded

catalog of documentation to maximize event reporting and capture the highest attainable volume

of reports; all “patient safety events” can be reported and analyzed by the PSO. The decision to

draft RIPSA to surpass its federal counterpart and both complement and supplement federal

protections for the reporting of patient safety events to PSOs occurred both on the backdrop of:

(a) the prior federal statute; and (b) our General Assembly’s finding that “Current solutions that

focus on reporting, discipline and retraining of individuals have proven inadequate alone....” R.I.

Gen. Laws §23-17.21-2. RIPSA, indeed, moves to a non-punitive model where “Patient safety

activities”22 are prioritized, including, but not limited to, “the utilization of patient safety work

22 Under RIPSA:

“patient safety activities” means: (1) efforts to improve patient safety and the quality of health care delivery; (2) the collection and analysis of patient safety work product; (3) the development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices; (4) the utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk; (5) the maintenance of procedures to preserve confidentiality with respect to patient safety work product; and (6) the provision of appropriate security measures with respect to patient safety work product. R.I. Gen. Laws § 23-17.21-4(e).

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product for the purposes of encouraging a culture of safety and of providing feedback and

assistance to effectively minimize patient risk.” R.I. Gen. Laws §23-17.21-4(e)(4). A decision

that ignores the privilege for PSWP under RIPSA frustrates the legislature’s intent.

3. In this case, the MERS Reports are “Patient Safety Work Product” under RIPSA and, accordingly, are not “subject to discovery in connection with a federal, state, or local civil, criminal, or administrative proceeding.”

Here, review of RIPSA leads to the conclusion that the language of the statute is clear

and unambiguous.  Under RIPSA, documentation qualifies as “patient safety work product” if

any of three independent requirements are met. “Patient safety work product” exists if a report,

record, memorandum, analysis, statement, root cause analysis, or written or oral statement was:

(1) prepared by a health care facility or provider for the purpose of disclosing a patient safety

event; (2) was disclosed by a reporting entity to a patient safety organization; or (3) was

received by a PSO from a reporting entity. In this case, the record evidences that Newport

Hospital’s MERS Reports were: (1) prepared by a health care facility or provider for the purpose

of disclosing a patient safety event; (2) disclosed to the patient safety organization; and (3)

received by the PSO from Newport Hospital, a licensed healthcare facility that is a “reporting

entity.” The MERS Reports, “documenting an event [that] occurred in order for you to learn

from something that happened”23, “always”, as Nurse Savage writes event reports “just to do

with patient safety”24 were submitted to the PSO which received them. (Chandler Aff. at ¶¶ 17-

18; App. 3, p. 34.)

As none of the statutory exceptions to this “privileged” status set forth in Section 23-

17.21-8(c) apply, both MERS Reports are “privileged and shall not be . . . subject to discovery in

23 Ryan Dep. at p. 24; App. 1, p.6.24 Savage Dep. at p. 120; App. 2, p. 26.

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connection with a federal, state, or local civil, criminal, or administrative proceeding…,”

pursuant to R.I. Gen. Laws § 23-17.21-8(a)(emphasis added). While the Nurses can and did

testify to what they witnessed and/or what was recorded in the original source medical records,

RIPSA (and the PSQIA) preclude anyone from having to testify about the content of an event

report, including its substance, detail or summary overview.

While this is the first case to arise under RIPSA, the New Jersey Appellate Division most

recently reversed a trial court’s error in ordering production of privileged patient safety

documentation under its state patient safety act where a malpractice plaintiff asserted that a

failure to comply with a state reporting mandate justified a finding that privilege was

inapplicable. Bruglaletta v. Garcia, 2017 WL 476219 (N.J. App. Div., Feb. 6, 2017). The

decision is instructive both in its application of an independent state patient safety act and in the

basis for its conclusion.

In Brugaletta, the trial court ordered partial production of a self-critical analysis of the

plaintiff’s care based on a finding that the incident at issue qualified as a “serious preventable

adverse event” that need be reported to the state’s health department, the Hospital had failed to

make such a report, and, therefore, the privilege could be pierced. Id. In contrast, the Hospital

argued that neither the law nor its implementing regulations authorize the partial or total loss of

the patient safety act privilege where it fails to report an adverse event to the state’s health

department. Id. at *2.

On appeal, the court reversed the trial court’s order, agreeing that “the privilege does not

depend on compliance with the requirement to report [an adverse event] to the [health]

department or the patient.” Id. at **1, 4. As the court explained, the act’s plain language, “does

not condition the privilege…on compliance with the reporting obligation.” Id. at *2.

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Here, a privilege has been asserted by Newport Hospital under an independent state law

that does not condition the privilege on any circumstances beyond those set forth in RIPSA.

“The burden of establishing entitlement to nondisclosure rests on the party resisting discovery.”

Id. “[P]rivileges, in general, are not favored in the law and therefore should be strictly

construed.” Moretti v. Lowe, 592 A.2d 855, 857 (R.I. 1991). However, “Certain privileges are

recognized because they are deemed to serve such a vitally important public good that

‘transcend[s] the normally predominant principle of utilizing all rational means for ascertaining

truth.’ ” Pastore v. Samson, 900 A.2d 1067 (R.I. 2006)(quoting Trammel v. United States, 445

U.S. 40, 50, 100 S.Ct. 906, 63 L.Ed.2d 186 (1980)).

RIPSA reflects the General Assembly’s weighing of policy considerations and its

legislative judgment that a privilege for the reporting of patient safety events serves a vitally

important public good that outweighs the search for truth in litigation. Fundamental canons of

statutory construction mandate giving full effect to RIPSA’s provisions.

4. The Department of Health’s PSO Regulations do not constrain RIPSA’s definition of “patient safety work product” and the DHHS Guidance for the PSQIA has no application under RIPSA.

While the HHS has issued its Guidance for the PSQIA, again, our Department of Health

has issued its own independent regulations for the implementation of RIPSA. See Rules and

Regulations Pertaining to Certification of Patient Safety Organizations. R23-17.21-PSO, (the

“DOH PSO Regulations”). HHS’s Guidance under the PSQIA applies solely to the PSQIA. The

DOH PSO Regulations serve as the authority implementing RIPSA. Notably, the Rhode Island

PSO Regulations are devoid of any basis to conclude that Newport Hospital’s MERS Reports are

disqualified as PWSP.

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Initially, the DOH PSO Regulations echo the statutory law with respect to privilege,

specifying:

3.1 Privilege. Notwithstanding any other provision of federal, state, or local law to the contrary, and subject to §3.3, patient safety work product and a document log shall be privileged and shall not be: * * *

(b) Subject to discovery in connection with a federal, state, or local civil, criminal, or administrative proceeding… R23-17.21-PSO §3.1(b).

Likewise, the DOH PSO Regulations repeat, verbatim, RIPSA’s definition of “patient safety

work product.” R23-17.21-PSO §1.16. Finally, the DOH PSO Regulations prescribe certain

requirements for “Reporting Entities” and further provide that “A reporting entity shall not be

exempt from the requirements of RIGL §23-17-40 or RIGL §5-37-9.” Id. at §4.3. This merely

imposes a requirement, understood and implemented by Newport Hospital, for continued

reporting pursuant to statutory mandate under the pertinent statute, which, again, has a self-

contained privilege that has been properly asserted for the two documents that are reports

pursuant to §23-17-40(i)25 : the June 25, 2013 Rhode Island Department of Health Hospital

Incident Reporting Form and the Follow-Up Report for Incidents dated October 18, 2013.

b. The Superior Court committed reversible error in ordering the production of the MERS Reports in contravention of RIPSA.

The Motion Justice’s misapprehension of RIPSA was apparent in his: (1) attempt to

reconcile the parties’ respective interests rather than evaluate the asserted privilege; (2)

confusion, perhaps, of the hearsay rule with a statutory privilege analysis; and (3) initial

recognition of the need to issue an Order that did not invade the privileges at issue26 followed by

25 “[A]ll reports under this section, together with the peer-review records and proceedings related to events and incidents so reported and the participants in the proceedings, shall be deemed entitled to all the privileges and immunities for peer-review records set forth in § 23-17-25.” R.I. Gen. Laws §23-17-40(i).26 “I’m not asking that [the Hospital] waive privilege.” (Tr. 4/6/15 at pp. 10-12; App. 9, pp. 113-15.)

48

the offending Order. Moreover, the Court ultimately ordered production of the privileged MERS

Reports with no concrete analysis of the privileges asserted.

Indeed, any legislation “‘in derogation of the common law’ ” is to be construed strictly.  

Providence Journal Co. v. Rodgers, 711 A.2d 1131, 1134 (R.I. 1998); see also Kelly v.

Marcantonio, 678 A.2d 873, 876 (R.I. 1996). Yet, here, the most strict and narrow construction

of RIPSA yields only the preceding analysis. The Superior Court’s decision to the contrary is a

clear error of law that this Court should reverse.

CONCLUSION

The harm to Petitioner/Appellant, Newport Hospital, and the peril to the system enshrined

by Rhode Island the United States to afford protection for the collection and aggregation of

information regarding patient safety events is clear, present, palpable and not subject to relief from

any other tribunal or entity. Based upon the foregoing, Respondent, Newport Hospital, respectfully

requests that this Most Honorable Court reverse the Order of the Superior Court, Mr. Justice Stone

presiding, which granted Plaintiffs’ Motion to Compel Newport Hospital’s patient safety work

product associated with the birth of Baby Carron.

Respectfully submitted,Petitioner/Appellant,NEWPORT HOSPITALBy Its Attorneys,

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___________________________Jason C. Preciphs (#6727)Roberts, Carroll, Feldstein & Peirce, Inc.10 Weybosset Street, Suite 800Providence, RI 02903-2808(401) 521-7000 (FAX) (401) 521-1328jpreciphs@rcfp.com

CERTIFICATE OF SERVICE

I hereby certify that, on the 27th day of February, 2017,

[X] I caused this document to be [X] mailed via First Class Mail, postage prepaid or [ ] hand-delivered to the attorney for the parties to this matter whose name(s) and address(es) are as follows:

Mark Mandell, Esq.Yvette M. Boisclair, Esq.Heather M. Bonnet-Hebert, EsqMANDELL, SCHWARTZ & BOISCLAIR, LTD.One Park Row, Suite 2CProvidence, RI 02903-1293

George E. Wakeman, Jr., Esq.ADLER, COHEN, HARVEY, WAKEMAN AND GUEKGUEZIAN, LLP55 Dorrance StreetProvidence, RI 02903

George E. LiebermanGianfrancesco & Friedemann LLP214 BroadwayProvidence, RI 02903

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