Daley v. Teruel

2018 IL App (1st) 170891
FIRST DISTRICT,
FOURTH DIVISION
June 28, 2018

No. 1-17-0891
TERRI DALEY, Independent Administrator of the Estate ) Appeal from the
of Rosalie Galmore Jones, deceased, ) Circuit Court of
) Cook County.
Plaintiff-Appellee, )
)
v. )
) No. 15 L 11684
KEVIN TERUEL, RN; VICTORIA HALL, RN; and )
INGALLS MEMORIAL HOSPITAL, )
)
Defendants, )
) Honorable
(Ingalls Memorial Hospital, Defendant-Contemnor­ ) Moira S. Johnson,
Appellant). ) Judge Presiding.

PRESIDING JUSTICE BURKE delivered the judgment of the court, with opinion.
Justices McBride and Ellis concurred in the judgment and opinion.

OPINION

¶1 Plaintiff Terri Daley, as independent administrator of the estate of Rosalie Galmore

Jones, deceased, sued defendants Kevin Teruel, RN; Victoria Hall, RN; and Ingalls Memorial

Hospital (Ingalls) (collectively, defendants) for medical malpractice. During discovery, in

response to one of plaintiff’s written interrogatories and a request to produce, Ingalls claimed a

privilege on certain documents based on the federal Patient Safety and Quality Improvement Act

of 2005 (Patient Safety Act) (42 U.S.C. § 299b-21 et seq. (2012)). Plaintiff subsequently filed a

motion to compel the production of the documents, which the Cook County circuit court granted.
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Ingalls refused, based on the Patient Safety Act and sought a contempt finding in order to

facilitate appellate review. The court found Ingalls in contempt, and Ingalls appealed.

¶2 In this appeal, Ingalls contends that the documents constitute patient safety work product

under the Patient Safety Act and the federal law preempts the circuit court’s production order.

We agree with both contentions, and accordingly, we reverse and remand the matter for further

proceedings.

¶3 I. BACKGROUND

¶4 A. The Patient Safety Act

¶5 The Patient Safety Act (Pub. L. No. 109-41, 119 Stat. 424 (codified at 42 U.S.C. § 299b­

21 et seq.)) established a voluntary reporting system of patient safety information by health care

providers designed to analyze and improve patient safety and the quality of health care. Patient

Safety and Quality Improvement, 73 Fed. Reg. 70,732, 70,732 (Nov. 21, 2008) (to be codified at

42 C.F.R. pt. 3). In order to encourage the voluntary reporting, the law provides privilege and

confidentiality protections for patient safety information (id.), known as “patient safety work

product,” a broad set of information, such as data, reports, records, and written statements, that

could help improve patient safety and the quality of health care. 42 U.S.C. § 299b-21(7)(A)

(2012)). Health care providers share this information with patient safety organizations, which are

federally certified groups who collect and analyze patient safety work product and, in turn,

recommend strategies to improve patient safety and the quality of health care. Id. §§ 299b-21(4),

299b-24; S. Rep. No. 108-196, at 5 (2003). Because the privilege and confidentiality protections

are essential to the functioning of the system created by the Patient Safety Act, health care

providers who disclose patient safety work product can face monetary fines of up to $10,000 per

disclosure. 42 U.S.C. § 299b-22(f)(1) (2012).

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¶6 B. The Litigation

¶7 Plaintiff’s February 2016 amended complaint frames this appeal. Her lawsuit alleged that

defendants committed medical malpractice when they failed to adequately monitor and treat the

blood glucose levels of Rosalie Galmore Jones over the course of November 17 and 18, 2013. As

a result of defendants’ alleged negligence, plaintiff asserted that Jones suffered injuries that

caused or contributed to her eventual death in October 2014.

¶8 Ingalls and Teruel filed an answer, denying any negligence. Hall filed a motion to dismiss

based on her noninvolvement in Jones’s care, though the record is unclear whether that motion

was resolved prior to this appeal. All the meanwhile, the parties were conducting discovery.

¶9 In one of plaintiff’s written interrogatories, she asked Ingalls to state whether the incident

identified in the complaint was reported to, or investigated by, any hospital or governmental

committee, agency, or body. Ingalls objected, as the interrogatory sought privileged information

and directed plaintiff to an attached privilege log, in which it claimed privilege on six

documents: incident review No. 25472, incident review No. 25753, complaint No. 5101,

complaint No. 5478, the security department incident report, and the privilege file of Dr. Rita

Oganwu. Concerning the first five documents, Ingalls claimed that they were privileged under

the Illinois Medical Studies Act (735 ILCS 5/8-2101 et seq. (West 2016)) and the federal Patient

Safety Act (42 U.S.C. § 299b-21 et seq. (2012)). Concerning the file of Dr. Oganwu, Ingalls

claimed it was privileged under Illinois’s Health Care Professional Credentials Data Collection

Act (410 ILCS 517/1 et seq. (West 2016)).

¶ 10 Additionally, in one of plaintiff’s requests to produce, she asked Ingalls to produce any

documents that describe statements made by Jones, her family, anyone with knowledge of the

events at issue in the complaint, or anyone investigating the events at issue in the complaint. In

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response, Ingalls stated that it had turned over several responsive documents already and directed

plaintiff to an attached privilege log, in which it claimed privilege on the same six documents on

the same bases as it did in its response to plaintiff’s interrogatory.

¶ 11 Plaintiff subsequently filed a motion to compel the production of the allegedly privileged

documents, arguing that, “[i]n light of Illinois broad discovery rules, if there is any doubt” about

whether the documents should be produced, they should be produced. The circuit court ordered

Ingalls to articulate the reasons for its claims of privilege and provide the documents for an

in camera review. 1 Shortly thereafter, Ingalls produced the security department incident report

and the privilege file of Dr. Rita Oganwu for plaintiff, and it accordingly updated its privilege

log to include only the four remaining documents. Ingalls provided the remaining documents for

the court’s review.

¶ 12 All four documents contain the heading “Healthcare Safety Zone Portal” on the top of the

page, and all four bear the name “Clarity Group, Inc. Copyright” at the bottom of the page.

Generally, incident review No. 25472 detailed an incident that occurred on November 18, 2013,

and its aftermath involving Jones’s blood glucose levels while she was hospitalized at Ingalls.

The document appears to have been created on December 5, 2013. Incident review No. 25753

detailed an incident involving Jones that occurred while she was hospitalized at Ingalls, but does

not relate to her blood glucose treatment around November 17 and 18, 2013. The document

appears to have been created on January 8, 2014. Complaint No. 5101 detailed an in-person

complaint made by Gladys Galmore, the daughter of Jones, to an employee at Ingalls regarding

the treatment administered to Jones on November 18, 2013. Galmore’s complaint itself was

1
These documents have been included in the record on appeal under seal.

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received by Ingalls on December 4, 2013, and it appears the report was created on December 11,

2013. Lastly, complaint No. 5478 detailed an incident not relevant to this appeal.

¶ 13 Ingalls also responded to the circuit court’s order and plaintiff’s motion, arguing that,

under the Medical Studies Act and the Patient Safety Act, the documents were privileged. Under

the Patient Safety Act, Ingalls posited that the documents constituted patient safety work

product, as they were assembled for submission to a patient safety organization for the purpose

of improving patient safety and the quality of health care.

¶ 14 Ingalls attached an affidavit from Linda Conway, its associate general counsel, who

averred that, in 2009, Ingalls contracted with Clarity Patient Safety Organization (Clarity), a

federally certified patient safety organization, to conduct activities to improve the hospital’s

patient safety and quality of health care pursuant to the Patient Safety Act. Conway asserted that

the documents at issue were created, prepared, and generated for submission to Clarity for those

purposes. According to Conway, the documents were patient safety work product, and the

healthcare safety zone portal provided the means for Ingalls to report such work product to

Clarity.

¶ 15 Plaintiff did not reply to Ingalls’s filing.

¶ 16 On November 28, 2016, following a hearing on plaintiff’s motion to compel, the circuit

court granted the motion in part and denied the motion in part, requiring Ingalls to disclose only

the portions of the documents that it had circled, which were parts of incident review No. 25472,

incident review No. 25753, and complaint No. 5101. The court determined that the information it

circled was “obtained prior to the peer review” and thus discoverable. Ingalls’s attorney posited

that, while that may be the standard under the Illinois Medical Studies Act, it was not under the

federal Patient Safety Act, which required only that the work product be assembled for purposes

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of reporting to a patient safety organization and actually be reported. The circuit court responded

that, unless the information in the documents had been tendered to plaintiff in some other form,

such as medical records, Ingalls could not broadly assert a privilege on the information circled in

the documents. The court observed that the documents contained “some of plaintiff’s medical

history” and conversations with her family and that Ingalls could not simply use the documents

in peer review for purposes of shielding them from disclosure. The court, however, ordered

complaint No. 5478 not to be disclosed in its entirety.

¶ 17 Ingalls filed a motion to reconsider, focusing its argument entirely on the documents

being privileged under the Patient Safety Act. Ingalls attached a supplemental affidavit from

Conway, who averred that Ingalls maintained a patient safety evaluation system for purposes of

collecting information in order to report it to Clarity. She additionally stated that the information

contained in incident review No. 25472, incident review No. 25753, and complaint No. 5101 was

assembled, developed, and prepared “solely” for submission to Clarity and that Ingalls reported

the documents to Clarity through its healthcare safety zone portal. Conway added that the

documents were not Jones’s original medical records and Ingalls had produced all original

medical records to plaintiff. Conway asserted that the documents had never been removed from

the patient safety evaluation system for any purpose other than for internal quality purposes and

they had not been reported to, or investigated by, any other agency or organization other than

Clarity. Lastly, she stated that there were no other reports pertaining to the incidents alleged in

plaintiff’s complaint that were collected or maintained separately from Ingalls’s patient safety

evaluation system.

¶ 18 Plaintiff did not file a response, but during the hearing on the motion to reconsider, her

attorney asserted that this was because he was “not privy” to the documents and thus could not

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adequately address the Patient Safety Act’s application to them. The circuit court denied

Ingalls’s motion. Thereafter, Ingalls refused to comply with the court’s production order and

requested that the court find it in “friendly contempt” in order to facilitate appellate review of the

privilege issue. The court subsequently found Ingalls in contempt and imposed a sanction of $1.

¶ 19 Ingalls timely appealed the circuit court’s order finding it in contempt pursuant to Illinois

Supreme Court Rule 304(b)(5) (eff. Mar. 8, 2016), which provides for the appeal of contempt

orders imposing monetary sanctions. When a party appeals a contempt order based on a

discovery violation, the underlying discovery order also becomes subject to appellate review.

Harris v. One Hope United, Inc., 2015 IL 117200, ¶ 6.

¶ 20 During the pendency of this appeal, we allowed the Illinois Health and Hospital

Association, the American Medical Association, the Alliance for Quality Improvement and

Patient Safety, the Illinois State Medical Society, and Clarity to file a joint amicus curiae brief in

support of Ingalls. We also allowed the Illinois Trial Lawyers Association to file an amicus

curiae brief in support of plaintiff.

¶ 21 II. ANALYSIS

¶ 22 On appeal, Ingalls contends that the circuit court erred in ordering the disclosure of the

documents because they constitute patient safety work product and are privileged under the plain

language of the Patient Safety Act. Ingalls further contends that the Patient Safety Act’s privilege

protection on such work product preempts the court’s production order.

¶ 23 A. Whether the Documents Constitute Patient Safety Work Product

¶ 24 1. Discovery Generally

¶ 25 We begin by addressing the propriety of the circuit court’s discovery order, which

compelled the production of incident review No. 25472, incident review No. 25753, and

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complaint No. 5101. In plaintiff’s brief, she does not identify on what basis she had a right to the

documents, but in her motion to compel filed in the circuit court, she argued that they should be

discoverable because of “Illinois broad discovery rules.” Presumably plaintiff was referring to

our supreme court rules on discovery, particularly Rule 201(b), which defines the scope of

discovery in civil cases. See Ill. S. Ct. R. 201(b) (eff. July 1, 2014). Under the rule, “full

disclosure” is the default discovery rule with only a few delineated exceptions, and a party may

obtain discovery “regarding any matter relevant to the subject matter involved in the pending

action, whether it relates to the claim or defense of the party seeking disclosure or of any other

party, including the existence, description, nature, custody, condition, and location of any

documents or tangible things, and the identity and location of persons having knowledge of

relevant facts.” Ill. S. Ct. R. 201(b)(1) (eff. July 1, 2014).

¶ 26 One such exception to the full disclosure requirement is privileged documents. Ill. S. Ct.

R. 201(b)(2) (eff. July 1, 2014). Privileges are created “to protect interests outside the truth-

seeking process,” and therefore, they must “be strictly construed as exceptions to the general

duty to disclose.” Klaine v. Southern Illinois Hospital Services, 2016 IL 118217, ¶ 15. The

burden of establishing the applicability of a privilege is on the party seeking to invoke it, here

Ingalls. Eid v. Loyola University Medical Center, 2017 IL App (1st) 143967, ¶ 40. A party may

meet this burden by submitting the allegedly privileged materials for an in camera review or by

submitting affidavits setting forth facts sufficient to establish the applicability of the privilege to

the particular documents being withheld. Nielson v. SwedishAmerican Hospital, 2017 IL App

(2d) 160743, ¶ 39. Ingalls did both in this case.

¶ 27 2. Standard of Review

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¶ 28 Generally, we review an order of the circuit court compelling discovery for an abuse of

discretion. Klaine, 2016 IL 118217, ¶ 13. However, where a party challenges a discovery order

on the basis that documents are subject to a statutory privilege, the issue becomes one of

statutory construction, which is a question of law, and we therefore review the issue de novo. Id.

As this case causes us to interpret the Patient Safety Act, we are guided by well-settled principles

of statutory construction. The primary objective in construing a statute is to determine and give

effect to the intent of the legislature. Id. ¶ 14. “The most reliable indicator of legislative intent is

the language of the statute, given its plain, ordinary, and popularly understood meaning.” Id. If

the statute’s language is unambiguous, the statute must be interpreted as written without

resorting to any external aids of statutory construction. Id. Yet, we also must presume that the

legislature did not intend for the effect of a statute to cause absurd or unjust results. Id.

¶ 29 3. The Patient Safety Act

¶ 30 In 1999, the Institute of Medicine released a report titled “To Err Is Human: Building a

Safer Health System,” in which it estimated that as many as 98,000 Americans die every year as

a result of preventable medical errors. S. Rep. No. 108-196, at 2 (2003). The Institute of

Medicine concluded that most errors were triggered by failures of the health care system and

advocated for the creation of a reporting system “through which medical error information can

be identified, analyzed and utilized to prevent further medical errors.” Id. The Institute of

Medicine, however, observed the difficulty of obtaining participation in such a system because

“the threat of malpractice litigation discourages health care professionals and organizations from

disclosing, sharing, and discussing information about medical errors.” Id. Given this reluctance,

the Institute of Medicine recommended that Congress pass legislation that encouraged the

sharing of information but gave health care providers legal protection in return. Id.

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¶ 31 In 2005, partially in response to the Institute of Medicine’s report, Congress enacted the

Patient Safety Act. Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41,

119 Stat. 424 (codified at 42 U.S.C. § 299b-21 et seq.). The federal law created a system of

voluntary, confidential, and nonpunitive sharing of health care errors to facilitate and promote

strategies to improve patient safety and the quality of health care. Patient Safety and Quality

Improvement, 73 Fed. Reg. 70,732, 70,732 (Nov. 21, 2008) (to be codified at 42 C.F.R. pt. 3).

To facilitate the sharing of medical errors, Congress provided for the creation of patient safety

organizations, private or public entities certified by the United States Department of Health and

Human Services (HHS), to receive information about medical errors, analyze the errors, and

recommend strategies to health care providers to prevent such errors in the future. 42 U.S.C.

§§ 299b-21(4), 299b-24 (2012); S. Rep. No. 108-196, at 5 (2003); H.R. Rep. No. 109-197, at 9

(2005).

¶ 32 Aware that health care providers would be reluctant to share such sensitive patient safety

information, Congress included “privilege and confidentiality protections” to encourage the

sharing of “data within a protected legal environment, both within and across states, without the

threat that the information will be used against the subject providers.” Patient Safety and Quality

Improvement, 73 Fed. Reg. 70,732, 70,732 (Nov. 21, 2008) (to be codified at 42 C.F.R. pt. 3).

These protections were “the foundation to furthering the overall goal of the statute to develop a

national system for analyzing and learning from patient safety events.” Id. at 70,741.

¶ 33 To this end, in relevant part, the Patient Safety Act provides:

“Notwithstanding any other provision of Federal, State, or local law, and

subject to subsection (c) of this section, patient safety work product shall be

privileged and shall not be—

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(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[.]” 42

U.S.C. § 299b-22(a)(1), (2) (2012).

“Patient safety work product” is

“any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral

statements—

(i) which—

(I) are assembled or developed by a provider for reporting

to a patient safety organization and are reported to a patient safety

organization; or

(II) are developed by a patient safety organization for the

conduct of patient safety activities;

and which could result in improved patient safety, health care quality, or health

care outcomes; or

(ii) which identify or constitute the deliberations or analysis of, or

identify the fact of reporting pursuant to, a patient safety evaluation

system.” Id. § 299b-21(7)(A).

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Thus, this definition provides three distinct ways that information can become patient safety

work product. See Patient Safety and Quality Improvement Act of 2005—HHS Guidance

Regarding Patient Safety Work Product and Providers’ External Obligations, 81 Fed. Reg.

32,655, 32,656 (May 24, 2016) (to be codified at 42 C.F.R. pt. 3) (hereinafter Patient Safety Act

Guidance).

¶ 34 A “provider” includes large health care entities such as hospitals or nursing facilities as

well as individual providers such as physicians, nurse practitioners, or physical therapists. 42

U.S.C. § 299b-21(8) (2012). A provider’s overall process of collecting patient safety work

product in order to report the information to a patient safety organization is considered a “patient

safety evaluation system.” Id. § 299b-21(6). The Secretary of HHS compiles and maintains a list

of the federally certified patient safety organizations, and providers face fines of up to $10,000

each time they knowingly or recklessly disclose certain patient safety work product. Id. §§ 299b­

22(f)(1); 299b-24(d).

¶ 35 Here, there is no dispute that Ingalls, as a hospital, is a statutorily defined provider, nor is

there any dispute that Clarity is a federally certified patient safety organization. Consequently,

this appeal turns on whether the information contained in incident review No. 25472, incident

review No. 25753, and complaint No. 5101 constitutes patient safety work product.

¶ 36 4. Patient Safety Work Product

¶ 37 As discussed, there are three distinct ways that information can become patient safety

work product. See id. § 299b-21(7)(A). Ingalls argues that its documents constitute patient safety

work product under the first method, which is considered the “reporting pathway.” Patient Safety

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Act Guidance, 81 Fed. Reg. 32,655, 32,656 (May 24, 2016) (to be codified at 42 C.F.R. pt. 3).2

Under the reporting pathway, patient safety work product is “any data, reports, records,

memoranda, analyses (such as root cause analyses), or written or oral statements” that “are

assembled or developed by a provider for reporting to a patient safety organization and are

reported to a patient safety organization” and “which could result in improved patient safety,

health care quality, or health care outcomes.” 42 U.S.C. § 299b-21(7)(A)(i)(I) (2012). The

regulations substantially echo this formulation but add that the documentation must include the

date the information is entered into the patient safety evaluation system. 42 C.F.R. § 3.20 (2016).

Under the reporting pathway, the critical inquiry is the purpose of creating the information, and

the information will only be considering patient safety work product if it is created “for the

purpose of reporting” to a patient safety organization. (Emphasis in original.) Patient Safety Act

Guidance, 81 Fed. Reg. 32,655, 32,656 (May 24, 2016) (to be codified at 42 C.F.R. pt. 3).

¶ 38 Based on the plain language of the statute and regulations, there are four requirements

necessary for the broad class of information to be considered patient safety work product under

the reporting pathway: (1) the information must be developed by a provider for the purpose of

reporting to a patient safety organization; (2) that information must have the ability to improve

patient safety and the quality of health care; (3) that information must be reported to the patient

safety organization, though there is some leeway for “functional reporting” of the information

(see Patient Safety and Quality Improvement, 73 Fed. Reg. 70,732, 70,741 (Nov. 21, 2008) (to

be codified at 42 C.F.R. pt. 3)), which is not relevant to this appeal; and (4) the information

contains the date it was entered into the patient safety evaluation system.

2
While the interpretation of a statute by the agency charged with its administration is not binding
on courts, the interpretation is entitled to deference. Chevron, U.S.A., Inc. v. National Resources Defense
Council, Inc., 467 U.S. 837, 844 (1984).

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¶ 39 Although the Patient Safety Act provides protection for information constituting patient

safety work product, Congress did not intend the law to provide absolute protection for all

documents related to patient safety. See H.R. Rep. No. 109-197, at 9 (2005) (explaining that the

disclosure protections only apply to “certain categories of documents and communications”). In

turn, the Patient Safety Act contains a “Clarification” to the definition of patient safety work

product and lists two exceptions. 42 U.S.C. § 299b-21(7)(B) (2012).

¶ 40 Under the first exception, “[i]nformation described in [the general 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.” Id. § 299b-21(7)(B)(i). The

regulations do not expound on this exception. See 42 C.F.R. § 3.20 (2016). But the legislative

history of the Patient Safety Act explains that “there may be documents or communications that

are part of traditional health care operations or record keeping” such as “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.” H.R. Rep. No. 109-197, at 14

(2005). While “these original documents and ordinary information about health care operations

may be relevant to a patient safety evaluation system,” they “are not themselves patient safety

work product.” Id.; see also Patient Safety Act Guidance, 81 Fed. Reg. 32,655, 32,658 (May 24,

2016) (to be codified at 42 C.F.R. pt. 3) (stating that “original provider records” include

“[o]riginal records (e.g., reports or documents) that are required of a provider to meet any

Federal, state, or local public health or health oversight requirement regardless of whether such

records are maintained inside or outside of the provider’s [patient safety evaluation system]”).

¶ 41 Under the second exception, “[i]nformation described in [the general definition of patient

safety work product] does not include information that is collected, maintained, or developed

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separately, or exists separately, from a patient safety evaluation system. Such separate

information or a copy thereof reported to a patient safety organization shall not by reason of its

reporting be considered patient safety work product.” 42 U.S.C. § 299b-21(7)(B)(ii) (2012). In

other words, if information was created for “purposes other than reporting” to a patient safety

organization, it is not considered patient safety work product. Patient Safety Act Guidance, 81

Fed. Reg. 32,655, 32,656 (May 24, 2016) (to be codified at 42 C.F.R. pt. 3). The Patient Safety

Act created a protected system that does not replace, but rather resides alongside, external

collection activities mandated by state and federal laws and regulations. Id. at 32,657. For

example, “[i]nformation is not patient safety work product if it is collected to comply with

external obligations” such as “state incident reporting requirements,” “adverse drug event

information reporting to the Food and Drug Administration,” or “certification or licensing

records for compliance with health oversight agency requirements,” among other obligations.

Patient Safety and Quality Improvement, 73 Fed. Reg. 70,732, 70,742-43 (Nov. 21, 2008) (to be

codified at 42 C.F.R. pt. 3).

¶ 42 Although there could be instances where documents fit both exceptions, the crux of the

exceptions are that, where health care providers create records for more than one purpose, the

records themselves do not qualify as patient safety work product because the intent of the Patient

Safety Act “is to protect the additional information created through voluntary patient safety

activities, not to protect records created through providers’ mandatory information collection

activities.” Patient Safety Act Guidance, 81 Fed. Reg. 32,655, 32,655 (May 24, 2016) (to be

codified at 42 C.F.R. pt. 3). Where other laws require the reporting of health care information,

the burden is on providers to assemble separate and original information for purposes of meeting

those reporting requirements and then create additional information as part of their voluntary

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participation under the Patient Safety Act. See Patient Safety and Quality Improvement, 73 Fed.

Reg. 70,732, 70,743 (Nov. 21, 2008) (to be codified at 42 C.F.R. pt. 3) (“The final rule is clear

that providers must comply with applicable regulatory requirements and that the protection of

information as patient safety work product does not relieve a provider of any obligation to

maintain information separately.”); see also University of Kentucky v. Bunnell, 532 S.W.3d 658,

668 (Ky. Ct. App. 2017) (“When a provider participates in this voluntary program, the data it

generates for that program must be superfluous to the documentation necessary for patient care

or regulatory compliance.”). Health care providers should not commingle information necessary

to satisfy mandatory record keeping or reporting obligations with information used in their

voluntary participation under the Patient Safety Act. See Patient Safety Act Guidance, 81 Fed.

Reg. 32,655, 32,659 (May 24, 2016) (to be codified at 42 C.F.R. pt. 3) (recommending that a

provider maintain at least two separate systems, one where it maintains records necessary to

satisfy external obligations and the other, its patient safety evaluation system, where it maintains

patient safety work product).

¶ 43 Lastly, the statutory “Clarification” provides that

“[n]othing in this part shall be construed to limit—

(I) the discovery of or admissibility of information described in

this subparagraph in a criminal, civil, or administrative proceeding;

(II) the reporting of information described in this subparagraph to a

Federal, State, or local governmental agency for public health

surveillance, investigation, or other public health purposes or health

oversight purposes; or

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(III) a provider’s recordkeeping obligation with respect to

information described in this subparagraph under Federal, State, or local

law.” 42 U.S.C. § 299b-21(7)(B)(iii) (2012).

The regulations explain that this language simply means that “[n]othing in this part shall be

construed to limit information that is not patient safety work product from being” discovered in

civil proceedings, reported to other government agencies for public health purposes, or

maintained as part of a provider’s record-keeping obligations under any other law. 42 C.F.R.

§ 3.20 (2016).

¶ 44 5. Illinois Precedent on the Patient Safety Act

¶ 45 The only case in Illinois that has examined the Patient Safety Act is Department of

Financial & Professional Regulation v. Walgreen Co., 2012 IL App (2d) 110452, which was

filed four years before HHS issued additional guidance on the law. See Patient Safety Act

Guidance, 81 Fed. Reg. 32,655 (May 24, 2016) (to be codified at 42 C.F.R. pt. 3). In the case, the

Department of Financial and Professional Regulation (Department) issued three subpoenas to

Walgreen Company, requesting reports of medication error involving three pharmacists it

employed. Walgreen, 2012 IL App (2d) 110452, ¶ 3. Months later, after Walgreen failed to turn

over the reports, the Department filed a petition to enforce the subpoenas. Id. Walgreen

responded by filing a motion to dismiss, arguing that the requested reports were privileged under

the Patient Safety Act as patient safety work product. Id. ¶¶ 4-5. Walgreen attached an

uncontested affidavit to its motion from its vice president of pharmacy services, who averred that

Walgreen maintained reports containing information about improperly processed or filled

prescriptions. Id. ¶ 6. Walgreen created a report each time one of its pharmacists made a

prescription error and eventually submitted the reports to Walgreen’s patient safety organization.

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Id. In Walgreen’s reply to its motion to dismiss, it attached another uncontested affidavit where

its vice president of pharmacy services averred that the reports were the only ones created

pertaining to medication error. Id. ¶ 8. The circuit court ultimately found that the reports were

privileged patient safety work product and granted Walgreen’s motion to dismiss. Id. ¶¶ 10-11.

¶ 46 On appeal, the Appellate Court, Second District, observed that the Patient Safety Act

contained broad evidentiary protections to further the law’s intent to improve patient safety

through voluntary reporting of patient safety data. Id. ¶ 16. The court determined that the reports

were created by Walgreen for purposes of reporting the information contained in them to its

patient safety organization and that the reports were transmitted to the patient safety

organization. Id. ¶ 18. The court accordingly found the reports privileged under the Patient

Safety Act. Id. It did not, however, explicitly address the issue of preemption.

¶ 47 6. The Instant Case

¶ 48 In light of the Patient Safety Act, its regulations, the HHS guidance, and the decision in

Walgreen, incident review No. 25472, incident review No. 25753, and complaint No. 5101

constitute patient safety work product. Our review of these documents demonstrates that they are

an amalgamation of data, reports, discussions, and reflections, the very type of information that

is by definition patient safety work product. See 42 U.S.C § 299b-21(7)(A) (2012). The

affidavits from Linda Conway, Ingalls’s associate general counsel, establish that the documents

were assembled and prepared by Ingalls “solely” for submission to Clarity and they were

reported to Clarity. See id. § 299b-21(7)(A)(i)(I); Bunnell, 532 S.W.3d at 690 (finding that,

where a report “was created for the sole purpose of submission” to a patient safety organization

“in accordance with” the Patient Safety Act “and for no other use whatsoever,” the report was

patient safety work product). Furthermore, based on Conway’s affidavits, the information

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contained in the documents had the ability to improve patient safety and the quality of health

care, and the documents themselves bear the dates information was entered into the patient safety

evaluation system. See 42 U.S.C § 299b-21(7)(A)(i)(I) (2012); 42 C.F.R. § 3.20 (2016).

Therefore, the documents satisfied the requirements of patient safety work product.

¶ 49 Plaintiff, however, argues that these documents met three of the statutory exceptions to

patient safety work product. See 42 U.S.C § 299b-21(7)(B) (2012). First, plaintiff posits that

information required to be in a patient’s medical record is excluded from the definition of patient

safety work product and thus not privileged. Under the Hospital Licensing Act, hospitals

licensed in Illinois must create a medical record for each patient. 210 ILCS 85/6.17(a) (West

2016). The medical record must be “adequate, accurate, timely, and complete.” 77 Ill. Adm.

Code 250.1510(b)(2) (2017). The medical record must contain at a minimum several items,

including, “[d]iagnostic and therapeutic reports on laboratory test results, x-ray findings, any

surgical procedure performed, any pathological examination, any consultation, and any other

diagnostic or therapeutic procedure performed,” “[o]rders and progress notes made by the

attending physician and, when applicable, by other members of the medical staff and allied

health personnel,” “[o]bservations notes and vital sign charting made by nursing personnel,” and

“[c]onclusions as to the primary and any associated diagnoses.” Id.

¶ 50 As we interpret the Patient Safety Act, the “medical records” exception to patient safety

work product means that, if a document is created for purposes of reporting to a patient safety

organization and that document references medical records, the original medical records

themselves do not become part of the patient safety work product merely by being referenced.

Instead, those records remain discoverable. According to HHS’s final rule, while “information

underlying an analysis may be protected,” “underlying information that is original medical

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records may not be protected if it is excluded by the definition of patient safety work product.”

Patient Safety and Quality Improvement, 73 Fed. Reg. 70,732, 70,743 (Nov. 21, 2008) (to be

codified at 42 C.F.R. pt. 3). In other words, if the information related to a patient’s care or

treatment is created as part of the patient’s original medical record, that information is not patient

safety work product. See Patient Safety Act Guidance, 81 Fed. Reg. 32,655, 32,657 (May 24,

2016) (to be codified at 42 C.F.R. pt. 3). But, if that same information is included within

documents that are intended to be submitted to a patient safety organization, the documents

containing the information are privileged. See id. Thus, contrary to plaintiff’s argument, merely

because information required to be in Jones’s medical record might also be contained in the

documents at issue, this fact does not mean the documents themselves are no longer patient

safety work product.

¶ 51 Plaintiff further asserts that, based on the circuit court’s comments following its review of

the documents, it appears that information that should have been included in Jones’s medical

record, but was not, was instead only contained within the allegedly privileged documents.

Highlighting what she considers “a large gap of time” and “ambiguity” in the care Jones received

from Ingalls, plaintiff posits that the medical records currently disclosed during discovery “are

almost entirely silent on the most important issues for approximately [seven] hours.” In light of

this, plaintiff insinuates that Ingalls had a nefarious intent when creating Jones’s medical records

and sought to abuse the Patient Safety Act by improperly concealing valuable health care

information under the guise of patient safety work product to the detriment of the original

medical records.

¶ 52 However, we cannot assume Ingalls violated its record-keeping requirements based on

supposition. Ingalls’s participation in the Patient Safety Act does not obviate its requirements to

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create an adequate, accurate, timely, and complete medical record for each patient. See id.

(“[T]he Patient Safety Act does not permit providers to use the privilege and confidentiality

protections for [patient safety work product] to shield records required by external recordkeeping

or reporting requirements.”). If Ingalls fails to properly record certain information mandated by

law, there are associated consequences. See, e.g., 210 ILCS 85/7(a) (West 2016) (providing that

a hospital who fails to comply with the requirements of the Hospital Licensing Act, such as

properly creating a patient’s medical record, risks losing its operating license).

¶ 53 Furthermore, as Ingalls notes, the documents were not created contemporaneously with

any treatment of Jones and were actually created more than two weeks after November 17 and

18, 2013, the critical time period according to the complaint. Ingalls further highlights that the

author of the documents referenced reviewing Jones’s actual medical records followed by a

description of the data obtained from the records. We additionally reiterate that all three

documents bear the notations of Ingalls’s healthcare safety zone portal and “Clarity Group, Inc.

Copyright.” Based on Conway’s affidavits, which establish that the documents were created

solely for the purpose of submission to Clarity, the Healthcare Safety Zone Portal was the means

of transmission to Clarity and the documents were actually submitted to Clarity, it is clear these

documents were created for the specific purpose of submission to a patient safety organization.

See Bunnell, 532 S.W.3d at 672 (finding in part that, where a record was “created post-care for

the specific purpose of submission to a [patient safety organization,]” the “subject matter” of the

report was the event summarized in the report, “not the patient identified in the report” and,

accordingly, the report did not constitute an original patient record). Consequently, nothing in the

record leads us to believe that the documents were Jones’s original medical records or contained

information that should have been included in her original medical records.

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No. 1-17-0891

¶ 54 Plaintiff next argues that the documents fall under a second exception to the definition of

patient safety work product, positing that, based on the circuit court’s comments following its

review of them, it appears that the information contained in the documents was not collected

solely for the purpose of reporting to a patient safety organization. Plaintiff highlights the court’s

statement that, while the documents were created for peer review, the content of the documents

was “obtained prior to the peer review.” As such, plaintiff asserts that these comments show the

information in documents was created for a purpose other than for reporting directly to Clarity,

including possibly for peer review under the Illinois Medical Studies Act, which Ingalls initially

stated as a reason the documents were privileged.

¶ 55 As previously discussed, another exception to the definition of patient safety work

product is information collected, maintained, or developed for a purpose other than reporting to a

patient safety organization. 42 U.S.C. § 299b-21(7)(B)(ii) (2012). However, plaintiff ignores the

unrebutted supplemental affidavit submitted by Ingalls, wherein Conway averred that the

information in the documents was assembled, developed, and prepared “solely” for submission

to Clarity, averments that we must accept as true. See Nielson, 2017 IL App (2d) 160743, ¶ 39;

see also Walgreen, 2012 IL App (2d) 110452, ¶ 18 (rejecting a similar argument based on an

unrebutted affidavit). Consequently, nothing in the record leads us to believe that the information

in the documents was assembled, developed, or prepared for a purpose other than reporting to

Ingalls’s patient safety organization.

¶ 56 Lastly, plaintiff argues that the documents fall under a third exception to the definition of

patient safety work product. Citing to section 299b-21(7)(B)(iii)(II) of the Patient Safety Act (42

U.S.C. § 299b-21(7)(B)(iii)(II) (2012)), plaintiff posits that any information collected to satisfy a

reporting requirement to a state agency is not patient safety work product. In turn, plaintiff

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highlights the Illinois Adverse Health Care Events Reporting Law of 2005 (Adverse Events

Law), which requires Illinois hospitals to report an adverse health care event to the Illinois

Department of Public Health within 30 days of the event. 410 ILCS 522/10-10, 10-15 (West

2016).

¶ 57 Initially, we note that plaintiff misconstrues section 299b-21(7)(B)(iii)(II) of the Patient

Safety Act (42 U.S.C. § 299b-21(7)(B)(iii)(II) (2012)). As discussed earlier, this subsection is

not an exception to the definition of patient safety work product but, rather, a clarification on

what the legislation does not prohibit. The regulations explain that this subsection simply means

that “[n]othing in this part shall be construed to limit information that is not patient safety work

product from being” discovered in civil proceedings, reported to other government agencies for

public health purposes, or maintained as part of a provider’s record-keeping obligations under

any other law. 42 C.F.R. § 3.20 (2016). Rather, plaintiff’s argument here falls under the second

exception of the definition of patient safety work product (see 42 U.S.C. § 299b-21(7)(B)(ii)

(2012)), where “[i]nformation is not patient safety work product if it is collected to comply with

external obligations” such as “state incident reporting requirements.” Patient Safety and Quality

Improvement, 73 Fed. Reg. 70,732, 70,742 (Nov. 21, 2008) (to be codified at 42 C.F.R. pt. 3).

Regardless of this misconstruction, plaintiff posits that, because Ingalls had a reporting

obligation under the Adverse Events Law, the information reported to Clarity under the Patient

Safety Act can no longer be considered patient safety work product.

¶ 58 In Charles v. Southern Baptist Hospital of Florida, Inc., 209 So. 3d 1199, 1205-06 (Fla.

2017), a hospital sought to shield certain adverse medical incident records from disclosure to a

plaintiff. But the Supreme Court of Florida held that, because Florida’s statutes and

administrative rules required health care providers to create and maintain adverse medical

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incident reports, the hospital’s reports “were not created solely” for the purpose of providing

them to a patient safety organization and thus not patient safety work product. Id. at 1216.

Similarly, in Tibbs v. Bunnell, 448 S.W.3d 796, 798 (Ky. 2014), a group of physicians sought to

shield from disclosure to a plaintiff an incident report created by a surgical nurse shortly after a

patient died during surgery. But the Supreme Court of Kentucky held that, because Kentucky’s

administrative regulations required incident investigation reports and the postincident report

contained information that normally would be found in a report required by the regulations, the

postincident report was not privileged despite the report being created in the physicians’ patient

safety evaluation system. Id. at 809.

¶ 59 Plaintiff would like for us to find just as the courts in Charles and Tibbs did, but as

observed by Ingalls, Illinois’s Adverse Events Law is not even operational at this point.

According to the law, the Illinois Department of Public Health was required to establish an

adverse health events reporting system by January 1, 2008 (410 ILCS 522/10-30(a) (West

2016)), but as of today, the law has not been implemented. See Adverse Health Care Events, Ill.

Dep’t of Pub. Health, http://dph.illinois.gov/topics-services/prevention-wellness/patient-safety­

quality/adverse-health-care-events#laws-rules (last visited June 25, 2018) (stating that the Illinois

Department of Public Health “is in the process of implementing this Act”). Thus, on the dates

relevant to the complaint, Ingalls had no obligation to report any adverse health care events

under the Adverse Events Law, rendering plaintiff’s argument meritless.

¶ 60 In sum, plaintiff has failed to demonstrate that these documents fall under an exception to

the definition of patient safety work product. But still, she and the Illinois Trial Lawyers

Association, as amicus curiae in support of plaintiff, believe that allowing these documents to

remain privileged would allow health care providers to hide valuable information and thus

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impede the truth-seeking process. However, nothing about these documents being privileged

renders the facts that underlie the patient safety work product as also privileged. Plaintiffs can

still obtain medical records, as plaintiff did in this case, have their experts analyze and make

opinions about those records, and depose doctors and nurses regarding an incident. See Jenkins

v. Wu, 102 Ill. 2d 468, 479 (1984) (finding that, while privileged protections under the Illinois

Medical Studies Act may deny plaintiffs access to documents in a medical malpractice case, the

denial “should have little impact” on plaintiffs’ abilities to maintain such causes of action

because they can obtain their medical records, “depose all persons involved in their treatment

and engage experts to give opinions as to the quality of care received”). When there is no

indication that a health care provider has failed to comply with its external record-keeping and

reporting requirements and it creates supplementary information for purposes of working with a

patient safety organization to improve patient safety and the quality of health care, that provider

is furthering the Patient Safety Act’s objectives while not preventing the discovery of

information normally available to a medical malpractice plaintiff. Under these circumstances,

that additional information must be protected from disclosure.

¶ 61 B. Preemption

¶ 62 Having concluded that incident review No. 25472, incident review No. 25753, and

complaint No. 5101 are patient safety work product, we next must determine whether the Patient

Safety Act preempts the circuit court’s production order of the documents. See Diaz v. Provena

Hospitals, 352 Ill. App. 3d 1165, 1171 (2004) (after concluding that the federal Health Care

Quality Improvement Act of 1986 required a hospital to file a report on a doctor, determining

whether the federal law preempted the circuit court’s orders to the contrary). As mentioned, the

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court’s production order was presumably based on the full disclosure discovery rule found in our

supreme court rules. See Ill. S. Ct. R. 201(b) (eff. July 1, 2014).

¶ 63 The supremacy clause of the United States Constitution provides that the laws of the

United States “shall be the supreme Law of the Land” and “any Thing in the Constitution or

Laws of any State to the Contrary notwithstanding.” U.S. Const., art. VI. Under the supremacy

clause, state action is “ ‘without effect’ ” where it conflicts with federal law. Busch v. Graphic

Color Corp., 169 Ill. 2d 325, 334 (1996) (quoting Maryland v. Louisiana, 451 U.S. 725, 746

(1981)). A federal statute will preempt state action in any of three circumstances: “(1) express

preemption—where Congress has expressly preempted state action; (2) implied field

preemption—where Congress has implemented a comprehensive regulatory scheme in an area,

thus removing the entire field from the state realm; or (3) implied conflict preemption—where

state action actually conflicts with federal law.” Carter v. SSC Odin Operating Co., 237 Ill. 2d

30, 39-40 (2010). Whether a federal law preempts state action is a question of law, and we

therefore review the question de novo. Kinkel v. Cingular Wireless, LLC, 223 Ill. 2d 1, 15

(2006).

¶ 64 Preemption is not favored (Bishop v. Burgard, 198 Ill. 2d 495, 501 (2002)), and because

of this, we generally begin with the presumption that Congress did not intent to preempt contrary

state action. Performance Marketing Ass’n v. Hamer, 2013 IL 114496, ¶ 50 (citing Maryland,

451 U.S. at 746). However, if a federal statute contains an express preemption clause, we do not

apply such a presumption. Puerto Rico v. Franklin California Tax-Free Trust, 579 U.S. ___,

___, 136 S. Ct. 1938, 1946 (2016). Thus, we begin by determining whether or not the Patient

Safety Act contains an express preemption clause.

¶ 65 The Patient Safety Act states:

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“Notwithstanding any other provision of Federal, State, or local law, and

subject to subsection (c) of this section, patient safety work product 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[.]” (Emphasis added.) 42 U.S.C. § 299b-22(a)(1), (2) (2012).

This language is clearly an express preemption clause. See Bunnell, 532 S.W.3d at 665 (stating

that the Patient Safety Act uses “the language of federal preemption”). Additionally, in State

Bank of Cherry v. CGB Enterprises, Inc., 2012 IL App (3d) 100495, aff’d, 2013 IL 113836, we

found an express preemption clause with similar wording. There, this court determined that the

federal Food Security Act of 1985 (7 U.S.C. § 1631(d) (2006)) contained “a clear expression of

an intent to preempt state law” when the federal law used the language: “ ‘Except as provided in

subsection (e) of this section and notwithstanding any other provision of Federal, State, or local

law ***.’ ” (Emphasis in original.) Cherry, 2012 IL App (3d) 100495, ¶¶ 14-16

(quoting 7 U.S.C. § 1631(d) (2006)). The language used in the Food Security Act is identical to

that of the Patient Safety Act.

¶ 66 Despite our finding that the Patient Safety Act contains an express preemption clause, our

inquiry does not end, as such language informs “us that Congress intended to supersede or

modify state law to some extent, but courts must still deal with the task of determining the

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substance and scope of Congress’ displacement of state law.” Performance Marketing, 2013 IL

114496, ¶ 51. “If the text of a preemption provision is open to more than one plausible reading,

courts ordinarily accept the reading that disfavors preemption.” Id.

¶ 67 Here, the express preemption clause in the Patient Safety Act demonstrates Congress’s

intent to supersede any court order requiring the production of documents that meet the

definition of patient safety work product. See Quimbey v. Community Health Systems

Professional Services Corp., 222 F. Supp. 3d 1038, 1043 (D.N.M. 2016) (finding that “the

express language of the [the Patient Safety Act] demonstrates Congressional intent to preempt”

any state laws providing for less protection of documents that constitute patient safety work

product); Patient Safety and Quality Improvement, 73 Fed. Reg. 70,732, 70,774 (Nov. 21, 2008)

(to be codified at 42 C.F.R. pt. 3) (stating that the Patient Safety Act “generally preempt[s] State

or other laws that would permit or require disclosure of information contained within patient

safety work product”).

¶ 68 Furthermore, section 299b-22(g)(5) of the Patient Safety Act (42 U.S.C. § 299b-22(g)(5)

(2012)) provides that nothing in the law should be construed as “preempting or otherwise

affecting any State law requiring a provider to report information that is not patient safety work

product.” In other words, when information is patient safety work product, the Patient Safety Act

should be construed as preempting any state action requiring a provider to disclose such work

product. Lastly, plaintiff’s argument on the preemption issue buttresses our conclusion, as she

only argues that, because the documents are not patient safety work product, the law cannot

preempt the court’s production order. With this argument, plaintiff, in essence, tacitly concedes

the preemptive effect of the Patient Safety Act on the discovery order. Consequently, the Patient

Safety Act preempts the circuit court’s production order.

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No. 1-17-0891

¶ 69 We briefly note the Supreme Court of Florida’s decision in Charles, where, during

discovery, the plaintiff filed requests for production pursuant to Florida’s “Amendment 7,” a

provision in the Florida Constitution that provided patients a right to access any adverse medical

incident records created by a health care provider in the course of business. Charles, 209 So. 3d

at 1203-05 (citing Fla. Const., art. X, § 25(a)). Although potentially responsive to the request, the

hospital refused to produce adverse medical incident records based on them being privileged

under the Patient Safety Act. Id. at 1206. The plaintiff moved to compel the production of the

documents, which the circuit court granted, finding that the documents were not patient safety

work product. Id.

¶ 70 On appeal to the Supreme Court of Florida, after finding that the documents were not

patient safety work product and not privileged, the court analyzed the preemption issue and

ultimately found neither express nor implied preemption of “Amendment 7.” Id. at 1213-16.

Concerning express preemption, the court simply held: “[T]he documents to which citizens have

a right to access pursuant to Amendment 7 are not patient safety work product under the Federal

Act’s definition. Accordingly, the Federal Act does not contain any express statement of

preemption relating to Amendment 7.” Id. at 1213. The court did not discuss express preemption

any further beyond this holding.

¶ 71 Although we do not quite follow the legal reasoning employed in Charles to find that the

Patient Safety Act did not contain an express preemption provision, we nevertheless find Charles

plainly distinguishable from the instant case. First, the documents at issue in this case are patient

safety work product. And second, plaintiff has failed to identify any similar Illinois constitutional

provision mandating a patient’s right to access his or her medical records like Florida’s. But to

the extent that the Supreme Court of Florida would find that the Patient Safety Act does not

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contain an express preemption provision with respect to documents that are patient safety work

product, we disagree. As previously discussed, the Patient Safety Act contains an unambiguous

express preemption clause (see 42 U.S.C. § 299b-22(a) (2012)), which clearly demonstrates

Congress’s intent to supersede any circuit court order requiring the production of documents that

meet the definition of patient safety work product. See Quimbey, 222 F. Supp. 3d at 1043;

Bunnell, 532 S.W.3d at 665; Patient Safety and Quality Improvement, 73 Fed. Reg. 70,732,

70,774 (Nov. 21, 2008) (to be codified at 42 C.F.R. pt. 3).

¶ 72 C. Contempt Finding

¶ 73 Lastly, Ingalls appealed this case pursuant to Illinois Supreme Court Rule 304(b)(5) (eff.

Mar. 8, 2016), which allows the appeal of contempt findings. As discussed, when a party appeals

a contempt order based on a discovery violation, the underlying discovery order also becomes

subject to appellate review. Harris, 2015 IL 117200, ¶ 6. “If the discovery order is invalid, then

the contempt order, for failure to comply with that discovery order, must be reversed.” In re

D.H., 319 Ill. App. 3d 771, 773 (2001). As the discovery order in this case was invalid, we must

reverse the circuit court’s order finding Ingalls in contempt based on its failure to comply with

the discovery order.

¶ 74 III. CONCLUSION

¶ 75 For the foregoing reasons, the orders of the circuit court of Cook County are reversed and

the matter is remanded for further proceedings.

¶ 76 Reversed and remanded.

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