Court Opinion

ID: 5283353
Source: CourtListenerOpinion
Date Created: 2022-01-06 23:49:50.764442+00
Date Added: 2024-06-11T08:28:27.555611
License: Public Domain

ABRAMSON, J.,
dissenting:
Respectfully I dissent. Although I agree with much of what Justice Scott has to say about the Patient Safety and Quality Improvement Act’s (PSQIA, the Patient Safety Act, or the Act) history, I believe the Court has given too little regard to the Act’s purpose, has misconstrued the privilege the Act creates, and thereby has undercut the Act’s effectiveness in advancing patient safety in Kentucky. The Act envisions a national medical error reporting *810system apart from and insulated from the fault-based tort (professional liability) and peer-review (professional discipline) systems, a system that will enhance patient care by identifying systemic failures in health care delivery through the vast collection and analysis of pertinent data. Participation in what has come to be referred to as the “patient safety” approach to medical errors will be discouraged if the attendant privilege is not strictly construed as Congress intended. The majority’s decision allows Kentucky judges to sift through federally protected patient safety data for otherwise discoverable material under state law, and thus, frustrates the Act’s intent. That said, I agree that the Patient Safety Act was never intended to displace state law and that Kentucky clearly requires hospitals to maintain incident investigation reports and other records which are discoverable by a patient or her estate. A hospital’s participation in the national reporting system created by the Patient Safety Act does not excuse compliance with those state record-keeping requirements. In my view, patients continue to have access to those records available to them under Kentucky law prior to the Patient Safety Act but now, as then, the source of the records must be the hospital’s state-mandated internal record system and not the in-house patient safety system or data clearinghouse used by the hospital to participate voluntarily in the PSQIA.

RELEVANT FACTS

Underlying the discovery dispute at issue here is a medical malpractice action brought by the estate of Luvetta Goff against three surgeons who performed back surgery on Ms. Goff at the University of Kentucky Hospital in January 2011. Ms. Goff died during the procedure, and the estate alleges that her death was caused by the surgeons’ negligence. Following Ms. Goffs death, a hospital nurse entered a post-event report into the hospital’s Patient Safety Evaluation System, an information collection and management system implemented at the hospital pursuant to the Patient Safety Act. When the estate made a discovery demand that the report be disclosed, the defendants moved for a protective order on the ground that under the Act the report is privileged.
The trial court denied the defendants’ motion, whereupon the defendants sought mandamus relief in the Court of Appeals. That Court agreed with the defendants to the extent of recognizing a federal privilege under the Act independent of any state-law privileges, but ruled that the federal privilege applies only to “documents that contain a self-examining analysis.” Accordingly the Court remanded the matter to the trial court with instructions to review the nurse’s report in camera and to grant or to deny discovery based on its view of whether the report contained such an analysis.
Arguing that the Court of Appeals read a limitation into the Patient Safety Act’s privilege that Congress did not put there, the defendants have asked this Court to correct its ruling and to order the trial court simply to deny discovery of the nurse’s report. The majority agrees that the Court of Appeals improperly rewrote the federal statute, but then undertakes its own revision and holds that the federal privilege does not apply to information “normally contained” in a state-mandated incident report. The majority authorizes the trial judge to conduct an in camera review to extract that “information normally contained in an incident report.”19 *811While I agree that patients or their estates are entitled to that information, I strongly disagree with this manner of obtaining it.

ANALYSIS

As the Court recounts, Congress passed the PSQIA, 42 U.S.C. §§ 299b-21—299b-26, in 2005 in response to wide-spread concerns that an alarming number of preventable medical errors result not from or not primarily from a particular practitioner’s carelessness, the sort of error the tort and peer-review systems respond to and seek to deter, but rather from systemic failures. Randall R. Bovbjerg and Robert H. Miller, Paths to Reducing Medical Injury: Professional Liability and Discipline vs. Patient Safety—and the Need for a Third Way, 29 J.L. Med. & Ethics 369 (2001) (discussing the 1999 Institute of Medicine’s report, To Err is Human: Building a Safer Health System, and its spawning of the “patient safety” movement); Frederick Levy, M.D., J.D., et al., The Patient Safety and Quality Improvement Act of 2005: Preventing Error and Promoting Patient Safety, 31 J. Legal Med. 397 (2010) (discussing the PSQIA as a congressional response to patient-safety-movement concerns). Hoping to borrow from the non-fault-based systems approach to safety improvement successfully employed by other industries, in particular the aviation industry, Congress created a system whereby health care providers can (the system is entirely voluntary) establish an in-house “patient safety evaluation sys-tern” for the “collection, management, or analysis” of patient safety-related information. 42 U.S.C. § 299b-21(6). The providers may then submit the collected information to data clearing houses referred to in the Act as Patient Safety Organizations (PSOs). 42 U.S.C. § 299b-24. The PSOs in turn, having rendered the data submitted to them nonidentifiable, provide it to “a network of patient safety databases,” which “shall have the capacity to accept, aggregate across the network, and analyze nonidentifiable patient safety work product.” 42 U.S.C. § 299b-23. This network-wide aggregation and analysis is intended to enable researchers to identify flaws in health care delivery practices and to recommend improvements to the health care providers. The purpose of the Act, as explained in the Senate Report accompanying the Act’s very similar 2003 version, is thus
to encourage a “culture of safety” and quality in the U.S. health care system by providing for broad confidentiality and legal protections of information collected and reported voluntarily for the purposes of improving the quality of medical care and patient safety. These protections will facilitate an environment in which health care professionals and organizations report and evaluate health care errors and share their experiences with others in order to prevent similar occurrences.
Senate Report No. 108-196, at 3 (Nov. 2003).20
*812Plainly, the success of the system is contingent upon the willingness of providers to supply safety-related information, including information about errors and near errors, to the PSOs. Accordingly the Act seeks to encourage provider participation by protecting their information. Specifically the Act provides in pertinent part as follows:
Notwithstanding any other provision of Federal, State, or local law, ... 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;
(3) subject to disclosure pursuant to section 552 of Title 5 (commonly known as the Freedom of Information Act) 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 rule making proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider, or
(5) admitted in a professional disciplinary proceeding of a professional disei-plinary body established or specifically authorized under State law.
42 U.S.C. § 299b-22(a). The intent to assure providers that their participation in the patient safety system is not to be used against them in either the tort or the peer-review system could hardly be clearer. Indeed, the Senate Report accompanying the 2003 version of the Act explained that the legislation
establishes confidentiality protections for this written and oral patient safety data to promote the reporting of medical errors. As a result, health care providers will be able to report and analyze medical errors, without fear that these reports will become public or be used in litigation. 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.
Senate Report 108-196 at 5.
On the other hand, the patient safety system fashioned by the PSQIA is not intended to supplant or to disable in any way the existing state-law tort and peer-review systems. This intent emerges from Congress’s careful distinction between “patient safety work product,” to which the privilege applies, and records or information existing apart from the patient safety system, to which state law discovery rules continue to be applicable:
Patient safety work product
(A) In general
*813Except as provided in subparagraph (B), the term “patient safety work product” means any data, reports, records, memo-randa, analyses (such as root cause anal-yses), 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.
(B) Clarification
(i) Information described in subpara-graph (A) does not include a patient’s medical record, billing and discharge information, or any other original patient or provider record.
(ii) Information described in subpara-graph (A) does not include information that is collected, maintained, or developed 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.
(iii) Nothing 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 (III) a provider’s recordkeeping obligation with respect to information described in this subpara-graph under Federal, State, or local law.
42 U.S.C. § 299b-21(7). The Act’s privilege thus applies to anything—data, reports, analyses, statements, etc.—processed within a patient safety evaluation system for submission to a PSO. It does not apply, however, to records, reports, and other information existing separately from the Act’s patient safety system.
Discussing this distinction, the Secretary of the Department of Health and Human Services, the agency responsible for implementing the PSQIA, has explained that
The Department recognizes that the Patient Safety Act’s protections are the foundation to furthering the overall goal of the statute to develop a national system for analyzing and learning from patient safety events. To encourage voluntary reporting of patient safety events by providers, the protections must be substantial and broad enough so that providers can participate in the system without fear of liability or harm to reputation. Further, we believe the protections should attach in a manner that is as administratively flexible as permitted to accommodate the many varied business processes and systems of providers and to not run afoul of the statute’s express intent to not interfere with other Federal, State, or local reporting obligations on providers.
73 FR 70741 (emphasis supplied). Or, as the Senate Committee explained
The committee finds that broad protections are essential to encourage reporting. Currently, there are few incentives and many barriers for providers to collect and report information regarding patient safety. The primary barrier relates to concerns that information shared to promote patient safety would expose providers to liability. Unless this information can be freely shared, *814errors will continue to be hidden and errors will be repeated. A more open, nonpunitive learning environment is needed to encourage health care professionals and organizations to identify, analyze, and report errors without facing the threat of litigation and, at the same time, without compromising plaintiffs’ legal rights or affecting existing and future public reporting initiatives with respect to the underlying data.
Senate Report 108-196 at 7.
To those ends,
The Patient Safety Act establishes a protected space or system that is separate, distinct, and resides alongside but does not replace other information collection activities mandated by laws, regulations, and accrediting and licensing requirements as well as voluntary reporting activities that occur for the purpose of maintaining accountability in the health care system.
73 FR 70742. To give effect to this separate, protected system,
Generally, information may become patient safety work product when reported to a PSO. Information may also become patient safety work product upon collection within a patient safety evaluation system. Such information may be voluntarily removed from a patient safety evaluation system if it has not been reported and would no longer be patient safety work product. As a result, providers need not maintain duplicate systems to separate information to be reported to a PSO from information that may be required to fulfill state reporting obligations. All of this information, collected in one patient safety evaluation system, is protected as patient safety work product unless the provider determines that certain information must be removed from the patient safety evaluation system for reporting to the state. Once removed from the patient safety evaluation system, this information is no longer patient safety work product.
73 FR 70742 (emphasis added). The Act is not intended to and does not displace state law, for
when laws or regulations require the reporting of the information regarding the type of events also reported to PSOs, the Patient Safety Act does not shield providers from their obligation to comply with such requirements. These external obligations must be met with information that is not patient safety work product and oversight entities continue to have access to this original information in the same manner as such entities have had access prior to the passage of the Patient Safety Act. Providers should carefully consider the need for this information to meet their external reporting or health oversight obligations, such as for meeting public health reporting obligations. Providers have the flexibility to protect this information as patient safety work product within their patient safety evaluation system while they consider whether the information is needed to meet external reporting obligations. Information can be removed from the patient safety evaluation system before it is reported to a PSO to fulfill external reporting obligations. Once the information is removed, it is no longer patient safety work product and is no longer subject to the confidentiality provisions.
73 FR 70742 (emphasis added). Until it is removed, however, such as by inclusion in a medical or hospital record or in a separately required report, information collected and being assessed in the patient safety evaluation system or information submitted to a PSO retains its federal protection.
What then about a provider who fails to generate a state-mandated record or re*815port, a record or report a civil plaintiff would like to see, as in this case? The remedy cannot be, as either the Court of Appeals or the majority would have it, that a trial court may then rummage through the provider’s patient safety evaluation system and PSO submissions in search of documents that do not “contain a self-examining analysis” or information “normally contained” in separate records and reports.21 Such a remedy would completely undermine Congress’s assurance to providers that they may participate in the patient safety system without fear of liability or harm to reputation. It is hard to imagine a holding more at odds with Congress’s clear intent to foster provider trust in the patient safety system. See Dep’t of Fin. & Prof l Regulation v. Walgreen Co., 361 IlLDec. 186, 970 N.E.2d 552 (IlLApp. 2012) (holding that incident reports submitted by a pharmacy to its PSO were privileged under the Act).
The remedy for a recalcitrant provider is not to seek judicial assistance in disregarding the terms and the clear intent of the Patient Safety Act. Instead, a provider’s failure under state law to report or to record may be remedied as the Secretary noted, in “the same manner as ... [it could have been remedied] prior to the passage of’ the Act. The estate, of course, has not alleged that the hospital has breached a state-law duty to report,22 but because various regulations require that providers generate incident reports, it maintains, and the majority has acceded to this, that it should be allowed access to anything incident-report-like within the hospital’s patient safety evaluation system.
As explained above, however, that is not how the Act’s privilege is meant to operate. Under the Act, state law governs a patient or her representative’s access to records and reports existing outside the patient safety evaluation system, and state law may well entitle an interested party to demand that a required record or report be generated. That pertinent information has been placed in the patient safety evaluation system would be no answer to such a demand. The federal privilege, however, precludes an adverse party’s—and a trial court’s—invasion of the patient safety evaluation system itself, since under the Patient Safety Act providers must be assured that their participation in the patient safety system will not subject them to adverse consequences. As the Senate Report explained,
‘protecting data in a reporting system ... does not mean that the plaintiff in a lawsuit could not try to obtain such information through other avenues if it is important in securing redress for harm, it just means that the plaintiff would not be assisted by the presence of a reporting system designed specifically for other purposes beneficial to society.’ Importantly, the bill does not alter existing rights or remedies available to injured patients. Laws that provide greater confidentiality or privilege protections are also not affected by this legislation.
*816Senate Report 108-196 at 8(quoting from the Institute of Medicine’s 1999 report, To Err is Human).
The Act, in other words, should have no bearing, one way or the other, on the state’s medical malpractice liability system. A provider’s submission of materials to a patient safety evaluation system or to a PSO does not shield it from state law record-keeping and reporting obligations, but neither should it expose it to state law liabilities. The majority’s failure to recognize the latter as well as the former of these facts will destroy the balance Congress has sought to create and will discourage participation in-the patient safety system by Kentucky’s healthcare providers. While the hospital could be compelled to prepare the incident report required by state law and such a report would be discoverable, the Court’s willingness to short-circuit those determinations and to permit the invasion of the hospital’s patient safely evaluation system violates the PSQIA. As the matter currently stands, I would grant the writ the defendants seek.

CONCLUSION

In sum, with the PSQIA, Congress has sought to provide for the healthcare industry an error-analyzing capacity that draws on safety data collected from healthcare providers throughout the country. This non-fault-based approach to identifying and mitigating safety hazards, an approach that has come to be referred to as “patient safety,” is modeled on similar data collecting and analyzing systems successfully employed in other industries. The system depends on provider candor, and since that candor will be inhibited to the extent that it is apt to be used against the provider in a malpractice setting, the PSQIA creates a broad privilege for information within the patient safety system. Significantly, the privilege does not excuse providers from state record-keeping and report-filing requirements, nor does it impact state-law discovery rules respecting those records and reports. It does, however, protect provider safety data until it is published somehow outside the patient safety system. By disregarding the purpose of the PSQIA, and by misconstruing the privilege it creates, the Court undermines Kentucky’s healthcare providers’ full participation in the patient safety system and to that extent, at least, both frustrates Congress’s intent and denies Kentuckians the benefits of PSQIA’s approach to healthcare safety. I respectfully dissent.
MINTON, C.J., joins.

. In addition to disregarding the clear import of the Act, this in camera review raises *811serious practical concerns since judges, not typically being medically trained, may have difficulty identifying what information is normally contained in an incident report. Judicially created “incident reports” are no substitute for the real thing prepared by trained medical professionals.

. As the majority correctly notes, the 2003 Senate version of the legislation (S.720) is not the version ultimately enacted in 2005. It was, however, a very close precursor of that version, both in its general purposes and structure and in its specific terms. See Robert A. Kerr, The Patient Safety and Quality Improvement Act of 2005: Who Should Pay For Improved Outcomes, 17 Health Matrix 319, 328 (2007) (noting that the 2005 version of the Act was to a large extent simply a reintroduction of the Senate’s 2003 version). In particular, S. 720 provided a privilege for *812"patient safety data” identical to the Act's privilege for "patient safety work product,” defined "patient safety data” in terms nearly identical to those in the Act defining “patient safety work product,” and similarly limited that definition so as not to include "information (including a patient's medical record) that is collected or developed separately from and that exists separately from patient safety data. Such separate information or a copy thereof submitted to a patient safety organization shall not itself be considered as patient safety data.” Senate Report No. 108-196, at 24. The Report accompanying S. 720, in other words, provides, in my view, meaningful insight into the congressional intent animating the PSQIA.

. This case concerns what the Court refers to as a mandated incident report, but as Goffs brief demonstrates, there is nothing in the Court’s reasoning that would prevent the trial court from looking for and disclosing information “normally contained” in any required record or report whatsoever.

. The estate acknowledges, in fact, that it has been provided with Ms. Goffs medical records. It alleges that the records are incomplete, but rather than asserting that the trial court should be free to sift through the hospital’s patient safety evaluation system for information "normally contained” in medical records, it recognizes that any dispute over the medical records is "a fight for another day.” So should be any dispute over allegedly missing incident reports.