Slap: Kentucky Court Case Could Slam Door on Patient Safety Information

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Published on
June 17, 2013

There’s an understandable amount of discussion around the disclosures of email and cellphone traffic being collected by U.S. intelligence agencies. But free speech enthusiasts may also want to pay attention to the unfolding legal case involving the University of Kentucky.

The outcome could have significant consequences for journalists and patient safety advocates.

When I wrote the university earlier this month for clarification on its lawsuit against a now-former public radio reporter, the university’s General Counsel William E. Thro provided a thorough explanation of the university’s position. It is rooted in federal law, and, if successful with the Kentucky courts, could set some powerful legal precedents. I’ve posted the full response for your review. I’m also going to dissect it in more detail in a few posts, starting with the idea that the Patient Safety and Quality Improvement Act of 2005 allows health care organizations to keep truckloads of information secret.

I am going to quote at length from Thro’s letter to me because the legal finer details are important and could prove to be the keys to whether the door to patient safety information remains open or is slammed shut.

Thro wrote:

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). The PSQIA provides that “patient safety work product shall be privileged and shall not be . . . subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding.” 42 U.S.C. § 299b–22(a). The purpose of this privilege is to provide “protections [that] will enable all health care systems, including multi-facility health systems, to share data within a protected legal environment, both within and across states, without the threat that the information will be used against the subject providers.” Final Rule, Dep't of Health & Human Servs., Patient Safety and Quality Improvement, 73 Fed. Reg. 70732 (Nov. 21, 2008) (effective Jan. 19, 2009). The statute is clear and unambiguous as to the scope of the privilege:

(A) PRIVILEGE. – Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c), 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, United States Code (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 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 U.S.C. § 299b-21 (7)(A) (emphasis added).

But surely the federal law doesn’t prevent state oversight agencies from gaining access to this patient safety information, right? Thro says otherwise:

Indeed, the PSQIA precludes disclosure of Patient Work Safety Work Product to state regulatory agencies. See Illinois Dep't of Fin. & Prof'l Regulation v. Walgreen Co., 970 N.E.2d 552, 558 (Ill. App. 2012). Moreover, substantial civil penalties are imposed for the disclosure of Patient Safety Work Product.  42 U.S.C. § 299b-22(f)(1). 

OK. But from this line of logic, it would seem that any piece of information that involves patients would be considered a secret. That can’t possibly be true. If so, health care would transform from a field where data collection and analysis are daily leading to quality improvements to a field where what happens in a health care organization becomes a complete mystery, even to people inside the organization.

Thro gives a little ground here, writing:

Of course, not every source of information is within the scope of the PSQIA privilege. The application of the PSQIA privilege turns on whether the information at issue constitutes Patient Work Safety Product. Under the terms of PSQIA, Patient Safety Work Product is defined as:

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

(i) which—

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

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.

 42 U.S.C. § 299b-21(7)(A) (emphasis added).

Note that the language here focuses tightly on the intent of the records. The records must be created “for reporting to a patient safety organization and are reported to a patient safety organization; or are developed by a patient safety organization for the conduct of patient safety activities.”

I’ll write later about some court precedents that hinge on this point. Have your own thoughts on whether patient safety information should be secret? Send them my way at askantidote [at] gmail [dot] org. Or via Twitter @wheisel.

Image by StockMonkeys.com via Flickr

Here are more of Heisel's posts on the University of Kentucky court case:

Slap: University of Kentucky Sues Its Own Public Radio Reporter

Slap: University of Kentucky Has Threatened A Reporter Before

Slap: University Says It Sued Reporter to Protect Patients

Slap: University Fighting Access to Patient Safety Records on All Fronts