A recent ruling in Rumsey v. Guthrie Med. provides positive support for those providing candid analysis of patient safety events without fear of discovery and all with the intent to improve patient safety and quality of healthcare.
In September, a Pennsylvania court ruling found that Richard Rumsey, a patient who sued for medical malpractice for failure to test or treat him for a MRSA infection following an elective hospital procedure, was not permitted to access information pertaining to the hospital's infection prevention efforts in accordance with the protection afforded to patient safety work product (PSWP), pursuant to the Patient Safety and Quality Improvement Act of 2005 (PSQIA).
Rumsey alleged the provider was negligent in failing to test or treat him for an MRSA infection that became more severe following the procedure. In the course of his medical malpractice suit, Rumsey sought discovery of information pertaining to the hospital's infection prevention procedures, analysis and protocols. He did this both through written discovery and in verbal questions to the hospital's infection prevention specialist during the infection prevention analyst's deposition.
The court ruled that the information he sought was properly patient safety work product, within the facility's patient safety evaluation system (PSES) and thereby within the protection afforded by the federal PSQIA. The PSQIA provides federal privilege and confidentiality protections for patient safety information, unparalleled by any prior confidentiality, privilege and protection vehicles previously afforded by state or federal law.
Passed in 2005 with the final Regulations effective in 2009, the PSQIA established a voluntary reporting system that supports the collection, analysis, sharing and learning from incidents, near misses and unsafe conditions for uniform reporting of patient safety events. It encourages the expansion of voluntary, provider-driven initiatives to improve the quality and safety of healthcare, promotes rapid learning about the underlying causes of risks and harm in the delivery of healthcare, and thereafter shares those findings widely, hopefully thereby speeding the pace of patient safety improvement. In sum, patient safety organizations (PSOs) do all of the following:
- Aggregate data from many providers to identify risk patterns of care and system failures.
- Allow providers to work together in a confidential, privileged and protected space.
- Are not a regulatory body and do not impose fines or other punitive results for participation with a PSO.
- Assure participating providers their safety work will not be used against them.
The final regulations, or the Patient Safety Rule, implement the PSQIA. It further delineates the Act and the privilege and confidentiality protections for patient safety work product, as well as further information on how to separate PSWP from the rest of the larger organization.
The Court in the Rumsey v. Guthrie Med. case explained that "[t]he patient safety work product privilege is intended to promote candor in patient safety evaluations from clinicians who may otherwise mince their words out of fear of malpractice litigation. The hope is that enabling blunt criticism will help to stem the staggering number of deaths from preventable medical errors each year - which at least one study estimated was the third leading cause of death in the United States."
Judge Matthew W. Brann, United States District Judge for the Middle District of Pennsylvania, ended his letter opinion in this same case by stating "[t]he patient safety work product privilege is a quiet corner of the room, not a private island. The statutes carve an exception to the presumption of free and open disclosure to facilitate a specific, carefully designed process of disclosure. If they are cautious to remain within the confines of the patient safety evaluation system, medical professionals may provide the brutally honest feedback hospitals need to keep their patients safe without fear of its use in litigation."
Plaintiff Rumsey was denied access to the hospital's infection prevention information as it was properly created patient safety work product within the facility's patient safety evaluation system and thereby confidential and protected by the PSQIA.
This case is another win for the Patient Safety and Quality Improvement Act and for those many hospitals and providers across the United States who are participating with a Patient Safety Organization. This case is evidence of the privilege and protection intended to be afforded to candid, open discussions with the intent to improve patient safety and the quality of healthcare for all receiving medical services in the United States. This Court clearly understood the privilege and protection intended by the federal law for properly created patient safety work product.
Molly A. Huffman and Colin Luke are partners with Waller Lansden Dortch & Davis LLP.