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Posted by Sharlene Hunt

Last week, the Appellate Division issued its decision in a case involving the scope of the confidentiality provisions of the New Jersey Patient Safety Act.  The Patient Safety Act, or PSA, requires licensed health care facilities to develop patient safety plans to improve the health and safety of patients within their facilities.  The patient safety plan must meet several requirements, including a requirement that there be a process to analyze events occurring within the facility that result in unintended injury or illness, which may or may not have been preventable, or which are “near-misses” of such events.  The PSA also provides that materials and information developed as part of this process are not subject to discovery or admissible in evidence in any civil, criminal or administrative matter.

The case before the Appellate Division, C.A. v. Bentolila, involved the issue of whether certain documentation developed by the hospital defendant was discoverable under either the PSA or under the so-called common-law privilege of self-critical analysis.  The self-critical analysis privilege applies to traditional peer review and quality improvement activities in hospitals, and applies a balancing approach, balancing one party’s need to know the information against the other party’s need to maintain the confidentiality of the information.

The case decided last week provides an analysis of the interplay between the confidentiality provisions under the PSA and the privilege of self-critical analysis.  Despite this analysis, because of the similarity of the activities required under the PSA and the activities required for peer review and quality improvement, and due to the highly factual analysis undertaken by the Court, there will remain many unanswered questions about the PSA privilege into the future.

In essence, the court upheld the absolute privilege to be applied to information developed under the PSA.  However, in doing so, Court issued several caveats to this holding, which will limit the application of the privilege, and will require the courts going forward to examine the factual scenario and the process followed in each case, to determine whether the privilege should apply.  Unfortunately, the end result will be that hospitals and other health care facilities will continue to face uncertainty as to whether actions they take under the PSA will be covered by the privilege.

In issuing its holding, the Court limited the application of the absolute privilege only to situations in which the information is developed exclusively under the PSA.  This issue of exclusivity is not as clear cut as it may seem, and will depend on the facts involved in any given scenario.  For example, in the case before the Court, the Director of Patient Safety was also involved in conducting investigations under the hospital’s quality improvement process, and could not, under cross-examination, explain how he distinguished investigations under the two programs.  The Court found that this blurring of functions and responsibilities weakened the hospital’s claim that the information in question was protected by the PSA privilege.

The Court also stressed that in order to retain the PSA privilege, a health care facility must adhere strictly to the requirements of the PSA and related regulations.  Whether a facility has complied with the PSA can also be driven by the facts.  For example, the Appellate Division found that the hospital had departed from the statutory requirements because no physicians were involved in reviewing the incident in question.  The event under review raised issues of whether there had been physician error.  The PSA requires review by teams comprised of various disciplines with “appropriate competencies.”  Since physician error was a potential issue, the Court found that the “appropriate competencies” included physicians in this particular case.

Of special note is a comment in a footnote, in which the Court stated that if information is developed through the PSA process but then “voluntarily disseminated within the hospital thereafter for a non-PSA use (such as a quality assurance program or for peer review), then the item is subject to potential disclosure” under laws applicable to non-PSA materials.  This footnote seems to require health care facilities to conduct parallel investigations if an event requires a PSA review and review under the facility’s quality assurance or peer review processes, which creates the potential for conflict between the PSA process and other processes designed to promote patient health and safety.

Due to the importance of strict compliance with the statutory and regulatory requirements, legal counsel should be consulted in creating and implementing PSA processes within a health care facility.  However, even with legal involvement, due to the highly fact specific analysis undertaken by the Court in this case and apparently to be applied by the courts considering the application of this privilege, uncertainty will remain as to the ultimate outcome in any given scenario.


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