Case law update
The PSQIA of 2005 does not require that privileged information be kept solely for provision to a Patient Safety Organization to be inadmissible in court Dr. Tara Loux filed an employment discrimination suit against her former employers BayCare Medical Group and St. Joseph's Hospital (collectively “BayCare”), after she was terminated due to surgical errors. As part of her lawsuit, she sought to discover BayCare's internal documents about the performance of other doctors who were not fired despite also committing errors. In response, BayCare argued that some of these files were privileged under the Patient Safety and Quality Improvement Act of 2005 (PSQIA). Specifically, BayCare objected to disclosing documents, such as its “quality files” and “referral logs,” that are stored in its secure electronic database. The PSQIA The Act creates a statutory privilege for work product prepared for or reported to patient safety organizations.1 Patient safety organizations analyze patient safety trends and propose new methods to providers to mitigate medical risks in the care process. Congress created the privilege to encourage the reporting and analysis of medical errors and health care systems by providing peer review protection of information reported to patient safety organizations for the purposes of quality improvement and patient safety, so an environment exists in which health care providers are able to discuss errors openly and learn from them. The PSQIA provides that “patient safety work product” cannot be “subject to discovery in connection with a Federal, State, or local civil … proceeding ….”2 More specifically, the PSQIA defines “patient safety work product” as, in relevant part, “any data, reports, records, memoranda, analyses, … or written or oral statements” that (1) “are assembled or developed by a provider for reporting to a patient safety organization and are reported” or (2) otherwise “identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.”3 The PSQIA excludes from its protection, among other things, “information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.”4 BayCare introduced evidence at trial about how it decides whether to make reports to a patient safety organization. In short, the quality care coordinator uses the information that is secured in the electronic database to generate a quality file which is separate from the information in the secure database. The quality file contains descriptions of the event and records the coordinator's analysis, including informal “peer review” such as input from department heads about whether there was a deviation in the standard of care and any corrective action taken by BayCare. The quality care coordinator will also analyze whether the concern was significant enough to forward to the Clinical Risk Department, the final step in BayCare's complaint evaluation process, which sends reports to a patient safety organization and then works with the organization to develop new safety protocols. BayCare has never used any of the files kept in the secure database to meet any external reporting obligation. However, it concedes that it uses information stored in a secure database for more than just reporting to a patient safety organization. In fact, multiple BayCare teams can access the stored information internally for risk management, quality assurance, peer review, or root cause analysis. After reviewing the contested documents and conducting a hearing, the magistrate judge recommended that the district court treat the documents as privileged under the PSQIA as patient safety work product. The district court, however, disagreed with the magistrate and ordered BayCare to provide Dr. Loux the disputed documents. It concluded that the PSQIA does not privilege documents if they have a “dual purpose,” only one of which relates to making reports to a patient safety organization. Based on that legal conclusion, the district court held that these documents were not privileged, since they were not “solely” for reporting to a patient safety organization. The district court also expressed concern that Dr. Loux would be “unable to have proper litigation discovery” without the documents. Accordingly, the court ordered BayCare to produce the quality files and referral logs. This case is based on BayCare's appeal for a writ of mandamus to the U.S. District Court for the Middle District of Florida. Does the peer review/patient safety work product privilege only apply when the documents sought are not solely for the purpose of reporting to a patient safety organization? The U.S. Court of Appeals reviewed the plain text of the PSQIA statute. In doing so, it concluded that nowhere in the text does it state that the data that BayCare is claiming as privileged can only be used for reporting to a patient safety organization, so there was no basis for the district court to impose that requirement. All BayCare must do is show that the disputed documents “identify or constitute the deliberations or analysis of” BayCare's process of “collect[ing], manag[ing], or analy[zing] information for reporting to or by a patient safety organization”5 to claim the privilege. Therefore, the quality documents and logs were privileged and not discoverable in Dr. Loux's case, and the decision of the district court was reversed. This case clarifies some interpretations of the PSQIA that quality improvement documents can be used for purposes other than reporting to a patient safety organization. Indeed, many risk and quality professionals use quality improvement reports for other patient safety purposes, such as root cause analyses, quality studies, and risk reduction analyses and activities. Under this decision, risk professionals can continue to use quality data and information in this way, as long as it is in furtherance of patient safety. As with any quality improvement function, it always helps the “privilege” argument when there is also a system pathway for reporting quality improvement activities and studies to the quality committee and eventually, to the Board of Directors or Trustees. This, of course, does not mean that quality data and information can be used by and disclosed to anyone in your organization. Strict protocols regarding who can access quality data and why they can access it should be observed to maintain the peer review privilege. Failure to maintain strict protocols can result in a court ruling the documents and data are not privileged because the information has been widely dispersed to various people and, therefore, is no longer kept confidential. Risk professionals should review their organization's protocols to ensure they are sufficiently strict and properly followed, as risk professionals will likely be the seekers of the privilege in court. In re: BayCare Medical Group Inc., Case No. 23–12571 (U.S. Ct. App. Mid.D. FLA. May 14, 2024). Idaho's near-abortion ban is not consistent with the EMTALA requirement to provide stabilizing care when a patient presents to the emergency room with an emergency medical condition An Idaho law (Idaho Code §18-622) prohibits abortions unless necessary to prevent a pregnant woman's death; the law makes no exception for abortions necessary to prevent grave harm to the woman's health, except that it allows for two very narrow affirmative defenses for physicians who are accused of violating the law. The relevant exception is that an abortion can be performed to save the life of the mother. Before the law could take effect, the Federal Government sued the State under the Emergency Medical Treatment and Labor Act (EMTALA). That law requires a Medicare-funded hospital to provide essential care to patients experiencing medical emergencies. The Government's suit contended that EMTALA preempts the Idaho abortion law in a narrow class of cases: when the state law bars a hospital from performing an abortion needed to prevent serious health harms, not just the death of the mother. The Federal District Court, believing the Government was likely to prevail in its suit, entered a preliminary injunction. During the year that the injunction was in place, women in Idaho were able to obtain abortions in medical emergencies. Idaho meanwhile sought to get the injunction lifted. When the Court of Appeals for the Ninth Circuit declined to stay the injunction, Idaho filed an emergency application with the U.S. Supreme Court. The Supreme Court stayed the injunction and granted Idaho's petition for certiorari before judgment. With that stay in effect, Idaho could enforce its abortion ban even when terminating a pregnancy was necessary to prevent grave harm to the woman. Ultimately, the Supreme Court ruled to vacate the stay and dismiss the writ of certiorari before the judgment. With the Supreme Court's writ of certiorari dismissed, the lower courts can proceed with litigation in the regular course. And with the Supreme Court's stay dissolved, the District Court's preliminary injunction again took effect, meaning that Idaho is prevented from enforcing its abortion ban when the termination of a pregnancy is needed to prevent serious harm to a woman's health. Does an abortion law violate EMTALA even if it is found constitutional under a state's constitution? EMTALA requires hospitals to provide emergency medical treatment when a person presents to the emergency department with an emergency medical condition. Under this Supreme Court ruling, abortions are included in the realm of emergency medical treatment that a hospital must provide, despite the state law, Idaho Code §18-622, that prohibits it. When federal law and state law are in conflict, the federal law preempts the state law. Here, the federal law and Idaho law are in conflict about the treatment of pregnant women facing health emergencies, so Idaho is not likely to win on the merits of their case, allowing for the stay to be lifted. For risk professionals, this case continues to unfold. As such, it is incumbent on risk professionals to be fully informed on the current state of the law affecting the delivery of health care in their locality. This will allow risk professionals to be the “go to” resource when our health care organizations need guidance on best practices and organizational policies and procedures. Risk professionals should work with their legal counsel to remain up-to-date on cases and laws in their states. Under the enterprise risk management model, risk professionals may be called upon to assist their organizations in guiding them through regulatory and clinical domains so that their organizations can ensure they are using best and compliant practices. Moyle v. United States, 603 U. S. ____ (2024) issued 6/27/2024. A patient fall lawsuit sounds in professional liability, not ordinary negligence, if it is within the course of treatment Somsak Limprasert was diagnosed with COVID-19 and acute hypoxic respiratory failure, among other illnesses, for which he received acute care from a hospital. He was subsequently transferred or admitted to respondent PAM Specialty Hospital of Las Vegas, LLC (PAM), for rehabilitation and treatment for the effects of COVID-19, respiratory failure, cough, fever, and general malaise. He remained at PAM for approximately 1 month. While at PAM, Mr. Limprasert was bedridden and unable to stand without support. PAM and individuals including nurse practitioners, caregivers, medical professionals, staff members, and/or employees, agents, or independent contractors working for PAM, and who were pleaded as fictitious Doe defendants, were aware that Mr. Limprasert was unable to stand without being supported. On August 3, 2020, PAM's workers assisted Mr. Limprasert to rise from his bed. Then, they unexpectedly let go of him while he was in a standing position, which caused him to fall to the ground and suffer injuries. Mr. Limprasert filed a complaint against PAM on August 3, 2021, asserting claims of negligence and abuse of the vulnerable. In the alternative, he asserted claims against PAM under Nevada's medical malpractice statutes. However, Mr. Limprasert failed to attach the supporting declaration of Stewart Curtis, D.O., to his complaint. On September 9, 2021, PAM filed a motion to dismiss. The following day, Mr. Limprasert filed an erratum to his complaint with Dr. Curtis's declaration attached. The erratum was therefore filed after the 1-year statute of limitations had run on his professional negligence claims. Following a hearing, the district court found that Mr. Limprasert's claims sound in professional negligence, that Mr. Limprasert filed his complaint without the required supporting declaration of an expert witness, and that the erratum was not filed at the same time as the complaint. Thus, the district court granted PAM's motion to dismiss. Mr. Limprasert appealed, and the court of appeals determined that the district court erred by dismissing Mr. Limprasert's complaint because it alleged facts that could entitle him to relief under ordinary negligence principles. Additionally, the court of appeals found the district court erred by dismissing Mr. Limprasert's professional negligence claims because he complied with the Nevada professional liability statute. The court of appeals reversed and remanded the case to the district court. PAM petitioned the Supreme Court of Nevada for judicial review, and they granted the petition. This case is a summary of the Supreme Court's ruling. Does a lawsuit resulting from a patient falling with injuries while receiving treatment from caregivers sound in general negligence or professional liability? Mr. Limprasert argued in this case that his claims sound in ordinary negligence because the negligence alleged does not involve medical judgment, treatment, or diagnosis and would not require expert testimony at trial. The Nevada Legislature defines professional negligence by statute as'the failure of a provider of health care, in rendering services, to use the reasonable care, skill or knowledge ordinarily used under similar circumstances by similarly trained and experienced providers of health care'.6 This definition suggests that a claim arising from services rendered within the course of the relationship between a patient and a health care provider sounds in professional negligence. Under Nevada law, to determine whether a claim sounds in professional negligence, the question is whether the claim pertains to an action that occurred within the course of a professional relationship. If it does not, the claim is for ordinary negligence. If it does, the claim sounds in professional negligence and requires an affidavit unless a statutory exception applies. The court further opined that whether a claim sounds in ordinary negligence or professional negligence focuses on the nature of the conduct rather than on the complexity of proving a claim. Therefore, the sole inquiry is whether the claim involves a provider of health care rendering services in a way that causes injury, not whether an expert affidavit or expert testimony is needed for a jury to understand the allegations. The court then looked at the nature of the conduct alleged by Mr. Limprasert and ruled that it was clear that his claims sound in professional negligence. Mr. Limprasert's complaint alleges PAM knew that he was bedridden and unable to stand without support. It further alleges that PAM workers did not follow reasonable policies and procedures and that Mr. Limprasert relied on them to follow the doctor's orders with respect to his weakness and inability to care for himself. Additionally, Mr. Limprasert averred in his complaint that PAM negligently assisted him by helping him rise from his bed to change his and then unexpectedly go of him while he was in a standing position, which caused him to fall to the ground and suffer injuries. The court therefore ruled that there was no that PAM is a provider of health care and that Mr. was a his and him to stand the process were services that PAM to Mr. Limprasert while he was and Thus, based on Mr. Limprasert's the court concluded his claims in professional negligence. the court reviewed whether Mr. Limprasert's professional liability case required an affidavit to be filed with it. Under Nevada law, an affidavit is required to be filed with a professional liability case, and expert testimony is required to a professional liability case, except in narrow cases are cases cases a would be able to that negligence has such as or and to a part not in The court concluded that Mr. Limprasert's case did not meet any of the and, therefore, an affidavit was required to be filed in his professional liability the court reviewed whether the affidavit would be as do this the court reviewed the of the affidavit and found that it was by Mr. Limprasert's expert before the complaint was the court found that the complaint the affidavit and it by As such, the court ruled that PAM had at of was in the affidavit and that they were not by its after the of the statute of Therefore, the of the affidavit the for it under Nevada law. The Supreme Court of reversed the decision of the Court of Risk professionals must assist in claims it is not clear if they sound in professional liability or general cases are general liability, such as or cases from cases are not so clear when they involve conduct that may or may not from a treatment, even if they are medical care, such as in this this case can provide a following the that a professional liability claim from the nature of the not whether or not expert testimony is Risk professionals should meet with their to discuss a professional liability claim a general liability claim under their This then can be used in the organization on of liability in the provision of health Limprasert v. PAM Specialty Hospital of Las Vegas, No. When a access to medical records to whether there is negligence, the statute of limitations may be the records are received under the was admitted on to and LLC While at developed a He was transferred from to a hospital on September and the following September death due to as the cause of she as a of clear or from about records from after received the records in with an in because she was whether there was any by A medical negligence lawsuit was filed on the lawsuit it was by the statute of The statute of limitations for medical malpractice from (1) the of the alleged or (2) the in which with reasonable the alleged negligence have been or The the statute of limitations when the patient has no to the doctor's negligence caused However, a must facts to show was in the circumstances the to from the argued the the statute of limitations at when she received the medical records in The trial court with that the statute of limitations had and the Does the the statute of limitations while a to medical records in a case there is no clear of The Supreme Court the application of the to be a process that requires a analysis of and when the knew about any alleged of negligence. The Supreme Court that can in the of negligence, so a patient or is in to whether there was any negligence. If the patient had no to the was a result of negligence, the will In this case, had only general about health and his very This information of the of negligence necessary to the of the statute of The Supreme Court found that was able to take of the because she to in the medical records and then the services of an The Court also that while it was not an in this case, the application of the to the statute of limitations in of a when there is an by the in providing the medical records to a While of limitations provide some about the time in which an organization negligence the the is for Risk the may also be by significant in providing medical records, Risk professionals should with the of department to make that to litigation are and while not to the statute of limitations it is about why she to an in her that she sought the services of an because of she as the of about the circumstances to As Risk professionals, understand that with patients and after or can provide them with and This the need to an as the way to get v. No. Emergency as a result of COVID-19 the statute of to allow time for a medical negligence to Emergency on of fever, and The providers in diagnosed as from an While in the issued a the was not to the upon by was from the 1 after the with to follow in condition and the following she to a was admitted to the in remained in the for As a result of the that required the of of her and has a statute of for medical negligence. In case, the statute of would on filed suit against for negligence in the lawsuit in the to in the it was by the statute of In 2020, the time litigation was the Supreme Court issued a Emergency or other time by statute for civil cases due to the COVID-19 In to argument that she was argued the Emergency her statute of and her was The trial court with on the basis that the Emergency did not of The Court of Appeals found in of The Supreme Court took the to the Emergency the statute of for medical Emergency or other time or In to this general the included a of of to be the concluded with a for other legal as determined to be necessary by the judicial argued that the Emergency did not of in its of to be so case should be In for the Supreme Court held that the Emergency did in fact have the of legal including of even not called in the The clear and meaning of as as case law that the statute of is a and within the Emergency state courts emergency orders and procedures. This case that courts in the same state can the application of these emergency orders This for health care providers and their professional liability who have been able to on and for of limitations and of will likely continue to legal appeals to COVID-19 emergency judicial v. Inc., is the of at is the of Risk at
Authors
- Christopher J. Allman (ORCID: https://orcid.org/0000-0002-7281-6258)
- Maggie Neustadt (ORCID: https://orcid.org/0009-0009-1421-1726)
Institutions
- BJC HealthCare (US)
Publication Details
- Journal
- Journal of Healthcare Risk Management
- Published
- 2024-10-17
- DOI
- https://doi.org/10.1002/jhrm.21584
- Primary Topic
- Health Services Management and Policy
- Type
- article
- Field-Weighted Citation Impact
- 0.00