Although fear and speculation are hitting a fever pitch, as of the publication of this writing, the coronavirus has yet to directly affect the southeastern United States in a significant way. However, my email in-box has been flooded in recent weeks with updates from the Centers for Disease Control, state health departments, various healthcare industry groups, including long-term care industry groups. This daily barrage of emails is comforting in one respect, and ominous in another. It is good to see that the government and health care industry recognize the potential threat and appear to be taking action. However, commentary on the effectiveness of government action will be left to political pundits and scientists.
As a lawyer who regularly represents healthcare providers, including healthcare providers in correctional settings and long-term care settings, I anticipate medical malpractice litigation in the wake of the virus. Although litigation may arise from healthcare providers’ failure to properly treat a patient once the patient has contracted the virus, plaintiff lawyers will also scrutinize healthcare providers’ infection control policies, procedures, and protocol. Healthcare providers’ actual follow-through and implementation will also be the subject of scrutiny.
Healthcare Quality Assurance
Healthcare providers anticipate this risk as well. Providers are conducting meetings and exchanging ideas through quality control/assurance committees and infection control committees. Despite those efforts, healthcare providers may experience the spread of coronavirus in a healthcare facility and may become the subject of medical malpractice claims. During discovery, the plaintiff will want to know:
- What did the healthcare facility know about the coronavirus?
- When did they know it?
- What policies, procedures, and protocols were in place to mitigate the risk?
- Were those steps within the applicable standards of care?
- Did the healthcare facility properly implement policies, procedures, and protocols to mitigate the risk?
The Plaintiffs’ bar will likely seek answers to these questions through discovery requests targeting information and documents generated by a health care facility’s quality control/assurance committees and infection control committees.
Healthcare facilities must balance the need to prepare for a coronavirus outbreak with the risk of fueling after-the-fact second-guessing by plaintiff lawyers who may seek discovery of internal discussions within the facility. Internal discussions and planning for an unpredictable event can be messy and chaotic at times. The old saying: “People love sausage but don’t like to see it being made” comes to mind. So, how does a healthcare facility balance these competing concerns and encourage open discussion of this potentially serious threat?
Many states have healthcare quality assurance statutes protecting quality assurance documents and information from discovery. Quality assurance statutes encourage open and honest discussions in evaluating the quality of medical care, and medical standards. In Alabama, health care quality assurance privileges arise from two statutes:
Ala. Code § 22–21–8
Ala. Code § 22–21–8. Confidentiality of accreditation, quality assurance credentialing materials, etc.:
(a) Accreditation, quality assurance, and similar materials as used in this section shall include written reports, records, correspondence, and materials concerning the accreditation or quality assurance or similar function of any hospital, clinic, or medical staff. The confidentiality established by this section shall apply to materials prepared by an employee, advisor, or consultant of a hospital, clinic, or medical staff and to materials prepared by an employee, advisor or consultant of an accrediting, quality assurance or similar agency or similar body and to any individual who is an employee, advisor or consultant of a hospital, clinic, medical staff or accrediting, quality assurance or similar agency or body.
(b) All accreditation, quality assurance credentialing and similar materials shall be held in confidence and shall not be subject to discovery or introduction in evidence in any civil action against a health care professional or institution arising out of matters which are the subject of evaluation and review for accreditation, quality assurance, and similar functions, purposes, or activities. No person involved in preparation, evaluation or review of accreditation, quality assurance or similar materials shall be permitted or required to testify in any civil action as to any evidence or other matters produced or presented during the course of preparation, evaluation, or review of such materials or as to any finding, recommendation, evaluation, opinion, or other action of such accreditation, quality assurance or similar function or other person involved therein. Information, documents, or records otherwise available from original sources are not to be construed as being unavailable for discovery or for use in any civil action merely because they were presented or used in the preparation of accreditation, quality assurance or similar materials nor should any person involved in the preparation, evaluation, or review of such materials be prevented from testifying as to matters within his knowledge, but the witness testifying should not be asked about any opinions or data given by him in preparation, evaluation, or review of accreditation, quality assurance or similar materials.
Ala. Code § 34-24-58
Ala. Code § 34–24–58 establishes a privilege for committees of physicians or surgeons:
(a) The decisions, opinions, actions, and proceedings rendered, entered or acted upon in good faith and without malice and on the basis of facts reasonably known or reasonably believed to exist of any committee of physicians or surgeons, acting as a committee of the Medical Association of the State of Alabama, or any state, county, or municipal medical association or society, or as a committee of any licensed hospital or clinic, or the medical staff thereof, undertaken or performed within the scope and function of such committee as legally defined herein shall be privileged, and no member thereof shall be liable for such decision, opinion, action, or proceeding.
(b) Within the words and meaning of this section, a committee shall include one formed or appointed as a utilization review committee, or similar committee, or committee of similar purpose, to evaluate or review the diagnosis or treatment or the performance of medical services which are performed with respect to private patients or under public medical programs of either state or federal design, with respect to any physical or mental disease, injury, or ailment or to define, maintain, or apply the professional or medical standards of the association, society, hospital, clinic, or medical staff from, by, or for which it was appointed.
Ex parte St. Vincent’s Hospital
Ex parte St. Vincent’s Hospital, is a cautionary tale for the legal practitioner as well as the health care provider with respect to the scope of protection afforded by Alabama’s quality assurance statutes. Ex parte St. Vincent’s Hosp., 652 So. 2d 225, 226 (Ala. 1994). The case is also a cautionary tale in effectively asserting the privilege as well. Id. at 227. In Ex parte St. Vincent’s, the Plaintiff sued both Zeneca and St. Vincent’s alleging medical malpractice and products liability claims. Id. at 226. The Plaintiff claimed Hibiclens, a pre-operative scrub, caused a chemical burn to the Plaintiff’s cornea. Id. St. Vincent’s filed a cross-claim against Zeneca, alleging Zeneca failed to warn the hospital of the dangers associated with the use of Hibiclens. Id.
Zeneca sought discovery of a “Dear Doctor” letter it sent to St. Vincent’s several months before the date of the plaintiff’s injury warning the hospital that the product should not be used around a patient’s face and eyes. Id. Depositions revealed that St. Vincent’s received the letter and the letter had been forwarded to the hospital’s Infection Control Committee. Ex parte St. Vincent’s Hosp., 652 So. 2d at 226. St. Vincent’s objected to any deposition testimony concerning the hospital’s actions in response to the Zeneca letter claiming the testimony was quality assurance information privileged pursuant to Alabama Code § 34–24–58 and Alabama Code § 22–21–8. Id.
Zeneca then sought discovery of the letter and documents evidencing the actions taken by the hospital in response to the “Dear Doctor” letter. Id. The trial court ordered St. Vincent’s to produce the requested “[i]nfection control actions, minutes, records, file and procedures relating to Hibiclens warnings, use or ‘Dear Doctor’ letters” for an in-camera inspection. Id. After an in-camera review of the documents, the trial court ordered St. Vincent’s to produce relevant portions of a report from the hospital’s Infection Control Committee and documents relating to the action taken by the hospital in connection with the use of Hibiclens. Id. The trial court found there could not be a “proper, legal or meaningful adjudication of this case unless the parties are privy to the report of the Infection Control Committee . . ..” Id. at 226-27. St. Vincent’s filed a Petition for Writ of Mandamus arguing that the trial judge abused his discretion in ordering the production of documents from the Infection Control Committee. Ex parte St. Vincent’s Hosp., 652 So. 2d at 228. St. Vincent’s argued the information was quality assurance material protected from discovery under Alabama Code § 22–21–8 or Alabama Code § 34–24–58. Id.
The Alabama Supreme Court denied St. Vincent’s Petition for Writ of Mandamus. Id. at 230. The Court noted St. Vincent’s had the burden of proving the existence of a privilege and proving the prejudicial effect of disclosing the information. Id. The Court found St. Vincent’s failed to produce evidence that its Infection Control Committee served as a utilization review committee and failed to produce evidence that the committee functioned as an accreditation or quality assurance committee. Id.
Six years later, the Plaintiff in Kingsley v. Sachitano, argued that Ex parte St. Vincent’s created an exception to the quality assurance privilege where the information sought is essential to providing the litigant with a full and fair trial. Kingsley v. Sachitano, 783 So. 2d 824, 825 (Ala. 2000). The Court in Kingsley declined to recognize such an exception. Id. See also Ex parte Burch, 730 So.2d 143, 150-51 (Ala.1999) (declining to find that the court created an exception to the privilege requirement, finding rather that the documents in question fell outside the statute’s scope).
The take-away from Ex parte St. Vincent’s Hospital is two-fold:
- A healthcare provider should a) establish clear goals and objectives at the outset of any effort to evaluate or review medical services or medical standards, b) communicate those objectives and goals to members of the committee, and c) maintain the confidentiality of information and documents exchanged within the committee. A clearly established set of goals and objectives will help support the assertion of a privilege over documents created as part of the evaluation or review of medical services or standards.
- The legal practitioner cannot rely on conclusory statements or document headings when asserting the quality assurance privilege. The healthcare provider asserting the privilege has the burden of proof. The legal practitioner should take great care in establishing the privilege by presenting evidence of the goals and objectives of the committee through a) non-conclusory affidavit and deposition testimony, and b) redacted documents reflecting the goals and objectives of the committee’s work.
Ex parte Mobile Infirmary Association
In 2018, the Alabama Supreme Court issued an opinion in Ex parte Mobile Infirmary Association, which stands in stark contrast with the outcome in Ex parte St. Vincent’s. Ex parte Mobile Infirmary Ass’n, 278 So. 3d 1195, 1213 (Ala. 2018). The trial court ordered Mobile Infirmary to produce certain documents created by the hospital’s Risk Management Department. Id. at 1200. The Alabama Supreme Court granted Mobile Infirmary’s Petition for Writ of Mandamus directing the trial court to vacate its order for production of the Risk Management documents. Id. at 1219.
The Plaintiff argued the documents were created and used in the ordinary course of the hospital’s business. Id. at 1212. The Plaintiff further argued that Mobile Infirmary failed to demonstrate the goal or purpose of the Risk Management Department in generating the disputed documents was quality assurance. Id. at 1212-13.
However, Mobile Infirmary presented an affidavit from its risk manager establishing: 1) the Risk Management Department performs quality assurance functions for the hospital and 2) the contents of the risk-management file “were requested, prepared, and/or utilized for quality assurance purposes to assess the quality of care of all patients at [the medical center].” Id. at 1199, 1211. The Alabama Supreme Court held that the risk manager’s affidavit constituted substantial evidence in support of Mobile Infirmary’s claim of privilege. Id. at 1213. See also Ex parte Fairfield Nursing, 22 So.3d at 450; Kingsley v. Sachitano, 783 So.2d 824 (Ala. 2000); Ex parte Qureshi, 768 So. 2d 374 (Ala. 2000).
Conclusion
Healthcare providers must prepare for a possible widespread coronavirus outbreak in the United States. Most, if not all, healthcare providers are taking some action through Quality Assurance committees and Infection Control committees in preparation for an adverse event. The Quality Assurance privilege helps foster the open and honest communication needed when preparing to face an unpredictable threat like the coronavirus. Healthcare providers must effectively establish the privilege during quality assurance and infection control meetings, and must effectively assert the privilege if protected documents are later sought by enterprising plaintiff lawyers.
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