QAA and QAPI: Are They Protected?

Note: This article was prepared by Mr. Horowitz and Dr. Ferrini with special thanks to Dr. Robert Gibson PhD JD, Psychologist, for his input. 

Alan C. Horowitz, Esq., RN, and Dr. Rebecca Ferrini will be speaking at AMDA - The Society for Post-Acute and Long-Term Care Medicine’s virtual annual meeting on how we can protect the results of our deliberations that occur in the context of a facility’s Quality Assessment and Assurance (QAA) committee. What follows is some of the main issues their presentation will address. 

“Privilege,” or restrictions on disclosure, is a legally recognized protection that shields communication – both verbal and written - from discovery.  For example, the communications between an attorney and his/her client or between a physician and his/her patient, or priest and penitent, are privileged.  We are all familiar with HIPAA and related restrictions on sharing privileged or protected health information, but perhaps less aware of the protections afforded the processes around quality monitoring and improvement. Effective process improvement depends on candid truth-telling, and  frank discussions of sensitive information. Information may be discussed that is protected from the prying eyes of surveyors or plaintiffs’ attorneys. In order to prevent problems that might be harmful to the facility’s residents, it is imperative to have total honesty about the root causes of adverse events and near misses. A lack of privilege for such discussions would have a chilling effect on such candid discussions.  

There is a widespread belief that a facility’s incident reports are privileged, but this is a misconception. Recent regulatory guidance makes this point clear that incident reports and logs generated from them (such as a fall or accident log) are in fact not privileged. 

In order for a document to be privileged, it must be: 1) contained within the QAA committee’s scope of work and 2) be the sort of document that enjoys the statutory and regulatory privilege.  Note that not all documents that are part of a QAA committee are privileged. For example, attendance lists and agendas do not enjoy a privilege. By contrast, the internal deliberations and internal documents of a QAA committee are indeed privileged.

The Federal regulation that deals with the QAA committee and privilege is found at 42 C.F.R. §483.75(h). That regulation states, “Disclosure of information. A State or the Secretary [of HHS] may not require disclosure of the records of such committee except insofar as such disclosure is related to the compliance of such committee with the requirements of this section.” Clearly, the regulation is not exactly a model of clarity. On the one hand it states that the Secretary (surveyors from State survey agencies are the agents of the Secretary) may not require disclosure but on the other hand it carves out an “exception.” Adding to the frequent confusion in this area is CMS’ State Operations Manual (“SOM”). The SOM contains detailed “guidance” for surveyors regarding privilege and in the opinion of the authors, is questionable. Specifically, the SOM directs surveyors to ask for and copy “internal documents” in some circumstances It is worth remembering, as CMS instructs surveyors, the SOM is merely guidance and cannot, by itself, be used as a basis for a deficiency. Still, surveyors have a legitimate need to ascertain whether a facility’s QAA committee is meeting all federal requirements. Whether or not surveyors can dig through otherwise privileged “internal documents” is likely to be decided by the courts.

If QAA documents contain evidence necessary to determine compliance with QAPI/QAA regulations, the facility must allow the surveyor to review and copy them, though these should not be used as a basis for sanctions if done in good faith. Attendance lists or agenda or action items determined for addressing a problem would be sought by the surveyors as proof of compliance with regulations. In contrast, the regulations note that incident and accident reports, logs or other reports or records used to track adverse events are not protected from disclosure, and surveyors may request these documents as part of the normal investigation of other areas of concern to the survey to support their findings.

Because incident reports are not protected, careful attention should be paid to what goes into those reports.  Essentially, incident reports should only contain actual and factual statements. For example, “Ms. Jones fell at 12:30 pm in her room. She denies pain but has a small bump on her forehead, vital signs stable, physician notified.” (Obviously, additional relevant factual information may be included.) The best legal advice is not to include any speculations by the person(s) filling out the incident report or deliberations.  A speculative comment might be related to the fact that the call light may have been on for an extended period, the CNA on break did not pass off the pager for responsibility or  perhaps that the floor had a wet spot. Uncovering the probability of these possibilities would be related to an investigation, a root cause analysis and the deliberations of the QAA committee. The incident report is merely a factual account of what occurred.

It is entirely appropriate to separate the incidents report from investigative reports. They serve two distinct functions and should not be commingled, based on the suggestion of legal counsel.  Within the QAA minutes, you may choose to refer to the request for an investigative report for conducting a root cause analysis for high risk events such as falls, aggressive incidents, pressure ulcers or medication errors. As there is a possibility you may show QAA Minutes to surveyors to verify compliance with regulations or to show evidence that you are working on a certain problem that had been identified during the survey, you might want to develop policies as to what is in the minutes and what might be kept as separate protected documents. The authors recommend that facilities separate bona fide QAA deliberations and confidential audits or consultant reports done at the behest of the QAA committee in a separate place from the minutes.  An example might be that we would state in the minutes “discussed increased fall percentages and engaged in a root cause analysis (protected deliberative process) and devised an action plan for increased education for the p.m. shift.” In the protected deliberative document you might have information such as “80% of falls are associated with 1 unit and 1 nurse working on the p.m. shift. Action plans failed in 1 area due to sabotage; 1 unit under reported falls. There was disciplinary action against employee.” 

Note that the QAA committee minutes example makes it explicit that deliberations, audits and quality reviews or consultant reports are created in the committee and are not utilized outside and are therefore under the umbrella of privilege.  Your facility would want to make efforts to develop policies and educate committee members on privileged documents and how they are to be maintained in a way to maintain privilege. Be cautious in referring to investigations, audits and deliberations in the context of privilege.  Reports or audits generated at the behest of the QAA a committee should clearly state the report was generated for QAA purposes only and documents used for the committee should not be used for non-authorized purposes. 

Phase 3 of the CMS revised Requirements of Participation became effective in November 2019, meaning that even though CMS has not yet provided guidance to surveyors, all facilities are expected to be in “substantial compliance” with the QAPI and QAA requirements. It is imperative that every facility’s QAPI program meets the revised requirements while safeguarding privileged material. 

In your QAPI plan, discuss the process of deliberation and how it occurs and how it is protected.  Also, have your QAA committee members been educated on their responsibilities? For example, if a member of the QAA committee discloses otherwise privileged QAA internal documents to anyone outside the committee, the privilege is waived. So, if a member of the QAA committee inadvertently discloses a document to a surveyor that enjoys a privilege, it is no longer privileged and plaintiffs’ attorney can also obtain copies of those internal documents. A good idea is to have one person designated to disclose QAA documents to surveyors. That individual should have a crystal clear understanding of what is privileged and what is not. All members of the QAA need to be reminded not to discuss or disclose any privileged QAA material outside of the QAA committee.

This article is not intended to be a substitute for qualified legal advice. It goes without saying that with complex legal issues, reading an article in the Wave is not sufficient to develop expertise and that your legal counsel will be of great help in developing and reviewing materials.  If this topic interests you, please plan on virtually attending this session, entitled “The New QAPI Regulations: What Medical Directors Need to Know” on Friday, April 3, 2020 at 3:30 PM in Chicago, Illinois.

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