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Are Your Quality Assessment and Assurance Documents Safe From Prying Eyes?

      Federal regulations require that all skilled nursing facilities must have a functioning Quality Assurance Performance Improvement (QAPI) program and a Quality Assessment and Assurance (QAA) committee (Medicaid and Medicare Programs; Reform of Requirements for Long Term Care Facilities, Fed Regist 2016;81:68688–68872; codified at 42 CFR § 483.75, effective November 28, 2017; http://bit.ly/38fnRmx). To help surveyors determine whether nursing facilities are in substantial compliance with the applicable federal regulations, the Centers for Medicare & Medicaid Services provides guidance in the form of the State Operations Manual (SOM).
      It is important to realize that the SOM is not law. It is considered “sub-regulatory guidance,” meaning that it merely attempts to explain to surveyors what each federal Requirement of Participation requires. Occasionally, the SOM leads to unanticipated and questionable results. As we’ll see, this is especially the case as it relates to a facility’s QAA committee.
      As a threshold matter, the regulations mandate that the medical director or his or her designee must be a member of the facility’s QAA committee (42 CFR § 483.75(g)(ii); http://bit.ly/38fnRmx). CMS notes that even if the medical director designates another physician to serve on the QAA committee, the medical director is ultimately responsible. So medical directors and their designees must have a keen interest in all aspects of both the QAPI program and QAA committee.

      Recommendations for the QAA Committee

      • Work with in-house or outside counsel to develop uniform templates.
      • Avoid commingling QAPI/QAA documents.
      • Identify specific documents sufficient to demonstrate compliance with the QAPI/QAA requirements (e.g., attendance list, agenda, etc.).
      • Expect increasing demands for documents as new audit contracts are awarded and implemented along with Office of Inspector General or Department of Justice subpoenas.
      • Do not use QAA documents for non-QAA purposes.
      • Have all QAPI/QAA members understand that any disclosure outside of the QAA committee generally waives the privilege.
      • Reports/audits generated at the “behest” of the QAA committee should clearly state that the report was generated for QAA purposes only.
      • Develop and implement policies and procedures to address processing document requests.
      • Educate the staff accordingly (e.g., state “just the facts” for incident reports, and distinguish facts from subsequent analysis).
      • Review/revise electronic storage and email policies to prevent inadvertent forwarding of “protected” email communications.
      • Carefully review how mandatory reports are written before they are submitted to state, federal, and accrediting agencies.
      • Be prepared for the increased movement toward transparency coupled with “right to know” laws in many jurisdiction to result in unexpected disclosures.
      • Always analyze who is asking for the document (e.g., surveyor, plaintiff’s attorney, family).
      • Identify a person(s) to review QAA documents for privileges and proper release.
      • Implement a tracking program (who, what, when, where, and why) for each document requested and disclosed.
      • Consult legal counsel when in doubt.Not everything that finds its way into the QAA committee is privileged and thereby shielded from discovery.

      The QAA Committee

      Every nursing facility that participates in the Medicare or Medicaid program must have an operational QAA committee. It must meet at least quarterly, or more often as indicated. In addition to the medical director, the QAA committee must include the director of nursing, an infection preventionist, and at least three other members of the staff, one of whom must be the owner, administrator, board member, or another person who serves in a leadership role.
      The responsibilities of the QAA committee include evaluating the effectiveness of the QAPI program, developing and implementing plans of action to correct known deficiencies, and analyzing data collected by the QAPI program and other areas such as drug regimen reviews. If there is an unanticipated resident death, an injury of unknown origin, or some other adverse outcome that possibly could have been prevented, those items fall squarely under the ambit of the QAA committee for analysis, discussion, and recommendation. Near misses should also be brought to the QAA committee for analysis so as to prevent possible harm in the future.
      Every physician — indeed, every member of the QAA committee — must recognize the importance of being able to have frank, candid discussions about the root causes of an avoidable and unexpected resident outcome. That is precisely why the federal regulations created a “privilege” against discovery of certain internal deliberations each QAA committee conducts.
      Note that not everything that finds its way into the QAA committee is privileged and thereby shielded from discovery. For example, an incident report is not privileged. Even though some lawyers still advise providers that incident reports are privileged, remember that they are not.

      QAA Documents and Privilege

      The first case in the federal courts dealing with whether incident reports sent to the QAA committee are privileged and can be shielded from discovery by surveyors was the Jewish Home of Eastern Pennsylvania v. HHS (413 Fed. Appx. 532 [3d Cir. 2011], cert denied, 132 S.Ct. 837 [2011]). (By way of full disclosure, I successfully argued this case when I represented CMS.) In that case, the facility’s lawyer claimed that the incident reports the surveyors asked for were privileged. He therefore claimed the deficiencies related to multiple resident falls, described in the incident reports, could not be used as a basis for the enforcement action by CMS (i.e., a civil money penalty).
      After a formal appeal, the Administrative Law Judge (ALJ) agreed that even if the documents were sent to a QAA committee for subsequent analysis, incident reports are not privileged. The provider then appealed the ALJ’s decision to the Health and Human Services (HHS) Departmental Appeals Board, which affirmed the ALJ decision.
      Undaunted, the provider further appealed to the U.S. Court of Appeals for the Third Circuit, which held there is no privilege for incident reports. The court noted that the privilege over QAA deliberations does not reach “contemporaneous routinely-generated incident reports that were part of the residents’ medical records and were not minutes, internal papers, or conclusions generated by [or at the direction of] the Quality Assurance Committee.”
      However, there is a yawning chasm between an incident report that merely recites a factual account of what happened and the subsequent deliberations by the QAA committee. The latter are privileged.
      In its most recent guidance to surveyors in the SOM, CMS states that “Protection from disclosure is generally afforded documents generated by the QAA committee, such as minutes, internal papers, or conclusions. However, if those documents contain the evidence necessary to determine compliance with QAPI/QAA regulations, the facility must allow the surveyor to review and copy them” (SOM, Appendix PP, F841; https://go.cms.gov/2VTlbGW).
      Medical directors and all members of the QAA committee must recognize that once “internal papers” are given to a surveyor (or anyone outside the QAA committee), the privilege against discovery is waived. The plaintiff’s lawyers can seek those internal papers and deliberations in the course of litigation against a facility. Disclosing a QAA committee’s internal papers to a surveyor eviscerates the privilege that normally shields internal deliberations from discovery. Such a practice would have a chilling effect on the QAA committee’s ability to have frank and candid discussions about avoidable adverse outcomes and near misses.

      A Balancing Act

      The regulations dealing with the QAA committee state that “a State or the Secretary 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.” So if a facility can demonstrate compliance with the regulation without disclosing privileged or otherwise protected confidential information, that should satisfy a surveyor’s legitimate need to determine if substantial compliance exists.
      I recommend that the QAA committee separate its internal papers and privileged information from the routine nonconfidential documents; the latter can be provided to surveyors. For example, items such as the QAA committee’s attendance list, agenda, and related documents could be given to surveyors to demonstrate compliance while keeping the internal deliberations separate and shielded from surveyors. According to CMS, as long as the facility can demonstrate that it has “identified its own high risk, high volume, and problem-prone quality deficiencies, and [made] a ‘good faith attempt’ to correct them,” it should be able to demonstrate substantial compliance without the need for disclosing internal deliberations. So I suggest keeping separate sets of documents to both (1) satisfy regulatory requirements and (2) maintain the QAA privilege.
      Every court that has addressed the issue of the privileged nature of the QAA committee’s internal documents has agreed: the privilege exists, and neither the government nor private litigants may compel a facility to disclose privileged QAA material. For example, a federal district court held that “Congress has explicitly created a QA&A Privilege. This privilege prevents both states and the Secretary [of HHS] from discovering the records of QA&A Committees … In short, federal statutes prohibit the Secretary and his subordinates from gaining access to the documents created by any QA&A Committee” (United State of America v. Lilburn Geriatric Center, U.S. District Court, Northern District of Georgia, [2003]).
      Yet another court that addressed the issue of privilege and a facility’s QAA committee held that “it is not the existence of the facts of an incident or accident that must be kept confidential in order for the [QAA] committee to effectuate its purpose; it is how the committee discusses, deliberates, evaluates, and judges those facts that the privilege is designed to protect” (Centennial Healthcare Management Corp. v. Mich. Dept. of Consumer & Industry Services, 254 Mich. App. 275, 657 N.W.2d 746 [2002]).
      Although it may be challenging, it is not impossible for facilities to meet the necessary goals of having a demonstrably effective QAA committee while simultaneously protecting its internal deliberations from discovery by surveyors and other litigants.
      Mr. Horowitz is a partner at Arnall Golden Gregory LLP. His practice involves regulatory compliance concerning skilled nursing facilities, hospices, and home health agencies. Prior to joining the firm, he served as Assistant Regional Counsel at the U.S. Department of Health and Human Services and represented the Centers for Medicare & Medicaid Services. Mr. Horowitz also has extensive experience as health care provider.