Maintaining Privilege for Quality Assurance Performance Improvement (QAPI) Documents and Reports
The Affordable Care Act (ACA), which was passed in 2010, provides authority for the Centers for Medicare & Medicaid Services (CMS) to establish and implement a Quality Assurance and Performance Improvement program for nursing facilities, known as a “QAPI” program. QAPI is aimed at improving the quality of care provided in long-term care facilities. QAPI merges CMS’ Quality Assurance (QA) and Performance Improvement (PI) programs to implement a systematic, comprehensive, data-driven and proactive approach to performance management and quality improvement.
Under the regulations implementing QAPI, every long-term care facility must “develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life.” 42 C.F.R. § 483.75. Also, facilities must maintain documentation and evidence of their ongoing QAPI program efforts. Id. When engaging in the data-driven, self-assessment processes required under the QAPI program, long-term care facilities should adhere to certain formalities to be sure QAPI-related documents and reports remain privileged and confidential.
QAPI Requirements for a QAA Committee
Among the many requirement of a QAPI program, long term care facilities must have a Quality Assessment and Assurance (“QAA”) Committee. 42 C.F.R. § 483.75(g). The QAA Committee must include, at a minimum, the director of nursing services, the medical director or her designee, the infection control and prevention officer, and at least three other members of the facility’s staff (of which at least one must be the administrator, owner, a board member, or other person in a leadership role at the facility). Id. The QAA committee at each long-term care facility must develop appropriate plans of action to correct any facility or staff deficiencies, within or outside of the QAPI program. Id. The QAA committee must also regularly review and analyze data collected under the QAPI program resulting from drug regimen reviews and act on available data to make improvements. Id.
Maintaining QAA Privilege for QAPI Documents
The QAA regulations explicitly state that certain documents or reports created pursuant to a long-term care facility’s QAA program will be privileged and confidential (the “QAA Privilege”). Specifically, 42 C.F.R. § 483.75(h) provides that “[a] State or the Secretary may not require disclosure of the records of [a QAA] committee [unless] such disclosure is related to the compliance of such committee with the requirements of this section.” Thus, in order to be shielded by QAA Privilege, documents or reports created for use at a QAA committee meeting, including documents or reports created pursuant to QAPI guidelines, should not raise issues of regulatory noncompliance; rather, such reports should focus only on quality assurance and performance improvement opportunities.
To increase the likelihood that QAPI documents or reports are protected by the QAA Privilege, long-term care facilities should adopt the following five policies:
- Any review of quality indicators should be directed by the QAA committee. Reports or documentation detailing the QAA committee’s findings should be authored by or at the behest of a member of the QAA committee.
- Reports and documents should not raise issues of compliance with regulations. Records of a QAA committee are not privileged if related to compliance of the QAA committee with the requirements of the regulations.
- Reports or documentation generated by or at the behest of the QAA committee should clearly state that the report is prepared for purposes of quality assurance. The substance of the documents must analyze and evaluate quality of care.
- Quality assurance discussions should be held within a formal committee and documents should be kept confidential. Importantly, sharing quality assurance documents with the Board of Directors does not operate as a waiver of the privilege and is encouraged by CMS.
- QAPI documents should not be utilized for non-QAPI purposes. Avoiding “mixed uses” decreases the likelihood of inadvertently waiving the QAA Privilege.