Phase 3 of the Centers for Medicare & Medicaid Services’ Requirements for Participation for nursing facilities will go into effect on November 28. But those who have not yet read CMS’s recent guidelines for surveyors may be in for an unpleasant surprise.
CMS has taken a very aggressive — and legally tenuous — position regarding the inner workings and deliberations of a facility’s QAPI program and its Quality Assessment & Assurance Committee.
The regulation formerly at 42 C.F.R. § 483.75(o) has been modified and moved to 42 C.F.R. § 483.75(a). (For those familiar with F-Tags, the F-Tag formerly at F520 has been moved to F865.) It is incumbent on providers to be familiar with the new regulatory requirements, such as the mandatory inclusion of an Infection Control Preventionist as part of the QAA Committee, as well as the CMS Interpretive Guidelines to Surveyors as articulated in the State Operations Manual.
While a full list of the requirements for a facility’s QAPI program and QAA committee are beyond the scope of this article, providers should note that the regulation requires that every 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.
Note that a facility must present its QAPI plan to the state survey agency or federal surveyors at each annual recertification survey and upon request during any other survey. A facility also must be able to provide evidence of its QAPI program’s implementation and the facility’s compliance with the QAPI requirements to a state survey agency, federal surveyor or CMS upon request.
Additionally, the QAA committee must include, at a minimum, the director of nursing, the medical director or his/her designee, the infection control and prevention officer, and at least three other members of the facility’s staff (one of whom must be the administrator, owner, a board member, or other person in a leadership role at the facility). 42 C.F.R. § 483.75(g). The QAA committee must meet at least quarterly; must develop appropriate plans of action to correct any deficiencies; and must also analyze and act on available data to implement improvements.
State Operations Manual
As providers are aware, the State Operations Manual, Appendix PP is CMS’ official Guidance to Surveyors for Long Term Care Facilities (available online only). Perhaps the most troubling aspect of the revised guidance is the directive to surveyors that they may ask for (or demand) certain “internal papers” of the QAA committee.
According to CMS, “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.” (Emphasis added.)
Even if a sensitive document belonging to the QAA committee would otherwise be privileged and shielded from discovery, once a disclosure is made outside the committee, the privilege is waived, thereby opening up a potential treasure trove for the prying eyes of plaintiffs’ attorneys. Thus, a facility needs to be vigilant about what QAA documents it discloses to surveyors and CMS.
A potential problem arises when and if a surveyor demands to see certain “internal papers” of the QAA committee and the facility has a good faith belief that such documents should remain shielded from disclosure and not given to a surveyor.
Keep in mind that if the surveyor feels that the documents are necessary to determine substantial compliance with program requirements and they are not disclosed, the result will be a deficiency, and if it’s not corrected, it will lead to a mandatory denial of payment for new admissions (DPNA) and termination from the Medicare and Medicaid programs within 90 days and 180 days, respectively.
The regulation 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.” 42 C.F.R. § 483.75(h). But will all surveyors accurately determine what records are necessary to determine compliance of the QAA committee; or might a surveyor inadvertently (or intentionally) ask for internal documents that should not be disclosed?
CMS advises surveyors — as the regulation requires — that if the “QAA committee, has identified and made a good faith attempt to correct the same issue identified by the survey team during the current survey, the facility will not be cited for QAA (it may however, still be cited with deficiencies related to actual or potential issues at other relevant tags).”
However, as noted above, if a surveyor asks a facility to disclose a privileged document in order to demonstrate substantial compliance with the QAA requirements, that places providers on the horns of a dilemma.
Patient Safety and Quality Improvement Act of 2005
Congress authorized the creation of Patient Safety Organizations (PSOs) when it enacted the Patient Safety and Quality Improvement Act of 2005 (PSQIA), which provided a privilege that shielded certain healthcare-related documents from discovery. When a healthcare provider participates with a PSO, it sends certain patient safety information, known as “Patient Safety Work Product” (PSWP) to the PSO. That material is privileged with few exceptions.
Providers should note that in its new guidance, CMS has stated that surveyors “must never ask or demand that a nursing home show them ‘patient safety work product.’” However, if that is the only place a provider has documentation that it is complying with the QAPI and QAA requirements and the facility refuses to disclose those documents, that provider would be cited with a deficiency and sanctions, including termination from the Medicare and Medicaid programs, could occur.
Recommendations
Because the risks of disclosing otherwise privileged documents are so potentially high, providers need to know how to navigate their way through complying with the regulation’s new requirements while not waiving any privilege for bona fide internal QAA documents. Some documents, such as incident and accident reports, wound logs, and other tracking forms, as well as an agenda and attendance list of QAA meetings, are clearly not privileged and should be disclosed to surveyors upon request.
However, I believe other types of “internal papers” such as some of the internal deliberations of the QAA committee are protected from disclosure. I suggest developing appropriate policies and procedures and educating key staff, especially the director of nursing and administrator about how to interact with surveyors before this becomes an issue. Additionally, competent legal advice in advance of an issue may be well worth the effort. An ounce of prevention is better than a pound of cure.
Conclusion
The goals of QAPI and a QAA committee are laudable and necessary. It is essential that healthcare providers can engage in a robust QAA process free from concerns that an honest self-examination following an adverse outcome or a near-miss may be used against a facility.
Ideally, CMS should continue to encourage such a critically important function while not issuing guidance that might have a chilling effect on frank internal deliberations geared at promoting patient safety. All stakeholders, especially residents, benefit when providers can engage in a sincere and meaningful QAA process without concerns about plaintiffs’ lawyers or regulators using that process again them.
Attorney Alan C. Horowitz represents providers as a partner with Arnall Golden Gregory LLP and also serves on the Board of Directors of a Colorado nonprofit hospice organization. Previously, he served as Assistant Regional Counsel in the Department of Health and Human Services’ Office of the General Counsel for more than 12 years.
