On October 14, 2008, the U.S. Department of Health & Human Services (HHS) released Interim Guidance to begin implementing the Patient Safety and Quality Improvement Act of 2005 (Act). The Interim Guidance announces that the Agency for Healthcare Research and Quality (AHRQ) will begin certifying Patient Safety Organizations (PSOs) as defined in the Act. The Interim Guidance describes a temporary legal framework consisting of the Act, Interim Guidance that closely follows the regulations proposed in a February 12, 2008 notice of proposed rulemaking (NPRM), and explanatory guidance detailing HHS’ interim procedures. The framework described by the Interim Guidance is effective immediately and will remain effective until the issuance of a final rule, which HHS expects to release before the end of 2008.
HHS hopes that the certification of PSOs will be the first step toward overall patient care improvement. The Act was designed to remove what Congress perceived as regrettable barriers that prevented hospitals, doctors, and other health care entities and practitioners (collectively, “providers”) from participating in multi-provider quality review activities. The Act granted privilege and confidentiality to work product prepared by a provider for the purpose of transmittal to a PSO, known as patient safety work product (PSWP). HHS, following Congress, believes this protection will be sufficient to encourage hospitals to provide data voluntarily about adverse events, medical errors, or “near misses” to PSOs. PSOs will then aggregate and analyze the data from multiple providers, permitting the identification of patterns suggestive of systemic or underlying causes of patient risks and hazards. Providers can then address these causes and improve patient safety.
The Interim Guidance includes an appendix of regulations that are binding until they are superseded by the issuance of a final rule. The remainder of the Interim Guidance is non-binding and offered only as HHS’ “current interpretation” of the Act and its “current thinking” on the topics. All discussion not explicitly declared binding creates no rights and imposes no legal obligation.
The Interim Guidance’s binding regulations republish most of the NPRM’s regulatory framework for certifying, listing, and delisting PSOs. Notable aspects include: (1) removal of provisions defining the scope of several exceptions to the confidentiality of PSWP, and (2) reasserting that component PSOs must maintain the separation of PSWP from the rest of the parent organization. All of the provisions contained in the Interim Guidance may be applied in any way not inconsistent with the Act.
The Interim Guidance’s procedures for certification are intended to be minimal. To be certified, applicants must attest to a number of statements regarding their ability to comply with requirements of the Act. The certification form is available on AHRQ’s PSO Web site. Specific certifications apply to applicant entities that are components of other organizations. These entities must certify that:
HHS may accept, deny, or conditionally approve PSO applications and maintains a list of certified PSOs on the AHRQ Web site. HHS also has the power to delist PSOs, conduct investigations, and levy significant civil monetary penalties for violations of the Act.
HHS issued the Interim Guidance in light of the public interest in beginning the PSO program as quickly as possible, but uncertainties remain, including the following:
The Interim Guidance makes it clear that HHS intends to begin implementing the Act. AHRQ can be expected to certify PSOs during the interim period in the manner described in the Interim Guidance.
Tina E. Dunsford
M. Leanne Habte
Shirley P. Morrigan
Judith A. Waltz
Mark J. Waxman