HHS Issues Interim Guidance To Begin Implementing The Patient Safety And Quality Improvement Act Of 2005
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, which can be found at http://www.pso.ahrq.gov/regulations/intguid.htm,
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are binding until they are superseded by the issuance of a final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...
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