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are binding until they are superseded by the issuance of a final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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