HHS released the final rule governing the creation and operations of patient-safety organizations.
Effective Jan. 19, 2009, organizations will have to certify they are in compliance with the guidelines in the rule to be designated a patient-safety organization under the Agency for Healthcare Research and Quality, which oversees the program. Currently, 15 organizations are operating under an interim rule AHRQ established in October; those groups will have to ensure they are in compliance with the final rule to continue their work after Jan. 19, according to an HHS news release.
The federal department made some changes from the proposed rule: It expanded the types of organizations that cannot become a patient-safety organization and included revisions on how groups should disclose relationships with healthcare providers in the final rule. In addition, the final rule contains increased flexibility in how patient-safety organizations can store work product, an expedited delisting process for serious problems, and an automatic expiration of listing after three years.
The groups that cannot operate patient-safety organizations are any that: accredit or license health providers; oversee or enforce statutory or regulatory requirements; act as an agent of a regulatory organization; or operate a federal, state or local patient-safety reporting system through which providers are mandated to report information.