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AMA Provides Guidance On Creation Of Patient Safety Organizations

Main Category: Public Health
Article Date: 14 Apr 2008 - 3:00 PDT

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"The AMA is dedicated to improving the quality and safety of health care for patients, and to help meet that goal we have provided the government with the physicians' viewpoint on how to best proceed with the creation of patient safety organizations (PSOs). Comments submitted today to the Agency for Health Care Research and Quality (AHRQ) highlight the AMA's strong support for the establishment of a federal framework that will allow health care professionals to voluntarily report patient safety information without fear of legal prosecution.

"The proposed rule strikes the appropriate balance between federal oversight and the creation of a voluntary reporting system, as the government will ensure the integrity of PSOs and allow for innovative initiatives to improve patient safety driven by health care professionals. To ensure success, the AMA will educate physicians on the reporting system, encourage their active participation and provide input on the system's creation. As a leading advocate for passage of the Patient Safety and Quality Improvement Act of 2005, we applaud HHS and AHRQ for capturing the legislation's intent in the proposed rule and look forward to working with them to improve health care safety for patients."

Notes

1. One of the most critical aspects of this proposed regulation is to ensure the confidentiality and legal protections of patient safety work product (PSWP). The AMA has urged AHRQ to adopt a broad definition of PSWP to ensure that a broad spectrum of data gathering and analytical efforts are fully protected and kept confidential and secure.

2. The AMA urges AHRQ to better clarify key definitions such as disclosure and use of PSWP to ensure that physicians are confident that the information they would report to a PSO remains confidential.

3. The AMA urges AHRQ to adopt reasonable timeframes for assembling, collecting, deliberating, developing, analyzing and reporting data to PSOs. The time frame should be contingent upon multiple factors, including but not limited to, the complexity of the facts and circumstances surrounding the analysis of a medical error or other event.

4. The AMA agrees with the proposed regulations that public and private entities that conduct regulatory oversight of health care providers, including accreditation and licensure, should be prohibited from seeking eligibility as a PSO.

5. The proposed regulations do allow a component organization of regulatory bodies to become PSOs as long as appropriate firewalls are in place. The AMA urges HHS to take additional measures to ensure that such components cannot circumvent the firewalls. The AMA recommends that component PSOs be required to explicitly identify their parent organization as a regulator, specify the scope of the parent organization's regulatory authority, and submit attestations from contracting providers that such providers are informed of the nature and scope of the parent organization's regulatory authority. These additional safeguards will assist providers in determining, as appropriate for their circumstance, whether they wish to contract with such a component PSO.

6. The AMA agrees that HHS should provide ongoing recommendations to PSOs on formats and definitions in order to facilitate aggregating PSWP. The common formats and standards should be developed and tested by individuals involved in the delivery of healthcare services. The AMA supports the proposed rule's creation of a Patient Safety Work Group. The Work Group must use a transparent consensus process that includes representatives of national physician and other health care professional specialty organizations and others with experience in safety reporting formats. The AMA will review the common formats that are expected to be published in July/August 2008.

American Medical Association

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