View from the Hill: Patient Safety Legislation. All Bark and No Bite?


May / June 2008

View from the Hill

Patient Safety Legislation: All Bark and No Bite?

It has been almost 3 years since President Bush signed the Patient Safety and Quality Improvement Act of 2005. However, we are quickly learning that law without federal regulation and funding is all bark and no bite.

When the President signed the legislation on July 29, 2005, we were optimistic we would finally begin to seriously address the issues surrounding medical error. The law requires the U.S. Department of Health and Human Services (HHS) to:


  • Facilitate the creation of a network of databases to collect, aggregate, and analyze submitted reports of medical errors or near-errors;
  • Adopt standard formats for reporting information to the databases; and
  • Make public analysis of regional and national statistics and trends via annual reports from patient safety organizations (PSOs).


The law applies to patient safety data compiled in conjunction with the Agency for Healthcare Research and Quality (AHRQ) supported initiatives. It also encourages the voluntary reporting of such data by assuring its confidentiality.

In February, HHS issued a proposed regulation to improve the quality and safety of healthcare for all Americans by fostering the establishment of PSOs. PSOs are private entities recognized by the Secretary to collect and analyze patient safety events reported by healthcare providers. They are new and separate from all currently existing entities that are addressing healthcare quality.

AHRQ will administer the rules for listing qualified PSOs. AHRQ Director Carolyn Clancy, MD, believes the proposed regulation provides a framework for PSOs to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients. “We want to make the right thing to do the easy thing to do,” said Clancy in a press release announcing the proposed regulation.

HHS released the proposed regulation on February 12, and the public had only 60 days to comment on a law that was signed almost 3 years ago. The numbers and timing just do not add up. We have become so patient in healthcare that we drag our feet even when we win legislative battles.

The creation of PSOs has been called for by the Institute of Medicine and would help improve the quality and safety of healthcare in several key ways. I encourage healthcare professionals to comment on the proposed regulation; our feedback will be used to shape the final regulation. Comments can be made via the Federal eRulemaking Portal at Comments should include agency name and ”RIN 0919-AA01.”

Both public and private entities, either for-profit or not-for-profit, can seek “listing” as a PSO. The statute prohibits insurers and components of insurers from becoming PSOs, and the Notice of Proposed Rule Making would prohibit public or private entities with regulatory authority over providers (such as accreditation and licensure bodies) from becoming PSOs. The preamble seeks comment on whether the regulatory prohibition should be broadened to preclude components of regulatory entities from becoming PSOs.

While the statute makes patient safety event reporting privileged and confidential, it does not relieve clinicians or healthcare organizations from meeting reporting requirements under federal, state, or local laws. However, the statute and the proposed regulation address an important barrier that currently exists — the fear of legal liability or sanctions that can result from discussing and analyzing patient safety events.

The HHS Office for Civil Rights (OCR) will be responsible for enforcing the confidentiality provisions of the act. The department plans to issue guidance soon that would allow entities to be listed as PSOs, consistent with the statute, prior to publication of the final rule.

The final rule will be published in the Federal Register and on the AHRQ PSO web site. The final rule will include a summary of the comments and responses to the comments, including any changes that were made to the proposed regulation as a result of the comments received.

Sen. Edward Kennedy (D-MA) has asked the Government Accountability Office (GAO) to investigate why HHS has not yet implemented the Patient Safety and Quality Improvement Act of 2005. Sen. Kennedy wrote in a January 17, 2008, letter to GAO, “Last week, my office was informed by HHS that Secretary Leavitt will not be providing the requested timeline or an explanation for their egregious delay.” He added, “For this reason, I request that the GAO initiate an investigation into the cause for the delay at HHS in finalizing these regulations so that this important law can finally be implemented.”

Where is the concern and outcry from healthcare professionals, the healthcare industry, and patient safety groups? One proposed rule from HHS is not fully implementing the law. The federal government is often overwhelmed with work and often those who yell the loudest receive the most attention. Once a bill becomes a law, the real work begins. A law without regulation and funding is simply on the books collecting dust on the regulators desk. The regulators need our help to bring the law to life! Who knows better than professionals in the healthcare industry how to fix what ails the system?

Be Part of the Solution
We must become involved in the entire legislative process — writing legislation, advocating for our issues and adequate funding levels, developing and strengthening relationships with legislators and regulators, drafting regulations, and monitoring laws. This seems to be a lot, but we can do more together than we can do apart.

HIMSS is sponsoring its 7th Annual Advocacy Day in Washington, D.C., June 10 and 11; this is definitely an issue we can address. Advocacy Day is a cornerstone event of National Health IT Week, June 9 to 13. We need to hear from healthcare professionals and patient safety groups regarding the Patient Safety and Quality Improvement Act of 2005 and other related issues. Organizations with diverse perspectives on health and care will gather in Washington, D.C., to work together under one banner with the goal of improving healthcare efficiency, quality, cost-effectiveness, and patient safety through health IT.

By supporting National Health IT Week, you send our nation’s policymakers a powerful message on the importance of fostering widespread health IT adoption in order to improve patient safety and healthcare quality. We value and invite your participation — please contact Zarb Consulting at for more information on how you can get involved in National Health IT Week 2008, or visit

Advocacy Day

Dave Roberts is vice president of government relations for the Healthcare Information and Management Systems Society (HIMSS) and senior executive of HIMSS’ Office of Advocacy & Public Policy in Arlington, Virginia. Formerly a professional staff member for both the U.S. House Appropriations Committee and the U.S. Senate Health Subcommittee on the Handicapped and a civilian financial analyst for the U.S. Air Force, Roberts now resides with his family in Solana Beach, California, where he is an elected member of the City Council and deputy mayor. He is a member of the Editorial Advisory Board for Patient Safety and Quality Healthcare and may be contacted at