Rules aim for better patient safety through confidential error reports

By Dave Hansen, AMNews staff

Washington — Federal regulators have proposed sweeping patient safety rules to give physicians and others a confidential, voluntary way to report medical errors and near mistakes. Several health care organizations applauded the release of the long-awaited regulations but want a closer look before making a final judgment.

The rules, published Feb. 12 by the Agency for Healthcare Research and Quality, would implement the Patient Safety and Quality Improvement Act of 2005. The law, supported by the American Medical Association, authorizes creating patient safety organizations to which doctors, other health professionals, hospitals and other institutions could report mistakes.

The PSOs would identify trends in errors and share them with the medical community. The idea is to gather information on outcomes for many patients to detect patterns of risk and harm in a variety of health care settings, from doctors’ offices to hospitals. The data then could be used to improve safety and quality.

The AMA had pushed the Dept. of Health and Human Services for the regulations’ release and welcomed their publication. “The proposed rule is the first step toward implementing this important legislation, which will allow health care professionals to report errors voluntarily without fear of legal prosecution and transform the current culture of blame and punishment into one of open communication and prevention,” said AMA Trustee J. James Rohack, MD. “When health care errors can be reported in a voluntary and confidential manner, future errors can be avoided.”

The rules acknowledge that physicians and others are sometimes reluctant to participate in quality review activities because they fear that the information ultimately could be used against them in a medical liability lawsuit or by a disciplinary body. Peer review protections don’t exist in every state, vary among the states that have them and typically apply only in hospitals, the document notes. The patient safety regulations would create uniform, national protections.

Regulators “are being very careful and moving in the right direction,” said Dr. Louis H. Diamond, president of the American College of Medical Quality, an organization focused on quality management. HHS wants to protect physicians because the patient safety program will fail if doctors don’t trust it, he explained. “I am optimistic that this will be OK. Minor modifications will be required at worst,” said Dr. Diamond, vice president and medical director of Thomson Healthcare, a medical management services firm in Stamford, Conn.

Under the proposed rules, information disclosed to a PSO could not be subpoenaed or offered into evidence in medical liability cases or most other legal proceedings. It would be exempt from the Freedom of Information Act. Violations could result in civil fines up to $10,000.

The rules would not protect original data existing apart from patient safety reports. For example, medical records or billing and discharge information still could be subpoenaed. But records in a patient safety report would be protected. So would deliberations or analysis made when deciding whether to report data to a PSO.

AHRQ cites a hypothetical scenario in which a hospital maintains a list of near misses from the last 30 days. It decides to review the list to determine whether it should be reported to a PSO. Analysis of the decision is protected, whether or not the hospital files a report. But the list of near misses is not, because it existed separate from the deliberations.

Reports scrubbed of a hospital’s or physician’s identity would be exempt from confidentiality provisions, as would data in which every doctor and other health care professional identified had authorized the disclosure.

Learning, not punishing

To reassure physicians that reported events would be used for learning instead of punishment, the rules would ban health insurers from becoming PSOs. They also would prohibit entities that have regulatory oversight of health care professionals from becoming PSOs unless a strong “firewall” separates the PSO from its parent.

Patient safety advocates expressed optimism that the proposed regulations would encourage reporting.

“The protections are fantastic,” said National Patient Safety Foundation President Diane C. Pinakiewicz. “This provides a safe haven for people to do this so the focus is where it should be — getting as much information reported and analyzed without having to worry about confidentiality. We expect this to encourage much more reporting than we have now.”

The proposal would help patients and the medical community, said Jay King, executive director of the Patient Safety Group in Boston, an organization promoting communication of medical errors among health care professionals. “Patients will win, because hospitals are more open to being transparent and actually [will] get better at what they do. And we are not limiting the ability of the patient to sue in the case of negligence.”

The American Hospital Assn. will study the new regulations and look for provisions that could discourage doctors from identifying harmful events, said Nancy Foster, AHA vice president for quality and patient safety. An example would be cumbersome forms for reporting mistakes.

The proposed regulations also emphasize the confidentiality of identifiable patient information. They require doctors and other error reporters to follow patient privacy standards laid out by the Health Insurance Portability and Accountability Act.

The patient safety rules specify that PSOs would be considered business associates of physicians. This means doctors and PSOs would need to enter into business associate agreements, in accordance with HIPAA.

But Deborah Peel, MD, a psychiatrist and chair of the Texas-based Patient Privacy Rights Foundation, worried that PSOs could erode patient privacy. “Even if information is de-identified, patients may still feel concerned about a disclosure,” she said. Patients should be asked to opt in before their medical records are used in a patient safety report, she said.

The 2005 patient safety law stemmed from a 1999 Institute of Medicine study reporting an estimate that as many as 98,000 Americans die every year from preventable medical errors.

HHS had been criticized for slow progress. In January, Sen. Edward Kennedy (D, Mass.) called for a Government Accountability Office probe into the lack of movement. AMA Executive Vice President and CEO Michael D. Maves, MD, MBA, wrote HHS Secretary Michael O. Leavitt on Feb. 6 urging him to propose the rules quickly.

Issuing the rules took 2½ years because the departments of Justice, Defense and Veterans Affairs had to review them, said William B. Munier, MD, director of AHRQ’s Center for Quality Improvement and Patient Safety. HHS will consider public comment until April 14.

Promoting participation

The proposed regulations contain provisions protecting the confidentiality of data contained in reports to patient safety organizations and deliberations about whether to report. These safeguards include:

  • Banning discovery or subpoena of the data and its admission into evidence in most civil, administrative or criminal proceedings in federal, state, local or tribal courts.
  • Exempting the data from Freedom of Information Act requests.
  • Penalizing disclosure of the data with fines of up to $10,000.
  • Prohibiting health insurers from becoming PSOs.

Agency for Healthcare Research and Quality’s patient safety organizations page (

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