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Understanding the Patient Safety and Quality Improvement Act

By: Susanne S. Warfield
Posted: May 3, 2010, from the May 2010 issue of
Medical files

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If you believe someone’s health information privacy rights have been compromised or someone has committed a violation of the HIPAA Privacy Rule, you may file a HIPAA Privacy Rule complaint at

If you believe a person or organization impermissibly disclosed information, you also may file a complaint. Your complaint must:

  1. Be filed in writing and sent by mail, fax or e-mail;
  2. Name the person that is the subject of the complaint, as well as describe the act or acts believed to be in violation of the Patient Safety Act requirement to keep PSWP confidential; and
  3. Be filed within 180 days of when you knew or should have known the act complained of occurred. The OCR may waive the 180-day time limit if good cause is shown.

The complaint form includes:

  • The contact information of the person filing a complaint, as well as the means to contact the person filing the compliant. The filer of the complaint may be a patient, a provider or a reporter who is identified in the information that was impermissibly disclosed;
  • The provider, patient safety organization or other person whom you believe disclosed the patient safety work products that violated the patient safety confidentiality is also required;
  • Date of impermissibly disclosed PSWP;
  • Details of the how and why you believe that a disclosure occurred; and
  • A signature and filing date.

The OCR is then responsible for the investigation and enforcement of the confidentiality provisions of the Patient Safety Rule. It will provide technical assistance and seek out an informal resolution of complaints involving the impermissible disclosure of PSWP through voluntary compliance from the responsible person, entity or organization.

If the OCR is unable to achieve an informal resolution of an indicated violation through such voluntary compliance, its Secretary may impose a civil money penalty of up to $10,000 for each knowing and reckless disclosure that is in violation of the confidentiality provisions.

Being compliant