The Patient Safety and Quality Improvement Act of 2005 is a federal law that has resulted from the federal government’s concern for the safety of patients receiving medical care. As the goal of the Act is to improve the safety and quality of care that patients receive, the Act provides for the creation of Patient Safety Organizations (“PSOs”) that gather facts, information, and statistics regarding the safety and quality of patient care. By collecting and analyzing this information, the federal government aims to enact measures and procedures to eliminate risks to patient safety. In order to implement the aims of the Act, Congress also enacted the Patient Safety Rule, which became effective January 19, 2009.
Although reporting of data is voluntary, the Act contains very specific confidentiality requirements that, if violated, can result in monetary fines. These confidentiality provisions limit the use and disclosure of collected data, such as in legal proceedings. Essentially, these provisions allow health care providers to report information and incidents using names of patients and healthcare providers that were involved in these incidents, without fear of increased liability. With the information provided under the Act, the goal is to analyze these incidents, discover their causes, and work toward a decreased number of these incidents.
The Office for Civil Rights (“OCR”), which is a division of the U.S. Department of Health and Human Services (“HHS”), enforces these confidentiality provisions. Under the Act, the OCR has the right to conduct reviews in order to determine whether a person or organization has complied with the Act, and to investigate complaints of violations of the confidentiality provisions.
If you feel that the Act has been violated with respect to its confidentiality provisions, you can file a complaint with the OCR, who has a duty to investigate your complaint. Your complaint should be made in writing to the OCR, and should be sent to the OCR by mail, fax, or e-mail. In your complaint, you must name the person whom you believe to be responsible for violating the Act, and describe the action(s) that you believe violated the Act in detail. Generally, you must file a complaint with the OCR within 180 days of the date that you knew, or should have known, that the violation occurred. However, the OCR does have the ability to waive the 180-day period for filing complaints for good cause.
You are not required to use any particular complaint form to make a complaint under the Act. However, you can access the official OCR complaint form to make your complaint online at the Department of Health and Human Servces website.
If the OCR finds a violation of the Act, it will make efforts to reach an informal resolution of the situation through voluntary compliance by the person or organization that has violated the Act. If an informal resolution is not possible, however, the Secretary of HHS may impose a fine of up to $10,000 for every knowing and reckless violation of the Act.