Section-by-Section Summary of the
“Patient Safety and Quality Improvement Act”

Purpose – To amend title XI of the Social Security Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely effect patient safety.  Specifically, this act will encourage a culture of safety by providing for the legal protection of information reported voluntarily for the purposes of quality improvement and patient safety, and ensure accountability by raising standards and expectations for continuous quality improvements.

Section 1.  Short title, “Patient Safety Improvement Act.”

Section 2. Amends Title XI of the Social Security Act.

Section 1181.  Creates a new process to allow confidential reporting of patient safety data from health care providers to Patient Safety Organizations (PSOs).  PSOs analyze reports from providers, provide feed-back to providers, share non-identifiable information with other PSOs and to the new Center for Quality Improvement and Patient Safety database of medical errors.  Identifiable patient safety data may be disclosed to other patient safety organizations with explicit authorization of the reporting provider involved.

Defines relevant terms, including non-identifiable information, patient safety data, patient safety organization (PSO) and provider. 

Providers are defined as current Medicare providers, including hospitals, physicians, skilled nursing facilities, home health agencies, and Medicare+Choice plans, among others.

Patient safety data means any data or reports collected or developed by a health provider for the purpose of reporting to a PSO, and are reported on a timely basis.  In addition, safety data is data collected by a PSO or the new errors data base, and includes corrective action taken by health providers in response to feed back from PSOs.

Nothing shall be construed to limit or discourage a health care provider from developing and using patient safety data within a provider to improve patient safety, health care quality or administrative efficiency of the provider.

PSO must be certified by the Secretary, and are public or private organizations assist health providers in improving patient safety.  Specifically, PSOs:

• Collect and analyze voluntary patient safety data reported by more than one  provider.
• Develop and disseminate information to providers to end errors and improve best practices.
• Must maintain confidentiality and security of health information.
• Submit non-identifiable information to the errors database.

PSOs must be managed and operated independently from reporting health providers.  If a PSO no longer qualifies, any data housed by the organization must be destroyed, returned to the provider or transferred to another PSO with the approval of the provider and that PSO.  If the organization charges a fee for its services, the fee must be applied uniformly among all classes and types of health providers based on size, and data collection is done in a standardized format.  In addition, PSOs cannot use patient safety data in regulatory enforcement activities it may conduct.

The Secretary is required to provide technical assistance to health providers in reporting data and maintaining confidentiality and security of the information.

Nothing in this part shall be construed to limit or discourage the reporting of information relating to patient safety within a health care provider.

Section 1182.  Provides for confidentiality and peer review protections for patient safety data.  The privilege shall apply to information, such as records of a patient’s medical diagnosis and treatment, other primary health care information, and other information to the extent that such information was collected and developed for the purpose of reporting to PSOs.  Such privilege shall not apply to information merely by reason of its inclusion or the fact of its submission in a report to a PSO.  That privilege does not apply to information that is available outside the process, such as records of a patient’s medical diagnosis and treatment and other primary health records of a health care provider.  A provider or PSO can disclose relevant information to the FDA.

This patient safety information is privileged and confidential and, therefore, cannot be subjected to civil or administrative subpoena; subject to discovery in connection with a civil,  or administrative proceeding; disclosed pursuant to FOIA; or admitted as evidence in any civil or administrative subpoena. 

Nothing in this part shall be construed as preempting or otherwise affecting any state law mandatory reporting requirement for health care providers.

A health care provider may not retaliate in any form against an employee that reports patient safety data to a PSO.

However, this protection does not imply that a provider should not comply with authorized requests for information that has been developed, maintained, or exists separately from the process of collecting or developing information for a patient safety organization (PSO). 

Any violation of these provisions is subject to the penalties under the current section of the Social Security Act relating to inappropriate disclosures made by current peer review organizations under the Medicare program, which provides a $1,000 fine per disclosure, up to six months in jail or both.

Additionally, the section clarifies that this privilege is meant to be a federal floor and provides states the opportunity to provide greater protections.  It also clarifies that this legislation is not intended to alter the Health Insurance Portability and Accountability Act, but establishes PSOs as business associates for purposes of the patient confidentiality rule.

Finally, the section authorizes a report by GAO to examine what laws related to peer review protections exist at the state level, and the effectiveness of those laws.

Section 1183.  Establishes a new Center for Quality Improvement and Patient Safety acting through the Agency for Healthcare Research and Quality.  The Center will:

• Certify and recertify PSOs.
• Collect and disseminate information regarding patient safety.
• Establish a Patient Safety Database to collect and support the analysis of non-identifiable data, and make recommendations to improve patient safety.
• Provide technical assistance to states that have or are developing medical errors reporting systems

The Secretary shall consult with and develop partnerships with health care organizations, health care providers, public and private sector entities and other relevant experts in patient safety.

The Secretary will use information gleaned from the database to develop patient safety goals and track the progress in implementing such goals. The Secretary may enter into contracts to use existing, private sector error reporting databases.

Finally, the Section authorizes to be appropriated such sums as may be necessary.

Section 1184.  Requires the Secretary to develop, in conjunction with the National Committee on Vital and Health Statistics, and a new Medical Information Technology Advisory Board, to develop voluntary, national standards that promote the interoperability of health care information technology systems across all health care settings.

Section 1185.  Requires the Secretary to encourage health care providers to adopt appropriate evidence-based methods to improve patient safety.  Such standards are not national practice guidelines.

Section 1186.  Five years after implementation of this part GAO shall conduct a comprehensive evaluation of the usefulness of the analyses, information and recommendations, effectiveness of the program in reducing medical errors, and the response of health care providers.

Section 3 Medical Information Technology Advisory Board

The Secretary shall appoint a 17 member Medical Information Technology Advisory Board with expertise in medical information, information technology, health researchers and purchasers.  The Board will make recommendations on best current practices in medical information technology and methods of implementing health care information technology interoperability.