Committee on Ways and Means, Subcommittee on Health, Summary of Changes to H.R. 4889

Summary of Changes to HR 4889
Made by Chairman's Amendment in the Nature of a Substitute

Markup of the “Patient Safety Improvement Act of 2002"

Section

Page

Explanation of Change

1181

2
Clarifies reporting process from health care provider to patient safety organization.

1181

2
Clarifies patient safety organizations supply feed back to health care providers information to improve patient safety, and must submit non-identifiable data to the Center for Quality Improvement and Patient Safety, an existing agency within the Agency for Healthcare Research and Quality.

1181

2
Clarifies definition of patient safety data is collected or developed by a health care provider for reporting to a patient safety organization and that are reported on a timely basis.

1181

2
Adds rule of construction to definition of patient safety data that internal use of data to improve safety, quality and efficiency is allowed and does not disqualify the data as protected information.

1181

3
Clarifies that patient safety data applies to corrective actions taken by a health care provider whether or not a patient safety organization has reported back to the provider.

1181

3
Requires that patient safety organizations are certified by the Secretary.

1181

5
Requires patient safety organizations to submit non-identifiable information regarding medical errors to the Center for Quality Improvement and Patient Safety, if appropriate.

1181

5
Requires that patient safety organizations are managed, controlled and operated independently from the health providers who report to the organization.

1181

5
Requires that if a patient safety organization charges a fee for its services, the fee is uniform among classes and types of providers taking into account the size of the provider.

1181

5
Adds new requirement that patient safety organizations must seek to collect data from providers in a standardized manner.

1181

5
Adds new provision that nothing shall be construed to limit or discourage reporting of patient safety information within an institution.

1181

5
Adds a Part A provider’s employees in the definition of health care provider.

1182

6
Eliminates privilege and confidentiality protections for information sought in connection with criminal proceedings.

1182

7
Clarifies scope of protection applies to patient safety data, and not information that exists separately from the safety report.

1182

7
Clarifies allowable disclosures by defining what lies outside of new privilege protections, such as underlying medical and primary health records.

1182

7
Extends privilege and confidentiality protections to patient safety data in disciplinary proceedings.

1182

8
Establishes that nothing in the bill preempts or affects any State law mandatory reporting requirement.

1182

8
Specifies disclosure of non-identifiable information is allowed from the National Patient Safety Database.

1182

8
Clarifies that penalties for disclosure of patient safety data apply to each disclosure.

1182

9
Clarifies patient safety organizations are business associates for purposes of the medical records confidentiality rule. Specifies disclosures by providers are health care operations for purposes of the medical records confidentiality rule.

1181

9
Adds new requirement that if an organization no longer qualifies as a patient safety organization that it return patient safety data to the reporting provider, destroy the data, or, with the permission of the provider and another patient safety organization, transfer the data to that organization.

1182

9
Clarifies that any disclosure of patient safety data to the FDA does not constitute a waiver of any Federal or State privilege. Privilege continues, even if a patient safety organization ceases operation.

1182

9
Provides for a General Accounting Office survey and report on State laws that relate to patient safety data peer review systems and the effectiveness of such laws in improving patient safety.

1183

9
Creates statutory authority for the existing Center for Quality Improvement and Patient Safety within HHS. The Center will certify patient safety organizations, collect and disseminate information regarding patient safety.
The Center will establish a Patient Safety Database to collect and support the analysis of non-identifiable data, and make recommendations to improve patient safety.

The Center will provide technical assistance to States that have or are developing medical error reporting systems, and assist States in developing standardized methods for data collection and inclusion in the Patient Safety Database.

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.

1184

11
Moves Section 1184 (technical assistance) to Section 1181, and renames Section 1185 as 1184, Interoperability Standards for Health Care Information Technology Systems. Eliminates the Workgroup on Data Interchange from list of groups with which the Secretary consults in developing the interoperability standards. Authorizes such sums as necessary to develop the voluntary standards.

1184

12
Adds new section 1185 to require the Secretary to encourage health providers to adopt evidence-based methods to improve patient safety. Clarifies these methods do not constitute national medical practice guidelines or conditions of participation in the Medicare program.

None

12
Adds new Section 1186 requiring the General Accounting Office to perform a fundamental evaluation of the programs authorized by the bill after five years.

3

12
Adds requirement that the Chairman of the Medical Information Technology Advisory Board also be a member of the National Committee on Vital and Health Statistics.

3

13
Deletes representative from a public health agency from the Advisory Board.

3

14
Requires the MITAB shall advise on an ongoing basis and make recommendations to the Secretary in developing interoperability standards and in implementing health information technology.

3

15
Adds new requirement for the Medical Information Technology Advisory Board to recommend methods to promote information exchange among health care providers.

3

15
Changes from two years to 18 months the timing of the Boards initial report.

Section	*Page*	*Explanation of Change*
1181	2	Clarifies reporting process from health care provider to patient safety organization.
1181	2	Clarifies patient safety organizations supply feed back to health care providers information to improve patient safety, and must submit non-identifiable data to the Center for Quality Improvement and Patient Safety, an existing agency within the Agency for Healthcare Research and Quality.
1181	2	Clarifies definition of patient safety data is collected or developed by a health care provider for reporting to a patient safety organization and that are reported on a timely basis.
1181	2	Adds rule of construction to definition of patient safety data that internal use of data to improve safety, quality and efficiency is allowed and does not disqualify the data as protected information.
1181	3	Clarifies that patient safety data applies to corrective actions taken by a health care provider whether or not a patient safety organization has reported back to the provider.
1181	3	Requires that patient safety organizations are certified by the Secretary.
1181	5	Requires patient safety organizations to submit non-identifiable information regarding medical errors to the Center for Quality Improvement and Patient Safety, if appropriate.
1181	5	Requires that patient safety organizations are managed, controlled and operated independently from the health providers who report to the organization.
1181	5	Requires that if a patient safety organization charges a fee for its services, the fee is uniform among classes and types of providers taking into account the size of the provider.
1181	5	Adds new requirement that patient safety organizations must seek to collect data from providers in a standardized manner.
1181	5	Adds new provision that nothing shall be construed to limit or discourage reporting of patient safety information within an institution.
1181	5	Adds a Part A provider’s employees in the definition of health care provider.
1182	6	Eliminates privilege and confidentiality protections for information sought in connection with criminal proceedings.
1182	7	Clarifies scope of protection applies to patient safety data, and not information that exists separately from the safety report.
1182	7	Clarifies allowable disclosures by defining what lies outside of new privilege protections, such as underlying medical and primary health records.
1182	7	Extends privilege and confidentiality protections to patient safety data in disciplinary proceedings.
1182	8	Establishes that nothing in the bill preempts or affects any State law mandatory reporting requirement.
1182	8	Specifies disclosure of non-identifiable information is allowed from the National Patient Safety Database.
1182	8	Clarifies that penalties for disclosure of patient safety data apply to each disclosure.
1182	9	Clarifies patient safety organizations are business associates for purposes of the medical records confidentiality rule. Specifies disclosures by providers are health care operations for purposes of the medical records confidentiality rule.
1181	9	Adds new requirement that if an organization no longer qualifies as a patient safety organization that it return patient safety data to the reporting provider, destroy the data, or, with the permission of the provider and another patient safety organization, transfer the data to that organization.
1182	9	Clarifies that any disclosure of patient safety data to the FDA does not constitute a waiver of any Federal or State privilege. Privilege continues, even if a patient safety organization ceases operation.
1182	9	Provides for a General Accounting Office survey and report on State laws that relate to patient safety data peer review systems and the effectiveness of such laws in improving patient safety.
1183	9	Creates statutory authority for the existing Center for Quality Improvement and Patient Safety within HHS. The Center will certify patient safety organizations, collect and disseminate information regarding patient safety. The Center will establish a Patient Safety Database to collect and support the analysis of non-identifiable data, and make recommendations to improve patient safety. The Center will provide technical assistance to States that have or are developing medical error reporting systems, and assist States in developing standardized methods for data collection and inclusion in the Patient Safety Database. 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.
1184	11	Moves Section 1184 (technical assistance) to Section 1181, and renames Section 1185 as 1184, Interoperability Standards for Health Care Information Technology Systems. Eliminates the Workgroup on Data Interchange from list of groups with which the Secretary consults in developing the interoperability standards. Authorizes such sums as necessary to develop the voluntary standards.
1184	12	Adds new section 1185 to require the Secretary to encourage health providers to adopt evidence-based methods to improve patient safety. Clarifies these methods do not constitute national medical practice guidelines or conditions of participation in the Medicare program.
None	12	Adds new Section 1186 requiring the General Accounting Office to perform a fundamental evaluation of the programs authorized by the bill after five years.
3	12	Adds requirement that the Chairman of the Medical Information Technology Advisory Board also be a member of the National Committee on Vital and Health Statistics.
3	13	Deletes representative from a public health agency from the Advisory Board.
3	14	Requires the MITAB shall advise on an ongoing basis and make recommendations to the Secretary in developing interoperability standards and in implementing health information technology.
3	15	Adds new requirement for the Medical Information Technology Advisory Board to recommend methods to promote information exchange among health care providers.
3	15	Changes from two years to 18 months the timing of the Boards initial report.