[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4673 Introduced in House (IH)]
107th CONGRESS
2d Session
H. R. 4673
To amend the Public Health Service Act to provide for voluntary
reporting by health care providers of medication error information in
order to assist appropriate public and nonprofit private entities in
developing and disseminating recommendations and information with
respect to preventing medication errors.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 7, 2002
Mrs. Morella introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for voluntary
reporting by health care providers of medication error information in
order to assist appropriate public and nonprofit private entities in
developing and disseminating recommendations and information with
respect to preventing medication errors.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medication Error Prevention Act of
2002''.
SEC. 2. VOLUNTARY REPORTING PROGRAM REGARDING MEDICATION ERRORS;
DEVELOPMENT AND DISSEMINATION OF RECOMMENDATIONS FOR
PREVENTING MEDICATION ERRORS.
Part B of title II of the Public Health Service Act (42 U.S.C. 238
et seq.) is amended by adding at the end the following section:
``SEC. 249. VOLUNTARY REPORTING PROGRAM REGARDING MEDICATION ERRORS;
DEVELOPMENT AND DISSEMINATION OF RECOMMENDATIONS FOR
PREVENTING MEDICATION ERRORS.
``(a) Privileged Legal Status of Reported Information.--If the
Secretary approves a program as meeting the criteria described in
subsection (b) to serve as the reporting program for purposes of this
section, any medication error information submitted to the reporting
program by a health care provider pursuant to an agreement under
paragraph (3) of such subsection is privileged for purposes of Federal
and State judicial proceedings in civil matters, and for purposes of
Federal and State administrative proceedings, including with respect to
discovery and subpoenas.
``(b) Criteria for Reporting Program.--With respect to the approval
by the Secretary of a reporting program for purposes of this section,
the criteria referred to in subsection (a) are as follows:
``(1) The reporting program is operated by The United
States Pharmacopeial Convention, Incorporated (except that if
such entity declines to operate a reporting program for
purposes of this section, the Secretary may accept another
nonprofit private entity for such purposes).
``(2) Under such program, health care providers voluntarily
submit medication error information to the program, and the
program uses the information for the purpose of developing and
disseminating recommendations and information with respect to
preventing such errors, including recommendations in the form
of protocols, procedures, and best-practices information.
``(3) The use by the program of medication error
information submitted to the program by a health care provider
is governed by an agreement entered into by the program and the
provider.
``(4) Such agreement includes the following policies
(without regard to whether the following language is used in
the agreement):
``(A) Subject to subparagraph (B), the reporting
program reserves the right to disclose to third parties
medication error information submitted by a health care
provider if, in the judgment of the program, the
information can be used for purposes of furthering
research, education, standards setting, improvement in
processes, product improvement, public health, or
public safety.
``(B) If such a disclosure is made, the extent of
information disclosed will be limited to the
information required to meet the purposes described in
subparagraph (A).
``(c) Federal Disclosures.--Officers and employees of a Federal
agency may not disclose any medication error information that is
received by the agency from the reporting program pursuant to an
agreement between the agency and the program, except to the extent that
disclosure of the information is authorized by the agreement. The
preceding sentence applies notwithstanding any other provision of law.
``(d) Scope of Privilege.--With respect to Federal and State
judicial proceedings in civil matters, and Federal and State
administrative proceedings:
``(1) In the case of a health care provider:
``(A) The privilege under subsection (a) protects
all medication error information of the provider that
is provided in a submission to the reporting program or
is developed for purposes of such a submission, subject
to subparagraph (B).
``(B) The privilege does not protect medication
error information in patient medical records of the
provider, or other information that is in the custody
of the provider and is developed or maintained by the
provider separately from the process of developing
medication error information for submission to the
program.
``(2) In the case of the reporting program, the privilege
protects all medication error information that is received by
the program pursuant to agreements under subsection (b)(3).
``(3) In the case of other entities (whether public or
private), the privilege protects all medication error
information that is received by the entity from the reporting
program pursuant to an agreement between the entity and the
program, except to the extent that disclosure of the
information is authorized by the agreement.
``(e) Rule of Construction.--The submission by a health care
provider of medication error information to the reporting program may
not be construed as waiving any privilege that, under Federal or State
constitutions or laws, may exist with respect to the information.
``(f) Definitions.--For purposes of this section:
``(1) The term `health care provider' means individuals and
organizations that provide health services. Such term
includes--
``(A) physicians, nurses, pharmacists, and other
health professionals; and
``(B) hospitals, pharmacies, clinics, long-term
care facilities, intermediate care facilities,
residential treatment centers, and other entities that
provide health services.
``(2) The term `medication error' means any preventable
event that may cause or lead to inappropriate medication use or
patient harm while the medication is in the control of the
health care professional, patient, or consumer. Such events may
be related to professional practice, health care products,
procedures, and systems, including prescribing; order
communication; product labeling, packaging, and nomenclature;
compounding; dispensing; distribution; administration;
education; monitoring; and use.
``(3) The term `medication error information' means
information developed by or on behalf of a health care provider
in connection with a medication error.
``(4) The term `reporting program' means the program
approved under subsection (a).''.
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