[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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