H.R. 664 (ih) To provide for substantial reductions in the price of prescription drugs for Medicare beneficiaries. [Introduced in House] ...

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108th CONGRESS
  1st Session
                                H. R. 663

 To amend title IX of the Public Health Service Act to provide for the 
  improvement of patient safety and to reduce the incidence of events 
     that adversely affect patient safety, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 11, 2003

Mr. Bilirakis (for himself, Mr. Brown of Ohio, Mr. Tauzin, Mr. Dingell, 
Mr. Barton of Texas, Mr. Waxman, Mr. Upton, Mr. Markey, Mr. Greenwood, 
   Mr. Towns, Mr. Burr, Mr. Pallone, Mr. Whitfield, Mr. Gordon, Mr. 
Norwood, Mr. Deutsch, Mr. Terry, Mr. Rush, Mr. Rogers of Michigan, Mr. 
Engel, Mr. Wynn, Ms. McCarthy of Missouri, Mr. Strickland, Mrs. Capps, 
  Mr. John, and Ms. Harman) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend title IX of the Public Health Service Act to provide for the 
  improvement of patient safety and to reduce the incidence of events 
     that adversely affect patient safety, and for other purposes.

    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 ``Patient Safety and Quality 
Improvement Act''.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--The Congress finds as follows:
            (1) In 1999, the Institute of Medicine released a report 
        entitled ``To Err Is Human'' that described medical errors as 
        the 8th leading cause of death in the United States, with as 
        many as 98,000 people dying as a result of medical errors each 
        year.
            (2) To address these deaths and injuries due to medical 
        errors, the health care system must identify and learn from 
        such errors so that systems of care can be improved.
            (3) Myriad public and private patient safety initiatives 
        have begun. The Quality Interagency Coordination Task Force has 
        recommended steps to improve patient safety that may be taken 
        by each Federal agency involved in health care and activities 
        relating to these steps are ongoing.
            (4) The Department of Health and Human Services has 
        initiated several patient safety projects. The Joint Commission 
        on Accreditation of Healthcare Organizations issued a patient 
        safety standard that went into effect on July 1, 2001, and the 
        peer review organizations are conducting ongoing studies of 
        clinical performance measurement of care delivered to 
        beneficiaries under the medicare program under title XVIII of 
        the Social Security Act.
            (5) Several steps can be taken now to improve patient 
        safety. For example, according to the Centers for Disease 
        Control and Prevention, hand washing is the single most 
        important means of preventing the spread of infection. Repeated 
        studies indicate that lack of or improper hand washing still 
        contributes significantly to disease transmission in health 
        care settings. Working with experts from the private sector, 
        the Centers for Disease Control and Prevention has drafted 
        ``Guidelines for Hand Hygiene in Healthcare Settings'' setting 
        forth recommendations to promote improved hand hygiene 
        practices and reduce transmission of pathogenic microorganisms 
        to patients and personnel in health care settings.
            (6) According to the Centers for Disease Control and 
        Prevention, nosocomial infections affect approximately 2 
        million patients annually in acute care facilities in the 
        United States at an estimated direct patient care cost of 
        approximately $3.5 billion each year.
            (7) The Congress encourages the continuation and 
        acceleration of private sector efforts to take immediate steps 
        to improve patient safety and recognizes the need for action in 
        the public sector to complement these efforts.
            (8) The research on patient safety unequivocally calls for 
        a learning environment, where providers will feel safe to 
        report health care errors, in order to improve patient safety.
            (9) Voluntary data gathering systems are more supportive 
        than mandatory systems in creating the learning environment 
        referred to in paragraph (8) as stated in the Institute of 
        Medicine's report.
            (10) Promising patient safety reporting systems have been 
        established throughout the United States, and the best ways to 
        structure and use these systems are currently being determined, 
        largely through projects funded by the Agency for Healthcare 
        Research and Quality.
            (11) Many organizations currently collecting patient safety 
        information have expressed a need for protections that will 
        allow them to review protected information so that they may 
        collaborate in the development and implementation of patient 
        safety improvement strategies. Currently, the State peer review 
        protections provide inadequate conditions to allow the sharing 
        of information to promote patient safety.
            (12) In 2001, the Institute of Medicine released a report 
        entitled ``Crossing the Quality Chasm'' that found that the 
        United States health care system does not consistently deliver 
        high-quality care to patients.
    (b) Purposes.--The purposes of this Act are--
            (1) to encourage a culture of safety and quality in the 
        United States health care system by providing for a health care 
        errors reporting system that both protects information and 
        improves patient safety and quality of health care; and
            (2) to ensure accountability by raising standards and 
        expectations for continuous quality improvements in patient 
        safety through the actions of the Secretary of Health and Human 
        Services.

SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.

    (a) In General.--Title IX of the Public Health Service Act (42 
U.S.C. 299 et seq.) is amended--
            (1) in section 912(c), by inserting ``, in accordance with 
        part C,'' after ``The Director shall'';
            (2) by redesignating part C as part D;
            (3) by redesignating sections 921 through 928, as sections 
        931 through 938, respectively;
            (4) in section 938(1) (as so redesignated), by striking 
        ``921'' and inserting ``931''; and
            (5) by inserting after part B the following:

                  ``PART C--PATIENT SAFETY IMPROVEMENT

``SEC. 921. DEFINITIONS.

    ``In this part:
            ``(1) Identifiable information.--The term `identifiable 
        information' means information that is presented in a form and 
        manner that allows the identification of any provider, patient, 
        or reporter of patient safety work product. With respect to 
        patients, such information includes any individually 
        identifiable health information as that term is defined in the 
        regulations promulgated pursuant to section 264(c) of the 
        Health Insurance Portability and Accountability Act of 1996 
        (Public Law 104-191; 110 Stat. 2033).
            ``(2) Nonidentifiable information.--The term 
        `nonidentifiable information' means information that is 
        presented in a form and manner that prevents the identification 
        of any provider, patient, or reporter of patient safety work 
        product. With respect to patients, such information must be de-
        identified consistent with the regulations promulgated pursuant 
        to section 264(c) of the Health Insurance Portability and 
        Accountability Act of 1996 (Public Law 104-191; 110 Stat. 
        2033).
            ``(3) Patient safety evaluation system.--The term `patient 
        safety evaluation system' means a process that involves the 
        collection, management, or analysis of information for 
        submission to or by a patient safety organization.
            ``(4) Patient safety organization.--The term `patient 
        safety organization' means a private or public organization or 
        component thereof that is certified, through a process to be 
        determined by the Secretary under section 925, to perform each 
        of the following activities:
                    ``(A) The conduct, as the organization or 
                component's primary activity, of efforts to improve 
                patient safety and the quality of health care delivery.
                    ``(B) The collection and analysis of patient safety 
                work product that is submitted by providers.
                    ``(C) The development and dissemination of 
                evidence-based information to providers with respect to 
                improving patient safety, such as recommendations, 
                protocols, or information regarding best practices.
                    ``(D) The utilization of patient safety work 
                product to carry out activities limited to those 
                described under this paragraph and for the purposes of 
                encouraging a culture of safety and of providing direct 
                feedback and assistance to providers to effectively 
                minimize patient risk.
                    ``(E) The maintenance of confidentiality with 
                respect to identifiable information.
                    ``(F) The provision of appropriate security 
                measures with respect to patient safety work product.
                    ``(G) The submission of nonidentifiable information 
                to the Agency consistent with standards established by 
                the Secretary under section 923(b) for any National 
                Patient Safety Database.
            ``(5) Patient safety work product.--
                    ``(A) The term `patient safety work product' means 
                any document or communication (including any 
                information, report, record, memorandum, analysis, 
                deliberative work, statement, or root cause analysis) 
                that--
                            ``(i) except as provided in subparagraph 
                        (B), is developed by a provider for the purpose 
                        of reporting to a patient safety organization, 
                        and is reported to a patient safety 
                        organization;
                            ``(ii) is created by a patient safety 
                        organization; or
                            ``(iii) would reveal the deliberations or 
                        analytic process of a patient safety evaluation 
                        system (as defined in paragraph (3)).
                    ``(B)(i) Patient safety work product described in 
                subparagraph (A)(i)--
                            ``(I) does not include any separate 
                        information described in clause (ii); and
                            ``(II) shall not be construed to include 
                        such separate information merely by reason of 
                        inclusion of a copy of the document or 
                        communication involved in a submission to, or 
                        the fact of submission of such a copy to, a 
                        patient safety organization.
                    ``(ii) Separate information described in this 
                clause is a document or communication (including a 
                patient's medical record or any other patient or 
                hospital record) that is developed or maintained, or 
                exists, separately from any patient safety evaluation 
                system.
                    ``(C) Information available from sources other than 
                a patient safety work product under this section may be 
                discovered or admitted in a civil or administrative 
                proceeding, if discoverable or admissible under 
                applicable law.
            ``(6) Provider.--The term `provider' means--
                    ``(A) an individual or entity licensed or otherwise 
                authorized under State law to provide health care 
                services, including--
                            ``(i) a hospital, nursing facility, 
                        comprehensive outpatient rehabilitation 
                        facility, home health agency, and hospice 
                        program;
                            ``(ii) a physician, physician assistant, 
                        nurse practitioner, clinical nurse specialist, 
                        certified nurse midwife, psychologist, 
                        certified social worker, registered dietitian 
                        or nutrition professional, physical or 
                        occupational therapist, or other individual 
                        health care practitioner;
                            ``(iii) a pharmacist; and
                            ``(iv) a renal dialysis facility, 
                        ambulatory surgical center, pharmacy, physician 
                        or health care practitioner's office, long-term 
                        care facility, behavioral health residential 
                        treatment facility, clinical laboratory, or 
                        community health center; or
                    ``(B) any other person or entity specified in 
                regulations by the Secretary after public notice and 
                comment.

``SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PRODUCT.

    ``(a) Privilege.--Notwithstanding any other provision of law and 
subject to subsection (c), patient safety work product shall not be--
            ``(1) subject to a civil or administrative subpoena or 
        order;
            ``(2) subject to discovery in connection with a civil or 
        administrative proceeding;
            ``(3) subject to disclosure pursuant to section 552 of 
        title 5, United States Code (commonly known as the Freedom of 
        Information Act), or any other similar Federal or State law;
            ``(4) required to be admitted as evidence or otherwise 
        disclosed in any State or Federal civil or administrative 
        proceeding; or
            ``(5) if the patient safety work product is identifiable 
        information and is received by a national accreditation 
        organization in its capacity as a patient safety organization--
                    ``(A) used by a national accreditation organization 
                in an accreditation action against the provider that 
                reported the information;
                    ``(B) shared by such organization with its survey 
                team; or
                    ``(C) required as a condition of accreditation by a 
                national accreditation association.
    ``(b) Reporter Protection.--
            ``(1) In general.--A provider may not use against an 
        individual in an adverse employment action described in 
        paragraph (2) the fact that the individual in good faith 
        reported information--
                    ``(A) to the provider with the intention of having 
                the information reported to a patient safety 
                organization; or
                    ``(B) directly to a patient safety organization.
            ``(2) Adverse employment action.--For purposes of this 
        subsection, an `adverse employment action' includes--
                    ``(A) the failure to promote an individual or 
                provide any other employment-related benefit for which 
                the individual would otherwise be eligible;
                    ``(B) an adverse evaluation or decision made in 
                relation to accreditation, certification, 
                credentialing, or licensing of the individual; and
                    ``(C) a personnel action that is adverse to the 

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