In 1999, the Institute of Medicine authored the article To Err is
Human. The article attributed 98,000 deaths per year, over 1,000,000
injuries per year, and $29,000,000,000.00 spent per year on medical
errors. It concluded that medical errors are a leading cause of death in
the United States, more than motor vehicle accidents, breast cancer, or
AIDS. Since 1999, there has been a shift toward quality improvement and
safety in healthcare.
On July 29, 2005, President Bush signed into law The Patient Safety and
Quality Improvement Act of 2005 (“The Act”). 42 U.S.C. Section 299b.
The Act allows voluntary reporting of medical errors to patient safety
organizations without legal reprisal.
The Act defines patient safety work product as data, memoranda, reports,
analyses, records memoranda, and written or oral statements that are assembled
or developed by a provider for reporting to a Patient Safety Organization
(“PSO”) and are reported to that PSO. PSOs cannot protect medical records,
billing and discharge information, original patient or provider records, or
information collected, maintained, or developed separately, or that exists
separately, from a PSO.
Providers under The Act is a broad category and include: hospitals, nursing
facilities, comprehensive outpatient rehabilitation facilities, home health
agencies, hospice programs, renal dialysis facilities, ambulatory surgical
enters, pharmacies, physician or healthcare practitioner’s offices, long term
care facilities, behavior health residential treatment facilities, clinical
laboratories, health centers, physicians, physician assistants, nurse
practitioners, clinical nurse specialists, certified registered nurse
anesthetists, certified nurse midwives, psychologists, certified social workers,
registered dieticians or nutrition professionals, physical or occupational
therapists, pharmacists and or any other individual or entity licensed or
otherwise authorized under state law to provide healthcare services.
Patient safety work product that is reported to TXPSO is not subject to
federal, state, or local civil, criminal, or administrative subpoena or
proceedings and is not subject to disclosure under under the Freedom of
Information Act, Title 5 U.S.C. § 552. Patient safety work product
reported to a PSO cannot be admitted as evidence or otherwise in civil,
criminal, or administrative proceeding, except in a criminal proceeding after a
court makes an in camera determination or determines that the information
relates to the commission of a crime and disclosure becomes necessary for
criminal law enforcement purposes. Patient safety work product reported to
a PSO will not be used in disciplinary proceeding against a provider who
reported the information. The Act assesses a civil monetary penalty up to
$10,000.00 per occurrence if privacy is breached when reporting to
TXPSO.
A comparison to Texas privileges shows the
value of TXPSO. The physician-patient communication privilege is waived
when the patient puts his or her health at issue in a lawsuit or a proceeding
against a physician, including disciplinary proceedings brought by the Board of
Medical Examiners. Tex. Rule Ev. 509(c); Occ. Code § 159.002(b). The
hospital committee privilege maintains a privilege for records and proceedings
of medical committees, but not for information that is routinely generated by
the hospital or gratuitously submitted to the committee. Health &
Safety Code § 161.032. The peer review privilege maintains confidentiality
of records, reports, evaluations, and recommendations received, maintained, or
developed by a peer review committee, but disclosure can be authorized by law,
if the action investigated is based on malice, anticompetitive actions, or
civil.
On November 19, 2008, TXPSO's listing as a patient
safety organization was effective and listed on AHRQ's website at www.pso.ahrq.gov.
TXPSO's listing is effective until November 18, 2011.
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