By Harvey Ferguson, Jr., R.Ph., J.D., LL.M. Candidate
The September 1999 report from the Institute of Medicine (IOM), To Err is Human: Building a Safer Health System, has been widely reported. The Report begins with the statement; “Health care in the United States is not as safe as it should be – and can be.” The IOM cites the results of a study done in Colorado and Utah and another study conducted in New York to conclude that at least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented. It called on Congress to create a national patient safety center to develop new tools and systems to address medical errors.
The stated goal of the IOM’s Report is to reduce the number of preventable medical errors. One of the recommendations of the IOM called for a nationwide public mandatory reporting system. Under the system proposed by the IOM, state governments would be required to collect standardized information concerning adverse medical events that result in death or serious harm. The IOM also envisioned a voluntary reporting system that focused on a much broader set of errors, mainly those that do no or minimal harm. Now some four years after the IOM’s report, the federal government is acting.
The U.S. House of Representatives has recently passed a bill to create a voluntary system for tracking medical errors. A bill pending in the Senate has yet to be considered. The House bill (H.R. 663), known as the Patient Safety and Quality Improvement Act (PSQIA), establishes a voluntary error reporting system. The Health and Human Services Secretary would be required to certify a number of public and private organizations as patient safety organizations. Those groups would analyze data on medical errors, determine their causes, and develop information for providers to help them implement changes that will improve patient safety.
The Senate’s version is entitled the Health Care Coverage Expansion and Quality Improvement Act of 2003 (HCCEQIA) (S. 10). This Bill would direct the Secretary of Health and Human Services to establish a center known as the Center for Quality Improvement and Patient Safety. Among its other functions, this Center would establish a national patient safety database to collect medical information with the goal of reducing medical errors.
Both bills have similar language protecting any submitted information from further disclosure. The House’s version states that “patient safety work product” shall not be subject to civil or administrative subpoena or order, or subject to discovery in connection with any civil or administrative proceeding. The PSQIA defines "patient safety work product” as a record concerning patient information either reported to a patient safety organization by a health care provider (doctor, hospital, etc.) or created by a patient safety organization. It also defines a patient safety organization as an organization, certified under the Act, that collects such information with the goal of improving patient safety and the quality of health care delivery. Patient safety work product is defined to exclude 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 submitted data. Information that is available from sources other than a patient safety work product may also be discovered or admitted in a civil or administrative proceeding, if discoverable or admissible under applicable law. A document cannot become privileged merely by reason of its inclusion in or submission under the Act. In addition, the PSQIA prohibits an employer from taking any adverse employment action against an individual who voluntarily reports information in good faith in accordance with the Act. The Senate’s version, now under consideration, has substantially the same provisions concerning privilege and protection for those who report in good faith.
The clear purpose of the privilege provisions in both bills is to protect the information provided to a central database from use in civil malpractice suits and administrative actions. For any voluntary reporting system to work, these protections are essential. The final Act must protect from discovery the documents and communications submitted to a national database and insure that retaliation for reporting is prohibited. Without these safeguards, health care providers will not participate voluntarily. Neither the House nor Senate bill goes the additional step of providing a qualified immunity from civil liability for those who participate in the program in good faith.
Compare the Texas Health and Safety Code and the Texas Medical Practice Act that create the medical committee and peer review privileges in Texas. The Texas Medical Practice Act provides that "all proceedings and records of a peer review committee" are privileged. See Texas Occupations Code § 160.007. The Texas statute states that a communication to a medical peer review committee is not subject to subpoena or discovery and is not admissible as evidence in any civil judicial or administrative proceeding without proper waiver of the privilege. Id. The Texas law also recognizes a qualified immunity from civil liability for committee members participating in the peer review process in good faith. See Texas Occupations Code § 160.010.
The overarching purpose of the Texas statutes is to foster a free, frank exchange among medical professionals about the professional competence of their peers. Records and proceedings generated by a medical peer review committee are considered confidential in order to encourage the hospital to conduct an open and thorough review of hospital procedures and employees. The peer review privilege is to encourage candid and voluntary studies and programs used to improve hospital conditions and patient care and to reduce the rates of death and disease. The statutes promote the belief that, absent the statutory peer review privilege, physicians would be reluctant to sit on peer review committees and engage in frank evaluations of their colleagues.
The proposed federal law must have similar wording that provides health care workers with as much assurance as possible: (1) that voluntary reporting of a medical error will not later be used against them in civil litigation or an administrative process brought by either a patient or a fellow worker; and (2) that reporting will not subject them to retaliation in the workplace. The Texas Supreme Court has consistently upheld the Texas peer review privilege. Justice Owen, writing for the Supreme Court in Irving Healthcare System v. Brooks, 927 S.W.2d 12, 17 (Tex.1996) (orig. proceeding), stated:
[o]nce a state has made the policy decision to afford privileged status for certain hospital records, the legislature and the courts should not undermine the policy objectives by circumventing or weakening the privileged status with exceptions not mandated by constitutional considerations or the long-run interests of justice. Nothing is worse than a half-hearted privilege; it becomes a game of semantics that leaves parties twisting in the wind while lawyers determine its scope. Citing Creech, Comment, The Medical Review Committee Privilege: A Jurisdictional Survey, 67 N.C.L.Rev. 179, 179-80 (1988).The current federal legislation should do no less. Nothing would be worse than an ineffective piece of legislation that is doomed from the start. Unless healthcare workers feel secure that any reporting to a national database is confidential and privileged, the federal law will not meet its goal of reducing medical errors.