To Err Is Human Building a Safer Health System (2000) / Chapter Skim
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6 Protecting Voluntary Reporting Systems from Legal Discovery
6 Protecting Voluntary Reporting Systems from Legal Discovery
Pages 109-131
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From page 109... ...
A hospital or clinic often produces the care directed by the physician. The consumer, purchaser, and health plan share in decisions to determine whether and how treatment decisions directed by the physician are paid, which influences access to care.
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From page 110... ...
Chapter 5 lays out a strategy to encourage greater recognition and analysis of errors and improvements in patient safety through a mandatory reporting system for errors that result in serious harm, and voluntary participation in error reporting systems that focus on "near misses" or errors resulting in lesser harm. The issue of whether data submitted to reporting systems should be protected from disclosure, particularly in litigation, arose early in the committee discussions.
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From page 111... ...
Legal protections like state peer review shields and laws created to protect a specific reporting system have much promise. Many current state peer review statutes, however, may not protect data about errors shared in collaborative networks, especially across state lines, or reported to voluntary reporting systems (e.g., independent data banks)
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From page 112... ...
Information about errors which have resulted in serious harm or death to patients and which are subject to mandatory reporting should not be protected. INTRODUCTION The systematic reporting and tracking of safety problems is an important approach to quality improvement.
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From page 113... ...
The committee notes that protecting data in a reporting system as recommended in this chapter does not mean that the plaintiff in a lawsuit could not try to obtain such information through other avenues if it is important in securing redress for harm; it just means that the plaintiff would not be assisted by the presence of a reporting system designed specifically for other purposes beneficial to society. THE BASIC LAW OF EVIDENCE AND DISCOVERABILITY OF ERROR-RELATED INFORMATION Demands for information on errors can come from any of the plaintiffs in medical malpractice lawsuits, which are almost always based on state law.= Whether and when plaintiffs can obtain access to such data or have such information admitted as evidence at trial depend on the general rules of evidence and civil procedure, as applied by a state judge under particular *
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From page 114... ...
Similarly, a suit may allege negligent oversight in credentialing or supervision by the institution, medical group or health plan within which the doctor practices. In such a lawsuit, the plaintiff would argue that the occurrence of similar problems before the case in dispute should have or did put the defendant on notice of a pattern of problems that should have been corrected before the plaintiff's injury occurred.
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From page 115... ...
A recent Florida case combined the notice and causation purposes of similar-occurrence evidence. An obese patient alleged that the defendant obstetrician injured her child by delivering her on a standard bed, rather than a drop-down bed.
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From page 116... ...
They could include external data banks, quality consultants, accrediting bodies such as ICAHO, and other persons or organizations that have information on errors. Subject to the judge's approval, the party seeking discovery simply issues a subpoena to the nonparty for the information.14 The same methods of discovery generally apply to nonparties as to parties, except that interrogatories (a set of written questions)
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From page 117... ...
Similarly, those who receive, de-identify, investigate, and analyze reports could be compelled to testify if they could be identified with sufficient particularity to be served with a subpoena. LEGAL PROTECTIONS AGAINST DISCOVERY OF INFORMATION ABOUT ERRORS Three main types of legal protections can block the discovery of data on errors.
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From page 118... ...
The policy rationale for the rule would argue for this extension; without it, defendants might be unwilling to undertake the analyses needed to devise remedial measures. A California court, for example, recently held that the rule protected the records of peer review committees from discovery, independently from California's peer review statute, which also applied.16 However, other states have ruled the opposite way or have not yet reached the question of whether evaluative reports are protected.17 Even in states that have extended the remedial measures rule to evaluative reports, protecting the reports outside of the institution involved in the lawsuit would require yet another extension of the rule.
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From page 119... ...
Attorney Work Product Doctrine This rule protects materials that are created by or on behalf of a lawyer in preparation for litigation. The purpose is to protect the thoughts and plans of the lawyer, and the privilege can be waived only by the lawyer.
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From page 120... ...
California defines a peer review body as including "a medical or professional staff of any licensed health care facility, a nonprofit medical professional society, or a committee whose function is to review the quality of professional care provided by the members or employees of the entity to which the committee belongs."25 No statute expressly covers systems or collaborations that cross state lines. States can develop statutes to accommodate reporting systems, such as in Oklahoma.
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From page 121... ...
against how much trouble and expense it imposes on the defendant.= Moreover, state or federal law enforcement authorities may be able to discover the information for use in criminal proceedings, although instances of criminal prosecution for medical errors are exceptionally rare. Many states' statutes prevent a plaintiff from compelling a member of the peer review committee to testify, but one might testify voluntarily.28 To close this loophole, hospitals can adopt bylaws prohibiting staff members from disclosing any information obtained through the peer .
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From page 122... ...
and does not extend to simple observation of medical errors "in the field." With regard to confidentiality, the act allows only designated authorized users to obtain information from the data bank, mainly hospitals and other health care organizations that credential practitioners. Regulations call for authorized users to use data only for credentialing or peer review and to keep data only within departments doing such authorized activities.
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From page 123... ...
, these entities monitor the utilization and quality of care for Medicare beneficiaries, including quality improvement projects, mandatory case review and oversight of program integrity (see Chapter 71. One responsibility involves the investigation and evaluation of instances of possibly substandard care provided to fee-for-service Medicare beneficiaries.
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From page 124... ...
This can be done with anonymous reporting (in which case the data recipient never receives any identified information to begin with) and by de-identification of reported data (in which case the identity of the reporter is removed after receipt of the report, often after a short lag to permit clarification or additional information to be obtained from the reporter)
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From page 125... ...
One legal fear is that disclosure of internal quality data to outside reviewers not under a peer review statute will lead to discovery from ICAHO in lawsuits; indeed, many fear that disclosure to ICAHO would invalidate even the nondiscoverability protections each hospital enjoys for its own data under its state peer review statute.= A practical fear is that involving numerous outsiders will increase the potential for security breaches. ICAHO is seeking federal statutory protection as a definitive solution to the problem.
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From page 126... ...
Hospitals submit reports on medication errors to MedMARx over the Internet, identified by a random number known only to the submitting hospital. This preserves anonymity, but allows the hospital to compare its experience to similar institutions.
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From page 127... ...
Specific statutory protection for a particular reporting system may be the most desirable form of protection, but this may not be a realistic option for many systems. Some states' peer review statutes could be used by some types of reporting systems for example in California and
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From page 128... ...
However, if an investigator spent some time on-site looking into a particular event, as might a JCAHO investigator examining a hospital's root cause analysis of a particular sentinel event, practical methods of protection would likely fail. Any reported data of an injury-causing error can be protected from use in a lawsuit involving that specific reported injury by practical methods (anonymous reporting or de-identification)
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From page 129... ...
This strong form of protection is used, for example, in the Health Care Quality Improvement Act's protection for the peer review process. The committee concludes that some combination of legal and practical protections would be best.
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From page 130... ...
29. See Medicare Payment Advisory Commission (1999)
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From page 131... ...
., et al. Promoting patient safety by preventing medical error.
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