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The Adverse Event of Unaddressed Medical Error: Identifying and Filling the Holes in the Health-Care and Legal Systems

Published online by Cambridge University Press:  01 January 2021

Bryan A. Liang
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Extract

Patient safety has assumed a prominent role on the policy agenda since the Institute of Medicine report To Err Is Human was released in November 1999. The report maintained that medical error is the predominant mechanism by which patients in the United States and around the world are injured. This finding, along with the report’s recommendation for a “systems” approach to reducing medical error, provided an extremely important insight into the operation of our medical delivery system. Clearly, while advances in medical technology, diagnostic techniques, and knowledge provide the foundation for saving lives, medical error has resulted in their loss. However, recognition that medical error is a primary cause of these avoidable patient injuries and deaths is a key one and may result in improvements within our system of health-care delivery as well as minimization of the emotional and financial toll that iatrogenic injury causes.

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Article
Information
Journal of Law, Medicine & Ethics , Volume 29 , Issue 3-4 , Fall Winter 2001 , pp. 346 - 368
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Copyright © American Society of Law, Medicine and Ethics 2001

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References

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See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 549–50. There may also be a significant conflict of interest in the Sentinel Event Policy itself. JCAHO not only decides the acceptability of the root cause analysis and, critically, accreditation status, but also offers consulting services to perform this analysis. This situation presents providers subject to the Sentinel Event Policy with difficult choices. See id. at 550; Liang, supra note 27. In addition, beginning July 2001, JCAHO requires physicians under its hospital accreditation standards to disclose “unanticipated outcomes” to patients, which is seen as requiring physicians to “tell patients when they received substandard care.”. Lovern, B., “JCAHO's New Tell-All; Standards Require That Patients Know about Below-Par Care,” Modern Healthcare, January 1, 2001, at 2. See JCAHO, Revisions to Joint Commission Standards in Support of Patient Safety and Medical/Health Care Error Reduction, at <http://jcprdwl.jcaho.org/standard/fr_ptsafety.html> (last visited January 10, 2001). Providers have expressed concerns regarding provider liability for this new policy, e.g., every admission has unanticipated outcomes, the standard will create awkwardness between hospitals and medical staffs, and “the hospital, by definition, is now intruding into the patient-physician relationship if there is a [JCAHO] documentation process required” for these disclosures. Lovern, supra. (last visited January 10, 2001). Providers have expressed concerns regarding provider liability for this new policy, e.g., every admission has unanticipated outcomes, the standard will create awkwardness between hospitals and medical staffs, and “the hospital, by definition, is now intruding into the patient-physician relationship if there is a [JCAHO] documentation process required” for these disclosures. Lovern, supra.' href=https://scholar.google.com/scholar?q=See+Liang,+,+“Promoting+Patient+Safety+Through+Reducing+Medical+Error,”+supra+note+4,+at+549–50.+There+may+also+be+a+significant+conflict+of+interest+in+the+Sentinel+Event+Policy+itself.+JCAHO+not+only+decides+the+acceptability+of+the+root+cause+analysis+and,+critically,+accreditation+status,+but+also+offers+consulting+services+to+perform+this+analysis.+This+situation+presents+providers+subject+to+the+Sentinel+Event+Policy+with+difficult+choices.+See+id.+at+550;+Liang,+supra+note+27.+In+addition,+beginning+July+2001,+JCAHO+requires+physicians+under+its+hospital+accreditation+standards+to+disclose+“unanticipated+outcomes”+to+patients,+which+is+seen+as+requiring+physicians+to+“tell+patients+when+they+received+substandard+care.”.+Lovern,+B.,+“JCAHO's+New+Tell-All;+Standards+Require+That+Patients+Know+about+Below-Par+Care,”+Modern+Healthcare,+January+1,+2001,+at+2.+See+JCAHO,+Revisions+to+Joint+Commission+Standards+in+Support+of+Patient+Safety+and+Medical/Health+Care+Error+Reduction,+at++(last+visited+January+10,+2001).+Providers+have+expressed+concerns+regarding+provider+liability+for+this+new+policy,+e.g.,+every+admission+has+unanticipated+outcomes,+the+standard+will+create+awkwardness+between+hospitals+and+medical+staffs,+and+“the+hospital,+by+definition,+is+now+intruding+into+the+patient-physician+relationship+if+there+is+a+[JCAHO]+documentation+process+required”+for+these+disclosures.+Lovern,+supra.>Google Scholar
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This characteristic of the legal system is important since a large majority of patients are now in some form of managed care, requiring physicians to obtain some managed care contract in order to practice. See Liang, , “Deselection under Harper v. Healthsource,” supra note 50, at 799 n.1 (noting 190 million U.S. citizens in managed care plans).Google Scholar
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It should be noted that other aspects of the medical liability system in practice make litigation a poor vehicle for quality improvement. For example, the Employee Retirement Income Security Act of 1974, 29 U.S.C.A. §§ 1001–1461 (West 1985 & Supp. 1998, is one area of the law that has been roundly criticized for its negative effect on quality in the world of managed care. Anti-managed care forces believe that the ERISA managed care legacy — indeed, managed care itself — could be brought down by the U.S. Supreme Court in a recent managed care case, namely, Pegram v. Herdrich, 530 U.S. 211 (2000). However, this case is not broadly applicable to the entire managed care industry based upon its facts (e.g., physician incentives as a possible breach of ERISA fiduciary duty in the context of a physician-owned health maintenance organization, hardly a common type of managed care arrangement). Second, an astounding number of courts appear to make significant errors themselves as to basic questions of jurisdiction in these ERISA cases; indeed, many federal district courts and virtually all federal courts of appeals that have addressed the issue of managed care liability in the context of ERISA have made completely erroneous jurisdictional assessments, making all of the cases so decided void. See Liang, , “Patient Injury Incentives in Law,” supra note 50, at 35–49. Note, however, that there may be a movement toward expanding agency theories of liability to managed care organizations.Google Scholar
This situation is exacerbated by the ease of hiding medical error as well as the medical and legal cultures of shame and blame. See Leape, supra note 6, at 1852.Google Scholar
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See, e.g., American Society for Healthcare Risk Management, Position Statement and Recommendations: JCAHO Sentinel Event Reporting Program (February 13, 1998), at <http://205.243.101.143/news/jcaho/jcahopos.html> (last visited April 3, 2000) (warning hospitals of high discoverability risk of collecting and performing JCAHO Sentinel Event Policy information); Medical Risk Management Associates, Conducting a Cost-Effective Root Cause Analysis, at <http://www.sentinel-event.com/costeffective.htm> (last visited March 22, 1999) (also warning hospitals of high discoverability risk of collecting and performing JCAHO Sentinel Event Policy information). See also Becker, supra note 29 (discussing case that held Sentinel Event Policy information discoverable).+(last+visited+April+3,+2000)+(warning+hospitals+of+high+discoverability+risk+of+collecting+and+performing+JCAHO+Sentinel+Event+Policy+information);+Medical+Risk+Management+Associates,+Conducting+a+Cost-Effective+Root+Cause+Analysis,+at++(last+visited+March+22,+1999)+(also+warning+hospitals+of+high+discoverability+risk+of+collecting+and+performing+JCAHO+Sentinel+Event+Policy+information).+See+also+Becker,+supra+note+29+(discussing+case+that+held+Sentinel+Event+Policy+information+discoverable).>Google Scholar
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See Liang, , “Risks of Reporting Sentinel Events,” supra note 4, at 117; Liang, and Storti, supra note 74, at 273-74. It should also be noted that there are risks of discovery on the basis of both the state and federal versions of the Freedom of Information Act if information on medical errors and safety is within any government boundaries. See Liang, , “Risks of Reporting Sentinel Events,” supra note 4, at 116.Google Scholar
See Liang, , “Risks of Reporting Sentinel Events,” supra note 4, at 117.Google Scholar
See id. at 116.Google Scholar
Courts may grant discovery even when a privilege applies if a balancing test by the judge indicates that the plaintiff legitimately needs the information and cannot sustain a claim without this relevant information. See Liang, , “Risks of Reporting Sentinel Events,” supra note 4, at 115; Liang, supra note 13, at 39.Google Scholar
See Liang, , “Risks of Reporting Sentinel Events,” supra note 4, at 116-17. Note that an entity cannot simply deem any and all professional staff members with some role in quality as part of a peer review or quality assurance committee in order to obtain privilege protections. Further, this privilege extends only to a body that actually performs peer review or quality assurance activities as its primary function. The extensive and qualitatively different activities involved in error and safety analysis seem to go beyond traditional peer review and quality assurance activities, and thus may be outside the privilege. See id. at 115.Google Scholar
See id. at 117.Google Scholar
See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 557.Google Scholar
See IOM Report, supra note 1, at 78–80, 210-17.Google Scholar
See Liang, , “Risks of Reporting Sentinel Events,” supra note 4.Google Scholar
See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 557–58 n.59.Google Scholar
See Liang, supra note 13, at 41.Google Scholar
See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 558, n.60.Google Scholar
See id. at 558–59 n.61. The related concept of attorney work product also does not shield error and safety information. See id. at n.61.Google Scholar
Rozovsky, F.A., Roosevelt, J. Jr. and Chaurette, K.A., “The JCAHO Sentinel Event Policy,” Health Law Digest, May 1998, at 3-11.Google Scholar
See Liang, supra note 13, at 28–29. See also Reason, supra note 8; Maurino, , Reason, , Johnston, and Lee, supra note 9; Moray, N., “Error Reduction as a Systems Problem,” in Bogner, M.S., ed., Human Error in Medicine (Hillsdale: Lawrence Erlbaum Associates, 1994).Google Scholar
See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 560; Liang, , “Risks of Reporting Sentinel Events,” supra note 4, at 117.Google Scholar
Pub. L. 104–191. The statute required that federal privacy legislation be enacted by Congress by August 21, 1999, with the Secretary of the Department of Health and Human Services (DHHS) to issue proposed privacy rules in the event of Congressional inaction. Congress did miss the deadline and thus DHHS issued proposed regulations, 45 C.F.R. pts. 160, 164, at 64 Fed. Reg. 59,917 (Nov. 3, 1999). Final regulations were issued at 65 Fed. Reg. 82,461 (Dec. 28, 2000).Google Scholar
See 45 C.F.R. §§ 160.102, 160.103, 164.500, 164.501 (2000).Google Scholar
See 45 C.F.R. §§ 160.102, 160.103, 164.104, 164.500 (2000).Google Scholar
See id., 45 C.F.R. § 164.530 (2000).Google Scholar
For health plans and health-care clearinghouses, the date is February 26, 2003. See 45 C.F.R. § 164.534 (2000). Small health plans (but not other small businesses) have thirty-six months to comply with the rule; compliance reviews by DHHS, covered entities' responsibilities under these reviews, and potential government actions for noncompliance are indicated in 45 C.F.R. §§ 160.308, 164.310, 164.312 (2000). Note, however, that final does not always mean final; because the regulations were not delivered to Congress on December 28, 2000 — their date of issuance — but instead were delayed until February 13, 2001, Congress did not have its 60-day period to review the agency rule. Thus, the effective date was 60 days after the actual delivery date, or April 14, 2001. This administrative glitch provided the Bush administration with an opportunity to reopen public comment on the regulations. See McQueen, A., “HHS to Review Privacy Rules,” AP Online, available on Westlaw, 2001 WL 13676231 (Feb. 23, 2001).Google Scholar
See 45 C.F.R. §§ 164.524, 164.526, 164.528 (2000). Note that for non-treatment, payment, and health-care operations disclosures or disclosures to the patient or DHHS, covered entities must note in the electronic or paper record when, to whom, and what information was disclosed, the purpose of disclosure or a copy of the patient's written authorization/request for a disclosure for the past six years or as requested, but exclude disclosures in the accounting that were made to a health oversight agency or law enforcement official. See 45 C.F.R. § 164.528 (2000). See also Liang, B.A., Killing Patient Safety—Privately: HIPAA and Impediments to Community Patient Safety Work (unpublished manuscript on file with author).Google Scholar
See, e.g., 45 C.F.R. §§ 164.504(c), 164.514(a), 164.530 (2000); 65 Fed. Reg. at 82,502, 82,761–82,762; Liang, supra note 102.Google Scholar
Pub. L. 104–191, § 262. Note, however, that the enforcement rule regarding these penalties has not yet been issued. 65 Fed. Reg. at 82,487.Google Scholar
See 45 C.F.R. §§ 160.201, 164.202, 164.203 (2000). Exceptions to the federal rule may be requested under 45 C.F.R. § 164.204 (2000).Google Scholar
See, e.g., 65 Fed. Reg. at 82,482–82,487. Such extensive interaction may also increase implementation costs.Google Scholar
See 45 C.F.R. § 164.506 (2000). Health-care operations include activities that are related to the covered entity's functions as a provider, health plan, or health-care clearinghouse, also known as the entity's “covered functions.” 45 C.F.R. §§ 164.501, 164.504 (2000).Google Scholar
See 45 C.F.R. §§ 164.506, 164.508 (2000). Providers that have direct treatment relationships with patients, i.e., those who see patients directly (as opposed to those, such as radiologists, who see patients indirectly), must obtain consent for treatment, payment, and health-care operations as well as provide specific notice of privacy practices and procedures written in “plain language.” See 45 C.F.R. §§ 164.506(b)(5), 164.508(b)(5), 164.508(c)(2), 164.520 (2000); 65 Fed. Reg. at 82,770. Other uses or disclosures require fulfilling extensive requirements for authorization. See 45 C.F.R. §§ 164.508(c)—(d) (2000).Google Scholar
See 45 C.F.R. § 164.506(b)(5); Liang, supra note 102.Google Scholar
See 45 C.F.R. § 164.512 (2000). For activities not specifically listed in the regulations, determinations of whether they meet an exception may be requested under the provisions of 45 C.F.R. §§ 160.204, 160.205 (2000).Google Scholar
See 45 C.F.R. §§ 164.506(a)(2)-(3), 164.512(j) (2000).CrossRefGoogle Scholar
For example, disclosure of patient information in a hospital's patient directory or to those individuals assisting in a patient's care requires only informal verbal agreement, which may be implied by the circumstances. See 45 C.F.R. § 164.510 (2000). Neither disclosure by a covered entity's worker who is a crime victim nor a covered entity's disclosure of protected health information related to evidence of criminal conduct is in violation of the rule. See 45 C.F.R. §§ 164.512(f) (2000). As well, no patient authorization is required for the release of information in a judicial or administrative proceeding if the request is from a court order or administrative tribunal. Patient notice of the request or assurance of confidentiality by the requester is required for the covered entity to release the patient's information in response to a subpoena or discovery request from a party in litigation, and covered entities may also disclose protected health information for law enforcement purposes as required by law. See 45 C.F.R. §§ 164.512(e), 164.512(f) (2000). Disclosure for research has specified requirements under 45 C.F.R. § 164.512(i). Note, however, that websites are not bound by HIPAA rules unless they fall within some other health-care provider, clearinghouse, or other covered entity definition.Google Scholar
See 45 C.F.R. § 164.522 (2000). Covered entities must provide patients with the opportunity to request restrictions on the uses or disclosures of protected health information for treatment, payment, or health-care operations and accommodate requests for confidential communications in certain specific situations. Id.Google Scholar
See 45 C.F.R. §§ 164.524(b), 164.526(b) (2000). Note that if the covered entity does not maintain the information requested by the patient, the entity must direct the patient to the appropriate entity for access. See 45 C.F.R. § 164.524(d)(3) (2000). If patient requests are denied in whole or in part, the patient has the right to have the covered entity provide him or her with a written statement describing the basis of the denial and the complaint mechanism to access the entity's procedures or the procedures of the Department of Health and Human Services. See 45 C.F.R. §§ 164.524, 164.526, 164.530 (2000). In some circumstances, the covered entity must provide the patient with a second health-care provider to review the denial. See 45 C.F.R. § 164.524(a)(4) (2000).Google Scholar
See 45 C.F.R. §§ 164.502(b), 164.514(d) (2000). Prior to any disclosures under this section, a covered entity must verify the identity as well as authority of the person who is requesting the protected health information if this is not known to the covered entity, as well as obtain relevant documentation, statements, or representations from the person as a condition of disclosure. See 65 Fed. Reg. at 82, 719; 45 C.F.R. § 164.54(h).Google Scholar
A health-care clearinghouse is defined as a “public or private entity that … [p]rocesses or facilitates the processing of nonstandard data elements of health information received from another entity in a nonstandard format … into standard data elements or a standard transaction … [or] [r]eceives a standard transaction … and processes or facilitates the processing of health information into nonstandard format. …” 45 C.F.R. § 164.103 (2000).Google Scholar
See 45 C.F.R. § 164.530 (2000).CrossRefGoogle Scholar
See 45 C.F.R. §§ 160.103, 164.502(e), 164.504(e) (2000). In these situations, the covered entity and the business associate must execute an agreement providing assurances that the business associate will fulfill the requirements of the rule. A violation of the rule by the business associate requires the covered entity, in specified circumstances, to investigate and act against the associate, including terminating the contract. All contractors and subcontractors of the business associate are similarly bound by these terms. See id.Google Scholar
See 45 C.F.R. § 164.504(e) (2000).CrossRefGoogle Scholar
45 C.F.R. § 504(e)(ii) (2000); 65 Fed. Reg. at 82,476. See also Hearing on Proposed Rule on the Privacy of Individually Identifiable Health Information Before Senate Committee on Health, Education, Labor, and Pensions, 106th Cong., 1st Sess. (April 26, 2000) (testimony of Dr.Heinrich, Janet, associate director of health financing and public health issues at the General Accounting Office), available at <http://labor.senate.gov/Hearings/apr00hrg/042600wt/042600jmj/042600emk/heinric1/heinric1.htm>. It is interesting to note that the policies, procedures, and sanctions relating to entity noncompliance with the rule seem not to be followed by the Department of Health and Human Services itself in similar circumstances. The Department's Office of Inspector General found that contrary to departmental policy, several divisions collected personally identifiable information through websites and did not warn the user that such information was being collected. Twenty-one of the Department's websites designed for children did not contain a privacy statement or link to a privacy statement as mandated by federal law. No report of sanctions for these violations appears forthcoming. See U.S. Office of Inspector General, Department of Health and Human Services, Monitoring of Personally Identifiable Information on Users of Departmental Internet Sites, Pub. No. A-01-01-03000 (Washington, D.C.: U.S. Department of Health and Human Services, April 16, 2001).Google Scholar
The highly complex statutory efforts at simplification have come under significant fire. See, e.g., Withrow, S.C., “The Next Compliance Crunch: Administrative Simplification,’” Health Care Fraud & Abuse Newsletter, February 2000, at 1: “Rather than promoting ‘administrative simplification,’ the proposed regulations establish reporting requirements that are simply stupefying. The regulations describe roughly 500 separate data elements that support a single health care claim. Embedded in these 500 data elements are dozens of code sets for both medical and nonmedical data requiring the provider to convert commonly understood words and terms into literally thousands of possible alphanumeric codes.”.Google Scholar
Pub. L. 104–191.Google Scholar
See, e.g., 65 Fed. Reg. at 82,511 (no model for consent); 65 Fed. Reg. at 82, 548 (no model for privacy notice); Liang, supra note 102.Google Scholar
See, e.g., Page, S.L. et al., “Proposed Federal Privacy Rules: Locking the Electronic File Cabinet,” Health Lawyer, December 1999, at 2. See also Withrow, supra note 121 (discussing highly complex coding requirements).Google Scholar
See 65 Fed. Reg. at 82,761, Table 1.Google Scholar
64 Fed. Reg. at 60,037; 65 Fed. Reg. at 82,780. Roughly half of all hospitals and more than 90 percent of physician offices are small businesses. See id. Note that these percentages would have been even higher if the Health Care Financing Administration had used the more current Small Business Association definition of health-care small business released prior to the final medical privacy regulations. See Liang, supra note 102.Google Scholar
Page, supra note 124, at 3. Indeed, additional concerns with compliance include the uncertainty by which providers and others can protect sensitive proprietary information in the context of the virtually unchallengeable subpoena power granted by HIPAA to the Department of Justice. The Department of Justice is not required to describe the activities upon which its investigation is based, not required to disclose the actual target of the investigation, has no statutory limitation by which a recipient of the subpoena can challenge it, has no limits on the scope of the documents requested, has no confidentiality requirements for the information obtained, and has continuing power to use the HIPAA subpoena in an ongoing investigation. 18 U.S.C. § 3486 (1999). See also Feldman, W.L. and O'Callaghan, E.C., “HIPAA Subpoenas: What Protections for Companies Served?,” Corporate Counselor, September 1998, at 1.Google Scholar
See 45 C.F.R. § 164.508(b)(3) (2000). “We prohibit the use of broad or blanket authorizations requesting the use or disclosure of protected health information for a wide range of unspecified purposes. Both the information that is to be used or disclosed and the specific purpose(s) for such uses or disclosures must be stated in the authorization.” 65 Fed. Reg. at 82,518. Such a standard also requires only the minimum necessary information be disclosed. See 45 C.F.R. § 164.514(d)(4) (2000); Liang, supra note 102.Google Scholar
45 C.F.R. §164.508(c)-(d) (2000). Note that there appear to be substantive differences between those patients who give researchers consent to use their personal identifiable health-care information and those who do not. This finding, apparently unrecognized by the Department of Health and Human Services, will create significant selection bias and limit the conclusions from patient safety and medical error work. See Woolf, S.H. et al., “Selection Bias from Requiring Patients to Give Consent to Examine Data for Health Services Research,” Archives of Family Medicine, 9 (2000): 1111–18.Google Scholar
See, e.g., van der Goes, P.H.W. Jr., “Comment: Opportunity Lost: Why and How to Improve the HHS-Proposed Legislation Governing Law Enforcement Access to Medical Records,” University of Pennsylvania Law Review, 147 (1999): 1009–67. This omission is particularly noteworthy because former Secretary Shalala indicated that, with regard to HIPAA, “Individuals' claims to privacy must be balanced by their public responsibility to contribute to the common good, through use of their information for important, socially useful purposes, with the understanding that their information will be used with respect and care and will be legally protected.”. Shalala, D., Confidentiality of Individually-Identifiable Health Information: Recommendations of the Secretary of Health and Human Services, Pursuant to Section 264 of the Health Insurance Portability and Accountability Act of 1996, submitted to the Senate Committee on Labor and Human Resources, the Senate Committee on Finance, the House Committee on Commerce, and the House Committee on Ways & Means, § I(D) (September 11, 1997), available at <http://aspe.os.dhhs.gov/admnsimp/pvcrec0.htm> (last visited October 5, 2001). Surely patient safety and medical error activities are as important as marketing, lawsuit, and law enforcement activities “to contribute to the common good.”.CrossRefGoogle Scholar
See 65 Fed. Reg. at 82,490. Note that “treatment” also refers to individual patients and, thus, treatment activities cannot be easily used to justify using patient data for safety work. See 65 Fed. Reg. at 82,497.Google Scholar
See 45 C.F.R. § 164.512(d) (2000).Google Scholar
See 65 Fed. Reg. at 82,491–82,942; 45 C.F.R. § 512(d) (2000).Google Scholar
See 45 C.F.R. §§ 164.501, 164.512(b) (2000); 65 Fed. Reg. at 82,497.Google Scholar
See 45 C.F.R. § 164.512(b)(iii) (2000). Other disclosures require authorization. See 45 C.F.R. §§ 164.506, 164.512(b)(v) (2000).Google Scholar
See Liang, supra note 13; Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4; Liang, , “Risks of Reporting Sentinel Events,” supra note 4; Liang, and Storti, supra note 74.Google Scholar
See 45 C.F.R. § 512(i) (2000).CrossRefGoogle Scholar
See, e.g., 65 Fed. Reg. at 82,516 (“We clarify the proposed research exception … for the purpose of research that includes treatment of the individual, including clinical trials. …”); 65 Fed. Reg. at 82,518 (“except for [research] authorizations requested for clinical trials …”); 65 Fed. Reg. at 82,520 (“research that includes treatment … including clinical trials”; “prior to the individual's enrollment in a clinical trial, but that is now providing [the] research-related treatment. …”); Liang, supra note 102.Google Scholar
Consent issues also arise here. Consent for treatment, payment, and health-care operations generally cannot be combined with other consents or authorizations. See supra note 128. However, consent and authorization for research may be necessary if a patient receives treatment for research and non-research purposes. 45 C.F.R. §§ 164.506(b)(4)(ii), 164.508(b)(3), 164.508(f) (2000). Unfortunately, because patient safety research does not generally include “treatment” as in clinical trials, this exception does not apply and authorization is mandated.Google Scholar
To fund this broad-based type of research, covered entities may consider fundraising. Authorization is not required when a covered entity uses or discloses demographic information regarding itself to raise funds or conduct marketing. 45 C.F.R. § 164.514(e)—(f) (2000). However, a covered entity must have the patient's authorization to use protected health information to solicit funds for a non-profit organization that engages in research, education, and awareness efforts regarding a particular disease state (see 65 Fed. Reg. at 82,534), once again stymying patient safety research efforts.Google Scholar
See 45 C.F.R. § 164.512(i)(1)(i)(A) (2000).Google Scholar
See 45 C.F.R. § 164.512(i)(1)(i)(B) (2000).CrossRefGoogle Scholar
See 45 C.F.R. § 164.514(d) (2000); 65 Fed. Reg. at 82,536–82,537.Google Scholar
See 65 Fed. Reg. at 82,534; 45 C.F.R. § 164.512(h) (2000). In addition, although covered entities may deny an individual access to protected health information that is obtained by a provider during the course of research that includes treatment, this is limited to the period while research is in progress. See 45 C.F.R. § 164.524(a)(2)(iii) (2000). At the end of the research, the patient has the right to inspect and copy the information. If this information relates to medical error, it will likely contain sensitive information regarding the health-care system and it may be used in a lawsuit against the provider. This potential provides additional reasons to avoid performing this kind of work. A covered entity can deny an individual access to protected health information if the source was given a promise of confidentiality. See 45 C.F.R. § 164.524(a)(2)(v) (2000). This might serve as a method to keep sensitive patient safety data confidential; however, this provision is not applicable if the source is a health-care provider. Id. Unfortunately, the implication is that one of the most valuable sources of information regarding health-care systems is limited in its communications due to the provisions of the rule.Google Scholar
See 45 C.F.R. § 164.514 (2000). The rule contemplates use of deidentified information in preparation for research rather than for primary research work, and limits this review to the site where the information is located. See 65 Fed. Reg. at 82,537.Google Scholar
See 45 C.F.R. §§ 164.502(d), 164.514 (2000).Google Scholar
See 65 Fed. Reg. at 82,542; 45 C.F.R. § 164.514(b)(2)(ii) (2000).Google Scholar
Note that any non-routine disclosures, including research, which seems to be what patient safety requests would fall under, are subject to the minimal necessary standard, and require covered entity procedures for requests to be reviewed individually. See 45 C.F.R. § 164.514(d) (2000). Indeed, this is true “in order to obtain information that will subsequently be disclosed to a third party, for example, … for quality assessment purposes.” 65 Fed. Reg. at 82,545. See Liang, supra note 102.Google Scholar
See 45 C.F.R. § 164.514(a)—(c) (2000). The rule expressly adopts the statutory standard for deidentification. See also 65 Fed. Reg. at 82,543 (discussing 45 C.F.R. § 164.514(a)—(c)).Google Scholar
45 C.F.R. § 164.514(b)(2)(i)(r) (2000) (emphasis supplied).Google Scholar
See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 561–68.Google Scholar
See id. at 561–62; Liang, , “Risks of Reporting Sentinel Events,” supra note 4, at 119.Google Scholar
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See IOM Report, supra note 1. Note that similar concerns attend in aviation, although the aviation industry has gleaned significant lessons by taking these concerns into account. See, e.g., Helmreich, R.L., “On Error Management: Lessons from Aviation,” British Medical Journal, 320 (2000): 781–85.CrossRefGoogle Scholar
See, e.g., National Patient Safety Foundation, A Tale of Two Stories: Contrasting Views of Patient Safety (Chicago: National Patient Safety Foundation, 2000); National Patient Safety Foundation, Current Research on Patient Safety in the United States: A Report to the Agency for Healthcare Research and Quality (Chicago: National Patient Safety Foundation, 2000).Google Scholar
See Leape, supra note 6, at 1857; Barach, P. and Small, S., “How the NHS Can Improve Safety and Learning: By Free Lessons from Near Misses,” British Medical Journal, 320 (2000):1683–84; Liang, supra note 27.Google Scholar
See, e.g., Weick, K.E., “Organizational Culture as a Source of High Reliability,” California Management Review, 29 (1987):112–27; Weick, K.E. et al., “Organizing for High Reliability: Processes of Collective Mindfulness,” Research in Organizational Behavior, 21 (1999): 23-81; Reason, J., “Human Error: Models and Management,” British Medical Journal, 768 (2000): 768-70. Note, however, that some attorneys may attempt to use near-miss data in lawsuits to show a pattern of error in health care; this potential indicates that there may even be negative incentives to collecting and analyzing near-miss data, emphasizing the overall need to protect safety data from discovery and evidentiary use.Google Scholar
See Liang, supra note 27.Google Scholar
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See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 562–63. Beyond continuing medical education, medical students and residents must be provided with education and the means to address medical error and improve patient safety. This is beginning to be done. See, e.g., Wu, A., “A Major Medical Error,” American Family Physician, 63 (2001): 985–86; Battles, J.B. and Shea, C.E., “A System of Analyzing Medical Errors to Improve GME Curricula and Programs,” Academic Medicine, 76 (2001): 125-33; Wu, A., “Handling Hospital Errors: Is Disclosure the Best Defense?,” Annals of Internal Medicine, 131 (1999): 970-72; Casarett, D. and Helms, C., “Systems Errors Versus Physicians' Errors: Finding the Balance in Medical Education,” Academic Medicine, 74 (1999): 19-22; Finkelstein, D. et al., “When a Physician Harms a Patient by a Medical Error: Ethical, Legal, and Risk Management Considerations,” Journal of Clinical Ethics, 8 (1997): 330-35. However, efforts by others with purported patient safety knowledge may stymie these efforts due to their shame-and-blame approach and imposition of legal risk. See, e.g., Liang, supra note 27; Liang, and Storti, supra note 74.Google Scholar
See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 563; Liang, , “Patient Injury Incentives in Law,” supra note 50, at 91-93.Google Scholar
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Voluntary reporting is the preferable method of encouraging providers to report errors due to its cooperative nature; however, politically, there may be calls for mandatory reporting. It is hoped that the poor experience with mandatory reporting will be instructive for those who pin their hopes on requiring errors and associated adverse events to be reported for patient safety. Further, within the infrastructure outlined above, supra notes 151–66 and accompanying text, much more information will be obtained through the use of the significantly more frequent near-miss reports. See Liang, , “Promoting Patient Safety Through Reducing Medical Error,” supra note 4, at 564. See also Rosenthal, J. et al., Current State Programs Addressing Medical Errors: An Analysis of Mandatory Reporting and Other Initiatives (Portland, Maine: National Academy for State Health Policy, 2001) (describing underreporting as the norm in mandatory error-reporting states).Google Scholar
See Weiler, P.C. et al., A Measure of Malpractice (Cambridge: Harvard University Press, 1993): at 75.Google Scholar
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See Liang, supra note 102.Google Scholar