The patient safety and quality improvement act of 2005: Preventing error and promoting patient safety

Journal of Legal Medicine

Volumn 31, Issue 4, 2010, Pages 397-422

  Levy, Frederick ^a   Mareniss, Darren ^a   Iacovelli, Corianne ^b   Howard, Jeffrey ^c  

^a DEPARTMENT OF PATHOLOGY   (United States)

^b Cigna   (United States)

^c FANNIE MAE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; HEALTH CARE QUALITY; HUMAN; LEGAL ASPECT; MEDICAL ERROR; SAFETY; TOTAL QUALITY MANAGEMENT; UNITED STATES;

HUMANS; MEDICAL ERRORS; QUALITY ASSURANCE, HEALTH CARE; QUALITY IMPROVEMENT; SAFETY MANAGEMENT; UNITED STATES;

EID: 78650767339     PISSN: 01947648     EISSN: 1521057X     Source Type: Journal    
DOI: 10.1080/01947648.2010.535424     Document Type: Article

References (181)

1. Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41, 119 Stat. 424 (2005) (codified as amended at 42 U.S.C. §§ 299b-21 to -26 (2006)).
2. The Health Care Quality Improvement Act of 1986, 42 U.S.C. §§ 11101-11152 (2006), indirectly addressed patient safety by focusing on individual provider conduct through peer review and other means.
3. Under the PSQIA, a Patient Safety Organization is certified by the Secretary of the Department of Health and Human Services and specifically compiles and analyzes error data. 42 U.S.C. § 299b-21(4) (2006).
4. COMM. ON QUALITY OF HEALTH CARE IN AM., INST. OF MED., TO ERR IS HUMAN: BUILDING A SAFER HEALTH SYSTEM (Linda T. Kohn et al. eds., 2000).
5. Id. at 4 (defining "error" as "the failure of planned action to be completed as intended or the use of a wrong plan to achieve an aim").Medical errors occurwhen, for example, thewrong care is administered, thewrong body part or tissue is removed, erroneous lab results are reported, or inappropriate medications or dosages are prescribed.
6. This figure was extrapolated from the collective data of two major studies that focused on the medical error rate in the United States: the Harvard Medical Practice Study in New York and the Colorado-Utah Study.
7. Id. at 26.
8. For a critical analysis of the methodology used by the IOM to estimate this number, see Maxine M. Harrington, Revisiting Medical Error: Five Years After the IOM Report, Have Reporting Systems Made a Measurable Difference?, 15 HEALTH MATRIX 329, 332-38 (2005).
9. The number of preventable errors exceeded the annual patient deaths caused by motor vehicle accidents, breast cancer, or HIV for that year. TO ERR IS HUMAN, supra note 4, at 1.
10. These figures did not include the additional intangible costs that arise from the diminished trust in the health care system and loss of patient and provider satisfaction. TO ERR IS HUMAN, supra note 4, at 1-3.
11. See Mike Celizic, Cancer Free Woman Underwent Double Mastectomy Because of Lab Mix Up, at http://www.msnbc.msn.com/id/21127917 (last visited Dec. 2, 2009).
12. Other types of avoidable error have involved surgical procedures performed on incorrect anatomic sites. For example, in 2006 and 2007 neurosurgeons at Rhode Island Hospital operated on the incorrect part of the brain on three separate occasions.
13. Dan Childs, Medical Errors, Past and Present, ABC NEWS, Nov. 27, 2007, available at http://abcnews.go.com/print?id=3789868 (last visited Dec. 2, 2009).
14. TO ERR IS HUMAN, supra note 4, at 49-66;
15. PATIENT SAFETY AND QUALITY IMPROVEMENT, 73 Fed. Reg. 8112, 8113 (Feb. 12, 2008).
16. John Tinker et al., Role of Monitoring Devices in Prevention of Anesthetic Mishaps: A Closed Claims Analysis, 71 ANESTHESIOLOGY 541, 541 (1989);
17. Randall R. Bovbjerg et al., Paths to Reducing Medical Injury: Professional Liability and Discipline vs. Patient Safety-and the Need for A Third Way, 29 J.L. MED. & ETHICS 369, 370 (2001).
18. Health care systems are particularly vulnerable to systemic error because they are highly complex and specialized, and have multiple components that operate interdependently. TO ERR IS HUMAN, supra note 4, at 58-59.
19. With respect to such systemic defects, it is often necessary to employ statistical analysis to sift through large quantities of error data to uncover the patterns revealing the underlying sources of these errors.
20. TO ERR IS HUMAN, supra note 4, at 89.
21. Bovbjerg et al., supra note 10, at 370.
22. The aviation industry is similar to the health care industry in that both involve highly complex systems of service delivery and an incentive to promote a good safety reputation. However, there may be more dissimilarities than similarities. See section IV, infra.
23. TO ERR IS HUMAN, supra note 4, at 111-12.
24. David Fine, The Medical Peer Review Privilege in Massachusetts: A Necessary Quality Control Measure or an Ineffective Obstruction of Equitable Redress?, 38 SUFFOLK U. L. REV. 811, 815-20 (2005).
25. Daniel Mulholland & Phil Zarone, Waiver of the Peer Review Privilege: A Survey of the Law, 49 S.D. L. REV. 424, 428 (2004).
26. Charles David Creech, The Medical Review Committee Privilege: A Jurisdictional Survey, 67 N.C. L. REV. 179, 180 (1988);
27. see also Kathryn Leaman, Comment, Let's Give Them Something to Talk About: How the PSQIA May Provide Federal Privilege and Confidentiality Protections to the Medical Peer Review Process, 11 MICH. ST. J. MED. & LAW 177, 180 (2007).
28. Bovbjerg et al., supra note 10, at 370;
29. see also Leaman, supra note 18, at 180 (discussing peer review committee powers).
30. Lisa M. Nijm, Pitfalls of Peer Review: The Limited Protections of State and Federal Peer Review Law for Physicians, 24 J. LEGAL MED. 541, 543 (2003).
31. S. Jay Jayasankar, Medical Peer Review and Risk Management, AAOSNOW, Oct. 2008, at 10, available at http://www.aaos.org/news/aaosnow/oct08/managing9.asp (last visited Jan. 2, 2010).
32. Leaman, supra note 18, at 180.
33. Gail Garfinkel Weiss, Is Peer Review Worth Saving?, MED. ECON., Feb. 18, 2005, available at http:// medicaleconomics.modernmedicine.com/memag/article/ articleDetail.jsp?id=147405 (last visited Jan. 2, 2010).
34. Talia Storch, Medical Peer Review in Florida: Is the Privilege Under Attack?, 32 NOVA L. REV. 269, 275 (2007). For a medical trade association's perspective, see Jayasankar, supra note 21.
35. Bovbjerg et al., supra note 10, at 372;
36. Christina A. Graham, Comment, Hide and Seek: Discovery in the Context of the State and Federal Peer Review Privileges,, 30 CUMB. L. REV. 111, 112-13 (2000).
37. Melissa Chiang, Promoting Patient Safety: Creating a Workable Reporting System, 18 YALE J. ON REG. 383, 400 (2001).
38. Id.
39. Mulholland & Zarone, supra note 17, at 427.
40. Susan O. Scheutzow, State Medical Peer Review: High Cost But No Benefit-Is It Time for a Change?, 25 AM. J. L. & MED. 7, 33-4 (1999).
41. Creech, supra note 18, at 184.
42. Chiang, supra note 26, at 400.
43. Creech, supra note 18, at 184.
44. -636 S.E.2d 416 (Va. 2006).
45. Creech, supra note 18, at 184.
46. See, e.g., VA. CODE § 8.01-581.17(C)(2007);
47. Tucson Medical Center, Inc. v. Misevch, 545 P.2d 958 (Ariz. 1976).
48. Mulholland & Zarone, supra note 17, at 429.
49. Scheutzow, supra note 29, at 29.
50. Id.
51. Arecent judicial trend has been to expand the conduct that constitutes waiver of peer review protections. Several court decisions have stripped peer review committees of their protection when records were disclosed to non-committee members. Mulholland & Zarone, supra note 17.
52. For example, in one case, non-committee members had access to a peer review committee's records, and the court found that the committee had waived its privilege. State ex rel. Brooks v. Zakaib, 588 S.E.2d 418 (W.Va. 2003).
53. This may indicate a shift towards recognizing that a broader scope of activities can waive privilege. Creech, supra note 18, at 188.
54. Scheutzow, supra note 29, at 25.
55. Bryan A. Liang, Regulating for Patient Safety: The Law's Response to Medical Errors, 12 WIDENER L. REV. 83, 92 (2005).
56. -955 P.2d 1169 (Kan. 1998). But see Hofflander v. St. Catherine's Hosp., Inc., 664 N.W.2d 545, 580 (Wis. 2003) (holding that Joint Commission survey documents were protected).
57. -72 Fed. Reg. at 8113 (Feb. 23, 2007). By contrast, courts in Illinois and Florida have found that thirdparty disclosures cannot waive the respective state privilege by intentional committee disclosures to non-committee members affiliated with the provider. Mulholland & Zarone, supra note 17, at 435-37 (discussing Chicago Trust Co. v. Cook County Hosp., 698 N.E.2d 641, 648 (Ill. App. Ct. 1998) and Hillsborough County Hosp. Auth. v. Lopez, 678 So. 2d 408 (Fla. App. 1996)).
58. Most state courts do not apply such a narrow waiver doctrine and usually find that intentional disclosure to third parties effectively waives the privilege. Mulholland & Zarone, supra note 17, at 437-38.
59. In addition to the variability of state protections, there are some concerns about the scope of peer review protection in general.
60. Some critics claim that these protections conflict with desirable goals such as due process and liberal discovery, which allow victims of medical errors to gather the documents they need to prove their malpractice claims.
61. Graham, supra note 25, at 113-14.
62. The pendent jurisdiction doctrine holds that federal courts have the authority to hear state claims that share the same core facts as the federal claim, when combination of the claims would produce administrative efficiencies. See 28 U.S.C. § 1367;
63. United Mine Workers of Am. v. Gibbs, 383 U.S. 715 (1966);
64. Finley v. United States, 490 U.S. 545 (1989).
65. The application of state peer review statutes to federal issues often involves the Emergency Medical Treatment and Active Labor Act (EMTALA), Federal Tort Claims Act (FTCA), Sherman Act, or Americans with Disabilities Act (ADA).
66. See Henderson v. Med. Center Enterprise, No. 1:05-cv-823-MEF, 2006 U.S. Dist. LEXIS 57898 (M.D. Ala. Aug. 14, 2006).
67. See Burrows v. Redbud Cmty. Hosp., 187 F.R.D. 606, 611 (N.D. Cal. 1998) (explaining that state actions pendant to federal question cases are governed by federal procedure and declining to apply state peer review statute).
68. -187 F.R.D. 606 (N.D. Cal., 1998).
69. Redbud Cmty. Hosp. v. Burrrows, 188 F.R.D. 356, 358 (N.D Cal. 1997).
70. Id.
71. Burrows, 187 F.R.D. at 612.
72. Id.
73. -2006 U.S. Dist. LEXIS 57898 at *19 (M.D. Ala. August 14, 2006).
74. Id. at 3.
75. Id. at 10.
76. See The Leapfrog Group, The Leapfrog Group Fact Sheet, at http://www.leapfroggroup.org/aboutus/leapfrog-factsheet (last visited Jan. 2, 2010).
77. Leapfrog requires service providers to use computerized order entry systems, evidence-based hospital referrals (which promotes the use of only high outcome facilities for elective surgeries), and trained clinical care physicians in hospital ICUs.
78. Staffing ICUs with intensivists has been shown to decrease patient mortality. See The Leapfrog Group, Fact Sheet, ICU Physician Staffing, at http://www.leapfroggroup.org/media/file/FactSheet IPS (last visited Jan. 2, 2010).
79. The Leapfrog Group, Leapfrog Members, at http://www.leapfroggroup.org/ for-members/who-are-members (last visited Sept. 8, 2009).
80. Id.
81. USP is an official, non-profit, public standards-setting body for pharmaceuticals and medical devices.
82. For a fuller description of the organization's mandate, see US Pharmacopeia, at http://www.usp.org/ (last visited Jan. 2, 2010).
83. US Pharmacopeia, at http://www.usp.org/hqi/patientSafety/medmarx/ (last visited Jan. 2, 2010).
84. Christopher R. Smith, Use of MEDMARX Data to Guide Population Health Improvement in the Perioperative Setting, 3 PERIOPERATIVE NURS. CLIN. 327, 327 (2008).
85. The Joint Commission, The Joint Commission Fact Sheet, at http://www.jointcommission.org/AboutUs/Fact-Sheets/joint-commission-facts.htm (last visited Jan. 2, 2010).
86. Id.
87. Kathy Dix, Root Cause Analysis, ICT (2006), available at http://www.infectioncontroltoday.com/articles/403/72h2212161293728.html (last visited Jan. 2, 2010) ("A root cause analysis is defined as a retrospective approach to error analysis-the investigation of the direct or original error that led to an adverse event. In healthcare, such an analysis is typically reserved for tracing the origin of serious adverse events. 'Near misses' are not reviewable under the sentinel event policy of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)").
88. S. 544. The House version was H.R. 3205, but the Senate version was ultimately adopted.
89. The PSQIA amends Title IX of the Public Health Service Act, 42 U.S.C. § 299 (2005);
90. see also 151 CONG. REC. S8741-44 (daily ed. July 22, 2005) (statement of Rep. Enzi).
91. Final Vote for Roll Call 434, at http://clerk.house.gov/evs/2005/roll434. xml (last visited Jan. 2, 2010). The Senate vote was by unanimous consent.
92. Remarks on Signing the Patient Safety and Quality Improvement Act of 2005, 41 WEEKLY COMP. OF PRESIDENTIAL DOCUMENTS 1227 (July 29, 2005).
93. Patient Safety and Quality Improvement, 73 Fed. Reg. 70031, 70732 (Nov. 21, 2008) (codified at 42 C.F.R. Part 3).
94. Information subject to discovery under the Act includes medical and billing records and original patient information.
95. For purposes of the Act, "providers" are licensed health care professionals such as physicians, psychologists, nurses, and dietitians, as well as health care entities such as hospitals, nursing facilities, and pharmacies. 42 U.S.C. § 299b-21(8) (2006).
96. Patient safety activities are broadly defined as efforts undertaken to improve the safety and delivery of health care, the utilization of qualified staff, and the collection of information derived from these activities.
97. -42 U.S.C. § 299b-23 (2006).
98. PSOs are third-party entities that evaluate provider generated patient safety information and provide advice about improving health care and patient safety.
99. Patient Safety and Quality Improvement, 73 Fed. Reg. 70031, 70798 (Nov. 21, 2008).
100. -42 U.S.C. § 299b-21(6) (2006) ("'Patient safety evaluation system' means the collection, management,or analysis of information for reporting to or by a patient safety organization.").
101. -42 U.S.C.§ 299b-21(6) (2006).
102. Patient Safety and Quality Improvement, 73 Fed. Reg. 70031, 70739 & 70798 (Nov. 21, 2008).
103. Id. at 70738.
104. Id. at 70738-39.
105. Id. at 70739.
106. -42 U.S.C. § 299b-22 (2006).
107. -42 U.S.C.§ 299b-21(7) (2006).
108. This includes dated information contained within a provider's PSES.
109. -73 Fed. Reg. 70743, 70743-44.
110. Id. at 70744.
111. Id. at 70741.
112. Id.
113. Id. This is true whether or not the information collected by the PSES was documented.
114. Id.
115. Id.
116. Id.
117. -42 U.S.C. § 299b-22 (a)(1) (2006).
118. Id. § 299b-22 (a)(2) (2006).
119. Id. § 299b-22 (e) (2006).
120. Id. § 299b-22(d)(4)(b) (2006).
121. The Act includes the loss of employment, denial of credentials, failure to promote, denial of benefits, or issuance of a negative employment evaluation as adverse employment actions. 42 U.S.C. § 299b-22(e)(1) (2006).
122. -73 Fed. Reg. 70732, 70741 (2008) ("The final rule provides that information documented as collected within a patient safety evaluation system by a provider shall be protected as patient safety work product ⋯. The information would become patient safety work product upon collection.").
123. -42 U.S.C. § 299b-22(d)(1) (2006).
124. Id. § 299b-21(7)(B)(ii) (2006);
125. see also 73 Fed. Reg. at 70744.
126. The Act contains an explicit prohibition against limiting the discovery or admissibility of patient safety information that does not qualify as PSWP. 42 U.S.C. § 299b-21(7)(B)(iii) (2006).
127. Id. § 299b-21(7)(B)(i) (2006).
128. -73 Fed. Reg. at 70743.
129. Id. at 70742.
130. Id. at 70743.
131. Id. at 70743-744.
132. Id. at 70742.
133. Id.
134. -42 U.S.C. § 299b-22(h) (2009);
135. -73 Fed. Reg. at 70742.
136. Id. § 299b-22(c)(1)(A) (2006).
137. Id. § 299b-22(c)(2)(G) (2006).
138. Id. § 299b-22(c)(1)(B) (2006).
139. Id. § 299b-22(c)(2) (2006).
140. Id. § 299b-22(c)(2) (2006).
141. Id. § 299b-22(f)(1) (2006).
142. Id. § 299b-22(f)(4)(A) (2006).
143. -73 Fed. Reg. at 70798.
144. -42 U.S.C. § 299b-21(5) (2006).
145. Id. § 299b-21(7) (2006).
146. Id. § 299b-21(5)(G) (2006).
147. Id. § 299b-21(5)(G) (2006).
148. Id. § 299b-21(7)(A)(ii) (2006).
149. Also, a committee's work product would be considered protected if reported to a PSO under 42 U.S.C. § 299b-21(7)(A)(i)(I) (2009) (stating that safety information accumulated by a provider to be disclosed to a PSO is considered PSWP).
150. Id. § 299b-21(6).
151. Id.
152. Id. § 299b-21(7)(A)(ii) (2006).
153. For example, the definition of PSWP encompasses more than the information generated from the list of patient safety activities.
154. -42 U.S.C. § 299b-21(8) (2009) (broadly defining a provider to include any licensed individual or facility, including "a hospital, nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care practitioner's office, long term care facility, behavior health residential treatment facility, clinical laboratory, or health center; or a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner").
155. Id. § 299b-22 (2006).
156. Id. § 299b-21(7) (2006).
157. -151 CONG. REC. S8743, 544 (2005).
158. Id.
159. -42 U.S.C. § 299b-21(7)(B)(i) (2006).
160. Id. § 299b-21(7)(B)(ii) (2006).
161. -151 CONG. REC. S8744, 555 (2005).
162. Leigh Ann Lauth, The Patient Safety and Quality Improvement Act of 2005: An Invitation for Sham Peer Review in the Health Care Setting, 4 IND. HEALTH L. REV. 151, 164 (2007) (citing Harrington, supra note 6, at 352-53).
163. Id. ("Physicians and facility employees, primarily nurses, are also concerned about job security and the use of reports in disciplinary and adverse employment actions.").
164. -42 USC § 299b-22(a)(2) (2006);
165. see also STEVEN R. SMITH, UNDERSTANDING THE PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005: KEY ISSUES 24 (Am. Health Lawyer Ass'n 2006) (citing Patient Safety andQuality Improvement Act of 2005, Pub. L. No. 109-41, 922(a)(1), 119 Stat. 424, 427 (2005)).
166. -42 U.S.C.§ 299b-22(e)&(f) (2006);
167. see also SMITH, supra note 138, at 23 ("Under the Act, an aggrieved individual may bring a civil action to enjoin an actor or practice of, or to obtain appropriate equitable relief from, a provider that has taken an adverse employment action against that individual subsequent to a report the individual has made to the provider or to a PSO.").
168. -42 U.S.C.§ 299b-22(f)(4) (2006). It could be argued that a provider fired for a record of errors is, in a sense, being fired for disclosing errors. Accordingly, this cause of action may apply; however, clarification would be prudent.
169. Id. § 299b-22(e)(2) (2006).
170. Additionally, the Act provides whistleblower protection. A provider may not take an adverse employment action against an individual who, in good faith, reports patient safety information to the provider or directly to a PSO. "Adverse employment action" includes "loss of employment, the failure to promote an individual ⋯ the failure to provide any other employmentrelated benefit forwhich the individual would otherwise be eligible, or an adverse evaluation or decision made in relation to accreditation, certification, credentialing or licensing of the individual."
171. Lauth, supra note 136, at 164.
172. THE JOINT COMMISSION, SENTINEL EVENT POLICY AND PROCEDURES, updated July 2007, at http://www.jointcommission.org/SentinelEvents/PolicyandProcedures/ (last visited Oct. 8, 2009) ("Asentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase 'or the risk thereof' includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.").
173. Lauth, supra note 136, at 164.
174. THE JOINT COMMISSION, SENTINEL EVENT POLICY AND PROCEDURES (2007), at http://www.jointcommission.org/NR/rdonlyres/F84F9DC6-A5DA-490F-A91F- A9FCE26347C4/0/SE-chapter-july07.pdf (last visited Jan. 2, 2010) (noting that sentinel event reporting is not required).
175. THE JOINT COMMISSION, SENTINEL EVENT STATISTICS (2009), available at http://www.jointcommission.org/NR/rdonlyres/241CD6F3-6EF0-4E9C-90AD- 7FEAE5EDCEA5/0/SE-Stats-6-09.pdf (last visited Jan. 2, 2010).
176. Id.
177. See FEDERAL AVIATION ADMINISTRATION, HISTORY OF THE FAA, Prologue (2009), available at http://www.faa.gov./about/history/historical-perspective/media/ historical-perspective-ch1.pdf (lasted visited Jan. 2, 2010);
178. ERR IS HUMAN, supra note 4, at 71 ("The risk of dying in a domestic jet flight between 1967 and 1976 was 1 in 2 million. By the 1990s, the risk had declined to 1 in 8 million.").
179. FAA, supra note 148, at 7.
180. TO ERR IS HUMAN, supra note 4, at 96 ("Near miss" reporting was instituted in 1976).
181. Id. at 73.