Source: http://www.healthinfolaw.org/federal-law/PSQIA
Timestamp: 2019-04-26 04:18:41+00:00

Document:
The patient safety and Quality Improvement Act of 2005 (PSQIA) amended Title IX of the Public Health Service Act (PHSA) to improve patient safety and reduce the occurrence of adverse events. The PSQIA establishes a voluntary reporting system for providers to report patient safety events to resolve patient safety and health care quality problems. PSQIA establishes Patient Safety Organizations (PSOs), which are run by the Agency for Healthcare Research and Quality (AHRQ), to collect and analyze such data. Reporting is encouraged by providing an environment where providers can report such events without fear of liability.
The Office for Civil Rights (OCR) is responsible for the implementation of the confidentiality protections and enforcement of PSQIA. It provides federal privilege and confidentiality protections for "patient safety work" (any identifying information for patients, providers, etc.), and can impose civil money penalties for improper use of this information.
The PSQIA and the regulations implementing the Act1 created new terms to identify the type of information covered by the privilege, and to describe the elements of the voluntary reporting program and the organizations and individuals involved and impacted.
What Entities are Involved with the Collection and Reporting of PSWP?
Entities owned, managed, or controlled by the provider.
How will PSWP be used?
Identifiable PSWP is subject to privilege and confidentiality requirements, each of which have specific exceptions that permit disclosure under certain circumstances. In order to ensure that disclosure of identifiable PSWP is limited to those circumstances in which it is authorized, a number of enforcement mechanisms are available, including an avenue for individuals to report suspected violations, Secretarial authority to conduct comprehensive compliance reviews, and civil monetary penalties.
PSWP is also considered confidential and may not be disclosed, subject to limited exceptions.
· The appropriate state or local licensing agency or organization of the penalty.
42 CFR § 3.504, et. seq.
42 CFR § 3.542(c). Note: good cause may include the presence in the record of identifiable patient safety work product.
1. 42 CFR § 3.504(a).
2. 42 CFR § 3.504(a).
3. 42 CFR § 3.504, et. seq.
4. 42 CFR § 3.542(a).
5. 42 CFR § 3.542(b).
6. 42 CFR § 3.542(c). Note: good cause may include the presence in the record of identifiable patient safety work product.
7. 42 CFR § 3.408.
8. 42 CFR § 3.408.
9. 42 CFR § 3.426.
10. 42 CFR § 3.204(c); 42 CFR § 3.206(d).
11. 42 CFR § 3.312(c)(2).
12. PSQIA, 42 U.S.C. § 299b-22(c)(2)(A).
13. 42 CFR § 3.206(b)(4)(i).
14. 42 CFR § 3.206(b)(4)(ii).
15. 42 CFR § 3.206(b)(4)(iii).
17. 42 CFR § 3.206(b)(4)(iv)(A).
18. Listed at 45 CFR 164.514(e)(2).
19. 42 CFR § 3.206(b)(4)(iv)(B).
20. PSQIA, 42 U.S.C. § 299b-22(c)(2)(B).
21. PSQIA, 42 U.S.C. § 299b-22(c)(2)(C). Note: if work product disclosed for research is by a HIPAA-covered entity (defined at 45 CFR 160.103) and contains HIPAA-defined protected health information (defined at 45 CFR 160.103), disclosure is only permissible to the same extent as it would be permissible under HIPAA (42 CFR § 3.206(b)(6)(ii)).
22. PSQIA, 42 U.S.C. § 299b-22(c)(2)(D). Note: any person permitted to receive patient safety work product pursuant to this exception may only further disclose such work product for the purpose of evaluating the quality, safety, or effectiveness of that product or activity to another such person or the disclosing provider (42 CFR § 3.206(b)(7)(ii)).
23. PSQIA, 42 U.S.C. § 299b-22(c)(2)(E). Note: an accrediting body may not further disclose patient safety work product it receives pursuant to this exception (42 CFR § 3.206(b)(8)(ii), and may not take an accrediting action against a provider based on good faith participation of the provider in the collection, development, reporting or maintenance of patient safety work product in accordance with these rules nor require a provider to reveal its communications with any PSO (42 CFR § 3.206(b)(8)(iii)).
24. 42 CFR § 3.206(b)(9)(i). Note: such contractors may not further disclose patient safety work product except to the entity from which they received the information.
25. PSQIA, 42 U.S.C. § 299b-22(c)(2)(F).
26. PSQIA, 42 U.S.C. § 299b-22(c)(2)(G). Note: law enforcement personnel receiving work product pursuant to this exception may only disclose such work product to other law enforcement authorities as needed for law enforcement activities related to the event that gave rise to the initial disclosure (42 CFR § 3.206(b)(10)(ii).
27. PSQIA, 42 U.S.C. § 299b-22(c)(2)(H)(i).
28. PSQIA, 42 U.S.C. § 299b-22(c)(2)(H)(ii).
29. Note: this is referred to the “safe harbor” provision in the implementing regulations (42 CFR § 3.206(c)).
30. 42 CFR § 3.102(c)(3)(i).
31. 42 CFR § 3.102(c)(3)(ii).
32. PSQIA, 42 U.S.C. § 299b-22(d)(1).
33. PSQIA, 42 U.S.C. § 299b-22(d)(2)(A).
34. PSQIA, 42 U.S.C. § 299b-22(d)(2)(B).
35. 42 CFR § 3.504(a).
36. 42 CFR § 3.504, et. seq.
37. 42 CFR § 3.542(a).
38. 42 CFR § 3.504(a).
39. 42 CFR § 3.504, et. seq.
40. 42 CFR § 3.542(a).
41. 42 CFR § 3.542(b).
42. 42 CFR § 3.542(c). Note: good cause may include the presence in the record of identifiable patient safety work product.
43. 42 CFR § 3.408.
44. 42 CFR § 3.408.
45. 42 CFR § 3.426.
46. 42 CFR § 3.204(c); 42 CFR § 3.206(d).
47. 42 CFR § 3.312(c)(2).
48. PSQIA, 42 U.S.C. § 299b-22(c)(2)(A).
49. 42 CFR § 3.206(b)(4)(i).
50. 42 CFR § 3.206(b)(4)(ii).
51. 42 CFR § 3.206(b)(4)(iii).
53. 42 CFR § 3.206(b)(4)(iv)(A).
54. Listed at 45 CFR 164.514(e)(2).
55. 42 CFR § 3.206(b)(4)(iv)(B).
56. PSQIA, 42 U.S.C. § 299b-22(c)(2)(B).
57. PSQIA, 42 U.S.C. § 299b-22(c)(2)(C). Note: if work product disclosed for research is by a HIPAA-covered entity (defined at 45 CFR 160.103) and contains HIPAA-defined protected health information (defined at 45 CFR 160.103), disclosure is only permissible to the same extent as it would be permissible under HIPAA (42 CFR § 3.206(b)(6)(ii)).
58. PSQIA, 42 U.S.C. § 299b-22(c)(2)(D). Note: any person permitted to receive patient safety work product pursuant to this exception may only further disclose such work product for the purpose of evaluating the quality, safety, or effectiveness of that product or activity to another such person or the disclosing provider (42 CFR § 3.206(b)(7)(ii)).
59. PSQIA, 42 U.S.C. § 299b-22(c)(2)(E). Note: an accrediting body may not further disclose patient safety work product it receives pursuant to this exception (42 CFR § 3.206(b)(8)(ii), and may not take an accrediting action against a provider based on good faith participation of the provider in the collection, development, reporting or maintenance of patient safety work product in accordance with these rules nor require a provider to reveal its communications with any PSO (42 CFR § 3.206(b)(8)(iii)).
60. 42 CFR § 3.206(b)(9)(i). Note: such contractors may not further disclose patient safety work product except to the entity from which they received the information.
61. PSQIA, 42 U.S.C. § 299b-22(c)(2)(F).
62. PSQIA, 42 U.S.C. § 299b-22(c)(2)(G). Note: law enforcement personnel receiving work product pursuant to this exception may only disclose such work product to other law enforcement authorities as needed for law enforcement activities related to the event that gave rise to the initial disclosure (42 CFR § 3.206(b)(10)(ii).
63. PSQIA, 42 U.S.C. § 299b-22(c)(2)(H)(i).
64. PSQIA, 42 U.S.C. § 299b-22(c)(2)(H)(ii).
65. 42 CFR § 3.504(a).
66. 42 CFR § 3.504, et. seq.
67. 42 CFR § 3.542(a).
68. 42 CFR § 3.542(b).
69. 42 CFR § 3.542(c). Note: good cause may include the presence in the record of identifiable patient safety work product.
70. 42 CFR § 3.408.
71. 42 CFR § 3.408.
72. 42 CFR § 3.426.
73. 42 CFR § 3.204(c); 42 CFR § 3.206(d).
74. 42 CFR § 3.312(c)(2).
75. PSQIA, 42 U.S.C. § 299b-22(c)(2)(A).
76. 42 CFR § 3.206(b)(4)(i).
77. 42 CFR § 3.206(b)(4)(ii).
78. 42 CFR § 3.206(b)(4)(iii).
80. 42 CFR § 3.206(b)(4)(iv)(A).
81. Listed at 45 CFR 164.514(e)(2).
82. 42 CFR § 3.206(b)(4)(iv)(B).
83. PSQIA, 42 U.S.C. § 299b-22(c)(2)(B).
84. PSQIA, 42 U.S.C. § 299b-22(c)(2)(C). Note: if work product disclosed for research is by a HIPAA-covered entity (defined at 45 CFR 160.103) and contains HIPAA-defined protected health information (defined at 45 CFR 160.103), disclosure is only permissible to the same extent as it would be permissible under HIPAA (42 CFR § 3.206(b)(6)(ii)).
85. PSQIA, 42 U.S.C. § 299b-22(c)(2)(D). Note: any person permitted to receive patient safety work product pursuant to this exception may only further disclose such work product for the purpose of evaluating the quality, safety, or effectiveness of that product or activity to another such person or the disclosing provider (42 CFR § 3.206(b)(7)(ii)).
86. PSQIA, 42 U.S.C. § 299b-22(c)(2)(E). Note: an accrediting body may not further disclose patient safety work product it receives pursuant to this exception (42 CFR § 3.206(b)(8)(ii), and may not take an accrediting action against a provider based on good faith participation of the provider in the collection, development, reporting or maintenance of patient safety work product in accordance with these rules nor require a provider to reveal its communications with any PSO (42 CFR § 3.206(b)(8)(iii)).
87. 42 CFR § 3.206(b)(9)(i). Note: such contractors may not further disclose patient safety work product except to the entity from which they received the information.
88. PSQIA, 42 U.S.C. § 299b-22(c)(2)(F).
89. PSQIA, 42 U.S.C. § 299b-22(c)(2)(G). Note: law enforcement personnel receiving work product pursuant to this exception may only disclose such work product to other law enforcement authorities as needed for law enforcement activities related to the event that gave rise to the initial disclosure (42 CFR § 3.206(b)(10)(ii).
90. PSQIA, 42 U.S.C. § 299b-22(c)(2)(H)(i).
91. PSQIA, 42 U.S.C. § 299b-22(c)(2)(H)(ii).
92. Note: this is referred to the “safe harbor” provision in the implementing regulations (42 CFR § 3.206(c)).
93. 42 CFR § 3.102(c)(3)(i).
94. 42 CFR § 3.102(c)(3)(ii).
95. PSQIA, 42 U.S.C. § 299b-22(d)(1).
96. PSQIA, 42 U.S.C. § 299b-22(d)(2)(A).
97. PSQIA, 42 U.S.C. § 299b-22(d)(2)(B).
98. 42 CFR § 3.504(a).
99. 42 CFR § 3.504, et. seq.
100. 42 CFR § 3.542(a).
101. 42 CFR § 3.504(a).
102. 42 CFR § 3.504, et. seq.
103. 42 CFR § 3.542(a).
104. 42 CFR § 3.542(b).
105. 42 CFR § 3.542(c). Note: good cause may include the presence in the record of identifiable patient safety work product.
106. 42 CFR § 3.504(a).
107. 42 CFR § 3.504, et. seq.
108. 42 CFR § 3.542(a).
109. 42 CFR § 3.542(b).
110. 42 CFR § 3.542(c). Note: good cause may include the presence in the record of identifiable patient safety work product.
111. 42 CFR § 3.408.
112. 42 CFR § 3.408.
113. 42 CFR § 3.426.
114. 42 CFR § 3.504(a).
115. 42 CFR § 3.504, et. seq.
116. 42 CFR § 3.542(a).
117. 42 CFR § 3.542(b).
118. 42 CFR § 3.542(c). Note: good cause may include the presence in the record of identifiable patient safety work product.

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