c.) ENFORCEMENT PROVISIONS
Reporting Confidentiality Violations: Any person who believes that patient safety work product has been disclosed in violation of the confidentiality provisions may file a complaint with HHS.117 Such complaint must be in writing,118 name the subject of the complaint and describe the acts believed to be in violation of the confidentiality provisions.119
Compliance Reviews: HHS may assess or verify any PSO’s compliance with requirements by requesting information or conducting reviews of, or site visits to, PSOs.120 HHS may inspect the physical or virtual sites maintained or controlled by the PSO, and may inspect or obtain copies of any necessary PSO records, including PSWP.121 Respondents must keep records and submit compliance reports as required by HHS,122 must cooperate with complaint investigations and compliance reviews,123 and must permit HHS access to any sources of information that are pertinent to ascertaining compliance with the confidentiality provisions.124
Confidentiality Violations: The Office for Civil Rights will investigate and enforce compliance with the confidentiality provisions.125 A person who knowingly or recklessly discloses identifiable PSWP in violation of the confidentiality requirements126 will be subject to a civil monetary penalty127 of up to $10,000 for each violation,128 as will any principal based on the act of his agent, in accordance with the federal common law of agency.129 In determining the amount of the penalty,130 HHS may consider aggravating or mitigating factors as appropriate.131 When a penalty is final, HHS will notify the following of the penalty and the reason it was imposed:132
- The public;
- The appropriate state or local medical or professional organization;
- State agenc(ies) administering or supervising the administration of state health care programs;
- The appropriate utilization and quality control peer review organization; and
- The appropriate state or local licensing agency or organization of the penalty.
ALJ Hearings: A respondent is permitted to request a hearing before an ALJ;133 if such request is granted, the hearing must conform to a number of adjudicatory requirements.134 The record of such hearing must be recorded and transcribed, and may be obtained following the hearing;135 the record of the decision, including the transcript of the testimony, exhibits and other evidence admitted at the hearing, and all papers and requests filed in the proceeding,136 may be inspected and copied by any person, unless otherwise ordered by the ALJ for good cause shown.137
Footnotes
- 117. 42 CFR § 3.306(a).
- 118. 42 CFR § 3.306(b)(1).
- 119. 42 CFR § 3.306(b)(2).
- 120. 42 CFR § 3.308.
- 121. 42 CFR § 3.110.
- 122. 42 CFR § 3.310(a).
- 123. 42 CFR § 3.310(b).
- 124. 42 CFR § 3.310(c)(1). Note: HHS must be granted such access during normal business hours; if HHS determines that exigent circumstances exist, access must be granted at any time and without notice. If the information required is exclusively in the possession of another entity, and the other entity fails or refuses to furnish the information, the respondent must so certify and set forth what efforts it has made to obtain the information (42 CFR § 3.310(c)(2)).
- 125. 42 CFR Part 3 (page 70732)
- 126. Note: Penalties may not be imposed under both the PSQIA and HIPAA for a single act or omission (42 U.S.C. § 299b-22(f)(3)).
- 127. Civil monetary penalties under the PSQIA will be applied in accordance with the provisions of Title 11 of the Social Security Act, § 1128A (Available at 42 U.S.C. § 1320a-7a), starting from the second sentence of § 1128A(c)(1).
- 128. PSQIA, 42 U.S.C. § 299b-22(f)(1).
- 129. 42 CFR § 3.402(b).
- 130. 42 CFR § 3.408.
- 131. 42 CFR § 3.408.
- 132. 42 CFR § 3.426.
- 133. 42 CFR § 3.504(a).
- 134. 42 CFR § 3.504, et. seq.
- 135. 42 CFR § 3.542(a).
- 136. 42 CFR § 3.542(b).
- 137. 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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