Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization: Interim Guidance (Continued)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization: Interim Guidance (Continued)

§ 3.110 Assessment of PSO Compliance.

The Secretary may request information or conduct announced or unannounced reviews of or site visits to PSOs, to assess or verify PSO compliance with the requirements of this subpart and for these purposes will be allowed to inspect the physical or virtual sites maintained or controlled by the PSO. The Secretary will be allowed to inspect and/or be given or sent copies of any PSO records deemed necessary and requested by the Secretary to implement the provisions of this subpart. Such PSO records may include patient safety work product in accordance with § 3.206(d) of this subpart.

§ 3.112 Submissions and forms.

Forms referred to in this subpart may be obtained on the AHRQ PSO website or a comparable future form of public notice or by requesting them in writing by email at psimplement@ahrq.hhs.gov, or by mail from the Agency for Healthcare Research and Quality, CQuIPS, PSO Liaison, 540 Gaither Road, Rockville, MD 20850. A form (including any required attachments) must be submitted in accordance with the accompanying instructions.
Information submitted to AHRQ in writing, but not required to be on a form, and requests for information from AHRQ, may be submitted by mail or other delivery to the Agency for Healthcare Research and Quality, CQuIPS, PSO Liaison, 540 Gaither Road, Rockville, MD 20850, by facsimile at (301) 427-1341, or by email at psimplement@ahrq.hhs.gov.
If a submission to the Secretary is incomplete or additional information is needed to allow a determination to be made under this subpart, the submitter will be notified if any additional information is required.

Subpart C - Confidentiality and Privilege Protections of Patient Safety Work Product

§ 3.204 Privilege of PSWP.

Privilege. Notwithstanding any other provision of Federal, State, or local law and subject to paragraph (b) of this section and § 3.208 of this subpart, PSWP shall be privileged and shall not be:
1. subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
2. subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
3. subject to disclosure pursuant to section 552 of Title 5, United States Code (commonly known as the Freedom of Information Act) or any other similar Federal, State, or local law;
4. admitted as evidence in any Federal, State, or local governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or
5. admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.
Exceptions to privilege. Privilege shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
1. Disclosure of relevant PSWP for use in a criminal proceeding, subject to the conditions at § 3.206(b)(1) of this subpart.
2. Disclosure to the extent required to permit equitable relief subject to the conditions at § 3.206(b)(2) of this subpart.
3. Disclosure pursuant to provider authorizations subject to the conditions at § 3.206(b)(3) of this subpart.
4. Disclosure of non-identifiable PSWP
Implementation and Enforcement of the Patient Safety Act. Privilege shall not apply to (and shall not be construed to prohibit) disclosures of relevant PSWP to or by the Secretary if such PSWP is needed to investigate or determine compliance with this part or is needed in seeking or imposing civil money penalties, or in making or supporting PSO certification or listing decisions, under the Patient Safety Act.

§ 3.206 Confidentiality of PSWP.

Confidentiality. Subject to paragraphs (b) through (e) of this section, and §§ 3.208 and 3.210 of this subpart, PSWP shall be confidential and shall not be disclosed.
Exceptions to confidentiality. The confidentiality provisions shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
1. Criminal proceedings - Disclosure of relevant PSWP for use in a criminal proceeding, but only after a court makes an in camera determination that:
  1. such PSWP contains evidence of a criminal act;
  2. such PSWP is material to the proceeding; and
  3. such PSWP is not reasonably available from any other source.
2. Equitable relief for reporters - Disclosure of PSWP to the extent required to permit equitable relief under section 922(f)(4)(A) of the Public Health Service Act.²⁷
3. Authorized by identified providers - Disclosure of identifiable PSWP if authorized by each provider identified in such work product.²⁸
4. Patient safety activities - Disclosure of PSWP to carry out patient safety activities.
5. Disclosure of nonidentifiable PSWP.²⁹
6. For research - Disclosure of PSWP to persons carrying out research, evaluation or demonstration projects authorized, funded, certified, or otherwise sanctioned by rule or other means by HHS for the purpose of conducting research to the extent that disclosure of protected health information would be allowed for such purpose under the HIPAA confidentiality regulations.³⁰
7. To the Food and Drug Administration (FDA) - Disclosure by a provider of PSWP concerning an FDA-regulated product or activity to the FDA.
8. Voluntary disclosure to an accrediting body - Voluntary disclosure by a provider of PSWP to an accrediting body that accredits that provider.
9. Business operations - Disclosure of PSWP by a provider or a PSO for business operations to attorneys, accountants, and other professionals subject to the professional's agreement not to further disclose the PSWP, except to the entity from which they received the information. (HHS has identified these exceptions pursuant to the Patient Safety Act provision giving HHS the authority to determine, by rule or other means, those disclosures that are necessary for business operations and are consistent with the goals of the Act.)
10. Disclosure to law enforcement - Disclosure of PSWP to an appropriate law enforcement authority relating to an event that either constitutes the commission of a crime, or for which the disclosing person reasonably believes constitutes the commission of a crime, provided that the disclosing person believes, reasonably under the circumstances, that the PSWP that is disclosed is necessary for criminal law enforcement purposes.
11. With respect to a person other than a PSO, the disclosure of PSWP that does not include materials that (i) assess the quality of care of an identifiable provider; or describe or pertain to one or more actions or failures to act by an identifiable provider.
Implementation and Enforcement of the Patient Safety Act. The confidentiality provisions shall not apply to (and shall not be construed to prohibit) disclosures of relevant PSWP to or by the Secretary if such PSWP is needed to investigate or determine compliance with this part or is needed in seeking and imposing civil money penalties, or in making or supporting PSO certification or listing decisions, under the Patient Safety Act.
No limitation on authority to limit or delegate disclosure or use. Nothing in subpart C shall be construed to limit the authority of any person to enter into a contract requiring greater confidentiality or delegating authority to make a disclosure or use in accordance with this subpart.

§ 3.208 Continued Protection of PSWP.

Except as provided in paragraph (b) of this section, PSWP disclosed in accordance with this subpart, or disclosed impermissibly, shall continue to be privileged and confidential.
1. PSWP disclosed for use in a criminal proceeding pursuant to section 922(c)(1)(A) of the Public Health Service Act and/or pursuant to § 3.206(b)(1) of this subpart continues to be privileged, but is no longer confidential.
2. Non-identifiable PSWP that is disclosed is no longer privileged or confidential and not subject to the regulations under this part.
3. Paragraph (b) of this section applies only to the specific PSWP disclosed.

§ 3.210 Required Disclosure of PSWP to the Secretary.

Providers, PSOs, and responsible persons must disclose PSWP upon request by the Secretary when the Secretary determines such PSWP is needed to investigate or determine compliance with this part or is needed in seeking and imposing civil money penalties or making determinations on certifying and listing PSOs.

Subpart D - Enforcement Program

§ 3.304 Principles for achieving compliance.

Cooperation. The Secretary will, to the extent practicable, seek the cooperation of providers, PSOs, and responsible persons in obtaining compliance with the applicable confidentiality provisions.
Assistance. The Secretary may provide technical assistance to providers, PSOs, and responsible persons to help them comply voluntarily with the applicable confidentiality provisions.

§ 3.306 Complaints to the Secretary.

Right to file a complaint. A person who believes that patient safety work product has been disclosed in violation of the confidentiality provisions may file a complaint with the Secretary.
Requirements for filing complaints. Complaints under this section must meet the following requirements:
1. A complaint must be filed in writing, either on paper or electronically.
2. A complaint must name the person that is the subject of the complaint and describe the act(s) believed to be in violation of the applicable confidentiality provision(s).
3. A complaint must be filed within 180 days of when the complainant knew or should have known that the act complained of occurred, unless this time limit is waived by the Secretary for good cause shown.
4. The Secretary may prescribe additional procedures for the filing of complaints, as well as the place and manner of filing, by notice in the Federal Register.
Investigation. The Secretary may investigate complaints filed under this section. Such investigation may include a review of the pertinent policies, procedures, or practices of the respondent and of the circumstances regarding any alleged violation. At the time of initial written communication with the respondent about the complaint, the Secretary will describe the act(s) that are the basis of the complaint.

§ 3.308 Compliance reviews.

The Secretary may conduct compliance reviews to determine whether a respondent is complying with the applicable confidentiality provisions.

§ 3.310 Responsibilities of respondents.

Provide records and compliance reports. A respondent must keep such records and submit such compliance reports, in such time and manner and containing such information, as the Secretary may determine to be necessary to enable the Secretary to ascertain whether the respondent has complied or is complying with the applicable confidentiality provisions.
Cooperate with complaint investigations and compliance reviews. A respondent must cooperate with the Secretary, if the Secretary undertakes an investigation or compliance review of the policies, procedures, or practices of the respondent to determine whether it is complying with the applicable confidentiality provisions.
Permit access to information.
1. A respondent must permit access by the Secretary during normal business hours to its facilities, books, records, accounts, and other sources of information, including patient safety work product, that are pertinent to ascertaining compliance with the applicable confidentiality provisions. If the Secretary determines that exigent circumstances exist, such as when documents may be hidden or destroyed, a respondent must permit access by the Secretary at any time and without notice.
2. If any information required of a respondent under this section is in the exclusive possession of any other agency, institution, or person, and the other agency, institution, or person fails or refuses to furnish the information, the respondent must so certify and set forth what efforts it has made to obtain the information.

§ 3.312 Secretarial action regarding complaints and compliance reviews.

Resolution when noncompliance is indicated.
1. If an investigation of a complaint pursuant to § 3.306 of this subpart or a compliance review pursuant to § 3.308 of this subpart indicates noncompliance, the Secretary may attempt to reach a resolution of the matter satisfactory to the Secretary by informal means. Informal means may include demonstrated compliance or a completed corrective action plan or other agreement.
2. If the matter is resolved by informal means, the Secretary will so inform the respondent and, if the matter arose from a complaint, the complainant, in writing.
3. If the matter is not resolved by informal means, the Secretary will -
  1. So inform the respondent and provide the respondent an opportunity to submit written evidence of any mitigating factors. The respondent must submit any evidence to the Secretary within 30 days (computed in the same manner as prescribed under § 3.504(l) of this subpart) of receipt of such notification; and
  2. If, following action pursuant to paragraph (a)(3)(i) of this section, the Secretary decides that a civil money penalty should be imposed, inform the respondent of such finding in a notice of proposed determination in accordance with § 3.420 of this subpart.
Resolution when no violation is found. If, after an investigation pursuant to § 3.306 of this subpart or a compliance review pursuant to § 3.308 of this subpart, the Secretary determines that further action is not warranted, the Secretary will so inform the respondent and, if the matter arose from a complaint, the complainant, in writing.
Uses and disclosures of information obtained.
1. Identifiable patient safety work product obtained by the Secretary in connection with an investigation or compliance review under this subpart will not be disclosed by the Secretary, except in accordance with §3.206(d) of this subpart, or if otherwise permitted by this part or the Patient Safety Act.
2. Except as provided for in paragraph (c)(1) of this section, information, including testimony and other evidence, obtained by the Secretary in connection with an investigation or compliance review under this subpart may be used by HHS in any of its activities and may be used or offered into evidence in any administrative or judicial proceeding.

§ 3.314 Investigational subpoenas and inquiries.

The Secretary may issue subpoenas in accordance with 42 U.S.C. 405(d) and (e), and 1320a-7a(j), to require the attendance and testimony of witnesses and the production of any other evidence including patient safety work product during an investigation or compliance review pursuant to this part. The Secretary will issue and serve subpoenas pursuant to this subpart in accordance with 45 CFR 160.314(a)(1) - (5), except the term "this part" shall refer to 42 CFR Part 3.
Investigational inquiries are non-public investigational proceedings conducted by the Secretary. The Secretary will conduct investigational proceedings in accordance with 45 CFR 160.314(b)(1) - (9).

§ 3.402 Basis for a civil money penalty.

General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty for each act constituting such violation.
Violation attributed to a principal. A principal is independently liable, in accordance with the federal common law of agency, for a civil money penalty based on the act of the principal's agent, including a workforce member, acting within the scope of the agency if such act could give rise to a civil money penalty in accordance with § 3.402(a) of this subpart.

§ 3.404 Amount of a civil money penalty.

The amount of a civil money penalty will be determined in accordance with paragraph (b) of this section and § 3.408 of this subpart.
The Secretary may impose a civil money penalty in the amount of not more than $10,000.

§ 3.408 Factors considered in determining the amount of a civil money penalty.

In determining the amount of any civil money penalty, the Secretary may consider as aggravating or mitigating factors, as appropriate, any of the following:

The nature of the violation.
The circumstances, including the consequences, of the violation, including:
1. The time period during which the violation(s) occurred; and
2. Whether the violation caused physical or financial harm or reputational damage;
The degree of culpability of the respondent, including:
1. Whether the violation was intentional; and
2. Whether the violation was beyond the direct control of the respondent.
Any history of prior compliance with the Patient Safety Act, including violations, by the respondent, including:
1. Whether the current violation is the same or similar to prior violation(s);
2. Whether and to what extent the respondent has attempted to correct previous violations;
3. How the respondent has responded to technical assistance from the Secretary provided in the context of a compliance effort; and
4. How the respondent has responded to prior complaints.
The financial condition of the respondent, including:
1. Whether the respondent had financial difficulties that affected its ability to comply;
2. Whether the imposition of a civil money penalty would jeopardize the ability of the respondent to continue to provide health care or patient safety activities; and
3. The size of the respondent.
Such other matters as justice may require.

§ 3.414 Limitations.

No action under this subpart may be entertained unless commenced by the Secretary, in accordance with § 3.420 of this subpart, within 6 years from the date of the occurrence of the violation.

§ 3.416 Authority to settle.

Nothing in this subpart limits the authority of the Secretary to settle any issue or case or to compromise any penalty.

§ 3.418 Exclusivity of penalty.

Except as otherwise provided by paragraph (b) of this section, a penalty imposed under this part is in addition to any other penalty prescribed by law.
Civil money penalties shall not be imposed both under this part and under the HIPAA Privacy Rule.

§ 3.420 Notice of proposed determination.

If a penalty is proposed in accordance with this part, the Secretary must deliver, or send by certified mail with return receipt requested, to the respondent, written notice of the Secretary's intent to impose a penalty. This notice of proposed determination must include:
1. Reference to the statutory basis for the penalty;
2. A description of the findings of fact regarding the violations with respect to which the penalty is proposed;
3. The reason(s) why the violation(s) subject(s) the respondent to a penalty;
4. The amount of the proposed penalty;
5. Any factors described in § 3.408 of this subpart that were considered in determining the amount of the proposed penalty; and
6. Instructions for responding to the notice, including a statement of the respondent's right to a hearing, a statement that failure to request a hearing within 60 days permits the imposition of the proposed penalty without the right to a hearing under § 3.504 of this subpart or a right of appeal under § 3.504(v) of this subpart, and the address to which the hearing request must be sent.
The respondent may request a hearing before an ALJ on the proposed penalty by filing a request in accordance with § 3.504 of this subpart.

§ 3.422 Failure to request a hearing.

If the respondent does not request a hearing within the time prescribed by § 3.504 of this subpart and the matter is not settled pursuant to § 3.416 of this subpart, the Secretary may impose the proposed penalty or any lesser penalty permitted by 42 U.S.C. 299b-21 - 299b-26. The Secretary will notify the respondent by certified mail, return receipt requested, of any penalty that has been imposed and of the means by which the respondent may satisfy the penalty, and the penalty is final on receipt of the notice. The respondent has no right to appeal a penalty under § 3.504(v) of this subpart with respect to which the respondent has not timely requested a hearing.

§ 3.424 Collection of penalty.

Once a determination of the Secretary to impose a penalty has become final, the penalty will be collected by the Secretary in accordance with 45 CFR 160.424, except the term "this part" shall refer to 42 CFR Part 3.

§ 3.426 Notification of the public and other agencies.

Whenever a proposed penalty becomes final, the Secretary will notify, in such manner as the Secretary deems appropriate, the public and the following organizations and entities thereof and the reason it was imposed: the appropriate State or local medical or professional organization, the appropriate State agency or agencies administering or supervising the administration of State health care programs (as defined in 42 U.S.C. 1320a-7(h)), the appropriate utilization and quality control peer review organization, and the appropriate State or local licensing agency or organization (including the agency specified in 42 U.S.C. 1395aa(a), 1396a(a)(33)).

§ 3.504 Procedures for hearings.

Hearings before an ALJ. A respondent may request a hearing before an ALJ. Hearings must be requested in accordance with 45 CFR 160.504 (a)-(c), except the language in paragraph (c) following and including "except that" shall not apply. The ALJ must dismiss a hearing request in accordance with 45 CFR 160.504(d).
Rights of the parties. The hearing rights of the parties will be determined in accordance with 45 CFR 160.506.
Authority of the ALJ. The ALJ will conduct a fair and impartial hearing in accordance with 45 CFR 160.508(a)-(c)(4).
Ex parte contacts. Ex parte contacts are prohibited in accordance with 45 CFR 160.510.
Prehearing conferences. Prehearing conferences will be conducted in accordance with 45 CFR 160.512, except the term "identifiable patient safety work product" shall be substituted for the term "individually identifiable health information."
Authority to settle. The Secretary has authority to settle issues in accordance with 45 CFR 160.514.
Discovery. Discovery will proceed in accordance with 45 CFR 160.516.
Exchange of witness lists, witness statements, and exhibits. The parties will exchange hearing material in accordance with 45 CFR 160.518, except the language in paragraph (a) following and including "except that" shall not apply.
Subpoenas for attendance at hearing. The ALJ will issue a subpoena for the appearance and testimony of any person at the hearing in accordance with 45 CFR 160.520.
Fees. Fees and mileage for subpoenaed witnesses will be paid in accordance with 45 CFR 160.522.
Form, filing, and service of papers. Hearing documents will be filed and serviced in accordance with 45 CFR 160.524.
Computation of time. Computation of time shall be in accordance with 45 CFR 160.526, except the term "this subpart" shall refer to 42 CFR Part 3, Subpart D, and the citation "§ 3.504(a) of 42 CFR Part 3" shall be substituted for the citation "§ 160.504."
Motions. Procedures for the filing and disposition of motions will be in accordance with 45 CFR 160.528.
Sanctions. The ALJ may sanction a person in accordance with authorities at 45 CFR 160.530.
Collateral estoppel. Collateral estoppel will apply to hearings conducted pursuant to this subpart in accordance with 45 CFR 160.532, except the term "a confidentiality provision" shall be substituted for the term "an administrative simplification provision."
The hearing. Hearings will be conducted in accordance with 45 CFR 160.534, except the following text shall be substituted for § 160.534(b)(1): "The respondent has the burden of going forward and the burden of persuasion with respect to any challenge to the amount of a proposed penalty pursuant to §§ 3.404 - 3.408 of 42 CFR Part 3, including any factors raised as mitigating factors." Good cause shown under 45 CFR 160.534(c) may be that identifiable patient safety work product has been introduced into evidence or is expected to be introduced into evidence.
Witnesses. The testimony of witnesses will be handled in accordance with 45 CFR 160.538, except that the citation "§ 3.504(h) of 42 CFR Part 3" shall be substituted for the citation "§ 160.518."
Evidence. The ALJ will determine the admissibility of evidence in accordance with 45 CFR 160.540, except that the citation "§ 3.420 of 42 CFR Part 3" shall be substituted for the citation "§ 160.420 of this part."
The record. The record of the hearing will be created and made available in accordance with 45 CFR 160.542. Good cause under 45 CFR 160.542(c)-(d) may include the presence in the record of identifiable patient safety work product.
Post hearing briefs. Post-hearing briefs, if required by the ALJ, will be filed in accordance with 45 CFR 160.544.
ALJ's decision. The ALJ will issue a decision in accordance with 45 CFR 160.546, except the citation "§ 3.504(v) of 42 CFR Part 3" shall be substituted for "§ 160.548."
Appeal of the ALJ's decision. Any party may appeal the decision of the ALJ in accordance with 45 CFR 160.548, except the following language in paragraph (e) shall not apply: "Except for an affirmative defense under § 160.410(b)(1) of this part."
Stay of the Secretary's decision. Pending judicial review, a stay of the Secretary's decision may be requested in accordance with 45 CFR 160.550.
Harmless error. Harmless errors will be handled in accordance with 45 CFR 160.552.

Dated:
Michael O. Leavitt,
Secretary.

References

¹ When we say in this Interim Guidance that certain provisions of the NPRM regulation text are binding, we mean that they are binding because they restate statutory provisions, are procedural rules, or reflect the Department's inherent authority to establish internal procedures that do not require notice and comment rulemaking. See the Administrative Procedure Act at 5 U.S.C. 553(b)(3)(A). Language that is merely guidance (which may be described herein as either "guidance" or "nonbinding guidance") is not binding.

² The Patient Safety Act (Public Law No. 109-41) amended the Public Health Service Act (42 U.S.C. 299 et. seq.) by renumbering existing sections and inserting new sections 921 through 926 (42 U.S.C. 299b-21 through 299b-26). The Public Health Service Act (PHS Act) is a compilation of legislation enacted to authorize activities of the Public Health Service, an organizational part of HHS. Thus, when references are made in this Interim Guidance to sections 921 through 926 or when consulting the attached statute, please be aware that those section numbers are not sections of the Patient Safety Act but instead refer to the PHS Act. The parallel citations to the U.S. Code will be referenced as well.

³ Institute of Medicine, "To Err is Human: Building a Safer Health System", 1999.

⁴ Id. at 75.

⁵ As explained in the preamble to the NPRM (see footnote 7 in the preamble), we use the concept of "patient safety events" as broadly encompassing both incidents of actual harm to patients as well as close calls that resulted in no serious harm but could have done so.

⁶We believe that Congress could not have intended that the privilege and confidentiality protections afforded to patient safety work product operate to frustrate the sole enforcement mechanism Congress provided for the punishment of impermissible disclosures and to preclude the imposition of CMPs. As a matter of public policy, the creation of a confidentiality protection is meaningless without the capacity to enforce a breach of those protections. The applicable provisions in the regulatory text of the NPRM are 3.204(c), 3.206(d), 3.210 and 3.310. These provisions supplement the statutory exceptions to privilege and confidentiality. The preamble language regarding these provisions serves as guidance.

⁷ We note that Subpart B of the NPRM regulation text is generally binding. However, the following provisions are not binding (and are not included in Appendix B): (a) Section 3.102(a)(2), but only in regard to regulatory oversight agencies as entities that cannot be PSOs; (b) Section 3.102(c)(1)(i)(B)(regarding component PSOs and shared information systems); (c) Section 3.102(c)(1)(ii)(regarding component PSOs and access to information); (d) Section 3.102(c)(2)(regarding component PSOs and restrictions on workforce members); (e) Section 3.102(d)(2)(i)(A) – (C) (defining contractual, financial and reporting relationships); (f) Section 3.104(a)(2) in regard to non-statutory criteria (providing bases for listing determinations); (g) Section 3.104(c)(1) (considering nature, significance and duration of disclosed relationships between PSO and providers); and (h) Section 3.106 (security requirements). Because most of the provisions in Subpart C of the NPRM regulation text are found in the statute, those provisions are binding. Appendix B generally does not include NPRM provisions that are not in the statute with the exception of sections 3.204(c), 3.206(d), and 3.210, which are binding. All of the provisions in Subpart D of the NPRM regulation text are binding (all of these provisions can be found in Appendix B).

⁸ Section 921(7)(B) of the PHS Act states: "CLARIFICATION.-- "(i) Information described in subparagraph (A) does not include a patient's medical record, billing and discharge information, or any other original patient or provider record. (ii) Information described in subparagraph (A) does not include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a patient safety organization shall not by reason of its reporting be considered patient safety work product. (iii) Nothing in this part shall be construed to limit-- (I) the discovery of or admissibility of information described in this subparagraph in a criminal, civil, or administrative proceeding; (II) the reporting of information described in this subparagraph to a Federal, State, or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight purposes; or (III) a provider's recordkeeping obligation with respect to information described in this subparagraph under Federal, State, or local law.

⁹ Nonbinding guidance: We have proposed to expand upon this in the NPRM, which proposes to define nonidentifiable PSWP to be PSWP that is not identifiable PSWP in accordance with the nonidentification standards proposed at section 3.212 of the NPRM. These criteria proposed in section 3.212 are not binding. Although meeting these criteria is not required during the interim period, and other interpretations of the statutory definition of nonidentifiable PSWP may be possible, HHS will treat the proposed nonidentification standards as a safe harbor and will consider disclosures that meet the criteria proposed in section 3.212 of the NPRM as having met the standard for nonidentifiable PSWP.

¹⁰ 42 U.S.C. §299b-24(a) and (b).

¹¹ See proposed section 45 CFR §3.112 regarding the use of forms.

¹² 42 U.S.C. 299b-24(a)(1) and (b)(1). See also 45 CFR §§ 3.102(b) and(c) in the NPRM.

¹³ See 45 CFR Part 160 and Part 164, Subparts A and C and see for example NIST Special Publication 800-66.

¹⁴ Because data aggregation is critical to causal analysis and such aggregation depends upon the collection of information in a standardized manner, the Secretary is providing ongoing guidance and technical assistance to facilitate use of common data elements and definitions, starting with publication of defined data elements related to the most common patient safety events in the FR on August 29, 2008: 73 FR 50974-50976.

¹⁵ See the definition of patient safety activities in section 921(5)(F) of the PHS Act, 42 U.S.C. 299b-21(5)(F) and also in proposed 45 CFR §3.20 in the NPRM.

¹⁶ A form has been developed for this purpose and may be obtained by PSOs from the AHRQ web site, when it is available.

¹⁷ Until a final rule is in place, the Secretary will interpret the statutory requirement that a minimum of two bona fide PSO contracts be for "a reasonable period of time" on a case-by-case basis.

¹⁸ The preamble discussion of this "minimum contracts requirement" found in the material related to proposed 45 CFR § 3.102(d) offers guidance that may be useful on this subject.

¹⁹See section 924(f )(1) of the PHS Act, 42 USC 299b-24(f )(1).

²⁰Required pursuant to a certification made under section 924(b)(1)(E) of the PHS Act, 42 U.S.C.299b-24(b)(1)(E).

²¹42 USC 299b-24(c)(3).

²²Section 922(a) and (c) of the PHS Act, 42 U.S.C. 299b-22.

²³Section 922(b) and (c) of the PHS Act, 42 U.S.C. 299b-22.

²⁴Nonbinding guidance: When exercising the discretion to disclose PSWP, we encourage providers, PSOs, and others to consider the purposes for which the disclosures are made. Disclosures should be narrow and consistent with the overarching goals of the privilege and confidentiality protections, even though these protections generally continue to apply to PSWP after disclosure. We encourage the disclosure of the least amount of identifiable PSWP that is appropriate for the purpose of the disclosure, which might mean the disclosure of less information than all of the information that would be permitted to be disclosed under the confidentiality provisions. We also encourage the removal of identifiable information when feasible regardless of whether protection under this rule continues.

²⁵A number of the provisions of Subpart D restate statutory provisions found in the Patient Safety Act or restate provisions of 1128A that the statute requires the Department to apply. Other NPRM Subpart D provisions are procedural rules or are internal procedures and, thus, do not require notice and comment rulemaking. See the Administrative Procedure Act at 5 U.S.C 553(b)(3)(A).

²⁶ In that a listing of an entity as a PSO under the Interim Guidance will be the first possible listing of an entity, the Secretary would not have previously delisted the entity and there would be no history of non-compliance with the Patient Safety Act.

²⁷This means disclosure of PSWP to the extent required in a civil action by any aggrieved individual (a) to enjoin any act or practice that violates the requirement that a provider may not take an adverse employment action against an individual based upon the fact that the individual in good faith reported information to the provider with the intention of having the information reported to a PSO or reported information directly to a PSO. (Adverse employment action includes loss of employment, the failure to promote an individual, or the failure to provide any other employment-related benefit for which the individual would otherwise be eligible; or an adverse evaluation or decision made in relation to accreditation, certification, credentialing, or licensing of the individual); or (b) to obtain other appropriate equitable relief (including reinstatement, back pay, and restoration of benefits) to redress such violation.

²⁸Nonbinding guidance: A valid authorization is a written document signed by the provider from whom authorization is sought containing sufficient detail to fairly inform the provider of the nature and scope of the disclosures being authorized.

²⁹Nonbinding guidance: PSWP is nonidentifiable if it meets the standards in 3.212 of the NPRM. HHS will treat these nonidentification standards as a safe harbor.

³⁰Nonbinding guidance: "[T]o the extent that disclosure of protected health information would be allowed for such purpose under the HIPAA confidentiality regulations" means that if the PSWP disclosed under this provision is by a HIPAA covered entity as defined at 45 CFR 160.103 and contains protected health information as defined by the HIPAA Privacy Rule at 45 CFR 160.103, such PSWP may only be disclosed under this exception in the same manner as would be permitted under the HIPAA Privacy Rule.

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