Frequently asked questions

The definition of Patient Safety Work Product is very broad. The following is from the Final Rule:

Patient safety work product:

1. Except as provided in paragraph 2 of this definition, patient safety work product means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material)
   1. Which could improve patient safety, health care quality, or health care outcomes; and
      1. Which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO, which includes information that is documented as within a patient safety evaluation system for reporting to a PSO, and such documentation includes the date the information entered the patient safety evaluation system; or
      2. Are developed by a PSO for the conduct of patient safety activities; or
   2. Which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.
2. 1. Patient safety work product does not include a patient’s medical record, billing and discharge information, or any other original patient or provider information; nor does it 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 PSO shall not by reason of its reporting be considered patient safety work product.
   2. Patient safety work product assembled or developed by a provider for reporting to a PSO may be removed from a patient safety evaluation system and no longer considered patient safety work product if:
      1. The information has not yet been reported to a PSO; and
      2. The provider documents the act and date of removal of such information from the patient safety evaluation system.
   3. Nothing in this part shall be construed to limit information that is not patient safety work product from being:
      1. Discovered or admitted in a criminal, civil or administrative proceeding;
      2. Reported to a Federal, State, local or Tribal governmental agency for public health or health oversight purposes; or
      3. Maintained as part of a provider’s recordkeeping obligation under Federal, State, local or Tribal law.

Patient safety evaluation system means the collection, management, or analysis of information for reporting to or by a PSO.

A summary of the rules is available in both online and Word format.

From the Final PSO Rule, Federal Register Vol 73 No 226 Pp 70742–4 11/21/2008:

Generally, information may become patient safety work product when reported to a PSO. Information may also become patient safety work product upon collection within a patient safety evaluation system. Such information may be voluntarily removed from a patient safety evaluation system if it has not been reported and would no longer be patient safety work product. As a result, providers need not maintain duplicate systems to separate information to be reported to a PSO from information that may be required to fulfill state reporting obligations. All of this information, collected in one patient safety evaluation system, is protected as patient safety work product unless the provider determines that certain information must be removed from the patient safety evaluation system for reporting to the state. Once removed from the patient safety evaluation system, this information is no longer patient safety work product.

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Even when laws or regulations require the reporting of the information regarding the type of events also reported to PSOs, the Patient Safety Act does not shield providers from their obligation to comply with such requirements. These external obligations must be met with information that is not patient safety work product and oversight entities continue to have access to this original information in the same manner as such entities have had access prior to the passage of the Patient Safety Act. Providers should carefully consider the need for this information to meet their external reporting or health oversight obligations, such as for meeting public health reporting obligations. Providers have the flexibility to protect this information as patient safety work product within their patient safety evaluation system while they consider whether the information is needed to meet external reporting obligations. Information can be removed from the patient safety evaluation system before it is reported to a PSO to fulfill external reporting obligations. Once the information is removed, it is no longer patient safety work product and is no longer subject to the confidentiality provisions.

The Patient Safety Act establishes a protected space or system that is separate, distinct, and resides alongside but does not replace other information collection activities mandated by laws, regulations, and accrediting and licensing requirements as well as voluntary reporting activities that occur for the purpose of maintaining accountability in the health care system. Information is not patient safety work product if it is collected to comply with external obligations, such as: state incident reporting requirements; adverse drug event information reporting to the Food and Drug Administration (FDA); certification or licensing records for compliance with health oversight agency requirements; reporting to the National Practitioner Data Bank of physician disciplinary actions; complying with required disclosures by particular providers or suppliers pursuant to Medicare’s conditions of participation or conditions of coverage; or provision of access to records by Protection and Advocacy organizations as required by law.

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For patient safety work product to be disclosed, even to a State entity, the discloser must have an applicable disclosure permission. While the Patient Safety Act does not preempt state laws that require providers to report information that is not patient safety work product, a State may not require that patient safety work product be disclosed.

From 42CFR3.204 “Privilege of patient safety work product”:

(a) Privilege. Notwithstanding any other provision of Federal, State, local, or Tribal law and subject to paragraph (b) of this section and § 3.208 of this subpart, patient safety work product shall be privileged and shall not be:

(1) Subject to a Federal, State, local, or Tribal civil, criminal, or administrative subpoena or order, including in a Federal, State, local, or Tribal civil or administrative disciplinary proceeding against a provider;

(2) Subject to discovery in connection with a Federal, State, local, or Tribal civil, criminal, or administrative proceeding, including in a Federal, State, local, or Tribal 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, local, or Tribal law;

(4) Admitted as evidence in any Federal, State, local, or Tribal 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.

(b) 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 patient safety work product for use in a criminal proceeding [but only after a court makes an in camera determination that such patient safety work product contains evidence of a criminal act and that such patient safety work product is material to the proceeding and not reasonably available from any other source].

(2) Disclosure to the extent required to [protect from retaliation a person who reports patient safety information].

(3) Disclosure pursuant to provider authorizations subject to the [requirements for recording valid authorizations from all identified providers].

(4) Disclosure of non-identifiable patient safety work product....

(c) Implementation and enforcement by the Secretary. Privilege shall not apply to (and shall not be construed to prohibit) disclosures of relevant patient safety work product to or by the Secretary if such patient safety work product is needed to investigate or determine compliance, or to seek or impose civil money penalties, with respect to this part or the HIPAA Privacy Rule, or to make or support decisions with respect to listing of a PSO.

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§ 3.208 Continued protection of patient safety work product.

(a) Except as provided in paragraph (b) of this section, patient safety work product disclosed in accordance with this subpart, or disclosed impermissibly, shall continue to be privileged and confidential.

(b)(1) Patient safety work product disclosed for use in a criminal proceeding ... continues to be privileged, but is no longer confidential.

(2) Non-identifiable patient safety work product 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 patient safety work product disclosed.

From the Final PSO Rule, Federal Register Vol 73 No 226 Pp 70736–7 11/21/2008:

The final rule does not limit the sharing of patient safety work product within an entity and permits sharing among providers under certain conditions. Affiliated providers may share patient safety work product for patient safety activities and non-affiliated providers may share anonymized patient safety work product. A provider may also share patient safety work product with a health care provider that has privileges to practice at the provider facility. Further, if all identified providers are in agreement regarding the need to share identifiable patient safety work product, each provider may authorize and thereby permit a disclosure.

Patient confidentiality protections are not reduced by the Patient Safety and Quality Improvement Act of 2005 (PSQIA).

From the Proposed PSO Rule, Federal Register Vol 73 No 29 P 8148 2/12/2008:

(g) Nothing in this section shall be construed—to limit the application of other Federal, State, or local laws that provide greater privilege or confidentiality protections than the privilege and confidentiality protections provided for in this section; [or] except as provided in subsection (i), to alter or affect the implementation of any provision of the HIPAA confidentiality regulations or section 1176 of the Social Security Act (or regulations promulgated under such section);

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(i) For purposes of applying the HIPAA confidentiality regulations—patient safety organizations shall be treated as business associates; and patient safety activities of such organizations in relation to a provider are deemed to be health care operations (as defined in such regulations) of the provider.

PSWP may be used for research only in very limited circumstances.

From the Notice of Proposed Rule Making, Federal Register Vol 73 No 29 P 8148 2/12/2008:

... § 3.206(b)(6) describes the disclosure of identifiable patient safety work product to entities carrying out research, evaluations, or demonstration projects that are funded, certified, or otherwise sanctioned by rule or other means by the Secretary. This disclosure is not for general research. Any research for which patient safety work product is disclosed under this exception must be sanctioned by the Secretary [of HHS].... Research that is not sanctioned by the Secretary is insufficient to be a basis for the disclosure of patient safety work product under this exception. Further, although disclosure can be made for any research, evaluation, or demonstration project sanctioned by the Secretary, we expect that most research that may be subject to this disclosure permission will be related to the methodologies, analytic processes, and interpretation, feedback and quality improvement results from PSOs, rather than general medical, or even health services, research. Patient safety work product disclosed for research under this provision continues to be confidential and privileged.