The Patient Safety And Quality Improvement Act of 2005

Question 1

What did the PSQIA do?

(4)

Answer 1

1. Amended Title IX of the PHSA to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety by authorizing creation of PSO’s.
2. Provided protections to patient safety work products.
3. Provided protections to providers who report patient safety incidents.
4. Created a network of patient safety databases.

Question 2

What did the PSQIA require of the DHS?

Answer 2

• Required that the Secretary of the DHS, in consultation with the Director of the AHRQ, prepare a report on effective strategies for reducing medical errors and increasing patient safety.
• Submitted to Congress in 2021, was made available for public comment, and was peer reviewed by the NAM.
• “Strategies to Improve Patient Safety: Final Report to Congress Required by the Patient Safety and Quality Improvement Act of 2005”

Question 3

What is the outline of the PSQIA?

Answer 3

• §299b-21: Definitions
• §299b-22: Privilege and Confidentiality Protections
• §299b-23: Network of Patient Safety Databases
• §299b-24: Patient Safety Organization Certification and Listing
• §299b-24a: Activities Regarding Women’s Health
• §299b-25: Technical Assistance
• §299b-26: Severability

Question 4

Define:

HIPAA Confidentiality Regulations

Answer 4

Regulations under §264(c) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996

Question 5

Define:

Patient Safety Activities

(A-H)

Answer 5

• (A) Efforts to improve patient safety and the quality of health care delivery.
• (B) The collection and analysis of PSWP.
• (C) The development and dissemination of information with respect to improving patient safety.
• (D) The utilization of PSWP for purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk.
• (E) The maintenance of procedures to preserve confidentiality with respect to PSWP.
• (F) The provision of appropriate security measures with respect to PSWP.
• (G) The utilization of qualified staff.
• (H) Activities related to the operation of a patient safety evaluation system and the provision of feedback to participants.

Question 6

Define:

Patient Safety Work Product (PSWP)

Answer 6

Any data, reports, memoranda, analyses (such as root cause analyses), or written or oral statements
WHICH:
- are assembled or developed by a provider for reporting to a PSO and are reported to a PSO; OR
- are developed by a PSO for the conduct of patient safety activities;
AND
- which could result in improved patient safety, health care quality, or health care outcomes; OR
- which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.

Question 7

Patient Safety Work Product (PSWP) does not include:

(2)

Answer 7

• Patients’ medical record, billing and discharge information, or any other original patient or provider record.
• Information that is collected, maintained, or developed separately, or exists separately from a patient safety evaluation system.

Question 8

Define:

Identifiable Patient Safety Work Product

(A-C)

Answer 8

• (A) Presented in form or manner that allows the identification of any provider that is a subject of the work product, or any providers that participate in activities that are subject to the work product.
• (B) Constitutes individually identifiable health information as defined by HIPAA.
• (C) Presented in form or manner that allows identification of an individual who reported information.

Question 9

What privilege and confidentiality protections are provided to PSWP by the PSQIA?

(5/1)

Answer 9

• PSWP is privileged, and shall not be:
  
  • subject to subpoena/order
  • subject to discovery
  • subject to disclosure pursuant to §552 of Title V (FOIA)
  • admitted as evidence
  • admitted in a professional disciplinary proceeding
• PSWP is confidential and shall not be disclosed.

Question 10

What are the exceptions from both the privilege and the confidentiality protections provided to PSWP by the PSQIA?

(A-C)

Answer 10

• (A) Criminal Proceedings – only after the court makes an in-camera determination that:
  
  • such PSWP contains evidence of a criminal act and
  • that such PSWP is material to the proceeding and
  • not reasonably available from any other source.
• (B) To the extent required to carry out subsection (f)(4)(a), grievance reference provider protections.
• (C) Disclosure of identifiable PSWP if authorized by each provider identified in such PSWP.

Question 11

What are the exceptions from the confidentiality protections provided to PSWP by the PSQIA?

(A-H)

Answer 11

• (A) Disclosure of PSWP to carry out patient safety activities.
• (B) Disclosure of non-identifiable PSWP.
• (C) Disclosure of PSWP to grantees, contractors, or other entities carrying out research, evaluation, or demonstration projects authorized, funded, certified, or otherwise sanctioned by rule or other means by the Secretary, for the purpose of conducting research to the extent that disclosure of PHI would be allowed under HIPAA.
• (D) Disclosure by a provider to the FDA with respect to a product or activity regulated by the FDA.
• (E) Voluntary disclosure of PSWP by a provider to an accrediting body that accredits that provider.
• (F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations and are consistent with the goals of this part.
• (G) Disclosure of PSWP to law enforcement authorities relating to the commission of a crime (or to an event reasonably believed to be a crime) if the person making the report believes, reasonably under the circumstances, that the PSWP disclosed is necessary for criminal law enforcement purposes.
• (H) 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
  • (ii) describe or pertain to one or more actions or failures to act by an identifiable provider.

Question 12

What are the exceptions from the privilege protections provided to PSWP by the PSQIA?

(1)

Answer 12

Privilege protections shall not apply to voluntary disclosure of non-identifiable PSWP.

Question 13

What are the protections provided to individuals who report patient safety information?

Answer 13

In general, a provider may not take an adverse employment action against any individual based upon the fact that the individual in good faith reported information —
- (A) to the provider with the intention of having the information reported to a PSO; OR
- (B) directly to a PSO.