The Patient Safety and Quality Improvement Act of 2005 (PSQIA): , 42 U.S.C.

Title 42 of the United States Code

Title 42 of the United States Code is the title of the United States Code dealing with public health, social welfare, and civil rights.—The Public Health Service—The Public Health Service, Supplemental Provisions—Sanitation and Quarantine—Leprosy—Cancer—Viruses, Serums, Toxins, Antitoxins,...

 ch. 6A subch. VII part C, established a system of patient safety organization

Patient safety organization

A patient safety organization is a group, institution or association that improves medical care by reducing medical errors. In the 1990s, reports in several countries revealed a staggering number of patient injuries and deaths each year due to avoidable adverse health care events...

s and a national patient safety database. To encourage reporting and broad discussion of adverse events, near miss

Near miss (safety)

See Close Call, for the 2002 film.A near miss is an unplanned event that did not result in injury, illness, or damage – but had the potential to do so. Only a fortunate break in the chain of events prevented an injury, fatality or damage; in other words, a miss that was nonetheless very near...

es, and dangerous conditions, it also established privilege

Privilege (evidence)

An evidentiary privilege is a rule of evidence that allows the holder of the privilege to refuse to provide evidence about a certain subject or to bar such evidence from being disclosed or used in a judicial or other proceeding....

 and confidentiality protections for Patient Safety Work Product (as defined in the act). The PSQIA was introduced by Sen. Jim Jeffords

Jim Jeffords

James Merrill "Jim" Jeffords is a former U.S. Senator from Vermont. He served as a Republican until 2001, when he left the party to become an independent. He retired from the Senate in 2006.-Background:...

 [I-VT]. It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005 with 428 Ayes, 3 Nays, and 2 Present/Not Voting.

Lexology, in cooperation with the Association of Corporate Counsel

Association of Corporate Counsel

The Association of Corporate Counsel , formerly the American Corporate Counsel Association , is the largest organization serving the professional and business interests of attorneys who practice in the legal departments of corporations, associations and other private-sector organizations around the...

, predicts that this law will be one of the top 10 health care law issues in 2010.

Context for the passage of the Act

The Notice of proposed rulemaking

Notice of proposed rulemaking

A notice of proposed rulemaking is a public notice issued by law when one of the independent agencies of the United States government wishes to add, remove, or change a rule or regulation as part of the rulemaking process. It is an important part of United States administrative law which...

 for this law describes the reason Congress passed it.

Definitions

Patient Safety Organization (PSO) must certify that it lists the requirements in the PSQIA and be listed on the Agency for Healthcare Research and Quality

Agency for Healthcare Research and Quality

The Agency for Healthcare Research and Quality is a part of the United States Department of Health and Human Services, which supports research designed to improve the outcomes and quality of health care, reduce its costs, address patient safety and medical errors, and broaden access to effective...

 (AHRQ) web site.

The definition of Patient Safety Work Product (PSWP) is quite broad. Patient safety work product includes any data, reports, records, memoranda, analyses (such as root cause analyses

Root cause analysis

Root cause analysis is a class of problem solving methods aimed at identifying the root causes of problems or events.Root Cause Analysis is any structured approach to identifying the factors that resulted in the nature, the magnitude, the location, and the timing of the harmful outcomes of one...

), or written or oral statements (or copies of any of this material), which could improve patient safety, health care quality, or health care outcomes, that are assembled or developed by a provider for reporting to a PSO and are reported to a PSO. It also includes information that is documented as within a patient safety evaluation system that will be sent to a PSO and information developed by a PSO for the conduct of patient safety activities.

However, patient safety work product does not include a patient’s medical record

Medical record

The terms medical record, health record, and medical chart are used somewhat interchangeably to describe the systematic documentation of a single patient's medical history and care across time within one particular health care provider's jurisdiction....

, 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.

Privilege and confidentiality protections

Patient Safety Work Product must not be disclosed, except in very specific circumstances and subject to very specific restrictions.

Note: the Patient Safety Activities Exception is the most common one that providers and PSOs will be working with.

Permitted Disclosures

• Patient Safety Activities — PSWP may be disclosed:
  • Between the Provider and the PSO — i.e.:
    • From the provider to the PSO, for Patient Safety Activities, and
    • From the PSO to the disclosing provider, for Patient Safety Activities
  • To a contractor of a Provider or a PSO
    • For contracted Patient Safety Activities
    • Contractor may not further disclose, except back to the contracted provider or PSO
  • Among affiliated providers, for Patient Safety Activities
    • From one PSO to another PSO or another provider, if
      • Direct identifiers (which are defined in the regulations) of any providers, affiliated organizations, corporate parents, subsidiaries, practice partners, employers, members of the workforce, or household members of such providers are removed; and
      • With respect to any Individually identifiable health information within the PSWP, a limited data set (also defined by regulation) is produced
• Business operations — A provider or PSO may disclose to attorneys, accountants or other professionals for business operations purposes.
  • Further disclosure (except back to the contracting entity) is prohibited
• Authorized by identified providers — Disclosure is permitted if all identified providers authorize the disclosure.
  • Authorization must be in writing, signed by the provider, and
  • Must state the nature and scope of the disclosure
• Accrediting bodies (e.g., The Joint Commission) — PSWP may be (but is not required to be) disclosed to an accrediting body if:
  • Any identified provider agrees to the disclosure; or
  • Direct identifiers of any provider (or affiliated organizations, corporate parents, subsidiaries, practice partners, employers, members of the workforce, or household members) are removed
• Nonidentifiable PSWP — May be disclosed
  • The regulations set out specific requirements for “nonidentification.”
• Research — This exception allows disclosure to researchers conducting certain types of research projects. If protected health information is involved, the HIPAA
  Health Insurance Portability and Accountability Act
  The Health Insurance Portability and Accountability Act of 1996 was enacted by the U.S. Congress and signed by President Bill Clinton in 1996. It was originally sponsored by Sen. Edward Kennedy and Sen. Nancy Kassebaum . Title I of HIPAA protects health insurance coverage for workers and their...
  
   privacy and security rules also apply.
• Food and Drug Administration (FDA) — PSWP may be disclosed to the FDA
  • By a provider concerning an FDA-regulated product or activity,
  • By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA-regulated product or activity, or
  • By a contractor acting on behalf of the FDA or entity for these purposes
• Law enforcement — PSWP may be disclosed to law enforcement personnel
  • If the information relates 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 patient safety work product that is disclosed is necessary for criminal law enforcement purposes
• Criminal proceedings — But only after a court makes an in camera
  In camera
  In camera is a legal term meaning "in private". It is also sometimes termed in chambers or in curia.In camera describes court cases that the public and press are not admitted to...
  
  (in closed chambers) determination that:
  • The PSWP contains evidence of a criminal act;
  • The PSWP is material to the proceedings; and
  • The PSWP is not reasonably available from any other source
• Disclosure to permit equitable relief for reporting individuals — This exception allows use of PSWP by individuals who claim they have been the victim of an adverse employment action because the individual reported information to a PSO (either directly to the PSO or with the intent of having it reported to the PSO)
  • There must be a “protective order” issued by the court or administrative tribunal to protect the confidentiality of PSWP used in the proceeding

Violations & Enforcement

• An individual who knowingly or recklessly violates the confidentiality provisions is subject to a civil penalty
  Civil penalty
  A civil penalty or civil fine is a term used to describe when a state entity, government agency, or private party seeks monetary relief against an individual as restitution for wrongdoing by the individual. The wrongdoing is typically defined by a codification of legislation, regulations, and decrees...
  
   of up to $10,000 for each act constituting such violation.
• Safe Harbor
  Safe harbor
  The term safe harbor has several special usages, in an analogy with its literal meaning, that of a harbor or haven which provides safety from weather or attack.-Legal definition:...
  
   — a provider whose workforce member discloses PSWP is not deemed to have violated the Act if that workforce member disclosure does not include written or oral statements that:
  • 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

Note: the individual workforce member of the provider would still be subject to possible penalties if the disclosure is knowing or reckless. This safe harbor does not apply to the PSO itself — i.e., a PSO workforce member’s disclosure is attributable to the PSO.

The Act is enforced by the Secretary of Health and Human Services

United States Department of Health and Human Services

The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...

• PSWP may be disclosed to (and the Secretary may require disclosure of PSWP) to investigate or determine compliance with the Patient Safety Act or with HIPAA.