Patient Safety and Quality Improvement: A Policy Assessment

Abstract

Background: The regulation implementing the Patient Safety and Quality Improvement Act of 2005 (PSQIA) was published on November 21, 2008, and became effective on January 19, 2009 (42 C.F.R. Part 3).¹ PSQIA establishes a voluntary reporting system to enhance the data available to assess and resolve patient safety and health care quality issues. To encourage the reporting and analysis of medical errors, PSQIA provides federal privilege and confidentiality protections for patient safety information.

Purpose: Greater reporting and analysis of patient safety events will yield increased data and better understanding of patient safety events. A PSO's workforce must have expertise in analyzing patient safety events, such as the identification, analysis, prevention, and reduction or elimination of the risks and hazards associated with the delivery of patient care.

Implications: This new legislation provides a vehicle to better understand at a macro level how the clinical laboratory threatens patient safety and how that threat can be better controlled. What is imperative is that the clinical laboratory staff be involved in collecting and analyzing data. If they are not, the probability is high that data being reported by the laboratory will be misunderstood at the PSO and laboratories may be cited as a threat to patient safety because of a lack of understanding of laboratory operations.

ABBREVIATIONS: AHRQ – Agency for Healthcare Research and Quality, OCR – Office of Civil Rights, PSO – Patient Safety Organization, PSQIA - Patient Safety and Quality Improvement Act of 2005, PSR – PSR, PSWP – Patient Safety Work Product