Annals of Long Term Care

More than a decade has passed since the publication of To Err Is Human: Building A Safer Health System,¹ a report that brought major public attention to patient safety in healthcare. In the past 10 years, tremendous attention has been paid to reducing medical errors in healthcare, but relatively little focus has been on laboratory medicine, despite specimen collection and testing being a routine part of healthcare practice used to diagnose and monitor patients’ conditions.² Approximately 60% to 70% of diagnostic and therapeutic monitoring relies on laboratory test results.³

In the United States, more than 160,000 medical events per year result from errors in specimen collection,⁴ and 19% of patients who are not adversely affected by specimen collection errors go on to receive unnecessary follow-up tests.⁵ A laboratory or specimen collection error is defined as “a defect occurring at any part of the laboratory cycle, from ordering tests to reporting results and appropriately interpreting and reacting on these.”¹ Approximately 46% to 68.2% of these errors occur before the specimens reach the laboratory for analysis, and these are referred to as preanalytic errors.³ Physician reports indicate that 27% of specimen collection errors affect patient care⁵ and could potentially have devastating consequences for patients.⁶

Less is known about specimen collection processes in long-term care (LTC) settings, but it is clear that improper specimen collection threatens patient safety, and relevant processes of care need to be examined to prevent significant adverse events. After a specimen collection error occurred at Baycrest, we reviewed the institution’s entire process of specimen collection, from the time of ordering until the specimen is received by the laboratory, to identify shortcomings and develop recommendations for improvement.

Background

Baycrest is an academically affiliated teaching site that comprises a 472-bed nursing home, a 300-bed hospital providing LTC services for complex chronic or subacute conditions, various community care programs, and several ambulatory care clinics that, as a whole, serve approximately 2500 elderly patients. One day in 2008, a laboratory received 12 specimens that had been collected from Baycrest patients 5 days earlier. The delay in submitting the specimens made them inadmissible for testing, and the event was reported to Baycrest’s Quality and Safety Coordinating Committee. Although no patients were adversely affected by the event, it triggered a rigorous quality improvement initiative at Baycrest, with the goal of enhancing the institution’s specimen collection process.

Methodology

This project received approval from the Baycrest Research Ethics Board. The multistep analysis was limited to Baycrest’s LTC complex continuing care program for patients with chronic or subacute conditions. We selected this setting because, compared with the other LTC units at Baycrest that use the specimen collection process, the complex continuing care program includes patients with higher patient acuity, submits the most laboratory specimens, and has reported the highest percentage of laboratory incidents.

We reviewed the specimen collection process using continuous quality improvement (CQI) methodology. This holistic approach to resolving complex issues brings together staff and leadership, who rely on its selective mechanisms to assess, plan, and implement improvements.⁷

Since no policy was available detailing the steps in the specimen collection process, we had the team and various stakeholders gather different types of information to develop an initial understanding of how specimen collection is conducted.⁸ This was followed by process mapping to provide a full picture of the actual specimen collection process used at Baycrest. Process maps, also referred to as flowcharts, are powerful tools in defining, describing, and communicating clinical, administrative, and operational processes.⁹

To help us create the process map, coauthor Robert Fraser, who is trained in quality improvement theory, interviewed four nurses, a porter, and the director of laboratory services. The scope of the analysis focused only on specimen collection, so physicians—who are not actively involved in this process—were excluded from the process map evaluation. Taking a systematic approach, Mr. Fraser asked each subject a series of questions about procedures for transferring the specimens from one location or individual to another and the documentation process used during handoffs, such as when samples are picked up. He also asked about variations in how the collection process is performed and sought to clarify discrepancies in descriptions of the process between personnel. In addition to informing development of the process map, answers were clustered into categories and incorporated into a fishbone diagram to help identify patterns in the specimen collection process (Figure 1 [click thumbnail for full view]).⁸

The final part of the assessment involved analyzing data from electronic incident reports¹⁰ filed between April 2009 and March 2010 to determine the origin and nature of specimen collection errors at Baycrest. These rates were compared with those in the published literature.

Summary of Results

Based on this multistep evaluation, we identified several breakdowns in the specimen collection process. First, during the review, it became clear that handoffs of the sample between the individual roles created opportunities for errors. Second, the evaluation revealed Baycrest’s lack of an organizational policy governing specimen collection. Third, a retrospective data analysis identified errors in physician ordering and a marked increase in errors for specimens delivered to the off-site laboratory.