Patient Safety & Post-analytical Error

Key points

Post-analytical error

Traditionally, the laboratory community has viewed post-analytical errors as errors that occur after the analysis is complete but within the confines of the 4 walls of the laboratory itself and under the control of the laboratory. Activities that fall into the post-analytical phase of the total testing process (TTP) include result reporting, critical value notification, manual transcription of results and subsequent data entry, and analysis of turnaround times (TAT).1, 2, 3, 4

The post-analytic

Post-post-analytical error

In this new era of health care with the widespread adoption of electronic health records and the focus on the continuum of patient care and quality outcomes, laboratory professionals are being asked to think outside the 4 walls of the laboratory and consider errors that involve the interface between the laboratory result and the clinician. A new term coined for this part of the resulting process is post-post-analytical.⁶ The post-post-analytical process can be thought of as closing the

Requirements for monitoring the post-analytical process

The Clinical Laboratory Improvement Amendments (CLIA) dictate that laboratories must monitor and evaluate the overall quality of post-analytic systems and correct identified problems.¹⁵ The standards in the “Post-analytical Systems” section are brief. The laboratory must assure that results are accurately and reliably sent to the final report destination. The standards address the content of the test result report, referred testing, as well as the changed result and critical result.

Detection and measurement of post-analytical errors

It is difficult to measure the prevalence of post-analytical errors of any type, which also makes it difficult to directly link laboratory errors and patient safety. The TTP is complex and involves a variety of different professions and settings.¹ With so many variables, it becomes hard to pinpoint a single reason or explanation for why a medical error was made. There is no standardized definition or denominators for laboratory errors,17, 18 which makes comparison among studies virtually

The post-analytical process

One of the most important challenges for laboratory professionals will be to assist in the management of patient test results. This assistance requires an expansion of the role of the laboratory. It is no longer enough to send our test results across an interface to an electronic record or call a critical result and assume our work is done. There is an often-quoted statistic that 70% of medical decisions are based on diagnostic test results, including laboratory or imaging.²³ The breakdown in

Communication of test results

The first type of post-analytical process failure is that the laboratory does not properly communicate the result. This issue might be an accuracy or timeliness issue. Laboratories should review indicators and existing quality monitors to address these potential failures. Failures in this step include the following:Failures in communication of test results

1. •

   Tests performed but not reported

2. •

   Patient identification error in results reporting

3. •

   Delay in reporting

4. •

   Incorrect calculation

5. •

   Critical result notification failed or delayed

6. •

   Results not sent

Test results communicated but not received

In the first article of its kind, Yackel and Embi³³ examined unintended errors in the management of test results in the electronic health record, focusing on the reasons why results communicated from the laboratory were never received. They identified 4 distinct categories of errors resulting in a test result sent but not received by the correct caregiver.Failure modes in electronic receipt of results

1. •

   Logic errors in interface and results routing

2. •

   Provider record issues

3. •

   Electronic health record (EHR) system settings

4. •

   System maintenance–related

Results not reviewed

Laboratories are not directly responsible for ensuring that all reported test results have been reviewed. In May of 2011, a kidney transplant program in the United States was voluntarily shut down following a failure to follow up on a laboratory test result. The results of a positive hepatitis C test sat in a living kidney donor's medical record for more than 2 months before her kidney was transplanted into a man who did not have the virus, according to the findings of a federal investigation

Results not interpreted correctly

Patient safety is getting the right laboratory result to the right person at the right time in a usable/interpretable format. The electronic health record enables large quantities of data to be sent from the laboratory to a variety of environments and displays. The following are just some of the areas of the EHR where laboratory results may be displayed:

• •

  Chart equivalent: report of an individual test or panel

• •

  Cumulative/chronologic view, such as the EHR patient summary record

• •

  Discharge summaries

• •

High-risk gaps in appropriate follow-up of test results

Failure to follow up on test results is not a new problem and is an underlying factor in many medical malpractice lawsuits. The frequency of the failure to follow up on laboratory test results in an ambulatory setting varies from 2% to 50% among primary care providers.³⁵

A very high-risk safety gap for patients occurs at the discharge of patients from the hospital. Two types of errors occur: the failure to review and follow up on results of tests that were pending at the time of the discharge

Tools to address post-analytical errors in the laboratory

Many tools exist to assist laboratories in identifying and correcting post-analytical errors. The Clinical Laboratory Standards Institute’s document on risk assessment (EP23A) is the newest tool available, even though it is based on concepts that have been actively and successfully used in manufacturing for decades but are somewhat new concepts to the laboratory. This document instructs laboratories in identifying both human and system factors that can fail in the total testing process, both

Summary

Health care in general is at a pivotal juncture in this country. With mandates for use of information technology, financial penalties imposed on hospitals when patients bounce back into the system within 30 days, and the potential of a national health care system (just to name a few big changes), health care professionals and facilities are scrambling to reduce costs, improve quality, and stay in business.

The laboratory is also at a pivotal point. For years we have made great progress in