Ensuring the Quality of Point-of-care Testing in a Large and Decentralized Ambulatory Care Setting

Valerie A. Arboleda, MD, PhD; Omai B. Garner, PhD; Valerie A. Arboleda, MD, PhD; Omai B. Garner, PhD

Disclosures

Am J Clin Pathol. 2017;148(4):336-344. 

In This Article

Abstract and Introduction

Abstract

Objectives. In this project, we assessed the breadth, quality, trends, and outcomes of point-of-care (POC) testing and regulatory compliance in 200 University of California, Los Angeles (UCLA) Health system outpatient clinics.

Methods. We retrospectively extracted clinic POC test orders, results, and e-prescription data from the UCLA electronic health record over a 1-year period.

Results. Over 100,000 total tests were performed, encompassing 10 POC tests. Initially, 40% of clinics did not have complete licensure, but after implementation of the POC team, this metric improved to 100% licensure within 6 months. Most clinics used two or fewer POC tests, resulted fewer than 200 tests per year, and performed little to no external quality control measures. Our data analytics approach showed that peak POC testing occurred in January 2015, driven by influenza and urinalysis testing, and that both the testing and resulting clinical decision making do not routinely follow society guidelines.

Conclusions. This decentralization of laboratory testing presents challenges to ensuring quality POC testing. Optimization and analysis of informatics data allow for the identification of POC test utilization trends, areas of improvement for clinical workflows, and increased education on national guidelines.

Introduction

Point-of-care (POC) testing is defined as a pathology or laboratory test that is performed at the site of clinical interaction, on or on behalf of the treating physician, at the time of patient consultation, therefore allowing the physician to make an immediate decision regarding treatment.[1] Because tests are performed in a nonlaboratory setting, the tests are designed to be as simple as possible. POC tests must undergo US Food and Drug Administration (FDA) waiver approval to be used in Clinical Laboratory Improvement Amendments (CLIA)–waived settings, such as an outpatient clinic. Alternatively, moderately complex POC testing can be performed in certain POC settings by licensed personnel. As technology has rapidly advanced, the number of POC tests performed throughout the University of California, Los Angeles (UCLA) Health system has increased, necessitating a structured approach to ensure quality. Globally, POC testing was estimated to be worth $15 billion in 2011 and represents more than a quarter of worldwide laboratory testing.[2,3]

Early diagnosis and monitoring is a major benefit of POC testing.[4] POC tests for infectious disease (eg, gonorrhea, chlamydia, group A strep [GAS], influenza) provide early diagnosis and treatment in selected groups.[5–7] A retrospective study in pediatric patients found that children with early diagnosis of influenza in the emergency department had shorter hospital stays, an increased chance of effective antiviral prescription, and decreased overall testing.[8] In addition, POC tests have improved the ability of patients and physicians to directly monitor chronic conditions such as diabetes[9,10] and improved clinic workflow by decreasing the number of follow-up calls for laboratory results.[11] With the increasing importance of patient satisfaction metrics, the availability of POC testing has improved patient satisfaction.[11,12]

The major difference between POC testing sites and CLIA-certified clinical laboratories is the rigor of the quality control measures and level of federal regulation that ensures the highest quality of clinical laboratory testing. POC tests are only valid within the manufacturers' protocols and reference ranges, outlined in the package insert. Deviation from protocols and regent expiration can result in errors that put patients at risk. Audits of POC sites with CLIA waivers identified serious issues with quality of testing[13] that include inadequate training, inability to locate procedure protocols, and failure to routinely follow manufacturers' instructions. In addition, physicians and mid-level providers have insufficient knowledge about the limits of POC tests, which can lead to poor patient care.

The rapid increase in POC testing locations and the expansion of the technology make it difficult to ensure quality in POC testing. Many countries and hospital systems, including UCLA, have attempted to provide oversight of POC tests using faculty from affiliated pathology departments,[14,15] who are experts in medicine and quality control for laboratory tests. The role of the UCLA Department of Pathology and Laboratory Medicine POC management team is to provide guidance for test implementation and performance. This article outlines the approach and goals of an interdisciplinary, pathology-led ambulatory outpatient program for POC testing. Through the use of data collected from the electronic health record (EHR), we assess the quantity, quality, and informatics needs of outpatient clinics using POC testing.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....