Documentation of Quality Control and Operator Training at Point-of-Care Testing: A College of American Pathologists Q-Probes Study of 106 Institutions

Abstract

Context.-Operator training, quality control, and proper follow-up for out-of-range quality control (QC) events are crucial steps that must be adequately performed and documented to ensure excellent patient care and regulatory compliance.Objective.-To examine point-of-care testing (POCT) personnel training and QC documentation/compliance.Design.-Participants in a POCT documentation study of the College of American Pathologists Q-Probes program collected data retrospectively for glucose and urine dipstick testing regarding test operators, operator competency assessment, and QC documentation. Documentation was assessed for participant adherence to 4 quality indicators: (1) whether test operator training was up to date, (2) whether the test operator names were noted in the test records, (3) whether QC was performed, and (4) whether out-of-range QC events were followed up. Data were analyzed for associations with institutional demographic and practice variables.Results P oint-of-care testing (POCT) is defined as testing that occurs at or near the site of patient care, with the goal of providing rapid information and improving patient outcomes.1,2 Point-of-care testing is growing several times faster than is central laboratory testing in the United States 2,3 and has become ubiquitous in both hospitals and outpatient care settings. Because POCT is typically performed by nonlaboratory personnel, many health care workers are now performing a wide variety of tests. Quality patient care is dependent on accurate laboratory results, necessitating assurance that POCT is well documented, equipment is well maintained, and testing operators are qualified to perform the tests. It is also important to ensure that quality control (QC) procedures are run consistently and that documentation of QC performance and follow-up of out-of-range QC results are recorded to ensure accurate results and high-quality patient care. Additionally, POCT is subject to regulatory requirements that, if ignored, can lead to loss of accreditation. 4 The College of American Pathologists (CAP) POCT accreditation checklist requires that (1) POCT instruments have defined QC ranges, (2) QC results are evaluated daily, (3) corrective action is taken when results exceed defined tolerance limits, and (4) QC results are verified before patient results are reported. 5A complete POCT program includes organization, supervision, written procedures, operator training and competency, instrument evaluation, quality control, proficiency testing, and appropriate recording of result and notification, all with the necessary documentation. However, achieving compliance with regulatory guidelines and ensuring the quality of POCT has proved challenging in many institutions. 6 In the authors' experience, performance of traditional QC is a misunderstood and undervalued concept for many nonlaboratory personnel because they are largely unfamiliar

Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa

“…The study has shown lack of documentation, this finding is in agreement with findings by Lewandrowski et al, 2011 and Dyhdalo et al, 2014 which highlighted that regulatory compliance as a great challenge for POC testing [ 36 , 37 ]. The results of our audit show inconsistencies in the duration of IQC analysis for every new test kit lot number, these findings are also supported by Lewandrowski et al, 2011 and Dyhdalo et al, 2014 studies, which highlighted that non-laboratory workers conducting POC testing may not fully understand the importance of quality control and documentation and therefore neglect to comply with regulations for POC diagnostics [ 36 , 37 ]. Our study findings on poor staffing for PHC clinic staff supports findings of a systematic review by Pai et al, 2015, which revealed understaffing as challenge for primary healthcare workers attending to a large number of patients [ 38 ].…”

A Comparison Study Between Point‐of‐Care Testing Systems and Central Laboratory for Determining Blood Glucose in Venous Blood

“…Although the POCT can provide rapid measurement results, the type of specimen, interference factors, environmental conditions, and hematocrit may affect the results . In addition, the POCT system lacks strict quality control and a management system . Furthermore, POCT is operated by non‐professional personnel, such as the patients, clinicians, and nurses.…”

“…With the development of immune technology and molecular biological technology, POCT has been widely used in diagnosis and treatment to test blood glucose (BG), blood gasses, cardiac markers, hemoglobin, beta‐human chorionic gonadotropin (β‐HCG), electrolyte, complete blood count, hematocrit, parathyroid hormone, etc . As it is simple to use and supplies rapid results, it might accelerate clinical decision‐making and improve patients' prognosis .…”

Status Update on Translation of Integrated Primary Dental-Medical Care Delivery for Management of Diabetic Patients

“…Moreover, recent field trials of integrated care delivery models (ICM) implemented in various healthcare settings have been reported with some examples cited in Table 2. These studies have examined feasibility and reliability, quality assurance, 39 acceptability, 40 and challenges associated with POC screening. Deterrents to POC screening to date include cost; reimbursement structures; requirement for dental practices to address Clinical Laboratory Improvement Amendment (CLIA) certification; POC HbA1c sensitivity (estimated at ~65%); 41 variability of glucometer accuracy; 42 and operator competency training/tracking requirement 39 for POC screening.…”