Pathology Residents as Testing Personnel in the Hematology Laboratory

Context.— Clinical laboratories and the training of pathology residents are tightly regulated environments. Compliance with regulatory requirements must be addressed when developing entrustable professional activities (EPAs) for pathology residents. Objective.— To describe the development of EPAs for peripheral blood and body fluid review in compliance with Clinical Laboratory Improvement Amendments and College of American Pathologists personnel and testing requirements. To examine the impact of EPA implementation on the workflow in a busy hematology laboratory. Design.— A training program was designed to prepare pathology residents to function as independent testing personnel in compliance with Clinical Laboratory Improvement Amendments. After a series of lectures, hands-on microscopy sessions, self-assessment quizzes, and achievement of a passing score on a training assessment exam, residents were deemed competent to release certain results independently. The volume and the turnaround time of hematology tests were compared before and after residents were integrated into the laboratory workflow. Faculty and residents were surveyed to assess satisfaction with the training. Results.— Empowering residents to independently release noncritical results from peripheral blood and body fluid reviews had no adverse impact on test turnaround time. The resident contribution to workflow resulted in a corresponding decrease in the number of cases that required attending pathologist review. Faculty and residents viewed the EPAs as beneficial to service and education. Conclusions.— The implementation of the EPAs had a beneficial effect on the laboratory, the trainees, and faculty. Our experience may be helpful to other training programs as EPAs become more widely implemented in residency training.

Considerations from the College of American Pathologists for implementation of an assay for SARS-CoV-2 testing after a change in regulatory status

The U.S. Food & Drug Administration FDA regulates the marketing of manufacturers’ in vitro diagnostic tests IVDs including assays for the detection of SARS-CoV-2. The U.S. government’s Clinical Laboratory Improvement Amendments CLIA of 1988 regulate the studies that a clinical diagnostic laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has authorized the marketing of SARS-CoV-2 IVDs exclusively through the Emergency Use Authorization EUA pathway. The regulatory landscape continues to evolve, and IVDs will eventually be required to pass through conventional non-EUA FDA review pathways once the emergency declaration is terminated in order to continue to be marketed as an IVD in the U.S. When FDA regulatory status of an IVD changes or is anticipated to change, the laboratory should review manufacturer information and previously performed internal verification studies to determine what, if any, additional studies are needed before implementing the non-EUA version of the IVD in accordance with CLIA regulations. Herein, the College of American Pathologists’ Microbiology Committee provides guidance for how to approach regulatory considerations when an IVD is converted from EUA to non-EUA status.

Continuous Noninvasive Blood Gas Estimation in Critically Ill Pediatric Patients With Respiratory Failure

BackgroundPatients supported by mechanical ventilation require frequent invasive blood gas samples to monitor and adjust the level of support. We developed a transparent and novel blood gas estimation model to provide continuous monitoring of blood pH and arterial CO2 in between gaps of blood draws, using only readily available noninvasive data sources in ventilated patients. MethodsThe model was trained on a derivation dataset (1,883 patients, 12,344 samples) from a tertiary pediatric intensive care center, and tested on a validation dataset (286 patients, 4,030 samples) from the same center obtained at a later time. The model uses pairwise non-linear interactions between predictors and provides point-estimates of blood gas pH and arterial CO2 along with a range of prediction uncertainty.ResultsThe model predicted within Clinical Laboratory Improvement Amendments of 1988 (CLIA) acceptable blood gas machine equivalent in 74% of pH samples and 80% of PCO2 samples. Prediction uncertainty from the model improved estimation accuracy by identifying and abstaining on a minority of high-uncertainty samples.ConclusionsThe proposed model estimates blood gas pH and CO2 accurately in a large percentage of samples. The model’s abstention recommendation coupled with ranked display of top predictors for each estimation lends itself to real-time monitoring of between gaps of blood draws, and the model may be used to help users determine when a new blood draw is required and delay blood draws when not needed.

The Community Pharmacy Technician’s Role in the Changing Pharmacy Practice Space

Purpose: The practice of pharmacy and role of pharmacists has evolved over the decades but markedly since the introduction of the Affordable Care Act (ACA) in 2010. The ACA allowed patients to have increased access to community pharmacy services, such as medication therapy management, leading to an increase in the clinical services provided by pharmacists. This expansion of pharmacist’s roles has led to pharmacists to feel an increase in workload which negatively impacts the time spent with patients. One way for this shift to occur without continuing to increase the pharmacist’s workload is by using technicians as pharmacist extenders to take on more technical tasks. Summary: The role of pharmacy technicians has been slow to expand from fear of public safety due to the lack of required education and training. Today, state requirements to practice as a pharmacy technician have become stricter with state requiring licensing, registration or certification. This increase in requirements as led to the expansion of pharmacy technician duties. Studies show that pharmacy technicians are able to perform technician accuracy checking, provide immunization and perform Clinical Laboratory Improvement Amendments (CLIA)-waived screenings. In addition to these duties, pharmacy technicians are being utilized in more novel ways such as collecting medication information in primary care and telepharmacy settings. Conclusion: In order for pharmacy to continue to grow as a profession, pharmacists need to use pharmacy technicians as extenders. As pharmacy technicians begin to take on more of the technical duties, pharmacists are able to increase the time spent with patients. Article Type: Commentary

Implementation of Laboratory Review of Test Builds Within the Electronic Health Record Reduces Errors

Context.— As electronic health records (EHRs) become more ubiquitous, physicians have come to expect that laboratory data from a variety of sources will be incorporated into the EHR in a structured format. The Clinical Laboratory Improvement Amendments have standards for data transmission traditionally met by pathologist review of their own hospital laboratory information system transmissions. However, with third-party laboratory data now being sent through external (nonhospital laboratory) interfaces, ownership of this review is less clear. Lack of an expert laboratory review process prior to changes being implemented can result in mapping and interfacing errors that could lead to misinterpretation and diagnostic errors. Objective.— To determine the impact of retrospective and prospective laboratorian-assisted review on the volume of interface errors and new builds. Design.— A seminal event led to a restructuring of the process for review of EHR laboratory builds, using laboratory expertise. Results.— A review of 26 500 test result fields found 61 of 4282 (1.4%) unique codes that could have led to misinterpretation. These were corrected and a process for proactive review and maintenance by laboratory experts was implemented. This resulted in monthly decreases in outbound error message from 4270 to 1820 (57.4%), in new test builds from 586 to 274 (53.2%), and in new result builds from 1116 to 552 (50.5%). Conclusions.— Regular review and maintenance of external laboratory test builds in EHRs by a laboratory review team reduces interface error messages and reduces the number of new builds required for results to file into the EHR.

Analysis of a Point-of-Care HbA1c Assay: Is It Time for an HbA1c Error Grid?

In an article in Journal of Diabetes Science and Technology, Arnold et al have presented a thorough study of imprecision components for a point-of-care hemoglobin A1c (HbA1c) assay. An interesting and innovative approach is the combination of data from different studies to arrive at a total error estimate. But total error has the oxymoron feature of estimating performance for most (95%) but not all of the results. An HbA1c error grid would provide the severity for results that exceed the 6% requirement. Since this device is intended for Clinical Laboratory Improvement Amendments waived labs and allows for finger-stick samples, monitoring the Food and Drug Administration adverse event database (MAUDE, Manufacturer and User Facility Device Experience) is recommended.

Validation of immunohistochemical tests performed on cytology cell block material: Practical application of the College of American Pathologists’ guidelines

The advent of fiberoptic endoscopy with biopsy has revolutionized procurement of specimens from deep sites. This has translated into more cytologic specimens whereby the material is limited and best handled by cytology laboratory staff. While the diagnosis of the pathologic process is of utmost importance, there is increasing expectation that the diagnosis be specific and accurate as not to require additional biopsy for initiation of treatment. This expectation has driven demand in immunohistochemical (IHC) and molecular studies conducted specifically on material processed as cytology specimens. The Clinical Laboratory Improvement Amendments of 1988 requires laboratories in the United States of America to verify the performance of patient tests. Due to varying laboratory practices with respect to validation of IHC assays, the College of American Pathologists introduced guidelines for analytic validation of IHC tests. These guidelines address how to perform validation by recommending the number of cases in the validation set, comparator concordance, and when to revalidate. The main thrust of the guidelines is based on formalin-fixed paraffin-embedded tissue with only one expert consensus opinion referring to validation of IHC tests on cytology specimens which delegates to the medical director, the determination of number of positive and negative cases to be tested. This article will outline how an academic center approaches validation of IHC studies performed on cytology cell block specimens using the College of American Pathologists guidelines. A stepwise approach from selection of antibodies to validate followed by building the validation panel and evaluating the stain results for concordance against the gold standard of histology tissue specimen will be described. A rationale for dealing with discordant results and future innovations will conclude the report.