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* Context.--Therapeutic drug monitoring has traditionally been widely used for first-generation antiepileptic drugs (AEDs) such as carbamazepine and phenytoin. The last 2 decades have seen the introduction of second- and third-generation AEDs (eg, lamotrigine, levetiracetam, and topiramate) into clinical practice. Objective.--To use data from the College of American Pathologists Therapeutic Drug Monitoring, Extended Proficiency Testing Survey to determine the performance of assays used for therapeutic drug monitoring of newer AEDs, including comparison of enzyme immunoassay and chromatographic techniques. Design.--Six years of proficiency testing surveys were reviewed (2013-2018). Results.--Steady growth was seen in participant volumes for newer AEDs. The analytical performance of automated enzyme immunoassays for lamotrigine, levetiracetam, and topiramate was similar to that of chromatographic methods, consistent with published literature using patient samples for comparisons. The majority of participating laboratories now use enzyme immunoassays to measure levetiracetam. Conclusions.--Survey results reflect steadily growing interest in therapeutic drug monitoring of newer AEDs. The increasing availability of robust immunoassays for new AEDs should facilitate their clinical utility, especially for clinical laboratories that do not perform chromatographic assays for therapeutic drug monitoring., A variety of structurally diverse medications are used for the treatment of seizures and epilepsy (antiepileptic drugs [AEDs]). (1-3) The first-generation or classic AEDs encompass drugs with decades of clinical [...]

* Context.--Urine drug testing is frequently ordered by health care providers. Immunoassays are widely used for drug testing, yet have potential limitations, including variable cross-reactivity. The last decade has seen worsening of a prescription drug abuse epidemic. Objective.--To use data from a College of American Pathologists proficiency testing survey, Urine Drug Testing, Screening, to determine and summarize the characteristics, performance, and limitations of immunoassays. Design.--Seven years of proficiency surveys were reviewed (2011-2017). Results.--Rapid growth was seen in participant volumes for specific immunoassays for synthetic opioids (eg, buprenorphine, fentanyl, oxycodone) and 3,4-methylene-dioxymethamphetamine ('ecstasy'). Participant volumes remained high for immunoassays targeting less commonly abused drugs such as barbiturates and phencyclidine. For opiate immunoassays, the number of laboratories using a 2000 ng/mL positive cutoff remained stable, and an increasing number adopted a 100 ng/mL cutoff. Opiate and amphetamine immunoassays showed high variability in cross-reactivity for drugs other than the assay calibrator. Assays targeting a single drug or metabolite generally performed well on drug challenges. Conclusions.--Survey results indicate strong clinical interest in urine drug testing and some adoption of new assays. However, urine drug testing availability does not parallel prevailing patterns of drug prescribing and abuse patterns. In particular, specific immunoassays for synthetic opioids and a lower positive cutoff for opiate immunoassays may be underused, whereas immunoassays for barbiturates, methadone, propoxyphene, and phencyclidine may be overused. Laboratories are encouraged to review their test menu, cutoffs, and assay performance and adjust their test offerings based on clinical needs and technical capabilities. (Arch Pathol Lab Med. 2020;144:177-184; doi: 10.5858/ arpa.2018-0562-CP), Substance abuse continues to be a significant problem in the United States and other countries. (1,2) In the last 2 decades, nonmedical use of opioids and other prescription medications has [...]

Context.--A recent government regulation incentivizes implementation of an electronic health record (EHR) with computerized order entry and structured results display. Many institutions have also chosen to interface their EHR with their laboratory information system (LIS). Objective.--To determine the impact of an interfaced EHR-LIS on laboratory processes. Design.--We analyzed several different processes before and after implementation of an interfaced EHR-LIS: the turnaround time, the number of stat specimens received, venipunctures per patient per day, preanalytic errors in phlebotomy, the number of add-on tests using a new electronic process, and the number of wrong test codes ordered. Data were gathered through the LIS and/or EHR. Results.--The turnaround time for potassium and hematocrit decreased significantly (P = .047 and P = .004, respectively). The number of stat orders also decreased significantly, from 40% to 7% for potassium and hematocrit, respectively (P < .001 for both). Even though the average number of inpatient venipunctures per day increased from 1.38 to 1.62 (P < .001), the average number of preanalytic errors per month decreased from 2.24 to 0.16 per 1000 specimens (P < .001). Overall there was a 16% increase in add-on tests. The number of wrong test codes ordered was high and it was challenging for providers to correctly order some common tests. Conclusions.--An interfaced EHR-LIS significantly improved within-laboratory turnaround time and decreased stat requests and preanalytic phlebotomy errors. Despite increasing the number of add-on requests, an electronic add-on process increased efficiency and improved provider satisfaction. Laboratories implementing an interfaced EHRLIS should be cautious of its effects on test ordering and patient venipunctures per day. (Arch Pathol Lab Med. 2017;141:410-417; doi: 10.5858/arpa.2016-0146-0A), To improve the quality of patient care and reduce errors, electronic health records (EHRs) have been increasingly adopted throughout the nation. (1-3) The Medicare and Medicaid Electronic Health Care Record [...]

Context.--Short patient wait times are critical for patient satisfaction with outpatient phlebotomy services. Although increasing phlebotomy staffing is a direct way to improve wait times, it may not be feasible or appropriate in many settings, particularly in the context of current economic pressures in health care. Objective.--To effect sustainable reductions in patient wait times, we created a simple, data-driven tool to systematically optimize staffing across our 14 phlebotomy sites with varying patient populations, scope of service, capacity, and process workflows. Design.--We used staffing levels and patient venipuncture volumes to derive the estimated capacity, a parameter that helps predict the number of patients a location can accommodate per unit of time. We then used this parameter to determine whether a particular phlebotomy site was overstaffed, adequately staffed, or understaffed. Patient wait-time and satisfaction data were collected to assess the efficacy and accuracy of the staffing tool after implementing the staffing changes. Results.--In this article, we present the applications of our approach in 1 overstaffed and 2 understaffed phlebotomy sites. After staffing changes at previously understaffed sites, the percentage of patients waiting less than 10 minutes ranged from 88% to 100%. At our previously overstaffed site, we maintained our goal of 90% of patients waiting less than 10 minutes despite staffing reductions. All staffing changes were made using existing resources. Conclusions.--Used in conjunction with patient waittime and satisfaction data, our outpatient phlebotomy staffing tool is an accurate and flexible way to assess capacity and to improve patient wait times. (Arch Pathol Lab Med. 2014; 138:929-935; doi: 10.5858/arpa.2013-0450-0A), Several studies have shown that patient wait times have a significant influence on patient satisfaction in the outpatient phlebotomy setting. (1-3) A College of American Pathologists Q-Probes study involving 29 [...]

* Context.--The timely availability of inpatient test results is a key to physician satisfaction with the clinical laboratory, and in an institution with a phlebotomy service may depend on the timeliness of blood collections. In response to safety reports filed for delayed phlebotomy collections, we applied Lean principles to the inpatient phlebotomy service at our institution. Our goal was to improve service without using additional resources by optimizing our staffing model. Objective.--To evaluate the effect of a new phlebotomy staffing model on the timeliness of inpatient phlebotomy collections. Design.--We compared the median time of morning blood collections and average number of safety reports filed for delayed phlebotomy collections during a 6-month preimplementation period and 5-month postimplementation period. Results.--The median time of morning collections was 17 minutes earlier after implementation (7:42 am preimplementation; interquartile range, 6:27-8:48 am; versus 7:25 am postimplementation; interquartile range, 6:20-8:26 am). The frequency of safety reports filed for delayed collections decreased 80% from 10.6 per 30 days to 2.2 per 30 days. Conclusion.--Reallocating staff to match the pattern of demand for phlebotomy collections throughout the day represents a strategy for improving the performance of an inpatient phlebotomy service. (Arch Pathol Lab Med. 2011;135:1576-1580; doi: 10.5858/arpa.2011-0061-OA), Timeliness of inpatient tests is central to physician satisfaction with laboratory services. (1-4) In the 2009 Q-Probes study, 27% of physicians listed either routine test turnaround time or inpatient stat [...]

Context.--To assist with patient diagnosis and management, physicians from pain services, drug treatment programs, and the emergency department frequently request that urine be tested for drugs of abuse. However, urine immunoassays for drugs of abuse have limitations. Objectives.--To use data from the College of American Pathologists Proficiency Testing Surveys to determine and summarize the characteristics, performance, and limitations of urine immunoassays for drugs of abuse. Design.--Six years of urine drug testing proficiency surveys were reviewed. Results.--Lysergic acid diethylamide and methaqualone are infrequently prescribed or abused and, therefore, testing may be unnecessary. However, implementation of more specific testing for methylenedioxymethamphetamine and oxycodone may be warranted. Each drug of abuse immunoassay exhibits a different cross-reactivity profile. Depending on the cross-reactivity profile, patients with clinically insignificant concentrations of drugs may have false-positive results, and patients with clinically significant concentrations of drugs may have false-negative results. Conclusions.--Laboratory directors should be aware of the characteristics of their laboratories' assays and should communicate these characteristics to physicians so that qualitative results can be interpreted more accurately. Furthermore, manufacturer's claims should be interpreted with caution and should be verified in each organization's patient population, if possible. (Arch Pathol Lab Med. 2010;134:735-739), Substance abuse is a significant problem in the United States. (1) More than 1.7 million emergency department visits in 2006 were associated with drug misuse or abuse, of which, 55% [...]

* Context.--Laboratory automation proposes to improve the quality and efficiency of laboratory operations, and may provide a solution to the quality demands and staff shortages faced by today&apos;s clinical laboratories. Several vendors offer automation systems in the United States, with both subtle and obvious differences. Arriving at a decision to automate, and the ensuing evaluation of available products, can be time-consuming and challenging. Although considerable discussion concerning the decision to automate has been published, relatively little attention has been paid to the process of evaluating and selecting automation systems. Objective.--To outline a process for evaluating and selecting automation systems as a reference for laboratories contemplating laboratory automation. Design.--Our Clinical Chemistry Laboratory staff recently evaluated all major laboratory automation systems in the United States, with their respective chemistry and immunochemistry analyzers. Our experience is described and organized according to the selection process, the important considerations in clinical chemistry automation, decisions and implementation, and we give conclusions pertaining to this experience. Results.--Including the formation of a committee, workflow analysis, submitting a request for proposal, site visits, and making a final decision, the process of selecting chemistry automation took approximately 14 months. We outline important considerations in automation design, preanalytical processing, analyzer selection, postanalytical storage, and data management. Conclusions.--Selecting clinical chemistry laboratory automation is a complex, time-consuming process. Laboratories considering laboratory automation may benefit from the concise overview and narrative and tabular suggestions provided., High standards of quality and customer service are required from clinical laboratories. Fulfilling these requirements, however, is becoming increasingly problematic because of decreases in staffing and efforts to control cost. [...]