{"doi":"10.1093/jalm/jfae050","title":"Proficiency Testing Customization in Clinical Trials: How the pSMILE Project Ensures High-Quality Proficiency Testing Coverage for International Laboratories","abstract":"The Johns Hopkins University Patient Safety Monitoring in International Laboratories (pSMILE) project is a National Institutes of Health contract resource designed to evaluate and develop the capability of laboratories to participate in National Institute of Allergy and Infectious Diseases supported prevention, vaccine, and therapeutic clinical studies conducted outside the United States (1, 2). One of the core functions of this project is to facilitate appropriate proficiency testing (PT), also known as external quality assessment (EQA), coverage for every specified analyte according to sponsor requirements. As a key quality assurance contractor, pSMILE is tasked to identify PT providers and assess the suitability of their available PT panels. Examples of criteria to take into consideration when evaluating suitability for an analyte include but are not limited to (3–5): instrument/method type available peer group shipping logistics frequency of survey events type and number of samples per event clinical relevance of samples evaluation scheme. When standard panels are not available, our team sources alternatives by working with suppliers and clinical trials network partners or developing our own (virtual) panels. Once panels have been selected, pSMILE facilitates the ordering and carefully monitors shipment to ensure that samples arrive in good condition. After testing by the laboratories and evaluation by the PT providers, pSMILE reviews each laboratory’s survey, grades and monitors their performance, and provides written reviews and summaries on a monthly basis. When performance failures or trends are identified, we assist the laboratories in troubleshooting by providing guidance and training in areas needing improvement. Additionally, a web-based investigation report procedure is used to systematically review each step in the testing process and lead laboratories through a detailed investigation to find the root cause of the error. Ensuring appropriate PT coverage commonly consists of reviewing the laboratory test menu and selecting a PT product that covers each analyte in each discipline. Laboratories may select their PT provider based on their accreditation status, as some accrediting bodies require a specific PT provider. In the United States, the Centers for Medicare & Medicaid Services website provides a list of Clinical Laboratory Improvement Amendments Approved Proficiency Testing Programs. After almost 2 decades of facilitating, reviewing, and evaluating PT, pSMILE has discovered that one size does not fit all. Additional challenges are met by international laboratories that may be using non-FDA-approved methods. Although the US-based sponsor prefers the use of FDA-approved methods, there are many cases where these methods are not locally available to international laboratories. Additionally, research studies may use new and developing technologies or methods that have not been approved or cleared by the FDA. In such cases, the use of US-based PT providers becomes problematic since many do not provide panels or do not have a sufficient peer group for non-FDA-approved methods. It is incumbent to evaluate each PT panel before purchase and again after each round of PT to ensure that the panel is appropriate for the analyte, the test methodology, the instrument, the assay range, and the clinical use of the analyte. In Table 1, we present a selection of case studies that demonstrate the need for PT customization and pSMILE’s approach. To summarize, PT ordering was tailored to specific laboratory needs in the fields of mycobacteriology, urine pregnancy, HIV serology, and microscopy by identifying PT providers with surveys containing an increased number of challenges, providing advantageous shipping, testing new methodologies, employing materials covering pre- and postanalytical testing phases, and addressing critical clinical cutoffs as well as by developing our own custom virtual survey. Examples of proficiency testing c","journal":"The Journal of Applied Laboratory Medicine","year":2024,"id":483717,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9496,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1325204,"name":"Kristin J Murphy","orcid":null,"position":1,"is_corresponding":false},{"id":1155447,"name":"Mandana Godard","orcid":null,"position":2,"is_corresponding":false},{"id":500607,"name":"Matthew Schwartz","orcid":"0000-0001-9563-5727","position":3,"is_corresponding":false},{"id":60419,"name":"Lori J. Sokoll","orcid":"0000-0001-5130-0060","position":4,"is_corresponding":false},{"id":1155055,"name":"Anne Leach","orcid":"0000-0001-6631-1889","position":0,"is_corresponding":true}],"reference_count":4,"raw_metadata":null,"created_at":"2026-07-19T02:07:33.718973Z","pmid":"39225459","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}