{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T07:09:16Z","timestamp":1775027356783,"version":"3.50.1"},"reference-count":31,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T00:00:00Z","timestamp":1761782400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T00:00:00Z","timestamp":1761782400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cytometry Part B Clinical"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Clinical flow cytometry laboratories are facing rising test volumes, greater assay complexity, and increasing requirements for quality control and assay validation. In response, the International Clinical Cytometry Society (ICCS) conducted a workload survey in early 2023 to gather updated information on assay volumes, complexity, staffing, and technology. Data analysis focused on identifying correlations between length of time to introduce new assays and other factors as a means to gain insight about laboratories that seem to be either adapting or struggling. Flow cytometry assays were categorized into 3 levels of technical\/interpretative complexity: high (e.g., measurable\/minimal residual disease (MRD assays)), moderate (e.g., leukemia\/lymphoma assays (Assays\n                    <jats:sub>L&amp;L<\/jats:sub>\n                    ), excluding MRD assays), and low (e.g., CD4 count). Annual assays per staff member were calculated according to staff involved in case sign\u2010out (Staff\n                    <jats:sub>Signout<\/jats:sub>\n                    ) or other laboratory operations (Staff\n                    <jats:sub>LabOps<\/jats:sub>\n                    ). Respondents were from 101 laboratories in the United States (69.3%), Canada (4.0%), and other countries (26.7%). Low, moderate, and high technical\/interpretative complexity assays were performed in 85.1%, 97.0%, and 47.5% of all laboratories, respectively. Median annual total assays (Assays\n                    <jats:sub>Total<\/jats:sub>\n                    ) per laboratory were 3515 and, based on complexity, were 1518.5 (low), 1808.8 (moderate), and 350 (high). Among all laboratories, the median time (interquartile range) to introduce new Assays\n                    <jats:sub>L&amp;L<\/jats:sub>\n                    was 6 mos. (4\u201312 mos.), to introduce MRD assays was 11 mos. (5\u201312 mos.), and to validate\/go\u2010live with new cytometers was 8 mos. (4\u201312 mos.); these times positively correlated with each other. This study confirmed significantly increased workload since the prior ICCS 2013 workload survey with a concurrent decrease in Staff\n                    <jats:sub>LabOps<\/jats:sub>\n                    . Faster introduction of new assays correlated with other successes, including quicker validation of and going live with new cytometers. Among all laboratories, those that performed myeloid MRD assays versus those that did not were also found to be faster to introduce new assays. The need for sufficient staffing has been emphasized because laboratories with both higher annual volumes of myeloma MRD assays and higher ratios of Assays\n                    <jats:sub>Total<\/jats:sub>\n                    per Staff\n                    <jats:sub>LabOps<\/jats:sub>\n                    were slower to introduce new assays. \u201cLack of staff and\/or time dedicated or protected for assay development\u201d and, more generally, \u201cstaff number\u201d were the most commonly identified major barriers for new assay development, with the former specifically linked to slower introduction of new assays among all laboratories.\n                  <\/jats:p>","DOI":"10.1002\/cyto.b.22259","type":"journal-article","created":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T12:32:06Z","timestamp":1761827526000},"page":"102-117","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["International Clinical Cytometry Society 2023 workload survey of clinical flow cytometry laboratories"],"prefix":"10.1002","volume":"110","author":[{"given":"D.","family":"Werner","sequence":"first","affiliation":[{"name":"Department of Pathology Moffitt Cancer Center  Tampa Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. A.","family":"Linden","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology University of Minnesota Medical School  Minneapolis Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L. E.","family":"Turner","sequence":"additional","affiliation":[{"name":"Division of Biostatistics and Health Data Science University of Minnesota School of Public Health  Minneapolis Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F.","family":"Kreisel","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology Saint Louis University  Saint Louis Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0707-1886","authenticated-orcid":false,"given":"A.","family":"Al\u2010Attar","sequence":"additional","affiliation":[{"name":"Department of Pathology University of Pittsburgh School of Medicine  Pittsburgh Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Dunlop","sequence":"additional","affiliation":[{"name":"Department of Hemato\u2010Oncology The Royal Marsden  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Ali","sequence":"additional","affiliation":[{"name":"School of Continuing &amp; Professional Studies Loyola University  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"Denny","sequence":"additional","affiliation":[{"name":"Duke Human Vaccine Institute and Department of Medicine Duke University  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W.","family":"Kern","sequence":"additional","affiliation":[{"name":"MLL Munich Leukemia Laboratory  Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V.","family":"Litwin","sequence":"additional","affiliation":[{"name":"Eurofins Clinical Trial Solutions, Montreal  Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"Marti","sequence":"additional","affiliation":[{"name":"National Heart, Lung, and Blood Institute National Institutes of Health  Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5783-4485","authenticated-orcid":false,"given":"H.","family":"Olteanu","sequence":"additional","affiliation":[{"name":"Division of Hematopathology, Department of Pathology and Laboratory Medicine Mayo Clinic Department of Laboratory Medicine and Pathology  Rochester Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Trindade","sequence":"additional","affiliation":[{"name":"Department of Health and Human Services Food and Drug Administration  Silver Spring USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Zhang","sequence":"additional","affiliation":[{"name":"Division of Biostatistics and Health Data Science University of Minnesota School of Public Health  Minneapolis Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.","family":"Langworthy","sequence":"additional","affiliation":[{"name":"Division of Biostatistics and Health Data Science University of Minnesota School of Public Health  Minneapolis Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7823-9917","authenticated-orcid":false,"given":"P. K.","family":"Wallace","sequence":"additional","affiliation":[{"name":"Department of Flow and Image Cytometry Roswell Park Comprehensive Cancer Center  Buffalo New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5638-999X","authenticated-orcid":false,"given":"S. A.","family":"Monaghan","sequence":"additional","affiliation":[{"name":"Department of Pathology University of Pittsburgh School of Medicine  Pittsburgh Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,30]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"ACLA v. FDA AMP v. FDA (consolidated). (2025).4:24\u2010cv\u201000479\u2010SDJ Doc. 93 Memorandum Opinion and Order (E.D. TX. Mar. 31)."},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.22125"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcp\/aqaa242"},{"key":"e_1_2_6_5_1","unstructured":"Clinical Laboratory Improvement Amendments.https:\/\/www.cms.gov\/medicare\/quality\/clinical\u2010laboratory\u2010improvement\u2010amendments. [Accessed 3rd May2025]."},{"key":"e_1_2_6_6_1","volume-title":"Validation of assays performed by flow cytometry. 1st ed. CLSI guideline H62","author":"CLSI","year":"2021"},{"key":"e_1_2_6_7_1","unstructured":"College of American Pathologists Laboratory Accreditation Program.https:\/\/www.cap.org\/laboratory\u2010improvement\/accreditation\/laboratory\u2010accreditation\u2010program2025."},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcp\/aqad149"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcp\/aqz096"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21953"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/labmed\/lmac090"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2021013626"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.5858\/arpa.2019-0493-CP"},{"key":"e_1_2_6_14_1","unstructured":"International Organization for Standardization. (2022).Medical laboratories \u2013 Requirements for quality and competence (ISO Standard No 15189:2022).https:\/\/www.iso.org\/standard\/76677.html"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.a.23895"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.5858\/arpa.2014-0543-CP"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cll.2023.04.004"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.1103"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.22166"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21233"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.3390\/cells12141875"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2016003715"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-021-04634-5"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.4300\/JGME-D-12-00156.1"},{"issue":"1","key":"e_1_2_6_25_1","article-title":"Technical aspects of flow cytometry\u2010based measurable residual disease quantification in acute myeloid leukemia: Experience of the European LeukemiaNet MRD working party","volume":"6","author":"Tettero J. M.","year":"2022","journal-title":"Hema"},{"key":"e_1_2_6_26_1","volume-title":"Medical devices; laboratory developed tests","author":"US Food and Drug Administration","year":"2024"},{"key":"e_1_2_6_27_1","unstructured":"Verifying Accurate Leading\u2010edge IVCT Development Act (Draft) Af.https:\/\/degette.house.gov\/sites\/evo\u2010subsites\/degette.house.gov\/files\/evo\u2010media\u2010document\/118\u2010valid\u2010act.pdf[Accessed 3rd May2025]."},{"key":"e_1_2_6_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.22140"},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.21398"},{"key":"e_1_2_6_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpcy.73"},{"key":"e_1_2_6_31_1","doi-asserted-by":"publisher","DOI":"10.1063\/10.0015301"},{"key":"e_1_2_6_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpz1.324"}],"container-title":["Cytometry Part B: Clinical Cytometry"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cyto.b.22259","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cyto.b.22259","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cyto.b.22259","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T17:40:35Z","timestamp":1774978835000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/cyto.b.22259"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,30]]},"references-count":31,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1002\/cyto.b.22259"],"URL":"https:\/\/doi.org\/10.1002\/cyto.b.22259","archive":["Portico"],"relation":{},"ISSN":["1552-4949","1552-4957"],"issn-type":[{"value":"1552-4949","type":"print"},{"value":"1552-4957","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,30]]},"assertion":[{"value":"2025-05-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}