Subscribe to RSS
DOI: 10.1055/s-0042-1756708
From Ink Pens to Computers: A Personal Look Back at Landmark Changes during 5 Decades as a Clinical Laboratory Scientist in U.S. Hemostasis Laboratories
Abstract
In 2023, Seminars in Thrombosis and Hemostasis will be celebrating its 50th anniversary, and similarly this will also mark my 5th decade of working in, or association with, laboratories that perform hemostasis testing. My career started at a large military medical center, but I also worked at several other facilities, including military dispensaries, community hospitals, and a large academic institution. The difference between each type of hemostasis laboratory was as expected, with larger facilities having better instrumentation and more prolific test menus. However, whether one worked in a large academic center, or a small rural hospital, regulatory changes affected every clinical laboratory to the same degree. Advances in technology also eventually affected every hemostasis laboratory, but these salient changes were more likely to occur earlier at the larger institutions. As Seminars in Thrombosis and Hemostasis celebrates its 50th anniversary, that milestone triggered recollection about those salient events that occurred during my own career in hemostasis testing. As such, I describe (my impression) the top ten landmark changes that altered laboratory practice at the facilities where I worked during the past 5 decades.
Keywords
laboratory - automation - safety - electronic data management - international normalized ratio - platelet function assay - CLIA - COVID-19 pandemicPublication History
Article published online:
29 September 2022
© 2022. Thieme. All rights reserved.
Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA
-
References
- 1 Seaman AJ. Owren's capillary blood thrombotest for office or bedside control of anticoagulant therapy: an evaluation. Ann Intern Med 1960; 53: 914-923
- 2 Centers for Disease Control (CDC). Update on acquired immune deficiency syndrome (AIDS)—United States. MMWR Morb Mortal Wkly Rep 1982; 31 (37) 507-508 , 513–514
- 3 Morbidity and Mortality Weekly Report (MMWR) Centers for Disease Control and Prevention. Atlanta, GA. August 21, 1987 /36(SU02);001. Accessed August 9, 2022 at: https://www.cdc.gov/mmwr/preview/mmwrhtml/00023587.htm
- 4 Leads from the MMWR. Leads from the MMWR. Update: universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. JAMA 1988; 260 (04) 462-465
- 5 Tokars JI, Marcus R, Culver DH. et al; The CDC Cooperative Needlestick Surveillance Group. Surveillance of HIV infection and zidovudine use among health care workers after occupational exposure to HIV-infected blood. Ann Intern Med 1993; 118 (12) 913-919
- 6 Wong ES, Stotka JL, Chinchilli VM, Williams DS, Stuart CG, Markowitz SM. Are universal precautions effective in reducing the number of occupational exposures among health care workers? A prospective study of physicians on a medical service. JAMA 1991; 265 (09) 1123-1128
- 7 Broussard IM, Kahwaji CI. Universal Precautions. 2021 December 15. In: StatPearls. Treasure Island, FL: StatPearls Publishing; 2022 Jan–. PMID: 29262198.
- 8 Kaplan B. Initial impact of a clinical laboratory computer system. Themes common to expectations and actualities. J Med Syst 1987; 11 (2-3): 137-147
- 9 Barnett GO. The application of computer-based medical-record systems in ambulatory practice. N Engl J Med 1984; 310 (25) 1643-1650
- 10 Shapiro GA, Huntzinger SW, Wilson III JE. Variation among commercial activated partial thromboplastin time reagents in response to heparin. Am J Clin Pathol 1977; 67 (05) 477-480
- 11 Walenga J, Fareed J, Bermes Jr EW. Automated instrumentation and the laboratory diagnosis of bleeding and thrombotic disorders. Semin Thromb Hemost 1983; 9 (03) 172-193
- 12 Mühl M, Bauer J, and Bayer PM. Evaluierung des Electra 1000 C MLA. Evaluation of the fully automated coagulation analyzer electra 1000 C MLA” Laboratoriums Medizin. J Lab Med 1991; 15 (10) 501-506
- 13 Wheeler M, Choong SC. Evaluation of the mla 1000 coagulation autoanalyzer. Pathology 1992; 24 (01) 16
- 14 Cambus JP, Nguyen F, de Graeve J, Aragon B, Valdiguie P. A data management program for the Electra 800 automatic analyser. Blood Coagul Fibrinolysis 1994; 5 (05) 837-840
- 15 Nair SC, Dargaud Y, Chitlur M, Srivastava A. Tests of global haemostasis and their applications in bleeding disorders. Haemophilia 2010; 16 (Suppl. 05) 85-92
- 16 Bogdanich W. Lax laboratories: the pap test misses much cervical cancer through labs' errors—cut-rate “Pap Mills” process slides using screeners with incentives to rush—misplaced sense of security?. Eastern edition; New York, NY: Wall Street Journal. November 2, 1987:1
- 17 Stoler MH. Are we insane? Observations on the idea of gynecologic screening cytology “productivity”. Am J Clin Pathol 2012; 138 (06) 766-769
- 18 100th US Congress Public Law 100–578 Clinical Laboratory Improvement Amendments of 1988. Accessed August 09, 2022 at: https://www.congress.gov/100/statute/STATUTE-102/STATUTE-102-Pg2903.pdf
- 19 Morbidity and Mortality Weekly Report (MMWR) Centers for Disease Control and Prevention. Atlanta, GA. February 28, 1992/41 (RR-2); 001. Accessed August 09, 2022 at: https://www.cdc.gov/mmwr/preview/mmwrhtml/00016177.htm
- 20 Kumar R, Ansell JE, Canoso RT, Deykin D. Clinical trial of a new bleeding-time device. Am J Clin Pathol 1978; 70 (04) 642-645
- 21 US Food and Drug Administration. Medical devices, clinical laboratory improvement amendments database; Simplate Bleeding Time Jul 1993. Accessed August 09, 2022 at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Detail.cfm?ID=61406&NoClia=1
- 22 US Code of Federal Regulations Title 42, Chapter IV, Subchapter G, Part 493, Subpart K, Analytic Systems, §493.1253(b)(2). Accessed August 09, 2022 at: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K/subject-group-ECFRc96daead380f6ed/section-493.1253
- 23 MacMillan RL, Brown KW, Watt DL. Prothrombin time of capillary blood for outpatient anticoagulant therapy. Am J Med Sci 1959; 238: 443-447
- 24 Hattersley PG. The activated coagulation time of whole blood as a routine pre-operative screening test. Calif Med 1971; 114 (05) 15-18
- 25 Bull MH, Huse WM, Bull BS. Evaluation of tests used to monitor heparin therapy during extracorporeal circulation. Anesthesiology 1975; 43 (03) 346-353
- 26 Nutescu EA. Point of care monitors for oral anticoagulant therapy. Semin Thromb Hemost 2004; 30 (06) 697-702
- 27 Leaning KE, Ansell JE. Advances in the monitoring of oral anticoagulation: point-of-care testing, patient self-monitoring, and patient self-management. J Thromb Thrombolysis 1996; 3 (04) 377-383
- 28 Gosselin R, Owings JT, White RH. et al. A comparison of point-of-care instruments designed for monitoring oral anticoagulation with standard laboratory methods. Thromb Haemost 2000; 83 (05) 698-703
- 29 WHO Expert Committee on Biological Standardization. 33rd Report. WHO Technical Report Series 687. 1983; Annex 3; 81–105. Accessed August 09, 2022 at: https://apps.who.int/iris/bitstream/handle/10665/39217/WHO_TRS_687.pdf?sequence=1&isAllowed=y
- 30 Loeliger EA. ICSH/ICTH recommendations for reporting prothrombin time in oral anticoagulant control. Acta Haemat 1984; 72: 405-407
- 31 van den Besselaar AM, Evatt BL, Brogan DR, Triplett DA. Proficiency testing and standardization of prothrombin time: effect of thromboplastin, instrumentation, and plasma. Am J Clin Pathol 1984; 82 (06) 688-699
- 32 van den Besselaar AM. Standardization of the prothrombin time in oral anticoagulant control. Haemostasis 1985; 15 (04) 271-277
- 33 Bader R, Mannucci PM, Tripodi A. et al. Multicentric evaluation of a new PT reagent based on recombinant human tissue factor and synthetic phospholipids. Thromb Haemost 1994; 71 (03) 292-299
- 34 Roussi J, Drouet L, Samama M, Sié P. French multicentric evaluation of recombinant tissue factor (recombiplastin) for determination of prothrombin time. Thromb Haemost 1994; 72 (05) 698-704
- 35 2nd ACCP Conference on Antithrombotic Therapy. American College of Chest Physicians. June 21, 1988. Proceedings. Chest 1989; 95 (suppl 2): 1S-169S
- 36 Triplett DA. Current recommendations for warfarin therapy. Use and monitoring. Med Clin North Am 1998; 82 (03) 601-611
- 37 Rodgers RP, Levin J. A critical reappraisal of the bleeding time. Semin Thromb Hemost 1990; 16 (01) 1-20
- 38 Mammen EF, Alshameeri RS, Comp PC. Preliminary data from a field trial of the PFA-100 system. Semin Thromb Hemost 1995; 21 (Suppl. 02) 113-121
- 39 Favaloro EJ. Clinical utility of the PFA-100. Semin Thromb Hemost 2008; 34 (08) 709-733
- 40 Heilmann EJ, Kundu SK, Sio R, Garcia C, Gomez R, Christie DJ. Comparison of four commercial citrate blood collection systems for platelet function analysis by the PFA-100 system. Thromb Res 1997; 87 (01) 159-164
- 41 Mammen EF, Comp PC, Gosselin R. et al. PFA-100 system: a new method for assessment of platelet dysfunction. Semin Thromb Hemost 1998; 24 (02) 195-202
- 42 FDA 510k premarket notification Dade PFA-100 Platelet Function Analyzer 1997. Accessed August 09, 2022 at: https://www.accessdata.fda.gov/cdrh_docs/pdf/K970505.pdf
- 43 US Food and Drug Administration. Notification to Congress. Framework for regulatory oversight of Laboratory Developed Tests (LDTs). July 2014. Accessed August 09, 2022 at: https://www.fda.gov/media/89316/download
- 44 The Public Health Evidence f or FDA Oversight of Laboratory Developed Tests. 20 Case Studies. Food and Drug Administration Office of Public Health Strategy and Analysis November 16, 2015. Accessed August 09, 2022 at: http://wayback.archive-it.org/7993/20171115144712/https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM472777.pdf
- 45 Genzen JR, Mohlman JS, Lynch JL, Squires MW, Weiss RL. Laboratory-developed tests: a legislative and regulatory review. Clin Chem 2017; 63 (10) 1575-1584
- 46 Thompson BM, Scott BI, Boiani JA. Understanding the food and drug administration's jurisdiction over laboratory-developed tests and divisions between food, drug, and cosmetic act-regulated and clinical laboratory improvement amendments of 1988-regulated activities. Clin Lab Med 2016; 36 (03) 575-585
- 47 Caliendo AM, Hanson KE. Point-counterpoint: The FDA has a role in regulation of laboratory-developed tests. J Clin Microbiol 2016; 54 (04) 829-833
- 48 US Food and Drug Administration Discussion Paper on Laboratory Developed Tests January 13, 2017. Accessed August 09, 2022 at: https://www.fda.gov/media/102367/download
- 49 US Food and Drug Administration. Department of Health and Human Services. Docket No FDA-2015-N-2919 In-vitro Diagnostic Testing for Direct Oral Anticoagulants; Public Workshop; Request for Comments. Silver Springs, MD Oct 26, 2015. Accessed August 09, 2022 at: https://www.govinfo.gov/content/pkg/FR-2015-08-26/pdf/2015-21095.pdf
- 50 Capital Reporting Company. Transcription: In Vitro Diagnostic Testing for Direct Oral Anticoagulants (October 26, 2015. Accessed August 09, 2022 at: https://fritsmafactor.com/sites/default/files/doac_testing_fda_transcript_10-26-15.pdf
- 51 US Code of Federal Regulations Title 42, Chapter IV, Subchapter G, Part 493, Subpart A, Analytic Systems, §493.2. Definitions. Accessed September 09, 2022 at: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-A/section-493.2
- 52 117th US Congress, H.R. 4128 Valid Act of 2021. Accessed August 09, 2022 at: https://www.congress.gov/bill/117th-congress/house-bill/4128/text?q=%7B%22search%22%3A%5B%22valid+act%22%5D%7D&r=1&s=1
- 53 US Food and Drug Administration. Template for Developers of Molecular Diagnostic Tests. Oct 6, 2021. Accessed August 09, 2022 at: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F135900%2Fdownload&wdOrigin=BROWSELINK
- 54 Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost 2020; 18 (04) 844-847
- 55 Schulman S. Coronavirus disease 2019, prothrombotic factors, and venous thromboembolism. Semin Thromb Hemost 2020; 46 (07) 772-776
- 56 Hashemi A, Madhavan MV, Bikdeli B. Pharmacotherapy for prevention and management of thrombosis in COVID-19. Semin Thromb Hemost 2020; 46 (07) 789-795
- 57 Favaloro EJ, Lippi G. Maintaining hemostasis and preventing thrombosis in coronavirus disease 2019 (COVID-19)-part I. Semin Thromb Hemost 2020; 46 (07) 757-762
- 58 Favaloro EJ, Lippi G. Maintaining hemostasis and preventing thrombosis in coronavirus disease 2019 (COVID-19): part II. Semin Thromb Hemost 2021; 47 (04) 333-337
- 59 Favaloro EJ, Lippi G. Maintaining hemostasis and preventing thrombosis in coronavirus disease 2019 (COVID-19)-Part III. Semin Thromb Hemost 2022; 48 (01) 3-7
- 60 Favaloro EJ, Lippi G. Recommendations for minimal laboratory testing panels in patients with COVID-19: potential for prognostic monitoring. Semin Thromb Hemost 2020; 46 (03) 379-382
- 61 Dorgalaleh A. Bleeding and bleeding risk in COVID-19. Semin Thromb Hemost 2020; 46 (07) 815-818
- 62 Favaloro EJ, Henry BM, Lippi G. COVID-19 and Antiphospholipid antibodies: time for a reality check?. Semin Thromb Hemost 2022; 48 (01) 72-92
- 63 Thachil J. COVID-19 vaccine-induced immune thrombosis with thrombocytopenia (VITT) and the shades of grey in thrombus formation. Semin Thromb Hemost 2022; 48 (01) 15-18
- 64 Sodium citrate blood specimen collection tube conservation strat egies – Letter to health care and laboratory personnel. June 10, 2021. Food and Drug Administration. Silverspring, MD. Accessed August 31, 2021 at: www.fda.gov/medical-devices/letters-health-care-providers/sodium-citrate-blood-specimen-collection-tube-conservation-strategies-letter-health-care-and#actions
- 65 Sodium citrate blood specimen collection tube conservation strategies – Letter to health care and laboratory personnel. United States Food & Drug Administration. July 22, 2021 Update. Accessed August 31, 2021 at: www.fda.gov/medical-devices/letters-health-care-providers/sodium-citrate-blood-specimen-collection-tube-conservation-strategies-letter-health-care-and#actions
- 66 Blue top tube recommendations. June 15, 2021. College of American Pathologists. Northfield, IL. Accessed August 31, 2021 at: https://documents.cap.org/documents/cap-blue-top-tubes-recommendations.pdf
- 67 Gosselin RC, Bowyer A, Favaloro EJ. et al. Guidance on the critical shortage of sodium citrate coagulation tubes for hemostasis testing. J Thromb Haemost 2021; 19 (11) 2857-2861