The Critical Value Chain: A Narrative Review of Systems Analysis, Human Factors, and Security-Based Interventions to Prevent Communication Failures in Life-Threatening Laboratory Result Reporting
Abstract
Background: The timely and reliable communication of critical laboratory values (CLVs)—results indicating imminent, life-threatening patient risk—is a non-negotiable patient safety standard. Despite long-standing protocols, failures in this communication chain persist, leading to diagnostic and treatment delays, patient harm, and sentinel events. These failures represent systemic vulnerabilities rather than isolated human errors.
Aim: This narrative review aims to analyze the multi-factorial causes of CLV communication breakdowns and synthesize evidence for a systems-based, security-informed response. It specifically evaluates the integrated roles of the clinical laboratory, nursing, and healthcare security/patient safety functions in designing fail-safe processes.
Methods: An integrative narrative review methodology was employed. A systematic search of PubMed, CINAHL, Scopus, and Web of Science (2010-2024) was conducted. Keywords included "critical results," "critical values," "communication failure," "patient safety," "laboratory reporting," and "systems analysis." Included literature comprised sentinel event reports, root cause analyses, quality improvement studies, and reviews on health information technology and human factors engineering.
Results: Communication failures arise from a complex interplay of latent system conditions (e.g., poorly designed interfaces, ambiguous policies, alert fatigue) and active errors (e.g., misdialed numbers, unacknowledged alerts). Effective mitigation requires a multi-layered defense: 1) Robust, redundant, and secure technological pathways mandated and audited by Health Care Security; 2) Clear, standardized protocols defining laboratory and nursing duties with closed-loop verification; 3) A proactive security mindset that treats failures as system breaches, necessitating rigorous root cause analysis and the implementation of corrective controls (e.g., read-back protocols, automated escalation, system hardening).
Conclusion: Safeguarding the critical value chain demands reconceptualizing it as a vital security protocol within the clinical environment. Moving beyond policy reiteration to engineered reliability, informed by human factors and security principles, is essential. A collaborative model where laboratory science, nursing practice, and security engineering jointly own the integrity of this high-stakes information pathway is paramount for eliminating preventable harm.
Full text article
References
Almasi, S., Rabiei, R., Moghaddasi, H., & Vahidi-Asl, M. (2021). Emergency department quality dashboard; a systematic review of performance indicators, functionalities, and challenges. Archives of academic emergency medicine, 9(1), e47. https://doi.org/10.22037/aaem.v9i1.1230
AlSadah, K., El-Masry, O. S., Alzahrani, F., Alomar, A., & Ghany, M. A. (2019). Reporting clinical laboratory critical values: a focus on the recommendations of the American College oF Pathologists. Journal of Ayub Medical College Abbottabad, 31(4), 612-618. https://ayubmed.edu.pk/jamc/index.php/jamc/article/view/6379
Ancker, J. S., Edwards, A., Nosal, S., Hauser, D., Mauer, E., Kaushal, R., & With the HITEC Investigators. (2017). Effects of workload, work complexity, and repeated alerts on alert fatigue in a clinical decision support system. BMC medical informatics and decision making, 17(1), 36. https://doi.org/10.1186/s12911-017-0430-8
Bates, D. W., & Singh, H. (2018). Two decades since to err is human: an assessment of progress and emerging priorities in patient safety. Health Affairs, 37(11), 1736-1743. https://doi.org/10.1377/hlthaff.2018.0738
Callen, J. L., Westbrook, J. I., Georgiou, A., & Li, J. (2012). Failure to follow-up test results for ambulatory patients: a systematic review. Journal of general internal medicine, 27(10), 1334-1348. https://doi.org/10.1007/s11606-011-1949-5
Driesen, B. E., Baartmans, M., Merten, H., Otten, R., Walker, C., Nanayakkara, P. W., & Wagner, C. (2022). Root cause analysis using the prevention and recovery information system for monitoring and analysis method in healthcare facilities: a systematic literature review. Journal of patient safety, 18(4), 342-350. DOI: 10.1097/PTS.0000000000000925
Getawa, S., Aynalem, M., Melku, M., & Adane, T. (2023). Blood specimen rejection rate in clinical laboratory: A systematic review and meta-analysis. Practical laboratory medicine, 33, e00303. https://doi.org/10.1016/j.plabm.2022.e00303
Gosselin, R. C., Adcock, D., Dorgalaleh, A., Favaloro, E. J., Lippi, G., Pego, J. M., ... & Siguret, V. (2020, June). International council for standardization in haematology recommendations for hemostasis critical values, tests, and reporting. In Seminars in Thrombosis and Hemostasis (Vol. 46, No. 04, pp. 398-409). Thieme Medical Publishers. DOI: 10.1055/s-0039-1697677
Harrison, M. I., Koppel, R., & Bar-Lev, S. (2007). Unintended consequences of information technologies in health care—an interactive sociotechnical analysis. Journal of the American medical informatics Association, 14(5), 542-549. https://doi.org/10.1197/jamia.M2384
Henneman, E. A., Roche, J. P., Fisher, D. L., Cunningham, H., Reilly, C. A., Nathanson, B. H., & Henneman, P. L. (2010). Error identification and recovery by student nurses using human patient simulation: Opportunity to improve patient safety. Applied Nursing Research, 23(1), 11-21. https://doi.org/10.1016/j.apnr.2008.02.004
Ialongo, C., Pieri, M., & Bernardini, S. (2017). Artificial neural network for total laboratory automation to improve the management of sample dilution: smart automation for clinical laboratory timeliness. SLAS TECHNOLOGY: Translating Life Sciences Innovation, 22(1), 44-49. https://doi.org/10.1177/2211068216636635
Karcher, D. S., & Lehman, C. M. (2014). Clinical consequences of specimen rejection: a College of American Pathologists Q-Probes analysis of 78 clinical laboratories. Archives of Pathology & Laboratory Medicine, 138(8), 1003-1008. https://doi.org/10.5858/arpa.2013-0331-CP
Karkoszka, T. (2023). Operational Control Model Based on Integrated Failure Analysis and Risk Assessment in Sustainable Technological Processes. Sustainability, 15(24), 16848. https://doi.org/10.3390/su152416848
Kennedy, G. A., Pedram, S., & Sanzone, S. (2023). Improving safety outcomes through medical error reduction via virtual reality-based clinical skills training. Safety Science, 165, 106200. https://doi.org/10.1016/j.ssci.2023.106200
Kushwaha, S. S., Joshi, S., Singh, D., Kaur, M., & Lee, H. N. (2022). Systematic review of security vulnerabilities in ethereum blockchain smart contract. Ieee Access, 10, 6605-6621. https://doi.org/10.1109/ACCESS.2021.3140091
Lippi, G., Adcock, D., Simundic, A. M., Tripodi, A., & Favaloro, E. J. (2017). Critical laboratory values in hemostasis: toward consensus. Annals of medicine, 49(6), 455-461. https://doi.org/10.1080/07853890.2016.1278303
Lawrence, M. B. (2018). The Social Consequences Problem in Health Insurance and How to Solve It. Harv. L. & Pol'y Rev., 13, 593.
Makary, M. (2019). The price we pay: what broke American health care--and how to fix it. Bloomsbury Publishing USA.
Meng, Y., Zhuge, W., Huang, H., Zhang, T., & Ge, X. (2022). The effects of early exercise on cardiac rehabilitation-related outcome in acute heart failure patients: a systematic review and meta-analysis. International Journal of Nursing Studies, 130, 104237. https://doi.org/10.1016/j.ijnurstu.2022.104237
Movahedi, A., Sadooghiasl, A., Ahmadi, F., & Vaismoradi, M. (2023). Smart care for dealing with nurses' alarm fatigue in the intensive care unit. Journal of Nursing Scholarship, 55(4), 825-833. https://doi.org/10.1111/jnu.12870
Ogundaini, O., de la Harpe, R., & McLean, N. (2022). Unintended consequences of technology-enabled work activities experienced by healthcare professionals in tertiary hospitals of sub-Saharan Africa. African Journal of Science, Technology, Innovation and Development, 14(4), 876-885. https://hdl.handle.net/10520/ejc-aa_ajstid_v14_i4_a876
Peerally, M. F., Carr, S., Waring, J., & Dixon-Woods, M. (2017). The problem with root cause analysis. BMJ quality & safety, 26(5), 417-422. https://doi.org/10.1136/bmjqs-2016-005511
Saffar, H., Sefidbakhat, S., Mirzaian, E., Najafabadi, M. K., & Saffar, H. (2022). Laboratory Critical Values; Brief review of definitions, diagnosis, utility of repeat testing, confirmation and reporting. Clinical Excellence, 11(4), 1-12.
Saini, K. S., Kaushik, A., Anil, B., & Rambabu, S. (2010). Harmonized medical device regulation: need, challenges, and risks of not harmonizing the regulation in Asia. Journal of Young Pharmacists, 2(1), 101-106.https://doi.org/10.4103/0975-1483.62221
Sartini, M., Carbone, A., Demartini, A., Giribone, L., Oliva, M., Spagnolo, A. M., ... & Cristina, M. L. (2022, August). Overcrowding in emergency department: causes, consequences, and solutions—a narrative review. In Healthcare (Vol. 10, No. 9, p. 1625). MDPI. https://doi.org/10.3390/healthcare10091625
Sheehan, P., Joy, A., Fleming, A., Vosper, H., & McCarthy, S. (2022). Human factors and patient safety in undergraduate healthcare education: a systematic review. Human factors in healthcare, 2, 100019. https://doi.org/10.1016/j.hfh.2022.100019
Stankovic, A. K., Blond, B. J., Coulter, S. N., Long, T., & Lindholm, P. F. (2023). Preanalytic Competency Assessment: A Q-Probes Study Involving 46 Health Care Institutions, 447 Blood Collectors/Phlebotomists, and 2212 Individual Assessments. Archives of Pathology & Laboratory Medicine, 147(3), 304-312. https://doi.org/10.5858/arpa.2021-0436-CP
Vesper, H. W., Myers, G. L., & Miller, W. G. (2016). Current practices and challenges in the standardization and harmonization of clinical laboratory tests. The American journal of clinical nutrition, 104, 907S-912S. https://doi.org/10.3945/ajcn.115.110387
Weiss, P. M. (2017). TRUST: How to build a support net for ObGyns affected by a medical error. OBG Management, 29(1), 25-31.
Yu, H. Y. E., Lanzoni, H., Steffen, T., Derr, W., Cannon, K., Contreras, J., & Olson, J. E. (2019). Improving laboratory processes with total laboratory automation. Laboratory Medicine, 50(1), 96-102. https://doi.org/10.1093/labmed/lmy031
Authors
Copyright (c) 2024 Yahya Hamad Ahmed Mahdi, Lamyaa Mahdi Mohammed Hazazi, Elham Ali A Mahnashi, Mohammed Ibrahim Mohsen Gome, Abdullah Essa Magbool Oraybi, Khalid Hamoud Najea Somaily, Ahlam Mohammed Ahmed Arishi, Essa Ali Ali Oraybi, Abdullah Zain Abdullah Abbas, Samira Ali Hussin Halawi, Amani Mohammed Ali Arishi, Huda Ali Hassan Alshehri, Reem Mohammed Ahmed Shaabi, Dhuha Nasser Hassan Muharraq
This work is licensed under a Creative Commons Attribution 4.0 International License.