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CC BY-NC-ND 4.0 · J Lab Physicians
DOI: 10.1055/s-0043-1775573
Original Article

Evaluation of the Effectiveness of Critical Result Notification Protocol of Biochemistry Laboratory at a Tertiary Care Hospital

Silpa Thota
1   Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences- SPMCW, Tirupati, Andhra Pradesh, India
,
Aparna R. Bitla
1   Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences- SPMCW, Tirupati, Andhra Pradesh, India
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Abstract

Background Critical value reporting is an essential aspect of laboratory medicine, ensuring prompt communication of life-threatening results to clinicians for immediate action. Existing guidelines emphasize the importance of timely notification, but protocols may vary. This study evaluated the effectiveness of the protocol for reporting critical results in the biochemistry laboratory of a tertiary care hospital and proposed alternative protocols for improvement.

Materials and Methods Data were collected over a 6-month period, including the total number of investigations, critical values detected, parameters analyzed, and clinical departments involved. Quality indicators such as turnaround time (TAT), unsuccessful reporting rates, and clinical actions taken were assessed. Statistical analysis was performed using Microsoft Excel.

Results Out of 390,000 investigations, 0.5% had critical values. Serum potassium (55.9%) had the highest frequency of critical values, followed by sodium, calcium, and glucose. The emergency department received the highest number of critical alerts. The success rate of critical result reporting within 1 hour was 86.8%, while unsuccessful reporting accounted for 10.7%. The causes of unsuccessful reporting included outpatient requests and delayed intimation due to patient transfers. Corrective action was taken in 91% of cases, with documentation primarily in nurse charts.

Conclusion Evaluation of the protocol for reporting critical results identified areas for improvement. Recommendations included revising the critical value list, reducing TAT through process optimization and automation, enhancing staff training and awareness, fostering interdisciplinary collaboration, and maintaining incident records. Implementing these changes can enhance compliance, reduce errors, and improve patient care.

Keywords

clinical decision-making - critical value - laboratory communication systems - turnaround time

Author Contribution

S.T. conceived and designed the study, conducted experiments, performed data collection, analyzed data, provided technical support, and wrote the manuscript.


A.R.B. conceived and supervised the project, critically reviewed the manuscript, and provided guidance throughout the study. All the authors read and approved the final version of the manuscript.


Approvals

The research protocol was reviewed and technical approval was given by Medical Research Committee of Sri Venkateswara Institute of Medical Sciences.


The institutional ethics committee of Sri Venkateswara Institute of Medical Sciences reviewed the protocol and approved the project vide IEC No1232.




Publication History

Received: 05 July 2023

Accepted: 22 August 2023

Article published online:
27 September 2023

© 2023. The Indian Association of Laboratory Physicians. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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  • References

  • 1 Lundberg GD. When to panic over abnormal values. MLO Med Lab Obs 1972; 4: 47-54
    Google Scholar
  • 2 Lundberg GD. Critical (panic) value notification: an established laboratory practice policy (parameter). JAMA 1990; 263 (05) 709
    CrossrefPubMedGoogle Scholar
  • 3 Clinical Laboratory Standards Institute (CLSI). Management of Critical- and Significant-Risk Results. CLSI GP47 Document. 1st ed.. Wayne, PA: CLSI; 2015: 17
    Google Scholar
  • 4 Campbell C, Horvath A. Towards harmonisation of critical laboratory result management: review of the literature and survey of Australasian practices. Clin Biochem Rev 2012; 33 (04) 149-160
    PubMedGoogle Scholar
  • 5 International Organization for Standardization (ISO). ISO 15189:2012. Medical Laboratories: Requirements for Quality and Competence. Geneva: International Organization for Standardization; 2012
    Google Scholar
  • 6 National Accreditation Board for Testing and Calibration Laboratories. Document 112: Specific Criteria for Accreditation of Medical Laboratories. Gurugram, India: NABL; 2022. Accessed June 16, 2023 at: https://nabl-india.org/nabl/file_download.php?filename=201905031045-NABL-112-effective-from-01.06.2019-doc.pdf
    Google Scholar
  • 7 Lippi G, Mattiuzzi C. Critical laboratory values communication: summary recommendations from available guidelines. Ann Transl Med 2016; 4 (20) 400
    CrossrefPubMedGoogle Scholar
  • 8 Mohan CK, Sugathan NV, Chandraja CV. Assessing the turnover time of critical value in hospitals. Clin Investig (Lond) 2019; 9 (01) 17-19
    Google Scholar
  • 9 Delgado Rodríguez JA, Pastor García MI, Gómez Cobo C, Pons Más AR, Llompart Alabern I, Bauça JM. Assessment of a laboratory critical risk result notification protocol in a tertiary care hospital and their use in clinical decision making. Biochem Med (Zagreb) 2019; 29 (03) 030703
    CrossrefPubMedGoogle Scholar
  • 10 Sirisali K, Manochiopinij S, Leelahakul P, Ruengrai V, Sattayakom A, Sirisali S. Critical value of the clinical laboratory test in Thailand. J Med Assoc Thai 2010; 93 (93, Suppl 6): S22-S27
    PubMedGoogle Scholar
  • 11 Campbell CA, Georgiou A, Westbrook JI, Horvath AR. What alert thresholds should be used to identify critical risk results: a systematic review of the evidence. Clin Chem 2016; 62 (11) 1445-1457
    CrossrefPubMedGoogle Scholar
  • 12 Tillman J, Barth JH. ACB National Audit Group. A survey of laboratory ‘critical (alert) limits’ in the UK. Ann Clin Biochem 2003; 40 (Pt 2): 181-184
    CrossrefPubMedGoogle Scholar
  • 13 Campbell CA, Horvath AR. Harmonization of critical result management in laboratory medicine. Clin Chim Acta 2014; 432: 135-147
    CrossrefPubMedGoogle Scholar
  • 14 Kost GJ, Hale KN. Global trends in critical values practices and their harmonization. Clin Chem Lab Med 2011; 49 (02) 167-176
    CrossrefPubMedGoogle Scholar
  • 15 Howanitz PJ, Steindel SJ, Heard NV. Laboratory critical values policies and procedures: a college of American Pathologists Q-Probes Study in 623 institutions. Arch Pathol Lab Med 2002; 126 (06) 663-669
    CrossrefPubMedGoogle Scholar
  • 16 Kuperman GJ, Boyle D, Jha A. et al. How promptly are inpatients treated for critical laboratory results?. J Am Med Inform Assoc 1998; 5 (01) 112-119
    CrossrefPubMedGoogle Scholar
  • 17 Dighe AS, Rao A, Coakley AB, Lewandrowski KB. Analysis of laboratory critical value reporting at a large academic medical center. Am J Clin Pathol 2006; 125 (05) 758-764
    CrossrefPubMedGoogle Scholar
  • 18 Park HI, Min WK, Lee W. et al. Evaluating the short message service alerting system for critical value notification via PDA telephones. Ann Clin Lab Sci 2008; 38 (02) 149-156
    PubMedGoogle Scholar
  • 19 Yang D, Zhou Y, Yang C. Analysis of laboratory repeat critical values at a large tertiary teaching hospital in China. PLoS One 2013; 8 (03) e59518
    CrossrefPubMedGoogle Scholar
  • 20 Agarwal R, Chhillar N, Tripathi CB. Study of variables affecting critical value notification in a laboratory catering to tertiary care hospital. Indian J Clin Biochem 2015; 30 (01) 89-93
    CrossrefPubMedGoogle Scholar
  • 21 Arbiol-Roca A, Corral-Comesaña S, Cano-Corres R, Castro-Castro MJ, Dastis-Arias M, Dot-Bach D. Analysis of laboratory critical values at a referral Spanish tertiary university hospital. Biochem Med (Zagreb) 2019; 29 (01) 010704
    CrossrefPubMedGoogle Scholar
  • 22 Li R, Wang T, Gong L. et al. Enhance the effectiveness of clinical laboratory critical values initiative notification by implementing a closed-loop system: a five-year retrospective observational study. J Clin Lab Anal 2020; 34 (02) e23038
    CrossrefPubMedGoogle Scholar
  • 23 Laguna J, Macias-Muñoz L, Bedini JL, Rico N. Notification of biochemistry critical results and its clinical impact on outpatient care: experience in a Spanish tertiary hospital. Clin Chem Lab Med 2021; 59 (11) 1777-1783
    CrossrefPubMedGoogle Scholar
  • 24 Jha PK, Agarwal R. Quality tools and strategy for critical alerts process improvements to ensure patient safety. J Lab Physicians 2022; 14 (04) 471-478
    Article in Thieme ConnectPubMedGoogle Scholar
  • 25 Barenfanger J, Sautter RL, Lang DL, Collins SM, Hacek DM, Peterson LR. Improving patient safety by repeating (read-back) telephone reports of critical information. Am J Clin Pathol 2004; 121 (06) 801-803
    CrossrefPubMedGoogle Scholar
  • 26 Murthy V, Altawallbeh G, Rapp M, Senn C, Karger AB. Missed critical value callbacks due to middleware flaw. Clin Biochem 2021; 96: 71-74
    CrossrefPubMedGoogle Scholar
  • 27 Callen JL, Westbrook JI, Georgiou A, Li J. Failure to follow-up test results for ambulatory patients: a systematic review. J Gen Intern Med 2012; 27 (10) 1334-1348
    CrossrefPubMedGoogle Scholar
  • 28 Piva E, Sciacovelli L, Zaninotto M, Laposata M, Plebani M. Evaluation of effectiveness of a computerized notification system for reporting critical values. Am J Clin Pathol 2009; 131 (03) 432-441
    CrossrefPubMedGoogle Scholar
  • 29 Thomas L. Critical limits of laboratory results for urgent clinician notification. EJIFCC 2003; 14 (01) 11-18
    PubMedGoogle Scholar
  • 30 Piva E, Pelloso M, Penello L, Plebani M. Laboratory critical values: automated notification supports effective clinical decision making. Clin Biochem 2014; 47 (13–14): 1163-1168
    CrossrefPubMedGoogle Scholar
  • 31 Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol 2011; 136 (06) 829-833
    CrossrefPubMedGoogle Scholar
  • 32 Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010; 47 (Pt 2): 101-110
    CrossrefPubMedGoogle Scholar
  • 33 Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chim Acta 2009; 404 (01) 16-23
    CrossrefPubMedGoogle Scholar