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The interpretations below are provided by Donna Castellone, MS, MT (ASCP) SH for Aniara Diagnostica.

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Hard to believe it is 2023! The beginning of a new year, no better time than to take a look at your coagulation testing and where the weakest link may be in your processes.

Where do your errors occur and what is a non-conforming event? What is the downstream effect from these flaws in the coagulation testing process? A non-conforming event is when something doesn't go as planned in the laboratory. It can be due to an accident, adverse event, error, incident, non-conformity, or an occurrence.⁽¹⁾ Errors can lead to undue repetition of laboratory tests, more invasive testing and consultations that create discomfort and increased costs for patients and the healthcare system. Anecdotal evidence indicates that one error can translate into 15 clinical consultations with primary-care physicians and hospital specialists, 77 laboratory tests, and inappropriate treatment.⁽²⁾

Up to 251,000 deaths per year occur because of errors in medical care. This makes medical errors the third leading cause of death, only after heart disease and cancer. A medical error as "an act of omission or commission in planning or execution that contributes or could contribute to an unintended result." By this definition, failures in laboratory tests certainly qualify. Lab test failures contribute to delayed or wrong diagnoses and unnecessary costs and care.⁽³⁾

A study estimated that diagnostic errors happen about 12 million times per year in U.S. outpatients. This represents 1 in 20 adults. The Institute of Medicine found that most people will experience at least one diagnostic error in their life. 13 billion laboratory tests are performed annually however they only comprise 2.3% of US health care expenditures and 2% of Medicare expenditures.⁽⁴⁾

An analysis of a systematic review from the Agency for Healthcare Research and Quality data revealed that 5.7% of patients from the emergency department are misdiagnosed. This represents approximately 7.4 million errors, 2.6 million harms and more than 370,000 patients suffering permanent disability or death. This translates in to 130 million ED visits annually with 1 in 18 patients receiving an incorrect diagnosis. Five conditions (#1 stroke, #2 myocardial infarction, #3 aortic aneurysm/dissection, #4 spinal cord compression/injury, #5 venous thromboembolism) account for 39 percent of serious misdiagnosis-related harms. Failures were found to occur in diagnostic assessment, test ordering and test interpretation. These were attributed to inadequate knowledge, skills or reasoning in particular when the cases were atypical or challenging.⁽⁵⁾

INPACT OF COAGULATION ERRORS:

Errors in coagulation testing can affect test results. Understanding the sources of errors is important in trouble shooting unexpected laboratory results that do not correlate with clinical information. Errors may occur in the pre-analytical, analytical and post analytical phase of testing. The most common errors in coagulation occur in the preanalytical testing phase. They are mostly due to inappropriate or problematic blood sample processing. Many errors occur in the collection phase which is a complex process and is difficult for the laboratory to control.⁽⁶⁾

Recommendations for laboratories to guide them to reducing preanalytical error that occurs post collection have been developed by the International Council for Standardization in Haematology (ICSH). It highlights the most common risks in transport, storage, and processing of citrated coagulation specimens and provides guidance on how to avoid them. The guidance document provides 23 recommendations in several areas including: pneumatic tube systems; clots in citrated samples; centrifugation; primary tube storage and stability; interfering substances including HIL (hemolysis, icterus, and lipemia); secondary aliquots and their transport, storage, and processing; and preanalytical variables for platelet function testing.⁽⁷⁾

In order to minimize errors, it is important to be aware of the possible impacts a pre-analytical error can have on a patient outcome. Some scenarios include:

• ERROR: Delay in transporting/testing coagulation specimens
  
• POTENTIAL IMPACT: Stroke, thrombophlebitis, and pulmonary embolism caused by unwarranted modification to blood thinner dosage based on inaccurate aPTT result.⁽⁸⁾
• ERROR: improper mixing
  
• POTENTIAL IMPACT: Patient mismanagement due to delays when anticoagulated tubes contain clots and must be recollected.⁽⁸⁾
• ERROR: patient misidentification
  
• POTENTIAL IMPACT: Transfusion- or medication-related death. Misdiagnosis, medication error, and general patient mismanagement due to being treated according to the results of another patient.⁽⁸⁾

• ERROR: filling tubes in the wrong order
  
• POTENTIAL IMPACT: Seizure and death from potassium carrying over from EDTA into tube to be tested for K+. Medication errors when additives carry over into coag tubes, falsely lengthening coagulation times and leading to unwarranted and life-threatening medication adjustments. Unnecessary antibiotic administration and prolonged hospitalization due to contaminated blood cultures.⁽⁸⁾

• ERROR: pouring blood from one tube into another
  
• POTENTIAL IMPACT: Patient mismanagement/misdiagnosis & medication errors based on altered results, especially potassium. Stroke/hemorrhage due to unwarranted modification to blood thinner dosage.⁽⁸⁾

SOLUTIONS:

Processes need to be put in place to be able to mitigate potential problems and ultimately reduce errors. It is important to ensure meaningful laboratory results that coagulation testing be part of the laboratory total quality management system (QMS). Implementing effective quality control and proficiency testing have helped to decrease analytical errors. This is more difficult when the errors occur in the preanalytical phase and the sample is unsuitable. Having a QMS system must look at a way to identify potential pre-examination errors, estimate their impact, look at the frequency and follow through with corrective actions. Having good SOPs, training policies, competency will aid in minimizing errors. Additionally, auditing specimen collection, processing and transport can help identify discrepant practices or errors. Goals should be established for the indicator and monitoring of activities should help in achieving the set goals.⁽⁹⁾

CONCLUSIONS:

One of the several things I have learned working in the laboratory is that technologists have great instincts. I always tell people, go with your gut! We are the professionals, and if a sample doesn't seem right, or a result is suspicious it is worth investigating. Understanding how a coagulation error can impact diagnosis and treatment is so important. Having a good QMS data driven system will help in identifying where the errors are happening and will arm you with good information to improve the process.

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REFERENCES:

1. Dawson, J, What is the Cost of Poor Quality? Calculating an ROI for your Lab’s Quality program, 6/2017; Webinar Cardinal Health
2. https://www.researchgate.net/publication/7052626_Errors_in_clinical_laboratories_or_errors_in_laboratory_medicine
3. Makary MA, Daniel M. Medical error-the third leading cause of death in the US. BMJ. 2016 May 3;353:i2139
4. Singh H, et al. BMJ Qual Saf 2014;23:727–731
5. Newman-Toker DE, Peterson SM, Badihian S, Hassoon A, Nassery N, Parizadeh D, Wilson LM, Jia Y, Omron R, Tharmarajah S, Guerin L, Bastani PB, Fracica EA, Kotwal S, Robinson KA. Diagnostic Errors in the Emergency Department: A Systematic Review. Comparative Effectiveness Review No. 258. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 75Q80120D00003.) AHRQ Publication No. 22(23)-EHC043. Rockville, MD: Agency for Healthcare Research and Quality; December 2022.
6. Anne Paxton. Steps to preventing coag test processing error, CAP Today, February, 2022. https://www.captodayonline.com/steps-to-preventing-coag-test-processing-error/
7. Kitchen S, et al. Int J Lab Hematol. 2021;43[6]:1272–1283).
8. Pre-analytic errors: Blood-Collection Errors and Their Impact on Patients https://www.capitalhealthcareinstitute.com/single-post/2016/05/06/Preanalytic-errors-BloodCollection-Errors-and-Their-Impact-on-Patients
9. Dorothy M.Adcock MD, Emmanuel J. Favaloro PhD FFSc (RCPA,) Giuseppe Lippi MDc, Critical pre-examination variables in the hemostasis laboratory and their quality indicators, Clinical Biochemistry Volume 49, Issue 18, December 2016, Pages 1315-1320

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