Technical expertise and warrior mentality define success

An astute medical laboratory scientist must be part warrior, part academic, and part technical expert. Your skill stems from your strength in saying “no” to the disparate solutions and “yes” to high-quality, differentiated products that increase confidence in your test results.

You are not a generalist but a highly trained, highly skilled expert in a very specific area of healthcare. You are in charge of your domain.

Whether considering the daily routine of bench work or the biennial survey of an inspection agency, a sound quality system is the bedrock of any laboratory operation. It is the evidence required to prove that on any given day, quality was properly addressed.

As new platforms have increased in sophistication to lower the risk of errors and to aid in the detection of the errors when they occur, the scientist has been able to focus on other technical concerns. When the errors do occur, it challenges the equilibrium of laboratory operations and staff.

It is, after all, the medical laboratory scientist’s responsibility to anticipate and mitigate any chaos that threatens to disrupt the workflow; chaos adds another level of complexity to the day’s work and distracts from your technical responsibilities.

So how does a seasoned laboratory professional initiate steps toward a better quality system?

Living the (Quality Lab) Life
Learning about the quality criteria and putting a quality management system in place is only the first step. Putting the proper protocols into practice and strictly adhering to them are the only ways to live the quality lab life.

Lucia Berte in her June 2009 Quality Qorner article1 lists activities that must happen without exception:
• Provide to staff only the latest approved versions of all documents
• Document and investigate every unexpected event and complaint; these events reveal problematic laboratory processes
• Validate every new or changed process before implementing it in the laboratory whether or not it includes testing

The very essence of quality must be woven into every routine procedure and every standard protocol the laboratory scientist uses. Making quality the rule rather than the exception provides a solid basis of value in the laboratory.

Leadership
Be mindful that leadership is a frame of mind, not a role or a title. It is a personal choice to be a professional and to take responsibility for adhering to the quality system.

In Forbes magazine Jeff Boss wrote “A leadership position is different than a position of leadership. The former speaks to more rank and rigidity whereas the latter connotes more influence. Anybody and everybody is a leader, for leaders create value and drive results that, in turn, create more value.” 2

It’s a fact as well that people produce higher quality work and are more efficient when collaborating. Leading does not mean “going it alone”; leading means embracing opportunities for healthy cooperation. In doing so, we alleviate burnout and increase trust among our peers. 2

Culture
Little impact will be felt from implementing these concepts without establishing a culture of quality as well.

“If your lab doesn’t currently have a strong culture of quality, the activities and systems comprising your quality program will be seen as unnecessary and likely be unsuccessful,” writes Jennifer Dawson “Quality from the Ground Up”3 published on LinkedIn. Even in the best run organizations, one can expect there will be push back to following a quality system, more so when the system is particularly rigorous.

In any organization concerned with cost overruns, QC can be the first thing to go due to the perspective that it has the least tangible benefit. When faced with a stressful environment that prizes production over quality, staff personnel may delay or eliminate quality protocols, feeling they are unnecessary. In this case, a natural bias towards their own capabilities may lead laboratorians to unintentionally jeopardize the reliability of their results.

Changing your culture to one of quality requires leadership commitment, education, and employee empowerment to allow the laboratory to rise to its greatest potential.

Cost of Poor Quality
Facility executives are sensitive to dollars and sense. Financial gains can provide demonstrable proof related to the quality program and consequently supply more support for the initiatives.

“One way a lab can do this is to calculate Cost of Poor Quality (CoPQ) as a baseline metric. CoPQ includes financial losses associated with rework and any costs incurred because something performed poorly the first time. CoPQ represents cost savings and cost avoidance, which contributes to the lab’s bottom line.” wrote Dawson in “Quality from the Ground Up”3.

As an illustration of cost avoidance, consider Troponin I (cTnI), an important immunoassay test, that has been used for decades as a rule-in/rule-out tool.

The loss of myocardium occurs in minutes, prompting the Emergency Department (ED) to require the results of cardiac enzymes as quickly as possible. The result of the first troponin test helps the ED gauge the likelihood of hospital admission versus discharge, and if the former is chosen, the test result guides the early inpatient care.4

As platform manufacturers have continued to improve the sensitivity, specificity and level of detection of the cTnI assay, it has become of critical importance to tightly monitor the performance of the assay by way of high-performing immunoassay quality control materials.

The accuracy of the test result has an immediate impact on both the patient’s life, the care he receives and the disposition of health care resources employed.

The ramifications of unnecessarily holding a patient suspected of myocardial infarction (MI) in CCU are large due to the downstream cost of an error in diagnosis. Such misdiagnoses and misappropriations of resources should never happen, and poor quality laboratory results should never be cause of such an error.

Quality Products
Be it a decision to invest in new instrumentation or in a comprehensive portfolio of quality control materials, your training and experience motivate you to trust in those manufacturers who consistently deliver products of the highest standards.

The Relationship of Immunoassay Platforms and Immunoassay QC Materials
Many of the immunoassay tests essential to the clinician’s diagnostic process are to rule-in or rule-out the suspected disease or clinical condition.

Procalcitonin (PCT) is an immunoassay test that has grown quickly in its importance and utility in the acute care setting as a biomarker for the detection of sepsis. Early detection, diagnosis and treatment are keys to patient survival rates. 5

A large body of evidence supports the use of PCT and lactic acid to differentiate bacterial from viral or non-infective diagnoses, to help risk-stratify patients, and to guide antibiotic therapy decisions about initial need for, and optimal duration of, therapy.6-7

For those institutions adopting the guidelines to test for PCT upon ICU admission with suspected or documented sepsis, producing an accurate result becomes hypercritical to lowering hospital and ICU length of stay8 and decreasing the total cost of septicemia hospitalization which topped $15.4 billion in 20097.

The only way to know if your patient PCT results are accurate is to run quality control at the recommended intervals and compare the results to the established QC ranges.

Trusted platform manufacturers and trusted quality control manufacturers are integral players in the overall reliability and integrity the laboratory can provide to the acute care setting.

Inventory Management
A second facet of improving the quality system is taking a critical look at inventory management. In her December 14, 2015 Advance article “10 Trials of Lab Quality”, Jennifer Dawson asked the questions “Has your lab ever run out of reagents, causing a delay in turnaround time? Have you ever run out of critical supplies? How frequently is your lab paying for overnight shipping due to a shortage in reagents or supplies?”.9 The answer to all those potential pitfalls is consistent inventory management.

Appropriate steps to improving inventory management include the following:

Assessing your daily routine
Items of daily use are at the highest risk of being depleted without high vigilance to stock levels. What items would these be? They include bench consumables like transfer pipets; quality control materials; reagents and other instrument consumables. In a just-in-time purchasing environment, strict surveillance of stock levels is crucial.

Your relationship with the supplier/manufacturer of these materials becomes of great importance in those dire situations when you must replenish on demand. Established manufacturers know that laboratories must adhere to cost-containment protocols and will request shipment of inventory as needed. In these circumstances, responsiveness of the manufacturer becomes an important facet of the quality system.

Assign team duties
If you have lead scientists overseeing each area of the laboratory, they are probably responsible for monitoring inventory levels of reagents exclusive to their department.

Although purchasing in bulk may save shipping costs, one must be cognizant of storage capacity – particularly the coveted refrigerated space. Establishing minimum thresholds for ordering, and placing orders with consideration to documented usage, rather than always purchasing in excess, may save money as well as space.

Working with a manufacturer whose quality of product you trust and upon whose delivery you can rely will make your inventory management system more robust.

Summary
So communication, collaboration and thorough preparation are essential in developing a quality system. We must never waver in the understanding that the quality system is a fundamental facet of the laboratory. One from which the lab draws great value in the healthcare delivery process. That value should not be overlooked and cannot be overstated.

Proactively maintaining your domain to ward off the chaos of errors and missteps requires constant vigilance. It’s not just one facet of quality that wins the race to the highest possible standard, it is the consistent and thoughtful approach to all areas of the laboratory that attains the best end result for the laboratory, the clinician, and, ultimately, the patient.

1. Berte, L.M., (2009, June). Living in quality. Lab Medicine, 4(6), pp. 330.

2. Boss, J. (2015, February). How to lead when you’re not a leader. Forbes. Retrieved from http://www.forbes.com/sites/jeffboss/2015/02/17/how-to-lead-when-youre-not-a-leader/#494b55c01a62

3. Dawson, J. (2017, January). Quality from the ground up. Critical Values, 10 (1), pp. 22-25.
4. Yiadom, M.Y., Jarolim, P., Jenkins, C., Melanson, S.E., Conrad, M., & Kosowsky, J.M. (2015, April). Diagnostic implications of an elevated troponin in the emergency department. Disease Markers. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415742/

5. Weissman, A. (2016, June). The laboratory’s role in combating sepsis. Medical Laboratory Observer, 48(6), pp. 18.

6. McCann, F.J., Chapman, S.J., Yu, W.C., Maskell, N.A., Davies, R.J., Lee, Y.C. (2012, December). Ability of procalcitonin to discriminate infection from non-infective inflammation using two pleural disease settings. PLoS One. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3520973/

7. Feinstein, D. (2016, September). The drive to standardize clinical practice for sepsis. Medical Laboratory Observer, 47(9), pp. 41.

8. Balk, R.A., Kadri, S.S., Cao, Z., Robinson, S.B., Lipkin, C., & Bozzette, S.A. (2017, January). Effect of procalcitonin testing on health-care utilization and costs in critically ill patients in the United States. Chest. 151, 1. pp. 23-33.

9. Dawson, J. (2015, December). 10 trials of lab quality. ADVANCE for Administrators of the Laboratory. Retrieved from http://laboratory-manager.advanceweb.com/10-trials-of-lab-quality/