ASCLS Today Volume 34, Number 2

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Volume 34, Number 2

THE PREANALYTICAL ERRORS: A CONTINUOUS CHALLENGE FOR CLINICAL LABORATORIES

Jie Gao, PhD, MLS(ASCP)CM

The clinical laboratory always seeks to improve services due to its close association to patient safety and satisfaction. However, clinical laboratory testing is a highly complex process (i.e., preanalytical phase, analytical phase, and postanalytical phase), and the frequency of laboratory errors has been reported to be 0.012-0.6 percent of all test results.1 According to a recent survey on laboratory errors, the preanalytical errors account for over 60 percent of laboratory errors.2

The preanalytical errors refer to all of the inappropriate performances before the specimens are measured by analyzers, such as improper sample collection, transport delays, illegible handwriting on requisition, and so on. Most preanalytical errors are rooted outside of the clinical laboratory, although laboratory professionals are the main work force to detect these errors. Here are some case examples of preanalytical errors that occurred over a period of one week at a local hospital.

Case One
A patient blood sample looked normal without any hemolysis, but the following critical values were obtained and flagged:

  Initial test Repeated test
Ca2+ 0.6mmol/L 0.7mmol/L
K+ 15.5mmol/L 15.5mmol/L
ALK 5U/L 4U/L

 

These abnormal data were not consistent with the patient’s medical history. As a result, the medical laboratory scientist communicated this to this patient’s nurse. The medical laboratory scientist learned this patient serum sample was contaminated by EDTA-K2 because the tested sample was a combination of his blood from a purple top tube (with EDTA-K2 as coagulant) and a red top tube.

EDTA is widely known as a chelator to electrolytes, including Mg2+, Zn2+, and Ca2+. The presence of EDTA in the serum not only falsely decreases the electrolytes levels, but also inhibits the ALK test, which requires Mg2+ and Zn2+ as cofactors in the test. In addition, the K+ in the EDTA-K2 falsely elevated the potassium level, explaining the lack of observed hemolysis.

Case Two
A male patient was admitted into the hospital due to head trauma. His coagulation test showed the following test results: PT>120sec, APTT>180sec, TT>120sec, but his fibrinogen, D-dimer, and fibrin degradation product (FDP) are normal.

It is unusual for a patient to have normal levels of fibrinogen, D-dimer, and FDP with enormously prolonged PT, APTT, and TT. In order to interpret these unreasonable data, the medical laboratory scientist questioned the patient’s nurse about their collection procedure. It was identified that his nurse collected the blood using a purple top tube and then pipetted the sample into a light blue top tube for coagulation testing. It is widely known that Ca2+ is an important factor in blood coagulation, but the anticoagulant EDTA in the purple top tube could chelate the majority of the calcium ions and falsely reduced the availability of Ca2+ in the specimen, which resulted in the prolong PT, APTT, and TT but normal FIB and D-dimers.

Case Three
A patient’s chemistry measurements are listed as follows:

  Monday Tuesday
Na2+ 118mmol/L 138.5mmol/L
K+ 16.8mmol/L 4.12mmol/L
Cl- 105mmol/L 104.3mmol/L
Glu 45.05 mg/dL 93.69 mg/dL

 

The laboratory technician detected the dramatic changes in the measurements of two consecutive days and consulted with the patient’s nurse. The blood sample tested on Monday remained uncentrifuged and stored in the refrigerator over the weekend. During this storage period, the Na-K-ATP pump on the red blood cells were arrested, which caused K+ to be secreted out of the cells and Na+ to be moved into the cells. The red blood cells metabolized the glucose in the blood and decreased the glucose levels.

Case Four
The morning laboratory tests of a patient indicated as follows:

WBC 1.9*10^9
HGB 4.4 g/dl
Glu 225.230 mg/dL

 

After notifying his nurse of these critical lab values, the laboratory scientist was told the patient’s clinical presentation didn’t match these test results. The patient’s sample was collected while the patient was having intravenous therapy. The IV fluid mixed with the blood sample and diluted the components in the blood sample and caused the aberrant test results. A recollected blood sample in the afternoon produced normal test results.

Case Five
A physician ordered several tests on a patient’s stool samples. The results are as follows:

  Monday Thursday Thursday (repeated) Thursday (new sample)
Color Yellow, waterish Yellow, soft Yellow, soft Yellow, soft
WBC + -- -- --
RBC + -- -- --
Rotavirus + + + --

 

The laboratory technician discussed the controversial results with the patient’s nurse on Thursday. It turned out the sample submitted on Thursday was dropped on the floor, where some rotavirus contaminated the stool and impaired the sterility of the sample. A new sample was requested, and the test results are normal as shown in the above table.

More Potential Errors
It has become a routine task for medical laboratory professionals to identify preanalytical errors and to take corrective measures. However, some preanalytical errors are not detectable at the laboratory end, which might cause significant impacts on test results. For example, the K+ level will be elevated by 2.5 percent if the tourniquet remains in place for more than 60 seconds at a time during phlebotomy.3 Application of the tourniquet for 60-120 seconds can also cause a 5 percent increase in the total cholesterol level.4 Moreover, the declines of total bilirubin and glucose from unprocessed blood samples averaged about 2.3 percent/hour5 and 5-7 percent/hour6, respectively; therefore, if the blood sample isn’t delivered to the laboratories within four hours, the false measurements of glucose and bilirubin can significantly impact physician’s decisions on the diagnosis and treatment of patients.

Preanalytical errors significantly increase the workload of the clinical laboratory. However, most of these errors are beyond the control of laboratory administration. More critically, the credibility of clinical laboratories is at stake due to the burden of the inconsistencies or incorrect reporting that can occur from these errors. Therefore, medical laboratory professionals have taken the responsibility to advocate for the development of quality control procedures at the preanalytical phase.

Currently, new specimen collection and processing protocols are developed and investigated in nurse practices since nurses are frequently responsible for specimen collection.7,8 Some medical laboratory professionals have initiated the standardization of the management of unsuitable specimens and reporting policies to deal with preanalytical errors.9,10 The quality control of the preanalytical phase remains an issue in many clinical laboratories; medical laboratory professionals are continuously contributing to this topic and providing valid evidence for future guidelines and recommendations.

References

  1. Rachna, A., Quality-Improvement Measures as Effective Ways of Preventing Laboratory Errors. Lab Medicine, 2014. 45(2): p. 9.
  2. Plebani, M., et al., Performance criteria and quality indicators for the pre-analytical phase. Clin Chem Lab Med, 2015. 53(6): p. 943-8.
  3. Asirvatham, J.R., V. Moses, and L. Bjornson, Errors in potassium measurement: a laboratory perspective for the clinician. N Am J Med Sci, 2013. 5(4): p. 255-9.
  4. Narayanan, S., Pre and post analytical errors in lipid determination. Indian Journal of Clinical Biochemistry, 1996. 11: p. 5.
  5. Rehak, N.N., S.A. Cecco, and G.L. Hortin, Photolysis of bilirubin in serum specimens exposed to room lighting. Clin Chim Acta, 2008. 387(1-2): p. 181-3.
  6. Turchiano, M., et al., Impact of blood sample collection and processing methods on glucose levels in community outreach studies. J Environ Public Health, 2013. 2013: p. 256151.
  7. Ning, H.C., et al., Reduction in Hospital-Wide Clinical Laboratory Specimen Identification Errors following Process Interventions: A 10-Year Retrospective Observational Study. PLoS One, 2016. 11(8): p. e0160821.
  8. Simundic, A.M., et al., Joint EFLM-COLABIOCLI recommendation for venous blood sampling. Ann BiolClin (Paris), 2019. 77(2): p. 131-154.
  9. Lima-Oliveira, G., et al., Pre-analytical phase management: a review of the procedures from patient preparation to laboratory analysis. Scand J Clin Lab Invest, 2017. 77(3): p. 153-163.
  10. Cadamuro, J., et al., European survey on preanalytical sample handling - Part 2: Practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples. On behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE). Biochem Med (Zagreb), 2019. 29(2): p. 020705.

Jie Gao is assistant professor in the Clinical Laboratory Sciences Program/Department of Clinical and Diagnostic Sciences at the University of Alabama at Birmingham.

CASE STUDY: SLE COMPLICATED BY CATASTROPHIC PRESENTATION OF ANTI-PHOSPHOLIPID SYNDROME

April Nelsen, MS, MLS(ASCP)CM; Rosemarie Clauson, MLS(ASCP)CM; Kassi Erickson, MS, MLS(ASCP)CM; Stacie Lansink, MS, MT(ASCP); and Tiffany Niemann, MLS(ASCP)CM

After weeks of shortness of breath and sharp chest pain, a 48-year-old Caucasian female presented to the ED in a hypertensive state; her blood pressure was 193/113. Her history revealed preeclampsia in a previous pregnancy resulting in acute renal failure and multiple pulmonary emboli. A post-partum renal biopsy showed thrombotic microangiopathy, in which the patient underwent dialysis and anticoagulation therapy. Five years post-partum, the patient was diagnosed with Systemic Lupus Erythematosus (SLE). At the time of SLE diagnosis, the patient tested negative for dsDNA and Sm/RNP antibodies but presented with a positive Antinuclear Antibodies (ANA) and antiphospholipid antibodies.

During the patient’s ED admission, a S-T elevation on an electrocardiogram (EKG) and diffuse ground glass bilateral pleural effusions on the computerized topography (CT) scan were observed. Metoprolol, heparin, and aspirin were immediately administered. Admission labs revealed progressive renal failure, anemia, thrombocytopenia, and prolonged coagulation results. Arterial Blood Gases showed the patient in a state of metabolic acidosis. One unit of packed red blood cells was transfused due to the patient’s anemia. A bronchoalveolar lavage (BAL) produced a red, turbid fluid. Cultures and respiratory pathogen serological tests came back negative. The bronchoscopy displayed bloody effusions in both the right and left upper lobes, suggestive of a diffuse alveolar hemorrhage. An EKG noted a mitral valve vegetation, known as Libman-Sacks endocarditis in SLE patients, and was also causing mitral valve regurgitation.

Due to the concern for advancing the alveolar hemorrhage, anti-coagulant therapy was delayed. To determine if the prolonged coagulation was due to a lupus anticoagulant or not, coagulation tests were sent to Mayo, but came back inconclusive. Tests for anticardiolipin and anti-beta 2 glycoprotein I antibodies (IgM and IgG isotypes) were recommended and came back weakly positive but were diagnostic of a catastrophic presentation of Antiphospholipid Syndrome (APS).

This diagnosis was consistent with the patient’s history of preeclampsia, seizures, mitral valve regurgitation (exacerbated by the Libman-Sacks endocarditis caused by SLE), hypertension, and increased protein in the urine. The patient’s kidneys continued to deteriorate rapidly, and the alveolar hemorrhage soon became a complication, so the patient was transferred to the transitional ICU and pulse dose steroid, along with oxygen therapy, were initiated.

The patient’s renal function soon digressed to Stage 4 Chronic Kidney Disease (CKD) and she was transferred to a hospital more equipped to address her complications. The diagnosis of SLE, despite being negative for all common autoantibodies associated with SLE, was unusual. The added catastrophic APS is a rare variant of the disease, and it resulted in the failure of multiple organs. The prognosis for this patient is poor with a renal transplant being the only long-term solution.

April Nelson is an instructor. Kassi Erickson is an instructor. Stacie Lansink is program director. Tiffany Niemann is laboratory support specialist. They are all with the Medical Laboratory Science Program at South Dakota State University in Brookings, South Dakota.

Rosemarie Clauson is an MLS-generalist at Jamestown Regional Medical Center in Jamestown, North Dakota.

BEST OF THE BEST BLOGS FROM THE PATIENT SAFETY AND HEALTHCARE QUALITY COMMUNITY

Sarah Beatty, MHSA, MLS(ASCP)CM, and Doryan Redding, ASCLS Patient Safety Committee Members

2019 was a busy year in patient safety. It saw new innovations in technology and practice as providers, health centers, and organizations move toward thinking of patients as more than just a number. Instead, patient safety initiatives, such as patient-centered care and personalized medicine, are becoming prioritized in hospital strategies because they demonstrate better health outcomes, quality scores, and cost-efficient care. The ASCLS Patient Safety Committee provides original content related to our profession that prove these exact points.

Last year this committee published 72 blog posts on ASCLS Connect through the Patient Safety and Healthcare Quality Community. In this article, we have assessed the best articles and resources from 2019 for ASCLS members who may not know about the latest information related to patient safety. We hope that by reading this you are inspired to help promote this shared purpose.

We divided the posts from the community into four categories: Provider Information (11), Policy Updates (16), New Resources and Innovation (14), and Choosing Wisely/Other Best Practices (31). Below read the one article per category that we chose to highlight as the best posts of 2019.

“Staying informed regarding patient safety initiatives is important because when medical errors occur, they not only have an impact on patients, but also on the medical professionals who make them.”

Provider Information
Advocate Excellence – ECRI’s Top 10 Patient Safety Concerns for 2019
The Emergency Care Research Institute (ECRI) released a list of the topics they see as the top challenges to the advancement of patient safety in the healthcare environment. Some of these concerns were on specific incidences, such as the recognition of sepsis or infections from incorrectly inserted IV lines. However, a majority of them spoke to the heart of the problems our committee is trying to address, such as patients’ insistence on receiving antibiotics, leading to overprescribing; burnout of health professionals; lack of development in training for high-risk situations; and standardizing patient safety efforts.

Furthermore, this article provided a detailed analysis on why these concerns should be taken seriously and suggested corrective action that could implement systemic change. Things like providers asking specific questions before prescribing antibiotics; centering on patient goals for treatment; and implementing simulation training for high-risk situations are just a handful of the great ideas that need to continue being generated to help propel our profession to new heights.

Policy Updates
Advocate Excellence – Using Informatics to Classify Sepsis for Better Outcomes
In 2019, University of Pittsburgh School of Medicine researchers used a machine learning algorithm to analyze 29 clinical variables found in the EHRs of over 20,000 UPMC patients recognized to have acute sepsis. This data concluded that by utilizing these new laboratory assays, the profession may now be better equipped to specifically relate individual cases with the treatment of best fit.

Today, informatics plays a large role in providing patients with quality care by generating both precise and accurate results to the most specific degree. One may say this is a significant increase in the way standard healthcare procedures are conducted. Yet, it also begs the question of whether or not current medical staff are competent at levels suited for allowing these processes to work to the best of their ability. With technology constantly on the rise, should laboratory education be putting a new emphasis on keeping up with the latest innovations in our field?

Regardless of the answer, we must recognize we are living in an age where procedures and policies, with regard to technology, are ever changing and evolving to ensure patients are provided with the best possible outcomes; in this case, pertaining to recognizing conditions and implementing treatment.

New Resources and Innovation
Advocate Excellence – Improving Diagnosis in Medicine (Diagnostic Error Change Package)
This article serves as a single point of strategy for executives, quality leaders, and managers for integrating patient safety into each aspect of daily operations. As medical laboratory professionals, we strive to advocate for clinical initiatives to protect patient safety and this package encapsulated it perfectly. The patient stories tug at your heartstrings while the toolkit provides detailed means by which patient safety can be ensured at any level.

One example is creating an anonymous feedback tool to alert providers and leadership to potential diagnostic issues or when testing is contraindicated or unnecessarily duplicated. Another example suggests instituting a metric for tracking laboratory errors that can contribute to diagnostic error and implementing tools to better perform information handoffs. Working with management to adjust shifts to ensure overlap would preserve the continuum of care for necessary information and complicated cases. Additionally, having an open discussion on root cause analysis, the process, and structural issues that led to the error to encourage a culture of safety and promote reporting of issues and errors.

Choosing Wisely and Other Best Practices
Advocate Excellence – Half of Hospital Infections Could Be Prevented with Proper Protocols
One of the reasons why patient safety is a cause for concern is because standard protocols are not being practiced uniformly. This results in poor outcomes for patients, which contradicts the goal of health professionals. Resources like the Choosing Wisely initiative, have been helpful in bridging dialogue between physicians, laboratorians, and patients about the risks and benefits of certain tests, treatments, and procedures. The data in this article exemplifies the need for that kind of communication.

As medical laboratory scientists, we are in a position to both alert and help other health professionals when we see best practices are not taking place. These kinds of discussions can lead to better shared decision-making in facilities to try and combat these kinds of systemic issues.

Another study conducted this year revealed diagnostic error accounts for one-third of malpractice claims. These errors were often attributed to mistakes in clinical judgement from physicians. With that knowledge, it should be clear there is still a lot of work to be done to reform healthcare practices. Visibility is always something our profession is striving to achieve. Perhaps with the recognition of this study and the data it provided, physicians and other healthcare providers may better understand the need for quality improvement.

The ASCLS Patient Safety Committee is instrumental in assuring the standard for a good healthcare community. Staying informed regarding patient safety initiatives is important because when medical errors occur, they not only have an impact on patients, but also on the medical professionals who make them. By reading through these blogs and recognizing all the hard work being done to create an environment where team members feel safe to report mistakes and learn from them, we are equipping the next generation of medical laboratory professionals with the knowledge they need to protect patient well-being.

Sarah Beatty is president and CEO of Improvement Intelligence in Brighton, Michigan.

Doryan Redding is a clinical laboratory science student at Texas State University in San Marcos, Texas.

FIFTY YEARS WITH ASCLS

George A. Fritsma, MS, MLS(ASCP)CM

Lt. George Fritsma in 1970 and George Fritsma now.

When I joined ASCLS—then the American Society for Medical Technology (ASMT)—in 1970, I was an Air Force first lieutenant directing a lab at Selfridge AFB north of Detroit. The annual convention was held at Cobo Hall (since demolished) in downtown Detroit, and it was the first convention I had ever attended. I found the exhibit hall but didn’t even know there were presentations in breakout rooms or hospitality suites.

In 1970 the Vietnam War had become a national disgrace, so to avoid disapproval I wore civilian clothes. I was the height of fashion in a green polyester suit with bell-bottoms and patent leather shoes. Selfridge’s commander learned that I had not worn my uniform and invited me to his office to “tear off a strip” when I returned. I subsequently wore my dress blues and drove the colonel’s staff car to the meeting.

When I separated from the Air Force in 1972, I attended an ASMT “lab tech” recruitment conference. While there I connected with my first civilian employer, Metropolitan Hospital in Detroit, associated with Highland Park Community College. Once in Detroit I became active in the Michigan Society for Medical Technology, serving as awards chair for a couple years.

Not every professional joins his or her association. Only 15 percent of practicing U.S. physicians join the American Medical Association. And of four million nurses, less than 200,000 join the American Nurses Association. Most health professionals are happy to meet the requirements of their positions with integrity, serving their patients well, and going home with a sense of professional satisfaction. We are not a nation of joiners, but we are happy to serve with competence.

So, who does join? Professional associations are the best sources for continuing education. Their workshops and seminars feature educators, thought leaders, and researchers working at the top of their profession. Associations blossomed when states began to mandate continuing education. Recently, however, we access electronic libraries and participate in inexpensive international webinars in the comfort of our home or workplace.

Wandering around the ASMT meeting in 1970, I noticed people seemed to spend their time chatting with colleagues, often while tipping a beer. I thought, “Not much going on here.” As I later found my own circle, I figured out these are people with responsibilities who relied on each other for information and support. Amidst many “superficial” conversations, we were learning new technologies, making personnel recommendations, and gaining professional insights.

As the years went on, through the Society I met many brilliant people; scientists, writers, and educators—each has been influential. And perhaps more importantly, every professional position I’ve held, every contribution I’ve made, and every opportunity that has come to me is a direct result of my involvement with ASCLS and the people I’ve met.

Garrison Keillor says that we join committees out of guilt. Some join just because we can’t say no. But most of us in ASCLS who have been around a few years participate as a means of giving back to our profession, from the gifts ASCLS continues to give us.

George Fritsma is proprietor of The Fritsma Factor, Your Interactive Hemostasis Resource, and lives near Birmingham, Alabama.

HOW STATE MEETINGS ENGAGE REGION I MEMBERS

Lisa Hochstein, MS, MLS(ASCP)CM, ASCLS Region I Director

ASCLS-NY brings continuing education opportunities to all members by holding meetings upstate and downstate in alternate years.

In Region I, we have three active constituent state societies. These societies are both large and small and each takes steps to make their state meetings work for their members. Here is a sample of what we do for continuing education.

ASCLS-New York is a one of the states with a large membership within Region I. Geographically, the state is also so large the meetings are held upstate and downstate in alternate years. ASCLS-NY moves the meeting to the larger cities in the upstate area and in the New York City area for the downstate meeting. New venues need to be found each time the meeting moves and a new host for the venue chosen. It would be easier to stay in one place, but this arrangement works well for the members. Using this approach, ASCLS-NY is able to bring continuing education opportunities to all members.

ASCLS-Maine has a smaller state membership within Region I. Despite being small in number, it knows how to put on a seminar! The three-day “Maine Meeting,” as people call it, is well known. It occurs each fall and is a joint venture with ASCLS-ME, AMT, and CLMA. This group shows that collaboration works, bringing together members of all three societies in the preparation of the meeting. Its meeting is a big success in a small state.

ASCLS-Central New England, one of the larger groups within Region I, also holds a very successful meeting each year. Rhode Island serves as the venue for the meeting for the states that make up CNE. This three-day meeting is well attended and brings members from Rhode Island, Vermont, New Hampshire, and Massachusetts together for both continuing education and comradery.

Continuing education is one of the many benefits of being an ASCLS member. Our constituent societies each try to deliver this benefit in their own unique way that benefits all their members.

Lisa Hochstein is associate professor/program director of the Clinical Laboratory Sciences Program at St. John’s University in Queens, New York.