Medical Laboratory Observer - March 2025

Clinical Significance of Ionized Magnesium in Critical Care

Blood gas analyzers are essential devices in point-of-care settings such as respiratory care units, surgical suites, intensive care units, emergency rooms, and the central lab. An advanced menu of tests that includes glucose, lactate, ionized calcium, ionized magnesium, electrolytes, estimated plasma volume, BUN and creatinine along with blood gas provides important results at the point of care. This presentation will discuss the clinical value of having access to an advanced complement of blood test results and the significance of ionized magnesium results in critically ill patients.

Primary Speaker

Jessica M Colón-Franco, PhD.

Section Head, Clinical Biochemistry

Medical Director, Special Chemistry

Department of Laboratory Medicine, Cleveland Clinic

Learning Objectives:

- Understand the benefits of whole blood critical care testing at the point of care

- Learn the significance of ionized magnesium testing for critically ill patients

- Describe the advanced tests now available on a blood gas analyzer

Ionized Not Total Magnesium Is a Better Indicator of Hypomagnesemia in Critically Ill Patients

Hypomagnesemia (low levels of magnesium) is associated with several clinical conditions, ranging from cardiovascular disease to respiratory disorders and sepsis. Traditionally, total magnesium (tMg) measured in the laboratory is used to identify patients with hypomagnesemia. However, various studies have shown the clinical significance of using iMg, the functional form of tMg, to correctly identify patients with hypomagnesemia. Marcin Pacek, PhD Senior Director of Medical and Scientific Affairs at Nova, will describe the clinical utility of measuring iMg in various clinical settings.

Speaker

Marcin Pacek, PhD

Senior Director

Medical and Scientific Affairs

Nova Biomedical

Webinar Dates:

Thursday, April 10, 1 pm Eastern Time Thursday, April 24, 3 pm Eastern Time

Register Now: novabiomedical.com/cc-img-mlo

This program offers 1 hour of P.A.C.E. continuing education credits. Nova Biomedical is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.

This program has been approved by the American Association of Critical-Care Nurses (AACN), for 1.00 CERPs, Synergy CERP Category A, File Number 25406. Approval refers to recognition of continuing education only and does not imply AACN approval or endorsement of the content of this educational activity, or the products mentioned.

Together for a better healthcare journey

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Expect more today with an expanding portfolio of solutions for the lab of tomorrow. Sysmex is dedicated to helping you improve patient care, reduce operating costs, increase accuracy and simplify processes. We’re proud to offer labs of all sizes award-winning services and innovative solutions to make laboratory life easier. As a global leader in diagnostics, our automated systems set the standards that transform healthcare and contribute to healthier lives. The sky is the limit: www.sysmex.com/us

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Robert F Moran, PhD, FCCM, FIUPAC

Dominique Dotson, PhD; Cathryn Mullen, BS, ASQ-QPA; Kellie Quash, MLS,

Notice of data security incident

By Christina Wichmann Editor in Chief

Ihave to tell you something — I’m getting tired of getting these notices in the mail. How many have you received the past few years? In 2024, I got the Change Healthcare letter; a Ticketmaster letter; and most recently, a letter from Walsworth, the publisher of my kids’ yearbooks. A few years ago, I was part of a big breach at DuPage Medical Group (now Duly Health and Care).

A recent survey of 1,309 healthcare IT and security professionals by Netwrix revealed 84% detected a cyberattack or intrusion in the past 12 months.1 According to the survey, 24% of the healthcare organizations are fully cloud-based, 12% have an on-premises IT infrastructure, and 64% have a hybrid infrastructure. Account compromise (74%) topped the list of security incidents for cloud attacks where a user or administrator account was compromised. Phishing was the most common type of incident experienced on premises (63%), but it was also high for cloud-based (62%). Protected health information (PHI) is one of the most expensive types of data sold on the darknet, which makes healthcare organizations a top target for cybercriminals. A PHI breach can include names, birthdays, addresses, Social Security numbers, insurance information, diagnosis/conditions, and other treatment information.

This month, we published the results of our fourth State of the Industry survey on laboratory data analytics. Thank you to all who responded to this survey. Current IT priorities in the lab include infrastructure and platform development/new LIS, data analytics optimization, revenue cycle management optimization, integration of the electronic health record, interconnectivity with reference and public health labs, and a bi-directional system to integrate within a health system. However, laboratory goals are encumbered by issues including staffing challenges, inadequate information technology (IT) support, and cost constraints. We did not ask specific cybersecurity questions, but looking at the incidents above (staff member account compromises and phishing), it would be interesting to know how much cybersecurity training and support healthcare staff are receiving from their organizations.

The February 2024 ransomware attack on UnitedHealth-owned Change Healthcare is the largest data breach of health and medical data in U.S. history. Originally estimated to affect at least 100 million people, the latest estimate confirmed by UnitedHealth is closer to 190 million. According to the UnitedHealth CEO’s testimony before the House, the criminal hackers “used compromised credentials to remotely access a Change Healthcare Citrix portal.” Citrix software allows employees to access their work computers remotely on their internal networks. The CEO did not explain how the credentials were stolen, but the user’s account was not set up with multi-factor authentication, which is a basic security feature to prevent password reuse attacks by requiring a second code sent to that account holder’s phone.

Human error is the primary cause of ransomware attacks. And criminals are getting more and more sophisticated and aggressive in getting access. Without regular training, staff members may not recognize the risks associated with suspicious emails, websites, or software downloads. Creating strong passwords that are not straight dictionary words and numbers and regularly changing these passwords are also important.

Speaking of error, in the last issue on page 14, Figures 2 and 3 were inverted.

I welcome your comments and questions — please send them to me at cwichmann@mlo-online.com.

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MLO EDITORIAL ADVISORY BOARD

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Electrolytes in blood (and water): Measurement and clinical overview

By Robert F. Moran, PhD, FCCM, FIUPAC

Electrolytes are simply electrically charged molecules or elements (ions) that get their charge as they dissolve by complete or partial dissociation in an aqueous medium — that is, in the water fraction of the fluid in which they are a part. Acids, bases, proteins, salts, and solids can be electrolytes under a specific set of circumstances. For example, table salt

Earning CEUs

or sodium chloride (NaCl), dissolves by dissociation into sodium ion and chloride ion with no remaining sodium chloride molecule in the solution: NaCl à Na+ + Cl-. However, carbonic acid (dihydrogen carbonate) partially dissociates into hydrogen ions and hydrogen carbonate ions (bicarbonate ions) with small amounts of the acid molecule remaining: H 2 CO 3 ⇌ H+ + HCO 3.

See test online at https://ce.mlo-online.com/courses/electrolytes-in-bloodand-water-measurement-and-clinical-overview/ Passing scores of 70 percent or higher are eligible for 1 contact hour of P.A.C.E. credit.

LEARNING OBJECTIVES

Upon completion of this article, the reader will be able to:

1. Describe what electrolytes are and the elements that constitute them.

2. Differentiate which electrolytes make up the different homeostatic systems.

3. Describe the advancements of measurement technology in enhanced blood gas analyzers and their limitations.

4. Discuss clinical implications of electrolyte imbalances using the anion gap.

Our focus here is the electrolytes of blood, primarily those that are major determinants of water and electrical balance within the homeostatic system (Figure 1). Other essential electrolytes (e.g., calcium, magnesium, bicarbonate, phosphate) are best covered in detail separately.

Electrolytes play several major roles in sustaining life. The complexity of the human organism is such that all these aspects can play a role in maintaining overall electrical neutrality/ electrochemical signal transmission and osmotic (cellular) balance. Further, some are essential to enzyme action and energy production when they function as co-factors in critical reactions. For the sake of brevity and with a focus on urgent care (e.g., point-of-care or POC), this discussion of electrolytes will take a simple approach.

Among the common electrolytes, sodium (Na) and potassium (K), are the principal cations (positive ions) in the extracellular and intracellular fluids, respectively. Jointly, they help to keep

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both electrical neutrality and cellular integrity, along with their counterpart anions (negative ions), chloride (Cl), and bicarbonate (HCO3-). Calcium(Ca) and magnesium (Mg) are significant in bone structure and a small fraction of each, as ions, are critical to functions such as energy production and cardiac function. Finally, proteins/proteinate (PR-) anions are contributors to ionic balance as well as to cell integrity because of their osmotic pressure.

Measurement technology affects clinical decisions

Clinical evaluation in the acute care setting requires both testing of body fluids for electrolyte levels and clinical diagnostic/therapeutic intervention activities. Therefore, the POC measurement’s capabilities must be not only rapid but as exact as central laboratory testing. The enhanced blood gas analyzers (eBGAs) as currently marketed meet that criterion, but in doing so, raise some issues that may not be fully appreciated by caregivers/physicians. These issues can impact terminology as well as clinical practice and judgment. Measurement of electrolytes in whole blood is an extension of the blood gas technology itself. That is, membranes cover the sensor to prevent cells from interfering and each electrolyte is sensed because of its quantitative interaction with material in or behind the membrane which in turn causes a change in voltage or current. While specific components may differ, the key is that the sensor detects the signal that results from the concentration in the water fraction. On the other hand, most central laboratory systems dilute the specimen and aqueous calibrator before measurement, meaning that the presence of plasma/ serum protein, which is not part of the fluid in which the electrolyte is dissolved, is ignored!

From the earliest days of measurement, amounts of electrolyte reported were based on the volume of liquid (serum or plasma), not on the liquid in which the electrolyte is dissolved. The result is thus factitiously lower. Fortunately, this does not matter if all patients

Critical Homeostatic Systems

Electrolytes

Metabolites

have the same protein levels (6–8% of serum/plasma volume). But as is well known, protein concentrations vary and protein abnormalities exist, and they can affect the apparent electrolyte results. There is a comparable situation that can exist in situations of high lipid levels — extremely low results can be reported using the older technology.

Modern technology wins. The electrolyte sensors in the eBGAs are selective for the concentration/activity in the water part of the whole blood. One added note to this issue, the eBGAs of at least the three major manufacturers (Siemens, Radiometer, and Werfen) are all designed to report the electrolytes with reference values based on normal plasma water (i.e., they are ‘harmonized’ to agree using the protocol of CLSI

Sodium (Na) Related Disorders

Hypernatremia

Water loss

• Diarrhea

• Excess sweating

Low intake

• Coma

• Hypothalamic lesion

Renal polyuria

• High calcium

• K+ depletion

• Interstitial nephritis

Polyuria

• Osmotic diuretics

• Diabetes: inspidus & mellitus

Hyponatremia

Dilutional

• CHF

• Edema hypoalbuminemia

• Nephrotic syndrome

• Malabsorption

Non-renal Na loss

• Vomiting

• Diarrhea

Renal Na loss

• Enforced diuresis

• Renal disease

Table 1. Sodium-related conditions. Note: When using directmeasuring ISEs as described, there is no longer the risk of artifactually low sodium. Since the measurement is in plasma water and on eBGAs, it is harmonized to agree with CL if plasma water is normal.

standard C29A2). So, despite the direct measurement technology, no meaningful change in reference values for electrolytes would be manifested. This was developed out of concern for potential confusion and issues with clinical care through a consensus process with the Clinical and Laboratory Standards Institute (CLSI), the National Institute of Standards and Technology (NIST), and the scientists of several manufacturers of systems having this technology.

Clinical implications

The two major ions of extracellular fluid (EC), especially of blood plasma, are sodium and chloride. These ions track each other in health and abnormal conditions with a few notable exceptions, such as metabolic acidosis, some cancer medications, and fluid replacement treatment (See Table 2).

Potassium is a cation like sodium but in a much lower concentration, and it is not a direct/major player in fluid balance. (Its role is due more to its effects on heart muscle.)

Sodium

Sodium’s typical values are 135–148 mmol/L, a narrow range. Deviations outside of < 120 mmol/L or > 155 may be life-threatening, but even small deviations outside the reference range may cause significant clinical changes. Note on unit used:The recommended unit of concentration is mol/L (molarity) or one of its fractions, usually millimole per liter (mmol/L). However, some reports use mEq/L. The numeric value for all monovalent ions is the same using either unit. Specimen collection: Routine electrolytes are typically measured on serum(s). However, with the proper anticoagulant,

Image credit: mySciences (RFMoran)

Figure 1. Critical homeostatic systems.

Chloride (Cl)-related conditions

Chloride Increased > 110 Decreased < 95

• Hyperchloremic metabolic acidosis

• Respiratory alkalosis/ Hyperventilation

• Severe dehydration (diabetes)

• IV saline

• Renal disease

• Metabolic alkalosis

• Overhydration

• Congestive heart failure

• Burns

• Salt depletion

• Addison’s disease

• Excess hypotonic IV fluids

plasma may be used. In critical care, whole blood collected in syringes, evacuated tubes, or capillary tubes (anatomic sources: arterial, venous, capillary bed) are used but the ion-selective electrodes (ISE) functionally separate the cells from liquid and the values are concentrations in plasma (p) or plasma-water (ph) harmonized to agree with the central lab method. Using whole blood reduces processing and waiting time, and if blood gases are required, eliminates a separate collection. However, collection devices must have standardized volumes of liquid heparin (usually lithium heparin to avoid other interferences) or very soluble dry/lyophilized (‘crystallized’) heparin. Caveat: The use of therapeutic heparin is likely to cause errors, due to specimen dilution variation and/ or electrolyte/pH effects from the heparin used (e.g., Na-heparin).

Clinical implications: Sodium is the major extracellular cation. As such, it controls the fluid space and balance and consequently osmotic relationships. See Table 1 for conditions related to too high of concentrations (hypernatremia) and too low of concentrations (hyponatremia) in the blood.

Chloride

The element/ion chloride is the major extracellular anion. (atomic number of 17, atomic mass 35.5 g/mol.). Chloride levels parallel those of the sodium ion (Na+). Typical values for chloride are between 95–110 mmol/L. Again, as with sodium, the concentration may be reported as mEq/L, with no numeric difference.

Specimen collection: Identical to sodium.

• Acidosis

the same specimen handling requirements as sodium and chloride, and using eBGA’s, it is also measured in plasma water. The fact that potassium is found in high concentrations in intact cells leads to the need for exceptional care in collecting specimens to avoid tissue or blood cell potassium introduction to the specimen by excessive manipulation of the limb during collection or of the specimen itself, leading to hemolysis, both of which may be factors in the values obtained (i.e., artefactually elevated).

Potassium measurement: Technology for potassium measurement has evolved along with other electrolytes.Originally, potassium was measured by techniques like that of sodium. Today, the eBGA’s measurements are based on ISEs with the sensor having a potassium-sensitive chromophore rather than the glass electrode used for sodium; other than that, the procedure is the same.

Clinical implications: Differing potassium values are shown in Table 3. Both elevated (hyperkalemia) and decreased (hypokalemia) potassium levels can affect important functions in the body.

Anion Gap

The anion gap (AnGap or A.G.) blood test is the difference between the ‘total’ concentration of cations and the measured number of anions and has been used as a diagnostic tool to differentiate between causes of electrolyte and acid-base disorders. On most eBGAs, the cations used are sodium and potassium and the anions are the measured chloride and the bicarbonate (hydrogen carbonate) from the blood gas measurements since all are readily available on the same measurement platform (See Figure 2).

Clinical Implications: The anion gap calculation aids in the assessment of non-respiratory/metabolic acidosis. A high anion gap usually shows the presence of some combination of the unmeasured anions already mentioned, as well as sulfate, acetoacetate, β-hydroxybutyrate, etc. Sources of these anions must be part of the evaluation of acidosis such as diabetic ketoacidosis (DKA) or alcohol abuse. Toxins such as methanol, glycol, iron, cyanide, aspirin, etc. or uremia/renal failure with decreased bicarbonate reabsorption, decreased acid excretion, accumulation of sulfates, urates, and phosphates should also be considered.

• Renal failure

Chloride measurement: Early measurement technology relied on the reaction of the chloride ion present in the specimen with either silver to form a precipitate of AgCl, or with a chelating agent to form a colored complex with later titration to obtain results. Most eBGA’s are based on ISEs with the sensor having a chloride-sensitive chromophore. The key is the selectivity of the sensor for chloride; that is the chromophore reaction with chloride only.

Clinical implications: An elevated or decreased chloride measurement can indicate several primary conditions as well as those that are secondary to other disorders (See Table 2).

Potassium

Potassium (K+)in the blood plasma/serum is a minor cation with a major impact. With typical values between 3.5–4.6 mmol/L, it is between two and three percent of the cationic load. However, as seen in Table 3, minor numerical changes have grave consequences. Potassium has the same unit (mmol/L) and

• Muscle necrosis

• IV administration

• NG suction

• Laxative abuse

• Malabsorption

• Diarrhea

• Transfusion of older blood

• Adrenogenital syndrome

• Mg Depletion

• Antibiotics

• Increased mineral corticoids

• Renal tubular acidosis

• Licorice abuse

• Adrenal insufficiency

• Thrombocytosis

• Hemolyzed specimen

• Familial hypokalemic paralysis

• DKA

• Acute myeloid leukemia

• Decreased K+ intake

Table 2. Chloride-related conditions.

Table 3. Potassium-related conditions. Potassium(K) - Related Conditions

AnGap = cNa+ + cK+ – cCl- - cHCO3or in a more familiar notation AnGap = [Na+] + [K+] – [Cl-] - [HCO3-]

Square brackets have been used by chemists to represent molar concentration but may be confused with a mathematical operator (second equation). Consequently, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Union of Pure and Applied Chemistry (IUPAC) recommend using an italic, lowercase ‘c’ (first equation). Typical values using this equation are between 11–20 mmol/L. Make sure you know your testing lab’s protocol and expected range before using any values to interpret patient status.

2. Calculating the anion gap.

Normal AnGap with acidosis can only be the result of decreased bicarbonate. To keep neutrality, chloride must increase as it is the only major anion. Loss of bicarbonate may be caused by GI loss (diarrhea), Renal loss (renal tubular acidosis), ingestions (ammonium chloride), or total parenteral nutrition (TPN).

Low AnGap can result fromloss of albumin or from an increase in chloride and bicarbonate to keep neutrality.

Electrolytes: An overall summary

The full scope of a discussion on electrolytes, both the analytical and the clinical, deserves much more space than we have here. But even in the brief paragraphs above, it is evident that electrolytes have a dramatic clinical impact on the overall well-being of the patient. The clinician must consider not only whether there is a primary electrolyte disturbance or one related to other therapeutic interventions. Especially when there is a discrepancy between the eBGA electrolytes and the central laboratory’s results, such differences must be clinically evaluated in addition to investigation of potential analytical error. The electrolyte homeostatic systems are related to the acid-base, and all are related to the pulmonary gas exchange, oxygen transport, and utilization.

REFERENCES/SUGGESTED READINGS

1. Clinical and Laboratory Standards Institute. Approved Standard C29-A2. Clinical and Laboratory Standards Institute; 2000. Wayne, PA. Available from: https://clsi.org/ media/1364/c29a2_sample.pdf.

2. Moran RF, Liesching TN. The ABC’s of Abg’s(Tm): A Cyclopedic Dictionary of the Testing Terms Used in Critical Care Momentum Press; 2018.

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3. Moran RF. POC Testing and Reporting of Sodium, and Other Small Molecules Need Modified IFCC Source/Type Designations to Improve Operational Efficacy and for Clinically Accurate, Unambiguous Reporting from LIMS and HIS. EJIFCC. 2023;34(4):271-275.

4. Moran RF. CE: Point of Care-Managing change when you are not in charge. MLO. 2024;56:8-12.

Robert F. Moran, PhD, FCCM, FIUPAC is the Principal Scientist at mviSciences, a consulting and educational services organization and President of AccuTest™ Proficiency Testing Services. Dr. Moran served multiple terms on the NCCLS (Now CLSI) Board of Directors and was an active participant or chairholder in several of their blood gas and electrolyte standards-writing teams. Also active in clinical chemistry internationally, he is an appointed Fellow of the International Union of Pure and Applied Chemistry (FIUPAC). He is a retired professor of chemistry and physics from Wentworth Institute of Technology but remains active in consulting work and writing.

Figure

Dear API Abby

By Sue Styles, MSI; Danielle Casey, MBA, MLS(ASCP)CM; Anita Hoeksema, MS, MLS(ASCP)CM

Thank you for submitting your proficiency testing questions. Dear API Abby is here with answers! The American Proficiency Institute (API) is pleased to share its technical expertise on all things proficiency testing. API, a global leader in proficiency testing programs, is dedicated to improving the accuracy and efficiency of clinical laboratory testing. Known for its constant innovation in the field, API offers technical expertise and checklists to help its laboratory customers become more proficient. Now let’s get to your questions!

Dear API Abby:

The laboratory world has always been my happy place, but writing skills, not so much. As much as I try to avoid them, typographical errors happen when submitting proficiency testing results. I really don’t mean to, but sometimes I type in the wrong number. What’s my penalty for these mistakes? Is there a corrective action that is assigned specifically for typographical errors?

— Oops I Did It Again

Dear Oops:

Reporting results is an essential component of laboratory testing. While it might be rare for you to type patient results, there are times when this may be necessary. Transcription errors could go unnoticed in the laboratory and have serious consequences. That is why proficiency testing issues due to transcription errors are treated by regulators the same as other proficiency testing failures. Even little errors can create major concerns; so as laboratorians, we need to take them quite seriously.

As with any failure, you should determine its root cause. All laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) must have corrective action policies and procedures in place to ensure accurate and reliable patient results and reports. Checking those policies specific to your laboratory would be a good place to start.

When it is determined that a transcription or clerical error occurred, additional thought should go into the reason why. Was the employee rushing?

Are they able to clearly read the instrument print out or interpret the test? Is the computer and work environment set up sufficiently? Is there a policy to proof manual entry? After questions such as these have been answered, you should determine what can be done to prevent this error from reoccurring. Retraining personnel on your laboratory’s policies and procedures, how to read the instrument print out, or interpretation of results may be necessary. Perhaps an employee may be due for an eye examination. This should be supported to ensure they are able to see computer screens and print texts clearly. Remember too that manual entry should be proofed before releasing results.

Even a small “oops” can have big consequences — for patients, for the laboratory, and for you. We applaud you for acknowledging the problem and encourage you to take action to prevent it from occurring again.

Dear API Abby:

I work in the microbiology laboratory of a hospital where my specialty

is bacteriology. The last time we added a new method in bacteriology, we knew we wanted to do proficiency testing for it. But do we have to add proficiency testing specifically for each new method we add?

— Curious Staph Member

Dear Curious:

Not necessarily, but there are several factors to consider. Proficiency testing for microbiology is regulated according to subspecialties: bacteriology, mycobacteriology, mycology, parasitology, and virology. Within each subspecialty, proficiency testing is not necessarily required for each specific method or technology used, but there are different types of testing that should be included as well as other regulatory requirements to keep in mind.

According to CLIA, a laboratory must perform a minimum of five challenges, three times per year for each of its microbiology subspecialties. Best practice is to spread the challenges over multiple procedures and methods within each subspecialty. For bacteriology, you should include methods for identification, antigen detection, toxin detection,

gram stain, and susceptibility testing. If your laboratory has a large test menu, you will likely exceed the minimum five challenges per subspecialty.You should also review both your laboratory accreditation and state requirements as they may mandate additional proficiency testing for specific procedures.

Although it may seem like a lot of “proficiency testing,” you are actually meeting other requirements too. Proficiency testing may serve as the “blind testing” element required for CLIA personnel competency documentation as listed in §493.1413(b)(8) and §493.1451(b) (8). Proficiency testing also helps your laboratory demonstrate reliability and accuracy on all tests performed within the laboratory, as required in §493.1236.

Each of these requirements contributes to ensuring the overall quality of patient testing.

Dear API Abby:

I am responsible for reporting our microbiology proficiency testing results, and here is my question: For culture samples, why are there so many options when reporting results for the organism recovered? Is it totally up to me how general

or specific my answer is, or is there some guidance I should be following?

— A Person of Culture

Dear Culture:

For better or worse, the guidance is the same for all proficiency testing: treat the sample as you would a patient sample. This includes reporting. When testing and reporting a culture for a patient, sometimes you arrive at a species identification, and sometimes a genus or category is where your testing stops. Your protocols for testing and reporting different organisms are determined by your laboratory director and may depend on factors such as the sample source or patient history. That could be why you see reporting options not used in your laboratory.

Please note that CLIA requires that organisms reported for proficiency testing results are at the same taxonomy level as used for patient results, and the updated language in the July 11, 2022, CLIA final rule makes that clearer and easier to enforce now. So if you are looking at identification options for a proficiency sample and would report that patient result to the species level,

do the same for the proficiency testing result. This does not mean all samples must have the same level of specificity, if that is what you are concerned about. Follow your laboratory procedure and choose the response that is closest to what you would report for a patient. If you have reviewed the list carefully and there is no match, your proficiency provider likely allows you to enter a description that would match what is used in your laboratory.

Dear API Abby:

I know there was a CLIA change related to prothrombin time, but I’m really not clear on all of the rules and how they will impact my lab. Would you clarify?

— Rules Not Clotting Fast Enough

Dear Clotting:

Glad to lend a hand. First, remember that proficiency test results must be reported in the same manner as patient test results. For prothrombin time, we know that patient results may be reported in seconds or as an international normalized ratio (INR). Prior to the CLIA updates effective in 2025, only prothrombin time in seconds was a regulated analyte. CLIA now includes both prothrombin time in seconds and as INR. Therefore, if you report patient results as seconds, INR, or both, you must report your proficiency testing results the same way: as seconds, INR, or both. You probably have already been doing this.

Starting in 2025, if proficiency testing results are reported as INR, they will be evaluated according to regulatory criteria. The criteria for acceptable performance of prothrombin time, whether in seconds or INR, is a target of ±15 percent.

If a laboratory reports both prothrombin time in seconds and as INR, both will be evaluated according to regulatory criteria. However, only one score will be transmitted and monitored by the Centers for Medicare & Medicaid Services (CMS), and the agency has clarified they prefer the INR score, if available.

Dear API Abby:

Must I perform proficiency testing if my laboratory is only conducting waived testing? What are the rules on this?

— Simon Says

tests, especially laboratories like yours, with a Certificate of Waiver or Certificate for Provider-Performed Microscopy. However, recent CLIA changes did mention proficiency testing for waived tests, so we understand your query. That change only affects moderate or high complexity laboratories. Keep reading for a question about that from another laboratory colleague at a different type of laboratory.

So for your waived testing laboratory, all that is required by CLIA is that you follow manufacturers’ instructions. But you should also follow up with your state or accrediting agency as they may have additional rules that could require proficiency testing for some waived tests.

And even if you, Simon, won’t say it, we will: proficiency testing is an essential tool for helping laboratories get the right results – no matter the complexity of testing. Proficiency testing provides an independent and external assessment in how tests are conducted, and helps laboratories manage risk. Proficiency test results are used to verify methods and equipment, and are excellent sources of continuous education for your laboratory staff. Even if it is not required for your laboratory, you may want to look deeper into how proficiency testing will ultimately benefit you.

Dear API Abby:

Can you help settle an argument in our laboratory? We have a moderate/high complexity laboratory, and we have point-of-care testing under the same CLIA number. But in point of care, we are only performing waived testing! Since the point-of-care testing is waived, I don’t think the CLIA rules about how to conduct proficiency testing apply to that department. Our new laboratory manager said that is not true.

— Don’t Worry; It’s Waived

Dear Waived:

Dear Simon:

CLIA does not require any laboratory to perform proficiency testing for waived

I’m sorry; I have to side with your new manager here. The recent CLIA change addresses this situation. The rule makes it clear that moderate or high complexity laboratories must treat all their proficiency testing the same, even proficiency testing for waived tests. This means you cannot test samples for waived tests more than once no matter how many staff you have performing those tests. You cannot assign your most experienced staff to perform all the proficiency testing, and you

cannot discuss the results with other laboratories until after the due date for submitting results. All the usual rules about proficiency testing apply to any proficiency testing moderate or high complexity laboratories perform. The “waived” status of the test doesn’t waive the CLIA requirements about how to handle proficiency testing.

Kudos to your laboratory for performing proficiency testing on your waived tests! Even though that is not required by CLIA, proficiency testing participation helps to ensure reliable and accurate results.

Sue Styles, MSI is Director of Quality and Regulatory Affairs at American Proficiency Institute. She is responsible for API’s CLIA compliance and approval with regulatory organizations and oversees reporting of laboratory data to those organizations. Ms. Styles led API’s accreditation to the ISO standard for proficiency testing providers, ISO/IEC 17043, and has conducted international training on topics related to the standard. As part of maintaining API’s quality management system, she is also involved with auditing, analyzing sample quality data, and setting policy.

Danielle Casey, MBA, MLS(ASCP)CM is Vendor Relations Manager at American Proficiency Institute. She oversees sample procurement, organizes pilot studies, and plays a critical role in the strategic planning of proficiency testing programs. Ms. Casey is the primary contact for IVD manufacturers to work with API to develop proficiency programs for novel test systems and analytes. She has been instrumental in researching, developing, and implementing over 30 new proficiency testing programs for API including a Urinary Tract Infection Panel and a Nail Infection Panel, both of which were the first of their kind in the world.

Anita Hoeksema, MS, MLS(ASCP)CM is the Technical Support Manager at American Proficiency Institute. She oversees the development and maintenance of proficiency testing programs including providing participant instructions, collecting results, and generating evaluations. Ms. Hoeksema provides technical leadership to a team of medical laboratory scientists who implement API programs according to CLIA requirements and provide technical support to participants.

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Point-of-care testing A new era for endurance medicine

By Dr. Stéphane Bermon, Mike Nassif, Anand Kapai

The New York City Marathon, one of the six prestigious “majors” worldwide,1 typically features more than 50,000 runners, attracts an average of 2 million spectators, and is supported by more than 10,000 dedicated volunteers. As marathon runners pound the streets and cyclists push through grueling endurance races, a revolution in healthcare is unfolding behind the scenes. At the intersection of medicine and competitive athletics, point-of-care testing (POCT) enables real-time diagnostics that provide essential care on site, easing pressure on local hospitals and helping to ensure safety for all participating athletes. This benefit is essential at events where smaller and local healthcare systems could easily become overwhelmed. Studies show POCT can reduce the rate of unnecessary transports and admissions, keeping healthcare resources focused on critical needs. 2

Effectively managing hydration challenges during the intense heat conditions of the marathon are medical experts tapping into the advantages of POCT technology. POCT is redefining how on-site event medical teams support athletes and event spectators, setting new standards for specialized medical care known as “endurance medicine.” It encompasses planning, staffing, and delivering healthcare services tailored to unique needs as well as addressing risks associated with the event and its attendees. This shift underscores the value of rapid testing in sporting events and speaks to a larger strategy: empowering medical professionals to keep athletes safe without overburdening local community healthcare resources.

This necessity to support communities on a broader scale, particularly in events with significant public attendance, has prompted sport federations like World Athletics3 and their related medical department and emergency medicine counterparts to adopt POCT into their own standardized medical

care concepts and protocols. By doing so, they aim to enhance endurance events by focusing on providing on-site patient care and treatment. The World Academy for Endurance Medicine (WAEM),4 co-founded by World Athletics, provides the Race Emergency Medicine Course (REMC), a specialized training program for medical directors of mass-participation endurance events, focusing on protocols and best practices in endurance medicine. In different endurance events, such as those of the Paris 2024 Olympic Games, WAEM staff trained Paris 2024’s medical staff on how to use POCT devices for the “Marathon Pour Tous,” a mass-endurance race organized during the Paris Olympic Games. As World Athletics Health and Science Department Science Manager Frederic Garrandes explained:

“Intervention represents, to some extent, the failure of prevention. Following this training, the medical staff in Paris are now ready to rapidly identify and optimally treat these medical conditions, but it is essential to continue sending out the right prevention messages to both elite and recreational athletes competing in Paris.”

The growing demand for POCT in endurance events

The past few years have seen a surge in interest in POCT applications in sports medicine, particularly as they apply to endurance events. Marathons, triathlons, cycling, and mountain running races pose unique health risks, requiring medical teams to provide immediate and specialized care in sometimes remote locations. Traditionally, an athlete needing diagnostic tests would be taken to a hospital, but transporting patients during large-scale events can disrupt local medical services and add logistical challenges such as strain on local healthcare systems, transport coordination, or delays in critical care decision-making, potentially impacting the athlete’s health and recovery.

Recognizing this, race directors and medical teams now prioritize on-site solutions that provide rapid diagnostics. World Athletics, known for its commitment to athlete safety, is leading efforts to equip events with the necessary tools and protocols to support this approach. During the recent 2024 New York City Marathon, for example, POCT-equipped medical tents provided diagnostics on-site, enabling medical teams to treat symptoms such as dehydration, overhydration (and its secondary condition hyponatremia), manage heat-related illnesses, and even stabilize chest-pain issues without resorting to hospital transfers. This careful coordination ensures local hospitals can focus on community needs while athletes receive prompt care. By fostering faster treatment times and reducing stress on the

Courtesy of World Athletics

local healthcare system, POCT benefits the athletes, spectators, and event organizers alike.

At the center of these advancements is a POCT blood analysis system that has gained popularity due to its versatility in providing lab-accurate blood gas, electrolyte, and metabolite (BGEM) results at the patient’s side in less than one minute from sample application.5 While other devices may require strict temperature control, the system’s test cards do not require refrigeration. This functionality is particularly useful for those trained in the field of endurance medicine, especially in varying temperature regions where determining hydration and sodium levels may escalate to life-or-death

Studies show POCT can reduce the rate of unnecessary transports and admissions, keeping healthcare resources focused on critical needs.

factors for the participating athletes. A portable, handheld device allows the medical team to quickly respond and deliver the right medical attention to every patient.

A unified front: the integration of labs and POCT

The rise of POCT in endurance sports doesn’t replace the critical role of clinical laboratories. Rather, it highlights a powerful partnership. Clinical laboratories are essential for training medical teams on POCT protocols, ensuring result accuracy, and providing a secondary level of analysis when necessary.6 Laboratories are also partnering with diagnostic manufacturers on standardized protocols for deploying POCT in various settings. This symbiotic relationship between POCT at event sites and laboratory support is shaping a future where diagnostic testing extends seamlessly from hospital labs to racecourses and beyond.

POCT offers a valuable solution for large-scale events by delivering rapid results within minutes, significantly reducing turnaround times compared to traditional laboratory testing. Such a swift response is particularly critical in time-sensitive environments such as marathons and concerts where prompt detection and intervention can prevent emergencies and optimize health management in a crowd.

The Future of POCT in endurance medicine: A transformative journey

The evolution of POCT is set to revolutionize endurance medicine, bringing forward cutting-edge innovations designed to meet increasingly complex and diverse diagnostic needs. With advancements in miniaturization, intuitive design, multiplexing, and advanced connectivity, POCT is paving the way for seamless diagnostic solutions in decentralized settings beyond traditional hospitals. Compact and portable POCT devices are becoming indispensable for events held in remote or crowded locations, such as medical tents or athlete recovery zones. Their optimized footprints allow for easy transport and deployment, even in space-constrained or high-pressure environments. These devices are also engineered with intuitive interfaces, ensuring that medical personnel with varying levels of expertise can operate them confidently and efficiently.

The integration of multiplexing capabilities further elevates the value of POCT in endurance events. By enabling simultaneous testing of multiple biomarkers from a single

sample, these devices streamline diagnostics, reducing the need for repeated blood draws and minimizing discomfort for athletes. This efficiency not only enhances the athlete’s overall experience but also optimizes the utilization of medical resources during large-scale competitions.

Connectivity features in modern POCT solutions allow real-time data sharing with medical teams and electronic health records (EHR). Immediate access to test results ensures rapid decision-making, a critical advantage when timely interventions are necessary to address potential health concerns during events.

Achieving widespread adoption of POCT at endurance events requires a holistic strategy, including the following:

• Public health education : Workshops focused on early intervention at endurance events, raising awareness about the benefits of POCT.

• Athlete empowerment : Training programs that teach athletes and their supporting staff to self-monitor using POCT devices, empowering them to make informed decisions about their health during competitions.

• Research collaborations: Partnerships between sports organizations and academic institutions to study the long-term impact of POCT on athlete safety and performance, driving evidence-based improvements in protocols.

As organizations explore the application of POCT in other large-scale events like festivals and concerts, the lessons from endurance medicine will serve as a blueprint. The combination of emerging technologies and evidence-based approaches will not only enhance athlete safety and performance but also set the stage for a transformative era in endurance medicine.

REFERENCES

1. Vitti A, Nikolaidis PT, Villiger E, Onywera V, Knechtle B. The “New York City Marathon”: participation and performance trends of 1.2M runners during half-century. Res Sports Med. 2020;28(1):121-137. doi:10.1080/15 438627.2019.1586705.

2. Kneifati-Hayek JZ, Incze MA. Reducing Unnecessary Admissions in the Emergency Department. JAMA Intern Med. Published online 2024. doi:10.1001/jamainternmed.2024.7075.

3. World Athletics home page. Worldathletics.org. Accessed January 24, 2025. https://worldathletics.org/.

4. World Academy for Endurance Medicine home. Worldathletics.org. Accessed January 24, 2025. https://worldathletics.org/ waendurancemedicine.

5. epoc® Blood Analysis System. Accessed January 24, 2025. https:// www.siemens-healthineers.com/en-us/blood-gas/blood-gas-systems/ epoc-blood-analysis-system.

6. Brun M, Füzéry AK, Henschke B, Rozak K, Venner AA. Identifying sources of error and selecting quality indicators for point of care testing. Pract Lab Med. 2021;25:e00216. doi:10.1016/j.plabm.2021.e00216.

Dr. Stéphane Bermon is the Director of the Health and Science Department at World Athletics. He also works as a Sports Physician (MD) and Exercise Physiologist (PhD) at the Monaco Institute of Sports Medicine and Surgery. Stéphane holds a Specialized Master (Ecole Centrale de Paris) in Health Engineering. He is or has been a medical advisor for several International Federations (UIM, IBSF) and Anti-Doping Organisations.

Mike Nassif is the head of Point of Care Diagnostics at Siemens Healthineers.

Anand Kapai is the Vice President of Global Marketing at Siemens Healthineers

Managing workplace violence in the laboratory

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)

As laboratory safety professionals, we often focus on chemical hygiene, biohazard safety, waste handling, and emergency management. However, there is another critical aspect of laboratory safety that is demanding our attention more and more: workplace violence. Unfortunately, this topic has historically been overlooked in lab safety discussions, but it is time to change that.

Workplace violence (WPV) encompasses a wide range of aggressive behaviors. The National Institute of Occupational Safety & Health (NIOSH) defines WPV as “any violent act, including physical assaults and threats of assault, directed toward team members at work or on duty and include physical injury, threats, abuse, hostility, harassment, discriminatory language/behavior and other forms of verbal violence that can potentially escalate to physical violence.”

It is crucial to understand that physical injury is not a prerequisite for an incident to be classified as workplace violence. Assault, in this context, includes any act that puts another person in reasonable apprehension of imminent harmful or offensive contact. For those that work directly with patients, this can be difficult to understand since, historically, some violent behaviors by patients have been tolerated by employees and treated as just part of the job.

Recognizing workplace violence

There are four main types of workplace violence, listed from the least to most common in healthcare settings: criminal intent, worker on worker, personal relationship, and customer/client (client on worker).

Criminal intent typically involves crimes like robbery or trespassing. Worker-on-worker violence often stems from breakdowns in relationships, sometimes between colleagues. Personal relationship violence, often related to domestic issues, involves a perpetrator with a personal connection to a laboratory employee. Customer/client violence, the most common in healthcare, occurs when a client becomes violent toward an employee or group of employees. This often occurs when there are disputes over service, products, or money.

Early recognition of potential violence is key to prevention. There are several signs of aggression that can be identified when employees keep watch for them. Disruptive behavior towards team members, patients, or visitors may occur. Co-workers or customers might be irritable and easily provoked to anger. Verbal

outbursts with an intent to intimidate or threaten are signs of potential violence. The use of foul language, insults, or clear threats of violence should always be addressed in the workplace. Sexually inappropriate or discriminatory language should be recognized and escalated to leadership properly. Physical actions like slamming doors, throwing objects, or kicking furniture as well as threatening gestures, attempts to strike people, or grabbing clothes should all be addressed early as workplace violence.

Domestic violence is something that can spill over into the workplace as well, affecting both patients and co-workers. It is characterized by a pattern of coercive behaviors, including physical, emotional, and sexual abuse, as well as social isolation and intimidation (see Table 1 for Indicators of domestic violence).

De-escalating workplace violence

Before violence is recognized in the laboratory, it is important to train laboratory staff in de-escalation techniques.

Physical Psychiatric Behavioral

Bruises, abrasions, lacerations

Feelings of isolation

Fractures and sprains Depression

Multiple injuries in various stages of healing

Injuries during pregnancy

Inconsistent explanations for injuries

Panic attacks

Partner insists on staying close

Reluctance to speak in front of partner

Intense jealousy or possessiveness by partner

Substance abuse Lack of eye contact

Post-traumatic stress symptoms

Table 1. Indicators of domestic violence.

Minimization of injuries

De-escalation is a crucial skill in managing potential violence, and there are helpful and effective strategies to put into practice. Teaching staff when to pick a battle can be key. Determine if the issue at hand is mandatory or negotiable. Offering flexibility when possible can be a powerful deescalation tool.

If someone exhibits violence and seems to be in crisis, they may not comply simply because someone else is insisting they do. Empowering someone to make their own choice is often more effective than overpowering them. When a situation arises, make sure staff do not hesitate to involve department leaders, security personnel, or risk managers when needed. A fast escalation can help to bring resolution to a violent situation very quickly.

Train staff to always maintain calm body language. Keep hands open and visible, maintain non-threatening eye contact, and avoid finger-pointing or crossing of arms. Active listening is also a valuable skill in such situations. Demonstrating empathy and acknowledging concerns can go a long way in diffusing tense situations. Lastly, ensure staff remembers to respect personal space in potentially violent situations. Always maintain an arm’s length distance and avoid touching the agitated person.

Good communication skills are vital when dealing with someone who may be upset. Ninety percent of human communication is non-verbal. Staff need to pay attention to their tone, volume, posture, and facial expressions. These can significantly impact how the de-escalating message is received.

Workplace violence response measures

Despite our best prevention efforts, violent situations may still occur in the laboratory setting. While having a visible security presence in the workplace can decrease the probability of active violence, every laboratory should have a comprehensive workplace violence response plan. This plan should outline clear procedures for various scenarios and be regularly reviewed and practiced by all staff members.

Some violent situations may involve an active shooter. The Federal Bureau of Investigations (FBI) recommends the RunHide-Fight strategy for any active shooter situations.

Run: Have an escape route planned. Leave personal belongings behind and evacuate regardless of whether others follow. Help others escape if possible, but do not move the wounded. Prevent others from entering the area where the shooter may be.

Hide: If you cannot run, hide in an area out of the shooter’s view. Lock the door or block the entry. Silence your cell phone (including vibrate mode) and remain quiet.

Fight: As a last resort, when your life is in imminent danger, fight with as much physical aggression as possible. Improvise weapons and commit fully to your actions.

If law enforcement arrives during an active violence situation, it is important to train team members how to act. They should remain calm and follow all the instructions given by the authorities. Staff should drop any items held in their hands. They should raise their hands and spread their fingers and keep their hands visible at all times while moving as directed.

Workplace violence and lab safety

Preventing workplace violence is about more than just responding to incidents — it is about creating a culture of safety and respect for employees and customers. Leaders should conduct regular training and competency sessions on recognizing potential threats, de-escalation techniques, and proper response procedures. Leaders should also foster an environment where laboratory employees feel comfortable reporting concerns without fear of retaliation.

Regularly assess the laboratory for potential security vulnerabilities and address them promptly. Establish support systems for employees who may be experiencing domestic violence or other personal issues that could potentially lead to workplace violence. Implement and strictly enforce a zero-tolerance policy for workplace violence, including verbal abuse and threatening behavior.

De-escalation is a crucial skill in managing potential violence, and there are helpful and effective strategies to put into practice.

In addition, laboratory leaders should establish strategies to identify and address the factors that contribute to violence throughout the workplace/ organization. The organization needs to maintain a process to ensure the prompt and accurate reporting of all incidents of violence, including those with no physical injury. All leaders and staff should be empowered with the necessary tools to eliminate violence in their areas, and leadership accountability should be cultivated to reduce violence.

Workplace violence is a serious issue that demands our attention and action. It is a safety topic that should be addressed in the laboratory and in every workplace. By understanding the types and signs of workplace violence, mastering de-escalation techniques, and implementing comprehensive response plans, we can create safer laboratory environments for everyone.

Remember, safety is everyone’s responsibility. Remain vigilant, communicate openly, and always prioritize the well-being of yourself and your colleagues. With the right knowledge and preparation, we can effectively manage and prevent workplace violence in our laboratories.

Dan Scungio, MT (ASCP), SLS, CQA (ASQ) has more than 25 years of experience as a certified medical tech. He was a lab manager for 10 years before becoming the laboratory safety officer for Sentara Healthcare, a system of 12 hospitals and more than 20 labs and draw sites in Virginia and North Caroline. As “Dan the Lab Safety Man,” he provides consulting, education, and training in the U.S. and Canada.

How small, high-complexity testing labs can adapt to FDA LDT regulatory shifts

By Dominique Dotson, PhD; Cathryn Mullen, BS, ASQ-QPA; Kellie Quash, MLS, MBA

The landscape of laboratory-developed tests (LDTs) is fraught with uncertainty, particularly as regulatory bodies like the U.S. Food and Drug Administration (FDA) continue to explore oversight mechanisms. For small, highcomplexity testing labs, this evolving environment presents unique challenges. However, it also offers opportunities to harness existing accreditation frameworks such as ISO 15189, CAP (College of American Pathologists), and NY CLEP (New York State Clinical Laboratory Evaluation Program) to build resilience and position for strategic flexibility. By leveraging these robust standards, labs can stay ahead of the curve, ensuring they are prepared to pivot as regulatory landscapes shift.

The current state of FDA LDT regulations

The regulatory framework for laboratory-developed tests (LDTs) remains a topic of significant debate and uncertainty. Historically, LDTs operated with minimal Centers for Medicare & Medicaid Services (CMS) oversight under CLIA (Clinical Laboratory Improvement Amendments). However, the FDA has consistently expressed concerns over the lack of uniform quality and safety standards, particularly for highcomplexity LDT tests.

Impending FDA regulatory compliance aims to bring LDTs closer to the standards applied to in vitro diagnostics (IVDs), including requirements for clinical validation, pre-market approval, and post-market surveillance (including medical device reporting, MDR). For small, high-complexity labs, navigating these changes requires proactive preparation and the leveraging of existing accreditation frameworks to align with the future FDA requirements. These evolving standards may include the need for substantially more validation studies, expanded access to diverse and representative sample populations, and significant financial investment. By strategically planning and optimizing resources, small, high-complexity labs can better position themselves to address these heightened regulations while maintaining compliance and operational efficiency.

A comparative analysis across key regulatory authorities, as seen in Table 1, reveals the following important insights for small, high-complexity labs:

• CLIA (Clinical Laboratory Improvement Amendments): While federally mandated, CLIA’s focus is limited to personnel qualifications and test accuracy. In addition, the enforcement is left up to each state’s discretion. This lack of clinical validation standards and

consistent oversight highlights gaps that FDA oversight would aim to address.

• NY CLEP: With its stringent pre-market test approval process, NY CLEP stands out as the most closely aligned framework to FDA’s proposed regulatory goals. Small, high-complexity labs operating under NY CLEP are already well-positioned for future FDA oversight.

• CAP (College of American Pathologists): CAP accreditation provides strong alignment with FDA goals in quality management, risk management, and test validation. However, it lacks mandatory pre-market review, which will be a key feature of the impending FDA oversight.

• ISO 15189: This international standard emphasizes systematic quality management processes, including defining how tests are validated against their intended use. Having this systematic quality management system already in place provides a strong foundation for labs aiming to prepare for FDA oversight.

Figure 1 illustrates how each of these key regulatory authorities align with the impending LDT regulations.

Bridging existing standards to future requirements

To navigate the evolving regulatory landscape for LDTs, small, high-complexity testing labs can proactively adapt their

operations by leveraging existing accreditation frameworks. By focusing on enhancing quality systems and test validation and also preparing for pre-market review and post-market surveillance, these labs can build resilience and readiness for potential FDA requirements.

1. Enhance quality systems1

A robust quality management system (QMS) is essential for ensuring compliance with both current and anticipated regulations. The FDA focus on consistent quality and risk mitigation underscores the importance of adopting systematic QMS practices.

• ISO 15189: Promotes a risk-based approach to quality management, encouraging labs to identify and mitigate risks proactively. This creates a culture of continuous improvement that can adapt to evolving regulatory needs.

• CAP: Focuses on proficiency testing and risk management, ensuring that labs not only meet current standards but are also prepared to address gaps identified during inspections.

• CLIA: Provides the foundational framework for personnel qualifications and quality control, which can be enhanced with elements from ISO and CAP for a more comprehensive QMS.

CLIA (Clinical Laboratory Improvement Amendments)

NY CLEP (New York Clinical Laboratory Evaluation Program)

CAP (College of American Pathologists)

Federally mandated for all diagnostic labs in the U.S.

State mandated for labs testing New York State (NYS) residents.

Voluntary; recognized as a gold standard by laboratories seeking higher quality benchmarks.

ISO 15189

FDA LDT Regulations

International standard that is voluntary for U.S. clinical labs, but is required for testing clinical samples from some countries outside of the U.S.

Impending regulatory oversight would place LDTs under FDA jurisdiction for safety and clinical validity, akin to medical device regulation.

Focuses on personnel qualifications, quality control, and accurate test performance.

Includes CLIA-like requirements but with additional focus on test approval and validation for clinical utility and accuracy.

Includes CLIA-like requirements but with additional emphasis on continuous quality improvement, risk management, and proficiency testing.

Focuses on the quality management system requirements to ensure well-defined with technical requirements.

Prioritizes pre-market review, clinical validation, and safety, bringing LDTs closer to the standards of in vitro diagnostics (IVDs).

Analytical validation required for non-waived tests & LDTs, no clinical validation required. Process to address complaints required without formal reporting.

Prescriptive analytical and clinical validation prior to FDA-modified & LDT approval. Specific components required for documenting complaints, but without formal reporting.

Specific performance specifications validated for all new and modified LDTs. Nonconforming events process, includes complaints, but without formal reporting.

Procedures required to define validation of examination methods against their intended use and to define the complaint process but without formal reporting.

Analytical and clinical validation against intended use for new and modified LDTs. Prescriptive complaint process requiring formal reporting to the FDA.

Enforcement by state government bodies for compliance with federal quality standards for clinical laboratories.

Enforcement by New York State Department of Health for compliance with NYCLEP Standards.

Laboratory Accreditation Program (LAP) oversight for compliance against customized CAP checklists.

ISO Certified Accreditation Body oversight for compliance against the ISO 15189 standard.

Enforcement by Center for Devices and Radiological Health (CRH) for compliance with federal quality standards, based on Good Manufacturing Practices (GMPs) for IVDs.

Table 1. Comparative analysis of the key regulatory authorities.

Strategies to augment quality systems include conducting a gap analysis to identify areas where the QMS can be strengthened, using ISO 15189 and CAP as benchmarks. Also, training staff on risk-based thinking and incorporating quality improvement tools, such as root cause analysis and process mapping are additional strategies for supplementing existing QMS structures. Establishing a system for regular internal audits to ensure continuous compliance is critical for external inspection readiness, such as an FDA audit.

2. Focus on validation2-3

Test validation is the cornerstone of both current and future regulatory requirements. The FDA’s impending LDT oversight places a strong emphasis on analytical and clinical validation to ensure test accuracy, precision, and clinical utility. Labs can begin strengthening their validation protocols by adopting practices from frameworks like ISO 15189, CAP, and NY CLEP:

• ISO 15189: Encourages a detailed approach to validation, requiring laboratories to define the process for ensuring every test meets its intended use. This aligns closely with FDA’s proposed expectations for LDTs, even though analytical and clinical validation is not called for outright.

• CAP: Already mandates validation and verification for all new and modified LDTs, providing a robust starting point for labs aiming to enhance their validation protocols.

• NY CLEP: Requires pre-market approval of all new LDTs and modified FDA-approved tests, with rigorous validation standards for accuracy, precision, and clinical utility, which small, high-complexity labs can use as a benchmark.

Actionable steps for labs to take are developing comprehensive validation processes, such as a master validation plan, which should include test design documentation, analytical performance evaluation, and clinical utility studies. Also important is the meticulous documentation of validation

By adhering to rigorous standards, labs are better positioned to meet future FDA requirements with minimal disruption.

efforts to ensure traceability and compliance with future regulations. Case studies and white papers from professional organizations like CAP and CLSI (Clinical and Laboratory Standards Institute) are great resources for determining validation best practices.

3. Prepare for pre-market review5-6

The potential for pre-market review under FDA oversight represents a significant shift for LDTs. The FDA impending requirements indicate the potential for extensive data submission demonstrating test safety and efficacy before commercialization. Labs can look to NY CLEP as a model for meeting these stringent requirements.

• NY CLEP: Already mandates test (pre-market) approval for all LDTs, which includes the review of both analytical and clinical validation. While labs might not be serving New York State residents, NY CLEP is a valuable resource for understanding future FDA expectations.

CLIA: Lacks

Clinical Validation, Pre-Market Approval, and Post-Market Surveillance

ISO: Lacks

Pre-Market Approval and Post-Market Surveillance

CAP: Lacks

Pre-Market Approval and Post-Market Surveillance

NY CLEP: Lacks

Post-Market Surveillance

FDA LDT Regulations:

QMS, Full Validation, Pre-Market Approval, and Post-Market Surveillance

QMS: Quality Management Systems create a foundation upon which FDA LDT requirements can be more easily built.

Full validation: Include the analytical validation (confirmation of test performance) and a clinical validation (confirmation of clinical utility).

Productive actions begin with reviewing and, where possible, adopting the NY CLEP test approval processes to simulate FDA pre-market review expectations. Collaborate with regulatory consultants and industry experts to understand data submission requirements and prepare comprehensive dossiers for LDTs.

4. Prepare for post-market surveillance5-6

Post-market surveillance may overlap with existing clinical laboratory regulations and standards; however, only the FDA requires the centralized reporting of adverse events.

Strategies for implementing these additional requirements would be to develop a centralized process for documenting potential adverse events and determining the reportability based upon FDA regulations. Existing requirements for complaints, non-conformances, and root cause analysis should be leveraged for the integration of post-market surveillance into a lab’s QMS.

Monitoring updates from the FDA and professional organizations like ADLM (Association for Diagnostics and Laboratory Medicine) are crucial for staying informed about regulatory changes.

Leveraging accreditation for strategic flexibility

While each of these frameworks offers distinct benefits, their real value lies in how they can be integrated to build a resilient, adaptable, operational foundation. By aligning processes with NY CLEP, CAP, and ISO 15189 standards, labs can achieve the following:

Streamline quality management: Unified quality systems reduce redundancies and enhance efficiency, freeing up

Figure 1. Key regulatory authorities alignment to impending FDA LDT regulations.

CONDUCT A GAP ANALYSIS:

Assess current operations against NY CLEP, CAP, and ISO 15189 requirements to identity areas for improvement.

Use tools such as checklists and mock inspections to evaluate readiness and pinpoint deficiencies.

ENGAGE STAKEHOLDERS:

Secure buy-in from leadership and staff, emphasizing the long-term benefits of accreditation.

Highlight how these frameworks not only prepare the lab for regulatory changes but also improve market positioning and can increase operational efficiency.

DEVELOP A TRANSITION PLAN:

Create a phased implementation plan that prioritizes high-impact areas while balancing resource constraints.

For instance, start with adopting ISO 15189’s quality management principles before integrating CAP’s proficiency testing requirements and NY CLEP’s validation standards.

INVEST IN TRAINING:

Equip staff with the knowledge and skills needed to uphold accreditation standards.

This includes providing training on documentation practices, risk-based thinking, and validation requirements, as well as fostering a culture of quality and accountability.

Figure 2. Roadmap of practical steps for bridging existing standards to future requirements.

resources for innovation and growth. For instance, ISO 15189’s emphasis on risk-based thinking can be integrated with CAP’s practical guidance and NY CLEP’s stringent validation protocols to create a cohesive quality management system. This not only reduces operational inefficiencies but also ensures consistency across all testing processes.

Anticipate regulatory changes: By adhering to rigorous standards, labs are better positioned to meet future FDA requirements with minimal disruption. For example, NY CLEP’s pre-market approval processes and CAP’s validation frameworks can act as proactive measures, allowing labs to adapt quickly to new regulatory mandates. This flexibility mitigates the risks of non-compliance and costly operational overhauls.

Enhance market competitiveness: Demonstrating commitment to high standards builds trust with clinicians, patients, and partners, providing a competitive edge. A CAP accredited lab that integrates ISO 15189’s global standards and NY CLEP’s rigorous validation requirements is likely to stand out as a reliable and high-quality service provider. This not only attracts more clients but also strengthens partnerships with stakeholders who value quality and compliance.

Facilitate innovation: Robust quality frameworks create an environment where innovation can thrive, enabling labs to expand their test offerings and adapt to market demands. For example, a lab that adopts ISO 15189’s culture of continuous improvement and CAP’s focus on proficiency testing is well-equipped to develop and validate new LDTs rapidly, keeping pace with advancements in diagnostic technologies.

Practical steps for implementation

For labs looking to leverage these accreditation frameworks, Figure 2 provides a roadmap of practical steps small, highcomplexity labs can take. By following these steps, labs can not only align with current accreditation frameworks but also build a resilient foundation that prepares them for the impending FDA regulations and any other future regulatory changes. This approach ensures operational excellence, mitigates risks, and positions labs as leaders in quality and innovation.

Looking ahead

The uncertainty surrounding FDA LDT regulations may persist, but for small, high-complexity labs, it doesn’t have to equate to instability. By aligning with NY CLEP, CAP, and ISO 15189 standards, labs can establish a robust

MONITOR AND ADJUST:

Establish mechanisms for continuous monitoring and improvement to ensure sustained compliance and readiness.

Regular internal audits, coupled with feedback loops, can help labs identify gaps early and address them proactively.

foundation that not only addresses today’s challenges but also empowers them to navigate and excel in a dynamic regulatory environment.

In times of change, adaptability is the cornerstone of success. For small, high-complexity labs, adopting these accreditation frameworks goes beyond compliance — it fosters resilience and positions the lab for sustainable growth in the face of regulatory enhancements.

REFERENCES

1. Berte L, Mortschman T, Ball J, et al. Quality Management System: A model for laboratory services; Approved guideline—Fourth Edition. Clinical & Laboratory Standards Institute (CLSI). Published June 2011. Accessed January 24, 2025. https://clsi.org/media/1523/ qms01a4_sample.pdf.

2. CAP Council on Accreditation. CAP laboratory accreditation program standards for ... College of American Pathologists (CAP). Published August 2017. Accessed January 24, 2025. https://documents-cloud.cap. org/appsuite/learning/LAP/TLTM/resources/standards/LAPstandards.pdf.

3. Technical Committee ISO/TEC 3212. ISO 15189:2012 Medical laboratories — Requirements for quality and competence. International Organization for Standardization (ISO). Published August 1, 2014. Accessed January 24, 2025. https://www.iso.org/standard/56115.html.

4. New York State Department of Health. Laboratory standards. Laboratory Standards | New York State Department of Health, Wadsworth Center. Published December 2024. Accessed January 24, 2025. https://www.wadsworth.org/regulatory/clep/clinical-labs/ laboratory-standards.

5. Center for Devices and Radiological Health. Laboratory developed tests. U.S. Food and Drug Administration (FDA). Updated January 8, 2025. Accessed January 24, 2025. https://www.fda.gov/ medical-devices/in-vitro-diagnostics/laboratory-developed-tests.

Dominique Dotson, PhD is the Quality Specialist at Sysmex Inostics, Inc. As the newest member of the team, she’s learning how to apply her knowledge from the academic and research sectors into the regulated industry of clinical laboratories.

Cathryn Mullen, BS, ASQ-QPA is the Senior Quality Specialist at Sysmex Inostics, Inc. As a long term employe she’s seen this small clinical lab go from two technologists to ten and has been pivotal in building their quality management system.

Kellie Quash, MLS, MBA is the Quality Manager at Sysmex Inostics, Inc. Coming to the company with fifteen years of clinical laboratory experience, she’s helped take their quality management system to the next level.

STATE OF THE INDUSTRY LAB DATA ANALYTICS

U.S. medical labs embrace digital transformation amid staffing, cost, and data challenges

By Kara Nadeau

Medical laboratory professionals continue on their digital transformation journey, moving from on-premise, legacy laboratory information systems (LIS) to hybrid and cloud-based solutions, digitizing more processes, and increasing use of analytics to support operations, according to the results of the 2025 MLO State of the Industry (SOI) Survey on Laboratory Data Analytics.

On the other hand, their advancement remains hindered by factors including disparate systems, data silos, staffing challenges, inadequate information technology (IT) support, and cost constraints.

Five key findings

1. Costs and staffing challenges top of mind : 71% ranked staffing and 66% funding high on their lists of challenges in short-term planning and forecasting. 64% report measuring cost per test as an operational performance indicator in their labs (up from 54% in 2024), and 47% report measuring staff productivity goals (up from 39% in 2024).

2. Greater digital functionality: 12% more respondents report their labs’ regulatory compliance/reporting is

electronic through their LIS (34% in 2025, up from 22% in 2024), and 11% more have electronic point-of-care testing (POCT) management functionality (41% in 2025, up from 30% in 2024), compared with last year.

3. Desire for more data analytics: There was an 18% increase in respondents reporting they are utilizing data analytics to support some aspects of lab operations and management and are planning more (54% in 2025, up from 36% in 2024).

4. Shift away from on-prem LIS: 18% fewer survey respondents reported using in-house software/servers compared with last year (52% in 2025, down from 70% in 2024).

5. System and data challenges remain: Although slightly fewer respondents reported interoperability and data integration issues with their LIS or electronic health record (EHR) systems are holding them back from digitizing processes, close to half of lab professionals (48%) still struggle with these stumbling blocks.

The survey averaged 106 respondents with most laboratory professionals working in hospital laboratories (59%) and holding lab manager, administrator

or supervisor positions (32%). Nearly one-quarter (24%) report working in labs with 1-10 employees, nearly one-third (28%) in labs with more than 100 employees, and the remaining 48% in labs with staff sizes in between.

Regarding annual volume of testing performed in their labs, 9% report less than 25,000 tests and 23% report more than 2M tests. More than one-third (31%) process between 500,001 – 2M tests per year, and the remaining fall in between 25,001 and 500,000 annually.

Priorities and planning

When asked to select their organization’s top strategic IT priority in the next three years, infrastructure and platform development and new LIS garnered the highest responses, at 19% and 18% respectively.

Data analytics optimization to support lab management was next on the list of priorities (15%), followed by revenue cycle management optimization (11%), digital pathology implementation (10%), integration of the EHR (9%), and POCT product (3%).

Additionally, 16% of lab professionals selected “other” when answering this question, commenting on top

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strategic IT priorities not offered in the survey. This included, new reference lab interfaces, more auto verification from analyzers, interconnectivity with reference and public health labs, and a bi-directional system to integrate with a health system’s hospitals.

“We see laboratory organizations and diagnostic providers implementing new, more scalable platforms and consolidating existing ones as a top strategic priority,” said John E. Johnson III, Senior Vice President, Sales, ELLKAY.“Laboratories are back operating in a world where their test menus are expanding and managing the entire test menu is important.”

Johnson has seen more “focused priority and activity” around lab technology infrastructure improvements, specifically in large reference laboratories, health system laboratories and specialty diagnostics. He stated:

“LIS and the interoperability platforms that feed data to them are IT priorities for organizations that are expanding their laboratory services. Health system laboratories and community hospitals with lab services are consolidating from multiple LIS to single platforms across all specialties.”

According to Johnson, these IT infrastructure improvements are multi-year initiatives that take careful strategic planning for IT and business teams. “Labs are uplifting platforms, replacing technology, and modifying processes that have been in place for many years, all while continuing to serve their providers and patients,” he explained.“Laboratories are looking for an experienced IT partner that offers a combination of technology advantage and laboratory experts that can advise and do the work with less disruption to the business and the laboratory professionals that are focused on delivering services and care.”

Forecasting

There was a slight increase in lab professionals reporting use of an electronic tool for management forecasting, 27% in 2025, up from 24% in 2024.

Challenges

Regarding challenges their organization currently faces or will face in the short-term (next three years) in their planning and forecasting environment, staffing topped the list, with 71% of lab professionals ranking it first or second. Funding was next, with 66% ranking it first or second.

Over one-third (32%) of lab professionals surveyed ranked return on investment/costs first or second in terms of challenges, while 17% ranked technology and 10% ranked training.

Only 5% ranked the U.S. Food and Drug Administration’s (FDA) Valid Act and Laboratory Developed Tests (LDT) regulation as their first or second greatest short-term challenge in their planning and forecasting environment.

“The biggest challenge is that some clinicians are not that interested in the running of the lab, just the results,” said Fred Morley, MA, MT(AMT), Certified Technical Consultant (ACHC), Fred Morley Services.“I wish there would be more strict regulations about yearly continuing education for their responsibilities in the lab. I would like to see COLA establish a rigid certification program for the technical consultants (TC) with examinations, unlike American Medical Technologists (AMT).”

Systems, processes and data

With regards to management forecasting, 68% of survey respondents reported their labs perform test utilization prediction, 55% staffing levels, 55% workloads, 27% supply utilization, 20% increased case volumes, and 9% other.

Comparing this year’s results to last year’s, there was a 9% jump in respondents reporting management forecasting of staffing levels (55% in 2025, up from 46% in 2024), and a 9% drop in those reporting forecasting of supply utilization (27% in 2025, down from 36% in 2024).

Surveying technology systems and data, over half of respondents (52%) report using software/servers in-house for their LIS infrastructure, which is an 18% decrease compared with 2024 (70%). There was also a drop in respondents reporting use of cloud-based LIS (20% in 2025, down from 28% in 2024).

New for this year, MLO offered hybrid LIS solution as an answer option for this question, with nearly one-third of respondents (28%) reporting use of this type of platform.

Morley commented on the LIS capabilities for the labs he consults for:

“As the technical consultant for six labs, only four have an LIS system. The other two just scan their lab results into the patients’ charts. Those with an LIS mostly use it for patient results, not administrative analysis. I am slowly urging them into analysis as I know how it can be a basis for improvement.

Are interoperability and data integration issues with your laboratory information systems (LIS) or electronic health records a stumbling block to implementing electronic processes at your lab?

They would be most helped by cost per test and productivity.”

Electronic functions

When asked what functions are electronic through their LIS, 93% selected electronic orders and results, 82% integration with analyzers, 64% billing/ revenue cycle management, 54% QA/QC, 41% POCT management, 34% regulatory compliance/reporting, 25% scheduling, 23% inventory control/supply chain management, and 20% customer service. Comparing this year’s survey results to last year’s to identify any interesting shifts, there was a 12% increase in respondents reporting their regulatory compliance/reporting functions are electronic through their LIS (34% in 2025, up from 22% in 2024), an 11% increase in those with electronic POCT management (41% in 2025, up from 30% in 2024), and an 8% increase in electronic inventory control/supply chain management (23% in 2025, up from 15% in 2024).

Challenges

When it comes to challenges with interoperability and data integration between their LIS or EHR systems, nearly half (48%) of medical lab professionals reported these issues as a stumbling block to implementing electronic processes at their labs. This was a 5% drop from last year when 53% reported these problems. MLO asked the survey respondents who are having interoperability and data integration issues to comment on the specific challenges they are facing. The comments fell into several categories:

• System deficiencies: Many respondents to this year’s survey wrote in comments related to systems lacking the capabilities they need, most notably, the inability to integrate. Comments included:

• “The issue is with the hospital system, not our LIS.”

Fred Morley, MA, MT(AMT)

• “[Vendor name] is our current EHR and they are very limiting on what they will work with us to implement.”

• “Time to implement new interfaces is lengthy.”

• “The medical records and LIS do not interface both ways.”

• “Interconnectivity issues between reference and public health labs.”

• “The current [EHR] does not have a blood bank module that will help integrate all results into one LIS.”

• “[Our] POCT software is old, trying to upgrade to better integrate with EMR is a challenge.”

• “Unable to connect to proficiency testing and some lab and POCT analyzers due to age of LIS.”

• “Running multiple middleware systems is a headache.”

• Lack of IT support : Lab professionals expressed frustration with insufficient IT resources in their organizations. Comments included:

• “IT decides which projects to work on.”

• “IT is backlogged with requests to update/change as the lab does.”

• “IT does not care about the laboratory one bit.”

• Cost constraints: Survey respondents voiced the challenge of cost when approaching solutions for lack of system interoperability and data integration. Comments included:

• “Cost is prohibitive to interface 500 clinic locations in a fourstate region.”

• “[Cost of] vendor pricing to integrate and interface to outside systems.”

• [Our system] needs middleware we can’t afford and there are other analyzers that just won’t stay connected.”

• “[Integrating] LIS and electronic health records is very expensive for an academic institution.”

• Data and reporting issues: It was clear from the comments that many lab teams still struggle with manual data entry and manipulation for reporting. Comments included:

• “Must enter every data point or process manually.”

• “Even with an LIS, data mining is difficult, and [we] still need to export to Excel to manipulate

Have you begun using analytics to support lab operation and management?

No, we are not using data analytics, and we have no plans to start in the near future.

Yes, we are utilizing data analytics for some aspects, and we are NOT planning more.

Yes, we are utilizing data analytics for all aspects of lab management.

No, we have not used data analytics yet in any significant way, but we want to start.

Yes, we are utilizing data analytics for some aspects, and we ARE planning more.

data, very time consuming and not necessarily real time. Always after the fact.”

• “Limited functionality requires multiple manual processes to extract and recompile data in order to manipulate into useful information.”

• “Information is too compartmentalized.”

• “Reports are difficult to generate as some are manual processes and some are electronic.”

• “Lack of interface and reporting capabilities.”

“One of the main challenges we face is integrating data from multiple sources into a cohesive and actionable format,” said Amanda J. Lewis MLS(ASCP)cm, Quality Assurance Supervisor Abilene Market Laboratories.“Different systems often use varied data formats and standards, making data integration and interoperability a complex task.”

“Additionally, ensuring data accuracy and consistency across systems is critical,” Lewis continued.“We also encounter challenges related to data privacy and security, as we must comply with stringent regulations while making the data accessible for analytics.”

“I’m not surprised that interoperability and data integration between LIS and EHR are top strategic priorities for survey respondents,” said Johnson. “This coincides with the trend in new LIS and data platform development to support analytics. Laboratories require access to more electronic data, and this is an opportunistic time to improve data integration between LIS and EHR.”

“There is a very active movement to improve data integration to drive automation and electronic process aimed at efficiently managing higher test volumes,” Johnson added. “Labs can’t optimize processes unless they optimize

interoperability. The continued uptick in genetic and complex testing requires a more robust electronic dataset and this in turn requires that the interoperability of LIS and EHR improve.”

MLO also asked survey respondents who are not having interoperability and data integration issues to comment on success factors. Comments included:

• “The updates occur as needed.”

• “[We have a] separate lab module that is user friendly.”

• “Vendor is well known to our automated equip vendors.”

• “We’ve had electronic processes since 2015 and continue to expand them.”

• “[Our EHR] is used between multiple facilities.”

• “It takes time to build a new test or instrument, but the process is a work in progress. Satisfied with result.”

• “We have competent hands to support the system and process integration.”

Data analytics and operational KPIs

When asked if they had begun using analytics to support lab operation and management, lab professionals utilizing data analytics for all aspects of lab management dropped by 5% compared with last year (12% in 2025, down from 17% in 2024).

Although those who said they are utilizing data analytics for some aspects and are planning more shot up 18%, with more than half of this year’s respondents (54%) selecting this as their answer compared with 36% in 2024.

For those considering a move in this direction, 11% reported not yet using data analytics in any significant way but wanted to start, although this was down from 22% in 2024.

“Our lab is increasingly accessing data from our laboratory information system (LIS) and other integrated systems for analytics and decision-making,” said Lewis. “This access allows us to track and analyze various performance metrics, identify trends, and make data-driven decisions that enhance our operational efficiency and patient care outcomes.”

Among those with no interest in pursuing analytics or expanding what they have in place, 14% report they are utilizing data analytics for some aspects but not planning more (up from 10% last year), and 10% report how they are not using data analytics and have no plans to start in the near future (down from 12% in 2024).

“We are not increasingly accessing data from our LIS,” said Sherrie White, MBA, MHA, MT (ASCP), laboratory consultant. “We are at a plateau of what we access for quality metrics and volume reporting. The challenge is the lack of cost data that is within the LIS for laboratory testing. It would be great if we could enter a dollar amount associated with each test to see what actual spending is.”

Specifically for lab professionals who are using data analytics in their operations, MLO asked how often the data is refreshed. The top selection was monthly at 34%, followed by real-time at 26%, daily at 22%, weekly at 9%, minutes at 5%, and hours at 4%.

With regards to data analytics tools, 40% of respondents said they use a tool integrated with their LIS, 32% one that is part of their LIS, and 27% a separate tool.

Kevin Haas, chief technology officer (CTO), Myriad Genetics, commented on the ongoing evolution of digital transformation in the medical laboratory environment, stating:

“While we used to think of medical lab professionals wearing white lab coats and using pipettes, their job is turning into data generation and research. For many, their primary aim has become data analytics - taking information out of their LIS, combining it with the clinical indications for testing, combining that with the outcomes, and bringing in the omics data from sequencing and other data sources. “Therefore, what was in the past a biology problem has become a data problem, because you must be

In your planning and forecasting environment, which of the following describes the challenges your organization currently faces or will face in the short term (next two years)?

* Final weighted average scores based on their difficulty are represented in this graph.

able to find the data, and it must be accessible, interoperable and reusable.”

According to Haas, all this data points to the challenge of the different platforms and systems that house it.

“It is a software engineering problem, he stated. “I think our industry is still in its adolescent phase, but other industries have overcome similar challenges. Back in the 1980s, computer companies had all these interoperability challenges, which prompted them to create open standards. The medical lab industry is now starting to do this. To figure out – ‘what is the data standard that we need to run a lab?’ Until then, every LIMs project is like starting from scratch, having to perform countless custom integrations to get things up and running.”

Haas said Myriad began tackling this challenge a decade ago in its own labs, building out a fully integrated environment to where today processes are highly automated from beginning to end.

“We have hundreds of different instruments that work in concert from a tube of blood, to advanced chemistry, to loading onto a sequencer, to fully automated data analysis,” he explained. “It is not until the later stages when humans specifically come into the loop to perform data interpretation and quality control. It really is the full vertical system integration that stitches together all the little pieces of information captured along the way.”

When most people think of lab automation, they envision taking one step somewhere that is performed by human hand and programming a robot to do that step,” Haas continued. “Our fully

automated approach involves designing for robotic processes first and leveraging human elements in places where complex abstract reasoning gives a justifiable reason to do so because that is what is necessary to run at scale and to accelerate scientific innovation.”

KPIs

Turnaround time topped the list of operational key performance indicators (KPI) the respondent’s labs measure, with 89% of lab professionals selecting this KPI. Next was quality improvement initiatives with 73% respondents selecting this metric.

Comparing this year’s to last year’s results, there were noticeable increased in survey respondents reporting measurement of cost per test (64% in 2025, up from 54% in 2024) and staff productivity goals (46% in 2025, up from 39% in 2024). Billable tests versus performed tests as a reported KPI increased as well (46% in 2025, up from 40% in 2024).

“Currently, I see labs using data and analytics to optimize electronic processes and increase automation to improve efficiency,” said Johnson. “Automation inside the lab is a priority that is getting more attention. Automation is not a single year project but rather an initiative that evolves to align with a lab’s advancing infrastructure. I am encouraged at the progress I see, because it is about modernizing the lab, and the data infrastructure to support the advancements in diagnostics that are the foundation for the future of precision medicine.”

Those reporting measurement of unnecessary tests was down from last year (16% in 2025, down from 23% in 2024), as well as medical necessity (30% in 2025, down from 37% in 2024).

Kevin Haas

Sherrie White

Commenting on her lab’s KPIs, Lewis stated, “We seek data on several key performance indicators, including cost per test, turnaround time, and staff productivity.” She described how this data helps them in several ways:

• Cost per test: “By analyzing the cost per test, we can identify areas where we can reduce expenses without compromising the quality of our services. This includes optimizing reagent usage, reducing waste, and negotiating better pricing with suppliers.”

• Turnaround time: “Monitoring turnaround times allows us to identify bottlenecks in our workflow and implement process improvements to ensure timely delivery of results. This is crucial for maintaining high levels of patient satisfaction and clinical efficiency.”

• Staff productivity: “Analyzing staff productivity helps us allocate resources more effectively, ensure balanced workloads, and identify training needs. It also allows us to recognize high-performing staff and address areas where additional support may be needed.”

• Error monitoring: “By comparing edited results and final anatomic pathology diagnosis, we are seeing where we can improve processes, training, and testing availability.”

“We would love to be able to have our LIS capable of calculating cost per test,” White commented.“This is the one area I feel could be added to LIS platforms.”

Lastly, looking at the types and number of tests tracked by medical labs, COVID-19 came out on top, with 73% of lab professionals reporting they track the number of COVID-19 tests performed (a slight change from 72% in 2024), followed by Influenza at 67% of respondents (up from 63% in 2024).

Compared with last year, there was an increase in lab professionals reporting they track the number of sexually transmitted infection STI/HIV tests performed, 45% in 2025, up from 40% in 2024, and a decrease in tracking the number of RSV tests, 49% in 2025, down from 59% in 2024. The number of strep tests tracked remained relatively the same year over year, 45% in 2025, down from 46% in 2024).

New for this year, MLO asked if those surveyed tracked the number of tests for healthcare associated infections (HAIs),

with 32% reporting they do track this infectious disease category.

Looking ahead

Medical lab professionals and others interviewed for this article commented on how use of data and analytics is trending in 2025.

John E. Johnson III, Senior Vice President, Sales, Ellkay

“In the past 25 years, I’ve seen a convergence between laboratory diagnostics and precision medicine. This convergence is beneficial, driving the utilization of precision medicine. As a result, there is an increasing need for digital and data strategies. Diagnostics is proving its value due to the growing demand for data utilization in precision medicine diagnostics. More and more, labs are playing a bigger role in delivering precision medicine. The use of precision diagnostics is increasing to inform more targeted treatments, particularly for better patient care in oncology (e.g., lung and breast cancer) and chronic diseases like diabetes and obesity.”

“This has led to a significant focus on data in digital pathology. Early adopters are using data to improve efficiency and access for patients, providers, and experts by automating manual processes.”

Amanda J. Lewis MLS(ASCP)cm

Quality Assurance Supervisor

Abilene Market Laboratories

“We see significant opportunities in leveraging AI and machine learning to predict trends, enhance diagnostic accuracy, and improve patient outcomes.” For instance:

• Predictive analytics: “AI can help us predict patient trends, such as the likelihood of disease outbreaks or the need for specific tests, enabling us to prepare and allocate resources more effectively.”

• Enhanced diagnostics: “Machine learning algorithms can assist in interpreting complex data sets, leading to more accurate and faster diagnoses. This can be particularly beneficial in fields like pathology and genetics.”

• Operational efficiency: “AIdriven automation can streamline administrative tasks, reduce manual errors, and optimize our

lab operations. This includes automating routine processes like sample sorting and result reporting, allowing our staff to focus on more complex tasks.”

• Test algorithms: “By using standardized testing algorithms enhanced with ML and AI, better test utilization and less wasted testing could streamline processes, costs, and patient satisfaction.”

Sherrie White, laboratory consultant “The integration of test cost information to the LIS would be very helpful. Pricing for the LIS systems themselves is going to be key in the future. With costs increasing and reimbursement decreasing, spending additional dollars on analytics gets tough. Having these analytics provided at no charge or included with the platform you use will be key to labs using them.”

Kevin Haas, chief technology officer (CTO), Myriad Genetics

Haas spoke to how many of the automation and data analytics techniques used in molecular diagnostics are leveraged in partnership with biopharma as well, including target identification, mechanism discovery, and preparing cohorts to test efficacy of the candidates with real-world data. He stated:

“At the meta level, the only thing that advances the speed of scientific discovery is increasing the iteration time by pulling in more data and performing more experiments faster. Because that is the multiomics problem of, ‘here are these people who have this condition. Here are all these interesting things I know about them from their EMRs. I can test all these hypotheses.’ But if I can go from testing one hypothesis a month to one hypothesis a day or an hour, that’s the promise of precision medicine.”

“The emerging trends in this area include taking AI and agentic workflows and applying them to the task of analyzing vast information. Asking AI: ‘do you see hits of anomalies that seem to correlate with a particular mechanism?’

Kara Nadeau has 20+ years of experience as a healthcare/medical/ technology writer, having served medical device and pharmaceutical manufacturers, healthcare facilities, software and service providers, non-profit organizations and industry associations.

John E. Johnson III

Amanda J. Lewis MLS(ASCP)cm

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The utility of polymerase chain reaction testing for urinary tract infections

By Brett Miller

Laboratorians and those of us who support the clinical laboratory space know that standard urine culture (SUC) has for decades been the “gold standard” for identifying pathogens causing urinary tract infections (UTIs) and informing UTI treatment therapies. Not only has urine culture testing provided reliable results, but providers and patients have become familiar and comfortable with culturebased UTI testing processes from sample collection to understanding results — adding an important level of trust around the process. However, over the years, known limitations of SUC and emerging patient priorities have spurred innovation in UTI testing. As with diagnostic testing for respiratory, bloodstream, sexually transmitted, gastrointestinal and other infections, providers are looking to molecular testing — more specifically polymerase chain reaction (PCR) testing for UTIs — to address concerns

like speed to treatment and proper antibiotic management.

UTI prevalence in the United States

Urinary tract infections remain one of the most common bacterial infections affecting individuals in the United States. Reports indicate that 33% to 60% of women in the U.S. will develop at least one UTI in their lifetime, with a doubledigit percentage of those diagnosed experiencing recurrent infection at some point. At least 12% of men will have a UTI in their lifetime. Furthermore, the Urology Care Foundation puts the number of UTI-related physician office visits in the U.S. each year to be around eight million.

A good percentage of UTIs that are timely and accurately diagnosed are responsive to empiric or personalized therapies. At the same time, other data indicates that UTIs that spread beyond the liver and kidneys create

complications that translate into 626,000 or 1.8% of all hospital admissions each year.1 Untreated or misdiagnosed UTIs can lead to chronic pain and recurrent symptoms, reduced quality of life issues, damage to vital organs, sepsis, and other life-threatening infections.

Older adults and the elderly continue to make up a sizable portion of the patient population being diagnosed with a UTI, mirroring longstanding data that shows that UTI occurrences increase with age. Lifestyle, care needs, and health conditions generally associated with the regular aging process — such as hormonal changes, weakened immune systems and other co-morbidities — make older adults more susceptible to UTI.

One notable observation related to delivery of UTI testing is the shifting preferences in where patients present to be tested. Following rising demand for molecular testing for respiratory, sexually transmitted,2 and other common infections at urgent care centers (demand

growing prior to and then fueled by the pandemic), patients suffering with UTI-like symptoms, who are unable or unwilling to wait to for an office appointment, are now expecting urgent care centers to provide reliable, on-demand UTI testing and treatment.

Culture-based and PCR testing for UTI

Increased education around the importance of early detection and risks of complications, an aging population, and prevalence of UTIs all contribute to the growth in volume of UTI testing and diagnoses cases in the United States.3 With increases in cases and testing, comes the necessity among providers to balance emerging patient priorities and concerns with long-standing best practices for UTI testing. An overarching challenge in UTI testing has become how to deliver accurate UTI testing, while addressing patient expectations around immediate symptom relief, expedient and accurate identification of UTI, and antibiotic stewardship.

In the United States, SUC is the most commonly used test for UTI. Culture-based platforms have been

comparatively reliable at identifying pathogens causing infection and providing antimicrobial susceptibility data to inform treatment. But, as we are hearing from laboratorians, more and more providers are looking to PCR-based testing solutions to complement or improve on culture-based platforms, with regard to the following:

1) Speed – UTIs can become more complicated just by letting time elapse. Many patients are looking for relief from symptoms present at the time of testing — symptoms that can be similar to those of other infections — or they worry about progression of infection.

PCR testing is successfully demonstrating its ability to provide accurate insights into the bacteria causing the infection within hours, versus the days or even weeks required for traditional testing.

2) Standardization – PCR testing is more standardized in labs, creating efficiency and consistency in labs.

3) Sensitivity and specificity – PCR testing reliably identifies fastidious, atypical, or uncommon pathogens and differentiates between types of pathogens in samples, helping to

lower the probability for false negatives and false positives. As importantly, improvements in UTI testing around speed, sensitivity, and standardization speak to current healthcare concerns about effective antibiotic management, as the practice of beginning broad spectrum antimicrobial therapy before UTI results are available is being called into question. PCR continues to demonstrate value in this regard, by being able to more quickly confirm single and multiple causative pathogens — independent of culture-related errors like low bacterial load, poor growing environment, or imperfect sample collection — and inform the most effective treatment.

Feasibility of PCR testing

The feasibility of integrating PCR to complement or enhance UTI testing capabilities typically prompts provider examination and conversation around the following:

Staffing – Running PCR tests may not require lab team members to have the higher level of education and experience that is necessary for proper SUC set up and analysis.

Urinalysis Solution

Costs – Technological advancements have made molecular testing equipment and consumables, including PCR, more affordable and accessible without sacrificing (and in some cases, improving) the accuracy of results. PCR testing for UTIs has become a realistic and wise investment for providers and

Increased education around the importance of early detection and risks of complications, an aging population, and prevalence of UTIs all contribute to the growth in volume of UTI testing and diagnoses cases in the United States.

facilities — even those with moderate testing volume — when just a few years ago this technology would be out of reach. Reliability of PCR results also saves dollars on confirmation tests and reflex testing, as well as saves valuable lab tech time spent on UTI testing and analysis of results.

Reimbursements and financial impact – While reimbursement programs vary among states and payors for UTI testing, recent information shows that molecular testing, in general, is more commonly

being reimbursed at higher rates against traditional methods.

Patient populations served – From the relationships we have across the continuum of care, we know that urgent care centers as well as providers involved with the care of the elderly and older Americans are seeing the utility of PCR testing in their labs. More physician offices (particularly in women’s health, sexual health, and immunology), emergency departments, and reference labs are inquiring about options for bringing PCR testing for UTIs into their practices.

Space and Infrastructure – PCR UTI testing equipment can work in facilities of all sizes, as the footprint required to run the technology can operate on floor or counter space.

Conclusion

Emerging patient priorities as well as limitations with traditional culturebased testing are driving innovation in UTI testing – leading to today’s growing interest in options for adding PCR testing to labs across the United States. While PCR has proved to be a platform that is improving efficiency in the laboratory, and in some cases is even profitable, providers themselves should determine utility of PCR testing in their businesses. Suppliers, industry experts, and healthcare associations can help evaluate the feasibility of adding PCR capabilities to your offering. As patient expectations for convenience and quality care continues to

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increase, healthcare providers need to keep pace. Optimizing laboratory diagnostic services is one of the areas that can have a direct and lasting impact on a lab’s outcomes and growth.

REFERENCES

1. Medina M, Castillo-Pino E. An introduction to the epidemiology and burden of urinary tract infections. Ther Adv Urol. 2019;11:1756287219832172. doi:10.1177/1756287219832172.

2. Pearson WS, Tao G, Kroeger K, Peterman TA. Increase in Urgent Care Center Visits for Sexually Transmitted Infections, United States, 2010-2014. Emerg Infect Dis. 2017;23(2):367-369. doi:10.3201/ eid2302.161707.

3. Urinary tract infection testing market size, share & trends analysis report by type (urethritis, cystitis, pyelonephritis), by end use (reference laboratories, general practitioners, urologists, urgent care), by region, and segment forecasts, 2023 - 2030. Grandviewresearch.com. Accessed January 24, 2025. https://www. grandviewresearch.com/industry-analysis/ urinary-tract-infection-testing-market-report.

Brett Miller is the East Division Manager of Medline Lab Diagnostics at Medline Industries, L.P. , where he oversees a team of laboratory consultants. With a comprehensive laboratory supplier network, supply chain expertise, and valuable insights into lab resilience, Brett and his team support clinical laboratories across the continuum of care. He has been instrumental in enhancing some of the country’s largest health systems by driving operational improvements in the lab that include increased efficiencies, accuracy, and innovation.

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