Medical Laboratory Observer - August 2024

The Peer-Authored Management Source for Lab Professionals since 1969

Point-of-care testing

Managing change when you are not in charge Page 8

LAB INNOVATOR

Cyril Verhille President and CEO, BYG4lab

PLUS

Critical lab values: 50 years later Page 14

Mass spectrometry’s place in the lab Page 20

State of the Industry: Disease Management Page 24

SAFE SOLUTIONS

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Robert F Moran, PhD, FCCM, FIUPAC

George D. Lundberg, MS, MD, ScD

Lots of blood tests

By Christina Wichmann

Editor in Chief

In this issue, I noticed a prominent theme of blood testing/specimen collection in the articles — our State of the Industry covers diabetes and sexually transmitted infection testing, the CE is on point-of-care testing, the Product Focus is on specimen collection, and we have articles on mass spectrometry, critical lab values, and phlebotomy safety. As you well know, blood work is one of the most commonly performed laboratory tests. And quite a lot goes into collecting it, testing it, and reporting it. And often — more than seven billion lab tests are performed in the United States each year, according to the American Clinical Laboratory Association.

For some patients, a blood test can save their life or greatly affect their quality of life. The blood test detects diabetes, thyroid function, kidney diseases, heart diseases, bone diseases, liver diseases, hemophilia, some cancers, HIV, Lyme disease, among others. Every day new research is published on how important the blood specimen is when used to detect diseases earlier — such as cancers and Alzheimer’s. Because the blood test is so important in so many respects, I wanted to recognize the individuals who perform this important work in the preanalytical phases of testing.

A lot goes into sample collection: Hand washing procedures, knowledge on how to protect against blood exposure, donning gloves and properly removing gloves, placing the tourniquet, properly cleansing the testing area on the patient, understanding the anatomy of veins and proper venipuncture, patient identification, proper specimen labeling, following guidelines for correct order of draw, following recommendations for proper draw volume, proper transport of specimens, and much more.

All this work in the pre-analytical phase is necessary for accurate diagnostic testing. Numerous articles have been published on the pre-analytical phase in this publication. A couple examples are provided below.

The annual Clinical Laboratory Reference (CLR) accompanies this August issue of MLO. In CLR, our landmark article: “When to panic over an abnormal value” by George D. Lundberg, MD, ScD is featured. This article was published in the March/ April 1972 issue of MLO, and it is still referenced by researchers today when writing about critical limits. I encourage you to read this important, historical article. I was able to connect with Dr. Lundberg (Who recently celebrated his 90th birthday!) for a new article. His article, “Critical lab values: A 50-year perspective honoring the MLO anniversary of publishing the laboratory panic values paper” is featured on page 14. I was very excited to be able to work with one of the magazine’s original authors this year as we celebrate our 55th anniversary.

It is that time of year at MLO that we start planning our editorial topics for the next year. I would love to hear from you if you have topics that you want to read more about in this publication. This past year, we also made modifications to our Continuing Education platform (https://www.mlo-online.com/ce). If you have any feedback on the usability of the site, please share that with me. In addition, I am very interested in knowing what CE topics would be beneficial to your continuing education efforts.

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

REFERENCES

1. Kaushik N. Pre-analytical errors: their impact and how to minimize them. Medical Laboratory Observer. Published May 18, 2014. Accessed July 11, 2024. https://www.mlo-online.com/home/ article/13006606/pre-analytical-errors-their-impact-and-how-to-minimize-them.

2. Skala K. Best practices in preanalytical sample quality: Managing and preventing in vitro hemolysis in the emergency department. Medical Laboratory Observer. Published June 24, 2024. Accessed July 11, 2024. https://www.mlo-online.com/diagnostics/hematology/article/55056397/ best-practices-in-preanalytical-sample-quality-managing-and-preventing-in-vitro-hemolysisin-the-emergency-department.

PUBLISHER Chris Driscoll cdriscoll@endeavorb2b.com

EDITOR IN CHIEF Christina Wichmann cwichmann@mlo-online.com

MANAGING EDITOR Erin Brady ebrady@endeavorb2b.com

PRODUCTION MANAGER Edward Bartlett

ART DIRECTOR Kermit Mulkins

AUDIENCE DEVELOPMENT/LIST RENTALS

Laura Moulton | lmoulton@endeavorb2b.com

ADVERTISING SERVICES MANAGER Karen Runion | krunion@endeavorb2b.com

ADVERTISING

DIRECTOR OF SALES EAST COAST/MIDWEST SALES, CLASSIFIEDS Carol Vovcsko (941) 321-2873 | cvovcsko@mlo-online.com

SOUTH/WEST COAST/ILLINOIS SALES Lora Harrell (941) 328-3707 | lharrell@mlo-online.com

MLO EDITORIAL ADVISORY BOARD

John Brunstein, PhD, Biochemistry (Molecular Virology) President & CSO PathoID, Inc., British Columbia, Canada

Lisa-Jean Clifford, COO & Chief Strategy Officer Gestalt, Spokane, WA

Barbara Strain, MA, SM(ASCP), CVAHP Principal, Barbara Strain Consulting LLC, Formerly Director, Value Management, University of Virginia Health System, Charlottesville, VA

Jeffrey D. Klausner, MD, MPH Professor of Preventive Medicine in the Division of Disease Prevention, Policy and Global Health, Department of Preventive Medicine at University of Southern California Keck School of Medicine. Donna Beasley, DLM(ASCP), Director Huron Healthcare, Chicago, IL

Anthony Kurec, MS, H(ASCP)DLM, Clinical Associate Professor, Emeritus , SUNY Upstate Medical University, Syracuse, NY

Suzanne Butch, MLS(ASCP)CM, SBBCM, DLMCM Freelance Consultant, Avon, OH

Paul R. Eden, Jr., MT(ASCP), PhD, Lt. Col., USAF (ret.) (formerly) Chief, Laboratory Services, 88th Diagnostics/Therapeutics Squadron, Wright-Patterson AFB, OH

Daniel J. Scungio, MT (ASCP), SLS, CQA (ASQ), Consultant at Dan the Lab Safety Man and Safety Officer at Sentara Healthcare, Norfolk, VA

CORPORATE TEAM

CEO Chris Ferrell

PRESIDENT June Griffin

COO Patrick Rains

CRO Paul Andrews

CHIEF DIGITAL OFFICER Jacquie Niemiec

CHIEF ADMINISTRATIVE AND LEGAL OFFICER Tracy Kane

EVP CITY SERVICES & HEALTHCARE Kylie Hirko 30 Burton Hills Blvd., Suite 185 Nashville, TN 37215 800-547-7377 | www.mlo-online.com

Medical Laboratory Observer USPS Permit 60930, ISSN 0580-7247 print, ISSN 2771-6759 online is published 10 times annually (Jan, Feb, Mar, Apr, May, Jul, Aug, Aug CLR, Sep, Nov) by Endeavor Business Media, LLC. 201 N Main St 5th Floor, Fort Atkinson, WI 53538. Periodicals postage paid at Fort Atkinson, WI, and additional mailing offices. POSTMASTER: Send address changes to Medical Laboratory Observer, PO Box 3257, Northbrook, IL 60065-3257. SUBSCRIPTIONS: Publisher reserves the right to reject non-qualified subscriptions. Subscription prices: U.S. $160.00 per year; Canada/Mexico $193.75 per year; All other countries $276.25 per year. All subscriptions are payable in U.S. funds. Send subscription inquiries to Medical Laboratory Observer, PO Box 3257, Northbrook, IL 60065-3257. Customer service can be reached toll-free at 877-382-9187 or at MLO@ omeda.com for magazine subscription assistance or questions. Printed in the USA. Copyright 2024 Endeavor Business Media, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopies, recordings, or any information storage

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Consistent Accurate Precise Introducing

Medical Product Alert N°2/2024: Falsified OZEMPIC (semaglutide)

This World Health Organization (WHO) Medical Product Alert refers to three falsified batches of OZEMPIC (semaglutide). This falsified product has been detected in Brazil (October 2023), the United Kingdom of Great Britain and Northern Ireland (October 2023), and the United States of America (December 2023), and was supplied in the regulated supply chain. The genuine manufacturer of OZEMPIC has confirmed that the three products referenced in this Alert are falsified: the products misrepresent their identify and source as they were not manufactured by Novo Nordisk: batch number LP6F832 is not recognized. the combination of batch number NAR0074 with serial number 430834149057 does not correspond to genuine

batch number MP5E511 is genuine, but the product is

The use of falsified OZEMPIC may result in the ineffective treatment of patients due to incorrect dosage, contamination with harmful substances, or use of unknown or substituted ingredients. It may pose other serious risks to health because of its subcutaneous injection administration that could be

Healthcare professionals should report any incident of adverse effects, lack of effectiveness and suspected falsification to the National Regulatory Authorities/National PharmacoNational regulatory/health authorities are encouraged to contact their marketing authorization holders for advice on identification of falsification, increase monitoring of informal including online sale of products; and are advised to immediately notify WHO if they identify these falsi -

https://www.who.int/news/item/25-06-2024-over-3-million-annual-deaths-

If you have any of the affected products, WHO recommends that you do not use them. If you, or someone you know, has or may have used the affected product, or suffered an adverse reaction or unexpected side-effect after use, you are advised to seek immediate medical advice from a healthcare professional. All medical products must be obtained from authorized/ licensed suppliers. If you have any information about the manufacture or supply of these falsified products, please contact WHO via rapidalert@who.int.

HHS finalizes rule establishing disincentives for healthcare providers that have committed information blocking

The U.S. Department of Health and Human Services (HHS) released a final rule that establishes disincentives for healthcare providers that have committed information blocking. HHS has established the following disincentives for healthcare providers found by the HHS Office of Inspector General (OIG) to have committed information blocking and referred by OIG to the Centers for Medicare & Medicaid Services (CMS):

• Under the Medicare Promoting Interoperability Program, an eligible hospital or critical access hospital (CAH) that has committed information blocking and is referred to CMS by OIG will not be a meaningful electronic health record (EHR) user.  If the eligible hospital is not a meaningful EHR user, the eligible hospital will not be able to earn three quarters of the annual market basket increase they would have been able to earn for successful program participation; for CAHs, payment will be reduced to 100 percent of reasonable costs in-

stead of 101 percent. This disincentive will be effective 30 days after publication of the final rule.

• Under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), a MIPS eligible clinician (including a group practice) who has committed information blocking will not be a meaningful EHR user. If the MIPS eligible clinician is not a meaningful EHR user, then they will receive a zero score in the MIPS Promoting Interoperability performance category. The MIPS Promoting Interoperability performance category score is typically a quarter of an individual MIPS eligible clinician’s or group’s total final score in a performance period/ MIPS payment year, unless an exception applies and the MIPS eligible clinician is not required to report measures for the performance category. CMS has modified its policy for this disincentive to clarify that if an individual eligible clinician is found to have committed information blocking and is referred to CMS, the disincentive under the MIPS Promoting Interoperability performance category will only apply to the individual, even if they report as part of a group. This disincentive will be effective 30 days after publication of the final rule.

• Under the Medicare Shared Savings Program, a healthcare provider that is an Accountable Care Organization (ACO), ACO participant, or ACO provider or supplier who has committed information blocking may be ineligible to participate in the program for a period of at least one year. Consequently, the healthcare provider may not receive revenue that they might otherwise have earned through the Shared Savings Program.

• Additional disincentives may be established through future rulemaking.

The Office of the National Coordinator for Health Information Technology (ONC) and CMS hosted a joint information session about the final rule on June 26, 2024 at 2pm ET.

CDC updates RSV vaccination recommendation for adults

The Centers for Disease Control and Prevention (CDC) updated its recommendation for the use of Respiratory Syncytial Virus (RSV) vaccines in people ages 60 and older.

For this upcoming respiratory virus season, CDC recommends:

• Everyone ages 75 and older receive the RSV vaccine.

• People ages 60–74 who are at increased risk of severe RSV, meaning they have certain chronic medical conditions, such as lung or heart disease, or they live in nursing homes, receive the RSV vaccine.

This recommendation is for adults who did not get an RSV vaccine last year. The RSV vaccine is not currently an annual vaccine, meaning people do not need to get a dose every RSV season. Eligible adults can get an RSV vaccine at any time, but the best time to get vaccinated is in late summer and early fall before RSV usually starts to spread in communities.

The updated recommendation for people 60 and older replaces the recommendation made last year to simplify RSV vaccine decision-making for clinicians and the public.

The updated recommendation is based on analyses of RSV disease burden among people 60 and older, as well as RSV vaccine effectiveness and cost-effectiveness studies. Those studies included the first real-world data since RSV vaccines were recommended for people 60 and older.

Lab professionals get their continuing education credits from a variety of sources

In a recent MLO survey, we asked readers what their top sources for continuing education credits are.

Of the 161 responses, most go to Media Lab for continuing education credits (44).

• Additional results:

• 28 respondents use MLO

• 6 respondents use Medline University

• 8 respondents use Labucate through ASCLS

• 13 respondents use Lab University

• 13 respondents use Labroots

• 2 respondents use 4CEUInc

• 5 respondents use Anderson Continuing Education

• 42 respondents use other sources like ADLM, API, ARUP Labs, ASCP, CAP, CDC, etc.

Visit MLO’s Continuing Education page to see our current CE offerings.

FDA permits marketing of point-ofcare hepatitis C

RNA test

The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, a hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.

The test may be performed in settings operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, such as certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments and urgent care clinics. Rather than requiring a sample to be sent to a central lab for testing, the test detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip.

The authorization of this test enables a test-and-treat approach where a person can be tested for HCV, and if positive for HCV RNA, be linked to care and potentially receive treatment during the same healthcare visit.

The test is indicated for adults with signs or symptoms of, or at risk for hepatitis C. The risks associated with the test include the possibility of false positive and false negative test results. False negative test results can delay effective treatment and potentially increase spread of infection to other persons throughout the community. False positive results could lead to an inappropriate diagnosis of, and unnecessary treatment for hepatitis C. This could cause psychological distress and delay receiving a correct diagnosis, in addition to the expense and risk of side effects from unnecessary treatment.

The FDA reviewed the Xpert HCV test and GeneXpert Xpress System under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.

Point-of-care testing Managing

change when you are not in charge

By Robert F. Moran, PhD, FCCM, FIUPAC

Managing change is never an easy task — even less so when you are not in charge — which is where most of us find ourselves in point-of-care environments. Point-of-care testing (POCT) defines itself: Clinical laboratory testing conducted close to where patient care is provided. It is focused on real turn-around-time (TAT), from

Earning CEUs

See test online at https://ce.mlo-online.com/ courses/point-of-care-testingmanaging-change-when-youare-not-in-charge/ 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 the organizational use and benefits of POCT testing in healthcare systems.

2. List personnel characteristics that should be employed when positively adapting to change.

3. Discuss tools that can be utilized when assessing the analytical performance of whole blood.

4. Describe the information and symbols that can be included in a lab report to add value and substance to the results.

specimen collection, to measurement, and then in the hands of the caregiver. Great for the treating caregiver but it comes at a cost — a technology investment if measurement devices are dedicated to a sufficiently small group of patients and a support infrastructure such as data management systems that must work seamlessly together. Those capital costs and the related system’s complexity leads us to a need to understand how it all fits together.

Whatever the regulatory and healthcare environments are, each professional associated with POCT should have a basic understanding of their entire system and their individual responsibilities. Understanding how those responsibilities relate to the ‘big picture’ will demonstrate how critical everyone’s contribution is to overall success. Each caregiver or POCT laboratorian undoubtedly looks at this as appropriate for their own duties, training, and experience. However, the caregiver’s or laboratorian’s own view should be governed by their organization’s circumstances and needs. Key elements of the big picture always depend on combinations of the following:

Healthcare environment:

• Primary care–standalone (e.g., community urgent care clinics, group practices) or one institutionally linked (e.g., urgent care clinics on or off campus to the sponsoring or proprietary organization)

• Secondary or tertiary care institutions where the central laboratory (CL) controls the entire POCT operation versus one where a unit/department other than the CL controls all or part of POCT operations.

Photo

Scan code to go directly to the CE test.

Regulatory environment:

• CLIA’88 and state regulations set the standard.

• Standards and professional organizations Clinical and Laboratory Standards Institute (CLSI)1 and Association for Diagnostics and Laboratory Medicine (ADLM)2

• Outside the United States, other country or regional authority regulations often incorporate existing standards from standards-setting organizations such as the International Organization for Standardization (ISO). Each team member’s application of their personal knowledge, skills, and attitude is important. Simply being a great laboratorian (or therapist or registered nurse) and applying technical knowledge and skills is not enough. In POCT, laboratorians work alongside direct care givers, sometimes in incredibly stressful and patient–critical circumstances. POCT may well not be the comfort zone.3 That is why change and its management is crucial. Note that this is not management by the ‘suits’ but by each active POCT professional. While this continuing education article is directed primarily to clinical laboratory professionals and related staff, many aspects can easily apply to other members of the POCT team.

POCT can bring much more realistic TAT for test results that are directly and immediately applied to patient care. Additionally, POCT can bring clinically better information to the bedside. The improved information may be in 1) the nature of the numeric value itself or 2) the ability to make better-informed clinical decisions because of the timeliness.

The technological advances in measurement and information management have supported many of the changes and have enabled the extension of the laboratory function to locations seen and required for both life-threatening situations or for operational efficiency (e.g., No second visit necessary for diagnosis or treatment). Clearly, this can bring about better immediate care, leading to improved clinical outcomes compared to central laboratory testing (CLT), and at the same time ensure that no patients are ‘lost’ between visit and testing and follow-up visit.4

Rather than focusing on the entire range of technical and managerial issues, this article will focus on three things: 1) Change and leading it when you are not in charge; 2) special quality control/assessment tools for POCT and their significance; and 3) specimen characteristics that affect result meaning, including how they can be readily communicated. Each of these is intertwined with the major aspects of POCT operation and management as defined by the AACC (now ADLM) Academy of Clinical Biochemistry Guideline (Academy Guideline), as well as being embodied in the CLSI Guideline mentioned above, both of which should be readily available to any professional involved in POCT.

Part I: Change management

Change is constant, or at least constantly occurring. What you thought you knew last week is different today. This requires awareness on the part of each professional in POCT. Not every change requires a new protocol or standard operating procedure (SOP), but it does require knowledge.

The management of POCT (i.e., the big picture) is outlined in the AACC (renamed ADLM) Guideline2 and encompass all major aspects that can apply in POCT. They are: 1) Interdisciplinary Committee, 2) Education,5 3) Staff and staffing, 4) PT/EQA programs, 5) Data management, 6) Selecting POCT, 7) Processes and outcomes.

‘The real picture’ reflects the AACC Guideline, but it is different. It is what each professional in POCT faces each shift.

There are several aspects to one’s personal management of change, but we will focus on one and lead into two examples. The most successful change management depends on you and how you interact with other team members.

Where are you in the POCT plan? The basic expectation for each person comes from the traditional job description It should go beyond that. An ideal job/position description that I have seen starts with the traditional job description, but adds the following in a clear, simple set of expectations: 1) Core knowledge required, 2) requisite technical skills, 3) attitude (KSA). This last item, attitude, possibly the most important, can encompass many things from internal team interactions to adhering to changing conditions cheerfully. A satisfactory attitude means that one conducts their use of knowledge and skills efficiently, pleasantly, and in accord with the reasonable expectations of the environment. Understanding these three aspects of you and the position is key to both personal and professional success. Depending on one’s own expertise or interest, discerning which of the Academy’s areas of focus is personally significant may have an impact on how you assess your own areas of activity outside the basic functions of the position.

Engage with others within the POCT Team and consider the make-up of your institution’s POCT interdisciplinary group. Considering what communities each represents may serve you well in understanding and conducting your role of managing when you are not in charge. Also see what informal systems exist to make things operate. When seeing something different than you expect, best to say,“Hey that’s a bit (or a lot) different than at my last place. Can you explain it, so I understand it better,” rather than, “I was taught” or “We did it this way at XX.” Recheck the SOP, then bring it up during coffee break. Engage with others outside the POCT Team, especially those who POCT interacts with. Engaging with others may be a challenge for some laboratorians. This is where the Attitude from KSA comes into play. To be most effective, it is important to know something of the demands placed on each area with whom one interacts. Those accustomed to direct patient care may have different sorts of demands and perspectives. They may not, for example, understand that not all heparin is ok for use in blood collection — you are just being fussy. When you see what a registered nurse or pulmonary function technician must do, you will be much better able to understand how their ‘attitude’ affects their perspective of the ‘Lab Tech.’ Engaging with ‘others’ is likely to make you realize they are not much different than the folks in the lab — your common point is resolving issues to improve the care of the patient. And that is the key to managing change when you are not in charge. Recent experiences with SARS-CoV-2 should be a reminder that while some change is always happening, occasionally the change is so abrupt and significant that it affects not just us but most of humanity. Being prepared suggests that having the basic technical knowledge and skills for the job isn’t enough.5 Looking outside the box and anticipating inevitable change is a requirement for survival not just success! Using the concepts described above may well be applicable to each of the topics that follow.

Part II: Assessing real system analytical performance – whole blood

The actual specimen type measured by many POCT systems is whole blood. Why then, are QC/EQA/PT materials used for validating performance made from other materials? Shouldn’t we know how well the system works on blood? An obvious

example where a difference is for oxygen partial pressure (pO2). Most, if not all artificial control media cannot completely mimic whole blood for the measurement of pO2. Less obvious are the electrolytes of whole blood, especially sodium and to a lesser extent chloride.6-9

Of course, the sellers of QC materials will all say that their materials work ‘like’ blood, and they are not misleading you — all are capable of validating calibration and basic functionality. The fact is that we are accustomed to QC/EQA materials used by the central lab that are just like the actual test specimen (i.e., serum or plasma). But even whole blood–based QC materials are different than our patient test specimen. After all, they need to be stabilized to make them last for several weeks, among other modifications. One solution to this technical dilemma is duplicate analysis of the same specimen. ‘Duplicates’ were really the method of choice before the onset of commercially available materials — and it is common to use it informally.

A laboratory may choose to assess quality control by using one instrument or even two or more instruments for near-simultaneous analysis of a specimen. The utility of this approach has been thoroughly studied.10-13 An excellent guide and reference for statistical methods is published by the National Institute for Standards and Technology.14

One should expect the same measuring system to be able to repeat its performance on the same specimen. The question is how closely? Duplicate measurement of multiple specimens will give a good estimate of how closely the system routinely performs. The average difference can be calculated, as well as the random variation of the average. Once this guidance set of statistics (average of duplicates and standard deviation [SD] of duplicates) for each instrument and measurand is set, a simple monitoring plan can be established.

Similarly, two or more instruments (within or between department POCT) are assumed unlikely to have the same measurement error at the same time. Within-instrument comparison using whole blood specimen duplicates is a key to understanding system performance and evaluating complaints of performance. Both inter-instrument bias (average difference) and variance/SD can be assessed and used as an operating guideline. The duplicate measurement approach should not be used as the only method of QC. However, when used as a supplement to and in conjunction with commercial controls, it is a very useful technique for detecting errors on a particular sample (e.g., an air bubble) and for troubleshooting. Duplicate measurements of whole blood specimens at various times during an interval of known conditions and sample stability can be used as secondary controls for detecting analyzer changes. This can reduce the need for expensive/ complicated assessments using a full range of commercial controls. For duplicate values on any whole blood system:

• Check legal/institutional policy regarding use of patient blood. (If there are legal or other concerns for the use of patient blood, consider staff volunteers.)

• Set up (with statistician assistance) a protocol for duplicate testing.

• Include each measurand/analyte

• Include within and between instruments/POCT site as appropriate

• Establish performance then write a policy/practice for routine use.

The duplicate analysis of whole blood on POCT systems that measure whole blood patient specimens is essential practice and helps meet quality management guidelines, especially

where it goes beyond the basic QC materials used. It can aid both within and between system assessment of performance, the latter being more significant with the common existence of multi-site measurement in the same healthcare system and the linkage of specimen reports and displays within that system.

This could be an opportunity to apply your KSA to make it happen.

Part III: Simple specimen symbols

Most laboratory information is consolidated in a laboratory information system (LIS) that links all systems and data together. However, are ‘all systems’ designed to link patient registration, wristband-scanner, the collection device itself, and the analyzers on which measurement occurs? The answers vary depending on your institution. Planning for these linkages requires awareness in the initial stages of system development, in which case the issues are relatively simple. Upfront awareness is crucial for long-term planning.

A recently proposed plan for identifying fundamental specimen characteristics can facilitate result interpretation to improve both clinical and quality management. This plan is a simple extension of a recommendation by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC). IFCC recommendations place specimen information in parenthesis following the measurand (analyte) name and identifies the anatomic source and type of specimen. The proposal simply adds symbols for unique measurement conditions that are available using modern technology (e.g., measuring sodium in the plasma of whole blood).15,16

The current system uses, for example, (aB) for arterial blood so the report would have pCO2(aB). A few additional symbols aids information system specialists since symbol sequence and position is systematic. The additional information makes it obvious if the specimen result is from a venous blood specimen pCO2(vB). If the specimen is from an arterialized capillary bed, a collection technique subject to certain unique errors, the symbol set would be for oxygen pO2(caB).

Each is linked to the specific specimen and patient, and there is no question regarding the source and its meaning for the laboratorian, caregiver, or information technology (IT) programmers who can link all from patient to collection device to the final report. An extension of this is what the sensors of the analytical systems do. Both bicarbonate and sodium are measured in a whole blood specimen but measured in the plasma. Bicarbonate could be displayed as HCO3(aBp). A similar pattern (primary anatomic source then a qualifying subscript followed by specimen type) can be used for other anatomic sources as shown in Table 1.

Measurement conditions, such as measurement in plasma (p) or plasma-water (p w) would follow the type (of specimen) symbol. Example of these currently would be blood gas systems reporting sodium, which uses ion selective electrode (ISE) technology, harmonized to agree with central laboratory systems if plasma protein/lipids levels are normal. 7 Harmonized blood gas systems would/ should display Sodium or Na(aBp h). Most sodium values from the analyzers will agree with the central lab results. But if significantly different (remember those duplicate statistics), there may be a physiological/clinical condition, not an analytical error.

An example of the pattern/sequence for (sqTYcq) is as follows: 1) anatomic source followed by the 2) specific qualifier, (subscripted), and the 3) type of specimen then the 4) measurement condition, and its 5) qualifier (subscripted).

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› Ideally suited for every testing environment

If you see the advantages of this approach, (i.e. Analyte Name (sqTYcq)), it is certainly something that will need some discussion, persuasion, and change management to make it work in your institution. But, given the current state of linkages between LIS/HIS and “all-in-one” data management systems, now is an optimal time.

Conclusion

Professional laboratory work in a point-of-care environment is significantly different than typical laboratory operations. By working in POCT areas, the laboratorian not only uses the technical knowledge and skills developed by education, training, and experience, but interacts with professionals who have diverse types of views of both laboratory results and of laboratorians. Coupling that with the critical care environment, which may have extremely intense and personal involvement of caregiver and patient at unpredictable times, even an experienced laboratory professional can be challenged. When given or choosing a POCT assignment, a laboratorian should not think of it as a simple schedule or location change. It can and likely will be far more than that.

• First, you are likely to be interacting directly with the patient. Certainly, in the collection of a specimen but more than that — under acute conditions found in the emergency department/trauma, critical care units, or the operating theater.

• Second, in addition to those aspects of direct care, reflect on and prepare yourself by considering the points of part one (managing change).

• Last, if you see either or both aspects as challenges you really want, jump into it with both feet. You will not be disappointed. It will be a genuinely exciting place — a place where one can see the application of all your laboratory education, training, and experience put into effect in situations where you see what is happening to real patients, and with care given by or to people you know. It will never be a routine day again! (Contact the author for some war stories!!)

REFERENCES

1. Quality Management System: A Model for Laboratory Services

2. Nichols JH, Alter D, Chen Y, et al. AACC Guidance Document on Management of Point-of-Care Testing. J Appl Lab Med. 2020;1;5(4):762-787. doi:10.1093/jalm/jfaa059.

3. Jenkins, J. What can go wrong in Point of care testing. CLN. Published July/August 2023. Accessed June 28, 2024. https://www.myadlm.org/CLN/Articles/2023/JulAug/ What-Can-Go-Wrong-With-Point-of-Care-Testing.

4. Nichols JH. Utilizing Point-of-Care Testing to Optimize Patient Care. EJIFCC. 2021;29;32(2):140-144.

5. Point of care specialist certificate program. Myadlm. org. Accessed June 28, 2024. https://myadlm.org/Education/Online-Certificate-Programs/Certificate-Programs/ Point-of-Care-Specialist-Certificate-Program.

6. Królicka AL, Kruczkowska A, Krajewska M, Kusztal MA. Hyponatremia in infectious diseases—A literature review. Int J Environ Res Public Health. 2020;17(15):5320. doi:10.3390/ijerph17155320.

7. Villanova PA. Standardization of Sodium and Potassium Ion-Selective Systems to the Flame Photometric[ Reference Method: Approved Standard NCCLS Document C29-A2.; 2000.

8. Maas A. Proposed recommendations on ion selective electrode determination of the substance concentration of sodium, potassium and ionized calcium in serum, plasma, or whole blood. In: Heiden C, Leijnse B, eds. Clinical Chemistry, An Overview. ; 1988:39-62.

Table 1. Example charted/displayed symbols and their description.

pO2(aB)

pO2(caB)

pO2(auB)

cNa(aBph)

The partial pressure of O2 in arterial blood plasma in equilibrium with whole blood .

The pO2 of arterialized capillary blood. The process of collection requires a specific symbol.

The pO2 of umbilical artery blood. (If artery or vein is not specified, insert the lower case ‘u’ unsubscripted, as the source.)

Concentration of sodium in arterial blood plasma, measured directly (without dilution) with calibration/measurement harmonized with the NIST SRM956.

cO2(vpaBt),

cO2(vmBt)

Concentration of oxygen in mixed venous blood, total of all forms of O2, (Hemoglobin bound + dissolved), collected from a pulmonary artery.

Note: Measurand names/symbols shown are examples. Local custom is acceptable or even preferable. Our focus is on the specimen characteristics only.

9. Vera MA, Sutphin A, Hansen L, El-Khoury JM. Resolving pseudohyponatremia: Validation of plasma sodium on radiometer ABL800 blood gas analyzers for immediate reflex testing. Lab Med. 2022;53(5):e105-e108. doi:10.1093/labmed/lmab114.

10. Westgard JO, Moran RF, Groth T. Performance validation of blood gas instruments using three levels of controls for pH, PCO2 and PO2 - procedure and assessment by interactive computer simulation. In: Blood pH, Carbon Dioxide Oxygen and Calcium Ion (Proceedings of 5th Meeting of the IFCC Expert Panel on pH and Blood Gases). ; 1980:115-137.

11. Moran RF. Assessment of quality control of blood gas/pH analyzer performance. Respir Care. 1981;26:538-546.

12. Burnett RW, Maas AH, Moran RF. Quality control in blood pH and gas analysis by use of a tonometered bicarbonate solution and duplicate blood analysis. Clin Chem. 1981;27(10):1761-1764. doi:10.1093/ clinchem/27.10.1761.

13. Elser R, Hess D, Moran RF. Assessment of the agreement between duplicate whole blood measurements of blood gases and pH on independently calibrated analyzers. Methodology and Clinical Applications of Electrochemical and Fiber Optic Sensors. 1990;11.

14. National Institute of Standards and Technology (NIST), SEMATECH. e-Handbook of Statistical Methods. Available at: https://www.itl.nist. gov/div898/handbook/. Accessed June 28, 2024.

15. 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;21;34(4):271-275.

16. Moran RF. Overcoming data management challenges: The biggest challenge of all is….us. Medical Laboratory Observer. Published January 29, 2024. Accessed June 28, 2024. https://www.mlo-online. com/information-technology/data-management/article/53081209/ overcoming-data-management-challenges-the-biggest-challenge-ofall-isus.

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.

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Critical lab values A 50-year perspective honoring the MLO anniversary of publishing the laboratory panic values paper

By George D. Lundberg, MS, MD, ScD

This month, MLO is republishing the original panic–critical value article1 in its annual Clinical Laboratory Reference supplement. A critical laboratory value represents a pathophysiologic state at such variance with normal as to be life threatening unless some action is taken quickly, and for which there is an appropriate action. Failure to act can threaten life and health in serious ways. Physicians and laboratorians have long recognized their importance. But it remained for us at the Los Angeles County/USC Medical Center in 1969 to call attention to this obvious need and to create and implement an organized system to recognize and act upon such as a routine. 2

Nothing operates in isolation. Everything is interconnected. And yet, sometimes one person at one moment with one decision begins something uniquely important. Such a person was Sol Bernstein, MD, Chief of General Medicine at the old “Big County” Hospital that had just transitioned into the Los Angeles County/ USC Medical Center, the largest hospital in the United States. Sol established a Laboratory Utilization Committee as one method to achieve solid sensible progress from a dismal 1968 to the present.

There were many sociologic and economic forces at play in L.A. at that time which, in aggregate, propelled this movement. Two other medical schools had just moved to other locations outside L.A.; new money in the form of Medicare was being realized, and MediCal was being defined. Prior, funding of county hospitals had been primarily from property taxes.

I had just been appointed into the leadership role for laboratory medicine and pathology, which at that time included requiring physicians to use ration stamps to get many lab tests performed. I am NOT making this up. To state that we had a few lab problems to solve in 1968 would be a huge understatement.

Roger O. Egeberg, MD was the Dean of the medical school at the University of Southern California. Egeberg was a “force of nature,” best known then as

the personal staff physician of General Douglas MacArthur during the South Pacific campaign of World War ll. Egeberg later became Assistant Secretary for Health and Scientific Affairs in the Department of Health, Education, and Welfare under President Richard Nixon.3

An inspirational and charismatic leader, Egeberg had initiated the patient-focused approach at the medical school, an early expression of patient-centeredness. We took that clue and created many “patient-focus committees” to guide a total laboratory re-organization based on turnaround time (TAT). We knew that patients could get sick at any time in a 24/7 period. Essential lab tests that are technically feasible and administratively sound must recognize no time or day limits. The key of timing was an ability to initiate an effective intervention. Critical values fit perfectly into that framework. We defined TAT as the time from which a specimen arrived at the laboratory somewhere until the result was available in the lab somewhere. We soon realized that such was a pragmatic solution since we in the lab could not control the rest of the process. That led to our inventing the “Brain-toBrain Loop” that redefined a lab test as beginning when one brain had the idea to get a specific lab test until another human brain had received the result, evaluated it, and acted.4 Nine steps in the performance of any laboratory test: order, collection, identification (at several stages), transportation, separation (or preparation), analysis, reporting, interpretation, and action.5

The large staff physician workforce (mostly residents and faculty) was justifiably angry and frustrated with the nine-step process — they perceived it to be a laboratory problem in the delays in their prompt receipt of laboratory results for their patients. Concurrent pressure from the Intern Resident Association of LA County helped to provide movement on the expense budget so the Laboratory could grow to do a better job, i.e., upgrade laboratory services and coverage.6

By chance, a publisher’s representative (Newton Townsend) for the Medical

Economics Publishing Company in Oradell, New Jersey was visiting our lab as part of our negotiation to publish a new book, which came to be entitled Managing the Patient-Focused Laboratory, one section of which was to deal with panic values.7 He asked that I describe the panic value system for their new periodical, Medical Laboratory Observer (MLO).1 The immediate and immense impact of this MLO paper needs to be considered from the vantage point of just how early it was. The year, 1970, was 25 years before the internet came into existence. Automated data processing in laboratories was just beginning to evolve into the Information Age. Although Avedis Donabedian is credited with fundamental work of medical quality beginning in 1966, the American College of Medical Quality was not founded until 1973. The national patient safety movement arose from Lucian Leape’s classic “Error in Medicine” paper, which appeared in JAMA in 1994. This MLO game-changer article antedated those efforts.

As“handoffs”of responsibility between medical professionals have become recognized to be a potential safety hazard issue, that phase of communication has become recognized as salient. The fields of pre- and post-analytic testing stemmed from this thinking. These fields are now recognized as prime sources of errors in medicine. There have always been differences of opinion among individuals and institutions about what analytes should be included and what the ranges should be. I originally stated that individual institutions should make these determinations. I mean, some panic earlier/more easily than others.

In my writings since the early 1970s, I have encouraged expansion of a system of “fail-safe” notification and feedback/

notification/acknowledgement of the action needed by a responsible person. In 1969, individual pieces of paper contained printed or even handwritten lab test results and were physically placed into paper charts for each patient, sometimes daily. Communicating critical results in a timely and reliable way is essential to teamwork and patient safety. Well-timed technology transfer has become increasingly recognized as a weak link in America’s healthcare system.

The delay from discovery/invention/ creation of a BETTER drug/device/procedure/process until widespread use/ application can be as long as 15 years or more. Many new ideas are ignored; some are tried and discarded. Not so critical values: it was an idea whose time had come. The practical commonsense of the panic value system just hit lab and clinical folks in the head and they “got it,” adopting it forthwith.“Why didn’t I think of that?” was a common reaction. I have always credited the editing–publishing folks at MLO for understanding that the colorful “centerfold” of a popular men’s magazine was an obvious prototypical display approach to get people’s attention. That brilliantly colored chart instantly adorned lab bulletin boards coast to coast. And change was lightning fast. It was just so obviously the right thing to do. Practice changed. The standards, accreditation, licensing, regulations, even laws (like CLIA) followed to codify the whole process. In 1990, pathologist Gerald Kost published a national survey that documented critical limits used by trauma and medical centers across the United States.8 Mean low and high critical limits for the most frequently listed tests were determined to help healthcare professionals improve the quality and efficiency of acute patient care.

Over time, we proposed expanding the critical value system to a vital value system in which acting on the life-threatening results was just as important as critical values but in which the urgency of time did not apply.9 Examples included a positive Gyn Pap smear or a positive TB culture. An example of a laboratory policy that distinguishes between critical and vital results/values and defines the process for notification of physicians or clinical personnel responsible for patient care is available from TriHealth Laboratories.10 In 2014, I called for the addition of a tenth step to the brain-to-brain loop, outcome.11 What was the outcome that resulted from the test? Were the laboratory tests appropriate? Were they beneficial? Were they economical?

I prompted my ChatGPT: “How might a well-functioning clinical AI system deal with laboratory panic-critical values?” Henry (my avatar) responded:

“A well-functioning clinical AI system dealing with laboratory panic-critical values should operate with precision, speed, and prioritization to ensure patient safety and efficient healthcare delivery. Here’s a framework for how such a system might operate:

• Real-time monitoring: The AI continuously monitors incoming laboratory results in real-time. It’s programmed to identify paniccritical values based on established medical thresholds for each test.

• Immediate alert system: Once a panic-critical value is detected, the AI triggers an immediate alert to the healthcare provider responsible for the patient’s care. This alert can be delivered through various channels such as the hospital’s electronic health record system, text message, or pager, ensuring timely response.

• Clinical context assessment: The AI doesn’t just alert based on raw data but also factors in clinical context. It considers the patient’s medical history, current condition, medications, and other relevant data to provide a more nuanced understanding of the urgency and potential implications of the abnormal result.

• Prioritization algorithm: Not all panic-critical values are equal in urgency. The AI employs a prioritization algorithm that categorizes alerts based on the severity of the abnormality and the potential impact on the patient’s health. This helps healthcare providers focus their attention on the most critical cases first.

• Guidance and decision support: Alongside the alert, the AI provides guidance and decision support to the healthcare provider. It may suggest immediate actions to stabilize the patient, recommend additional tests or interventions, and offer relevant clinical guidelines or protocols to follow.

• Documentation and follow-up: The AI ensures proper documentation of the alert, including timestamped records of when the alert was generated, who responded to it, and the actions taken. It may also facilitate follow-up care by scheduling necessary appointments or consultations.

By integrating these functionalities, a well-functioning clinical AI system can effectively manage laboratory panic-critical values, leading to faster response times, improved patient outcomes, and enhanced overall healthcare quality.” I could not have said it better myself. And that’s the way it is in MLO August 2024. Keep up your good work.

George D. Lundberg, MS, MD, ScD of Los Gatos, California is Editor in Chief of Cancer Commons and Editor at Large at Medscape . A practicing and academic pathologist since 1962 and medical editor since 1982, he is best known as the Editor in Chief of JAMA from 1982-1999 and Medscape 1999-2009. His top jobs in Laboratory Medicine were as Professor and Chair of Pathology at UC Davis and President of ASCP.

References are available online at mlo-online.com/55091533.

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Safety and phlebotomy Considerations for a common invasive procedure

By Tammy Oppy, BS, MLS(ASCP)and Shama Fronczak, BS, MLS(ASCP)CM

Phlebotomy — collecting a blood specimen directly from the circulatory system via puncture for analysis and diagnosis — is one of the most common invasive procedures in healthcare. Approximately 450 million blood draws occur each year in U.S. hospitals,1 which may lead some to take phlebotomy for granted. However, the humble blood draw is an essential step in the journey to diagnosing, monitoring, and treating countless health conditions. It also comes with inherent risks to patients and health workers alike.

Safety in phlebotomy can be divided into two major categories: patient safety and healthcare worker safety.

• Patient safety includes the risk of injury or harm as a result of the blood collection process.

• Healthcare worker safety includes protection from exposure to bloodborne pathogens and needlestick injuries.

For patients, the potential physical effects of unsafe phlebotomy range from pain and bruising to nerve damage or hematoma.2 For healthcare workers, the primary physical concerns are sharps injuries and accidental exposure to infectious agents. Standards of care and best practices, along with advances in sharps injury prevention measures, all contribute to establishing a physically safe blood draw.

Adherence to clinical laboratory standards for phlebotomy also helps ensure specimen quality and subsequent test result integrity. The benefits of obtaining a high-quality specimen are two-fold – it not only contributes to accurate diagnosis and/or therapy management for the patient, but also reduces the need for additional blood draws that would be required in the case of an unacceptable specimen.

Preparing for safe blood specimen collection

For any healthcare worker performing phlebotomy, safety begins even before a patient encounter. From practicing in a safe environment to assembling the proper materials ahead of time, for example in a phlebotomy tray or cart, preparation sets the stage for safe blood collection.

The World Health Organization (WHO) has established five key points in phlebotomy preparation that can directly contribute to patient and health worker safety as well as sample quality:2

• Availability of appropriate supplies and protective equipment, including a sufficient supply of blood collection tubes and safety-engineered equipment

• Availability of post-exposure prophylaxis

• Avoidance of contaminated phlebotomy equipment

• Adequate training in phlebotomy

• Patient cooperation, aided by clear communication throughout the procedure

Adequate training cannot be overstressed, especially since professionals from many different healthcare disciplines with varying degrees of experience or specialization in phlebotomy

may be responsible for collecting blood samples. Standards for safe practice aim to equip and protect them all but are only effective with proper education.

Safety from the first “Hello”

The first introductions with a patient can set the tone for safe sample collection. Guidelines from both CLSI (Clinical Laboratory Standards Institute) and WHO emphasize addressing patients with empathy and respect from the first “Hello.” Always remember: Patients are human beings, and each one is unique. Phlebotomy often happens in high-pressure environments — it can be challenging to slow down and connect with each patient. But a patient-centered approach can make all the difference.

Phlebotomists draw samples from a wide range of patient populations. Even within a single acute care facility, the same phlebotomist may be responsible for collecting blood samples from multiple units in a day — from the ICU to pediatrics, the emergency department to medical/surgical and anywhere in between. With such diverse patients, being able to correctly assess each one’s unique condition and select the appropriate approach and products for their specimen collection is a crucial skill to improving safety and sample quality.

A few simple steps in patient assessment include:

• Ask whether the patient has any allergies, phobias related to blood draws, or other conditions that may influence specimen collection.

• Note if the patient appears anxious or afraid; if so, take extra steps to make them comfortable.

• Be aware of any physical limitations that may prohibit comfortable arm extension, such as injury or stroke.

• For pediatric patients, ask whether a parent would like to assist by holding or comforting the child.

• In inpatient scenarios, take note of any signage, bracelets, or other indicators signaling patient-specific precautions. 3

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Identifying the patient

While it may seem like an obvious precaution, patient identification should never be overlooked. A recent study found that 53% of wrong blood in tube (WBIT) errors involved a combination of protocol violations and slips/lapses.4 Whether the intended patient is drawn, and an incorrect sample label is applied or vice versa, the potential risks of a WBIT error include misdiagnosis and inappropriate therapies, which may lead to serious injury and even death.

CLSI advises taking extra precautions in high-risk situations, such as when drawing from siblings or twins; patients with common names, look-alike or sound-alike names; and multiple patients within the same room. The same study that linked WBIT errors to protocol lapses also found that 61% of WBIT errors occurred when another patient’s sample labels or tubes were available during phlebotomy.4 It is possible to misidentify a sample even when using electronic positive patient identification, so always double-check that you have both the intended patient and correct tube labels.

Collecting the sample

Once satisfied that the patient, test requests, and sample labels are verified, sample collection may begin. When performing a venous sample collection, the physical risks largely center on injury or accidental exposure. The risks to clinical accuracy include selecting the inappropriate products for the required draw or improper collection site preparation and tube handling.

Having the proper tools within reach helps ensure both physical safety and clinical integrity during sample collection. For venipuncture, this includes a needle of appropriate gauge for the patient’s vein conditions. Too large of a needle may damage the vein while too small may contribute to higher rates of hemolysis.

CLSI also strongly encourages the use of safety-engineered blood collection devices, such as safety winged collection sets (“butterflies”). Safety devices, when used according to manufacturer’s instructions and activated immediately after specimen collection, help reduce the risk of needlestick injuries.

Collection site selection and preparation also factor into a safe draw and quality sample.CLSI recommends drawing venous blood samples from the antecubital fossa – the interior of the elbow bend. This area features several large veins that are relatively easy to access. The veins in the center of this area (median cubital veins) also lay over a fibrous membrane that offers additional protection to underlying nerves and arteries.3

The use of a tourniquet may aid vein palpation and specimen collection, but also poses risks to sample integrity when used inappropriately. Pay attention to the amount of pressure – it should feel comfortable to the patient while exerting enough pressure to make the veins more prominent – and the amount of time a tourniquet is applied. More than one minute may cause hemoconcentration, which affects several analytes. Note that vein selection, supply assembly, glove donning, site cleansing, needle insertion, and establishment of blood flow must all occur during this minute, so plan accordingly and have supplies ready at hand.

Once a vein is selected, supplies are assembled, and gloves are donned, the collection site must be cleansed with a 70% isopropyl alcohol solution to minimize the risk of specimen contamination or patient infection. Allowing the alcohol solution to air dry will ensure decontamination and reduce the likelihood of a burning sensation during venipuncture. The site must be re-cleansed if palpated again before venipuncture.

Tips for safe and successful venipuncture include the following:

• Anchor the vein from below, never from above, which increases needlestick risks.

• Be prepared for sudden, unexpected patient movements.

• Insert the needle at an angle of 30° or less.

• Release the tourniquet as soon as blood flow is established (unless doing so may cause vein collapse).

Once the needle is successfully inserted into the vein, sample collection may begin. When using evacuated tubes, blood should flow freely into the tube to the required draw volume (that is, until the vacuum is exhausted). Once filled, the tube may be removed from the needle/holder and mixed by gentle inversion according to manufacturer’s instructions for use before inserting additional tubes as required.

Be careful to observe the recommended order of draw as outlined by CLSI GP41 or according to facility protocol. Adhering to the order of draw makes a considerable contribution to sample quality by ensuring that the additives of the previous tube do not carry over into subsequent tubes, causing interference and ultimately erroneous results.

Immediately upon completion of sample collection, remove the needle and activate the safety mechanism according to the manufacturer’s instructions.

Post-collection sample handling

After administering post-venipuncture care, properly disposing of sharps, and ensuring the patient is comfortable, samples must be labeled while still in the patient’s presence. Once again, verify the tube labels match the patient’s identification and test request.

Observe any special requirements for sample transportation, such as the need for refrigeration, protection from light, or other considerations to preserve specimen integrity.

Conclusion

To achieve the best possible results in the safest possible manner, it is essential to consider the entire phlebotomy process holistically. Every step, from evaluating the patient to venipuncture and specimen tube handling, can influence sample quality and impact the patient’s health.

REFERENCES

1. Psaila J, Parsons TF, Hahn SA, Fichera L. Prospective Study Evaluating Whether Standard Peripheral Intravenous Catheters Can Be Used for Blood Collection Throughout Hospital Stay. J Infus Nurs 2023;46(1):43-47. doi:10.1097/NAN.0000000000000493.

2. Best Practices in Phlebotomy. World Health Organization; 2010.

3. Collection of Diagnostic Venous Blood Specimens.; 2017.

4. Dunbar NM, Kaufman RM; WBIT Study Investigators, The Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Factors associated with wrong blood in tube errors: An international case series - The BEST collaborative study. Transfusion. 2022;62(1):44-50. doi:10.1111/trf.16716.

Tammy Oppy, BS, MLS(ASCP) serves as Product Manager for Preanalytics at Greiner Bio-One, a global company specialized in the development, production, and distribution of high-quality laboratory products. Tammy focuses on Greiner Bio-One’s blood collection safety products, transfer devices and holders, and products for the collection and analysis of urine. Shama Fronczak, BS, MLS(ASCP)CM is also a Product Manager for Preanalytics at Greiner Bio-One. Her focus areas include evacuated blood collection tubes and capillary blood collection tubes and lancets.

Tammy and Shama both bring a wealth of expertise to their roles, with 16 and 13 years of experience in the medical laboratory, respectively.

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Mass spectrometry’s place in the clinical lab: How it’s used and why

By Darren Weber

Acritical technique in clinical laboratory testing, mass spectrometry (MS) involves, at its core, examining a mass of molecules. Think of mass spectrometry as a tiny scale for molecules. Yet, unlike the scale in your bathroom, it doesn’t measure actual weight (which is influenced by gravity) but instead identifies the mass of a molecule based on its massto-charge ratio (m/z) after one or more molecules have been electrically charged (or turned into ions).

Why is assessing the mass of molecules important? Because it helps to carefully characterize those molecules, measure them and, in some cases, discover unknown ones.

Mass spectrometry can be like searching for a needle in a haystack. As an example, laboratorians routinely measure compounds in the blood — both small molecules, like drugs or steroids, or large molecules, like proteins or lipids — that exist in part-per-billion or even part-per-trillion levels. Imagine a machine that can help identify if a patient’s specimen contains both a prescribed opioid, which may be highly beneficial to the patient for pain relief, and an illicit fentanyl opioid, which can be lethal, through all that noise. Or a specimen that has tiny quantities of molecules of the amyloid brain protein circulating in the blood in the earliest stages of Alzheimer’s disease. That’s the power of mass spectrometry.

Despite its advantages, several challenges prevent broad implementations of this technique, despite the continued emergence of clinical applications for the technology.3

How mass spectrometry is utilized in a clinical laboratory

Mass spectrometry evaluates the quantity of molecules that make up a substance and has been found to have improved specificity and sensitivity when compared to traditional techniques in several applications where precise measurement of molecules is necessary. It can be used across a range of specimen types: serum, plasma, blood spots, even breath!

Mass spectrometry involves many different techniques. One advanced version of this testing is called tandem mass spectrometry. This technique involves two separate stages of mass analysis that a lab professional can use for comparison, with two levels of mass filtering. The first level filters based on the mass of the molecule itself. The molecule is then broken apart by collision with high-pressure gas, and the second level of mass filtering occurs on the fragments of this molecule. This can be helpful when used to decipher relationships among ions in a mass spectrum.1

Because it involves two analyzers, tandem mass spectrometry may provide more specificity than mass spectrometry.2 The results have many analytical implications when interpreted, spanning everything from drug monitoring to brain health testing. Another commonly used form of mass spectrometry is liquid chromatography (LC), which involves separating compounds in a sample prior to analysis.

Typically, tests that utilize mass spectrometry technology (or liquid chromatography coupled with mass spectrometry, or LC-MS, are highly advanced tests that require specialized skill and technology to perform. In addition, sample preparation before analysis can be complex and time-consuming because of the number of variables that can impact results.7

However, mass spectrometry technology has several specific use cases with the potential to empower the development of clinical diagnostics and precision medicines. There are many different ways a clinical lab can use this technology, but three specific ways we at Quest are using mass spectrometry is in prescription drug monitoring, “Forever Chemicals” PFAS blood testing and for neurology testing related to risk assessment for Alzheimer’s disease.

Last year, Quest launched a confirmatory testing service for novel psychoactive substances (NPS). The panel tests for 88 compounds and covers a broad array of drug classes, such as designer opioids, designer benzodiazepines, designer stimulants, fentanyl analogs, synthetic cannabinoids, and other illicit additives.4

NPS are versions of established prescription and illicit drugs that are routinely chemically altered to enhance drug effects and evade tracking by law enforcement. As their chemical composition frequently evolves, conventional point-of-care and laboratory test methods may fail to detect NPS, increasing risks for individual patients and challenging efforts to understand their long-term health effects or prevalence in communities.

Our panel uses liquid chromatography with advanced tandem mass spectrometry–based testing to establish NPS

misuse. Specifically, a team of toxicologists, medical experts and data analysts will periodically review and update the panel to include the most relevant and prevalent substances present in communities. This way, the panel will continue to address the changing drug epidemic.

Mass spectrometry’s place in the science behind Alzheimer’s disease Alzheimer’s disease is the most prevalent dementia, affecting nearly 7 million Americans.8 Diagnosis of the disease has traditionally involved cerebrospinal fluid and PET imaging tests, which can be specialist-dependent and expensive. In recent years, blood tests have changed how physicians approach assessing risk and diagnosing this disease. Certain blood tests, which measure biomarkers like p-tau217 or 181, or amyloid-beta proteins, rely on mass spectrometry to provide the sensitivity and specificity necessary to give patients insights on their risk of developing Alzheimer’s disease.

Our AD-Detect blood test portfolio has several tests that leverage this technology in patients with cognitive impairment. The increased sensitivity and specificity are needed for highly precise amyloid-beta testing, which evaluates a ratio of proteins in the brain that also circulate in the blood stream. When monitoring changes over time, these tests can also look at a patient’s changing risk or disease progression.9

While PET scans have traditionally evaluated patients for Alzheimer’s disease, new blood tests offer the potential for primary care physicians as well as specialists to identify people at risk even before symptoms manifest.5 In fact, research shows these highly sensitive mass spectrometry tests could help reduce PET brain scan evaluations by about 40% — identifying lower risk patients who would have otherwise been dependent on this expensive and specialist-dependent form of imaging. 5 The findings show immense promise in mass spectrometry, and can potentially lead to cost savings if blood tests become able to prevent a need for further tests and care.

Hurdles

to a larger rollout of mass spectrometry

Yet, there are some drawbacks preventing the widespread adoption of this technology in clinical testing. Employing mass spectrometry requires a technical specialist with a skill set that can be difficult and time-consuming to teach.3 Given the lab industry has been plagued, since the COVID-19 pandemic, with issues of staffing shortages and burnout, 6 it may be difficult to find specialists capable of this complex work with the certifications needed to perform clinical assays. Mass spectrometry requires analyzing complex algorithms for data processing, quantification, and identification of proteins. For some labs, identifying and employing these specialists may also be cost-prohibitive.

The future of mass spectrometry adoption

The evolution of mass spectrometry within a clinical laboratory setting has, and will, continue to grow. More frequently, the advantages of mass spectrometry-based applications have been realized in laboratory medicine.3 Furthermore, the clinical lab industry has started to see a shift towards personalized medicine that is unlikely to stop. From oncology to drug monitoring, mass spectrometry–based approaches are influencing the ways labs deliver testing and results reporting.

Barriers like costs and training may hinder the widespread adoption of this technology, but the superior specificity and sensitivity offered for this type of testing may make addressing these hurdles well worth it for labs. By expanding its use, labs can continue to address patient needs faster, bringing them the insights needed to deliver effective care.

Darren Weber is an Associate Scientific Director in the R&D Mass Spectrometry department at Quest Diagnostics-Nichols Institute in San Juan Capistrano, California. Darren is primarily responsible for the development of high-throughput quantitative mass spectrometry-based proteomic assays for the clinical laboratory, with an emphasis on Alzheimer’s disease and other neurodegenerative disorders. Prior to joining Quest Diagnostics, Darren was a member of the UC Davis Proteomics Core where he gained extensive experience in protein sample preparation and high-resolution mass spectrometry.

References are available online at mlo-online.com/55092072.

The UNIVANTS of Healthcare Excellence award program recognizes 12 new teams for transformational care

By Colleen Strain, PhD

The UNIVANTS of Healthcare Excellence program is proud to announce 12 new integrated clinical care teams that are recognized for achieving measurably better health outcomes by “UNIFYING” across disciplines to enable the development and implementation of “AVANT-GARDE” processes. Among many applications from across the globe, the final outcomes for the 2024 UNIVANTS of Healthcare Excellence awards revealed three top global winners, three teams of distinction, and six teams of achievement.

The 2024 top global winners of this prestigious healthcare excellence award include British Columbia Centre for Disease Control, Premier Integrated Labs Sdn. Bhd., and Kaiser Permanente Southern California.

GetCheckedOnline: Better access to testing for sexually-transmitted and blood-borne infections

An integrated clinical care team from the British Columbia Centre for Disease Control in Vancouver, Canada, recognized that screening for sexually transmitted and blood-born infections (STBBI) is not only a crucial step in enabling treatment and mitigating transmissions, but that accessing regular screening can be difficult. Compounding the challenge of access, is the stigma often associated with STBBI testing. With this in mind, GetCheckedOnline (GCO) was created in partnership with the BC Public Health Laboratory, Provincial Laboratory Medicine Services, LifeLabs, and participating regional health authorities. GCO is an anonymous, internet-based testing service offering a range of STBBI tests. Patients create anonymous test requisitions on the GCO website; receive free-of-charge testing at participating collection sites; and depending on the results, findings are either given online or by a specialized STBBI nurse.1

Thanks to the GCO program, patients are more engaged in their STBBI care. 87% of people testing through GCO report that they test earlier and more often than they would if they were testing through a regular clinic or healthcare provider. This is particularly true for equity-seeking populations.

Further, by streamlining STBBI testing, ten-fold more patients can be managed through GCO compared to equivalent nursing time in the Provincial STI Clinic at the BC CDC. This enables enhanced resource utilization and reduced costs to the overall healthcare system.

Early detection of metabolic-dysfunction associated steatotic liver disease using FIB-4

Metabolic-dysfunction associated steatotic liver disease (MASLD, formerly NAFLD) is a leading cause of liver disease worldwide, with the global prevalence increasing, likely due in part to the obesity epidemic.2 The phenomenon is especially true in Malaysia where rates of obesity, diabetes, and prediabetes are high.3 Consequently, screening for MASLD is important for mitigating long-term adverse outcomes, however, this can be difficult due to the often-asymptotic nature of MASLD, with symptoms typically manifesting only once the disease has progressed. While the gold standard for diagnosing liver disease is a liver biopsy, screening requires less invasive and more accessible options. Non-invasive screening options exist, including FibroScan and liver function tests (LFTs), however, both are not without significant limitations including access to Fibroscan and/or the difficulties often reported in primary care associated with interpreting and/or following up on LFTs. Thus, the need for a clinical care pathway that can easily enable screening, diagnosis, and treatment for MASLD in primary care is of the upmost importance.

In response to this need, Premier Integrated Labs Sdn. Bhd. in Kula Lupar, Malaysia implemented the Fibrosis-4 (FIB-4) scoring system for early MASLD screening in high-risk patients. This screening enables early intervention, when needed, and improved outcomes. One of the keys to success is that FIB-4 utilizes easily accessible and affordable clinical and laboratory parameters: age, ALT, AST and platelet count. Since implementation in July 2022, more than 39,000 patients have been screened, of which 5,662 patients were newly identified with ‘moderate- or high-risk’ of MASLD, enabling early referral and

Premier Integrated Labs Sdn. Bhd. team from Kula Lupar, Malaysia.

Integrated clinical care team from the British Columbia Centre for Disease Control in Vancouver, Canada.

appropriate intervention. For those at ‘low-risk’ no further referral is required, saving time and resources. Utilizing FIB-4 to guide care has not only improved resource utilization, but has improved wellness and enhanced clinical decision-making.

Improved management of patients with high LDL-C through electronic health recorddirected algorithms for guideline-concordant high-intensity statin prescribing Cardiovascular diseases (CVDs) are the leading cause of death globally, thus, risk minimization efforts are of high importance.4 One such risk factor is dyslipidaemia, which is characterized by elevated low-density lipoprotein cholesterol (LDL-C). Statin initiation for those patients is known to not only reduce LDL-C but help mitigate future CVD risk. Unfortunately, high-intensity statins are underutilized among adults with LDL-C ≥190 mg/dL.5 Understanding this care gap, an integrated clinical care team at Kaiser Permanente Southern California implemented the High LDL-C Statin Start program, under the SureNet umbrella. This program uses algorithms to scan electronic health records to identify adults with a recent LDL-C result ≥190 mg/dL and no evidence of any statin fill within the prior 2–6 months. Subsequently, high-intensity statin orders, along with follow-up lipid panel orders are automatically generated for primary care provider approval. Primary care providers are alerted of pending statin and lab orders by care managers, and once approved, letters are sent to each patient with reminders to retrieve their statin medication and to complete a follow-up lab test. This cross-functional and collaborative effort has improved the likelihood patients will fill their prescription by 32% (relative increase), patients are now 41% more likely to complete follow-up testing, and most importantly, 21% more likely to lower their LDL-C. An important success factor for this initiative is that clinicians did not find that it substantially increased their workload, even suggesting more education to enable awareness.

These impressive and diverse care initiatives involve impactful and meaningful outcomes enabling recognition with the 2024 UNIVANTS of Healthcare Excellence awards. Congratulations to all teams who received recognition in 2024!

For more information on UNIVANTS, the 2024 winners, and/or to apply starting Aug 1st, please visit www.UnivantsHCE.com.

Colleen Strain, PhD is a Scientific Manager at Abbott, Core Diagnostics focused on innovation and the value of laboratory medicine to stakeholders outside of the clinical laboratory. Colleen serves as the Scientific Lead for the UNIVANTS of Healthcare Excellence award program , which recognizes, celebrates and amplifies best practices in healthcare that are enabled by laboratory medicine.

References are available online at mlo-online.com/55092172.

Integrated clinical care team at Kaiser Permanente Southern California.

STATE OF THE INDUSTRY DISEASE MANAGEMENT

By Kara Nadeau

The 2024 Medical Laboratory Observer (MLO) State of the Industry (SOI) survey on Disease Management focused on diabetes (type 1 and type 2) and sexually transmitted infection (STI) testing. Alongside the quantitative results, we include commentary from BD, Hologic, Nova Biomedical, Revvity, and Roche Diagnostics on diabetes and STI sampling and testing trends and innovations.

Among the survey respondents, the majority (63%) hold laboratory manager, administrator, or supervisor positions and are employed by health system or hospital labs (63%). When asked how many employees work in their lab, 30% reported 1-10, 25% 21-50, 23% 11-20, 13% more than 100, and 10% between 51-100.

Key survey findings are as follows:

• 46% of respondents report a moderate or significant increase in diabetes testing

• 50% of respondents report a moderate or significant increase in STI testing

• Increased positive results for specific STIs as reported by lab professionals surveyed:

• Bacterial vaginosis: 11% increase (28% in 2024, compared with 17% in 2023)

• Gonorrhea: 6% increase (23% in 2024, compared with 17% in 2023)

• Trichomoniasis: 6% increase (15% in 2024, compared with 9% in 2023)

Diabetes testing trends

When asked if their lab has seen an increase in diabetes testing over the past 12 months, 46% of respondents reported

a moderate or significant increase, while 55% said they have not seen an increase.

Regarding methodologies for diabetes testing, most lab professionals (92%) reported using HbA1c, followed by fasting plasma glucose test (68%), oral glucose tolerance test (47%), and random plasma glucose test (45%).

Turning to testing methods for HbA1c, nearly half of survey respondents (47%) report using immunoassay as their methodology, 32% enzymatic testing, 18% cation exchange HPLC, 8% capillary separation, and 5% boronate affinity chromatography.

For those labs performing both the fasting blood glucose test and HbA1c test as screening measures for types 1 and 2 diabetes, 40% report using more HbA1c tests, 38% more fasting blood glucose tests, and 23% said they use both testing methodologies equally.

With the Centers for Disease Control and Prevention (CDC) reporting that 38.4 million people in the U.S. have diabetes,1 MLO questioned lab professionals on whether their current diabetes testing procedures are meeting their patient populations’ needs/expectations.

Nearly three-quarters of lab professionals surveyed (72%) said their procedures fully meet their populations’ needs/ expectations, 18% said they somewhat meet them, 8% said they are researching options, and 5% said their testing procedures do not meet their patient populations’ needs/expectations.

Among those survey respondents who are researching options, one commented on how they are currently sending out HbA1c testing but have purchased an analyzer to be validated in the near future.

Innovations in diabetes testing

Point-of-care (POC) testing

According to Dennis Begos, MD, FACS, senior medical director, Medical and Scientific Affairs, Nova Biomedical, while the company is primarily known for its glucose testing, they are now focusing more on chronic disease management, specifically outside of the hospital. He stated:

“With almost 80% U.S. market share in glucose testing inside of the hospital, we are still heavily focused on that, but what we are seeing as a trend is point-of-care (POC) testing outside of the hospital setting. Laboratory testing is moving away from people having to go to the hospital or outpatient lab to have blood drawn to having everything done when they visit their PCP in the office. This way, with a finger stick, they can have their HbA1c and cholesterol checked, as well as other testing, such as coagulation and kidney function testing.”

As Begos pointed out, this approach is less expensive, more convenient and has been shown to have improved outcomes because the PCP and patient have results immediately and can discuss diagnosis, preventative actions, and/or course of treatment during the care visit.

“Certainly, in the next five years we will see more availability of outpatient fingerstick blood testing,” said Begos. “In Italy and Spain, they are doing a lot of this testing in pharmacies. For kidney disease, patients who are on medications that may be harmful to the kidneys or are diabetic and at risk for kidney disease, the pharmacist can test for kidney function and adjust medications as needed.”

Speaking to the role of hospital pharmacies when it comes to POC testing, Begos stated:

“If a POC test is abnormal, it will have to be verified by a central lab. POC testing will increase the number of people tested overall, so I think it will increase labs’ testing volumes overall as well.”

Neonatal detection

The CDC estimates that 304,000 children and adolescents under 20 years of age in the U.S. have

diagnosed type 1 diabetes, with incidence significantly increasing among this population during the most recently recorded period (2002-2018).1

Chief Scientific Officer at Revvity Dr. Madhuri Hegde, spoke to the company’s development of an assay for neonatal detection of type 1 diabetes, noting how the “future of helping those with type 1 diabetes will soon come down to a drop of blood.” She stated:

“Here at Revvity, our singular focus is constantly figuring out how we stand side by side with our customers as a scientific partner and help revolutionize life by solving some of the most complex diseases and challenges that we face today. This includes type 1 diabetes. When we talk about the life-saving impact that Revvity’s newborn screening capabilities have on millions of babies around the world – it begins with just one drop of blood from a heel prick.”

Revvity designs and manufactures dried blood spot – or DBS cards – which enable blood samples to be transported to labs and analyzed for life-altering, metabolic diseases. According to Dr. Hegde, the company has screened more than 800 million newborns for rare diseases using DBS, saving the lives of 700,000 on a global scale for nearly four decades.

“It’s something we’re very proud of,” she commented. “It’s amazing to see how much this technology has meant in blood sample collection and logistics, combining scientific precision, efficiency, and affordability, to provide important diagnostic answers for families. We are enthusiastic about the potential to screen for type 1 diabetes with the use of DBS.”

Dr. Hegde described the benefits of using DBS to test all ages for type 1 diabetes:

“We would have a non-invasive sample collection and unique logistical advantage that also allows for a centralized screening strategy with the possibility of developing different sample collection strategies until reaching the home kit concept. This ultimate goal will give answers to the patient sooner for quicker and more effective health intervention.”

Dr. Madhuri Hegde

Dennis Begos MD, FACS

Sexually transmitted infection (STI) testing trends

MLO revisited the topic of STI testing in this year’s survey, having included it in the 2023 State of the Industry (SOI) survey on Disease Management. When asked if their labs had seen an increase in STI testing in the past 12 months, 50% of respondents reported a moderate or significant increase, compared with 46% in 2023. The other half of respondents (50%) reported no increase.

With the CDC reporting that one in five Americans have an STI,2 access to testing is critical to diagnosis and preventing the spread of infections.

“Labs play a critical role in delivering accurate results that help healthcare providers choose the appropriate treatment for their patients,” said Jennifer Schneiders, PhD, president, Diagnostic Solutions at Hologic.“The most common STIs identified in the most recent CDC Surveillance Report were chlamydia and gonorrhea. Strategically combining molecular diagnostic testing for similar infections can help accurately identify the cause in a timely manner.”

“It’s never been more important to provide accurate testing information quickly to doctors and their patients for assessing risk and helping to diagnose, monitor and treat patients,” said Denise Heaney, chief medical partner for molecular solutions, Roche Diagnostics.“Access to screening and diagnostic testing is often the first line of defense. Innovative, reliable, and accessible testing can transform STIs into manageable conditions.”

“Because many STIs are asymptomatic or have mild symptoms that can be mistaken for other conditions, people are often unaware of their infection status and do not seek testing or care,” said Alyssa Davis, MS, PA-C, medical science liaison II, U.S. Region, Women’s Health & Cancer, Scientific Affairs, BD. “As a result, many STIs remain undiagnosed and untreated, posing a threat to individual and public health, so it’s important to make testing easier and speed up the time to diagnosis so that patients with an infection can start the right treatment right away and reduce potential spread.”

from 9% in 2023), HPV infection (8% in 2024, down from 13% in 2023), and syphilis (10% in 2024, down from 13% in 2023). Reported increases in positive results for chlamydia remained relatively the same, only decreasing 1% (38% in 2024, down from 39% in 2023).

When asked whether their current STI testing procedures are meeting their patient populations’ needs/ expectations, more than half of lab professionals (54%) said they fully meet needs/ expectations, 36% somewhat meets, 10% said they were researching options, and 8% said their procedures do not meet their populations’ needs/expectations.

Among those researching options for STI testing, one lab professional noted how their lab was planning to switch from a wet prep panel to a molecular vaginosis panel. Another said they had recently validated Cepheid’s multiplex vaginal panel (MVP).

Supply challenges

Looking at testing for specific STIs, those surveyed reported the most positive results for chlamydia (38%), bacterial vaginosis (BV) (28%), and gonorrhea (23%). This was followed by hepatitis and Trichomoniasis (both at 15%), syphilis (10%), pelvic inflammatory disease (PID) and human papillomavirus (HPV) infection (both at 8%), Mycoplasma genitalium (3%), and herpes and HIV/AIDS (both at 3%).

Comparing this year’s survey results to last year’s results, the data showed trends in positive results for BV, with an 11% increase (28% in 2024, compared with 17% in 2023), gonorrhea with a 6% increase (23% in 2024, compared with 17% in 2023), and Trichomoniasis with a 6% increase (15% in 2024, compared with 9% in 2023).

Reported increases in positive results for the following STIs were also slightly higher: PID (8% in 2024, up from 4% in 2023), hepatitis (15% in 2024, up from 13% in 2023), Mycoplasma genitalium (3% in 2024, up from 0% in 2023), and HIV/ AIDS (3% in 2024, up from 0% in 2023).

Trending downward were positive increases for herpes (3% in 2024, down

Turning to supply challenges, 31% of those surveyed say they have had trouble acquiring swabs for STI testing, 23% assays, 10% blood specimen tubes, and 5% urine collection devices.

When comparing these findings to last year’s survey results, more lab professionals are struggling with the acquisition of assays for STI testing (23% in 2024, up from 18% in 2023), while fewer face challenges acquiring blood specimen tubes (10% in 2024, down from 36% in 2023), swabs (31% in 2024, down from 55% in 2023), and urine collection devices (5% in 2024, down from 27% in 2023).

Innovations in STI sample collection and testing

Sample collection modalities

Davis said one way to make STI testing easier is through self-collection of samples, where a person in a healthcare setting - not necessarily a doctor’s office, but a clinic, lab, or even retail pharmacy - performs a simple swab themselves, in privacy, which is then tested for multiple STIs using just the one sample.

“Improving ease and access by expanding the availability of STI testing services, especially in rural and remote

Alyssa Davis, MS, PA-C

Denise Heaney

Jennifer Schneiders, PhD

areas and among underserved populations, can go a long way,” Davis added.“U.S. Food and Drug Administration (FDA) approved combination tests that detect the most prevalent non-viral STIs - Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis - simultaneously and separately allow clinicians to get results for all three from one sample, and that’s easier for the patient, too.”

“Our collection device helps streamline testing for providers and labs by testing up to seven infections and disease states with one vaginal sample,” said Schneiders.“We are able to not only test for chlamydia and gonorrhea but vaginitis and other STIs such as Mycoplasma genitalium. This allows healthcare providers to identify the cause with one sample and offer the right treatment as quickly as possible.”

Heaney pointed to the FDA’s approval of the Roche HPV self-collection solution as a recent example of how innovation in STIs can potentially change the testing landscape.*

“This is an important innovation in cervical cancer diagnostics that expands access to HPV screening options by enabling women and individuals with a cervix to privately collect their own vaginal sample in a healthcare setting,” said Heaney. “The sample is then placed by trained personnel into a preservative solution and transported in controlled conditions to the laboratory where it is analyzed with the Roche cobas HPV test, which runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems.”

“This solution allows for broader access to care and could support the lessening of health disparities in cervical cancer, which is more prevalent among Black women and Hispanic-Latina women,” Heaney added. “Black women are less likely to be diagnosed with cervical cancer, yet they have the highest death rates compared to all other racial and ethnic groups due to profound survival disparities, which may be attributed to a lack of access to timely, high-quality care.”3

*HPV self-collection is FDA-approved but not yet available for sale in the U.S.

Testing modalities

“Once the sample has been collected, the speed and accuracy of diagnosis is an important factor, so the ability to run the tests through diagnostic devices quickly makes a difference,” said Davis. “Samples are often sent to labs for processing through high-throughput molecular diagnostics platforms which can deliver results in about a day.”

Schneiders, said she is seeing many healthcare providers (HCPs) moving to nucleic acid amplification testing (NAAT) for detecting BV, Candida vaginitis (CV), and Trichomoniasis (TV).

“Compared to conventional testing methods, NAATs offer objective, comprehensive and accurate results with the first test,” said Schneiders . “NAATs are FDA cleared and recognized by the CDC and the American College of Obstetricians and Gynecologists (ACOG). Testing all three infections together is important because they are all are similar, yet each cause has its own characteristics, consequences and treatment recommendations. Identifying the specific cause of a patient’s vaginitis, including those with mixed infections, can allow women to be more effectively diagnosed and then treated.”

According to Heaney, labs need a broad-based portfolio for early diagnosis to treatment monitoring, especially in areas for syphilis, Chlamydia trachomatis, Neisseria gonorrhoeae and HPV. She emphasized the need to provide fast-turnaround results in small to large laboratories and near-patient settings, such as emergency departments and urgent care clinics.

“Roche aims to improve access to diagnostics by being where the laboratorian, clinician, and their patients most need testing, said Heaney. She noted how this could include “home testing, point-of-care testing and multiplex testing for multiple STIs.”

“This is especially important as we know that the emergency department visit or urgent care clinic visit may be the only clinician visit that patient has for a year, or two or more,” Heaney continued. Clinicians need to diagnose and potentially start treatment before that visit has concluded.”

Davis spoke to additional challenges faced by laboratory teams today and the importance of testing modalities that support efficiency. She stated:

“We all know the pandemic exacerbated the challenges labs face with regards to staffing, volume and demand. Reducing manual processes and increasing ‘walk-away time’ by eliminating the need to sort specimens frees up laboratorians’ time for other critical lab processes.”

She commented on the importance of modalities that speed time to diagnosis, as well as those that enable labs to test multiple types of specimens for different types of infections simultaneously.

“COVID-19 taught us all how important point of care testing is, so the ability to provide same-visit lab-quality results within 15-20 minutes using a table-top device is very valuable,” said Davis. “Combine self-collection with same-visit speed of diagnosis using a single test that detects multiple kinds of infections — that’s where STI testing needs to go.”

REFERENCES

1. CDC. National Diabetes Statistics Report. Diabetes. Published June 6, 2024. Accessed July 2, 2024. https://www.cdc.gov/diabetes/php/ data-research/index.html.

2. CDC. STD news media resources. NCHHSTP Newsroom. Published May 20, 2024. Accessed July 2, 2024. https://www.cdc.gov/ nchhstp-newsroom/resources/std.html.

3. Cohen CM, Wentzensen N, Castle PE, et al. Racial and Ethnic Disparities in Cervical Cancer Incidence, Survival, and Mortality by Histologic Subtype. J Clin Oncol. 2023;10;41(5):1059-1068. doi:10.1200/ JCO.22.01424.

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.

The future of blood collection

The BD MiniDraw Capillary Blood Collection System’s innovative design collects a blood sample that produces lab-quality test results with just a fraction of the volume of traditional venous collections. By expanding access to blood collection to new locations, including retail pharmacies, it is also more convenient for the patient. BD

Moisture damage resistant cryogenic lab labels

The original CryoLabel permanently adheres to glass vials, test tubes, and plates. It easily handles cryogenic temps and LN 2 exposure. CryoLabel can adhere to already frozen surfaces. It will resist moisture through repeated freeze and thaw cycles. Sticks well around curves of tight diameter vials. Available in very small sizes.

Electronic Imaging Materials

Easy urine collection and processing

New urine cup with handle provides easier collection, with urine in cup, not on fingers! Innovative infection control double lid with pour spout allows easy access, yet microbiologist does not have to remove lid, just flip up and loop, aspirate or pour!

Safe- Easy- Efficient!

Choyce Products

Seamless urine sample transfer system

TransferTop Urine Collection and Direct Transfer Cups facilitate a secure, “closed system” transfer of urine directly to vacuum sample tubes. This system eliminates the need for manual sample pouring, reducing spill risks and contamination. Compatible with most vacuum urine tubes, it enhances lab efficiency and hygiene by ensuring consistent sample volumes and safer handling. Globe Scientific

Hygienic and safe routine urine collection

Greiner Bio-One’s VACUETTE Urine System provides for hygienic routine urine collection. Urine tube options include no additive tubes for chemical tests, test strips and microscopy and Urine CCM tubes with preservative for microbiological testing. Accessories include a urine cup with integrated transfer device, transfer devices and preassembled Urine CCM kits.

Greiner Bio-One

Higher collection and elution of specimens

Puritan sterile, patented HydraFlock featuring multilength microfibers, each with a floret structure that effectively absorbs and elutes more specimens when compared to traditional spun fiber swabs. Available in various tip shapes and sizes, ideal for pediatrics, nasopharyngeal sampling, and several other collection sites when maximum absorbency and elution are required.

Puritan Medical Products

Stabilize samples prior to analysis

Streck Cell Preservative is a liquid preservative that maintains white blood cell integrity and CD marker expression in peripheral and cord blood samples, surgical tissue samples, bone marrow and fine needle aspirates for up to 7 days prior to analysis by flow cytometry. Streck

Safe and hygienic needless urine transfer

NFT is a closed system for needle-free urine transfer. Needle-free containers feature an integrated transfer unit with pierceable membrane. Following collection with the Urine Monovette using a syringe technique, the membrane reseals ensuring hygienic sample collection. The Urine Monovette then acts as a primary tube for transport, analysis and centrifugation. Sarstedt

Sampling simplified.

Puritan® Opti-Swab® Liquid Amies Collection + Transport Systems featuring Puritan® HydraFlock®

For aerobic, anaerobic, and fastidious bacteria specimens. Designed for ease of use, patient comfort and to bring you closer to finding answers.

VISIT US IN PERSON AT ADLM BOOTH #3441

Streamline Proficiency Testing

Effortlessly upload results from your LIS and eliminate the #1 cause of PT failures—clerical errors.

• No changes to your firewall or security

• No interface required or software to install

• No additional fees—API DataDirect is free

Join the over 7 million results uploaded utilizing API DataDirect! American Proficiency Institute

Sample-to-Customizable Answers for Your Respiratory Algorithms

The LIAISON PLEX®

Respiratory Flex Assay is now FDA cleared on the next-generation, multiplex, sample-to-answer molecular diagnostic platform—the LIAISON PLEX® System. The flexible respiratory assay allows for customizable results based on patient needs.

Diasorin

Affordable Safe Solutions to Decap / Recap

Repetitive manual Decapping and/ or Recapping of tubes exposes your staff to potential repetitive stress injuries. We offer a variety of models to fit any volume needs. Our Pluggo Decappers and KapSafe Recappers will eliminate potential injuries.

Laboratory Growth & Productivity

cobas 5800: No Room to Compromise

The cobas® 5800 system is a compact, fully automated molecular system that provides testing efficiency, flexibility and ease-ofuse. The system’s built-in contamination preventions help to ensure the highest quality and integrity of patient results.

Roche Diagnostics

Say goodbye to exhausting verifications!

Complete your verifications and validations in days, not weeks. Visit booth #549 at ADLM to discover Validation Manager - the software solution that has transformed quality and efficiency in laboratories and test manufacturers worldwide.

BYG4lab

Detect the “Big 5” in 15 minutes

NG-Test® CARBA 5 is the only rapid, multiplex, phenotypic, lateral flow, FDA cleared assay capable of detecting KPC, OXA-48like, VIM, IMP and NDM carbapenemases produced by Enterobacterales and Pseudomonas aeruginosa. Detects the gene expression!

Hardy Diagnostics

Dipper POCT® Urinalysis Dipstick Control

Dipper POCT® Urinalysis Dipstick Control is a single-use quality control designed for use in every testing environment.

• 3 years stability w/ 3 months at RT

• Full immersion dipper QC

• Includes hCG

Quantimetrix

SARSTEDT Tempus600® Specimen Transportation System

The Tempus600® is a dedicated system for sending specimen tubes quickly and reliably to the laboratory. Sample tubes are placed directly into a sending station and arrive within seconds to the laboratory without carrier batching.

SARSTEDT Inc.

CA-Series™ and CS-Series™ Automated Coagulation Analyzers

Sysmex’s innovative portfolio of hemostasis analyzers, reagents and controls are designed with quality, reliability and efficiency in mind. We provide advanced hemostasis technology across multiple platforms to match the needs of laboratories of all sizes.

Sysmex America Inc.

ACL TOP® Family 50 Series

ACL TOP® Family 50 Series Hemostasis Testing systems offer the most advanced automation, quality management, and routine to specialty assays for mid- to high-volume clinical laboratories, including those with lab automation tracks.

Werfen - Hemostasis

GEM ® Premier TM 5000 blood gas system with iQM®2 assures quality before, during and after every sample in lab and POC testing—for improved patient care. All-in-one, multi-use cartridge offers advanced simplicity.

LABORATORY INNOVATOR

Cyril Verhille, an electronics and IT engineer, began his career as an R&D engineer in the aerospace industry. In 1989, he transitioned to the diagnostics industry with Technicon, working in sales and marketing of IT solutions (LIS and data management), a department he would eventually lead. Following Bayer Diagnostics’ acquisition of Technicon, he took full responsibility for launching lab automation.

Later, Cyril became the director of marketing and communications for Siemens Diagnostics in France, overseeing LIS, lab automation, immunology, clinical chemistry, hematology, P.O.C., molecular, and cellular businesses. He also managed all customer service activities. An entrepreneur at heart, Cyril left Siemens in 2012 to acquire BYG4lab.

BYG4lab is a European company new to the United States.

Could you share the company’s history and your vision for the company in the United States?

BGY4lab is a European company that created one of the first data management solutions dedicated to the lab industry. When I took over BYG4lab 12 years ago, I already had over 20 years’ experience in international roles within diagnostics groups. My immediate focus was to elevate BYG4lab to a global player. Today, we have over 5,000 solutions operating worldwide, including more than 1,000 in the United States.

Due to the growing demand, our successful international partnerships—especially with U.S. companies—and our new offerings, we have decided to significantly expand our presence in the U.S. with local operations supporting our laboratory and diagnostic customers. BYG4lab Inc. is based in Chicago and plans to grow progressively. We have high expectations for our solutions in the U.S. market and have decided to launch our next generations of software suites gradually, always prioritizing total customer satisfaction. The

Tackling lab challenges

By Christina Wichmann

first one is Validation Manager, dedicated to method validation. The second is nYna, our central lab data management solution.

In five years, our goal is to establish ourselves as the gold standard in our industry and the preferred partner for major players in the U.S. market, including lab networks, LIS providers, and instrument vendors.

What do you think are the challenges that laboratories are facing today, and how do your software solutions address them?

Laboratories are facing several challenges, which can be categorized in four main areas: quality of results, data security, managing complexity, and improving efficiency.

Quality of results is mission-critical. Labs must ensure 100% accurate results are delivered on time to the right clinician, on the appropriate device with the relevant analytics. This category also includes accreditation requirements, proficiency testing, staff skills certification, and equipment qualification.

Security is another key challenge, encompassing data privacy, cybersecurity, and the security of the growing interoperability demand. Data integrity and security are essential but also represent some of the most risk-prone aspects of many innovations.

Managing complexity is essential in our ever-changing environment. Coordinating across multiple labs and sites, along with various stakeholders, creates significant interoperability needs. As workloads grow with the rise of megalabs, we are transitioning from hospital-centred healthcare to a patient-centric approach. Clinician accessibility requires lab digitalization and enriched results, making data management increasingly complex. Predictive, descriptive, and prescriptive analytics are crucial. Big data in healthcare is particularly valuable for diagnosis, decision-making, and public health management, including surveillance of antibiotic resistance and epidemic alerts.

Productivity gains are also essential. The lab industry is experiencing consolidation, mergers, acquisitions, an increase in volume due to aging populations, the prevalence of chronic diseases, and new technologies. Simultaneously, laboratories are facing staffing challenges, including shortages of lab professionals and physicians, staff burnout, and the need for new skills and training as job roles evolve. There are changing expectations

for working conditions and increasing financial pressures due to declining reimbursement rates, increasing privatization of healthcare, rising competition, and the delocalization of testing. Labs must focus on avoiding redundancy by testing only what is essential, optimizing costs, reducing headcount, streamlining processes, and sharing resources.

Globally, labs are required to achieve more with fewer resources.

Our mission is to help laboratories to achieve these strategic objectives. Our solutions are designed to generate cost savings, address staffing challenges, enhance lab agility and attractiveness, and improve the quality of patient care. Additionally, we aim to be a partnership-driven organization, committed to helping our partners achieve their visionary goals.

How are these software solutions unique compared to those currently used by labs?

We are vendor-neutral, offering a comprehensive software suite that covers all laboratory needs for all disciplines, including POCT, epidemiology, and infection control. Our solutions are built on a state-of-the-art, web-based architecture using SaaS, private cloud, or on-premises model. Our Validation Manager, dedicated to method validation, features a unique SaaS architecture that eliminates the need for software installation in the lab. It’s incredibly user-friendly, with pre-loaded compliance study metrics included, and the ability to import data from any instrument via a simple drag-and-drop feature. Training is only a two-hour e-learning session, saving time, streamlining processes, and improving efficiency without any hardware or software installation.

Another example is nYna, our central lab data management solution, which we are showcasing at ADLM. nYna is designed to enhance lab efficiency and monitor all processes. Users can design personalized dashboards with dedicated widgets and alerts tailored to their working environment. The graphical rule-based system in nYna is so easy to use that the lab can leverage it to improve TAT, improve auto validation rates, and decrease rerun rates.

We would love to provide detailed demonstrations of any of our solutions, The best way to learn more is to visit us at our booth, #549 at ADLM or reach out to our dedicated team and request a demonstration.

'!validation manager TM

Software truly automating, standardizing and centralizing method validations

• 6x faster than traditional approaches

• 95% less time on data management

• 20% less routine quality work

Manager hasbeen an extremely great tool to have fordata analysis andreport development forlaboratory validations andmethodcomparisons."

The Intelligent Analyzer

GEM Premier 5000 blood gas testing system provides automated quality assurance with every whole-blood* sample. Now with next-generation Intelligent Quality Management (iQM2), featuring IntraSpect™ technology, potential errors are detected not only before and after, but also during sample analysis, along with real-time correction and documentation. Plus, it’s simple—just change the all-in-one GEM PAK once a month. So regardless of testing location or point-of-care operator, quality results and compliance are assured with every sample. Real-time assurance and advanced simplicity. Now that’s intelligent.

For more information, contact your local Werfen representative. werfen.com

*Heparinized.