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Why Quality Matters


Quality is the mantra of medical laboratory professionals, but what is quality? What does it really mean? Why does it matter? Isn’t quality control (QC) good enough? Isn’t it the same thing as quality assurance (QA)? If we run quality control samples, why do we bother with external proficiency testing (EPT)? Isn’t plotting QC results on graphs good enough? What is the point of spending all this time and money on quality? Is it really worth it?

Quality is almost like a religion that everyone working in a medical laboratory is expected to believe in and practice. We run QC samples, controls, and the occasional EPT testing sample and may think that is good enough. Running these samples and controls is an excellent start but in itself is insufficient. Anomalous fridge/freezer temperature, QC, and EPT data need to be acted upon. There is no point in dutifully plotting out-of-range QC data or fridge and freezer temperatures without taking action. 

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Looking ahead to respiratory virus season


With respiratory virus season near, those with a close eye on it in August gave the lay of the land for test algorithms, technologies, and forecasts, even as SARS-CoV-2 and RSV cases were rising in parts of the country.

Roche Diagnostics is emphasizing to customers the importance of multiplex testing in differentiating between pathogens that cause overlapping respiratory symptoms. "But also we need to be closely monitoring what’s happening in the U.S.," says Alesia McKeown, PhD, scientific partner at Roche, "because indications might be that we’re going to have an early season."

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People, Partners, and Platforms at the Point of Care


Point-of-care testing—the requests and the committees that oversee them, the connectivity, what AI might bring. CAP TODAY publisher Bob McGonnagle on July 21 met online with a laboratory operations director and a medical director from large health systems and with company representatives for a look at where things stand today. Their conversation follows.

It’s important that we define what the term point of care is and what it isn’t. We know it’s testing that’s done close to the patient and for which the test result is provided when the patient is still onsite so an intervention, such as adjusting a dosage, can happen. We talk about the tradeoff—convenience versus cost. We know that point-of-care testing and central or core lab testing have to coexist. This is overlaid now with a serious shortage of skilled labor, and, increasingly, patients being directed to patient service centers for their draws.

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Disruptive Technologies at the Point of Care


A wrist-worn high-sensitivity cardiac troponin I monitor was one of the wearable devices and health monitors highlighted in a session on emerging technologies for point-of-care testing at the Association for Diagnostics and Laboratory Medicine meeting in July.

James Nichols, PhD, D(ABCC), of Vanderbilt University Medical Center, in his talk on disruptive technologies, cited a study published this year in which a transdermal infrared spectrophotometric sensor was shown to be clinically feasible for rapid, bloodless prediction of elevated hs-cTnI levels in patients with acute coronary syndromes (Sengupta S, et al. Eur Heart J Digit Health. 2023;4[3]:145–154).

For the study, 238 hospitalized patients with ACS at five sites in India were enrolled.

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Applying Laboratory Quality Principles to Real World POCT Systems

By Kathleen David, MT (ASCP) and Jeanne Mumford, MLS (ASCP)

In the Continuing Education article in the April 2023 issue of MLO, laboratory quality management systems were discussed and details provided on each component. When it comes to maintaining quality in point-of-care testing (POCT), we are often presented with very different sets of challenges than our laboratory counterparts. While POCT is subject to the same CLIA regulations, minimal guidance is offered on how to meet those needs in POCT systems. One challenge is that testing personnel who perform POCT are non-laboratorians, meaning that some of the guidance available may not be written in language that non-laboratorian staff can easily understand. Another is that ..

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What Can Go Wrong With Point-of-Care Testing?

Clinical Laboratory News / July/August 2023

Point-of-Care testing (POCT) provides rapid test results with the potential to improve treatment. Additional advantages of POCT include small sample volumes, a wide variety of tests available, little to no processing required to run the tests, and ease of use within the clinical patient flow. However, when incorrectly performed or inappropriately utilized, POCT can generate misleading results that require additional follow-up testing at increased cost and risk to the patient.

Just as in traditional laboratory testing, the majority of POCT errors occur in the pre-analytical phase. These are processes that occur before the specimen is analyzed. Unfortunately, the instrument, operator, or clinician interpreting the results cannot readily identify most pre-analytical errors. Some pre-analytical variables specific to POCT are patient misidentification, improper specimen collection, air bubbles, hemolysis, improper site selection, and interfering substances.


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Connectivity marks an evolution in point-of-care testing

Tech-driven diagnosis, accuracy and quality control are driving the uptake of point-of-care testing.

By Farhana Chowdhury

Patients are more comfortable with finger pricks versus a venous draw, which is strengthening the popularity of point-of-care testing across the globe, shared Prof. Rajiv Erasmus, Head of the Department of Chemical Pathology at the University of Stellenbosch in South Africa, at his session, “Connectivity strategies in managing Point of Care services” that took place on Day two of the Medlab Middle East Congress 2023.

Complimenting the phenomenon, multiplex testing is further set to be the next biggest trend in the field, as it provides an accurate diagnosis of multiple underlying infections in one sitting while retaining quality control. “We are now getting point of care instruments that are very precise, accurate, portable and use very small amounts of blood,” Prof. Erasmus added.

Prof. Erasmus was among the speakers sharing the latest insights and developments under the Technological Advances and Vital Clinical Impact track, supported by The International Federation of Clinical Chemistry and Laboratory Medicine.

Point-of-care testing is currently at the forefront of creating value in healthcare...

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The Role of Point-of-Care Ketone Testing in the Hospital

MLO | May2023 | Dennis Begos, MD, FACS

Blood glucose testing in hospitals using point-of-care testing (POCT) devices has been a mainstay of glycemic control for decades, and the benefits of this are well documented and recognized by patients, providers, and laboratory professionals. POCT measurement of ketones is a more recent development and is the next logical step in managing patients with diabetes in the hospital. Measuring ketones goes hand in hand with hyperglycemia, and POCT ketone testing confers the same advantages as it does for glucose: rapid, accurate results with the ability to make treatment decisions in real time.

Learn more >


Tight and terrible: Lab leaders on budgets and staffing

CAP TODAY, December 2021

The staffing crisis lives on, despite labs having plans of all kinds in place to alleviate the shortage. “It’s the only thing we’re talking about,” Ochsner Health’s Greg Sossaman, MD, said on Nov. 2 when members of the Compass Group met by Zoom. SARS-CoV-2 testing and test supplies and vaccination are “taking a back seat” to staffing, he said. CAP TODAY publisher Bob McGonnagle led the roundtable last month, when COVID-19 positivity rates were up in some areas and down in others. Here is what Dr. Sossaman and other lab leaders had to say. The Compass Group is an organization of not-for-profit IDN system lab leaders who collaborate to identify and share best practices and strategies.

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Saving Your Sanity With POCT Connectivity

November 2021, Clinical Laboratory News, By Kerstin Halverson, BA, MS Point-of-care testing (POCT) is designed to place devices at or near the bedside and provide results as quickly as possible. However, the distance of these devices from the lab presents a dilemma for getting results into the patient’s chart as quickly as possible. Various connectivity solutions have evolved to deal with this problem.

Some manufacturers’ software enables the result to pass from the device to the lab information system (LIS) and then into the hospital information system (HIS) or electronic medical record (EMR). There are also vendor-neutral middleware solutions that can connect many POC devices, regardless of manufacturer.

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New hope for lab data interoperabilityCAP Today, November 2021, By Anne Paxton

November 2021—Interoperability, a problem of long standing in health care, has a new push and new prospects. Interoperability has become a front-burner issue because it has become increasingly urgent to bring the standardized communication of health care data up to speed. Since the 2009 Affordable Care Act, significant resources have been directed to bringing widespread use of electronic health record systems. But interoperability among those EHRs has been held up by the lack of mechanisms and standards to ensure interoperability of laboratory data, which has drawn special concern during the pandemic.

An initiative led by federal agencies could turn that shortage of standards for laboratory data around. The key is a public/private initiative called SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data), launched in 2016 by the Food and Drug Administration. Starting early in 2022, the profile of lab data interoperability should rise as SHIELD takes major public steps forward.

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Rapid Point-of-Care Antigen Assay Could Aid Hospital Infection Control

October 2021 | Clinical Laboratory News

A new assay might detect SARS-CoV-2 antigens with enough sensitivity and specificity to inform infection control measures and potentially inform novel, point-of-care testing methods, according to a recent Clinical Chemistry paper. Many nucleic acid-based methods are sensitive enough to detect acute COVID-19 infections. However, persistent nucleic acid positivity after symptom resolution and disease recovery complicates infection control measures. This is true especially in immunocompromised patients who show long periods of nucleic acid positivity and have diverse presentations.

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AST and safety at core of microbiology checklist changes

October 2021 | CAP Today | Valerie Neff Newitt

By Jan. 1, 2024, laboratories must use current breakpoints to interpret antimicrobial minimum inhibitory concentration and disk diffusion test results, according to a new requirement in the latest edition of the CAP Accreditation Programs microbiology checklist, released Sept. 22. The same requirement calls for laboratories to implement new breakpoints within three years of the official publication date of the updated breakpoint.

“That is going to be a challenge and real work for a lot of laboratories,” Sheldon Campbell, MD, PhD, a member of the CAP Checklists Committee, says of the new requirement (MIC.11385 Current Antimicrobial Susceptibility Test Interpretation Breakpoints). His advice to laboratories: “Start thinking now about how you are going to accomplish that.”

The new requirement is one of several changes to the 2021 microbiology checklist. Those changes were made for three main reasons, the first having to do with clarity.

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The Value of Molecular POCT for Managing Infectious Diseases

By Kim Futrell, MT (ASCP), MSHI, Aug 25th, 2021, MLO

Point-of-care testing (POCT) technology continues to advance at a fast pace, making it easier to shrink complex testing platforms into point-of-care (POC) devices. Though not without its challenges, testing at a molecular level far surpasses the accuracy of other POCT methodologies. Molecular POCT devices allow quick, easy-to-use testing in near-patient scenarios where a rapid diagnosis can be the difference between treating one patient and treating a multitude of patients who become infected because the initial diagnosis is delayed.

Molecular testing is a broad term that refers to the detection and/or quantification of specific DNA or RNA sequences in a specimen. Molecular tests are used to detect microorganisms, look for genetic mutations associated with certain diseases and cancers, perform paternity tests, and much more. Highly complex molecular testing is performed in molecular or microbiology specialty laboratories by trained laboratory professionals.

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FDA approves OTC and POC COVID-19 tests

MLO - April 2021 - The U.S. Food and Drug Administration (FDA) approved amended emergency use authorization (EUA) requests for multiple tests this week, expanding over-the-counter and point-of-care testing options for COVID-19, the agency said in a news release. “The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable,” the FDA said. The authorizations the FDA approved are:

  • Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening
  • Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
  • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test – authorized for OTC at-home serial screening with telehealth
  • Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription
  • BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription

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Coronavirus: Guidance for Better Mental Health

During the COVID-19 pandemic, there will be a lot of information about the virus and its effects on mental health. That’s because coronavirus and the social, financial and psychological implications it carries can seriously impact one’s mental wellbeing. Government legislation, mass media coverage, and the increasing global death toll will cause a lot of stress, especially for the older population, children, and people with a history of mental health problems.

It’s of the utmost importance that we try to remain as composed as we can during this time. The fear and anxiety that is gripping the nation are as contagious, if not more so than the illness itself. Learn more >

Know the Curves Guide to COVID-19 Testing

Educational guide helps anyone understand COVID-19 testing
Testing is an important tool in the fight against COVID-19. But many people are still confused about the different types of tests that are available. This simple, non-commercial, guide is written in clear language so anyone can understand:

  • The difference between viral RNA, antigen, and antibody testing
  • Why it’s important to get the right test at the right time
  • What a positive result means
  • When people are most contagious
  • And more

Feel free to forward this to patients, friends, family, and anyone else who might be interested. Download the PDF here

Checklist, CLIA line up on COVID-19 Reporting

CAP Today, November 2020, By Anne Paxton - It’s been well understood since the Ten Commandments that rules that appear simple in theory can be fiendishly complex or even impossible to execute. The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now: It may not be clear which rules are mandatory, desirable, or optional—and those aren’t the only sources of confusion. Since March, much attention at the federal level has been focused on clear standards for reporting results of SARS-CoV-2 testing. But many fear that new rules to standardize reporting could require hammering a multitude of diverse square pegs into round holes. At present, labs will be penalized only if they fail to report both positive and negative test results to their state and local public health authorities. While the June 4 guidance is required, the Centers for Medicare and Medicaid Services has said it will enforce only a few key aspects. Read more >

At POC and in the Lab, 2 new checks on SARS-CoV-2 testing

CAP Today, November 2020, By Valerie Neff Newitt - The CAP released in September its proficiency testing program for SARS-CoV-2 antigen testing, with the first shipment to laboratories set for Nov. 30. It also introduced recently a Quality Cross Check program that makes it possible for labs performing nucleic acid amplification testing for SARS-CoV-2 to monitor performance across multiple instruments, in compliance with the CMS directive prohibiting proficiency testing on multiple instruments. “Even with its limitations, antigen testing could have a role in a well-designed testing strategy, but nucleic acid testing remains the standard of care for a definitive diagnosis,” says Daniel D. Rhoads, MD, member of the CAP Microbiology Committee, which helped to develop the proficiency test. With laboratory medicine having “pushed to the forefront of news” during the pandemic, “it’s critically important that we are performing well in all testing formats and meeting the need in this time of crisis,” says Dr. Rhoads, assistant professor and section head of microbiology at the Cleveland Clinic.
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UMASS' JoAnn Crain Named 2020 POCC of the Year!

As the Point of Care Manager, JoAnn Crain oversees and coordinates the POCT for the entire UMass Memorial Healthcare System, including multiple member hospitals and several remote locations. Currently, she manages the
POCT under 10 CLIA licenses with over 100 departments in various hospitals and clinics. JoAnn oversees training and competencies of thousands of clinical POCT users and reviews all Quality Control, Quality Assurance records and all necessary testing validations.  The Point-of-Care Testing (POCT) Coordinator Award is given annually to recognize outstanding achievements in the POCT field by persons who are primarily responsible for a given institution’s POCT program. The award selection is made by the Awards Committee of the AACC Critical and Point-of-Care Testing (CPOCT) Division and is based on the extent of the nominee’s responsibilities and accomplishments, particularly the impact this person has made in improving the quality of the POCT program at their facility. Read more >

John Peterson, PhD Receives AACC Outstanding Contributions to POCT Award!

John Petersen has trained professional clinical laboratory scientists and taught critical and point of care testing at the undergraduate, postgraduate, and practicing level. He has conducted meritorious scientific and educational research, and made contributions to the critical and point of care testing field at multiple professional organizations. Dr. Petersen has actively participated in AACC to support point of care programs and educational activities. He has served on the Critical and Point of Care Testing Division’s nomination committee, was chair of the Awards committee, a Member at Large, and also Treasurer. The Outstanding Contributions to Point of Care Testing Award recognizes an individual who has made an outstanding contribution in the field of critical and point of care testing. This may be for a single outstanding achievement, or for a body of accomplishments that have broadly advanced the field of point-of-care testing. Such accomplishments may include, but are not limited to, the training of professional clinical laboratory scientists; the teaching and integration of critical and point of care testing at the undergraduate, postgraduate, and practicing level; meritorious scientific, educational and research contributions; and contributions through service to critical and point of care testing. Read more >

Flu Mounts COVID's Bustling Stage

CAP Today, October 2020 - Barely a half year into the pandemic’s presence in the United States, history has already begun pressing down on SARS-CoV-2 testing. Like an actor playing Hamlet, it’s been difficult not to feel the burden of
past performances when preparing for the months ahead. Now, at the start of fall, that also means readying for the return of influenza. Here, even longer experience has shown that each new season is, indeed, a new season. Read more >

States Scaling Up Rapid COVID-19 Tests

MLO, October, 2020 - State governments are distributing Abbott BinaxNOW COVID-19 tests to numerous types of institutions, the Department of Health and Human Services (HHS), which purchased the tests, said in a press release.Of the states that have provided preliminary reports, use of the BinaxNOW allocations are largely being deployed to local health departments, K-12 schools and universities, nursing homes, hospitals and correctional facilities, HHS said. Other states, however, have additional priorities. For example, Alaska is sending tests to oil drilling sites; Mississippi and other states to veterans’ homes; Nevada to tribal health clinics; and Colorado to local public health agencies to test homeless populations.HHS purchased 150 million Abbott BinaxNOW rapid tests from Abbott in August... Read more >

Managing Point-of-Care Testing During COVID-19: What We’ve Learned
Kathleen David, MT (ASCP), Manager, Point-of-Care Testing, TriCore Reference Laboratories

What have we learned from COVID-19? The bigger questions may be, why was there so much to learn? Why weren’t we, in the pointof-care testing (POCT) community, better prepared, we who have been through the Zika and Ebola viruses, as well as Hurricane Katrina and other health crises? The truth is, there is no one-size-fits-all when it comes to disaster planning. COVID-19 is not Zika, and Zika was not Ebola. It is also true that there is a dearth of published literature or other trusted resources, specifically addressing disaster planning for POCT.

The intent of this article is not to provide answers, but to start a conversation in the POCT community. Asking ourselves better questions now can help us be better prepared for future pandemics and crises. We know they will come, as will further waves of COVID-19, which threatens to make the coming flu season particularly challenging. Read the article>

CLSI Webinar: Thanks to CLSI, a Zoom Webinar that took place on Wednesday, September 9, was recorded and available
for playback on their eLearning platform. Click here or on the image to the right to register for the webinar. There is no cost to register, but if you don’t already have a CLSI account, you’ll need to create one by registering your email address and creating a password.

As the Pandemic Meets Flu Season, Labs Turn to Rapid Molecular Testing
by Sherry A. Dunbar, MBA, PhD., MLO, August 2020

Bracing for flu season is challenging for most clinical labs even in the best of times. With the COVID-19 pandemic, though, laboratories will face an unprecedented respiratory testing situation this fall and winter. Rapid molecular tests and flexible platforms that allow for multiplexing several pathogens in a single assay will be an essential tool for dealing with the potential crisis that lies ahead of us and should help to ease the supply chain stress associated with dramatically higher testing rates. Read the article >

The Laboratory Tests of a Pandemic Summer
Karen Titus, CAP Today, August 2020

In March, the COVID-19 pandemic came in like a lion—and has yet to leave, like a lamb or anything else. Instead, it roared through April and May in early hot spots like New York City and New Orleans. As lockdowns took hold, the cautious hope was that by summer the virus would be tamed (if not simply go away “like a miracle” or “as the heat comes in,” per several infamous predictions), giving health care providers a chance to exhale before a likely second wave in the fall. Instead, June and July saw other cities and states hit hard in turn, while many places that appeared to have flattened the curve were starting to see concerning upticks in cases. And rather than planning for a return of the virus later in the year, laboratories are now talking about SARS-CoV-2 as an ongoing presence. Read more >

HHS CARES Act Guidance for Labs

The U.S. Department of Health and Human Services (HHS) released new guidance related to laboratory result reporting specified in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The new guidance covers entities required to report, methods for submission, required data elements, data reporting and transmission requirements, and recommendations for capturing laboratory data in electronic health records. The new guidance is now posted on CDC’s 
How to Report COVID-19 Laboratory Data web page.

A Panel’s Take on Instruments, Connectivity, COVID
CAP Today, July 2020

Has the pandemic changed your thinking or that of your customers? That’s one of the questions CAP TODAY
publisher Bob McGonnagle put to seven representatives of five companies and two other panelists in a roundtable on chemistry/immunoassay analyzers and testing. But first up were other topics: scalability, connectivity, standardizing platforms across health systems, consistent sourcing of antibodies, and open automation.

The panelists were Gyorgy Abel, MD, PhD, of Lahey Hospital and Medical Center; David Grenache, PhD, D(ABCC), of TriCore Reference Laboratories; Brittany Greiner of Roche Diagnostics; Denise Pastore of Siemens Healthineers; John Naizer, BSc, MSc, of Randox; Timea Zsiray and Sean Roberts of Beckman Coulter; and Chad Meyers and Jeffrey Watson, MT(ASCP), MBA, of Sunquest Information Systems. Read what they had to say.

AACC releases guidance document on using POC tests to improve patient care
MLO, June 2020

AACC has issued a new guidance document detailing best practices that hospitals and other healthcare institutions should follow when running a point-of-care testing program. As point-of-care tests emerge for more and more conditions—including COVID-19—the guidance emphasizes that it is essential for laboratory professionals and clinicians to collaborate on point-of-care testing programs to ensure this testing benefits patients.Point-of-care tests are clinical tests that can be performed... Read more >

A Lab World Embroiled in Pandemic
CAP Today, May 2020, By Karen Titus

Along with SARS-CoV-2, clinical laboratory testing has been hiding in plain sight far longer than many people realize.
But it took the novel coronavirus (which, frankly, hardly feels novel anymore) to make that clear to the rest of the world.

As the COVID-19 pandemic spread across the globe, laboratory testing crashed the news cycle. National leaders sought to reassure citizens by promising millions of test kits. Economies shattered—and have since sought to return to life—based on
testing availability. Ordinary people woke before dawn to wait in lines at drive-through testing sites—often to be turned away when supplies ran out. Emergency use authorization became a common phrase. And behind every heartbreaking photo from an emergency department or ICU lingered an unnerving thought: We don’t have tests. Read more >

What’s Next on the Point-of-Care Testing Menu?
From SARS-CoV-2 to cardiac biomarkers, a steady stream of IVD innovation shows no signs of letting up
By Kimberly Scott, MAY 2020, Clinical Laboratory News

While point-of-care (POC) testing in recent years has drastically altered how patients are treated for conditions such as diabetes, HIV, and cardiovascular disease, new advancements on the horizon are expected to vastly improve near-patient treatment for strokes, infectious diseases, and cancer, according to experts.

In vitro diagnostics (IVD) companies are working to improve specificity and sensitivity of devices so that testing can be done on smaller specimen samples, said Nick Collier, PhD, chief technology officer for Sagentia Medical, a contract research organization based in the U.K. “There is a lot of interest in reducing sample size—using capillary blood samples to do testing, for example.”

While there are more than 100 POC tests available in the U.S., not all are widely implemented, such as tests for proteins in blood used for cancer diagnosis, noted Kathleen David, MT(ASCP), POC testing manager for TriCore Reference Laboratories in Albuquerque, New Mexico. “Availability is one thing. Then there’s acceptance and implementation,” she said. “Some of these we will see in cutting-edge places in the next couple of years...' Read more >

AACC Reschedules 2020 Annual Meeting & Clinical Lab Expo to December

The ongoing spread of COVID-19 is a serious concern and as its global impact grows daily, AACC’s priority is always the health and safety of our community. AACC’s leadership has been carefully monitoring the outbreak and has been consulting members, staff, industry, and other experts.

Based on input from all stakeholder groups, and in close collaboration with host city officials, the organization is pleased to announce that AACC will be able to preserve the complete Annual Scientific Meeting & Clinical Lab Expo experience to which its members, exhibitors, and the entire laboratory medicine community have been looking forward. The 2020 AACC Annual Scientific Meeting & Clinical Lab Expo will now be held December 13 – 17, 2020 at McCormick Place in Chicago, IL. Read more >

Congratulations to Lenox Hill Hospital as the winner of MLO’s 2020 Lab of the Year Award!

Located in New York City’s prestigious Upper East Side, Lenox Hill Hospital opened its doors to the community in 1865 and continues to serve approximately 325,000 patients per year through those same doors. Earning its reputation over the years as a teaching hospital, the 632-bed Lenox Hill Hospital has provided care to both celebrity and layperson alike, with the same attention to treating a wide range of medical conditions and diseases. Read more >

Runners Up - Norman Regional Hospital | Mary Lanning Healthcare

Hospitals to report COVID-19 test data daily to the federal government

The Centers for Medicare & Medicaid Services (CMS) sent a letter to the nation’s hospitals, detailing how they should report data on tests they are performing to detect COVID-19, the agency said in a press release. The letter was sent on behalf of Vice President Mike Pence. Specifically, the federal government wants hospitals to report daily data on COVID-19 test results conducted at in-house labs to both the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network. CMS said the data should
not include personal identifying information to protect patients’ privacy. Read more >

Staying Connected with POCT
Use online resources to keep up with what's happening in POCT
While every news bureau will keep you updated on the latest COVID-19 happenings, POC resources are also available that will enable you to stay connected with what is happening in our community.

POC Listservs
Listervs are a great way to communicate with your POC peers and if you are not part of one, or many, we encourage you to join. Examples include the POCT Listerv, AACC LIstserv and the AACC Artery can be found in the column to the right.

POC Webinars
Whitehat Communications will continue to host POC Group webinars through the support of POC vendors. You can visit the Whitehat website or our calendar pages for upcoming webinars. POC vendors such as Siemens, Orchard, Fisher and others also have webinars on their websites that you can listen to. Click here for a Google search page.Others, such as Abbott Rapid Diagnostics Informatics / RALS hold monthly sessions that you join.

POC Publications
While publications will most likely continue to print and distribute the journals, you can also go online to latest from CAP Today,Medical Laboratory Observer (MLO), Clinical Laboratory News and others. Visit our POC publications page to access their websites.

Abbott launches molecular point-of-care test novel coronavirus in as little as 5 minutes

ID NOW™ COVID-19 tests available to HCPs in urgent care settings in the U.S

March 27, 2020 - Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus
(COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments. The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is already the most widely available molecular point-of-care testing platform in the U.S. today. Read more >

FDA authorizes first rapid ‘point-of-care’ test for coronavirus
The test, to be used in hospitals, will deliver results in 45 minutes

The Food and Drug Administration approved the first coronavirus test that can be conducted entirely at the point of care for a patient — and deliver results in 45 minutes. The FDA granted “emergency use authorization” to Cepheid, a California company that makes a rapid molecular test for the coronavirus. The turnaround time for Cepheid’s product is far shorter than for the tests being used, which are typically sent to centralized labs that may not return results for days. The FDA authorization is for use in “patient care settings,” including doctors’ offices, but the test initially will be used primarily by hospitals and emergency departments, the company said.

As covid-19 cases proliferate, fears are growing that hospitals will become overwhelmed by patients seeking tests or care. David Persing, Cepheid’s chief medical and technology officer, said in an interview that the test will “help alleviate the pressure” on health-care facilities by helping doctors find out quickly whether a patient has the disease and select the appropriate treatment. “This is not a test for the worried well,” he said, but rather a tool for doctors to quickly assess patients suspected of having covid-19. The specimen can be collected either by a nasal swab or by a saline wash using a small catheter. Neither is particularly comfortable, but the advantage of the wash is that it doesn’t require swabs, which are in short supply, Persing said. Read more here and here...

Diagnostic Errors, Maternal Health Top ECRI’s 2020 Patient Safety Concern

Clinical Lab Products, March 2020 - ECRI, an independent, nonprofit organization dedicated to improving the safety, quality, and cost-effectiveness of care across all healthcare settings, recently released its report on Top 10 Patient Safety Concerns 2020. Diagnostic errors and maternal health were in the top two spots. The annual report helps organizations identify looming patient safety challenges across the continuum of care and includes suggestions and resources for addressing them. “Unsafe healthcare delivery harms millions of patients,” says Marcus Schabacker, MD, PhD, president and chief executive officer of ECRI. “Our annual patient safety report provides a roadmap to help healthcare leaders know what goes wrong and how to prevent harm.” ECRI’s Top 10 Patient Safety Concerns relies on the analysis of... Read more >

The Expanding Role of Point-of-Care Testing in Patient Care
Medical Laboratory Observer (MLO)

Over the past 50 years, we have witnessed a rapid evolution in the availability of point-of-care laboratory testing. Point-of-care (POC) testing is best defined as laboratory testing near the patient, which rapidly provides results for immediate patient care management. There are several reasons for growth in the near patient testing market: The growth of electronic medical records (EMRs) provides a central repository for all patient care information. This, in turn, has made the use of point-of-care technology more attractive in hospitals, offices, clinics, urgent care centers and emergency departments, because the information obtained at the various locations can be more widely available to multiple providers. Read more >

Errors in Point-of-Care Testing: An Alladin's Cave of Treasures

Omni Health - Traditionally, in most point-of-care testing (POCT) programmes, there has been a large focus on Quality Control (QC) analysis. Through regular monitoring of internal QC and proficiency testing reports, we can evaluate the performance of instruments. We can identify any inaccuracies and/or imprecision that may exist and take appropriate action. For the most part, instruments provided by long-established manufacturers perform very well. Reviewing QC summary data, I rarely see problems from one month to the next. If we were to focus exclusively on the QC performance of our devices, we would be fooled into thinking that all is well in the world of POCT.While the analytic performance of our instruments must...Read more >

Personal Paradox and More: POC Pitfalls
CAP Today

Point-of-care testing makes up only about 10 percent of all laboratory testing but the aggravation factor and number of people involved far exceeds that, said Deborah A. Perry, MD, medical director of pathology at Methodist Hospital in Omaha, Neb., speaking at CAP19 and calling POC testing “a whole different world.”

In a session titled “Point-of-care testing pitfalls: what you don’t know can hurt you,” Dr. Perry and Brad S. Karon, MD, PhD, professor of laboratory medicine and pathology and co-director of the point-of-care program at Mayo Clinic, used scenarios to illustrate point-of-care testing risks and how to mitigate them. “Initially, people kind of let the point-of-care side of the world go to the medical technologists, and the laboratory medical directors hoped we wouldn’t have to worry about it too much,” said Dr. Perry. Read more>

Dodging POCT Potholes in PT, IQCP
CAP Today

For point-of-care testing, perform proficiency testing on only one method or instrument unless your testing procedure says all patient samples must be tested on multiple instruments. And if a single IQCP is written for more than one POC testing location, account for all variations.These and other tips come from a CAP19 session, “Point-of-care testing pitfalls: what you don’t know can hurt you,” presented by Deborah A. Perry, MD, medical director of pathology at Methodist Hospital in Omaha, Neb., and Bradley S. Karon, MD, PhD, chair of the Division of Clinical Core Laboratory Services, Department of Laboratory Medicine and Pathology, Mayo Clinic. They used scenarios to illustrate how best to approach PT, the IQCP, and CAP inspections for POC testing. (Part one is published in the November issue of CAP Today.) Read more >

20 Years After 'To Err Is Human'
Healthcare Innovation

Organization seeing fewer deaths from preventable errors it monitors

Coinciding with the 20th anniversary of the Institute of Medicine’s groundbreaking “To Err is Human” report, the Leapfrog Group’s fall 2019 Hospital Safety Grades highlight progress on patient safety. The Leapfrog Hospital Safety Grade is a bi-annual grading assigning “A” through “F” letter grades to general acute-care hospitals in the U.S. It is the nation’s only rating focused entirely on patient safety—preventable errors, accidents, injuries and infections. Read more >

POCT Professional Certification Validates Expertise in the Field

At Aculabs, an East Brunswick, New Jersey-based company that services long-term and acute-care facilities, laboratory director Rita Khoury, MD, DABCC, FAACC, CPP, spends her days overseeing testing for these entities, with the goal of turning around test results quickly to help reduce hospital readmission among residents. This includes a point-of-care testing (POCT) program started in 2014, which became the first and only laboratory program in the Mid-Atlantic that can help maintain, train and integrate bedside blood analysis.

So when Khoury saw an email from AACC last year announcing its new POCT Professional Certification, she was very excited, and applied immediately. Khoury became one of the first POCT professionals to take the exam last November, and soon added the CPP (certified point-of-care testing professional) initials to her name. Read more >

New test diagnoses Lyme disease within 15 mins

MLO, October 2019

Some 300,000 people in the U.S. are diagnosed with Lyme disease every year. Caused by Borrelia burgdorferi and transmitted by the bite of infected Ixodes ticks, the disease if left untreated can cause serious neurologic, cardiac, and/or rheumatologic complications.

Current testing for Lyme disease, called the standard 2-tiered approach or the STT, involves running two complex assays (ELISA and western blot) to detect antibodies against the bacterium, and requires experienced personnel in a lab, and a few hours to carry out and interpret. A team led by Sam Sia, professor of biomedical engineering at Columbia Engineering, has developed a rapid microfluidic test that can detect Lyme disease with similar performance as the STT in a much shorter time—15 minutes. Read more >

The New Wave of Diabetes Management

Monitoring Technologies Surge as Disease Prevalence Mounts
By Whitney J. Palmer, Clinical Laboratory News, October 2019

Big data and bioengineering advances are fueling rapid changes in diabetes technologies, which offer the promise of better self-management and quality of life for individuals with the disease, and easier care oversight by physicians. With the incidence of diabetes rising, these innovations are coming into use when “the ability of an individual living with diabetes to have human-to-human contact with their healthcare provider is not keeping pace with the number of people developing diabetes,” according to a recent review. Read more >

New Requirements for Molecular Micro Waived Testing
By Karen Lusky, CAP Today, September 2019

Four new checklist requirements for waived molecular-based microbiology tests have been added to the CAP point-of-care testing, limited service laboratory, and immunology accreditation program checklists, as part of the 2019 checklist edition released this month.

“The CAP has decided to improve patient care by providing additional safeguards that wouldn’t necessarily be performed otherwise,” says Bobbi Pritt, MD, MSc, DTM&H, chair of the CAP Microbiology Committee and professor, Mayo Clinic Alix School of Medicine.

Dr. Pritt and other members of the Microbiology Committee have noticed that even though the new cartridge-based waived molecular tests are self-contained, and the risk for nucleic acid leakage and contamination is low, nucleic acid contamination can occur. Read more >

CPOCT Division Announces 2019 Awards!

Kathleen David - TriCore System POCT Manager is the 2019 Point of Care Coordinator of the Year

Kathleen is the POCT Manager at Tricore, responsible for general operation of assigned Point-of-Care Testing (POCT) at TriCore Sites: 15 hospitals and 140+ clinics. She manages the department and coordinates activities with other areas of the organization and with internal and external customers to ensure that quality standards are met.

She is responsible for ensuring service quality to the satisfaction of the hospital or client. She works closely with appropriate medical/scientific director(s), Site Managers and Rapid Response Lab (RRL) Director regarding decisions on matters relating to patient care, technical performance, quality and finances. She oversees and directs the efforts of POCT Coordinators to ensure goals and standards of the sponsors are met.

Rick Import - Whitehat Communications, is the 2019 recipient of the Outstanding Contributions to POCT Award!

Rick founded Whitehat Communications in 2008 to fill an educational need for Point-of-Care Coordinators (POCCs).

Prior to Whitehat, Rick led interactive and educational discussions at POC Groups throughout the country titled "Leadership Communication" which provided attendees with techniques and tips to improve their communications with their supervisors and operators using real-life issues in the lab and on the floor.

Rick formed Whitehat Communications with one sole purpose – to produce webinars for the hospital laboratory and point of care community across the U.S. that would provide educational sessions covering a wide range of timely and practical topics chosen by the POC groups themselves.

Challenging the Status Quo on Quality Control

A focus on patient risk is driving changes to old paradigms
By Kimberly Scott, Clinical Laboratory News, June 2019

Despite knowing that errors in testing can lead to serious patient harm, too many clinical laboratories are performing only the minimum amount of quality control (QC) required by regulation and recommended by manufacturers, leading some in the industry to call for labs to adopt more robust statistical quality control (SQC) approaches designed to focus on patient risk.

A recent study of current SQC practices in U.S. laboratories found that 21 leading academic laboratories surveyed typically employ two standard deviation (SD) control limits in spite of their known high false rejection rate. It also found that labs generally use a minimum number of control measurements per run (two) and often perform the minimum frequency of SQC, explained James Westgard, PhD, founder of Westgard QC (Am J Clin Pathol 2018;150:96-104). “Based on this survey, it appears that current QC practices are based on mere compliance to CLIA minimums, rather than the best practices for patient care,” Westgard said. Read more >

A focus on patient risk is driving changes to old paradigms
By Kimberly Scott, Clinical Laboratory News, June 2019

Despite knowing that errors in testing can lead to serious patient harm, too many clinical laboratories are performing only the minimum amount of quality control (QC) required by regulation and recommended by manufacturers, leading some in the industry to call for labs to adopt more robust statistical quality control (SQC) approaches designed to focus on patient risk.

A recent study of current SQC practices in U.S. laboratories found that 21 leading academic laboratories surveyed typically employ two standard deviation (SD) control limits in spite of their known high false rejection rate. It also found that labs generally use a minimum number of control measurements per run (two) and often perform the minimum frequency of SQC, explained James Westgard, PhD, founder of Westgard QC (Am J Clin Pathol 2018;150:96-104). “Based on this survey, it appears that current QC practices are based on mere compliance to CLIA minimums, rather than the best practices for patient care,” Westgard said. Read more >

The Evolution of Leadership in POCT
By Kimberly Scott, Clinical Laboratory News, July/August 2019

As point-of-care testing (POCT) continues to grow in hospitals, physician offices, retail clinics, and other settings, professional roles are also evolving to keep pace with changes in this technology, the complexity of testing, and the need to engage with clinicians.

Once consisting of just a handful of assays, POC tests now number in the hundreds, ranging from blood glucose monitoring to rapid strep to prothrombin time/international normalized ratio (PT/INR). The market for POCT grew by an estimated 9.3% between 2013 and 2018, and worldwide, the POCT and rapid diagnostics market is projected to top $38 billion by 2022, according to industry experts.

With the growth of POCT comes challenges for laboratory directors, POC coordinators, and other professionals responsible for ensuring that instruments are maintained and that those performing testing are trained, follow quality control protocols, and remain in compliance with clinical and regulatory standards.

Brenda Suh-Lailam, PhD, DABCC, FAACC, director of clinical chemistry and point-of-care testing at the Ann & Robert H. Lurie Children’s Hospital of Chicago, said much of her time is spent ensuring the quality of testing done at patients’ bedsides by defining, implementing, and monitoring the standards of performance. Read more >

Mass Casualty Plan Puts POCT in the ED
Jayne O'Donnell, USA TODAY May 15, 2019

If a mass casualty event brings patients to Le Bonheur Children’s Hospital in Memphis, Tenn., clinical laboratory staff will head straight to the bedside. Le Bonheur Children’s Hospital is a level-one trauma center. Its new mass casualty response plan, two years in the making, has laboratory staff in the emergency department and triage areas, where they will perform point-of-care testing for frontline providers.

“Having medical lab scientists just sitting in the lab waiting for blood to come to them made no sense,” says laboratory director Lisa M. Griffin, BS, MT(ASCP). “Instead of keeping them away from where all the injured patients are, we decided to send the techs to them. It’s the best way to use the trained, professional human resources we already have.” Read more>

Low rated US Hospitals are deadlier due to mistakes, botched surgery, infections
Jayne O'Donnell, USA TODAY May 15, 2019

The Leapfrog Group's latest hospital safety rankings gave 168 US hospitals out of about 2,600 failing or near-failing grades, while about one-third got A grades. A report from the Armstrong Institute for Patient Safety and Quality at Johns Hopkins Medicine, based on the Leapfrog data, found about 160,000 people die a year from avoidable medical errors, down from 205,000 in 2016. Read more >

Glucose Meters: Current Regulatory Guidance for Manufacturers and Providers
April 2019, MLO, By Jeffrey A. DuBois

Therapeutic management of blood glucose in patients with diabetes in the home or in the hospital involves the use of glucose meters for the rapid assessment of whole blood glucose. On Oct. 11, 2016, the U.S. Food and Drug Administration (FDA) published guidance documents for glucose meters. These guidance documents are for manufacturers, not for providers. The Centers for Medicare and Medicaid Services (CMS) and its designees provide accreditation (certification) for and oversight of provider compliance under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This is an important distinction for all stakeholders involved in the management of dysglycemia in hospitalized patients, many of who are on intensive insulin therapy to achieve safe and effective glycemic control.

The FDA guidance documents make a clear distinction between devices that are designed, cleared, and classified for self-monitoring of blood glucose in the home and devices that are designed, cleared, and classified for blood glucose monitoring for prescription point-of-care (POC) use. It took six years for the FDA to publish these guidance documents for manufacturers. Read more >

MLO Selects 2019 Lab of the Year!
Penn Medicine Lancaster General Health

Selecting a Lab of the Year is never an easy task thanks to the outstanding nominations MLO receives year after year. And since history tends to repeat itself, 2019 was no different. With much respect and admiration, MLO is proud to present the 2019 LOY winner: Penn Medicine Lancaster General Health Laboratory. Located in Southern Pennsylvania, approximately 70 miles west of Philadelphia, sits Lancaster General Health Laboratory, part of Lancaster General Hospital (LGH). This 533-bed, nonprofit hospital is part of Lancaster General Health/Penn Medicine, a member of the University of Pennsylvania Health System (Penn Medicine). Read more >

Critical Points - AACC Critical and POCT News

The latest edition of the CPOCT Division Newsletter has been posted to the CPOCT Division webpage. Please navigate to the Division webpage within, or copy and paste this link below to take you directly Highlights include: Division Awards Nominations and upcoming 2019 CPOCT division activities not to be missed!

POC Roundtable: Risks, Resources, Relationships
CAP Today, March 2019

Infection control and the heavy demands on point-of-care coordinators were among the top concerns that came up in a recent CAP TODAY roundtable on point-of-care glucose testing. CAP Publisher Bob McGonnagle spoke with four POC testing experts: Sharon Geaghan, MD, Cynthia Bowman, MD, Steven Cotten, PhD, and Corinne Fantz, PhD. Read what they had to say..

HealthGrade's Best Hospitals for 2019
By HealthLeaders Media, February 2019

Healthgrades released its annual list Tuesday of "America's Best Hospitals," using clinical outcomes to identify the top 5% of hospitals nationwide.In years past, Healthgrades released two separate awards, one for the top 250 hospitals in clinical excellence and the other for the the top 50 and 100 hospitals. But this year is the first time the two awards have been consolidated into a single list.

"Consumers have many options for care, so when hospitals prove their long-term commitment to the patient and to achieving high-quality clinical outcomes, it sets their system apart in a sea of choices," Healthgrades Chief Medical Officer Brad Bowman said.

To see the top 50 hospitals for 2019, as identified by Healthgrades and grouped by state,
click here >

Complimentary Training Support for Urinalysis and Diabetes

Siemens Healthineers is pleased to announce the availability of complimentary training support tools for our point-of-care chronic disease management portfolio. Listed below are the resources available to you. These online options provide you with easy access to in-service product training, forms, and procedures for your staff.

For the CLINITEK Advantus® Urine Chemistry Analyzer, CLINITEK Status® family of analyzers, DCA Vantage® Analyzer and Xprecia Stride™ Coagulation Analyzer, we offer the following:

Sign up for Remote Video Training: Receive telephone or video training from a medical technologist. To schedule your complimentary training session, email or call 1 (866) 748-7463 to speak with a training specialist.

Individualized, Competency-based Education: Click here to register for personalized product training modules and assessment tools.

In-service Training tools: Click here to conduct in-house training events for your staff and access product-specific training and support documents to maintain your audit-readiness.

Navigating the Quandaries of Coagulation Testing
CAP TODAY January 2019, by Anne Paxton

Naming the things about coagulation testing that most perplex clinicians isn’t easy for Michael Laposata, MD, PhD. But there’s a good reason for that: He finds confusion to be pervasive. New drugs with untoward effects on traditional coagulation tests, revamped clinical guidelines, and assays that can be difficult to interpret have been among the more recent contributors to clinicians’ bewilderment. Dr. Laposata, however, sees a more basic problem: “All of coagulation testing is confusing for the average physician in all specialties.”

It’s been that way for some time, says Dr. Laposata, chairman of the pathology department at the University of Texas Medical Branch at Galveston—and he should know. He’s been a faculty member at different institutions since 1985, but even earlier, on his first encounter with clinicians as a resident, he saw there was a knowledge gap. “I realized that the doctors on the floor didn’t know how to interpret even the simplest coag test result—even the brightest doctors. To me, that was a shock.” He found they needed to know not only which test to order but also what the results meant and what the recommended next steps would be. Read more >

Hemoglobin A1c Testing and Diabetes Management
By: Jessica Pawlak, Michael Sweatt, Catherine Cahill, Ralph Ito, December 21, 2018, MLO

The Diabetes Research Institute Foundation has estimated a 50 percent increase in the number of people living with diabetes mellitus in the United States over the past decade. With more than 400 million people living with and managing diabetes worldwide, the ability to accurately diagnose and track patient management is a growing need. The diagnosis of diabetes mellitus uses a combination of measurements: fasting serum glucose levels, presentation of symptoms, two-hour plasma glucose levels during a glucose tolerance test, and hemoglobin A1c (HbA1c) levels.2 Current patient management includes diet, exercise, medication, daily monitoring of blood glucose, and HbA1c monitoring.

Mayo Clinic Laboratories emphasizes the value of controlling glucose levels to prevent long-term complications such as retinopathy, neuropathy, and cardiovascular disease. However, solely measuring and monitoring blood glucose levels has some limitations as the test only measures glucose levels at the time of testing and it relies on the patient to consistently test their levels at home, using a point-of-care device. To address these limitations and provide a broader indication of long-term glycemic control, HbA1c testing is used. It is typically performed in a laboratory setting and the test indicates the patient’s average levels of blood glucose over the past 8 to 12 weeks. The NGSP, originally called the National Glycohemoglobin Standardization Program, supports the American Diabetes Association’s recommendations that patients who are meeting glycemic goals be tested for HbA1c twice a year, while patients not meeting glycemic goals or patients with changes to therapies be tested every three months. The American Diabetes Association sets a normal patient at < 5.7 percent, prediabetes patients at ≥ 5.7-6.5 percent, and diabetic patients at ≥ 6.5 percent HbA1c. Read more >

Rapid PCR Rules as Labs ready Flu Arsenal
December 2018, CAP Today, Anne Paxton

With the memory of the 2017–2018 “high-severity” influenza season fresh in mind—49 million cases, 960,000 hospitalizations, a marginally effective vaccine, 79,000 deaths—clinical laboratories have been bracing for the customary annual surge in emergency room, outpatient clinic, and physician office influenza test orders. Although flu admissions have been rising somewhat, it is too soon to know how the season will play out, but laboratories are hoping for a season closer to average.

Avoiding a repeat of last year’s travails—lengthy turnaround times, supply shortages, and the need to triage patients for testing—is a must, many laboratory directors say. “We had difficulty keeping up with last year’s demand. It was extremely time-consuming,” says Mary Kay O’Connor, national laboratory director at Summit Health Management, the management arm of the Summit Medical Group, an 800-provider practice on the East Coast. Read more >

The Power of Internal Audits and Site Inspections for Improving Point-of-Care Testing
By Vikram Palamalai, PhD, November 2018, Clinical Laboratory News

At MetroHealth, a county-wide healthcare system based in Cuyahoga County, Ohio, the volume and complexity of our point-of-care testing (POCT) have increased rapidly. In the past, we had a decentralized POCT system in which individual testing centers held independent CLIA licenses.

While this was a reasonable strategy when POCT was available only at a few sites, the mushrooming dissemination of this modality led to a situation in which our POCT coordinators could provide only initial training and guidance with technical issues but were not involved in overseeing individual testing areas.

Though qualified medical staff were designated as directors, oversight was lacking at some sites. The limitations of this decentralized system came into sharp focus during an accreditation visit that found significant shortcomings, primarily due to the fragmented nature of the POCT program. Read more >
Improve Point-of-Care Glucose Measurements with Staff Outreach
By Uyen B Chu, PhD and Tiffany N Heady, PhD, Medical Lab Management, October 2018

Bedside glucose testing using strip technologies constitutes the highest test volume in most hospital-based point-of-care testing (POCT) programs. A 2010 study estimated that in health care settings, 51 percent of POCT involves bedside glucose meters using strip technologies. However, since the 2014 published warnings from the US FDA and CMS (both since retracted) on the potential erroneous results produced by glucose meters in critically ill patient populations, managing the off-label use of bedside glucose testing presents a significant challenge for hospital POCT programs.

Issues Exacerbated in Critically Ill
Originally designed as an over-the-counter product for managing glucose levels in diabetic patients, glucose meters are now used on virtually every hospital patient regardless of medical condition or the limitations specified in the manufacturer’s package insert. Glucose meters were initially... Read more >

The Pros and Cons of Point-of-Care Testing versus Laboratory Testing
By Lisa-Jean Clifford, MLO

Point-of-care testing (POCT) is used to refer to any patient testing that is done at, or near, the actual location of the patient.
But how does software enable these testing capabilities, and are the results comparably applicable to the results in the lab?

Read more >

The Laboratory’s Role in Guiding the Best Use of Point-of-Care Testing
By Kim Futrell, MLO

Continued growth in point-of-care testing (POCT) is certain as technologies improve and the benefits of POCT are realized in value-based healthcare. However, POCT is a diverse and complex area of laboratory testing, riddled with the challenges inherent to multiple locations, disparate devices, and non-laboratory trained operators. To reap the advantages POCT has to offer, POCT programs can greatly benefit from laboratory intervention and oversight. Laboratory professionals who approach POCT oversight as a team endeavor, keeping end users’ workflows and backgrounds in mind, can be instrumental in helping reap the potential benefits that POCT offers in patient care.

POCT’s renewed value instigates continued growth
The rapid turnaround time (TAT), convenience, and mobility of POCT—in specific patient scenarios—can speed clinical decision-making and treatment decisions and simultaneously help avoid other unnecessary procedures and associated risks. POCT’s rapid results can help optimize which patients receive advanced care, and improve patient understanding and engagement, giving POCT a more important role in patient-centered care. Read more >

Create a Strong Lab Team Through Recruiting
By Milly Keeler, MT(ASCP), CLC(AMT), CCCP, Medical Laboratory Management

No matter how much money is spent on sophisticated laboratory instrumentation, a lack of qualified, well-trained personnel will undermine the laboratory’s success at every turn. In fact, well-trained and skilled laboratory personnel are the single greatest determining factor of operational success. That said, recruiting and retaining new laboratorians can be difficult, time consuming, and expensive.

Managing risk is more important than ever in this litigious age and as experienced laboratory staff members are retiring faster than new employees are able to fill those positions, many laboratories are experiencing significant increases in workload and work-related stress. These circumstances are a breeding ground for potential mistakes, increased costs due to overtime and temporary workers, and for the cessation or abandonment of improvement projects. Therefore, a concerted effort should be invested in how the laboratory is bringing new staff on board. Read more >


Top 10 Health Technology Hazards for 2019

Health Data Management, October 2018


Health technology—ranging from simple devices to complex information systems—poses unanticipated risks for healthcare organizations. It’s important to identify these risks, understand them and try and correct them. Each year, the ECRI Institute’s Health Devices Group produces a list of the top 10 health technology hazards, identifying potential sources of danger that warrant the most attention for the coming year. “All the items on our list represent problems that can be avoided or risks that can be minimized through the careful management of technologies,” ECRI reports. Read more >

The Evolution of Group A Streptococcus Pharyngitis Testing
By Dithi Banerjee, PhD, and Rangaraj Selvarangan, BVSc, PhD, D(ABMM), FIDSA Sept 2018, Clinical Laboratory News

Molecular assays may soon eliminate the need for supplemental testing, but patient selection and appropriate test methods remain key


Acute pharyngitis, an inflammation of the pharynx and/or tonsils, is a common illness caused by many microorganisms. Although viruses are the main etiological agents, Streptococcus pyogenes, commonly known as group A streptococcus (GAS), is the primary bacterial cause, accounting for pharyngitis in 5%–15% of adults and 20%–30% of children worldwide (1). GAS pharyngitis mainly affects children 3–15 years of age and can lead to suppurative and non-suppurative complications, the latter being more common in developing countries. Suppurative complications include oral or peritonsillar abscesses, cervical lymphadenitis, and rarely, septicemia. Read more >

POC in the Lab: A Regional Experience in Urinalysis and Pregnancy Testing
MLO, Yu Chen, Susan McDonald, and Jason Weshler

Horizon Health Network operates 12 hospitals and more than 100 medical facilities, clinics and offices in the province of New Brunswick in Canada. Providing services ranging from acute care to community-based health services, Horizon Health Network has more than 12,400 employees, including 1,000 physicians, and has 5,700 volunteers, auxiliary workers, and alumni. The network consists of four areas with core lab services provided only in the four regional hubs. As part of the provincial laboratory standards, all sites performing point-of-care testing (POCT) must be accredited by the Institute for Quality Management in Healthcare IQMH (former Ontario Laboratory Accreditation 2013). Findings from a 2013 audit identified minor non-conformances specific to ISO 22870 in urinalysis POCT, which remained unresolved during a subsequent audit in 2015 and were escalated to major non-conformances. Read more >
A Novel Point-of-Care Approach for Improving Acute Bleeding Management
MLO, By Todd Allen and Francesco Viola

Whole blood viscoelastic testing (VET) for perioperative bleeding management is systematically increasing in clinical use and is approaching the level of standard of care for many clinical settings such as cardiovascular surgery, liver transplantation, trauma, and obstetric hemorrhage. Conventional coagulation testing has proven to be inadequate for directing therapeutic intervention in these critical settings.

Physicians managing acute bleeding events require faster turnaround times for test results and prefer assays that more accurately reflect the whole blood or cell-based hemostatic process described by Hoffman and Monroe. The benefits of VET have been well-documented. There exists an abundance of publications and systematic reviews in a variety of clinical settings, including review articles in this area published in previous issues of MLO. Several medical societies have given strong recommendations for the use of VET in conjunction with goal-directed treatment algorithms guided by VET for managing acute bleeding in the perioperative setting. To date, two technologies have emerged at the forefront of whole blood VET: thromboelastography and rotational thromboelastometry. Read more >

One and Done?
Prospective trial suggests that a single blood test may be sufficient to diagnose diabetes.

Clinical Laboratory News, July 2018

Multiple blood tests have been the clinical mainstay for confirming type 2 diabetes. However, a study that tracked individuals over several decades for incident diabetes and other conditions found that measuring elevated fasting glucose and HbA1c levels from a single blood sample may suffice for an accurate diagnosis. Investigators published the results of their prospective cohort study in the Annals of Internal Medicine.

Clinicians under current guidelines rely on two glucose tests to confirm a diabetes diagnosis. “Whether 2 different tests from a single blood sample provide adequate confirmation is uncertain,” wrote the study’s investigators, who launched a prospective study known as the Atherosclerosis Risk in Communities (ARIC) trial to see if this approach was possible.



The FDA reviews guidelines for capillary glucose testing in critically ill patients
By Jeffrey A. DuBois, MLO, June 21, 2018

Capillary whole blood testing with point-of-care (POC) glucose meters in hospitalized patients and, particularly, in critically ill patients, remains a topic of interest in the medical and regulatory communities. However, determining the requirements for effective clinical use has proved challenging.


An FDA panel convenes

This past March, the U.S. Food and Drug Administration (FDA) convened its Clinical Chemistry and Clinical Toxicology Devices Advisory Panel, seeking guidance and recommendations on the acceptability of capillary specimens in critically ill patients based on benefits and risks, and whether capillary specimen testing in this patient population meets the criteria for waived status under the Clinical Laboratory Improvements Amendments (CLIA) regulations. The FDA began by summarizing the history of POC glucose testing for the panel and emphasized the need for manufacturers to submit data supporting their glucose meters’ acceptability for use with critically ill patients. The FDA reviewed the data submitted for a glucose meter cleared for use with these patients using arterial and venous specimens, and related that no manufacturer had submitted data for capillary whole blood. Read more >

Keeping the lab environment clean and safe

By Daniel J. Scungio, MLO, June 21, 2018


The clinical laboratory is an inherently dangerous place. Laboratorians face a variety of dangers working in an environment that contains biohazards. Utilizing standard precautions and correctly employing Personal Protective Equipment (PPE) are essential keys to ensure laboratorians’ safety. Maintaining a clean and orderly environment and employing good disinfection practices are vital as well. A cluttered workspace and an area contaminated with biohazards threaten the safety of both employees and visitors.


General disinfection tips

Lab directors should conduct audits of their department’s physical environment to identify safety hazards specific to their lab. Such audits typically do not need to interfere with the day-to-day lab processes, and they should be performed on a regular basis, at least monthly. Many changes can occur in a laboratory at any time, such as the movement of instruments, the placement of new equipment, or even the movement and stocking of lab supplies, and the implications of such changes for safety should be recognized. Read more >

New guidelines and studies suggest improved approaches to C. difficile testing
By Sherry A. Dunbar, MLO, June 21, 2018

Clostridium difficile represents a significant health threat around the world. In the United States, infections caused by C. difficile are now the most common type of healthcare-associated infection. Nearly half a million infections occur in the U.S. annually, with an estimated 29,000 deaths within 30 days of the initial diagnosis.

Consequently, much effort is ongoing toward the development of better testing and treatments for C. difficile. This year, new clinical guidelines were released that included significant changes to how healthcare teams respond to C. difficile infections. In addition, scientists and clinicians are conducting a number of studies and generating useful information that could guide new expectations or policies about testing and treatment.

For example, studies have shown that molecular tests targeting a marker specific to a single C. difficile strain are less useful now, as other strains of the pathogen have become more prevalent.3-5 These findings could help clinical labs fine-tune their C. difficile testing procedures to ensure the most reliable results. Also, several recent studies have demonstrated that... Read more >

Christiane Nooney from Duke Hospital Named 2018 POCC of the Year by AACC

The AACC Critical and Point of Care Testing (CPOCT) Division has announced that Christiane “Chris” Nooney, MBA/MHA, MT(AMT), DUH POC Supervisor, Duke Hospital, DukeHealth has been award the 2018 Point of care Coordinator of the Year.

Chris was unanimously selected as the 19th recipient of this auspicious award given annually to recognize outstanding achievements in the POCT field by persons who are primarily responsible for a given institution’s POCT program. It is based on the extent of the nominee’s responsibilities and accomplishments, particularly the impact this person has made in improving the quality of the POCT program at their facility. The award also includes a cash award and funds to support attendance at the AACC Annual Meeting as well as an elegant trophy. Read more >

Point of Care Testing Compliance
How Partnering With Nursing Leadership and Sharing Data Upped Performance on a Crucial Parameter
By Adil I. Khan, MSc, PhD, Clinical Laboratory News, June 2018

The of the hardest aspects of point-of-care testing (POCT) is trying to make the diverse users of POCT devices follow written procedures and perform testing exactly as stated by manufacturers. The simplicity of POCT devices, often involving disposable kits with no maintenance or troubleshooting, tempts users to take shortcuts. The downside of this approach is that when procedures are not followed to the letter, mistakes happen. POCT devices are designed so they can be used by anyone with at least a high school diploma, hence users range from students to physicians. Read more >

Preanalytical Errors and Critical Variables in Point-of-Care Testing
By Aparna Jha Ahuja, MD, May 24, 2018, MLO

Today’s “smart” technology enables us to have important information at our fingertips. Point-of-care testing (POCT)—also referred to as “near patient, bedside, and extra-laboratory testing”1—offers the rapid delivery of healthcare information as well.

Centralized laboratory testing was the standard until the mid-1980s. Since that time, many laboratory tests (e.g., glucose and blood gas testing) have transitioned to patient care settings, including physicians’ offices, ambulances, and hospital units (e.g., the intensive care unit, emergency department, surgical suites), as well as clinics, dialysis centers, and nursing homes.2 Devices for POCT range in size from small handheld meters for glucose monitoring to larger benchtop analyzers for hematology. Read more >

Field-Portable MDx
MLO, By John Brunstein, May 24, 2018

There is an enduring appeal to the concept of point-of-care (POC) or near-POC diagnostic methods. Having the ability to perform a diagnostic test in the doctor’s office while a patient is present, rather than having to send a sample off to a centralized lab for testing, means that what would otherwise need to be two patient visits could be replaced by a single session. It also suggests the potential for a more timely response with a specific rather than empirical treatment strategy, with particular implications for the appropriate, limited use of antibiotics. Carrying the POC concept a step further, one can imagine the potential utility if cheap, effective, reliable diagnostic systems could be made small, portable, simple, and rugged enough for use in low-resource settings, where they might have the greatest human impact.

Of course, many such diagnostic methods exist, but they are most frequently some form of a rapid immunological test. While these excel in simplicity, low cost, and speed, they generally lack the sensitivity and specificity that a molecular method would provide. That they are so widely used even with these shortcomings underscores the need for POC/near-POC testing and the potential for growth in this field if suitable molecular devices and tests can be developed. Read more >

CMS gives 213 hospitals 'five stars' for patient experience. See how yours fared...
May 2018 |

CMS on April 25 updated its Hospital Compare website with new Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) summary star ratings.

CMS' summary star rating scores hospitals on a one-to-five-star scale based on the 11 publicly reported measures in HCAHPS survey, which assesses patient experiences. The agency started assigning hospitals patient experience star ratings based solely on HCAHPS scores in April 2015. The latest update is based on HCAHPS survey data collected between July 1, 2016, and June 30, 2017.

4 ways patient experience may be costing you
The patient experience summary star ratings are distinct from CMS' overall quality star ratings, which are scheduled to be updated in July. Overall star ratings are based on 62 quality measures from seven categories: effectiveness of care, efficient use of imaging, mortality, patient experience, readmissions, safety, and timeliness of care.


A map of the country’s hospitals and their rankings is available on the Advisory Board’s Web site (registration is required to view the map). Read more >

Considerations for Implementing New POC Testing
Tyler Gledhill, BS, Robert L. Schmidt, MD, PhD, MBA, Brenda VanCleve, MT(ASCP), Sandra K. White, MS, Medical Laboratory Management, Clinical Leadership & Management Review

Point-of-care testing (POCT) can deliver significant benefits to both patients and providers, and due to this, POCT has experienced rapid growth in recent years. While the end result of POCT can be quite positive, proper implementation and management can present challenges and requires vigilant oversight to ensure success. Regardless of whether the organization is new to POCT or has a fully functioning POCT department, implementing a new POC test requires careful planning. Test implementation can raise unique issues that may be unfamiliar to laboratory and hospital staff. These include consideration of federal and state regulations, relationships with regulatory and accreditation bodies, POC test management and technical performance, and overall fit with the organization. Taking an administrative viewpoint, laboratory directors must focus on test justification and dispersion when considering a new POCT. Before approving an application to implement POCT, it is key that laboratory leadership consider the following issues.

Determine Necessity and Benefit
Requests for new POC tests typically originate from clinicians who desire more expedited results. Ideally, a rapid result enables physicians to provide a diagnosis or prescribe a treatment at the time of the patient encounter. This can reduce the time to therapy, increase adherence, and reduce the potential for errors in handling specimens. However, managers should exercise caution before instituting new POCT, as the benefits are highly dependent on the context in which the test will be implemented. Read more >

American College of Physicians Recommends Less Restrictive HbA1c Targets

The Sample: May 2018, Clinical Laboratory News

In a controversial new clinical guideline, the American College of Physicians (ACP) recommends less restrictive HbA1c targets for glycemic control in most patients with type 2 diabetes; between 7% and 8% rather than 6.5% or 7% as recommended by other groups (Ann Intern Med 2018; doi:10.7326/M17-0939). ACP based this advice on evidence about the benefits and harms of lower HbA1c targets from clinical trials considered by the other groups in setting their HbA1c targets. “ACP’s analysis of the evidence behind existing guidelines found that treatment with drugs to targets of seven percent or less compared to targets of about eight percent did not reduce deaths or microvascular complications such as heart attack or stroke but did result in substantial harms,” said Jack Ende, MD, president of ACP. Read more >

POC Glucose: Views on Volume, Critical Care, ACOs

CAP Today, April 2018


Test volume, limitations on devices used in critical care, consolidation, and population health is what CAP TODAY asked about when it spoke in March with the makers of three bedside glucose testing systems. “Customers are more aware than ever of the limitations that are in the package inserts from the glucose manufacturers,” says Corrine Fantz, PhD, director of medical and scientific affairs for point-of-care testing, Roche Diagnostics. But she and Kevin Peacock, clinical marketing manager, HemoCue America, say there is still confusion.  This article features responses to the following questions posed by CAP Today senior editor Amy Carpenter Aquino.

  • How has the decline in reimbursement coupled with a retreat from tight glycemic control affected test volume for patients at the bedside?

  • How are your customers adapting to the limitations on glucose devices for critical care applications?

  • How has system consolidation—including established system clinics, ERs, and acquired physician practices—affected POC glucose testing for ambulatory patient testing?

  • How does glucose testing and the management of patients with diabetes fit into the concern laboratories have now for population health and accountable care organizations?

For the complete article, click here.  |  Glucose systems are profiled here.

Thinking Beyond The Instrument

Laboratories are using IQCP to bring preanalytic and postanalytic factors into focus and improve patient care


Nearly 5 years ago, the U.S. Centers for Medicaid and Medicare Services (CMS) introduced a new option for laboratory quality control (QC) called the Individualized Quality Control Plan (IQCP). Laboratories could create an IQCP as an alternative to performing two levels of external QC per day of patient testing (default QC), as long as their risk assessment supported a longer QC interval and it complied with manufacturers’ instructions.


The catch? Equivalent quality control (EQC), an option that had been available since 2004, was being eliminated. EQC allowed labs to run external QC on a weekly or monthly basis for tests with built-in QC features, as long as the schedule met minimum manufacturers’ recommendations.


Under the new rules, which took effect in January 2016 after a 2-year educational period, labs needed to write an IQCP for every test that had been operating with EQC or perform default QC. Laboratory managers, particularly those in charge of point-of-care testing (POCT, were faced with the daunting task of conducting risk assessments and writing IQCPs for dozens or even hundreds of tests.  Read more >

IBM Watson Health Announces 100 Top Hospitals
Formerly the Truven Health Analytics 100 Top Hospitals, 2018 Study Finds Top U.S. Hospitals Improve Outcomes at Lower Cost and Higher Profit Margins than Peers

IBM Watson Health™ today published its 100 Top Hospitals® annual study identifying top–performing hospitals in the U.S. based on overall organizational performance. Formerly known as the Truven Health Analytics® 100 Top Hospitals, this study spotlights the best–performing hospitals in the U.S. based on a balanced scorecard of publicly available clinical, operational, and patient satisfaction metrics and data. It has been conducted annually since 1993.

Overall, the Watson Health 100 Top Hospitals® study found that the top-performing hospitals in the country achieved better risk-adjusted outcomes while maintaining both a lower average cost per beneficiary and higher profit margin than non-winning peer group hospitals. Did your hospital make the list?

What's New in Point-of-Care Testing?
Point of Care: March 2018 - Volume 17 - Issue 1
By Kantartjis, Michalis BS; Melanson, Stacy E.F. MD, PhD

Point-of-care testing (POCT) is one of the fastest growing sectors in diagnostics, becoming a well-established laboratory tool in healthcare systems across the world. Recent research has focused on increasing cost-effectiveness and improving overall performance of existing POCT. Lower costs as well as rapid and accurate results have allowed for POCT to be used in resource-limited regions and positively impact patient care globally. Literature on POCT published between January 1, 2016 and December 31, 2016 was reviewed. Select articles are summarized and grouped into the following categories:

  • hematology and coagulation

  • cardiac disease

  • infectious disease and human immunodeficiency virus

  • gastrointestinal disease

  • emergency medicine

  • glucose and diabetes

  • technological advancements, and other.

Read more > Note, you have to subscribe to the POC Journal or purchase this article.

Labs Take Stock of Surprising Flu Season
CAP Today, March 2018, by Amy Carpenter Aquino

In a severe flu season that started early, laboratories faced unprecedented test volumes, used new testing platforms, and negotiated vendor supply shortages. When laboratory staff at Arkansas Children’s Hospital in Little Rock began seeing a rising number of requests for respiratory tests, and five positive flu results, in September 2017, they suspected they were in for a record flu season, says Sherry Childress, BSMT(ASCP), technical chief, molecular diagnostics and immunology. Read more >

CDC Warns of a Second Wave of Flu Virus
By LABline, March 28, 2018

The flu season may be winding down, but parents of young children have reason to remain watchful. As flu activity continued to decrease across the nation, the A-strain H3N2 influenza virus, which had dominated previously, was reported less frequently than B viruses, the CDC weekly surveillance report indicated Friday. During the week ending March 17, nearly 58% of all laboratory-confirmed cases of flu were caused by B-strain viruses, according to the CDC report. Circulating strains this season, which began in October, were a mix of A viruses (H3N2 and H1N1) and B viruses. Generally, the H3N2 strain leads to more severe illness and more hospitalizations than B strains, according to the CDC. Read more >

MLO's 2018 Lab of the Year: St. Luke’s Health System’s Core Laboratory
By MLO Staff, March 2018

The competition was tough, the judging was not easy—but MLO is proud to present the 2018 Lab of the Year: St. Luke’s Health System’s Core Laboratory.

St. Luke’s Health System (SLHS) is a not-for-profit, locally owned health system serving southern Idaho and eastern Oregon. St. Luke’s Core Laboratory was established in 2011 and is a department of SLHS. The laboratory includes five physical locations in Boise, Idaho; one main testing site, and four outreach phlebotomy sites. Read more >

MLO’s 2018 Annual Salary Survey of Laboratory Professionals

How Much does a Point-of-Care Coordinator Earn?

By: MLO Staff, February 2018

The United States Department of Labor, Bureau of Labor Statistics (BLS) states that employment in “Healthcare Occupations” is projected to grow 18 percent from 2016 to 2026, much faster than the average for all occupations. Healthcare occupations will add about 2.4 million new jobs to the workforce. In fact, healthcare is projected to add more jobs than any of the other occupational groups. This projected growth is mainly due to an aging population which leads to greater demand for healthcare services. Read more >

Diabetes Roundup
By MLO Staff, February 22, 2018

Diabetes is not so much being cured as it is being surrounded. Researchers are coming at this common disorder from a number of different perspectives, and some of their discoveries are finding their way, or soon might find their way, into clinical practice.  MLO provides a roundup of some recent scientific approaches regarding type 1, type 2, and gestational diabetes mellitus (GDM), as well as an exciting recent FDA approval of a needle-free glucose testing device that may make life easier for people with diabetes.
Read more >

CLP Tech Guide: Lab and POC Glucose Monitors
February 8, 2018

The Clinical Lab Products Tech Guide features lab and point-of-care glucose monitors from such companies as Arkray USA, Nova Biomedical, and Oak Tree Health. The guide is available as a free download.

Flu Map Shows How the Biggest Influenza Outbreak in Years Spread Across the U.S.
TIME Health, By JAMIE DUCHARME and DAVID JOHNSON January 19, 2018

With months left to go in the 2018 flu season, the U.S. has already hit an unfortunate benchmark, as shown on the flu map below: For the first time in the Centers for Disease Control and Prevention’s 13 years of influenza monitoring, every state in the continental U.S. is seeing “widespread” virus activity.

The U.S. is experiencing such an active flu season that the CDC held a special briefing on the topic last week, explaining that there’s an uptick in both confirmed cases of the disease and hospitalizations related to it this year. The flu is so widespread, in fact, that the agency has declared it an epidemic, and urged those who have not been vaccinated to seek out the flu shot. But how did this year’s flu season get so bad? Read more >

Blood Glucose Test Strips
Another Shared Diabetic Supply Harboring Bacterial Contamination
Clinical Laboratory News, By Sharon Geaghan, MD, January 2018

When you or a family member are admitted to the hospital, you expect that the room will be cleaned and disinfected thoroughly. You do not expect to find half-used tissue paper boxes or leftover bandages from the previous patient. To the contrary, patients expect that hospitals will take all necessary precautions to avoid spreading disease, including disposing of patients’ medications when they are discharged from a facility.

Perhaps the only exception to the current practice of single-use, single-patient hospital supplies is blood glucose test strips. Hospitals and other institutions often procure blood glucose test strips in 25- or 50-count vials and bring them from patient to patient and room to room for testing purposes. Testing sites range from acute care hospitals, outpatient clinics, skilled nursing facilities and long term care facilities to prisons, shelters, surgery centers, schools, and camps. Read more >

Devices, Decisions: Glucose in the Critically ill
CAP Today, January 2018, by Anne Ford


Using point-of-care glucose meters in critically ill patients can feel like tiptoeing through a regulatory minefield. Perhaps your preferred meter hasn’t been cleared by the FDA for use in this population. Or maybe you’re not sure which assay performance requirements should be regulating the performance of your meters. Or perhaps you’re still trying to define “critically ill.”


Recently published studies have aimed to clear some of those mines by evaluating the accuracy of glucose meter results in ICU and non-ICU settings and by also assessing meter performance in a clinical context rather than a strictly analytical manner. Those studies, the four options labs have, and a look at the POC policy in place at Ohio State University Wexner Medical Center were spotlighted at last year’s AACC annual meeting in a session, “The Burden of Proof for Point-of-Care Glucose Monitoring in Critically Ill Patients,” presented by James H. Nichols, PhD; Alison Woodworth, PhD; and Steven Cotten, PhD.

While nursing tends to think that capillary samples are easier than phlebotomy, Dr. Nichols said, variations in operator technique mean there is ample room for error. And getting an adequate reflection of the patient’s physiology isn’t a given. What if the patient is...

Read more >

Looking Beyond HbA1c Outcomes for Type 1 Diabetes
Leading diabetes organizations release consensus definitions for hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis.
January 4,2018; CLN Stat

A consensus report by major diabetes organizations includes standard definitions for outcomes in type 1 diabetes, including hypoglycemia, hyperglycemia, time in range, and diabetic ketoacidosis. After doing their homework on the clinical evidence, major diabetes organizations issued a series of priority outcomes for type 1 diabetes (T1D), looking beyond the scope of hemoglobin A1c (HbA1c). HbA1c, which assesses mean blood glucose measures over a 3-month period, is an important tool in diabetes care management. However, the test is limited in that it can’t capture short-term fluctuations in blood glucose, exposure to hypoglycemia and hyperglycemia, or the impact of blood glucose variations on quality of life. “Recent advances in type 1 diabetes technologies and research have made it feasible to assess the efficacy of therapies and technologies using a set of outcomes beyond HbA1C and to refine definitions of outcomes such as hypoglycemia. However, while definitions for hypoglycemia in clinical care exist, they are not standardized, causing inconsistency in the definitions used in different research studies,” according to a statement from the American Diabetes Association (ADA). Read more >

HbA1c Shows its Mettle Predicting Diabetes Risk
CAP Today, Anne Paxton, December 2017

The longitudinal Framingham Heart Study, which first identified the concept of risk factors and made serum LDL cholesterol a household name, could help increase the celebrity status of HbA1c, with the Oct. 26 publication of a new study in Diabetes Care. International and national organizations since 2010 have recognized HbA1c as a valid way to diagnose abnormalities in glycemia and diabetes mellitus. But there has been less consensus on its use as a screen for elevated diabetes risk. It has been shown that elevated HbA1c and elevated fasting glucose are better at diabetes prediction than fasting glucose alone. But is HbA1c associated with incident diabetes independently, such that HbA1c results can identify individuals with high diabetes risk? That was the question addressed in the Diabetes Care retrospective study “Prediction of type 2 diabetes by hemoglobin A1c in two community-based cohorts,” in which the authors reviewed extensive data collected on subjects of the Framingham Heart Study and the Atherosclerosis Risk in Communities (ARIC) study (Leong A, et al. Based on that data... Read more >

Role of Medical Devices in the Data Management Processes of the Modern Clinical Laboratory
By Shawn Hall, MLO, November 2017

As the modern clinical laboratory becomes more connected, it becomes increasingly difficult to efficiently exchange and manage data. This is especially true with regard to interoperability, where data is exchanged among several clinical systems. Yet diagnostic laboratories have become such an integral part of the connected healthcare paradigm that methods for expanding their scalability, improving performance, and managing data are critical to achieving the core objectives of meeting the needs of clinicians and patients. Laboratories have long stressed efficiency, safety, and quality in the management of diagnostic data; however, the focus has primarily been on the analytical phase. But the trends toward lab automation and increasing testing require that laboratories constantly adapt to ever-changing data management requirements in all phases of the testing process. This article addresses pre- and post-analytical data management processes; discusses challenges such as patient safety, complex workflows, and reporting responsibilities; and examines how data management features of analytical medical devices can have a positive impact in today’s connected clinical laboratory. Read more >

Point-of-Care Tests Help Manage Influenza
CLP, By Patrick Murray, PhD, November 2017

This year’s flu season requires clinical labs to take into account a variety of new considerations, including FDA reclassification of RIDTs. Vaccines are the best defense against influenza, but predicting when influenza will occur and which strains will appear is a challenge (see Figure 1). In 2009, a novel strain of influenza A arose during the summer, and continued with significant disease into the fall.1 In 2013, a new strain, H3N2, made its debut and was responsible for the majority of disease that year.1 This strain has been the predominant virus in seasonal outbreaks for the past 3 years. Despite the fact that this strain is covered under current vaccines and was once again responsible for the majority of influenza cases during the 2016–2017 flu season, however, the prevalence of the strain led to particularly severe outcomes for children and older adults. Read more >

Horizons in Point-of-Care Testing
CLP, By Kate McLaughlin, PhD, and Donna Hochberg, PhD, November 2017

POC testing is unlocking new markets for commercial IVDs, but reaching potential new customers can be a challenge. Diagnostic testing that is capable of being performed at the point of care holds the potential to improve patient care by enabling faster clinical decisions with small sample volumes. New instrument platforms are addressing historic concerns over quality and data integrity to allow a wider variety of tests to be performed outside of the lab. At the same time, new models of more-convenient healthcare delivery, and the prospect of capturing additional revenue by performing tests for which lab proficiency testing and inspections are waived under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), are together giving physicians, pharmacists, and nurses more power to shift testing volume to the point of care. Still, commercialization of point-of-care (POC) technologies remains... Read more >

Benefits and Bumps of Shifting to Beaker
By Anne Paxton, CAP Today, November 2017


If they were located in the Land of Oz, laboratories selecting a laboratory information system might not have to make a choice between full functionality and seamless integration with their electronic medical record system. They could just follow the helpful advice of the Scarecrow to Dorothy at a crossroads: “Go both ways.” Down here in Dorothy’s Kansas, however, having to weigh an LIS that is part of an enterprise wide solution against a standalone LIS creates a classic quandary for hospital laboratories: Follow one brick road and you may have top-flight integration between the LIS and EMR but possibly less LIS functionality. Go down the other road and you may acquire a best-of-breed LIS but risk stumbling on the interface with the EMR. Increasing numbers of hospital and health care system laboratories, already operating in an Epic environment for their EMR, are casting their lots with integration by choosing Epic’s Beaker for their LIS. As of August 2017, Epic had 375 installations worldwide, 28 of them between August 2016 and August 2017... Read more >

From Many One A Case Study on Standardizing Point of Care Testing Instrumentation

Clinical Laboratory News, Bench Matters: November 2017, Brenda Suh-Lailam, PhD, DABCC, FACB


Point-of-care testing (POCT) goes a long way toward helping institutions improve patient care by returning fast and reliable results near patients, thereby enabling prompt clinical interventions. POCT’s vital role in patient management makes it popular across clinical settings but often with different device types for the same test. Our institution is no exception to this POCT device creep, as at one point we had more than four types of blood gas analyzers, three table tops and one hand-held. Realizing that this confounded many of our quality and efficiency aims, we undertook a deliberate and durable process to standardize these instruments... Read more >

Convincing Hospitals that Glucose Management Matters
By Dan Fleshler | Published on 23 October 2017

Patients' blood glucose (BG) levels in many American hospitals run dangerously high, but hospitals aren’t doing nearly enough to address the problem.

Between 70% and 80% of patients with diabetes experience hyperglycemia when they’re hospitalized for critical illnesses or have cardiac surgery. And about 30% of all inpatients experience high blood sugars (>180 mg/dL). Even if you stay in the hospital for just a few days, rising glucose levels increase the mortality risk and the risk of eventual kidney failure, poor healing, dehydration and other problems. Meanwhile about 6% of hospital inpatients experience potentially dangerous hypoglycemia (low blood sugar) as well!

It doesn’t have to be this way. In this day and age of continuous glucose monitoring (CGM) and closed loop technology, hospital diabetes management has the potential for a seismic shift -- if they choose to adopt these newer innovations.

For example, recently on Oct. 18, the FDA approved a first-of-its-kind CGM for surgical ICUs that can monitor glucose levels and alert physicians and hospital staff of any highs or lows. It's a sign of the times, as this type of tech to monitor glucose and dose insulin promises to improve patient health, reduce hospital readmissions and cut health care costs.

Yet only about 10% of Americans hospitals now use these “e-Glycemic solutions,” says Linda Beneze, CEO of Monarch Medical Technologies, which provides high-tech glucose management systems to hospitals. Read more >

How to Choose a Quality Improvement Project
Q&A with Michael Astion, MD, PhD, Editor-in-Chief, CLN Patient Safety Focus

In the October issue of CLN, a reader asked...


'I took a new job as a supervisor in a medium-sized hospital lab. The lab is in reasonably good shape with no emergent problems, but my co-workers and I agree that certain areas need improvement. I am confident I can do a quality improvement (QI) project and have worked in organizations that used different approaches—like Lean, Six Sigma, and homegrown strategies—and feel I will be able to fit into any system.


I know how to choose metrics and incremental goals. But how do I know which problems to work on first? It is important to me that these first QI projects succeed and are meaningful to the staff.'


For Dr. Michael Astion's answer, click here...

Keeping Up with POCT Regulatory Compliance
MLO, October 2017, By Connie Mardis

Today, hundreds of tests once considered too complex for point-of-care testing (POCT) are routinely performed outside the laboratory. Due to hospitals’ decentralized structure, laboratory testing is performed on a multitude of POCT devices from various manufacturers in many hospital wards, critical care departments, clinics, and physician offices. Typically, POC devices in a hospital can include dozens of blood gas analyzers, urine chemistry and cardiac marker systems, and handheld coagulation instruments, as well as hundreds of glucose devices. Perceived barriers to implementing POCT have been attributed to accountability factors such as quality control, adequate staff training, and oversight for accreditation purposes. This article will review accreditation requirements and advances in open, vendor-neutral POCT data management to facilitate billing capture, regulatory compliance, and inspection preparedness.


Why POCT? Because of its convenience, timeliness, and potential to improve patient outcomes, POCT’s popularity continues to rise.1 Near-patient testing increases the likelihood that healthcare professionals and the patient will receive test results faster, which may facilitate faster diagnoses, more timely treatment interventions, and improved patient compliance. For example... Read more >

Urinalysis Quality Control at the Point-of-Care
MLO, October 2017, By Brian Fernandez

The goal of any clinical diagnostic test procedure is to provide critical information in a timely manner so that appropriate actions may be taken, ultimately improving patient outcomes. Point-of-care testing (POCT) is a term that has come to describe a multitude of rapid medical tests that can be performed at or near the site of patient care. The most compelling benefit of these tests is that, as opposed to having to wait hours or days for results to arrive from an outside laboratory, clinicians can obtain the results immediately, allowing for clinical management decisions to be made while the patient is still at the care facility. While the implementation of rapid diagnostic tests dates back to ancient history (sweet-tasting urine was once commonly used to diagnose diabetes mellitus), it was not until the 1950s that these rapid diagnostic methods gained any real predictive value.

Today, the popularity and demand for POCT are increasing rapidly. TriMark Publications estimates that the global market for POCT was $14.5 billion in 2016, and is expected to grow by seven percent over the next five years.

Urinalysis dipsticks at the point-of-care Urinalysis using multi-analyte dipsticks is a point-of-care test performed at any hospital, clinical laboratory, doctor’s office, health clinic, and nursing facility. Various iterations of these tests have existed for decades, and they continue to be among the most commonly performed tests of any kind. Urinalysis dipsticks contain... Read more >

FDA Raises the Bar for Flu Tests, Aiming for Better Testing and Better Outcomes
Clinical Lab Products, October 2017, By K.C. McGrath

FDA’s recent regulatory reclassification of antigen-based rapid influenza diagnostic tests (RIDTs) from Class I to Class II was prompted by concerns about the tests’ performance during severe flu seasons, most notably during the H1N1 influenza pandemic of 2009. The goal of the reclassification is to improve point-of-care influenza testing, in order to reduce misdiagnoses and accelerate linkage to appropriate treatment.

The Rationale for Reclassification FDA’s device classification system reflects the regulatory controls needed to ensure that devices are safe and effective for human use. There are three device classifications based on risk: Class I, Class II, and Class III. All three classes of devices must satisfy basic requirements specified by FDA (‘general controls’), such as proper packaging and labeling. Read more >

The Journey to 100% Point-of-Care Connectivity
Clinical Laboratory News, October 2017, By Christiane Nooney, MHA/MBA, MT(AMT)

At first glance, the need for centralized connectivity of point-of-care (POC) instruments may seem conceptually at odds with the primary benefit these devices provide. Indeed, caregivers generate results and may well have acted on them by the time POC staff can view test data on their middleware server. Nonetheless, the value of POC connectivity has risen steadily in concert with the growing importance of informatics in care delivery. Connectivity not only facilitates dissemination of clinical data to caregivers across the house but also provides numerous advantages to laboratorians under the broad heading of compliance management. Unlike hospital laboratories...  Read more >

The Role of Lab Automation in Reducing Diagnostic Errors
Medical Laboratory Observer, By Brad F. Tieman, September 2017

A recent study reported that medical error is the third-leading cause of death in the United States, just ahead of respiratory illness and behind only cardiac disease and cancer. More than 200,000 American deaths each year are associated with preventable harm in hospitals. In addition to putting patients at risk, medical errors contribute to substantial avoidable costs estimated to exceed $17 billion annually in direct costs in the U.S. alone. Given that up to 70 percent of clinician decisions are influenced by laboratory test results, there is a major role for the clinical laboratory to play in reducing avoidable medical error, enhancing patient safety, and improving outcomes. Click here to download the Executive Brief

Lab error and patient safety The ECRI Institute publishes an annual report on the Top 10 Patient Safety concerns. In the most recent report, two of the top ten, “test result reporting and follow-up,” and “patient identification errors,” are directly related to issues that can be addressed by the clinical laboratory. Patient identification errors and test result reporting are associated with the pre-analytical and post-analytical stages of clinical diagnostic testing. And while recent studies have shown... Read more >

Bringing data analytics to bear on diabetes care
CAP Today, September 2017, By Amy Carpenter Aquino

September 2017—Can data move the dial on diabetes? That’s the thinking behind Roche Diabetes Care’s new partnership with Accenture, and it’s how some labs and health care systems are already driving diabetes care to a whole new level. “At Roche Diabetes Care, we want to create a leading open digital diabetes ecosystem,” says Yan Beynon, head of digital and health solutions. To do so, the company will use Accenture’s existing Intelligent Patient Platform to build a core data platform that gathers “vital pieces of diabetes information,” he says. The data will be categorized, analyzed, and transformed into “powerful insights to support improved therapy routines and outcomes.”

Within this ecosystem, Beynon says, blood glucose, insulin, blood pressure, and cholesterol levels, along with co-medication, physical activity, food intake, and other information, will be collected and analyzed and put into context. “Having all therapy-relevant data in one place and the smart algorithms to perform the ana­lyses will help to improve therapy adaptation and results,” he says. Read more >


CDC Releases 2017 National Diabetes Statistics Report

The National Diabetes Statistics Report is a periodic publication of the Centers for Disease Control and Prevention (CDC) that provides updated statistics about diabetes in the United States for a scientific audience. It includes information on prevalence and incidence of diabetes, prediabetes, risk factors for complications, acute and long-term complications, deaths, and costs. These data can help focus efforts to prevent and control diabetes across the United States. 
Click here for a copy of the report.

A Limitless Lab
By Peter Koerte, PhD, Clinical Lab Products, on August 2017

With connectivity, point-of-care testing is on the front line when it comes to diagnosing and managing chronic diseases
Across the globe, studies of healthcare delivery systems have led researchers to the inescapable realization that fragmented patient care is not a sustainable way to manage patient health in the face of growing economic pressures. The United States, for example, spends more on healthcare than any other high-income nation, yet it is well known that Americans have a lower life expectancy and graver health outcomes than residents of many other countries. Such disparities can be attributed, in part, to the failure of encounter-based medicine to meet the growing demands of a population that is heavily afflicted with chronic disease. In response to such trends, healthcare delivery systems in the United States and elsewhere are in the midst of... Read more >

Training Non-Laboratorians to Perform POCT

Elizabeth Terry Named 2017 POCC of the Year!

Elizabeth Anne (Betty) Terry is part of a two person POCT team that manages 1500 POCT users at the Kaiser Permanente Medical Center in Oakland, California. The POCT program encompasses a 349-bed, state-of-the-art hospital and 6 medical office buildings.

Betty is a native of Pennsylvania, raised in the San Francisco Bay Area, received a BA in Bacteriology from the University of California, Berkeley and completed the Curriculum in Medical Technology from University of California, San Francisco. During the course of her career Betty has worked in all shifts and all areas of the clinical lab. Read more >

“Off-Label” Use of Blood Glucose Monitoring Systems in Critically ill Patients
MLO letters to the Editor, June 22, 2017

The article by Scott Isbell, PhD, DABCC, entitled “Bedside blood glucose testing in critically ill patients,” published in the April edition of MLO [2017;49(4):8-12] summarized some of the current issues related to testing capillary blood and the “Off-Label” use of blood glucose monitoring systems (BGMS) in critically ill patients. However, in our view the article did not completely nor adequately explain all the recent concerns about using BGMS in critically ill patient care settings and the reasons behind the publication of the new FDA guidance with specific critical care accuracy criteria and clearance requirements for manufacturers.  More specifically, the article did not address the patient dangers associated with using blood glucose meters not cleared for use in critically ill patients, nor the regulatory risks to hospitals when they use a meter not cleared for critically ill patients in an “Off-Label” application. The concern about the accuracy of BGMS used in critically ill patients is related to deaths and serious adverse events reported in the US FDA MAUDE database, as well as in peer-reviewed medical journals. These reports and publications represent the tip of the iceberg and are still being reported for certain glucose meters used routinely in hospital settings. Read more >

CDC data show C. diff infection rates are falling after steady increase

Preliminary analysis of data from the CDC's Emerging Infections Program showed that the rate of new Clostridium difficile infections in hospitals and nursing homes nationwide declined by 9% to 15% from 2011 to 2014, suggesting revised antibiotic use guidelines and more aggressive cleaning standards are working. C. difficile infection rates climbed annually from 2000 to 2010, and in 2011 caused almost 500,000 illnesses and killed about 29,000 people in the US. Read more >

CDC: Flu season moderate, influenza H3N2 most dominant strain

CDC researchers reported that flu activity this season was moderate, with influenza A (H3N2) being the most dominant strain for most of the season. The findings in the agency's Morbidity and Mortality Weekly Report also showed that flu vaccines distributed this season were tied to a 42% lower overall risk of flu-related medical visits. Read more >

poctHUB Launches: Take It for a Spin

By Christopher Fetters, Nextivity, May 2017


poctHUB is a portal for professional POCT products that includes the ability to read and write reviews, link journal articles, browse product specifications and search for your next great POCT product. poctHub is a clearinghouse of product information which is unbiased and normalized across products. Each product will be rated by its users based on Clinical Efficacy, Reliability, Ease-of-Use, Product Support, and an Overall score.  Viewers will be able to see how many other hospitals have connected to each product and how many have reviewed each product.  Scientific journal articles, case studies, and product brochures can all be linked to each product limiting the need to scour the web for product information.  poctHUB will put much of the information you need, right at your fingertips. Using poctHUB is free for anyone who directly or indirectly treats clinical patients:  POCCs, lab managers, medical directors, respiratory, nursing, POL office managers, etc.  Take it for a spin today!

Untangling Glycaemia and Mortality in Critical Care
Vincent Uyttendaele, , Jennifer L. Dickson, Geoffrey M. Shaw, Thomas Desaive and J. Geoffrey Chase Critical Care, June 2017

Glycaemic control (GC) in the intensive care unit (ICU) is a controversial subject . Whereas some studies showed improved mortality with GC within a tight or intermediate range, several others studies and larger analyses did not reproduce these results. Increased hypoglycaemia induced by the GC protocol, patient variability and/or protocol compliance further confounds results. T
he strong associations of blood glucose (BG) level and/or variability with mortality have been used to make a case for GC. The association of moderate or severe hypoglycaemia with increased mortality similarly indicates that improved control must be achieved safely, despite high inter- and intra- patient variability. The association of high times in intermediate bands with reduced mortality would indicate... Read more > | Online | PDF

Looking at POCT Through a New “Value” Lens
By Kim Futrell, June 22, 2017, Medical Laboratory Observer

Advances in technology, combined with the value focus of today’s healthcare system, are changing the how, when, and where of laboratory testing. As part of this shift, these trends are increasing the demand for point-of-care testing (POCT) and broadening the impact that POCT can make in improved patient outcomes and cost savings. Improvements in patient satisfaction also can be realized when laboratory results are made available in real time at the patients’ point of care. In order to utilize POCT to its fullest, however, we have to learn to look at POCT with a different perspective than in the past—through a new “value” lens. We have to carefully determine when and where POCT can have the most benefit and implement IT solutions that ease the complexity of POCT integration and oversight so that the benefits are not overshadowed by the burden of management and integration.

Read more >

Bringing POCT to the Community 
American Pharmacists Association
The expansion of POCT services to pharmacies increases patient access, but barriers exist. According to CDC, 8 million people have undiagnosed diabetes, 240,000 people have undiagnosed HIV, and 800,000 people have undiagnosed hepatitis C in the United States.1 POCT—medical diagnostic testing performed in close proximity to the patient and outside traditional, clinical laboratory settings—can identify all three of these diseases. The testing can be provided at primary care clinics, community pharmacies, paramedical vehicles, rural and remote areas, and during times of natural disasters or emergencies. POCT offers many advantages toward improving the quality of, access to, and cost effectiveness of patient care. For example... Read more >
HbA1c Test May Improve Diabetes Detection
By Miriam E Tucker, Medscape

HbA1c may be the most effective method to identify patients with undiagnosed prediabetes and diabetes, and point-of-care testing further enhances that screening ability in primary-care settings, new research suggests. The findings were published recently in the Annals of Family Medicine by Heather P Whitley, PharmD, of Auburn University Harrison School of Pharmacy, Montgomery, Alabama, and colleagues. "First, diabetes and prediabetes need to be on our radar as possible diagnoses. In the United States, where we have such a heavy prevalence of diabetes, we need to be thoughtful and aggressive in screening," Dr Whitley told Medscape Medical News. And, for screening purposes, the data suggest that HbA1c... Read more >

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From Micro-hospitals to Mobile ERs...
New Models of Healthcare Create Challenges and Opportunities for Pathologists and Medical Laboratories

Dark Daily

New low-cost alternatives to emergency department and hospital visits could require flexibility from pathology groups and clinical laboratories to provide the best quality care In response to the rising cost of conventional hospital services, innovative healthcare models such as micro-hospitals, bedless hospitals, and mobile and freestanding emergency rooms (ERs), are attempting to lower costs while maintaining quality of care by providing alternatives to traditional ER visits and hospital stays. This means new challenges and opportunities for pathology groups and medical laboratories that can adapt to the different needs of these new healthcare delivery models. Each different care model will want clinical lab testing services and the reporting of lab test results to be handled in ways that enable these providers to achieve improved patient outcomes.  Read more >
Molecular-Based Point-of-Care Laboratory Testing Will Revolutionize Healthcare, But Practical Considerations Exist
Contagion Live - Infectious Diseases Today, William Todd Penberthy, PhD 

The American Academy of Microbiology had a point-of-care colloquium in October 2016 that brought together clinical laboratory microbiologists, physicians, investors, global health experts, patient collection experts, government agencies, foundations, and commercial industry to discuss how to enact modern molecular diagnostic protocols most effectively for point-of-care (POC) testing settings.
Contagion® sat down with the chair of the colloquium and a commentary-author with vast experience in POC clinical trials; Melissa B. Miller, PhD, Professor and Director of the Clinical Molecular Microbiology Laboratory, University of North Carolina School of Medicine, Chapel Hill and Robin Patel, MD, ASM Microbe 2017 Co-Chair, Director, Infectious Diseases Research Laboratory, Mayo Clinic.
Dr. Miller emphasized that one of the issues at the POC colloquium was about changing paradigms. Read more >

In Flu Season Management, POC Molecular to the Fore
Cap Today, May 2017, By Anne Paxton

May 2017—Stacked against some of the nation’s previous bouts with influenza—such as the 2014–15 season—the 2016–17 flu season didn’t break records for drama. To be sure, every flu season is different, and regional variation was prominent. In Central Texas, some outbreaks appeared to start later than usual, but the dominant viruses were the same as last year’s—H1N1, H3N2, and influenza B—says Bob Fader, PhD, chief of the virology and microbiology laboratory at Baylor Scott & White Health, Temple, Tex. The strains identified were a good match with this year’s trivalent and quadrivalent vaccine. Testing volume was up, as were positive PCRs.

From her vantage point in the northeast, “I’d say this season was about average,” says Donna M. Wolk, MHA, PhD, D(ABMM), system director of clinical and molecular microbiology for Geisinger Health System, Danville, Pa. Read more >

POCT HbA1c Boosts Screening, Identification of Prediabetes, Diabetes

May 2017, Clinical Laboratory News

A comparison of point-of-care (POCT) HbA1c testing versus standard diabetes screening tests in family medicine clinic patients found that POCT HbA1c identified significantly more patients with previously undiagnosed hyperglycemia and prediabetes (Ann Fam Med 2017;15:162–4). The authors also determined that systematically screening patients via POCT HbA1c “greatly increases the chances for a screen to occur.” Read more >

Point-of-Care or Clinical Lab INR for Anticoagulation Monitoring: Which to Believe?
By Stacy A. Johnson, MD, Clinical Laboratory News, April 2017

68-year-old female with a history of hypertension, diabetes mellitus, stroke, and atrial fibrillation presents for routine follow-up at your hospital’s anticoagulation clinic. The clinical pharmacist checks her international normalized ratio (INR) with a point-of-care (POC) device to monitor her anticoagulant therapy (warfarin).  The POC INR result is elevated to 4.0, which is above the recommended INR goal range of 2.0–3.0 based on her clinical indication of atrial fibrillation. The pharmacist enters the POC INR result into the patient’s electronic medical record and discovers she had an INR obtained earlier that same day, along with a basic metabolic panel and complete blood count ordered by her primary care physician. The clinical lab (CL) INR result was 2.9, and obtained just 90 minutes earlier. All other test results were normal. The patient says...... Read more >

Bedside Blood Glucose Testing in Critically Ill Patients
By T. Scott Isbell, MLO, April 2017

This month's issue of MLO has a really good, continuing education, article on how studies have demonstrated that the practice of hospital bedside blood glucose testing is a necessary and effective means of managing and monitoring glycemic control. Protocols vary by institution, but there is general consensus among providers that this process is an essential component of patient care. However, the use of handheld blood glucose meters within some critically ill patient populations has resulted in varying degrees of confusion about off-label use and potential discrepancies in results.


  1. Define what constitutes a critically ill patient population and discuss the use of handheld blood glucose monitors in critically ill populations.

  2. Discuss agencies that regulate off-label device use and identify the guidelines that laboratories must adhere to, in order to be compliant with off-label device use.

  3. Recognize the characteristics of diabetes statistics as the relate to healthcare and morbidity.

  4. List testing methods for diagnosing and monitoring diabetes and define the limitations with each method.

Read more >


For more on diabetes/glucose testing, check out the April MLO Digital Edition.

Management of Inpatient Hyperglycemia and Diabetes in Older Adults

Diabetes Care 2017;40:509–517 | DOI: 10.2337/dc16-0989


Adults aged 65 years and older are the fastest growing segment of the U.S. population, and their number is expected to double to 89 million between 2010 and 2050. The prevalence of diabetes in hospitalized adults aged 65–75 years and over 80 years of age has been estimated to be 20% and 40%, respectively. Similar to general populations, the presence of hyperglycemia and diabetes in elderly patients is associated with increased risk of hospital complications, longer length of stay, and increased mortality compared with subjects with normoglycemia. Clinical guidelines recommend target blood glucose between 140 and 180 mg/dL (7.8 and 10 mmol/L) for most patients in the intensive care unit (ICU). A similar blood glucose target is recommended for patients in non- ICU settings; however... Read more

HbA1c in CVD Treatment: Farewell to One Size Fits All
By Anne Paxton, CAP Today, March 2017

Anchor. Central pillar. Cornerstone. It would be hard to find a weighty synonym for “linchpin” that hasn’t been used to describe HbA1c’s role in diabetes diagnosis and management since 2010, when the assay was recognized by key standard-setting organizations as the equal of fasting glucose and oral glucose tolerance testing in diabetes and prediabetes testing. But recognition of the complex nature of the relationship between HbA1c and diabetes-related complications has influenced and modified HbA1c’s clinical use as the test evolves. A new review article by experts in the field outlines how use of the HbA1c test in cardiovascular disease treatment and prevention is trending toward a more patient-centered approach as the assay’s intricacies are explored. Read more >

Diabetes Decision Time: Proficiency testing hurdle slows use of POC HbA1c tests
By: Deborah Levenson, March 2017, Clinical Laboratory News

More than 29 million Americans—about 9% of the U.S. population—have diabetes, according to the American Diabetes Association (ADA). Racial and ethnic minority groups have higher rates of the disease, which, when not managed effectively, leads to debilitating complications like cardiovascular disease, kidney disease, stroke, and blindness. As it is, however, some patients are well down the road to developing these sequelae before being diagnosed formally with diabetes. Since point-of-care (POC) tests that measure HbA1c are well-established tools for monitoring and managing long-term glycemic control, some healthcare professionals believe using them for diagnosis would catch individuals earlier in the diabetes disease process, enabling timelier treatments and better outcomes. More >

Advances in POCT technologies outpace regulatory and accreditation requirements
Jeffrey A. DuBois, MLO, February 2017

Long after their deaths, two famous scientists continue to challenge us with their words. “Knowing is not enough; we must apply. Being willing is not enough; we must do,” said Leonardo da Vinci, Italian artist, scientist, and inventor. “The true sign of intelligence is not knowledge but imagination,” spoke German-born theoretical physicist Albert Einstein. Their pioneering work has influenced all areas of science and, perhaps, even science fiction. The imaginary tricorder in the Star Trek series may represent the ultimate goal of integrated point-of-care diagnostics, but it remains a fictional object. However, the Internet of individual care (and with it, the creation of high volumes of clinical data), where sensors, tests, and wearable devices have moved out of the laboratory and clinic directly into our lives for self-management and remote monitoring, has already begun and presents significant challenges to providers, regulators, and accreditation agencies alike. More >


IQCP: The Critical First-Year Findings
By Irwin Rothenberg, MBA, MS, MLS(ASCP), Advance for Administrators of the Lab, February 2017

A year ago, laboratory journals, professional meetings and in-house planning were all about the pending deadline for implementation of the new CMS quality control option, the Individualized Quality Control Plan (IQCP), which was replacing the Equivalent Quality Control (EQC) testing already in place. With the January 1, 2017 implementation date rapidly approaching, many laboratorians had already begun performing their risk assessments, and making revisions to their existing QC Plans (as needed). Laboratory quality assessment schedules were revised to include QAs for the new IQCPs. Whether or not IQCP is judged effective at actually improving the quality of the testing performed depends on how well the implementation process is carried out, along with the subsequent quality assessments performed. More >

How did your lab do with POCT?
Patrick Murray, MLO, February 2017

The end of flu season is in view
At this point in the year, most healthcare providers are seeing a steady wave of patients with flu-like symptoms. They may be struggling to pinpoint underlying causes and identify the appropriate treatment in a timely manner. Flu and respiratory syncytial virus (RSV) have overlapping peak infection seasons, making it difficult to distinguish the two clinically. Group A streptococcus is also common now. We’ve likely seen the peak of flu season, and RSV may be starting its wind-down as well, so this is a good time to begin reflecting on how point-of-care testing (POCT) in your institution affected performance in managing winter respiratory tract infections. Upon reflection, how might your POCT strategy be improved for the next flu season? Here are some considerations for lab managers, which may help with planning for 2017-2018.

Effect on overuse of antibiotics
An incorrect diagnosis or inaccurate test result may point providers to the wrong treatment, exacerbating the overuse of antibiotics. More than 25 percent of antibiotics are prescribed for conditions that don’t warrant them.3 Out of 97 million annual office visits among adults in the United States between 2007 and 2009 that resulted in an antibiotic prescription, 41 percent were for a respiratory condition, the most common out of seven categories. More >

Accriva Diagnostics Acquired by Werfen and Instrumentation Laboratory

Accriva Diagnostics, a Warburg Pincus portfolio company, announced today the definitive agreement with Werfen, a privately held medical diagnostics firm headquartered in Barcelona, Spain, and its subsidiary Instrumentation Laboratory (IL) headquartered in Bedford, MA, whereby Werfen and IL have acquired all shares of Accriva. The transaction was successfully closed on January 19, 2017. The Accriva portfolio, including globally recognized point-of-care (POC) diagnostic products for coagulation and anti-platelet therapy response, will allow IL to establish a market-leading position in hospital-based POC Hemostasis testing, expand its position in POC Critical Care testing and complement its leadership in the Hemostasis Laboratory segment.


Accriva Website  |  Accriva Press Release  |  Werfen/IL Press Release

Is improving access for patients equaling loss of critical quality oversight?
Advance for Adminstrators of the Lab, At the Bedside, By Peter Koerte on January 2017

Diagnostic testing traditionally performed in healthcare settings such as hospitals and reference laboratories is increasingly expanding beyond the brick-and-mortar boundaries of which we’ve grown accustomed. Today, point-of-care testing (POCT), or testing conducted outside the laboratory, is quickly evolving to help expedite patient care and clinical decision-making. There are key benefits to the point-of-care testing approach. The first pertains to response time and its effect on patient care. Critical Stat tests can be processed more quickly, expediting patient care for emergency situations such as suspected venous thromboembolism. More >

FDA Releases Two Final Guidance Documents on Blood Glucose Monitors
Clinical Laboratory News, December 2016

The Food and Drug Administration (FDA) has released the final versions of two guidance documents, “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” and “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.” These documents describe the studies and criteria that manufacturers should submit when seeking clearance for blood glucose monitors designed for use by healthcare professionals and patients at home, respectively. More > The complete versions of both guidance documents are available at

Point-of-Care Testing: The Great Boom Ahead
Kim Futrell, MT (ASCP), Products Marketing Manager, Orchard Software Corporation | Cap Today Online

White Paper features POC testing management and integration

A new white paper from Orchard Software titled “Point-of-care Testing: The Great Boom Ahead” discusses the history of POC testing connectivity and shares specific case study savings and improvements associated with the adoption of a POC testing connectivity and management solution. 

The value-focused environment of today’s healthcare is increasing the demand for POCT; and not just POCT, but rapid, accurate, and integrated POCT results. Improvements in patient outcomes and satisfaction can be realized when laboratory results are made available in real-time at the patients’ point-of-care. Yet, POCT tends to be siloed and often is not managed by the lab. To meet the evolving needs of healthcare, laboratories need to actively manage POCT. To do so effectively... More > 


Laboratory Management of POCT
Thorough evaluation and stewardship by the laboratory are necessary before and during implementation.


Thorough evaluation and stewardship by the laboratory are necessary before and during implementation. The demand for point-of-care testing (POCT) is increasing in response to the value-shift in healthcare and advancements in technology. A number of factors are converging to promote the value of POCT (e.g., increases in infectious diseases; increases in lifestyle diseases, such as cardiac diseases and diabetes; increased patient desire to use home-based POC devices; and technological advancements creating faster and easier-to-use devices). More >


CAP to Discontinue WBG WG2 Surveys


The College of American Pathologists’ (CAP) Laboratory Accreditation Program (LAP) will no longer require enrollment and participation in proficiency testing (PT) for waived whole blood glucose on glucose meters (ie, WB2/WBG) and waived whole blood Protime/INR (ie, WP10) beginning with the 2017 PT program year. Laboratories will be required to perform alternative performance assessment for these analytes. To read the letter from CAP, click here. If you have questions regarding this change, please contact a PT Compliance representative at 1-800-323-4040 ext. 6052 or 1-847-832-7000 ext. 6052. To learn more about CAP Quality Crosscheck products, please visit the CAP online store (please note, the whole blood glucose Quality Cross Check product will not be available until the 2017 ordering information is posted) or contact CAP Customer Service at 1-800-323-4040 (Option 1).


Addressing Antibiotic Resistance with Molecular Diagnostics
New methods promise faster and more accurate detection of MDROs

By Elena V. Grigorenko, PhD, and Donald R. Stalons, PhD, D(ABMM), MPH, CLP, October 2016

Antibiotics are marvels of modern medicine that have helped healthcare professionals fight infections caused by bacteria for the past 70 years. However, there is concern for the current use and future benefits of antibiotics. According to the World Health Organization (WHO), widespread inappropriate use of antibiotics has created global resistance that may soon drive every nation into a post-antibiotic era. More >


Rapid point-of-care assays for influenza testing
By: Norman Moore, October 2016, MLO

The estimated overall vaccine effectiveness rate for the 2015-2016 flu vaccine was below 50 percent, underscoring the importance of accurate and timely diagnosis for improving patient outcomes and reducing the public health impact of this potentially deadly illness. Clinical guidelines from the U.S. Centers for Disease Control and Prevention (CDC) and other expert groups recommend initiating antiviral treatment within 48 hours of onset.1 Yet many of the influenza assays widely used today do not realize the full potential of diagnosis because they do not provide highly accurate results quickly enough for clinicians to make informed treatment decisions while the patient is still under their care. More >


CMS: Nurses Can Perform High Complexity Tests
By Glen McDaniel, Advance Newsmagazines -


The Centers for Medicare and Medicaid Services (CMS) recently published a memo that it sent to CLIA inspectors on how to interpret educational requirements. CLIA had always specified the minimum educational requirements for individuals performing laboratory tests. In recent years there has been quite a strong lobby from nursing to recognize a nursing degree as a biological science degree, having the requisite credit hours of biology, chemistry etc. Those of us with oversight for point of care testing (POCT) had also been unsure as to whether nurses could perform non-waived tests and maybe even fully manage a POCT program where non-waived tests were utilized. Now CMS has weighed in definitively by saying that, yes, a nursing degree is a science degree making nurses qualified to perform non-waived tests. A careful reading of the CLIA regulations would suggest that if that is true, then nurses may in fact be allowed to even direct laboratory testing. Read more >


Point-of-Care Hemoglobin Testing: Methods and Relevance to Combat Anemia
By: Katja Lemburg, Medical Laboratory Observer, September 2016


Anemia is a condition that causes a high degree of personal disability but, historically, has lacked adequate resourcing in many public health systems. This situation is even less understandable when you consider that the main diagnostic, hemoglobin testing, is one of the most commonly used point-of-care (POC) tests, and one of the easiest to perform.

POC hemoglobin testing is often needed in settings where the use of a benchtop laboratory hematology analyzer is not practical. It is ideal for use in settings where resources are poor, or there is a need for mobility and simplicity in field use, or where turnaround time (TAT) for the test result needs to be short, as in acute clinical situations. Read more >


Let’s Close the Knowledge Gap
CAP Today, From the President's Desk, August 2016


Most of us have heard the laboratory described as a black box where specimens are exchanged for information and diagnoses. This tells me that we work beside some highly skilled people who don’t know what we do and that the knowledge gap makes them uncomfortable enough to joke about it. This incomplete understanding of what takes place within the laboratory has meaningful consequences in multiple contexts.


I am certain you will be asked (often by someone well into the process of creating a budget) to quantify your value to the institution. Because this is virtually inevitable, we should anticipate it and formulate a succinct response. For example, one might say that we know how to ask the right questions, to work with complex systems, or to keep stuff from blowing up. Ideally, we can transition from there to the real answer: Our value lies more in how we think than in what we do. Read more >


Not fit to test: battling high hemolysis rates in the ED
By Anne Ford, CAP Today, August 2016

Poverty, unemployment, crime, dropout rates: In some categories, no community wants to be No. 1. And in some categories, no hospital wants to be No. 1 either. High on that list: hemolysis.

“Hemolysis is a big issue,” Michael Phelan, MD, said at the Executive War College meeting this spring. In fact, “it’s the leading cause of unsuitable specimens” at the Cleveland Clinic’s main campus, where Dr. Phelan is an emergency medicine physician. As he discovered at the start of a CDC-funded project to study and reduce hemolysis at his hospital between 2014 and 2015, his emergency medicine department led all other departments in hemolysis rates. Over the course of one week... Read more >


2016 AACC POCC Forum Highlight

Effective communication skills when discussing an overdue PPM competency assessment with a physician


The 2016 Point of Care Forum topic at the AACC Annual Conference in Philadelphia
was ‘Leadership Communication for the POCC: Overcoming the Barriers of Productive Communication’, presented by Rick Import of Whitehat Communications.


Among the forum highlights was a role play session 'acted' by a panel of POCCs. One of the role play dialogs that drew a lot of attention from the audience was between a POCC and physician on the subject of PPM competency. Many in attendance requested that it be made available for reference in their own settings. 


Here is that dialog. We hope it helps and want to thank Marcia Zucker, PhD for providing the segment of the dialog that POCC’s will find so valuable when discussing PPM competency with physicians.


Note: Many more POCT highlights from AACC will be available on this website and through the eNewsletter in the coming weeks.

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