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

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 AACC.org, or copy and paste this link below to take you directly there...www.aacc.org/community/divisions/... 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.

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 | https://www.advisory.com/daily-briefing/2018/05/08/hcahps-star-ratings

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

By Julie Kirkwood, APR.1.2018, Clinical Laboratory News

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. doi.org/10.2337/dc17-0607). 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

By Peggy A. Mann, MS, MT(ASCP), Clinical Laboratory News, Ask the Expert: August 2017

Peggy A. Mann, MS, MT(ASCP), delves into the challenges that point-of-care coordinators (POCCs) face when training non-laboratorians to perform POC testing, from time constraints to designing programs suited for a diverse range of healthcare staff positions. Read more >

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. The 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 >

Note: You must be a Medscape Subscriber to view this article. Subscriptions are free.

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.

LEARNING OBJECTIVES

Define what constitutes a critically ill patient population and discuss the use of handheld blood glucose monitors in critically ill populations.
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.
Recognize the characteristics of diabetes statistics as the relate to healthcare and morbidity.
List testing methods for diagnosing and monitoring diabetes and define the limitations with each method.

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 www.fda.gov

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.
By Kim Futrell, BS, MT(ASCP), 30 NOVEMBER 2016 • ADVANCE /LABORATORY • WWW.ADVANCEWEB.COM

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 - www.advanceweb.com

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

Pat Kraft from Good Samaritan Hospital, Dayton, Ohio, and Greg Cosentino from Hunterdon Medical Center, Flemington, NJ, read from one of the scripted dialogs that were performed by a panel of POCC’s to demonstrate effective communication skills.

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 PointofCare.net eNewsletter in the coming weeks.

Point-of-Care Versus Lab-Based Testing: Striking a Balance
Bench Matters: July 2016, By Kathleen David, MT(ASCP), Clinical Laboratory News

Point-of-care testing (POCT) is all the rage right now, and for good reason. These often portable, easy-to-operate devices and instruments return results quickly, enabling immediate treatment or intervention. POCT also short- circuits many steps involved in lab-based testing, obviating the need to collect a specimen, transport it to the lab, perform testing, and transmit the results back to the provider. This speed and efficiency often greatly improves both patient outcomes and patient satisfaction.

Despite its popularity, however, POCT has downsides... Read more >

AACC POC Award Winners | More

Kerstin Halverson Named 2016 POCC of the Year
The AACC CPOCT Division has announced that Kerstin Halverson of Children’s of Minnesota has been named the 2016 Point of Care Coordinator of the Year. Since 2003, Kerstin has overseen the entire POCT program for two hospitals, one ambulatory surgery center, three clinics and one ancillary testing site. Read more >

Pat Kraft Receives 2016 Outstanding Contributions to POCT Award
Patricia Kraft, M.A., MT (ASCP), Laboratory POCT/Safety/Education Coordinator at Good Samaritan Hospital in Dayton, Ohio is the recipient of the 2016 Outstanding Contributions to POCT Award. Pat graduated with a BS in Medical Technology from the University of Dayton... More>

Role of Calibration Verification/Linearity in the POCT Market
By Glenn Mitchell

If you are one of the many who have purchased an instrument for point-of-care testing (POCT), this is a very legitimate question. POCT user manuals will typically state in one form or another that the linearity of the instrument should be checked... Read more >

The Continuing Case for POCT for HbA1c
By Gavin Jones

There is an ongoing conflict between traditional clinical laboratories and the relative new kid on the block, point-of-care testing (POCT). Of course, the laboratory system will likely always be king. But... Read more >

Resolving QC failures
By W. Greg Cooper

Most medical technologists and technicians, responsible for outputting test results as quickly and reliably as possible, hate it when their smooth flow of work is abruptly interrupted by an out-of-control QC rule flag. Suddenly they are faced with delayed reports, the prospect of a complicated technical investigation, and a litany of questions they must ask themselves, such as... Read more >

CLSI Solution Packages Cover Top 10 Deficiencies in the Lab

CLSI identified the top 10 most commonly cited deficiencies by major accreditation organizations, and created solution packages to address each area. Each package is designed to provide you with the tools to prepare for accreditation inspection, improve areas of interest, or resolve any deficiencies cited on your last inspection. Packages include:

Controls: Mean and Standard Deviation
Specimen and Reagent Storage
Personnel Records, Responsibilities, and Competence
Lab Director Responsibilities
Waived and Quantitative QC

Patient and Specimen Identification
Method Validation and Verification
Method Correlation
Proficiency Testing
Adverse and Nonconforming Events

Taking Ebola Personally
Anthony Fauci, MD, recounts his recent experience and offers advice to laboratories
By Maria Stevens Hardy, IMA(ASCP), AHI(AMT), CLC(AMT), Advance for Administrators of the Lab

Ebola has not only called into question the adequacy of the medical response in West African nations, but also in the U.S. and Spain. U.S. hospital nurses went on strike for lack of training for Ebola. Many U.S. reference laboratories refused to accept samples where Ebola virus was suspected. The CDC revised and disseminated guidelines for handling suspected Ebola samples, but also confirmed that confirmatory testing was to only be conducted in their laboratories. At times, there seems to be more questions than answers to the pandemic. Learn more >

Using Glucose Meters in Intensive Care Units

By Brad Karon, MD, PhD, Clinical Laboratory News, January 2015

In the current CLN 'Ask the Expert' article, Brad Karon, MD, PhD addresses the question: How should I approach evaluating a glucose meter for use in the ICU? The answer to this question has both patient care and regulatory considerations. For patient care purposes, the choice of sample type may be as important as the choice of device: arterial whole blood offers the most accurate measurement in the ICU, while capillary sampling may lead to erroneous results in patients with poor tissue perfusion. Venous catheter sampling can lead to overestimation of glucose at higher concentrations depending on meter technology. The ideal approach to evaluating a meter is to collect nearly simultaneously whole blood glucose meter samples and plasma or serum laboratory samples.

Using the actual end users to perform bedside measurement—and the intended sample type from ICU patients—allows observation of the variables most likely to impact glucose meter accuracy, such as hematocrit effect, medication interferences, and user errors.

To complement a patient-based assessment of meter accuracy... More >

Flu View - Upcoming Season Tests & Predictions

By Ann Griswold, PhD, CAP Today

Whether exotic influenza viruses will surface this winter remains to be seen, but one thing is clear: The coming season will pack a punch in terms of promising diagnostics and forecasting models. Alere, Nanosphere, Cepheid, and Roche have new molecular tests for influenza that aim to transform the diagnostic landscape. And researchers are harnessing the power of big data to build stronger municipal- and national-level models of flu transmission that can potentially provide laboratories, hospitals, schools, and health officials with weeks of valuable prep time. Against that backdrop of innovation, the Centers for Disease Control and Prevention anticipates that the nation may see a departure from the influenza A 2009 H1N1 virus that has prevailed in recent years.

“It’s too early to tell, but just based on how homogeneous last season was with H1, it’s likely that we might have a B or an H3 season,” says Daniel B. Jernigan, MD, MPH, deputy director of the CDC’s Influenza Division in the National Center for Immunization and Respiratory Diseases. Click here for more...

Key Steps for POCT in Physician Offices
Edwina Szelag, MHM, BSMT (ASCP)

You’ve been asked to take a look at a physician’s office practice after a recent merger. Do physician office laboratories (POL) need to follow the same CLIA standards as traditional clinical laboratories and point-of-care testing programs?

Answer: All clinical laboratory testing is subject to CLIA regulations, and the type of CLIA certificate for the POL should be considered along with the test menu to be offered, devices that will be used, and staff performing testing. There are several CLIA certificates. For example, if the POL will be performing only waived testing, then a CLIA Certificate of Waiver is appropriate. If the POL will be performing wet mounts, fern tests, and other microscopy, the Certificate of Provider Performed Microscopy Procedures is needed.

For more Q & A's on this subject, click here.

FDA Clears Nova StatStrip® Glucose Monitoring System for Use in

Hospital Critical Care Units

The Nova StatStrip Meter is the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients.

September 24, 2014 - Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.

The Nova StatStrip is the first blood glucose monitoring system to receive clearance from the U.S. Food and Drug Administration (FDA) for use throughout all hospital and all professional healthcare settings, including intensive care settings.

StatStrip Glucose is now the ONLY glucose monitoring system that is FDA-cleared for the detection and management of dysglycemia throughout all professional healthcare settings including critical care. It is also CLIA*-waived. The announcement comes after an extensive, four-year project with the FDA and five prestigious university medical centers. It represents a landmark clinical breakthrough in improved patient care and safety. More...

In Lab QC, How Much Room for Improvement?
Anne Paxton, CAP Today

The debut of the CMS’ new quality control option, IQCP, has sharpened the focus on QC in the laboratory and raised hopes that risk management concepts can make QC more robust. But one of the most highly regarded quality control experts in the U.S. voices skepticism about the impact of IQCP—and indeed, about U.S. quality control standards in general. As a voluntary, customizable QC option under CLIA, IQCP or Individualized Quality Control Plan is expected to give labs greater flexibility in achieving QC compliance. However, the CLIA QC standards, unchanged since 2003, will remain the same—and that’s a problem, says James Westgard, PhD, who spoke about QC weaknesses at the 2013 Lab Quality Confab presented by The Dark Report.

To read an interview with James Westgard, PhD, click here...

The FDA Is Not Giving Up on Regulating Laboratory-Developed Tests
Agency Plans a Decade-Long Road to Implementation
By Bill Malone, Clinical Laboratory News, November 2014, An AACC Publication

After the Food and Drug Administration (FDA) announced in 2010 its intention to regulate laboratory-developed tests (LDTs), lab advocacy groups, biotech companies, and even Congress pushed back so hard that by 2013, FDA leaders described their efforts as mired in politics and, at best, uncertain. Now, with a surprise announcement in July that FDA will proceed with plans to regulate LDTs followed by a draft guidance published October 3, a newly confident and determined FDA has hit the ground running.

According to FDA, its plan will give labs plenty of time to accommodate stepped-up oversight. During a September 10 AACC webinar, FDA Director of In Vitro Diagnostics Alberto Gutierrez, PhD, laid out a 9-year timeframe to implement LDT regulation. But the clock doesn’t even start on that timeline until after FDA issues a final guidance, a process that could take years. Based on FDA’s history with LDTs, the one thing certain is that the initial plan will not look exactly like the final plan—and it will probably take even longer to implement than the agency would like. Click here for more...

Treating Patients with Ebola Virus Infection in the U.S.: Lessons Learned
IDWeek, October 2014, Bruce Ribner, MD, MPH, Emory Univ. Hosp., Atlanta, GA

At the recently held IDWeek, Dr. Bruce Ribner spoke on caring for Ebola patients in the US. Dr. Ribner led the team at Emory University that cared for two patients with Ebola virus disease (EVD) in August. In light of the recent Ebola cases in Dallas and Spain he agreed that a summary could be provided to assist ID specialists in their ongoing preparedness efforts.

Planning for the care of patients This involves the entire institution, and needs many sections to coordinate their work. EMS services were an important coordination point for the transport of the 2 patients to Emory. On the medical staff, many types of expertise were needed for clinical management: ID, critical care, anesthesiology and several other subspecialties. Nursing, environmental management, facilities, security and media relations were all intensively involved ahead of time so that expected roles were defined. Even so, there were times when questions arose after the patients arrived.

For a summary of this talk, click here. For basic information about Ebola, click here or on the image to the right. For more details on Ebola click here to visit the CDC website or many of the other healthcare sites with articles on the Ebola situation.

Optimizing Point-of-Care PT/INR Testing
Marcia L. Zucker, PhD, Clinical Laboratory News, September, 2014

Coagulation testing, especially the global coagulation test prothrombin time (PT), is not exactly an ideal laboratory test. I say this because PT does not evaluate a well-defined analyte with results reflected as a concentration of that analyte. Rather, PT assesses the interaction of more than a dozen different enzymes within a blood sample, and a PT test result reflects a clotting time measured at a different end point for each instrument used.

In addition, the reagent for the PT test, thromboplastin, is not standardized. The original thromboplastin reagents were crude preparations from multiple tissue types from several different species. Today, thromboplastins may consist of recombinant rabbit or human brain protein complexed with phospholipids. There is limited standardization, achieved through use of the international normalized ratio (INR), for patients on long-term oral anticoagulant therapy with vitamin K antagonists such as warfarin and coumarin. More >

Quality Practices & POCT
Defining quality in POCT is offering more than just quick results
By Charles K. Cooper, MD, September 4, 2014, Advance for Administrators of the Lab, Issue 9

Point-Of-Care Testing
The world of laboratory medicine has changed considerably in the last decade. Specifically, the need for hospitals to improve capacity utilization and efficiency as more patients seek care has propelled clinical laboratories into a bold new journey in point-of-care testing (POCT). As new efforts bring advanced testing to point-of-care (POC) locations, there must also be new criteria for evaluating POC tests. To effectively meet the goal of POCT-which is to offer high-quality testing at primary care locations to streamline patient management-POC diagnostics need to meet quality standards across a broader range of categories. Beyond providing accurate and fast results, the quality of these tests must be equally determined by evaluating their scalability, ease-of-use, cost structure, and effectiveness in improving healthcare system efficiency. POCT Success Factors more >

Risk Management Steps Up Labs’ QC Game Under IQCP
By Anne Paxton, CAP Today, September 2014

Industrial risk management. It may not seem all that sexy as a concept, but in the field of laboratory quality control, risk management has become about as buzzworthy as is possible. One of the key reasons: The Centers for Medicare and Medicaid Services has embraced risk management as the foundation of a new option for meeting CLIA quality control standards called IQCP, or Individualized Quality Control Plan.

A voluntary QC option under CLIA, IQCP aims to give labs greater flexibility in achieving QC compliance by customizing lab QC plans to each unique testing environment via the use of risk-management strategies. Employing electronic/integrated controls, IQCP intends to adapt to future technological advances and strengthen manufacturer-laboratory partnerships.

“Many assays appear to be okay when we run our QC,” says Alison Woodworth, PhD, director of esoteric chemistry, associate director of clinical chemistry, and assistant professor in the Department of Pathology, Microbiology, and Immunology at Vanderbilt University Medical Center. “But when we do more in-depth risk analyses, they may not be okay.” With IQCP, “labs will have a choice now. They can use a one-size-fits-all approach of running two levels of external QC material once a day, the bare minimum under CLIA requirements, or they can do a risk-assessment evaluation to better determine how their assays are performing and how much QC they should run.”

Read more >

Managing Risk: Preventing Errors at the POC
July 2014, by Sarah Njoroge, PhD and James H. Nichols, PhD, DABCC, FACB, Clinical Laboratory News

Although point-of-care testing (POCT) provides rapid test results and the opportunity for faster medical decisions, the unique risk of errors with POCT raises concern over the quality and reliability of test results. In contrast to the central laboratory, where errors predominately occur in the pre- and post-analytic phases, POCT errors occur primarily in the analytic phase of testing. This might be related to the non-laboratory staff involved in POCT, but might also be due to test limitations and misuse of POCT in extreme environmental conditions. Clinical personnel with minimal laboratory skills and experience, such as nurses and patient care technicians, perform the majority of POCT. These operators are focused on patient care and do not necessarily understand why they must handle POCT—a task viewed as a laboratory role and not a job for clinical staff.Yet regulatory standards hold the laboratory director responsible for managing and supervising POCT quality. In a clinic setting, the laboratory director may be a physician, but in a hospital or health system, the chief of pathology and head of the central laboratory often become responsible. POCT is thus at odds with both the clinical staff performing the test as well as the laboratory staff responsible for supervising the test. This conflict creates a situation ripe for errors. More >

A POC Glucose Program Turned Upside Down:
How a 17-hospital system survived a rollout and new requirements
Anne Ford, CAP Today, July 2014

When Rosemary Frederick learned last year that her employer, North Shore-LIJ Health System of New York state, would be switching from the Roche Accu-Chek Inform I point-of-care glucose meter to the Inform II due to a maltose interference issue, she knew she and her colleagues were facing a heck of a lot of work. “I want you to realize the enormousness of this project,” says Frederick, who is the point-of-care manager for the health system’s core laboratories. “It wasn’t one hospital and 1,500 people. We had to roll out over 1,000 meters, and we had to train over 13,000 people system-wide.”

Click here

FDA Moves on Blood Glucose Meters
Manufacturers, Labs Wary of Big Changes
By Bill Malone, May 2014 Clinical Laboratory News: Volume 40, Number 5

Few laboratory instruments are as ubiquitous as the humble blood glucose meter. Yet in recent years, they have become essential not only for managing patients with diabetes, but also for improving outcomes for other groups of patients at the point-of-care. Studies connecting hyperglycemia with poor outcomes have led many hospitals to rely on the convenience of these meters for managing care across a spectrum of hospitalized patients.

Regulators, however, including the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), have become increasingly concerned about this practice because none of the meters on the market are FDA-cleared for use in critically ill patients, such as in the emergency department or intensive care unit. In fact, manufacturers submit meters intended for hospital use as over-the-counter devices, which means that FDA clears them based on the same standard as the home-use meters found in drug stores. More >

AACC Supports FDA Effort

to Improve Blood Glucose Meters

But Believes the New Standards Could Encumber the Use of These Monitors Without Benefiting Patients

In January, the U.S. Food and Drug Administration (FDA) released draft guidance proposing separate performance and accuracy criteria for over-the-counter blood glucose meters used in the home and prescription blood glucose meters used in hospitals. AACC supports FDA's initiative to improve the quality of these devices and enhance patient care, but recommends revising this draft guidance to ensure that it does not unnecessarily increase the regulatory burden and costs on the healthcare system.

Blood glucose meters are best known in their over-the-counter form for helping many of the 19 million Americans with diabetes to manage their condition. These devices have also become essential for managing care for other groups of patients in hospitals in recent years, as studies have uncovered a connection between high blood sugar and poor outcomes. FDA has become increasingly concerned about this practice, however, because blood glucose meters aren't cleared for use in critically ill patients, who may present with physiological variables that could interfere with the accuracy of these devices. More >

Quality Control in POCT

By Sarah Kee, MAY 2014 ADVANCE/ LABORATORY

The variety of point-of-care tests (POCT) has evolved significantly in recent years. Whilst these instruments bring undisputed benefits in obtaining rapid results at the patient’s bedside, these benefits are only true if the results are accurate and reliable. Quality controls (QC) exists to ensure accuracy and reliability. For many of the healthcare workers using POCT instruments, QC will be unfamiliar territory. More >

How POC Testing is Pushing the Envelope

From New Tests to Glucose Meters and the FDA

CAP Today, April 2014, By Anne Paxton

It can be hard to remember a time when GPS was not available in cars, the Web didn’t exist, and only eight diagnostic tests were classified as waived and able to be performed at the point of care. But after CLIA’s enactment in 1988, those were some basic realities of location and speed.

Today, whether for blood gas and electrolytes, glucose, coagulation, cardiac markers, drugs of abuse, food pathogens, hemoglobin, or infectious diseases, hundreds of tests once considered too complex for point of care are routinely performed outside the laboratory. But some of the nation’s experts in point-of-care testing say that developments on the near horizon could make previous advances in POC testing look tame. More

Glucose vs. Hemoglobin A1c
Usefulness, limitations and complementary markers are explored
By David Plaut and Audrey Farrell; APRIL 2014 • ADVANCE/LABORATORY • WWW.ADVANCEWEB.COM

There is no argument that measurements of hemoglobin A1c (A1c) and glucose (G) each play important roles in the diagnosis and treatment of diabetics. As useful as these two markers are, we must accept the fact that neither is a perfect marker. Understanding the limitations of these markers will aid clinicians in better use of them and assist them when choosing complementary markers when A1c and/or G are not satisfactory or sufficient. A1c Value
More > PDF I Online

Point-of-Care Testing - Pros, cons and how the lab can benefit
By Jonathon Northover, JD; APRIL 2014 • ADVANCE/LABORATORY • WWW.ADVANCEWEB.COM

The point-of-care testing (POCT) market (perhaps more accurately referred to as the point of testing), is an established growth area. Predictions regarding the growth rate vary but the general consensus is that in the United States, we have already entered a significant growth phase. While it is a relatively new market, we are arguably two-thirds of the way through the typical 30 year period that it takes for a new healthcare technology to become fully established.

A Growing Market Between 2003 and 2009 it is said to have doubled in size. In 2012, one study suggested that it will be worth $16.5 billion worldwide in 2013, about $3.93 billion of which will be in the United States. Of these values, glucose testing is by far the largest component. There are multiple underlying drivers of this growth. For example, the technology (the devices as well as the reagents) is becoming less expensive to create and deploy, and therefore more widely used. Another driver is the need for increased efficiency. POCT usually decreases turnaround times, with immediate results. Faster results mean faster treatment. No additives are needed, and a sample will often only require a finger stick. In the current healthcare environment where cost pressures to do more with less continue, this is no small advantage. Pros of POCT... More > PDF I Online

Diabetes Debate: HbA1c or Glucose?
By Anne Paxton, CAP Today, February 2013

If it were a boxing match, the debate over whether hemoglobin A1 c should be used to diagnose diabetes would place the odds-on favorite in the “Yes” corner. In the “No” corner would be the underdog. At least based on the mainstream consensus since 2010, HbA1c for diagnosis is well established as an alternative to measuring glucose. At the July 2013 meeting of the American Association for Clinical Chemistry, where opposing sides on this question squared off in a debate, a quick vote beforehand showed “Yes” with a 20-to-one edge. But the speakers came armed with provocative data on comparative benefits and drawbacks, and both sides scored solid points. More >

Dropping the ball on critical value POC glucose results?
By Anne Paxton, CAP Today, December 2013

Prompt reporting of critical laboratory results is considered an important patient safety goal. But for one of the most commonly performed tests, point-of-care glucose, there has been limited information about how critical results are handled. A new CAP Q-Probes study finds there is a great deal of variability. In addition to having widely differing critical result cutoff values, many laboratories are not repeating critical POC glucose test results for verification despite the relative high rate of erroneous results on first measurement. More >

POCT Supports New Demands

By Kim Futrell, MT(ASCP), ADVANCE for Administrators of the Laboratory, RESOURCE DIRECTORY 2014 & ANNUAL REPORTS

Changes in healthcare open door for point-of-care testing to improve outcomes

One of the fastest areas of growth is point-of-care (POC) testing, estimated to be increasing at 10-12% annually, compared to a 6-7% annual increase in other clinical lab testing. Although home-based point-of-care testing (POCT) is also increasing, 70% of POCT takes place in hospitals, doctors’ offices and other provider locations, and this growth is predicted to continue. More >

The Biggest Mistake Doctors Make

Misdiagnoses are harmful and costly. But they're often preventable.

By Laura Landro, assistant managing editor for The Wall Street Journal

Not only are diagnostic problems more common than other medical mistakes—and more likely to harm patients—but they're also the leading cause of malpractice claims, accounting for 35% of nearly $39 billion in payouts in the U.S. from 1986 to 2010, measured in 2011 dollars, according to Johns Hopkins. The good news is that diagnostic errors are more likely to be preventable than other medical mistakes. And now health-care providers are turning to a number of innovative strategies to fix the complex web of errors, biases and oversights that stymie the quest for the right diagnosis. More >

An Uneasy Dance with POC Glucose in the ICU

By Anne Paxton, CAP Today, October 2013

“Too much of a good thing can be wonderful,” Mae West famously said. And some feel our culture of excess reflects that value. Perhaps as a reaction there has been a surge of interest recently in the embrace of “enough” as a worthwhile goal. But when it comes to precise measurement of glucose values in the intensive care unit, the often-warring needs for speed and accuracy make the issue a critical matter of patient care. For point-of-care glucose testing in the ICU, how much precision is “enough”? more...

POCT & Patient Safety - Solutions to point-of-care safety concerns are explored
By Anna K. Füzéry, PhD, and William A. Clarke, PhD, MBA, DABCC Advance for Administrators of the Lab, Vol. 22 • Issue 7 • Page 36

POCT - Quality laboratory testing is an essential part of modern medicine. Historically, such testing has been performed in a central location by highly trained medical technologists. Rapid advances in analytical and computer technology, however, have shifted a significant amount of it to the patient bedside or other non-laboratory sites. While point-of-care testing (POCT) offers some key advantages in patient management, it is also giving rise to notable safety concerns related to infection transmission, patient identification and specimen integrity.

Hospital-Acquired Infections - Healthcare-associated infections (HAIs) are a major safety concern due to their adverse effects on patients, their families and the health system. Estimates suggest that approximately 1.7 million HAIs occur annually in the United States alone.1 Multiple studies indicate that hospital surfaces, including POCT devices, may act as vehicles for the transmission of pathological agents such as methicillin-resistant Staphylococcus aureus and HIV.2,3 In August 2010 the FDA and CDC issued a joint recommendation that point-of-care blood testing devices should not be shared and that, if this is not possible, they should be cleaned and disinfected after every use. More >

Lessons From America's Safest Hospitals
More than 180,000 people die every year from hospital errors. Here's what the top medical centers are doing to improve your odds

by Beth Howard, AARP The Magazine, April/May issue

About 400,000 drug-related injuries occur each year in hospitals, according to an Institute of Medicine study. To help solve the problem, many of the safest hospitals have embraced the use of a computerized provider order entry (CPOE) system, which forces doctors to enter prescriptions into the computer electronically. "It basically eliminates transcription errors," says Anthony J. Ardire, M.D., senior vice president for quality and patient safety at Lehigh Valley Health Network in Allentown, Pennsylvania. More >>

Order More Tests? With Diabetes, May Be ‘YES’
CAP Today, March 2013, Feature Story, By Jan Bowers

In patients with diabetes mellitus, hemoglobin A1c testing frequency is largely in line with recommended guidelines. In those same patients, LDL testing is not performed frequently enough, and urine protein testing frequency falls far short of recommendations. Those are the results of a recently completed Q-Probes study of whether and how laboratories monitor the frequency of diabetes testing, and how closely the frequencies in their institutions hew to the American Diabetes Association recommended guide-lines. “It’s important to focus on both over- and underutilization, because sometimes in the lab we tend to focus only on whether we’re performing tests that may not be necessary,” says Peter L. Perrotta, MD, medical director of clinical laboratories at West Virginia University Hospital, professor of pathology at West Virginia University School of Medicine, and a coauthor of the CAP study. But there’s another side, he says: “Tests that should be ordered are not, or they’re not ordered frequently enough.” More >

Bedside Glucose Testing Systems
Cap Today, March 2013, Brendan Dabkowski

New to the CAP TODAY lineup of point-of-care blood glucose systems is the Roche Accu-Chek Inform II, which the FDA cleared last fall. It offers meter level wireless technology, conducts extensive integrity checks with each test, has an advanced laser bar-code scanner, and provides up to three unique patient identifiers. On the market since 2004, HemoCue’s Glucose 201 DM analyzer has “withstood the test of time,” says product marketing manager Terry Carmichael, who adds that the recent focus has been to develop more flexible connectivity solutions. HemoCue plans to make available options that allow clients to select how they connect HemoCue devices to their [information] system. Abbott Diabetes Care is working with hospitals to help them achieve their patient safety goals. The Precision Xceed Pro blood glucose and beta-ketone monitoring system is built on Abbott’s “three pillars of patient safety”—bedside accuracy, cross contamination prevention, and hospital compliance. Nova Biomedical’s StatStrip measures and corrects for common interferences such as hematocrit, acetaminophen, and ascorbic acid. StatStrip biosensors eliminate the need for calibration coding, and the system’s large color display presents multiple patient identifiers. Ten bedside glucose testing systems from six companies are profiled. All information is supplied by the companies. More >

Standards of Medical Care in Diabetes - 2013
The American Diabetes Association has released their Standards of Medical Care in Diabetes 2013.Diabetes mellitus is a chronic illness that requires continuing medical care and ongoing patient self-management education and support to prevent acute complications and to reduce the risk of long-term complications. Diabetes care is complex and requires multifactorial risk reduction strategies beyond glycemic control. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes. For more on the Position Statement, click here. For more on the Executive Summary, click here.

Preventing Infections Related to Using Point-of-Care Testing Devices

An Interview with Sharon M. Geaghan, MD
January 2013 Clinical Laboratory News: Volume 39, Number 1

The convenience and immediacy of point-of-care testing (POCT) has led to its use in many settings. But untrained or busy healthcare workers may overlook some basic sanitary practices when using POCT devices. This lack of attention is leading to nosocomial infections that can be attributed to contaminated devices. Here, Sharon M. Geaghan, MD, discusses how these infections occur and how to prevent them. Dr. Geaghan is professor of pathology and pediatrics at Stanford University School of Medicine in Palo Alto, Calif.
Click here for more...

Glycemic Control Data Show Improvement in Glucose Levels
Journal of Hospital Medicine, December 2012

New data show that hospitals may be making some progress in the battle to control glucose levels in non-ICU patients. Research published in the Journal of Hospital Medicine compared point-of-care blood glucose test results from 126 hospitals taken in 2007 and 2009. The values of those test results decreased by 5 mg/dL in non-ICU patients from 2007-2009, but remained unchanged for patients in the ICU. In this first analysis of glucose changes in US hospitals, improvements over 2 years occurred in non-ICU patients. Ongoing analysis will determine whether this trend continues. Read more.

Understanding Low Sugar from NICE-SUGAR
The New England Journal of Medicine, December 2012

In his editorial about the Normoglycemia in Intensive Care Evaluation–Survival Using Glucose Algorithm Regulation (NICE-SUGAR) study, Hirsch (Sept. 20 issue) declares, “For surgical patients, especially those who have undergone cardiac procedures, hospitals that can safely achieve lower targets should do so.” No justification for this statement is provided. Concerns exist regarding the generalizability of studies of glycemic control in other populations of patients treated in intensive care units (ICUs) that have shown either harm1 or no benefit and regarding both the generalizability and applicability of studies that have shown benefit. Read more.

Glucose in the ICU — Evidence, Guidelines, and Outcomes
The New England Journal of Medicine, December 2012

Agus et al. (Sept. 27 issue)1 report that targeting a blood glucose level of 80 to 110 mg per deciliter (4.4 to 6.1 mmol per liter) in critically ill infants and toddlers (<3 years of age) after cardiac surgery did not alter the clinical outcome. Although the target range for the blood glucose level was “normal” in fasting adults, it indicated
hyperglycemia in infants (normal range, 50 to 80 mg per deciliter [2.8 to 4.4 mmol per liter]). Read more.

Connecting With POCT

By Adetoun Ejilemele, MB.CHB, FWACP, FMCPath (Nig), and Anthony O. Okorodudu, PhD, MBA, DABCC, FACBB

Point-of-care testing plays a significant role in a value-based purchase system Value-based purchasing (VBP) is focused on ensuring synchrony between clinical and financial responsibilities in our healthcare systems. In the VBP, future healthcare payment is linked to quality and efficiency of the care provided. This article was part of the Advance for Administrators of the Laboratory's December 2012 issue which feature a 2013 Resource Directory. For more on this article and to view the digital edition, click here >

Article Archive

FDA clears ACCU-CHEK Inform II
Roche’s new hospital point-of-care system for blood glucose testing with improved accuracy and wireless data transfer as well as advances in patient care and durability. Roche announced on Monday, October 15, that it has received clearance from the U.S. Food and Drug Administration (FDA) for the ACCU-CHEK Inform II system, a next-generation blood glucose monitor for hospital point-of-care testing. The ACCU-CHEK Inform II system offers healthcare professionals the first truly wireless hospital blood glucose device. The system utilizes new patented technology to deliver improved accuracy and enables automatic real-time wireless transfer of patient data between hospital medical staff and the laboratory.

“Accuracy and patient safety are the foremost concerns for blood glucose testing in hospitals and other point-of-care settings,” said Roland Diggelmann, chief operating officer at Roche Diagnostics. “ACCU-CHEK systems have been proven in hospitals around the world and this next-generation wireless system sets a new standard by offering U.S. healthcare professionals new capabilities to help ensure the accuracy of test results, streamline data communications and provide optimal patient care.”

The Growth of Point-of-Care Testing in Hospitals
Cardiac Markers Fuel Growth in $5 Billion Market
Hospital point-of-care (POC) testing continues to grow steadily, with hospitals adding more instruments and rapidly increasing the volume of cardiac testing in particular, according to a new report from strategic consulting firm Enterprise Analysis Corporation (EAC). This brief analyzes data from a 2011 survey of hundreds of hospital-based point-of-care coordinators (POCC), and compares data to the company’s previous survey in 2007.

While POC glucose, blood gas, coagulation, and HbA1c tests have seen a slow, steady rise over the past 4 years, cardiac marker testing has risen sharply, according to EAC senior consultant Michelle Keane. “We were surprised to find 10 percent more hospitals performing cardiac marker testing compared to 2007, and volumes have increased significantly as well,” Keane commented. For stand-alone troponin, nearly twice as many hospitals surveyed by EAC now perform POC testing.

Two instruments continue to dominate the cardiac marker POC market, Abbott’s i-STAT system and Alere’s Triage system. The Triage has seen a 70% increase in volume for cardiac tests, and i-STAT’s volumes have tripled.

Keane also noted that POC has become more complex in hospitals, with 23% of institutions reporting use of six or more different POC instruments in 2011 compared to just 5% in 2007. Nearly 50% of hospitals EAC surveyed now have four or more instruments.

Spotlight on Point-of-Care Testing
Innovation, Expansion Evident at AACC Clinical Lab Expo in LA
By Bill Malone, Clinical Laboratory News

The current issue of CLN features a Spotlight on the 2012 AACC Meeting where more than 120 companies came to Los Angeles to showcase POC products at the AACC Clinical Lab Expo, and the buzz about POC spilled over into sessions at the AACC Annual Meeting. Speakers covered many POC topics, including the explosion of technology and where future opportunities lie. This issue also includes an interview with the 2012 POCC of the Year Pet Maniquis. In addition, hundreds of new products made their debut in Los Angeles and are highlighted in CLN's New Products Review. More >
Note: To access this issue you must be an AACC member - and now is great time to join and take advantage of all the POC related programs AACC and the Critical and Point-of-Care Testing Division have to offer.

Abbott Introduces Advanced Quality Features on its i-STAT Handheld System

Abbott has introduced five new advanced quality features on its leading i-STAT handheld blood analyzer, designed to help hospitals better manage their point-of-care testing programs and ensure compliance with changing laboratory regulations. The i-STAT Advanced Quality Features will help organizations improve compliance, oversight and control of their point-of-care program.

A Review of Tight Glycemic Control more >

Assessing Inpatient Glycemic Control: What Are the Next Steps?

Which Metric Should be Used? more >

Glucose Meter Update
Lifescan customers, follow these tips to smooth your transition to a new meter more >

Update on Inpatient Glycemic Control in Hospitals in the United States
Many quality improvement organizations have been focusing on improving the management of inpatient hyperglycemia. A recent survey of hospitals in the United States demonstrated that the frequencies of hypoglycemia and hyperglycemia were the top 2 metrics of interest to hospitals, and many hospitals have either fully or at least partially implemented inpatient diabetes quality improvement programs. Several quality improvement organizations are promoting the need for better inpatient glycemic control and have developed educational resources to help hospitals achieve better management. Finally, in certain clinical scenarios, better glucose control has been shown to improve patient outcomes. more >

The Evolving World of POCT
more >

Focus on: COAGULATION Monitoring
more >

Panel Advises Glucose Testing in All Hospitalized Patients
More >

Diabetes Cases Double to 347 Million
Rates of diabetes have nearly tripled in the U.S., and more than doubled worldwide since 1980, according to a report this week in the British journal Lancet. More than 347 million patients have diabetes globally, and nearly 25 million in the U.S.. more >

References for "Urine Drug-of-Abuse Testing in the Clinical Lab"
By Jill Hoffman, Advance for the Administrators of the Laboratory
According to a 2009 review in Bioanalysis, use of clinical urine drug tests (UDTs) to monitor patients prescribed controlled substances is a new aspect of clinical medicine that will play an increasing role as physicians treat chronic pain while trying to minimize abuse of opioid analgesics. more >

Glucose Meter Evolution
By Bob Kaplanis, Advance for the Administrators of the Laboratory, At the Bedside
It's hard to imagine what point-of-care testing (POCT) would be like if the glucose meter had never been invented and all glucose testing was performed in the main laboratory of the hospital. more >

Testing/Diagnostics: Point Taken
Clinical Lab Products - July 2011by Sarah Michaud
Overview of point-of-care testing, technological challenges, and future opportunities.
Point-of-care testing (POCT) technology provides immediate, portable, and convenient medical diagnostics near the site of patient care. POCT's near-instantaneous results allow health care providers to make treatment decisions for their patients in a shorter amount of time compared to traditional laboratory diagnostics. Faster test results translate to rapid treatment for patients—which can save lives in critical care scenarios. More >

Glucose Monitoring Technology
By Jill Hoffman, ADVANCE for Administrators of the Laboratory; June 6, 2011

Blood glucose monitoring evaluates the concentration of glucose in blood and is a critical component of diabetes mellitus care. Tests are performed by piercing the skin to draw and apply blood to a chemically active test strip. Small handheld devices-glucometers-can measure blood glucose. To get accurate readings, it is important to make sure the glucose meter is operating correctly by applying quality control (QC) material to the strip, often sold separately for home glucometers, says Frederick L. Kiechle, MD, PhD, director of Clinical Pathology, Pathology Consultants of South Broward, Memorial Healthcare System, Hollywood, FL. more >

POC Coag Technology Path: Simple to Savvy
CAP Today, May 2011, by Brendan Dabkowski

Smart businesses stick to the principle that the customer is always right. For manufacturers of point-of-care coagulation test systems, whose customers are often now individual patients, keeping that principle top of mind is imperative. Offering test systems that help ensure customers/ patients are right—that is, in obtaining accurate coagulation status—protects lives. more > I See CAP TODAY’s coagulation analyzers lineup

The Growth of POCT
By Carlos Prieto-Granada, MD, and James H. Nichols, PhD, DABCC, FACB March 2011 • advance/Laboratory

The development of newer technologies and overall improvement of POCT quality has led to an exponential growth in the POCT field. As an emerging, rapidly evolving and ever expanding specialty in laboratory medicine, point-of-care testing (POCT) has been generating a whole new set of issues since its popularization in the late 1980s. Tconcept of POCT, also known as bedside, near-patient testing and decentralized testing, relates to tests that are conducted by clinical operators at the site of patient care where immediate medical action is taken on the results. The fact that POCT represents a departure from conventional laboratory medicine has created new challenges, especially regarding standardization and regulation. These topics, including new regulatory changes, glucose meter performance criteria and increasing reliance on transcutaneous POCT methods, are addressed. more >

Preventing Medical Errors
RFID technology helps identify patient, hardware and staff locations, as well as preventable gaps in care.
By Mayank Trivedi, April 2011 • advance/Laboratory

More than 10 years after the publication of "To Err is Human," few hospitals have successfully heeded the call to cut down the number of fatal medical errors in the United States. The failure certainly is not due to lack of effort or commitment. Hospitals have published innumerable studies, protocols, and analysis to improve patient safety. But the results have too often fallen short. With increasing clinical workloads and cost pressures, many healthcare organizations have begun to investigate how technologies such as radiofrequency identification (RFID) tags, which "sense" staff and asset locations, can enhance clinical and biomedical workflow. RFID technology can track the physical location of patients, staff, equipment, as well as instruments and pharmaceuticals, helping to increase patient safety. This technology can reduce medical errors in a number of ways. More >

Accuracy above all for POC glucose analyzers - See CAP TODAY’s glucose analyzers lineup

By Brendan Dabkowski, CAP Today, March 2011

Makers of point-of-care glucose testing systems are responding to customers’ demands for devices that are nimble, responsive, and durable—but above all, accurate. “Hospitals continue to demand improved accuracy of bedside glucose monitors as they adopt protocols for better glycemic management,” says Nova Biomedical marketing specialist Rick Rollins. more >

10 years out, Connectivity Standard Still not in
CAP Today, February 201, Feature Story, by Anne Ford
By their first birthday, most babies show signs of dental development. But the point-of-care connectivity standard POCT1-A celebrates its 10th anniversary this year, and some say it has yet to start growing teeth. That is, the standard has no enforcing body, and so adoption has been left up to individual vendors, some of whom are not inclined to spend financial resources making their legacy systems compliant with POCT1A. More >

Too far, Too Fast on ICU TGC?
CAP Today, March 2011, Feature Story, by Anne Paxton
Ten years ago, a study conducted in Leuven, Belgium, took U.S. hospital intensive care units by storm. Reported in the New England Journal of Medicine, the trial, led by Greet Van den Berghe, MD, PhD, found that when adult surgical ICU patients’ blood glucose was maintained between 80 and 110 mg/dL by means of an insulin infusion, it reduced ICU mortality by 42 percent and in-hospital mortality by 34 percent (2001;345:1359–1367). Implementing an ICU protocol of tight glycemic control, the study concluded, also decreased the incidence of acute renal failure, septicemia, and critical illness polyneuropathy.

These conclusions galvanized hospital ICUs. In the wake of the study, “Intensive care units in the U.S. went from almost nobody using insulin to using it on almost every patient,” says Stanley A. Nasraway, MD, director of the surgical intensive care units at Tufts Medical Center, Boston. As one indicator of the impact on laboratory testing, Barnes Jewish Hospital in St Louis, Mo., doubled the number of glucose strips it consumes.

“In 2001, we used 250,000 strips a year and we’re at almost half a million strips a year now, just with essentially the same number of beds,” says Mitchell G. Scott, PhD, professor of pathology and immunology and co-medical director of clinical chemistry at Washington University School of Medicine.

But as tight glycemic control (TGC) became more and more the standard for adult patients across the critical care landscape in the U.S., there were ripples of concern. Efforts to duplicate the Leuven study did not all pan out. One of Dr. Van den Berghe’s own later studies in medical ICU patients showed only morbidity benefits. Then, two large-scale studies in 2008 and 2009 suggested that, in fact, very tight glycemic control may actually put patients at greater risk of death and complications from hypoglycemia. more >

Selecting Point-of-Care Devices
Direct patient care professionals are looking for rapid testing options to accelerate diagnoses and treatment plans.
By Ginger A. Baker, MS, MT(AAB), Posted: January 2011, ADVANCE for Medical Laboratory Professionals

The point-of-care (POC) test and device market has been one area with sustained growth, even in a difficult economic climate. This sector has sustained a 7.5 percent annual growth. Additionally, with the need to reach a diagnosis and treatment plan as quickly as possible, direct patient care professionals are looking for rapid POC testing options. Both factors polarize vendor focus on the POC market. The test options can seem endless at times. In this installment of "At the Bedside," a few key questions and considerations are recommended.

Meeting Electronic Records Needs Like laboratory instruments, POC devices are not all created equal. Each has enhanced options or methodologies that set it apart from the market. The real trick is knowing what information to target and what questions to ask. With the coming HITECH requirements, it is probable that all devices will need to be interfaced to the electronic health record (EHR) and the EHR must have a module to record results and quality control (QC) for manual POC testing. While most devices offer connectivity, all connectivity is not created equally. One only needs to look at bedside glucose testing to get a clear picture on the number of options available. more >

New Go-to Guide for Solving POC Conundrums
CAP Today, January 2011, Feature Story, by Karen Lusky
A patient with type 1 diabetes has a 450 mg/dL fingerstick glucose value when tested at a clinic but a 100 mg result when the central lab repeats the test on another specimen. An emergency department physician complains that the ED point-of-care pregnancy test results are suddenly all positive. The Clinical and Laboratory Standards Institute’s new consensus guideline, “Quality Management Approaches to Reducing Errors at the Point of Care,” is aimed at helping labs and health care providers parse and preempt those types of problems and many more. more >

Glycemic Control Economics in the ICU

Scurlock C, Raikhelkar J, Mechanick JI, Curr Opin Clin Nutr Metab Care. 2010 Dec 29. [Epub ahead of print]

Currently the USA has an aging population, with increasing deficits and a healthcare system that most would agree is in need of repair. Finding ways to curtail costs is urgently needed. Attention to glycemic control and metabolic care offers a cost-effective method of treatment to reduce complications. Healthcare-related expenses occupy an expanding portion of gross domestic product in the US and are a driver of the deficit. more >

Glucose Meters in the ICU
By Brad S. Karon, MD, PhD, 14 January 2011 At the bedside: poct - advance/Laboratory
The subject of glucose meter accuracy for use in monitoring critically ill patients on glycemic control protocols has received an incredible amount of attention lately. Some of the issues surrounding this controversy are summarized here. Prior to 2001, the “state of the art” in critical care was to monitor glucose levels in critically ill patients and intervene (with insulin administration) only if glucose levels exceeded 200 mg/dL. In 2001, Van den Berghe and colleagues published the first of their studies on glycemic control. more

Advances in POCT
POCT will continue to be driven by technology and the need to produce results in a timely manner
By Adetoun Ejilemele, MBBS, FMC Path, FWACP, and Anthony O. Okorodudu, PhD, MBA, DABCC, FACB
ADVANCE for Administrators of the Laboratory, Top 10 Features of 2010
The widespread use of point-of-care testing (POCT) has become feasible thanks to improvements in the ease of use of instruments and enhancements in automation. In many cases, software applications have been incorporated into the instruments to provide automated calibration and quality control. There's also been a shift away from the use of liquid reagents to solid-phase reagents and electrochemical methods. more >

POCT key to widespread access to healthcare
By Harry Glorikian, BA, MBA; Aruna Rajan; and Kerry Xie, Medical Laboratory Observer, January 2011
Decentralization of healthcare is a major trend impacting the delivery of in vitro diagnostics and is driving the need for point-of-care testing/tests (POCT). With fast turnaround times (TAT) and portability to a variety of settings, POCT offers many advantages for disease management. POCT enables migration from core hospital labs to specialty-care units, doctors’ offices, and homes to provide access to healthcare services, thus improving patient compliance, reducing hospital stays, and lowering overall healthcare costs. more >

CLSI Publishes Quality Practices in Noninstrumented POCT

The Clinical and Laboratory Standards Institute(CLSI) recently published Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline (POCT08-A). This instructional guideline delivers laboratory science concepts and activities with the goal of increasing knowledge and quality of laboratory testing for testing personnel with little or no laboratory background. “POCT08-A is designed to make the basic principles of good laboratory practice accessible to all the diverse personnel performing noninstrumented tests at the point of care. It contains discussion and examples of basic practices that support accurate testing, and an extensive set of forms and protocols to use as resources for those managing such testing,” said Sheldon Campbell, MD, PhD, FCAP, Yale University School of Medicine, and chairholder of the subcommittee that created the document. more >

Three Cs of Coagulation Testing
Avoid interferences & find an approach to specimen rejection that works for your lab
By Jill Hoffman, posted December 27, 2010, ADVANCE for Medical Laboratory Professionals
The most common coagulation tests are prothrombin (PT) and activated partial thromboplastin time (aPTT). Physicians will often order PT to determine the degree of blood anticoagulation in patients using anticoagulants or blood thinners such as Warfarin as well as to detect acquired bleeding disorders (e.g., vitamin K deficiency and liver damage). PT is more commonly reported in the International Normalized Ratio unit system. aPTT detects hereditary clotting abnormalities and monitors heparin therapy. Both tests are often ordered in conjunction. more >

More Hospitals Advertise Shorter Patient Wait Times for Emergency Departments
The Dark Report, November 29 2010
New trend pressures clinical pathology laboratories to shorten turnaround times for key lab tests Anyone who says there’s not much competition for patients has ignored the marketing battle among hospitals to attract patients to their emergency departments (EDs). In a growing number of cities, major hospitals now aggressively advertise guarantees of ever-shorter wait times in their EDs. This trend has a direct impact on clinical pathology laboratories because they must improve turnaround time (TAT) on lab test results to support faster patient care in EDs. Using the promise of faster patient access to a doctor in the ED is a fascinating phenomenon. It shows that patients do recognize the difference in service they get from hospitals in their community. more >

The International Normalized Ratio: A Tool for Monitoring Warfarin Therapy

Warfarin is a widely prescribed oral anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors in blood. Too much warfarin, however, causes bleeding and can even result in death. Therefore, dosage of the drug must be individualized for each patient. To avoid adverse events associated with warfarin such as excessive bleeding, clinicians regularly monitor patients’ anticoagulation status using prothrombin time (PT) and the international normalized ratio (INR). Individuals who are at risk for bleeding while receiving warfarin include the elderly, as well as patients with liver disease, congestive heart failure, or those on hemodialysis. Recent major surgery, malnutrition, hyperthyroidism, and many drugs, including amiodarone (an anti-arrhythmic), also increase the chances of bleeding. Furthermore, there are also important genetic factors that modulate the response to warfarin. Patients with such risk factors may benefit from more frequent monitoring, careful dose adjustment to desired INR, and shorter duration of therapy. Clinicians also commonly use PT and INR to assess patients’ hemostastic systems. more

Report Finds Drop in MRSA Infections

A new report released by the American Medical Association found that the number of invasive healthcare-related methicillin-resistant Staphylococcus aureus (MRSA) infections has decreased among patients with healthcare-associated infections that were acquired in community settings. MRSA infection rates also declined among those with hospital-onset invasive disease. more

Tight Glycemic Control:What Do We Really Know, and What Should We Expect?

Tight glycemic control has engendered large numbers of investigations, with conflicting results. The world has largely embraced intensive insulin as a practice, but applies this therapy with great variability in the manner of glucose control and measurement. This commentary reviews what we actually know with certainty from this vast sea of literature, and what we can expect looking forward. more

Exploring the Relationship between Hyperglycemia and Surgical Site Infection

Study Suggests Potential Glycemic Target
AACC Clinical Laboratory Strategies, November 2010, by Genna Rollins
Numerous studies have examined the impact of tight glycemic control in different populations of hospitalized patients, with varying results. Some have found benefits such as reduced surgical site infections (SSI), while others have reported harms like increased mortality. Now, new research examines the impact of perioperative hyperglycemia on the incidence of SSI in general and vascular surgery patients. NOTE: viewing the rest of this article requires AACC membership. more >

Strengthening POCC Support
ADVANCE for Administrators of the Laboratory, November 2010 At the Bedside, by Rebecca Taalbi, point-of-care coordinator, Wheaton Franciscan Healthcare, St. Francis Hospital, Milwaukee, WI.
Do point-of-care (POC) employees belong to nursing or to lab? Who should pay for the oversight? What is fair pay? These are typical questions from managers and technicians alike.POC coordinators (POCC) are responsible for ensuring that nursing staff perform accurate, error-free lab work but in this role do not work with patient samples. Because of this, some lab employees feel POCCs should be budgeted into nursing staff. They argue that the lab should not accrue a cost to perform oversight that offers no revenue. more >

Packing POC Dossier into New Online Tool Kit

CAP Today, August 2010, Feature Story, by Anne Ford

It’s often said that to get what you want, you have to identify what you want. And what Eileen Esposito, RN, DNP, wants is more pathologists who are willing to collaborate with colleagues on point-of-care testing. “I want someone who can sit at a table with the end users and not say, ‘You can’t have that point-of-care test,’ but ‘Let’s talk about the test you’re requesting, and let’s talk about its pros and cons,’” says Esposito, assistant executive director of ambulatory patient care services and quality, North Shore-Long Island Jewish Health System, Manhasset, NY, and a consultant to the College’s POC Testing Committee. more

Strengthening Care

By Steven Melnick, PhD, MD, Advance for Administrators of the Lab • Issue 9 • Page 16

At The Bedside Every day, clinical laboratories are faced with an expanding set of challenges in providing timely patient care. Staffing shortages, new technology and increasing demands for accountability from the healthcare industry mean that laboratory directors must routinely implement new patient testing protocols and data management techniques. Point-of-care testing (POCT) is an important component of comprehensive testing in today's laboratories. At Miami Children's Hospital, our laboratory manages, integrates and centralizes POCT information originating from the intensive care units, operating rooms, emergency department (ED), off-site centers and air and ground transport to ensure a continuum of care. more

POCT & AfterGlow Highlights from the AACC Annual Meeting

Bob Kaplanis Awarded POCC of the Year!

Congratulations to Bob Kaplanis from Banner Health in Arizona, second from left above, (with L-R Bill Noble and Brian Gunderson from MAS and Kim Gregory from Mass. General Hospital) who received the CPOCT Division’s Point of Care Coordinator of the Year award at this year’s Annual Meeting. To see photos, click here. Following the Mixer, Rebecca Paw, POC Specialist from Adventist Health in Southern Cal, right, welcomed 200+ people to AfterGlow 2010. For more photos from AfterGlow, click here,

8th Annual POCC Forum Presentations Now Available

"Records and Regulations in the Age of the EMR" drew a large audience during the Annual Meeting and the presentations are now available for viewing. Click on the title of image below for a pdf of the slides. POCT and the CLIA SURVEY, Gary Yamamoto, Centers for Medicare & Medicaid Services San Francisco Regional Office, Preparing for a New Era in Health Care Integrated Electronic Health Records System, Ginger A. Baker, MS, MT (AAB)

Accounting Practices

Build a skillful financial justification for your point of care testing program additions and changes.

August 16, 2010 | By Ginger A. Baker, MS, MT(AAB) ADVANCE for Medical Laboratory Professionals

It has been a difficult time for most. Payer mixes have changed and financial reserves are dwindling. There has never been a more critical need to understand the accounting methods of determining a test's worth and cost. Savvy point of care coordinators(POCCs) or lab managers know point of care tests (POCT) are not as financially friendly as their lab performed counterparts. More

Connectivity Pitfalls at the Point of Care
By Kim Gregory, MT(ASCP), NCA, ClS, Associate Director, POCT, Massachusetts General Hospital, Boston, POC CONNECTIVITY CONCEPTS, Advance for Administrators of the Laboratory
In the infancy of point-of-care testing (POCT) the newly deemed POCT coordinator was challenged with the task of creating compliance from chaos using a mountain of paper", and if they were lucky, a laptop containing a data management system for glucose meters fondly referred to as "SneakerNet". Read more >

Blood Glucose Meters: Is FDA Ready to Tighten Up Accuracy Standards?
By Bill Malone, Clinical Laboratory News, May 2010

After a well attended March meeting on blood glucose meters, FDA now has support from stakeholders to work toward a two-track regulatory approach that would distinguish the needs of individuals monitoring diabetes at home versus healthcare professionals maintaining tight glycemic control (TGC) protocols in clinical settings. More >

Lessons from the POCT Front
By Genna Rollins, March 2010 Clinical Laboratory News
How Can Labs Improve Implementation, Tackle Compliance Challenges?
For at least a decade, point-of-care testing (POCT) has been the darling of the medical diagnostics industry, with sustained growth in testing volume and continual technological breakthroughs. The trend shows no sign of abating, as drivers such as the need for hospitals and clinics to better manage capacity and improve care, coupled with further innovations, are making POCT ever more attractive.

Yet hospitals and health systems continue to experience challenges in implementing and sustaining POCT programs, at times leaving both laboratorians and clinicians frustrated and wary about the process. The reasons for less-than-satisfactory outcomes are as varied as the programs themselves, but experts cite many factors that can make or break a POCT application. More >

POCT Quality
By Anthony O. Okorodudu, PhD, MBA, DABCC, FACB, Advance for Administrators of the Laboratory - Print

The value of POCT is mainly dependent on reducing pre- and post-analytical errors. Click here

Urinalysis at the Point-of-Care
Advance for Administrators of the Laboratory, 0310

Listen in to pieces of an interview from the February print edition of Advance for Administrators of the Laboratory.
Maria Peluso-Lapsley, global commercial marketing manager, Urinalysis, Siemens Healthcare Diagnostics, spoke with ADVANCE for the urinalysis article featured in the February print edition. Click here to hear her talk about some of the benefits of performing urinalysis at the point of care, and learn about the CLINITEK Status family of analyzers from Siemens.

What’s New in POC Glucose Analyzers
By Brendan Dabkowski, CAP Today, February 2010, Feature Story
Sometimes, turning your attention away from the rest of the proverbial forest to care for a specific tree can prove positive. So long as you pick the right tree. For makers of bedside glucose testing systems, the right tree is accuracy. And growing it can yield such benefits as fewer errors, reduced costs, and greater patient safety. “The most significant trend within the marketplace has been for hospitals to demand improved accuracy of bedside glucose monitors as hospitals adopt protocols for better glycemic management of patients,” says Rick Rollins, marketing specialist, Nova Biomedical. Rollins adds that the FDA, American Association of Clinical Endocrinologists, and Society of Critical Care Medicine are calling for enhanced glucose meter accuracy. And as point-of-care glucose testing expands, says Peter Karkantis, general manager of hospital and government, Abbott Diabetes Care, “health care institutions must have assurance that their point-of-care glucose monitoring system provider can deliver consistent accuracy across thousands of glucose analyzers and millions of test strips.” More >

Eye the Basics, Not Baubles,for POCT
CAP Today, January 2010, Feature Story, by Anne Ford
The major gift-giving holidays may be over, but the hankering for new gadgets continues. Just ask point-of-care coordinators, some of whom continue to check their metaphorical stockings for new tests as they plead, “I’ve been a very good coordinator this year. How about, say, a POC molecular assay for respiratory infection?”

But focusing on the new—new assays, new platforms, new bells and whistles—can be detrimental to achieving excellence in your POC program, some experts say. “There’s a lot of tantalizing technology out there that looks really fun but that’s not practical or not indicated,” says Cynthia Foss Bowman, MD, medical director of clinical laboratories and director of POC testing at Long Island Jewish Medical Center, New York. “From my perspective, we should be making the bread-and-butter POC testing better. I don’t want to inhibit technical development, but I would hate to see a barrage of new tests come out without attending to the issues that we’ve got right now.” For example? Not being aware of the limitations of each type of POC test performed in your institution. Reinventing the wheel instead of taking advantage of vendor resources. Letting clinicians dictate which tests are performed at the point of care. Read more >

Glycemic Control in the Hospital: How Tight?
Nursing, November 2009, By Christine Kessler, RN, ANP, BC-ADM, MN

Consider the latest evidence as you explore the controversial issue of glycemic control in critically ill patients. PATIENTS WITH DIABETES are often our most challenging. Although diabetes isn’t usually the reason that patients are admitted to the hospital, it’s the fourth most common co-morbidity. Half of patients with type 1 and 2 diabetes will face surgery in their lifetime. During hospitalization, up to 12% of patients who don’t have a history of diabetes will develop hyperglycemia, which is defined as a fasting blood glucose over 126 mg/dL or a random glucose over 200 mg/dL. Surprisingly, these patients will have a nearly 18-fold increased risk of in-hospital mortality compared with the 3-fold risk experienced by patients known to have diabetes. Recent studies have demonstrated that better glycemic control can greatly reduce mortality, morbidity, and hospital costs.

So how tight should glycemic control in hospitalized patients be? Based on recent studies, the answer to that question remains controversial. More >

POC Glucose Testing in Critically ill Patients

Editorial article from Critical Care Medicine 2009 Vol. 37, No. 10

Visual logistics and a glycemic variability hypothesis In this (current) issue of Critical Care Medicine, the paper by Dr. Meynaar et al represents a step in the right direction. It focuses on critically ill patients, presents a systematic approach to glucose meter evaluation, and applies locally smoothed median absolute difference (LS MAD) curves to evaluate bedside testing. LS MAD curves provide compact visual representation of performance by means of “visual logistics”— readily interpretable and clinically relevant graphics that reveal accuracy simultaneously at different decision levels, which for glucose include hypoglycemia, tight glucose control (TGC), hyperglycemia, and critical limits.

LS MAD curves facilitate comprehension of performance without lengthy explanation and also show that most glucose meter systems do not provide consistent enough measurements for therapeutic decisions in the extremely high or low glucose range where Dr. Meynaar et al captured too few paired observations to arrive at a conclusion. More >

Perspectives on Cost and Outcomes for POCT
Elizabeth Lee-Lewandrowski, PhD, MPH, Kent Lewandrowski, MD, Research Core Laboratory, Massachusetts General Hospital, Clin Lab Med 29 (2009)

Rapid TAT provided by POCT main factor ultimately responsible for improvement in outcomes Point-of-care testing (POCT) is usually more expensive on a unit-cost basis than testing performed in a central laboratory. It is difficult to manage POCT and to maintain regulatory compliance, especially in large institutions... More >

Higher Standards on the Way for Glucose Meters?
By Bill Malone, Clinical Laboratory News, September 2009: Volume 35, Number 9

FDA Seeking ISO Revision to Improve Performance Requirements The FDA will consider tightening standards for strip-based blood glucose meters, echoing the concerns of many in the clinical lab field who have warned for a decade that the meters are not reliable. More >

POC Leader Spreads Winning Ways Far & Wide
CAP Today, September 2009, Feature Story, by Anne Paxton

July 2009 was not a bad month for the point-of-care testing program at Nebraska Methodist Hospital in Omaha. First, the 430-bed hospital earned recognition from the Hospital Compare program sponsored by the Centers for Medicare and Medicaid Services, which placed Methodist among the elite two percent of institutions in the nation with the lowest mortality for heart attack patients. Capping that accolade, the American Association for Clinical Chemistry tapped the hospital’s point-of-care coordinator, Brenda Franks, MT(ASCP), for its Point-of-Care Coordinator of the Year Award.

Franks would be the first to say there’s no magic method for a POC testing program to arrive at such a plane, but she has a few words of advice for other POC testing programs. Among them: Get people to focus on the data. Pin down specific ways to reduce errors. Solve problems through coordinated teamwork. And make sure that POC solutions actually address problems you are trying to fix.

Nebraska Methodist’s point-of-care program started out with a slight advantage over most. “When point-of-care glucose testing first became available 20-plus years ago, the laboratory here was privately owned, so we brought it on as a phlebotomy-based program,” Franks says. There was a benefit to that, because every POC glucose performed was put into the patient medical record via the hospital information system.

More >

Avoiding POCT Deficiencies
Advance for Administrators of the Lab, Kelly J. Graham, Vol. 18 • Issue 9

Errors easily arise in point-of-care testing programs; assess yours to maintain efficiency.

A common downside to rapidly changing, developing and improving technologies is a struggle to maintain a high level of efficiency and quality with minimal errors. Point-of-care testing (POCT) is no exception-as more facilities adopt the practice and new platforms and applications become available, common deficiencies in POCT programs may arise. But in the quality-centric healthcare industry, methods for eliminating problems are rarely far behind the identification of a concern. Assess your own POCT program for the deficiencies below and ascertain which improvement measures might work for your facility.

Identifying Common Issues

Peggy Mann, MS, MT(ASCP), POC and Lab/Facility coordinator, University of Texas Medical Branch, Clinic Administration lists a few of the most frequently seen deficiencies as:

lack of required competency documentation,
lack of required quality control (QC) performance,
failure to recognize out-of-range QC values,
improper or lack of required instrument maintenance and/or documentation,
lack of appropriate personal protective equipment and
lack of awareness that testing sites must have appropriate CLIA certificates for the type of testing performed.

More >

Pieces of the POCT puzzle
POC testing: changing the way patient care is delivered
By Kristin N. Hale, BS, BA, and Gerald J. Kost, MD, PhD, MS, FACB, MLO, June 2009

Point-of-care testing (POCT) is defined as testing at or near the site of patient care. The goal of POCT is to facilitate rapid diagnosis and faster treatment decisions to improve patient care and reduce morbidity and mortality.1 POCT impacts every branch of the healthcare system, including hospitals, outpatients, and disaster and emergency situations. The ability of POCT to be utilized in all these respective locations has demonstrated the significant potential POCT has to positively impact and change the way healthcare is delivered to the patient population — ultimately, with the goal of improving patient care — wherever that may be. More >

Positive Patient Outcomes

The Joint Commission has implemented key changes in 2009 that enhance focus on quality and patient safety.

By Margaret Peck, MS, MT (ASCP) Advance for Admin of the Lab: May 2009

Safe, quality patient care is highly dependent on the excellence of laboratory services, yet laboratories quite often rely on external processes and staff that impact its ability to provide timely, quality results. The landmark 1999 Institute of Medicine report To Err is Human stated that 70 percent of laboratory errors occur in the pre- and post-analytical phases of laboratory testing. Therefore, the interface between the clinical laboratory and other care providers can be a crucial part of the entire scope of the provision of lab services. More >

Aiming for Lab-like Accuracy at the Point of Care
CAP Today, April 2009, Feature Story, By Brendan Dabkowski

American frontiersman and gunslinger Wyatt Earp is credited with the gem “fast is fine, but accuracy is everything.” Though physicians at the point of care are unlikely to find themselves in an Old West-style gunfight, most, like Earp, would choose accuracy over speed. And that means makers of bedside glucose testing systems must be ever vigilant in meeting customers’ requests for improved accuracy.

“The primary need for clinicians using POC glucose monitors is that they give accurate results—even in the presence of interfering substances like maltose, abnormal hematocrit, ascorbate, etc.—so that correct treatment decisions can be made,” says Ron Newby, Nova Biomedical’s director of marketing. Also crucial: obtaining the right glucose read the first time, at the point of care, to eliminate the “time-wasting need for repeat measurements,” he says. Analyzers must deliver results quickly, but without sacrificing accuracy. Hospitals now face the “need to provide even higher levels of accuracy in handheld devices, in effect delivering lab-like accuracy at the bedside,” says Mary Catherine Coyle, MS, MT(ASCP), director of product marketing in the professional diagnostics division of Roche Diagnostics. More >

Win-Win POCT

Scott Warner, MLT(ASCP), ADVANCE for Administrators of the Laboratory
Vol. 18 • Issue 3 • Page 10 At the Bedside

Imagine 10 employees in your small hospital laboratory. Suddenly, there are 30 more performing tests on all shifts, and as a manager you aren't sure if they are fully trained or understand quality control (QC) concepts. This can happen with point-of-care testing (POCT). With diabetes being the sixth leading cause of death1and accounting for 22 percent of hospital charges,2your hospital's POCT program is a crucial part of managing inpatient diabetic care. Your partnership with nursing is the key to success, whether starting from scratch or upgrading an existing program. More

BNP in the Diagnosis of Heart Failure
By Barry I. Bluestein, PhD, MT(ASCP); Normand Despres, PhD; Alexander Belenky, PhD; Farooq Ghani, MD, PhD; and E. Glenn Armstrong, PhD, ADVANCE for Administrators of the Laboratory

Heart failure or congestive heart failure (CHF), when heart failure patients experience a buildup of fluid, is a clinical syndrome characterized by shortness of breath, fatigue and peripheral edema caused by the heart's inability to adequately circulate blood to the body's essential organs. CHF has become so common that it is considered by some to be a new epidemic.1 This dysfunction is associated with coronary artery disease (CAD), chronic hypertension, valvular heart diseases and cardiomyopathies.

The World Health Organization now estimates that 16 million people worldwide are living with some degree of heart failure. Approximately two-thirds of those, according to the National Institutes of Health, will die within five years of their diagnosis. Eighty percent of hospitalized patients age 65 and older are admitted with a diagnosis of CHF, making it the most common diagnosis of hospitalized patients in that age group.2 As a result, more Medicare dollars are spent on heart failure than any other single diagnosis. More

POCT Precision
Accuracy of point-of-care testing devices is proven; educating testing personnel is key.
By David Plaut and Carol Smola, Advance for the Administrators of the Lab

Advance for Administrators of the Lab February 2009 issue has a great article on POCT and reports that the demand for POCT is expected to increase by 80 percent over the next three years. The article states that the market is forecasted to grow from $10.3 billion (2005) to $18.7 billion by 2011. Click here to visit Advance for Administrators of the Laboratory website and then under CURRENT ISSUE, click on the "Log in to View Digital" button. That will take you to a really cool digital version of the publication.

Point-of-Care Sagas: A Tale of Three Cities
CAP Today, January 2009, Feature Story, by Anne Paxton

Baystate Health in Springfield, MA; Mayo Clinic in Rochester, MN: and SUNY Downstate Medical Center in Brooklyn, NY talk about their POC programs...

As increasingly complex laboratory tests start being performed rapidly at the bedside and elsewhere, the steady migration of testing from central laboratory to the point of care seems inexorable. But laboratory managers and directors in many care settings can confirm that, when point-of-care testing is adopted too hastily, it can be a case of the technology tail wagging the diagnostic testing dog.

At Baystate Health in Springfield, Mass., for example, “We do a complex menu of point-of-care testing, and we’re dealing with dozens of sites, hundreds of devices, and thousands of operators,” says James H. Nichols, PhD, DABCC, FACB, director of clinical chemistry. Sometimes, “physicians say ‘I need POC testing,’ and think it’s going to solve all the problems of the world—when in fact it can just throw another wrench of technology into an already overburdened system.” Read more >

New Glycohemoglobin Standard: Will Estimated Average Glucose Boost Patient Understanding?

By John R. Bell, Clinical Laboratory News, October 2008: Volume 34, Number 10

Despite the widespread use of HbA1c as a clinical measurement of patients’ diabetes control, standardization of test results has been a challenge for labs. The National Glycohemoglobin Standardization Program took the first step 12 years ago when it initiated a program to standardize HbA1c measurements on the basis of the Diabetes Control and Complications Trial, results of which were published in 1993. Read more >

Consensus from Endocrinologists on Prediabetes Testing

Lab Tests Online, October 2008

New guidelines from two major endocrinology organizations recommend strategies for diagnosis and management of prediabetes, a condition that occurs when blood glucose levels are higher than normal but not elevated enough to warrant a diagnosis of type 2 diabetes. The guidelines are an extension of efforts to detect and treat type 2 diabetes earlier and more aggressively, according to AACE. They aim to help physicians recognize prediabetes, those at risk for developing full-blown diabetes, and to make treatment decisions to prevent diabetes and ameliorate many of its risk factors. These include unhealthy weight, high blood pressure, and elevated lipid levels. Read more >

Putting Hospital Data to Hospital-wide Use
July 2008, CAP Today, Feature Story, Anne Paxton

Implementing a tight glycemic control protocol in the hospital should be straightforward: Monitor blood glucose levels, assess how well they’re meeting target ranges, use the information to improve, and reap the benefits in shorter lengths of stay and lower mortality and costs. But even when hospital staff are eager to comply with the protocol, the challenge of getting the right data together can hamper hospitals’ ability to benefit from tight glycemic control, or TGC. More >

POCT in the ED Enables Quicker Treatment
Clinical Lab Products

Patient side point-of-care testing -- where diagnostic testing is conducted at or near the site of the patient -- enables doctors to make decisions on patients presenting with chest pain up to 20 minutes faster than those whose lab tests are evaluated by a standard lab, according to a study appearing this month in the peer-reviewed journal Annals of Emergency Medicine. More >

Platform Consolidation in Critical Care
Advance for the Administrators of the Lab POC Connectivity, October 2008 By Brad Karon, MD, PhD

Recent consolidation of testing platforms has been driven by two factors—increasing evidence for improved patient care outcomes for analytes such as glucose, lactate and creatinine and the desire to use a single platform in multiple patient care settings. Read more >

Stuck in the Middle of Middleware
By Deborah Levenson, May 2008, Clinical Laboratory News

Labs Look for Answers as New Consortium Aims to Untangle the Mess
Mention “middleware” in a room full of lab directors, and you are likely to hear varied definitions of what it is and a wide array of uses for it. But generally speaking, the term has come to describe any hardware and software that acts as an intermediary between instruments and lab information systems (LIS) and allows them to exchange data or perform data management tasks the LIS can’t.

Middleware’s popularity took off in the early 1990s when personal computers that generated reports and buffered results became more common. Since then, middleware has become mainstream in POCT and a common, relatively inexpensive solution for core labs grappling with a wide range of problems including shortages of med techs, increases in test volume, more complex devices and lab operations, a federal push for electronic health records, and an overall trend toward ensuring quality of care.

Connectivity Success

Two major data management systems for POCT now comply with the CLSI’s connectivity standard, easing the transfer of data in institutions with labs that use these systems from Telcor (Lincoln, Neb.) and Medical Automation Systems (Charlottesville, Va.). Connectivity enabled by the standard and compliant systems not only improves patient care, but also eases billing and compliance documentation.

With the forthcoming IICC standard, core labs may one day enjoy the sort of connectivity POC users and lab staff at Carolinas Medical Center-NorthEast in Concord, N.C. now have. With the aid of her RALS+ system from Medical Automation Systems and its ability to connect to Roche Accuchek Inform glucose meters, Laboratory Education and POC Coordinator Deb Norkett, MT, ASCP has seen marked improvements in compliance and billing. She interfaces all manual tests through the Accucheck, which also allows her to enter pregnancy test results. After taking advantage of that function, she now achieves a 100% billing rate, while in the past she grappled with a 15% deficit in billing because of lack of documentation in the emergency room.

“Before using RALS, we couldn’t capture figures on the volume of certain manual tests, so they were built into the room charge,” she recalled. Click here for more >

Never Give In - Fighting for POC Patient Safety
Cap Today, June 2008, Feature Story By Anne Ford

In grammar school, the “three Rs” still hold sway (or so we all hope). But in point-of-care testing, there’s just one R that matters: Relentless. It’s a word that comes up over and over again in conversation with hospital POC testing coordinators—yes, even more often than “specimen” or “CLIA.”

“People pretty much know I’m relentless about certain things,” says Tim Deen, MLT(ASCP), MT (HEW), POC testing manager at Medical City Hospital, Dallas. “My chief nursing officer has kindly referred to me as a ‘tough-love’ type of person.” More >

In that regard he has a lot in common with Deb Phaup, BS (MT), MT(ASCP), CLS (NCA, POC coordinator at Mount Auburn Hospital, Cambridge, Mass. “I’m relentless,” she admits, laughing.

POC testing safety is nothing to joke about

Personable as Deen and Phaup are, they know that POC testing safety is nothing to joke about. With thousands of POC tests performed in their hospitals each month, theirs is not exactly a sit-back-and-relax situation. With their colleague Joann Bauwens, BS(MT), MT(ASCP), MA(HSM), interim director of laboratory services and POC testing coordinator at SSM St. Mary’s Health Center, St. Louis, Mo., they provide insight into what keeps POC testing on the safe side.

Both Deen and Phaup assumed their POC responsibilities just over a decade ago, when bedside testing wasn’t as frequently conducted or as closely regulated as it is now. When Deen began, he says, Medical City Hospital’s point-of-care program was “a lax system, where the lab was not involved.” And at Mount Auburn Hospital, where the POC coordinator position was created for Phaup, “nobody even knew what POC testing was,” she says. “The first week I started the job, I came into work and the then-manager didn’t even know where to put me. I was just standing in the hall without a clue.”

Click here for more>

Putting POCT in good hands
CAP Today, April 2008, Feature Story

Waived testing? Wave goodbye to that, says William A. Rock Jr., MD, medical director of the clinical laboratory, University Hospitals and Clinics, University of Mississippi Medical Center, Jackson, who did just that when he began putting together a point-of-care testing program for his institution a decade ago. Today, he and three other colleagues run an extensive POCT program that involves 61 sites and more than 2,000 employees at three hospitals and a large outpatient clinic—all without relying on the waived tests that typically anchor POCT programs.

Waived tests are somewhat oddball actors in the highly ordered, detail-driven world of laboratory medicine. Though regulated, these tests fall short on full commitment, like the Sondheim character in “Company” who sings, “Marry me a little.” So simple are these tests, the FDA has cleared them for home use, and CLIA requires test users to follow only manufacturers’ instructions. No proficiency testing, no patient test management, no quality assurance, no quality control, and no personnel qualifications. For Dr. Rock and his colleagues, it was also a no-go. At UMMC, they decided, the POCT program would be built to last. Any test supported in the POC program, even if CLIA has given it waived status, would have to meet CAP and Joint Commission guidelines. Click here for more.

Bedside Tests Can Speed Results, Ease Crowded ERs
The Tennessean. 07/15/08

It used to take emergency physicians at Middle Tennessee Medical Center an hour and a half to get back results from a blood test. That changed to only a few minutes three months ago when the hospital bought equipment that allows tests to be done at a patient's bedside.

The Murfreesboro hospital is one of several in the Nashville area moving to point-of-care testing, which a Vanderbilt professor's research calls part of the solution to relieve emergency room overcrowding.

At many hospitals, tests are sent to labs in another part of the building and certain results might take as long as an hour and a half to get back to the physician. That can sometimes delay initial treatment and push back other tests, such as X-rays that won't be scheduled until those initial results are returned. That, in turn, may keep beds occupied that otherwise could go to other patients. Soon, Middle Tennessee Medical Center plans to add pregnancy and urine tests to those performed at the bedside, a development made possible by the availability of smaller, less costly testing units and improved technology.

"It's been one of the biggest accelerators of our patient flow," said Dr. Kevin H. Beier, an emergency physician who also practices at Baptist Hospital here and is chairman of governmental affairs for the American Academy of Emergency Medicine. Vanderbilt, meanwhile, is considering putting a small lab within its adult emergency department or buying some of the small portable testing devices already on the market.

Overcrowding on rise

The move follows a study by Dr. Alan Storrow, associate professor of emergency medicine, that suggested putting labs or machines that determine results closer to a patient's bedside can help solve overcrowding in emergency rooms and perhaps free up bed space in the main hospital more quickly. "We could see a great deal more patients in less time because we're able to get our labs back in a much more time-efficient manner," Storrow said.

Overcrowding has become more of an issue as hospitals begin to see sicker patients, some of whom don't seek care until their medical problem gets worse because of a lack of insurance. Every other day, at least one Nashville-area hospital sends patients elsewhere because of a lack of room in departments such as the ER and the critical care unit. Although Vanderbilt — where the adult and pediatric emergency departments combined see 100,000 patients a year — recently doubled its ER capacity to 46 beds, overcrowding still occurs.

One barrier to adopting point-of-care testing is that it often costs less to process batches of tests in a larger main hospital or central lab, Storrow said. "There has to be a balance between cost and improvements in efficiency.

Speeding Toward Real Time with POC Glucoses
CAP Today, March 2008, Feature Article

In the case of wireless setups for point-of-care glucose testing, do results arrive in the electronic medical record in real time or "real time"? And how important is that distinction?

To back up a moment: As reported in the October 2007 issue of CAP TODAY ("Wireless Glucose Results-The Latest in Real-Time Data"), the University of North Carolina Hospitals, Chapel Hill, has implemented LifeScan's OneTouch DataLink system to greatly shorten the length of time it takes to obtain, view, and track point-of-care blood glucose results on clinical workstations, laboratory IT systems, and even physicians' PDAs. Other institutions are gradually following suit.

The LifeScan system speeds glucose result delivery by using a wireless unit to transmit data from LifeScan's OneTouch Flexx meter into the electronic medical record rather than requiring point-of-care staff to take the meter to a docking station for upload. Here's what some consider the sticking point: The wireless unit is external, meaning the user must connect it to the meter with a serial cable before connectivity can be established.

True, the LifeScan wireless unit is stored in the same carrying tote that holds the meter. But it's still an external solution."It's not real-time wireless," says James H. Nichols, PhD, DABCC, FACB, who, as a member of the Connectivity Industry Consortium, helped create the POCT1-A connectivity standard for point-of-care devices in 2001.

Dr. Nichols is medical director of chemistry at Baystate Health, Springfield, Mass., and associate professor of pathology at Tufts University School of Medicine, Boston. "It's a stepping stone on the way to real time, but it's not there yet. It's not like you have the device in your hand, you push the button to scan the patient, and it communicates wirelessly with your server. It still has that limitation of intermittent transmitting." Click here for more >

Integrating POCT In the ED

POC Connectivity Concepts, Advance for the Administrators of the Lab, Vol. 17 •Issue 2 • Page 9 By Valerie L. Ng, PhD, MD; R. Clayton Hooper, RN; Ruth Pfeiffer, RN; Mary N. Clancy, MS, CLS; and Eberhard Fiebig, MD

You can't get much more diametrically opposed cultures than that of the ED and the laboratory. The laboratory culture is one of careful and methodical processes and quality systems designed to ensure high-quality results and meet regulatory requirements. The ED culture is one of speed, algorithmic medical practice and rapid reflexive actions necessary to save lives in emergencies; regulatory compliance tasks are often an afterthought.

Ironically, many ED interventions rely on accurate laboratory test results. Point-of-care testing (POCT) results in the ED must, by definition, be of the highest quality and always correct because clinical action will be taken immediately based on the test result.

Why has POCT become so important for the ED? The backdrop is the unraveling of the healthcare system, driving many uninsured and sick patients without primary care access to the ED for routine or urgent (but not emergency) medical care. Click here for more >

Nurses on Point-of-Care IT Usage: Study
By: Jean DerGurahian/ HITS staff writer; Modern Healthcare Online Posted: January 4, 2008 - 5:59 am EDT

An increase on patient safety issues, higher healthcare costs and labor shortages are driving hospitals to use more information technology at the point of care; however, some devices and technology are more cumbersome than helpful, according to a new study of nurses and their bedside treatment practices.

The Point of Care Computing for Nursing study, conducted by Spyglass Consulting Group, shows that healthcare facilities are making "significant investments" in clinical information systems so that nurses and other practitioners can access patient information near or at the point of care. Nurses are using fixed or mobile devices to search different applications that help them treat their patients, according to the report, Spyglass spent four months interviewing more than 100 nurses across the healthcare fields for its study.

It found that 86% of acute-care nurses and 94% of home health nurses interviewed are using devices to access reference materials—including drug databases, manuals and medical calculators—and make informed patient decisions. While nurses spend nearly half their time documenting their treatments, 78% of nurses record their care at the patient's bedside through IT applications, in efforts to cut down on first writing the information on paper and then transferring it to electronic reports, according to the study. Another timesaver has been the use of automated products to capture vital signs data for high-acuity patients, immediately present it for nursing review and automatically upload it to the patient’s electronic record, with 36% of nurses adopting this practice. Bar coding also has helped nurses reduce medical errors. More than half the nurses interviewed—53%—said that they use devices to ensure positive patient identification, medication administration, blood transfusion verification and laboratory specimen collection, according to the report.

Nurses are spending time on the Internet as well to stay up-to-date on nursing trends and new treatments, according to the report. "Nurses discovering online nursing communities and resources enabling them to communicate and collaborate with colleagues more effectively," Spyglass said in its report. While nurses seem ready to embrace point-of-care technology, they also say devices currently available are cumbersome and difficult to move with, and networks are unreliable, according to the report. "Point-of-care solutions need to evolve to provide higher levels of synchronization and integration of hardware, software and infrastructure to streamline nursing workflow process and improve communications amongst care team members," Spyglass said.

Content for Point of Care Computing for Nursing was derived from more than 100 interviews with nurses working in acute-care and ambulatory environments nationwide. Spyglass conducted the telephone interviews over a four-month period beginning April 2007.

Wireless glucose results - latest on real-time data

More than a decade after tight glycemic control made its debut in the early 1990s, numerous studies, and recommendations from organizations such as the American Association of Clinical Endocrinologists and the American Diabetes Association, have affirmed its ability to decrease everything from mortality and comorbidity to the risk of heart failure and organ damage. But from a point-of-care testing coordinator's point of view, tight glycemic control increases a few things, too.

A few? Make that 1,000—the approximate number of glucose results that point-of-care staff at University of North Carolina Hospitals, Chapel Hill, manage every day. After UNC implemented a TGC protocol a few years ago, "the first thing that I noticed as a point-of-care person was that it required more glucose meters and testing strips, and more data was being generated," says Beverly Robertson, MPH, MT (ASCP), until recently UNC's point-of-care testing coordinator and now a technical service representative for Somerset, NJ-based in Ventiv Health and an authorized installer of LifeScan equipment. In addition to reviewing and charting a greatly increased number of glucose results, the new TGC protocol meant that Robertson was faced with managing more frequent data downloads and data flow bottlenecks. Not only were there more results to deal with, but "all those results were being hand-charted," Robertson says. "And the only way that physicians could review them was to be physically at the nursing locations." In a large institution like UNC, which has 750 beds, 100 units, and nine ICUs, that meant relying on what Connie Bishop, MT (ASCP) SH, UNC assistant administrative director of core laboratories and point-of-care testing, laughingly terms the "sneaker network." Click here for more>

The Challenges of Point-of-Care Connectivity
How A New Tool Can Aid Labs with Device and Data System Purchasing
By Deborah Levenson, Clinical Laboratory News, July 2007

Point-of-care testing (POCT) devices with the ability to link to each other and lab information systems (LISs)—known as connectivity—can help reduce medical errors, improve staff compliance with regulatory requirements, boost revenue from testing, and track wasted supplies. In most labs, POCT connectivity has come a long way from the 1990s, when many POCT devices lacked essentials such as ports that allowed them to transfer results to a lab data management system or ports with keypads for data entry. In those early days, a few manufacturers offered instruments that allowed labs to move data from the device to a patient’s chart, but each had its own suite of products, necessitating multiple computers to handle data.

Today, while issues with POCT connectivity are not as troublesome, labs often fall short of the ultimate goal of using such devices: fast, complete transfer of accurate information.

Click here for more >

Utilization of a Computerized Intravenous Insulin Infusion Program to Control Blood Glucose in the Intensive Care Unit

Rattan Juneja, Corbin Roudebush, Nilay Kumar, Angela Macy, Adam Golas, Donna Wall, Cheryl Wolverton, Deborah Nelson, Joni Carroll, Samuel J. Flanders. Diabetes Technology & Therapeutics. Jun 2007, Vol. 9,

No. 3: 232-240

This proof of concept study was designed to evaluate the safety and effectiveness of an intravenous insulin dosing calculator, the Clarian GlucoStabilizer™ program, and to determine the feasibility of its use as part of a glycemic control program. This paper discusses the impact of the GlucoStabilizer program on the glycemic control of intensive care patients with hyperglycemia.

Patients admitted to the intensive care unit (ICU), requiring intravenous insulin, were treated using the GlucoStabilizer program. This program calculates an insulin drip rate based on the low and high blood glucose (BG) levels of the desired target range, the patient's current and previous BG levels, and an insulin sensitivity factor, with a goal of safely and expeditiously achieving and maintaining the patient's BG in the target range.

From October 2004 through March 2006, the GlucoStabilizer program has been used to treat 2,398 patients in the ICUs, with 177,279 BG measurements in its database.

For more on this study, or to request a copy, click here.

Intensive Insulin Protocol Improves Glucose Control and Is Associated with a Reduction in Intensive Care Unit Mortality

Charles C Reed, BSN, Ronald M Stewart, MD, FACS, Michele Sherman, BSN, John G Myers, MD, FACS, Michael G Corneille, MD, FACS, Nanette Larson, BSN, Susan Gerhardt, MSN, Randall Beadle, BSN, Conrado Gamboa, MS, RPh, Daniel Dent, MD, FACS, Stephen M Cohn, MD, FACS, Basil A Pruitt Jr, MD, FACS. American College of Surgeons, 2007

Intensive insulin therapy to maintain serum glucose levels between 80 and 110 mg/dL has previously been shown to reduce mortality in the critically ill; recent data, however, have called this benefit into question.

In addition, maintaining uniform, tight glucose control is challenging and resource demanding. We hypothesized that, by use of a protocol, tight glucose control could be achieved in the surgical trauma intensive care unit (STICU), and that improved glucose control would be beneficial. During the study period, a progressively more rigorous approach to glucose control was used, culminating in an implemented protocol in 2005.

We reviewed STICU patients’ blood glucose levels, measured by point-of-care testing, from 2003 to 2006.Mortality was tracked over the course of the study, and patient charts were retrospectively reviewed to measure illness and injury severity.

For the results of this study, click here to access the pdf file.

CAP Today April 2007 Feature Story
Glucose Test Frequency Spawns New Analyzer Needs
By Anne Ford

In dieting—as in so much else—good intentions aren’t enough. To lose weight, calorie-counters can’t stock up on carrot sticks and hope for the best; they have to actually monitor their diet via a food diary or some other method. (Hence the saying: “If you bite it, write it.”) But if the monitoring method becomes too cumbersome, it’s likely to go by the wayside, and any new, healthier eating habits will probably follow. Conversely, making the monitoring process as painless as possible is a major step toward success. And that’s a lesson that applies to many endeavors, including tight glycemic control.

“Because of the increased testing frequency mandated by most tight glycemic control protocols,” says LifeScan marketing manager Grant Choe, “anything we can do to increase ease and simplicity is going to be welcomed with open arms.” Harlan Polishook, Nova Biomedical marketing communications manager, agrees: Under tight glycemic control protocols, he says, some nurses find themselves performing bedside glucose testing “as frequently as every half hour for some patients.” In turn, “more frequent bedside testing has driven the demand for faster, easier testing and smaller blood volumes.”

The makers of the bedside glucose testing systems featured in this month’s instrumentation survey have responded to that demand with new and forthcoming instruments and features, from multiple measuring wells to wireless capabilities. Click here for more >

Industry Overview
Surprise, We’re Here! Gearing up for unannounced inspections
By Renee DiIulio

In 2004, deficiencies at Maryland General Hospital (MGH) in Baltimore brought oversight attention to the process of laboratory accreditation and inspections. The title of a resulting Government Accountability Office (GAO) report, published in June 2006, summarizes the result: “Clinical Labs: CMS and Survey Organization Oversight Is Not Sufficient to Ensure Lab Quality.” Something had to change. Congressmen called for a switch to unannounced inspections. At the same time, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Oakbrook Terrace, Ill, was in the process of altering its accreditation process, implementing a plan named Shared Visions—New Pathways, which became effective January 1, 2004.

“In 2004, JCAHO announced its intent to implement unannounced surveys in 2006 as part of our Shared Vision—New Pathways effort,” says Margaret Peck, MS, MT(ASCP), the organization’s director of the lab accreditation program. The goal was to provide a more accurate picture of a laboratory’s day-to-day function. “It would allow our accreditation process to be used as a systems improvement tool,” Peck says.

College of American Pathologists (CAP) followed suit, influenced, says R. Bruce (RB) Williams, MD, pathologist and head of CAP’s accreditation committee, by the concern of the GAO and Congress. “We are continually improving our lab accreditation process, and we underwent a systemic review following MGH,” he says. A subsequent bill—HR 686: Clinical Laboratory Compliance Improvement Act of 2005, introduced by Rep Elijah Cummings (D-Md)—aims to make unannounced inspections a requirement if passed.

Click here for more >

CAP Today, April 2006, Feature Story
When POC Connects the Data, Everyone Wins
By Sue Parham

The story of point-of-care connectivity is quickly becoming one of laboratory medicine’s twice-told tales: POC setups have come a long way, and hospitals are reaping the benefits. For Debra Norkett, MT (ASCP), education coordinator for the laboratory and point-of-care coordinator at NorthEast Medical Center, a 457-bed hospital in Concord, NC, incorporating POC test data into an electronic patient record system is the ultimate goal. “Our hospital is working toward having electronic patient records, and theoretically, point-of-care connectivity has been set up to support such a system,” she says.

NorthEast Medical Center implemented POC connectivity about three years ago, beginning with the installation of a positive patient identification system that uses bar-coded patient wristbands in conjunction with bar-coded POC instrument operator badges to capture the data from each encounter that involves a POC test. “The success of our POC connectivity is tied into our bar-code system. The bar-coded wristbands and badges have enabled us to reduce patient misidentification errors, as well as automate POC test ordering and result reporting,” Norkett says. Since bar coding became part of the POC process at NorthEast, patient identification errors have dropped to below one percent.

Because NorthEast installed its vendor-neutral Rals-Plus POC data-management system at the same time it implemented its positive patient identification system, POC connectivity has always been enabled by the bar-code system. “I took the job of POC coordinator a few years before we implemented POC connectivity. Then, we had about 30 glucose meters and I would carry a laptop from unit to unit and actually download the information,” Norkett recalls. “At the time, it took so long to gather the data that report generation was always about a month after the fact.”

Click here for more >

CAP Today, March 2006, Cover Story Nearing High Tide on Low Blood Sugars
By Anne Paxton

Since its emergence in the early 1990s, tight glycemic control could almost have been called an orphan protocol. Despite evidence that it sharply lowers patient mortality and morbidity and hospital length of stay, the use of insulin to keep patient's blood glucose at or near normal levels has spread slowly beyond a few pockets of fervent support, and has yet to sweep the nation's hospitals. As Curtiss B. Cook, MD, associate professor of medicine in the Division of Endocrinology at Mayo Clinic Arizona puts it: "A lot of people haven't quite bought into the concept yet."

But in recent weeks, with a major new controlled study and a public statement from leading professional associations in diabetes care, tight glycemic control may have reached its tipping point. The American Association of Clinical Endocrinologists and the American Diabetes Association are now advocating widespread adoption of tight glycemic control protocols not only in intensive care units but also in other areas of the hospital. Their position statement, released Feb. 1, calls for implementing "structured protocols for aggressive control of blood glucose in both intensive care units and other hospital settings."

One day later, Belgian researchers led by Greet Van den Berghe, MD, PhD, reported in the New England Journal of Medicine (354:449-461) that intensive insulin therapy, or tight glycemic control, significantly reduced morbidity among all patients in the medical ICU—a benefit that was demonstrated earlier on patients in surgical ICUs.

Click here for more >

Avoiding Glucose Monitoring Errors in Patients Receiving Other Sugars

FDA issued a reminder about the potential for falsely elevated glucose readings in patients who are also receiving products that contain other sugars. These products include oral xylose, parenterals that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin.

A patient recently died because of this problem. His glucose readings were very high, so he was given aggressive insulin treatment. The glucose readings were falsely high, however, and too much insulin was administered. The patient suffered irreversible brain damage and died. In this case the glucose meter was reading the patient's actual blood glucose level, plus the maltose that was contained in the IV immune globulin he was receiving. The readings were falsely elevated because the glucose monitoring device couldn't distinguish between glucose and other sugars. All glucose meters don't suffer from this problem. There are four kinds of enzymatic glucose monitoring methods that are used, and only one of those has this problem. This problem occurs only with the monitoring method that uses an enzyme called GDH-PQQ. This method is employed in some glucose monitoring devices used by diabetics at home and in point-of-care settings.

The other three test methods currently used in glucose monitoring systems are called GDH-NAD, glucose oxidase, and glucose hexokinase, and they are capable of distinguishing between glucose and other sugars. The test method used in glucose meters is identified in the package insert that comes with the glucose test strips. The package insert is also available from the manufacturer. The most important thing to remember is not to use the GDH-PQQ method if the patient recently received other sugars. That includes oral xylose for a D-Xylose absorption test, or an IV solution containing maltose or galactose, or a peritoneal dialysis solution containing icodextrin. Click here for more >

Additional Information:
FDA MedWatch Safety Alert 2005 - Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products:

Major Medical Associations Call for Better Blood Glucose Management in Hospitalized Patients

WASHINGTON, DC – February 1, 2006 – The American Association of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE – the scientific and educational arm of AACE) and the American Diabetes Association (ADA) have joined forces to develop strategies for management of adult patients with high blood glucose (sugar) in hospitals. Co-sponsored by ten other major medical associations, AACE and ADA released a new position statement today on improving inpatient glycemic control at a joint consensus conference.

Awareness about the importance of glycemic control in the hospital setting has increased as result of the ACE Consensus Development Conference on Inpatient Diabetes and Metabolic Control in 2003. In order to suggest a plan for better care, AACE and ADA came together to conduct the “Improving Inpatient Diabetes Care: A Call to Action Conference - Consensus Development Conference,” January 30 and 31, 2006 in Washington, DC.
Click here for more >

Tight Glucose Control Cuts Heart Disease by Half in Type 1 Diabetes
Published by the U.S. Dept. of Health and Human Services - NIH News

Intensive glucose control lowers the risk of heart disease and stroke by about 50 percent in people with type 1 diabetes, researchers report in the December 22, 2005, issue of the New England Journal of Medicine. Their findings are based on a follow-up study of patients who took part more than a decade ago in the Diabetes Control and Complications Trial (DCCT) www.diabetes.niddk.nih.gov/dm/pubs/control/index.htm, a major clinical study funded by the National Institutes of Health (NIH).

“We see a greater reduction in cardiovascular events from intensive blood glucose control than from drugs that lower blood pressure and cholesterol,” said Saul Genuth, M.D, of Case Western University. Genuth chairs the follow-up study of DCCT participants, called the Epidemiology of Diabetes Interventions and Complications (EDIC) study, which is examining the long-term effects of prior intensive versus conventional blood glucose control.

“The benefits of intensive control strongly reinforce the message that this therapy should begin as early as possible and be maintained as long as possible.” Click here for more >

Opening up the throttle on POC-hospital connectivity
CAP Today, December 2005, Feature Story By Anne Paxton

For point-of-care testing managers, true connectivity is now within reach, which means tantalizing efficiencies lie ahead. POC departments are aligning their connectivity solutions with hospital wide moves to sharpen treatment protocols and become paperless and wireless. For many POC testing programs, the integration of it all is complicated by the demand for bedside testing—and its brisk growth.

Six hospitals, three outpatient clinics, and seven nursing homes make up Sentara Healthcare in the Hampton Roads area of Virginia. Employing 300 glucose meters and about 170 i-Stats, the Sentara system now does well over 1 million POC tests a year, says Lou Ann Wyer, MT(ASCP), POC testing clinical specialist with Sentara Laboratories. Like many other health systems, Sentara has seen a sharp increase in glucose testing because all units are using tight glycemic protocols.

Wyer's chief project now is rolling out troponin testing in the emergency department. "For this test there was a lot of up-front work to be done. It's been a long process, including extensive evaluation of the cartridge—an i-Stat product—and making sure physicians are comfortable with the method and how to interpret results, because they don't match the main laboratory results. They have different cutoff values." Click here for more >

Connective issue: Linking POC with Wireless Hospitals
CAP Today, November 2005, Feature Story By Anne Paxton

Most point-of-care testing managers are thrilled with the new devices and software available to streamline their operations. But with connectivity becoming standard operating procedure, POC testing programs are facing a new challenge: making sure that connectivity meshes with hospitalwide initiatives to adopt new treatment paradigms, eliminate patient ID errors, and eventually say goodbye to cables and wires, as well as to paper. Whether their programs are in a state of steady expansion or extreme makeover, POC testing managers say the possible efficiencies now in view or just around the corner are tantalizing.

How are they turning the visionary schemes into smooth-functioning routines?

At Lewis-Gale Medical Center, Salem, Va., connectivity is fairly well established. “We have three different connectivity solutions,” says point of care coordinator John La Rosa, MA, CLS (NCA). “Biosite Census connectivity for cardiac markers has been in place since 2001, we’ve had the Roche Diagnostics glucose meters on RALS-Plus since 2002, and Abbott Central Data Station for the i-Stats just started this summer.”

The laboratory and hospital information systems are from Meditech. The software updates are included in the hospital’s three- to five-year contracts with the vendors, and may be carried out remotely if the vendors have access to the hospital’s network.

“The big plus of connectivity is it allows us to capture billing that wasn’t captured before, and make sure we are billing to the correct account or patient. We are billing and getting reimbursed wherever we can,” La Rosa says.

Tight glycemic control is the hot topic of 2005 in his region, he says, because the evidence shows that keeping patient blood sugar under a certain benchmark prevents some infections, raises postoperative wound healing rates, and reduces length of stay.
“This year we kicked up tight glycemic control where we monitor blood sugars every hour on patients on insulin drip. Right now we just have TGC in critical areas, but when we move it out to the whole hospital, we expect glucose testing to go up quite a bit.” Click here for more >

Outpatient Setting: Alternatives to Connectivity
Vol. 14 •Issue 11 • Page 10 November 2005 Advance for Administrators of the Lab - AT THE BEDSIDE By Peggy Mann, MS, MT(ASCP)

Maintaining a unified point-of-care (POC) program across a university-based hospital system can prove challenging to coordinators responsible for compliance oversight. If a process is designed without regard to the differences between in-patient, campus-based, out-patient clinics, and remote off-site provider offices, it increases the chance that the target or goal will not be met.

One striking disparity between on- and off-campus sites is how campus-based services are delivered. An example at our institution of how distance complicates standardization of POC across an enterprise is delivery of reagents from a campus materials department. Another example is the impracticality of operators traveling to campus for observation check-offs available to on-campus operators. A third example is establishing the need for connecting the POC devices in use across the enterprise. In light of the financial burden to connect, what benefits make it worth an off-site clinic finding the money if they have to fund their participation? Are there alternative ways to manage a POC program? Click here for more >

A Tight Glycemic Control Initiative
June 2005 • Advance for Administrators of the Lab • At the Bedside: By Nicole Woody, MT(ASCP)

Tight Glycemic Control (TGC) should qualify as the 2005 phrase of the year. TGC is everywhere in the health care literature, Web casts, listservs and continuing education programs. A Google search of the term yields over 30,000 hits. My experience with TGC began in November 2004, when a glycemic taskforce convened to discuss glycemic control in the hospital. The taskforce was made up of physicians, nurses, dietitians, laboratory professionals, information services employees and pharmacists.

Four Basic Groups The taskforce's first assigned duty was to identify existing patient safety issues with glycemic control and prioritize those issues. To accomplish this, the task force was broken into four work groups. The groups included nursing, laboratory/devices, dietary and pharmacology. Nursing looked at the various issues concerning TGC and its impact on the staff. Dietary looked at the food we were serving our patients. Pharmacology looked at many issues, including the types of insulin we use and dextrose concentrations used for intravenous drips. Finally, the laboratory/devices group looked at our existing point-of-care (POC) glucose testing meters, who uses the meters, staff education and the number of meters in use.

The first phase of the task force went relatively well. There were meetings every other week to discuss and work through the issues that arose. A protocol was developed for use in the Cardiothoracic Surgical Intensive Care Unite (CT SICU) and its related step-down unit. Unfortunately, everyone wanted TGC to work without looking at the reality of the protocol.

Click here for more >

POCT Compliance with JCAHO's National Patient Safety Goals
Point of Care: The Journal of Near-Patient Testing & Technology: Vol 4(2) June 05, Ehrmeyer, Sharon S PhD, MT(ASCP); Darcy, Teresa P MD, MMM.

Today, ensuring patient safety through error prevention is a priority for healthcare organizations. In response to the Institute of Medicine report that 98,000 deaths annually in US hospitals result from preventable medical errors, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) disseminated its first national patient safety goals (NPSG).

On January 1, 2005, JCAHO began surveying accredited healthcare organizations for implementation of applicable 2005 goals and requirements. It is essential that point of care testing (POCT) sites in the approximately 4500 US hospitals accredited by the JCAHO understand these goals and create the necessary policies and procedures for achieving them. This report addresses the relevant NPSG identified by JCAHO for its Laboratory Program and a total quality management strategy for POCT to follow to ensure compliance with the relevant goals.

For 2005 JCAHO identified 12 NPSG for its 10 healthcare programs. These programs are ambulatory care and office-based surgery, assisted living, behavioral health care, critical access hospital, disease-specific care, home care, hospital, laboratory, long term care, and networks (integrated delivery systems, managed care and preferred provider organizations).

Click here > for the rest of this article.

Access does require a subscription to Point of Care: The Journal of Near-Patient Testing & Technology.

POC Connectivity Takes Hold
CAP Today, June 2005, Feature Story, by Anne Paxton

Point-of-care testing connectivity presents POC coordinators with a dilemma: Should they let other hospitals be the early adopters while the bugs are ironed out? Or should they rush to take advantage of the streamlined, comprehensive data capture that connectivity has to offer?

Both choices have their pluses and minuses, but point-of-care testing coordinators who have taken the leap into POC connectivity say once they got past the learning curve blues, the payoff was worth it. With the array of POC vendors and diverse analytical profiles, POC data can’t be handled by the laboratory information system or HIS without a local data-management system that connects them on a single platform.

Helped by the industry-wide POC connectivity standard approved in 2001, POC data-management systems are gaining a foothold in the nation’s hospitals, but obstacles remain before point-of-care results glide swiftly, seamlessly, and accurately into hospital records.

Connectivity solutions from Abbott POC (PrecisionWeb), Lifescan (Datalink), Medical Automation Systems (RALS), Telcor (QML) are referenced throughout this article. Click here for more >

Glucose Testing Variability and the Need for an Expert Oversight Committee
CAP Today, May 2005, Feature Story, Joyce G. Schwartz, MD, Samuel B. Reichberg, MD, PhD Raymond S. Gambino, MD

In 1979 a work group of the National Diabetes Data Group¹ established the criteria, later endorsed by the World Health Organization Committee on Diabetes, that patients with a fasting or 2-h postprandial glucose concentration greater than 140 or 200 mg/dL, respectively, were to be considered diabetic.

In 1997, the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus was convened to reexamine the classification and diagnostic criteria for diabetes based on the 1979 publication of the National Diabetes Data Group. As a result of its deliberations, the committee recommended several changes to the diagnostic criteria for diabetes and for lesser degrees of impaired glucose regulation.² The use of a fasting plasma glucose, or FPG, test for the diagnosis of diabetes was recommended, and the cut point separating diabetes from nondiabetes was lowered from a FPG > 140 mg/dL to > 126 mg/dL. This change was based on data that showed an increase in prevalence and incidence of diabetic retinopathy beginning approximately at a FPG of 126 mg/dL, as well as on the desire to reduce the discrepancy that existed in the number of cases detected by the FPG cut point of > 140 mg/dL and the 2-h value in the OGTT (2-h plasma glucose) of > 200 mg/dL. Click here for more >

Improving Patient Care With Blood Gas Connectivity
By Michael Dalton, Advance for the Administrators of the Lab, Vol. 14 •Issue 3 • POC Connectivity Concepts

The intensive nature of a critical care environment requires physicians to respond quickly to the needs of a patient to accurately diagnose and treat him. In this diminished state of health, a patient's condition can change rapidly, so a more efficient system enables a physician to obtain arterial blood gas results rapidly. This enhanced turnaround of patient information allows the physician to assess the patient's status and implement therapeutic measures within a very short timeline.

One way to ensure rapid and accurate blood gas diagnostic test results is to utilize point-of-care (POC) instruments in the critical care setting linked with connectivity management solutions. There are several ways connectivity in the POC setting can bring real advantages to hospitals and laboratories and help enrich patient care in crucial areas such as system efficiency, patient security, data management and equipment and staff support. All of these workflow benefits ultimately deliver improved patient care. Click here for more

ICUs Tighten Belts on Blood Glucose Levels
CAP Today, February 2005, Cover Story by William Check, PhD

Tight glycemic control shows growing evidence of improving morbidity and mortality

As George and Ira Gershwin famously wrote, "Love is sweeping the country!" including "All the sexes from Maine to Texas." True, "tight glycemic control in critically ill patients" doesn't have the instant emotional appeal that love evokes, but it too has been sweeping the country, becoming routine in intensive care units from Oregon to Connecticut and many places in between. And whereas love is often blamed in song with making people feel blue and brokenhearted, tight glycemic control actually makes people feel better and live longer, with some of its strongest health benefits seen in patients with cardiac conditions.

Most important, growing evidence indicates that tight glycemic control improves morbidity and mortality not just in diabetics, but in all critically ill patients, setting the stage for comprehensive blood glucose protocols to be adopted in ICUs. Click here for more >

January 1, 2005
Bringing New POCT Equipment on Board
Advance for the Administrators of the Lab, Vol. 14, Issue 1 POC Connectivity Concepts, by Matthew T. Patton

When point-of-care testing (POCT) is to be implemented on a large scale—involving multiple clinics and units or even multiple hospitals—pre-planning by multidisciplinary teams is essential. Equally important is to incorporate instrument vendor expertise into the training process. Involvement at all levels can help ensure that labs stay in regulatory compliance and remain competent users of POCT equipment.

Staff Involvement When dealing with quality control for employees new to the instrumentation, Lou Ann Wyer, MT(ASCP), clinical specialist, POCT/QM, Sentara Laboratory Services, Norfolk, VA, tells ADVANCE that her facility conducts precision, reportable range or calibration validation and method comparison studies during the pre-planning phase. Statistical analysis is performed on each set of data and the method's performance is approved prior to implementation. Click here for the complete article >

Breaking it Down POCT: The Salary Dilemma
Advance for Medical Laboratory Professionals, Vol. 17, Issue 3, Page 14, by Kerri Penno

Point-of-care testing professionals often have a difficult time obtaining compensation for additional duties.The scenario is familiar across the healthcare field: lines of responsibility are blurred, expectations are high and compensation and recognition decidedly are not. Point-of-care testing (POCT) professionals are being stretched too thin and wearing too many hats. POCT coordinators (POCCs) act more like managers, and some laboratorians are in charge of more POCT work in addition to their own responsibilities without any additional compensation. This job description and salary discrepancy is generating a buzz among POCT professionals across the nation. Click here for more >

November 2004
More Studies Support Tight Glycemic Control in Hospitals
By Kay Downer, Clinical Laboratory News

For years physicians have known the importance of controlling blood glucose levels in diabetic patients, but only recently have they begun to realize its importance in treating critically ill patients—both those with and without diabetes. In the past few years, several studies have shown that a range of patient outcomes can be significantly improved by tight glycemic control, a process of maintaining blood glucose levels within a narrow target range via frequent insulin administration.

The rest of this article can be found in the November 2004 issue of Clinical Laboratory News. Visit www.aacc.org/cln/default.stm for more information.

Push for Electronic Medical Records Gains Momentum
By Penny Allen, Clinical Laboratory News

In an executive order last April, President George W. Bush called for widespread deployment of health information technology within the next 10 years. Intended to improve health care safety, quality, efficiency, and coordination between providers in the U.S., implementing this technology is a noble but lofty goal considering that the Healthcare Information and Management Systems Society (HIMSS) reported that this year only 19% of health care provider organizations have fully operational electronic medical records (EMRs).

The rest of this article can be found in the November 2004 issue of Clinical Laboratory News. Visit www.aacc.org/cln/default.stm for more information.

October 2004
Making the Connection
By Todd Smith, Advance for Administrators of the Lab

Amid the information age where technologies are exploding and prices are shrinking, there is little excuse for point-of-care testing that is not interfaced.

Connectivity is an important and complicated issue in point-of-care testing (POCT). The basic idea is to replace all manual data entry, but there still is a lot of manual testing. With non-connected testing, the operator must manually enter the result and other pertinent data to get it into the information system.

The aim of connectivity is to provide all this in an electronic, instantaneous fashion. But one of the most significant issues surrounding connectivity is the question of compatibility.The benefits of interfacing POCT are obvious. All lab testing—whether it is point of care, central lab, satellite lab, etc.—must be made part of the medical record. Nearly 40 percent of testing is performed at the patient's bedside, say experts. With technology becoming more affordable, more devices bearing wireless capability and all the networks present in the hospitals, there are numerous options for connecting devices.

"To do point of care without interfacing makes no sense at all," says Kenneth E. Blick, PhD, professor, department of Pathology, University of Oklahoma Health Sciences Center and Medical Center, Oklahoma City. "There are no excuses for letting devices proliferate throughout the hospital and having non-lab people select the devices and use them in a way that is not very businesslike."

This is only a small part of this article. The complete story can be found in the October 2004 issue of Advance for the Administrators of the Lab, Vol. 13 • Issue 10 • Page 63. Click here for more >>

September 2004
POCT and the New CMS Guidelines
By Sue Auxter-Parham, Clinical Laboratory News

Late last year, the Centers for Medicare and Medicaid Services (CMS) released “Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services”.

This 300-plus-page resource not only provides a general guide for implementing CLIA ’88, but also gives clinical labs a new way to approach quality control (QC). Check out the September 2004 issue of Clinical Laboratory News for more on this story >>

August 2004
Applying Evidence-Based Medicine to Point-of-Care Testing to Improve Medical Care
By Renee DiIulio, CLP, August 2004

Point-of-care testing (POCT) has been embraced by a medical community that equates new technology with better patient care. Providers of medical care are under pressure to provide care more quickly than in the past, and many see POCT as a solution to remove patient bottlenecks.

However, James H. Nichols, PhD, DABCC, FACB, said there is a proliferation of misinformation about POCT. Nichols, associate professor of pathology at Tufts University School of Medicine in Boston and director of clinical chemistry at Baystate Health System in Springfield, Mass, gave the keynote address, “Finding Value at the Bedside: Evidence-Based Practice for POCT,” at the 20th International Symposium on Critical Care and Point-of-Care Testing in Wurzburg, Germany. “Faster is often understood to mean better outcomes without the research to back this conclusion,” he said.

Evidence-Based Medicine (EBM) represents a new age in health care. Nichols traced medicine’s development through the ages, from its dawn with humors, astrology, and bloodletting, through its dark period characterized by belief-based treatments, into an enlightenment with the discovery of the pathologic basis of disease, and followed by subsequent growth with advances in prevention, diagnosis, and treatment. Click here for more >>

August 2004
Optimizing Point-of-Care Testing
By Barbara M. Goldsmith, PhD, FACB

POCT Applications as a Useful Tool for Rapid Laboratory Results

Point-of-care testing is growing rapidly at an estimated rate of 12 percent to 16 percent per year and is predicted to double by 2005, becoming a $950 million market. In 1997, the Food and Drug Administration convened an expert panel to describe future trends in medical device technology over the next 10 years.The panel identified six major trend categories. Home and self-care and minimally invasive procedures were among the six categories, each having applications in POCT.

POCT is referred to as laboratory testing performed outside of the clinical laboratory. It can be performed at the patient's bedside or in a centralized area within a unit, such as an intensive care unit. POCT applications include:

Testing for emergency diagnosis (e.g. acute cardiac syndromes)
Treatment and monitoring of existing disease (e.g. diabetes)
Testing in the physician's office
Self-testing

The diversity of testing locations also is broad, including: acute care settings

Ambulances
Clinics
Schools
Drug treatment centers
Patients' homes

Click here for more >>

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