News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Clinical Chemists and Medical Laboratory Scientists Gather in Chicago for American Association of Clinical Chemistry and ASCLS Joint Meeting

Among the hundreds of lab industry vendors exhibiting, there were more companies showing LIS and lab informatics products this year than last year

CHICAGO, ILLINOIS—Anytime 20,000 clinical chemists and medical laboratory scientists gather in the same place, at the same time, there is sure to be many different opinions about the state of laboratory medicine and key trends in the clinical laboratory testing marketplace.

That was certainly true of this year’s annual meetings of the American Association of Clinical Chemistry (AACC) and the American Society of Clinical Laboratory Scientists (ASCLS) that took place here in the Windy City and ended yesterday. Your Dark Daily editor was in attendance and saw many interesting things during the exhibition, which opened on Tuesday and closed Thursday.

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Across the Globe, ISO 15189 Enjoys Growing Acceptance by Governments for the Accreditation of Medical Laboratories in their Countries

Clinical laboratory organizations that seek to set themselves “apart from the herd” are seeking internally recognized quality accreditation, such as ISO 15189

Even as only a small number of clinical laboratories, in the United States have taken the steps to earn accreditation to ISO 15189 Medical Laboratories, it is a different story in other nations, particularly where no statutory requirement for medical laboratory licensure or accreditation exists.

North of the border, the Canadian Province of Ontario has based medical laboratory accreditation on ISO 15189. Over the past decade, more than 130 laboratory organizations in the province have earned accreditation to ISO 15189. Other provinces in Canada have taken steps to develop their own ISO 15189 accreditation programs. (more…)

This Week in Houston, Clinical Laboratory Industry’s Largest Trade Show Provided a Look at New Diagnostic Technologies

Many IVD vendors are cautiously optimistic about the “state of the medical lab industry,” but recognize that declining reimbursement for lab tests is now harming many lab organizations

DATELINE: Houston, Texas—Once again, the American Association of Clinical Chemistry (AACC) and the American Society for Clinical Laboratory Science (ASCLS) attracted a large crowd for their joint annual meeting. And, as is true every year, the activity on the exhibit floor provides valuable insights about the state of the clinical laboratory.

Your Dark Daily editorial team was here all week and had conversations with many executives from in vitro diagnostic  (IVD) manufacturers, laboratory informatics vendors, and specialty test companies.

Nation’s Largest Trade Show for Medical Laboratory Vendors (more…)

“Choosing Wisely” Program Wants to Encourage Better Utilization of Clinical Pathology Laboratory Tests

New lab test market could open up if research findings lead Consumer Reports and nine medical specialty associates join forces to target the overuse of certain diagnostic procedures, including some medical laboratory tests

For years, pathologists and physicians have spoken out about the overuse of medical laboratory tests and other diagnostic procedures. Now an interesting alliance of a medical specialty association and Consumer Reports has come together with a highly-publicized plan designed to reduce unnecessary or inappropriate testing by encouraging physicians to more deeply involve patients in the process.

It is the American Board of Internal Medicine Foundation (ABIMF) that is working with Consumer Reports. Their common goal is to stanch the overuse of unnecessary healthcare tests and procedures that do not improve patient outcomes and do run up healthcare costs. Experts estimate the wasteful use of healthcare resources accounts for as much as 30% of current healthcare costs in the United States.

The program is called “Choosing Wisely” (CW). According to a story in Modern Healthcare (MH), “Choosing Wisely” is a campaign to get physicians and patients to discuss whether a particular test is likely to improve patient health or outcome.

Choosing Wisely by Amc Soc Nephrologycrop

Pictured above is the press conference conducted by the American Board of Internal Medicine Foundation (ABIMF) to announce the launch of the “Choosing Wisely” campaign. The goal of this campaign is to reduce overutilization or unnecessary ordering of diagnostic procedures. Each of nine medical specialty associations has put forth a list of specific diagnostic procedures that should be part of this campaign and a number of clinical laboratory tests are on these lists. (Photo copyright by American Society of Nephrology.)

Participating in this initiative are about 375,000 physicians in nine specialty societies. Each of these nine medical specialty groups has identified five diagnostic tests or procedures within their specialty area that warrant re-evaluation by physicians and patients as to whether they will provide useful information or lead to a positive outcome. Clinical laboratory managers and pathologists will be interested to learn that a number of these medical specialty associations have included clinical laboratory tests on their respective lists.

“What we’re asking for is for people to have a conversation,” stated Daniel B. Wolfson, M.H.S.A., ABIM Foundation Executive Vice President and Chief Operating Officer, in the MH story. “These are not rules; they are guidelines used to guide most—but not all—cases,” he explained.

Writing in a commentary in The Huffington Post (HP), Donald M. Berwick, M.D., Chief Executive Officer of the Institute for Healthcare Improvement and former Administrator of the U.S. Centers for Medicare & Medicaid Services, called the program a game-changer. The physician specialty societies support their claims of overuse with copious scientific citations, Berwick noted.

“These societies have shown tremendous leadership in starting a long overdue and important conversation between physicians and patients about what care is really needed,” said Christine K. Cassel, M.D., President and Chief Executive Officer of the ABMF. “Physicians, working together with patients, can help ensure the right care is delivered at the right time for the right patient.” She was quoted in a Choosing Wisely press release.

According to the release, Consumer Reports is working with American Association of Retired People (AARP) and other organizations representing the lay public to get the word out about the “Choosing Wisely” campaign.

Specialist Physicians Identify Some Medical Laboratory Tests for Review

Below are listed the recommendations made by the different medical specialty associations that identify a clinical laboratory test:

American Academy of Allergy, Asthma & Immunology

  • Don’t perform unproven diagnostic tests, such as immunoglobulin G (IgG) testing or an indiscriminate battery of immunoglobulin E (IgE) tests, in the evaluation of allergy.
  • Don’t routinely do diagnostic testing in patients with chronic urticaria.
  • Don’t recommend replacement immunoglobulin therapy for recurrent infections unless impaired antibody responses to vaccines are demonstrated.

American Academy of Family Physicians

  • Don’t perform Pap smears on women younger than 21 or who have had a hysterectomy for non-cancer disease. read article.

American College of Physicians

  • In patients with low pretest probability of venous thromboembolism (VTE), obtain a high-sensitive D-dimer measurement as the initial diagnostic test; don’t obtain imaging studies as the initial diagnostic test.

American Society of Clinical Oncology

  • Don’t perform surveillance testing (biomarkers) or imaging… for asymptomatic individuals who have been treated for breast cancer with curative intent.
  • Don’t use white cell stimulating factors for primary prevention of febrile neutropenia for patients with less than 20% risk for this complication.

American Society of Nephrology

  • Don’t perform routine cancer screening for dialysis patients with limited life expectancies without signs or symptoms.
  • Don’t administer erythropoiesis-stimulating agents (ESAs) to chronic kidney disease (CKD) patients with hemoglobin levels greater than or equal to 10g/dL without symptoms or anemia.

In its coverage of the “Choosing Wisely” initiative, Clinical Laboratory News, a publication of  the American Association for Clinical Chemistry, (AACC) reported that the utilization changes CW seeks may sound like bad news for the lab,. But sometimes these types of program can end up promoting appropriate clinical laboratory testing over other options, the writer noted.

Medical laboratories should emphasize making sure the right clinical lab tests are used at the right time, suggested Stephen E. Kahn, Ph.D., Chair of AACC’s Evidence-Based Laboratory Medicine Committee.

The “Choosing Wisely” initiative, at a minimum, does provide another opportunity for pathologists and clinical laboratory managers to add value to physicians and their patients by helping clinicians have confidence they they are ordering the right test at the right time, supported by evidence-based medicine (EBM) guidelines.

—Pamela Scherer McLeod

Related Information:

U.S. Physician Groups Identify Commonly Used Tests or Procedures They Say Are Often Not Necessary

“Choosing Wisely”: Physicians Step to the Front in Health Care Reform

June 2012 Clinical Laboratory News: Screening Tests in the Age of Austerity

Researchers Predict that Aging Populations in Europe Will Increase Clinical Pathology Laboratory Testing Volume by 69.5% in Only Seven Years

Study evaluated the Western European market for in vitro diagnostic manufacturers

Are clinical laboratories in the United States and other developed nations around the world capable of meeting the expected surge of medical laboratory testing that is expected to come as large numbers of people age into their 60s and 70s? That is a question which has yet to be answered with much confidence by leading healthcare experts.

Recently a respected research firm offered its best guess at what lab specimen growth rates may be and its predictions may surprise many pathologists and clinical laboratory managers. At the same time, the right answer to this important question is critical for lab administrators when planning strategy.

It Takes Years to Expand Capacity of a Clinical Pathology Laboratory

That is because it typically requires years to expand the capacity of a medical laboratory organization. Then there is the challenge of hiring additional pathologists, Ph.D.s, and laboratory scientists at a time when many developed countries already report an acute shortage of trained medical laboratory professionals.

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