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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Two Different Research Teams Announce Tests for Alzheimer’s Disease That Could Be Useful for Clinical Laboratories after Clearance by the FDA

A university research team and a global diagnostics company simultaneously but independently unveil two new tests that accurately identify people predisposed to Alzheimer’s at earlier stages in the disease

Medical laboratory scientists and clinical pathologists have long awaited an accurate and clinically-useful test for the predisposition and early diagnosis of Alzheimer’s disease. Now comes pioneering efforts from two organizations that suggest real progress is being made.

One organization is an academic center and the other is an in vitro company. It was a research team at Rowan University School of Osteopathic Medicine (RowanSOM) that announced development of the first blood test to use the body’s own immune system to detect mild cognitive impairment (MCI), an early stage of Alzheimer’s disease.

Similarly, research scientists for Randox Laboratories unveiled to pathologists, clinical laboratory leaders, and others attending the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting, how their biochip-based technology also could be used to detect elevated risk for Alzheimer’s disease. (more…)

Recent Study Confirms that Clinical Laboratories and Pathologists Have an Opportunity to Help Educate Consumers in Key Health Information, such as Cholesterol, and Blood Glucose Levels

Reviewing medical laboratory test results online is a popular resource among consumers, says a different study by Kaiser Permanente

More than half of patients and consumers have trouble understanding their health information, along with the steps needed to further improve their health, according to a recent study conducted by HealthMine. This gap in consumer understanding represents a great opportunity for clinical laboratories and pathology groups that want to forge stronger bonds with patients and consumers.

In its survey of more than 7,200 healthcare consumers about their health knowledge, HealthMine determined that about 52% of consumers find it difficult to understand their health information and/or what is required of them to maintain or improve their health.

Knowledge of one’s health, or the health of a loved one, is critical to the management of chronic diseases and other health conditions. In this Internet age of patient portals and mobile health devices, the assumption is that most folks would be comfortable using the new technologies. Apparently, this is not the case. At least not among those HealthMine polled. (more…)

Adoption of Quality Management Systems Could Mean Competitive Advantage for Clinical Pathology Laboratories

ISO 15189 is a quality management system  specifically designed for the needs of medical laboratories

Use of quality management systems (QMS) by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.

Going the Extra Mile to Improve Quality Could Be Strategic Opportunity

On all fronts of laboratory medicine, requirements are becoming more stringent. Each year, labs find themselves held to higher standards for compliance with both Clinical Laboratory Improvement Act (CLIA) requirements and Medicare accreditation guidelines. This situation will become further complicated as clinical labs face the need to also meet the requirements of accountable care organizations (ACOs) and similar models of integrated clinical care. Early adopters are responding to these marketplace dynamics by making strategic use of a QMS to boost the performance of their clinical laboratory organizations. As they do, they often gain a competitive advantage. (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

Experts Predict Explosive Growth in Molecular Diagnostics and Next-Generation Gene Sequencing for Clinical Pathology Laboratories

Upcoming Executive War College conference features experts on molecular and genetic testing

Explosive rates of growth in clinical use of molecular diagnostics assays seen in recent years are about to be matched by a new opportunity for medical laboratory testing. Experts predict the coming “big thing” in clinical laboratory and anatomic pathology will be next-generation gene sequencing (NGS).

This should be welcome news for financially-beleaguered pathology groups and clinical lab organizations. Lab tests that incorporate next-generation gene sequencing technologies are expected to offer clinicians greater value by making it possible to more accurately detect and characterize disease at earlier stages. For this reason, these lab tests are expected to be adequately reimbursed by most government and private payers.

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