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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UCLA Researchers Develop Lens-Free Smartphone Microscope, Pathologists May Be Able to Take the Clinical Pathology Laboratory Just About Anywhere

In a trial, the lens-free microscope invention from the UCLA California Nano Systems Institute enabled a board-certified pathologist to detect cancers and other cellular abnormalities at 99% accuracy

One of our favorite innovators is at it again, this time with a device that could eventually allow pathologists to use a device coupled with a smartphone to view cancer and other abnormalities at the cellular level.

At UCLA, Professor Aydogan Ozcan, Ph.D. is already well known for having invented attachments that use a smartphone’s camera to create a tiny, lens-free microscope. Now Ozcan, who is the Chancellor’s Professor of Electrical Engineering and Bioengineering at the UCLA Henry Samueli School of Engineering and Applied Science, has created an inexpensive smartphone device that produces holographic images of tissue samples that allow pathologists to view cancer and other abnormalities at the cellular level, according to a December 17, 2014, Science Translational Medicine (STM) article. (more…)

Genomic Study Reveals Role of Human Papillomavirus in Cervical Cancer and Identifies Novel Therapeutic Targets for the Disease

Findings may help physicians tailor cervical cancer therapies to specific gene mutations and improve the accuracy of diagnostic screening tests for this disease

New scientific knowledge about the role of human papillomavirus (HPV) in the growth of cervical cancer is creating excitement within the medical community. Among other things, these findings could encourage more widespread vaccination against HPV. That in turn would lead to reduced Pap smear testing by pathology laboratories over time.

For these reasons, cytopathologists and cytotechnologists will be particularly interested in the research findings that were published as a first-ever, international genomic study of cervical cancer, which was published online December 25, 2013, at Nature.com. Researchers discovered that the location where HPV integrates itself into the human genome, is where it causes amplified gene expression that promotes and elevates mutated gene activity that may cause cervical cancer to develop. (more…)

Clinical Pathology Laboratories Should Be Aware of New Malpractice Risks from Genetic Testing

Some medical laboratories may be exposed to malpractice suits involving prenatal genetic testing associated with “wrongful birth” claims

Genetic testing is creating a new source of medical malpractice liability and early cases have generated substantial settlements for the plaintiffs. Any clinical laboratory organization or pathologist involved in genetic testing should pay serious attention to this emerging field of malpractice law.

In particular, the media is reporting on malpractice lawsuits that involve prenatal genetic testing that was performed on behalf of parents who were attempting to determine the possibility of serious inheritable diseases in their unborn children.

In these cases, parents of a child born with a debilitating—and frequently financially-devastating—disease that could have been detected by accurate genetic testing are suing their healthcare providers, including medical laboratories. These plaintiffs claim that, through inaccurate genetic testing or lack of available testing, they were denied the choice of terminating a pregnancy that tested positive for serious inherited disease. (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

British Professor Advocates Less Pathology Testing for Cervical Cancer

Professor Peter Sasieni says women vaccinated for HPV may only need two cervical cancer screening tests during their lifetime


Here’s a spicy new subject for debate among pathologists and women’s health specialists. Would it be safe for a woman who has been vaccinated for HPV (human papillomavirus) to get just two cervical cancer screening tests in her lifetime—one at age 30 and the other at age 45? A prominent professor in the United Kingdom recently advocated just such a medical laboratory testing protocol.

Earlier this month, at the United Kingdom’s National Cancer Research Institute conference in Liverpool, England, Professor Peter Sasieni made a presentation about HPV vaccinations and cervical cancer screening that generated press headlines throughout the United Kingdom. Sasieni believes enough progress has been made in vaccinating young women for HPV in the U.K. that it would be clinically appropriate to change the current guidelines for cervical cancer screening.
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