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
Sign In

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.
(more…)

Alberta’s Next Round of Clinical Laboratory Consolidation Alarms Pathologists

Plans are to centralize all cervical cancer screening in just two Alberta medical laboratories


Ongoing efforts to further consolidate clinical laboratory testing in the Canadian Province of Alberta caused local pathologists earlier this year to go on record to specifically oppose a proposed consolidation of Pap Smear testing. Over the past 15 years, the Alberta government has never been timid in its efforts to use consolidation of clinical pathology laboratory testing as a way to achieve cost savings.

During the past winter, more than 30 pathologists in Alberta signed letters to Health Minister Gene Zwozdesky to protest the consolidation of all the province’s Pap Smear testing into just two clinical laboratories—one in Edmonton and one in Calgary. As a result of the government’s decision to consolidate this medical laboratory testing service, cytology laboratories in Lethbridge, Medicine Hat, Red Deer, and the University of Alberta Hospital would no longer perform Pap smear testing.
(more…)

Is New Cervical Cancer Test Better Than a Pap Smear?

Intense research into cervical cancer detection and treatment has yielded significant progress in the past decade. One common cause of such cancer is the human papillomavirus (HPV). New developments involving HPV have produced thin-layer Pap smears, HPV testing, and HPV vaccines. Now, researchers in Italy are reporting a new twist in HPV screening and detection. In research published in the journal Lancet Oncology, Guglielmo Ronco, a cancer epidemiologist at the Centre for Cancer Prevention in Turin, reported that a new way to test for cervical cancer is more accurate than a pap smear alone and identified more dangerous lesions.

Clinicians can improve the specificity of DNA tests for HPV by testing for the presence of a protein that is over-expressed in cervical cancer cells, the new research shows. The molecular test tends to give more false positives, increasing the number of unneeded referrals for colposcopy, Ronco and colleagues reported online in the journal Lancet Oncology. (Carozzi F, et al “Use of p16-INK4A overexpression to increase the specificity of human papillomavirus testing: a nested substudy of the NTCC randomised controlled trial” Lancet Oncology 2008; DOI: 10.1016/S1470-2045(08)70208-0.)

DNA tests for HPV are more likely to pick up cases of high-grade cervical intraepithelial neoplasia (CIN) than conventional cytology, Ronco and colleagues reported. Since the molecular method gives more false positives, it tends to increase the number of unneeded referrals for colposcopy, Dr. Ronco and colleagues reported. To improve specificity, the researchers considered the cyclin-dependent kinase inhibitor p16-INK4A (p16), which is considered to be a marker of HPV infection, according to a report on the findings at www.medpagetoday.com.

Since only a small percentage of women who have an HPV infection actually develop cancer, the challenge for researchers is to identify those who have the highest risk for developing the disease. By testing for a the presence of P16, the researchers said they had identified a biomarker showing cell changes that indicated whether a woman was likely to have pre-cancerous lesions, Ronco and colleagues reported. “The marker shows there was some sort of disruption by the HPV virus,” Ronco said.

“Our data show that in HPV-positive women, p16-INK4A over-expression is strongly associated with the presence of histologically confirmed CIN2+, suggesting that it actually is a marker of progression,” Dr. Ronco said. “This study supports the application of triage by P16INK4A immunostaining in HPV-positive women,” he added.

Data from the U.S. National Cancer Institute show that an estimated 11,000 women in the United States would be diagnosed with this type of cancer and nearly 4,000 would die from it last year. Cervical cancer strikes nearly half a million women each year worldwide, claiming a quarter of a million lives. Studies show 26% of women aged 14 to 59 will contract HPV.

For More Information:

;