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Put It on the Board, 4/16

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Logistics hurdles overcome for single Pap-HPV report

In EHR inboxes, test results outnumbered

Automated cervical cancer screening system approved

Cell-free DNA-Seq kits gain ISO 13485 certification

Mass General will study Philips’ WSI for primary Dx

AMP criticizes FDA action on lab-developed Zika test

DiaSorin to acquire Focus Diagnostics

Logistics hurdles overcome for single Pap-HPV report

Is one test better than two? That question—primary HPV versus the Pap-HPV cotesting option—has roiled the world of cervical cancer screening since the Food and Drug Administration approved a primary HPV screening test in April 2014. However clinicians decide to answer that question, this much is clear: A single report is better than two separate results.

That was the conclusion that leaders at Northwestern Memorial Hospital’s cytopathology laboratory came to in concert with their ob-gyn colleagues after changes were made to cervical cancer screening and management guidelines. At Northwestern, the high-risk HPV/genotyping and the cervical cytology results are combined into a single report that is sent to clinicians through the electronic health record system.

Dr. Nayar

Dr. Nayar

“The clinician needs both results in the case of cotesting [Pap and HPV] and reflex HPV or reflex cytology orders, to make follow-up decisions,” says Ritu Nayar, MD, medical director of Northwestern’s cytopathology laboratory. “Getting the results separately creates extra work at the clinical end since the clinician has to look at two separate results, often at two different times before proceeding with patient management.”

While simple in concept, achieving the combined Pap-HPV report was no easy task, says Dr. Nayar. She is a professor of pathology at Northwestern University’s Feinberg School of Medicine and director of the cytopathology fellowship program at Northwestern’s McGaw Medical Center.

“The issues we had to tackle before implementation included the logistics of combining a clinical pathology-type result with an anatomic pathology report, who would do it, how, what impact ‘informed cytology’—knowledge of the HPV result when looking at the Pap test—would have on cytotechnologists and pathologists, and what the resultant time delay in such a report would be,” she says. After examining workflow and turnaround times, the cytopathology laboratory’s leaders decided it would make the most sense for cytotechnologists to add the HPV result to the cytology report for cotesting and reflex testing.

Samolczyk

Samolczyk

The combined report is then released by either a cytotechnologist or a pathologist, per laboratory and regulatory guidelines. The integrated report is sent to clinicians between one and two days later than each result had been sent individually. Dr. Nayar and Julia Samolczyk, CT(ASCP), Northwestern Memorial’s anatomic pathology manager, worked with the staff in their diagnostic molecular laboratory, their clinician offices and, of course, information technology to make the combined report a reality in September 2014.

From start to finish the process took half a year, but the feedback has “been great,” Dr. Nayar says. “Soon after go-live, I received many calls and emails from our various clinicians thanking us for initiating and completing the process for combined Pap-HPV results. It takes a little longer to get the result out, but there are no complaints.”

The combined reporting is not a first for Northwestern’s cytopathology laboratory. For more than a decade, the lab has produced integrated reports for fine needle aspiration, core biopsy/touch preparations, and on-site evaluation/triage. A survey conducted through the CAP Cytopathology Committee, in which Dr. Nayar participated, found that 47.7 percent of 844 responding laboratories perform on-site evaluation of core biopsies using touch imprints. Eighty-eight percent of these laboratories integrated the touch imprint/core biopsy results into one report, either surgical pathology or cytopathology. Look for more on this topic in an upcoming issue of CAP TODAY in the “Cytopathology and More” section.

Back in the area of cervical cancer screening, Northwestern will soon produce another combined report, for primary HPV testing with reflex cytology. The only wait is for IT testing before the go-live, Dr. Nayar says. She has heard from a handful of other laboratories that are combining their Pap and HPV reports. Dr. Nayar says the idea makes even more sense now that many patients can easily access their own pathology reports and may get the wrong idea when only one set of results is reported.

Careful attention must be paid to logistical factors that involve cytology and molecular diagnostic testing laboratories, IT, and clinicians’ willingness to wait a bit longer to receive the combined report, Dr. Nayar says.

“While it is not required, I think combined reports are in the interest of clinicians and patients,” she says. “Having an integrated, single report from the laboratory can go a long way in improving client satisfaction, quality, consistency, and preventing possible errors. . . . It can take a while, but it is certainly worth the time and effort.” —Kevin B. O’Reilly
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In EHR inboxes, test results outnumbered

Primary care physicians spend more than one hour a day reading, understanding, and acting on electronic health record inbox messages, and the vast majority of those notifications do not relate to test results. Houston-area medical researchers examined three months’ worth of notification logs at three large Texas practices (two primary care, one multispecialty), two of which used the Epic system and one of which used GE’s Centricity (Murphy DR, et al. JAMA Intern Med. Published online ahead of print March 14, 2016. doi:10.1001/jamainternmed.
2016.0209).

Primary care doctors got an average of 77 notifications daily, and just 20 percent were related to test results. Specialists received an average of 29 such notifications daily, with only 36 percent communicating test results. The remaining messages covered a wide array of activity, such as responses to referrals, medication refill requests, and messages from other doctors and health professionals.
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Automated cervical cancer screening system approved

Becton Dickinson has received FDA approval for its BD Totalys MultiProcessor and BD Totalys SlidePrep instruments. Together with the BD FocalPoint SlideProfiler, these products make up the full BD Totalys System, which further automates slide preparation, imaging, and review for use in cervical cancer screening, as well as provides ancillary testing aliquot capability.

The BD DataLink middleware connects the BD Totalys instruments to a laboratory information system, improving efficiency while providing continuous sample tracking to ensure patients get the right results.
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Cell-free DNA-Seq kits gain ISO 13485 certification

Bioo Scientific announced that its Nextflex Cell Free DNA-Seq Kits for the construction of libraries for cell-free DNA sequencing are now manufactured under ISO 13485 certification.

The company’s Nextflex BRCA1 and BRCA2 Amplicon Panels also are manufactured under ISO 13485 certification. Bioo Scientific is in the process of moving the manufacture of the NextPrep-Mag cfDNA Isolation Kits under the umbrella of ISO 13485 certification. The company said the rigorous medical device certification is a critical step in its efforts to deliver industry-leading reagents to laboratories that depend on quality-assured genomic tools.
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Mass General will study Philips’ WSI for primary Dx

Royal Philips announced that Massachusetts General Hospital will serve as a key testing site for a multicenter instrument precision study involving Philips’ digital pathology whole slide imaging IntelliSite Solution. The study is designed to show the reproducibility of the IntelliSite pathology solution in disease detection as part of the industry’s efforts to obtain regulatory clearance of WSI for primary diagnostic use.

“Through this study we hope to provide evidence for regulatory purposes that this technology is valid and reliable for primary diagnostic use,” Veronica Klepeis, MD, PhD, the key enrollment pathologist in the study, said in a statement.

Recent discussions with the FDA have the potential to streamline the regulatory clearance pathway for digital pathology WSI.
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AMP criticizes FDA action on lab-developed Zika test

The Association for Molecular Pathology says it “is very concerned and disappointed” about the FDA’s letter to the Texas developers of a molecular test that can detect Zika virus-specific RNA sequences in a large metropolitan area.

“Given the ongoing outbreak of the infection and risk of infection in the Houston area, these types of tests are critical for patient care and should be made available to these patients in need,” the AMP said in an organizational statement. The action “is another clear example” of how the FDA’s plan to require premarket review of many laboratory-developed procedures “would hinder patient access to vital medical services,” the AMP said.

The FDA has granted emergency-use authorization for antibody testing at the Centers for Disease Control and Prevention or state public health laboratories. But that testing “will not provide results in the timely fashion needed for immediate patient care,” the AMP said. “In addition, antibody testing has limitations mitigated by molecular testing for Zika.”

The FDA’s March 2 “It Has Come to Our Attention Letter” said the Zika test, developed by physicians at the Texas Children’s and Houston Methodist hospitals, “appears to meet the definition of a device” under federal law.

“We believe you are offering a high-risk test that has not been the subject of premarket clearance, approval, or Emergency Use Authorization review by the Food and Drug Administration,” wrote James L. Woods, deputy director of patient safety and product quality in the Office of In Vitro Diagnostics and Radiological Health. The letter requests more information to “better understand the test’s design, validation, and performance characteristics, and in addition, CDC and CMS have asked us to review the science behind your test.”

In a statement, Houston Methodist communications director Stefanie Asin said the two hospitals “are working collaboratively with [the FDA] and sharing information” about the test. She said the agency has not asked the hospitals to stop performing the test, which is offered only to patients registered at Houston Methodist or Texas Children’s.
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DiaSorin to acquire Focus Diagnostics

DiaSorin will buy Quest’s Focus Diagnostics immunodiagnostic and molecular diagnostic products business for $300 million in cash. The deal includes all the tangible and intangible assets of Focus used to develop, manufacture, and distribute its molecular diagnostic products and its traditional immunoassay ELISA products, including relevant intellectual property, contracts, and customer list.

Focus’ products include the Simplexa molecular product line, Her­peSelect HSV serology, and the line of DxSelect IFA and ELISA assays. DiaSorin expects to continue to manufacture Focus products from the company’s base facility in Cypress, Calif., where about 180 employees are employed in manufacturing, research and development, sales and marketing, and administration. The acquisition will be carried out by DiaSorin through a newly created U.S. affiliate and is expected to be completed by mid-2016. In 2015, the Focus products business brought in $80 million in revenue, about 80 percent of which came from sales to U.S.-based customers.
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Quest acquires PhenoPath
November 2018—Quest Diagnostics has acquired PhenoPath Laboratories, which provides immunophenotyping, hematopathology, and molecular pathology services. The PhenoPath business, in Seattle, will operate as part of AmeriPath, a wholly owned business of Quest. Steve Rusckowski, Quest chairman, president, and CEO, said in a statement: “PhenoPath has a strong record of innovation and provides several capabilities that complement and extend our own, particularly in pathology and molecular oncology. It also deepens our presence in the Pacific Northwest.” PhenoPath founder Allen Gown, MD, tells CAP TODAY that continued consolidation in the laboratory industry and insurance reimbursement challenges have posed significant risks to PhenoPath’s future growth. “In Quest/AmeriPath,” he says, “we found an organization that realized not only the excellence of PhenoPath’s past and present but also the extraordinary future that, with their assistance, we can have.” Dr. Gown founded PhenoPath in 1998.

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