CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
“We have insights from our pharmaceutical partners as to what programs they might be bringing to the clinic in eight or 12 or 24 months down the line,” he says. “Because of that, our test content tends to be forward-looking. If we’re exactly on guideline, then almost by definition we’re going to be behind. By adding Roche’s insight—they have one of the world’s deepest pharma pipelines—we will certainly improve the content of our tests.”
Foundation Medicine will remain operationally independent and will continue to be run by president and CEO Michael J. Pellini, MD.
ACLA’s legal eagles slam FDA ‘overreach’ on LDTs
The American Clinical Laboratory Association released a white paper that aims to provide a systematic and detailed rejection of the FDA’s proposal to extend its regulatory authority over laboratory-developed tests by reclassifying them as medical devices.
The white paper, written by former Bush administration solicitor general Paul Clement and Harvard University constitutional law professor Laurence Tribe, was released a day ahead of the FDA’s two-day January public hearing on its proposal to phase in regulation of LDTs over the course of a decade.
“FDA’s novel effort to expand its jurisdiction is foreclosed by the plain text of the FDCA [Food, Drug, and Cosmetic Act],” Clement and Tribe wrote. “Congress gave FDA the authority to regulate medical devices, and laboratory-developed testing services are not devices.”
The 25-page ACLA white paper dubs the FDA’s LDT oversight proposal a “dramatic overreach,” and advises the agency to withdraw its draft guidance. The document is available at http://j.mp/aclaldts.
Meanwhile, the two-day FDA hearing featured a wide array of testimony from stakeholders. Several speakers representing the CAP urged the FDA to make significant changes to its plan. Among the objections is that the agency’s proposal would classify too many tests into a high-risk category.
“Based on the draft guidance as written, we estimate 1,000 LDTs considered to be companion diagnostics will be classified as high-risk LDTs and require [premarket approvals] despite these tests being well-established in medical practice and the standard of care,” said Gail Vance, MD, a member of the CAP’s Personalized Health Care Committee.
The CAP also recommended that an LDT used within a health care network be treated as a “traditional LDT” exempt from premarket approval. In addition, minor changes to LDTs should not be treated as entirely new tests, said Emily Volk, MD, vice chair of the CAP’s Council on Government and Professional Affairs Committee.
“Some laboratories have modified a test to automate a manual method,” Dr. Volk said. “The clinical claim and performance characteristics for the test do not change.”
CAP president Gene N. Herbek, MD, expanded on these and other points in written comments submitted to the FDA on Feb. 2. The 58-page document is at http://j.mp/capldtletter.
“There are significant differences in how our proposal defines an LDT and the risk classification for LDTs,” Dr. Herbek wrote. “We also differ in our view of the appropriate role of CLIA and the CMS within the regulatory process.”
Report: Where mistakes are most likely to occur
An analysis of nearly 2,700 diagnosis-related malpractice cases in ambulatory care finds that foul-ups in testing and results processing were the least likely source of missed or delayed diagnoses.
Twenty-nine percent of the cases involved testing failures of some kind, “from the scheduling, performance, and interpretation of diagnostic tests, through the management of test results,” the report said. Fifty-eight percent of cases involved the initial diagnostic assessment, and 46 percent of cases were follow-up and coordination failures.
Within testing, “the factors that trigger malpractice allegations are primarily related to breakdowns in clinical systems for test result management, the cognitive skills related to interpretation, and communication of results to the ordering physicians,” said the report, released by CRICO Strategies, a division of the Risk Management Foundation of Harvard Medical Institutions.
Missteps in test performance included failing to perform ordered tests, incorrectly performing the tests, and mishandling or mislabeling the specimens. These contributed to just three percent of the diagnostic errors examined, and pathology was identified as the primary responsible service in just 16 percent of these cases, said Gretchen Ruoff, MPH, of CRICO, who provided some pathology-specific data not in the report. Another area within testing that contributed to five percent of diagnostic errors was the ordering physician not having received or reviewed the test result, or having done so after a significant delay. Pathology was pinpointed as the responsible service in only six percent of these results-communication mixups.
Mistakes in interpretation, involved in 23 percent of the testing-related cases analyzed, included incomplete or inaccurate reports and failure to rule out abnormal findings.
There were 608 cases involving a misinterpreted test, said the December report, “2014 Annual Benchmarking Report: Malpractice Risks in the Diagnostic Process.” The service responsible for the final diagnosis in these cases was most frequently radiology, accounting for 49 percent of the misinterpretations. By comparison, 17 percent of misinterpretations involved pathology, in areas such as benign neoplasms, uterine or cervical cancer, and skin cancer. So, of the 2,685 ambulatory-based diagnosis-related malpractice cases analyzed, fewer than four percent involved misinterpretations by a pathologist.
—Kevin B. O’Reilly