College of American Pathologists
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CAP Today




January 2012

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Baldrige quality honor for Henry Ford

The White House in April will present to Detroit’s Henry Ford Health System a 2011 Malcolm Baldrige National Quality Award. The health system is one of only four 2011 Baldrige award recipients and the only winner of the award in Michigan.

“For our system, this is an incredible recognition and validation of what we do every day for our citizens of southeast Michigan and especially in one of the poorest cities in America,” Richard J. Zarbo, MD, DMD, senior vice president and ward chair, Pathology and Laboratory Medicine, Henry Ford Health System, told CAP TODAY. The quality for which HFHS received the award was a five-year systemwide quest by a workforce of nearly 30,000.

“We were given the award on our first site visit, which is also quite an accomplishment, as is the fact that this was awarded to a large health care system, not a single hospital medical center,” Dr. Zarbo says.

HFHS’ integrated laboratory service line was the first integrated clinical service line in the system. It encompasses five acute care hospital laboratories and 30 regional medical center labs.

“We have distinguished ourselves in process improvement and practice-based advances,” Dr. Zarbo says of Pathology and Laboratory Medicine and crediting the Henry Ford Production System, the philosophy of W. Edwards Deming, and the Toyota Production System. The Henry Ford laboratory management system, now in its seventh year, is “powered by an empowered workforce,” he says, and operates by the motto “Relentlessly pursuing perfection.” HFHS laboratories in 2010 made 1,392 process improvements.

“Through effective laboratory management and manufacturing-based quality improvement techniques and designs, we continuously target a reduction in process defects and waste” to ensure patient safety and timeliness of reporting and to increase productivity, employee engagement, and customer satisfaction, Dr. Zarbo says. He and others in laboratory management at Henry Ford teach the principles and tools of process improvement throughout the year and will soon begin their fourth year of doing so.

HFHS is a market leader in the area it serves and has increased its inpatient market share by an average of three percent per year since 2004. Despite an increase in uncompensated care from about $130 million in 2007 to about $200 million in 2010, HFHS maintained a positive net operating income during that period of more than $25 million per year. Satisfaction with Henry Ford medical centers exceeded the 90th percentile level for southeast Michigan in a 2011 Press Ganey survey, with 80 percent of patients saying they were likely to recommend the organization.

Congress established the Baldrige award in 1987 to recognize U.S. corporations for their process excellence and to publicize their successful strategies.

‘A step toward integrated diagnostics’

Agfa HealthCare has developed and implemented a comprehensive solution that integrates digital pathology with x-ray imaging and informatics through the company’s Impax picture archiving and communication system (PACS) platform. The solution, in clinical review at La Pitié-Salpêtrière Hospital in Paris, includes a high-throughput, whole-slide–scanning device coupled with dedicated workstations for viewing digital pathology images.

Once slides are digitally scanned, the pathologist can select regions of interest to be integrated automatically into the Impax PACS. Combining digital pathology and radiology images on the same image-management system improves multidisciplinary team discussions, such as tumor boards, and education within teaching hospitals; enhances research; and makes peer review more convenient. Integration also optimizes workflow in terms of image management and facilitates collaboration among clinicians, radiologists, and pathologists.

“Combining radiology and pathology images represents a critical step toward integrated diagnostics where a multidisciplinary approach and subspecialization are highly used, such as in a large teaching hospital,” says Philippe Grenier, MD, professor and head of radiology at La Pitié-Salpêtrière.

Agfa HealthCare’s digital pathology solution is in the preclinical validation phase and expected to be available this year.

Referral of proficiency testing samples—laboratory wins administrative appeal

A laboratory has prevailed in an administrative appeal of a case in which the Centers for Medicare and Medicaid Services cited it for intentionally referring proficiency testing samples to another laboratory for analysis.

In J.B. and Greeta B. Arthur Comprehensive Cancer Center v. CMS, an HHS Departmental Appeals Board administrative law judge decided that CMS could not revoke the CLIA certificate of the cancer center laboratory based on it having sent unused portions of the PT samples to a lab operated by Audrain Medical Center, of Mexico, Mo., with which the cancer center is affiliated. The medical center’s laboratory tested the samples, which had been sent to it for storage, before the cancer center lab reported its PT results. The cancer center’s position was that testing of the PT samples by another laboratory was not in and of itself a basis on which to find that a sample had been referred to another lab for analysis.

The ALJ agreed, finding it significant that the cancer center laboratory did not direct the medical center to test its PT samples and did not require or suggest that the medical center advise it of its own test results. The ALJ said it was clear that “the prohibition is against the sending of the proficiency samples to another laboratory for analysis. The intent requirement is not met by the simple act of sending PT samples to another laboratory.”

The decision was issued Sept. 21, 2011. No appeal was filed before the appeal period ended at the end of November, says the attorney for the laboratory, Robert Mazer of Ober/Kaler in Baltimore.

Mazer advises “extraordinary care” in handling and testing PT specimens, saying seemingly minor violations of protocols can lead to allegations of specimen referral. “CMS has revoked the CLIA certificates of laboratories that had no intention of violating the PT referral prohibition,” he says.

If a laboratory believes it has not violated the referral prohibition and cannot reach an agreement with the CMS that would permit it to retain its CLIA certificate, it should consider requesting an ALJ hearing, Mazer says.

FDA approves Cervista automation

Hologic has received FDA approval for its Cervista HTA (high throughput automation) system for use with the company’s previously approved Cervista human papillomavirus HR test. The test uses Hologic’s proprietary Invader technology to detect 14 high-risk types of HPV associated with cervical cancer and precancerous lesions.

The Cervista HTA system automates the DNA extraction and detection steps of the HPV HR test, allowing users to walk away after loading the instrument and return the next morning to review the test results. It can process multiple batch sizes of samples, making it possible for mid- to high-volume laboratories to use Hologic’s automation and reagents efficiently.

CLIA waiver for rapid HCV test

The FDA has granted a CLIA waiver to OraSure Technologies for its OraQuick HCV rapid antibody test for use with fingerstick whole blood and venous whole blood specimens. The test provides results in 20 minutes.

OraSure has entered into agreements with Merck to collaborate on the development and promotion of the OraQuick HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in physician office markets in the United States and internationally. The CLIA waiver will enable physicians to use the test in their offices.

Pertuzumab for HER2-positive metastatic breast cancer

Roche recently announced results from CLEOPATRA, the first randomized phase three study of the investigational HER2-targeted medicine pertuzumab. The study compared the combination of pertuzumab, Herceptin (trastuzumab), and docetaxel chemotherapy to Herceptin and docetaxel alone in patients with pre-viously untreated HER2-positive metastatic breast cancer. Those who received pertuzumab in combination with Herceptin and chemotherapy experienced a 38 percent reduction in the risk of their disease worsening or death (progression-free survival), (HR=0.62; P<0.001). The median progression-free survival improved by 6.1 months, from 12.4 months for Herceptin and chemotherapy to 18.5 months for pertuzumab, Herceptin, and chemotherapy.

No new safety signals were observed and adverse events were consistent with those seen in previous studies of pertuzumab and Herceptin, in combination or alone. The results were presented last month at the San Antonio Breast Cancer Symposium and published Jan. 12 in the New England Journal of Medicine (Baselga J, et al. 366:109–119).