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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Rice University Researchers Publish Study about Variation in Drop-to-Drop Samples of Capillary Blood Collected by Fingerprick and Used for Clinical Laboratory Testing

Researchers determined that as many as nine successive capillary blood drops must be collected and tested to achieve results that would be comparable to testing with venous blood

A new study is raising questions about the implications of using fingerprick blood samples for point-of-care tests. Done by researchers at Rice University’s Department of Bioengineering, the study suggests clinicians use measurements with caution when assessing patients’ conditions based on the results of clinical laboratory tests using a single drop of capillary blood collected by fingerstick.

Pathologists and clinical laboratory scientists were quick to call attention to the study, based on the press release Rice University issued. That’s because, for almost 30 years, medical laboratories have struggled to correlate the results for such biomarkers as glucose. It is common for capillary blood specimen collected by finger stick and tested on a point-of-care device to produce different results for the same patient when compared with that of a venous specimen tested on the automated, high-volume analyzes in a central laboratory. The Rice researchers offer useful insights about such variation. (more…)

Two FDA Inspection Reports Show Theranos’ Blood-Collection ‘Nanotainer’ Was an Uncleared Class II Medical Device

FDA details findings from visits by five federal inspectors at California clinical lab company over 10 days in late August and early September; heavily redacted reports outline 14 compliance deficiencies

Two reports released Tuesday by the Food and Drug Administration (FDA) brought more bad news to Theranos, of Palo Alto, California. The clinical laboratory company has been the subject of much unwanted press coverage since October 15. In the FDA inspection reports, Theranos is required to explain or correct each of 14 “inspectional observations.”

Pathologists, clinical laboratory scientists, and in vitro company executives who take the time to read both FDA reports about the federal agency’s inspection of Theranos will find insights into how FDA assessors view the lab company’s compliance with FDA regulations and requirements. There were 14 issues described in the two FDA reports.

FDA Said Theranos Nanotainer Blood-Collection Container Is Class II Medical Device (more…)

Theranos Selects Phoenix Metro to Plant Its Flag and Enter the Competitive Market for Clinical Pathology Laboratory Testing

As predicted by Fortune Magazine in its coverage of Theranos, with its expansion into Phoenix, the lab company is getting its closest scrutiny from pathologists and medical technologists

Recent developments in Phoenix, Arizona, make it clear that Theranos has chosen this desert metropolis to be the launching pad for its much-publicized proprietary clinical laboratory testing business.

The highly-secretive company, which claims to have more market value than either Quest Diagnostics Incorporated (NYSE: DGX) or Laboratory Corporation of America (NYSE: LH), is now building the infrastructure needed to operate as a local medical laboratory company in Phoenix.

Theranos Has CLIA Laboratory in Scottsdale

The April 20 issue of The Dark Report presented two exclusive intelligence briefings about Theranos and its business plans. The company now has its “wellness centers” operating in about 41 Walgreens pharmacies throughout the Phoenix metropolitan area. It has opened a clinical laboratory facility in Scottsdale and is currently working to acquire its CLIA certification. When certified, this lab facility will allow Theranos to perform testing locally, eliminating the need to transport all specimens to its CLIA lab in Fremont, California. (more…)

Wall Street Journal Writes about Federal Investigation of Health Diagnostic Laboratory and Certain Specialty Medical Lab Test Companies

Did “processing fees” paid by certain clinical laboratory companies to physicians represent an inducement that violated federal anti-kickback laws?

Once again, allegations of fraudulent practices at a fast-growing clinical laboratory company have made national headlines. This time it was a front-page story in The Wall Street Journal (WSJ) that last week discussed the controversy surrounding Health Diagnostic Laboratory (HDL) of Richmond, Virginia.

According to the WSJ story, federal healthcare authorities are looking into a practice by HDL and other medical laboratory companies of paying physicians “to process” blood specimens collected in their offices. As described by the WSJ, this “processing fee” was as much as $20 and included a $3 portion for the venipuncture. (more…)

Ratings Agencies Go Negative on Not-for-Profit Hospitals for 2014; Their Projections Signal Fewer Resources for Hospital-based Clinical Laboratories

This hospital industry sector is expected to achieve lower growth rates and less revenue and are likely to reduce operating budgets for medical laboratories

Tough financial times are ahead for not-for-profit hospitals, according to the projections of multiple rating agencies. Financial analysts attribute this to an extended period of massive and disruptive change. This is not good news for hospital-based clinical laboratory managers and pathology groups.

Big Three credit-rating agencies Moody’s Investors Service (NYSE: MCO), Fitch Ratings, and Standard & Poor’s Financial Services LLC (S&P) echoed a common theme in their 2014 outlooks for not-for-profit hospitals, which represent 60% of the nation’s hospitals. Environmental pressures will suppress revenue growth, while fresh cost-cutting measures will become increasingly harder to find. (more…)