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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Second National Journalism Award Goes to The Dark Report and Robert Michel

Best Investigative Reporting honors earned for story about problems with Vitamin D testing

Top honors in a prestigious national journalism competition were recently awarded to our sister publication, The Dark Report. Editor-In-Chief Robert L. Michel traveled to Washington, DC, to accept the first place award for “Best Investigative Reporting.”

The occasion was the 33rd annual conference of the Specialized Information Publishers Association (SIPA). Handing Editor Robert Michel his first place award was Nora O’Donnell, News Anchor and Political Reporter for NBC News and MSNBC. (more…)

Medical Errors Become a Headline News Item

Consumers raise the bar on expectations of error-free healthcare

Multiple cases of medical errors hit the headlines in recent months. Collectively, these headlines raise an interesting point. Patients and the public at large have changed expectations about the quality of healthcare. Consumers increasingly expect medical services to be error-free. When news surfaces that a provider committed a pattern of medical errors over an extended period of time, it becomes a major news story. (more…)

Quest Diagnostics Undertakes Patient Retest Program Due to Inaccurate Test Results

Starting in October, Quest Diagnostics Incorporated (NYSE:DGX) has quietly notified certain physicians and patients that it had reported “inaccurate” lab test results for Vitamin 25(OH) D. This ongoing campaign appears to be the largest voluntary patient recall/retest program known to have been instituted by a clinical laboratory company.The Dark Report and Dark Daily are first to report this remarkable story. Quest Diagnostics has told The Dark Report that, for a period of time in 2007 and extending into 2008, it reported inaccurate results for Vitamin 25(OH) D to some patients. The problem is related to Quest Diagnostics’ decision, several years ago, to switch away from immunoassay methods for Vitamin 25(OH) D testing and create a home brew assay that utilizes liquid chromatography-tandem mass spectrometry (LC-MS/MS).

To date, Quest Diagnostics’ voluntary program to alert physicians and patients to possibly inaccurate Vitamin 25(OH) D results seems most active in the Northeast. In particular, competing labs in the New York metropolitan area are reporting their belief that thousands of physicians have gotten letters from Quest Diagnostics informing them that certain of their patients had received unreliable results for Vitamin 25(OH) D tests performed during the period in question. Quest Diagnostics is offering a free retest to these patients, subject to the referring physicians’ authorization of the retest.

This rare campaign by Quest Diagnostics to alert physicians and patients and to offer free retesting is significant for a number of reasons. First, it is extraordinarily rare for any licensed, accredited laboratory in this country to acknowledge that, due to internal deficiencies in analytical processes, it reported unreliable test results on a sizeable number of patients over a specified period of time.

Second, Quest Diagnostics’ program to alert physicians and patients about the questionable Vitamin D test results and offer a free retest provides the entire laboratory industry with a management case study on how to respond to a laboratory discovers that significant numbers of patients and their physicians might have received unreliable test results that could negatively affect patient care.

Third, because the source of the unreliable Vitamin 25 (OH) D test results is a home brew assay, this episode could catch the attention of federal and state healthcare regulators. For example, the Food and Drug Administration (FDA) is known to want more authority to regulate laboratory-developed tests (LDTs), commonly called “home brew” tests.

Fourth, this recall/retest campaign has the potential to involve large numbers of physicians and patients. That is because the volume of Vitamin D testing tripled at Quest Diagnostics between May 2006 and May 2008, and Web sources report that Quest Diagnostics is doing as many as 500,000 Vitamin D tests each month. Accordingly, even a tiny percentage of the millions of Vitamin D home brew tests performed at Quest Diagnostics during this time could mean that tens of thousands of patients may be getting recall/retest letters from Quest Diagnostics. The number of patients and physicians affected by this episode may motivate federal and state healthcare regulators to take a closer look at what internal deficiencies created this problem at the nation’s largest lab company.

The current issue of The Dark Report provides detailed coverage of these events. This issue has been distributed to existing subscribing members. To see the individual intelligence briefings, use this link (or paste this URL in your browser: http://www.darkreport.com/dark/past.htm) For more information on Charter Memberships go here.

Dark Daily asks that anyone with knowledge of this remarkable story about inaccurate Vitamin D results and willing to share insights can contact editor Robert L. Michel in complete confidence at rmichel@darkreport.com or by dialing 512-264-7103.)

Additionally, Dark Daily would be interested in the opinions, advice, and questions that laboratory professionals have on this voluntary program of Vitamin D retesting. Because it provides a rare opportunity to learn how clinical laboratories and pathology groups should improve their own contingency plans, Dark Daily intends to provide ongoing news and intelligence about the full spectrum of issues triggered when a laboratory discovers it has reported inaccurate results to significant numbers of physicians and their patients.

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Lab Acquisition Activity Stays Busy as Stanford and Carilion Negotiate with Buyers

With demand driving prices to record levels for clinical laboratory companies and anatomic pathology practices, merger and acquisition (M&A) activity in the lab industry continues to grow across the United States.

Just two weeks ago, Sonic Healthcare, Ltd. announced that it was purchasing Clinical Laboratories of Hawaii, LLP for an estimated $121 million dollars. That sale is expected to be completed by the end of third quarter this year. (See Dark Daily, June 30, 2008)

Still unannounced as of this date are the winning bidders for the laboratory outreach business of Stanford University Medical Center and the laboratory testing division of Carilion Clinic. Earlier this year, officials from both institutions disclosed that their laboratory businesses were up for sale. (See Dark Daily, April 15, 2008)

At this year’s Executive War College in May, attendees participated in the lab industry’s first-ever conference on “Mergers & Acquisitions in Clinical Laboratories and Anatomic Pathology,” a program designed to bring potential sellers of clinical labs, pathology groups, and hospital lab outreach programs together with experts in law, valuation, negotiation, and financial planning.

Two speakers attracted particular attention: Doug Brown, Managing Director of Wachovia Securities and attorney Antony Konkoly, Esquire, of McDonald Hopkins.

Brown provided a concise review of the factors supporting higher valuations for laboratory assets and discussed details of some recent noteworthy lab acquisitions. According to Brown, lab owners need to recognize that there is no simple way to establish a single value for their laboratories because different buyers will place different values on a lab company’s existing assets and future growth prospects.

Brown also discussed details of the 2007 acquisition of AmeriPath, Inc. by Quest Diagnostics, Inc. for approximately $2 billion. With annual revenue of $750 million, it was estimated that the multiple paid in this transaction was as high as 17 times EBITDA (earnings before interest, taxes, depreciation, and amortization). Brown pointed to several unique factors, including market timing, that supported AmeriPath’s top-of-market valuation at the moment the deal was inked. He also explained that these same factors were not likely to be seen in the laboratory industry again anytime soon.

In this same session, Antony Konkoly offered some important M&A do’s and don’ts based on his considerable experience representing various parties in the sale of laboratory businesses, the establishment of laboratory joint ventures and the formation of new lab companies.

If you weren’t able to participate in this exciting new M&A conference, here’s another opportunity to hear Doug Brown’s take on the current state of mergers and acquisitions in laboratory and pathology.

Attorney Antony Konkoly, Esq. will once again join Doug Brown in this discussion. From Konkoly, you’ll learn about the mistakes lab sellers often make, and how you can fix those issues before offering your laboratory for sale. You’ll also get several proven recommendations on how to minimize tax consequences and maximize the net proceeds from the sale.

Whether you’re a lab owner or pathologist, you won’t want to miss this comprehensive new audio conference. Join Dark Daily and The Dark Report as they present, “Lab and Pathology Mergers & Acquisitions: Must-Have Essentials To Learn Before You Buy Or Sell A Lab,” on Wednesday July 30, beginning at 1:00 p.m. EDT (10:00 a.m. Pacific) and running for 90 minutes.

Don’t miss this special audio conference and your chance to listen to and ask questions of these two veteran lab industry dealmakers.

Register on or before July 18, 2008 and you’ll save $50. So don’t wait-Register today! http://www.darkreport.com/Audio/7.30.08/audio-register.htm

Sonic Healthcare Acquires Labs in USA and Switzerland

Sonic Healthcare was busy in the month of May. Last Thursday, on May 31, it announced the acquisition of a laboratory company in Zurich, Switzerland. Earlier, on May 1, it acquired Mullins Laboratory of Augusta, Georgia. Sonic Healthcare has also won a hospital laboratory contract in the United Kingdom.

Sonic Healthcare will pay US $80 million to purchase Medica Medizinische Laboratorien. Medica has annual revenues of approximately US $44.9 million. It is one of the larger laboratory companies in Switzerland. Sonic intends to keep the existing management team in place, under the leadership of Medica’s current CEO, Dr. Franz Käppeli.

With little fanfare and even less publicity, Sonic Healthcare, Ltd. acquired Mullins Laboratory. Sonic Healthcare did not issue a press release to announce the acquisition. Mullins Laboratory is a private independent laboratory company that was founded in 1954. In recent years, it has been operated by Stephen C. Mullins, M.D., whose father founded the lab company. Mullins is a pathologist boarded in clinical and anatomic pathology, as well as dermatopathology.

With five pathologists and annual revenues estimated in the $17 million range, Mullins Laboratory serves office-based physicians in Augusta, Georgia and nearby communities. With a population of 195,000, Augusta, is Georgia’s second largest city and is located about 150 miles east of Atlanta. Augusta is a self-contained market for laboratory services and Sonic Healthcare’s business strategy is to maintain the acquired laboratory’s name, local identity, and existing staff. The nearest laboratory division owned and operated by Sonic Healthcare is located in Orlando, Florida, about 400 miles south of Augusta. It is Cognescenti Health Institute and was acquired by Sonic Healthcare last fall.

Earlier this year, in the United Kingdom, Sonic Healthcare won a management contract to provide pathology services to the Ealing Hospital NHS Trust and Ealing Primary Care Trust in north London. Sonic will manage the hospital laboratory and provide laboratory testing services to the primary care clinics affiliated with the trust. The contract is for five years and is like a similar agreement recently signed by Quest Diagnostics Incorporated with West Middlesex University Hospital and the Hounslow Primary Care Trust in north London. The management contract commences in the summer of 2007 and has a five-year term.

Since acquiring Clinical Pathology Laboratories (CPL) in Austin, Texas, in 2005, Sonic Healthcare has been steadily expanding its operations in the United States. Last year it acquired Cognescenti Health Institute in Orlando, Florida, and American Esoteric Laboratories, based in Nashville, Tennessee. Lab directors and pathologists should expect to hear about more laboratory acquisitions by Sonic Healthcare. The company is in active negotiations with a number of independent lab companies.

Related articles:

Sonic Healthcare acquires Medica group

Sonic Healthcare Acquires The Medica Laboratory Group in Switzerland

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