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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Auckland Hospital Laboratories Play Defined Role in Supporting Patient Care

Highly-automated hospital labs are organized to serve inpatient testing and don’t compete for “outreach” lab business from office-based physicians in the community

DATELINE: AUCKLAND, NEW ZEALAND—In this nation’s single payer health system, clinical laboratory testing services are allotted to hospital laboratories and commercial laboratories in very specific ways. Consequently, hospital laboratories in New Zealand tend to provide testing primarily for inpatients and for outpatients seen by specialists who practice within the hospital’s facilities.

This is an interesting distinction which sets New Zealand hospital laboratories apart from hospital labs in such countries as the United Kingdom, the United States, Canada, and Australia. In each of these countries, it is common for hospital laboratories to provide some laboratory testing to the outpatient and outreach sector, particularly to primary care clinics and office-based specialist physicians.

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James Peter, M.D., Ph.D., Founder of Specialty Laboratories, Dies of Cancer

Peter Built His Company into a Major National Esoteric Laboratory

One of laboratory medicine’s most successful scientist-entrepreneurs died last Friday, October 30, 2009. James B. Peter M.D., Ph.D., Founder of Specialty Laboratories, Inc., died in his home in Santa Monica, California of complications from cancer. He was 76 years old.

A native of Omaha, Nebraska, it was 1958 when Peter earned his M.D. from St. Louis University. He then went to the University of Minnesota where he earned a Ph.D. in Biochemistry in 1963. It was here that he worked with Professor Paul D. Boyer, Ph.D., a laureate for the 1997 Nobel Prize in chemistry. Peter also worked with Boyer at UCLA. At UCLA, Peter served as Professor, Clinical Professor, and College of Letters and Sciences Advisory Board Member. He had a strong interest in clinical chemistry and immunology.

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HITECH ACT Mandates New Patient Privacy Requirements on Labs and Pathology Groups

Labs Must Report Privacy Breaches of 500 or More to the Media

Call it HITECH collides with HIPAA! Most pathologists and lab executives know that passage of the HITECH Act was the part of 2009’s American Recovery and Reinvestment Act (also referred to as “ARRA” or the “stimulus bill”). HITECH provides incentives for the expanded use of electronic health records by physicians and other providers.

But what is lesser known is how the HITECH Act creates new legal obligations of covered entities and business associates under the Health Insurance Portability and Accountability Act of 1996 (HIPPA). These new legal mandates are designed to protect the privacy and security of the patient. They require clinical laboratories and all providers to take specific actions whenever patient privacy is breached.
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FDA Panel to Consider Digital Pathology and Whole Slide Imaging

Are digital whole slide imaging systems ready to replace conventional light microscopy for diagnostic surgical pathology?

Next week, an FDA committee will consider whether to allow pathologists to use digital pathology systems for primary diagnosis. Even if the committee does not make a positive recommendation, the timing demonstrates the swift progress in the quality of digital pathology images and the systems that present them to the pathologists.

Digital pathology imaging systems are slowly replacing microscopes in the nation’s clinical labs. There is now enough momentum in the market for digital pathology imaging that the FDA’s Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee will meet October 22 and 23 in Gaithersburg, Maryland, to hear from experts in digital imaging. (See agenda) The FDA review committee may later make recommendations on the public health issues related to the use of digital whole slide imaging systems to replace conventional light microscopy for diagnostic surgical pathology.
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Genetic Test for Celiac Disease Is Marketed Directly to Consumers Via Internet

Prometheus Laboratories targets millions of individuals with undiagnosed celiac disease

Direct-to-consumer (DTC) testing for celiac disease is now a reality. One company is now marketing a saliva-based genetic test that allows a patient to request, administer, and check the results of the test without leaving his or her home!

The market for this test is substantial. According to the National Digestive Diseases Clearinghouse’s web site, more than two million people in the United States have the disease, or about one in 133 people. A significant number of these individuals are undiagnosed or misdiagnosed celiac victims, which is why a DTC test may prove to be a marketplace winner.

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