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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Clinical Pathology Laboratories in the United States Face Tougher Accreditation and CLIA Environment

Federal and state laboratory regulators tighten down during inspections of nation’s medical laboratories

Across the United States, medical laboratory accreditation and CLIA compliance is quietly getting tougher. This is a trend which affects every clinical laboratory and anatomic pathology medical group that must comply with CLIA and meet the accreditation requirements of the Medicare program.

One sign that laboratory accreditation and compliance is getting tougher is the increased number of hospital laboratories willing to publicly acknowledge that a recent assessment, survey, or inspection resulted in serious deficiencies.

Federal and state clinical laboratory regulators are backing up tough talk about tighter enforcement of the requirements of the Clinical Laboratory Improvement Act (CLIA) requirements. Over the past 18 months, Dark Daily is aware that two nationally-prominent medical laboratory companies—following CLIA inspections of certain lab facilities—were required to cease certain types of clinical testing until serious deficiencies were corrected. These consequences demonstrate that it is not just hospital laboratories feeling the brunt of more rigorous CLIA inspections.
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Anatomic Pathology in China Is a Booming Growth Industry

Shortage of pathologists only adds to the challenges of providing high quality anatomic pathology testing services

DATELINE: Hangzhou, China—More than 1,200 Chinese pathologists and medical laboratory scientists assembled this weekend in a city marked by 1,500 years of history. The occasion was the first-ever combined meeting of the Chinese Society of Pathology and the Pathology Branch of the Chinese Medical Association.

Across the globe, pathologists and clinical laboratory professionals regularly hear about the rapid economic growth in China. This country is modernizing at an astounding rate and the evidence is easy to see in its major cities. That is certainly true here in Hanghzou, which has a population of 8.7 million people and is the anchor city for Zhejiang Province, with a population of approximately 54.4 million. It has many new buildings in its downtown and construction cranes are visible in every direction.
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Medical Laboratories in Egypt Are Earning ISO 15189 Accreditation

Agreement with Germany’s INSTAND will include developing clinical lab proficiency testing program in Egypt

DATELINE: CAIRO, EGYPT—Here in Egypt’s capital city, the Egyptian Society of Laboratory Medicine (ESLM) is conducting its 22nd Annual Conference. One of Wednesday’s main sessions during this gathering of pathologists and clinical laboratory scientists centered on the topic of ISO 15189, as well as Lean and Six Sigma methods.

Your Dark Daily Editor, Robert Michel, is here in Cairo and delivered two presentations during this session. One presentation addressed growing global acceptance of ISO 15189. The second presentation discussed the adoption and use of Lean and Six Sigma by medical laboratories throughout the world. There is keen interest in ISO 15189 among Egyptian pathologists because the nation is incorporating ISO 15189 into its national program for accreditation of clinical pathology laboratories. (more…)

Globalization of Laboratory Medicine is Seen in Two Big Cairo Clinical Pathology Laboratories

Two site visits showcased smooth-running medical laboratories with great staff

DATELINE: CAIRO, EGYPT—on Monday, your Dark Daily editor was privileged to visit two clinical laboratories here in Cairo. Each site visit provided ample proof that, despite differences in the Egyptian healthcare system, there are plenty of similarities in how each clinical pathology department is equipped, organized, and operated, compared to clinical laboratories in other countries.

First stop on the Dark Daily medical laboratory tour was Ain Shams Specialized Hospital in Cairo. This teaching hospital is affiliated with Ain Shams University and has more than 800 beds. It is primarily a surgical hospital. Its laboratory is organized to serve the needs of surgeons. There is also an emergency room and ICU service, which means that Ain Shams Specialized Hospital does admit, and treat, a certain number of inpatients with a variety of diseases and health conditions.

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Clinical Pathology Laboratories Have Opportunity to Learn More about ISO 15189

A2LA, CAP, and QMP-LS to Participate in an Informational Event on January 20th

 

 

ISO 15189 is gaining a foothold among laboratories in the United States. Since the first clinical pathology laboratory in the U.S. earned accreditation to “ISO 15189:2007 Medical Laboratories” in 2008, there has been a steady increase in the number of clinical laboratories that have embarked on their own path to accreditation.

This fall, The Dark Report and Dark Daily invited all three of the organizations in North America that offer accreditation services for ISO 15189 to speak at the fourth annual Lab Quality Confab, which took place in San Antonio, Texas, on November 2-3, 2010. It marked the first time that all three of these ISO-accrediting organizations spoke in public at one time and in one place. (more…)

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