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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FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

Many products that medical laboratories use will be covered under the new UDI system

You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers.

You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally every retail product. UPCs make scanning at the cash register possible. Now a similar system is coming to medical devices, including the lab analyzers, reagents, and other products used by medical laboratories and pathology. (more…)

Clinical Lab Industry Should Prepare for Many Marketplace Changes, Predict Experts at Yesterday’s Executive War College

Labs are facing new threats as managed care plans cut reimbursement levels and new companies are coming between labs and their physician clients

*** Revised Version – Original Version Misstated: The previous version had statements attributed to Ignis Systems that were incorrect. The corrected version is below.

DATELINE: NEW ORLEANS, LOUISIANA—It was a big opening for the 17th annual Executive War College (EWC) on Laboratory and Pathology Management yesterday. A record crowd of about 700 enthusiastic clinical laboratory managers and pathologists heard lab industry leaders predict a fast-changing future for the medical laboratory testing industry.

The editorial team from The Dark Report and Dark Daily are all here to cover the sessions and provide you with useful intelligence and insights about market trends and innovations in the management and operations of clinical laboratories. That was true of yesterday’s opening general session, followed by an afternoon of clinical laboratory management case studies.
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Experts Predict Shortage of Clinical Laboratory Labor Will Create Need for More Sophisticated Laboratory Information Systems

Recent reports show why labs need more robust laboratory information systems (LIS), including a shrinking workforce, new requirements to connect to EMRs in hospitals and physicians’ offices, and the development of health information exchanges.

Clinical laboratories nationwide are realizing they need new and more powerful laboratory information systems (LIS) as they seek to process larger volumes of medical laboratory tests with a shrinking number of medical technologists and clinical laboratory scientists.

In response to the critical shortages of MTs, CLSs, and other laboratory scientists, most clinical laboratories are beefing up automation in all areas of the lab. From the high-volume core chemistry/hematology laboratory to microbiology and histology, laboratory automation systems are becoming ubiquitous. But all this lab automation increases the need to use information technologies to manage both automation and the flow of specimens through the laboratory.

A report published earlier this year by Kalorama Information of Rockville, Maryland, actually links the shortage of skilled medical laboratory staff as one of the most important factors in fostering growth in the LIS market. Researchers estimated the size of the LIS market at $800 million and predicted that it would grow about 6% annually for the next few years.

As pathologists and clinical laboratory managers know, labor accounts for more than 60% of the cost of producing medical laboratory test results. The Kalorama report stated that laboratory automation and better information management systems can reduce the number of manual procedures and tasks in the typical medical laboratory, In turn, this helps optimize labor efficiency, said the report titled, Laboratory Information Systems (LIS / LIMS) Markets. (more…)

Hospitals, Physicians, and Clinical Pathology Laboratories Scramble to Prepare for Use of Form 5010 Beginning January 1, 2012

Some medical laboratory organizations risk coming up short on the deadline for implementation of 5010 standards

Less than eight weeks remain before the January 1, 2012, deadline for implementation of Form 5010. Every sector of the healthcare system—from government and private payers to hospitals, physicians, pathologists, and clinical laboratories—is involved in this important healthcare reform.

Many providers and payers are scrambling to meet the Health Insurance Portability and Accountability Act (HIPAA) version 5010 compliance deadline. This is the latest version of standards for the conversion of electronic health records (EHRs).

The Centers for Medicare and Medicaid Services (CMS) continues to maintain a hard line position regarding the deadline, according to an article in Modern Healthcare. “There is no wiggle room,” Denise Buenning, Director of the Administrative Simplification Group in CMS’ Office of E-Health Standards and Services, stated. “We’re holding fast to the date.”

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Hospital CIOs Pessimistic about Pace of EHR Adoption, as Numbers Show Mixed Story

CIOs across America are concerned that their hospitals might not make the 2015 meaningful use deadline

For all the excitement about hospital and physician adoption of electronic health record (EHR) systems, many CIOs of the nation’s leading health systems and hospitals are pessimistic about their organization’s ability to meet “meaningful use” (MU) requirements by the year 2015.

This is probably not news to most pathologists and clinical laboratory managers working in hospital laboratories. Generally, members of their medical laboratory team are usually part of every hospital’s EHR implementation task force, since clinical laboratory test data makes up a significant portion of the typical patient health record.

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