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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Scanadu is Preparing Consumer Self-Test Device for Review by the FDA as Part of Its Mission to Enable Patients to Monitor Their Health without the Need for Clinical Pathology Laboratory Tests

Scanadu’s device is called the ScanaFlo and is designed to collect biometric data from consumers using a variety of methods, including urine specimens

Now gathering study data needed to launch a review by the Food and Drug Administration (FDA) is a low-cost lab urinalysis device that returns results via a smartphone for conditions such as pregnancy and diabetes. More significant for pathologists and clinical laboratory executives, this handy point-of-care device is capable of doing tests for traditional medical laboratory tests, ranging from glucose and leukocytes to bilirubin and creatinine.

The device was invented at Scanadu, Inc., a health-tech startup based at NASA Ames Research Center in Mountain View, California. It is a new low-cost lab urinalysis kit that uses a smartphone to return test results on liver, kidneys, urinary tract, and metabolic functions. The company uses imaging and sound analysis, molecular diagnostics, data analytics, and a suite of algorithms to create devices that offer consumers comprehensive, real-time health data on mobile devices. (more…)

Many Hospitals and Health Systems Report Flat or Falling Rates of Inpatient Admissions, a Trend that Causes Hospital Laboratory Budgets to Shrink

Weaker finances at the nation’s hospitals causes administrators to further shrink the budgets for clinical laboratory and anatomic pathology services

Hospital admissions across the country continue to be flat or in decline over recent years. The result is less revenue for many hospitals. As a result, administrators continue to shrink the budgets of hospital service lines—including clinical laboratory services. For pathologists and clinical laboratory leaders, this poses the challenge of setting innovative strategies that take into account the changes in payment and delivery models.

Hospital Inpatient Admissions Have Been Declining over Recent Years

Modern Healthcare (MH) recently published a story on the declining inpatient admissions trend. The story, written by Rachel Landen, focused on admission rates at thirteen large hospital systems for the third quarter of 2014. These included: (more…)

Are CLIA Inspections of Clinical Pathology Laboratories Getting Tougher? Why It Pays to Achieve “Inspection Readiness”

Experts say that CLIA inspections are becoming more rigorous, with inspectors taking more interest in how medical labs comply in the areas of personnel, PT, and quality control

Recent reports indicate that regulatory inspections of clinical laboratories are getting tougher. Some pathologists and medical lab managers acknowledge that they’ve had to scramble in response to the unexpected deficiencies identified by Clinical Laboratory Improvement Amendments (CLIA) inspectors following inspections of their labs.

These developments make it more important than ever that clinical laboratories work to become “inspection ready.” At the same time, it is essential that every laboratory compliance officer stay up to date with changes in how CLIA and other regulatory inspections are conducted.

Unwelcome Publicity When Medical Lab Regulators Find Deficiencies

There’s another factor at play in this unfolding story. News headlines immediately follow when federal and state lab regulators discover a problem with a laboratory and the quality of the test results that it is reporting. This raises the stakes for every lab director, because even highly respected medical laboratory organizations can find themselves at the center of unwelcome attention when the public becomes aware of inspection deficiencies. (more…)

ACOs Are Learning to Use Big Data

Pathologists and clinical laboratory managers could find opportunity to add value as providers learn to use big data to improve patient outcomes and lower costs

Early adopter accountable care organizations (ACOs) are establishing data warehouses. This is a first step in collecting and analyzing healthcare big data. The move toward integrated care makes big data critical to an ACO’s success. Pathologists and clinical laboratory managers will want to follow the healthcare big data trend because laboratory test results will be a major component of that data.

The Goal of Healthcare Big Data

The goal for healthcare big data is twofold: 1) develop the ability to aggregate a vast amount of data from wide-ranging sources, and 2) use that data in real time to improve care and lower costs, a recent story published in Modern Healthcare (MH) reported. New performance-based reimbursement models mean that big data analytics will be essential for ACOs to succeed going forward. (more…)

New Medical Laboratory-in-a-Suitcase Detects Ebola in 15 Minutes or Less

Demand for a rapid, accurate diagnostic solution to combat Ebola is motivating research teams in many countries to develop solutions that can be put to immediate use

In West Africa, the outbreak of Ebola in several countries motivated researchers in Germany to develop a fast, accurate, and inexpensive test that could be performed in patient care settings without the need for a centralized medical laboratory.

In these West African countries, lack of electricity and reliable cold storage or diagnostic equipment handicaps clinical laboratory technicians who are testing patients for the Ebola virus. A new test developed by researchers at the German Primate Center (DPZ) in Göttingen, Germany, cuts the time to answer an Ebola diagnosis to just 15 minutes. It requires no electricity and is portable. Previously, the fastest Ebola diagnostics test took three hours to get results and required transporting samples to often-distant medical laboratories. (more…)

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