| R. Lewis Dark:
Lab Test Methodology and Widespread EMR Use
IN BIRMINGHAM, ENGLAND, LAST WEEK to participate at the Frontiers in Laboratory
Medicine (FiLM) conference, Editor Robert Michel picked up an interesting
theme that connects to current laboratory events here in the United States.
"General practice (GP) clinics in England are establishing electronic
medical record (EMR) systems as a preliminary step toward the goal of a
national patient health record (PHR)," explained Michel. "Consequently,
pathologists and clinical biochemists who run the nation's laboratories are
beginning to foresee how one longstanding practice in laboratory medicine
has the potential to create confusion among physicians and patients.
"In each city across the country, individual laboratories have always selected
their test methodology, then used specimens collected from local residents to
validate the test and develop reporting ranges," he continued. "Now, some lab
professionals realize that,when a national patient health record becomes a reality,
the individual patient's record will contain lab test data produced by several
different labs. Because of different methodologies and different reporting
ranges for the same test, they can foresee how physicians and patients, as they
consult the individual's electronic medical record, will find the presentation of
these cumulative lab test results to be confusing and not easy to understand.
This realization by forward thinkers in the laboratory profession is causing
some to predict that greater standardization of testmethodology and reporting
guidelines across all laboratory sites will need to occur as a consequence of a
single national system of electronic medical records."
Michel's observation about this development in the United Kingdom has a
parallel here in the United States. Wider adoption of a universal patient health
record that is transportable across different providers, hospitals, and health
insurers will raise the same issue in this country. The explosion of interest in
Vitamin 25(OH) D testing may provide our health system with a first example
of the problem generated by the use of different test methodologies. Today,
different labs are using different methodologies to test for Vitamin 25(OH) D.
They use locally-collected specimens to establish reporting ranges. This means
that clinicians and patients, looking at Vitamin D results from different labs,
cannot automatically assume that one lab's result means the same as another
lab's result. Evidence exists that this situation has caused confusion among
some physicians and patients during the past two years-a time when interest
in Vitamin D testing grew dramatically.
When Does Cost Cutting Affect a Lab's Quality?
Pathologists understand that any lab's quality
and performance requires a careful balancing act
CEO SUMMARY: Many lab professionals note the irony that a
laboratory so publicly committed to Six Sigma quality management
methods is now identified with the single largest episode
of systemic failure in lab test accuracy. Looking in from the outside,
some pathologists suggest that a decade of aggressive
cost cutting and the current campaign to remove another $500
million of costs in 36 months,may be a contributing factor in the
18-month period of systemic deficiencies.
Laboratory Industry Has
"Elephant in the Room"
In January, a major lab failure was national news,
but the story went unremarked by most lab sources
CEO SUMMARY: In almost every laboratory across the United
States and in several countries around the globe, one much-discussed
topic in recent weeks has been the Vitamin D testing program
deficiencies at Quest Diagnostics Incorporated. Yet, even
as rank and file laboratorians actively talked to each other
about what this story means, the lab industry's professional
associations, societies, and publications were silent on this
matter, with few exceptions.
Quest's Deficiencies
Trigger QA/QC Questions
Problems in test accuracy should be studied
and relevant lessons shared with lab industry
CEO SUMMARY: Experts in laboratory QA/QC and proficiency
testing (PT) are following the news that Quest
Diagnostics admitted to an 18-month problem with lab test
accuracy in its home brew Vitamin 25(OH) D assay. It is recognized
as a major failure in the existing system of laboratory
licensure, accreditation, and proficiency testing. However, to
improve current lab quality standards, more needs to be
known about how quality systems failed at Quest Diagnostics.
Got a Lab Test Question?
Call an ASCLS Lab Guru!
ASCLS service gets 115 queries every day,
almost 42,000 a year—and patients love it!
CEO SUMMARY: Each year since its launch in 2001, the ASCLS
Consumer Response Team serves increasing numbers of patients
and physicians. Clinical Laboratory Scientist volunteers from the
American Society for Clinical Laboratory Science provide
answers and help patients understand the meaning of their lab
test results. After sending a question by e-mail, these patients get
answers within 24 hours. This non-commercial, peer-reviewed,
patient-centered site is helping fill a gap in care delivery.
Staunch Laboratory Advocate
Retires After 31 Years of Service
Joe Boone, Ph.D., stepped down last month
from his position at CDC’s Division of Lab Services
Denver's UniPath Sells
Its Histo Labs to APP
UniPath and American Pathology Partners
announce a two-part business agreement
CEO SUMMARY: UniPath ended a long search for a business
partner with ample capital and resources to help it continue
its aggressive rates of growth in specimen volume,
market share, and revenue. UniPath announced the sale of
its technical laboratories to American Pathology Partners of
Brentwood, Tennessee, along with a business agreement to
provide pathology professional services. The agreement
leaves UniPath in full control of its professional corporation.
Did CMS Err in Issuing
New Anti-Markup Rules?
CMS commentary creates uncertainty about
whether technical component supervision is needed>
CEO SUMMARY: In the latest anti-markup rules that took
effect on January 1, CMS may have unintentionally stated that
the anti-markup rule doesn't apply when a pathologist is
reviewing histology slides. While the rule itself is unclear, the
commentary that accompanies the rule says that supervision
is not required. This ambiguity has been noticed by experts. It
means that patholologists, lab directors, and their attorneys
must act carefully to ensure compliance.
INTELLIGENCE: Late & Latent
NHS BRANDED AS "AGEIST" BY CRITICS
MORE ON: UK's NHS |