| R. Lewis Dark:
Quality Management Systems (QMS) & Healthcare
OFF THE RADAR SCREEN OF THE LABORATORY INDUSTRY is an evolving management
approach that gives unity to the mishmash of quality improvement
tools that carry a variety of names, but have several common attributes.
Soon lab directors and pathologists will be quite familiar with the concept of
the "quality management system" (QMS). Wikipedia describes it thusly:
Quality Management System (QMS) can be defined as a set of policies,
processes and procedures required for planning and execution (production /
development / service) in the core business area of an organization. QMS
integrates the various internal processes within the organization and intends
to provide a process approach for project execution. QMS enables the organizations
to identify, measure, control and improve the various core business
processes that will ultimately lead to improved business performance.
Over recent decades, industry has developed the concept of “qualitymanagement
systems” as a way to allow all business, organizational, and operational
functions within the enterprise to utilize the basic management
principles identified by W. Edwards Deming, Joseph Juran, Taiichi Ohno,
and others, including Henry Ford. These principles are rooted in such shared
management precepts as “system of prevention,” continuous improvement,
“only the customer defines quality,” and use of statistical process control
(SPC) to improve quality and reduce variation.
QMS is just now reaching healthcare.Within the laboratory industry, it is
well known to the in vitro diagnostics (IVD) manufacturers and the QA/QC
professionals inside clinical laboratories. I predict that soonmany labs will have
aQMS. Since early in this decade,THE DARK REPORT has been consistently early,
if not the first voice in the lab profession, to alert laboratory leaders as to how
and why calls for improved patient safety, reduced medical errors and greater
use of evidence-based medicine (EBM) will require their laboratories to adopt
different management philosophies and methods. So it is with QMS.
ISO 15189:2007 Medical Laboratories is a qualitymanagement system. In
this issue of THE DARK REPORT, you have the only public interviews by the
nation’s first two laboratories to adopt ISO 15189:2007. It marks another
milestone on the quality management journey of the laboratory profession,
and once again, THE DARK REPORT is giving you a front row seat to watch
events unfold and position your laboratory for success with QMS!
Two U.S. Labs Pursuing
ISO 15189 Accreditation
Nation's first ISO:15189 accreditations will be
milestone in use of quality management systems
CEO SUMMARY: In their first public interviews, the
nation's only two laboratories to seek ISO 15189:2007 accreditation
share insights about the process, along with its challenges
and benefits. Both laboratories are in the final stages of
implementation and expect to earn accreditation by year end.
Their achievement will represent the next advance in how laboratories
in the United States use quality management systems
and the tools of continuous improvement.
Piedmont Med Lab Mixes
ISO with Lean & Six Sigma
While working toward ISO:15189 accreditation,
Piedmont Med Lab generates increased productivity
CEO SUMMARY: Piedmont Medical Laboratory (PML) could
be the only clinical laboratory ever to pursue three quality
improvement initiatives simultaneously. Even as it was in the
early stages of implementing both Lean and Six Sigma methods,
PML also decided to seek ISO 15189:2007 accreditation. Since
2004, the lab has worked diligently to put all three programs in
place. The lab is currently preparing for its final assessment that
will lead to formal accreditation under ISO 15189:2007.
ISO 15189 Is the Goal
At Avera McKennan Lab
Lab is using four years experience with Lean
as cornerstone for ISO 15189:2007 accreditation
CEO SUMMARY: Now entering its ninth month on
the path to accreditation under ISO 15189:2007 Medical
Laboratories, Avera McKennan's lab recently completed its "gap
analysis." This important step prepared the laboratory for the
pre-assessment and assessment steps that will result in accreditation.
Leaders at Avera McKennan expect this achievement will
provide competitive advantage to the laboratory, as well as reinforce
the health system’s public reputation for quality.
Health Record Databanks
Are Different Than RHIOs
Health Record Banks (HRBs) are designed
to be patient-controlled central data repositories
CEO SUMMARY: Forget CHINS from the 1990s and RHIOs
from this decade. The future of regional health data repositories
may turn out to be a patient-controlled model, often called a
"Health Record Bank" (HRB). Here is the lab industry's first look
at this nascent movement. HRBs are under development in
Louisville, Kentucky, the State of Oregon (for the state's Medicaid
beneficiaries), and the State of Washington. Other notable HRB
advocates investing in the concept are Microsoft and Google.
Low Vitamin D Linked
To Greater Risk of Death
Just-published study indicates how patients
with vitamin D deficiency have higher risk of death
CEO SUMMARY: A new report in the Archives of Internal
Medicine is likely to further spur demand for vitamin D testing.
Already, labs are dealing with a dramatic increase in testing for
vitamin D deficiency,with test volumesmore than doubling in the
past 12 months. This new research is considered themost definitive
to date. Media reports are educating patients about these
findings. Laboratories have an opportunity to ensure that they are
running the most appropriate tests for vitamin D deficiency.
INTELLIGENCE: Late & Latent
BIO-REFERENCE REPORTS
* EARNINGSTRANSITIONS:
Next week, Rick Panning
becomes the new Vice
President, Laboratory Services
for Allina Hospitals and
Clinics | 
