| R. Lewis Dark:
Lean, Six Sigma and Laboratory Errors
IT IS TOUGH TO IGNORE THE STEADY DRUMBEAT about patient safety. In every
sector of healthcare, accrediting bodies, state legislatures, private insurers,
and federal health administrators are instituting programs designed to focus
providers on eliminating the sources of medical errors and reducing the
variability in care provided to patients.
As you will read on pages 17-18, just last week two medical errors commited
by national lab companies triggered newspaper headlines and coverage
on television news programs. In both cases, simple errors in specimen
handling at the laboratory caused a woman to get an inaccurate diagnosis of
cancer. Only after undergoing life-changing surgery and other procedures,
did these women’s physicians learn about the lab errors. It was the post-surgery
pathology review which uncovered the original laboratories' errors.
These types of errors are unusual and uncommon but they do occur with
some regularity, given the large volume of specimens handled annually by the
nation's laboratories. All lab directors and pathologists know stories about how
a lab error caused a patient to receive inappropriate care. Although most of these
stories escape the notice of journalists and television news reporters, they do
represent an area of lab medicine that does not get the attention it deserves.
However, as more laboratories actively incorporate quality management
systems, like Six Sigma and Lean, into their operations and clinical services,
they are discovering effective tools that will further drive down the already low
rate of medical errors that occur in laboratories. That was one clear
theme at last month's Lab Quality Confab, where the profession's first mover
and early adopter labs shared their case studies and successes with improvement
programs and projects. (See pages 3-5.)
I can foresee the day when laboratories will cease to report the performance
of laboratory functions using decimals and percentages and will use either a Six
Sigma scale or a defects-per-million figure. Those two measurement terms were
a common lingua franca at Lab Quality Confab. By effective use of quality management techniques and methods, laboratories at this conference are achieving
a notable reduction in error rates within their lab operations. That is a positive
omen for the future of laboratory medicine. It represents early evidence that the
laboratory profession can achieve paradigm-shifting gains in quality and
reduction of medical errors.
More Labs Actively Adopt
Quality Management
Lab Quality Confab draws global audience
to share improvement breakthroughs, successes
CEO SUMMARY: With almost 300 speakers, attendees, and
vendors in attendance from seven countries, Lab Quality Confab
was a significant milestone for the global lab industry. On one
level, it was a sign that the quality improvement trend has come
of age. On another level, it provided ample and powerful evidence
that labs using Lean and Six Sigma are actively raising the benchmarks
for measuring the quality of laboratory testing services.
Shiel Medical Lab Grows In Tough NYC Market
Flying under the radar screen, lab firm builds
market share to achieve yearly sales of $50 million
CEO SUMMARY: There’s a new lab player emerging in the
New York metropolitan market. Shiel Medical Laboratory of
Brooklyn, New York, is growing steadily and now reports $50 million
in annual revenue. It is taking full advantage of the managed
care contracting turmoil and adding new clients at a surprising
rate. During the first 12 weeks of 2007, Shiel Medical Laboratory
says nightly specimen volume increased by 50%.
Lab Briefs:
NEW CEO NAMED
AT ROCHE DIAGNOSTICS,
VENTANA OFFER EXTENDED
BILL WOULD REPEAL
LAB BIDDING DEMO
CDC Convenes Institute To Leverage Lab Testing
“Summit” brought healthcare leaders together to explore how lab testing can play a bigger role
In convening the 2007 Institute “Managing for Better Health,” in Atlanta last week, the Division of
Laboratory Systems of the CDC invited a broad spectrum of
healthcare experts and policymakers to participate. The ambitious
goal was to facilitate discussions involving stakeholders
such as employers, payers, policymakers, clinicians, and others
to identify ways that laboratory medicine could more effectively
leverage outcomes and patient care.
Medicare Soon Won’t Pay
Hospitals for Errors
Private payers may be encouraged to adopt
similiar policies of no pay for “preventable errors”
CMS issued new rules, effective in October
2008, that it will no longer pay the extra cost of treating
patients after preventable errors, infections, or injuries that
occur in hospitals. It continues Medicare’s transformation from
a “passive payer simply processing claims” to an “active purchaser
with a stake in quality and efficiency.” Many experts
believe that private payers will follow Medicare’s lead and also
cease to reimburse for conditions related to preventable errors.
Laboratory Error Results
In Mistaken Mastectomy
NY Dept. of Health determines that lab tech cut
corners with tissue samples, causing wrong diagnosis
In New York, because of a laboratory error
and wrong diagnosis, a woman underwent a needless double
mastectomy. In reporting the case, New York newspapers discovered
another case of lab error and both women are suing
the labs involved. Each case is a reminder that the public and
state healthcare regulators are becoming increasingly intolerant
of preventable laboratory errors.
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