The Laboratory’s Role in Guiding the
Best Use of
Point-of-Care Testing
By Kim
Futrell, MLO
Continued growth in point-of-care testing (POCT) is
certain as technologies improve and the benefits of
POCT are realized in value-based healthcare.
However, POCT is a diverse and complex area of
laboratory testing, riddled with the challenges
inherent to multiple locations, disparate devices,
and non-laboratory trained operators. To reap the
advantages POCT has to offer, POCT programs can
greatly benefit from laboratory intervention and
oversight. Laboratory professionals who approach
POCT oversight as a team endeavor, keeping end
users’ workflows and backgrounds in mind, can be
instrumental in helping reap the potential benefits
that POCT offers in patient care.
POCT’s renewed value instigates continued growth
The rapid turnaround time (TAT), convenience, and
mobility of POCT—in specific patient scenarios—can
speed clinical decision-making and treatment
decisions and simultaneously help avoid other
unnecessary procedures and associated risks. POCT’s
rapid results can help optimize which patients
receive advanced care, and improve patient
understanding and engagement, giving POCT a more
important role in patient-centered care. Read more > |
Create a Strong Lab Team Through Recruiting
By
Milly Keeler, MT(ASCP), CLC(AMT), CCCP, Medical
Laboratory Management
No
matter how much money is spent on sophisticated
laboratory instrumentation, a lack of qualified,
well-trained personnel will undermine the
laboratory’s success at every turn. In fact,
well-trained and skilled laboratory personnel are
the single greatest determining factor of
operational success. That said, recruiting and
retaining new laboratorians can be difficult, time
consuming, and expensive.
Managing risk is more important than ever in this
litigious age and as experienced laboratory staff
members are retiring faster than new employees are
able to fill those positions, many laboratories are
experiencing significant increases in workload and
work-related stress. These circumstances are a
breeding ground for potential mistakes, increased
costs due to overtime and temporary workers, and for
the cessation or abandonment of improvement
projects. Therefore, a concerted effort should be
invested in how the laboratory is bringing new staff
on board. Read more > |
Top 10 Health
Technology
Hazards for 2019
Health Data
Management,
October 2018
Health
technology—ranging
from simple
devices to
complex
information
systems—poses
unanticipated
risks for
healthcare
organizations.
It’s
important to
identify
these risks,
understand
them and try
and correct
them. Each year,
the ECRI
Institute’s
Health
Devices
Group
produces a
list of the
top 10
health
technology
hazards,
identifying
potential
sources of
danger that
warrant the
most
attention
for the
coming year.
“All the
items on our
list
represent
problems
that can be
avoided or
risks that
can be
minimized
through the
careful
management
of
technologies,”
ECRI
reports. Read more
>
|
The Evolution of Group A Streptococcus
Pharyngitis Testing
By
Dithi Banerjee, PhD, and Rangaraj Selvarangan, BVSc,
PhD, D(ABMM), FIDSA Sept 2018, Clinical Laboratory
News
Molecular assays may
soon eliminate the need for supplemental testing,
but patient selection and appropriate test methods
remain key
Acute pharyngitis,
an inflammation of the pharynx and/or tonsils, is a
common illness caused by many microorganisms.
Although viruses are the main etiological agents,
Streptococcus pyogenes, commonly known as group A
streptococcus (GAS), is the primary bacterial cause,
accounting for pharyngitis in 5%–15% of adults and
20%–30% of children worldwide (1). GAS pharyngitis mainly affects children 3–15 years
of age and can lead to suppurative and non-suppurative
complications, the latter being more common in
developing countries. Suppurative complications
include oral or peritonsillar abscesses, cervical
lymphadenitis, and rarely, septicemia. Read more > |
POC in the Lab: A Regional Experience in
Urinalysis and Pregnancy Testing
MLO, Yu
Chen, Susan McDonald, and Jason Weshler
Horizon
Health Network operates 12 hospitals and more than
100 medical facilities, clinics and offices in the
province of New Brunswick in Canada. Providing
services ranging from acute care to community-based
health services, Horizon Health Network has more
than 12,400 employees, including 1,000 physicians,
and has 5,700 volunteers, auxiliary workers, and
alumni. The network consists of four areas with core
lab services provided only in the four regional
hubs. As part of the provincial laboratory
standards, all sites performing point-of-care
testing (POCT) must be accredited by the Institute
for Quality Management in Healthcare IQMH (former
Ontario Laboratory Accreditation 2013). Findings
from a 2013 audit identified minor non-conformances
specific to ISO 22870 in urinalysis POCT, which
remained unresolved during a subsequent audit in
2015 and were escalated to major non-conformances. Read more > |
|
A Novel Point-of-Care Approach for
Improving Acute Bleeding Management
MLO, By Todd Allen and Francesco Viola
Whole
blood viscoelastic testing (VET) for
perioperative bleeding management is
systematically increasing in clinical
use and is approaching the level of
standard of care for many clinical
settings such as cardiovascular surgery,
liver transplantation, trauma, and
obstetric hemorrhage. Conventional
coagulation testing has proven to be
inadequate for directing therapeutic
intervention in these critical settings.
Physicians managing acute bleeding
events require faster turnaround times
for test results and prefer assays that
more accurately reflect the whole blood
or cell-based hemostatic process
described by Hoffman and Monroe. The
benefits of VET have been
well-documented. There exists an
abundance of publications and systematic
reviews in a variety of clinical
settings, including review articles in
this area published in previous issues
of MLO. Several medical societies have
given strong recommendations for the use
of VET in conjunction with goal-directed
treatment algorithms guided by VET for
managing acute bleeding in the
perioperative setting. To date, two
technologies have emerged at the
forefront of whole blood VET:
thromboelastography and rotational
thromboelastometry.
Read more > |
One and Done?
Prospective
trial suggests that a single blood test may be
sufficient to diagnose diabetes.
Clinical
Laboratory News, July 2018
Multiple blood tests have been the clinical mainstay
for confirming type 2 diabetes. However, a study
that tracked individuals over several decades for
incident diabetes and other conditions found that
measuring elevated fasting glucose and HbA1c levels
from a single blood sample may suffice for an
accurate diagnosis. Investigators published the
results of their prospective cohort study in the
Annals of Internal Medicine.
Clinicians under current guidelines rely on two
glucose tests to confirm a diabetes diagnosis.
“Whether 2 different tests from a single blood
sample provide adequate confirmation is uncertain,”
wrote the study’s investigators, who launched a
prospective study known as the Atherosclerosis Risk
in Communities (ARIC) trial to see if this approach
was possible.
Read more... |
The FDA reviews guidelines for capillary glucose
testing in critically ill patients
By
Jeffrey A. DuBois, MLO, June 21, 2018
Capillary whole
blood testing with point-of-care (POC) glucose
meters in hospitalized patients and, particularly,
in critically ill patients, remains a topic of
interest in the medical and regulatory communities.
However, determining the requirements for effective
clinical use has proved challenging.
An FDA panel
convenes
This past March,
the U.S. Food and Drug Administration (FDA) convened
its Clinical Chemistry and Clinical Toxicology
Devices Advisory Panel, seeking guidance and
recommendations on the acceptability of capillary
specimens in critically ill patients based on
benefits and risks, and whether capillary specimen
testing in this patient population meets the
criteria for waived status under the Clinical
Laboratory Improvements Amendments (CLIA)
regulations. The FDA began by summarizing the
history of POC glucose testing for the panel and
emphasized the need for manufacturers to submit data
supporting their glucose meters’ acceptability for
use with critically ill patients. The FDA reviewed
the data submitted for a glucose meter cleared for
use with these patients using arterial and venous
specimens, and related that no manufacturer had
submitted data for capillary whole blood.
Read more > |
The clinical laboratory
is an inherently
dangerous place.
Laboratorians face a
variety of dangers
working in an
environment that
contains biohazards.
Utilizing standard
precautions and
correctly employing
Personal Protective
Equipment (PPE) are
essential keys to ensure
laboratorians’ safety.
Maintaining a clean and
orderly environment and
employing good
disinfection practices
are vital as well. A
cluttered workspace and
an area contaminated
with biohazards threaten
the safety of both
employees and visitors.
General disinfection
tips
Lab directors should
conduct audits of their
department’s physical
environment to identify
safety hazards specific
to their lab. Such
audits typically do not
need to interfere with
the day-to-day lab
processes, and they
should be performed on a
regular basis, at least
monthly. Many changes
can occur in a
laboratory at any time,
such as the movement of
instruments, the
placement of new
equipment, or even the
movement and stocking of
lab supplies, and the
implications of such
changes for safety
should be recognized.
Read more >
|
New guidelines and studies suggest improved
approaches to C. difficile testing
By
Sherry A. Dunbar, MLO, June 21, 2018
Clostridium
difficile represents a significant health threat
around the world. In the United States, infections
caused by C. difficile are now the most common type
of healthcare-associated infection. Nearly half a
million infections occur in the U.S. annually, with
an estimated 29,000 deaths within 30 days of the
initial diagnosis.
Consequently, much effort is ongoing toward the
development of better testing and treatments for C.
difficile. This year, new clinical guidelines were
released that included significant changes to how
healthcare teams respond to C. difficile infections.
In addition, scientists and clinicians are
conducting a number of studies and generating useful
information that could guide new expectations or
policies about testing and treatment.
For example, studies have shown that molecular tests
targeting a marker specific to a single C. difficile
strain are less useful now, as other strains of the
pathogen have become more prevalent.3-5 These
findings could help clinical labs fine-tune their C.
difficile testing procedures to ensure the most
reliable results. Also, several recent studies have
demonstrated that...
Read more > |
Christiane Nooney from Duke Hospital
Named 2018 POCC of the Year by AACC
The
AACC Critical and Point of Care Testing (CPOCT)
Division has announced that Christiane “Chris”
Nooney, MBA/MHA, MT(AMT), DUH POC Supervisor, Duke
Hospital, DukeHealth has been award the 2018 Point
of care Coordinator of the Year.
Chris was unanimously selected as the 19th recipient
of this auspicious award given annually to recognize
outstanding achievements in the POCT field by
persons who are primarily responsible for a given
institution’s POCT program. It is based on the
extent of the nominee’s responsibilities and
accomplishments, particularly the impact this person
has made in improving the quality of the POCT
program at their facility. The award also includes a
cash award and funds to support attendance at the
AACC Annual Meeting as well as an elegant trophy.
Read more >
|
Point of Care Testing Compliance
How Partnering
With Nursing Leadership and Sharing Data Upped
Performance on a Crucial Parameter
By Adil
I. Khan, MSc, PhD, Clinical Laboratory News, June
2018
The of the hardest aspects of point-of-care testing
(POCT) is trying to make the diverse users of POCT
devices follow written procedures and perform
testing exactly as stated by manufacturers. The
simplicity of POCT devices, often involving
disposable kits with no maintenance or
troubleshooting, tempts users to take shortcuts. The
downside of this approach is that when procedures
are not followed to the letter, mistakes happen.
POCT devices are designed so they can be used by
anyone with at least a high school diploma, hence
users range from students to physicians.
Read more > |
Preanalytical Errors and Critical Variables in
Point-of-Care Testing
By
Aparna Jha Ahuja, MD, May 24, 2018, MLO
Today’s “smart” technology enables us to have
important information at our fingertips.
Point-of-care testing (POCT)—also referred to as
“near patient, bedside, and extra-laboratory
testing”1—offers the rapid delivery of healthcare
information as well.
Centralized laboratory testing was the standard
until the mid-1980s. Since that time, many
laboratory tests (e.g., glucose and blood gas
testing) have transitioned to patient care settings,
including physicians’ offices, ambulances, and
hospital units (e.g., the intensive care unit,
emergency department, surgical suites), as well as
clinics, dialysis centers, and nursing homes.2
Devices for POCT range in size from small handheld
meters for glucose monitoring to larger benchtop
analyzers for hematology.
Read more > |
Field-Portable MDx
MLO, By
John Brunstein, May 24, 2018
There is an
enduring appeal to the concept of point-of-care (POC)
or near-POC diagnostic methods. Having the ability
to perform a diagnostic test in the doctor’s office
while a patient is present, rather than having to
send a sample off to a centralized lab for testing,
means that what would otherwise need to be two
patient visits could be replaced by a single
session. It also suggests the potential for a more
timely response with a specific rather than
empirical treatment strategy, with particular
implications for the appropriate, limited use of
antibiotics. Carrying the POC concept a step
further, one can imagine the potential utility if
cheap, effective, reliable diagnostic systems could
be made small, portable, simple, and rugged enough
for use in low-resource settings, where they might
have the greatest human impact.
Of course, many
such diagnostic methods exist, but they are most
frequently some form of a rapid immunological test.
While these excel in simplicity, low cost, and
speed, they generally lack the sensitivity and
specificity that a molecular method would provide.
That they are so widely used even with these
shortcomings underscores the need for POC/near-POC
testing and the potential for growth in this field
if suitable molecular devices and tests can be
developed.
Read more > |
CMS gives 213 hospitals 'five
stars' for patient experience. See how yours fared...
May
2018 |
https://www.advisory.com/daily-briefing/2018/05/08/hcahps-star-ratings
CMS on April 25 updated its Hospital Compare website
with new Hospital Consumer Assessment of Healthcare
Providers and Systems (HCAHPS) summary star ratings.
CMS' summary star rating scores hospitals on a
one-to-five-star scale based on the 11 publicly
reported measures in HCAHPS survey, which assesses
patient experiences. The agency started assigning
hospitals patient experience star ratings based
solely on HCAHPS scores in April 2015. The latest
update is based on HCAHPS survey data collected
between July 1, 2016, and June 30, 2017.
4 ways patient experience may be costing you
The patient experience summary star ratings are
distinct from CMS' overall quality star ratings,
which are scheduled to be updated in July. Overall
star ratings are based on 62 quality measures from
seven categories: effectiveness of care, efficient
use of imaging, mortality, patient experience,
readmissions, safety, and timeliness of care.
A map of the country’s hospitals and
their rankings is available on the Advisory Board’s
Web site (registration is required to view the map).
Read more > |
Considerations for Implementing New POC Testing
Tyler
Gledhill, BS, Robert L. Schmidt, MD, PhD, MBA,
Brenda VanCleve, MT(ASCP), Sandra K. White, MS,
Medical Laboratory Management, Clinical Leadership &
Management Review
Point-of-care testing (POCT) can deliver significant
benefits to both patients and providers, and due to
this, POCT has experienced rapid growth in recent
years. While the end result of POCT can be quite
positive, proper implementation and management can
present challenges and requires vigilant oversight
to ensure success. Regardless of whether the
organization is new to POCT or has a fully
functioning POCT department, implementing a new POC
test requires careful planning. Test implementation
can raise unique issues that may be unfamiliar to
laboratory and hospital staff. These include
consideration of federal and state regulations,
relationships with regulatory and accreditation
bodies, POC test management and technical
performance, and overall fit with the organization.
Taking an administrative viewpoint, laboratory
directors must focus on test justification and
dispersion when considering a new POCT. Before
approving an application to implement POCT, it is
key that laboratory leadership consider the
following issues.
Determine
Necessity and Benefit
Requests for new POC tests typically originate from
clinicians who desire more expedited results.
Ideally, a rapid result enables physicians to
provide a diagnosis or prescribe a treatment at the
time of the patient encounter. This can reduce the
time to therapy, increase adherence, and reduce the
potential for errors in handling specimens. However,
managers should exercise caution before instituting
new POCT, as the benefits are highly dependent on
the context in which the test will be implemented.
Read more > |
American College of Physicians
Recommends Less Restrictive HbA1c
Targets
The Sample: May 2018, Clinical
Laboratory News
In a controversial new clinical
guideline, the American College of
Physicians (ACP) recommends less
restrictive HbA1c targets for
glycemic control in most patients
with type 2 diabetes; between 7% and
8% rather than 6.5% or 7% as
recommended by other groups (Ann
Intern Med 2018;
doi:10.7326/M17-0939).
ACP based this advice on evidence
about the benefits and harms of
lower HbA1c targets from clinical
trials considered by the other
groups in setting their HbA1c
targets. “ACP’s analysis of the
evidence behind existing guidelines
found that treatment with drugs to
targets of seven percent or less
compared to targets of about eight
percent did not reduce deaths or
microvascular complications such as
heart attack or stroke but did
result in substantial harms,” said
Jack Ende, MD, president of ACP.
Read more >
|
POC Glucose: Views on Volume,
Critical Care, ACOs
CAP Today, April
2018
Test volume,
limitations on devices used in critical care,
consolidation, and population health is what CAP
TODAY asked about when it spoke in March with the
makers of three bedside glucose testing systems. “Customers are
more aware than ever of the limitations that are in
the package inserts from the glucose manufacturers,”
says Corrine Fantz, PhD, director of medical and
scientific affairs for point-of-care testing, Roche
Diagnostics. But she and Kevin Peacock, clinical
marketing manager, HemoCue America, say there is
still confusion. This article
features responses to the following questions posed
by CAP Today senior editor Amy Carpenter Aquino.
-
How has the
decline in reimbursement coupled with a retreat
from tight glycemic control affected test volume
for patients at the bedside?
-
How are your
customers adapting to the limitations on glucose
devices for critical care applications?
-
How has
system consolidation—including established
system clinics, ERs, and acquired physician
practices—affected POC glucose testing for
ambulatory patient testing?
-
How does
glucose testing and the management of patients
with diabetes fit into the concern laboratories
have now for population health and accountable
care organizations?
For the complete article, click here.
|
Glucose systems are profiled here. |
Thinking Beyond The Instrument
Laboratories are using IQCP to bring
preanalytic and postanalytic factors
into focus and improve patient care
By
Julie Kirkwood, APR.1.2018, Clinical Laboratory
News
Nearly 5 years ago, the U.S. Centers
for Medicaid and Medicare Services
(CMS) introduced a new option for
laboratory quality control (QC)
called the Individualized Quality
Control Plan (IQCP). Laboratories
could create an IQCP as an
alternative to performing two levels
of external QC per day of patient
testing (default QC), as long as
their risk assessment supported a
longer QC interval and it complied
with manufacturers’ instructions.
The catch? Equivalent quality
control (EQC), an option that had
been available since 2004, was being
eliminated. EQC allowed labs to run
external QC on a weekly or monthly
basis for tests with built-in QC
features, as long as the schedule
met minimum manufacturers’
recommendations.
Under the new rules, which took
effect in January 2016 after a
2-year educational period, labs
needed to write an IQCP for every
test that had been operating with
EQC or perform default QC.
Laboratory managers, particularly
those in charge of point-of-care
testing (POCT, were faced with the
daunting task of conducting risk
assessments and writing IQCPs for
dozens or even hundreds of tests.
Read more >
|
IBM Watson Health Announces 100 Top Hospitals
Formerly the Truven Health Analytics 100 Top
Hospitals, 2018 Study Finds Top U.S. Hospitals
Improve Outcomes at Lower Cost and Higher Profit
Margins than Peers
IBM Watson Health™ today published its 100 Top
Hospitals® annual study identifying top–performing
hospitals in the U.S. based on overall
organizational performance. Formerly known as the
Truven Health Analytics® 100 Top Hospitals, this
study spotlights the best–performing hospitals in
the U.S. based on a balanced scorecard of publicly
available clinical, operational, and patient
satisfaction metrics and data. It has been conducted
annually since 1993.
Overall, the Watson Health 100 Top Hospitals® study
found that the top-performing hospitals in the
country achieved better risk-adjusted outcomes while
maintaining both a lower average cost per
beneficiary and higher profit margin than
non-winning peer group hospitals.
Did your hospital make the list? |
What's New in Point-of-Care Testing?
Point of Care: March 2018 - Volume 17 - Issue 1
By
Kantartjis, Michalis BS; Melanson, Stacy E.F. MD,
PhD
Point-of-care
testing (POCT) is one of the fastest growing sectors
in diagnostics, becoming a well-established
laboratory tool in healthcare systems across the
world. Recent research has focused on increasing
cost-effectiveness and improving overall performance
of existing POCT. Lower costs as well as rapid and
accurate results have allowed for POCT to be used in
resource-limited regions and positively impact
patient care globally. Literature on
POCT published between January 1, 2016 and December
31, 2016 was reviewed. Select articles are
summarized and grouped into the following
categories:
-
hematology
and coagulation
-
cardiac
disease
-
infectious
disease and human immunodeficiency virus
-
gastrointestinal disease
-
emergency
medicine
-
glucose and
diabetes
-
technological
advancements, and other.
Read more > Note, you have to
subscribe to the POC Journal or purchase this
article. |
Labs Take Stock of Surprising Flu Season
CAP
Today, March 2018, by Amy Carpenter Aquino
In
a severe flu season that started early, laboratories
faced unprecedented test volumes, used new testing
platforms, and negotiated vendor supply shortages.
When laboratory staff at Arkansas Children’s
Hospital in Little Rock began seeing a rising number
of requests for respiratory tests, and five positive
flu results, in September 2017, they suspected they
were in for a record flu season, says Sherry
Childress, BSMT(ASCP), technical chief, molecular
diagnostics and immunology.
Read more > |
CDC Warns of a Second Wave of Flu Virus
By
LABline, March 28, 2018
The
flu season may be winding down, but parents of young
children have reason to remain watchful. As flu
activity continued to decrease across the nation,
the A-strain H3N2 influenza virus, which had
dominated previously, was reported less frequently
than B viruses, the CDC weekly surveillance report
indicated Friday. During the week ending March 17,
nearly 58% of all laboratory-confirmed cases of flu
were caused by B-strain viruses, according to the
CDC report. Circulating strains this season, which
began in October, were a mix of A viruses (H3N2 and
H1N1) and B viruses. Generally, the H3N2 strain
leads to more severe illness and more
hospitalizations than B strains, according to the
CDC.
Read more > |
MLO's 2018 Lab of the Year: St. Luke’s Health
System’s Core Laboratory
By
MLO Staff, March 2018
The
competition was tough, the judging was not easy—but
MLO is proud to present the 2018 Lab of the Year:
St. Luke’s Health System’s Core Laboratory.
St.
Luke’s Health System (SLHS) is a not-for-profit,
locally owned health system serving southern Idaho
and eastern Oregon. St. Luke’s Core Laboratory was
established in 2011 and is a department of SLHS. The
laboratory includes five physical locations in
Boise, Idaho; one main testing site, and four
outreach phlebotomy sites.
Read more > |
MLO’s 2018 Annual
Salary Survey of Laboratory
Professionals
How Much does a
Point-of-Care Coordinator Earn?
By: MLO Staff,
February 2018
The United States
Department of Labor, Bureau of Labor Statistics (BLS)
states that employment in “Healthcare Occupations”
is projected to grow 18 percent from 2016 to 2026,
much faster than the average for all occupations.
Healthcare occupations will add about 2.4 million
new jobs to the workforce. In fact, healthcare is
projected to add more jobs than any of the other
occupational groups. This projected growth is mainly
due to an aging population which leads to greater
demand for healthcare services.
Read more > |
Diabetes
Roundup
By MLO
Staff, February 22, 2018
Diabetes is not so much being cured as it is being
surrounded. Researchers are coming at this common
disorder from a number of different perspectives,
and some of their discoveries are finding their way,
or soon might find their way, into clinical
practice. MLO provides a
roundup of some recent scientific approaches
regarding type 1, type 2, and gestational diabetes
mellitus (GDM), as well as an exciting recent FDA
approval of a needle-free glucose testing device
that may make life easier for people with diabetes.
Read more > |
CLP Tech Guide: Lab
and POC Glucose Monitors
February 8, 2018
The Clinical Lab Products Tech Guide features lab
and point-of-care glucose monitors from such
companies as Arkray USA, Nova Biomedical, and Oak
Tree Health. The guide is available as a
free download. |
Flu Map Shows How
the Biggest Influenza Outbreak in Years Spread
Across the U.S.
TIME Health, By JAMIE DUCHARME and
DAVID JOHNSON January 19, 2018
With months left to go in the 2018 flu season, the
U.S. has already hit an unfortunate benchmark, as
shown on the flu map below: For the first time in
the Centers for Disease Control and Prevention’s 13
years of influenza monitoring, every state in the
continental U.S. is seeing “widespread” virus
activity.
The U.S. is experiencing such an active flu season
that the CDC held a special briefing on the topic
last week, explaining that there’s an uptick in both
confirmed cases of the disease and hospitalizations
related to it this year. The flu is so widespread,
in fact, that the agency has declared it an
epidemic, and urged those who have not been
vaccinated to seek out the flu shot. But how did
this year’s flu season get so bad?
Read more >
Blood Glucose Test Strips
Another Shared
Diabetic Supply Harboring Bacterial Contamination
Clinical Laboratory News, By Sharon Geaghan, MD,
January 2018
When you or a family member are admitted to the
hospital, you expect that the room will be cleaned
and disinfected thoroughly. You do not expect to
find half-used tissue paper boxes or leftover
bandages from the previous patient. To the contrary,
patients expect that hospitals will take all
necessary precautions to avoid spreading disease,
including disposing of patients’ medications when
they are discharged from a facility.
Perhaps the only exception to the current practice
of single-use, single-patient hospital supplies is
blood glucose test strips. Hospitals and other
institutions often procure blood glucose test strips
in 25- or 50-count vials and bring them from patient
to patient and room to room for testing purposes.
Testing sites range from acute care hospitals,
outpatient clinics, skilled nursing facilities and
long term care facilities to prisons, shelters,
surgery centers, schools, and camps.
Read more >
Devices, Decisions: Glucose in the Critically ill
CAP
Today, January 2018, by Anne Ford
Using
point-of-care glucose meters in critically ill
patients can feel like tiptoeing through a
regulatory minefield. Perhaps your preferred meter
hasn’t been cleared by the FDA for use in this
population. Or maybe you’re not sure which assay
performance requirements should be regulating the
performance of your meters. Or perhaps you’re still
trying to define “critically ill.”
Recently
published studies have aimed to clear some of those
mines by evaluating the accuracy of glucose meter
results in ICU and non-ICU settings and by also
assessing meter performance in a clinical context
rather than a strictly analytical manner. Those
studies, the four options labs have, and a look at
the POC policy in place at Ohio State University
Wexner Medical Center were spotlighted at last
year’s AACC annual meeting in a session, “The Burden
of Proof for Point-of-Care Glucose Monitoring in
Critically Ill Patients,” presented by James H.
Nichols, PhD; Alison Woodworth, PhD; and Steven
Cotten, PhD.
While nursing tends to think that capillary samples
are easier than phlebotomy, Dr. Nichols said,
variations in operator technique mean there is ample
room for error. And getting an adequate reflection
of the patient’s physiology isn’t a given. What if
the patient is...
Read more > |
Looking Beyond HbA1c Outcomes
for Type 1 Diabetes
Leading
diabetes organizations release consensus definitions
for hypoglycemia, hyperglycemia, time in range,
diabetic ketoacidosis.
January 4,2018; CLN Stat
A consensus report by major diabetes organizations
includes standard definitions for outcomes in type 1
diabetes, including hypoglycemia, hyperglycemia,
time in range, and diabetic ketoacidosis.
After doing their homework on the clinical evidence,
major diabetes organizations issued a series of
priority outcomes for type 1 diabetes (T1D), looking
beyond the scope of hemoglobin A1c (HbA1c). HbA1c,
which assesses mean blood glucose measures over a
3-month period, is an important tool in diabetes
care management. However, the test is limited in
that it can’t capture short-term fluctuations in
blood glucose, exposure to hypoglycemia and
hyperglycemia, or the impact of blood glucose
variations on quality of life.
“Recent advances in type 1 diabetes technologies and
research have made it feasible to assess the efficacy
of therapies and technologies using a set of
outcomes beyond HbA1C and to refine definitions of
outcomes such as hypoglycemia. However, while
definitions for hypoglycemia in clinical care exist,
they are not standardized, causing inconsistency in
the definitions used in different research studies,”
according to a statement from the American Diabetes
Association (ADA).
Read more > |
HbA1c Shows its Mettle Predicting Diabetes Risk
CAP
Today, Anne Paxton, December 2017
The
longitudinal Framingham Heart Study, which first
identified the concept of risk factors and made
serum LDL cholesterol a household name, could help
increase the celebrity status of HbA1c, with the
Oct. 26 publication of a new study in Diabetes Care.
International and national organizations since 2010
have recognized HbA1c as a valid way to diagnose
abnormalities in glycemia and diabetes mellitus. But
there has been less consensus on its use as a screen
for elevated diabetes risk.
It has been shown that elevated HbA1c and elevated
fasting glucose are better at diabetes prediction
than fasting glucose alone. But is HbA1c associated
with incident diabetes independently, such that
HbA1c results can identify individuals with high
diabetes risk? That was the question addressed in
the Diabetes Care retrospective study “Prediction of
type 2 diabetes by hemoglobin A1c in two
community-based cohorts,” in which the authors
reviewed extensive data collected on subjects of the
Framingham Heart Study and the Atherosclerosis Risk
in Communities (ARIC) study (Leong A, et al. doi.org/10.2337/dc17-0607).
Based on that data...
Read more > |
Role of Medical Devices in the Data
Management Processes of the Modern Clinical
Laboratory
By
Shawn Hall, MLO, November 2017
As the modern clinical laboratory becomes more
connected, it becomes increasingly difficult to
efficiently exchange and manage data. This is
especially true with regard to interoperability,
where data is exchanged among several clinical
systems. Yet diagnostic laboratories have become
such an integral part of the connected healthcare
paradigm that methods for expanding their
scalability, improving performance, and managing
data are critical to achieving the core objectives
of meeting the needs of clinicians and patients.
Laboratories have long stressed efficiency, safety,
and quality in the management of diagnostic data;
however, the focus has primarily been on the
analytical phase. But the trends toward lab
automation and increasing testing require that
laboratories constantly adapt to ever-changing data
management requirements in all phases of the testing
process. This article addresses pre- and
post-analytical data management processes; discusses
challenges such as patient safety, complex
workflows, and reporting responsibilities; and
examines how data management features of analytical
medical devices can have a positive impact in
today’s connected clinical laboratory.
Read more > |
Point-of-Care Tests Help Manage Influenza
CLP,
By Patrick Murray, PhD, November 2017
This year’s flu
season requires clinical labs to take into account a
variety of new considerations, including FDA
reclassification of RIDTs.
Vaccines are the best defense against influenza, but
predicting when influenza will occur and which
strains will appear is a challenge (see Figure 1).
In 2009, a novel strain of influenza A arose during
the summer, and continued with significant disease
into the fall.1 In 2013, a new strain, H3N2, made
its debut and was responsible for the majority of
disease that year.1 This strain has been the
predominant virus in seasonal outbreaks for the past
3 years. Despite the fact that this strain is
covered under current vaccines and was once again
responsible for the majority of influenza cases
during the 2016–2017 flu season, however, the
prevalence of the strain led to particularly severe
outcomes for children and older adults.
Read more > |
Horizons in Point-of-Care Testing
CLP,
By Kate McLaughlin, PhD, and Donna Hochberg, PhD,
November 2017
POC testing is unlocking new markets for commercial
IVDs, but reaching potential new customers can be a
challenge.
Diagnostic testing that is capable of being
performed at the point of care holds the potential
to improve patient care by enabling faster clinical
decisions with small sample volumes. New instrument
platforms are addressing historic concerns over
quality and data integrity to allow a wider variety
of tests to be performed outside of the lab. At the
same time, new models of more-convenient healthcare
delivery, and the prospect of capturing additional
revenue by performing tests for which lab
proficiency testing and inspections are waived under
the terms of the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), are together giving
physicians, pharmacists, and nurses more power to
shift testing volume to the point of care.
Still, commercialization of point-of-care (POC)
technologies remains...
Read more > |
Benefits and Bumps of Shifting to Beaker
By Anne
Paxton, CAP Today, November 2017
If they were
located in the Land of Oz, laboratories selecting a
laboratory information system might not have to make
a choice between full functionality and seamless
integration with their electronic medical record
system. They could just follow the helpful advice of
the Scarecrow to Dorothy at a crossroads: “Go both
ways.”
Down here in Dorothy’s Kansas, however, having to
weigh an LIS that is part of an enterprise wide
solution against a standalone LIS creates a classic
quandary for hospital laboratories: Follow one brick
road and you may have top-flight integration between
the LIS and EMR but possibly less LIS functionality.
Go down the other road and you may acquire a
best-of-breed LIS but risk stumbling on the
interface with the EMR. Increasing
numbers of hospital and health care system
laboratories, already operating in an Epic
environment for their EMR, are casting their lots
with integration by choosing Epic’s Beaker for their
LIS. As of August 2017, Epic had 375 installations
worldwide, 28 of them between August 2016 and August
2017...
Read more > |
From Many One A Case Study on
Standardizing Point of Care Testing
Instrumentation
Clinical Laboratory News, Bench Matters:
November 2017, Brenda Suh-Lailam, PhD,
DABCC, FACB
Point-of-care testing (POCT) goes a
long way toward helping institutions
improve patient care by returning
fast and reliable results near
patients, thereby enabling prompt
clinical interventions. POCT’s vital
role in patient management makes it
popular across clinical settings but
often with different device types
for the same test. Our institution
is no exception to this POCT device
creep, as at one point we had more
than four types of blood gas
analyzers, three table tops and one
hand-held. Realizing that this
confounded many of our quality and
efficiency aims, we undertook a
deliberate and durable process to
standardize these instruments...
Read more >
|
Convincing Hospitals
that Glucose Management Matters
By Dan
Fleshler | Published on 23 October 2017
Patients'
blood glucose (BG) levels in many American hospitals
run dangerously high, but hospitals aren’t doing
nearly enough to address the problem.
Between 70% and 80% of patients with diabetes
experience hyperglycemia when they’re hospitalized
for critical illnesses or have cardiac surgery. And
about 30% of all inpatients experience high blood
sugars (>180 mg/dL). Even if you stay in the
hospital for just a few days, rising glucose levels
increase the mortality risk and the risk of eventual
kidney failure, poor healing, dehydration and other
problems. Meanwhile about 6% of hospital inpatients
experience potentially dangerous hypoglycemia (low
blood sugar) as well!
It doesn’t have to be this way. In this day and age
of continuous glucose monitoring (CGM) and closed
loop technology, hospital diabetes management has
the potential for a seismic shift -- if they choose
to adopt these newer innovations.
For example, recently on Oct. 18, the FDA approved a
first-of-its-kind CGM for surgical ICUs that can
monitor glucose levels and alert physicians and
hospital staff of any highs or lows. It's a sign of
the times, as this type of tech to monitor glucose
and dose insulin promises to improve patient health,
reduce hospital readmissions and cut health care
costs.
Yet only about 10% of Americans hospitals now use
these “e-Glycemic solutions,” says Linda Beneze, CEO
of Monarch Medical Technologies, which provides
high-tech glucose management systems to hospitals.
Read more > |
How to Choose a Quality Improvement Project
Q&A
with Michael Astion, MD, PhD, Editor-in-Chief, CLN
Patient Safety Focus
In
the October issue of CLN, a reader asked...
'I took a new
job as a supervisor in a medium-sized hospital lab.
The lab is in reasonably good shape with no emergent
problems, but my co-workers and I agree that certain
areas need improvement. I am confident I can do a
quality improvement (QI) project and have worked in
organizations that used different approaches—like
Lean, Six Sigma, and homegrown strategies—and feel I
will be able to fit into any system.
I know how to
choose metrics and incremental goals. But how do I
know which problems to work on first? It is
important to me that these first QI projects succeed
and are meaningful to the staff.'
For Dr. Michael
Astion's answer,
click here... |
Keeping Up with POCT Regulatory
Compliance
MLO,
October 2017, By Connie Mardis
Today, hundreds of tests once considered too complex
for point-of-care testing (POCT) are routinely
performed outside the laboratory. Due to hospitals’
decentralized structure, laboratory testing is
performed on a multitude of POCT devices from
various manufacturers in many hospital wards,
critical care departments, clinics, and physician
offices. Typically, POC devices in a hospital can
include dozens of blood gas analyzers, urine
chemistry and cardiac marker systems, and handheld
coagulation instruments, as well as hundreds of
glucose devices. Perceived barriers to implementing
POCT have been attributed to accountability factors
such as quality control, adequate staff training,
and oversight for accreditation purposes. This
article will review accreditation requirements and
advances in open, vendor-neutral POCT data
management to facilitate billing capture, regulatory
compliance, and inspection preparedness.
Why POCT?
Because of its convenience, timeliness, and
potential to improve patient outcomes, POCT’s
popularity continues to rise.1 Near-patient testing
increases the likelihood that healthcare
professionals and the patient will receive test
results faster, which may facilitate faster
diagnoses, more timely treatment interventions, and
improved patient compliance. For example...
Read more > |
Urinalysis Quality
Control at the Point-of-Care
MLO,
October 2017, By Brian Fernandez
The goal of any clinical diagnostic test procedure
is to provide critical information in a timely
manner so that appropriate actions may be taken,
ultimately improving patient outcomes. Point-of-care
testing (POCT) is a term that has come to describe a
multitude of rapid medical tests that can be
performed at or near the site of patient care. The
most compelling benefit of these tests is that, as
opposed to having to wait hours or days for results
to arrive from an outside laboratory, clinicians can
obtain the results immediately, allowing for
clinical management decisions to be made while the
patient is still at the care facility. While the
implementation of rapid diagnostic tests dates back
to ancient history (sweet-tasting urine was once
commonly used to diagnose diabetes mellitus), it was
not until the 1950s that these rapid diagnostic
methods gained any real predictive value.
Today, the popularity and demand for POCT are
increasing rapidly. TriMark Publications estimates
that the global market for POCT was $14.5 billion in
2016, and is expected to grow by seven percent over
the next five years.
Urinalysis dipsticks at the point-of-care
Urinalysis using multi-analyte dipsticks is a
point-of-care test performed at any hospital,
clinical laboratory, doctor’s office, health clinic,
and nursing facility. Various iterations of these
tests have existed for decades, and they continue to
be among the most commonly performed tests of any
kind. Urinalysis dipsticks contain...
Read more > |
FDA Raises the Bar for Flu
Tests, Aiming for Better Testing and Better Outcomes
Clinical Lab Products, October 2017, By K.C. McGrath
FDA’s recent
regulatory reclassification of antigen-based rapid
influenza diagnostic tests (RIDTs) from Class I to
Class II was prompted by concerns about the tests’
performance during severe flu seasons, most notably
during the H1N1 influenza pandemic of 2009. The goal
of the reclassification is to improve point-of-care
influenza testing, in order to reduce misdiagnoses
and accelerate linkage to appropriate treatment.
The Rationale for Reclassification FDA’s
device classification system reflects the regulatory
controls needed to ensure that devices are safe and
effective for human use. There are three device
classifications based on risk: Class I, Class II,
and Class III. All three classes of devices must
satisfy basic requirements specified by FDA
(‘general controls’), such as proper packaging and
labeling.
Read more > |
The Journey to 100% Point-of-Care
Connectivity
Clinical Laboratory News, October 2017, By
Christiane Nooney, MHA/MBA, MT(AMT)
At first glance, the need for centralized
connectivity of point-of-care (POC) instruments may
seem conceptually at odds with the primary benefit
these devices provide. Indeed, caregivers generate
results and may well have acted on them by the time
POC staff can view test data on their middleware
server. Nonetheless, the value of POC connectivity
has risen steadily in concert with the growing
importance of informatics in care delivery.
Connectivity not only facilitates dissemination of
clinical data to caregivers across the house but
also provides numerous advantages to laboratorians
under the broad heading of compliance management.
Unlike hospital laboratories...
Read more > |
The Role of Lab Automation in Reducing Diagnostic
Errors
Medical
Laboratory Observer, By Brad F. Tieman, September
2017
A recent study
reported that medical error is the third-leading
cause of death in the United States, just ahead of
respiratory illness and behind only cardiac disease
and cancer. More than 200,000 American deaths each
year are associated with preventable harm in
hospitals. In addition to putting patients at risk,
medical errors contribute to substantial avoidable
costs estimated to exceed $17 billion annually in
direct costs in the U.S. alone. Given that up to 70
percent of clinician decisions are influenced by
laboratory test results, there is a major role for
the clinical laboratory to play in reducing
avoidable medical error, enhancing patient safety,
and improving outcomes.
Click here to download the Executive
Brief
Lab error and patient safety
The ECRI Institute publishes an annual report on the
Top 10 Patient Safety concerns. In the most recent
report, two of the top ten, “test result reporting
and follow-up,” and “patient identification errors,”
are directly related to issues that can be addressed
by the clinical laboratory. Patient identification
errors and test result reporting are associated with
the pre-analytical and post-analytical stages of
clinical diagnostic testing. And while recent
studies have shown...
Read more > |
Bringing data analytics to bear on diabetes care
CAP
Today, September 2017, By Amy Carpenter Aquino
September 2017—Can data move the dial on diabetes?
That’s the thinking behind Roche Diabetes Care’s new
partnership with Accenture, and it’s how some labs
and health care systems are already driving diabetes
care to a whole new level.
“At Roche Diabetes Care, we want to create a leading
open digital diabetes ecosystem,” says Yan Beynon,
head of digital and health solutions. To do so, the
company will use Accenture’s existing Intelligent
Patient Platform to build a core data platform that
gathers “vital pieces of diabetes information,” he
says. The data will be categorized, analyzed, and
transformed into “powerful insights to support
improved therapy routines and outcomes.”
Within this ecosystem, Beynon says, blood glucose,
insulin, blood pressure, and cholesterol levels,
along with co-medication, physical activity, food
intake, and other information, will be collected and
analyzed and put into context. “Having all
therapy-relevant data in one place and the smart
algorithms to perform the analyses will help to
improve therapy adaptation and results,” he says.
Read more >
|
CDC
Releases 2017 National Diabetes Statistics Report
The National Diabetes Statistics Report is a
periodic publication of the Centers for Disease
Control and Prevention (CDC) that provides updated
statistics about diabetes in the United States for a
scientific audience. It includes information on
prevalence and incidence of diabetes, prediabetes,
risk factors for complications, acute and long-term
complications, deaths, and costs. These data can
help focus efforts to prevent and control diabetes
across the United States.
Click here for a copy of the report. |
A Limitless Lab
By
Peter Koerte, PhD, Clinical Lab Products, on August
2017
With
connectivity, point-of-care testing is on the front
line when it comes to diagnosing and managing
chronic diseases
Across the globe, studies of healthcare delivery
systems have led researchers to the inescapable
realization that fragmented patient care is not a
sustainable way to manage patient health in the face
of growing economic pressures. The United States,
for example, spends more on healthcare than any
other high-income nation, yet it is well known that
Americans have a lower life expectancy and graver
health outcomes than residents of many other
countries. Such disparities can be attributed, in
part, to the failure of encounter-based medicine to
meet the growing demands of a population that is
heavily afflicted with chronic disease. In response
to such trends, healthcare delivery systems in the
United States and elsewhere are in the midst of...
Read more >
Training Non-Laboratorians to Perform
POCT
By Peggy
A. Mann, MS, MT(ASCP), Clinical Laboratory News,
Ask the Expert: August 2017
Peggy A. Mann, MS, MT(ASCP), delves
into the challenges that
point-of-care coordinators (POCCs)
face when training non-laboratorians
to perform POC testing, from time
constraints to designing programs
suited for a diverse range of
healthcare staff positions.
Read more >
|
Elizabeth Terry
Named 2017 POCC of the Year!
Elizabeth
Anne (Betty) Terry is part of a two person POCT team that
manages 1500 POCT users at the Kaiser Permanente
Medical Center in Oakland, California. The POCT
program encompasses a 349-bed, state-of-the-art
hospital and 6 medical office buildings.
Betty is a native
of Pennsylvania, raised in the San Francisco Bay
Area, received a BA in Bacteriology from the
University of California, Berkeley and completed the
Curriculum in Medical Technology from University of
California, San Francisco. During the course of her
career Betty has worked in all shifts and all areas
of the clinical lab.
Read more > |
“Off-Label” Use of Blood Glucose Monitoring Systems
in Critically ill Patients
MLO
letters to the Editor, June 22, 2017
The
article by Scott Isbell, PhD, DABCC, entitled
“Bedside blood glucose testing in critically ill
patients,” published in the April edition of MLO
[2017;49(4):8-12] summarized some of the current
issues related to testing capillary blood and the
“Off-Label” use of blood glucose monitoring systems
(BGMS) in critically ill patients. However, in our
view the article did not completely nor adequately
explain all the recent concerns about using BGMS in
critically ill patient care settings and the reasons
behind the publication of the new FDA guidance with
specific critical care accuracy criteria and
clearance requirements for manufacturers. More
specifically, the article did not address the
patient dangers associated with using blood glucose
meters not cleared for use in critically ill
patients, nor the regulatory risks to hospitals when
they use a meter not cleared for critically ill
patients in an “Off-Label” application. The concern about
the accuracy of BGMS used in critically ill patients
is related to deaths and serious adverse events
reported in the US FDA MAUDE database, as well as
in peer-reviewed medical journals. These reports and
publications represent the tip of the iceberg and
are still being reported for certain glucose meters
used routinely in hospital settings.
Read more > |
CDC data show C. diff infection rates are falling
after steady increase
Preliminary analysis of data from the CDC's Emerging
Infections Program showed that the rate of new
Clostridium difficile infections in hospitals and
nursing homes nationwide declined by 9% to 15% from
2011 to 2014, suggesting revised antibiotic use
guidelines and more aggressive cleaning standards
are working. C. difficile infection rates climbed
annually from 2000 to 2010, and in 2011 caused
almost 500,000 illnesses and killed about 29,000
people in the US.
Read more > |
CDC: Flu season moderate,
influenza H3N2
most dominant strain
CDC researchers reported that flu activity this
season was moderate, with influenza A (H3N2) being
the most dominant strain for most of the season. The
findings in the agency's Morbidity and Mortality
Weekly Report also showed that flu vaccines
distributed this season were tied to a 42% lower
overall risk of flu-related medical visits.
Read more > |
poctHUB Launches: Take It for a Spin
By Christopher
Fetters, Nextivity, May 2017
poctHUB
is a portal for professional POCT products that
includes the ability to read and write reviews, link
journal articles, browse product specifications and
search for your next great POCT product. poctHub is a
clearinghouse of product information which is
unbiased and normalized across products. Each
product will be rated by its users based on Clinical
Efficacy, Reliability, Ease-of-Use, Product Support,
and an Overall score. Viewers will be able to see
how many other hospitals have connected to each
product and how many have reviewed each product.
Scientific journal articles, case studies, and
product brochures can all be linked to each product
limiting the need to scour the web for product
information. poctHUB will put much of the
information you need, right at your fingertips. Using poctHUB is
free for anyone who directly or indirectly treats
clinical patients: POCCs, lab managers, medical
directors, respiratory, nursing, POL office
managers, etc.
Take it for a spin today!
Untangling Glycaemia and Mortality in Critical Care
Vincent Uyttendaele, , Jennifer L. Dickson, Geoffrey
M. Shaw, Thomas Desaive and J. Geoffrey Chase Critical Care,
June 2017
Glycaemic control (GC) in the intensive care unit
(ICU) is a controversial subject . Whereas some
studies showed improved mortality with GC within a
tight or intermediate range, several others studies
and larger analyses did not reproduce these results.
Increased hypoglycaemia induced by the GC protocol,
patient variability and/or protocol compliance
further confounds results. The strong associations of blood glucose (BG) level
and/or variability with mortality have been used to
make a case for GC. The association of moderate or
severe hypoglycaemia with increased mortality
similarly indicates that improved control must be
achieved safely, despite high inter- and intra-
patient variability. The association of high times
in intermediate bands with reduced mortality would
indicate...
Read more >
|
Online |
PDF |
Looking at POCT Through a New “Value” Lens
By Kim
Futrell, June 22, 2017, Medical Laboratory Observer
Advances in technology, combined with the value
focus of today’s healthcare system, are changing the
how, when, and where of laboratory testing. As part
of this shift, these trends are increasing the
demand for point-of-care testing (POCT) and
broadening the impact that POCT can make in improved
patient outcomes and cost savings. Improvements in
patient satisfaction also can be realized when
laboratory results are made available in real time
at the patients’ point of care. In order to utilize
POCT to its fullest, however, we have to learn to
look at POCT with a different perspective than in
the past—through a new “value” lens. We have to
carefully determine when and where POCT can have the
most benefit and implement IT solutions that ease
the complexity of POCT integration and oversight so
that the benefits are not overshadowed by the burden
of management and integration.
Read more > |
Bringing POCT
to the Community
American
Pharmacists Association
The expansion of POCT services to
pharmacies increases patient access, but
barriers exist. According to CDC, 8
million people have undiagnosed
diabetes, 240,000 people have
undiagnosed HIV, and 800,000 people have
undiagnosed hepatitis C in the United
States.1 POCT—medical diagnostic testing
performed in close proximity to the
patient and outside traditional,
clinical laboratory settings—can
identify all three of these diseases.
The testing can be provided at primary
care clinics, community pharmacies,
paramedical vehicles, rural and remote
areas, and during times of natural
disasters or emergencies.
POCT offers many advantages toward
improving the quality of, access to, and
cost effectiveness of patient care. For
example... Read
more >
|
HbA1c Test May Improve Diabetes Detection
By Miriam E
Tucker, Medscape
HbA1c may be the most
effective method to identify patients with
undiagnosed prediabetes and diabetes, and
point-of-care testing further enhances that
screening ability in primary-care settings, new
research suggests. The findings were published
recently in the Annals of Family Medicine by Heather
P Whitley, PharmD, of Auburn University Harrison
School of Pharmacy, Montgomery, Alabama, and
colleagues.
"First, diabetes and prediabetes need to be on our
radar as possible diagnoses. In the United States,
where we have such a heavy prevalence of diabetes,
we need to be thoughtful and aggressive in
screening," Dr Whitley told Medscape Medical News.
And, for screening purposes, the data suggest that
HbA1c... Read
more >
Note: You must be a
Medscape Subscriber to view this article.
Subscriptions are free. |
From Micro-hospitals
to Mobile ERs...
New Models of
Healthcare Create Challenges and Opportunities for
Pathologists and Medical Laboratories
Dark Daily
New low-cost alternatives to emergency department
and hospital visits could require flexibility from
pathology groups and clinical laboratories to
provide the best quality care
In response to the rising cost of conventional
hospital services, innovative healthcare models such
as micro-hospitals, bedless hospitals, and mobile
and freestanding emergency rooms (ERs), are
attempting to lower costs while maintaining quality
of care by providing alternatives to traditional ER
visits and hospital stays.
This means new challenges and opportunities for
pathology groups and medical laboratories that can
adapt to the different needs of these new healthcare
delivery models. Each different care model will want
clinical lab testing services and the reporting of
lab test results to be handled in ways that enable
these providers to achieve improved patient
outcomes.
Read more > |
Molecular-Based Point-of-Care Laboratory
Testing Will Revolutionize Healthcare,
But Practical Considerations Exist
Contagion Live -
Infectious Diseases Today, William Todd Penberthy,
PhD
The American Academy of Microbiology had a
point-of-care colloquium in October 2016 that
brought together clinical laboratory
microbiologists, physicians, investors, global
health experts, patient collection experts,
government agencies, foundations, and commercial
industry to discuss how to enact modern molecular
diagnostic protocols most effectively for
point-of-care (POC) testing settings.
Contagion® sat down with the chair of the colloquium
and a commentary-author with vast experience in POC
clinical trials; Melissa B. Miller, PhD, Professor
and Director of the Clinical Molecular Microbiology
Laboratory, University of North Carolina School of
Medicine, Chapel Hill and Robin Patel, MD, ASM
Microbe 2017 Co-Chair, Director, Infectious Diseases
Research Laboratory, Mayo Clinic.
Dr. Miller emphasized that one of the issues at the
POC colloquium was about changing paradigms. Read
more > |
In Flu Season Management, POC Molecular to the Fore
Cap
Today, May 2017, By Anne Paxton
May 2017—Stacked against some of the nation’s
previous bouts with influenza—such as the 2014–15
season—the 2016–17 flu season didn’t break records
for drama. To be sure, every flu season is
different, and regional variation was prominent. In
Central Texas, some outbreaks appeared to start
later than usual, but the dominant viruses were the
same as last year’s—H1N1, H3N2, and influenza B—says
Bob Fader, PhD, chief of the virology and
microbiology laboratory at Baylor Scott & White
Health, Temple, Tex. The strains identified were a
good match with this year’s trivalent and
quadrivalent vaccine. Testing volume was up, as were
positive PCRs.
From her vantage point in the northeast, “I’d say
this season was about average,” says Donna M. Wolk,
MHA, PhD, D(ABMM), system director of clinical and
molecular microbiology for Geisinger Health System,
Danville, Pa.
Read more > |
POCT HbA1c Boosts Screening, Identification
of Prediabetes, Diabetes
May
2017, Clinical Laboratory News
A
comparison of point-of-care (POCT) HbA1c
testing versus standard diabetes
screening tests in family medicine
clinic patients found that POCT HbA1c
identified significantly more patients
with previously undiagnosed
hyperglycemia and prediabetes (Ann Fam
Med 2017;15:162–4). The authors also
determined that systematically screening
patients via POCT HbA1c “greatly
increases the chances for a screen to
occur.”
Read more >
|
Point-of-Care or Clinical Lab INR for
Anticoagulation Monitoring: Which to Believe?
By
Stacy A. Johnson, MD, Clinical Laboratory News,
April 2017
68-year-old female with a history of hypertension,
diabetes mellitus, stroke, and atrial fibrillation
presents for routine follow-up at your hospital’s
anticoagulation clinic. The clinical pharmacist
checks her international normalized ratio (INR) with
a point-of-care (POC) device to monitor her
anticoagulant therapy (warfarin).
The POC INR result is elevated to 4.0, which is
above the recommended INR goal range of 2.0–3.0
based on her clinical indication of atrial
fibrillation. The pharmacist enters the POC INR
result into the patient’s electronic medical record
and discovers she had an INR obtained earlier that
same day, along with a basic metabolic panel and
complete blood count ordered by her primary care
physician. The clinical lab (CL) INR result was 2.9,
and obtained just 90 minutes earlier. All other test
results were normal.
The patient says......
Read more >
Bedside Blood Glucose Testing
in Critically Ill Patients
By
T. Scott Isbell, MLO, April 2017
This
month's issue of MLO has a really good, continuing
education, article on how studies have demonstrated
that the practice of hospital bedside blood glucose
testing is a necessary and effective means of
managing and monitoring glycemic control. Protocols
vary by institution, but there is general consensus
among providers that this process is an essential
component of patient care. However, the use of
handheld blood glucose meters within some critically
ill patient populations has resulted in varying
degrees of confusion about off-label use and
potential discrepancies in results.
LEARNING OBJECTIVES
-
Define what
constitutes a critically ill patient population
and discuss the use of handheld blood glucose
monitors in critically ill populations.
-
Discuss
agencies that regulate off-label device use and
identify the guidelines that laboratories must
adhere to, in order to be compliant with
off-label device use.
-
Recognize the
characteristics of diabetes statistics as the
relate to healthcare and morbidity.
-
List testing
methods for diagnosing and monitoring diabetes
and define the limitations with each method.
Read more >
For more on diabetes/glucose testing, check out
the April MLO Digital Edition.
Management of Inpatient Hyperglycemia and Diabetes in Older Adults
Diabetes Care 2017;40:509–517 | DOI:
10.2337/dc16-0989
Adults aged 65 years and older are the fastest
growing segment of the U.S. population, and their
number is expected to double to 89 million between
2010 and 2050. The prevalence of diabetes in
hospitalized adults aged 65–75 years and over 80
years of age has been estimated to be 20% and 40%,
respectively. Similar to general populations, the
presence of hyperglycemia and diabetes in elderly
patients is associated with increased risk of
hospital complications, longer length of stay, and
increased mortality compared with subjects with
normoglycemia. Clinical guidelines recommend target
blood glucose between 140 and 180 mg/dL (7.8 and 10
mmol/L) for most patients in the intensive care unit
(ICU). A similar blood glucose target is recommended
for patients in non- ICU settings; however...
Read more
HbA1c in CVD Treatment: Farewell to One Size Fits All
By Anne
Paxton, CAP Today, March 2017
Anchor. Central pillar. Cornerstone. It would be
hard to find a weighty synonym for “linchpin” that
hasn’t been used to describe HbA1c’s role in
diabetes diagnosis and management since 2010, when
the assay was recognized by key standard-setting
organizations as the equal of fasting glucose and
oral glucose tolerance testing in diabetes and
prediabetes testing. But recognition of the complex nature of the
relationship between HbA1c and diabetes-related
complications has influenced and modified HbA1c’s
clinical use as the test evolves. A new review
article by experts in the field outlines how use of
the HbA1c test in cardiovascular disease treatment
and prevention is trending toward a more
patient-centered approach as the assay’s intricacies
are explored.
Read more >
Diabetes Decision
Time: Proficiency testing
hurdle slows use of POC HbA1c
tests
By:
Deborah Levenson, March 2017, Clinical Laboratory
News
More than 29 million Americans—about 9% of the U.S.
population—have diabetes, according to the American
Diabetes Association (ADA). Racial and ethnic
minority groups have higher rates of the disease,
which, when not managed effectively, leads to
debilitating complications like cardiovascular
disease, kidney disease, stroke, and blindness. As
it is, however, some patients are well down the road
to developing these sequelae before being diagnosed
formally with diabetes. Since point-of-care (POC)
tests that measure HbA1c are well-established tools
for monitoring and managing long-term glycemic
control, some healthcare professionals believe using
them for diagnosis would catch individuals earlier
in the diabetes disease process, enabling timelier
treatments and better outcomes.
More > |
Advances in POCT technologies outpace regulatory and
accreditation requirements
Jeffrey A. DuBois, MLO, February 2017
Long after their deaths, two famous scientists
continue to challenge us with their words. “Knowing
is not enough; we must apply. Being willing is not
enough; we must do,” said Leonardo da Vinci, Italian
artist, scientist, and inventor. “The true sign of
intelligence is not knowledge but imagination,”
spoke German-born theoretical physicist Albert
Einstein. Their pioneering work has influenced all
areas of science and, perhaps, even science fiction.
The imaginary tricorder in the Star Trek series may
represent the ultimate goal of integrated
point-of-care diagnostics, but it remains a
fictional object. However, the Internet of
individual care (and with it, the creation of high
volumes of clinical data), where sensors, tests, and
wearable devices have moved out of the laboratory
and clinic directly into our lives for
self-management and remote monitoring, has already
begun and presents significant challenges to
providers, regulators, and accreditation agencies
alike.
More > |
IQCP: The Critical First-Year Findings
By
Irwin Rothenberg, MBA, MS, MLS(ASCP), Advance for
Administrators of the Lab, February 2017
A
year ago, laboratory journals, professional meetings
and in-house planning were all about the pending
deadline for implementation of the new CMS quality
control option, the Individualized Quality Control
Plan (IQCP), which was replacing the Equivalent
Quality Control (EQC) testing already in place. With the January
1, 2017 implementation date rapidly approaching, many laboratorians had already begun performing their
risk assessments, and making revisions to their
existing QC Plans (as needed). Laboratory quality
assessment schedules were revised to include QAs for
the new IQCPs.
Whether or not IQCP is judged effective at actually
improving the quality of the testing performed
depends on how well the implementation process is
carried out, along with the subsequent quality
assessments performed.
More > |
How did your lab do with POCT?
Patrick
Murray, MLO, February 2017
The end of flu
season is in view
At this point in the year, most healthcare providers
are seeing a steady wave of patients with flu-like
symptoms. They may be struggling to pinpoint
underlying causes and identify the appropriate
treatment in a timely manner. Flu and respiratory
syncytial virus (RSV) have overlapping peak
infection seasons, making it difficult to
distinguish the two clinically. Group A
streptococcus is also common now.
We’ve likely seen the peak of flu season, and RSV
may be starting its wind-down as well, so this is a
good time to begin reflecting on how point-of-care
testing (POCT) in your institution affected
performance in managing winter respiratory tract
infections. Upon reflection, how might your POCT
strategy be improved for the next flu season? Here
are some considerations for lab managers, which may
help with planning for 2017-2018.
Effect on
overuse of antibiotics
An incorrect diagnosis or inaccurate test result may
point providers to the wrong treatment, exacerbating
the overuse of antibiotics. More than 25 percent of
antibiotics are prescribed for conditions that don’t
warrant them.3 Out of 97 million annual office
visits among adults in the United States between
2007 and 2009 that resulted in an antibiotic
prescription, 41 percent were for a respiratory
condition, the most common out of seven categories.
More > |
Accriva Diagnostics Acquired by Werfen and Instrumentation Laboratory
Accriva
Diagnostics, a Warburg Pincus portfolio company,
announced today the definitive agreement with Werfen,
a privately held medical diagnostics firm
headquartered in Barcelona, Spain, and its
subsidiary Instrumentation Laboratory (IL)
headquartered in Bedford, MA, whereby Werfen and IL
have acquired all shares of Accriva. The transaction
was successfully closed on January 19, 2017.
The Accriva portfolio, including globally recognized
point-of-care (POC) diagnostic products for
coagulation and anti-platelet therapy response, will
allow IL to establish a market-leading position in
hospital-based POC Hemostasis testing, expand its
position in POC Critical Care testing and complement
its leadership in the Hemostasis Laboratory segment.
Accriva Website |
Accriva Press Release |
Werfen/IL Press Release |
Is improving access for patients equaling loss of
critical quality oversight?
Advance
for Adminstrators of the Lab, At the Bedside, By
Peter Koerte on January 2017
Diagnostic testing traditionally performed in
healthcare settings such as hospitals and reference
laboratories is increasingly expanding beyond the
brick-and-mortar boundaries of which we’ve grown
accustomed. Today, point-of-care testing (POCT), or
testing conducted outside the laboratory, is quickly
evolving to help expedite patient care and clinical
decision-making.
There are key benefits to the point-of-care testing
approach. The first pertains to response time and
its effect on patient care. Critical Stat tests can
be processed more quickly, expediting patient care
for emergency situations such as suspected venous
thromboembolism.
More > |
FDA Releases Two Final Guidance Documents
on Blood Glucose Monitors
Clinical Laboratory News, December 2016
The
Food and Drug Administration (FDA) has released the
final versions of two guidance documents, “Blood
Glucose Monitoring Test Systems for Prescription
Point-of-Care Use” and “Self-Monitoring Blood
Glucose Test Systems for Over-the-Counter Use.”
These documents describe the studies and criteria
that manufacturers should submit when seeking
clearance for blood glucose monitors designed for
use by healthcare professionals and patients at
home, respectively.
More > The complete
versions of both guidance documents are available at
www.fda.gov |
Point-of-Care Testing: The Great Boom Ahead
Kim Futrell, MT (ASCP),
Products Marketing Manager, Orchard
Software Corporation | Cap
Today Online
White Paper
features POC testing management and integration
A
new white paper from Orchard Software titled
“Point-of-care Testing: The Great Boom Ahead”
discusses the history of POC testing connectivity
and shares specific case study savings and
improvements associated with the adoption of a POC
testing connectivity and management solution.
The value-focused environment of today’s healthcare
is increasing the demand for POCT; and not just POCT,
but rapid, accurate, and integrated POCT results.
Improvements in patient outcomes and satisfaction
can be realized when laboratory results are made
available in real-time at the patients’
point-of-care. Yet, POCT tends to be siloed and
often is not managed by the lab. To meet the
evolving needs of healthcare, laboratories need to
actively manage POCT. To do so effectively... More
>
Laboratory Management of POCT
Thorough
evaluation and stewardship by the laboratory are
necessary before and during implementation.
By Kim
Futrell, BS, MT(ASCP), 30 NOVEMBER 2016 • ADVANCE
/LABORATORY • WWW.ADVANCEWEB.COM
Thorough
evaluation and stewardship by the laboratory are
necessary before and during implementation.
The demand for point-of-care testing (POCT) is
increasing in response to the value-shift in
healthcare and advancements in technology. A number
of factors are converging to promote the value of
POCT (e.g., increases in infectious diseases;
increases in lifestyle diseases, such as cardiac
diseases and diabetes; increased patient desire to
use home-based POC devices; and technological
advancements creating faster and easier-to-use
devices).
More >
CAP to Discontinue WBG WG2 Surveys
The College of
American Pathologists’ (CAP) Laboratory
Accreditation Program (LAP) will no longer require
enrollment and participation in proficiency testing
(PT) for waived whole blood glucose on glucose
meters (ie, WB2/WBG) and waived whole blood Protime/INR
(ie, WP10) beginning with the 2017 PT program year.
Laboratories will be required to perform alternative
performance assessment for these analytes. To read the letter from CAP, click here. If you have
questions regarding this change, please contact a PT
Compliance representative at 1-800-323-4040 ext.
6052 or 1-847-832-7000 ext. 6052. To learn more
about CAP Quality Crosscheck products, please
visit the CAP online store (please note,
the whole blood glucose Quality Cross Check product
will not be available until the 2017 ordering
information is posted) or contact CAP Customer
Service at 1-800-323-4040 (Option 1).
Addressing Antibiotic Resistance with Molecular
Diagnostics
New methods promise
faster and more accurate detection of MDROs
By
Elena V. Grigorenko, PhD, and Donald R. Stalons,
PhD, D(ABMM), MPH, CLP, October 2016
Antibiotics are marvels of modern medicine that have
helped healthcare professionals fight infections
caused by bacteria for the past 70 years. However,
there is concern for the current use and future
benefits of antibiotics. According to the World
Health Organization (WHO), widespread inappropriate
use of antibiotics has created global resistance
that may soon drive every nation into a
post-antibiotic era.
More >
Rapid point-of-care assays for influenza testing
By:
Norman Moore, October 2016, MLO
The estimated overall vaccine effectiveness rate for
the 2015-2016 flu vaccine was below 50 percent,
underscoring the importance of accurate and timely
diagnosis for improving patient outcomes and
reducing the public health impact of this
potentially deadly illness.
Clinical guidelines from the U.S. Centers for
Disease Control and Prevention (CDC) and other
expert groups recommend initiating antiviral
treatment within 48 hours of onset.1 Yet many of the
influenza assays widely used today do not realize
the full potential of diagnosis because they do not
provide highly accurate results quickly enough for
clinicians to make informed treatment decisions
while the patient is still under their care.
More >
CMS: Nurses Can Perform
High Complexity Tests
By Glen
McDaniel, Advance Newsmagazines - www.advanceweb.com
The
Centers for Medicare and Medicaid Services (CMS)
recently published a memo that it sent to CLIA
inspectors on how to interpret educational
requirements. CLIA had always specified the minimum
educational requirements for individuals performing
laboratory tests. In recent years
there has been quite a strong lobby from nursing to
recognize a nursing degree as a biological science
degree, having the requisite credit hours of
biology, chemistry etc. Those of us with oversight
for point of care testing (POCT) had also been
unsure as to whether nurses could perform non-waived
tests and maybe even fully manage a POCT program
where non-waived tests were utilized. Now CMS has
weighed in definitively by saying that, yes, a
nursing degree is a science degree making nurses
qualified to perform non-waived tests. A careful
reading of the CLIA regulations would suggest that
if that is true, then nurses may in fact be allowed
to even direct laboratory testing.
Read more >
Point-of-Care Hemoglobin Testing: Methods and Relevance to Combat Anemia
By:
Katja Lemburg, Medical Laboratory Observer,
September 2016
Anemia is a
condition that causes a high degree of personal
disability but, historically, has lacked adequate
resourcing in many public health systems. This
situation is even less understandable when you
consider that the main diagnostic, hemoglobin
testing, is one of the most commonly used
point-of-care (POC) tests, and one of the easiest to
perform.
POC hemoglobin testing is often needed in settings
where the use of a benchtop laboratory hematology
analyzer is not practical. It is ideal for use in
settings where resources are poor, or there is a
need for mobility and simplicity in field use, or
where turnaround time (TAT) for the test result
needs to be short, as in acute clinical situations.
Read more >
Let’s Close the Knowledge Gap
CAP
Today, From the President's Desk, August 2016
Most
of us have heard the laboratory described as a black
box where specimens are exchanged for information
and diagnoses. This tells me that we work beside
some highly skilled people who don’t know what we do
and that the knowledge gap makes them uncomfortable
enough to joke about it. This incomplete
understanding of what takes place within the
laboratory has meaningful consequences in multiple
contexts.
I am certain you
will be asked (often by someone well into the
process of creating a budget) to quantify your value
to the institution. Because this is virtually
inevitable, we should anticipate it and formulate a
succinct response. For example, one might say that
we know how to ask the right questions, to work with
complex systems, or to keep stuff from blowing up.
Ideally, we can transition from there to the real
answer: Our value lies more in how we think than in
what we do.
Read more >
Not fit to test: battling high hemolysis rates in
the ED
By Anne
Ford, CAP Today, August 2016
Poverty, unemployment, crime, dropout rates: In some
categories, no community wants to be No. 1. And in
some categories, no hospital wants to be No. 1
either. High on that list: hemolysis.
“Hemolysis is a big issue,” Michael Phelan, MD, said
at the Executive War College meeting this spring. In
fact, “it’s the leading cause of unsuitable
specimens” at the Cleveland Clinic’s main campus,
where Dr. Phelan is an emergency medicine physician.
As he discovered at the start of a CDC-funded
project to study and reduce hemolysis at his
hospital between 2014 and 2015, his emergency
medicine department led all other departments in
hemolysis rates. Over the course of one week...
Read more >
2016 AACC POCC Forum
Highlight
Effective communication skills when discussing an
overdue PPM competency assessment with a physician
 |
Pat Kraft
from Good Samaritan Hospital, Dayton,
Ohio, and Greg Cosentino from Hunterdon
Medical Center, Flemington, NJ, read
from one of the scripted dialogs
that were performed by a panel of POCC’s
to demonstrate effective communication
skills. |
The 2016 Point of
Care Forum topic at the AACC Annual Conference in
Philadelphia
was ‘Leadership Communication for the POCC:
Overcoming the Barriers of Productive Communication’,
presented by Rick Import of Whitehat Communications.
Among the forum highlights was a role play session
'acted' by a panel of POCCs. One of the role play
dialogs that drew a lot of attention from the
audience was between a POCC and physician on the
subject of PPM competency. Many in attendance
requested that it be made available for reference in
their own settings.
Here is that dialog.
We hope it helps and want to thank Marcia Zucker,
PhD for providing the segment of the dialog that
POCC’s will find so valuable when discussing PPM
competency with physicians.
Note: Many
more POCT highlights from AACC will be available on
this website and through the PointofCare.net
eNewsletter in the coming weeks. |
Point-of-Care Versus Lab-Based Testing: Striking
a Balance
Bench
Matters: July 2016, By Kathleen David, MT(ASCP),
Clinical Laboratory News
Point-of-care testing (POCT) is all the rage right
now, and for good reason. These often portable,
easy-to-operate devices and instruments return
results quickly, enabling immediate treatment or
intervention. POCT also short- circuits many steps
involved in lab-based testing, obviating the need to
collect a specimen, transport it to the lab, perform
testing, and transmit the results back to the
provider. This speed and efficiency often greatly
improves both patient outcomes and patient
satisfaction.
Despite its popularity, however, POCT has
downsides...
Read more > |
AACC POC Award Winners |
More |
Kerstin
Halverson Named
2016 POCC of the Year
The AACC CPOCT Division has announced that
Kerstin Halverson of Children’s of Minnesota has
been named the 2016 Point of Care Coordinator of
the Year. Since 2003, Kerstin has overseen the
entire POCT program for two hospitals, one
ambulatory surgery center, three clinics and one
ancillary testing site.
Read more >
Pat
Kraft Receives 2016 Outstanding Contributions to
POCT Award
Patricia Kraft, M.A., MT (ASCP), Laboratory POCT/Safety/Education
Coordinator at Good Samaritan Hospital in
Dayton, Ohio is the recipient of the 2016
Outstanding Contributions to POCT Award. Pat
graduated with a BS in Medical Technology from
the University of Dayton...
More> |
Role of Calibration Verification/Linearity in
the POCT Market
By
Glenn Mitchell
If you are one of the many who have purchased an
instrument for point-of-care testing (POCT), this is
a very legitimate question. POCT user manuals will
typically state in one form or another that the
linearity of the instrument should be checked...
Read more >
The Continuing Case for
POCT for HbA1c
By
Gavin Jones
There is an ongoing conflict between traditional
clinical laboratories and the relative new kid on
the block, point-of-care testing (POCT). Of course,
the laboratory system will likely always be king.
But...
Read more >
Resolving QC failures
By W.
Greg Cooper
Most medical
technologists and technicians, responsible for
outputting test results as quickly and reliably as
possible, hate it when their smooth flow of work is
abruptly interrupted by an out-of-control QC rule
flag. Suddenly they are
faced with delayed reports, the prospect of a
complicated technical investigation, and a litany of
questions they must ask themselves, such as...
Read more >
CLSI Solution Packages Cover Top 10 Deficiencies in the Lab
CLSI identified the top 10 most commonly cited
deficiencies by major accreditation organizations,
and created solution packages to address each area.
Each package is designed to provide you with the
tools to prepare for accreditation inspection,
improve areas of interest, or resolve any
deficiencies cited on your last inspection. Packages
include:
-
Controls: Mean and Standard Deviation
-
Specimen and Reagent Storage
-
Personnel Records, Responsibilities, and
Competence
-
Lab Director Responsibilities
-
Waived and Quantitative QC
|
-
Patient and Specimen Identification
-
Method Validation and Verification
-
Method Correlation
-
Proficiency Testing
-
Adverse and Nonconforming Events
|
More on CLSI Solution Packages >
Glucose Proficiency Testing Criteria Stirs Standards Debate
By Anne
Paxton, CAP Today, June 2016
It may not be an exact science, but resetting
standards is a long-established means of improving
quality of testing, and it can also be a way of
adapting to improvements in quality that have
already been realized. In the case of the CAP’s
recent tightening of proficiency testing criteria
for hospital glucose testing, both purposes are at
work. The new criteria reflect the fact that glucose
meter performance has improved significantly, CAP
Chemistry Resource Committee chair Gary L. Horowitz,
MD, explains in the 2016 Program Update on Glucose
Meter Performance. But the change in Survey criteria
has brought unexpected pushback from one of the
leading hospital glucose meter manufacturers.
The CAP’s Chemistry Resource Committee approved and
implemented the new PT grading criteria for hospital
glucose meter performance in early 2015. The cutoff
for passing was changed from within...
Read more >
More Clarity Over Time for Heart Failure Biomarkers
By
Karen Lusky, CAP Today, June 2016
Robert Christenson, PhD, a professor of pathology
and of medical and research technology at the
University of Maryland School of Medicine, likens
the U.S. mortality rate for myocardial infarction to
three or four jumbo jets crashing daily. For heart
failure, it’s about half that many deaths, “so maybe
one and one-half jumbo jets,” Dr. Christenson said
in a session on cardiac biomarkers at the CAP annual
meeting last year. With more people living longer in
general but surviving acute MI, said co-presenter
and cardiologist Christopher deFilippi, MD, “we are
seeing..."
Read more > |
The Next Step for Molecular POCT
Shrinking
Technology and Tighter Turnaround Times Shake Up
the Field
By
Julie Kirkwood, Clinical Laboratory News, June
2016
The year 2015 may well be remembered as the the
time when molecular diagnostics began to expand
beyond the laboratory. In January, the Food and
Drug Administration (FDA) granted its first CLIA
waiver to a nucleic acid-based test, the Alere i
Influenza A&B. A few months later, Roche
received a CLIA waiver for the cobas Liat System
and Strep A. By the end of the year, Alere’s i
Strep A, Roche’s Liat influenza A & B, and
Cepheid’s Xpert Flu+RSV Xpress had also received
CLIA waivers.
Read more > |
Molecular Platforms on the market >
|
Medical Errors Are the Third Leading Cause
of Death in the US
Fatal
mistakes, which account for more than 250,000
deaths each year, merit a closer look
June 2016, Clinical Laboratory News
Fatal medical errors—whether occurring by
omission or commission—go unmentioned on death
certificates and are not tracked by the Centers
for Disease Control and Prevention (CDC).
A new analysis published May 3 in the BMJ,
however, suggests these mistakes merit a closer
look. By examining four prior studies that
reported such deaths between 2000 and 2008, and
then making new calculations based on the
hospital admission rate in 2013, researchers
estimated that 251,454 deaths that year stemmed
from medical errors. This amounts to 9.5% of all
deaths each year in the U.S, they say.
Read more > |
Zika Virus Puts Testing in the Forefront
Major new funding, testing sought as disease
rages
By
Gary Tufel, Clinical Lab Products, May 2016
One of the biggest healthcare surprises of the
past year has been the sudden and frightening
rise to prominence of the Zika virus in the
Western Hemisphere. An arbovirus spread
predominantly by the Aedes aegypti mosquito,
Zika typically causes a mild illness whose
symptoms include conjunctivitis, fever, joint
pain, and rash lasting several days to a week.
Previously thought to be a mild virus that
resulted in symptoms for only about 20% of those
infected, Zika is turning out to be the cause of
a number of serious diseases. Of special concern
is recent definitive evidence that the virus
causes microcephaly in infants as well as
causing serious brain and nerve cell damage.
Read more >
With High-Sensitivity Troponins, Watching and Waiting Continue
By
Karen Lusky, CAP Today, May 2016
Laboratories and hospitals in the U.S. continue
to look forward to high-sensitivity troponin
assays. Judd E. Hollander, MD, says all he’s
heard for the past five years is that an assay
will be out at the end of the year. “And once
you get halfway through the year, it will be out
next year,” says Dr. Hollander, chair of the
Department of Emergency Medicine and associate
dean of strategic health initiatives at Sidney
Kimmel Medical College of Thomas Jefferson
University. Robert Christenson, PhD, DABCC, professor of
pathology at the University of Maryland School
of Medicine, sees the odds as good that the FDA
will clear one such assay this year. He predicts
it will be a Roche or an Abbott assay.Read more >
Making a Smooth Pivot to Point-of-Care
IQCP
By
Anne Paxton, CAP Today, May 2016
Practically speaking, there’s a limit to the
number of balls a human can juggle. And there’s
probably a limit to how complex a quality
control plan a point-of-care testing coordinator
can handle. Last year, many POC coordinators
felt that the Centers for Medicare and Medicaid
Services would be pushing that limit pretty hard
with its new Individualized Quality Control
Plan. The
voluntary-in-name-only QC program had a Jan. 1
deadline, but Adonica Wilson, MT(ASCP) (right),
confesses that when she contemplated developing
an IQCP, she procrastinated a little, in hopes
that the program would somehow get canceled.
Read more >
POCT in the
Emergency
Department
The healthcare
industry has realized the value of POCT
as an option in
emergencies
By
Benjamin Roussel, PharmD, Advance for the
Administrators of the Laboratory, May 2016
Point-of-care
testing (POCT) refers to the performance of
analytical tests on patient specimens outside of
the laboratory by inexperienced staff. Among the
existing point-of-care tests, there are two
different types: simple lateral flow tests
(pregnancy, HIV, glucose or even drugs-of-abuse
(DOA) testing), where no complex fluid
management is required and complex microfluidics-based
tests. POCT testing based on microfluidic
technology is expected to grow from $2.7 billion
in 2015 to $7.4 billion in 2019-with a compound
annual growth rate of 23% between 2015-2020.
Read more >
Late Flu Season, Early Signs of New Test Impact CAP Today, April 2016, by Kevin B. O’Reilly
The 2015–2016 influenza season is shaping up to
be lighter than physician offices and hospitals
have seen in recent years, with fewer flu
positives reported, a lower death count, and a
smaller share of flu-like illnesses among
outpatients. Last year’s flu season, by
contrast, was “very hectic,” says MAJ Charlotte
Lanteri, PhD, deputy chief of microbiology at
Brooke Army Medical Center at Fort Sam Houston
in San Antonio, Tex. It is not just the lower
number of patients presenting with flu-like
symptoms in the medical center’s inpatient and
outpatient settings that has made for a quieter
season so far, she says. Also contributing to
the peaceful, easy feeling at Fort Sam
Houston—at least as regards the flu—is the
medical center’s implementation of a rapid
molecular test for influenza A and B.
Read more >
IQCP Without Agony at the Point of Care
CAP Today, April 2016, by Anne Paxton
For many point-of-care testing coordinators, the
prospect of developing Individualized Quality
Control Plans is far from enticing. But there
has never been much chance that laboratories
could opt out of the Centers for Medicare and
Medicaid Services’ new quality control framework
for much of their non-waived testing.
Even though IQCP is an optional program, says
Kerstin Halverson, BA, MS, point-of-care
coordinator at Children’s Hospitals of
Minnesota, the alternative—meeting the minimum
QC requirements set by CLIA ’88—is often
impractical. “I didn’t stop to calculate what it
would cost to do liquid quality control on all
the i-Stat cartridge types every eight hours
because the number would have been through the
roof,” she says.
Read more >
Sentara
Laboratory Services Named
MLO’s 2016 Lab of the Year
April 2016, MLO's Lab of the
Year Award, By: MLO Staff
Based in Norfolk, Virginia, the
not-for-profit Sentara system operates more than
100 sites of care with more than 2,800 hospital
beds, including 12 acute care hospitals in
Virginia and North Carolina. The system, which
has a 3,800-provider medical staff, includes the
area’s only Level I Trauma Center, advanced
imaging centers, assisted-living and nursing
centers, physical therapy and rehabilitation
services, home health and hospice services, and
medical transport and air ambulances.
Read more >
POCT & Diabetes
Advantages to POCT in
monitoring and diagnosing type 1 diabetes
By David Plaut and Natalie Lepage, April 28,
2016, Advance for Administrators of the Lab
There is no doubt that point of care testing (POCT)
will grow-not only in hospitals, clinics and
single physician's offices, but also in homes of
patients with diabetes and other chronic
diseases. There are many advantages to this
approach to monitor and even diagnosis diseases
in real time at the patient's bedside. However,
with this technology comes varied challenges. Inoue et al.1
reviewed 11 studies comparing the accuracy of
blood-glucose measurements with blood gas
analyzers and POCT devices, using arterial blood
as the specimen type for both techniques. The
blood gas analyzer results were significantly
higher than those measurements using POCT.
Furthermore, in the hypoglycemic range (less
than 81 mg/dl), the incidence of errors using
the POCT was even higher. Other sources of POCT
errors on accuracy of glucose results were
unstable hemodynamics (edema and use of a
vasopressor) or use of insulin.
Read more >
POCT and
Its Implications for STIs
MLO,
March 2016, By Maj. Paul R. Eden and Jessica
Johnson
Sexually transmitted infections (STIs)
incorporate a particular set of clinical
infection and disease processes typically
associated with transmission through sexual
activity. In 2010, the United States spent
approximately $15.6 billion on identification
and treatment of STIs.
In addition, in 2013, according to Tucker et al
“the WHO estimated 448 million new cases of
curable sexually transmitted infections…are
diagnosed each year.” The testing traditionally
performed by laboratory personnel is thorough,
but hours or days are often required to obtain
the results. This testing capability usually
requires a secondary level medical facility or
higher, but that level of care is difficult for
many patients to obtain in outlying or rural
areas and requires multiple appointments for the
patient to be tested and receive results.
However, several recent advancements in sexually
transmitted infection (STI) detection using
point-of-care testing (POCT)...
Read more >
Point-of-Care Testing: Today and Tomorrow
POCT
continues to expand, and its future is bright
By
David Plaut, Deena Davis and Nathalie Lepage,
Advance for Administrators of the Lab, March,
2016
The
advantages and occasional drawbacks of
point-of-care testing (POCT) are widely
publicized; it’s apparent to the clinical
laboratory that POCT is here to stay and will
continue to enhance its role in efficient
patient care. Here, we discuss pros and cons,
look at a partial menu of what these tools offer
and provide hints of what we can expect over the
next few years. Recognizing the Need for POCT
A good deal of research, time and money is being
devoted to POCT instruments…
Read more >
A Win-Win Situation
5 tips to
ensure patient-centered vs. patient-serving care
By
William Maples, MD, Advance for Administrators
of the Lab, February, 2016
Here are five tips healthcare organizations can
implement to guide teams from patient-serving
care to patient-centered care : Patient care
1. Put the individual's interests first: Patients often approach healthcare with the
belief that they are the experts and bring with
them specific expectations about the services
they should receive. Healthcare providers should
be aware of these expectations and be prepared
to address them. Patient-serving care simply
require...
Read more >
Monitoring Point-of-Care Testing Compliance
Olga Camacho-Ryan, MBA, MT(ASCP), and Roger L.
Bertholf, PhD, DABCC, Clinical Laboratory News,
February 2016
Beginning in the 1980s, point-of-care testing (POCT)
departed from conventional clinical laboratory
medicine by decentralizing laboratory services.
Deploying POCT devices created challenges for
laboratory management, especially in ensuring
the proper use of these devices. Today,
point-of-care coordinators use a variety of
processes to maintain control over multiple
devices and monitor regulatory compliance of
many operators at locations across healthcare
enterprises....
Read more >
Management of Diabetes: The Future is Now
MLO | February 2016 | By: Ross Molinaro and
Carole Dauscher
Diabetes
is a worldwide epidemic. Its prevalence
continues to rise globally at an average rate of
8.7 percent, and it currently affects 382
million of the world’s population. Significant
increases in populations diagnosed with diabetes
have been reported by many nations as their
lifestyle and dietary norms evolve with
globalization. National healthcare budgets bear
the financial burden of treating diabetes and
its complications, exceeding $548 billion
dollars globally.
More >
How Point-of-Care Testing Improves
More Than Your Bottom Line
Hospital
decision makers, including C-suite executives,
face new economic and clinical challenges every
day. To help address these challenges in an
environment where the Affordable Care Act (ACA)
and Centers for Medicare and Medicaid Services
(CMS) require new value-based measures, it’s
imperative that testing procedures help reduce
readmissions while increasing productivity.
Download the free white paper here >
Latest HbA1c Debate Examines Race as Nonglycemic Factor
In
2010, the American Diabetes Association endorsed
the use of hemoglobin A1c to diagnose type 2
diabetes, and fierce arguments over the wisdom
of that move have ensued ever since. A 2013
debate at the American Association for Clinical
Chemistry’s annual meeting featured a spirited
dialogue on the merits of using HbA1c as a
diagnostic marker, compared with the
traditional—and still
ADA recommended—alternatives, fasting plasma
glucose and two-hour plasma glucose.
More >
The "Tricorder" of Patient Care
From
glucometers to genetics and the future of
testing
The
healthcare paradigm is moving rapidly toward
point-of-care testing (POCT) in several areas.
With this dramatic move, however, there are
several issues to take under consideration. The
benefits entail such things as increased
timeliness of results and convenience for
patients.
More >
Note:
Parts 1 and 3 of this article can also be accessed on
the
Advance for Administrators of the Laboratory
website.
Point-of-Care Testing Continues Growth
Sometimes referred to under the heading of
“near-patient” or “bedside” testing,
point-of-care (POC) diagnostics encompass a
variety of test platforms that sometimes appear
to have very little in common with one another.
More >
Assessing New Molecular Influenza Tests
Following
best practices can help labs maximize the
utility and cost-effectiveness of flu testing.
Screening for influenza infection may be
important for improving patient outcomes and
reducing the public health impact of this
potentially deadly illness. Yet, despite the
availability of dozens of influenza testing
devices, most such tests do not realize the full
potential of diagnosis because they do not
provide highly accurate results quickly enough
for healthcare providers to make informed
treatment decisions while the patient is still
under their care.
More >
IQCP for POCT
Quality control continues to be problematic for
point-of-care tests (POCT). According to
literature, 75 percent of arterial blood gas (ABG)
testing errors can be attributed to
pre-analytical errors. And CMS has noted that
19% of POCT operators were not trained for the
testing they were performing. Such
inconsistencies spell trouble for lab managers
responsible for overseeing POCT quality.
More >
Is Your POCT Program Inspection-Ready?
For point-of-care (POC) devices operating under
the central laboratory license, the single
biggest challenge for the adoption of POC
testing is maintaining control, regulatory
compliance, and training records for thousands
of operators performing testing in anywhere from
30 to 50 locations within the hospital.
More >
Measuring
Point-of-Care Blood Glucose in Critically Ill
Patients
Nursing Critical Care, July 2015, Corl, Dawn E.
MN, RN, CDE, CDTC
Critically ill patients require frequent,
accurate blood glucose (BG) monitoring. BG
measurement devices and sample types have
significant differences related to cost,
convenience, turnaround time, and accuracy. More
stringent standards have been drafted for
hospital point-of-care (POC) devices. Safety
considerations include: blood-borne pathogen
contamination, sample-related errors,
interferences, and patient conditions.
More >
Glucose Control in Critical Care
Jeremy Clain, Kannan Ramar, Salim R Surani,
World Journal of Diabetes
Glycemic control among critically-ill patients
has been a topic of considerable attention for
the past 15 years. An initial focus on the
potentially deleterious effects of hyperglycemia
led to a series of investigations regarding
intensive insulin therapy strategies that
targeted tight glycemic control. As knowledge
accumulated, the pursuit of tight glycemic
control among critically-ill patients came to be
seen as counterproductive, and moderate glycemic
control came to dominate as the standard
practice in intensive care units. In recent
years, there has been increased focus on the
importance of hypoglycemic episodes, glycemic
variability, and premorbid diabetic status as
factors that contribute to outcomes among
critically-ill patients.
More >
Hyperglycemia in Critically Ill Patients
Amina Godinjak, Amer Iglica, Azra Burekovic,
Selma Jusufovic, Anes Ajanovic, Ira Tancica,
Adis Kukuljac, Med Arh. 2015 Jun; 69(3): 157-160
Hyperglycemia is a common complication of
critical illness. It was originally considered
to be part of the adaptive stress-response which
is beneficial for survival. However, over the
past two decades, there is growing evidence that
hyperglycemia is associated with increased
mortality and morbidity.
More >
Performance of Cleared Blood Glucose Monitors
David C. Klonoff, MD, FACP, FRCP (Edin), Fellow
AIMBE1, and Priya Prahalad, MD, PhD, Journal of
Diabetes Science and Technology, June 2015
Cleared blood glucose monitor (BGM) systems do
not always perform as accurately for users as
they did to become cleared. We performed a
literature review of recent publications between
2010 and 2014 that present data about the
frequency of inaccurate performance using ISO
15197 2003 and ISO 15197 2013 as target
standards. We performed an additional literature
review of publications that present data about
the clinical and economic risks of inaccurate
BGMs for making treatment decisions or
calibrating continuous glucose monitors (CGMs).
More >
Glucose Meters in Critically Ill Patients: What
New Guidance Means for Labs
Clinical Laboratory News, By James Nichols, May
2015
What is all the buzz about use of glucose meters
in critically ill patients? Glucose meters have
been used for more than 30 years to provide
rapid measurement of glucose on whole blood
fingersticks from patients with diabetes.
Originally developed for patient self-testing,
glucose meter use has expanded throughout the
healthcare industry...
More >
Pressing Questions in POC Glucose Testing
CAP Today,
April 2015, By Kevin B. O’Reilly
Sometimes major changes to a health care
organization’s point-of-care testing system come
from powerful regulatory agencies in Washington,
DC. Or they may arise when a child with diabetes
objects to frequent venipuncture. In either kind
of case, experts say, pathologists and
laboratory professionals must form strong
relationships with clinicians and build
structural foundations to help them meet these
and other demands.
Read more >
Study, Strategy Lift up Point-of-Care Critical Value Practices
By Ann Griswold, PhD, CAP TODAY,
www.captodayonline.com
Too many point-of-care glucose test results
in the critical high and low ranges may be
nonreproducible and therefore should be
repeated.
That was the
finding of a study published last year that said
POC glucose results in the critical ranges
should be considered to have a relatively high
probability of signaling a potential preanalytic
error.
The retrospective analysis of POC glucose
testing in routine patient care settings found
that as many as half of all critically high or
low test results, when repeated, were not so
critical after all (Schifman RB, et al. Arch
Pathol Lab Med. 2014;138:962–966).
“The lesson we learned is that you need a
strategy for confirming, verifying, and
reporting critical point-of-care blood glucose
values,” says lead author Ron B. Schifman, MD,
chief of diagnostics for the Southern Arizona VA
Healthcare System, Tucson, and vice chair of the
CAP Quality Practices Committee. He hopes such
studies will help others become aware that
critical values must be addressed in the
point-of-care setting just as they are in the
laboratory setting.
Learn more >
Performance Evaluation of a Glucose Monitoring
System
for POCT With Critically Ill Patients
A Multicenter Study
Louie, Richard F. PhD, FACB, Point of Care: The
Journal of Near-Patient Testing & Technology:
March 2015
The purpose of this study was to evaluate the
performance of the ACCU-CHEK Inform II glucose
meter system for use in critically ill patients,
and to assess the effects of blood oxygen
tension, hematocrit, sodium levels on glucose
measurements.
A multicenter study involving the collection and
testing of remnant de-identified whole blood
samples from the blood gas laboratory at 3
institutions. Glucose meter measurements were
compared to the Hitachi/Cobas c501 Isotope
Dilution Gas Chromatograph aligned glucose
hexokinase reference method, and the hospital’s
laboratory comparison method. Blood gas, whole
blood electrolyte, glucose, and hematocrit test
results were documented for each sample.
More on this abstract...
Note, to access this article you need to
subscribe to Point of Care: The Journal of
Near-Patient Testing & Technology.
Preventing an
Outbreaks
Point-of-care testing can help manage and
contain an infectious disease outbreak
By
Rebecca Mayer Knutsen, Advance for
Administrators of the Lab
Early detection of infectious diseases such as
HIV/AIDS and TB can lead to an improved disease
outcome. As a result of the recent Ebola scare,
experts are hoping point-of-care tests (POCTs)
will play an important role in handling
potential infectious disease outbreaks.
In a 2013 study published in Biomarkers in
Medicine titled "Point-of-care testing and the
control of infectious diseases," study authors
Khayriyyah Mohd Hanafiah, Mary Garcia and David
Anderson stated "the uptake of an accurate test
that is simple, rapid and robust can
significantly alter the epidemiology and control
of the disease."
Learn more >
The Lab's Role in
Patient-Centered Care
How proactive is your staff in becoming an
integral part of the new healthcare team?
By Stephanie Mihane, MLS(ASCP)cm, POCS(AACC),
Advance for Administrators of the Lab
Point-of-Care Testing
I became interested in the "catch phrase of the
day" - patient-centered care - as my
responsibilities as a point-of-care coordinator
evolved beyond my original perception of the
role. I was to provide regulatory guidance,
technical expertise and ensure that the many
departments within my organization that required
reliable, timely and quality testing by
non-laboratory personnel was provided in an
efficient, economical and satisfying means to
our patients.or at least that's what I thought
it was.
A New Light It's time for
laboratorians to "get out of the basement" and
become an integral part of the healthcare team
and patient-centered care. I work for Kaiser
Permanente, Colorado Region, and we advocate the
total health of our members and communities. At
Kaiser Permanente, we see ourselves as a health
advocacy organization. We are here to help the
patient get the most out of his/her journey
toward total health - a journey that is
different for every single person we encounter.
Learn more >
Taking Ebola Personally
Anthony Fauci, MD, recounts his recent
experience and offers advice to laboratories
By
Maria Stevens Hardy, IMA(ASCP), AHI(AMT),
CLC(AMT), Advance for Administrators of the Lab
Ebola has not only called into question the
adequacy of the medical response in West African
nations, but also in the U.S. and Spain. U.S.
hospital nurses went on strike for lack of
training for Ebola. Many U.S. reference
laboratories refused to accept samples where
Ebola virus was suspected. The CDC revised and
disseminated guidelines for handling suspected
Ebola samples, but also confirmed that
confirmatory testing was to only be conducted in
their laboratories. At times, there seems to be
more questions than answers to the pandemic.
Learn more >
Using Glucose Meters in Intensive
Care Units
By
Brad Karon, MD, PhD, Clinical Laboratory
News, January 2015
In the current CLN 'Ask
the Expert' article, Brad Karon,
MD, PhD addresses the question:
How should I approach evaluating
a glucose meter for use in the
ICU?
The answer to this question has
both patient care and regulatory
considerations. For patient care
purposes, the choice of sample
type may be as important as the
choice of device: arterial whole
blood offers the most accurate
measurement in the ICU, while
capillary sampling may lead to
erroneous results in patients
with poor tissue perfusion.
Venous catheter sampling can
lead to overestimation of
glucose at higher concentrations
depending on meter technology.
The ideal approach to evaluating
a meter is to collect nearly
simultaneously whole blood
glucose meter samples and plasma
or serum laboratory samples.
Using the actual end users to
perform bedside measurement—and
the intended sample type from
ICU patients—allows observation
of the variables most likely to
impact glucose meter accuracy,
such as hematocrit effect,
medication interferences, and
user errors.
To complement a patient-based
assessment of meter accuracy...
More >
Flu View -
Upcoming Season Tests & Predictions
By
Ann Griswold, PhD, CAP Today
Whether exotic influenza viruses will surface
this winter remains to be seen, but one thing is
clear: The coming season will pack a punch in
terms of promising diagnostics and forecasting
models. Alere, Nanosphere, Cepheid, and Roche
have new molecular tests for influenza that aim
to transform the diagnostic landscape. And
researchers are harnessing the power of big data
to build stronger municipal- and national-level
models of flu transmission that can potentially
provide laboratories, hospitals, schools, and
health officials with weeks of valuable prep
time. Against that backdrop of innovation, the
Centers for Disease Control and Prevention
anticipates that the nation may see a departure
from the influenza A 2009 H1N1 virus that has
prevailed in recent years.
“It’s too early to tell, but just based on how
homogeneous last season was with H1, it’s likely
that we might have a B or an H3 season,” says
Daniel B. Jernigan, MD, MPH, deputy director of
the CDC’s Influenza Division in the National
Center for Immunization and Respiratory
Diseases.
Click here for more...
Key Steps for POCT in Physician Offices
Edwina Szelag, MHM, BSMT (ASCP)
You’ve been asked to take a look at a
physician’s office practice after a recent
merger. Do physician office laboratories (POL)
need to follow the same CLIA standards as
traditional clinical laboratories and
point-of-care testing programs?
Answer: All clinical laboratory testing is
subject to CLIA regulations, and the type of
CLIA certificate for the POL should be
considered along with the test menu to be
offered, devices that will be used, and staff
performing testing. There are several CLIA
certificates. For example, if the POL will be
performing only waived testing, then a CLIA
Certificate of Waiver is appropriate. If the POL
will be performing wet mounts, fern tests, and
other microscopy, the Certificate of Provider
Performed Microscopy Procedures is needed.
For more Q &
A's on this subject,
click here.
FDA Clears Nova StatStrip® Glucose Monitoring
System for Use in
Hospital Critical Care Units
The Nova StatStrip Meter is the first
FDA clearance of a device specifically indicated
for use in all types of hospital patients,
including critically ill patients.
September 24, 2014 - Today the U.S. Food and
Drug Administration cleared a new indication for
the Nova StatStrip Glucose Hospital Meter
System, extending its use to critically ill
patients who have been hospitalized. This is the
first blood glucose monitoring system (BGMS)
cleared by FDA for use in these patients.
The Nova StatStrip is the first blood glucose
monitoring system to receive clearance from the
U.S. Food and Drug Administration (FDA) for use
throughout all hospital and all professional
healthcare settings, including intensive care
settings.
StatStrip Glucose is now the ONLY glucose
monitoring system that is FDA-cleared for the
detection and management of dysglycemia
throughout all professional healthcare settings
including critical care. It is also CLIA*-waived.
The announcement comes after an extensive,
four-year project with the FDA and five
prestigious university medical centers. It
represents a landmark clinical breakthrough in
improved patient care and safety.
More...
In Lab QC, How Much Room
for Improvement?
Anne Paxton, CAP Today
The debut of the CMS’ new quality control
option, IQCP, has sharpened the focus on QC in
the laboratory and raised hopes that risk
management concepts can make QC more robust. But
one of the most highly regarded quality control
experts in the U.S. voices skepticism about the
impact of IQCP—and indeed, about U.S. quality
control standards in general.
As a voluntary, customizable QC option under
CLIA, IQCP or Individualized Quality Control
Plan is expected to give labs greater
flexibility in achieving QC compliance. However,
the CLIA QC standards, unchanged since 2003,
will remain the same—and that’s a problem, says
James Westgard, PhD, who spoke about QC
weaknesses at the 2013 Lab Quality Confab
presented by The Dark Report.
To read an interview with James Westgard, PhD,
click here...
The FDA Is Not Giving Up on Regulating
Laboratory-Developed Tests
Agency Plans a Decade-Long Road to
Implementation
By Bill Malone, Clinical Laboratory News,
November 2014, An AACC Publication
After the Food and Drug Administration (FDA)
announced in 2010 its intention to regulate
laboratory-developed tests (LDTs), lab advocacy
groups, biotech companies, and even Congress
pushed back so hard that by 2013, FDA leaders
described their efforts as mired in politics
and, at best, uncertain. Now, with a surprise
announcement in July that FDA will proceed with
plans to regulate LDTs followed by a draft
guidance published October 3, a newly confident
and determined FDA has hit the ground running.
According to FDA, its plan will give labs plenty
of time to accommodate stepped-up oversight.
During a September 10 AACC webinar, FDA Director
of In Vitro Diagnostics Alberto Gutierrez, PhD,
laid out a 9-year timeframe to implement LDT
regulation. But the clock doesn’t even start on
that timeline until after FDA issues a final
guidance, a process that could take years. Based
on FDA’s history with LDTs, the one thing
certain is that the initial plan will not look
exactly like the final plan—and it will probably
take even longer to implement than the agency
would like.
Click here for more...
Treating Patients with Ebola Virus Infection
in the U.S.: Lessons Learned
IDWeek, October 2014, Bruce Ribner, MD, MPH,
Emory Univ. Hosp., Atlanta, GA
At the recently held
IDWeek, Dr. Bruce Ribner spoke on
caring for Ebola patients in the US. Dr. Ribner
led the team at Emory University that cared for
two patients with Ebola virus disease (EVD) in
August. In light of the recent Ebola cases in
Dallas and Spain he agreed that a summary could
be provided to assist ID specialists in their
ongoing preparedness efforts.
Planning
for the care of patients This involves the
entire institution, and needs many sections to
coordinate their work. EMS services were an
important coordination point for the transport
of the 2 patients to Emory. On the medical
staff, many types of expertise were needed for
clinical management: ID, critical care,
anesthesiology and several other subspecialties.
Nursing, environmental management, facilities,
security and media relations were all
intensively involved ahead of time so that
expected roles were defined. Even so, there were
times when questions arose after the patients
arrived.
For a summary of this talk,
click here. For basic information
about Ebola,
click here or on the image to the
right. For more
details on Ebola
click here to visit the CDC website
or many of the other healthcare sites with
articles on the Ebola situation.
Optimizing Point-of-Care PT/INR Testing
Marcia L. Zucker, PhD, Clinical Laboratory News,
September, 2014
Coagulation testing, especially the global
coagulation test prothrombin time (PT), is not
exactly an ideal laboratory test. I say this
because PT does not evaluate a well-defined
analyte with results reflected as a
concentration of that analyte. Rather, PT
assesses the interaction of more than a dozen
different enzymes within a blood sample, and a
PT test result reflects a clotting time measured
at a different end point for each instrument
used.
In addition, the reagent for the PT test,
thromboplastin, is not standardized. The
original thromboplastin reagents were crude
preparations from multiple tissue types from
several different species. Today,
thromboplastins may consist of recombinant
rabbit or human brain protein complexed with
phospholipids. There is limited standardization,
achieved through use of the international
normalized ratio (INR), for patients on
long-term oral anticoagulant therapy with
vitamin K antagonists such as warfarin and
coumarin.
More >
Quality Practices & POCT
Defining
quality in POCT is offering more than just quick
results
By
Charles K. Cooper, MD, September 4, 2014,
Advance for Administrators of the Lab, Issue 9
Point-Of-Care Testing
The world of laboratory medicine has changed
considerably in the last decade. Specifically,
the need for hospitals to improve capacity
utilization and efficiency as more patients seek
care has propelled clinical laboratories into a
bold new journey in point-of-care testing (POCT).
As new efforts bring advanced testing to
point-of-care (POC) locations, there must also
be new criteria for evaluating POC tests. To
effectively meet the goal of POCT-which is to
offer high-quality testing at primary care
locations to streamline patient management-POC
diagnostics need to meet quality standards
across a broader range of categories. Beyond
providing accurate and fast results, the quality
of these tests must be equally determined by
evaluating their scalability, ease-of-use, cost
structure, and effectiveness in improving
healthcare system efficiency. POCT Success Factors
more >
Risk Management Steps Up Labs’ QC Game Under
IQCP
By
Anne Paxton, CAP Today, September 2014
Industrial risk management. It may not seem
all that sexy as a concept, but in the field of
laboratory quality control, risk management has
become about as buzzworthy as is possible. One
of the key reasons: The Centers for Medicare and
Medicaid Services has embraced risk management
as the foundation of a new option for meeting CLIA quality control standards called IQCP, or
Individualized Quality Control Plan.
A voluntary QC option under CLIA, IQCP aims to
give labs greater flexibility in achieving QC
compliance by customizing lab QC plans to each
unique testing environment via the use of
risk-management strategies. Employing
electronic/integrated controls, IQCP intends to
adapt to future technological advances and
strengthen manufacturer-laboratory partnerships.
“Many assays appear to be okay when we run our
QC,” says Alison Woodworth, PhD, director of
esoteric chemistry, associate director of
clinical chemistry, and assistant professor in
the Department of Pathology, Microbiology, and
Immunology at Vanderbilt University Medical
Center. “But when we do more in-depth risk
analyses, they may not be okay.”
With IQCP, “labs will have a choice now. They
can use a one-size-fits-all approach of running
two levels of external QC material once a day,
the bare minimum under CLIA requirements, or
they can do a risk-assessment evaluation to
better determine how their assays are performing
and how much QC they should run.”
Read more >
Managing Risk: Preventing Errors at the POC
July 2014, by Sarah Njoroge, PhD and James H.
Nichols, PhD, DABCC, FACB, Clinical Laboratory
News
Although point-of-care testing (POCT) provides
rapid test results and the opportunity for
faster medical decisions, the unique risk of
errors with POCT raises concern over the quality
and reliability of test results. In contrast to
the central laboratory, where errors
predominately occur in the pre- and
post-analytic phases, POCT errors occur
primarily in the analytic phase of testing. This
might be related to the non-laboratory staff
involved in POCT, but might also be due to test
limitations and misuse of POCT in extreme
environmental conditions.
Clinical personnel with minimal laboratory
skills and experience, such as nurses and
patient care technicians, perform the majority
of POCT. These operators are focused on patient
care and do not necessarily understand why they
must handle POCT—a task viewed as a laboratory
role and not a job for clinical staff.Yet regulatory standards hold the laboratory
director responsible for managing and
supervising POCT quality. In a clinic setting,
the laboratory director may be a physician, but
in a hospital or health system, the chief of
pathology and head of the central laboratory
often become responsible. POCT is thus at odds
with both the clinical staff performing the test
as well as the laboratory staff responsible for
supervising the test. This conflict creates a
situation ripe for errors.
More >
A POC Glucose Program Turned Upside Down:
How a
17-hospital system survived a rollout and new
requirements
Anne Ford, CAP Today, July 2014
When
Rosemary Frederick learned last year that her
employer, North Shore-LIJ Health System of New
York state, would be switching from the Roche
Accu-Chek Inform I point-of-care glucose meter
to the Inform II due to a maltose interference
issue, she knew she and her colleagues were
facing a heck of a lot of work. “I want you to
realize the enormousness of this project,” says
Frederick, who is the point-of-care manager for
the health system’s core laboratories. “It
wasn’t one hospital and 1,500 people. We had to
roll out over 1,000 meters, and we had to train
over 13,000 people system-wide.”
Click here
FDA
Moves on Blood Glucose Meters
Manufacturers, Labs Wary of Big Changes
By Bill
Malone, May 2014 Clinical Laboratory News: Volume 40,
Number 5
Few laboratory instruments are as ubiquitous as the
humble blood glucose meter. Yet in recent years, they
have become essential not only for managing patients
with diabetes, but also for improving outcomes for other
groups of patients at the point-of-care. Studies
connecting hyperglycemia with poor outcomes have led
many hospitals to rely on the convenience of these
meters for managing care across a spectrum of
hospitalized patients.
Regulators, however, including the Food and Drug
Administration (FDA) and the Centers for Medicare and
Medicaid Services (CMS), have become increasingly
concerned about this practice because none of the meters
on the market are FDA-cleared for use in critically ill
patients, such as in the emergency department or
intensive care unit. In fact, manufacturers submit
meters intended for hospital use as over-the-counter
devices, which means that FDA clears them based on the
same standard as the home-use meters found in drug
stores.
More >
AACC
Supports FDA Effort
to Improve Blood Glucose Meters
But Believes the New
Standards Could Encumber the Use of These Monitors
Without Benefiting Patients
In January, the U.S. Food and Drug Administration (FDA)
released draft guidance proposing separate performance
and accuracy criteria for over-the-counter blood glucose
meters used in the home and prescription blood glucose
meters used in hospitals. AACC supports FDA's initiative
to improve the quality of these devices and enhance
patient care, but recommends revising this draft
guidance to ensure that it does not unnecessarily
increase the regulatory burden and costs on the
healthcare system.
Blood glucose meters are best known in their
over-the-counter form for helping many of the 19 million
Americans with diabetes to manage their condition. These
devices have also become essential for managing care for
other groups of patients in hospitals in recent years,
as studies have uncovered a connection between high
blood sugar and poor outcomes. FDA has become
increasingly concerned about this practice, however,
because blood glucose meters aren't cleared for use in
critically ill patients, who may present with
physiological variables that could interfere with the
accuracy of these devices.
More >
Quality Control in POCT
By Sarah Kee,
MAY 2014
ADVANCE/ LABORATORY
The variety of point-of-care tests (POCT) has evolved
significantly in recent years. Whilst these instruments
bring undisputed benefits in obtaining rapid results at
the patient’s bedside, these benefits are only true if
the results are accurate and reliable. Quality controls
(QC) exists to ensure accuracy and reliability.
For many of the healthcare workers using POCT
instruments, QC will be unfamiliar territory.
More > |
How POC Testing is Pushing the Envelope
From New Tests to Glucose Meters and the FDA
CAP Today, April
2014, By Anne Paxton
It can be hard to
remember a time when GPS was not available in cars, the
Web didn’t exist, and only eight diagnostic tests were
classified as waived and able to be performed at the
point of care. But after CLIA’s enactment in 1988, those
were some basic realities of location and speed.
Today, whether for
blood gas and electrolytes, glucose, coagulation,
cardiac markers, drugs of abuse, food pathogens,
hemoglobin, or infectious diseases, hundreds of tests
once considered too complex for point of care are
routinely performed outside the laboratory. But some of
the nation’s experts in point-of-care testing say that
developments on the near horizon could make previous
advances in POC testing look tame.
More |
Glucose vs. Hemoglobin A1c
Usefulness,
limitations and complementary markers are explored
By David
Plaut and Audrey Farrell; APRIL 2014 •
ADVANCE/LABORATORY • WWW.ADVANCEWEB.COM
There is no argument that measurements of hemoglobin A1c
(A1c) and glucose (G) each play important roles in the
diagnosis and treatment of diabetics. As useful as these
two markers are, we must accept the fact that neither is
a perfect marker. Understanding the limitations of these
markers will aid clinicians in better use of them and
assist them when choosing complementary markers when A1c
and/or G are not satisfactory or sufficient. A1c Value
More >
PDF
I
Online |
Point-of-Care Testing
- Pros, cons and how
the lab can benefit
By Jonathon
Northover, JD; APRIL 2014 • ADVANCE/LABORATORY •
WWW.ADVANCEWEB.COM
The point-of-care testing (POCT) market (perhaps more
accurately referred to as the point of testing), is an
established growth area. Predictions regarding the
growth rate vary but the general consensus is that in
the United States, we have already entered a significant
growth phase. While it is a relatively new market, we
are arguably two-thirds of the way through the typical
30 year period that it takes for a new healthcare
technology to become fully established.
A Growing Market Between 2003 and 2009 it is said
to have doubled in size. In 2012, one study suggested
that it will be worth $16.5 billion worldwide in 2013,
about $3.93 billion of which will be in the United
States. Of these values, glucose testing is by far the
largest component. There are multiple underlying drivers
of this growth. For example, the technology (the devices
as well as the reagents) is becoming less expensive to
create and deploy, and therefore more widely used. Another driver is the need for increased efficiency.
POCT usually decreases turnaround times, with immediate
results. Faster results mean faster treatment. No
additives are needed, and a sample will often only
require a finger stick. In the current healthcare
environment where cost pressures to do more with less
continue, this is no small advantage. Pros of POCT... More >
PDF
I
Online
Diabetes Debate: HbA1c or Glucose?
By Anne
Paxton, CAP Today, February 2013
If it were a boxing match, the debate over whether
hemoglobin A1 c should be used to diagnose diabetes
would place the odds-on favorite in the “Yes” corner. In
the “No” corner would be the underdog. At least based on
the mainstream consensus since 2010, HbA1c for diagnosis
is well established as an alternative to measuring
glucose. At the July 2013
meeting of the American Association for Clinical
Chemistry, where opposing sides on this question squared
off in a debate, a quick vote beforehand showed “Yes”
with a 20-to-one edge. But the speakers came armed with
provocative data on comparative benefits and drawbacks,
and both sides scored solid points.
More >
Dropping the ball on critical value
POC glucose results?
By Anne
Paxton, CAP Today, December 2013
Prompt reporting of critical laboratory results is
considered an important patient safety goal. But for one
of the most commonly performed tests, point-of-care
glucose, there has been limited information about how
critical results are handled. A new CAP Q-Probes study
finds there is a great deal of variability. In addition
to having widely differing critical result cutoff
values, many laboratories are not repeating critical POC
glucose test results for verification despite the
relative high rate of erroneous results on first
measurement.
More >
POCT Supports New Demands
By Kim Futrell,
MT(ASCP), ADVANCE for Administrators of the Laboratory, RESOURCE DIRECTORY
2014 & ANNUAL REPORTS
Changes in
healthcare open door for point-of-care testing to
improve outcomes
One of the fastest
areas of growth is point-of-care (POC) testing,
estimated to be increasing at 10-12% annually, compared
to a 6-7% annual increase in other clinical lab testing.
Although home-based point-of-care testing (POCT) is also
increasing, 70% of POCT takes place in hospitals,
doctors’ offices and other provider locations, and this
growth is predicted to continue.
More >
The Biggest Mistake Doctors Make
Misdiagnoses are
harmful and costly. But they're often preventable.
By Laura Landro,
assistant managing editor for The Wall Street Journal
Not only are
diagnostic problems more common than other medical
mistakes—and more likely to harm patients—but they're
also the leading cause of malpractice claims, accounting
for 35% of nearly $39 billion in payouts in the U.S.
from 1986 to 2010, measured in 2011 dollars, according
to Johns Hopkins. The good news is that
diagnostic errors are more likely to be preventable than
other medical mistakes. And now health-care providers
are turning to a number of innovative strategies to fix
the complex web of errors, biases and oversights that
stymie the quest for the right diagnosis.
More >
An
Uneasy Dance with POC Glucose in the ICU
By Anne Paxton,
CAP Today, October 2013
“Too
much of a good thing can be wonderful,” Mae West
famously said. And some feel our culture of excess
reflects that value. Perhaps as a reaction there has
been a surge of interest recently in the embrace of
“enough” as a worthwhile goal. But when it comes to
precise measurement of glucose values in the intensive
care unit, the often-warring needs for speed and
accuracy make the issue a critical matter of patient
care. For point-of-care glucose testing in the ICU, how
much precision is “enough”?
more...
POCT
& Patient Safety - Solutions to
point-of-care safety concerns are explored
By Anna K.
Füzéry, PhD, and William A. Clarke, PhD, MBA, DABCC
Advance for Administrators of the Lab, Vol. 22 • Issue 7
• Page 36
POCT - Quality laboratory testing is an
essential part of modern medicine. Historically, such
testing has been performed in a central location by
highly trained medical technologists. Rapid advances in
analytical and computer technology, however, have
shifted a significant amount of it to the patient
bedside or other non-laboratory sites. While
point-of-care testing (POCT) offers some key advantages
in patient management, it is also giving rise to notable
safety concerns related to infection transmission,
patient identification and specimen integrity.
Hospital-Acquired Infections -
Healthcare-associated infections (HAIs) are a major
safety concern due to their adverse effects on patients,
their families and the health system. Estimates suggest
that approximately 1.7 million HAIs occur annually in
the United States alone.1 Multiple studies indicate that
hospital surfaces, including POCT devices, may act as
vehicles for the transmission of pathological agents
such as methicillin-resistant Staphylococcus aureus and
HIV.2,3 In August 2010 the FDA and CDC issued a joint
recommendation that point-of-care blood testing devices
should not be shared and that, if this is not possible,
they should be cleaned and disinfected after every use.
More >
Lessons From America's Safest Hospitals
More than 180,000 people die every year from hospital
errors. Here's what the top medical centers are doing to
improve your odds
by Beth Howard, AARP
The Magazine, April/May issue
About 400,000 drug-related injuries occur each year in
hospitals, according to an Institute of Medicine study.
To help solve the problem, many of the safest hospitals
have embraced the use of a computerized provider order
entry (CPOE) system, which forces doctors to enter
prescriptions into the computer electronically. "It
basically eliminates transcription errors," says Anthony
J. Ardire, M.D., senior vice president for quality and
patient safety at Lehigh Valley Health Network in
Allentown, Pennsylvania.
More >>
Order
More Tests? With
Diabetes, May Be ‘YES’
CAP Today,
March 2013, Feature Story, By Jan Bowers
In patients with diabetes mellitus, hemoglobin A1c
testing frequency is largely in line with recommended
guidelines. In those same patients, LDL testing is not
performed frequently enough, and urine protein testing
frequency falls far short of recommendations.
Those are the results of a recently completed Q-Probes
study of whether and how laboratories monitor the
frequency of diabetes testing, and how closely the
frequencies in their institutions hew to the American
Diabetes Association recommended guide-lines.
“It’s important to focus on both over- and
underutilization, because sometimes in the lab we tend
to focus only on whether we’re performing tests that may
not be necessary,” says Peter L. Perrotta, MD, medical
director of clinical laboratories at West Virginia
University Hospital, professor of pathology at West
Virginia University School of Medicine, and a coauthor
of the CAP study. But there’s another side, he says:
“Tests that should be ordered are not, or they’re not
ordered frequently enough.”
More >
Bedside Glucose Testing Systems
Cap Today,
March 2013, Brendan Dabkowski
New to the CAP TODAY lineup of point-of-care blood
glucose systems is the Roche Accu-Chek Inform II, which
the FDA cleared last fall. It offers meter level wireless
technology, conducts extensive integrity checks with
each test, has an advanced laser bar-code scanner, and
provides up to three unique patient identifiers. On the market since 2004, HemoCue’s Glucose 201 DM
analyzer has “withstood the test of time,” says product
marketing manager Terry Carmichael, who adds that the
recent focus has been to develop more flexible
connectivity solutions. HemoCue plans to make available
options that allow clients to select how they connect
HemoCue devices to their [information] system. Abbott Diabetes Care is working with hospitals to help
them achieve their patient safety goals. The Precision
Xceed Pro blood glucose and beta-ketone monitoring
system is built on Abbott’s “three pillars of patient
safety”—bedside accuracy, cross contamination
prevention, and hospital compliance. Nova Biomedical’s StatStrip measures and corrects for
common interferences such as hematocrit, acetaminophen,
and ascorbic acid. StatStrip biosensors eliminate the
need for calibration coding, and the system’s large
color display presents multiple patient identifiers. Ten bedside glucose testing systems from six companies
are profiled. All information is supplied by the
companies.
More >
Standards of Medical Care in
Diabetes - 2013
The American Diabetes Association has released their
Standards of Medical Care in Diabetes 2013.Diabetes
mellitus is a chronic illness that requires continuing
medical care and ongoing patient self-management
education and support to prevent acute complications and
to reduce the risk of long-term complications. Diabetes
care is complex and requires multifactorial risk
reduction strategies beyond glycemic control. A large
body of evidence exists that supports a range of
interventions to improve diabetes outcomes. For more on the
Position Statement,
click here. For more on the Executive
Summary,
click here.
Preventing Infections Related
to Using
Point-of-Care Testing Devices
An
Interview with Sharon M. Geaghan, MD
January 2013 Clinical Laboratory News: Volume 39, Number
1
The convenience and immediacy of point-of-care testing (POCT)
has led to its use in many settings. But untrained or
busy healthcare workers may overlook some basic sanitary
practices when using POCT devices. This lack of
attention is leading to nosocomial infections that can
be attributed to contaminated devices. Here, Sharon M.
Geaghan, MD, discusses how these infections occur and
how to prevent them. Dr. Geaghan is professor of
pathology and pediatrics at Stanford University School
of Medicine in Palo Alto, Calif.
Click here for more...
Glycemic Control Data
Show Improvement in Glucose Levels
Journal of
Hospital Medicine, December 2012
New data show that hospitals may be making some progress
in the battle to control glucose levels in non-ICU
patients. Research published in the Journal of Hospital
Medicine compared point-of-care blood glucose test
results from 126 hospitals taken in 2007 and 2009. The
values of those test results decreased by 5 mg/dL in
non-ICU patients from 2007-2009, but remained unchanged
for patients in the ICU.
In this first analysis of glucose changes in US
hospitals, improvements over 2 years occurred in non-ICU
patients. Ongoing analysis will determine whether this
trend continues.
Read more. |
Understanding Low Sugar from
NICE-SUGAR
The New
England Journal of Medicine, December 2012
In his editorial about the Normoglycemia in Intensive
Care Evaluation–Survival Using Glucose Algorithm
Regulation (NICE-SUGAR) study, Hirsch (Sept. 20 issue)
declares, “For surgical patients, especially those who
have undergone cardiac procedures, hospitals that can
safely achieve lower targets should do so.” No
justification for this statement is provided. Concerns
exist regarding the generalizability of studies of
glycemic control in other populations of patients
treated in intensive care units (ICUs) that have shown
either harm1 or no benefit and regarding both the
generalizability and applicability of studies that have
shown benefit.
Read more. |
Glucose in the ICU —
Evidence, Guidelines, and Outcomes
The New
England Journal of Medicine, December 2012
Agus et al. (Sept. 27 issue)1 report that targeting a
blood glucose level of 80 to 110 mg per deciliter (4.4
to 6.1 mmol per liter) in critically ill infants and
toddlers (<3 years of age) after cardiac surgery did not
alter the clinical outcome. Although the target range
for the blood glucose level was “normal” in fasting
adults, it indicated
hyperglycemia in infants (normal range, 50 to 80 mg per
deciliter [2.8 to 4.4 mmol per liter]).
Read more. |
Connecting With POCT
By Adetoun
Ejilemele, MB.CHB, FWACP, FMCPath (Nig), and Anthony O.
Okorodudu, PhD, MBA, DABCC, FACBB
Point-of-care
testing plays a significant role in a value-based
purchase system Value-based purchasing (VBP)
is focused on ensuring synchrony between clinical and
financial responsibilities in our healthcare systems. In
the VBP, future healthcare payment is linked to quality
and efficiency of the care provided. This
article was part of the Advance for Administrators of
the Laboratory's December 2012 issue which feature a
2013 Resource Directory. For more on this article and to
view the digital edition,
click here > |
Article
Archive
FDA clears ACCU-CHEK
Inform II
Roche’s new hospital point-of-care system for blood
glucose testing with improved accuracy and wireless data
transfer as well as advances in patient care and
durability. Roche announced on Monday, October 15, that
it has received clearance from the U.S. Food and Drug
Administration (FDA) for the ACCU-CHEK Inform II system,
a next-generation blood glucose monitor for hospital
point-of-care testing. The ACCU-CHEK Inform II system
offers healthcare professionals the first truly wireless
hospital blood glucose device. The system utilizes new
patented technology to deliver improved accuracy and
enables automatic real-time wireless transfer of patient
data between hospital medical staff and the laboratory.
“Accuracy and patient safety are the foremost concerns
for blood glucose testing in hospitals and other
point-of-care settings,” said Roland Diggelmann, chief
operating officer at Roche Diagnostics. “ACCU-CHEK
systems have been proven in hospitals around the world
and this next-generation wireless system sets a new
standard by offering U.S. healthcare professionals new
capabilities to help ensure the accuracy of test
results, streamline data communications and provide
optimal patient care.”
The Growth of
Point-of-Care Testing in Hospitals
Cardiac Markers Fuel Growth in $5 Billion Market
Hospital point-of-care (POC) testing continues to
grow steadily, with hospitals adding more instruments
and rapidly increasing the volume of cardiac testing in
particular, according to a new report from strategic
consulting firm Enterprise Analysis Corporation (EAC).
This brief analyzes data from a 2011 survey of hundreds
of hospital-based point-of-care coordinators (POCC), and
compares data to the company’s previous survey in 2007.
While POC glucose, blood gas, coagulation, and HbA1c
tests have seen a slow, steady rise over the past 4
years, cardiac marker testing has risen sharply,
according to EAC senior consultant Michelle Keane. “We
were surprised to find 10 percent more hospitals
performing cardiac marker testing compared to 2007, and
volumes have increased significantly as well,” Keane
commented. For stand-alone troponin, nearly twice as
many hospitals surveyed by EAC now perform POC testing.
Two instruments continue to dominate the cardiac
marker POC market, Abbott’s i-STAT system and Alere’s
Triage system. The Triage has seen a 70% increase in
volume for cardiac tests, and i-STAT’s volumes have
tripled.
Keane also noted that POC has become more complex in
hospitals, with 23% of institutions reporting use of six
or more different POC instruments in 2011 compared to
just 5% in 2007. Nearly 50% of hospitals EAC surveyed
now have four or more instruments.
Spotlight on
Point-of-Care Testing
Innovation, Expansion Evident at AACC Clinical Lab Expo
in LA
By Bill Malone, Clinical Laboratory News
The current issue of CLN features a Spotlight on the
2012 AACC Meeting where more than 120 companies came to
Los Angeles to showcase POC products at the AACC
Clinical Lab Expo, and the buzz about POC spilled over
into sessions at the AACC Annual Meeting. Speakers
covered many POC topics, including the explosion of
technology and where future opportunities lie. This
issue also includes an interview with the 2012 POCC of
the Year Pet Maniquis. In addition, hundreds of new
products made their debut in Los Angeles and are
highlighted in CLN's New Products Review. More >
Note: To access this issue you must be an AACC member -
and now is great time to join and take advantage of all
the POC related programs AACC and the Critical and
Point-of-Care Testing Division have to offer.
Abbott Introduces Advanced Quality Features on its i-STAT
Handheld System
Abbott has introduced five new advanced quality features
on its leading i-STAT handheld blood analyzer, designed
to help hospitals better manage their point-of-care
testing programs and ensure compliance with changing
laboratory regulations. The i-STAT Advanced Quality
Features will help organizations improve compliance,
oversight and control of their point-of-care program.
A
Review of Tight Glycemic Control
more >
Assessing Inpatient Glycemic Control: What
Are the Next Steps?
Which Metric Should
be Used? more >
Glucose Meter Update Lifescan customers, follow these tips to
smooth your transition to a new meter
more >
Update on Inpatient Glycemic Control in Hospitals in the
United States
Many quality improvement organizations have been
focusing on improving the management of inpatient
hyperglycemia. A recent survey of hospitals in the
United States demonstrated that the frequencies of
hypoglycemia and hyperglycemia were the top 2 metrics of
interest to hospitals, and many hospitals have either
fully or at least partially implemented inpatient
diabetes quality improvement programs. Several quality
improvement organizations are promoting the need for
better inpatient glycemic control and have developed
educational resources to help hospitals achieve better
management. Finally, in certain clinical scenarios,
better glucose control has been shown to improve patient
outcomes.
more >
The Evolving World of POCT
more >
Focus on: COAGULATION Monitoring
more >
Panel Advises Glucose Testing in All
Hospitalized Patients
More >
Diabetes Cases Double to 347 Million
Rates of diabetes have nearly tripled in the U.S., and
more than doubled worldwide since 1980, according to a
report this week in the British journal Lancet. More
than 347 million patients have diabetes globally, and
nearly 25 million in the U.S..
more >
References for "Urine
Drug-of-Abuse Testing in
the Clinical Lab"
By Jill
Hoffman, Advance for the Administrators of the
Laboratory
According to a 2009 review in Bioanalysis, use of
clinical urine drug tests (UDTs) to monitor patients
prescribed controlled substances is a new aspect of
clinical medicine that will play an increasing role as
physicians treat chronic pain while trying to minimize
abuse of opioid analgesics.
more >
Glucose Meter Evolution
By Bob
Kaplanis, Advance for the Administrators of the
Laboratory, At the Bedside
It's hard to imagine what point-of-care testing (POCT)
would be like if the glucose meter had never been
invented and all glucose testing was performed in the
main laboratory of the hospital.
more >
Testing/Diagnostics:
Point Taken
Clinical Lab Products - July
2011by Sarah Michaud
Overview of point-of-care testing, technological
challenges, and future opportunities.
Point-of-care testing (POCT) technology provides
immediate, portable, and convenient medical diagnostics
near the site of patient care. POCT's near-instantaneous
results allow health care providers to make treatment
decisions for their patients in a shorter amount of time
compared to traditional laboratory diagnostics. Faster
test results translate to rapid treatment for
patients—which can save lives in critical care
scenarios.
More >
Glucose Monitoring
Technology
By Jill Hoffman, ADVANCE for
Administrators of the Laboratory; June 6, 2011
Blood
glucose monitoring evaluates the concentration of
glucose in blood and is a critical component of diabetes
mellitus care. Tests are performed by piercing the skin
to draw and apply blood to a chemically active test
strip. Small handheld devices-glucometers-can measure
blood glucose. To get accurate readings, it is important
to make sure the glucose meter is operating correctly by
applying quality control (QC) material to the strip,
often sold separately for home glucometers, says
Frederick L. Kiechle, MD, PhD, director of Clinical
Pathology, Pathology Consultants of South Broward,
Memorial Healthcare System, Hollywood, FL.
more >
POC Coag Technology Path: Simple to Savvy
CAP
Today, May 2011, by Brendan Dabkowski
Smart businesses stick to the principle that the
customer is always right. For manufacturers of
point-of-care coagulation test systems, whose customers
are often now individual patients, keeping that
principle top of mind is imperative. Offering test
systems that help ensure customers/ patients are
right—that is, in obtaining accurate coagulation
status—protects lives.
more > I
See CAP TODAY’s
coagulation analyzers lineup
The
Growth of POCT
By Carlos Prieto-Granada, MD, and
James H. Nichols, PhD, DABCC, FACB March 2011 • advance/Laboratory
The development of newer technologies and overall
improvement of POCT quality has led to an exponential
growth in the POCT field. As an emerging,
rapidly evolving and ever expanding specialty in
laboratory medicine, point-of-care testing (POCT) has
been generating a whole new set of issues since its
popularization in the late 1980s. Tconcept of POCT,
also known as bedside, near-patient testing and
decentralized testing, relates to tests that are
conducted by clinical operators at the site of patient
care where immediate medical action is taken on the
results.
The fact that POCT represents a departure from
conventional laboratory medicine has created new
challenges, especially regarding standardization and
regulation. These topics, including new regulatory
changes, glucose meter performance criteria and
increasing reliance on transcutaneous POCT methods, are
addressed.
more >
Preventing Medical Errors
RFID technology helps identify patient, hardware and
staff locations, as well as preventable gaps in care.
By Mayank
Trivedi, April 2011 • advance/Laboratory
More than 10 years after the publication of "To Err is
Human," few hospitals have successfully heeded the call
to cut down the number of fatal medical errors in the
United States.
The failure certainly is not due to lack of effort or
commitment. Hospitals have published innumerable
studies, protocols, and analysis to improve patient
safety. But the results have too often fallen short.
With increasing clinical workloads and cost pressures,
many healthcare organizations have begun to investigate
how technologies such as radiofrequency identification (RFID)
tags, which "sense" staff and asset locations, can
enhance clinical and biomedical workflow. RFID
technology can track the physical location of patients,
staff, equipment, as well as instruments and
pharmaceuticals, helping to increase patient safety.
This technology can reduce medical errors in a number of
ways.
More >
Accuracy above all for POC glucose analyzers -
See CAP TODAY’s glucose analyzers lineup
By Brendan
Dabkowski, CAP Today, March 2011
Makers of
point-of-care glucose testing systems are responding to
customers’ demands for devices that are nimble,
responsive, and durable—but above all, accurate.
“Hospitals continue to demand improved accuracy of
bedside glucose monitors as they adopt protocols for
better glycemic management,” says Nova Biomedical
marketing specialist Rick Rollins.
more >
10
years out, Connectivity Standard Still not in
CAP Today, February 201,
Feature Story, by Anne Ford
By their first birthday, most babies show signs of
dental development. But the point-of-care connectivity
standard POCT1-A celebrates its 10th anniversary this
year, and some say it has yet to start growing teeth.
That is, the standard
has no enforcing body, and so adoption has been left up
to individual vendors, some of whom are not inclined to
spend financial resources making their legacy systems
compliant with POCT1A.
More >
Too far, Too Fast on ICU TGC?
CAP
Today, March 2011, Feature Story, by Anne Paxton
Ten years
ago, a study conducted in Leuven, Belgium, took U.S.
hospital intensive care units by storm. Reported in
the New England Journal of Medicine, the trial, led by
Greet Van den Berghe, MD, PhD, found that when adult
surgical ICU patients’ blood glucose was maintained
between 80 and 110 mg/dL by means of an insulin
infusion, it reduced ICU mortality by 42 percent and
in-hospital mortality by 34 percent
(2001;345:1359–1367). Implementing an ICU protocol of
tight glycemic control, the study concluded, also
decreased the incidence of acute renal failure,
septicemia, and critical illness polyneuropathy.
These
conclusions galvanized hospital ICUs. In the wake of
the study, “Intensive care units in the U.S. went from
almost nobody using insulin to using it on almost every
patient,” says Stanley A. Nasraway, MD, director of the
surgical intensive care units at Tufts Medical Center,
Boston. As one indicator of the impact on laboratory
testing, Barnes Jewish Hospital in St Louis, Mo.,
doubled the number of glucose strips it consumes.
“In
2001, we used 250,000 strips a year and we’re at almost
half a million strips a year now, just with essentially
the same number of beds,” says Mitchell G. Scott, PhD,
professor of pathology and immunology and co-medical
director of clinical chemistry at Washington University
School of Medicine.
But as tight glycemic control (TGC) became more and
more the standard for adult patients across the critical
care landscape in the U.S., there were ripples of
concern. Efforts to duplicate the Leuven study did
not all pan out. One of Dr. Van den Berghe’s own later
studies in medical ICU patients showed only morbidity
benefits. Then, two large-scale studies in 2008 and 2009
suggested that, in fact, very tight glycemic control may
actually put patients at greater risk of death and
complications from hypoglycemia.
more >
Selecting
Point-of-Care Devices
Direct patient care professionals are looking
for rapid testing
options to accelerate diagnoses and
treatment plans.
By Ginger A. Baker, MS, MT(AAB),
Posted: January 2011, ADVANCE for Medical Laboratory
Professionals
The point-of-care (POC) test and device market has been
one area with sustained growth, even in a difficult
economic climate. This sector has sustained a 7.5
percent annual growth. Additionally, with the need to
reach a diagnosis and treatment plan as quickly as
possible, direct patient care professionals are looking
for rapid POC testing options. Both factors polarize
vendor focus on the POC market. The test options can
seem endless at times. In this installment of "At the
Bedside," a few key questions and considerations are
recommended.
Meeting Electronic Records Needs
Like laboratory
instruments, POC devices are not all created equal. Each
has enhanced options or methodologies that set it apart
from the market. The real trick is knowing what
information to target and what questions to ask. With
the coming HITECH requirements, it is probable that all
devices will need to be interfaced to the electronic
health record (EHR) and the EHR must have a module to
record results and quality control (QC) for manual POC
testing. While most devices offer connectivity, all
connectivity is not created equally. One only needs to
look at bedside glucose testing to get a clear picture
on the number of options available.
more >
New Go-to Guide for
Solving POC Conundrums
CAP Today, January 2011,
Feature Story, by Karen Lusky
A patient with type 1 diabetes has a 450 mg/dL
fingerstick glucose value when tested at a clinic but a
100 mg result when the central lab repeats the test on
another specimen. An emergency department physician
complains that the ED point-of-care pregnancy test
results are suddenly all positive. The Clinical and
Laboratory Standards Institute’s new consensus
guideline, “Quality Management Approaches to Reducing
Errors at the Point of Care,” is aimed at helping labs
and health care providers parse and preempt those types
of problems and many more.
more >
Glycemic
Control Economics in the ICU
Scurlock C, Raikhelkar J, Mechanick JI, Curr Opin
Clin Nutr Metab Care. 2010 Dec 29. [Epub ahead of
print]
Currently the USA has an
aging population, with increasing deficits and a
healthcare system that most would agree is in
need of repair. Finding ways to curtail costs is
urgently needed. Attention to glycemic control
and metabolic care offers a cost-effective
method of treatment to reduce complications.
Healthcare-related expenses
occupy an expanding portion of gross domestic
product in the US and are a driver of the
deficit.
more >
Glucose Meters
in
the ICU
By Brad S. Karon, MD, PhD, 14
January 2011 At the
bedside: poct - advance/Laboratory
The subject of glucose meter accuracy for use in
monitoring critically ill patients on glycemic control
protocols has received an incredible amount of attention
lately. Some of the issues surrounding this controversy
are summarized here.
Prior to 2001, the “state of the art” in critical care
was to monitor glucose levels in critically ill patients
and intervene (with insulin administration) only if
glucose levels exceeded 200 mg/dL. In 2001, Van den
Berghe and colleagues published the first of their
studies on glycemic control.
more
Advances in POCT
POCT will continue to be driven by technology and the
need to produce results in a timely manner
By Adetoun
Ejilemele, MBBS, FMC Path, FWACP, and Anthony O.
Okorodudu, PhD, MBA, DABCC, FACB
ADVANCE for Administrators of the
Laboratory, Top 10 Features of 2010
The widespread use of point-of-care testing (POCT) has
become feasible thanks to improvements in the ease of
use of instruments and enhancements in automation. In
many cases, software applications have been incorporated
into the instruments to provide automated calibration
and quality control. There's also been a shift away from
the use of liquid reagents to solid-phase reagents and
electrochemical methods.
more >
POCT key to widespread
access to healthcare
By Harry
Glorikian, BA, MBA; Aruna Rajan; and Kerry Xie, Medical
Laboratory Observer, January 2011
Decentralization
of healthcare is a major trend impacting the delivery of
in vitro diagnostics and is driving the need for
point-of-care testing/tests (POCT). With fast turnaround
times (TAT) and portability to a variety of settings,
POCT offers many advantages for disease management. POCT
enables migration from core hospital labs to
specialty-care units, doctors’ offices, and homes to
provide access to healthcare services, thus improving
patient compliance, reducing hospital stays, and
lowering overall healthcare costs.
more >
CLSI
Publishes Quality Practices in Noninstrumented POCT
The Clinical and
Laboratory Standards Institute(CLSI) recently published Quality
Practices in Noninstrumented Point-of-Care Testing: An
Instructional Manual and Resources for Health Care
Workers; Approved Guideline (POCT08-A). This
instructional guideline delivers laboratory science
concepts and activities with the goal of increasing
knowledge and quality of laboratory testing for testing
personnel with little or no laboratory background. “POCT08-A is
designed to make the basic principles of good laboratory
practice accessible to all the diverse personnel
performing noninstrumented tests at the point of care.
It contains discussion and
examples of basic practices that support accurate
testing, and an extensive set of forms and protocols to
use as resources for those managing such testing,” said
Sheldon Campbell, MD, PhD, FCAP, Yale University School
of Medicine, and chairholder of the subcommittee that
created the
document.
more >
Three Cs of Coagulation Testing
Avoid interferences & find an approach to specimen
rejection that works for your lab
By Jill
Hoffman, posted December 27, 2010, ADVANCE for Medical
Laboratory Professionals
The most common coagulation tests are prothrombin (PT)
and activated partial thromboplastin time (aPTT).
Physicians will often order PT to determine the degree
of blood anticoagulation in patients using
anticoagulants or blood thinners such as Warfarin as
well as to detect acquired bleeding disorders (e.g.,
vitamin K deficiency and liver damage).
PT is more commonly reported in the International
Normalized Ratio unit system. aPTT detects hereditary
clotting abnormalities and monitors heparin therapy.
Both tests are often ordered in conjunction.
more >
More
Hospitals Advertise Shorter Patient Wait Times for
Emergency Departments
The Dark
Report, November 29 2010
New
trend pressures clinical pathology laboratories to
shorten turnaround times for key lab tests Anyone
who says there’s not much competition for patients has
ignored the marketing battle among hospitals to attract
patients to their emergency departments (EDs). In a
growing number of cities, major hospitals now
aggressively advertise guarantees of ever-shorter wait
times in their EDs. This trend has a direct impact on
clinical pathology laboratories because they must
improve turnaround time (TAT) on lab test results to
support faster patient care in EDs. Using the promise of
faster patient access to a doctor in the ED is a
fascinating phenomenon. It shows that patients do
recognize the difference in service they get from
hospitals in their community.
more >
The International
Normalized Ratio: A Tool for Monitoring Warfarin
Therapy
Warfarin is a widely
prescribed oral anticoagulant that acts by inhibiting
vitamin K-dependent coagulation factors in blood. Too
much warfarin, however, causes bleeding and can even
result in death. Therefore, dosage of the drug must be
individualized for each patient. To avoid adverse events
associated with warfarin such as excessive bleeding,
clinicians regularly monitor patients’ anticoagulation
status using prothrombin time (PT) and the international
normalized ratio (INR). Individuals who are at risk for
bleeding while receiving warfarin include the elderly,
as well as patients with liver disease, congestive heart
failure, or those on hemodialysis. Recent major surgery,
malnutrition, hyperthyroidism, and many drugs, including
amiodarone (an anti-arrhythmic), also increase the
chances of bleeding. Furthermore, there are also
important genetic factors that modulate the response to
warfarin. Patients with such risk factors may benefit
from more frequent monitoring, careful dose adjustment
to desired INR, and shorter duration of therapy.
Clinicians also commonly use PT and INR to assess
patients’ hemostastic systems.
more
Report Finds Drop in
MRSA Infections
A new report released by the American Medical
Association found that the number of invasive
healthcare-related methicillin-resistant Staphylococcus
aureus (MRSA) infections has decreased among patients
with healthcare-associated infections that were acquired
in community settings. MRSA infection rates also
declined among those with hospital-onset invasive
disease.
more
Tight Glycemic Control:What Do We Really Know,
and What Should We Expect?
Tight glycemic control has engendered large numbers
of investigations, with conflicting results. The
world has largely embraced intensive insulin as a
practice, but applies this therapy with great
variability in the manner of glucose control and
measurement. This commentary reviews what we
actually know with certainty from this vast sea of
literature, and what we can expect looking forward.
more
Exploring the Relationship between Hyperglycemia and
Surgical Site Infection
Study Suggests
Potential Glycemic Target
AACC
Clinical Laboratory Strategies, November 2010, by Genna Rollins
Numerous studies have examined the impact of tight
glycemic control in different populations of
hospitalized patients, with varying results. Some have
found benefits such as reduced surgical site infections
(SSI), while others have reported harms like increased
mortality. Now, new research examines the impact of
perioperative hyperglycemia on the incidence of SSI in
general and vascular surgery patients. NOTE:
viewing the rest of this article requires AACC
membership.
more >
Strengthening POCC Support
ADVANCE for
Administrators of the Laboratory, November 2010 At the
Bedside, by Rebecca Taalbi, point-of-care coordinator,
Wheaton Franciscan Healthcare, St. Francis Hospital,
Milwaukee, WI.
Do point-of-care (POC) employees belong to nursing or to
lab? Who should pay for the oversight? What is fair pay? These are typical
questions from managers and technicians alike.POC coordinators (POCC) are responsible for ensuring
that nursing staff perform accurate, error-free lab work
but in this role do not work with patient samples.
Because of this, some lab employees feel POCCs should be
budgeted into nursing staff. They argue that the lab
should not accrue a cost to perform oversight that
offers no revenue.
more >
Packing POC Dossier into
New Online Tool Kit
It’s often said
that to get what you want, you have to identify what
you want. And what Eileen Esposito, RN, DNP, wants
is more pathologists who are willing to collaborate
with colleagues on point-of-care testing.
“I want someone
who can sit at a table with the end users and not
say, ‘You can’t have that point-of-care test,’ but
‘Let’s talk about the test you’re requesting, and
let’s talk about its pros and cons,’” says Esposito,
assistant executive director of ambulatory patient
care services and quality, North Shore-Long Island
Jewish Health System, Manhasset, NY, and a
consultant to the College’s POC Testing Committee. more
Strengthening Care
By Steven
Melnick, PhD, MD, Advance for Administrators of the
Lab • Issue 9 • Page 16
At
The Bedside Every day, clinical
laboratories are faced with an expanding set of
challenges in providing timely patient care.
Staffing shortages, new technology and
increasing demands for accountability from the
healthcare industry mean that laboratory
directors must routinely implement new patient
testing protocols and data management
techniques. Point-of-care
testing (POCT) is an important component of
comprehensive testing in today's laboratories.
At Miami Children's Hospital, our laboratory
manages, integrates and centralizes POCT
information originating from the intensive care
units, operating rooms, emergency department
(ED), off-site centers and air and ground
transport to ensure a continuum of care.
more
POCT
& AfterGlow Highlights from the AACC Annual Meeting
Bob Kaplanis
Awarded POCC of the Year!
Congratulations to Bob Kaplanis
from Banner Health in Arizona, second from left above,
(with L-R Bill Noble and Brian Gunderson from MAS and
Kim Gregory from Mass. General Hospital) who received
the CPOCT Division’s Point of Care Coordinator of the
Year award at this year’s Annual Meeting.
To see photos,
click here. Following
the Mixer, Rebecca Paw, POC Specialist from Adventist
Health in Southern Cal, right, welcomed 200+ people to
AfterGlow 2010. For more photos from
AfterGlow,
click here,
8th Annual POCC Forum Presentations Now Available
"Records and
Regulations in the Age of the EMR" drew a large audience
during the Annual Meeting and the presentations are now
available for viewing. Click on the title of image below
for a pdf of the slides.
POCT
and the CLIA SURVEY,
Gary Yamamoto,
Centers for Medicare & Medicaid Services San Francisco
Regional Office, Preparing
for a New Era in Health Care
Integrated Electronic Health Records System,
Ginger A. Baker, MS, MT (AAB)
Accounting Practices
Build a skillful
financial justification for your point of care testing
program additions and changes.
August 16, 2010
|
By Ginger A. Baker, MS, MT(AAB)
ADVANCE for Medical Laboratory Professionals
It has been a
difficult time for most. Payer mixes have changed and
financial reserves are dwindling. There has never been a
more critical need to understand the accounting methods
of determining a test's worth and cost. Savvy point of
care coordinators(POCCs) or lab managers know point of
care tests (POCT) are not as financially friendly as
their lab performed counterparts.
More
Connectivity Pitfalls at the Point of Care
By Kim
Gregory, MT(ASCP), NCA, ClS, Associate Director, POCT,
Massachusetts General Hospital, Boston, POC CONNECTIVITY
CONCEPTS, Advance for Administrators of the Laboratory
In the infancy of point-of-care testing (POCT) the newly
deemed POCT coordinator was challenged with the task of
creating compliance from chaos using a mountain of
paper", and if they were lucky, a laptop containing a
data management system for glucose meters
fondly referred to as "SneakerNet".
Read more >
Blood Glucose Meters:
Is FDA Ready
to Tighten Up Accuracy Standards?
By Bill Malone, Clinical
Laboratory News, May 2010
After
a well attended March meeting on blood glucose meters,
FDA now has support from stakeholders to work toward a
two-track regulatory approach that would distinguish the
needs of individuals monitoring diabetes at home versus
healthcare professionals maintaining tight glycemic
control (TGC) protocols in clinical settings. More >
Lessons from the
POCT Front
By Genna
Rollins, March 2010 Clinical Laboratory News
How
Can Labs Improve Implementation, Tackle Compliance
Challenges?
For at least a decade, point-of-care testing (POCT) has
been the darling of the medical diagnostics industry,
with sustained growth in testing volume and continual
technological breakthroughs. The
trend shows no sign of abating, as drivers such as the
need for hospitals and clinics to better manage capacity
and improve care, coupled with further innovations, are
making POCT ever more attractive.
Yet hospitals and
health systems continue to experience challenges in
implementing and sustaining POCT programs, at times
leaving both laboratorians and clinicians frustrated and
wary about the process. The reasons for
less-than-satisfactory outcomes are as varied as the
programs themselves, but experts cite many factors that
can make or break a POCT application.
More >
POCT Quality
By Anthony
O. Okorodudu, PhD, MBA, DABCC, FACB, Advance for
Administrators of the Laboratory - Print
The value of POCT is
mainly dependent on reducing pre- and post-analytical
errors.
Click here
Urinalysis at the Point-of-Care
Advance
for Administrators of the Laboratory, 0310
Listen in to
pieces of an interview from the February print edition
of Advance for Administrators of the Laboratory.
Maria
Peluso-Lapsley, global commercial marketing manager,
Urinalysis, Siemens Healthcare Diagnostics, spoke with
ADVANCE for the urinalysis article featured in the
February print edition.
Click here to hear her talk about some of the
benefits of performing urinalysis at the point of care,
and learn about the CLINITEK Status family of analyzers
from Siemens.
What’s New in POC
Glucose Analyzers
By Brendan
Dabkowski, CAP Today, February 2010, Feature Story
Sometimes, turning your attention away from the rest of
the proverbial forest to care for a specific tree can
prove positive. So long as you pick the right tree. For
makers of bedside glucose testing systems, the right
tree is accuracy. And growing it can yield such benefits
as fewer errors, reduced costs, and greater patient
safety.
“The most significant trend within the marketplace has
been for hospitals to demand improved accuracy of
bedside glucose monitors as hospitals adopt protocols
for better glycemic management of patients,” says Rick
Rollins, marketing specialist, Nova Biomedical. Rollins
adds that the FDA, American Association of Clinical
Endocrinologists, and Society of Critical Care Medicine
are calling for enhanced glucose meter accuracy. And as
point-of-care glucose testing expands, says Peter Karkantis, general manager of hospital and government,
Abbott Diabetes Care, “health care institutions must
have assurance that their point-of-care glucose
monitoring system provider can deliver consistent
accuracy across thousands of glucose analyzers and
millions of test strips.” More >
Eye the Basics,
Not Baubles,for POCT
CAP Today,
January 2010, Feature Story, by Anne Ford
The major gift-giving holidays may be over, but the
hankering for new gadgets continues. Just ask
point-of-care coordinators, some of whom continue to
check their metaphorical stockings for new tests as they
plead, “I’ve been a very good coordinator this year. How
about, say, a POC molecular assay for respiratory
infection?”
But focusing on the new—new assays, new platforms, new
bells and whistles—can be detrimental to achieving
excellence in your POC program, some experts say.
“There’s a lot of tantalizing technology out there that
looks really fun but that’s not practical or not
indicated,” says Cynthia Foss Bowman, MD, medical
director of clinical laboratories and director of POC
testing at Long Island Jewish Medical Center, New York.
“From my perspective, we should be making the
bread-and-butter POC testing better. I don’t want to
inhibit technical development, but I would hate to see a
barrage of new tests come out without attending to the
issues that we’ve got right now.”
For example? Not being aware of the limitations of each
type of POC test performed in your institution.
Reinventing the wheel instead of taking advantage of
vendor resources. Letting clinicians dictate which tests
are performed at the point of care.
Read more >
Glycemic
Control in the Hospital: How Tight?
Nursing, November
2009, By Christine Kessler, RN, ANP, BC-ADM, MN
Consider the latest
evidence as you explore the controversial issue of
glycemic control in critically ill patients.
PATIENTS
WITH DIABETES are often our most challenging. Although
diabetes isn’t usually the reason that patients are
admitted to the hospital, it’s the fourth most common
co-morbidity. Half of patients with type 1 and 2 diabetes
will face surgery in their lifetime. During hospitalization, up to 12% of patients who don’t
have a history of diabetes will develop hyperglycemia,
which is defined as a fasting blood glucose over 126 mg/dL
or a random glucose over 200 mg/dL. Surprisingly, these
patients will have a nearly 18-fold increased risk of
in-hospital mortality compared with the 3-fold risk
experienced by patients known to have diabetes. Recent
studies have demonstrated that better glycemic control
can greatly reduce mortality, morbidity, and hospital
costs.
So how tight should glycemic control in hospitalized
patients be? Based on recent studies, the answer to
that question remains controversial.
More >
POC
Glucose Testing in Critically ill Patients
Editorial
article from Critical Care Medicine 2009 Vol. 37, No. 10
Visual logistics and a
glycemic variability hypothesis
In this (current) issue of Critical Care Medicine, the
paper by Dr. Meynaar et al represents a step in the
right direction. It focuses on critically ill patients,
presents a systematic approach to glucose meter
evaluation, and applies locally smoothed median absolute
difference (LS MAD) curves to evaluate bedside testing.
LS MAD
curves provide compact visual representation of
performance by means of “visual logistics”— readily
interpretable and clinically relevant graphics that
reveal accuracy simultaneously at different decision
levels, which for glucose include hypoglycemia, tight
glucose control (TGC), hyperglycemia, and critical
limits.
LS MAD curves
facilitate comprehension of performance without lengthy
explanation and also show that most glucose meter
systems do not provide consistent enough measurements
for therapeutic decisions in the extremely high or low
glucose range where Dr. Meynaar et al captured too few
paired observations to arrive at a conclusion.
More >
Perspectives on Cost and Outcomes for
POCT
Elizabeth Lee-Lewandrowski, PhD, MPH, Kent
Lewandrowski, MD,
Research Core
Laboratory, Massachusetts General Hospital,
Clin Lab
Med 29 (2009)
Rapid TAT provided by
POCT main factor ultimately responsible for
improvement in outcomes
Point-of-care testing (POCT)
is usually more expensive on a unit-cost basis than
testing performed in a central laboratory. It is
difficult to manage POCT and to maintain regulatory
compliance, especially in large institutions...
More >
Higher Standards on the
Way
for
Glucose Meters?
By
Bill Malone,
Clinical
Laboratory News, September 2009: Volume 35,
Number 9
FDA Seeking ISO Revision to Improve Performance
Requirements
The FDA will consider
tightening standards for strip-based blood glucose
meters, echoing the concerns of many in the clinical lab
field who have warned for a decade that the meters are
not reliable.
More >
POC Leader Spreads Winning Ways Far & Wide
CAP
Today, September 2009, Feature Story, by Anne Paxton
July
2009 was not a bad month for the point-of-care
testing program at Nebraska Methodist Hospital in
Omaha. First, the 430-bed hospital earned
recognition from the Hospital Compare program
sponsored by the Centers for Medicare and Medicaid
Services, which placed Methodist among the elite two
percent of institutions in the nation with the
lowest mortality for heart attack patients. Capping
that accolade, the American Association for Clinical
Chemistry tapped the hospital’s point-of-care
coordinator, Brenda Franks, MT(ASCP), for its
Point-of-Care Coordinator of the Year Award.
Franks would be the first to say there’s no magic
method for a POC testing program to arrive at such a
plane, but she has a few words of advice for other
POC testing programs. Among them: Get people to
focus on the data. Pin down specific ways to reduce
errors. Solve problems through coordinated teamwork.
And make sure that POC solutions actually address
problems you are trying to fix.
Nebraska Methodist’s point-of-care program started
out with a slight advantage over most. “When
point-of-care glucose testing first became available
20-plus years ago, the laboratory here was privately
owned, so we brought it on as a phlebotomy-based
program,” Franks says. There was a benefit to that,
because every POC glucose performed was put into the
patient medical record via the hospital information
system.
More >
Avoiding POCT Deficiencies
Advance for Administrators of the Lab,
Kelly J.
Graham, Vol. 18 • Issue 9
Errors
easily arise in point-of-care testing programs;
assess yours to maintain efficiency.
A
common downside to rapidly changing, developing
and improving technologies is a struggle to
maintain a high level of efficiency and quality
with minimal errors. Point-of-care testing (POCT)
is no exception-as more facilities adopt the
practice and new platforms and applications
become available, common deficiencies in POCT
programs may arise. But in the quality-centric
healthcare industry, methods for eliminating
problems are rarely far behind the
identification of a concern. Assess your own
POCT program for the deficiencies below and
ascertain which improvement measures might work
for your facility.
Identifying Common Issues
Peggy Mann, MS, MT(ASCP), POC and Lab/Facility
coordinator, University of Texas Medical Branch,
Clinic Administration lists a few of the most
frequently seen deficiencies as:
-
lack of
required competency documentation,
-
lack of
required quality control (QC) performance,
-
failure
to recognize out-of-range QC values,
-
improper
or lack of required instrument maintenance
and/or documentation,
-
lack of
appropriate personal protective equipment
and
-
lack of
awareness that testing sites must have
appropriate CLIA certificates for the type
of testing performed.
More >
Pieces of the POCT puzzle
POC testing: changing the way
patient care is delivered
By Kristin N. Hale, BS, BA, and Gerald J. Kost,
MD, PhD, MS, FACB, MLO,
June 2009
Point-of-care testing (POCT) is defined as
testing at or near the site of patient care. The
goal of POCT is to facilitate rapid diagnosis
and faster treatment decisions to improve
patient care and reduce morbidity and
mortality.1 POCT impacts every branch of the
healthcare system, including hospitals,
outpatients, and disaster and emergency
situations. The ability of POCT to be utilized
in all these respective locations has
demonstrated the significant potential POCT has
to positively impact and change the way
healthcare is delivered to the patient
population — ultimately, with the goal of
improving patient care — wherever that may be.
More >
Positive Patient Outcomes
The Joint Commission has implemented key changes
in 2009 that enhance focus on quality and
patient safety.
By Margaret
Peck, MS, MT (ASCP) Advance for Admin of the Lab:
May 2009
Safe, quality patient care is highly dependent
on the excellence of laboratory services, yet
laboratories quite often rely on external
processes and staff that impact its ability to
provide timely, quality results. The landmark
1999 Institute of Medicine report To Err is
Human stated that 70 percent of laboratory
errors occur in the pre- and post-analytical
phases of laboratory testing. Therefore, the
interface between the clinical laboratory and
other care providers can be a crucial part of
the entire scope of the provision of lab
services.
More >
Aiming
for Lab-like Accuracy at the
Point of Care
CAP Today, April 2009, Feature Story, By Brendan
Dabkowski
American
frontiersman and gunslinger Wyatt Earp is credited
with the gem “fast is fine, but accuracy is
everything.”
Though physicians at
the point of care are unlikely to find themselves in
an Old West-style gunfight, most, like Earp, would
choose accuracy over speed. And that means makers of
bedside glucose testing systems must be ever
vigilant in meeting customers’ requests for improved
accuracy.
“The primary need for clinicians using POC glucose
monitors is that they give accurate results—even in
the presence of interfering substances like maltose,
abnormal hematocrit, ascorbate, etc.—so that correct
treatment decisions can be made,” says Ron Newby,
Nova Biomedical’s director of marketing. Also
crucial: obtaining the right glucose read the first
time, at the point of care, to eliminate the
“time-wasting need for repeat measurements,” he
says. Analyzers must deliver results quickly, but
without sacrificing accuracy. Hospitals now face the
“need to provide even higher levels of accuracy in
handheld devices, in effect delivering lab-like
accuracy at the bedside,” says Mary Catherine Coyle,
MS, MT(ASCP), director of product marketing in the
professional diagnostics division of Roche
Diagnostics.
More >
Win-Win POCT
Scott
Warner, MLT(ASCP),
ADVANCE
for Administrators of the Laboratory
Vol. 18 • Issue 3 • Page 10 At
the Bedside
Imagine 10
employees in your small hospital laboratory.
Suddenly, there are 30 more performing tests on all
shifts, and as a manager you aren't sure if they are
fully trained or understand quality control (QC)
concepts. This can happen with point-of-care testing
(POCT).
With diabetes being the sixth
leading cause of death1and accounting for 22 percent
of hospital charges,2your hospital's POCT program is
a crucial part of managing inpatient diabetic care.
Your partnership with nursing is the key to success,
whether starting from scratch or upgrading an
existing program.
More
BNP in the Diagnosis of
Heart Failure
By Barry I. Bluestein, PhD,
MT(ASCP); Normand Despres, PhD; Alexander Belenky,
PhD; Farooq Ghani, MD, PhD; and E. Glenn Armstrong,
PhD,
ADVANCE
for Administrators of the Laboratory
Heart failure or congestive heart failure (CHF),
when heart failure patients experience a buildup of
fluid, is a clinical syndrome characterized by
shortness of breath, fatigue and peripheral edema
caused by the heart's inability to adequately
circulate blood to the body's essential organs. CHF
has become so common that it is considered by some
to be a new epidemic.1 This dysfunction is
associated with coronary artery disease (CAD),
chronic hypertension, valvular heart diseases and
cardiomyopathies.
The World Health
Organization now estimates that 16 million people
worldwide are living with some degree of heart
failure. Approximately two-thirds of those,
according to the National Institutes of Health, will
die within five years of their diagnosis. Eighty
percent of hospitalized patients age 65 and older
are admitted with a diagnosis of CHF, making it the
most common diagnosis of hospitalized patients in
that age group.2 As a result, more Medicare dollars
are spent on heart failure than any other single
diagnosis.
More
POCT Precision
Accuracy of
point-of-care testing devices is proven; educating
testing personnel is key.
By
David Plaut and Carol Smola, Advance for the
Administrators of the Lab
Advance for
Administrators of the Lab February 2009 issue has a
great article on POCT and reports that the demand
for POCT is expected to increase by 80 percent over
the next three years. The article states that
the market is forecasted to grow from $10.3 billion
(2005) to $18.7 billion by 2011.
Click here to visit Advance for
Administrators of the Laboratory website and then
under CURRENT ISSUE, click on the "Log in to View
Digital" button. That will take you to a really cool
digital version of the publication.
Point-of-Care Sagas:
A
Tale of Three Cities
CAP
Today, January 2009, Feature Story, by Anne Paxton
Baystate Health in Springfield, MA; Mayo Clinic
in Rochester, MN: and SUNY Downstate Medical Center
in Brooklyn, NY talk about their POC programs...
As increasingly
complex laboratory tests start being performed
rapidly at the bedside and elsewhere, the steady
migration of testing from central laboratory to the
point of care seems inexorable. But laboratory
managers and directors in many care settings can
confirm that, when point-of-care testing is adopted
too hastily, it can be a case of the technology tail
wagging the diagnostic testing dog.
At
Baystate Health in Springfield, Mass., for example, “We do a
complex menu of point-of-care testing, and we’re
dealing with dozens of sites, hundreds of devices,
and thousands of operators,” says James H. Nichols,
PhD, DABCC, FACB, director of clinical chemistry.
Sometimes, “physicians say ‘I need POC testing,’ and
think it’s going to solve all the problems of the
world—when in fact it can just throw another wrench
of technology into an already overburdened system.”
Read more >
New
Glycohemoglobin Standard:
Will Estimated Average Glucose Boost Patient Understanding?
By John R. Bell,
Clinical Laboratory News, October 2008:
Volume 34, Number 10
Despite the widespread use of HbA1c as a
clinical measurement of patients’ diabetes control, standardization
of test results has been a challenge for labs. The National Glycohemoglobin Standardization Program took the first step 12 years
ago when it initiated a program to standardize HbA1c measurements on
the basis of the Diabetes Control and Complications Trial, results
of which were published in 1993.
Read more >
Consensus from Endocrinologists on Prediabetes Testing
Lab Tests Online,
October 2008
New guidelines from two major endocrinology organizations recommend
strategies for diagnosis and management of prediabetes, a condition
that occurs when blood glucose levels are higher than normal but not
elevated enough to warrant a diagnosis of type 2 diabetes.
The guidelines are an extension of efforts to detect and treat type
2 diabetes earlier and more aggressively, according to AACE. They
aim to help physicians recognize prediabetes, those at risk for
developing full-blown diabetes, and to make treatment decisions to
prevent diabetes and ameliorate many of its risk factors. These
include unhealthy weight, high blood pressure, and elevated lipid
levels.
Read more >
Putting Hospital
Data
to Hospital-wide Use
,
Anne
Paxton
Implementing a tight glycemic control protocol in the hospital
should be straightforward: Monitor blood glucose levels, assess
how well they’re meeting target ranges, use the information to
improve, and reap the benefits in shorter lengths of stay and
lower mortality and costs.
But even when hospital staff are
eager to comply with the protocol, the challenge of getting the
right data together can hamper hospitals’ ability to benefit
from tight glycemic control, or TGC.
More >
POCT in the ED Enables Quicker Treatment
Clinical Lab Products
Patient side
point-of-care testing -- where diagnostic testing is conducted
at or near the site of the patient -- enables doctors to make
decisions on patients presenting with chest pain up to 20
minutes faster than those whose lab tests are evaluated by a
standard lab, according to a study appearing this
month in the peer-reviewed journal Annals of Emergency Medicine.
More >
Platform Consolidation in Critical Care
Advance for the
Administrators of the Lab
POC Connectivity, October 2008 By Brad Karon, MD, PhD
Recent consolidation of testing platforms has been driven by two
factors—increasing evidence for improved patient care outcomes for
analytes such as glucose, lactate and creatinine and the desire to
use a single platform in multiple patient care settings.
Read more >
Stuck in the Middle
of Middleware
By Deborah Levenson, May
2008, Clinical Laboratory News
Labs
Look for Answers as New Consortium Aims to Untangle
the Mess
Mention
“middleware” in a room full of lab directors, and
you are likely to hear varied definitions of what it
is and a wide array of uses for it. But generally
speaking, the term has come to describe any hardware
and software that acts as an intermediary between
instruments and lab information systems (LIS) and
allows them to exchange data or perform data
management tasks the LIS can’t.
Middleware’s popularity took off in the early 1990s
when personal computers that generated reports and
buffered results became more common. Since then,
middleware has become mainstream in POCT and a
common, relatively inexpensive solution for core
labs grappling with a wide range of problems
including shortages of med techs, increases in test
volume, more complex devices and lab operations, a
federal push for electronic health records, and an
overall trend toward ensuring quality of care.
Connectivity Success
Two major data
management systems for POCT now comply with the
CLSI’s connectivity standard, easing the transfer of
data in institutions with labs that use these
systems from Telcor (Lincoln, Neb.) and Medical
Automation Systems (Charlottesville, Va.).
Connectivity enabled by the standard and compliant
systems not only improves patient care, but also
eases billing and compliance documentation.
With the
forthcoming IICC standard, core labs may one day
enjoy the sort of connectivity POC users and lab
staff at Carolinas Medical Center-NorthEast in
Concord, N.C. now have. With the aid of
her RALS+ system from Medical Automation Systems and
its ability to connect to Roche Accuchek Inform
glucose meters, Laboratory Education and POC
Coordinator Deb Norkett, MT, ASCP has seen marked
improvements in compliance and billing. She
interfaces all manual tests through the Accucheck,
which also allows her to enter pregnancy test
results. After taking advantage of that function,
she now achieves a 100% billing rate, while in the
past she grappled with a 15% deficit in billing
because of lack of documentation in the emergency
room.
“Before using
RALS, we couldn’t capture figures on the volume of
certain manual tests, so they were built into the
room charge,” she recalled.
Click here for more >
Never Give In - Fighting for POC
Patient Safety
Cap Today,
By Anne Ford
In
grammar school, the “three Rs” still hold sway (or
so we all hope). But in point-of-care testing,
there’s just one R that matters: Relentless. It’s a
word that comes up over and over again in
conversation with hospital POC testing
coordinators—yes, even more often than “specimen” or
“CLIA.”
“People pretty much
know I’m relentless about certain things,” says Tim
Deen, MLT(ASCP), MT (HEW), POC testing manager at
Medical City Hospital, Dallas. “My chief nursing
officer has kindly referred to me as a ‘tough-love’
type of person.”
More >
In that regard he has a lot in
common with Deb Phaup, BS (MT), MT(ASCP), CLS (NCA, POC coordinator at Mount Auburn Hospital, Cambridge,
Mass. “I’m relentless,” she admits, laughing.
POC testing safety
is
nothing to joke about
Personable as Deen
and Phaup are, they know that POC testing safety is
nothing to joke about. With thousands of POC tests
performed in their hospitals each month, theirs is
not exactly a sit-back-and-relax situation. With
their colleague Joann Bauwens, BS(MT), MT(ASCP),
MA(HSM), interim director of laboratory services and
POC testing coordinator at SSM St. Mary’s Health
Center, St. Louis, Mo., they provide insight into
what keeps POC testing on the safe side.
Both Deen and Phaup
assumed their POC responsibilities just over a
decade ago, when bedside testing wasn’t as
frequently conducted or as closely regulated as it
is now. When Deen began, he says, Medical City
Hospital’s point-of-care program was “a lax system,
where the lab was not involved.” And at Mount Auburn
Hospital, where the POC coordinator position was
created for Phaup, “nobody even knew what POC
testing was,” she says. “The first week I started
the job, I came into work and the then-manager
didn’t even know where to put me. I was just
standing in the hall without a clue.”
Click here for more>
Putting
POCT in good hands
CAP Today,
Waived
testing? Wave goodbye to that, says William A.
Rock Jr., MD, medical director of the clinical
laboratory, University Hospitals and Clinics,
University of Mississippi Medical Center, Jackson,
who did just that when he began putting together a
point-of-care testing program for his institution a
decade ago. Today, he and three other colleagues run
an extensive POCT program that involves 61 sites and
more than 2,000 employees at three hospitals and a
large outpatient clinic—all without relying on the
waived tests that typically anchor POCT programs.
Waived tests are
somewhat oddball actors in the highly ordered,
detail-driven world of laboratory medicine. Though
regulated, these tests fall short on full
commitment, like the Sondheim character in “Company”
who sings, “Marry me a little.” So simple are these
tests, the FDA has cleared them for home use, and
CLIA requires test users to follow only
manufacturers’ instructions. No proficiency testing,
no patient test management, no quality assurance, no
quality control, and no personnel qualifications.
For Dr. Rock and his colleagues, it was also a
no-go. At UMMC, they decided, the POCT program would
be built to last. Any test supported in the POC
program, even if CLIA has given it waived status,
would have to meet CAP and Joint Commission
guidelines.
Click here for more.
Bedside Tests Can Speed Results,
Ease Crowded ERs
The Tennessean. 07/15/08
It used to take emergency physicians at Middle Tennessee Medical Center
an hour and a half to get back results from a blood test. That changed
to only a few minutes three months ago when the hospital bought
equipment that allows tests to be done at a patient's bedside.
The Murfreesboro hospital is one of several in the Nashville area moving
to point-of-care testing, which a Vanderbilt professor's research calls
part of the solution to relieve emergency room overcrowding.
At many hospitals, tests are sent to labs in another part of the
building and certain results might take as long as an hour and a half to
get back to the physician. That can sometimes delay initial treatment
and push back other tests, such as X-rays that won't be scheduled until
those initial results are returned. That, in turn, may keep beds
occupied that otherwise could go to other patients. Soon, Middle
Tennessee Medical Center plans to add pregnancy and urine tests to those
performed at the bedside, a development made possible by the
availability of smaller, less costly testing units and improved
technology.
"It's been one of the biggest accelerators of our patient flow," said
Dr. Kevin H. Beier, an emergency physician who also practices at Baptist
Hospital here and is chairman of governmental affairs for the American
Academy of Emergency Medicine.
Vanderbilt, meanwhile, is considering putting a small lab within its
adult emergency department or buying some of the small portable testing
devices already on the market.
Overcrowding on
rise
The move follows a study by Dr. Alan Storrow, associate professor of
emergency medicine, that suggested putting labs or machines that
determine results closer to a patient's bedside can help solve
overcrowding in emergency rooms and perhaps free up bed space in the
main hospital more quickly. "We could see a great deal more patients in
less time because we're able to get our labs back in a much more
time-efficient manner," Storrow said.
Overcrowding has become
more of an issue as hospitals begin to see sicker patients, some of
whom don't seek care until their medical problem gets worse because
of a lack of insurance.
Every other day, at least one Nashville-area hospital sends patients
elsewhere because of a lack of room in departments such as the ER and
the critical care unit. Although Vanderbilt — where the adult and
pediatric emergency departments combined see 100,000 patients a year —
recently doubled its ER capacity to 46 beds, overcrowding still occurs.
One barrier to adopting point-of-care testing is that it often costs
less to process batches of tests in a larger main hospital or central
lab, Storrow said. "There has to be a balance between cost and
improvements in efficiency.
Speeding Toward Real
Time with POC Glucoses
CAP Today, March 2008, Feature
Article
In the case of
wireless setups for point-of-care glucose testing,
do results arrive in the electronic medical record
in real time or "real time"? And how important is
that distinction?
To
back up a moment: As reported in the
October 2007
issue of CAP TODAY ("Wireless Glucose Results-The
Latest in Real-Time Data"), the University of North
Carolina Hospitals, Chapel Hill, has implemented LifeScan's OneTouch DataLink system to greatly
shorten the length of time it takes to obtain, view,
and track point-of-care blood glucose results on
clinical workstations, laboratory IT systems, and
even physicians' PDAs. Other institutions are
gradually following suit.
The LifeScan system
speeds glucose result delivery by using a wireless
unit to transmit data from LifeScan's OneTouch
Flexx meter into the electronic medical record
rather than requiring point-of-care staff to take
the meter to a docking station for upload. Here's
what some consider the sticking point: The wireless
unit is external, meaning the user must connect it
to the meter with a serial cable before connectivity
can be established.
True, the LifeScan wireless unit
is stored in the same carrying tote that holds the
meter. But it's still an external solution."It's not real-time
wireless," says James H. Nichols, PhD, DABCC, FACB,
who, as a member of the Connectivity Industry
Consortium, helped create the POCT1-A connectivity
standard for point-of-care devices in 2001.
Dr.
Nichols is medical director of chemistry at Baystate
Health, Springfield, Mass., and associate professor
of pathology at Tufts University School of Medicine,
Boston. "It's a stepping stone on the way to real
time, but it's not there yet. It's not like you have
the device in your hand, you push the button to scan
the patient, and it communicates wirelessly with
your server. It still has that limitation of
intermittent transmitting."
Click here for more >
Integrating POCT In the ED
POC Connectivity Concepts,
Advance for the Administrators of the Lab, Vol. 17 •Issue 2
• Page 9
By
Valerie L. Ng, PhD, MD; R. Clayton Hooper, RN; Ruth
Pfeiffer, RN; Mary N. Clancy, MS, CLS; and Eberhard Fiebig,
MD
You can't get much more
diametrically opposed cultures than that of the ED and the
laboratory. The laboratory culture is one of careful and
methodical processes and quality systems designed to ensure
high-quality results and meet regulatory requirements. The
ED culture is one of speed, algorithmic medical practice and
rapid reflexive actions necessary to save lives in
emergencies; regulatory compliance tasks are often an
afterthought.
Ironically, many ED
interventions rely on accurate laboratory test results.
Point-of-care testing (POCT) results in the ED must, by
definition, be of the highest quality and always correct
because clinical action will be taken immediately based on
the test result.
Why has POCT become so important
for the ED? The backdrop is the unraveling of the healthcare
system, driving many uninsured and sick patients without
primary care access to the ED for routine or urgent (but not
emergency) medical care.
Click here for more >
Nurses on
Point-of-Care IT Usage: Study
By: Jean DerGurahian/ HITS
staff writer; Modern Healthcare Online Posted: January 4,
2008 - 5:59 am EDT
An
increase on patient safety issues, higher healthcare costs
and labor shortages are driving hospitals to use more
information technology at the point of care; however, some
devices and technology are more cumbersome than helpful,
according to a new study of nurses and their bedside
treatment practices.
The Point
of Care Computing for Nursing study, conducted by Spyglass
Consulting Group, shows that healthcare facilities are
making "significant investments" in clinical information
systems so that nurses and other practitioners can access
patient information near or at the point of care.
Nurses are
using fixed or mobile devices to search different
applications that help them treat their patients, according
to the report,
Spyglass spent four months interviewing more than 100 nurses
across the healthcare fields for its study.
It found
that 86% of acute-care nurses and 94% of home health nurses
interviewed are using devices to access reference
materials—including drug databases, manuals and medical
calculators—and make informed patient decisions.
While
nurses spend nearly half their time documenting their
treatments, 78% of nurses record their care at the patient's
bedside through IT applications, in efforts to cut down on
first writing the information on paper and then transferring
it to electronic reports, according to the study.
Another timesaver has been the use of automated products to
capture vital signs data for high-acuity patients, immediately
present it for nursing review and automatically upload it to the
patient’s electronic record, with 36% of nurses adopting this
practice. Bar coding
also has helped nurses reduce medical errors. More than half the
nurses interviewed—53%—said that they use devices to ensure
positive patient identification, medication administration,
blood transfusion verification and laboratory specimen
collection, according to the report.
Nurses are
spending time on the Internet as well to stay up-to-date on
nursing trends and new treatments, according to the report.
"Nurses discovering online nursing communities and resources
enabling them to communicate and collaborate with colleagues
more effectively," Spyglass said in its report. While nurses
seem ready to embrace point-of-care technology, they also say
devices currently available are cumbersome and difficult to move
with, and networks are unreliable, according to the report.
"Point-of-care
solutions need to evolve to provide higher levels of
synchronization and integration of hardware, software and
infrastructure to streamline nursing workflow process and
improve communications amongst care team members," Spyglass
said.
Content for
Point of Care Computing for Nursing was derived from more than
100 interviews with nurses working in acute-care and ambulatory
environments nationwide. Spyglass conducted the telephone
interviews over a four-month period beginning April 2007.
Wireless glucose
results - latest on real-time data
More than a
decade after tight glycemic control made its debut in the
early 1990s, numerous studies, and recommendations from
organizations such as the American Association of Clinical
Endocrinologists and the American Diabetes Association, have
affirmed its ability to decrease everything from mortality
and comorbidity to the risk of heart failure and organ
damage. But from a point-of-care testing coordinator's point
of view, tight glycemic control increases a few
things, too.
A few? Make
that 1,000—the approximate number of glucose results that
point-of-care staff at University of North Carolina
Hospitals, Chapel Hill, manage every day. After UNC
implemented a TGC protocol a few years ago, "the first thing
that I noticed as a point-of-care person was that it
required more glucose meters and testing strips, and more
data was being generated," says Beverly Robertson, MPH, MT (ASCP),
until recently UNC's point-of-care testing coordinator and
now a technical service representative for Somerset,
NJ-based in Ventiv Health and an authorized installer of
LifeScan equipment. In addition to reviewing and charting a
greatly increased number of glucose results, the new TGC
protocol meant that Robertson was faced with managing more
frequent data downloads and data flow bottlenecks. Not only
were there more results to deal with, but "all those results
were being hand-charted," Robertson says. "And the only way
that physicians could review them was to be physically at
the nursing locations." In a large institution like UNC,
which has 750 beds, 100 units, and nine ICUs, that meant
relying on what Connie Bishop, MT (ASCP) SH, UNC assistant
administrative director of core laboratories and
point-of-care testing, laughingly terms the "sneaker
network."
Click here for more>
The
Challenges of Point-of-Care Connectivity
How A New Tool Can Aid Labs
with Device and Data System Purchasing
By Deborah Levenson,
Clinical Laboratory News, July 2007
Point-of-care testing (POCT)
devices with the ability to link to each other and lab
information systems (LISs)—known as connectivity—can help
reduce medical errors, improve staff compliance with
regulatory requirements, boost revenue from testing, and
track wasted supplies.
In most labs,
POCT connectivity has come a long way from the 1990s, when many
POCT devices lacked essentials such as ports that allowed them
to transfer results to a lab data management system or ports
with keypads for data entry. In those early days, a few
manufacturers offered instruments that allowed labs to move data
from the device to a patient’s chart, but each had its own suite
of products, necessitating multiple computers to handle data.
Today, while issues with POCT connectivity are not as
troublesome, labs often fall short of the ultimate goal of using
such devices: fast, complete transfer of accurate information.
Click here for more >
Utilization of a Computerized Intravenous Insulin Infusion
Program to Control Blood Glucose in the Intensive Care Unit
Rattan Juneja, Corbin Roudebush,
Nilay Kumar, Angela Macy, Adam
Golas,
Donna Wall, Cheryl Wolverton, Deborah
Nelson, Joni Carroll, Samuel J. Flanders.
Diabetes Technology &
Therapeutics.
Jun 2007, Vol. 9,
No. 3:
232-240
This proof of concept study was designed
to evaluate the safety and effectiveness of an intravenous
insulin dosing calculator, the Clarian GlucoStabilizer™
program, and to determine the feasibility of its use as part
of a glycemic control program. This paper discusses the
impact of the GlucoStabilizer program on the glycemic
control of intensive care patients with hyperglycemia.
Patients admitted to the intensive care unit
(ICU), requiring intravenous insulin, were treated using the
GlucoStabilizer program. This program calculates an insulin
drip rate based on the low and high blood glucose (BG)
levels of the desired target range, the patient's current
and previous BG levels, and an insulin sensitivity factor,
with a goal of safely and expeditiously achieving and
maintaining the patient's BG in the target range.
From October 2004 through March 2006, the
GlucoStabilizer program has been used to treat 2,398
patients in the ICUs, with 177,279 BG measurements in its
database.
For
more on this study, or to request a copy,
click here.
Intensive Insulin Protocol
Improves Glucose Control and Is Associated with a Reduction in
Intensive Care Unit Mortality
Charles C Reed, BSN, Ronald M Stewart, MD, FACS, Michele
Sherman, BSN, John G Myers, MD, FACS, Michael G Corneille, MD,
FACS, Nanette Larson, BSN, Susan Gerhardt, MSN, Randall Beadle,
BSN, Conrado Gamboa, MS, RPh, Daniel Dent, MD, FACS, Stephen M
Cohn, MD, FACS, Basil A Pruitt Jr, MD, FACS. American College of
Surgeons, 2007
Intensive insulin therapy to maintain serum glucose levels
between 80 and 110 mg/dL has previously been shown to reduce
mortality in the critically ill; recent data, however, have
called this benefit into question.
In addition, maintaining
uniform, tight glucose control is challenging and resource
demanding. We hypothesized that, by use of a protocol, tight
glucose control could be achieved in the surgical trauma
intensive care unit (STICU), and that improved glucose control
would be beneficial. During the study period, a progressively
more rigorous approach to glucose control was used, culminating
in an implemented protocol in 2005.
We reviewed STICU patients’ blood glucose
levels, measured by point-of-care testing, from 2003 to
2006.Mortality was tracked over the course of the study, and
patient charts were retrospectively reviewed to measure illness
and injury severity.
For
the results of this study,
click here to access the pdf file.
Glucose Test
Frequency Spawns
New Analyzer Needs
Anne
Ford
In dieting—as in so much else—good
intentions aren’t enough. To lose weight, calorie-counters can’t
stock up on carrot sticks and hope for the best; they have to
actually monitor their diet via a food diary or some other
method. (Hence the saying: “If you bite it, write it.”) But if
the monitoring method becomes too cumbersome, it’s likely to go
by the wayside, and any new, healthier eating habits will
probably follow.
Conversely, making the monitoring
process as painless as possible is a major step toward success.
And that’s a lesson that applies to many endeavors, including
tight glycemic control.
“Because
of the increased testing frequency mandated by most tight
glycemic control protocols,” says LifeScan marketing manager
Grant Choe, “anything we can do to increase ease and simplicity
is going to be welcomed with open arms.” Harlan Polishook, Nova
Biomedical marketing communications manager, agrees: Under tight
glycemic control protocols, he says, some nurses find themselves
performing bedside glucose testing “as frequently as every half
hour for some patients.” In turn, “more frequent bedside testing
has driven the demand for faster, easier testing and smaller
blood volumes.”
The
makers of the
bedside glucose testing systems featured in this month’s
instrumentation survey have responded to that demand
with new and forthcoming instruments and features, from multiple
measuring wells to wireless capabilities.
Click here for more >
Industry Overview
Surprise, We’re Here!
Gearing up for
unannounced inspections
By
Renee DiIulio
In 2004, deficiencies at Maryland
General Hospital (MGH) in Baltimore brought oversight attention
to the process of laboratory accreditation and inspections. The
title of a resulting Government Accountability Office (GAO)
report, published in June 2006, summarizes the result: “Clinical
Labs: CMS and Survey Organization Oversight Is Not Sufficient to
Ensure Lab Quality.” Something had to change. Congressmen called
for a switch to unannounced inspections. At the same time, the
Joint Commission on Accreditation of Healthcare Organizations
(JCAHO), Oakbrook Terrace, Ill, was in the process of altering
its accreditation process, implementing a plan named Shared
Visions—New Pathways, which became effective January 1, 2004.
“In 2004, JCAHO announced its intent
to implement unannounced surveys in 2006 as part of our Shared
Vision—New Pathways effort,” says Margaret Peck, MS, MT(ASCP),
the organization’s director of the lab accreditation program.
The goal was to provide a more accurate picture of a
laboratory’s day-to-day function. “It would allow our
accreditation process to be used as a systems improvement tool,”
Peck says.
College of American Pathologists
(CAP) followed suit, influenced, says R. Bruce (RB) Williams,
MD, pathologist and head of CAP’s accreditation committee, by
the concern of the GAO and Congress. “We are continually
improving our lab accreditation process, and we underwent a
systemic review following MGH,” he says. A subsequent bill—HR
686: Clinical Laboratory Compliance Improvement Act of 2005,
introduced by Rep Elijah Cummings (D-Md)—aims to make
unannounced inspections a requirement if passed.
Click here for more >
When
POC Connects the Data, Everyone Wins
The
story of point-of-care connectivity is quickly becoming one of
laboratory medicine’s twice-told tales: POC setups have come a
long way, and hospitals are reaping the benefits. For Debra
Norkett, MT (ASCP), education coordinator for the laboratory and
point-of-care coordinator at NorthEast Medical Center, a 457-bed
hospital in Concord, NC, incorporating POC test data into an
electronic patient record system is the ultimate goal. “Our
hospital is working toward having electronic patient records,
and theoretically, point-of-care connectivity has been set up to
support such a system,” she says.
NorthEast Medical Center
implemented POC connectivity about three years ago, beginning
with the installation of a positive patient identification
system that uses bar-coded patient wristbands in conjunction
with bar-coded POC instrument operator badges to capture the
data from each encounter that involves a POC test. “The success
of our POC connectivity is tied into our bar-code system. The
bar-coded wristbands and badges have enabled us to reduce
patient misidentification errors, as well as automate POC test
ordering and result reporting,” Norkett says. Since bar coding
became part of the POC process at NorthEast, patient
identification errors have dropped to below one percent.
Because NorthEast installed its
vendor-neutral Rals-Plus POC data-management system at the same
time it implemented its positive patient identification system,
POC connectivity has always been enabled by the bar-code system.
“I took the job of POC coordinator a few years before we
implemented POC connectivity. Then, we had about 30 glucose
meters and I would carry a laptop from unit to unit and actually
download the information,” Norkett recalls. “At the time, it
took so long to gather the data that report generation was
always about a month after the fact.”
Click here for more >
CAP Today, March 2006, Cover
Story
Nearing High Tide on Low Blood Sugars
By Anne Paxton
Since its emergence in the early 1990s, tight
glycemic control could almost have been called an orphan
protocol. Despite evidence that it sharply lowers patient
mortality and morbidity and hospital length of stay, the use of
insulin to keep patient's blood glucose at or near normal levels
has spread slowly beyond a few pockets of fervent support, and
has yet to sweep the nation's hospitals. As Curtiss B. Cook, MD,
associate professor of medicine in the Division of Endocrinology
at Mayo Clinic Arizona puts it: "A lot of people haven't quite
bought into the concept yet."
But in recent weeks, with a major new
controlled study and a public statement from leading
professional associations in diabetes care, tight glycemic
control may have reached its tipping point. The American
Association of Clinical Endocrinologists and the American
Diabetes Association are now advocating widespread adoption of
tight glycemic control protocols not only in intensive care
units but also in other areas of the hospital. Their position
statement, released Feb. 1, calls for implementing "structured
protocols for aggressive control of blood glucose in both
intensive care units and other hospital settings."
One day later, Belgian researchers led by
Greet Van den Berghe, MD, PhD, reported in the
New England Journal of Medicine (354:449-461)
that intensive insulin therapy, or tight glycemic control,
significantly reduced morbidity among all patients in the
medical ICU—a benefit that was demonstrated earlier on patients
in surgical ICUs.
Click here for more >
Avoiding
Glucose Monitoring Errors in Patients Receiving Other Sugars
FDA issued a reminder about the potential for falsely elevated
glucose readings in patients who are also receiving products
that contain other sugars. These products include oral xylose,
parenterals that contain maltose or galactose, and peritoneal
dialysis solutions that contain icodextrin.
A patient recently died because of this problem. His glucose
readings were very high, so he was given aggressive insulin
treatment. The glucose readings were falsely high, however, and
too much insulin was administered. The patient suffered
irreversible brain damage and died. In this case the glucose
meter was reading the patient's actual blood glucose level, plus
the maltose that was contained in the IV immune globulin he was
receiving. The readings were falsely elevated because the
glucose monitoring device couldn't distinguish between glucose
and other sugars. All glucose meters don't suffer from this
problem. There are four kinds of enzymatic glucose monitoring
methods that are used, and only one of those has this problem.
This problem occurs only with the monitoring method that uses an
enzyme called GDH-PQQ. This method is employed in some glucose
monitoring devices used by diabetics at home and in
point-of-care settings.
The other three test methods currently used in glucose
monitoring systems are called GDH-NAD, glucose oxidase, and
glucose hexokinase, and they are capable of distinguishing
between glucose and other sugars. The test method used in
glucose meters is identified in the package insert that comes
with the glucose test strips. The package insert is also
available from the manufacturer. The most important thing to
remember is not to use the GDH-PQQ method if the patient
recently received other sugars. That includes oral xylose for a
D-Xylose absorption test, or an IV solution containing maltose
or galactose, or a peritoneal dialysis solution containing
icodextrin.
Click here for more >
Additional
Information:
FDA MedWatch Safety Alert 2005 - Parenteral Maltose/Parenteral
Galactose/Oral Xylose-Containing Products:
Major
Medical Associations Call for Better Blood Glucose Management in
Hospitalized Patients
WASHINGTON, DC – February 1, 2006 –
The American Association of Clinical Endocrinologists (AACE),
American College of Endocrinology (ACE – the scientific and
educational arm of AACE) and the American Diabetes Association
(ADA) have joined forces to develop strategies for management of
adult patients with high blood glucose (sugar) in hospitals.
Co-sponsored by ten other major medical associations, AACE and
ADA released a new position statement today on improving
inpatient glycemic control at a joint consensus conference.
Awareness about the
importance of glycemic control in the hospital setting has
increased as result of the ACE Consensus Development Conference
on Inpatient Diabetes and Metabolic Control in 2003. In order
to suggest a plan for better care, AACE and ADA came together to
conduct the “Improving Inpatient Diabetes Care: A Call to Action
Conference - Consensus Development Conference,” January 30 and
31, 2006 in Washington, DC.
Click here for more >
Tight Glucose Control Cuts
Heart Disease by Half in
Type 1 Diabetes
Published by the U.S. Dept. of Health and Human Services - NIH
News
Intensive
glucose control lowers the risk of heart disease and stroke by
about 50 percent in people with type 1 diabetes, researchers
report in the
December 22, 2005, issue of the New England
Journal of Medicine. Their findings are based on a
follow-up study of patients who took part more than a decade ago
in the Diabetes Control and Complications Trial (DCCT)
www.diabetes.niddk.nih.gov/dm/pubs/control/index.htm,
a major clinical study funded by the National Institutes of
Health (NIH).
“We see a greater reduction in
cardiovascular events from intensive blood glucose control than
from drugs that lower blood pressure and cholesterol,” said Saul
Genuth, M.D, of Case Western University. Genuth chairs the
follow-up study of DCCT participants, called the Epidemiology of
Diabetes Interventions and Complications (EDIC) study, which is
examining the long-term effects of prior intensive versus
conventional blood glucose control.
“The benefits of intensive
control strongly reinforce the message that this therapy should
begin as early as possible and be maintained as long as
possible.”
Click here for more >
Opening up the throttle on
POC-hospital connectivity
CAP
Today, December 2005, Feature Story
By Anne Paxton
For point-of-care testing managers,
true connectivity is now within reach, which means tantalizing
efficiencies lie ahead. POC departments are aligning their
connectivity solutions with hospital wide moves to sharpen
treatment protocols and become paperless and wireless. For many
POC testing programs, the integration of it all is complicated by
the demand for bedside testing—and its brisk growth.
Six hospitals, three outpatient
clinics, and seven nursing homes make up Sentara Healthcare in the
Hampton Roads area of Virginia. Employing 300 glucose meters and
about 170 i-Stats, the Sentara system now does well over 1 million
POC tests a year, says Lou Ann Wyer, MT(ASCP), POC testing
clinical specialist with Sentara Laboratories. Like many other
health systems, Sentara has seen a sharp increase in glucose
testing because all units are using tight glycemic protocols.
Wyer's chief project now is rolling
out troponin testing in the emergency department. "For this test
there was a lot of up-front work to be done. It's been a long
process, including extensive evaluation of the cartridge—an i-Stat
product—and making sure physicians are comfortable with the method
and how to interpret results, because they don't match the main
laboratory results. They have different cutoff values."
Click here for more >
Connective issue: Linking POC
with Wireless Hospitals
CAP
Today, November 2005, Feature Story
By Anne Paxton
Most point-of-care
testing managers are thrilled with the new devices and software
available to streamline their operations. But with connectivity
becoming standard operating procedure, POC testing programs are
facing a new challenge: making sure that connectivity meshes
with hospitalwide initiatives to adopt new treatment paradigms,
eliminate patient ID errors, and eventually say goodbye to
cables and wires, as well as to paper. Whether their programs
are in a state of steady expansion or extreme makeover, POC
testing managers say the possible efficiencies now in view or
just around the corner are tantalizing.
How are they
turning the visionary schemes into smooth-functioning routines?
At Lewis-Gale
Medical Center, Salem, Va., connectivity is fairly well
established. “We have three different connectivity
solutions,” says point of care coordinator John La Rosa, MA,
CLS (NCA). “Biosite Census connectivity for cardiac
markers has been in place since 2001, we’ve had the Roche
Diagnostics glucose meters on RALS-Plus since 2002, and
Abbott Central Data Station for the i-Stats just started
this summer.”
The laboratory
and hospital information systems are from Meditech. The
software updates are included in the hospital’s three- to
five-year contracts with the vendors, and may be carried out
remotely if the vendors have access to the hospital’s
network.
“The big plus of connectivity is it allows us to capture
billing that wasn’t captured before, and make sure we are
billing to the correct account or patient. We are billing
and getting reimbursed wherever we can,” La Rosa says.
Tight glycemic
control is the hot topic of 2005 in his region, he says,
because the evidence shows that keeping patient blood sugar
under a certain benchmark prevents some infections, raises
postoperative wound healing rates, and reduces length of
stay.
“This year we kicked up tight glycemic control where we
monitor blood sugars every hour on patients on insulin drip.
Right now we just have TGC in critical areas, but when we
move it out to the whole hospital, we expect glucose testing
to go up quite a bit.”
Click here for more >
Outpatient Setting:
Alternatives to Connectivity
Vol. 14 •Issue 11 • Page 10 November 2005 Advance for
Administrators of the Lab - AT THE BEDSIDE
By
Peggy Mann, MS, MT(ASCP)
Maintaining
a unified point-of-care (POC) program across a university-based
hospital system can prove challenging to coordinators
responsible for compliance oversight. If a process is designed
without regard to the differences between in-patient,
campus-based, out-patient clinics, and remote off-site provider
offices, it increases the chance that the target or goal will
not be met.
One striking disparity between on- and off-campus sites is how
campus-based services are delivered. An example at our
institution of how distance complicates standardization of POC
across an enterprise is delivery of reagents from a campus
materials department. Another example is the impracticality of
operators traveling to campus for observation check-offs
available to on-campus operators. A third example is
establishing the need for connecting the POC devices in use
across the enterprise.
In light of
the financial burden to connect, what benefits make it worth an
off-site clinic finding the money if they have to fund their
participation? Are there alternative ways to manage a POC
program?
Click here for more >
A Tight Glycemic
Control Initiative
June 2005 • Advance for Administrators of the Lab
• At the Bedside:
By
Nicole Woody, MT(ASCP)
Tight
Glycemic Control (TGC) should qualify as the 2005 phrase of the
year. TGC is everywhere in the health care literature, Web
casts, listservs and continuing education programs. A Google
search of the term yields over 30,000 hits. My experience with
TGC began in November 2004, when a glycemic taskforce convened
to discuss glycemic control in the hospital. The taskforce was
made up of physicians, nurses, dietitians, laboratory
professionals, information services employees and pharmacists.
Four Basic
Groups
The taskforce's first assigned duty was to identify existing
patient safety issues with glycemic control and prioritize those
issues. To accomplish this, the task force was broken into four
work groups. The groups included nursing, laboratory/devices,
dietary and pharmacology. Nursing looked at the various issues
concerning TGC and its impact on the staff. Dietary looked at
the food we were serving our patients. Pharmacology looked at
many issues, including the types of insulin we use and dextrose
concentrations used for intravenous drips. Finally, the
laboratory/devices group looked at our existing point-of-care (POC)
glucose testing meters, who uses the meters, staff education and
the number of meters in use.
The first
phase of the task force went relatively well. There were
meetings every other week to discuss and work through the issues
that arose. A protocol was developed for use in the
Cardiothoracic Surgical Intensive Care Unite (CT SICU) and its
related step-down unit. Unfortunately, everyone wanted TGC to
work without looking at the reality of the protocol.
Click here for more >
POCT Compliance with JCAHO's National Patient Safety Goals
Point of Care:
The Journal of Near-Patient Testing & Technology:
Vol 4(2)
June 05,
Ehrmeyer, Sharon S PhD, MT(ASCP); Darcy, Teresa P
MD, MMM.
Today, ensuring
patient safety through error prevention is a priority for
healthcare organizations. In response to the Institute of
Medicine report that 98,000 deaths annually in US hospitals
result from preventable medical errors, the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) disseminated
its first national patient safety goals (NPSG).
On January 1,
2005, JCAHO began surveying accredited healthcare organizations
for implementation of applicable 2005 goals and requirements. It
is essential that point of care testing (POCT) sites in the
approximately 4500 US hospitals accredited by the JCAHO
understand these goals and create the necessary policies and
procedures for achieving them. This report addresses the
relevant NPSG identified by JCAHO for its Laboratory Program and
a total quality management strategy for POCT to follow to ensure
compliance with the relevant goals.
For 2005
JCAHO identified 12 NPSG for its 10 healthcare programs. These
programs are ambulatory care and office-based surgery, assisted
living, behavioral health care, critical access hospital,
disease-specific care, home care, hospital, laboratory, long
term care, and networks (integrated delivery systems, managed
care and preferred provider organizations).
Click here > for
the rest of this article.
Access does require a subscription to
Point of Care: The
Journal of Near-Patient Testing & Technology.
POC Connectivity Takes
Hold
CAP Today, June 2005,
Feature Story, by
Anne Paxton
Point-of-care testing
connectivity presents POC coordinators with a dilemma:
Should they let other hospitals be the early adopters while the
bugs are ironed out? Or should they rush to take advantage of
the streamlined, comprehensive data capture that connectivity
has to offer?
Both choices have their pluses and
minuses, but point-of-care testing coordinators who have taken
the leap into POC connectivity say once they got past the
learning curve blues, the payoff was worth it. With the array of
POC vendors and diverse analytical profiles, POC data can’t be
handled by the laboratory information system or HIS without a
local data-management system that connects them on a single
platform.
Helped by the industry-wide POC
connectivity standard approved in 2001, POC data-management
systems are gaining a foothold in the nation’s hospitals, but
obstacles remain before point-of-care results glide swiftly,
seamlessly, and accurately into hospital records.
Connectivity solutions from
Abbott POC (PrecisionWeb), Lifescan (Datalink), Medical
Automation Systems (RALS), Telcor (QML) are referenced
throughout this article.
Click here for more >
Glucose Testing Variability and
the Need for an Expert Oversight Committee
CAP
Today, May 2005, Feature Story,
Joyce G.
Schwartz, MD, Samuel B. Reichberg, MD, PhD
Raymond S. Gambino, MD
In 1979 a work group of the
National Diabetes Data Group1
established the criteria, later endorsed by the World Health
Organization Committee on Diabetes, that patients with a fasting
or 2-h postprandial glucose concentration greater than 140 or 200
mg/dL, respectively, were to be considered diabetic.
In 1997, the Expert Committee
on the Diagnosis and Classification of Diabetes Mellitus was
convened to reexamine the classification and diagnostic criteria
for diabetes based on the 1979 publication of the National
Diabetes Data Group. As a result of its deliberations, the
committee recommended several changes to the diagnostic criteria
for diabetes and for lesser degrees of impaired glucose
regulation.2
The use of a fasting plasma glucose, or FPG, test for the
diagnosis of diabetes was recommended, and the cut point
separating diabetes from nondiabetes was lowered from a FPG >
140 mg/dL to > 126 mg/dL. This change was based on data
that showed an increase in prevalence and incidence of diabetic
retinopathy beginning approximately at a FPG of 126 mg/dL, as well
as on the desire to reduce the discrepancy that existed in the
number of cases detected by the FPG cut point of > 140 mg/dL
and the 2-h value in the OGTT (2-h plasma glucose) of > 200
mg/dL.
Click here for more >
Improving Patient Care With Blood Gas Connectivity
By
Michael Dalton, Advance for the Administrators of the Lab,
Vol. 14 •Issue
3 • POC Connectivity Concepts
The intensive nature of a critical care environment requires
physicians to respond quickly to the needs of a patient to
accurately diagnose and treat him. In this diminished state of
health, a patient's condition can change rapidly, so a more
efficient system enables a physician to obtain arterial blood gas
results rapidly. This enhanced turnaround of patient information
allows the physician to assess the patient's status and implement
therapeutic measures within a very short timeline.
One way to ensure rapid and accurate
blood gas diagnostic test results is to utilize
point-of-care (POC) instruments in the critical care setting
linked with connectivity management solutions. There are
several ways connectivity in the POC setting can bring real
advantages to hospitals and laboratories and help enrich
patient care in crucial areas such as system efficiency,
patient security, data management and equipment and staff
support. All of these workflow benefits ultimately deliver
improved patient care.
Click here for more
ICUs Tighten Belts on Blood Glucose
Levels
CAP Today, February 2005,
Cover Story
by
William Check, PhD
Tight glycemic control shows growing evidence of improving
morbidity and mortality
As George and Ira
Gershwin famously wrote, "Love is sweeping the country!" including
"All the sexes from Maine to Texas." True, "tight glycemic control
in critically ill patients" doesn't have the instant emotional
appeal that love evokes, but it too has been sweeping the country,
becoming routine in intensive care units from Oregon to
Connecticut and many places in between. And whereas love is often
blamed in song with making people feel blue and brokenhearted,
tight glycemic control actually makes people feel better and live
longer, with some of its strongest health benefits seen in
patients with cardiac conditions.
Most important, growing evidence
indicates that tight glycemic control improves morbidity and
mortality not just in diabetics, but in all critically ill
patients, setting the stage for comprehensive blood glucose
protocols to be adopted in ICUs.
Click here for more >
January
1, 2005
Bringing New POCT Equipment on Board
Advance for the Administrators of the Lab,
Vol. 14, Issue 1 POC Connectivity
Concepts,
by Matthew T.
Patton
When
point-of-care testing (POCT) is to be implemented on a large scale—involving
multiple clinics and units or even multiple hospitals—pre-planning by
multidisciplinary teams is essential. Equally important is to incorporate
instrument vendor expertise into the training process. Involvement at all
levels can help ensure that labs stay in regulatory compliance and remain
competent users of POCT equipment.
Staff
Involvement
When dealing
with quality control for employees new to the instrumentation, Lou Ann Wyer,
MT(ASCP), clinical specialist, POCT/QM, Sentara Laboratory Services, Norfolk,
VA, tells ADVANCE that her facility conducts precision, reportable
range or calibration validation and method comparison studies during the
pre-planning phase. Statistical
analysis is performed on each set of data and the method's
performance is approved prior to implementation.
Click here for the complete
article >
Breaking it Down POCT:
The Salary Dilemma
Advance for
Medical Laboratory Professionals,
Vol. 17, Issue 3, Page 14,
by
Kerri Penno
Point-of-care testing professionals often have a difficult
time obtaining compensation for additional duties.The
scenario is familiar across the healthcare field: lines of
responsibility are blurred, expectations are high and
compensation and recognition decidedly are not.
Point-of-care testing (POCT) professionals are being
stretched too thin and wearing too many hats. POCT
coordinators (POCCs) act more like managers, and some
laboratorians are in charge of more POCT work in addition to
their own responsibilities without any additional
compensation. This
job description and salary discrepancy is generating a buzz
among POCT professionals across the nation.
Click here for more >
November 2004
More Studies
Support
Tight Glycemic
Control in Hospitals
By Kay Downer,
Clinical Laboratory News
For years physicians have known the importance
of controlling blood glucose levels in diabetic patients, but only recently
have they begun to realize its importance in treating critically ill
patients—both those with and without diabetes. In
the past few years, several studies have shown that a range of patient
outcomes can be significantly improved by tight glycemic control, a
process of maintaining blood glucose levels within a narrow target
range via frequent insulin administration.
The
rest of this article can be found in the November 2004 issue of Clinical
Laboratory News. Visit www.aacc.org/cln/default.stm
for more information.
Push for Electronic
Medical Records
Gains Momentum
By Penny Allen,
Clinical Laboratory News
In an executive order last April, President
George W. Bush called for widespread deployment of health information
technology within the next 10 years. Intended to improve health care safety,
quality, efficiency, and coordination between providers in the U.S.,
implementing this technology is a noble but lofty goal considering that the
Healthcare Information and Management Systems Society (HIMSS) reported that
this year only 19% of health care provider organizations have fully
operational electronic medical records (EMRs).
The rest of this article can be found in the
November 2004 issue of Clinical Laboratory News. Visit
www.aacc.org/cln/default.stm
for more information.
October 2004
Making the Connection
By Todd Smith,
Advance for Administrators of the Lab
Amid
the information age where technologies are exploding and prices
are shrinking, there is little excuse for point-of-care testing
that is not interfaced.
Connectivity
is an important and complicated issue in point-of-care testing (POCT).
The basic idea is to replace all manual data entry, but there
still is a lot of manual testing. With non-connected testing, the
operator must manually enter the result and other pertinent data
to get it into the information system.
The aim of
connectivity is to provide all this in an electronic,
instantaneous fashion. But one of the most significant issues
surrounding connectivity is the question of compatibility.The
benefits of interfacing POCT are obvious. All lab testing—whether
it is point of care, central lab, satellite lab, etc.—must be made
part of the medical record. Nearly 40 percent of testing is
performed at the patient's bedside, say experts. With technology
becoming more affordable, more devices bearing wireless capability
and all the networks present in the hospitals, there are numerous
options for connecting devices.
"To do point
of care without interfacing makes no sense at all," says Kenneth
E. Blick, PhD, professor, department of Pathology, University of
Oklahoma Health Sciences Center and Medical Center, Oklahoma City.
"There are no excuses for letting devices proliferate throughout
the hospital and having non-lab people select the devices and use
them in a way that is not very businesslike."
This is only a
small part of this article. The complete story can be found in
the October 2004 issue of Advance for the Administrators of the
Lab, Vol. 13 • Issue 10 • Page 63.
Click here for more >>
September 2004
POCT and the New CMS
Guidelines
By Sue Auxter-Parham, Clinical
Laboratory News
Late last year, the Centers for Medicare and
Medicaid Services (CMS) released “Appendix C, Survey Procedures and
Interpretive Guidelines for Laboratories and Laboratory Services”.
This
300-plus-page resource not only provides a general guide for implementing
CLIA ’88, but also gives clinical labs a new way to approach quality control
(QC).
Check
out the September 2004 issue of Clinical Laboratory News for more on this
story >>
August
2004
Applying Evidence-Based Medicine to Point-of-Care Testing to Improve Medical Care
By Renee DiIulio, CLP,
August 2004
Point-of-care testing (POCT)
has been embraced by a medical community that equates new
technology with better patient care. Providers of medical
care are under pressure to provide care more quickly than in
the past, and many see POCT as a solution to remove patient
bottlenecks.
However, James H. Nichols,
PhD, DABCC, FACB, said there is a proliferation of
misinformation about POCT. Nichols, associate professor of
pathology at Tufts University School of Medicine in Boston
and director of clinical chemistry at Baystate Health System
in Springfield, Mass, gave the keynote address, “Finding
Value at the Bedside: Evidence-Based Practice for POCT,”
at the 20th International Symposium on Critical Care and
Point-of-Care Testing in Wurzburg, Germany. “Faster is
often understood to mean better outcomes without the
research to back this conclusion,” he said.
Evidence-Based
Medicine
(EBM) represents a new age in health care.
Nichols traced medicine’s development through the ages,
from its dawn with humors, astrology, and bloodletting,
through its dark period characterized by belief-based
treatments, into an enlightenment with the discovery of the
pathologic basis of disease, and followed by subsequent
growth with advances in prevention, diagnosis, and
treatment.
Click
here for more >>
August
2004
Optimizing
Point-of-Care Testing
By
Barbara M. Goldsmith, PhD, FACB
POCT
Applications as a Useful Tool for Rapid Laboratory Results
Point-of-care testing is
growing rapidly at an estimated rate of 12 percent to 16
percent per year and is predicted to double by 2005,
becoming a $950 million market. In
1997, the Food and Drug Administration convened an expert
panel to describe future trends in medical device technology
over the next 10 years. The panel identified six
major trend categories. Home and self-care and minimally
invasive procedures were among the six categories, each
having applications in POCT.
POCT is referred to as
laboratory testing performed outside of the clinical
laboratory. It can be performed at the patient's bedside or
in a centralized area within a unit, such as an intensive
care unit. POCT applications include:
-
Testing for emergency diagnosis
(e.g. acute cardiac
syndromes)
-
Treatment and monitoring of existing disease
(e.g. diabetes)
-
Testing in the physician's
office
-
Self-testing
The diversity of testing locations also is
broad, including: acute care settings
-
Ambulances
-
Clinics
-
Schools
-
Drug treatment centers
-
Patients' homes
Click
here for more >>
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