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Management of Remote Laboratory Data
H. Nichols, PhD, DABCC, FACB, Medical Director, Clinical
Chemistry, Baystate Health System
This article looks into some of the reasons why more than two thirds of the POCT results never make it into a CIS or an electronic patient record. This is surprising as recent surveys estimate that one in four laboratory tests are done at point-of care and this number is growing at the rate of 12% annually. These reasons include: not having a common information system throughout the health system network, about half of the tests done at the point of care are manual/visual tests and must be manually entered into a computer system in order to be captured, and the lack of connectivity standards for POCT devices.
The article also looks at the Connectivity Industry Consortium’s (CIC) plan to develop, pilot and transfer the basis for a set of “plug and play” point-of-care communication standards addressing bidirectionality, device connection commonality, commercial software interoperability, security, and quality control/regulatory compliance.
The Benefits of Connectivity for POCT
Point-of-care testing (POCT) goes beyond the hospital setting and is now performed in clinics, ambulances, physicians' offices and patients' homes. Within the next five years, POCT is predicted to grow by 30 percent.1
Informatics at the Point of Care
Although we live in an age of technology, it's not always easy to convince people to embrace it. But employing cutting edge technology can improve patient and end-user satisfaction, and enhance organizational efficiency.
Authors demonstrate how extensive preliminary research was used to identify the best tool for informatics-data collection/management at the point of care (POC)-by describing the decision making process used to select mobile POC devices for the facility, the technical aspects of the device and the data collection process and its subsequent management capture by the POC device. http://www.advanceforal.com/
Paperless is the buzzword for a new era in clinical data management and the seemingly ever-elusive goal of removing paper from the day-to-day activities of patient care. In December of 1997, Southeast Texas Medical Associates (SETMA) began looking at information systems that would take our clinic into the new paperless millennium. We determined the need for a new Central Business Office (CBO) system, a laboratory information system (LIS) and an electronic medical record (EMR).
We needed systems that would provide the level of complex care our customers required yet control costs. The order of the day: Take care of individuals, but also populations, and do it better than has ever been possible, and do it for less money.
We chose systems, therefore, that were offered by stable companies, had a national reputation and were forward-thinking in their management and development philosophies. We approached our selection with a "best of breed" mentality as we began to look at CBO systems, LIS and EMR.
Today, August 2001,
Baystate Health System does it
across the board, but Sentara Healthcare doesn't do it at all. Christus
Santa Rosa Health Care used to do it, while Johns Hopkins never did it.
What is it?
It's point-of-care test billing.
Despite the intense pressure on hospital departments to tap revenue
streams, if you talk to point-of-care testing coordinators around the
country, you're likely to find little consistency. While some have found
POCtest billing can bring in seven-figure revenues, many have shied away
POC Testing Nearing Reality
More than half a century into the Information Age, it comes as a surprise to many people that only a small fraction of point-of-care test results are downloaded electronically to hospital computers, and only about half of POC test results make it into the information systems at all, whether entered by hand or by computer.
Historically, "the minute testing escaped the laboratory, it could not be tracked," says Emery Stephans, president of Enterprise Analysis Corp., Stamford, Conn. As long as POC testing was one percent of the total volume, nobody cared. But it's no longer a minor problem. "POC testing is growing at 12 percent to 16 percent per year, now one in four tests is POC, and in 10years it may be 40 percent of tests, measured in dollar terms."
Point-of-care instrument connectivity is the focus of articles in several laboratory journals
The authors emphasize the problems
arising as POC expands with different vendors, different interfaces and
different hardware needs for reviewing and uploading data. The
Connectivity Industry Consortium is listed as the answer to these
concerns in standardizing POC interface solutions in order to streamline
workflow. Medical Automation Systems, Johnson & Johnson, and Abbott
all have advertising adjoining the articles in these journals. Advance
for Administrators of the Laboratory, Vol. 9, No. 6, June, 2000. CAP
Today, Vol. 14, No. 6, June, 2000.
CareNet ASP focuses on small physician office practices Health Management Technology, Vol. 21, No. 6, June, 2000.
New fluorescence based technology may allow more point-of-care (POC) testing in the critical care hospital environment CAP Today, Vol. 14, No. 5, May, 2000.
Internet-based clinical decision support systems introduced
APACHE Medical Systems in McLean, VA has introduced Internet-based clinical decision support systems focused on intensive care treatment for cardiovascular, acute and neonatal patients. Health Informatics, Vol. 17, No. 6, June, 2000.
Government Affairs Update
The U.S. House of Representatives passed the E-Sign Act approving the development of uniform national standards for the use of digital signatures in transactions that would otherwise require a written signature. It is hoped that the new law will save time and money. Encryption guarantees the identity of the sender and that the document has not been altered in transit. Companies are already selling the technology that allows digital signature capability. Abcnews.com, June 14, 2000.
HCFA has delayed the implementation of the hospital outpatient prospective payment system (PPS) from July 1, 2000 to August 1, 2000. Similar to the diagnostic related groups (DRG) system for reimbursing inpatient costs, the PPS will bundle reimbursement according to the diagnosis. Laboratory testing costs are not affected and will continue to be reimbursed on a fee-for-service basis. American Society of Clinical Pathologists Washington Report, June 7, 2000.
Final Clinical Laboratory Improvement Act (CLIA) quality control (QC) regulations may be published as early as this summer. The deadline for publication has been pushed back several times due to the complexities of regulating this dynamic, rapidly changing area of laboratory medicine. The new QC regulations will cover the entire testing process, including the test environment, the operator and the test system. With the recent national focus on preventing medical errors, HCFA officials hope that the revised regulations will help laboratories to identify and prevent testing errors. Clinical Laboratory News, Vol. 26, No. 6, June, 2000.
C-Reactive Protein and
Cardiovascular Disease (New Research Strengthens Association between CRP
Real-Time Monitoring of Diabetes
(How Laboratories Can Provide Real-Time Results)
HCFA Readies New CLIA'88 Quality
Control Regulation (New Rule Will Focus on Quality Systems, Error
Elements of a Comprehensive Security Solution (A close look at threatened breaches and vulnerable) By David Katz, June 2000, Health Management Technology, Volume 21, Number 6, p.12 -16
PPS preview; hospital payments
up, but snags persist
Partial drawback: iffy APTTSs
lead to tube's exit
Laboratory Accreditation News:
Getting the Skinny on Scores: what you should know
A Comparison of Point-of-Care
Instruments Designed for Monitoring Oral Anticoagulation with Standard
On-Line Monitoring of
Anticoagulation with Recombinant Hirudin in Patients with HIT II Using
the TAS Ecarin Clotting Time: Reliability During Cardiovascular Surgery
with and Without Cardiopulmonary Bypass
Blood Glucose: Measurement in the
Measuring Cardiac Markers in the
Each year in the United States more than 6 million patients present to the Emergency Department (ED) with the initial symptom of chest pain. Some of these patients will rule in for myocardial infarction (MI) and a significant subset will have unstable angina and be at risk for the occurrence of cardiac events over time. However, the majority of these patients will not have MI. This article explores new technology for POCT devoted to cardiac markers.
More research on Cardiac Biomarkers
"What's in the News"
Laser Glucose Monitoring Being Developed. SpectRx, along with partner ABBOTT Laboratories, is developing two advanced glucose monitoring products based on its painless, bloodless micropore interstitial fluid (ISF) collection technology, according to company officials. ISF is the clear fluid under the skin through which glucose and other nutrients travel from the blood stream to the cells.
Be POC Inspection Ready
The biggest accreditation headache for laboratory managers is point of care testing (POCT). In fact, it is the most frequently cited area of noncompliance with regulatory requirements. But the best cure for this headache is to prevent it before it happens-know the rules, avoid the potholes, and practice for inspection.
Need a POCT job description?
Laboratory based Point-of-Care Coordinators are becoming more numerous. But the lack of a defined job description can cause confusion. Marcy Anderson, Senior Clinical Specialist and previous POCC provides her job description to Progress.
Technology Behind Diagnostic
Reagent Strips by Michael J.
Diagnostic reagent strips are commonly used in clinical analysis of urine and blood, in particular for monitoring glucose concentration. Results are obtained instrumentally or visually as thresholds and quantitative outputs. Dry reagents are applied in the construction of strips in a variety of ways. The mechanism used to make strips operational and practices used by manufacturers to establish performance are reviewed, and limitations and benefits or reagent strips are assessed.
Diagnosing and Monitoring Patients
with Diabetes by Laura Burton,
This article addresses the old and new
criteria for diagnosing an individual with diabetes as well as why the
thresholds were changed. The article then educates one on the categories
of diabetes and the importance of monitoring this disease. The article
then provides the new developments in monitoring glucose and the choices
At the Bedside Measurement of
In the United States, more than 6 million patients present to the Emergency Department (ED) with the initial presentation of chest pain. Some of theses patients will rule in for myocardial infarction (MI) and a significant subset will have unstable angina and become at risk for the occurrence of cardiac events over time. However the majority of these patients will not have MI.
News from the FDA: FDA Advisory
Committee Recommends Approval for GlucoWatch
On December 6, FDA's Clinical Chemistry and Clinical Toxicology Devices panel unanimously recommende pre-market approval of Cygnus' GlucoWatch, a non-invasive, wristwatch-like device that helps diabets monitor their glucose levels.
Laboratories on the Move: Blood Gas
We evaluated the performance of a
portable instrument for measuring pH, Pco2, and Po2 during land and air
transport of critical care patients. We determined accuracy and
precision by analyzing control materials with known values and by
running duplicate analysis of patient specimens. The control data showed
that the instrument performed as well in a moving ambulance and in an
airborne jet-propelled aircraft as I did while in a stationary position
on the ground.
"First steps taken to
'harmonize' whole blood assays"
- CAP Today. p 24.
"Support of lower fasting
glucose cut point for diagnosis of diabetes"
- CAP Today. p 81.
Establishing a Program." -
Clinical Laboratory Management Review. p 275.
cutoffs and tradeoffs"
- CAP Today. p 66.
"With POC, Why
Automate?" - CAP
Today. Cover Story Sidebar.
"A Cost Effective, High
Performance Approach to Critical Care Testing"
- Laboratory Medicine. p 601.
Abstract: Faced with pressure to reduce costs and improve service for critical care testing, our community hospital implemented remotely monitored point-of-care testing for intensive and cardiac care units. We were able to improve turnaround times substantially and generated nearly 75% savings compared with the cost of previous critical-care laboratory testing. Coordinating with the nursing, and information technology departments was crucial to successful implementation. To our knowledge, this is the first analysis to show the cost savings in replacing a traditional stat laboratory with point-of-care testing operated by caregivers in a critical care setting.
Reaches New Heights"
- Advance for Administrators of the Laboratory. p. 52.
"At the Bedside:
Decentralized Critical Care Testing, Remote Access Connectivity"
- Advance for Administrators of the Laboratory. p 8.
"Choreograph the Chaos of
- Advance for Administrators of the Laboratory. p 30.
Quest for cholesterol levels
only skin deep" -
CAP Today. p. 26.
"Point of care devices
dishing up fuller menus" -
CAP Today. p 48.
"Fresh forum for POC dialogue:
critical care Web site" - CAP Today. pp 52-56.
The Critical Care Information Center will be funded in part through an unrestricted educational grant from AVL-Roche Diagnostics Global Alliance, but the College will be solely responsible for supplying the content and links. “CAP has had a longstanding leadership in addressing POC testing,” says Bernard Kasten, MD, chair of the CAP’s World Wide Web Editorial Board. “We were a natural home for this kind of topic.” Dr. Kasten is vice president and chief laboratory officer at Quest Diagnostics Inc., Teterboro, NJ..." Find this article online at: http://cap.org/html/publications/feature2.html The Critical Care Information Center can be found at: http://www.cap.org/html/publications/critical_care.html
"Quality control in POCT: An
outlier?" - Critical Care
"Connectivity at core of POC
growing pains" - Critical
Care Information Center
"Glucose tests at the point of
care" - Critical Care
"Point-of-care testing: How
much growth lies ahead?" -
Critical Care Information Center
"How best to approach
point-of-care testing" -
Critical Care Information Center
"Bedside glucose meters
and the missing link" -
CAP Today. p 44.
"Noninvasive Test for
Blood Glucose on the Horizon" -
Laboratory Medicine. p 368.
"Coagulation Analysis at
the Point of Care" -
CAP Today. p 65.
"An Electronic Clinical
Data Repository: How Labs Can Add Value to Lab Data"
- Clinical Laboratory News
The Relation between the
Platelet-activated Clotting Test (HemoSTATUS) and Blood Loss after
Cardiopulmonary Bypass - Anesthesiology
NursingManagement. pp 34-36.
by C. Gresham Bayne.
Point-of-care testing is changing for the better the way we practice medicine. Whether it is an anesthesiologist doing a blood gas in the operating room, a nurse measuring serum glucose in the home or on the unit, or an intensive care nurse testing by the bedside before calling an intensivist, newer instrumentation provides for a limited number of quality tests to instantly add value to the critical decision-making process of modern staff. This movement is a true paradigm shift that will reduce unnecessary testing, provide timely measurement of critical values, and avoid unnecessary and catastrophic mistakes.
Coagulation Tests Predict
Bleeding After Cardiopulmonary Bypass
- Journal of Cardiothoracic and Vascular
by C. Gresham Bayne.
Newer miniature testing and monitoring machines are profoundly changing the delivery of health care. Blood gases, X-rays, electrocardiograms, all can be done within the privacy of the patient's home. Yet, government regulations are just beginning to catch up with this technologic revolution. These technologies and their effect on patients and the health care environment are discussed.
"Analyzing Blood at the
Bedside" - Critical
Care Choices 97
"Joining Forces to
Improve Point-of-Care Testing"
"Point of care testing
and the regulations" - Wisconsin
State Laboratory of Hygeine Infoline
Determination: Point of Care Testing" - Southern
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