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Article Watch

Management of Remote Laboratory Data

James H. Nichols, PhD, DABCC, FACB, Medical Director, Clinical Chemistry, Baystate Health System , Laboratory Medicine, September 2001, number 9, volume 32, pages 532-534

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
By Lou Dunka, PhD, and Kirsten Kempe, PhD
Advance for the Administrators of the Lab

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

The Challenge
A major challenge of POCT is the integration of test results into host information systems such as laboratory information systems (LISs), hospital information systems (HISs) and electronic patient medical records. POCT results have been reported verbally, written in a logbook at the testing site or manually downloaded to a workstation from each POCT device. As a result, managing the data collection from the bedside testing devices has been a labor-intensive process. New technologies have emerged that eliminate the need for point-of-care coordinators (POCCs) or lab staff to retrieve test results directly from each testing site. Many POCT systems now use remote connectivity to interface the POCT device with the laboratory and other clinical information systems (CISs).

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/

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Case Study: 
Laboratory Information Systems Improving Data Management

by Richmond E. Holly, BA, Advance for Administrators of the Laboratory

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.

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Labs Waver on Whether to Bill for POC tests

CAP Today, August 2001, By: Anne Paxton  

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 from it.

Clutter-Free POC Testing Nearing Reality
CAP Today, March 2001, Vol. 15 No. 3, Page 1, 12,14,16,18,20,22,24
By: Anne Paxton  

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."

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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.

From the Office of Audit Services HHS website:
Medicare Program; Expanded Coverage of Outpatient Diabetes Self-Management Training Services
This final report points out that proposed payment rates established for diabetes self-management training (DSMT) for both individual and group sessions are inflated because the proposed rates include calculation errors. In addition, it appears the group session payment rate is substantially higher than that being charged in the marketplace. As a result, Medicare could make improper payments for SDMT training totaling $50 million for Fiscal Years 2000 through 2003. Also, Medicare beneficiaries could be adversely affected by the inflated payment rates in the amount of $12.5 million for co-payments during the same period. http://www.hhs.gov/progorg/oas/whatsnew.html

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.

A Comparison of Point-of-Care Instruments Designed for Monitoring Oral Anticoagulation with Standard Laboratory Methods 
Thrombosis and Haemostasis, 2000, 83: 698-703
Robert Gosselin, MT (ASCP), John T. Owings, M.D.

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
Journal of Cardiothoracic and Vascular Anesthesia, Vol. 14, No 3 (June) 2000

 

May 2000

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Blood Glucose: Measurement in the Point-of-Care Setting
Laboratory Medicine, May 2000,
Vol. 21, No. 5, page 276
Frederick L. Kiechle, MD, PhD
Rhonda Ingram Main, MHSA, SH(ASCP)

 

February 2000

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Measuring Cardiac Markers in the Point-of-Care Setting
Advance for Medical Laboratory Professionals, 2/14/00, p. 8
Craig C. Foreback PhD.

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"
Advance for Medical Laboratory Professionals, 2/14/00, 21

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
Progress in Medical Laboratory Management Feb. 2000, p. 1
Sharon S. Ehrmeyer

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?
Progress for Medical Laboratory Management, Feb. 2000, p. 9
Marcy Anderson MS MT(ASCP)

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. Pugia, PhD
Laboratory Medicine Volume 31 Number 2 pp. 92-96

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, MA, MT(ASCP)
Laboratory Medicine Volume 31 Number 2 pp. 84-90

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 patients have.

 

January 2000

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At the Bedside Measurement of Cardiac Markers
by Craig C. Foreback, PhD
Advance for Administrators of the Laboratory, Volume 9 Number 1,pp.8-9

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
Clinical Laboratory News, Volume 26, Number 1, p. 19

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 Analysis
by Virginia Randolph MA, MT(ASCP),Diane Kahler, RRT, Carol Howard, MPH, MT(ASCP), Glen Hortin, MD, PhD
Laboratory Medicine Volume 31 Number 1 pp. 45-48

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.

October 1999

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"First steps taken to 'harmonize' whole blood assays" - CAP Today. p 24.
Physicians, medical device manufacturers, government officials, and others who met recently in Washington, DC, to discuss ways to calibrate whole blood clotting assays didn't expect to have a definitive answer by the end of the half-day workshop. But they got more than they bargained for.

"Support of lower fasting glucose cut point for diagnosis of diabetes" - CAP Today. p 81.
Dr. JWG Yarnell
An expert committee of the American Diabetes Association recently recommended that the medical community lower the cut point of fasting plasma glucose from 140mg/dL to 126mg/dL for the diagnosis of diabetes.

 

September 1999

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"Competency Assessment: Establishing a Program." - Clinical Laboratory Management Review. p 275.
Ann Tiehen
This article describes how a competency assessment program can be implemented in a clinical laboratory. The author review applicable standards and regulations and describes a 10-step process for establishing a program. Sample forms are provided for documenting assessments.

"Defining Diabetes: cutoffs and tradeoffs" - CAP Today. p 66.
Barbara Chapman
This article addresses the question of whether individuals are being inappropriately diagnosed with diabetes under the revised guidelines introduced by the American Diabetes Association in July of 1997,or is failure to diagnose the disease now a greater problem.

 

August 1999

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"With POC, Why Automate?" - CAP Today. Cover Story Sidebar.
Anne Paxton
• Read this article online

"A Cost Effective, High Performance Approach to Critical Care Testing" - Laboratory Medicine. p 601.
Michale Weilert, MD; Ronald D. Workman, MD; Manijeh Danaye-Elmi, MT(ASCP); Christine Darmanian, MT(ASCP)

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.

"Point-of-Care Testing Reaches New Heights" - Advance for Administrators of the Laboratory. p. 52.
Nancy Newton, MLT (ASCP); Paula J Santrach, MD.
POCT for medical transport allows the flight crew to intervene and treat the patient quickly, deliver a stable patient to the emergency department and provide vital information that affords the hospital staff the ability to prepare for the patient's arrival.

"At the Bedside: Decentralized Critical Care Testing, Remote Access Connectivity" - Advance for Administrators of the Laboratory. p 8.
Jeffrey A. Dubois, PhD
This article describes a lab process improvement initiative implemented at University Hospitals of Cleveland (primary teaching affiliate of Case Western Reserve University, School of Medicine) with a special focus on the implementation of point-of-service critical care testing.

"Choreograph the Chaos of Lab Inspections" - Advance for Administrators of the Laboratory. p 30.
Janet G. Clarke
Accreditation inspection doesn't have to be a painful process. A few simple steps can ensure your laboratory's inspection is a successful one.

Quest for cholesterol levels only skin deep" - CAP Today. p. 26.
by Mark Uehling
Report on the Cholesterol 1,2,3 from International Medical Innovations (IMI), a new skin cholesterol test kit for use in physician office laboratories.

"Point of care devices dishing up fuller menus" - CAP Today. p 48.
by Raymond Aller, MD. 
Profiles on 23 hospital blood gas instruments.

• Abbott Diagnostics - i-STAT System
• AVL Medical Instruments - OPTI Critical Care Analyzer
• AVL Medical Instruments - AVL OMNI Modular System
• Bayer Corp - RapidLab 800
• Bayer Corp - RapidPoint 400
• Diametrics Medical - IRMA Blood Analysis System
• Instrumentation Laboratory - Synthesis 10 & 15
• Instrumentaiton Laboratory - Synthesis 20 & 25
• Instrumentation Laboratory - Synthesis 30 & 35
• Instrumentation Laboratory - Synthesis 40 & 45
• Instrumentation Laboratory - GEM Premiere Plus
• Instrumentation Laboratory - GEM 2100
• Nova Biomedical - Stat Profile pHOx
• Nova Biomedical - Stat Profile M
• Radiometer America Inc - ABL 700 Series
• Radiometer America Inc - ABL 500/600 Series
• Radiometer America Inc - ABL 5
• Radiometer America Inc - ABL 70

 

July 1999

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"Fresh forum for POC dialogue: critical care Web site" - CAP Today. pp 52-56.
by Karen Southwick
"Starting this month, the CAP’s World Wide Web site (www.cap.org) will feature a special information center devoted to critical care news relating to near-patient testing. The center will display pertinent articles on the subject archived from CAP Today, original content from experts in the field, which will be available only on the Web site, and a question-and-answer board.

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 Information Center
by Marcia Ringel
Find this article online at: http://www.cap.org/html/publications/point/62199ncc.html

"Connectivity at core of POC growing pains" - Critical Care Information Center
by William Check, PhD
Find this article online at: http://www.cap.org/html/publications/point/499cov.html

"Glucose tests at the point of care" - Critical Care Information Center
by Barbara Chapman
Find this article online at: http://www.cap.org/html/publications/point/498feat.html

"Point-of-care testing: How much growth lies ahead?" - Critical Care Information Center
by Anne Paxton
Find this article online at: http://www.cap.org/html/publications/point/498poc.html

"How best to approach point-of-care testing" - Critical Care Information Center
by Michael Dalton and Julie S Williams, PhD
Find this article online at: http://www.cap.org/html/publications/point/1297feat.html

 

June 1999

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"Bedside glucose meters and the missing link" - CAP Today. p 44.
by Raymond Aller, MD. 
Profiles on 11 hospital glucose meters.

• Abbott Diagnostics: Medisense Precision PCx
• Bayer Diagnostics: Glucometer Encore QA+ Professional System (Model 5856)
• Chronimed Inc: Supreme II Blood Glucose Meter
• Chronimed Inc: Assure Blood Glucose Meter
• Diametrics Medical Inc: IRMA SL with SureStep Pro Blood Glucose Module
• GDS Diagnostics: Stat-Site
• Hemocue: Hemocue Glucose Analyzer
• LifeScan Inc: OT II Hospital - Data Dock
• LifeScan Inc: SureStep Pro
• Roche Diagnostics: Accu-Chek HQ
• Roche Diagnostics: AccuData GTS Advantage System
  

"Noninvasive Test for Blood Glucose on the Horizon" - Laboratory Medicine. p 368.
News and Views. 

 

February 1999

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"Coagulation Analysis at the Point of Care" - CAP Today. p 65.
by Raymond D. Aller, MD
Profiles on 15 coagulation instruments.  Download this article as a .pdf from: ftp://ftp.cap.org/captoday/0299poc.pdf  If you do not have the Adobe Acrobat Reader, it will need to be downloaded and installed.

• Array Medical: Actalyke
• Avocet Medical, Inc: AvocetPT
• Chiron Diagnostics: RapidPoint Coag (formerly CVDI TAS)
• International Technidyne Corp (ITC): Hemochron Jr. Signature
• International Technidyne Corp (ITC): Hemochron 401 + 801
• International Technidyne Corp (ITC): Hemochron 8000
• International Technidyne Corp (ITC): ProTime Microcoagulation System
• Instrumentation Laboratory (IL): GEM PCL (Portable Coagulation Laboratory)
• Medtronic: ACT II
• Medtronic: HMS
• Roche Diagnostics: CoaguChek Pro DM
• Roche Diagnostics: CoaguChek System (Self Testing/Professional Use)
• Chrono-Log Corp: WBA
• Dade Behring: PFA-100 (Platelet Function Analyzer)
• Sienco, Inc:  Sonoclot Coagulation & Platelet Function Analyzer

 

October 1998

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"An Electronic Clinical Data Repository: How Labs Can Add Value to Lab Data" - Clinical Laboratory News
By Joel Saltz, MD, PhD; Jerry Rottman, MD; Martin Kroll, MD
Click here to read the article on-line.

 

April 1998

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The Relation between the Platelet-activated Clotting Test (HemoSTATUS) and Blood Loss after Cardiopulmonary Bypass - Anesthesiology 1998; 88:962-9
by Mark H. Ereth, M.D., Gregory A. Nuttall, M.D., Paula J. Santrach, M.D., Jacinta T. Klindworth, B.A., William C. Oliver, Jr., M.D.,Hartzell V. Schaff, M.D.
• Review abstract

 

November 1997

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"Point-of-Care Testing: Testing the System?"
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 Anesthesia 11:815-823
by Gregory A. Nuttall, MD, William C. Oliver, MD, Mark H. Ereth, MD, and Paula J. Santrach, MD
• Review Abstract

August 1997

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"Pocket-sized Medicine" - NursingManagement. pp 30-32.
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
by Michael A Frakes

"Joining Forces to Improve Point-of-Care Testing" - NursingManagement
by Kathy A Miller & Natalie A Miller
Point-of-care (POC) testing takes a "laboratory" test directly to the patient's bedside. Although bedside testing is not new, the compliance standards are relatively new. Regulations ensure that all personnel are trained to properly perform the test. The central laboratory and nursing of this hospital merge the best skills of both units to create a successful POC testing program.

 

July 1997

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"Point of care testing and the regulations" - Wisconsin State Laboratory of Hygeine Infoline
Short article listing the different regulatory scenarios supporting POCT.  Click here to read the article on-line.

"Blood Glucose Determination: Point of Care Testing" - Southern Medical Journal
By Betsy D. Bennett, MD, PhD, Mobile, Ala
ABSTRACT: Mechanisms for point of care glucose determinations have changed significantly since first introduced approximately 20 years ago. Such tests are now commonly done in acute and chronic care hospitals, as well as in physicians' offices and patients' homes. Although basically reliable, there are a number of potential problems with glucose determination by these methods that may not be considered by physicians interpreting these tests. This is a brief review of such problems, especially in the acute care setting.   • Read online

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