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JOURNAL OF THE AMERICAN SOCIETY FOR CLINICAL LABORATORY SCIENCE

A S C L S

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CLINICALLABORATORY

SCIENCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Summer 2003 Volume 16/Number 3

Feature: Assessing Reliability and Validity Measures

Focus: Cardiac Protocols

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ASCLS Vision StatementThe American Society for Clinical Laboratory Science, as the pre-eminent organization for clinical laboratory science practitioners,provides dynamic leadership and vigorously promotes all aspectsof clinical laboratory science practice, education and managementto ensure excellent, accessible cost-effective laboratory services forthe consumers of health care.

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ASCLS MEMBER EDITORSEditor-in-ChiefSusan J Leclair PhD CLS(NCA)Department of Medical Laboratory ScienceUniversity of Massachusetts DartmouthNorth Dartmouth MA [email protected]

Continuing Education EditorsCarol McCoy PhD CLS(NCA)Department of Clinical Science, 4096 HSCUniversity of Wisconsin–La CrosseLa Crosse WI [email protected]

Vicki Freeman, PhD CLS(NCA)Dept. of Clinical Laboratory Sciences301 University BoulevardGalveston, TX [email protected]

Clinical Practice EditorBernadette Rodak MS CLS(NCA)Clinical Laboratory ScienceIndiana University, 409 Fesler1120 South AvenueIndianapolis IN [email protected]

Research and Reviews EditorIsaac D Montoya PhD CMC CLS(NCA)Affiliated Systems Corporation3104 Edloe, Suite 330Houston TX [email protected]

P.A.C.E.® LiaisonSharon Miller/St Charles IL

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Contributing EditorsEileen Carreiro/N Dartmouth MAGeorge Fritsma/Trussville ALSandra Heatherley/Corpus Christi TXRebecca Laudicina/Chapel Hill NCConnie Mahon/San Antonio TXTeresa Nadder/Richmond VAClaudette Ryan/Nashville TNLinda Smith/San Antonio TXMichelle Wright-Kanuth/Galveston TX

REVIEW BOARDRichard Bamberg/Greenville NCKathleen Blevins/Oklahoma City OKDianne Cearlock/DeKalb ILPeter Colaninno/Jamaica NYJo Ann Fenn/Salt Lake City UTEllis Frohman/St Louis MOMildred Fuller/Norfolk VAAbraham Furman/Portland ORRichard Gregory/Indianapolis INDenise Harmening/Baltimore MDLinda Hogan/Wichita KSJean Holter/Morgantown WVCherry Horn/Washington NCVirginia Hughes/Montgomery ALElizabeth Kenimer/Augusta GANancy Konopka/Gettysburg PALinda Laatsch/Milwaukee WIHal Larsen/Lubbock TXLouAnn Lawrence/New Orleans LADonna Leach/Winston-Salem NCLauralynn Lebeck/La Jolla CACraig Lehmann/Stony Brook NYLynn Little/Dallas TXDavid McGlasson/Lackland AFB TXShirlyn McKenzie/San Antonio TXSharon Miller/St Charles ILHarriette Nadler/King of Prussia PAAlison Pohl/Alameda CAJoan Prince/Milwaukee WIMargaret Reinhart/Philadelphia PAJohn Seabolt/Lexington KYCatherine Sheehan/Middletown RIStephen Sodeke/Tuskegee AL

ASCLS BOARD OF DIRECTORS 2002-2003Paula Garrott, PresidentBarbara Brown, President-electDavid Fowler, Past PresidentScott Aikey, Secretary/TreasurerEllen Libby, Director Region IMary Ann McLane, Director Region IILynn Ingram, Director Region IIISuzanne Butch, Director Region IVLeola Olsen, Director Region VDianne Cearlock, Director Region VIShirlyn McKenzie, Director Region VIISusanne Zanto, Director Region VIIIHeidi Smith, Director Region IXMarcia Armstrong, Director Region X

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Managing EditorIvan Schwabbauer

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© Copyright 2003 American Society for Clinical LaboratoryScience Inc. All rights reserved.

Masthead Vol.16/2 4/14/03, 7:05 PM1

CLINICALSUMMER 2003 LABORATORY VOLUME 16/NUMBER 3

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DIALOGUE AND DISCUSSION130 Editorial: HIPAA–Are We Over-reacting?

Bernadette Rodak132 Letter to the Editor

Judy A Horton135 Washington Beat: 15th Annual ASCLS Legislative Symposium

Kathy Hansen, Don Lavanty

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CLINICAL PRACTICE137 Health Education Strategy in the Control of Urinary Schistosomiasis

Kamga F H Lucien, Gerard Nkwelang, Gabriel C Ejezie142 ASCLS Meeting Abstracts151 Abstract Form and Instructions

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REPORTS AND REVIEWS153 Assessing Validity and Reliability Measures in Managed Care Studies

Isaac D Montoya163 Continuing Education Questions: Assessing Validity and Reliability Measures

in Managed Care Studies

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FOCUS: CARDIAC PROTOCOLS166 The Emerging Roles of BNP and Accelerated Cardiac Protocols in Emergency Laboratory Medicine

Charis Hainaut, Wayne Gade180 Accelerated Cardiac Protocols in Emergency Laboratory Medicine: Four Case Studies

Wayne Gade, Charis Hainaut, Jean Gade188 Continuing Education Questions: Cardiac Protocols

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EDITORIAL

HIPAA–Are We Over-reacting?

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BERNADETTE RODAK

Y2K came and went relatively uneventfully. Of course, manypreparations had been made, but none of the devastating di-sasters predicted occurred. We were quickly back to life asusual with no dramatic changes. Not so after April 14, 2003…

April 14, 2003 was the date that healthcare systems had tobe in compliance with the HIPAA Privacy Rule (Health In-surance Portability and Accountability Act). Even with allthe HIPAA training programs in place, there are still manyquestions and more than a few surprises.

The intention of HIPAA is to allow portability of healthinsurance, while protecting the privacy of the consumer.There has been some excellent coverage of what HIPAA isand how we THINK it might affect laboratory operationsand education.1,2 I am not proposing to debate that infor-mation in this column, and I certainly respect a patient’sright to privacy, but I’d like to give you my personal perspec-tive and pose some questions.

A scenario was related to me recently. Clinical laboratoryscience (CLS) students at a university based program hadbeen assigned case studies as part of their capstone experi-ence. These case studies were to be prepared for a 15-minutepresentation to the class, as well as a paper suitable for pub-lishing in their professional journal Clinical Laboratory Sci-ence. For the past eight years this scenario had been usedwithout any problems. For this assignment, students at theinstitution work with a CLS faculty member and a pathol-ogy resident as advisors. The usual preparatory work hadbeen done: coordinating with the chief resident for the as-signing of residents, sending a class picture to MedicalRecords Research, and even sending copies of documenta-tion of HIPAA training for all students.

Until April 14, 2003 students were able to access a patientchart and take notes in the medical records department. As ofApril 14, 2003 more forms were needed before charts couldbe used. The first form was an “Authorized Medical RecordRequest for Research Purposes”. The institution would onlyhonor that form if it was signed by a physician, and so it wasdone. The chief resident requested all of the records. The nextday, the instructor received a call that an Institutional ReviewBoard exemption or approval was needed. The instructor con-tacted the director of compliance at the institution and wastold that the student project would fall under Health Opera-tions and not research. Medical records still would not releasethe records until they received authorization from the privacyofficer. Finally after almost a week, the students were allowedto review charts. In one case, a copy of the discharge summaryhad been made and the identification had been removed. Thestudent was asked to return the information since they werenot supposed to de-identify records. Hmmm—we can’t iden-tify information, but we can’t de-identify it, either… so wheredoes that leave us?

Having been to multiple HIPAA presentations–at the Clini-cal Laboratory Educators Conference meeting (great job, EdPeterson), at the hospital on campus, at the university, andone at our state meeting presented by an attorney, it appearsthere are several inconsistencies and many ‘gray’ areas. Cur-rently the guidelines are vague and common sense is notalways being used to implement the intent of the legislation.The fact that privacy is a multidisciplinary issue complicatesthe issue because each discipline has to interpret the issuefrom its own perspective and that can be very different fromone department to another.

Some of the situations that either have occurred or could beencountered include:• High on my list is what will happen to case studies for the

clinical practice section. My thoughts are that educationand training at an academic medical center would be con-sidered healthcare operations, so that access to protectedhealth information (PHI) of patients would be allowed.Of course, only the minimum information necessary toaccomplish the intended purpose should be accessed.

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The Dialogue and Discussion Section is a forum for editorials, shortarticles, commentaries, and letters to the editor on clinical laboratoryscience topics and professional issues of general interest to readers in-cluding ASCLS activities and position papers. For more informationabout submissions to the Dialogue and Discussion section contact: SusanLeclair PhD, Editor-in-Chief, Clinical Laboratory Science EditorialOffice, Attn: Dialogue and Discussion, PO Box 5399, Coralville, IA52241-5399. (319) 351-2922, (319) 351-2927 (fax). [email protected]

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VOL 16, NO 3 SUMMER 2003 CLINICAL LABORATORY SCIENCE 131

• Some laboratories are breaking the ends off of glass slides,because they contain bar codes or patient identification.This will definitely protect the privacy of the patient, butis it overkill and does it create a dangerous situation tothose breaking the slides? How likely is it that someonewill pry the top from a sharps container at a medical wastefacility, take the slide to a microscope, and examine it todiscover that patient XYZ has chronic lymphocytic leu-kemia? Shouldn’t discarding microscope slides as sharpssatisfy the intent of HIPAA?

• Other laboratories are blacking out the identification onthe end of a slide. Is that necessary if slides are properlydisposed of in a sharps container and taken to a licensedmedical waste management facility?

• What about side by side instrument comparisons? Thatwould be using patient specimens for other than thepurpose collected. Would this then be considered re-search and thus need IRB approval or exemption, orwould it fall under quality assurance and be consid-ered healthcare operations?

• When we give results out over the telephone, how can weverify the identity (ID) of the caller–will we need callerID on every telephone–what if a cell telephone is beingused? Caller ID identifies the telephone from which thecall is being made–but not the individual making the call.

• When we fax results, how can we be sure that they reachthe correct location and that only authorized persons seethem? If they do reach an incorrect location, what is ourresponsibility to see that they are destroyed? If an incor-rect fax reaches the laboratory, what is our responsibilityto notify the sender of the error?

• Will we eventually have to encrypt all PHI? How muchexpense will that add?

• One of the purposes of HIPAA was to reduce paperwork–so far I personally have received or signed forms at thepharmacy, dentist, health insurer, and physician. I’m sureI am not yet finished with them. Where will all this paperbe stored (in an age of paperwork reduction)?

• Can we continue to take photomicrographs of patient slides,since there may be identification on the slide itself, althoughthe patient ID will not be on the image? Will this fall un-der healthcare operations for educational purposes? Somefeel that specific permission of the patient will be neededto allow their specimen to be used for any educational pur-poses, identified or not. Will this request for permission be

added to the form that patients sign on admission? If theyrefuse to sign, how will we separate their specimens fromothers that can be used for teaching purposes?

• Just last week I rode in an elevator with a physician whowas carrying an X-ray envelope with the patient’s nameand area X-rayed clearly visible. Common sense would sug-gest that the materials at least be turned so that they are notvisible to the public. When one is in a hurry, however, thatfact can easily escape one’s attention. Perhaps hospital staffwill need to be more careful about shielding PHI whileusing public elevators, or be more conscientious about us-ing staff elevators. Whose responsibility is it to remind anindividual that they are violating patient privacy?

• What will happen to shadowing opportunities for pre-CLS students? Will each facility have to develop a stu-dent observation form that is signed by the student andkept as a record of compliance?

Gary Gill, who is the corporate compliance officer at DCLMedical Laboratories in Indianapolis suggests that we ad-dress the HIPAA Privacy Rule in a practical, common sensemanner, not literally black and white. Some solutions to pro-tect privacy may only be adding expense without addingany advantage, and as Mr. Gill stated, “Adding cost withoutbenefit is not a good thing”.3

A recent article by Ham and Boothe gives suggestions onhow to give your laboratory a privacy checkup and addressessome of the situations that I have mentioned.4 The next fewmonths/years should prove interesting in the arena of HIPAA.We look forward to receiving more and varied articles abouthow HIPAA has impacted the patient, the practice of medi-cine, and education in CLS.

REFERENCES:1. Hovis KB, Veillon DM. HIPAA privacy rule: the debate continues.

Clin Lab Sci 2003;16(2):85-8.2. Peterson EJ. What every student should know about compliance

and HIPAA regulations. Presentation at the ASCLS Clinical Labo-ratory Educators Conference, March 2003, New Orleans LA.

3. Gill G. Conversation with author. April 29, 2003.4. Ham NJ, Boothe JF .Can you keep a secret? Give your lab results a

HIPAA privacy checkup. MLO Med Lab Obs 2003;Jan;35(1):32-4.

Bernadette Rodak MS CLS(NCA) is the Clinical LaboratoryScience Clinical Practice Editor.

EDITORIAL

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DIALOGUE AND DISCUSSION

Letter to the Editor

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C

I am writing to respond to Dr McCoy’s editorial in the Springissue of Clinical Laboratory Science [Clin Lab Sci2003;16(2):66] concerning an entry level Masters degree forclinical laboratory professionals.

Dr. McCoy used the National Accrediting Agency for Clini-cal Laboratory Sciences (NAACLS) standards for CLS/MTto make the case for a masters prepared entry level clinicallaboratory scientist (CLS).1 She cites the responsibilities of“… clinical decision-making, regulatory compliance, qual-ity assurance/process improvement, evaluation of test sys-tems, …aspects of laboratory management, and adequateknowledge of research and design principles to evaluate pub-lished studies” as evidence that “entry-level knowledge hasgone beyond the baccalaureate level.”2

Intrigued, I decided to look at these responsibilities in detailand compare them with the entry-level competencies of otherhealthcare professionals. First I wrote down each responsibil-ity listed in the editorial and looked at what was required forthe task and then looked at the implied level of achievement(using Bloom’s Taxonomy levels). Then I decided to see wheresimilar levels of competence/achievement were found in en-try-level competencies of other health professions. The respon-sibilities emphasized in the editorial are analyzed below:• Clinical decision-making. The implication here is that in-

formation must be gathered, analyzed, some sort of algo-rithm or decision-tree used, and a decision made. Theunderlying responsibility is that the decision-maker mustknow what data to gather and what is and is not perti-nent to the decision. This is an application-level task us-ing Bloom’s taxonomy.

• Regulatory compliance. In this case one must comply withpredetermined criteria (established protocols). The taskhere is to keep up to date with criteria and follow therules. This is also an application-level task.

• Quality assurance/process improvement. The competencerequired here is to follow standard quality assurance guide-lines (established protocols) and be able to develop a pro-cess to improve quality or improve the system for qualityassurance. This does involve logical thought processes tomodify existing protocols (the synthesis level), but is thissomething only expected of a master’s educated individual?

• Evaluation of test systems. This is written at the evaluationlevel but in general an algorithm or decision-tree processis used. (As a matter of fact, the NAACLS standards in-dicate algorithms will be used and that the CLS will “playa role in” development of such algorithms.) Once thistype of process is used, it is possible to help write a deci-sion-tree for a new set of test systems.1 However, typi-cally, an entry-level CLS/MT will be following a deci-sion-tree process. This is actually very similar to clinicaldecision-making above, where the decision maker/evalu-ator must know what data is pertinent to the evaluationprocess and what is not. A good decision-tree or algo-rithm will help with the evaluation. The overall tasks arethen frequently application tasks or synthesis tasks.

• All aspects of laboratory management. This is indeed a loftyexpectation. However, the use of certain managementtools, systems, and principles can be expected of an en-try-level CLS/MT. “All aspects of laboratory manage-ment” are being learned every day by career laboratorymanagers—no one knows everything. The specificNAACLS responsibility actually states that the CLS will“possess basic knowledge, skills, and relevant experiencesin” certain defined areas of management to “enable cost-effective, high-quality, value-added laboratory services.”1

The CLS will function at the application level in someinstances and at the synthesis level in others.

• Adequate knowledge of research design principles to evalu-ate published studies. The end of this sentence in theNAACLS standards indicates that the CLS must “func-tion as an informed consumer”, not as a scientific jour-nal editor.1 Once again, a system of rules for evaluation isused to evaluate published studies. The rules here relateto “research design”, but the concept of algorithm anddecision tree still apply. Adequate knowledge does notrequire a graduate course in research design. And wouldone course in educational research design be adequate?

So, these six responsibilities come down to decision-makingbased on a set of criteria, compliance with protocols andguidelines, applying finance, marketing, and managementprinciples to clinical laboratory management, and evaluat-ing published studies as an informed consumer.

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Let’s look at our co-workers in the healthcare field to seewhat the expectations are for entry-level practitioners. I chosethree professions that do not require a master’s prepared en-try level practitioner, but that do offer bachelor’s and master’slevel course work in their field of study. It was easy to findthe competencies from Web sites maintained by professionalsocieties and educational organizations. The results of myinvestigations for respiratory therapists, dental hygienists, andregistered nurses are enlightening.

Respiratory therapistAccording to the American Association for Respiratory Care(AARC) Web site, respiratory therapists “perform intensivecare, critical care, and neonatal procedures…[and] an in-creasing number of respiratory therapists are now workingin skilled nursing facilities… and patients’ homes.”3 The typi-cal duties of a respiratory therapist are then listed. A few are:• diagnosis—interpreting data…• treatment—monitoring and managing therapy, admin-

istering medications, conducting smoking cessation pro-grams for patients…and in the community.3

You can see that these duties are at the application, analysis,synthesis, and evaluation levels.

If you know a respiratory therapist, you know that they rou-tinely make and implement independent decisions about treat-ment and medication that are critical to keeping patientsalive. Do you know what level of education is employed tomore than adequately train respiratory therapists? The nec-essary skills and knowledge are taught in a two-year degree inapplied science program. If you go to the AARC Web siteyou’ll see a list of duties that includes education of the gen-eral public. The respiratory therapists have learned how toget the education and training done for these analytical, syn-thesis, and evaluation responsibilities in two years! Maybewe need to take a lesson from them.

Dental hygienistAccording to the American Dental Education Association(ADEA) Web site, the competencies for entry into the pro-fession of dental hygiene include among those in a four-page list (emphasis added):• core: Use evidence-based decision making to evaluate and

incorporate treatment modalities.• community involvement: Evaluate reimbursement

mechanisms and their impact on the patient’s/client’saccess to oral healthcare.

• assessment: Select, obtain, and interpret diagnostic informa-tion…, perform a comprehensive examination using clini-

cal, radiographic, periodontal, dental charting, and otherdata collection procedures to assess the patient’s/client’s needs.

• diagnosis: Use critical decision making skills to reach con-clusions about the patient’s/client’s needs based on allavailable assessment data.

• planning: Establish a planned sequence of care (educational,clinical, and evaluation) based on dental hygiene diagno-sis, identified oral conditions, potential problems, etiologicand risk factors, and available treatment modalities.4

When you visit your dental hygienist I’m sure you’ve foundthat he/she is conversant in immunology, scientific data gath-ering, and clinical decision-making. Do you know what levelof education is employed? You may have guessed: a two-yeardegree in an applied science program is what is needed to be-come a dental hygienist. In some states, dental hygienists canopen an independent practice and in others they can admin-ister anesthetics. How do they learn all that medicine, deci-sion-making, and office management in two years? Perhapsclinical laboratory educators should investigate how it is done.

Registered nurseFor information on the competencies, skills, and knowledgerequired for the various levels of nursing care practitioner, Iwent to a document prepared by the Illinois ArticulationInitiative (IAI) that includes competencies in nursing for arange of providers from certified nurse assistants to bachelor’sprepared nurses. Because of the levels of competencies I foundfor associate degree prepared respiratory therapists and den-tal hygienists, I only investigated the associate degree/diplomaentry level nursing competencies (note, the IAI indicates thatthese competencies are not repeated at the BSN level, theyare added to). These competencies include (emphasis added):• conceptual function: Utilizes principles of leadership, problem

solving, decision-making, and conflict resolution in the manage-ment of care; applies teaching/learning principles to adapt stan-dardized teaching plans to meet individual learner needs.

• technical/professional: Establishes data base for client basedon … assessment; establish priorities for organizing nursingcare among individual clients; carries out established researchprotocols;…delegates to peers and assistive personnel; seeksassistance from peers and other members of the healthcareteam in situations that require level of knowledge.

• interpersonal communication: Provides direction for othermembers of the healthcare team; participates in determin-ing the feasibility of research plans.

• integrative: Analyzes data from client, family, and otherhealthcare resources and selects appropriate nursing diag-nosis; uses research findings in problem solving and decision


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making; participates in integration of research results in themodification of practice standards, policies, and procedures.

• adaptive: Modifies teaching/learning plan based on evalu-ation of learner response.

• member discipline: assesses own abilities and potential, setsgoals and demonstrates on-going personal and profes-sional development.5

Based on this quick investigation into some of our peers inhealthcare, I propose that we in CLS education need to take afresh look at how and what we teach at various levels of edu-cation. It seems that the claims for the need for a master’sprepared entry-level laboratory professional are out of syncwith our peers (never mind the pay issues and the years oftraining frequently mentioned). We seem to be out of touchwith what other healthcare students and professionals are ex-pected to do. Our students have the same basic science coursesthey do—in many cases, our students have more basic sci-ence—yet we say that our bachelor’s level students cannot “ac-quire adequate knowledge of research design to evaluate pub-lished studies.” This is expected of the associate degree nurse(ADN) and the associate degree dental hygienist. We just needto teach our students to do this. Perhaps the real problem is afear of this unknown material for some bachelor’s level educa-tors. Then our professional organization needs to offer work-shops in that subject rather than waste time lobbying for amaster’s level “lab tech”. Our students just need to be taughtthe principles of research design as they apply to laboratorymedicine and evaluation of methods.

It is obvious that clinical decision making, analysis, synthesis,and evaluation skills can be covered in a two-year health careereducation program. Our peers in healthcare education do itnow. Why do CLS educators feel they cannot cover this mate-rial in a baccalaureate program? It seems from looking at ourpeers that the material could be covered in two-year program.

Look at the last competency I noted for ADNs above. It is thecompetency to assess [one’s] own abilities and potential, set goals,and demonstrate on-going personal and professional develop-ment.5 I would suggest that clinical laboratory medicine educa-tors do just that: assess what our abilities and potentials are andset realistic goals. I propose a task force on clinical laboratoryeducation whose charge is to begin with no pre-conceived no-tions of what can or cannot be taught in two, four, or six yearcollege programs. This task force should investigate how otherhealthcare professionals are taught the skills and competenciesnecessary to function autonomously. Such a task force mightindeed recommend that the CLS/MT responsibilities can be

taught in a two-year program. I know this smacks of heresy, butwe need to open our minds to self-assessment of our profession.

I have been a CLS educator for more than 20 years. In thattime I have taught in integrated BS level programs, a hospi-tal based program, the college-based portions of a 3+1 pro-gram and a CLT/MLT program (along the way I taught someengineering students biotechnology, as well). I have foundthat MLT students, on the whole, are more mature and ca-reer-oriented than undergraduates in four-year schools. Thisis not surprising; the average age of community/technicalcollege students is 29. Also, I have found that they can learnthe material covered in the responsibilities noted for CLS/MTs above. They can, and do, routinely apply criteria toevaluate information and make informed decisions.

In sum, my analysis of a few of the responsibilities requiredof CLS/MTs and the entry-level competencies of only threeother healthcare professions leads me to make a modest pro-posal (to borrow a phrase). I propose that CLS educatorsand CLS professionals and employers endorse a task force tothoroughly evaluate how to educate laboratory professionalswith the charge that the final goal is enough competent en-try-level professionals to fill the anticipated vacancies in ourprofession. I sincerely hope I have sparked the curiosity andevaluative traits (found in laboratory professionals) in enoughpeople in our field to continue my brief investigation.

Judy A Horton MS MT(ASCP)8021 Rocky Rd

Laytonsville, MD 20882

REFERENCES1. NAACLS, Standards of accredited educational programs for the clini-

cal laboratory scientist/medical technologist. Chicago, IL (2001)available at www.naacls.org/PDFviewer.asp?mainURL=/docs/standards_cls-mt.pdf. Accessed May 7, 2003.

2. McCoy, C. Future directions for the clinical laboratory scientist, CLS2003;16(2):66.

3. American Association for Respiratory Care. What is a respiratorytherapist. Dallas, TX (August, 2002). Available at www.aarc.org/pa-tient-education/whatacrp.asp. Accessed May 7, 2003

4. American Dental Education Association. Competencies for entryinto the profession of dental hygiene. House of Delegates Manual.Feb 6, 2003. Available at: http://www.adea.org/HOD-manual/c-competencies.pdf. Accessed May 7 ,2003.

5. Illinois Articulation Initiative. Nursing competencies. Illinois Boardof Higher Education, Illinois Community College Board, IllinoisState Board of Education and Transfer Coordinators of Illinois Col-leges and Universities (1997-2003). Available at http://www.itransfer.org/IAI/Majors/Nur/Default.taf?page=LPN. AccessedMay 7, 2003.


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○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

WASHINGTON BEAT

15th Annual ASCLS Legislative Symposium

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KATHY HANSEN, DON LAVANTY

Washington Beat is intended to provide a timely synopsis of activity inthe nation’s capitol of importance to clinical laboratory practitioners.This section is coordinated jointly by Kathy Hansen, Chair of theASCLS Government Affairs Committee, and Don Lavanty, ASCLSLegislative Counsel. Direct all inquiries to ASCLS (301) 657-2768extension 3022; (301) 657-2909 (fax); or mail to ASCLS, 6701Democracy Blvd., Suite 300, Bethesda MD 20814, Attention: Wash-ington Beat.

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Another successful ASCLS Legislative Symposium was heldMarch 17 and 18, 2003, co-sponsored by CLMA. The Hillvisits were done in collaboration with the Clinical LaboratoryCoalition (CLC), which held a ‘fly-in’ on March 18. The CLCis a group of professional associations that lobbies together onlegislation of interest to the laboratory community, especiallyissues of reimbursement for laboratory services.

Over 85 participants representing 38 states attended educa-tional sessions on Monday, March 17. These were intendedto familiarize attendees with the issues which would be partof the lobbying efforts, to provide background education onother bills that they might be asked about at Congressionaland Senate offices, and to educate them on how to lobbyeffectively.

As is typically the case, about half of the participants wereattending the Legislative Symposium for the first time. At-tendees ranged in experience from four clinical laboratoryscience (CLS) students to a handful of members who haveattended every year for the 15 years of this event.

The program also included a presentation by Judy Yost, Di-rector of the CLIA program for the Center for Medicare andMedicaid Services (CMS), who presented a summary of theCLIA regulatory changes that were published in the January24, 2003 Federal Register. (See Washington Beat column inthe Spring 2003 issue of Clinical Laboratory Science.)

On Tuesday, March 18, participants made visits to the of-fices of their Senators and Congresspersons, including themember of Congress from the district where they live, aswell as others from their state in some instances. Membersfrom about ten states were matched up with about 15 at-

tendees from the CLC, who came from the AACC, AMT,AAB, Ortho Clinical Diagnostics, ASM, Quest, andMarshfield Clinic. In some instances, these groups were ac-companied by a staff person or lobbyist from one of the CLCorganizations.

Three issues were on the docket for our lobbying efforts.

Personnel shortageWe asked for House co-sponsors and a Senate sponsor forHR 623, the Medical Laboratory Personnel Shortage Act of2003. Original sponsors are Representatives John Shimkus(R-IL), Jesse Jackson Jr (D-IL), and Michael Bilirakis (R-FL). This is very similar to the 2002 bill introduced by thesame sponsors. It would provide funding for laboratory edu-cation programs, and some scholarships and loan forgive-ness for students. We presented factual and anecdotal infor-mation about laboratory personnel shortages and their im-pact on access and quality for the patients we serve.

Legislative Symposium participants were successful in find-ing six co-sponsors for HR 623. These include Representa-tives Harold Ford (D-TN), Charles Gonzalez (D-TX), DonYoung (R-AK), Martin Frost (D-TX), Frank Wolf (R-VA),and Colin Petersen (D-MN).

Drawing feeWe asked for House cosponsors and a Senate sponsor forHR 883, the Medicare Laboratory Services Access Act of2003 introduced by Representatives Phil English (R-PA)and Peter Deutsch (D-FL). The specimen collection (veni-puncture) reimbursement has been $3.00 since 1984. Costsof providing the service have risen due to the safety re-quirements for safer needles, gloves, and other disposableequipment, as well as increases in personnel costs over 19years. The bill asks for the fee to be raised to $5.42, whichis what it would be if annual inflationary increases had beengiven. (Note: Even this amount would not cover costs formany laboratories.) The poor reimbursement for collec-tion has been a factor in many laboratories declining toservice nursing homes, which limits access to testing forMedicare beneficiaries there.

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WASHINGTON BEAT

Legislative Symposium participants were successful in find-ing five co-sponsors for HR 883. These include Representa-tives Harold Ford (D-TN), Charles Gonzalez (D-TX), Mar-tin Frost (D-TX), Frank Wolf (R-VA), and Colin Petersen(D-MN).

Laboratory CPI updateClinical laboratories received the first consumer price index(CPI) update in six years in 2003. The Medicare ClinicalLaboratory fee schedule had been frozen for five years (1998-2002), until a 1.1 % increase was given for 2003. By law,the fee schedule must receive a CPI adjustment annuallyunless Congress takes action to freeze it during the budgetprocess. There are concerns that a freeze may be imposedagain, as Congress searches for funding for a Medicare pre-scription drug benefit. In this instance, we were urging thatno further freeze be imposed, as laboratories have been hurtby the previous actions.

As of about six weeks after the Legislative Symposium, bothHR 623 and HR 883 had been referred to the House Sub-committee on Health but not yet acted upon. We expectthat will happen as part of discussions on a Medicare pre-scription drug benefit, which will likely prompt examina-tion of other Medicare issues, including these three. Thisdebate is likely to occur in late May or June.

Whenever Congress looks at funding of the Medicare pro-gram, there is always the possibility that some proposals from

past years may resurface for consideration, if there is a percep-tion that they would generate savings for the program andfree up money for a drug benefit. One of these is competitivebidding for laboratory services for Medicare beneficiaries. Thishas long been opposed by ASCLS, on the grounds that labo-ratory services are not a commodity, that competitive biddingwould restrict access to services by putting some laboratoriesout of business, and that Medicare already controls its cost oflaboratory services via its fee schedule. Another possibility isthe imposition of a co-pay for laboratory tests, a feature thatwas eliminated years ago when the fee schedule was imple-mented with a concurrent decrease in reimbursement. A co-pay requirement would greatly increase administrative bur-den and administrative costs for laboratories.

The Legislative Symposium participants are urged to con-tinue their advocacy efforts by staying in touch with Wash-ington staffers they met with, visiting the home offices oftheir elected officials, and inviting their elected officials totour a clinical laboratory when they are home in their state.On the Washington end, Don Lavanty, ASCLS legislativeconsultant, uses the debriefing reports submitted by partici-pants to continue follow-up with offices that have showninterest in supporting our issues.

This event is one of the most important things we do toadvocate for visibility and recognition for our profession. Ifyou have never attended, start thinking now about next year–you will learn a lot and come away energized!

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CLINICAL PRACTICE: EDUCATION

Health Education Strategy in theControl of Urinary Schistosomiasis

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KAMGA F H LUCIEN, GERARD NKWELANG, GABRIEL C EJEZIE

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The peer-reviewed Clinical Practice section seeks to publish case stud-ies, reports, and articles that are immediately useful, of practical na-ture, or demonstrate improvement in the quality of laboratory care.Direct all inquiries to Bernadette Rodak MS CLS(NCA), CLS Clini-cal Practice Editor, Clinical Laboratory Science Program, IndianaUniversity, Fesler 409, 1120 South Avenue, Indianapolis, IN 46202-5113. [email protected]

The purpose of this study was to determine the impact ofhealth education intervention on the perception and preva-lence of urinary schistosomiasis among school children inendemic rural communities in Cameroon. The rapid as-sessment technique method was used to determine theprevalence of Schistosoma heamatobium infection inGounougou (experiment 1), Ouro-Doukoudje (experiment2), and Lagdo (control). There was a positive correlationbetween the questionnaire approach, the biochemical test-ing, and ova detection rate (r dispersed between 0.98 and1.00). In the first phase of the study, after collection of thebaseline data, school children of the experimental villagesreceived health education. Unlike in Gounougou wherechildren were given a predesigned control procedure, thosein Ouro-Doukoudje were asked to design their own con-trol procedure under the supervision of the investigators.A second investigation conducted eight months after theend of the first intervention showed a significant drop ofprevalence in Gounougou (53.2% vs 29.6%, p <0.0005)and Ouro-Doukoudje (39.4% vs 17.7%, p <0.0005) butnot in Lagdo (31.4% vs 30.4%, p >0.25). It also showed asignificant increase of the awareness in Gounougou (14.5%vs 94.7%, p <0.0005) and Ouro-Doukoudje (4.5% vs98.5%, p <0.0005) but not in Lagdo (18.4% vs 19.4%, p>10); with the greater increase in Ouro-Doukoudje (94.0%)as compared to Gounougou (80.2%, p <0.05). The inves-tigators concluded that health education through the frame-work of school could be adopted as a national policy forurinary schistosomiasis control programs in tropical devel-oping countries, planned with school children as full part-ners, provided they received appropriate orientation.

INDEX TERMS: Health education, urinary schistosomiasis.

Clin Lab Sci 2003;16(3):137

Address for correspondence: Dr Kamga Fouamno Henri Lucien,Faculty of Health Sciences, University of Buea-Republic ofCameroon, (+237) 7769464. [email protected].

Schistosomiasis is one of the most widespread of all humanparasitic diseases, affecting over 200 million people in morethan 74 countries.1 It is the most prevalent of water-bornediseases and a great health risk in rural areas of developingcountries.2

Although schistosomiasis is not the most serious of diseasesin the tropics, compared to malaria, diarrhea, acute respira-tory infections, or malnutrition, it is widespread, particu-larly in young populations, and its chronicity has made itdifficult to determine the impact on overall morbidity andmortality in endemic areas.3

Schistosomiasis, like the majority of the parasitic diseases, isinfluenced: 1) by human behaviour, mainly water use prac-tices and indiscriminate urination and defecation, and 2) byfailure to take advantage of available screening services or tocomply with medical treatment.

In schistosomiasis, like in many other parasitic diseases, theaim of health education is: 1) to help people understandthat their own behaviour is a key factor in the transmissionof the disease, and 2) to find a common ground betweentraditional beliefs and practices, and modern scientific knowl-edge and methods.

In this study, social science principles were used to deter-mine the impact of health education on the perception andprevalence of urinary schistosomiasis among school childrenin three rural communities in Cameroon.

MATERIALS AND METHODSStudy area and subjectsThe study was conducted from September 2000 to June 2001in the North Province of Cameroon in an area known asLagdo dam region, where 20 years ago, an artificial lake wascreated by the construction of a dam on the river Bénoué, inLagdo village. The three villages targeted in this study (Lagdo,Gounougou, and Ouro-Doukoudje) are all situated around

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the lake, about 60 km from each other. The three villages aretypical rural African communities. There is no pipe-bornewater, electricity, or drainage system. The residents rely whollyon water from the artificial lake for their economic and do-mestic needs.

Phases of the studyPhase 1Collection of samplesUrine samples were collected into clean universal contain-ers. Samples were collected from school pupils between 5and 19 years of age. Pupils were requested to exercise byrunning to increase the chances of recovery of ova from urine.Samples were collected between 12:00 (noon) and 2:00 P.M.when maximum egg excretion occurs.4

Detection of hematuria and ovaHematuria was detected soon after collection in the fieldusing dipsticks (Ames, Bayer Diagnostic, Brussels, Belgium).The results were read immediately and recorded. Thereafter,five mL of sample was transferred into a clean universal con-tainer holding 1% aqueous solution of carbol fuchsin forstaining and preservation of ova. Filtration of samples wasdone using Whatman No 1 filter paper as described by

Ejezie.5 Examination for the ova of Schistosoma haematobiumwas done using a light microscope with the 10X objective.

Health education intervention strategyHealth education intervention was utilized in Gounougou(experiment 1) and Ouro-Doukoudje (experiment 2), andwas aimed at promoting and reinforcing health behaviour.The basic messages communicated were: what schistosomiasisis, how the disease is acquired, what the signs and symptomsof the disease are, and what can be done about it.

Health education methodIn Gounougou, school children were given predesigned cri-teria and procedures for implementation for the control ofschistosomiasis. In Ouro-Doukoudje children were asked todesign a method for control of schistosomiasis in their vil-lage. Under the supervision of the investigators, one of theproposed methods was selected for implementation. In Lagdo(control) only the base data were collected.

Phase 2This phase was conducted eight months after the end of thefirst intervention and consisted of the collection of samplesand detection of hematuria and ova.


Table 1. Comparison of the prevalence of S. haematobium infection and hematuria among school children inGounougou, Ouro-Doukoudje, and Lagdo, according to age, before and after health education intervention

Before health education After health educationVillages Age group Samples Positive Positive for Samples Positive for Positive for

tested for ova (%) hematuria (%) tested for ova (%) hematuria (%)

Gounougou 5-9 153 49(32.0) 50(32.7) 152 39(25.3) 41(26.9)Experiment 1 10-14 165 126(76.4) 128(77.6) 165 57(34.5) 61(36.9)

15-19 22 6(27.3) 7(31.8) 21 4(19.1) 4(19.1)Total 340 181(53.2) 185(54.4) 338 100(29.6) 106(31.4)

Ouro-Doukoudje 5-9 131 34(25.9) 34(25.9) 130 23(17.7) 23(17.7)Experiment 2 10-14 75 49(65.3) 50(66.7) 75 13(173) 14(18.7)

15-19 15 4(26.6) 5(33.3) 15 3(20.0) 3(20.3)Total 221 87(39.4) 89(40.3) 220 39(17.7) 40(18.1)

Lagdo 5-9 169 51(30.2) 51(30.2) 167 48(28.7) 49(29.3)Control 10-14 174 112(64.4) 113(64.9) 174 108(62.1) 112(64.4)

15-19 487 98(20.1) 106(21.8) 487 96(19.7) 102(20.9)Total 830 261(31.4) 270(32.5) 828 252(30.4) 263(31.8)

Note: Percentages are based on the number of samples tested

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Data analysisChi-square, student-t-test, and Pearson’s product momentcorrelation were used to test for the significance of the results.

RESULTSTable 1 shows the prevalence of Schistosoma haematobiuminfection and hematuria among school children inGounougou, Ouro-Doukoudje, and Lagdo, according to age,before and after health education intervention. It was ob-served that in Gounougou (experiment 1) and Ouro-Doukoudje (experiment 2), where health education strate-gies were implemented, there was a significant drop in theprevalence (53.2% vs 29.6%, p <0.0005 in Gounougou;39.4% vs 17.7%, p <0.0005 in Ouro-Doukoudje) whichappeared to be very pronounced among children between

ages 10 and 14 years (76.4% vs 34.5%, p <0.0005 inGounougou; 65.3% vs 17.3%, p <0.0005 in Ouro-Doukoudje). No significant changes were observed in Lagdo(control) (31.4% vs 30.4%, p >0.25).

Table 2 shows the validation of children’s questionnaires withbiochemical and parasitological techniques in Gounougou,Ouro-Doukoudje, and Lagdo. There appeared to be a strongpositive correlation between the questionnaire approach andthe biochemical and parasitological techniques (r dispersedbetween 0.99 and 1.0).

Table 3 depicts the perception of urinary schistosomiasisbefore and after health education in Gounougou, Ouro-Doukoudje, and Lagdo. There was a significant increase in


Table 2. Validation of children’s questionnaires with biochemical and parasitological techniques

Villages (%)Survey methodology Lagdo Gounougou Ouro-Doukoudje

n = 830 n = 340 n = 221Children questionnaire

Number positive for blood in urine 259 (31.2) 178 (52.4) 76 (34.4)Number positive for schistosomiasis 244 (29.3) 169 (49.7) 73 (33.0)Statistical analysis (p value) p >0.10 p >0.10 p >0.10

Biochemical testing (BT)Number positive for hematuria 270 (32.5) 185 (54.4) 89 (40.3)BT vs blood in urine r = 0.99, p >0.10 r = 0.99, p >0.10 r = 0.99, p >0.10BT vs schistosomiasis r = 0.99, p >0.10 r = 1.0, p >0.10 r = 0.99, p >0.10

Detection of ovaNumber of positive 261 (31.4) 181 (53.2) 87 (39.4)Ova count vs blood in urine r = 0.99, p >0.10 r = 1.0, p >0.10 r = 0.99, p >0.10Ova count vs schistosomiasis r = 0.99, p >0.10 r = 0.99, p >0.10 r = 0.98, p >0.10

n = number of samples

Table 3. Children’s perception of the source of urinary schistosomiasis before and after health education

Village Number (%)* of children aware of water as source of infection P value

Before health education After health educationGounougou (experiment 1) 48 (14.5) 320 (94.7) p <0.0005Ouro-Doukoudje (experiment 2) 8 (4.5) 216 (98.2) p <0.0005Lagdo (control) 149 (18.4) 151 (19.4) p >0.10

* Percentage based on number of respondents

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awareness in Gounougou (14.5% vs 94.7%, p <0.0005) andOuro-Doukoudje (4.5% vs 98.5%, p <0.0005) but not inLagdo (18.4% vs 19.4%, p >0.10). The increase in Ouro-Doukoudje appeared to be greater than that in Gounougou(94.0% vs 80.2%, p <0.05). The relationship between theperception and the prevalence of urinary schistosomiasis inthe two experimental villages showed a strong negative cor-relation (r = -0.99).

DISCUSSIONThe purpose of this study was to determine the impact ofhealth education on the perception and prevalence of uri-nary schistosomiasis. Previous studies had emphasized thelimits of epidemiological and control studies based only onchildren in school.6,7 In most rural communities of Sub-Sa-haran Africa, only about 68% of children go to school andfemales are generally marginalized.8,9

The study was targeted at school children as they are mostof the heavily infected individuals in the community, andare at risk of developing severe disease.10-13 School childrenare likely to contribute most to transmission and they arereadily accessible through the framework of school.14 Fur-thermore, it is believed that school children are more recep-tive to health education and can easily spread the messagewithin the community.15

Comparing among school children the prevalence of uri-nary schistosomiasis obtained during the first and secondphases of the study, it was observed in Gounougou (experi-ment 1) and Ouro-Doukoudje (experiment 2), where thestrategies of the health education were implemented, therewas a significant drop in the prevalence of urinary schistoso-miasis. On the other hand there was no significant changein the prevalence of urinary schistosomiasis in Lagdo, thecontrol village in which no health education strategy wasimplemented. The significant change in prevalence observedin Gounougou and Ouro-Doukoudje can not be attributedto social or seasonal variation; the three villages share thesame social, geographical, and climatic features.16 Only healtheducation applied in the experimental villages could haveaccounted for the observed prevalence decrease.

The comparison of the prevalence of urinary schistosomiasisaccording to age in the three villages under study indicatesthat more children between 10 and 14 years of age were re-ceptive to health education in the experimental villages. It isbelieved that the majority of these children who were either atthe end of the primary education or in the secondary school

had a better understanding than the younger ones (5 to 9years). On the contrary, children of the 15 to 19 age group,even though more educated, did not perceive urinary schisto-somiasis as a serious problem, probably for one of the follow-ing reasons: 1) It is now accepted that effective resistance toinfection/ re-infection develops after 5 to 15 years of expo-sure.17 It follows that the worm burden may be milder in olderchildren, so they found no reason for visiting the health cen-tre of their locality, even after health education. 2) the major-ity of children aged between 15 to 19 years of age might havebeen hosting the parasite for many years, and thus did notlook upon blood in urine as a cause of worry. They regrettablyrejected health education and consequently refused to visitthe health centre.

The validation of children’s questionnaires with biochemi-cal and parasitological techniques (Table 2) showed a strongpositive correlation between the questionnaire approach andother techniques (r = 0.99). These findings support the useof reagent strips and questionnaires to screen in areas withhigh risk of urinary schistosomiasis as earlier proposed byLengeler.18 Thus, instead of spending many resources in car-rying out definitive diagnosis before mass treatment of schoolchildren in schistosomiasis endemic areas, a simple question-naire administered to these children, along with biochemi-cal testing, could be used as a diagnostic method.

The strong negative correlation between the perception andthe prevalence of urinary schistosomiasis in Gounougou (ex-periment 1) and Ouro-Doukoudje (experiment 2) indicatesthat the prevalence (in percentage of infected subjects) wasinversely proportional to the awareness. In other words, ig-norance of the cause of urinary schistosomiasis is stronglyrelated to its prevalence. This is explained by the fact that,children who are conversant with the knowledge of the dis-ease are more aware of the consequences of many attitudesand practices than those who have not been exposed to suchan opportunity. It follows that through health education, achild is exposed to health ideals which enhance the promo-tion of his physical, social, and psychological health through-out life. It is therefore important to select appropriate strat-egies, if health education is to be successful, for addressingthe factors contributing to behaviour that influences health.2

The present study has shown that the strategy applied inOuro-Doukoudje (experiment 2) and proposed by schoolchildren (under our supervision) yielded a greater increaseof awareness than the strategy applied in Gounougou, whichwas predesigned by the investigators. This observation is


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consistent with WHO recommendations that if health edu-cation is to be effective, it must encourage participation ofthe target population as full partners in planning.2

It is therefore recommended that health education throughthe framework of school be adopted as a national policy forurinary schistosomiasis control programs. The strategy ofthis policy should be planned with school children as fullpartners, provided they receive appropriate orientation.

This paper was accepted for oral presentation at IAMLT-ASCLS World Congress 2002 in Orlando, Florida USA.

REFERENCES1. World Health Organization. The control of schistosomiasis. Tech

Rep Ser Wld Hth Org 1985;3:6,7.2. World Health Organization. Health education in the control of schis-

tosomiasis. Tech Rep Ser Wld Hth Org 1990;WC 810.3. Mott KE, (1983). A reusable polyamide filter for diagnoses of

Schistosoma haematobium infection by urine filtration. Bull de la Socde Pathol Exotique 1983;76:101-4.

4. Chen MG, Mott KE. Progress in assessment due to schistosomiasis.Trop Dis Bull 1989;86:1-56.

5. Ejezie GC Ade-Serrano MO. Schistosoma haematobium in Ajara com-munity of Badagry Nigeria. A study on prevalence, intensity andmorbidity from infection among primary school children. Trop GeogMed1981;37:175-0.

6. Useh MF Ejezie GC. Prevalence and morbidity of Schistosomahaematobium infection in Adim community of Nigeria. Nigerian JMed Lab Sci 1996;5:17-28.

7. Useh MF, Ejezie GC. School-based schistosomiasis control programs:a comparative study on the prevalence and intensity of urinary schis-

tosomiasis among Nigerian school-age children in and out of school.Trans Roy Soc Trop Med Hyg 1999;93:1-5.

8. UNESCO (United Nations Educational Scientific and CulturalOrganisation) (1993). World Education Report 1993.UNESCO.

9. Csapo M. Religious, social and economic factors hindering the edu-cation of girls in northern Nigeria. Comparative education1981;3:121-9.

10. Anderson RM, May RM. Herd immunity to helminth infection andimplications to parasitic control, Nature London 1985;315:493-6.

11. Anderson RM, May RM. Herd immunity to helminth: mathemati-cal models. Population dynamics and control. Adv Parasitol1985;24:1-101.

12. Anderson RM, Medley GF. Community control of helminth infec-tions of man by mass and selective chemotherapy. Parasitol1985;90:629-60.

13. Butterworth AE, Sturrock RF, Ouma JH, and others. Comparisonof different chemotherapy strategies against Schistosoma mansoni inMachakos Districk, Kenya: effects on human infection and morbid-ity. Parasitol 1991;103.339-45.

14. Ouma JH. (1987). Transmission of Schistosoma mansoni in an en-demic area of Kenya with special reference of the role of humandefecations behaviour and sanitary practices. PhD thesis, Universityof Liverpool, UK.

15. Somerset HCA. Child-to-Child. A questionnaire review and studiesof projects in three countries. Institute of Education, University ofLondon. 1988.

16. MEAVSB (Mission d’Etude et d’Aménagement de la vallée Supérieurede la Benoué). Suggestions pour le mise en valeur des mares deGounougou et Djanga. Haskoning, MEAVSB, 1989. Univ. Leyde.

17. Hogan P. Immunity and morbidity in infection due to Schistosomahaematobium. Am J Trop Med Hyg 1996;55(5),116-20.

18. Lengeler C, Desavingny D, Mshinda H, and others. Community-based questionnaires and health statistics as tools for the cost-effec-tive identification of communities at risk of urinary schistosomiasis.Int J Epidemiol 1991;20:796-807.

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CLINICAL PRACTICE: IN PRACTICE

ASCLS 2003 Annual Meeting:Official Abstracts of Submitted Papers and Posters

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PHILADELPHIA, PENNSYLVANIA

The following abstracts have been accepted for presentationat the 2003 American Society for Clinical Laboratory Sci-ence (ASCLS) Annual Meeting and Clinical LaboratoryExposition to be held July 22 through July 26, 2003 in Phila-delphia PA. The preliminary meeting program was publishedin the Spring 2003 issue of Clinical Laboratory Science. Ab-stracts are reviewed by appropriate representatives of theASCLS Scientific Assembly Sections. They are the final au-thority in selecting or rejecting an abstract.

Papers and posters will be presented during the followingtimes at the annual meeting. Room assignments will belisted in the final program.

POSTER PRESENTATIONSPennsylvania Convention Center.Tuesday and Wednesday, July 22 and 23, 2003. 10:00 A.M. -4:30 P.M. Thursday, July 24, 2003. 10:00 A.M. - 3:30 P.M.

Authors will be present Thursday, July 24, 2003 from 10:00A.M. to 11:00 A.M. to discuss their poster.

CASE STUDY PRESENTATIONSWyndham Franklin Plaza HotelFriday, July 25, 2003, 9:00 A.M. to 10:30 A.M.

RESEARCH PAPER PRESENTATIONSWyndham Franklin Plaza HotelFriday, July 25, 2003, 2:15 P.M. to 5:30 P.M.

POSTER PRESENTATIONS

Adaptation of a Urine-Based Drug Screening Assay toUse SerumMary Ann McLane PhD CLS(NCA), Kenneth Wannemacher,University of Delaware, Newark DE; Samuel Miller C(ASCP),Hospital of the University of Pennsylvania, Philadelphia PA.

Routine analysis of drugs of abuse commonly includes quali-tative screening analysis of random urine specimens usingenzyme-mediated immunoassay techniques (EMIT). Suchscreening is difficult for patients on renal dialysis since theirurine output is negligible to absent. An investigation was

conducted to determine whether the same qualitative methodcould be used with serum, rather than urine, as the speci-men. Seven different purified drugs were added to pooleddrug-free serum at concentrations two- to ten-fold higherthan the established urine-based drug cutoff used for estab-lishing ‘positives’ from ‘negatives’. Dilutions of these serumdrug stocks were processed by a column chromatographyextraction, and eluates analyzed by EMIT. Results at eachdrug concentration were graphed and compared with theestablished urine cutoff to determine the comparable cutoffthat could be used for serum samples. For two drug classes(amphetamine and phencyclidine), the analytical sensitivitywas unacceptable. Calculation of summary predictive valuesfor the other five drugs studied indicated 94.0% sensitivity,98.7% specificity, 98.7% positive predictive value, and93.8% negative predictive value, which were all comparableto the values found when urine testing is performed. Thissuggests that serum is an acceptable sample for qualitativedrug screening for five of the seven drugs tested.

Alleviating Shortages with Rural InterdisciplinaryHealthcare TeamsLorraine Doucette MS MT(ASCP), Eileen M Patton MSMT(ASCP) RM(AAM), University of Maryland School ofMedicine, Baltimore MD.

Shortages of healthcare providers in rural areas, includingclinical laboratory scientists, continue to negatively impactthe health care available to citizens of those communities. Inresponse, rural interdisciplinary healthcare teams have beenformed to provide this care. Interdisciplinary teams are anintegrated approach in which team providers actively coor-dinate care and services across disciplines to their patientpopulation. In recognition that laboratory professionals arean integral part of the healthcare team, the Department ofMedical and Research Technology (DMRT) at the Univer-sity of Maryland School of Medicine in 2000 joined a pre-established interdisciplinary healthcare team coordinatedthrough the Western Maryland Area Health Education Cen-ter (AHEC). Team members developed Web-based modulesand learning activities for students to raise awareness of in-terdisciplinary teaming and to recruit possible new provid-ers of rural healthcare (www.allconet.org/ahec/rihp).Healthcare disciplines represented on the team included:

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clinical laboratory science (CLS), nursing, occupationaltherapy, physical therapy, public health, respiratory therapy,and social work. Examples as to how CLS educators canintegrate these modules within their own curriculum areprovided to broaden CLS students’ knowledge concerningrural interdisciplinary healthcare teams.

Collaborative Development of a Medical TechnologyCertification Computer-Adaptive ExaminationBetty Ciesla MS MT(ASCP)SH, Diane Wilson PhDMT(ASCP), Morgan State University, Baltimore MD.

Morgan State University’s Medical Technology (MT) Pro-gram has experienced extensive curriculum changes in thepast five years. One of the goals was to provide a ‘simulatedcertification’ examination for senior students. Although soft-ware is available for such a project, the faculty enlisted theservices of senior students in the university’s computer sci-ence department. A team of six students enrolled in the se-nior software engineering course-COSC 458, was assignedto develop the computer-adaptive examination (CAE). TheMT Program became the ‘client’ for the student-created soft-ware company. Four hundred questions, at three taxonomiclevels, were submitted by MT faculty for the major disci-plines. The software was programmed to select questionsaccording to the student’s ability. Additional features of theCAE include password protected entry, question recall, andpre-set test time. The benefits of this collaboration includedthe development of the CAE, a viable alternative for a bud-get-strained program and a promotional opportunity.

Correlation Between MTHFR677 (C→T),Hyperhomocysteinemia, and BMIJean M Chappell MS MT(ASCP), Sara Hesson, Jarrett Roth,Porrani Sekar, Elizabeth Murray, Gary Wright, Todd Green,Bowie Kahle, Marshall University, Huntington WV; BrendaHill, West Virginia State College, Institute WV; Mark Flood,Fairmont State College, Fairmont WV.

Two major risk factors for CVD are obesity andhyperhomocysteinemia. One goal of this study was to evalu-ate the relationships between a common CVD risk factorallele, MTHFR 677 (C→T), hyperhomocysteinemia, andobesity status. Genomic DNA was extracted and a 198bpfragment correlating to the MTHFR677 region wasgenotyped. Hinf 1 digested samples revealed three distinctbanding patterns: Normal, A/A, having one band at 198bp;heterozygous, A/V, having three bands at 198bp, 175bp, and23bp; and homozygous variant, V/V, having two bands at

175 bp, and 23 bp. Homocysteine was measured using theAbbott IMX Immunoanalyzer. Of the samples processed,143 samples were genotyped for MTHFR677(C→T) andanalyzed for homocysteine; ten samples were analyzed forhomocysteine only (genotyping in process); and 114 sampleswere genotyped only. The data are as follows: 67 wild-typehomozygotes, 15 homozygous variants, and 61 heterozygotes.In this preliminary study the obese population had signifi-cantly higher homocysteine levels (p = .03) than the non-obese population. Homocysteine levels were strongly corre-lated with age but no significant difference between malesand females was found. As compelling as these data are, amore detailed evaluation needs to be conducted with a largerpatient population to determine valid correlations betweenobesity and hyperhomocysteinemia.

Effects of Brown Recluse Spider (Loxoceles reclusa)Venom on the Coagulation Mechanism in Rabbits(Oryctolagus cunniculus)DL McGlasson MS CLS(NCA), HH Harroff DVM, E DickDVM, J Sutton. 59th Clinical Research Squadron, WilfordHall Medical Center, Lackland AFB TX.

The brown recluse spider (BRS) bite causes a necrotizingskin cellulitis in both animals and humans. It has also beenreported to cause DIC-like symptoms in humans. In a studygroup of 36 rabbits we report here a dramatic effect on thecoagulation mechanism following BRS envenomation. Onegroup received a saline injection, and the other two groupsreceived a 4.0 µg/mL or 10.0 µg/mL dose of the BRS venom.Samples were collected at baseline, 24-, 48-, and 72-hoursfor CBC/platelets and coagulation testing. The WBC countsand platelets decreased dramatically at 24-hours in rabbitsreceiving the venom. The APTT and fibrinogen (bothclottable and antigenic), FV, FVII, FVIII, FIX, FX, anti-thrombin, and alpha-2 antiplasmin levels were greatly in-creased in test subjects receiving the venom doses. The Pro-tein C decreased at 24-hours through the 72-hour sampling.However, mixing studies corrected the APTT to normalranges. FII, FXI, and FXII levels showed no significantchanges at any time. In the rabbit we had an elevated APTTthat corrected in mixing studies despite the presence of sev-eral elevated coagulation factors present or normal resultsfollowing the BRS envenomation. This suggests a coagula-tion factor not yet identified by our testing. There is noevidence of DIC in the rabbit. This is the second study inwhich we have been able to induce increased coagulationfactors in this animal model following BRS envenomation.


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Evaluation of CB-18 for the Detection of Mycobacte-rium bovisDouty H Bamba, Janine D Cook PhD, Lorraine Doucette MS,University of Maryland Baltimore; Charles Thornton PhD,Chris Caroter, Integrated Research Technology.

The efficiency of C18

-carboxypropylbetaine (CB-18), a zwit-terionic detergent used in sample processing to recover My-cobacterium bovis in infected subjects was investigated. CB-18 has been reported to improve the recovery of mycobacte-ria during centrifugation, a critical step in sample process-ing. PCR-based methodology has the greatest potential as arapid and effective ante mortem test if quantitative recoveryof bacilli during specimen processing using CB-18 can beaccomplished. Fourteen cows were experimentally infectedwith Mycobacterium bovis strain 1315. Every month for sixmonths, oral, nasal, and intratonsilar swab specimens werecollected and processed with CB-18. At the end of sixmonths, the animals were sacrificed and tissue specimenswere collected and processed. All the processed specimenswere cultured and PCR-based procedures will be performedand compared with traditional processing method. Prelimi-nary results show that all cultures are negative at this pointin time. Hence ante mortem testing by culture does not ap-pear to be a viable means for identifying animals in earlystage disease. We are awaiting the amplification results.

Folate Status in Pregnant Women at the First Prenatal VisitSandra Cabrera MS CLS(NCA). Christina Thompson EdDCLS(NCA), Texas A&M University-Corpus Christi, CorpusChristi TX.

Research demonstrates the importance of nutrients, vitamins,and minerals not only on the health of normal adults, butalso on the health of the developing fetus. Low folate levelshave been associated with neural tube defects and, in 1998,the Food and Drug Administration required the fortifica-tion of enriched cereal and grain products with folic acid.The purpose of this study was to evaluate the folate status ofpregnant women at their first prenatal visit. Two bloodsamples were obtained from a total of 133 patients duringthe months of May, June, and July at two clinics in the Cor-pus Christi area. One clinic was at private womens’ centerand the other clinic was associated with the city/county healthdepartment. An EDTA sample was used for hematocrit test-ing and a clot sample was collected for serum folate. Thepatients ranged in age from 15 to 43 years and gestationranged from four weeks to 39 weeks. No patients were testedbefore the fourth week gestation, which is after the neural

tube closure. Fifty-three percent of the patients were in thefirst trimester and 8% in the last trimester. Fifteen percentof the patients had hematocrits below 35%. Twenty-onepercent of the patients at the health department clinic had ahematocrit below 35%. The mean folate at the health de-partment (12.4 ng/mL) was significantly lower (p <.01) thanthe folate at the private clinic (17.6 ng/mL).

Hands-on Opportunity to Discover Laboratory Profession-alism through Structured CourseworkDeborah L Costa MT(ASCP) CLS(NCA), Mary Ann McLanePhD CLS(NCA), University of Delaware, Newark DE.

Clinical laboratory science students, from freshmen to gradu-ates, spend the majority of their intensive training learningthe basics of their chosen field. While the theory of profes-sionalism is included in their curriculum, there is limitedopportunity to practice the concepts learned. Therefore, aone-credit “Anatomy of Professionalism” course was devel-oped by the Medical Technology Department at the Uni-versity of Delaware. This course included travel to the 70thAnnual Meeting of the American Society for Clinical Labo-ratory Science (ASCLS) and the International Associationof Medical Laboratory Technologists (IAMLT) in OrlandoFL July 30–August 3, 2002. Course assignments, objectives,and schedules were placed on WebCT for easy access to stu-dents. Pre-meeting assignments assessed the level of ‘profes-sionalism’ awareness in each student. On-site meetings in-cluded an orientation session (review of registration materi-als and the Meeting program), an assignment that encour-aged interaction between the students and the vendors, andparticipation in the ASCLS Opening Ceremony, Awards,and Keynote Presentation. Students compared and contrastedprofessional societies with regard to purpose, membership,and governance, and reviewed current legislative issues. Stu-dents had an opportunity to meet other students and mem-bers of the ASCLS/IAMLT organizations. Student feedbackwas positive. They rated the program very highly, reportedpositive experiences, and recommended the program to otherclinical laboratory science students.

Impact of Full-time Professional Practice on StudentPerception of Medical Science as a CareerRalph E B Green FAIMS, RMIT University, Melbourne,Australia.

A 40-week full-time Professional Practice course in third yearhas been part of the undergraduate degree in Medical Labo-ratory Science at RMIT University since 1994. The learn-


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ing outcomes for this course are structured around ten broadcompetencies that have been defined by the professions forentry level medical scientists. Assessment is based upon ajournal, reflective essay, seminar presentation, and a perfor-mance appraisal by the laboratory supervisor. Evaluation ofstudent responses to the 2001 course experience question-naire indicated on occasions they felt as if they were beingused as cheap labor, and they questioned the value of main-taining a journal. Frequent comments in reflective essays weremade to automation in clinical biochemistry, lack of careerpaths, high workloads, lack of training opportunities, andthe negative attitudes of laboratory staff to their work envi-ronments. These responses have been fed back to laboratorysupervisors and Professional Practice guidelines amended toinclude: allocated time to work on journals each week, ap-pointment of a recent graduate as a mentor, and provisionof a training schedule at the start of the placement period.

Novel Educational Strategy for Clinical ElectrophoresisWorkshopJean M Chappell MS MT(ASCP), Dorothy Fike MSMT(ASCP) SBB, Marshall University, Huntington WV.

The objective of this project was to develop an enhancedelectrophoresis workshop for senior-level clinical labora-tory science (CLS) students thereby providing an additionallevel of clinical skill. This involved a combination of com-puter-based simulations, didactic education, and hands-on experience. Senior CLS students were introduced tovarious electrophoresis topics using traditional classroomdidactic methods. Using the Beckman-Coulter “Electro-phoresis Tutorial” CD-ROM, topics were emphasized us-ing visual and graphic representations of theories presented.Using hands-on laboratory experiments designed for theBeckman-Coulter Paragon SystemTM, specific diseases werechosen to further emphasize critical points. Students dem-onstrated their mastery of the topics by passing a compre-hensive examination on the topics discussed with an aver-age of 98%. This is a significant increase over the previousyears in which this format was not used. In addition, thestudents reported feeling more in control of their learninggoals and that the immediate feedback provided by thetutorial allowed them to correct their deficiencies beforeinaccurate information was committed to memory. Evalu-ation of this learning format will continue for several se-mesters to determine a more precise outcome.

Teaching Hematology Using Live Digital MicroscopyRobin G Krefetz MEd CLS(NCA), Glenn Flodstrom MSMT(ASCP), Community College of Philadelphia, Philadelphia PA.

One of the core competencies for clinical laboratory sci-ence students in hematology is the identification of cells inthe WBC differential. The use of 35mm slides and indi-vidual practice with blood films are well-established tech-niques in the development of these skills. Our experienceincludes the use of live digital microscopy as an additionalteaching resource in the student laboratory. Among theadvantages of this technique are: its low cost, the high reso-lution images produced, ease of instructor use, the abilityto develop permanent images for later use, and the studentcentered nature of the ‘group’ differential. Both studentsand faculty found this method of teaching microscopy andlearning WBC morphology better than the traditionalmethods. Interviews of faculty and students, including thosefrom other colleges indicate that they prefer this teachingmethod. The use of live digital microscopy was found tobe an improvement over traditional teaching methods forboth microscopic urinalysis and WBC differentials, a tech-nique that can also be applied to teaching gram stain ex-amination and other microscopic procedures.

The Use of Audio Visuals in the Teaching of UrinalysisDyan Monte Verde MS CLS(NCA), Monte Verde Produc-tions Inc, Rochester NY.

This study was an attempt to apply the use of audiovisualsand learning theory to a situation which approaches the labo-ratory setting. This was achieved by the manipulation of tapedinstructions and visual aids to different groups of students.Group I was the Preparatory Group; they did not have anyprior classes or laboratories in urinalysis. Group II was theAdvance Group; they did have prior classes and laboratoriesin urinalysis. Group III was medical students. All subjectswere given a pretest before the slide tape was shown to seehow much knowledge they had in the area of urinary sedi-ment. Immediately following their exposure to the instruc-tional material, all the subjects completed a post test. Thiswas done to assess ability to recall in order to measure theinfluence of the tape on the learning process. That is, whatdid the subjects learn from this instructional medium? Sub-jects without any classes or laboratories in urinalysis dem-onstrated almost as good recall of urinary sediments as theircounterparts who had had classes and laboratories in uri-nalysis. The slide tape program and script will be availableto view and purchase.


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Using Theory-Driven Evaluations to DetermineStrengths and Weaknesses of a CLS ProgramSandra M Weiss EdD CLS(NCA), Neumann College, Aston PA.

Theory provides a lens to look at the meaning and functionof events. However, many programs fail to incorporate theoryin program evaluation. According to the literature, manyprograms are evaluated by a set of predetermined questionsthat provide information that is uniformly applied. Thisapproach may supply information about the success or fail-ure of the program, but does not identify any underlyingcause. The clinical laboratory science (CLS) department con-ducted an evaluation of the CLS program to identify thecausal processes underlying the program’s value. The CLSprogram had been restructured from a traditional programinto a non-traditional night/weekend format located withinthe Division of Nursing and Health Sciences. Normativetheory was used to guide the goals and outcomes that shouldbe pursued, designed, and implemented for the program.Consistency between goals and activities used to attain goalswere examined using various normative evaluations. Con-sistency between goals and activities was established for allevaluations except for the normative context evaluation andthe normative implementing evaluation. In order to correctfor these inconsistencies, the CLS program was restructuredback into a traditional program as a concentration withinthe biological science program rather than a separate major.

CASE STUDY PRESENTATIONS

The Arts of Urine Analysis...Crystals and CalculiDyan Monte Verde MS CLS(NCA), Monte Verde Produc-tions Inc, Rochester NY.

Using a case study, this presentation will provide an updatedview of the “true arts” of urine analysis...crystaluria and re-nal calculi. Many common crystals are readily recognized inurine sediment under light microscopy, but further differ-entiation may require more detailed examination using po-larization techniques. If they are morphologically similar,their refractive properties can be of particular importance intheir identification. Some crystals demonstrate a unique abil-ity to assume various forms in the same patient. Also, crys-tals normal to one patient may be pathological to another ifcertain conditions exist. Crystalline forms of many drugs,medications, and radiocontrast dyes appear in the urine andwill be discussed. The participants will enjoy learning aboutother non-crystal “art forms” in urinalysis and understandtheir clinical significance.


Finding the Cause of Hypercoagulability: A CriticalRole for the LaboratoryShirlyn B McKenzie PhD CLS(NCA), University of TexasHealth Science Center at San Antonio, San Antonio TX.

Repeated thrombotic events, hypercoagulability, may be due tocongenital or acquired factors. Proper treatment or preventionof thrombosis requires not only clinical assessment but also ex-tensive diagnostic testing. This case concerns a 34-year-old malewith a ten-year history of thrombotic episodes. Although hewas on coumadin therapy, he experienced chronic venous oc-clusion in the left leg. He was admitted to the hospital for venousreconstruction in the affected leg. At time of admission his INRwas 1.55, while his platelet count and CBC were normal. Atadmission he was switched from coumadin to heparin andmonitored by the APTT. The day after surgery he developedchest pain and hypotension and despite medical intervention,expired. Cause of death, identified by autopsy, was cardiac tam-ponade. The patient was never tested for congenital coagula-tion defects until after his death. Blood drawn before death wassent to a reference laboratory for molecular analysis. Resultsrevealed heterozygosity for Factor V Leiden. Since this singledefect is unlikely to have caused this extensive history of throm-bosis, it is probable that other factors were present that actedsynergistically with Factor V Leiden. Whether this patient’s lifecould have been spared by a complete coagulation testing pro-file for congenital abnormalities is unknown.

Mini Cases in Microscopic UrinalysisDyan Monte Verde MS CLS(NCA), Monte Verde Produc-tions Inc, Rochester NY.

Microscopic examination of the urinary sediment has beendescribed as a “mini biopsy” of the kidney. It provides a vitaldiagnostic tool for physicians and their patients to diagnosean asymptomatic patient and enables one to follow the pro-gression of illness and recommend further treatment. Usingcase studies, this presentation will focus on the over all im-portance of microscopic urinalysis. Atypical epithelia, cells,crystals, and casts found in the urinary sediment will beshown utilizing various stains and polarization techniques.

Treatment of Severe Plasmodium falciparum Infectionwith Exchange TransfusionLinda A Smith PhD CLS(NCA), Stephen Alaniz, Universityof Texas Health Science Center, San Antonio TX.

Malaria affects more than 2.5 million persons worldwide.Although most cases are diagnosed in individuals living in

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endemic areas such as Africa, South America, and SoutheastAsia, travelers to these areas are also at risk of acquiring in-fection, especially if malarial prophylaxis is not taken.Plamodium falciparum is recognized as the most severe ofthe malarial infections and is associated with significantmorbidity and mortality. It may present with high levels ofparasitemia and multiple complications. Although treatmentfor non-resistant strains is usually successful using only anti-malarial drugs, some cases require additional forms of treat-ment. This case is that of an African-American male whopresented with symptoms of malaria after a trip to Africa.His peripheral blood smear showed high-grade parasitemiawith intraerythrocytic rings identified as P. falciparum. Bothanti-malarial medication and multiple red blood cell ex-changes were required to successfully treat this patient.

Unusual Sequential Development of Alloantibodiesin a Multitransfused Patient with IdiopathicHemolytic AnemiaLinda Hawthorne MHS, Deepti Shukla MD, Diana VeillonMD, Xin Gu MD, James D Cotellingam MD, Louisiana StateUniversity Health Sciences Center, Shreveport LA.

A 31-year-old female was hospitalized for symptomatic ane-mia with initial hemoglobin of 5.7 g/dL. Her last transfusionoccurred one year ago. Within twenty-four hours her hemo-globin dropped to 4.7. Compatibility testing detected a strongcold autoantibody. Five units of warmed blood were trans-fused. By day nine her hemoglobin was 4.4 g/dL despite noobvious bleeding. Compatibility testing identified anti-s andanti-Jka and six units were transfused. On day fourteen, herhemoglobin was 4.0 g/dL and anti-C was detected. She wastreated with prednisone, transfused with one unit of blood,and plasmapheresis was initiated. On day fifteen, her hemo-globin was 3.6 and transfusions were suspended in favor oftreatment with erythropoietin. On day eighteen, anti-Fya waseluted from her cells. By day twenty-one, her hemoglobin was2.8 g/dL and four units were transfused. Her hemoglobin sta-bilized around 6.0 g/dL and she complained of abdominalpain. CT scan confirmed a massive splenic infarct and a sple-nectomy was performed. Pathological examination revealedsplenomegaly with a wedge shaped infarct and extramedul-lary hematopoiesis was evident microscopically. A diagnosisof idiopathic cold autoimmune hemolytic anemia with su-perimposed alloantibody related hemolysis was made. Follow-ing splenectomy, the patient is doing well and hemoglobinlevels have normalized.

ORAL PRESENTATIONS:

An Evaluation of the Platelet Function Effect of Aspirinand Plavix in Subjects with Stable Coronary DiseaseDL McGlasson MS CLS(NCA); JD Geoghagan CPT MD;CPT MK Murphy BSN RN, Wilford Hall Medical Center,Lackland AFB TX.

The purpose of this study was to evaluate the anti-plateleteffects of Plavix, when combined with aspirin therapy inpatients with CAD. Thirty-two specimens from subjects withstable CAD taking aspirin (ASA) daily were evaluated. Thesubjects were administered a loading dose of 300mg Plavixand then a daily dose of 75 mg for four weeks. Testing atbaseline, four weeks and eight weeks was performed. Plate-let studies were performed by platelet aggregometry (PA)using ADP and collagen agonists and the PFA-100 PlateletFunction Analyzer using ADP/COLL and EPI/COLL car-tridges on 3.8% sodium citrated blood. Results on subjects(n=16) on ASA only had two decreased (PA) patterns atbaseline; four with abnormal PFA results (EPI/COLL only);seven with both abnormal PA and PFA results. In three speci-mens no effects were measured. Specimens in which the sub-jects (n = 16) were taking both ASA and Plavix had two withabnormal PA, two with ADP/COLL and EPI/COLL PFAprolongations, and 12 specimens with abnormal PA andprolonged PFA results (two ADP/COLL and 12 EPI/COLL). Specimens obtained when the subjects were on bothASA and Plavix had a higher incidence of decreased plateletfunction in both the PA patterns and PFA results. Therewere no significant differences in the effect of ASA strengthin the platelet studies.

Applications of Evidence Based Practice in ClinicalLaboratory ScienceElizabeth Kenimer Leibach EdD CLS(NCA) SBB(ASCP),Lynn Black MT SC, Barbara Russell MHE MT SH, MedicalCollege of Georgia, Augusta GA.

Evidence based practice (EBP) has been defined as “consci-entious, explicit, and judicious use of current best evidencein making decisions about patients”. EBP in clinical labora-tory science (CLS) is defined as benchmarking the medicaleffectiveness of laboratory testing practices with the stan-dardization of testing guidelines based on these benchmarks.Studies are reported that demonstrate applications of mea-surements of cost-efficiency and criteria of medical effec-


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tiveness that define a process for benchmarking best prac-tices to support decision making in CLS. This process wasapplied to evaluations of blood gas and hemoglobin A

1C

methodologies. In each case, the “quality ratio” derived fromthe analysis was used to support and justify decision mak-ing. A study was also undertaken in which this EBP processwas used to determine medically meaningful critical valuesin point-of-care glucose testing and suggest changes in labo-ratory confirmation practices.

Asking Different Questions about the LaboratoryProfessionMoira M Grant MEd ART, Ontario Institute for Studies inEducation of the University of Toronto, Toronto Canada.

Medical laboratory science is experiencing challenges relatedto workforce shortages and to the lack of recognition andrespect for the profession. Researchers have queried the po-tential for credential upgrading and curriculum change toresolve these issues. Past efforts to implement such changehave had limited success. This presentation outlines a socio-logical inquiry into issues of gender, race, and class in medi-cal laboratory science in Canada. The methodological ap-proach to this doctoral thesis work included detailed docu-ment analysis and a practitioner survey that incorporatedboth qualitative and quantitative elements. The findingssuggest that credentialing or curriculum change alone maynot offer solutions to issues of professional recognition andshortages. They reveal the potential for sociological analysisof the profession to highlight historical and structural issuesthat may lead to greater understanding of the challenges fac-ing medical laboratory science. This understanding facili-tates an informed approach to professional change that ad-dresses systemic and implicit assumptions about the role oflaboratory science in healthcare. Further avenues for inquiryand change are proposed with these assumptions in mind.

Co-morbidity of Type II Diabetes and Alzheimer’s De-mentia: Frequency and Treatment StrategiesBreAnn Davis, Dianne M Cearlock PhD CLS(NCA), North-ern Illinois University, DeKalb IL.

The purpose of this study is to investigate the frequency ofco-morbidity with Type II diabetes and Alzheimer’s demen-tia in elderly patients and document treatment strategies.Although Alzheimer’s dementia and Type II diabetes are twoprevalent health problems in the older adult, few studies have

investigated co-morbidity with both. In a study of 476 pa-tients, the authors conclude that there is no significant asso-ciation between dementia and diabetes. However, severalinvestigators suggest that the risk of Alzheimer’s dementiaamong patients treated with insulin is higher than that amongpatients treated with oral hypoglycemic agents. In this ret-rospective pilot study, 74 medical records of patients resid-ing in a long-term care facility are reviewed. Of those, nine(12%) patients have diabetes, 10 (13.5%) have Alzheimer’s,and five (6.7%) are diagnosed with both. Age does not ap-pear to be a factor in co-morbidity as the mean age for all 74patients is 86, as is the mean age for patients presenting withco-morbidity. Polypharmacy is noted from the medicalrecords of all five patients with co-morbidity. Results fromthis and similar studies may provide a stimulus for enhanc-ing prevention, treatment, and monitoring of diabetes inAlzheimer’s patients.

Development of a Computer Program to Grade Stu-dents’ Evaluation of Peripheral Blood SmearsDonald C Lehman EdD MT(ASCP) SM(NRM), Raelene EMaser PhD MT(ASCP), University of Delaware, Newark DE.

Information in the clinical laboratory science (CLS) field isincreasing with instructors expected to teach more contentin the same amount of time with similar resources. We ex-amined whether computer-assisted assessment could evalu-ate student performance of differentials accurately while re-ducing the instructors’ grading time. Authorware®(Macromedia) and educational computer software designtheories were used to create a computer application to assessCLS students’ ability to evaluate peripheral blood smears ina senior hematology course. The students were evaluated inthree areas: white blood cell differential, platelet estimate,and red blood cell morphology and white blood cell abnor-malities. If the students did not get satisfactory results ontheir first attempt, the computer program informed the stu-dents immediately which areas were unsatisfactory. The stu-dents were then given the opportunity to repeat their evalu-ation of the blood smear. Overall, the program correctly as-sessed the students’ results. Even though the program wasnot written as a tutorial, the immediate response given tothe students was perceived to help improve their ability toaccurately perform a differential (Spearman rho = 0.604, p =0.013). While the program was initially designed as a grad-ing tool, by incorporating meaningful feedback and a tuto-rial, the program could also become a teaching tool.


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Estimated Incidence of Sickle Cell Anemia and HIVInfection in Northeastern HaitiTim R Randolph MS CLS(NCA), Saint Louis University, StLouis MO.

The purpose of this study was to estimate the incidence ofsickle cell anemia and HIV infection among subjects likely toutilize Bethesda Medical Clinic in Vaudreuil, Haiti. Haiti isone of the poorest countries in the Western Hemisphere withminimal access to healthcare. HIV and sickle cell disease aretwo of many serious health issues. Knowledge of disease preva-lence will improve laboratory test ordering practices and diag-nostic decisions. Sickle cell and HIV screening was offered toclinic patients, staff, and local residents on a regular clinic day.Capillary punctures were performed on 61 patients. All 61had sickle cell testing and 59 also had HIV testing performed.The hemoglobin solubility technique was used for sickle celltesting and an immunochromatographic method was per-formed to detect HIV antibodies. Of the 61 subjects, 31(50.8%) were clinic patients being seen for pregnancy follow-up, 10 (16.4%) were clinic staff and the remaining 20 (32.8%)were local residents. The incidence of sickle cell was 14.8%and HIV was 3.4%. According to other reports, the estimatedincidence of sickle cell and HIV in Haiti is approximately25% and 5%, respectively. The incidences determined in thisstudy are considered estimates because no confirmatory test-ing was available.

Incorporation of Management Skills in an Under-graduate Medical Laboratory Science DegreeRalph E B Green FAIMS, RMIT University, MelbourneAustralia.

Management skills are incorporated at two points in theMedical Laboratory Science degree conducted at RMITUniversity. The third year full-time 40-week ProfessionalPractice program provides an opportunity for students toenroll in a concurrent Diploma in Frontline Managementthat is conducted according to a national curriculum. Thisprogram is seen by many employers as an entry-level man-agement program and is based on workplace assessment ofcompetency. Approximately two thirds of the competenciesthat students are required to demonstrate in ProfessionalPractice align with the competencies required for the Di-ploma in Frontline Management. In fourth year, studentsare required to take a course in medical informatics and labo-ratory management. The medical informatics componentincludes principles of digitizing information, digital imag-

ing and analysis, expert/knowledge-based systems, labora-tory information systems, and telepathology. The laboratorymanagement component includes topics on leadership,change management, automation, point of care testing,healthcare economics, quality systems, and laboratory ac-creditation. Medical scientists who have specialized in manyof these fields provide a number of the lectures and illustratealternative future career paths following graduation for finalyear students.

Nutritional Status in Pregnant Women at the First Pre-natal VisitChristina Thompson EdD CLS(NCA), Sandra Cabrera MSCLS(NCA), Texas A&M University-Corpus Christi, Cor-pus Christi TX.

Research demonstrates the importance of nutrients, vitamins,and minerals not only on the health of normal adults, butalso on the health of the developing fetus. The purpose ofthis study was to evaluate the nutritional status of pregnantwomen at their first pre-natal visit. Two blood samples wereobtained from a total of 133 patients during the months ofMay, June, and July at two clinics in the Corpus Christiarea. One clinic was a private women’s center and the otherclinic was associated with the city/county health department.An EDTA sample was used for hematocrit testing and a clotsample was collected for serum iron, ferritin, andtransthyretin (prealbumin) testing. The patients ranged inage from 15 to 43 years and gestation ranged from 4 to 39weeks. Fifty-three percent of the patients were in the firsttrimester and 8% in the last trimester. Fifteen percent of thepatients had hematocrits below 35%. Twenty-one percentof the patients at the health department clinic had a hemat-ocrit below 35%. The mean pre-albumin was significantlylower (p <.05) at the private clinic (15.5 mg/dL) than at thehealth department (17.8 mg/dL). Fifteen percent of the pa-tients at the private clinic had a pre-albumin below the nor-mal 10 mg/dL.

Universal Leukocyte Reduced Transfusions: Cost andBenefitsDeborah McCaskill MT(ASCP) SBB, Michael ConstantinescuMD, Diana Veillion MD, Linda Hawthorne MT(ASCP) SBBMHS, Debbie McDaniel MT(ASCP), Xin Gu MD, Louisi-ana State University Health Sciences Center, Shreveport LA.

The purpose of this study was to determine the benefits andcost of universal leukocyte reduced transfusions (URLT) inour institution. The use of URLT is controversial and itsfinancial impact cannot be readily assessed. The definite ben-


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efits of leukocyte reduced products are prevention of febrilenonhemolytic transfusion reactions (FNHTR), HLAalloimmunization, e.g., prevention of platelet refractoriness,and cytomegalovirus (CMV transfusion related transmis-sion). In our study we evaluated the benefits of ULR trans-fusions as measured by the total FNHTR. In the six-monthperiod prior to the implementation of ULRT, there were 6FNHTR/5450 units (0.11%), compared with 0 FNHTR/5639 units (0%) with ULRT. Each filtered RBC unit costs


an additional $16, with a total additional cost/six-monthsof $90,224. There were 1150/5639 (20.4%) of total unitstransfused in trauma patients in whom prevention ofalloimmunization, CMV transmission, and FNHTR maynot be significant in the larger clinical trauma picture. Theadditional cost was approximately $18,400. We concludethat while ULRT eliminated FNHTR, it also represents anunnecessary financial burden on our institution, especiallywhen used indiscriminately.

STUDENT RESEARCH ABSTRACT

This student research paper is the winner of the ASCLSEducation Scientific Assembly (ESA) 2003 competitionfor CLS/CLT student research papers and case studies.Student Research Papers were to address scientific aswell as applicable educational, technical, administrative,consulting, and management studies. The student mustbe a current ASCLS member and have been enrolled ina NAACLS accredited CLS/CLT program at the timethe research was conducted. The student winner of theresearch paper award receives an all-expense paid trip tothe ASCLS annual meeting in Philadelphia, Pennsylva-nia on July 22-26, 2003, to present their paper and willbe honored at the awards ceremony during the ASCLSannual meeting. In addition the paper will be submittedfor publication in a future issue of the journal ClinicalLaboratory Science.

Rapid Detection of West Nile Virus in Birds Using theVecTest™ WNV Antigen AssayGay Henson, University of Mississippi Medical Center,School of Health Related Professions, Department ofClinical Laboratory Sciences.

OBJECTIVE: To determine if the VecTest™ WNV An-tigen Assay (for testing mosquitoes) could be adapted todetect West Nile virus rapidly and accurately in birdsfor screening purposes.

DESIGN: Cloacal swabs and tissue (kidney and spleen)were harvested from forty fresh dead birds. TheVecTest™ was used for each swab specimen for detec-tion of West Nile virus and PCR was used for each tis-sue specimen for confirmation of West Nile virus.

SETTING: Mississippi Veterinary Diagnostic Labora-tory (MVDL) in Jackson, Mississippi and College of Vet-erinary Medicine-Mississippi State University (CVM-MSU) in Starkville, Mississippi.

SPECIMENS/SUBJECTS: Forty birds of the Corvidfamily (31 Bluejays and 9 American Crows) were in-cluded in the study. Fresh dead birds that died from noobvious cause were submitted for testing.

RESULTS: VecTest™ results were 35 positives and 5negatives. PCR results were 35 positives and 5 negatives.

CONCLUSION: VecTest™ showed 100% accuracy.

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CALL FOR ABSTRACTS

POSTERS AND TECHNOLOGY DEMONSTRATIONS

2004 CLINICAL LABORATORY EDUCATORS CONFERENCEFebruary 26-28, 2004 Milwaukee, Wisconsin

AMERICAN SOCIETY FOR CLINICAL LABORATORY SCIENCE

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EDUCATION SCIENTIFIC ASSEMBLY

This form must accompany all submitted abstracts.Abstracts must be received by OCTOBER 1, 2003.

Abstract Title:__________________________________________________________________________________________________________________________________________

Presenting Author:_____________________________________________________________________

Street Address: ___________________________________________________________________________________________________________________________________________________________________________

City/State/Zip: _________________________________________________________

Work Phone: ( ) ________________

Fax Number: ( ) ________________ ASCLS Member Number: __________

E-mail Address: _________________________________________________________

Format Requested: [ ] Poster [ ] Technology Demonstration

Signature of Presenting Author: ____________________________________________

E-mail this completed form, abstract, and multiple choice questions and answers by OCTOBER 1, 2003 to:[email protected]; Joan Polancic, ASCLS Director of Education and Project Planning. This form may be faxedto 303-904-8933, Attn: Joan Polancic.

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2004 CLINICAL LABORATORY EDUCATORS CONFERENCE

ABSTRACT SUBMISSION INSTRUCTIONS

GENERAL1. Abstracts must be submitted according to the instructions provided and be received no later than OCTOBER 1,

2003. Failure to follow format instructions will result in rejection of the abstract.2. A nonmember may submit an abstract for presentation if an ASCLS member coauthors the abstract. All presenting

authors must register for the meeting.3. The technology demonstrations are for authors only, not retailers. Those individuals who wish to exhibit their pro-

grams for market purposes must buy an exhibit booth from CLEC.

PREPARATION OF COPYAll abstracts must be typed double-spaced on plain, white 8 + x 11-inch paper with one-inch margins. Recommendedtypeface is Times New Roman, 12-point type. Abstract text format is flush left. Text length (not including title andauthor information) must be 200 to 250 words, not to exceed 250 words. A single space return should be used to separatetitle, author information, and abstract.

1. Title: Use a concise title that reflects the abstract content. Capitalize the first letter of the first word and all otherwords except prepositions, conjunctions, and articles. Underline scientific genus and species names of organisms.Acronyms, abbreviations, and initialisms cannot be used in a title.

2. Author/Institution: Type authors’ names, first name first. Asterisk (*) the name of the presenting author. Academicdegrees are limited to the highest degree earned. Authors should use the NCA credential (when applicable). On thenext line type the institutional affiliation of the authors. Do not include any other information (i.e. department,division, etc.). On the next line, list the city and the state of the institution.

3. Abstract: Begin typing the abstract on a new line and flush with the left margin. The abstract should be a oneparagraph concise summary of the: 1) problem, 2) method/design/intervention used, 3) results/outcomes measure-ments, and 4) conclusions/applications/implications.

4. P.A.C.E.® Credit Questions: In order to be granted continuing education contact hours, participants attending theposter and technology demonstration sessions must submit answers to questions related to the problem, methods, andoutcomes presented in the respective poster/demo sessions. For this purpose, three multiple-choice questions withanswers must be submitted along with the abstract. Questions submitted should address information that can only begained by viewing the poster; this is a way to reinforce the objectives or conclusions of the presentation. These ques-tions are in addition to the 250 maximum word limit for the abstract.

5. Submission requirements: Submit the completed application form, the abstract, and three multiple-choice questionsand answers (MS Word or WordPerfect) by email to Joan Polancic, Director of Education and Project Planning [email protected] (you may FAX the submission form to 303-904-8933, attn: Joan Polancic). Hard copies are nolonger required. All materials must be received by October 1, 2003.

ACCEPTANCE PROCEDUREAppointed representatives of the ASCLS Education Scientific Assembly will review abstracts. Submitters will be notified bymail for acceptance/rejection of the abstract in December 2003. Date and time of presentation will be included in theacceptance letter. NOTE: Abstracts not postmarked by the deadline will be rejected without review or author notification.

MODE OF PRESENTATIONThe program committee will schedule both poster sessions and technology demonstration sessions. For poster sessions,each author is provided an approximately 4-foot-high x 8-foot-wide bulletin board on which to display a summary of thepaper. For technology demonstrations, a table with electrical service will be provided for set-up. Authors are responsiblefor providing their own equipment and making any special arrangements for hook-up. Authors remain at their poster/demonstration site for the duration of the time specified to present and answer questions from attendees.

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REPOR TS AND REVIEWS

Assessing Reliability and Validity Measuresin Managed Care Studies

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ISAAC D MONTOYA

BACKGROUND: To review the reliability and validity lit-erature and develop an understanding of these concepts asapplied to managed care studies.

RESULTS: Reliability is a test of how well an instrumentmeasures the same input at varying times and under varyingconditions. Validity is a test of how accurately an instru-ment measures what one believes is being measured.

METHODS: A review of reliability and validity instruc-tional material was conducted.

CONCLUSIONS: Studies of managed care practices andprograms abound. However, many of these studies utilizemeasurement instruments that were developed for other pur-poses or for a population other than the one being sampled.In other cases, instruments have been developed without anytesting of the instrument’s performance. The lack of reliabil-ity and validity information may limit the value of these stud-ies. This is particularly true when data are collected for onepurpose and used for another. The usefulness of certain stud-ies without reliability and validity measures is questionable,especially in cases where the literature contradicts itself.

INDEX TERMS: Managed care; reliability; validity.

Clin Lab Sci 2002;16(3):153

Isaac D Montoya PhD CMC CLS(NCA) is Clinical Profes-sor, College of Pharmacy, University of Houston, Houston TX.

Address for correspondence: Isaac D Montoya, College of Phar-macy. University of Houston, 3104 Edloe, Suite 330, HoustonTX 77027.

Continuing Education Credit: see pages 163 to 165 for learn-ing objectives, test questions, and application form.

LEARNING OBJECTIVESAfter completing this article, the reader will be able to:1. define measurement, describing sources and types of mea-

surement errors.2. define reliability and validity.3. cite numerical ranges for reliability and validity.4. describe how reliability and validity are each calculated.5. explain how reliability and validity relate to measurement

error(s).6. apply reliability and validity concepts to the evaluation of

managed care and similar studies.7. describe the relationship between a theoretical concept

and its operationalization.8. list and define the types of validity that apply to evalua-

tion of managed care and similar studies, includingmethod(s) of measurement.

The introduction of the managed care paradigm has had agreater impact on healthcare delivery than any other singledevelopment. All aspects of healthcare have been substantiallyinfluenced by managed care. This paradigm has mandatedthat practitioners of both physical and behavioral medicinere-examine their clinical practices and protocols, focusing onefficiency and quality measures in an effort to control costs.The value of these measurements has been inconsistent dueto the complex nature of measuring healthcare outcomes. Theemphasis of the managed care paradigm is on efficiency with-out the sacrifice of quality. To accurately assess this, outcomemeasures must be employed to evaluate clinical improvements;such measures have been the subject of countless studies at-tempting to evaluate them. Some of these studies are complexand credible scientific research efforts, while others are sim-pler attempts merely to understand a particular intervention.The purpose of this paper is to examine those tools essentialin high quality studies of managed care that measure actualchanges resulting from this new paradigm.

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The Reports and Reviews Section seeks to publish information on im-portant clinical laboratory-related topics such as technological, clinical,and experimental advances and innovations. Case studies and litera-ture reviews are also included. In addition, brief reviews of books, com-puter programs, audiovisual materials or other materials of interest toreaders are appropriate for this section. Manuscripts and literature re-views published as a Report are peer reviewed. Direct all inquiries toIsaac Montoya PhD, Affiliated Systems Corporation, 3104 Edloe, Suite330, Houston TX 77027-6022. (713)439-0210, (713)439-1924(fax). [email protected]

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It is often the case that scientists are interested in measuringconcepts that are not directly observable. Concepts such as‘kidney failure’, ‘cardiac disease’, ‘self-esteem’, or ‘depression’must be estimated using such variables as clinical laboratorymeasurements or responses to a questionnaire. The processby which a theoretical concept, such as ‘self-esteem’, is mea-sured is called the ‘operationalization’ of the concept. Whena concept is operationalized, it is represented by an observ-able variable as illustrated in Figure 1.

As the theoretical concept and the observable variable aredistinct from each other, the question always arises as to theadequacy of the observable variable as a direct and meaning-ful measure of the concept. Obviously, the utility of the ob-servable variable for research depends on how well the vari-able captures the meaning of the concept. Reliability andvalidity are the two standard criteria by which the adequacyof the measurement can be assessed.

A note on terminology—when an observable variable is beingused to estimate the value of an unobservable theoretical con-cept, the process is referred to as ‘measurement’. Thus, a ques-tionnaire item such as “your feelings are easily hurt” is beingused to measure the theoretical concept of self-esteem. Whenan attempt to assess the quality or adequacy of the process ofmeasurement is made, we say that we are making an assessmentof the measurement. When we ask how well the item “yourfeelings are easily hurt” measures self-esteem, we are assessingthe validity of the item. When we ask how consistently respon-dents answer the item, we are assessing the reliability of theitem. The meaning of reliability and validity are considered next.

RELIABILITYReliability deals with the consistency of a measure.1 Reliabil-ity assesses the extent to which an experiment, test, or anymeasurement yields the same results on repeated traits.2 Con-sistency of an observable variable, as shown in Figure 2, cancome from the validity of the variable as a measure of thetarget theoretical concept (t). Consistency can also come fromother sources to the extent to which the observable variablemeasures some other concept, usually not intended (b in thefigure). In Figure 2, e summarizes all the (random) sourcesof nonreliability.

VALIDITYValidity is the extent to which an observable variable suc-cessfully measures (estimates the value of ) a given theoreti-cal concept.1,2 Thus validity is always described in terms ofan observable variable and a theoretical concept. In Figure2, the validity of the item as a measure of self-esteem is givenby the arrow t. If we can estimate the value of t, this estimatewill be the assessment of the validity of the item as a mea-sure of the concept. In the figure, b and e summarize all thesources of nonvalidity.

Thus validity is an assessment of how well one has done themeasurement job from the perspective of theory. Validity isthe purpose of measurement. Validity is, as we shall see, verydifficult to assess because the very assessment process requiresjudgments about theory. Reliability is a more limited assess-ment of how well one has done the measurement job. How-ever, it is easier to assess because the assessment can be car-ried out empirically without reference to the theory.

ASSESSMENT OF RELIABILITYClassical Test Theory or True Score Theory (TST) is a theoryabout measurement.3-6 According to TST, any measurementhas two components: the true value of the theoretical con-cept, and an error component. Thus, any measure can berepresented by:

(1) x = X + error

where x = observed score (value of the observable variable),X = true score (value of the theoretical variable), and error =the deviation of the value of the observed variable from thevalue of the theoretical concept.

Two types of errors exist; random error and systematic error.Random error is caused by any factor that randomly affectsthe measurement of a variable across the entire sample. For

REPORTS AND REVIEWS

Figure 1. A concept and its measurement

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example, a person’s mood at the time ofcompleting a health questionnaire is asource of random error. Some individu-als may be in a ‘bad mood’ as they aretaking the test while others may be in a‘good mood’. Random errors do nothave any systematic effects on thesample. They just push observed scoresupward or downward randomly. Be-cause there will be as many positives asnegative errors, the expected mean ofrandom errors will be zero. Randomerrors add variance to the data, but donot affect the average performance forthe group. Because of this, random er-rors are sometimes called noise. Figure3 illustrates the effect of random errorsin the measurement.7 In Figure 2, ran-dom error is indicated by the arrow e.

Systematic errors, on the other hand,are caused by factors that systematicallyaffect the measurement of the variableacross the entire sample. Unlike ran-dom errors, systematic errors can beconsistently either positive or negative.Systematic errors are sometimes calledbias in measurement. For example, ifthere is a loud noise outside the roomwhere the patients are completing

questionnaires, the noise will affect theresponses for all patients, depending onthe susceptibility of each patient tonoise. Another example is the readinglevel of each patient: if the reading levelof the measuring instrument is abovethe reading level of some patients, thenthe scores of those patients will be bi-ased (usually lowered). Figure 4 illus-trates the effect of systematic error inthe measurement of a concept.7 In Fig-ure 2, bias (systematic error) is indi-cated by the systematic error term b.

Because the error term in equation 1is composed of two parts, equation (1)can be rewritten as:

(2) x = X + Z + ε,

where x and X are as described above,Z is the unstandardized systematic er-ror and ε is the unstandardized ran-dom error. In this equation, X + Z, thecombined score, represents the con-stant part of the measure x, part ofwhich represents the intended conceptX and part of which represents othersources of stability (bias). This stablepart can be represented as W.

REPORTS AND REVIEWS

(3) x = W + ε

When one is concerned about reliabil-ity, this equation is a useful transfor-mation. When one is concerned aboutvalidity, this transformation is inappro-priate because it confuses X, the sta-bility from what one wants to measurewith Z, the stability from unintendedeffects.

Another way to write equation (2) iswith standardized variables. This shiftsthe focus from the descriptive view ofx as composed of multiple scores. In-stead it conceptualizes x in terms of thecauses of its observed value. When thevariables x, X, Z, and e are standard-ized, the equation becomes:

(4) x = tX + bZ + eε = rW + eε,

where t is the validity of concept X, bis the validity of all other systematicsources of error (concepts) not in-tended, r is the effect of the compositeconcept W, and e is the effect of ran-dom error.

The TST assumptions can be pre-sented more formally as:a) E(ε) = 0;b) ρxz = 0;c) ρxε = 0 and ρwε = 0; andd) ρε

1ε

2 = 0.

Assumption (a) implies that the ex-pected mean error score is zero. As-sumption (b) states that the correlationbetween the true score and the bias iszero. Assumption (c) implies that thecorrelation between the error and thetrue score is zero, as well as the corre-lation between the error and the com-bined score. Assumption (d) states thatthe correlation between errors on dif-ferent measurements is zero.

Figure 2. Reliability and validity

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Reliability, however, is not meant to capture the consistencyof a measure for an individual, but rather the consistency of ameasure across individuals. Thus,

(5a) Var(x) = Var(rW + eε) = r2 + e2,

in terms of effects, and

(5b) Var (x) = Var(W + ε)=Var(W)=Var(ε),

in terms of scores,

when X, Z, and ε are standardized and given the assump-tions (a) through (c) above. Similar results to (5a) are givenin Heise, and to (5b) in Pindyck and Rubinfeld.4,8

Equation (5a) shows the variance of x, a standardized vari-able, and r represents the stable, consistent factors determin-ing x; the reliability (consistency) of x is given by the pro-portion of variance in x that is due to W:

(6) ρx = r2 ÷ r2= e2 = Var(W) ÷ Var(W) + Var(ε)

Reliability then is a ratio or fraction of the combined scorevariance to observed variance. In other words, reliability maybe defined as the proportion of consistency in the measure.Reliability thus varies between 1 and 0. Because x = rW +eå, by equation 5, equation 6 can be re-written as

(7) ρx =r2 ÷ r2 + e2 = Var(W) ÷ Var(W) + Var(ε)

If a measure is perfectly reliable, then there is no randomerror in measurement. That is, all we observed is the com-

bined score (that is, true score and bias or systemic error).Thus, for a perfectly reliable measure, ε will be zero, and ε

x =

1. On the other hand, if we have a perfectly unreliable mea-surement, there is no true score (t and b are zero). The mea-surement is entirely error. In this case, the above equation isreduced to:

(8) ρ = 0 ÷ e2 = 0 ÷ VAR(ε) = 0

Thus, reliability will always vary between 1 and 0. The valueof the reliability assessment tells us the proportion of vari-ability in the measure attributable to the combined score.For example, a reliability of 0.5 tells us that about half of thevariance of the observed score is attributable to the com-bined score and half is attributable to random error. A reli-ability of 0.8 means a variability is about 80% combinedscore and 20% random error and so on.

We have seen that the term reliability means ‘repeatability’or ‘consistency’. That is, a measure is considered reliable tothe extent that it gives the same result repeatedly (assumingthat what we are measuring isn’t changing).

In the following section, X is represented by x, t is repre-sented by W, and e is represented by epsilon (ε). Since reli-ability is based on consistency, the assessment of reliability isbased on the comparison of two or more measurements. Suchmeasurements are described as “parallel measurements.” Anassessment of a measure’s reliability can be obtained by cor-relating parallel measurements. Two measurements are saidto be parallel if they have identical composite scores andequal variances. Thus x and x’ will be parallel if:

(9) x = W + ε

REPORTS AND REVIEWS

Figure 3. Random error

Figure 4. Bias (systematic error)

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and

(10) x’ =W + ε’

where Var(ε) = Var(ε’).

Thus, parallel measurements are dis-tinct from one another, but similar andcomparable in many ways. Parallelmeasurements have the same value ofthe theoretical composite variable W,and the differences between parallelmeasurements are the result of purelyrandom errors. The correlation be-tween parallel measurements can be ex-pressed as:

(11) ρxx’

= σxx’

÷ σxσ

x’

since X = t + e, then

(12) ρxx’

= σ(t+e)

σ(t+e’)

÷ σxσ

x’

Distributing terms,

(13) ρxx’

= σt2 + σ

te + σ

et + σ

ee’ ÷ σ

xσ

x’

Because the errors are uncorrelatedwith composite scores (assumption c)and uncorrelated with each other (as-sumption d), and because the variance,hence the standard deviations, of par-

allel measures are assumed to be equal,equation 13 reduces to:

(14) ρxx’

= σt2 ÷ σ

x2

That is, the correlation between par-allel measures is equal to the compos-ite score variance divided by the ob-served variance. Rearranging terms,the unobservable composite scorevariance can be expressed as:

(15) σt2 = σ

x2ρ

xx’

From equation 6 where reliability wascomputationally defined, and substi-tuting, we have:

(16) ρx = σt2 ÷ σx

2 = σx2ρxx’ ÷ σx

2 = ρxx’

Thus, an assessment of reliability canbe obtained by estimating the correla-tion between parallel measures. For ex-ample, if we have two or more itemsor a single item measured at two dif-ferent times we can assess the reliabil-ity of the measurement.

Returning to the effects model of equa-tions (4), (5a), and (6), reliability isequivalent to the following:

(17) ρxx’

= r2 = t2 + b2

REPORTS AND REVIEWS

Figure 5. Assessing test-retest reliability

METHODS FOR ASSESSING RE-LIABILITYThe next question is how one can findparallel measures so that reliability canbe assessed. There are four differentmethods of obtaining parallel mea-sures: test-retest, alternative forms,split-half, and internal consistencymethods2. Each of these methods isexplained below.

Test-retest methodThe test-retest method of establishingreliability entails administering thesame instrument twice to the samegroup of individuals under the sameconditions after some time interval haselapsed. The correlation coefficientbetween the first test and the retest iscalled coefficient of stability. As the nameindicates, it gives an assessment of howstable the results are over a given timeperiod. The shorter the period betweentests, the higher the coefficient of sta-bility. However, if the time intervalbetween test and retest is very short,the participant is likely to rememberhow he/she answered the first time.This will give a misleadingly high co-efficient of stability.

An example of an assessment of test-retest reliability is given in Figure 5. Inthis figure we see how the correlationbetween the item at two points in timeis equal to r2. This method assumes thatthe value of the theoretical conceptdoes not change from time 1 to time2. It assumes that the item reflects thetheoretical concepts (r) at each timeperiod equally well and that the ran-dom error effect is the same at eachtime period. It assumes that the sumof the effects of X and Z remains con-stant from time 1 to time 2 (there arenot any different stable effects at thetwo time periods). Because the sameitem (or the same scale or the sameinstrument) is being administered at

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two times with the assumption that theunderlying theoretical concept has notchanged, time stability is taken as thecausal effect of the theoretical concepton the observable variable.

Alternative-form methodThe alternative or equivalent formmethod entails administering the re-search instrument to the same groupof individuals at two different timesusing different, but equivalentforms.6,10,11 The reliability coefficientis called the coefficient of equivalence.A high coefficient of equivalence indi-cates that both research instruments areassessing similar contents of the instru-ment. This method is illustrated in Fig-ure 6, where two items are taken asequivalent measures of the self-esteemtheoretical concept. This method as-sumes that each item (or each scale oreach instrument) involves exactly thesame causal effect from the theoreticalvariable and takes the consistency ofresponses as an assessment of the causaleffect of the theoretical concept oneach of the alternative forms of theitem (scale, instrument).

Split-half methodThe split-half method is the most fre-

quent method used to assess reliabil-ity.2,6,11 Under this method, the researchinstrument is administered to a groupof respondents and then the items aresplit in half, for example odds and evens,for purposes of scoring. The results ofthe two halves are then compared. Theassociation between the two halves iscalled the coefficient of internal consis-tency and measures the degree to whichthe two halves are equivalent. In Figure6, this process is represented as the com-parison of one item with another (al-though the comparison can be of sev-eral items with several other items). Thesplit-half method offers a clear advan-tage in terms of time and resources overthe test-retest and the alternative formmethods in that it does not require thetest to be administered twice to the samegroup of respondents.

The correlation between the two halvesof the test, however, is a measure of thereliability for each half of the test ratherthan the total test as correlations onfewer items are usually less than on moreitems. Thus, a statistical correctionshould be made so that the researchercan get an assessment for the whole test,not just for the odd or even questionsof the test.2,6,11 This procedure is known

REPORTS AND REVIEWS

as the Spearman-Brown prophecy for-mula. If the total test is twice as long aseach half, the Spearman-Brown formulawill be given by:

(18) ρxx’’ = 2ρxx’ ÷ 1 + ρxx’

where ρxx’’

is the reliability coefficientfor the entire test and ρxx’ is the split-half correlation. For example, if thesplit-half correlation is 0.75, the reli-ability for the whole test is (2 * 0.75)/(1 + 0.75) = 0.857.

One disadvantage of the split-method,however, is that the reliability obtainedmay depend on the number of waysthe instrument is subdivided. For ex-ample, it is possible that the correla-tion between the first and secondhalves of the test may be different thanthe correlation between odd and evenitems in the test. Thus using the split-half method, it is possible that reliabil-ity may differ even though the sameitems are administered to the same in-dividuals at the same time.

Internal consistency methodAs seen above, even the split-halfmethod is not without its shortcomings.However, there are other methods of es-timating reliability that do not requireeither the splitting of the items nor therepeating of items. The internal consis-tency method is one such method. Un-der the internal consistency method, asingle test is administered. Within thetest, questions are grouped together thatmeasure the same concept and are thenused to assess reliability of that portionof the test.

Another and more common way ofcomputing correlation values amongthe questions in an instrument is theCronbach’s alpha. The Cronbach alphasplits all the questions on the instru-ment every possible way and computes

Figure 6. Assessing alternate forms, split-half, and internal consistencyreliability

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correlation values for all of them (us-ing a statistical software program suchas SPSS or SAS). At the end, the soft-ware program will generate a numberfor Cronbach alpha and just like a cor-relation coefficient, the closer it is toone, the higher the reliability assess-ment of the instrument. TheCronbach’s alpha can be defined as:

(20) α = [N ÷ (N – 1)][1 – (Σσ2Yi ÷ σ

x2)]

where N = the number of items, Σσ2Yi

is the sum of the items variances, andσ

x2 is the total variance. Alternatively,

the Cronbach alpha may be defined as:

(21) α = Nρ_ ÷ [1 + ρ

_(N – 1)]

where N is the number of items, and ρ_

is the mean of the inter-item correlation.

In both cases the alpha coefficient canbe interpreted as the expected correla-tion of one test with an alternative formcontaining the same number of items.

If the responses are dichotomies (1 or0), however, one can use the Kuder-Richardson formula given by:;

(22) KR20 = N ÷ N-1[1 - Σρ(1 – ρ) ÷ σx2]

where N is the number of dichotomousitems, p is the proportion responding‘yes’ to the item, ρ

x2 is the variance of

the total test. KR2O has the same in-terpretation of the regular alpha.

RELIABILITY SUMMARYReliability is one important perspec-tive from which to assess theoperationalization of a concept. How-ever, because all measurement involvesuncertainty, not only because of ran-dom error, but also because of the in-volvement of unobservable theoreticalconcepts, reliability cannot be assessedwith absolute accuracy. It must be es-timated from fallible data. There arefour methods to assess reliability: test-retest, alternative form, split-half, andinternal consistency methods. As dis-cussed above, both the test-retest andthe split-half methods have shortcom-ing as estimators of reliability. Themain shortcoming of the test-retestmethod is that experience of the firsttesting can influence the responses inthe second testing. The shortcomingsof the split-half method, on the other

REPORTS AND REVIEWS

hand, are that correlation betweenhalves will differ depending on how thetotal number of items in the instru-ment was divided. The internal con-sistency method is easy to use becauseit requires only a single test adminis-tration. Regardless of the method usedto assess reliability, researchers agreethat reliability should not be below0.80.2 Furthermore, it is not only im-portant to achieve a high reliabilitylevel, but also it is important to reporthow reliability was assessed.

ASSESSMENT OF VALIDITYThe second tool in evaluating the opera-tionalization of a concept is validity.Validity may be defined as the extentto which any measuring instrumentmeasures what it is intended to mea-sure.2 There are three common typesof validity common to the social sci-ences: content related, criterion-re-lated, and construct validity.2,6,10,11

Each of them is explained below.

Content validityMeasuring how well the operation-alization of the concept compares to therelevant content domain for the con-cept assesses content validity. Thus, it ismostly applicable to concepts measuredby multiple items. Content validity isassessed by the extent to which empiri-cal measurement reflects the specificdomain of the theoretical concept. Forexample, a test on mathematical abilitywill not be content-valid if it only in-cludes summation problems and ne-glects subtraction, division, and others.Thus, content validity deals with thethoroughness or completeness of itsobservable variables. Content validityshould answer the question of whetherthe assessment strategy covers the ma-jor dimensions or factors of the subjectmatter under assessment.

Figure 7. Assessment of validity

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Content validity, unlike criterion and construct validity, isnot assessed statistically. The assessment of content validityis a subjective judgment by the investigator, observer, orgroups of subject matter experts. Like all validity issues, con-struct validity depends directly on theory. In this case, thetheory involves the definition of the theoretical variable. Con-tent validity can be neither achieved nor assessed unless thedimensions of the theoretical concept are clearly and explic-itly defined. Content validity is directly and exclusively anassessment of measurement theory.

Criterion-related validityAll assessments of validity involve theory. All assessments ofvalidity involve measurement theory (the effect of the theo-retical concept on the observable variable) because it is theassertion that the observable variable measures the targetconcept that is being assessed. The most convincing assess-ments of validity also involve substantive theory, in whichthe target concept is tied to a related criterion concept.

In criterion-related validity one checks the performance ofthe operationalization against some criterion. For this to bedone there must be an acknowledged and accepted theorythat the target variable is causally related to the criterion con-cept. The assessment of criterion validity is depicted in Figure7. We see, as in Figure 2, that a target concept is being mea-sured (operationalized) by an observable variable. That is, thevalues on the observable variable are seen to depend causallyon the theoretical variable. The observable variable is also seento be dependent on other theoretical concepts as well, con-cepts that may be known or not known. The effect of the

target concept X on the observable variable x is measured by t.In addition, the effect of the (unknown) other concept(s) Zon the observable variable is b. The coefficient t is the validitycoefficient. The coefficient b is the bias in measurement.

The assessment of criterion validity involves computing acorrelation coefficient (r in Figure 7) between the measureof the target concept and the measure of the criterion con-cept. Mathematically, in all assessments of criterion validity,it is assumed that Z, the unmeasured and unknown otherthings that affect the observable variable are not associatedwith the criterion concept, (i.e., d = 0), so that r = tac. In thisanalysis, t, a, and c are standardized effects, so that their prod-uct varies in absolute value between 0 and 1. If the

r = tac + bdc

criterion variable is considered to be a very good measure ofthe criterion concept (c is approximately equal to 1) and ifthe criterion theory is considered to be very strong (a is ap-proximately equal to 1), then the correlation coefficient r isapproximately equal to the validity coefficient t.

If the theory describes an effect in the future (or in the past),criterion validity is called “predictive validity”.5 If the theorydescribes an effect in the same time period, criterion validityis called “concurrent validity”. In predictive validity, for ex-ample, a measurement of mathematical ability should be ableto predict how well a person will do in an engineering pro-fession. A high correlation between the observable measureof mathematical ability and the observable measure of engi-neering professional success is taken as an assessment of howwell the mathematical ability observable variable measuresthe mathematical ability theoretical concept.

A limitation of using criteria-related validity is that one oftenlacks well established theory with which the measurement canbe evaluated. Another limitation is that the validity assess-ment of the observable variable against its target concept isalso an evaluation of the theory that links the target conceptwith the criterion concept and the measurement theory thatlinks the criterion concept and the criterion measure.

Construct validityConstruct validity assesses the extent to which the observ-able variable measures the theoretical concept by comparingthe observed variable(s) with observed variable(s) of relatedconcepts. That is, construct validity is concerned with theextent to which a particular measure relates to measures of

REPORTS AND REVIEWS

Figure 8. Assessment of construct validity:convergence

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the same or different concepts. Con-struct validity is assessed by conver-gence and by discriminability.

ConvergenceConvergence refers to direct attemptsto measure the same concept by mul-tiple methods or in multiple settings.1

Convergence is depicted in Figure 8.Kerlinger describes how convergenceis used to assess construct validity.1 InFigure 8, a new observable variable (orset of variables) is being assessed as ameasure of the target concept. This isaccomplished by computing the asso-ciation between the new observable vari-able and another observable variablethat is recognized as already providingadequate measurement of the targetconcept. For example, computing thecorrelation of the new measure with theBeck Depression Scale assesses a newmeasure of depression. Thus the oldobservable variable is used to assess theadequacy of the new theoretical variable.A variation on convergence is to com-pare the observable variable with a mea-sure of a closely related concept. It is, of

course, a theoretical issue as to the close-ness of two concepts.

DiscriminabilityDiscriminability refers to assessments ofan observable variable as a measure of atarget concept by comparing the observ-able variable with observable variablesof unrelated concepts. Discriminabiltyis depicted in Figure 9.

The adequacy of the observable variableas a measure of the target concept is as-sessed by computing the association be-tween the observable variable and anotherobservable variable measuring a conceptthat is known or expected to have a verydifferent meaning than the target concept.In this case a correlation near zero is con-sidered to provide some evidence for theadequacy of the observable variable.Discriminability is always assessed along-side of convergence. It is not consideredinformative that an observable variable isnot associated with unrelated conceptsunless it is simultaneously shown that theobservable variable is associated with othermeasures of the same concept or closelyrelated concepts.

REPORTS AND REVIEWS

Validity summaryAs seen above, validity is more diffi-cult to assess than reliability. Unlikereliability, the assessment of validity ismore closely linked to the theory un-derlining the concept. There are threebasic forms to assess validity. Contentvalidity focuses on content relevanceand coverage. It assesses whether theitems on the test are part of theconcept’s domain and whether theitems included represent the breadthof the concept. Criterion-related valid-ity assesses the measurement accord-ing to the predictive or concurrent util-ity of the measurement. That is, crite-rion-related validity assesses the ad-equacy of the measurement at the sametime that it assumes the predictive orconcurrent adequacy of the theory. Fi-nally, construct validity compares theobservable variables of the target con-cept to observable variables of the sameor different concepts.

RELIABILITY AND VALIDITYSUMMARYValidity and reliability are both impor-tant tools to assess the operationalizationof a concept. A measure can be very re-liable, but not valid. That is, a measurecan never be more valid than it is reli-able. And of course a measure can beneither reliable nor valid. The goal ofthe managed care study should be tohave a measurement that is both reli-able and valid.

CONCLUSIONThe use of reliability and validity mea-sures in studying managed care greatlyimproves the scientific rigor and qual-ity of research and evaluation studies.Only when it has been established thatthe instruments used in managed carestudies are consistent and actually mea-sure the parameters of the variable thatthey purport to measure, will it be pos-sible to develop outcome measures that

Figure 9. Assessment of construct validity: discriminability

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are of value in improving managed care practices. It is bymeans of such outcome measures that positive changes canbe identified and implemented in order to achieve the goalsof improved efficiency and effectiveness of, as well as accessto, the contemporary managed healthcare system.Health services researchers seeking to accurately measureoutcomes should first consider creating an instrument thatwill measure exactly what the researcher intends to measureusing language specific to the population that will be sampled.This instrument should then be pilot tested and reliabilityand validity measurements assessed. Only then should sam-pling for the intended study begin. These measurementsshould also be reported in all ensuing reports and publica-tions. This will provide the reader with an increased com-fort level and enhance the credibility of the study.

ACKNOWLEDGEMENTSSupport for this research was provided by grant DA11414 to the Investigator from the National Instituteon Drug Abuse. The author would like to thank Travis ECal for his assistance in the preparation of this manuscript.

REPORTS AND REVIEWS

REFERENCES1. American Psychological Association. Standards for educational and

psychological tests. Washington DC: American Psychological Asso-ciation; 1974.

2. Cannines EG, Zeller RA. Reliability and validity assessment. BeverlyHills CA: Sage; 1979.

3. Cronback FL, Gleser GL, Nanda H, Rajaratnan N. The depend-ability of behavioral measurements: theory of generalizability forscores and profiles. New York: Wiley; 1972.

4. Heise DR. Causal analysis. New York: Wiley; 1975.5. Kerlinger FN. Foundations of behavioral research. 2nd ed. New York:

Holt, Rinehart and Winston; 1973.6. Lord FM, Novick MR. Statistical theories of mental scores. Read-

ing, MA: Addison-Wesley; 1968.7. Nunnally JC. Psychometric theory. New York: McGraw-Hill; 1978.8. Pindyck R, Rubinfeld D. Econometric models and economic fore-

cast. 3rd ed. New York: McGraw-Hill; 1991.9. Stanley JC. In: Thorudike RL, editor. Educational measurement.

Washington, DC: American Council on Education; 1971.10. Steltiz C, Jahoda M, Deutsch M, Cook S. Research methods in so-

cial relations. Rev ed. New York: Holt Rinehart and Winston; 1959.11. Trochim. Http:ITrochim.Human.Cornell.Edu. 1998 (cited. http:/

trochim.human.cornell.edu)

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FOCUS: RELIABILITY AND VALIDITY MEASURES

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Sharon M Miller is the liaison for the CLS Continuing Educationsection. She reviews Focus articles, assigns contact hours, and editslearning objectives and test questions. Direct all continuing educationinquiries to Sharon M Miller, 7N591 Cloverfield Circle, St Charles,IL 60175. (630) 513-1986. [email protected]

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To receive 1.5 contact hours of intermediate level P.A.C.E.®‚credit for Reliability and Validity Measures, insert your an-swers in the appropriate spots on the immediately followingpage; then complete and mail the form as directed.

NOTE: There may be more answer spaces on the answersheet than needed. If so, leave them blank. Make sure thenumber of the answer space you fill matches the number ofthe question you are answering.

LEARNING OBJECTIVESAfter completing this article, the reader will be able to:1. define measurement, describing sources and types of mea-

surement errors.2. define reliability and validity.3. cite numerical ranges for reliability and validity.4. describe how reliability and validity are each calculated.5. explain how reliability and validity relate to measurement

error(s).6. apply reliability and validity concepts to the evaluation of

managed care and similar studies.7. describe the relationship between a theoretical concept

and its operationalization.8. list and define the types of validity that apply to evalua-

tion of managed care and similar studies, includingmethod(s) of measurement.

CONTINUING EDUCATION QUESTIONS1. Reliability may be defined as:

a. how specific an instrument is.b. how accurate an instrument is.c. how well an instrument measures the same input at

varying times and under varying conditions.d. how complete an instrument is.

2. Reliability is a ratio or fraction of the combined scorevariance to observed variance.a. Trueb. False

3. Reliability varies between:a. 1 and 0b. 1 and 10c. 1 and 100d. none of the above

4. If a measure is perfectly reliable there is no error in mea-surement.a. Trueb. False

5. Which is not a measure for assessing reliability?a. Test-retest.b. Gher-Wong.c. Alternative-form.d. Split-half.e. Internal consistency.

6. Researchers agree that the reliability of an instrumentshould not be below:a. 0.50.b. 0.60.c. 0.70.d. 0.80.

8–CE Questions_Montoya 6/16/03, 10:19 AM163


FOCUS: RELIABILITY AND VALIDITY MEASURES

7. Validity may be defined as:a. how reliable the instrument is.b. how complete an instrument is.c. how up to date an instrument is.d. how accurately an instrument measures what one

believes is being measured.

8. The process by which a theoretical concept is measuredis called the:a. operationalization of the concept.b. reliability of the concept.c. validity of the concept.d. theoretical stage.

9. A type of validity that is common is:a. content related.b. criterion-related.c. construct validity.d. all of the above.

10. Measuring how well the operationalization of the con-cept compares to the relevant content domain is whichtype of validity?a. Content relatedb. Criterion-relatedc. Construct validityd. All of the above

11. Which validity method is applicable to concepts mea-sured by multiple items?a. Content relatedb. Criterion-relatedc. Construct validityd. All of the above

12. Which validity method is not assessed statistically?a. Content related.b. Criterion-related.c. Construct validity.d. All of the above.

13. Assessments of validity do not involve theory.a. Trueb. False

14. Which validity method involves computing a correla-tion coefficient between the measure of the target con-cept and the measure of the criterion concept?a. Content related.b. Criterion-related.c. Construct validity.d. All of the above.

15. The theory that any measurement has two components:the true value and the observed value, is referred to as:a. random error theory.b. classical test theory.c. true score theory.d. both b and c.

16. The two types of error are:a. random error.b. infinity error.c. systemic error.d. a and b.e. a and c.



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FOCUS: CARDIAC PROTOCOLS

The Emerging Roles of BNP and Accelerated CardiacProtocols in Emergency Laboratory Medicine

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CHARIS HAINAUT, WAYNE GADE

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The Focus section seeks to publish relevant and timely continuingeducation for clinical laboratory practitioners. Section editors, topics,and authors are selected in advance to cover current areas of interest ineach discipline. Readers can obtain continuing education credit (CE)through P.A.C.E.® by completing the tearout form/examination ques-tions included in each issue of CLS and mailing it with the appropri-ate fee to the address designated on the form. Suggestions for futureFocus topics and authors, and manuscripts appropriate for CE creditare encouraged. Direct all inquiries to Vicki Freeman, Dept. of ClinicalLaboratory Sciences, 301 University Boulevard, Galveston, TX 77555-1028; vfreemanutmb.edu, incoming Continuing Education Editor.

BACKGROUND: The role of the clinical laboratory inemergency cardiac medicine is rapidly evolving; with recentredefinitions of acute myocardial infarction (AMI) and un-stable angina (UA) based on troponin levels, recommendedacceleration of cardiac testing protocols, and increased clini-cal measurement of B-type natriuretic peptide (BNP). Webriefly review the background pathophysiology of acute coro-nary syndromes (ACS) and congestive heart failure (CHF),along with an overview of the biochemistry and physiologyof the natriuretic peptides.

METHODS: The assay principles and performance charac-teristics of the rapid BNP assays are discussed. The perfor-mance characteristics of troponin assays are at the center ofcontroversy regarding the redefinition of AMI and UA, andwill be discussed.

RESULTS: We review the rapidly expanding evidence re-garding the clinical utility of BNP for CHF patients. WhileBNP has gained wide acceptance as a rapid diagnostic tool,considerable controversy remains concerning its potentialfor prognosis, screening, and therapeutic monitoring. Al-though a thorough discussion of the use of cardiac markersis well beyond the scope of this review, overviews of the re-definitions of AMI and UA, and the trend toward acceler-ated testing protocols to obtain a quicker diagnosis or rul-ing-out of AMI are included. In addition to accelerating theretesting of existing markers, a recent test for ischemia modi-fied albumin (IMA) promises another quantum leap in car-diac diagnoses.

CONCLUSIONS: The positive impact of these develop-ments on the healthcare costs and overall improvement in thequality of healthcare delivery will be discussed. A brief analy-sis of the downstream costs of BNP testing is also offered.

ABBREVIATIONS: ACS = acute coronary syndromes; AMI= acute myocardial infarction; BNP = B-type natriureticpeptide; CHF = congestive heart failure; COPD = chronicobstructive pulmonary disease; ECG = electrocardiogram;ED = emergency department; hsCRP = high sensitivity C-reactive protein; IMA = ischemia modified albumin; LV =left ventricular; MI = myocardial infarction; NCAB = Na-tional Academy of Clinical Biochemists; NPV = negativepredictive value; NYHA = New York Heart Association; PE= pulmonary embolism; RAAS = renin-angiotensin-aldos-terone system; RV = right ventricular; UIA = unstable I angina.

INDEX TERMS: acute coronary syndromes; BNP; cardiacprotocols; coronary testing; myocardial infarction.

Clin Lab Sci 2003;16(3):166

Charis Hainaut CLS(NCA) is a CLS in the Clinical Labora-tory, Decatur Memorial Hospital, Decatur IL.

Wayne Gade PhD MT(ASCP) is assistant Professor of Clini-cal Laboratory Science, University of Illinois at Springfield,Springfield IL.

Address for correspondence: Wayne Gade PhD MT(ASCP)Clinical Laboratory Science Program, HSB 314, University ofIllinois at Springfield, Springfield, IL 62703-5407. (217) 206-7349.

Wayne Gade is the Focus: Cardiac Protocols guest editor.

Focus Continuing Education Credit: see pages 188 to 190 forlearning objectives, test questions, and application form.

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LEARNING OBJECTIVESAfter reading the following articles, the reader will demon-strate his/her understanding of the material by achieving thefollowing:1. Describe the biochemistry of the BNP and the other

natriuretic peptides.2. Describe the major physiologic responses to the eleva-

tion of BNP levels.3. Discuss the mechanism by which the binding of BNP

to the target cell results in alteration of Na+ and waterreabsorption.

4. Describe the formation of arterial plaque and the devel-opment of coronary artery disease and acute coronarysyndromes (ACS).

5. Describe the physiological conditions that develop intoCHF and cause the release of BNP.

6. Describe and interpret the diagnostic accuracy, sensitiv-ity, specificity, and negative predictive values reportedfor rapid BNP assays.

7. Describe the trend toward “accelerated cardiac proto-cols,” including which markers are suggested, and thesuggested time-course of sequential testing.

8. Evaluate patient data and derive appropriate diagnosticconclusions.

9. Discuss the use of BNP for prognosis and screening ofpatients for LV dysfunction.

10. Discuss the interpretations of slightly elevated levels oftroponin and C - reactive protein (CRP) as they relateto ACS and risk analysis.

CLINICAL LABORATORY’S ROLE IN CARDIACMEDICINEDuring the past few years, the clinical laboratory has assumeda much more active role in risk assessment and diagnosis ofcardiac disease. While traditional lists of risk factors had fo-cused primarily on family history, personal habits (smokingand sedentary life style), and related health characteristics(diabetes and obesity), most recent additions to the list ofrisk factors fall within the realm of clinical chemistry. Thesefactors include high sensitivity C-reactive protein (hsCRP),measured LDL-cholesterol, homocysteine, and others.

As late as the mid 1990s, traditional cardiac markers wererelatively non-specific and frequently took six to eight hoursto elevate sufficiently for a physician to confirm the diagno-sis of acute myocardial infarction (AMI). Prior to 2000, pa-tients with dyspnea and chest pain presented an even moredifficult differential diagnosis, because physicians had to dis-tinguish between congestive heart failure (CHF), various

chronic pulmonary disorders, pneumonia, other acute coro-nary syndromes (ACS), cardiomyopathies, and even suchdiverse possibilities as severe anemias and acute anxiety. As aresult, the diagnosis of CHF frequently took hours or daysand relied on expensive, often ambiguous, imaging evidenceto exclude all other diagnoses and confirm CHF.

With the acceptance of new cardiac markers, and a recom-mended acceleration of testing protocols, many emergencycardiac units now expect to diagnose or rule out AMI within90 minutes. Since 2000, diagnosing CHF has also becomefaster, easier, less expensive, and more reliable through theintroduction of rapid laboratory testing for B-type natriureticpeptide (BNP).

This paper reviews the evidence supporting BNP as a rapiddiagnostic test, capable of distinguishing CHF from othercauses of ambiguous symptoms such as dyspnea and angina.The physiologic role of BNP in CHF and left ventricular dis-orders is also discussed, along with its use in prognosis, thera-peutic monitoring, and staging of CHF patients. BNP’s con-troversial role as a pre-screen for patients suspected of left ven-tricular (LV) dysfunction is also discussed. Finally, the emerg-ing role of BNP is placed in the context of accelerated cardiacprotocols with troponin, myoglobin, and ischemia-modifiedalbumin to illustrate the active diagnostic role for the clinicallaboratory in a wider range of cardiopulmonary conditions.

BACKGROUND OF CARDIAC DISEASESPlaque formation and its relationship to inflammationACSs are described as a wide spectrum of conditions rang-ing from a thrombotic event causing complete occlusion ofa coronary artery (an MI), to the partial occlusions associ-ated with mild exertional angina.1,2 Plaque development isthe central process in ACS, and contributes directly to nearly500,000 cardiac deaths, over three million hospital admis-sions, and estimates of between $10 billion and $56 billionin healthcare costs per year.3,4

Plaque formation is a complex, inflammatory process (illus-trated by Figure 1) that is initiated by the oxidation of LDLlipoproteins, followed by their endocytosis by macrophages.1,2

In patients at high risk for developing heart disease, large num-bers of LDLs are engulfed and transform these macrophagesinto foam cells. Foam cells congregate in locations betweenthe endothelial layer and underlying layers of extracellular ma-trix and smooth muscle in arterial walls. Foam cells also re-lease chemotactic and growth-promoting substances reminis-cent of a typical inflammatory response following an infec-


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tion or allergic episode. The inflamma-tory aspect of the plaque developmentis further accentuated by reports thathigher baseline levels of hsCRP are as-sociated with an increased risk of heartdisease.5

As plaques continue to enlarge, withincreased fibrous material and calcifi-cation, they eventually bulge into the

artery lumen and cause partial occlu-sion. Deposition of plaque material isa lifelong process that starts as fattystreaks in childhood and can continueuntil arteries become total occluded.Restricted blood flow (ischemia) leadsto angina even in arteries that are onlypartially occluded. Plaque rupture can,of course lead to the thrombosis andtotal occlusion that define an AMI. Al-


Figure 1. Steps in the development of arterial plaques

ternatively, near-total occlusion and/ormicrothrombosis is characteristic ofunstable angina and often precedes anAMI as a pre-infarction, or mini-inf-arction.6 Elevated levels of troponinbelow the myocardial infarction (MI)cutoff provide evidence of myocardialinjury, and unify the concept that bothMI and unstable angina (UA) belongon the same ACS continuum.7 Notethat even in the absence of plaque rup-ture or an acute event, partial occlu-sion causes increased vascular resis-tance, and thereby contributes signifi-cantly toward the development of mostcases of CHF.

What is CHF and how common is it?According to the 1996 Data Fact Sheetreleased by the National Heart, Lung,and Blood Institute, nearly five mil-lion Americans suffer from CHF, de-fined by an inability of the heart toprovide sufficient circulation to thebody (ischemia).8 Dyspnea (shortnessof breath) is generally the primary pre-senting symptom for CHF patients,with the accompanying hypoxia (in-adequate oxygen delivery to tissues)frequently resulting in chest pain (an-gina).

CHF affects all age groups, with400,000 new diagnoses, and more than2.5 million hospitalizations each year.The incidence of CHF increases dra-matically with age, affecting 2% ofpeople ages 40 to 59 and 10% of thoseover 70. CHF is the leading cause ofhospital admissions in the elderly, ac-counting for 20% of their total admis-sions. The five-year mortality rate forCHF patients approaches 50%. Theincidence of CHF is expected to in-crease dramatically as the U.S. popu-lation ages, and as more patients sur-vive an MI, but suffer myocardial dam-age resulting in CHF.8

(Reprinted from Kaplan and others. Clinical chemistry, theory, analysis, correlation. 4thEd., St Louis MO, Mosby, with permission.)

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Causes of congestive heart failureConditions that lead to CHF are listed in Table I, and canbe divided into three categories. These categories include: 1)increased vascular resistance (atherosclerosis, pulmonary dis-ease, and hypertension); 2) damaged cardiac tissue (previ-ous ischemic heart disease or infection); or 3) malfunctionsof heart valves, neuronal stimulation (arrhythmias), or car-diac muscle (cardiomyopathies).2,4 Each of these conditionsforces the heart to compensate until it fails to maintain ad-equate oxygenation and circulation.

The leading cause of CHF is coronary artery disease. Theslow development of arterial plaques and partial occlusionof the arteries results in increased vascular resistance and in-creased cardiac workload.9,10 Other conditions such as hy-pertension and edema can also increase vascular resistance.

Renal conditions, such as hyper-secretion of renin or aldos-terone, or deficiencies in glomerular filtration can lead tohypertension. However, hypertension also results from nor-mal compensation by kidneys and lungs in response to thedecreased blood flow that is characteristic of CHF. This com-pensation includes activation of the Renin-Angiotensin-Al-dosterone System (RAAS), which promotes retention of bothsodium and water and leads to increased blood pressure.Regardless of the underlying cause, activation of RAAS forcesthe heart to increase the rate and strength of contractions toovercome the increased resistance. Thus, renal function caninitiate and/or accelerate the multi-organ compensation spi-

rals that can become uncontrolled, and lead to a worseningof CHF symptoms or decompensation (see Figure 2).9

Edema can be caused by hypertension, renal protein losses(glomerular nephritis or nephrotic syndrome), increasedvascular permeability, or decreased liver function. What-ever the origin, edema increases backpressure and continu-ance of a compensation spiral. Thus, it is often difficult topinpoint the initiating factor among other factors that con-tribute to the spiral.

Plaque ruptures can lead to clot formation, total occlusion(an MI), and result in significant myocardial necrosis. Thedamaged tissue is replaced by fibrotic tissue, and the remain-ing muscle is forced to work harder. This sequence (illus-trated in Figure 2) frequently leads to CHF in MI survi-vors.9,10 Although Figure 2 describes the events initiated byan MI to cause myocardial damage, a similar chain of eventscould result from numerous other initiating events. For ex-ample, various forms of chronic obstructive pulmonary dis-ease (COPD) can cause episodes of dyspnea, angina, and ifhypoxia becomes too severe, they can damage myocardialtissue. Pulmonary disorders that impair gas diffusion (suchas pulmonary fibrosis) can also cause hypoxic damage to car-diac or renal tissue, without the restricted blood flow thatdefines ischemia.9 Heart valve dysfunction, arrhythmias, andcardiomyopathies cause inefficient contractions, decrease car-diac output, and lead to CHF. Again, compensation by otherorgans, including activation of RAAS, can initiate a com-pensation spiral and lead to further development of CHF.

Decompensation in CHF refers to a serious decrease in circu-lation that converts the chronic disease into an acute episode.Decreased circulation causes blood to pool in the veins (steno-sis), and results in edema as fluids leak into extravascularspaces.9-11 CHF can involve only one side of the heart or bothsides; however, LV failure typically occurs first. LV failure causesinadequate circulation to peripheral tissues, and pulmonaryedema develops as fluids build up in the lungs. Right ven-tricular (RV) failure causes peripheral edema because bloodreceived from the body cannot be pumped toward the lungsfor reoxygenation.9,10 Pulmonary edema, resulting from LVfailure, often leads to congestion and ischemic damage to theright side, or RV failure as shown in Figure 2.

Symptoms and pathogenesis of CHFUnless an acute event (such as an MI) causes immediate tis-sue damage, CHF frequently has an insidious onset.9,10 Manypatients are asymptomatic during early stages of heart fail-


Table 1. Conditions known to cause CHF

Coronary artery disease and atherosclerosis

Myocardial damage resulting from MIs or ischemicheart disease

Uncontrolled blood pressure (hypertension)

Pulmonary diseases such as COPD and pneumonia

Heart valve problems resulting from an infection orcongenital defects

Cardiomyopathies (abnormalities of the heartmuscles) and arrhythmias

Anemias or other hematological disorders thatrequire coronary compensation

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ure because the body effectively com-pensates for the decreased circulation.Initially, the heart enlarges (hypertro-phy) to compensate for inefficiencyduring the early stages of CHF. Atsome point, hypertrophy becomes lim-

ited, and inadequate cardiac output ul-timately leads to a series of events simi-lar to those described in Figure 2.

Once cardiac output has decreased sub-stantially, blood will be diverted from


other organs to maintain an adequatesupply to the heart and brain. Decreasesin renal circulation result in hyperten-sion, decreased glomerular filtration,and azotemia (elevated BUN and crea-tinine). The first renal response is toactivate RAAS. Another important re-nal response to ischemia is the releaseof erythropoietin, which stimulates thebone marrow to increase production ofred blood cells. These two renal mecha-nisms normally help protect againstdehydration, blood loss, hypoxia, andcirculatory shock.2,9 However, activationof RAAS and release of erythropoietinboth cause increased blood pressure andvolume. Therefore, each can be coun-terproductive to the CHF patient byincreasing backpressure and workloadfor the failing heart.

As overall circulation decreases in CHF,blood flow to organs such as the gas-trointestinal tract decreases dispropor-tionately as blood is diverted to morecritical organs. This compensationworks initially, but inevitably weakensthe entire body. As the digestive tractloses blood flow, there is a loss of ap-petite with tendencies toward nauseaand inadequate nutrition. Eventually,this further weakens the heart andbody, and the patient becomes symp-tomatic. Early CHF symptoms includefatigue, dyspnea, persistent coughingor wheezing, edema, confusion, nau-sea, lack of appetite, and increasedheart rate. Symptoms suggestive of LVfailure are related primarily to pulmo-nary edema, and include a persistentcough and dyspnea. RV failure causessymptoms related to peripheral edema.Neurological symptoms such as con-fusion may result from fluctuations inelectrolytes and critical metabolitessuch as glucose.

Once a diagnosis of CHF is made, theclassification according to symptom

Figure 2. The development of congestive heart failure following damageto heart muscle from an MI or other cause

(Reprinted from Gould B. Pathophysiology for the health professions, WB SaundersCompany with permission from Elsevier Science.)

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severity is done using the New YorkHeart Association (NYHA) System.Class I patients have asymptomaticCHF. Patients in Class II experiencemild symptoms, such as exertional dys-pnea, and minor limitations to normalphysical activity. Class III is reservedfor those limited to less-than-normalactivity, and Class IV patients are se-verely limited, and usually bedridden.A summary of the activity levels fordefining the NYHA categories of CHFpatients is given in Table 2.

If the underlying condition is not cor-rected, the heart’s capacity will con-tinue to decrease, and physical activitywill be severely restricted as seen inthose in NYHA categories III and IV.Without intervention, the heart willultimately decompensate, resulting inan acute episode.

Traditional diagnosis of CHFThe differential diagnosis of CHFmust rule out all other causes of short-ness of breath and chest pain. Untilrecently, the diagnosis of CHF de-pended on the medical history, symp-toms, physical examination, and non-laboratory diagnostic tests. The medi-cal history identifies contributing fac-

tors and symptoms, such as dyspnea,loss of appetite, swelling of the anklesand feet, or a persistent, non-produc-tive cough.9,10 Physical examinationidentifies hypertension, breathsounds, edema, abdominal fluidbuildup, and swollen neck veins. IfCHF is suggested, an electrocardio-gram (ECG) and diagnostic imagingsuch as chest x-rays andechocardiography (cardiac ultra-sound) are likely to be ordered to as-sess the heart’s size, shape, and func-tion. Exercise stress tests monitor thepatient’s physiological responses totreadmill exercise, and help assign pa-tients to the appropriate NYHA cat-egory. Cardiac catheterization canconfirm vascular occlusion andangioplasty is frequently used to treata localized problem.

Acute pulmonary diseases, such aspneumonia, COPD, and pulmonaryembolism (PE), also cause dyspnea andmust also be ruled out in the acute caresetting before CHF is diagnosed. Onecommon consequence of acute pulmo-nary disorders is an increase in vascu-lar permeability, which results inedema, congestion, and even a possi-bility of vascular shock (severe hypov-


olemia). Hypertension resulting fromeither renal or pulmonary conditionscan also add stress to an overworkedcardiovascular system. Thus, hyperten-sion and dyspnea, the presenting symp-toms in many CHF cases, can be simi-lar in various renal and pulmonary dis-eases and can easily be misdiagnosedas CHF.9,10 Furthermore, these condi-tions frequently contribute to myocar-dial damage and the congestion thathelp define CHF. Much of the clinicaldifficulty lies in identifying the initi-ating factor of the sequence of factorscontributing to the downward com-pensation spiral.

Finally, a laboratory test for CHFIn the past, the diagnosis and stagingof CHF patients was often difficultbecause symptoms were ambiguous,imaging tests were non-specific, andCHF frequently overlaps with othercardiopulmonary diseases. Since theirdiscovery in 1988, the natriuretic pep-tides have been well documented asmarkers for CHF; however, the earlyRIA procedures were cumbersome andimpractical for routine ED use.11-25 InNovember 2000, the Food and DrugAdministration approved a rapid assayfor B-type natriuretic peptide (BNP),manufactured by BioSite. More re-cently, other manufacturers have addedtheir versions of the rapid BNP assay.These breakthrough BNP assays areeasy and require only 15 to 20 min-utes, making them especially useful inthe ED setting. Numerous studies, dis-cussed below, have found the rapidBNP assays to be very useful in thediagnosis, staging, and prognosis ofCHF.11-22,27-32

The biochemistry of BNP and ANPAll three members of the natriureticpeptide family (designated ANP, BNP,and CNP) possess a similar 17-aminoacid looped structure. Each loop has 11

Table 2. NYHA classification of CHF and correlation with BNP levels

NYHA class Symptoms BNP Levels*

I Asymptomatic 83.1 pg/mLNo limitation of normal activity (49.4-137 pg/mL)

II Minimal limitation of normal activity, 235 pg/mLbut activity limited during exercise (137-391 pg/mL)

III Moderate limitation of even normal activity 459 pg/mLNo significant exercise possible (200-871 pg/mL)

IV Severe limitation of normal activity 1119 pg/mLFrequently bedridden (728- >1300 pg/mL)

*BNP levels from Wieczorek 2002. Am Heart J 2002;144(5):934-9.

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conserved residues and is held together by a disulfide bondbetween two cysteines.23-25 Both A- and B-type natriureticpeptides reduce blood volume and pressure, and regulate elec-trolyte balance.23-25 ANP is produced in the atrium of the heart,while BNP is made in the both the brain and ventricles of theheart. (CNP has less natriuretic effect, and does not appear tobe clinically relevant.)

Both peptides are synthesized as preprohormones and pro-cessed to prohormones prior to release from the cell. Sub-stantial amounts of ProANP are stored in secretory vesiclesand can be released quickly as the active 28-amino acid pep-tide. In fact, ANP can be released by such minor stimuli asexercise.11,23 By contrast, very little ProBNP is stored, so theincreased release of BNP requires an upregulation of mRNAtranscription prior to secretion from the left ventricle.11,23-25

The active 32-amino acid BNP is normally found in lowerplasma concentrations than the 76-residue precursor pep-tide (designated as NT-proBNP), which contains a long N-terminal sequence that is cleaved to form the active pep-tide.23,25 This upregulation of transcription means the BNPresponse, triggered by ventricular overload, is slower and ‘lessvolatile’ than the ANP response.23-25 For example, in caseswhere an MI causes cardiac damage, and results in the acuteonset of CHF symptoms, the response of ANP is immedi-ate, whereas the BNP levels can peak between 16 and 20hours.25 In addition, the primary clearance mechanisms,enzymatic degradation and receptor-mediated internaliza-tion, both favor the rapid turnover of ANP over BNP.25 Thereported half-life of ANP in humans is only two to fourminutes, making ANP too variable, and less reliable for di-agnostic purposes.25

Because CHF is typically a chronic disease, the stabile BNPresponse correlates well with cardiac overload, and LV fail-ures.11,23-25,30-33 Binding of either ANP or BNP to high-affin-ity target-cell receptors activates a signaling mechanism thatcauses elevated cGMP (cyclic-GMP) levels and results in theirdescribed effects.23-25

Natriuretic peptides counteract RAASBoth ANP and BNP are released in response to volume ex-pansion and pressure overload, and both counteract theRAAS cascade.23-25 While the RAAS causes vasoconstriction,increased sodium reabsorption, and increased blood pres-sure, the natriuretic peptides inhibit sodium reabsorptionand increase water excretion. An increase in glomerular fil-tration rate (GFR) results from BNP-induced dilation of theafferent arterioles and constriction of the efferent arterioles.

The net effect of BNP is the increased excretion of bothsodium and water, decreasing blood pressure and volume.11,23-

25 Because the same overload conditions that lead to CHFalso cause BNP release, elevated BNP levels correlate wellwith the CHF diagnosis and prognosis. Hypertension, in-cluding pulmonary hypertension, is frequently seen in CHFpatients; however, it is worth noting that hypertension alonedoes not directly cause release of BNP.23,25

Interesting studies with transgenic mice, which over-expressthe genes for natriuretic peptides, found ten-fold higher pep-tide levels and lower blood pressure. Furthermore, these miceavoided pulmonary hypertension when exposed to chronichypoxia.36 Another interesting role for BNP is implied bystudies of mice that lacked the BNP gene. These mice pro-duce no BNP and, under normal circumstances, did notdevelop hypertension or ventricular hypertrophy. Ventricu-lar pressure overload would cause release of BNP in normalmice; however, these mice could not release BNP and devel-oped focal fibrotic lesions.37 This suggests that BNP has anantifibrotic effect, which counteracts the reported cardiacfibrosis promotion mediated by the RAAS system.

METHODSRapid BNP and NT-proBNP assaysAcceptance of the clinical utility of BNP has resulted in a newgeneration of immunoassays to fulfill the rapid turnaroundtimes required for emergency medicine. In addition to differ-ent assay formats and methods of signal generation, research-ers have chosen to detect different portions of the natriureticpeptides, such as NT-proBNP and mid-proBNP (detectingmiddle portion of pro-BNP), in addition to BNP itself.25 Areview of cardiac natriuretic peptide assays suggests that as-says for NT-proBNP may be easier to develop than BNP dueto the higher plasma concentrations of NT-proBNP.25 An-other important factor to be considered is the stability of vari-ous peptide fragments in plasma. Such assay differences wouldobviously necessitate different reference ranges and cutoff lev-els for results to be interpreted, and could result in confusionwhen results from different laboratories are compared.

Assay principle and performance characteristics of a rapidBNP assayThe most common rapid BNP assay (from BioSite, Inc., SanDiego, CA) requires 250 mL of EDTA-anticoagulated bloodor plasma, and uses membrane filtration and a sandwich im-munoassay procedure to generate a fluorescent signal. If wholeblood is used, the cells are removed by filtration and fluores-cent-tagged antibodies are allowed to bind any BNP present.


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In the reaction chamber, the sandwich is completed as thepreviously formed BNP-antibody complexes bind to captureantibodies attached to the solid phase. The measured inten-sity of fluorescence is related to the BNP level.

Assay performance characteristics of the BioSite BNP assayreported by Morrison included intraassay precision (coeffi-cient of variation or CV) of 9.5%, 12.0%, and 13.9% forBNP levels of 28.8 ng/L, 584 ng/L, and 1180 ng/L, respec-tively.14 Interassay values for the same specimens were 10%,12.4%, and 14.8%, respectively. They reported an analyticalrange for the assay of 5.0 ng/L to 1,300 ng/L, and an excellentcorrelation coefficient of r = 0.9878, when plasma and wholeblood were compared.14 Although these authors stated thatBNP concentrations compared from plasma and whole bloodwere “not significantly different”, their reported equation (y =0.925x + 13.439) suggests that there may be noticeable dif-ferences at both ends of the measurable range. However, atlevels that represent therapeutic ‘decision points’, these samplevariations would probably be insignificant and unlikely to al-ter treatment. A comparison of the rapid fluorescent BNPassay with the most common radiometric immunoassay re-sulted in a good correlation coefficient of r = 0.9236.14

As other assays, such as the newly approved NT-proBNPassay from Roche Diagnostics, and new generations of as-says become commercially available, the performance expec-tations will be revised.

Performance characteristics of troponin assaysThe Laboratory Practice Guidelines of the National Academyof Clinical Biochemists (NACB) in 1999 suggested that thehigh specificity of cardiac troponins, relative to previous mark-ers, could lead to new interpretation of results.6 The primarychange was toward a two-decision limit system, which de-fined levels between the upper limit of the reference rangeand the AMI cutoff as indicative of “myocardial injury”.6 Giventhe clinical evidence that suggests important prognostic dif-ferences at low levels of troponin (<0.1ng/mL), assays musthave rather extraordinary performance characteristics, at theselow levels. For example, Morrow, reported an increased rela-tive risk of 2.2 to 3.0 of death or MI within 43 days in pa-tients whose troponin levels were >0.1 ng/mL.38 However, atsuch low levels, very small variations due to slight inaccuracyor imprecision of the assay could impact treatment decisions.Although current troponin assays have excellent precisionthrough most portions of the linear range (CV 2% to 4%),the requirement for 10% imprecision (CV) at levels as low as0.01 ng/mL was not attained by any of the assays studied.38

Review of the clinical utility of BNPBNP improves both speed of diagnosis and diagnostic accuracyin CHFDr Alan Maisel and his colleagues at the Veterans Adminis-tration Medical Center in San Diego, have investigated theuse of the rapid BNP assay for the diagnosis CHF in EDpatients presenting with dyspnea.11-17 In one study, 250 pa-tients who presented with dyspnea were diagnosed andtreated by ED physicians without knowledge of BNP levels.Two cardiologists who were blinded to both the ED diagno-sis and BNP results, retrospectively reviewed all traditionalcriteria of patient history, physical examination, imaging, orlaboratory tests performed (including x-rays, systolic anddiastolic function, and hemodynamic monitoring), and re-sponse to treatment.12 Only after the cardiologists confirmeda diagnosis, were the ED diagnoses and BNP levels revealed.Confirmed CHF patients had much higher BNP levels, 1076+/– 138 pg/mL, than COPD patients without CHF, 86 +/–39 pg/mL.12 Furthermore, the ED physicians (using tradi-tional criteria) had incorrectly diagnosed 15 non-CHF pa-tients as having CHF, and misdiagnosed another 15 trueCHF patients with an inappropriate alternative diagnosis.Of these 30 misdiagnosed patients, 29 would have been cor-rectly identified simply based on their BNP levels.12

In a similar study, 321 patients presenting with dyspnea weredefined as CHF and/or non-CHF pulmonary diseases. Themean BNP levels of the CHF group were 758 pg/mL, com-pared to a mean level of 61 pg/mL for the COPD group.14

Likewise, patients whose edema was caused by CHF hadhigher BNP levels (1038 +/– 116 pg/mL) than those withedema from other causes (63 +/– 16 pg/mL). This studydemonstrated that mean BNP levels were less than 100 pg/mL in dyspneic patients with various pulmonary diagnosesof COPD, asthma, pneumonia, TB, acute bronchitis, andpulmonary fibrosis. However, BNP levels averaged 120 pg/mL in four lung cancer patients and 207 pg/mL in threepatients with pulmonary embolism.14 Interestingly, 11 pa-tients were diagnosed with an acute COPD episode, eventhough they had a history of CHF. Successful therapy ap-parently had controlled their cardiac disorder, so their cur-rent diagnoses were COPD, and their mean BNP levels wereonly 47 pg/mL.14

Maisel and his colleagues have concluded that at BNP levelsabove 80 pg/mL, the sensitivity of the assay was 98% andspecificity was 92%.11,12 The negative predictive value (NPV)of BNP levels below the 80 pg/mL cutoff was 98%, givingphysicians confidence that CHF was unlikely to be the cause


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of dyspnea in patients with low BNP levels. In the multina-tional “Breathing Not Properly (BNP)” study, McCulloughconcluded that BNP levels alone had a higher diagnosticaccuracy (82.1%) than clinical judgment of ED physiciansblinded to BNP levels (74.0%). When clinical judgment wasadded to BNP levels, the diagnostic accuracy improved onlyslightly to 82.5%.17

BNP levels correlate with disease severitySeveral studies have shown that BNP levels roughly correlatewith disease severity.11,12,22 Data presented in Table 2 showthat even asymptomatic patients in NYHA category I hadelevated BNP levels 83.1 pg/mL, while patients in category IIhad a mean level of 235 pg/mL.22 Similar correlations betweenBNP levels and CHF severity have been made when patientsymptoms were classified as mild, moderate, or severe.12 Pa-tients in stages I and II have few limitations in their normalactivities, and may go undiagnosed until the disease progressesto later stages. Earlier diagnosis, based on elevated BNP levelsmight prevent further deterioration in some patients.10,11

BNP is also useful in prognosisIn 1997, Tsutamoto studied 85 patients with chronic CHFand reported that BNP, but not ANP, had independent prog-nostic value in a multivariate analysis of 14 hemodynamicand neurohormone variables.21 Using a rapid assay, Bergerfound that BNP was the only independent predictor of sud-den death in their study of 452 CHF patients with LV dys-function. Patients with BNP values less than 130 pg/mLhad a greater than 99% survival during the study, comparedto only 81% survival for patients with BNP levels above the130 pg/mL level.27 The prognostic benefit indicated by theseand other studies could help patients and hospitals avoidreadmissions, and decrease morbidity and mortality rates inCHF patients.26-32

BNP levels predict outcomes for MI patientsBecause a previous MI may cause tissue damage and lead toCHF, researchers wondered if BNP levels might help predictoutcomes in patients with MI. Richards studied 121 MI pa-tients and reported that early post-infarction decreases in BNPlevels (within two to four days) were good predictors of futureCHF episodes, nonfatal MIs, unstable angina episodes, andcardiac related deaths.30 Richards also showed that higher BNPlevels in 220 MI patients measured within four days of admis-sion correlated well with LV dysfunction, and were a “power-ful independent predictor” of increased risk of heart failure ordeath within 14 months.31 Another study of 70 MI patientsfound that those with higher BNP levels had higher odds for

cardiac death during an 18-month follow-up than patientswith low BNP levels.11,26 Harrison found that patients withhigh BNP levels (>450 pg/mL) had a greater than 51% chanceof a further cardiac event (readmission or death) within sixmonths, whereas CHF patients with lower BNP levels hadonly 2.5% reoccurrence.29 Similarly, Omland also reported astrong correlation between elevated BNP levels in patients withacute coronary syndromes and early death.32

BNP used to pre-screen patients for LV failureBNP levels may provide a valuable screen of patients nor-mally referred for evaluation of LV function byechocardiography.11,15,20-22 Echocardiograms identify CHF-related abnormalities such as thickening of heart walls anddecreased or backward blood flow through the valves. Onestudy followed 200 patients who were referred by a cardi-ologist for evaluation of LV function by echocardiography,without knowledge of BNP results.15 Patients with LV dys-function had much higher BNP levels (489 +/– 75 pg/mL)than those with normal LV function (29.5 +/– 62.4 pg/mL),suggesting that relatively inexpensive BNP assays could pre-screen patients for LV dysfunction prior to more expensiveechocardiography.11,15 Maisel asserted that low BNP levels(<80 pg/mL) had a negative predictive value of 98%, mean-ing that LV dysfunction is highly unlikely.11 This confirmsobservations made previously that BNP levels can effectivelypre-screen symptomatic patient populations.20,21,33

However, researchers of the Framingham Study recently cau-tioned that BNP-screening for the general community-basedpopulation, or even high-risk populations of asymptomaticpatients, was not supported.42 Ramachandran found that thelow cutoffs required for adequate sensitivity in the asymp-tomatic populations, resulted in unacceptably poor specific-ity and, thus, the potential cost savings were negated. How-ever, screening of the general population was accepted inJapan following large studies of asymptomatic patients.43

BNP levels used to monitor success of therapyMonitoring of BNP levels to evaluate the success of thera-pies, such as ACE inhibitors, was supported by Murdoch.33

Cheng reported that BNP levels correlate with success oftreatment and outcome in 72 patients hospitalized with heartfailure.13 During this 30-day follow-up study, treatment wasineffective and BNP levels increased by 233 pg/mL duringhospitalization for the 22 patients who died or were re-ad-mitted. More successful treatment resulted in a mean de-crease of 215 pg/mL BNP in 50 stabilized patients who werenot re-admitted during the study.13 Statistical analysis of


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univariate predictors suggests that patients, who are dis-charged with low BNP levels below 450 pg/mL, or lowNYHA classifications, have a better prognosis (less chanceof re-admission within 30 days or death) than other patientgroups. A decreased BNP or NYHA class during hospital-ization was a good sign, but even this did not signify a goodprognosis, unless their discharge levels of BNP or theirNYHA classifications were low.13

The well-established benefits of ACE inhibitors in control-ling CHF can be compromised by the risk of side effects, suchas hypotension and kidney impairment.34 Monitoring BNPlevels, rather than treating empirically, might minimize theserisks. Identifying patients with higher BNP levels followingan acute episode might help physicians modify treatments andthereby decrease their risk for re-admission or death.

BNP used as a therapeuticBNP infusions resulted in favorable decreases in blood pres-sure and increases in renal excretion.23,39 However, the an-ticipation of therapeutic benefits for CHF patients is tem-pered by observations of decreased responsiveness to BNPin patients with severe CHF.40 A possible mechanism for thisdeceased responsiveness may have been described byTsutamoto, who showed that elevated BNP levels resultedin elevated cGMP levels in a group of chronic CHF patientswho survived their two-year study.21 However, in thenonsurvivors, elevated BNP levels did not cause the expectedincreases in cGMP.21,23-25

Note of caution: BNP is not totally specific for CHF. Al-though there is a good correlation with BNP elevations andCHF episodes, there are a number of other conditions thatalso cause BNP elevations.23-25,41 Multiple traumas, abdomi-nal or thoracic surgery, subarachnoid hemorrhage, and otherbrain disorders are all known to result in elevations of BNP.In addition, BNP was elevated in diabetic patients with re-nal complications, indicated by microalbuminuria.41

Accelerated protocols for testing BNP and other cardiacmarkersA major diagnostic challenge for ED physicians treating pa-tients presenting with chest pain and dyspnea is to quicklyand accurately distinguish between MI patients in need ofimmediate thrombolytic intervention, and angina patientsfor whom thrombolytics themselves may be detrimental oreven life threatening. Given the relatively short time span(20 to 30 minutes) between the thrombic event of an MIand the beginning of myocardial necrosis, it is essential that

the distinction be made rapidly so that thrombolytic therapycan be initiated within its ‘window’ of maximum benefit.Thus, essential laboratory data must be rapidly available sothat informed diagnostic decisions can be made.

Recently, researchers have focused on accelerated protocols fordiagnosis of cardiac patients within the first few hours as an-other way to control healthcare costs.4,44-46 For example, Ngproposed a 90-minute protocol in which cardiac markers aredrawn on admission and again at 30-, 60-, and 90-minutes.46

Similarly, McCord proposed a protocol for exclusion of AMIswithin 90-minutes.45 An accelerated protocol combining tropo-nin, C-reactive protein, myoglobin, and BNP can assist withrapid diagnosis and risk stratification of ACS.44 Much of theemphasis of early decision-making within emergency medicineis based on the benefits for patients who receive thrombolyticsquickly, and the potential cost savings by avoiding unnecessaryhospital admissions for observation of patients who can bequickly identified as non-critical.4 In 1997, Roberts found thatED diagnosis based on acceleration of protocols saved an aver-age of $567 compared with more conservative hospitalization.4

The Laboratory Practice Guidelines of the NACB recom-mended in 1999 that markers such as troponin should betested at least every 2 to 4 hours until a diagnosis is con-firmed.6 In addition to troponin and CK-MB, most acceler-ated protocols use myoglobin, a rapidly appearing but less-specific marker to obtain a quicker diagnosis or exclusion ofMI.6,44-47 A sample accelerated algorithm for the combineduse of BNP and cardiac markers (such as troponin and myo-globin) is shown in Figure 3.

C-reactive protein has been demonstrated to be an impor-tant, independent risk factor in long-term cardiac risk as-sessment in apparently healthy patients.5,47-49 However, re-cent evidence shows that hsCRP values also add valuableinformation to standard cardiac markers for risk stratifica-tion in acute patients presenting with chest pains.5,47-49 Otherreports have demonstrated that soon after onset of pain,hsCRP elevations were an independent risk indicator.48 Thesefindings reaffirm an inflammatory aspect in ACS in addi-tion the thrombolytic/necrotic aspect represented by mark-ers such as troponin.5,47-49

Detection of cardiac ischemia as well as AMIsSeveral reviews have reported meta-analysis of published car-diac marker data for the diagnosis of AMI and also cardiacischemia.50-52 Not surprisingly, the common markers, whichare released upon cell death, are substantially better at de-


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tecting AMIs than ischemia, whichmay never result in necrosis. In gen-eral, these reviews confirm that a com-bination of cardiac markers is benefi-cial, as compared to any individualmarker, and serial determinations ofcardiac markers have much better sen-sitivity than single determination atpresentation.50,52

Very recently, another exciting additionto cardiac testing appeared on the hori-

zon for use in the diagnosis of MIs.53-55

This assay, recently approved by theFDA, measures a reduction in the bind-ing of exogenous cobalt to the aminoterminus of albumin during ischemia.Because this assay detects a change dueto ischemia rather than myocardial ne-crosis, these changes occur much ear-lier than even the elevation in myoglo-bin. Although this test is not intendedfor MI, the early confirmation of seri-ous ischemia could potentially lead to


Figure 3. Sample algorithm for use of BNP and cardiac markers (such astroponin, myoglobin, and possibly CK and CK-MB)

This figure is intended to provide a simplistic representation of a diagnostic algorithmusing only clinical chemistry assays. Obviously, physician’s algorithm would include EKG,history and examination results, etc. and could become much more complex.

much more rapid treatments of patientswho are having an MI.53-55

Troponin and a redefinition of myo-cardial infarction and unstable anginaA further challenge to the emergencyphysician lies in accurately distinguish-ing between stable angina and unstableangina that is much more likely to pro-ceed to a life threatening MI in the nearfuture. Historically, there has been littlehard evidence on which the ED phy-sician could base a conclusion of stableversus unstable angina and physicianswere forced to simply use their bestclinical judgment. Evidence suggeststhat low troponin levels can be used asan objective measure of ‘mini-infarcts’or ‘pre-infarcts’ that characterize UAand are associated with an increasedlikelihood of a heart attack within thenext few weeks.6,7

In 1999, the NACB recommended asystem of two cutoffs for troponin lev-els. The higher cutoff indicated anAMI, while a lower level (but still abovethe reference range) essentially rede-fined unstable angina.6 Refinement ofthis concept has resulted in an inten-tional blurring of these distinctions toconsider any elevated troponin as in-dicative of an ACS.6,7 Simply put, anMI is further along the same ACS con-tinuum than a UA, but the underly-ing processes are similar. This molecu-lar level analysis may be valid, but itstill leaves the clinician with therapeu-tic decisions to make. Several clinicalevaluation schemes have sought to pre-dict AMI and UA outcomes in orderto assess the benefits of thrombolyticsand other aggressive treatments for UApatients.52 For example, Sabatinefound significant benefit in treatingUA patients with the glycoprotein llb/llla inhibitor, tirofiban.52

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Cardiac risk stratification for non-acute patientsAn understanding of plaque development helps explain sev-eral factors related to increased risk of heart disease (shownon Table 3). Historically, risk factor lists were dominatedmostly by life-style and genetic predisposition factors suchas family history, obesity, diabetes, smoking, sedentary lifestyle, hypertension, stress, gender, age, and total cholesterol.Recently, molecular-level risk factors such as elevated baselinehsCRP, elevated homocysteine, lipoprotein a, and the LDL/HDL ratio, have been added to the lists. In general, thesebiochemical factors relate directly to the process of plaquedevelopment and inflammation. As our understanding ofthe process of plaque formation improves, risk assessmenthas also become more sophisticated and now focuses on fac-tors that accelerate plaque deposition.

Conclusion and Summary of the Clinical Utility of BNPCongestive heart failure is the leading cause of hospitaliza-tion of patients over 65 years of age, estimated at about900,000 hospitalizations a year and costing roughly $30 bil-lion. Almost 50% of discharged patients are re-admittedwithin six months, and their five-year mortality rate ap-proaches 50%.8 The use of the BNP assay when heart failureis suspected has the potential to reduce the diagnostic time,and identify those patients at high risk for experiencing re-currence. By identifying these high-risk patients, treatmentsmight be modified to decrease risk of readmissions and re-duce the length of stay and hospital costs. In addition, modi-fied treatments might improve the quality of patients’ lives,and prolong patient survival.


In addition to the benefits of prompt identification of CHFpatients through their high BNP levels, the implicationsof low BNP levels are also important. Studies have reportedNPVs of greater than 98%, indicating that physicians canessentially eliminate CHF from the differential diagnosiswhen a patient’s BNP level is below 50 pg/mL.11,12 Recentstudies also found misdiagnosis of patients presenting withdyspnea to be a significant and costly problem when BNPis not available (initial diagnosis was made solely on his-tory and clinical judgment).12,17,18 The multinational BNPtrials reported by McCullough showed that BNP levelsalone had higher diagnostic accuracy than traditional clini-cal judgment by ED physicians.17

Cost analysis of testing vs downstream savingsIn 1994, O’Connell estimated that approximately $38 bil-lion in healthcare costs were associated with CHF (5.4% oftotal healthcare costs), with hospitalization accounting forapproximately 60% of these costs.56 Many of these healthcaredollars are spent on patients who have been admitted forfurther observation, awaiting a definitive diagnosis and ini-tiation of treatment.8,56 According to the National HealthcareCost and Utilization Project (see website listings), the meancost of a hospital admission for CHF was $15,024 in 2000and the mean length of stay (LOS) was 5.6 days. The meancosts and LOS for AMIs and COPD diagnoses were $28,227and 5.5 days, and $12,351 and 5.3 days, respectively. This iscompared with ‘non-specific chest pain’ statistics of $7,488and 1.8 days. Obviously, if even a small fraction of thesecosts can be avoided with a more rapid diagnosis and treat-ment for the more than one million CHF admissions, thetotal healthcare savings would be enormous.

With a 15-minute assay time for BNP, and an NPV of 98%,a BNP value below the cutoff level might avoid hospital ad-missions-for-observation of tens of thousands of non-CHFpatients. At a cost to the laboratory of approximately $30,depending on volume, etc., and an approved reimbursementcost of $47, this assay would appear to be an extremely costeffective addition to the cardiac workup.

Savings will also be realized if BNP levels can provide anobjective method to monitor or ‘tailor’ treatments such asACE-inhibitors, rather than the current empirical approach.34

Healthcare costs, morbidity, and mortality would be reducedif patient prognosis can be determined using BNP levels,and patients who should receive more aggressive treatmentsare identified.

Table 3. Cardiac risk stratification factors

Clinical history factorsCurrent smoking Male genderDiabetes mellitus ObesityFamily history Sedentary lifestyleHypertension StressIncreasing age

Elevated clinical chemistriesHomocysteine Lipoprotein (a)hsCRP Total cholesterolLDL/HDL Ratio TriglyceridesLDL-cholesterol

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Finally, the increased diagnostic accuracy described earlierneeds to be considered.12,17,18 These studies reported misdi-agnosis of 10% to 20% by emergency staff that could havebeen largely avoided by consideration of BNP results alone.These results are confirmed in another study where nearly18% of dyspnea patients were misdiagnosed, and in 90% ofthose, BNP would have helped correct the diagnosis.18 In-clusion of BNP testing would obviously save unnecessarysuffering, morbidity, and even mortality of the misdiagnosedpatients, as well as saving the substantial financial burden ofmisdiagnosis.

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Accelerated Cardiac Protocols in EmergencyLaboratory Medicine: Four Case Studies

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WAYNE GADE, CHARIS HAINAUT, JEAN GADE

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The Focus section seeks to publish relevant and timely continuingeducation for clinical laboratory practitioners. Section editors, topics,and authors are selected in advance to cover current areas of interest ineach discipline. Readers can obtain continuing education credit (CE)through P.A.C.E.® by completing the tearout form/examination ques-tions included in each issue of CLS and mailing it with the appropri-ate fee to the address designated on the form. Suggestions for futureFocus topics and authors, and manuscripts appropriate for CE creditare encouraged. Direct all inquiries to Vicki Freeman, Dept. of ClinicalLaboratory Sciences, 301 University Boulevard, Galveston, TX 77555-1028; vfreemanutmb.edu, incoming Continuing Education Editor.

This paper illustrates the diagnostic dilemmas in a small hos-pital emergency department when four patients present withsimilar symptoms of dyspnea, angina, and edema. These casesillustrate a new role for the clinical laboratory, as the new car-diac markers and protocols help overcome the ambiguity ofsymptoms, delays in diagnosis, and high costs of imaging teststhat may be unavailable in many small hospitals.

Frequently, dyspnea and chest pain are associated with car-diac disorders such as congestive heart failure (CHF), unstableangina, and acute myocardial infarction (MI). However, thesesame presenting symptoms may also be seen in obstructivepulmonary disorders, pulmonary embolism, pneumonia, andnon-pulmonary disorders as diverse as anemia and anxiety.

The recent addition of troponin and myoglobin to cardiacpanels and the increasing use of accelerated cardiac proto-cols have improved speed and accuracy in the diagnosis ofMI. While certain aspects of the interpretation of troponindata remain controversial, the use of accelerated testing pro-tocols is gaining acceptance, following the recommendationsof the National Academy of Clinical Biochemistry in 1999.With the introduction of rapid laboratory testing for B-typenatriuretic peptide (BNP) in 2000, the diagnosis of CHFhas also become faster, easier, and more reliable.

A companion paper in this issue reviews plaque develop-ment, acute coronary syndromes (ACS), and pathophysiol-ogy of CHF.1 In addition, the biochemistry and physiologyof BNP, and the clinical evidence supporting its use in thediagnosis, risk stratification, staging, and therapeutic moni-toring of CHF patients are also reviewed.

Rapid BNP assays and high sensitivity C-reactive protein(hsCRP), along with other cardiac markers, such as troponinand myoglobin, enable the clinical laboratory to assume a moreactive role in the diagnosis of a wide range of cardiac condi-tions. Rapid advances in diagnosis of cardiac disease will forceclinical laboratory science (CLS) training programs to expanddiscussion of such topics as CHF and stable/unstable anginathat were previously minimized to reflect the minimal involve-ment of the clinical laboratory in their diagnoses.

ABBREVIATIONS: ABG = arterial blood gas; ACS = acutecoronary syndromes; BNP = B-type natriuretic peptide; CBC= complete blood count; CHD = coronary heart disease;CHF = congestive heart failure; CLS = clinical laboratoryscience; CMP = comprehensive metabolic profile; COPD =chronic obstructive pulmonary disease; ECG = electrocar-diogram; ED = emergency department; EMT = emergencymedical technician; hsCRP = high sensitivity C-reative pro-tein; MI = myocardial infarction; NPV = negative predictivevalue; RAAS = renin-angiotensin-aldosterone system; UA =urinalysis; WBC = white blood count;.

INDEX TERMS: acute coronary syndromes; BNP; cardiacprotocols; coronary testing; myocardial infarction.

Clin Lab Sci 2003;16(3):180

Wayne Gade PhD MT(ASCP) is assistant Professor of Clini-cal Laboratory Science, University of Illinois at Springfield,Springfield IL.

Charis Hainaut CLS(NCA) is a CLS in the Clinical Labora-tory, Decatur Memorial Hospital, Decatur IL.

Jean Gade MS RN is an Instructor in the Chemistry Depart-ment, Northern Kentucky University, Highland Heights, KY.

Address for correspondence: Wayne Gade PhD MT(ASCP)Clinical Laboratory Science Program, HSB 314, University ofIllinois at Springfield, Springfield, IL 62703-5407. (217) 206-7349.

Wayne Gade is the Focus: Cardiac Protocols guest editor.

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Focus Continuing Education Credit: seepages 188 to 190 for learning objectives,test questions, and application form.

LEARNING OBJECTIVESAfter reading the following articles, thereader will demonstrate his/her under-standing of the material by achievingthe following:1. Describe the biochemistry of the

BNP and the other natriureticpeptides.

2. Describe the major physiologicresponses to the elevation ofBNP levels.

3. Discuss the mechanism by whichthe binding of BNP to the targetcell results in alteration of Na+ andwater reabsorption.

4. Describe the formation of arterialplaque and the development ofcoronary artery disease and acutecoronary syndromes (ACS).

5. Describe the physiological condi-tions that develop into CHF andcause the release of BNP.

6. Describe and interpret the diag-nostic accuracy, sensitivity, speci-ficity, and negative predictive val-ues reported for rapid BNP assays.

7. Describe the trend toward “accel-erated cardiac protocols,” includ-ing which markers are suggested,and the suggested time-course ofsequential testing.

8. Evaluate patient data and deriveappropriate diagnostic conclusions.

9. Discuss the use of BNP for prog-nosis and screening of patients forLV dysfunction.

10. Discuss the interpretations ofslightly elevated levels of troponinand C - reactive protein (CRP) asthey relate to ACS and risk analysis.

FOUR CASES IN THE EMER-GENCY ROOMThe four cases described below illus-trate a scenario in a small hospitalemergency department (ED) prior tothe recent advances in cardiac testing.The epilogue, which follows the dis-cussion, represents a ‘fast-forward’ toa present-day ED, with the insertionof B-type natriuretic peptide (BNP),myoglobin, and high sensitivity C-re-active protein (hsCRP) into the car-diac panel, and the use of acceleratedtesting protocol with specimens drawnevery two hours.


Table 1. Selected admission laboratory results for Michael

Analyte Result Flag Reference rangepH 7.38 7.35-7.45PCO

233.0 L 34.0-46.0 mm Hg

PO2

132 H 80-97 mm HgHCO

3-(calc) 19.9 L 22.0-26.0 mmol/L

% O2 Sat (calc) 99 95-99%

Hct 37.5 L 42-50%Hgb 11.9 L 14.0-18.0 g/dLWBC 15.6 H 4.8-11.8 x 109/LTroponin 0.3 AMI cutoff <0.40 ng/mLTotal CK 207 20 – 220 U/LCK-MB 3.5 0.3 – 4.0 ng/mL

MichaelMichael, a 70-year-old man with a his-tory of congestive heart failure (CHF),lay quietly on Bed # 4 in the small hos-pital ED. Quietly that is, except for theconstant heaving of his chest, and rapidsuction of his lungs demanding moreoxygen from the mask covering his face.

The arterial blood gas (ABG), completeblood count (CBC), cardiac markers,and urinalysis (UA) results were nowavailable, since Michael had arrived byambulance one hour earlier (selectedvalues are shown in Table 1). His ABGresults showed full compensation for therespiratory alkalosis resulting from hisdyspnea. Michael’s CBC indicated anelevated white blood count (WBC)count and slight anemia, his UA results(not shown) were normal except for pro-tein (1+) and Hgb (1+), and his admis-sion cardiac markers were high-normal(Troponin 0.3 mg/mL, CK 207, andCK-MB 3.5%).

The nurse efficiently checked his moni-tor for changes in electrocardiogram(ECG) rhythms, pulse, and oxygensaturation while she adjusted the flowrate of his IV. She noted that his dysp-nea had improved as the 50% oxygentherapy answered his lungs’ demands.His chest pain had also decreased,thanks to medication. But Michael wasleft alone, wondering why this pain wasworse than his previous CHF episodesas the nurse scurried from the roomwithout hearing his questions.

CharlesIn Bed #5, Charles, a 68-year-old manwith no history of heart or pulmonarydisease, looked down at his swollen feetand pondered his recent tendency todevelop angina and shortness-of-breathduring normal activities. His currentepisode had started the previous after-noon, when he was mowing the lawn.

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His decision to trade the yard work for acouple of cans of beer had temporarilyimproved his symptoms, but they hadreappeared early this morning. With noprevious records to guide their test selec-tions, the ED staff had ordered an ECG,chest X-ray, comprehensive metabolicprofile (CMP), CBC, cardiac markers,and coagulation and lipid profiles (seeTable 2 below for selected values).

Like his neighbor in Bed #4, Charles’CBC indicated a slight anemia; how-ever he had only a slight increase inWBCs (11.9 x 109/L). His electrolytes,liver enzymes, and coagulation valueswere all normal. The lipid profileshowed slightly elevated cholesterol,and a poor LDL/HDL ratio (see Table2). Charles’ renal function also ap-peared to be compromised, with eleva-tions in both BUN and creatinine. TheED physician was relieved to see thatthe cardiac markers were normal and,despite an ambiguous ECG, an MInow seemed unlikely.

The doctor’s explanation of Charles’condition was not particularly infor-mative, and had a disconcerting effecton Charles. “We’ll have to see the nextset of cardiac markers to be sure, but

considering the time of onset of yourpain, the markers should have beenpositive by now if you had an MI.However, your heart is somewhat en-larged, and with the shortness ofbreath, we’re concerned about the pos-sibility of congestive heart failure.Tomorrow we’d like to transfer you toMemorial Hospital for an echo-cardiogram and other testing.”

Charles hardly heard another word af-ter the phrase “heart failure.” He knewlittle about medicine, but had his ownunderstanding about the inevitableoutcome of heart failure.

MaryMary’s entrance into the ED was a dra-matic contrast to the quiet anxiety ofthe other patients. She arrived by am-bulance with an entourage of emer-gency medical technicians (EMTs) andED staff rushing her into Room #1,while her vitals were recited rapidly.Her pale face was etched with anxietyand pain (she later rated it a 7 on the10-point scale), but she was mainlyconcerned about catching her nextbreath without experiencing the in-tense pain that she knew would accom-pany a deep breath. Her ECG pattern


was not definitive, so the ED physi-cian ordered the standard cardiac test-ing profiles. The low hemoglobin andhematocrit values (included along withother selected laboratory results shownin Table 3) helped explain Mary’s palecomplexion, but the rest of her chem-istry and hematology data offered noclear explanation of her condition.

As the oxygen mask reduced her needto gasp for breath, Mary relaxed a bitand reflected on her last, turbulent hour.Luckily, several people had witnessedher collapse, and she had received im-mediate attention. Mary didn’t want tothink about what might have happenedif she had been alone. The short timebetween her collapse and the admissionblood draws meant that the traditionalcardiac markers would not yet be el-evated. This, along with the inconclu-sive ECG had caused the physician todelay thrombolytic intervention untilthe next set of laboratory results couldconfirm her condition.

EdwardAcross the hallway in Bed #2, 38-year-old Edward also gasped for breath andwondered why the pain in his chest wasso intense. As a rotund, long-timesmoker with worsening emphysema,Edward was accustomed to dyspnea,but he was alarmed by the intensity ofthis new pain. Edward also had edema,and complained of increasing lethargy.He noted that his chronic, dry coughhad produced discolored sputum in re-cent days. Edward’s chemistry test re-sults were already available, since he hadarrived four hours earlier. His coagula-tion values, chemistry profile, and car-diac markers were all normal (data notshown), as was his CBC, except for el-evated WBCs (17.3 x 109/L). A spu-tum gram stain, showed purple diplo-cocci with apparent capsular ‘halos’.“Clearly, you have developed a strep-

Table 2. Selected admission laboratory results for Charles

Analyte Result Flag Reference RangeHct 38.1 L 42-50%Hgb 12.9 L 14.0-18.0 g/dLBUN 23.0 H 5-17 mg/dLCreatinine 2.7 H 0.7-1.7 mg/dLCholesterol 210 H 120-200 mg/dL

LDL chol 135 Mod risk 95-130 mg/dLHDL chol 22 L 30-75 mg/dLTroponin 0.01 AMI cutoff <0.40 ng/mLTotal CK 45 Mod risk 20 – 220 U/LCK-MB Cancelled 0.3 – 4.0 ng/mL

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tococcal pneumonia,” the doctor statedconfidently, without waiting for cul-ture results. “We’re concerned aboutone of your cardiac markers, but we’llwatch that closely, and we’ll need a fewmore tests to determine whether or notheart failure is contributing to yourchest pain and causing the edema.”

In the end, all four patients were leftwith several hours of discomfort andanxiety while the doctors tried to di-agnose their conditions as MI, CHF,other cardiac diseases, or one of sev-eral possible pulmonary diseases.

RECENT DEVELOPMENTS INCARDIAC MEDICINEACS and accelerated cardiac testingAcute coronary syndromes (ACS) rep-resent a wide spectrum of conditionsranging from the partial occlusions as-sociated with mild exertional angina tothe thrombosis and total occlusion ofa coronary artery, which defines MI.1,2

Plaque development is the central pro-cess in the development of ACS, andcontributes directly to more than threemillion hospital admissions, 500,000cardiac deaths, and over $10 billion inhealthcare costs per year.3

Patients presenting with chest painsand dyspnea create a major diagnosticchallenge for ED physicians. Physi-cians must quickly and accurately dis-

tinguish between MI patients in needof immediate thrombolytic interven-tion, and angina patients for whomthrombolytic therapy may be detri-mental or even life threatening. Giventhe relatively short time span (20 to30 minutes) between a thrombolyticevent of an MI and the beginning ofmyocardial necrosis, it is obviously es-sential that the distinction be maderapidly. Similarly, thrombolytictherapy has a relatively short ‘window’of maximum benefit once a clot hasoccurred. Essential laboratory datamust be rapidly available so that diag-nostic decisions can be made quickly.The recent emphasis on acceleratedcardiac testing protocols has enabledsome cardiac units to strive for diag-nosis and initiation of treatment of allcardiac patients within 90 minutes ofarrival at the ED.4,5

CHD, risk assessment, and inflammationA primary focus in prevention of CHDfor many years has been the identifi-cation of risk factors, such as familyhistory, smoking, obesity, and totalcholesterol. Overweight patients whowere smokers, and had high cholesterolwere counseled to alter their lifestyleto improve those risk factors that weremodifiable. Recently, researchers haveidentified molecular level analytes thatare associated with increased risk of de-veloping CHD, such as hsCRP, ho-


mocysteine, LDL/HDL ratios, andapolipoproteins such as Apo a-1.6 Inaddition, research into the plaque for-mation process has shown similaritieswith normal inflammatory processes asdescribed in the companion reviewpaper in this issue. For example, el-evated baseline levels of the inflamma-tory response protein, hsCRP, havebeen shown to have a strong associa-tion with increased cardiac risk.7-9

Background of CHFCHF is characterized by an inabilityof the heart to supply sufficient cir-culation to the body (ischemia).Nearly five million Americans are af-flicted, and it is particularly prevalentin the elderly, causing 20% of theirhospital admissions.10,11 CHF repre-sents a major national health crisis,with 400,000 new diagnoses, 2.5 mil-lion hospitalizations per year, andnearly 50% five-year mortality.

Conditions that lead to CHF (listedin Table 1 of the companion reviewarticle)1 can include increased vascularresistance, damaged or malfunction ofcardiac tissue, and many other condi-tions that force the heart to compen-sate until it fails to maintain adequatecirculation and oxygenation.10-12

Early stages of CHF are often asymp-tomatic because the heart initially com-pensates for the decreased circulationwith an increased heart rate and hy-pertrophy (to increase strength of con-traction). However, as circulation con-tinues to decrease (ischemia) the kid-ney responds by activation of theRAAS described in the companion re-view article.1 If hypoxia develops, thekidney also responds with the secretionof erythropoietin. These responses maybe beneficial in cases of trauma andblood loss to protect against dehydra-tion, hypoxia, and circulatory shock by

Table 3. Selected admission laboratory results for Mary

Analyte Result Flag Reference RangeHct 32.1 L 42-50%Hgb 9.9 L 14.0-18.0 g/dLBUN 18 H 5-17 mg/dLCreatinine 0.7 0.7-1.7 mg/dLTroponin 0.01 AMI cutoff <0.40 ng/mLTotal CK 58 20 – 220 U/LCK-MB 0.4 0.3 – 4.0 ng/mL

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maintaining blood pressure and volume.10-12 However, to theCHF patient these increases may represent harmful increasesin workload for the already failing heart.

The release of BNP represents another compensation by anoverloaded heart. The net effect of natriuretic peptides and BNPis the release of both sodium and water in urine, which leads todecreases in blood pressure and blood volume.13,14 Thus, BNPcounteracts the RAAS, which caused vasoconstriction, increasedsodium reabsorption, and increased blood pressure.

Traditionally, the diagnosis of CHF has been based on medi-cal history, symptoms, physical examination, ECG, chest x-ray, and non-laboratory diagnostic tests to rule out all othercauses of dyspnea. Follow-up testing involvedechocardiography and exercise stress tests to assess the heart’ssize, shape, and function. The clinical relevance of BNP re-lates to its critical role in the biochemical and physiologicalresponse to the pressure and volume overload conditionscharacteristic of CHF. The rapid and easy BNP assays nowavailable make BNP determinations especially useful in theED setting.

Rapid BNP improves speed of CHF diagnosisSince their introduction in 2000, rapid BNP assays (turn-around times as low as 15 minutes) have been shown to pro-vide valuable information for the diagnosis of CHF, whichpreviously took several hours or even days to diagnose. Onestudy of 250 patients reported mean BNP levels of 1076 forCHF patients, compared with a mean of 86 in chronic ob-structive pulmonary disease (COPD) patients withoutCHF.15 Another study reported patients presenting withdyspnea had a mean BNP levels of 758 pg/mL in those di-agnosed with CHF, compared to 61 pg/mL in patients withnon-CHF pulmonary diseases.16 Numerous other studies(reviewed in reference 1) have reported similarly elevatedlevels of BNP in patients with CHF.

With a BNP level of 80 pg/mL established as the cutoff, therapid assay had a sensitivity of 98% and specificity of 92%for the diagnosis of CHF.15,17 Perhaps more important wasthe 98% negative predictive value (NPV), which allows phy-sicians to confidently rule out CHF as the cause of dyspneain patients with BNP levels below the cutoff.

BNP improves the accuracy of CHF diagnosisIn one study, two cardiologists (using additional data notavailable to the ED physicians) identified 30 of 250 patientswho were misdiagnosed by ED physicians using traditional

criteria. The use of BNP levels alone would have correctlyidentified 29 of these 30 misdiagnosed patients.15 Similarly,a multinational study showed a higher diagnostic accuracy(82.1%) with BNP levels alone than clinical judgment ofED physicians who were blinded to BNP levels (74.0%).Combining clinical judgment to BNP levels only increasedthe diagnostic accuracy 82.5%.17

CHF and the clinical utility of BNPCHF is the leading cause of hospitalization of patients over65 years of age, with an estimated 900,000 hospitalizationsa year, costing roughly $30 billion. The use of the BNP as-say for CHF has the strong potential to reduce diagnostictime, reduce misdiagnosis, identify those patients most likelyto experience recurrence, and monitor treatments.10,11 Inaddition to the rapid diagnosis of CHF patients with veryhigh BNP levels, the implications of normal low levels areequally valuable. The reported NPVs of greater than 98%,indicate that CHF can essentially be eliminated from thedifferential diagnosis when a patient’s BNP level is low.

Delayed diagnosis and even misdiagnosis of patients pre-senting with dyspnea has been shown to be a significant andcostly problem when BNP was not available and initial di-agnosis was based on traditional clinical judgment. A multi-national study showed that elevated BNP levels had a higherdiagnostic accuracy than traditional clinical judgment by EDphysicians.17

In general, the prognosis for CHF patients has not been en-couraging, with 50% re-admission within six months afterdischarge, and nearly 50% five-year mortality.10,11 Numerousstudies have indicated that BNP levels could help identifypatients with the poorest prognosis.18-24 One study found thatpatients with high BNP levels (above 480 pg/mL) had a 51%risk of a further cardiac event (readmission or death) withinsix months, compared to only 2.5% reoccurrence in CHFpatients with lower BNP levels.20 Once identified, these pa-tients could receive a more aggressive treatment and therapycould be carefully monitored using BNP levels to avoid read-missions and possibly decrease mortality rates.

ACCELERATED PROTOCOLS FOR RULE-OUT OF AMIsResearchers have suggested the use of myoglobin, troponin,hsCRP, and BNP in accelerated protocols for exclusion of AMIas a diagnosis within 90 minutes, and diagnosis and risk strati-fication for most cardiac patients within the first few hours.4,5,25-

27 One group suggests that cardiac markers be repeated at 30-minute intervals for the first 90 minutes and McCord pro-


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posed a protocol for exclusion of MIs within 90 minutes.5,26

These protocols use myoglobin, a rapidly appearing, but rela-tively non-specific marker to obtain a rapid diagnosis or ex-clude MI.25-27 Because of its non-specific nature, myoglobin’sdiagnostic value is limited, primarily suggesting a quick rule-out of MI in patients with normal levels.27

The Laboratory Practice Guidelines of the National Academyof Clinical Biochemists recommended in 1999 that markersshould include troponin, to be tested at least every two to fourhours. The emphasis of early decision-making within emergencymedicine and cardiology is based on the benefits for patientswho receive thrombolytics quickly, and the expenses saved byavoiding unnecessary admissions for observation of patientswhose possible MI might be quickly ruled-out.4,27

Similarly, a low BNP value for a patient might avoid costlyfollow-up tests or hospital admission for many non-CHFpatients.11,14,18,28-30 The benefits of improved diagnostic ac-curacy and a NPV of 98% described earlier could preventthe enormous financial cost of misdiagnosis and, more im-portant, avoid unnecessary suffering.28 Thus, recent advancesin cardiac diagnosis and treatments are likely to reduce hos-pitalization of patients, reduce hospital costs, improve thequality of patients’ lives, and reduce mortality.

FAST FORWARD TO PRESENTSo what ever happened to Michael, Charles, Edward, and Mary?In the traditional setting, the ED physician treating our four‘chest pain’ patients could not reach a diagnosis, based onthe data available earlier. In fact, the diagnosis for all fourpatients may take several hours or days, while expensive im-aging or catheterization procedures are performed and in-terpreted. In addition ‘ruleout of MI’ will require sequentialsets of cardiac markers to be performed at traditional six toeight hour intervals.

Was Michael having an MI or was his chest pain and dysp-nea simply due to an extreme episode of his previously diag-nosed CHF? Was Charles’ problem related to a developing

CHF, or was his dyspnea caused by development of a lungdisease or infection? Was Edward’s pain due to the pneumo-nia or was he also having an MI or possibly developing CHF?And finally, was Mary’s pain and difficulty breathing due toan MI, CHF, acute respiratory disease, a pulmonary embo-lism, or extreme anxiety?

Answers to each of the patient conditions can be derived byanalysis of the additional data in Tables 4 through 6. Addi-tional admission results, including BNP and myoglobin lev-els for all four patients are shown in Table 4. Unlike theother cardiac markers, elevations in BNP and myoglobinfrequently precede the patient’s arrival in the ED, thus avoid-ing the agonizing hours of waiting for the more data. Thishospital has changed its emergency procedures to adopt anaccelerated protocol for cardiac cases, based upon repeat test-ing at two-hour intervals (data seen in Tables 5 and 6).

Michael did have an MI, probably related to the extra stress ofCHF on his overworked heart. On admission his traditionalcardiac markers were not yet positive for AMI (see Table 1).However, one can see from Table 4 that the initial ambiguityof his condition would have been clarified if the doctor hadbeen aware of his admission myoglobin and BNP levels. Thetwo-hour data confirmed that Michael was having an MI (seeTable 5). Only then, was a thrombolytic initiated to dissolveMichael’s clot. It was fortunate that the ED’s cardiac protocoldetermined his diagnosis after only a two-hour delay, ratherthan the six to eight hour delay of their previous cardiac pro-tocol. The data also suggests that Michael’s MI had occurredseveral hours earlier, since his myoglobin level decreased be-tween the two- and four-hour draws, while other markers con-tinue to elevate. Unfortunately, the combination of damagefrom his MI, delayed treatment, and elevated BNP levels gaveMichael a poor prognosis. His New York Heart Association(NYHA) classification had previously been II, which trans-lates to some limitation of physical activity. The current MIfurther reduced his cardiac function, and Michael was reclas-sified to category III following this incident.Charles was also diagnosed with CHF, which was later con-


Table 4. Admission BNP and myoglobin results for all four patients

Marker Michael Charles Mary EdwardMyoglobin (20-90 ng/mL) 1235 43 107 87BNP (0 – 100 pg/mL) >1300 1070 36 59hsCRP (<1µg/mL) 35.2 1.3 3.8 105

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firmed by echocardiography to be left ventricle (LV) dys-function. Had his doctor been aware that his admissionmyoglobin was normal and BNP level was markedly elevated(Table 4), his preliminary diagnosis of CHF might have oc-curred within minutes after Charles’ arrival. Without thisinformation, the rule-out of MI took several hours (see Tables5 and 6), and his final CHF diagnosis was only confirmedtwo days later, after his transfer to a larger hospital forechocardiography. His follow-up BNP levels declined sig-nificantly over the next few days with medication, indicat-ing a much better prognosis than Michael.

Mary was also having an MI, as suggested by her slightlyelevated myoglobin on admission (Table 4), and confirmedby her two- and four-hour cardiac markers (Tables 5 and 6).Mary’s case illustrates one of the benefits the accelerated pro-tocols. Her initial results, including the slightly elevatedmyoglobin, were hardly conclusive for an MI. When accel-erated diagnostic protocols are used, the non-specificity ofmyoglobin leads to low confidence in positive values. Myo-globin elevations can be correlated chronologically with thechest pain when a ‘delta myoglobin’ value is used.26 Thismethod simply looks for increased myoglobin levels for se-quential tests. When compared to her admission level of 107ng/mL, Mary’s two-hour level of 278 ng/mL (Table 5) rep-resents a large increase, or delta myoglobin. Thus, despitethe ambiguous results of her other two-hour markers, thelarge increase in myoglobin would suggest an MI before theother markers became elevated. Mary’s low BNP level on


admission would have essentially ruled out any likelihoodof a preexisting CHF.

Edward’s pneumonia was confirmed by culture, and waseventually resolved with antibiotics. His initial total CK value(185 U/L) had concerned the physician; however, subsequentdecreases (Tables 5 and 6) erased the concern. Given Edward’slarge size, these CK values were probably normal. Both Ed-ward and his doctor were relieved to find no evidence ofCHF, as evidenced by both the admission BNP value in Table4, and follow-up data in Tables 5 and 6. In the end, Edwardwas released following a stern lecture about his lifestyle andthe long-term consequences of smoking.

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Table 5. Two-hour cardiac marker results for all four patients

Marker Michael Charles Mary EdwardTroponin (AMI <0.40 ng/mL) 4.3 0.014 0.4 0.012Total CK (20 – 220 U/L) 1367 46 126 174CK-MB (0.3 – 4.0 ng/mL) 11.8 Cancelled 3.6 CancelledMyoglobin (20-90 ng/mL) 1452 53 278 81

Table 6. Four-hour cardiac marker results for all four patients

Marker Michael Charles Mary EdwardTroponin (AMI < 0.40 ng/mL) 28.5 0.010 2.3 0.012Total CK (20 – 220 U/L) 2166 55 426 171CK-MB (0.3 – 4.0 ng/mL) 21.8 Cancelled 5.8 CancelledMyoglobin (20-90 ng/mL) 1128 56 572 84

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15. Dao Q, Krishnaswamy P, Kazanegra R, and others. Utility of B-typenatriuretic peptide in the diagnosis of congestive heart failure in anurgent-care setting. J Am Col Cardiol 2001;37:379-85.

16. Maisel AS, Koon J, Krishnaswamy P, and others. Utility of B-natri-uretic peptide as a rapid, point-of-care test for screening patientsundergoing echocardiography to determine left ventricular dysfunc-tion. Am Heart J 2001;141(3):367-74.

17. McCullough PA, Nowak RM, McCord J, and others. 2002, B-typenatriuretic peptide and clinical judgment in emergency diagnosis ofheart failure: analysis from breathing not properly (BNP) multina-tional study. Circ 2002;106(4):416-20.

18. Maisel A. B-type natriuretic peptide in the diagnosis and manage-ment of congestive heart failure. Cardiol Clin 2001;19(4):557-71.

19. Cheng V, Kazanagra R, Garcia A, and others. A rapid bedside testfor B-type peptide predicts treatment outcomes in patients admit-ted for decompensated heart failure: a pilot study. J Am Coll Cardiol

2001;37(2):386-91.20. Harrison A, Morrison L, Krishnaswarmy K, and others. B-type natri-

uretic peptide predicts future cardiac events in patients presentingto the emergency department with dyspnea. Ann Emer Med2002;39(2):131-8.

21. Omland T, de Lemos JA, Morrow DA, and others. Prognostic valueof n-terminal pro-atrial and pro-brain natriuretic peptide in patientswith acute coronary syndromes. Am J Cardiol 2002;89(4):463-5.

22. Arakawa N. Nakamura M, Aoki H, and others. Plasma brain natri-uretic peptide concentration predicts survival after acute myocardialinfarction. J Am Coll Cardiol 1996;27:1656-61.

23. Berger R, Huelsman M, Strecker K, and others. B-type natriureticpeptide predicts sudden death in patients with chronic heart failure.Circ 2002;105(20):2392-7.

24. Bettencourt P, Ferriera A, Dias P, and others. Predictors of prognosisin patients with stable mild to moderate heart failure. J Cardiac Fail2000;6:306-13.

25. Sabatine MS, Morrow DA, de Lemos JA, Multimarker approach torisk stratification in non-ST elevation acute coronary syndromes:simultaneous assessment of troponin I, C-reactive protein, andB-type natriuretic peptide. Circ 2002;105(15):1760-3.

26. McCord J, Nowak RM, McCullough PA, and others. Ninety-minuteexclusion of acute myocardial infarction by use of quantitativepoint-of-care testing of myoglobin and troponin I. Circ2001;104(13):1483-8.

27. Wu Alan HB, Apple FS, Gibler WB, and others. National Academyof Clinical Biochemistry Standards of Laboratory Practice: recom-mendations for the use of cardiac markers in coronary artery dis-eases. Clin Chem 1999;45:1104-21.

28. Maisel AS, and others. B-type natriuretic peptide levels: diagnosticand prognostic in congestive heart failure: what’s next? Circ2002;105(20):2328-31.

29. Wieczorek SJ, Wu AHB, Christenson R, and others. A rapid B-typenatriuretic peptide assay accurately diagnoses left ventricular dys-function and heart failure: a multicenter evaluation. Am Heart J2002;144(5):934-9.

30. Wu AHB. 2001. B-type natriuretic peptide and its clinical utility inpatients with heart failure. Med Lab Obs 2001;33(10):10-4.


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Continuing Education Questions

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SUMMER 2003

Sharon M Miller is the liaison for the CLS Continuing Educationsection. She reviews Focus articles, assigns contact hours, and editslearning objectives and test questions. Direct all continuing educationinquiries to Sharon M Miller, 7N591 Cloverfield Circle, St Charles,IL 60175. (630) 513-1986. [email protected]

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To receive 3.0 contact hours of intermediate level P.A.C.E.®‚credit for Focus: Cardiac Protocols, insert your answers inthe appropriate spots on the immediately following page;then complete and mail the form as directed.

NOTE: There may be more answer spaces on the answersheet than needed. If so, leave them blank. Make sure thenumber of the answer space you fill matches the number ofthe question you are answering.

LEARNING OBJECTIVESAfter reading the two Cardicac Protocols articles, the readerwill demonstrate his/her understanding of the material byachieving the following:1. Describe the biochemistry of the BNP and the other

natriuretic peptides.2. Describe the major physiologic responses to the eleva-

tion of BNP levels.3. Discuss the mechanism by which the binding of BNP

to the target cell results in alteration of Na+ and waterreabsorption.

4. Describe the formation of arterial plaque and the devel-opment of coronary artery disease and acute coronarysyndromes (ACS).

5. Describe the physiological conditions that develop intoCHF and cause the release of BNP.

6. Describe and interpret the diagnostic accuracy, sensitiv-ity, specificity, and negative predictive values reportedfor rapid BNP assays.

7. Describe the trend toward “accelerated cardiac proto-cols,” including which markers are suggested, and thesuggested time-course of sequential testing.

8. Evaluate patient data and derive appropriate diagnosticconclusions.

9. Discuss the use of BNP for prognosis and screening ofpatients for LV dysfunction.

10. Discuss the interpretations of slightly elevated levels oftroponin and C - reactive protein (CRP) as they relateto ACS and risk analysis.

CONTINUING EDUCATION QUESTIONS1. Which of the following statements best describes the

BNP molecule?a. BNP is a steroid hormone similar to aldosterone.b. BNP is a short peptide of 8 amino acids similar to

anti-diuretic hormone (ADH).c. BNP is a 32-amino acid peptide with a loop held in

place by a disulfide bond.d. BNP has 2 peptide chains, which are held together

by disulfide bonds, similar to insulin.

2. Which combination of renal responses do elevated lev-els of BNP promote?a. BNP causes increased excretion of Na+ and decreased

excretion of H2O.

b. BNP inhibits the renal excretion of both Na+ andH

2O.

c. BNP promotes the renal excretion of both Na+ andH

2O.

d. BNP blocks binding of aldosterone to renal cells, thusantagonizing the effects of mineralosteroids.

3. Binding of BNP to the cell surface leads to an increasein which ‘second messenger’ system in the target cell?a. BNP binding to the cell surface receptor leads to an

increase in cAMP.b. BNP binding to the cell surface receptor leads to an

increase in cGMP.c. BNP binding to the cell surface receptor causes

autophosphorylation of tyrosine kinase.d. BNP binds to a nuclear receptor and directly pro-

motes transcription.

11-CE Questions_Gade 6/16/03, 10:32 AM188



4. Identify the correct series of events involved with devel-opment of arterial plaque and leading to rupture andthrombosis.a. Oxidized foam cells engulf LDLs, form plaques, fatty

streaks develop, followed by rupture, and thrombosis.b. Macrophages engulf oxidized LDLs, become foam

cells, form fatty streaks, plaques rupture, and causethrombosis.

c. Oxidized HDLs are engulfed by foam cells to formfatty streaks and plaques, which may rupture to causethrombosis.

d. Macrophages engulf oxidized LDLs, become fattystreaks, form plaques, and cause thrombosis whenfoam cells rupture.

5. Which of the following combinations of physiologicalconditions leads to ventricular release of BNP?a. Hypertension and hypernatremiab. Hypoxia and dyspneac. Hypervolemia and hypoxiad. Hypervolemia and hypertension

6. Accelerated cardiac protocols for MI diagnosis and rule-out include the following cardiac markers and frequencyof sequential testing:a. myoglobin, CK-MB, troponin, LDH drawn at 6 to

8 hour intervals.b. total CK, CK-MB, troponin drawn at 4 to 6 hour

intervals.c. myoglobin, troponin, CK-MB drawn at 30 minute

to 2 hour intervals.d. BNP, troponin, CK-MB drawn at 30 minute to 2

hour intervals.

7. The reported diagnostic sensitivity and specificity ofBNP assays (with a cutoff of 80 pg/mL) for diagnosis ofCHF are approximately:a. sensitivity of 65% and specificity of 75%.b. sensitivity of 98% and specificity of 92%.c. sensitivity of 95% and specificity of 82%.d. sensitivity of 82% and specificity of 84%.

8. A 53-year old male patient with dyspnea and chest painhas the following values for cardiac markers two hoursafter admission: troponin 0.3 ng/mL (reference <0.1ng/mL), BNP 248 pg/mL (reference <80 pg/mL), myo-globin 77 ng/mL (reference 20 to 90 ng/mL), and CK-MB 2.5 ng/mL (reference 0.3 to 4.0 ng/mL).a. He is having an acute myocardial infarction.b. He is experiencing an episode of stable angina.c. He is experiencing an episode of congestive heart fail-

ure.d. He is experiencing an episode of unstable angina.

9. A 48-year old female patient with dyspnea and chestpain has the following values for cardiac markers at ad-mission: troponin 0.5 ng/mL (reference <0.1 ng/mL),BNP 321 pg/mL (reference <80 pg/mL), myoglobin 457ng/mL (reference 20 to 90 ng/mL), and CK-MB 5.6ng/mL (reference 0.3 to 4.0 ng/mL).a. She is having an acute myocardial infarction.b. She is experiencing an episode of stable angina.c. She is experiencing an episode of congestive heart

failure.d. She is experiencing an episode of unstable angina.

10. A 35-year old male patient with elevated baseline levelsof CRP has which of the following:a. increased risk of development of CHF.b. decreased risk of development of ACS.c. increased risk of development of ACS.d. decreased risk of development of CHF.



To earn continuing education (P.A.C.E.®) credit, (1) complete the form below, (2) record your answers, and (3) tear out and mail thisform with a check or money order ($18 for ASCLS members, $28 for non-members for all articles) to:

American Society for Clinical Laboratory ScienceP.O. Box 79154

Baltimore, MD 21279-0154

A certificate and credit will be awarded to participants who achieve a passing grade of 70% or better. Participants should allow eight weeksfor notification of scores and receipt of certificates.

Focus: Cardiac Protocols carries 3.0 hours of intermediate level credit. This form can be submitted for credit for up to one year from thedate of issue.

Print or type carefully.

(01) NAME ______________________________________________________ ASCLS membership number _______________Last First Middle

(02) ADDRESS _________________________________________________________________________________________

(03) CITY_____________________(04) STATE/COUNTRY _______________(05) ZIP/POSTAL CODE_________________

(06) DAYTIME PHONE ( ____ )__________________________(07) E-MAIL:_____________________________________

(08) CREDIT CARD # ____________________________ TYPE (CIRCLE) AE MC VIS EXP. DATE __________

Continuing Education Registration Form

Check all that apply❑ I am an ASCLS member

❑ I am not an ASCLS member

❑ I would like to receive ASCLS membership information

❑ I have previously participated in Focus

❑ I would like information on other continuing education sources

Answers

Circle correct answer (questions are on previous two pages).








Participant InformationPlease circle the most appropriate answers.

1. Is this program used to meet your CE requirements for:(a) state license (b) NCA (c) employment (d) other

2. Specialty: (a) biochemistry/urinalysis (b) microbiology(c) lab administration (d) hematology/hemostasis (e) education(f )immunology (g) immunohematology

3. Workplace: (a) hospital over 500 beds (b) hospital 200–499beds (c) hospital 100–199 beds (d) hospital under 100 beds(e)private lab (f ) community blood bank (g) group practice(h) private physician (i) clinic (j) other

4. Salary range: (a) under $10,000 (b) $10,000 to $20,000(c) $20,000 to $30,000 (d) $30,000 to $40,000(e) over $40,000

5. Did these articles achieve their stated objectives?(a) yes (b) no

6. How much of these articles can you apply in practice?(a) all (b) some (c) very little (d) none

7. Employment status: (a) full time (b) part time (c) student(d) not employed (e) retired

8. How long did it take you to complete both the readingand the quiz? ___________minutes

9. What subjects would you like to see addressed in futureFocus articles?



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TRENDS AND TECHNOLOGY

Trends and Technology: Summer 2003

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MARY JANE GORE

The Trends and Technology section seeks topublish product and technology information(including black-and-white glossy photo-graphs), news items (such as FDA approv-als), and information about laboratory re-sources of all kinds. The intent of this sectionis to provide a cutting-edge, one-stop shoptailored to the current practical needs andconcerns of clinical laboratory practitioners.Let us hear from you with suggestions on howto improve this section. Direct inquiries andinformation to Mary Jane Gore, CLS Trendsand Technology Editor, c/o ASCLS, 6701Democracy Blvd., Suite 300, Bethesda, MD20814, [email protected]. Please send all mate-rials clearly marked NEW PRODUCTS.

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Trends and Technology welcomes re-leases and information about newproducts, services, Web sites, trends,and upcoming events (give us sixmonths lead time for seminars andmeetings). If your company has a Website that you would like for us to re-view, please send us news for ourOnline section, or tell us about sitesthat would interest clinical laboratoryscientists. These sites, as well as the newproduct information, are offered forreader information only. We cannotvouch for them and their presence heredoes not constitute an endorsement byCLS or ASCLS.

FDA APPROVALSDade Behring Holdings received clear-ance from the U.S. Food and DrugAdministration (FDA) to make its D-dimer test available on its Stratus® CSinstrument, for use in STAT and cen-tral laboratories and in acute care set-tings, such as emergency departments.An elevated D-dimer result reflects in-creased fibrin formation and lysis, in-

dicating the presence of a clot, and hasbeen reported in venous thromboem-bolic diseases. Contact MelissaZiriakus at (847) 236-7038.

Digene Corporation announced thatthe FDA has approved its High-Risk(HR) HPV DNA test as a screeningtest in conjunction with the Pap testfor HPV infection in women age 30and older. Called DNAwithPap, thetesting combination brings improvedsensitivity to screening for the cause ofthe second leading cancer in womenworldwide. Contact Dan Hewitt at(202) 530-4695.

Bayer’s Diagnostics Division has re-ceived FDA premarket approval afteran expedited review for its VERSANT®

HCV viral load assay. This hepatitis Cassay measures HCV viral load levelsto help physicians guide therapeuticdecisions early in treatment. ContactAmy Samaha at (914) 366-1815.

The FDA has granted the OlympusTreponemal Palladium assay clearancefor a modification. The PK™ TP sys-tem previously required specimen test-ing within two days; now screening canbe performed on samples up to fivedays after collection. Contact TimothyVotapka at (631) 756-7160.

CONTINUING EDUCATIONDade Behring has announced that itsKnowITTM virtual classroom (Knowl-edge-building Interactive Technology)is now available for its Dimension® RxLinstrument customers. KnowIT(a) isthe company’s proprietary on-linecourseware, which provides interactive

learning on-site in the laboratory, andis accessed by logging on towww.dadebehring.com. Contact Mel-issa Ziriakus at (847) 236-7038.

Roche Molecular Diagnostics and RWDTechnologies offer a new training andcertification program designed to meetthe continuing education needs of clini-cal laboratory professionals. The MDxS(Molecular Diagnostic Services) continu-ing education program provides studentswith CD-ROM-based courseware thatthey can study at their own pace. Theythen complete an exam on a Web site:http://Roche.MDxS.Certification.Net.Students can purchase a specific test viacredit card at a cost of $15 per credit or$90 for a six-credit test. For details, con-tact Faith DiBiasi of Roche MolecularDiagnostics at [email protected].

NEW PRODUCTSThe new Olympus OLA2500™ labo-ratory automation solution is available.This system is designed for use in me-dium- to high-volume clinical labora-tories and sample processing depart-ments. The system automaticallydecaps, aliquots, and sorts tubes to anyanalyzer rack. Contact TimothyVotapka at (631) 756-7160.

Olympus OLA2500

12-T&T 6/16/03, 10:40 AM191


Tecan US offers the new GENios Pro,a cost effective multimode microplatereader with increased sensitivity andmeasurement capabilities to meet thedemands of both academic andbiopharmaceutical company researchlaboratories. Complete with flash, lu-minescence, fluorescence, and fluores-cence polarization, GENios Pro is anexcellent addition to Tecan US’s state-of-the-art GENios line of automatedproducts and incorporates Tecan’syears of experience with liquid han-dling. Contact Michele Valenta at(919) 361-5200 or www.tecan.comfor more information.

GENios Pro microplate reader

Knovel hosts full-text online versionsof today’s most popular chemistry,safety books, and databases – titles likePerry’s Chemical Engineers’ Hand-book, Lange’s Handbook of Chemis-try, and the Dictionary of Substancesand Their Effects (DOSE). The 450+titles on Knovel have been“Knovelized”, a process that convertsstatic book pages into interactive tools.These books are interactive and deeplysearchable with a range of values. Formore information, visit http://www.knovel.com.

Designed to run smoothly throughcopiers, printers, and presses with fewerjams and misfeeds, new heavyweightcharting paper from Carstens, Inchelps healthcare facilities save time and

money by quickly and efficiently du-plicating, on demand, durable, high-quality medical and patient recordforms. With ringbinder holes and dust-free edges, the 24 lb. or 28 lb. chartingpaper is guaranteed for use in all popu-lar high-speed copiers and laser print-ers. Carstens further has launched twoWeb sites that allow healthcare facili-ties to quickly and easily download, atno cost, a wide variety of chartingforms or design their own customizedringbinder divider sets. Atcarstensfreeforms.com, healthcare fa-cilities currently may download nearlytwo-dozen different charting and pro-fessional paper forms that can beprinted onto Carstens’ charting andprofessional papers. Simple to follow,step-by-step instructions atcarstenscustom.com make it possibleto quickly create, preview, and submitfor quote custom poly or paper dividersets for ringbinder chartholders. Formore information, call 1-800-782-1524 or visit www.carstens.com.

Carstens charting paper

The Board of Commissioners of theJoint Commission on Accreditation ofHealthcare Organizations (JCAHO)

will begin conducting all regular ac-creditation surveys on an unan-nounced basis beginning in January2006. Unannounced surveys will bepilot-tested in volunteer organizationsduring 2004 and 2005. For more in-formation on this substantially newsurvey process, contact Charlene DHill at (630) 792-5175 or visitwww.jcaho.org.

GPI Anatomicals is one of the largestmanufacturers of anatomical modelsfor teaching settings and medical of-fices. These realistic and technicallyaccurate models are helpful also in pa-tient education. Contact Scott Gallo-way at [email protected] visit www.gpianatomicals.com.

GPI anatomical model

VWR International and Point Systemstogether offer VWR Connect, a busi-ness-to-business procurement solutionenabling buyers to place electronic or-ders directly from the various web sitesof suppliers they select, includingVWR International with its portfolioof 750,000 products. The foundationfor VWR Connect is Point Systems’Point Purchasing™ intranet-basedpurchasing software system. For moreinformation, visit www.vwr.com orphone 1-800-932-5000.

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