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Improving Quality Care Through
Accurate Diagnostic Testing
Nowoffering
CAP-ApprovedAnalytes!!
A Service of
pproved by: CAP*, CMS, COLA, TJC (formerly JCAHO), U.S. State Agencies, several international regulatory bodiesor selected analytes
8/7/2019 catalog US 2011
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With MLE, save BIG on PT!
CAP-accredited?Whether you use MLE as your primary or secondary PT provider, you'll save on PT for the CAP-approved
analytes (see listing on page 17, 18) that we offer, and we'll even waive the annual administration fee!When you order, select ADVANTAGE offer #10.
PLUS, only 3 shipments per year leaves you more time for other important activities throughout the year!
TJC, CLIA, or State-accredited?Compare MLE to your current PT provider. If our discounts arent the best, we will match our competitorspricing for the same test menu coverage. Details on page 20.
Why Choose MLE? Cost-effective add-ons
Only 3 shipments per year
ADVANTAGE discounts and Price Matching Option (see pages 20, 21, and Inside Back Cover)
Off-Schedule Proficiency TestingAvailable to every laboratory, regardless of MLE enrollment status
(see page 16)
Immediate, live Customer Service and Technical Support
Online Options Online result reporting
Participant summariesPrint the entire summary or only the pages you need
Evaluation reportsAccess current and past reports FREE continuing education courses
Program forms
Waived Testing and PPM Services Special two-sample test menu
A cost-effective Waived and PPM packageall the tests you need in one module
FREE E-notification service on newly approved waived tests and on recalls for waived devices
FREE Waived TestingDoing It Right, answers questions about waived testing criteria, test categories,
standards, and cost
MLE Exceeds the Standard
For 38 years, MLE, a service of the American College of Physicians, has provided reliable, user-friendly PT serviceat a substantial cost savings.
Act Now!Locate the tests you need (see pages 216), check the inside back cover of this catalog to see which discount is right
for you, then complete the PT Order Form on page 24 or online at www.acponline.org/mle/enroll.htm. Its THAT easy!
MLE9
8/7/2019 catalog US 2011
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Table of Contents
Overview/Whats New
Whats New . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Back cover
Overview/How MLE Works . . . . . . . . . . . . . . . . . . . . . . . . . .4
Test Index and Module Descriptions
Test Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
(See P. 17, 18 for CAP-Approved Analytes listing)
Hematology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Blood Bank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Urinalysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
PPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Microbiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Waived Testing
Waived Module Descriptions . . . . . . . . . . . . . . . . . . . . . . .14
E-Notification of Waived Devices and Recalls . . . . . . . . .14
Provider-Performed Microscopy (PPM) . . .7, 16
Lab Supplies & Services . . . . . . . . . . . . . . . . . . . . .16
Automatic Renewal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Online Result Reporting SystemWDES . . . . . . . . . . . . .16Off-Schedule Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
NEW! "CAP-Approved Analytes" . . . . . . . .17, 18
Ordering and Discounts
MLE ADVANTAGE Discounts . . . . . . . . .Inside Back Cover
Price Match Service . . . . . . . . . . . . . . . . . . . . . . . . . .20, 21
How to Order/Ordering Instructions . . . . . . . . . . . . . . . . .22
Order Changes/Cancellations . . . . . . . . . . . . . . . . . . . . . . .19
FAQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Price List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Proficiency Testing Order Form . . . . . . . . . . . . . . . . . . . . .24
At a Glance
Customer Service Hours and ContactInformation
Monday through Friday from 9:00 a.m. to 5:00 p.m. ET
Telephone: 1-800-338-2746, option 5
E-mail: [email protected]
Fax: 202-835-0440
Web: www.acponline.org/mle
Enrollment/Renewal of Proficiency Testing
Whichever method of enrollment you select, once we process
your order, you will be mailed an order verification for your
review and signature.
Online Order Form: Visit www.acponline.org/mle. Click
on the Enrollment Info link. Complete the appropriate
electronic order form to automatically calculate pricing,and you will receive an order summary page.
MLE PT Order Form: Detach the order form, complete it
and fax it. (If submitting a purchase order, please fax.)
Fax: 202-835-0440.
Mail:
Method of Payment
Enroll now to ensure the availability of specimens for the
2011 program year. We will not bill you until November.
Subsequent enrollments will be billed within 1 week after
activation and are payable within 30 days. Payment options
include credit card (Mastercard or Visa), purchase order, or
check.
Off-Schedule Proficiency TestingProvides laboratories with an option for immediate, on-
demand proficiency testing, a complement to the regular
scheduled proficiency testing. For more details on this
service, see page 16.
Medical Laboratory Evaluation 2011 www.acponline.org/mle
2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12
Save Money!Price Matching forUnmatched Service
Found a lower price? Well match it!
Complete the MLE Price Match Request Form
(page 21), listing only the tests you
actually perform. If our prices arent the lowest,
well match our competitors pricing for the same
test menu coverage.
Mailing Form with Payment Mailing Form w/o Payment
RO800
ACP/MLE
PO Box 7777
Philadelphia, PA 19175-0800
MLE/ACP
Suite 700
25 Massachusetts Ave. NW
Washington, DC 20001-7401
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Test Index(Descriptions are located on pages 516)
Regulated tests are listed in bold type.
ABO Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Acetaminophen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Acetone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12Affirm VPIII (DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
AFP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Albumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Alcohol, Serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Alkaline Phosphatase . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Allergy Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
ALT (SGPT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Amikacin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Amylase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Antibody Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Anti-dsDNA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-HBc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Anti-HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Anti-RNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-RNP/Sm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-Sm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-SSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-SSB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-SSA/SSB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Anti-Streptolysin O (ASO) . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Antibody Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Antimicrobial Susceptibility Testing . . . . . . . . . . . . . . . . .8
Antinuclear Antibody (ANA) . . . . . . . . . . . . . . . . . . . . . . . .10
Apolipoprotein A1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Apolipoprotein B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12AST (SGOT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Beta ()-lactamase Testing . . . . . . . . . . . . . . . . . . . . . . . . . . .8, 9
Beta ()-2 Microglobulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Bilirubin, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Bilirubin, Direct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12, 13
Bilirubin, Neonatal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Blood Cell Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Blood Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Blood Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Blood Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Blood Smear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
BNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
C-Peptide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CA 125 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13CA 15-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CA 19-9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CA 27-29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Calcium, Ionized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 13, 16
Candida, Affirm VPIII(DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Carbamazepine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Carboxyhemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Cardiac panel/markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
CEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
C. difficile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Chlamydia (EIA/DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 13, 15, 16
Cholesterol, Total . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Cholesterol, HDL . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Cholesterol, LDL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
CK-MB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15, 16
Colony Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Compatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Complement C3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Complement C4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Cortisol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
C-Reactive Protein (CRP) . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 10
C-Reactive Protein, high sensitivity (HS-CRP) . . . . . . . . . . . .10
Creatine Kinase (CK) . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Creatinine, Serum . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15, 16
Creatinine, Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 15, 16
Crossmatch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Cryptosporidium, Antigen Detection . . . . . . . . . . . . . . . . .9
Crystal Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
CSF Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
D-dimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Dermatophyte Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Differential, Automated . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Digoxin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Drug Screen, Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Eosinophils Nasal (PPM) . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
Estradiol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Fecal Leukocytes (PPM) . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
Fecal Occult Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 15
Fecal Suspension, parasitology . . . . . . . . . . . . . . . . . . . . . .9
Fern Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
Ferritin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Fetal Membrane Rupture Test . . . . . . . . . . . . . . . . . . . . . . . . . .7
Fibrinogen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6Fluid Cell Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Folate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Fructosamine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
FSH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Gardnerella, Affirm VPIII (DNA) . . . . . . . . . . . . . . . . . . . . .9
GC (EIA/DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Genital Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8, 9
Gentamicin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
GGT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Giardia lamblia, Antigen Detection . . . . . . . . . . . . . . . . . .9
Glucose, serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 15, 16
Whole blood methods . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
Glycohemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13, 16Gram stain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
HAV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
HbeAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
HbsAb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
HbsAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
hCG, serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
hCG, urine (waived methods) . . . . . . . . . . . . . . . . . . . . .7, 14, 15
HCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
HDL Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Hematocrit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 7, 11, 14, 15
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 7, 14, 15
2 www.acponline.org/mle Medical Laboratory Evaluation 2011
2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12
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Hemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 7, 11, 14, 15
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . .5, 7, 14, 15, 16
Hemoglobin A1C (Glycohemoglobin) . . . . . . . . . . . . . . . . .13, 16
Hepatic Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Homocysteine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
H. pylori, Antibody Detection . . . . . . . . . . . . . . . . . . . . . . .11, 15
i-STAT Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Waived cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 16
IgA, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
IgE, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
IgG, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
IgM, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Infectious Mononucleosis . . . . . . . . . . . . . . . . . . . . . . . . .9, 10
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10, 15
Influenza A, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . .9
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 15
Influenza B, Antigen Detection . . . . . . . . . . . . . . . . . . . . . .9
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 15
Influenza A/B Combo, Antigen Detection . . . . . . . . . . . . . .9
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 15
Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
KOH Vaginal Prep (PPM) . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
KOH Skin Prep (Slides) . . . . . . . . . . . . . . . . . . . . . . . . . .7, 9, 16
LDH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
LDL Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Legionella, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . .9
LH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Lipase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Lipid Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Lithium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Lyme Disease Serology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Magnesium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Methemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Microalbumin, quantitative . . . . . . . . . . . . . . . . . . . . . . . . .7, 15
Microalbumin, urine dipstick . . . . . . . . . . . . . . . . . . . . . . . .7, 15
MRSA Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9Mycoplasma, IgG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Myoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Nasal Eosinophils (PPM) . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
NT-pro BNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
O2 Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Occult Blood, Fecal . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 15
Oxyhemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Parasitology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Parathyroid hormone (PTH) . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Partial Thromboplastin Time (APTT) or (PTT) . . . . . . . .6
pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
pH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Phenobarbitol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Phenytoin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12Phosphorus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Pinworms (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
Platelet Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
pO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Potassium . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 13, 15, 16
Progesterone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Prolactin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Protein, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Prothrombin Time (PT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Whole blood methods (non-waived) . . . . . . . . . . . . . . . . .6
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6, 15
Provider-Performed Microscopy (PPM) . . . . . . . . . . . . .7, 14, 16
PSA, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
PSA, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
PVA Slide, parasitology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
QBC Hematology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
RBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Respiratory Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Reticulocyte Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Rheumatoid Factor (RA) . . . . . . . . . . . . . . . . . . . . . . . . .9, 10Rh Factor (D Type) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Rotavirus, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . .9
RSV, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9, 15
Rubella . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Salicylate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Sedimentation Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6, 15
Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 13, 15, 16
Sperm (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
Stool Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Strep A, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . . . .8
Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 8, 14, 15
Strep pneumoniae, Antigen Detection . . . . . . . . . . . . . . . .9
Syphilis Serology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10T3, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
T3, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
T3, Uptake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
T4, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
T4, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Testosterone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Theophylline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Throat Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Thyroglobulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Thyroglobulin antibody . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Thyroid Microsomal antibody . . . . . . . . . . . . . . . . . . . . . . . . . .13
Thyroid Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
TIBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12Transferrin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Trichomonas, Affirm VPIII (DNA) . . . . . . . . . . . . . . . . . . . . . . .9
Triglyceride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Troponin I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Troponin T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
TSH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Tumor Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
UIBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Urea Nitrogen (BUN) . . . . . . . . . . . . . . . . . . . . . .11, 12, 15, 16
Uric Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 15
Urine Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Urine Dipstick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 15
Urine Drug Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Urine hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 15
Urine Sediment Identification . . . . . . . . . . . . . . . . . . . .7, 14, 16
Valproic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Vancomycin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Viral Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Vitamin B12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Vitamin D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
WBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Waived and PPM package . . . . . . . . . . . . . . . . . . . . . . . .7, 14, 16
Wet Mount Preparations (PPM) . . . . . . . . . . . . . . . . . . .7, 14, 16
Wound Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
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Overview
An essential tool for quality improvement, Proficiency Testing (PT) was originally developed as an educational tool to help
laboratories investigate internal procedural problems and take corrective action to minimize the effect on patient results.
Today, PT is the standard of competency most heavily weighed by regulatory inspectors. MLEs Proficiency Testing (PT)
program is designed for easy access, simple performance, and clear reporting.
PT is the practice of testing specimens of unknown values sent from an outside source. After submitting your test results, you receive
data that compare your laboratorys performance with that of other labs that did the same procedures on the same specimens.
All tests in the MLE Program are included in the same shipment. Ordering information and instructions start on page 19.
Our GuaranteeIf a specimen is missing, leaking, broken, not labeled, hemolyzed, or crushed, and you contactus within three (3) working days of receipt of your kit, we will provide a replacement for thespecimen(s) FREE of charge (limited to material availability) or your lab will receive a gradingexception for that test.
How ML E Works
1 MLE sends you a catalog to review orderingoptions.
2 You complete an online or hard copy order form(page 24) and return it to MLE for processing.
3 MLE processes your order and sends youan Order Verification for your review andapproval. This is your proof of enrollment.
4 Approximately two weeks prior to the upcomingshipment, MLE sends you a program guide toprepare for your first testing event.
5 MLE sends you scheduled shipments of test kitswhich include specimens to analyze in the sameway that you regularly test patient specimens.
6 Upon completion of the testing, you submityour results online or mail to MLE for evaluation.
7 MLE performs statistical compilation of allparticipants results.
8 MLE mails or e-mails you an evaluation report,graded according to regulatory requirements,that compares your performance with that ofother laboratories that used similar methodsand instruments.
1 2 3 4 5 6 7 8MLE Order Order Program Kit Test Data EvaluationCatalog Form Verification Guide Shipments Completion Processing Distribution
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Hematology
Please pay close attention to instrument compatibilitynotes when selecting hematology modules.Questions? Contact MLE Customer Service.
See Table below or see Hematology Instrument Listonline at www.acponline.org/mle/enroll.htm
and scroll to Forms.
5-part Differential RecommendedInstrument(s) Module
ABX Pentra series 228
CELL-DYN 3000-3700, 4000 223CELL-DYN Ruby and Sapphire 223
COULTER AcT 5diff 228
COULTER GenS, HmX, MAXM,LH series 226
Sysmex X-series 229
210 Hematology Module . . . . . . . . . . . . . . . . . . . . . .$198
Includes 211 and 230.
211 Basic Hematology . . . . . . . . . . . . . . . . . . . . . . . .$186
Five challenges each.
Hemoglobin RBC
Hematocrit Platelet Count
WBC
212 Hemoglobin/Hematocrit . . . . . . . . . . . . . . . . . . .$165
Five challenges each.
213 Hemoglobin/HematocritWaived . . . . . . . . . . . .$120
For waived methods only.
Two challenges each.
215 Hemoglobin/Glucose . . . . . . . . . . . . . . . . . . . . . .$138
For HemoCue only.
Two challenges each.
223 Hematology with 5-part Differential . . . . . . . . . .$294
Compatible with most Abbott CELL-DYN 5-part
differential instruments only.
Five challenges each.
Hemoglobin RBC
Hematocrit Platelet Count
WBC Automated Differential
224 Sysmex with 3-part Differential . . . . . . . . . . . . . .$213
Compatible with Sysmex 3-part automated differential
instruments only.
Five challenges each.
Hemoglobin RBC
Hematocrit Platelet Count
WBC Automated Differential
225 Hematology with 3-part Differential . . . . . . . . . .$237
Compatible with most 3-part differential instruments.
Sysmex users see module 224.
Five challenges each.
Hemoglobin WBC
Hematocrit Platelet Count
RBC Automated Differential
226 Hematology with 5-part Differential . . . . . . . . . .$294
Compatible with most BeckmanCoulter 5-part
differential instruments EXCEPT for the AcT 5diff
(see module 228).
Five challenges each.
Hemoglobin RBC
Hematocrit Platelet Count
WBC Automated Differential
227 QBC Hematology . . . . . . . . . . . . . . . . . . . . . . . .$294
Compatible with Becton Dickinson QBC instruments
including models with 2-part differential.
Five challenges each.
Hemoglobin Platelet Count
Hematocrit Lymphocytes/MonocytesWBC Granulocytes
228 Hematology with 5-part Differential . . . . . . . . . .$294
Compatible with Beckman Coulter AcT 5diff and ABX
Pentra 5-part differential instruments.
Five challenges each.
Hemoglobin RBC
Hematocrit Platelet Count
WBC Automated Differential
229 Sysmex with 5-part Differential . . . . . . . . . . . . . .$294
Compatible with most Sysmex 5-part differential
instruments only.
Five challenges each.
Hemoglobin WBC
Hematocrit Platelet Count
RBC Automated Differential
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Note: Module descriptions within each category are NOT listedin numerical order. They are grouped by the type of test.
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230 Blood Cell Identification (Add-On) . . . . . . . . . . . .$27
Same as 231.
Only available with 211 through 229.
Five challenges consisting of color photographs.
231 Blood Cell Identification . . . . . . . . . . . . . . . . . . . .$90
Stand-alone module.
Five challenges consisting of colorphotographs.
240 Reticulocyte Count . . . . . . . . . . . . . . . . . . . . . . .$186
Compatible with automated and manual reticulocyte
counting methods. Not for use with brilliant cresyl
blue staining methods.
Two challenges.
247 Sedimentation Rate . . . . . . . . . . . . . . . . . . . . . . .$147
Two challenges.
248 Sedimat 15 ESR . . . . . . . . . . . . . . . . . . . . . . . . . .$147Compatible with the Polymedco Sedimat 15
instrument only.
Two challenges.
250 Fluid Cell Count/Crystals . . . . . . . . . . . . . . . . . . .$144
For Hemocytometer cell count and manual detection
and identification of crystals.
Two challenges each.
WBC Count RBC Count
Crystal Screening
Blood BankNEW!450 Rh Factor (D Type) . . . . . . . . . . . . . . . . . . . . . . . .$225
For Slide Methods ONLY.
Five challenges.
451 ABO & Rh Factor (D Type) . . . . . . . . . . . . . . . . . .$276
Not for use with slide methods.
Five challenges each.
452 Blood Bank 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . .$540
Not for use with slide methods.Five challenges each.
ABO Group Rh Factor (D Type)
Antibody Detection
453 Blood Bank 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . .$567
Not for use with slide methods.
Five challenges each.
ABO Group Compatibility Testing
Rh Factor (D Type) (Crossmatch)
Antibody Detection Antibody Identification
Coagulation
320 Coagulation Module . . . . . . . . . . . . . . . . . . . . . .$165
Requires 1-mL pipette (see item 121 on page 16).
Five challenges each.
Prothrombin Time Fibrinogen
Partial Thromboplastin Time
321 Prothrombin Time . . . . . . . . . . . . . . . . . . . . . . .$156
Requires 1-mL pipette (see item 121 on page 16).
Five challenges.
330 CoaguChek XS Plus Prothrombin Time . . . . . . . .$192
For CoaguChek XS Plus only.Five challenges.
NEW!
331 CoaguChek XS Plus Waived . . . . . . . . . . . . . . .$111
For CoaguChek XS Plus Only.
Two challenges.
328 i-STAT Prothrombin Time . . . . . . . . . . . . . . . . . . .$225
Compatible with the i-STAT instrument only.
Five challenges.
329 ITC Pro Time SystemWaived . . . . . . . . . . . . . .$129
For ITC ProTime Microcoagulation System only.
Two challenges.
6 www.acponline.org/mle Medical Laboratory Evaluation 2011
2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12
See Table for assistance in selecting a whole blood
coagulation module. If you have questions
please contact MLE Customer Service.
-Whole blood Pro Time RecommendedInstrument(s) Module
Roche CoaguChek XS NONE availableRoche CoaguChek
XS PlusNOT for the XS model 330 / 331
INRatio Monitor NONE available
i-STAT 328
ITC Pro TimeMicrocoagulation System 329
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Urinalysis
530 Urinalysis Module . . . . . . . . . . . . . . . . . . . . . . . . $84
Includes 531 and 532.
531 Urinalysis Dipstick . . . . . . . . . . . . . . . . . . . . . . . .$66
hCG not included.
One challenge each.
Bilirubin pH
Blood/Hemoglobin Protein
Nitrite Specific Gravity
Glucose Microalbumin
Ketones (dipstick only)
Urobilinogen Leukocyte Esterase
532 Urine Sediment Identification . . . . . . . . . . . . . . . $90
Two challenges consisting of color
photographs.
533 Urine Sediment Identification (Add-On) . . . . . . . .$18
Same as 532. Only available with 531, 534.
Two challenges consisting of color
photographs.
536 Microalbumin (Add-On) . . . . . . . . . . . . . . . . . . . . .$72
Same as 539. Only available with 530, 531, 541.
539 Microalbumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$87
Stand-alone module.One challenge each.
Microalbumin, Creatinine
quantitative
537 Fecal Occult Blood (Add-On) . . . . . . . . . . . . . . . . .$66
Same as 542.
Only available with 530, 531, 532, 534.
Two challenges.
542 Fecal Occult Blood . . . . . . . . . . . . . . . . . . . . . . . $84
Stand-alone module.Designed to allow the reporting and evaluation of
results for as many as four different testing locations
or personnel.
Two challenges.
540 Urine hCG (Add-On) . . . . . . . . . . . . . . . . . . . . . . .$21
Same as 541.
Only available with 530, 531.
One challenge.
541 Urine hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$63
Stand-alone module.
One challenge.
550 AmniSure Fetal Membrane Rupture Test . . . . . . .$249
For use with the AmniSure ROM Test kit only.
One challenge.
901 Waived and PPM Package . . . . . . . . . . . . . . . . . .$196
Number of challenges noted in parentheses.
Fecal Occult Blood* (2) Urinalysis (1)
Hemoglobin (2) Urine hCG (1)Hematocrit (2) Urine Sediment (2)
PPM (6) Strep A Antigen
Whole Blood Glucose (2) Detection (2)
*Fecal occult blood testing not required by CAP.
Provider-PerformedMicroscopy
534 Provider-Performed Microscopy (PPM) . . . . . . . . .$93
Color photographs depicting microscopic fields for the
examination of Vaginal Wet Mount Preparations,
Vaginal KOH Preparations, Nasal Eosinophils, Fecal
Leukocytes, Pinworms, Sperm, and FERN testing.
Urine sediment identification not included.
Six challenges.
535 Provider-Performed Microscopy (PPM)Add-On .$21
Same as 534. Only available with 530, 531, 532.
538 KOH Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$120
Two fixed glass slides for determining the presence or
absence of fungal elements in skin scrapings.
Two challenges.
CAP-approved analytes/modules
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Microbiology
The specimens included may contain dangerous pathogens
and must be treated with extreme care. These specimens
must be handled and disposed of only by personnel
trained to work with pathogenic microorganisms.
630 Bacteriology 1 . . . . . . . . . . . . . . . . . . . . . . . . . . .$255
Consists of each of the following:
Urine Culture (1) Gram Stain (1)
Throat Culture (1) Antimicrobial
Genital Culture (1) Susceptibility Testing (1)
Plus, an additional three challenges will also be pro-
vided from the following sources: blood, CSF, wound,
respiratory, and/or stool for a total of 6 cultures.
(not CAP-approved for miscellaneous cultures)
640 Bacteriology 2 . . . . . . . . . . . . . . . . . . . . . . . . . . .$249
Urine Culture (2) Strep A Antigen
Throat Culture (2) Detection (1)
Gram Stain (1) Antimicrobial
Genital Culture (1) Susceptibility Testing (1)
643 Urine Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . .$249
Urine Culture (5) Gram Stain (1)
Antimicrobial
Susceptibility Testing (1)
644 Urine Culture/Strep A Antigen Detection . . . . . .$249
Urine Culture (2) Strep A Antigen
Gram Stain (1) Detection (3)
Antimicrobial
Susceptibility Testing (1)
645 Urine/Throat Culture . . . . . . . . . . . . . . . . . . . . . .$249
Urine Culture (3) Throat Culture (2)
Gram Stain (1) Antimicrobial
Susceptibility Testing (1)
647 Urine Presumptive ID/Colony Count . . . . . . . . . .$288
Best suited for paddle-dipping methods.
Presumptive Colony Count (2)
Identification (5) Antimicrobial
Gram Stain (1) Susceptibility Testing (1)
648 Colony Count* . . . . . . . . . . . . . . . . . . . . . . . . . . .$177
*This module is for Colony Count ONLY!
No presumptive identification may be submitted for
this module.
For presumptive identification, order module 647.
Two challenges.
649 Urine Presumptive ID/Strep A Antigen
Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$273
Best suited for urine paddle-dipping methods.
Presumptive Colony Count (2)
Identification (2) Antimicrobial
Gram Stain (1) Susceptibility Testing (1)
(directly from Strep A Antigen
sample provided) Detection (5)
652 Urine Presumptive ID/Throat Culture . . . . . . . . .$288
Best suited for urine paddle-dipping methods.
Presumptive Colony Count (2)Identification (2) Antimicrobial
Gram Stain (1) Susceptibility Testing (1)
(directly from Throat Culture (3)
sample provided)
650 Gram Stain . . . . . . . . . . . . . . . . . . . . . . . . . . . . $153
Five fixed glass slides.
Five challenges.
641 Throat Culture . . . . . . . . . . . . . . . . . . . . . . . . . .$240
Not suitable for Strep A kits. Appropriate for determin-
ing the presence or absence of group A streptococcus.Five challenges.
642 Throat Culture/Strep A Antigen Detection . . . . .$243
Throat Culture (2) Strep A Antigen
Detection (3)
660 Strep A Antigen Detection . . . . . . . . . . . . . . . . $147
For Strep A Antigen Detection kits only.
Five challenges.
662 Strep A Antigen DetectionWaived . . . . . . . . . . $87For waived Strep A Antigen Detection kits only.
Two challenges.
646 Genital Culture . . . . . . . . . . . . . . . . . . . . . . . . . .$240
Genital Culture (5) Gram Stain (1)
Beta ()-Lactamase Testing,
when applicable
CAP-approved analytes/modules
8/7/2019 catalog US 2011
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654 Genital Culture (Add-On) . . . . . . . . . . . . . . . . . .$100
Same as 646. Only available with 641 through 645,
647, 649, 650, 652, 660, 670.
Two challenges.
668 Affirm VP III (DNA) . . . . . . . . . . . . . . . . . . . . . . .$354
Five challenges each.
Candida sp. Trichomonas vaginalis
Gardnerella vaginalis
670 Chlamydia (EIA, DNA) . . . . . . . . . . . . . . . . . . . . .$279
Five challenges.
675 Chlamydia/GC (EIA, DNA) . . . . . . . . . . . . . . . . . .$306
Five challenges each.
Chlamydia trachomatis Neisseria gonorrhoeae
673 Chlamydia (EIA, DNA)Add-On . . . . . . . . . . . . .$117
Same as 670. Only available with 630 through 647,649, 650, 652, 660.
Two challenges.
Note Federal law requires a minimum of five non-waived
bacteriology challenges per shipment. Individual state
laws may differ. When enrolling, confirm your states
requirements and place your order accordingly.
All urine culture specimens are suitable for pre-
sumptive identification (ie, growth/no growth,
Gram stain interpretation) and/or definitive identifi-cation (ie, genus and/or species).
The number of challenges is noted in parentheses.
678 Dermatophyte Screen . . . . . . . . . . . . . . . . . . . . .$159
Appropriate for determining the presence or absence
of dermatophytes.
Two challenges.
538 KOH Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$120
Two fixed glass slides for determining the presence or
absence of fungal elements in skin scrapings.Two challenges.
680 Respiratory Antigen DetectionWaived . . . . . . .$156
Two challenges each.
Influenza A Influenza A/B Combo
Influenza B RSV
681 Respiratory Antigen Detection . . . . . . . . . . . . . .$249
Five challenges each.
Influenza A Influenza A/B Combo
Influenza B RSV
682 C. difficile/Rotavirus Antigen Detection . . . . . . .$222
Five challenges each.
C. difficile Toxin/ Rotavirus
Common Antigen
683 Giardia lamblia/Cryptosporidium Antigen
Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$279
Five challenges each.
Cryptosporidium Giardia lamblia
686 Legionella Antigen Detection . . . . . . . . . . . . . . .$183
For use with the Binax NOW Legionella Urinary
Antigen Detection kits only.
Five challenges.
687 Streptococcus pneumoniaeAntigen Detection . .$183
For use with the Binax NOW Streptococcus pneumoniae
Urinary Antigen Detection kit only.
Five challenges.
690 Parasitology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$222
Provides five challenges from among the following:
PVA Slide (for permanent stain), Fecal Suspension
(direct wet mount examination for ova and parasites),
Blood Smear for Parasites.
695 MRSA Screening . . . . . . . . . . . . . . . . . . . . . . . . .$237
Screening for the prescence or absence of methicillin-
resistant Staphylococcus aureus only.
Five challenges.
Immunology
750 Immunology Module . . . . . . . . . . . . . . . . . . . . . .$234
Five challenges each.
Infectious Mononucleosis Anti-Streptolysin O
Rheumatoid Factor (ASO)
751 Rheumatology Module . . . . . . . . . . . . . . . . . . . .$159
Five challenges each unless otherwise
noted in parentheses.
C-Reactive Protein (2) Rheumatoid Factor
Not for high-sensitivity methods
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755 Infectious MononucleosisWaived . . . . . . . . . . . .$90
For waived Infectious Mononucleosis kits only.
Two challenges.
762 Infectious Mononucleosis . . . . . . . . . . . . . . . . . .$156
Five challenges.
761 Infectious Mononucleosis/Rheumatoid Factor . . .$219
Includes 762 and 763.
Five challenges each.
763 Rheumatoid Factor . . . . . . . . . . . . . . . . . . . . . . .$156
Five challenges.
764 C-Reactive Protein (CRP) . . . . . . . . . . . . . . . . . . . .$90
Not for high-sensitivity methods.
Two challenges.
776 C-Reactive Protein (CRP)Add-On . . . . . . . . . . . .$45
Not for high-sensitivity methods.
Only available with 750.
Two challenges.
765 High-Sensitivity C-Reactive Protein (HS-CRP) . . . .$93
Two challenges.
777 High-Sensitivity C-Reactive Protein
(HS-CRP)Add-On . . . . . . . . . . . . . . . . . . . . . . . .$48
Only available with 750, 751.Two challenges.
766 Antinuclear Antibody (ANA) . . . . . . . . . . . . . . . .$147
For Latex methods ONLY.
Five challenges.
778 Antinuclear Antibody (ANA)Add-On . . . . . . . . .$90
Same as 766.
For Latex methods ONLY. Only available with 751.
Five challenges.
767 Antinuclear Antibody (ANA) . . . . . . . . . . . . . . . .$153
For ELISA and Immunofluorescence methods ONLY.
Five challenges.
779 Antinuclear Antibody (ANA)-Add-On . . . . . . . . . .$96
Same as 767.
For ELISA and Immunofluorescence methods ONLY.
Only available with 751.
Five challenges.
782 ANA Expanded . . . . . . . . . . . . . . . . . . . . . . . . . .$204
For ELISA and IFA methods ONLY.
Five challenges each.
ANA Anti-SSA
Anti-dsDNA Anti-SSB
Anti-RNP Anti-SSA/SSB
Anti-RNP/Sm Anti-Sm
783 ANA Expanded (Add-On) . . . . . . . . . . . . . . . . . .$147Same as 782. Only available with 751.
For ELISA and IFA methods ONLY.
NEW!
784 Complement/Immunoglobulins . . . . . . . . . . . . . .$186
Five challenges each.
C3 IgG, Total
C4 IgM, Total
IgA, Total
771 Rubella . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$153
Five challenges.
772 Syphilis Serology . . . . . . . . . . . . . . . . . . . . . . . . .$168
RPR ONLY.
Five challenges.
770 Specific Allergen Testing . . . . . . . . . . . . . . . . . . .$315
Number of challenges noted in parentheses.
Includes 2 sets of samples for large volume requirements
Does not include Total IgE.
Allergen Specific IgE (14)
773 Diagnostic Allergy . . . . . . . . . . . . . . . . . . . . . . . .$315
Number of challenges noted in parentheses.
Allergen Specific IgE (14) Total IgE (5)
774 Lyme Disease Serology . . . . . . . . . . . . . . . . . . . .$201
Two challenges.
Anti-Borrelia burgdorferi
CAP-approved analytes/modules
8/7/2019 catalog US 2011
13/28
Chemistry Ordering Tips
775 Viral Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . .$468
Five challenges each.
HbsAb HbsAg
Anti-HIV HbeAg
HAV Anti-HBc
HCV
780 H. pyloriAntibody Detection . . . . . . . . . . . . . . .$135For waived and non-waived methods.
Two challenges.
781 Mycoplasma . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$117
IgG only.
Two challenges.
790 Anti-HIVWaived . . . . . . . . . . . . . . . . . . . . . . . .$132
For waived HIV kits only.
Two challenges.
Anti-HIV1 Anti-HIV 1/2
791 Anti-HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$300
Five challenges.
Anti-HIV1 Anti-HIV 1/2
Chemistry
If you perform chemistry panels designed to match
CPT panels, see modules 813 through 816, which are
configured to match CPT profiles.
If you use the i-STAT instrument, select modules 817,
818, or 832 which are specifically for i-STAT instruments.
Please pay close attention to instrument compatibility
notes when selecting any of the chemistry modules.
If you need further assistance, call MLE Customer
Service at 1-800-338-2746, option 5, or e-mail us at
811 Cholestech Waived Chemistry . . . . . . . . . . . . . . .$147For the LDX Cholestech Instrument (Waived testing
ONLY).
Two challenges each.
ALT (SGPT) Glucose
AST (SGOT) HDL Cholesterol
Cholesterol, Total Triglyceride
812 Piccolo Waived Chemistry . . . . . . . . . . . . . . . . . .$186
For the Abaxis Piccolo Instrumentwaived cartridges
ONLY.
Two challenges each.
Albumin CO2 Potassium
Alkaline Phosphatase Creatine Kinase Sodium
ALT (SGPT) (CK) Total Bilirubin
Amylase Creatinine Total Protein
AST (SGOT) GGT Triglyceride
Calcium Glucose Urea Nitrogen
Chloride HDL Uric Acid
Cholesterol Phosphorus
817 i-STAT Chemistry 1 . . . . . . . . . . . . . . . . . . . . . . . .$300
Five challenges
For i-STAT analyzer only. Includes 818 and 847.
See modules 818 and 847 for CAP-approved analytes.
818 i-STAT Chemistry 2 . . . . . . . . . . . . . . . . . . . . . . . .$210
For i-STAT analyzer only.Five challenges each.
Chloride Hemoglobin
CO2 Ionized Calcium
Creatinine Potassium
Glucose Sodium
Hematocrit Urea Nitrogen
832 i-STAT ChemistryWaived . . . . . . . . . . . . . . . . . .$141
For i-STAT analyzer (Waived cartridges only).
Two challenges each.
Chloride Hemoglobin
CO2 Ionized Calcium
Creatinine Potassium
Glucose Sodium
Hematocrit Urea Nitrogen
810 Chemistry Module . . . . . . . . . . . . . . . . . . . . . . . .$306
Includes 821, 822, 823, 825, 827, 842. CAP-approved
for all analytes except LDL, TIBC, and UIBC.
Five challenges.
813 Comprehensive Metabolic Panel . . . . . . . . . . . . .$228
Includes 814, 816, 822. CAP-approved for all analytes
except D.bili, TIBC, and UIBC.
Five challenges.
814 Basic Metabolic Panel . . . . . . . . . . . . . . . . . . . . .$180
Five challenges unless otherwise noted in
parentheses.
Calcium Glucose
Chloride Potassium
CO2 (2) Sodium
Creatinine Urea Nitrogen
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815 Hepatic Profile . . . . . . . . . . . . . . . . . . . . . . . . . . .$198
Five challenges each unless otherwisenoted in parentheses.
Albumin Direct Bilirubin (2)
Alkaline Phosphatase Total Bilirubin
ALT (SGPT) Total Protein
AST (SGOT)
816 Hepatic Profile (Add-On) . . . . . . . . . . . . . . . . . . . .$39
Same as 815. Only available with 814, 819-821, 824,
826, 830.
819 Chemistry 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$174
Five challenges each.
Cholesterol, Total Urea Nitrogen
Glucose Potassium
820 Chemistry 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$204
Five challenges each unless otherwise
noted in parentheses.
Total Bilirubin Glucose
Chloride Potassium
Cholesterol, Total Sodium
CO2 (2) Urea Nitrogen
Creatinine Uric Acid
821 Chemistry 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$234
Five challenges each unless otherwisenoted in parentheses.
Total Bilirubin LDL Cholesterol (2)
Chloride Potassium
Cholesterol, Total Sodium
CO2 (2) Triglyceride
Creatinine Urea Nitrogen
Glucose Uric Acid
HDL Cholesterol
822 Chemistry (Add-On) . . . . . . . . . . . . . . . . . . . . . . . .$39
Only available with 814, 815, 819-821, 824, 826, 830.
Five challenges each unless otherwise
noted in parentheses.
Albumin Phosphorus (2)
Calcium Total Protein
Iron TIBC
Magnesium UIBCUric Acid
823 Enzyme Chemistry (Add-On) . . . . . . . . . . . . . . . . .$39
Only available with 813, 814, 815, 819821, 824, 826, 830.
Five challenges each unless otherwisenoted in parentheses.
ALT (SGPT) Creatine Kinase (CK)
Alkaline Phosphatase GGT (2)
Amylase LDH
AST (SGOT) Lipase (2)
824 Thyroid Profile . . . . . . . . . . . . . . . . . . . . . . . . . . .$210
Five challenges each unless otherwisenoted in parentheses.
Cortisol Thyroxine (T4)
Free T3 (2) Triiodothyronine (T3)
Free T4 TSH
T3 Uptake
825 Thyroid Profile (Add-On) . . . . . . . . . . . . . . . . . . . .$48
Same as 824. Only available with 813815, 819821,
826, 830.
826 Lipid Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$204
Five challenges each unless otherwise
noted in parentheses.
Cholesterol, Total LDL Cholesterol (2)
HDL Cholesterol Triglyceride
827 Lipid Profile (Add-On) . . . . . . . . . . . . . . . . . . . . . .$39
Same as 826. Only available with 813-815, 819, 824, 830.
829 Apolipoproteins . . . . . . . . . . . . . . . . . . . . . . . . . .$114
Two challenges each.
Apolipoprotein A1 Apolipoprotein B
830 Therapeutic Drug Monitoring . . . . . . . . . . . . . . .$204
Five challenges each.
Acetaminophen Gentamicin Salicylate
Amikacin Lithium Theophylline
Carbamazepine Phenobarbital Valproic Acid
Digoxin Phenytoin Vancomycin
831 Therapeutic Drug Monitoring (Add-On) . . . . . . . .$48
Same as 830. Only available with 810, 813815,
819821, 824, 826. Theophylline also CAP-approved in
this module.
835 Serum Alcohol/Acetone . . . . . . . . . . . . . . . . . . . .$201
Five challenges each.
Alcohol Acetone
836 Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$135
Two challenges.
841 Neonatal Bilirubin . . . . . . . . . . . . . . . . . . . . . . . .$192
Number of challenges noted in parentheses.
Direct Bilirubin (2) Total Bilirubin (5)
842 Direct Bilirubin (Add-On) . . . . . . . . . . . . . . . . . . . .$30
Same as 843.
Only available with 814, 819821, 824, 826.
Two challenges.
CAP-approved analytes/modules
8/7/2019 catalog US 2011
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843 Direct Bilirubin . . . . . . . . . . . . . . . . . . . . . . . . . . .$90
Two challenges.
845 Cardiac Markers . . . . . . . . . . . . . . . . . . . . . . . . .$168
Number of challenges noted in parentheses.
Requires 1 mL volumetric pipette (see item 121, p. 16).
CK-MB (5) Troponin T (2)
Troponin I (2) Myoglobin (2)
846 BNP/NT-pro BNP . . . . . . . . . . . . . . . . . . . . . . . . .$183
B-type Natriuretic Peptide
Two challenges.
848 Biosite Triage SOB Panel . . . . . . . . . . . . . . . . . . .$354
For Biosite Triage users only.
Five challenges each.
BNP Myoglobin
CK-MB Troponin I
D-dimer
847 Blood Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . .$261
Compatible with the i-STAT analyzer as well as other
blood gas instruments.
Five challenges each unless otherwise
noted in parentheses.
Chloride pO2Ionized Calcium (2) Potassium
pCO2 Sodium
pH
850 Glycohemoglobin . . . . . . . . . . . . . . . . . . . . . . . .$156NOT compatible with Afinion analyzer.
For waived and non-waived methods.
Two challenges.
851 Afinion Glycohemoglobin . . . . . . . . . . . . . . . . . .$156
Two challenges.
855 Fructosamine . . . . . . . . . . . . . . . . . . . . . . . . . . . .$138
NOT compatible with the LXN Test System.
Two challenges.
856 Blood Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . .$231
Five challenges each.
Carboxyhemoglobin Oxyhemoglobin
Hemoglobin, Total O2 Saturation
Methemoglobin
857 Blood Oximetry (Add-On) . . . . . . . . . . . . . . . . . . .$96
Same as 856. Only available with 847.
859 PSA (Add-On) . . . . . . . . . . . . . . . . . . . . . . . . . . . .$42
Same as 861. Only available with 860.
860 Endocrinology/Hematology/Oncology . . . . . . . .$180
Two challenges each.
CEA LH
Estradiol Progesterone
Ferritin Prolactin
Folate Testosterone
FSH Transferrin
Homocysteine Vitamin B12
861 PSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$99
Two challenges.
862 Tumor Markers . . . . . . . . . . . . . . . . . . . . . . . . . .$357
Two challenges each.
AFP CA 27-29
Beta ()-2 Microglobulin CEA
CA 125 Free PSA
CA 15-3 PSA
CA 19-9 Thyroglobulin
863 Endocrinology 2 . . . . . . . . . . . . . . . . . . . . . . . . .$159
Lyophilized samples. 2 ml volumetric pipette required
for reconstitution.
Two challenges each.
C-Peptide Parathyroid hormoneInsulin (PTH)
Vitamin D
864 Thyroid Antibodies . . . . . . . . . . . . . . . . . . . . . . .$201
Two challenges each.
Thyroglobulin Antibody Thyroid Microsomal
Antibody (Anti-TPO)
865 Serum hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$153
Five challenges.
866 Serum hCG (Add-On) . . . . . . . . . . . . . . . . . . . . . . .$75
Same as 865. Only available with 810, 813, 814, 815,
819, 820, 821, 824, 826.
CAP-approved analytes/modules
8/7/2019 catalog US 2011
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868 Urine Drug Screen . . . . . . . . . . . . . . . . . . . . . . . .$174
Two challenges each.
For the qualitative detection of drugs in urine. 10ml each.
Each challenge will include one or more of the following:
Acetaminophen Methadone
Amphetamines Methamphetamines
Barbiturates Methaqualone
Benzodiazepines MorphineBuprenophrine Opiates
Cannabinoids Oxycodone
Cocaine Metabolites Phencyclidine
Ethanol Propoxyphene
MDMA Tricyclic Antidepressants
870 Whole Blood Glucose . . . . . . . . . . . . . . . . . . . . .$237
Designed to allow the reporting and evaluation of
results for as many as five different glucose analyzers.
Five challenges.
871 Whole Blood GlucoseWaived . . . . . . . . . . . . . .$135For waived methods only.
Designed to allow the reporting and evaluation of
results for as many as five different glucose analyzers.
Two challenges.
215 Glucose/Hemoglobin . . . . . . . . . . . . . . . . . . . . . .$138
For HemoCue only.
Two challenges each.
880 Additional Chemistry Testing Material . . . . . . . . .$99
Includes all analytes in Chemistry Module 810 andTherapeutic Drug Monitoring Module 830. It is the
same material used in those modules and will be
shipped to your laboratory at the same time as your
regular Chemistry samples. You can use it as:
Extra PT material in case you have a problem and
need extra testing material.
A way to double-check unacceptable PT results after
corrective action.
An educational tool to train personnel.
A means to meet the CMS quality assurance
requirements for a second chemistry instrument.
Waived Testing
Waived TestingThe Importance ofPerforming Proficiency Testing
Certificate of Waiver (COW) laboratories must only perform
waived laboratory tests. When the Centers for Medicare& Medicaid Services (CMS) began random inspections ofsome COW laboratories in 2002, many laboratories chose toparticipate in proficiency testing as a quality assurancecheck. MLE responded by preparing special two-sampleproficiency modules, designed for the needs of the waivedtesting laboratory. Our custom selection of waived modulesappears on the following pages.
E-notification Service
A value-added service to enhance the quality and safety of
patient care. The e-mail notification service will provide
Class I and Class II recall information and field corrections
pertaining to waived test devices.
Class I recalls are those that have a probable risk
of harm or death to a patient if the items remain
in use. Class II recalls have a significant risk of
harm to a patient if they remain in use.
In addition to the recall e-notification service, MLE provides:
Notification of changes or additions to the CMS listof waived laboratory tests.
A wide array of cost-saving Waived Testing Modules
for continued quality assurance at a lower cost.
A reminder prompt for notifications involvingMicrobiology tests, to ensure regulatory compliance
for any remaining non-waived analytes.
To receive E-Notify on Waived Tests and the Recalls and
Field Corrections: DevicesClass I and Class II report,
send an e-mail to [email protected] and request to beadded to the recipient list. In the e-mail request, be sure to
include your MLE ID number.
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The Best in Proficiency Testing, Now in a More
Convenient Package.
901 Waived and PPM Package . . . . . . . . . . . . .$196Number of challenges noted in
parentheses.
Fecal Occult Blood* (2) Urinalysis (1)
Hemoglobin (2) Urine hCG (1)
Hematocrit (2) Urine Sediment (2)
PPM (6) Whole Blood Glucose (2)
Strep A Antigen *Fecal occult blood
Detection (2) testing not required
by CAP.
CAP-approved analytes/modules
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2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12
Hematology
213 Hemoglobin/Hematocrit . . . . . . . . . . . . . . . . . . .$120
For waived methods only.
Two challenges each.
215 Hemoglobin/Glucose . . . . . . . . . . . . . . . . . . . . . .$138
For HemoCue only.
Two challenges each.
247 Sedimentation Rate . . . . . . . . . . . . . . . . . . . . . . .$147
Two challenges.
Coagulation
329 ITC ProTime System . . . . . . . . . . . . . . . . . . . . . .$129
For ITC ProTime Microcoagulation System only.
Two challenges.
NEW!
331 CoaguChek XS Plus Waived . . . . . . . . . . . . . . .$111
For CoaguChek XS Plus Only.
Two challenges.
Urinalysis
531 Urinalysis Dipstick . . . . . . . . . . . . . . . . . . . . . . . . .$66
hCG not included.
One challenge each.
536 Microalbumin (Add-On) . . . . . . . . . . . . . . . . . . . . .$72
Same as 539. Only available with 530, 531, 541.
537 Fecal Occult Blood (Add-On) . . . . . . . . . . . . . . . . .$66
Same as 542. Only available with 530, 531, 532, 534.
Two challenges.
539 Microalbumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$87
One challenge each.
Microalbumin, Creatinine
quantitative
540 Urine hCG (Add-On) . . . . . . . . . . . . . . . . . . . . . . .$21
Same as 541.
Only available with 530, 531.
One challenge.
541 Urine hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$63
One challenge.
542 Fecal Occult Blood . . . . . . . . . . . . . . . . . . . . . . . .$84
Designed to allow the reporting and evaluation ofresults for as many as four different testing locationsor personnel.
Two challenges.
Microbiology
662 Strep A Antigen DetectionWaived . . . . . . . . . . .$87For waived methods only.
Two challenges.
680 Respiratory Antigen DetectionWaived . . . . . . .$156
Two challenges each.
Influenza A Influenza A/B ComboInfluenza B RSV
Immunology
755 Infectious MononucleosisWaived . . . . . . . . . . . .$90
For waived methods only.
Two challenges.
780 H. pyloriAntibody Detection . . . . . . . . . . . . . . .$135
For waived and non-waived methods.
Two challenges.
790 Anti-HIVWaived . . . . . . . . . . . . . . . . . . . . . . . .$132
For waived HIV kits only.
Two challenges.
Anti-HIV1 Anti-HIV 1/2
Chemistry
811 Cholestech Waived Chemistry . . . . . . . . . . . . . . .$147
For the LDX Cholestech Instrument (Waived testingONLY).
Two challenges each.
ALT (SGPT) GlucoseAST (SGOT) HDL CholesterolCholesterol, Total Triglyceride
812 Piccolo Waived Chemistry . . . . . . . . . . . . . . . . . .$186
For the Abaxis Piccolo InstrumentWaived cartridgesONLY.
Two challenges each.
Albumin CO2 PotassiumAlkaline Phosphatase Creatine Kinase Sodium
ALT (SGPT) Creatinine Total Bilirubin
Amylase GGT Total Protein
AST (SGOT) Glucose Triglyceride
Calcium HDL Urea Nitrogen
Chloride Phosphorous Uric Acid
Cholesterol
CAP-approved analytes/modules
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2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12
832 i-STAT ChemistryWaived . . . . . . . . . . . . . . . . . .$141
For i-STAT analyzer. Waived cartridges only.
Two challenges each.
Chloride Glucose Ionized Calcium
Creatinine Hematocrit Potassium
CO2 Hemoglobin Sodium
Urea Nitrogen
850 Glycohemoglobin . . . . . . . . . . . . . . . . . . . . . . . .$156
For waived and non-waived methods.
Two challenges.
871 Whole Blood GlucoseWaived . . . . . . . . . . . . . .$135
For waived methods only. Designed to allow the reporting
and evaluation of results for as many as
five different glucose analyzers.
Two challenges.
215 Hemoglobin/Glucose . . . . . . . . . . . . . . . . . . . . . .$138For HemoCue only.
Two challenges each.
Provider-Performed Microscopy (PPM)
532 Urine Sediment Identification . . . . . . . . . . . . . . . .$90
Two challenges consisting of color photographs.
534 Provider-Performed Microscopy (PPM) . . . . . . . . .$93
Color photographs depicting microscopic fields for the
examination of Vaginal Wet Mount Preparations, Vaginal
KOH Preparations, Nasal Eosinophils, Fecal Leukocytes,
Pinworms, Sperm, and FERN testing.
Urine sediment identification not included.
Six challenges.
538 KOH Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$120
Two fixed glass slides for determining the presence or
absence of fungal elements in skin scrapings.
Two challenges.
Lab Supplies & Services
Supplies
121 Pipette1mL . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$20
For use with 320, 321, 845. Reusable Class A volumetric
pipette required for reconstitution of lyophilized
proficiency testing specimens.
126 Pipette Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .$24
For use with product 121 above.
Services
107 Hard Copy of Participant Summary for the Year . .$15
108 Additional Program Binder . . . . . . . . . . . . . . . . . .$15
116 Automatic Program Renewal . . . . . . . . . . . . . . . .FREE
Free yourself from re-enrollment/re-ordering hassles.
Well do it for you! To enroll, add module 116 to your
order.
E-Notify
Notification of newly waived tests and FDA Recalls delivered
to your e-mail account . . . . . . . . . . . . . . . . . . . .FREE
To sign up for E-Notify, send an e-mail to
Web Data Entry System (WDES)
Online Result Reporting Program . . . . . . . . . . . . . . . .FREE
To register or receive more information, send an e-mail
Off-Schedule Proficiency Testing
Starts at . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$200
Off-schedule proficiency testing (PT) provides laborato-
ries with immediate, on-demand, customized proficiency
testing for reinstatement or remedial purposes; a comple-
ment to the regularly scheduled PT program.
Who Needs Off-Schedule Testing?
Laboratories with unsuccessful performance (score of less
than 80%) for two out of three regular testing events may
be required to perform off-schedule PT to lift a cease-
testing order from their regulatory or accrediting agency.
In these cases, two acceptable proficiency performances
(score of 80% or better) may be required for the lab to
resume testing patients.
Some laboratories use off-schedule PT to verify that
corrective actions were effective.
This service is available to every laboratory, regardless of
MLE enrollment status.
For information on cost and availability, contact MLE
Customer Service at 800-338-2746, option 5, or e-mail us at
CAP-approved analytes/modules
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IMMUNOLOGY
Module 750 Immunology ModuleInfectious Mononucleosis Rheumatoid Factor
Module 751 Rheumatology Module * Module 767 Antinuclear Antibody (ANA) (ELISA)Module 755 Infectious Mononucleosis (waived) * Module 779 Antinuclear Antibody (ANA) (Add On) (ELISA)Module 761 Infectious Mononucleosis/Rheumatoid Factor * Module 784 Complement C3 and C4, ImmunoglobulinsModule 762 Infectious Mononucleosis Module 771 RubellaModule 763 Rheumatoid Factor Module 772 Syphilis Serology RPR ONLYModule 764 C-Reactive Protein (CRP) Module 775 Viral Markers
Module 776 C-Reactive Protein (CRP) (Add On) Hepatitis B Surface Antibody Anti-HIV HCVModule 765 High-Sensitivity C-Reactive Protein (HS-CRP) Module 780 H. pylori Antibody DetectionModule 777 High-Sensitivity C-Reactive Protein (HS-CRP) (Add On)
CHEMISTRY
Module 810 Chemistry Module All tests EXCEPT LDL, TIBC, and UIBC
Module 811 Cholestech Waived ChemistryCholesterol, Total HDL Cholesterol Triglyceride
Module 812 Piccolo Waived ChemistryAlbumin Chloride PotassiumAlkaline Phosphatase Cholesterol SodiumALT (SGPT) CO2 Total BilirubinAST (SGPT) Creatinine Total ProteinCalcium Glucose Triglyceride
HDL Cholesterol Urea Nitrogen
Module 819 Chemistry 1 * Module 813 Comprehensive Metabolic Panel * EXCEPT D. Bili, TIBC, and UIBCModule 820 Chemistry 2 * Module 814 Basic Metabolic Panel *Module 821 Chemistry 3 * EXCEPT LDL Module 816 Hepatic Profile (Add On) *Module 822 Chemistry (Add On) * EXCEPT TIBC, UIBCModule 823 Enzyme Chemistry (Add On) *
Module 817 i-STAT Chemistry 1Chloride Sodium From blood gas sample:Creatinine Urea Nitrogen pHGlucose Hematocrit PO2Potassium Hemoglobin pCO2
Module 818 i-STAT Chemistry 2 * EXCEPT CO2 and Ionized Calcium Module 826 Lipid Profile * EXCEPT LDLModule 824 Thyroid Profile * Module 827 Lipid Profile (Add on) * EXCEPT LDLModule 825 Thyroid Profile (Add on) *
Module 830 Therapeutic Drug MonitoringCarbamazepine Phenobarbital Valproic AcidDigoxin Phenytoin
Module 831 Therapeutic Drug MonitoringCarbamazepine Phenobarbital TheophyllineDigoxin Phenytoin Valproic Acid
Module 841 Neonatal Bilirubin * Module 847 Blood Gases pH, pO2, pCO2Module 842 Direct Bilirubin (Add On) Module 850 GlycohemoglobinModule 845 Cardiac Markers * EXCEPT Troponin T Module 860 Endocrinology/Hematology/Oncology * EXCEPT TransferrinModule 848 Biosite Triage SOB Panel * Module 861 PSAModule 846 BNP/NT-pro BNP ONLY BNP approved Module 859 PSA (Add On)
Module 862 Tumor MarkersBeta-2 Microglobulin CA 27-29 PSACA 125 CEA
CA 15-3 Free PSAModule 863 Endocrinology 2 Parathyroid hormone (PTH) ONLYModule 865 Serum hCGModule 866 Serum hCG (Add On)
Module 868 Urine Drug ScreenAmphetamines Ethanol OpiatesBarbiturates MDMA PhencyclidineBenzodiazepines Methadone PropoxypheneCannabinoids Methamphetamines Tricyclic AntidepressantsCocaine Metabolites Methaqualone
Module 870 Whole Blood GlucoseModule 871 Whole Blood Glucose (waived)
*All analytes in module approved.
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2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12
Frequently AskedQuestions
1. Automatic Renewal Option: I do not want to worry aboutwhether we are enrolled from year to year. Do you have anautomatic renewal option?
We sure do! By checking the Automatic Renewal box on the PTorder form or your renewal form, you will never again have toworry about proficiency testing enrollment or placing your orderfor a new program year. We will automatically re-order themodules in which you participated the previous year, generatean order verification for your review, and send an order changeform should you wish to add or delete modules from yourrenewed order. Simple. Easy. And best of all, one importantmanagement detail that you never have to worry about again!See the Cancelling an Automatic Renewal Order section formore information.
2. When to Order: When does my order have to be submittedto ensure availability of the modules I ordered?
We encourage you to enroll in MLE as soon as you can to guaran-tee product availability. Enrolling by December 17, 2010, willensure that you receive shipments for the entire year. Remember,payment is not due until 30 days AFTER enrollment. (Enroll anytime before November and we will not invoice you untilNovember.)
You may enroll any time thereafter at a prorated cost dependingon the availability of specimens. For every missed event that youare not enrolled, 1/3 of the module price is deducted. The annualadministration fee remains. Note: The online ordering form auto-matically displays prorated prices. See question 4 for more detailson prorated pricing.
3. Individual International Orders: I live outside the UnitedStates and Canada and I am not with a distributor of MLEin my country. Please tell me about the shipping process.
Individual laboratories outside the U.S. and Canada are subject to
a minimum $50 fee per shipment to cover shipping costs. Somedestinations may be subject to additional S/H. Contact MLECustomer Service for specific shipping pricing information.Additionally, MLE cannot replace kits that are delayed or refusedentry into your country. We will not issue credit or refunds onsuch shipments.
When enrolling in any of the MLE modules that involve hazardousmaterial, laboratories outside the U.S., including Canadian labora-tories, must send to MLE any copies of the necessary valid permitsfor attachment to each shipment. The shipments will not be sentwithout required documentation.
Freight charges are not included in the commercial pricing. Youwill be invoiced for freight charges AFTER each shipment. Thesecharges are due BEFORE your evaluation is mailed.
4. Order Changes: Can I change my order at any time?
Sure! We make every effort to accommodate new orders or order
changes throughout the year, subject to product availability.See New Orders or Additions and Cancelling a Module formore information.
5. Irregular Order Frequency: Can I order modules outsidemy regular order? If so, do I have to be an MLE participantto order modules from you?
Proficiency Testing is available upon request at any time duringthe program year (subject to product availability). Those enrolledwith other PT providers are welcome to call upon MLE for helpwith reinstatement and compliance emergencies. See page 16 fordetails on off-schedule testing.
6. Needing Assistance: What if I need help with my order,testing, or regulations? Who can I turn to for immediateservice?
Our friendly and knowledgeable MLE Customer ServiceRepresentatives are available to assist with order selection, billing,address/name changes, order changes, and regulatory information.Additionally, experienced laboratory professionals will guide youthrough technical issues, interpretation of your results, and stepsnecessary for corrective action.
Changes/Cancellations
New Orders or AdditionsAll new orders must be submitted in writing to MLE. All changesto an existing order must be submitted in writing to MLE beforethey can be entered into the order processing system. Please sendyour order or order changes in writing at least four weeks prior tothe next shipping date to avoid additional shipping fees. MLEships three times per year. You may enroll throughout the year.
Note: The MLE catalog lists prices for the full year. After the firstevent, module pricing is prorated. If you add a module less thanfour weeks prior to the next shipping date, you MAY be subject toa rush order fee. Call MLE Customer Service at 1-800-338-2746,
option 5, for more information.
Cancelling a ModuleIf we receive your written request for cancellation of a module(s)at least four weeks prior to the next shipping date, you will not beheld accountable for payment of the module for the remainingshipments. Unless otherwise requested, we will credit your accountfor that amount and the credit will be applied to additions to yourorder or toward enrollment for the next year.
If you cancel a module less than four weeks prior to thenext shipping date, you are financially responsible for thecost of the module for the next shipment.You will NOT befinancially responsible for subsequent shipments. For example, you
cancel (in writing) a module on January 10, 2011. The first ship-ment (M1) is scheduled to be shipped on February 7, 2011. You areresponsible for the cost of the module for M1 but not for M2 or M3.
Cancelling an AnalytePlease submit a Test Menu Deletion form if your laboratoryreported tests during the previous event that have since beendiscontinued, but you are not cancelling the module. Downloadthe form at www.acponline.org/mle/enroll.htm, scroll to Forms,or copy the form in your MLE Program Guide, p. 32.
Cancelling the Entire OrderWe will refund any charges for unshipped specimens if we receivenotification in writing four weeks prior to the next shipping date.Once we have shipped orders for pipettes, we cannot cancel theorder or refund the cost. The annual administration fee is non-refundable.
Cancelling an Automatic Renewal OrderIf you are enrolled in Module 116 (automatic renewal) and wish tocancel your entire order, you are required to contact MLE in writ-ing NO LATER THAN December 17, 2010, to avoid any chargesfor the upcoming year.
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Price Matching forUnmatched Service!
Found a better price? Well match it! MLEprotects your need for budgetary constraintwhile providing the best possible PT servicein the industry.
Complete the MLE Price Match RequestForm (page 21), listing only the tests youactually perform. This form enables MLEto match your actual needs to our mosteconomic offerings and save you the mostmoney. If our prices arent the best, we willmatch our competitors pricing for the sametest menu coverage. We strive to give youmore of what you need without the excess!
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2011 Price Match Request Form: Medical Laboratory Evaluation
Questions? Contact MLE
Fax this form AND your current PT providers quote/order to: 202-835-0440 800-338-2746, #5 or [email protected]
Contact:__________________________________________________ Facility:_____________________________________State:__________
Phone:_________________________ Fax: ____________________ E-mail:_____________________________________________________
Accreditation Service: CAP_______ COLA __________________ CMS_______ TJC (JCAHO)_______ OTHER: ___________________
Primary PT Service: AAB________ AAFP______________ AccuTest________ CAP Surveys________ CAPExcel__________
MLE________WSLH________ OTHER: _________________________________________
Secondary PT Service:___________________ For which tests? _______________________________________________________________
ABBREVIATION CODE: Waived (W) Nonwaived (NW) Full Instrument Name (I)
HEMATOLOGY__Blood Cell Identification
(manual differential)__CBC
Differential, Automated:__1-3 Part Diff__5 Part DiffI: ________________________________________
__Crystal Screening__Fluid Cell Count__Hematocrit _____W _____NW__Hemoglobin _____W ______NW__Reticulocyte Count IM:________ Manual?_______Sedimentation Rate IM: ____________________COAGULATION
__Fibrinogen__Partial Thromboplastin Time (APTT) or (PTT)__Prothrombin Time (PT) I: ____________________PT/INR whole blood methods _____W_____NWBLOOD BANK (check here if all apply)_______ABO Group__Antibody Detection__Antibody Identification__Compatibility Testing__Crossmatch__Rh Factor (D Type)URINALYSIS__Creatinine, Urine__Fecal Occult Blood__hCG, urine _____W _____NW__Microalbumin, quantitative__Urine Dipstick__Urine Sediment Identification__Urine Drug Screen
PPM__Eosinophils Nasal__Fecal Leukocytes__Fern Testing__KOH Vaginal Prep__KOH Skin Prep__Nasal Eosinophils__Pinworms__Sperm__Wet Mount PreparationsMICROBIOLOGY__Affirm VPIII (DNA)__Antimicrobial Susceptibility Testing__Chlamydia (EIA/DNA)__Dermatophyte Screen__GC Culture__GC (EIA/DNA)__Gram stain__MRSA Screening
__Stool, Parasitology__Throat Culture__Urine Colony Count__Urine Culture Method: ______________________Culture Other Sources:____________________ANTIGEN DETECTION__C. difficile__Cryptosporidium__Giardia lamblia__Influenza B _____W _____NW__Influenza A _____W _____NW__Legionella, urine__Rotavirus__RSV _____W _____NW__Strep A _____W _____NW__Strep pneumoniae, urine
IMMUNOLOGY__Allergen Specific IgE I: _______________________Anti-Streptolysin O (ASO)__Antinuclear Antibody (ANA) Method: _______
__Anti-DsDNA__Anti-RNP__Anti-Sm__Anti-SSA__Anti-SSB
__Complement C3/C4__C-Reactive Protein (CRP)__C-Reactive Protein, high sensitivity (HS-CRP)__H. pylori, Antibody Detection__IgA, Total__IgE, Total__IgG, Total
__IgM, Total__Infectious Mononucleosis _____W _____NW__Lyme Disease Serology__Rheumatoid Factor (RA)__Rubella__Syphilis SerologyV