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  • 8/7/2019 catalog US 2011

    1/28

    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

    2/28

    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

    Medical Laboratory Evaluation 2011 www.acponline.org/mle

    2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12

    Note: Module descriptions within each category are NOT listedin numerical order. They are grouped by the type of test.

    CAP-approved analytes/modules

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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

    CAP-approved analytes/modules

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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

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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

    Medical Laboratory Evaluation 2011 www.acponline.org/mle

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    CAP-approved analytes/modules

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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

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    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

    [email protected].

    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

    Medical Laboratory Evaluation 2011 www.acponline.org/mle

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    CAP-approved analytes/modules

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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

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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

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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.

    14 www.acponline.org/mle Medical Laboratory Evaluation 2011

    2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12

    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

    [email protected].

    Web Data Entry System (WDES)

    Online Result Reporting Program . . . . . . . . . . . . . . . .FREE

    To register or receive more information, send an e-mail

    to [email protected].

    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

    [email protected].

    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.

    2011 SHIP DATES M1: Feb. 7 M2: May 16 M3: Sept. 12

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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.

    Medical Laboratory Evaluation 2011 www.acponline.org/mle

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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!

    20

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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