2016 Proficiency Testing Catalog Follow ACP on Facebook for MLE updates: www.facebook.com/acpinternists Approved by: CMS, COLA, TJC, U.S. State Agencies and International regulatory bodies. CAP accepted analytes offered. MLE is already known for providing prompt, courteous service to all of our customers; but now we are excited to provide the best-inclass customer service experience with personalized care from the beginning to the end of your ordering process. MLE’s White Glove Concierge Service Our White Glove Concierge Service will provide: • Responses to your calls within two hours (during normal business hours) • Affordable test packages • Assistance in choosing the appropriate test modules for your instrumentation • Verification of orders within one week • Analysis of your reported analyte test menu for CLIA compliance. • Assistance in your entire process from ordering to submission • Auto renewal of customers with their previous year’s orders upon request As an extra special touch, our expert concierge team is responsible for your overall accounts and will be at your side from ordering to submission by assisting in your entire proficiency testing process. Rest assured, with our expert concierge team on the job, you can leave the worry to us. From your White Glove Concierge Team 1-800-338-2746, option 5 [email protected] www.acponline.org/mle 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 Table of Contents At a Glance Overview Customer Service Hours and Contact Information Overview/How MLE Works . . . . . . . . . . . . . . . . . . . . . . . . . .4 Monday through Friday from 9:00 a.m. to 5:00 p.m. ET Test Index and Module Descriptions Telephone: 1-800-338-2746, option 5 Test Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3 E-mail: [email protected] (See pages 16 and 17 for CAP Accepted Analytes listing) Fax: 202-835-0440 Hematology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Web: www.acponline.org/mle Blood Bank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Provider-Performed Microscopy (PPM) . . . . . . . . . . . . . . . .6 Enrollment/Renewal of Proficiency Testing Enroll early to ensure the availability of specimens for the Urinalysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 2016 program year. Once we process your order, you will be Microbiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 mailed an order verification for your review and signature. Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Waived Testing Online Order Form: Visit www.acponline.org/mle. Click on the “Enrollment Information” link. Complete the appropriate electronic order form to automatically calculate pricing, and you will receive an order summary page. “E-Notification” of Waived Devices and Recalls . . . . . . . . .14 MLE PT Order Form: Detach the order form on page 24, complete it and fax it. (If submitting a purchase order, please fax.) Supplies & Services . . . . . . . . . . . . . . . . . . . . . . . . . .15 Fax: 202-835-0440. Automatic Renewal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Continuing Education . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Online Result Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Off-Schedule Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 CAP Accepted Analytes . . . . . . . . . . . . . . . . . .16, 17 Ordering and Discounts MLE DISCOUNT OFFERS . . . . . . . . . . .Inside Back Cover Mail: Mailing Form with Payment Mailing Form w/o Payment AC003 American College of Physicians 190 N. Independence Mall West Philadelphia, PA 19106-1572 ACP/MLE Suite 700 25 Massachusetts Ave. NW Washington, DC 20001-7401 Method of Payment Enrollments received by renewal form or order form will be Price Match Service . . . . . . . . . . . . . . . . . . . . . . . . .19, 20, 21 invoiced within one week of activation. Auto Renewals will How to Order/Ordering Instructions . . . . . . . . . . . . . . . . .22 be invoiced in early October. Invoices are due within 30 FAQ days. Payment options include credit card (Mastercard or . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 Order Changes/Cancellations . . . . . . . . . . . . . . . . . . . . . . .18 Visa), purchase order, or check. Overdue accounts are Price List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 subject to holds and/or cancellations. Proficiency Testing Order Form . . . . . . . . . . . . . . . . . . . . .24 Off-Schedule Proficiency Testing Provides laboratories with an option for immediate, ondemand proficiency testing, a complement to the regular Save Money!—Price Matching for Unmatched Service Found a lower price? We’ll match it! Complete the MLE Price Match Request Form (pages 20-21), listing only the tests you actually perform. If our prices aren’t the lowest, we’ll match our competitor’s quote for the same total test menu coverage. scheduled proficiency testing. For more details on this service, see page 15. Educational Resources For a listing of Educational Resources, including the G2 NIR publication, please see our web site at: www.acponline.org/running_practice/mle/edu_cat.htm Medical Laboratory Evaluation 2016 www.acponline.org/mle 1 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 Test Index CMS regulated analytes for CLIA purposes are in bold type. ABO Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Acetaminophen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Acetone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Affirm VPIII (DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Albumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Alcohol, Serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Alkaline Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Allergy Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Alpha-fetoprotein (AFP) . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 ALT (SGPT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Amylase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 14 Anti-dsDNA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Anti-HAV (IgM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Anti-HAV (Total/IgG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Anti-HBc (IgM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Anti-HBc (Total/IgG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Anti-HBs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Anti-HCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Anti-HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Anti-RNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Anti-RNP/Sm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Anti-SSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Anti-SSA/SSB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Anti-SSB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Anti-Sm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Anti-Streptolysin O (ASO) . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Antibody Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Antimicrobial Susceptibility Testing . . . . . . . . . . . . . . . . .8 Antinuclear Antibody (ANA) . . . . . . . . . . . . . . . . . . . . . . . .10 Apolipoprotein A1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Apolipoprotein B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 AST (SGOT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Beta (b)-2 Microglobulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Bilirubin, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Bilirubin, Direct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12, 13 Bilirubin, Neonatal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Blood Cell Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Blood Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Blood Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Blood Smear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 BNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 C-Peptide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 CA 125 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 CA 15-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 CA 19-9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 CA 27/29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 14 Calcium, Ionized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 13 Candida, Affirm VPIII(DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Carbamazepine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 CEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 C. difficile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Chlamydia (EIA/DNA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 2 www.acponline.org/mle Chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 13, 14 Cholesterol, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 CK-MB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Colony Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Compatibility 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 Creatinine, Serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Creatinine, Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 14 Crossmatch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Cryptosporidium, Antigen Detection . . . . . . . . . . . . . . . . .9 Crystal Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 CSF Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 D-Dimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Dermatophyte Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 DHEA-S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Differential, Automated . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Digoxin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Drug Screen, Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Eosinophils, Nasal (PPM) . . . . . . . . . . . . . . . . . . . . . . . . .6, 7, 15 Estradiol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Fecal Leukocytes (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . .6, 7, 15 Fecal Occult Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 15 Fecal Suspension, parasitology . . . . . . . . . . . . . . . . . . . . . .9 Fern Testing (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6, 7, 15 Ferritin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Fibrinogen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Fluid 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 Giardia lamblia, Antigen Detection . . . . . . . . . . . . . . . . . .9 Glucose, serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 11, 14, 15 Whole blood methods . . . . . . . . . . . . . . . . . . . . . . . .5, 7, 14, 15 Glucose, urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Glycohemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Gram Stain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8, 9 Gram Stain Morphology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8, 9 HBeAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 HBsAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 hCG, serum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 hCG, urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 15 HDL Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Hematocrit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 11 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 7, 11, 15 Hemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 11 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 7, 11, 15 Hemoglobin A1C (Glycohemoglobin) . . . . . . . . . . . . . . . . . . . .13 Homocysteine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 H. pylori, Antibody Detection . . . . . . . . . . . . . . . . . . . . . . . . . .11 Medical Laboratory Evaluation 2016 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 i-STAT Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Waived cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 IgA, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 IgE, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 IgG, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 IgM, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Infectious Mononucleosis . . . . . . . . . . . . . . . . . . . . . . . . .9, 10 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Influenza A, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . .9 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Influenza B, Antigen Detection . . . . . . . . . . . . . . . . . . . . . .9 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Influenza A/B Combo, Antigen Detection . . . . . . . . . . . . . .9 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 INR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 KOH Vaginal Prep (PPM) . . . . . . . . . . . . . . . . . . . . . . . . .6, 7, 15 KOH Skin Prep (Slides) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 9 Lactic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12, 13 LDH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 LDL Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Lead, Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Legionella, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . .9 LH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Lipase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Lithium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Lyme Disease Serology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Magnesium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12, 14 Microalbumin, quantitative . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 Microalbumin, urine dipstick . . . . . . . . . . . . . . . . . . . . . . . . . . .7 MRSA Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Mycoplasma, IgG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Myoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Nasal Eosinophils (PPM) . . . . . . . . . . . . . . . . . . . . . . . . .6, 7, 15 NT-proBNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Occult Blood, Fecal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 15 Osmolality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Parasitology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Parathyroid hormone (PTH) . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Partial Thromboplastin Time (APTT) or (PTT) . . . . . . . .6 pCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 pH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Phenobarbital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Phenytoin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Phosphorus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 14 Pinworms (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6, 7, 15 Platelet Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 pO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Potassium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 13, 14 Progesterone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Prolactin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Protein, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 14 Prothrombin Time (PT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Whole blood methods (non-waived) . . . . . . . . . . . . . . . . .6 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Provider-Performed Microscopy (PPM) . . . . . . . . . . . . . .6, 7, 15 PSA, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 PSA, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 PVA Slide, parasitology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Red Blood Cell Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6 Medical Laboratory Evaluation 2016 Respiratory Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Reticulocyte Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Rheumatoid Factor (RA) . . . . . . . . . . . . . . . . . . . . . . . . .9, 10 Rh Factor (D Type) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Rotavirus, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . .9 RSV, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Rubella, IgG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Salicylate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Scabies (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6, 7, 15 Sedimentation Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6 SHBG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 13, 14 Sperm (PPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6, 7, 15 Stool Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Strep A, Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . . . .8 Waived methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 8, 15 Strep pneumoniae, Antigen Detection . . . . . . . . . . . . . . . .9 Syphilis Serology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 T3, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 T3, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 T3, Uptake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 T4, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 T4, Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 tCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Testosterone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Testosterone, Bioavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Testosterone, Free . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Theophylline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Throat Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Thyroglobulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Thyroglobulin antibody . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Thyroid Microsomal antibody . . . . . . . . . . . . . . . . . . . . . . . . . .13 TIBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Transferrin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Trichomonas, Affirm VPIII (DNA) . . . . . . . . . . . . . . . . . . . . . . .9 Triglyceride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12 Troponin I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Troponin T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 TSH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 UIBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Unexpected Antibody Detection . . . . . . . . . . . . . . . . . . . . . .6 Urea Nitrogen (BUN) . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 14 Uric Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11, 12, 14 Urine Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Urine Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Urine Dipstick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 15 Urine Drug Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Urine hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7, 15 Urine Sediment Identification . . . . . . . . . . . . . . . . . . . . . . .7, 15 Valproic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Vancomycin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Vitamin B12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Vitamin D, 25-Hydroxy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Waived and PPM packages . . . . . . . . . . . . . . . . . . . . . . . . . .7, 15 Wet Mount Preparations (PPM) . . . . . . . . . . . . . . . . . . . .6, 7, 15 White Blood Cell Count . . . . . . . . . . . . . . . . . . . . . . . . . . .5, 6 Wound Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 www.acponline.org/mle 3 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 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. MLE’s 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 laboratory’s 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 18. Our Guarantee If a specimen is missing, leaking, broken, not labeled, hemolyzed, or crushed, and you contact us within three (3) working days of receipt of your kit, we will provide a replacement for the specimen(s) FREE of charge (limited to material availability) or your lab will receive a grading exception for that test. H o w M L E Wo r k s 1 2 3 4 5 6 7 8 MLE Catalog Order Form Order Verification Program Binder Kit Shipments Test Completion Data Processing Evaluation Distribution 1 MLE sends you a catalog to review ordering options. 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 you an Order Verification for your review and approval. This is your proof of enrollment. 4 Approximately four weeks prior to the upcoming shipment, MLE sends you a program binder to prepare for your first testing event. 4 www.acponline.org/mle 5 MLE sends you scheduled shipments of test kits that include specimens to analyze in the same way that you regularly test patient specimens. 6 Upon completion of the testing, you submit your results online or mail to MLE for evaluation. 7 MLE performs statistical compilation of all participants’ results. 8 MLE mails or e-mails you an evaluation report, graded according to regulatory requirements, that compares your performance with that of other laboratories that used similar methods and instruments. Medical Laboratory Evaluation 2016 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 Hematology 225 Hematology with 3-part Differential . . . . . . . . . .$282 Note: Module descriptions within each category are NOT listed in numerical order. They are grouped by the type of test. Please pay close attention to instrument compatibility notes when selecting hematology modules. 210 Hematology Module . . . . . . . . . . . . . . . . . . . . . .$240 Includes 211 and 230. Platelet Count Red Blood Cell Count White Blood Cell Count 211 Basic Hematology . . . . . . . . . . . . . . . . . . . . . . . .$228 Five challenges each. Hematocrit Hemoglobin Platelet Count Five challenges each. Automated Differential Hematocrit Hemoglobin Questions? Contact MLE Customer Service. See “Hematology Instrument List” online at www.acponline.org/running_practice/mle/ enroll_us.htm Blood Cell Identification Hematocrit Hemoglobin Compatible with most 3-part differential instruments. Sysmex users see 224. Red Blood Cell Count White Blood Cell Count 212 Hemoglobin/Hematocrit . . . . . . . . . . . . . . . . . . .$204 Five challenges each. 213 Hemoglobin/Hematocrit—Waived . . . . . . . . . . . .$147 For waived methods only. 226 Hematology with 5-part Differential . . . . . . . . . .$330 Compatible with most Beckman–Coulter 5-part differential instruments EXCEPT for the AcT 5diff (see 228). Five challenges each. Automated Differential Hematocrit Hemoglobin Platelet Count Red Blood Cell Count White Blood Cell Count 228 Hematology with 5-part Differential . . . . . . . . . .$330 Compatible with Beckman Coulter AcT 5diff and ABX Pentra 5-part differential instruments. Five challenges each. Automated Differential Hematocrit Hemoglobin Platelet Count Red Blood Cell Count White Blood Cell Count 229 Sysmex with 5-part Differential . . . . . . . . . . . . . .$330 Compatible with most Sysmex 5-part differential instruments only. Five challenges each. Automated Differential Hematocrit Hemoglobin Two challenges each. Platelet Count Red Blood Cell Count White Blood Cell Count Platelet Count Red Blood Cell Count White Blood Cell Count 215 Hemoglobin/Glucose . . . . . . . . . . . . . . . . . . . . . .$156 230 Blood Cell Identification (Add-On) . . . . . . . . . . . .$36 For HemoCue only. Same as 231. Two challenges each. Only available with 223 through 229. 223 Hematology with 5-part Differential . . . . . . . . . .$330 Compatible with most Abbott CELL-DYN 5-part differential instruments only. Five challenges each. Automated Differential Hematocrit Hemoglobin Platelet Count Red Blood Cell Count White Blood Cell Count 224 Sysmex with 3-part Differential . . . . . . . . . . . . . .$273 Compatible with Sysmex 3-part automated differential instruments only. Stand-alone module. Five challenges consisting of color photographs. 240 Reticulocyte Count . . . . . . . . . . . . . . . . . . . . . . .$210 Compatible with automated and manual reticulocyte counting methods. Not for use with brilliant cresyl blue staining methods. Two challenges. 247 Sedimentation Rate . . . . . . . . . . . . . . . . . . . . . . .$168 Five challenges each. Automated Differential Hematocrit Hemoglobin 231 Blood Cell Identification . . . . . . . . . . . . . . . . . . .$108 Platelet Count Red Blood Cell Count White Blood Cell Count Medical Laboratory Evaluation 2016 Not for use with Sedimat 15 / 15 Plus Two challenges. *Sedimentation Rate is not required by CAP. CAP accepted analytes www.acponline.org/mle 5 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 248 Sedimat 15 ESR . . . . . . . . . . . . . . . . . . . . . . . . . .$168 Compatible with the Polymedco Sedimat 15 / 15 Plus instruments only. Two challenges. 324 Roche CoaguChek XS INR . . . . . . . . . . . . . . . . $174 Two challenges. INR 328 i-STAT Prothrombin Time . . . . . . . . . . . . . . . . . . .$333 *Sedimentation Rate is not required by CAP. 250 Fluid Cell Count/Crystals . . . . . . . . . . . . . . . . . . .$183 Fluid for Hemocytometer cell count and color photographs for identification of crystals. Compatible with the i-STAT instruments only. Five challenges each. INR Prothrombin Time 330 CoaguChek XS Plus Prothrombin Time . . . . . . . .$285 Two challenges each. Crystal Screening RBC Count WBC Count For CoaguChek XS Plus only. Five challenges each. INR Blood Bank Prothrombin Time 331 CoaguChek XS Plus Prothrombin Time—Waived $174 For CoaguChek XS Plus only. 450 Rh Factor (D Type) . . . . . . . . . . . . . . . . . . . . . . . .$237 For Slide Methods ONLY. Two challenges each. INR Prothrombin Time Five challenges. 451 ABO & Rh Factor (D Type) . . . . . . . . . . . . . . . . . .$276 Not for use with slide methods. Five challenges each. 452 Blood Bank 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . .$378 Not for use with slide methods. Provider-Performed Microscopy Five challenges each. ABO Group Rh Factor (D Type) Unexpected Antibody Detection 453 Blood Bank 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . .$396 Not for use with slide methods. Five challenges each. ABO Group Antibody Identification Compatibility Testing (Crossmatch) Rh Factor (D Type) Unexpected Antibody Detection Coagulation 534 Provider-Performed Microscopy (PPM) . . . . . . . .$114 Color photographs depicting microscopic fields for the examination of: Fecal Leukocytes (M2,M3) FERN testing (M1,M3) Nasal Eosinophils (M1,M2,M3) Pinworms (M1,M2) Scabies (M1,M2)* Sperm (M2,M3) Vaginal KOH Preparations (M1,M3) Vaginal Wet Mount Preparations (M1,M2,M3) Six challenges total per shipment as indicated in parentheses above. *Scabies examination is not required by CAP. 320 Coagulation Module . . . . . . . . . . . . . . . . . . . . . .$189 Requires 1-mL pipette (see item 121 on page 15). Same as 534. Only available with 530, 531, 532, 541. Five challenges each. Fibrinogen INR 535 Provider-Performed Microscopy (PPM)—Add-On ..$33 Partial Thromboplastin Time Prothrombin Time 321 Prothrombin Time . . . . . . . . . . . . . . . . . . . . . .$180 Requires 1-mL pipette (see item 121 on page 15). 538 KOH Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$153 Two fixed glass slides for determining the presence or absence of fungal elements in skin scrapings. Two challenges. Five challenges each. INR 6 Prothrombin Time www.acponline.org/mle CAP accepted analytes Medical Laboratory Evaluation 2016 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 Urinalysis 542 Fecal Occult Blood . . . . . . . . . . . . . . . . . . . . . . $105 Stand-alone module. Two challenges. 530 Urinalysis Module . . . . . . . . . . . . . . . . . . . . . . . $105 Includes modules 531 and 532. One challenge each unless otherwise noted in parentheses. 540 Urine hCG (Add-On) . . . . . . . . . . . . . . . . . . . . . . .$27 Same as 541. Only available with 530, 531. Bilirubin pH Blood/Hemoglobin Protein Nitrite Specific Gravity Glucose Microalbumin Ketones (dipstick only) Urobilinogen Leukocyte Esterase Urine Sediment Identification (2) 541 Urine hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$81 Stand-alone module. One challenge. 901 Waived and PPM Package . . . . . . . . . . . . . . . . . .$249 531 Urinalysis Dipstick . . . . . . . . . . . . . . . . . . . . . . . .$84 Number of challenges noted in parentheses. Fecal Occult Blood* (2) Urine hCG (1) Hemoglobin (2) Urine Sediment (2) Hematocrit (2) Strep A Antigen PPM (6)** Detection (2) Urinalysis (1) Whole Blood Glucose (2) *Fecal occult blood testing is not required by CAP. **Scabies examination is not required by CAP. hCG not included. One challenge each. Bilirubin Blood/Hemoglobin Nitrite Glucose Ketones Urobilinogen *Fecal occult blood testing is not required by CAP. pH Protein Specific Gravity Microalbumin (dipstick only) Leukocyte Esterase 532 Urine Sediment Identification . . . . . . . . . . . . . . $108 Two challenges consisting of photographs. 533 Urine Sediment Identification (Add-On) . . . . . . . .$27 Same as 532. Only available with 531, 534, 541. 536 Urine Microalbumin/Creatinine (Add-On) . . . . . . .$87 Same as 539. Only available with 530, 531, 541, 868, 872. 902 Basic Waived and PPM Package . . . . . . . . . . . . .$210 Number of challenges noted in parentheses. Fecal Occult Blood* (2) Urinalysis (1) PPM (6)** Urine hCG (1) Strep A Antigen Urine Sediment (2) Detection (2) Whole Blood Glucose (2) *Fecal occult blood testing is not required by CAP. **Scabies examination is not required by CAP. 539 Urine Microalbumin/Creatinine . . . . . . . . . . . . . .$108 Stand-alone module. Compatible with quantitative and semi-quantitative (dipstick) methods. One challenge each. 537 Fecal Occult Blood (Add-On) . . . . . . . . . . . . . . . . .$81 Same as 542. Only available with 530, 531, 532, 534, 541. *Fecal occult blood testing is not required by CAP. Medical Laboratory Evaluation 2016 CAP accepted analytes www.acponline.org/mle 7 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 Microbiology 648 Colony Count* . . . . . . . . . . . . . . . . . . . . . . . . . . .$207 *Colony Count does not contribute to the overall minimum of five bacteriology challenges! 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 . . . . . . . . . . . . . . . . . . . . . . . . . . .$306 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$315 Consists of each of the following: Best suited for urine paddle-dipping methods. Urine Culture (1) Gram Stain (2) Antimicrobial Throat Culture (1) Genital Culture (1) Susceptibility Testing (1) Gram Stain Morphology (2) Presumptive Colony Count (2) Antimicrobial Identification (2) Gram Stain (1) Susceptibility Testing (1) (directly from Strep A Antigen sample provided) Detection (5) Gram Stain Morphology (1) Plus, an additional three challenges from the following sources: blood, CSF, wound, respiratory, and/or stool for a total of 6 cultures each shipment. 652 Urine Presumptive ID/Throat Culture . . . . . . . . .$333 Best suited for urine paddle-dipping methods. 640 Bacteriology 2 . . . . . . . . . . . . . . . . . . . . . . . . . . .$294 Urine Culture (2) Strep A Antigen Throat Culture (2) Detection (1) Gram Stain (2) Antimicrobial Genital Culture (1) Susceptibility Testing (1) Gram Stain Morphology (2) 643 Urine Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . .$282 Urine Culture (5) Gram Stain (1) Antimicrobial Gram Stain Susceptibility Testing (1) Morphology (1) 644 Urine Culture/Strep A Antigen Detection . . . . . .$273 Urine Culture (2) Strep A Antigen Gram Stain (1) Detection (3) Antimicrobial Gram Stain Susceptibility Testing (1) Morphology (1) Presumptive Identification (2) Gram Stain (1) (directly from sample provided) Colony Count (2) Antimicrobial Susceptibility Testing (1) Throat Culture (3) Gram Stain Morphology (1) 650 Gram Stain . . . . . . . . . . . . . . . . . . . . . . . . . . . . $177 Five fixed glass slides. Five challenges each. Gram Stain Gram Stain Morphology 641 Throat Culture . . . . . . . . . . . . . . . . . . . . . . . . . .$282 Not suitable for Strep A kits. Five challenges. 642 Throat Culture/Strep A Antigen Detection . . . . .$273 645 Urine/Throat Culture . . . . . . . . . . . . . . . . . . . . . .$288 Urine Culture (3) Throat Culture (2) Gram Stain (1) Antimicrobial Gram Stain Morphology (1) Susceptibility Testing (1) Throat Culture (2) Strep A Antigen Detection (3) 660 Strep A Antigen Detection . . . . . . . . . . . . . . . . $174 Not suitable for culture. 647 Urine Presumptive ID/Colony Count . . . . . . . . . .$333 Five challenges. Best suited for paddle-dipping methods. Presumptive Colony Count (2) Identification (5) Antimicrobial Gram Stain (1) Susceptibility Testing (1) Gram Stain Morphology (1) 662 Strep A Antigen Detection—Waived . . . . . . . . . $108 For waived Strep A Antigen Detection kits only. Two challenges. 646 Genital Culture . . . . . . . . . . . . . . . . . . . . . . . . . .$282 Genital Culture (5) Gram Stain (1) Gram Stain Morphology (1) 8 www.acponline.org/mle CAP accepted analytes Medical Laboratory Evaluation 2016 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 654 Genital Culture (Add-On) . . . . . . . . . . . . . . . . . .$123 Same as 646. Only available with 641 through 645, 647, 649, 650, 652, 660, 670. Genital Culture (2) Gram Stain (1) Gram Stain Morphology (1) 681 Respiratory Antigen Detection . . . . . . . . . . . . . .$285 Five challenges each. Influenza A Influenza B Influenza A/B Combo RSV 682 C. difficile/Rotavirus Antigen Detection . . . . . . .$249 668 Affirm VP III (DNA) . . . . . . . . . . . . . . . . . . . . . . .$399 Five challenges each. Candida sp. Gardnerella vaginalis Trichomonas vaginalis 670 Chlamydia (EIA, DNA) . . . . . . . . . . . . . . . . . . . . .$327 Five challenges. Five challenges each. C. difficile Toxin/ Common Antigen Rotavirus 683 Giardia lamblia/Cryptosporidium Antigen Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$300 Five challenges each. Cryptosporidium Giardia lamblia 675 Chlamydia/GC (EIA, DNA) . . . . . . . . . . . . . . . . . .$354 Five challenges each. Chlamydia trachomatis 686 Legionella Antigen Detection . . . . . . . . . . . . . . .$225 Neisseria gonorrhoeae 673 Chlamydia (EIA, DNA)—Add-On . . . . . . . . . . . . .$144 Same as 670. Only available with 630 through 647, 649, 650, 652, 660. Two challenges. Five challenges. 687 Streptococcus pneumoniae Antigen Detection . .$225 For use with the Binax NOW Streptococcus pneumoniae Urinary Antigen Detection kit only. Note Five challenges. • Federal law requires a minimum of five CMS regulated (non-waived methods) bacteriology challenges per shipment. Individual state laws may differ. When enrolling, ensure your order meets the requirement that is the most stringent of the two. • All urine culture specimens are suitable for presumptive identification (ie, growth/no growth, Gram stain interpretation) and/or definitive identification (ie, genus and/or species). • The number of challenges is noted in parentheses. 678 Dermatophyte Screen . . . . . . . . . . . . . . . . . . . . .$189 Appropriate for determining the presence or absence of dermatophytes. Two challenges. 538 KOH Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$153 Two fixed glass slides for determining the presence or absence of fungal elements in skin scrapings. Two challenges. 680 Respiratory Antigen Detection—Waived . . . . . . .$186 690 Parasitology . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$276 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 . . . . . . . . . . . . . . . . . . . . . . . . .$267 Screening for the prescence or absence of methicillinresistant Staphylococcus aureus only. Five challenges. Immunology 750 Immunology Module . . . . . . . . . . . . . . . . . . . . . .$264 Five challenges each. Infectious Mononucleosis Rheumatoid Factor Anti-Streptolysin O (ASO) 751 Rheumatology Module . . . . . . . . . . . . . . . . . . . .$186 Includes 763 and 764. Two challenges each. Influenza A Influenza B For use with the Binax NOW Legionella Urinary Antigen Detection kits only. Influenza A/B Combo RSV Medical Laboratory Evaluation 2016 C-Reactive Protein (2) Rheumatoid Factor (5) Not for high-sensitivity methods CAP accepted analytes www.acponline.org/mle 9 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 755 Infectious Mononucleosis—Waived . . . . . . . . . . .$111 782 ANA Expanded . . . . . . . . . . . . . . . . . . . . . . . . . .$240 For waived Infectious Mononucleosis kits only. For non-latex methods ONLY. Two challenges. Five challenges each. 762 Infectious Mononucleosis . . . . . . . . . . . . . . . . . .$183 Five challenges. 761 Infectious Mononucleosis/Rheumatoid Factor . . .$246 Includes 762 and 763. ANA Anti-dsDNA Anti-RNP Anti-RNP/Sm Anti-SSA Anti-SSB Anti-SSA/SSB Anti-Sm 783 ANA Expanded (Add-On) . . . . . . . . . . . . . . . . . .$180 Same as 782. Only available with 750, 751. Five challenges each. For non-latex methods ONLY. 763 Rheumatoid Factor . . . . . . . . . . . . . . . . . . . . . . .$180 784 Complement/Immunoglobulins . . . . . . . . . . . . . .$213 Five challenges each. Five challenges. 764 C-Reactive Protein (CRP) . . . . . . . . . . . . . . . . . . .$108 Not for high-sensitivity methods. Two challenges. Complement C3 Complement C4 IgA, Total IgG, Total IgM, Total 771 Rubella . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$177 776 C-Reactive Protein (CRP)—Add-On . . . . . . . . . . . .$57 Not for high-sensitivity methods. Only available with 750. For lgG methods only. Five challenges. 772 Syphilis Serology . . . . . . . . . . . . . . . . . . . . . . . . .$198 Five challenges each. 765 High-Sensitivity C-Reactive Protein (HS-CRP) . . .$111 Two challenges. 777 High-Sensitivity C-Reactive Protein (HS-CRP)—Add-On . . . . . . . . . . . . . . . . . . . . . . . .$60 MHA-TP RPR TPA VDRL 789 diagnostics direct Syphilis Health Check . . . . . . .$210 Five challenges each. TPA - For the Syphilis Health Check ONLY. RPR - For use with any RPR methods. Only available with 750, 751. Two challenges. 766 Antinuclear Antibody (ANA) . . . . . . . . . . . . . . . .$171 770 Specific Allergen Testing . . . . . . . . . . . . . . . . . . .$336 For Latex methods ONLY. Number of challenges noted in parentheses. Five challenges. Includes 2 sets of samples for large volume requirements. Does not include Total IgE. 778 Antinuclear Antibody (ANA)—Add-On . . . . . . . .$108 Same as 766. For Latex methods ONLY. Only available with 751. 767 Antinuclear Antibody (ANA) . . . . . . . . . . . . . . . .$183 For non-latex methods ONLY. 779 Antinuclear Antibody (ANA)-Add-On . . . . . . . . .$120 For non-latex methods ONLY. Only available with 751. 740 Additional Specific Allergen Material . . . . . . . . . . $78 Includes 1 additional set of samples for large volume requirements. Only available with 773. Allergen Specific IgE (14) Five challenges. Same as 767. Allergen Specific IgE (14) 773 Diagnostic Allergy . . . . . . . . . . . . . . . . . . . . . . . .$336 Number of challenges noted in parentheses. Allergen Specific IgE (14) Total IgE (5) 774 Lyme Disease Serology . . . . . . . . . . . . . . . . . . . .$216 Two challenges. Anti-Borrelia burgdorferi *Lyme Disease Serology is not required by CAP. 10 www.acponline.org/mle CAP accepted analytes Medical Laboratory Evaluation 2016 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 775 Viral Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . .$450 Five challenges each. Anti-HAV (IgM) Anti-HAV (Total/IgG) Anti-HBc (IgM) Anti-HBc (Total/IgG) Anti-HBs 812 Piccolo Waived Chemistry . . . . . . . . . . . . . . . . . .$210 For the Abaxis Piccolo Instrument (waived cartridges ONLY). Anti-HCV Anti-HIV HBeAg HBsAg Two challenges each. 780 H. pylori Antibody Detection . . . . . . . . . . . . . . .$153 Two challenges. 781 Mycoplasma . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$135 IgG only. Albumin Alkaline Phosphatase ALT (SGPT) Amylase AST (SGOT) Calcium Chloride Cholesterol CO2 Phosphorus Creatine Kinase Potassium (CK) Sodium Creatinine Total Bilirubin GGT Total Protein Glucose Triglyceride HDL Cholesterol Urea Nitrogen LDL Cholesterol Uric Acid - Calculated* *LDL Cholesterol - Calculated is not required by CAP. 817 i-STAT Chemistry 1 . . . . . . . . . . . . . . . . . . . . . . . .$336 Two challenges. Five challenges. 790 Anti-HIV—Waived . . . . . . . . . . . . . . . . . . . . . . . .$159 For i-STAT analyzer only. Includes 818 and 847. For waived HIV kits only. 818 i-STAT Chemistry 2 . . . . . . . . . . . . . . . . . . . . . . . .$237 Two challenges. For i-STAT analyzer only. 791 Anti-HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$312 Five challenges. Five challenges each. Chloride Ionized Calcium Creatinine Potassium Glucose Sodium Hematocrit tCO2 * Hemoglobin Urea Nitrogen *tCO2 is not required by CAP. Chemistry Chemistry Ordering Tips 832 i-STAT Chemistry—Waived . . . . . . . . . . . . . . . . . .$168 • If you perform chemistry panels designed to match CPT panels, see modules 813 through 816, which are configured to match CPT profiles. For i-STAT analyzer (Waived cartridges only). Two challenges each. • 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]. Chloride Ionized Calcium Creatinine Potassium Glucose Sodium tCO2 * Hematocrit Hemoglobin Urea Nitrogen *tCO2 is not required by CAP. 810 Chemistry Module . . . . . . . . . . . . . . . . . . . . . . . .$342 811 Lipid Panel/Glucose - Waived . . . . . . . . . . . . . . .$168 Includes CMP, BMP, hepatic, thyroid and lipid profiles. For Waived testing ONLY. Includes 821, 822, 823, 825, 827, 842. Two challenges each. Five challenges. Cholesterol, Total LDL Cholesterol - Calculated* Glucose Triglyceride HDL Cholesterol *LDL Cholesterol - Calculated is not required by CAP. 833 Piccolo Waived Chemistry (Add-On) . . . . . . . . . . .$75 Same as 812. Only available with 824. NEW! 813 Comprehensive Metabolic Panel . . . . . . . . . . . . .$276 Includes 814, 816, 822. Five challenges. 814 Basic Metabolic Panel . . . . . . . . . . . . . . . . . . . . .$216 Five challenges each. Calcium Chloride CO2 Creatinine Medical Laboratory Evaluation 2016 CAP accepted analytes Glucose Potassium Sodium Urea Nitrogen www.acponline.org/mle 11 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 815 Hepatic Profile . . . . . . . . . . . . . . . . . . . . . . . . . . .$210 Five challenges each. Albumin Alkaline Phosphatase ALT (SGPT) AST (SGOT) Five challenges each. Direct Bilirubin Total Bilirubin Total Protein 816 Hepatic Profile (Add-On) . . . . . . . . . . . . . . . . . . . .$45 Same as 815. Only available with 814, 819-821, 824, 826, 828, 830, 834. 819 Chemistry 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$192 Five challenges each. Cholesterol, Total Glucose 828 Enzyme Chemistry - Ship Alone . . . . . . . . . . . . .$216 ALT (SGPT) Alkaline Phosphatase Amylase AST (SGOT) NEW! Creatine Kinase (CK) GGT LDH Lipase 823 Enzyme Chemistry (Add-On) . . . . . . . . . . . . . . . . .$45 Same as 828. Only available with 813-815, 819–821, 824, 826, 830, 834. 824 Thyroid Profile . . . . . . . . . . . . . . . . . . . . . . . . . . .$237 Five challenges each. Urea Nitrogen Potassium 820 Chemistry 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$228 Alpha-fetoprotein (AFP) Cortisol Free T3 Free Thyroxine (T4) T3 Uptake Thyroxine (T4) Triiodothyronine (T3) TSH Five challenges each. Total Bilirubin Chloride Cholesterol, Total CO2 Creatinine Glucose Potassium Sodium Urea Nitrogen Uric Acid 821 Chemistry 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$258 Five challenges each. Total Bilirubin LDL Cholesterol Chloride Direct Cholesterol, Total Potassium CO2 Sodium Creatinine Triglyceride Glucose Urea Nitrogen HDL Cholesterol Uric Acid LDL Cholesterol Calculated* *LDL Cholesterol - Calculated is not required by CAP. 834 Additional Chemistries . . . . . . . . . . . . . . . . . . . .$216 825 Thyroid Profile (Add-On) . . . . . . . . . . . . . . . . . . . .$54 Same as 824. Only available with 813–815, 819–821, 826, 828, 830, 834. 826 Lipid Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$228 Five challenges each. Cholesterol, Total LDL Cholesterol HDL Cholesterol Direct LDL Cholesterol Triglyceride Calculated* *LDL Cholesterol - Calculated is not required by CAP. 827 Lipid Profile (Add-On) . . . . . . . . . . . . . . . . . . . . . .$45 Same as 826. Only available with 813-815, 819, 824, 828, 830, 834. 829 Apolipoproteins . . . . . . . . . . . . . . . . . . . . . . . . . .$129 Two challenges each. Apolipoprotein A1 Stand alone module. Five challenges each. Albumin Total Protein Calcium TIBC - Calculated* Iron TIBC - Direct Lactic Acid UIBC - Direct Magnesium Uric Acid Phosphorus *TIBC - Calculated is not required by CAP. Apolipoprotein B 830 Therapeutic Drug Monitoring . . . . . . . . . . . . . . .$225 Five challenges each. Acetaminophen Carbamazepine Digoxin Gentamicin Lithium Phenobarbital Phenytoin Salicylate Theophylline Valproic Acid Vancomycin 831 Therapeutic Drug Monitoring (Add-On) . . . . . . . .$60 822 Additional Chemistries (Add-On) . . . . . . . . . . . . . .$45 Same as 834. Only available with 814, 815, 819-821, 824, 826, 828, 830. Same as 830. Only available with 810, 813–815, 819–821, 824, 826, 828, 834. 835 Serum Alcohol/Acetone . . . . . . . . . . . . . . . . . . . .$225 Five challenges. 12 www.acponline.org/mle CAP accepted analytes Medical Laboratory Evaluation 2016 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 836 Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$159 Two challenges. 855 Fructosamine . . . . . . . . . . . . . . . . . . . . . . . . . . . .$153 NOT compatible with the LXN Test System. Two challenges. 837 Blood Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$336 854 SHBG/Testosterone Five challenges. . . . . . . . . . . . . . . . . . . . . . .$318 Lyophilized samples. 838 Blood Lead—Waived . . . . . . . . . . . . . . . . . . . . . .$201 Two challenges. 841 Neonatal Bilirubin . . . . . . . . . . . . . . . . . . . . . . . .$219 Five challenges each. Direct Bilirubin NEW! Two challenges each. Sex Hormone Binding Globulin Testosterone, Bioavailable Testosterone, Free Testosterone 859 PSA (Add-On) . . . . . . . . . . . . . . . . . . . . . . . . . . . .$57 Total Bilirubin Same as 861. Only available with 860. 842 Direct Bilirubin (Add-On) . . . . . . . . . . . . . . . . . . . .$39 Same as 843. Only available with 814, 819–821, 824, 826, 828. 843 Direct Bilirubin . . . . . . . . . . . . . . . . . . . . . . . . . .$141 Five challenges. 845 Cardiac Markers . . . . . . . . . . . . . . . . . . . . . . . . .$297 Five challenges each. Quantitative only. BNP CK-MB D-Dimer Myoglobin NT-proBNP Troponin I Troponin T 860 Endocrinology/Hematology/Oncology . . . . . . . .$216 Two challenges each. CEA DHEA-S Estradiol Ferritin Folate FSH Homocysteine LH Progesterone Prolactin Testosterone Transferrin Vitamin B12 861 PSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$129 Two challenges. 846 BNP/D-Dimer . . . . . . . . . . . . . . . . . . . . . . . . . . . .$213 B-type Natriuretic Peptide 862 Tumor Markers . . . . . . . . . . . . . . . . . . . . . . . . . .$381 Two challenges each. Two challenges. Beta (b)-2 Microglobulin CA 125 CA 15-3 CA 19-9 BNP* NT-proBNP D-Dimer *CAP accepted for waived methods only. CA 27/29 CEA Free PSA PSA Thyroglobulin 847 Blood Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . .$288 Compatible with the i-STAT analyzer as well as other blood gas instruments. Five challenges each. Chloride Ionized Calcium Lactic Acid pCO2 863 Endocrinology 2 . . . . . . . . . . . . . . . . . . . . . . . . .$186 Lyophilized samples. Two challenges each. pH pO2 Potassium Sodium C-Peptide Insulin 864 Thyroid Antibodies . . . . . . . . . . . . . . . . . . . . . . .$228 850 Glycohemoglobin . . . . . . . . . . . . . . . . . . . . . . . .$180 Two challenges each. Thyroglobulin Antibody NOT compatible with Afinion analyzer. CAP accepted for waived methods only. Two challenges. Thyroid Microsomal Antibody (Anti-TPO) 865 Serum hCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$171 851 Afinion Glycohemoglobin . . . . . . . . . . . . . . . . . .$192 Two challenges. Parathyroid hormone (PTH) Vitamin D, 25-Hydroxy Five challenges. 866 Serum hCG (Add-On) . . . . . . . . . . . . . . . . . . . . . . .$87 Same as 865. Only available with 810, 813, 814, 815, 819, 820, 821, 824, 826, 828, 834. Medical Laboratory Evaluation 2016 CAP accepted analytes www.acponline.org/mle 13 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 872 Urine Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . .$219 Two challenges each. Amylase Calcium Chloride Creatinine Glucose Magnesium Osmolality Phosphorus Potassium Sodium Total Protein Urea Nitrogen Uric Acid 868 Urine Drug Screen . . . . . . . . . . . . . . . . . . . . . . . .$198 Two challenges each. For the qualitative detection of drugs in urine. 10ml each. Each challenge will include one or more of the following: Acetaminophen Amphetamines Amphetamines/ Methamphetamines Barbiturates Benzodiazepines Buprenorphine Cannabinoids (THC) Cocaine Metabolites Cotinine EDDP Ethanol (Alcohol) Fentanyl LSD MDMA Methadone Methamphetamines Methanol Methaqualone 6-Monoacetylmorphine Opiates (Morphine Trihydrate) Oxycodone Phencyclidine Propoxyphene Tramadol Tricyclic Antidepressants 870 Whole Blood Glucose . . . . . . . . . . . . . . . . . . . . .$255 Five challenges. 871 Whole Blood Glucose—Waived . . . . . . . . . . . . . .$153 Two challenges. 880 Additional Chemistry Testing Material . . . . . . . .$108 Includes all analytes in Chemistry Module 810 and Therapeutic 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: Waived Testing Waived Testing—The Importance of Performing Proficiency Testing Certificate of Waiver (CW) laboratories must only perform waived laboratory tests. When the Centers for Medicare & Medicaid Services (CMS) began random inspections of some CW laboratories in 2002, many laboratories chose to participate in proficiency testing as a quality assurance check. MLE responded by preparing special two-sample proficiency modules, designed for the needs of the waived testing laboratory. Our custom selection of waived modules appears 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 list of 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 involving Microbiology tests, to ensure regulatory compliance for any remaining non-waived analytes. To receive “E-Notify on Waived Tests” and the “Recalls and Field Corrections: Devices—Class I and Class II” report, send an e-mail to [email protected] and request to be added to the recipient list. In the e-mail request, be sure to include your MLE ID number. • 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. 14 www.acponline.org/mle CAP accepted analytes Medical Laboratory Evaluation 2016 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 Cost Effective Package for Waived Testing 901 Waived and PPM Package . . . . . . . . . . . . .$249 Number of challenges noted in parentheses. Fecal Occult Blood* (2) Urine hCG (1) Hemoglobin (2) Urine Sediment (2) Hematocrit (2) Strep A Antigen PPM (6)** Detection (2) Urinalysis (1) Whole Blood Glucose (2) *Fecal occult blood testing is not required by CAP. **Scabies examination is not required by CAP. 902 Basic Waived and PPM Package . . . . . . . . . . . . .$210 Number of challenges noted in parentheses. Fecal Occult Blood* (2) Urinalysis (1) PPM (6)** Urine hCG (1) Strep A Antigen Urine Sediment (2) Detection (2) Whole Blood Glucose (2) *Fecal occult blood testing is not required by CAP. **Scabies examination is not required by CAP. “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]. Continuing Education MLE CEexpress . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FREE MLE offers continuing education through COLA’s LabUniversity®. MLE CEexpress courses are provided free of charge to MLE participants. Discounts available on COLA courses. Call MLE at 1-800-338-2746, option 5 or e-mail us at [email protected] to learn more. Discounted Price Publication 142 G2’s National Intelligence Report Subscription $176 Bi-weekly newsletter covering government policy for diagnostic testing and related medical services. Supplies & Services Supplies Off-Schedule Proficiency Testing 121 Pipette—1mL . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$25 For use with 320 and 321. Reusable Class A volumetric pipette required for reconstitution of lyophilized proficiency testing specimens. 126 Pipette Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .$45 For use with product 121 above. Starts at . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$200 Off-schedule proficiency testing (PT) provides laboratories with immediate, on-demand, customized proficiency testing for reinstatement or remedial purposes; a complement to the regularly scheduled PT program. Who Needs Off-Schedule Testing? 107 Hard Copy of Participant Summary for the Year . .$75 108 Additional Program Binder . . . . . . . . . . . . . . . . . .$15 Services Automatic Program Renewal • 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. 116 Automatic Program Renewal . . . . . . . . . . . . . . . .FREE Free yourself from re-enrollment/re-ordering hassles. We’ll do it for you! To enroll, add module 116 to your order. 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]. Online Result Reporting . . . . . . . . . . . . . . . . . . . . . . .FREE To register or receive more information, send an email to [email protected]. Medical Laboratory Evaluation 2016 CAP accepted analytes www.acponline.org/mle 15 College of American Pathologists (CAP) Accepted Analytes for the MLE PT Program—As of JANUARY 1, 2016. To download, visit: www.acponline.org/running_practice/mle/cap_accepted_analytes.pdf HEMATOLOGY Module 210 – Hematology Module Module 211 – Basic Hematology Module 212 – Hemoglobin/Hematocrit Module 213 – Hemoglobin/Hematocrit (waived) Module 215 – Hemoglobin/Glucose (waived Hemocue only) Module 223 – Hematology with 5-part Differential (CL samples) Module 224 – Sysmex with 3-part Differential Module 225 – Hematology with 3-part Differential Module 226 – Hematology with 5-part Differential (DIF samples) Module 228 – Hematology with 5-part Differential (BCX samples) Module 229 – Hematology with 5-part Differential (MX samples) Module 230 – Blood Cell Identification (Add-On) Module 231 – Blood Cell Identification Module 240 – Reticulocyte Count Note: Sedimentation rate is not required by CAP COAGULATION Module 324 – Roche CoaguChek XS INR Module 328 – I-STAT Prothrombin Time – PT/INR Module 330 – CoaguCheck XS Plus – PT/INR Module 331 – CoaguCheck XS Plus-Waived – PT/INR BLOOD BANK (IMMUNOHEMATOLOGY) Module 451 – ABO & Rh Factor (D Type) Module 452 – Blood Bank 1 Module 453 – Blood Bank 2 – EXCEPT Antibody Identification URINALYSIS Module 530 – Urinalysis Module Module 531 – Urinalysis Dipstick Module 532 – Urine Sediment Identification Module 533 – Urine Sediment Identification (Add-On) Module 536 – Urine Microalbumin/Creatinine (Add-On) Module 538 – KOH slides (fungal elements) Module 539 – Urine Microalbumin/Creatinine Module 540 – Urine hCG (Add-On) Module 541 – Urine hCG Module 901 – Waived and PPM Package * Module 902 – Basic Waived and PPM Package * * Note: Fecal Occult Blood & Scabies Identification are not required by CAP PROVIDER-PERFORMED MICROSCOPY (PPM) Module 534 – Provider-Performed Microscopy (PPM) - Except Scabies Identification Module 535 – Provider-Performed Microscopy (PPM) (Add-On) - Except Scabies Identification Note: Scabies Identification is not required by CAP MICROBIOLOGY Module 630 – Bacteriology 1 Module 640 – Bacteriology 2 Module 643 – Urine Culture Module 644 – Urine Culture/Strep A Antigen Detection Module 645 – Urine/Throat Culture Module 647 – Urine Presumptive ID/Colony count Module 648 – Colony Count Module 649 – Urine Presumptive ID/Strep A Antigen Detection Module 650 – Gram Stain Module 652 – Urine Presumptive ID/Throat Culture Module 641 – Throat Culture Module 642 – Throat Culture/ Strep A Antigen Detection Module 660 – Strep A Antigen Detection Module 662 – Strep A Antigen Detection (waived) Module 646 – Genital Culture Module 654 – Genital Culture (Add On) Module 668 – Affirm VP III (DNA) Module 670 – Chlamydia (EIA, DNA) Module 673 – Chlamydia (EIA, DNA) (Add On) Module 675 – Chlamydia/GC (EIA, DNA) Module 678 – Dermatophyte Screen Module 680 – Rapid Antigen Detection 1 (Waived) Module 681 – Rapid Antigen Detection 1 Module 682 – Rapid Antigen Detection 2 Module 686 – Legionella antigen Detection Module 687 – Streptococcus pneumonia Antigen detection Module 695 – MRSA Screening IMMUNOLOGY Module 750 – Immunology Module - EXCEPT ASO Module 751 – Rheumatology Module Module 755 – Infectious Mononucleosis (waived) Module 761 – Infectious Mononucleosis/Rheumatoid Factor Module 762 – Infectious Mononucleosis Module 763 – Rheumatoid Factor Module 764 – C-Reactive Protein (CRP) Module 779 – Antinuclear Antibody (ANA) (Add On) (ELISA) Module 771 – Rubella Module 772 – Syphilis Serology – RPR ONLY Module 780 – H. pylori Antibody Detection Module 776 – C-Reactive Protein (CRP) (Add On) Module 765 – High-Sensitivity C-Reactive Protein (HS-CRP) Module 766 – Antinuclear Antibody (ANA) (Latex method) Module 767 – Antinuclear Antibody (ANA) (ELISA) Module 777 – High-Sensitivity C-Reactive Protein (HS-CRP) (Add On) Module 778 – Antinuclear Antibody (ANA) (Add On) (Latex method) Module 782 – ANA Expanded - ANA ONLY Module 783 – ANA Expanded (Add On) - ANA ONLY Module 775 – Viral Markers: Anti-HBs, Anti-HCV, Anti-HIV & HbsAg ONLY Module 790 – Anti-HIV-Waived Module 791 – Anti-HIV Note: Lyme Disease Serology is not required by CAP 16 www.acponline.org/mle Medical Laboratory Evaluation 2016 College of American Pathologists (CAP) Accepted Analytes for the MLE PT Program—As of JANUARY 1, 2016. To download, visit: www.acponline.org/running_practice/mle/cap_accepted_analytes.pdf CHEMISTRY Module 810 – Chemistry Module – All analytes EXCEPT AFP & T Uptake * Module 811 – Lipid Panel/Glucose - Waived * Module 812 – Piccolo Waived Chemistry * Module 833 – Piccolo Waived Chemistry (Add-On) * Module 819 – Chemistry 1 Module 820 – Chemistry 2 Module 821 – Chemistry 3 * Module 822 – Chemistry (Add On) * Module 834 – Additional Chemistries * Module 813 – Comprehensive Metabolic Panel * Module 814 – Basic Metabolic Panel Module 815 – Hepatic Profile Module 816 – Hepatic Profile (Add On) Module 823 – Enzyme Chemistry (Add On) Module 828 – Enzyme Chemistry - Ship Alone Module 824 – Thyroid Profile Module 826 – Lipid Profile * Module 825 – Thyroid Profile (Add on) Module 827 – Lipid Profile (Add on) * * Note: For TIBC & LDL: CAP does not monitor calculated values; only direct measurement is accepted. Module 817 – i-STAT Chemistry 1 ** Chloride Creatinine Glucose Hematocrit Hemoglobin Ionized Calcium Potassium Sodium Urea Nitrogen From blood gas sample: pH pO2 pCO2 Module 818 – i-STAT Chemistry 2 ** Module 832 – i-STAT Chemistry-Waived ** ** Note: For tCO2: CAP does not monitor calculated values; this analyte is not required. Module 830 – Therapeutic Drug Monitoring - Digoxin & Phenytoin ONLY Module 831 – Therapeutic Drug Monitoring (Add-On) - Digoxin & Phenytoin ONLY Module 841 – Neonatal Bilirubin Module 842 – Direct Bilirubin (Add On) Module 843 – Direct Bilirubin Module 845 – Cardiac Markers - EXCEPT NT-proBNP & Troponin T Module 846 – BNP/D-Dimer - EXCEPT NT-proBNP. BNP accepted for waived methods only Module 847 – Blood Gases - pH, pO2, pCO2 Module 862 – Tumor Markers CA 125 CA 15-3 Module 850 – Glycohemoglobin for waived methods only Module 851 – Afinion Glycohemoglobin Module 860 – Endocrinology/Hematology/Oncology - EXCEPT Transferrin Module 861 – PSA Module 859 – PSA (Add On) CA 27/29 CEA Free PSA PSA Cocaine Metabolites Ethanol MDMA Methadone Methamphetamines Oxycodone Opiates (Morphine Trihydrate) Phencyclidine Propoxyphene Tricyclic Antidepressants Module 863 – Endocrinology 2 – Parathyroid hormone (PTH) ONLY Module 865 – Serum hCG Module 866 – Serum hCG (Add On) Module 868 – Urine Drug Screen Acetaminophen Amphetamines Barbiturates Benzodiazepines Buprenorphine Cannabinoids Module 870 – Whole Blood Glucose Module 871 – Whole Blood Glucose (waived) Medical Laboratory Evaluation 2016 www.acponline.org/mle 17 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 Frequently Asked Questions 1. Automatic Renewal Option: I do not want to worry about whether we are enrolled from year to year. Do you have an automatic renewal option? We sure do! By checking the Automatic Renewal box on the PT order form or your renewal form, you will never again have to worry about proficiency testing enrollment or placing your order for a new program year. We will automatically re-order the modules in which you participated the previous year, generate an order verification for your review, and send an order change form should you wish to add or delete modules from your renewed order. Simple. Easy. And best of all, one important management detail that you never have to worry about again! See the “Cancelling an Automatic Renewal Order” section for more information. 2. When to Order: When does my order have to be submitted to ensure availability of the modules I ordered? We encourage you to enroll in MLE as soon as you can to guarantee product availability. Enrolling by December 11, 2015, will ensure that you receive shipments for the entire year. Remember, payment is not due until 30 days AFTER enrollment. You may enroll any time during the year at a prorated cost depending on the availability of specimens. For every missed event that you are not enrolled, 1/3 of the module price is deducted. The annual administration fee remains. Note: The online ordering form automatically displays prorated prices. 3. 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” for more information. 4. Irregular Order Frequency: Can I order modules outside my regular order? If so, do I have to be an MLE participant to order modules from you? Proficiency Testing is available upon request at any time during the program year (subject to product availability). Those enrolled with other PT providers are welcome to call upon MLE for help with reinstatement and compliance emergencies. See page 15 for details on off-schedule testing. 5. Individual International Orders: I live outside the United States and Canada and I am not with a distributor of MLE in 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. Some destinations may be subject to additional S/H. Contact MLE Customer Service for specific shipping pricing information. Additionally, MLE cannot replace kits that are delayed or refused entry into your country. We will not issue credit or refunds on such shipments. When enrolling in any of the MLE modules that involve hazardous material, laboratories outside the U.S., including Canadian laboratories, must send to MLE any copies of the necessary valid permits for attachment to each shipment. The shipments will not be sent without required documentation. Freight charges are not included in the commercial pricing. You will be invoiced for freight charges AFTER each shipment. These charges are due BEFORE your evaluation is mailed. 6. Individual Non-Continental U.S. Orders: Individual Non-Continental U.S. laboratories are subject to a minimum $15 fee per shipment to cover additional shipping costs (Alaska and Hawaii excluded). 7. Needing Assistance: What if I need help with my order, testing, or regulations? Who can I turn to for immediate service? 18 www.acponline.org/mle Our friendly and knowledgeable MLE Customer Service Representatives are available to assist with order selection, billing, address/name changes, order changes, and regulatory information. Additionally, experienced laboratory professionals will guide you through technical issues, interpretation of your results, and steps necessary for corrective action. Changes/Cancellations New Orders or Additions All new orders must be submitted in writing to MLE. All changes to an existing order must be submitted in writing to MLE before they can be entered into the order processing system. You must send your order changes in writing at least four weeks prior to the next shipping date to avoid additional shipping fees. MLE ships three times per year. You may enroll throughout the year. Note: The MLE catalog lists prices for the full year. After the first event, module pricing is prorated. If you add a module less than four weeks prior to the next shipping date, you MAY be subject to a “rush order” fee. Call MLE Customer Service at 1-800-338-2746, option 5, for more information. Cancelling a Module If we receive your written request for cancellation of a module(s) at least four weeks prior to the next shipping date, you will not be held accountable for payment of the module for the remaining shipments. Unless otherwise requested, we will credit your account for that amount and the credit will be applied to additions to your order or toward enrollment for the next year. If you cancel a module less than four weeks prior to the next shipping date, you are financially responsible for the cost of the module for the next shipment. You will NOT be financially responsible for subsequent shipments. For example, you cancel (in writing) a module on January 2, 2016. The first shipment (M1) is scheduled to be shipped on February 1, 2016. You are responsible for the cost of the module for M1 but not for M2 or M3. Cancelling an Analyte Please submit a “Test Menu Deletion” form if your laboratory reported tests during the previous event that have since been discontinued, but you are not cancelling the module. Download the form at www.acponline.org/mle/enroll_us.htm, scroll to “Forms for Current Enrollees,” or copy the form in your MLE Program Guide, p. 34. Cancelling the Entire Order ALL Cancellations must be requested in writing. Failure to return the Order Verfication Form and/or not paying your invoice are not indications of cancellation. We will refund any charges for unshipped specimens if we receive notification in writing four weeks prior to the next shipping date. The annual administration fee is non-refundable. Once shipped, orders for pipettes/pumps are non-refundable and non-returnable. Cancelling an Automatic Renewal Order If you are enrolled in Module 116 (automatic renewal) and wish to cancel your entire order, you are required to contact MLE in writing NO LATER THAN December 11, 2015, to avoid any charges for the upcoming year. Failure to return the Order Verfication Form and/or not paying your invoice are not indications of cancellation. Medical Laboratory Evaluation 2016 Price Matching for Unmatched Service! Found a better price? We’ll match it! MLE protects your need for budgetary constraint while providing the best possible PT service in the industry. Complete the “MLE Price Match Request Form” (pages 20-21), listing only the tests you actually perform. This form enables MLE to match your actual needs to our most economic offerings and save you the most money. If our prices aren’t the best, we will match our competitor’s pricing for the same test menu coverage. We strive to give you more of what you need without the excess! Medical Laboratory Evaluation 2016 www.acponline.org/mle 19 2016 Price Match Request Form: Fax this form AND your current PT provider’s quote/order to: 202-835-0440 Medical Laboratory Evaluation Questions? Contact MLE 800-338-2746, #5 or [email protected] Contact:__________________________________ Facility:_________________________________________________ Phone:__________________________ Fax:____________________________ Email: ____________________________ Accreditation Service: CAP_________ COLA_________ CMS_________ TJC (JCAHO)________ OTHER:__________ Primary PT Service: AAB_________ AAFP_________ AccuTest_________ CAP Surveys_________CAPExcel_______ API_________ WSLH_________ OTHER:______________________________ Secondary PT Service:_______________________ For which tests?___________________________________________ ABBREVIATION CODE: W = Waived HEMATOLOGY __Blood Cell Identification (manual differential) __CBC Primary Instrument: _______________________ __CBC Secondary Instrument: ______________________ __Crystal Screening __Fluid Cell Count __Hematocrit __W __NW __Hemoglobin__W __NW __Reticulocyte Count __Sedimentation Rate Method: ___________________ COAGULATION __Fibrinogen __Partial Thromboplastin Time (APTT) or (PTT) __Prothrombin Time (PT) I:________ __PT/INR whole blood methods: __W__NW I:_________________ URINALYSIS __Creatinine, Urine __Fecal Occult Blood __hCG, urine __Microalbumin, dipstick __Microalbumin, quantitative __Urine Chemistry (See next page) __Urine Dipstick __Urine Drug Screen __Urine Sediment Identification 20 NW = Non-Waived BLOOD BANK __ABO Group __Antibody Identification __Compatibility Testing __Rh Factor (D Type) __Unexpected Antibody Detection PPM __Fecal Leukocytes __Fern Testing __KOH Vaginal Prep __KOH Skin Prep __Nasal Eosinophils __Pinworms __Scabies __Sperm __Wet Mount (Vaginal) MICROBIOLOGY __Affirm VPIII (DNA) __Antimicrobial Susceptibility Testing __Chlamydia (EIA/DNA) __Dermatophyte Screen __Genital Culture __GC (EIA/DNA) __Gram stain __MRSA Screening __Stool, Parasitology __Throat Culture __Urine Colony Count __Urine Culture Method:_____________________ __Culture from other sources: _______________________________ _______________________________ I = Instrument ANTIGEN DETECTION __C difficile __Cryptosporidium __Giardia lamblia __Influenza A/B __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 __Mycoplasma (IgG) __Rheumatoid Factor (RA) __Rubella __Syphilis Serology (RPR) VIRAL MARKERS __Anti-HAV __Anti-HBc __Anti-HBs __Anti-HCV __Anti-HIV __W __NW __HBeAg __HBsAg CHEMISTRY Primary Instrument: _____________________ Secondary Instrument: _____________________ LIVER TESTS __Bilirubin, Total __Bilirubin, Direct __Bilirubin, Neonatal __ALT (SGPT) __AST (SGOT) __Alkaline Phosphatase __Albumin __GGT LIPID TESTS __Cholesterol, Total __Triglyceride __HDL Cholesterol __LDL Cholesterol THYROID TESTS __Anti-Thyroglobulin __Anti-Microsomal (TPO) __T3, Free __T3, Total __T3, Uptake __T4, Free __T4, Total __TSH ELECTROLYTES __Sodium __Potassium __Chloride __CO2 OTHER CHEMISTRY TESTS __Alcohol, Serum __Acetone __AFP __Ammonia __Amylase __Apolipoprotein A1/B __Calcium __Cortisol __Creatine Kinase (CK) __Creatinine, Serum __Fructosamine __Glucose, whole blood __W__ NW I:_____________________ __Glucose, serum __hCG, serum __Ionized Calcium __Iron __Lactic Acid __Lead __W __NW __LDH __Lipase __Magnesium __Phosphorus __Protein, Total __TIBC/UIBC __Urea Nitrogen (BUN) __Uric Acid URINE CHEMISTRY __Amylase __Calcium __Chloride __Creatinine __Glucose __Magnesium __Osmolality __Phosphorus __Potassium __Sodium __Specific Gravity __Total Protein __Urea Nitrogen __Uric Acid ENDOCRINOLOGY __C-Peptide __CEA __DHEA-S __Estradiol __Ferritin __Folate __FSH __Glycohemoglobin I: __________________ __Homocysteine __Insulin __LH __Parathyroid Hormone (PTH) __Progesterone __Prolactin __PSA, Total __PSA, Free __SHBG __Testosterone, Bioavailable __Testosterone, Free __Testosterone __Transferrin __Vitamin B12 __Vitamin D, 25-Hydroxy THERAPEUTIC DRUGS: __Acetaminophen __Carbamazepine __Digoxin __Gentamicin __Lithium __Phenobarbitol __Phenytoin __Salicylate __Theophylline __Valproic Acid __Vancomycin BLOOD GASES Primary Instrument: _____________________ Secondary Instrument: _____________________ __Ionized Calcium __pCO2 __pH __pO2 CARDIAC MARKERS Instrument: _____________________ __BNP __CK-MB __D-Dimer __Myoglobin __NT-pro BNP __Troponin I __Troponin T TUMOR MARKERS __Beta-2 Microglobulin __CA 125 __CA 15-3 __CA 19-9 __CA 27/29 __Thyroglobulin OTHER TESTS NOT LISTED _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ _________________________ 21 2016 SHIP DATES M1: Feb. 1 • M2: May 16 • M3: Sept. 12 How To Order If you would like assistance with designing the most economical order or have questions about our service or your order, contact MLE for assistance at 1-800-338-2746, option 5, or send us an e-mail at [email protected]. Order Online with Ease! www.acponline.org/mle • Click on the “Enrollment Information” link. • Click on the “2016 MLE PT Online Order Form” link. • Complete the electronic form. It will calculate pricing for you. Once you submit the form, it will provide you with a summary of your order to print for your records. That’s it! CMS Regional Office. 5. Print the address of the location where the proficiency testing specimens and program paperwork should be shipped (if different from the “BILL TO” address). We will send the PT specimens via one-day express delivery to the “SHIP TO” address. For this reason, we cannot deliver specimens to a PO Box, so please provide a complete street address. 6. Designate the regulatory agency(ies) or lab consultant(s) to receive a copy of your PT results by checking the appropriate box. Don’t forget to include the COLA or state agency number assigned to you, if applicable, and the name, address, and phone number of any other persons who should receive a copy of your results. Indicate “Auto Renewal” 7. Indicate a module number, description and price. Method of Payment 8. Specify the method of payment by checking the corresponding box. Order by Fax Complete the MLE PT order form on page 24. Fax your completed order form to MLE: 202-835-0440. If using a PO, please fax a copy of it with the order form. Order by Mail Complete the MLE PT order form according to these instructions and mail it to the address printed on the form. Note: Purchase Orders (PO) must be accompanied by a renewal form or order form. POs by themselves will not be accepted. PT Order Form Instructions Enroll in MLE by December 11, 2015, to ensure you receive shipments for the entire year. You may enroll any time after the first event at a prorated cost depending on the availability of specimens. Using the PT Order Form Formulate Your Order Review the catalog to determine the products which best meet your proficiency testing (PT) needs. Note any instructions that refer to specific regulatory requirements or instrument/method compatibility. Choose the product most appropriate for your testing needs. Please pay close attention to instrument compatibility notes when selecting modules. Top Section Complete the PT order form (last page of catalog). 1. Indicate whether you are new to the MLE program or renewing your enrollment. 2. Print the address of the location where the invoice statement should be mailed (“BILL TO”). Enroll now to ensure the availability of specimens for the 2016 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. Invoice Option: FAX (202-835-0440) the order form or MAIL it to the Washington, DC, address listed on the form. Billing terms are normally net 30 days from the date of invoice. Credit Card Option: FAX (202-835-0440) the order form or MAIL it to the Washington, DC, address listed on the form. Check VISA or MasterCard, indicate the card bearer’s name, card number, CVV2#, and signature and the expiration date. Check Option: MAIL the order form and check to the Philadelphia address listed on the form. Purchase Order (PO) Option: FAX (202-835-0440) the order form or MAIL the order form and a copy of the PO to the Washington, DC, address listed on the form. Billing terms are net 30 days from the date of invoice. Tax ID: 23-1520302 DUNS NO: 071625974 Amount Due/Discounts 9. Add the cost of all the items you checked to the annual administration fee of $85. Enter the total amount in the box. If you qualify for a discount, please check the appropriate box and provide the appropriate information. Next Step • Photocopy the order form for your records. • Within two weeks, you should receive an “Order Verification” confirming receipt of this order. If you do not receive the order verification within two weeks, please contact us immediately. The MLE products you order may contain pathogenic material. By returning the order form, you assume all risk and responsibility in connection with the receipt, handling, storage, use, and disposal of the products. 3. Print the name of the laboratory director. 4. Enter the laboratory’s CLIA identification number. If you do not know your CLIA identification number, contact your 22 www.acponline.org/mle Medical Laboratory Evaluation 2016 MLE Proficiency Testing Price List Code/Description *Full Year HEMATOLOGY 210/Hematology . . . . . . . . . . . . . . . . . . . . . . . . .$240 211/Basic Hematology . . . . . . . . . . . . . . . . . . . .$228 212/Hemoglobin/Hematocrit . . . . . . . . . . . . . . .$204 213/Hemoglobin/Hematocrit . . . . . . . . . . . . .$147 215/Hemoglobin/Glucose—HemoCue . . . . . . . .$156 223/Abbott 5-Part Diff . . . . . . . . . . . . . . . . . . . .$330 224/Sysmex 3-Part Diff . . . . . . . . . . . . . . . . . . .$273 225/Hematology 3-Part Diff . . . . . . . . . . . . . . . .$282 226/Hematology 5-Part Diff . . . . . . . . . . . . . . . .$330 228/Hematology 5-Part diffACT 5 & Pentra 60C+ . . . . . . . . . . . . . . . . . . .$330 229/Hematology 5-Part diff-Sysmex XE/XT . . . . . . . . . . . . . . . . . . . . .$330 230/Blood Cell Id . . . . . . . . . . . . . . . . . . . . . . .$36 231/Blood Cell Id . . . . . . . . . . . . . . . . . . . . . . . .$108 240/Reticulocyte Count . . . . . . . . . . . . . . . . . . .$210 247/Sed Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . .$168 248/Sed Rate-Sedimat15 . . . . . . . . . . . . . . . . . .$168 250/Body Fluid/Cell Ct/Cryst . . . . . . . . . . . . . .$183 Code/Description *Full Year 648/Colony Count . . . . . . . . . . . . . . . . . . . . . . . .$207 649/Presump.ID/CC/Strep A Antigen . . . . . . . .$315 650/Gram Stain . . . . . . . . . . . . . . . . . . . . . . . . .$177 652/Throat Culture/Urine Presump ID . . . . . . . . . . . . . . . . . . . . . . . . . . .$333 654/Genital Culture . . . . . . . . . . . . . . . . . . . $123 660/Strep A Antigen Detection . . . . . . . . . . . . .$174 662/Strep A Antigen . . . . . . . . . . . . . . . . . . .$108 668/Affirm VP Antigen Testing . . . . . . . . . . . . .$399 320/Coagulation . . . . . . . . . . . . . . . . . . . . . . . . .$189 321/Prothrombin Time . . . . . . . . . . . . . . . . . . . .$180 324/Roche CoaguChek XS INR . . . . . . . . . .$174 328/i-STAT Pro Time . . . . . . . . . . . . . . . . . . . . .$333 330/CoaguChek XS PLUS Pro Time . . . . . . . . .$285 331/CoaguChek XS PLUS Pro Time . . . . . .$174 BLOOD BANK 450/Rh Factor (D Type) . . . . . . . . . . . . . . . . . . .$237 451/ABO & Rh Factor (D Type) . . . . . . . . . . . . .$276 452/Blood Bank I . . . . . . . . . . . . . . . . . . . . . . . .$378 453/Blood Bank II . . . . . . . . . . . . . . . . . . . . . . .$396 *Full Year CHEMISTRY 810/Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . .$342 811/Lipid Panel/Glucose . . . . . . . . . . . . . . .$168 812/Piccolo Waived Chemistry . . . . . . . . . . . . . .$210 813/Comp. Metabolic Panel . . . . . . . . . . . . . . . .$276 814/Basic Metabolic Panel . . . . . . . . . . . . . . . . .$216 815/Hepatic Profile . . . . . . . . . . . . . . . . . . . . . . .$210 816/Hepatic Profile . . . . . . . . . . . . . . . . . . . . .$45 817/i-STAT Chemistry 1 . . . . . . . . . . . . . . . . . .$336 670/Chlamydia (EIA, DNA) . . . . . . . . . . . . . . . .$327 818/i-STAT Chemistry 2 . . . . . . . . . . . . . . . . . .$237 819/Chemistry 1 . . . . . . . . . . . . . . . . . . . . . . . . .$192 673/Chlamydia . . . . . . . . . . . . . . . . . . . . . . . .$144 820/Chemistry 2 . . . . . . . . . . . . . . . . . . . . . . . . .$228 675/Chlamydia/GC (EIA, DNA ) . . . . . . . . . . . .$354 821/Chemistry 3 . . . . . . . . . . . . . . . . . . . . . . . . .$258 678/Dermatophyte Screen . . . . . . . . . . . . . . . . .$189 822/Add’l Chemistry . . . . . . . . . . . . . . . . . . . .$45 680/Resp. Antigen Det. . . . . . . . . . . . . . . . . .$186 823/Enzyme Chemistry . . . . . . . . . . . . . . . . . .$45 681/Resp. Antigen Detection . . . . . . . . . . . . . . .$285 682/C. diff/Rotavirus Ag Det. . . . . . . . . . . . . . . .$249 683/Giardia lamblia/ Cryptosporidium Ag Det . . . . . . . . . . . . . . . .$300 COAGULATION Code/Description 686/Legionella Antigen Detection . . . . . . . . . . .$225 687/Strep Pneumoniae Antigen Det. . . . . . . . . .$225 690/Parasitology . . . . . . . . . . . . . . . . . . . . . . . . .$276 695/MRSA Screen (5 challenges) . . . . . . . . . . . .$267 IMMUNOLOGY 740/Additional Specific Allergen Material . . . . .$78 750/Immunology Module . . . . . . . . . . . . . . . . .$264 751/Rheumatology Module . . . . . . . . . . . . . . . .$186 755/Infectious Mono . . . . . . . . . . . . . . . . . . .$111 824/Thyroid Profile . . . . . . . . . . . . . . . . . . . . . . .$237 825/Thyroid Profile . . . . . . . . . . . . . . . . . . . . .$54 826/Lipid Profile . . . . . . . . . . . . . . . . . . . . . . . . .$228 827/Lipid Profile . . . . . . . . . . . . . . . . . . . . . . .$45 828/Enzyme Chemistry . . . . . . . . . . . . . . . . . . .$216 829/Apolipoproteins . . . . . . . . . . . . . . . . . . . . . .$129 830/TDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$225 831/TDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$60 832/i-STAT Chemistry . . . . . . . . . . . . . . . . .$168 833/Piccolo Waived Chemistry . . . . . . . . .$75 834/Additional Chemistries . . . . . . . . . . . . . . .$216 835/Serum Alcohol/Acetone . . . . . . . . . . . . . . . .$225 836/Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . .$159 837/Blood Lead . . . . . . . . . . . . . . . . . . . . . . . . . .$336 838/Blood Lead . . . . . . . . . . . . . . . . . . . . . . .$201 763/Rheumatoid Factor . . . . . . . . . . . . . . . . . . .$180 URINALYSIS 841/Neonatal Bilirubin . . . . . . . . . . . . . . . . . . .$219 842/Direct Bilirubin . . . . . . . . . . . . . . . . . . . .$39 843/Direct Bilirubin . . . . . . . . . . . . . . . . . . . . . .$141 845/Cardiac Markers . . . . . . . . . . . . . . . . . . . . .$297 764/CRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$108 846/BNP/D-Dimer . . . . . . . . . . . . . . . . . . . . . . . $213 530/Urinalysis . . . . . . . . . . . . . . . . . . . . . . . . . .$105 531/Urinalysis Dipstick . . . . . . . . . . . . . . . . . . . .$84 532/Urine Sed Id . . . . . . . . . . . . . . . . . . . . . . . .$108 533/Urine Sed Id . . . . . . . . . . . . . . . . . . . . . . .$27 534/PPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$114 535/PPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$33 536/Microalbumin/Creatinine—Quant . . . . .$87 537/Fecal Occult Blood . . . . . . . . . . . . . . . . . .$81 538/KOH Slides . . . . . . . . . . . . . . . . . . . . . . . . .$153 539/Microalbumin/Creatinine—Quant . . . . . . .$108 540/Urine hCG . . . . . . . . . . . . . . . . . . . . . . . .$27 541/Urine hCG . . . . . . . . . . . . . . . . . . . . . . . . . . .$81 542/Fecal Occult Blood . . . . . . . . . . . . . . . . . . . .$105 765/HS-CRP . . . . . . . . . . . . . . . . . . . . . . . . . . . .$111 847/Blood Gases 766/ANA LATEX . . . . . . . . . . . . . . . . . . . . . . . .$171 850/Glycohemoglobin . . . . . . . . . . . . . . . . . . . . .$180 MICROBIOLOGY 630/Bacteriology 1 . . . . . . . . . . . . . . . . . . . . . . .$306 640/Bacteriology 2 . . . . . . . . . . . . . . . . . . . . . . .$294 641/Throat Culture . . . . . . . . . . . . . . . . . . . . . .$282 642/Throat Culture/Strep A Antigen . . . . . . . . .$273 643/Urine Culture . . . . . . . . . . . . . . . . . . . . . . .$282 644/Urine Culture/Strep Antigen . . . . . . . . . . .$273 645/Urine/Throat Culture . . . . . . . . . . . . . . . . .$288 646/Genital Culture . . . . . . . . . . . . . . . . . . . . . .$282 647/Urine Culture/Presump.ID/CC . . . . . . . . . .$333 761/Infect Mono/Rheumatoid Factor . . . . . . . . .$246 762/Infectious Mono . . . . . . . . . . . . . . . . . . . . . .$183 . . . . . . . . . . . . . . . . . . . . . . . .$288 767/ANA (ELISA/IMMUNO ONLY) . . . . . . . . .$183 851/Afinion Glycohemoglobin . . . . . . . . . . . . . .$192 770/Specific Allergen Testing . . . . . . . . . . . . . . .$336 854/SHBG/Testosterone . . . . . . . . . . . . . . . . . . .$318 771/Rubella . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$177 855/Fructosamine . . . . . . . . . . . . . . . . . . . . . . . .$153 772/Syphilis Serology . . . . . . . . . . . . . . . . . . . . .$198 773/Diagnostic Allergy . . . . . . . . . . . . . . . . . . . .$336 774/Lyme Disease Serology . . . . . . . . . . . . . . . $216 775/Viral Markers . . . . . . . . . . . . . . . . . . . . . . .$450 776/CRP NOT HIGH-SENSITIVITY . . . . . . . . . . . . . . .$57 777/HS-CRP . . . . . . . . . . . . . . . . . . . . . . . . . . .$60 778/ANA (LATEX ONLY) . . . . . . . . . . . . . . .$108 779/ANA (ELISA/IMMUNO ONLY) . . . . . .$120 780/H. pylori Antibody Det . . . . . . . . . . . . . . . .$153 781/Mycoplasma Antibody . . . . . . . . . . . . . . . . .$135 782/ANA Expanded . . . . . . . . . . . . . . . . . . . . . .$240 783/ANA Expanded . . . . . . . . . . . . . . . . . . . .$180 784/Complement/Immunoglobulins . . . . . . . . .$213 859/PSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$57 860/Endocrinology/Hematology/Oncol . . . . . . . .$216 861/PSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$129 862/Tumor Markers . . . . . . . . . . . . . . . . . . . . . .$381 863/Endocrinology 2 . . . . . . . . . . . . . . . . . . . . . .$186 864/Thyroid Antibodies . . . . . . . . . . . . . . . . . . .$228 865/Serum hCG . . . . . . . . . . . . . . . . . . . . . . . . .$171 866/Serum hCG . . . . . . . . . . . . . . . . . . . . . . . .$87 868/Urine Drug Screening—Qual . . . . . . . . . . .$198 870/Whole Blood Glucose . . . . . . . . . . . . . . . . . .$255 871/Whole Blood Glucose . . . . . . . . . . . . . . .$153 872/Urine Chemistry . . . . . . . . . . . . . . . . . . . . .$219 880/Add’l Chem Testing Material . . . . . . . . . . .$108 901/Waived and PPM Package . . . . . . . . . . . . .$249 902/Basic Waived and PPM Package . . . . . . . .$210 789/diagnostics direct Syphilis Health Check .$210 SUPPLIES & SERVICES 790/Anti-HIV . . . . . . . . . . . . . . . . . . . . . . . . .$159 791/Anti-HIV . . . . . . . . . . . . . . . . . . . . . . . . . . .$312 100/Annual Fee (Includes Binder) . . . . . . . . . . . .$85 107/Hard copy of Participant Summary . . . . . . .$75 121/1mL Pipette . . . . . . . . . . . . . . . . . . . . . . . . . .$25 126/Pipette Pump . . . . . . . . . . . . . . . . . . . . . . . . .$45 142/G2 NIR Subscription . . . . . . . . . . . . . . . . . .$176 =Waived • =Add-On • *Enroll after the 1st event and prices are prorated by 1/3 per event. Medical Laboratory Evaluation 2016 www.acponline.org/mle 23 2016 MLE Proficiency Testing Order Form 1 New Enrollee Renewing Participant: MLE ID # _________________________ CTLG 5 Ship To: (no PO boxes for kit delivery) Same as “bill to” address. 2 Bill To: (please clearly print or type) Contact ________________________________________________ Contact ________________________________________________ Facility Name __________________________________________ Facility Name __________________________________________ Address ________________________________________________ _______________________________________________________ Address ________________________________________________ _______________________________________________________ City _____________________________State ____ZIP _________ City _________________________State________ZIP _________ Country (other than U.S.): _______________________________ Phone ______________________Fax _______________________ Country (other than U.S.) _______________________________ E-mail: ________________________________________________ Phone ______________________Fax _______________________ Ship kit to different address (attach information) E-mail _________________________________________________ 6 Send a copy of my PT results to: 3 Lab Director ____________________________________ CMS State Agency ID #__________________________ CAP/LAP # _________________________________________ COLA ID #__________________________________________ TJC ID # ___________________________________________ Other (attach name, address and phone number) 4 CLIA ID # _______________________________________ Activate Auto Renewal at no charge. (see page 16 for details) 7 Module # Description Price Ext. Module # Description Price Ext. Please note: Cancel a module IN WRITING up to 4 weeks prior to the upcoming shipment to avoid being charged. The MLE products you have ordered may contain pathogenic material. By returning this order form, you assume all risk and responsibility in connection with the receipt, handling, storage, use, and disposal of the material. 8 Method of Payment (Tax ID # 23-1520302) (DUNS #: 071625974) Send Invoice Check (payable to ACP/MLE) U.S. funds drawn on U.S. bank disclosure Purchase Order # ______________________ Charge to: VISA MasterCard Card # ___________________________________ Exp. ____________CVV2 (# on back)_________ Name on Card ____________________________ Signature ________________________________ Billing Street Number ____________________ Billing Zip _______________________________ Mailing the Order Form/Renewal Form WITH check: AC003 American College of Physicians 190 N. Independence Mall West Philadelphia, PA 19106-1572 24 www.acponline.org/mle DISCOUNT OFFERS WITHOUT check: Medical Laboratory Evaluation Suite 700 25 Massachusetts Avenue, NW Washington, DC 20001-7401 (Offers cannot be combined--see full description on the following page) Ongoing Discounts ACP - SAVE $85 9 Amount Due Total Cost of Items Above = $ _______ – Applied Discount Amount Subtotal = $ _______ $ _______ + Annual Administration Fee 85 $ _______ + Non-Continental Shipping Fee $ _______ (if applicable) Total Amount Due = $ _______ FAX this form to: 202-835-0440 (call 1-800-338-2746, option 5, to confirm receipt of fax) ACP Member No. ______________________ Multisite - SAVE 10% on 5 or more labs Management Group Code ____________ Consultant - SAVE 10% on 5 or more labs Consultant Code_____________________ Government - SAVE 15% (U.S.) One-Time Discounts COLA (New to MLE’s COLA) - SAVE $85 CAP - SAVE $85 NEW (New to MLE) - SAVE $85 Medical Laboratory Evaluation 2016 MLE DISCOUNT OFFERS Your Solution to Savings Starts Here! Review the table below to see if you qualify for any of the DISCOUNT offers. Then, simply check the appropriate DISCOUNT OFFER box and complete any other required information on the online or hard copy PT Order Form. Discount Savings Description Eligibility Requirements Ongoing Discounts (applied each year enrolled in MLE) ACP Save $85 ACP Members • Current in or new to MLE and ACP Multisite *Save 10% Multisite • Current in or new to MLE • Must have 5 or more enrolled labs Consultant *Save 10% Consultant affiliation • Current in or new to MLE • Order must indicate independent consultant • Consultant must have 5 or more enrolled labs Government *Save 15% State and Federal agencies(including FQHC and IHS) • Current in or new to MLE One-Time Discounts (applied for 2016 program only) COLA Save $85 COLA Members For add'l benefits, visit: www.acponline.org/ mle/acp-cola • New to MLE and current in or new to COLA CAP Save $85 CAP accredited • CAP accredited and new to MLE NEW Save $85 New to MLE • Never enrolled in MLE • Minimum order of $500 *Percentage discounts are applied to module pricing only. Note: Select the eligible offer that provides the greatest discount. We are unable to apply more than one DISCOUNT offer. Price matching also available. See pages 19 to 21. Proficiency Testing at its Best. What’s New for 2016 NEW MODULES Module No. Description Catalog Page No. 828 Enzyme Chemistry—Ship Alone 12 833 Piccolo Waived Chemistry (Add-On) (can be added on to 824, Thyroid Profile) 11 854 SHBG/Testosterone 13 MODULE RECONFIGURATIONS Module No. Description 536 Urine Microalbumin/Creatinine (Add-On) (can now be added on to 868, Urine Drug Screen) 7 868 Urine Drug Screen—Now contains Fentanyl and Tramadol 14 25 Massachusetts Avenue NW, Suite 700 Washington, DC 20001-7401 Catalog Page No.
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