2021 Proficiency Testing Catalog acponline.org/mle
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2021 Proficiency Testing Catalog acponline.org/mle Approved by: CMS, COLA, TJC, U.S. State Agencies and International regulatory bodies.
AT A GLANCE Expert Customer Service Enrollment/Renewal of Proficiency Enjoy the best-in-class customer service experience with Testing personalized care to support you from module selection to re- Enroll early to ensure the availability of specimens for the 2021 sult evaluation. program year. Once we process your order, you will be mailed an order verification for your review and signature. What you can expect: • Response to your call within two hours (during standard business hours) How to Order • Help in choosing test modules Online • Verification of orders within one week • Visit acponline.org/mle and click on the “Enrollment Information” link. Complete the appropriate electronic order form to automatically calculate pricing and receive your order summary. MLE PT Order Form • Detach the order form on page 35, complete it and fax it. (If submitting a purchase order, please include it with your order form.) Making a Payment Enrollments received by renewal form or order form will be invoiced within one week of activation. Auto Renewals will be invoiced in early October. Invoices are due within 30 days. Payment options include credit card (Mastercard or Visa), purchase order, or check. Overdue accounts are subject to holds and/or cancellations. Off-Schedule/Reinstatement Testing Contact Information Provides laboratories with an option for immediate, on-demand proficiency testing, a complement to the regular scheduled p: 1-800-338-2746, ext. 4510 (M-F, 9 a.m.- 5 p.m. ET) proficiency testing. For more details on this service, e: mle@acponline.org see page 2. f: 1-202-835-0440 w: acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Table of Contents How to Order Other Products & Services 2 Ordering 30 Supplies & E-notification Services 30 Continuing Education & Publication Module Descriptions & Test Index Ordering and Discounts 3 Hematology 6 Coagulation 34 Price List 7 Blood Bank 35 Proficiency Testing Order Form 8 Provider-Performed Microscopy 9 Urinalysis & Occult Blood 11 Waived Testing Packages 12 Microbiology 18 Immunology 21 Chemistry 31 Test Index Save Money! Price Matching for Unmatched Service. Found a lower price? We’ll match it! Complete the MLE Price Match Request Form online, 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. See Inside Back Cover for MLE Discount OFFERS. acponline.org/mle Medical Laboratory Evaluation 2021 1
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Ordering Information Order Changes and Cancellations MLE accepts enrollments throughout the year. Order early to All order changes/cancellations/additions must be made in ensure product specimen availability. If you are enrolling for writing. To avoid additional costs, MLE must be notified at the entire 2021 program, you should order by December 4, least 4 weeks prior to the affected shipment date. 2020 to ensure product specimen availability. You may enroll anytime during the program year depending on specimen Module additions: Modules may be added throughout the availability at a prorated price. year, depending on availability, at least 4 weeks prior to the next shipment at no additional cost. After that time, an addi- Please call or email the ACP MLE PT team for a quote or help tional shipping fee will apply. selecting the appropriate modules for your laboratory. Module cancellations: Modules may be cancelled through- • Phone: 800-338-2746, ext. 4510 out the year. Cancellation requests received at least 4 weeks • Email: mle@acponline.org prior to the next shipment will be prorated. After that time, we will only be able to cancel any remaining shipments and you will be financially responsible for the uncancelled ship- How To Order ment. Analyte cancellation: To cancel an analyte(s), submit a Test • Online at acponline.org/mle Menu Deletion Form available on the MLE web site. • Fax the completed order form included here (w/ PO if applicable) to: 1-202-835-0440 Entire order cancellation: Order cancellations may be made at any time. Written cancellations must be received at least 4 weeks prior to the next shipment to receive a refund for that Next Steps and subsequent shipments, if applicable. The annual admin- istration fee is non-refundable. Order Verification: MLE will process your order and send you an Order Verification within one week for your review. Automatic Renewal order cancellation: Written notification Contact MLE for any corrections. must be received no later than December 4, 2020 to avoid any charges for the upcoming year. Invoice: Your invoice will follow within two weeks. Invoices may be paid by check, VISA or Mastercard. Billing terms are Failure to return the Order Verification form and/or not net 30 days. paying your invoice are NOT indications of cancellation. Tax ID: 23-1520302 Notification must be submitted in writing. DUNS NO: 071625974 Non-Continental U.S. Orders: An additional $30 fee will Off-Schedule Proficiency Testing be added per shipment ($90 annually), Alaska and Hawaii excluded. Off-schedule proficiency testing (PT) provides laboratories with immediate, on-demand, customized proficiency testing Single Module Orders: An additional $20 shipping fee will for reinstatement or remedial purposes; a complement to be added per shipment ($60 annually). the regularly scheduled PTprogram. NOTE: Overdue accounts are subject to holds and/or Who Needs Off-Schedule Testing? cancellations. • Laboratories with unsuccessful performance for two out of three regular testing events may be required to Automatic Renewal perform off-schedule PT to lift a “cease-testing” order from their regulatory or accrediting agency. In these Activate Automatic Renewal to ensure uninterrupted yearly cases, two acceptable proficiency performances may be enrollment. Prior to the next program year, you will receive an required for the lab to resume testing patients. Order Verification for review in late summer and your annual invoice in October. You may make any changes at this time. • Some laboratories use off-schedule PT to verify that corrective actions were effective. This service is available to every laboratory, regardless of MLE enrollment status. Contact MLE Customer Service for information on cost and availability at 1-800-338-2746, ext. 4510, or e-mail us at mle@acponline.org. 2 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Hematology Pay close attention to instrument compatibility notes when selecting hematology modules. Questions? Contact MLE Customer Service. See the “Hematology Instrument List” online at www.acponline.org/mle in the Enrollment Information & Forms section. 210 Hematology Module................................................................................$279 Five challenges each. Blood Cell Identification Platelet Count Hematocrit Red Blood Cell Count Hemoglobin White Blood Cell Count 212 Hemoglobin/Hematocrit/WBC...............................................................$237 Five challenges each. 213 Hemoglobin/Hematocrit—Waived.........................................................$177 For waived methods only. Two challenges each. 215 Hemoglobin/Glucose...............................................................................$195 For HemoCue only. Two challenges each. 223 Hematology with 5-part Differential.....................................................$372 Compatible with most Abbott CELL-DYN 5-part differential instruments only. Five challenges each. Automated Differential Platelet Count Hematocrit Red Blood Cell Count Hemoglobin White Blood Cell Count 224 Sysmex with 3-part Differential.............................................................$330 Compatible with Sysmex 3-part automated differential instruments only. Five challenges each. Automated Differential Platelet Count Hematocrit Red Blood Cell Count Hemoglobin White Blood Cell Count Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 3
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Hematology (continued) 225 Hematology with 3-part Differential.....................................................$321 Compatible with most 3-part differential instruments EXCEPT Sysmex (see 224). Five challenges each. Automated Differential Platelet Count Hematocrit Red Blood Cell Count Hemoglobin White Blood Cell Count 226 Hematology with 5-part Differential.....................................................$372 Compatible with most Beckman–Coulter 5-part differential instruments EXCEPT for the AcT 5diff (see 228). Five challenges each. Automated Differential Platelet Count Hematocrit Red Blood Cell Count Hemoglobin White Blood Cell Count 228 Hematology with 5-part Differential.....................................................$372 Compatible with Beckman Coulter AcT 5diff and ABX Pentra 5-part differential instruments. Five challenges each. Automated Differential Platelet Count Hematocrit Red Blood Cell Count Hemoglobin White Blood Cell Count 229 Sysmex Hematology with 5 or 6-part Differential...............................$372 Compatible with most Sysmex 5 or 6 part differential instruments only. Five challenges each. Automated Differential Platelet Count Hematocrit Red Blood Cell Count Hemoglobin White Blood Cell Count Immature Granulocytes Continued on next page 4 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Hematology (continued) 231 Blood Cell Identification..........................................................................$138 Stand-alone module. Five challenges consisting of color photographs. 230 Blood Cell Identification (Add-On)..........................................................$48 Same as 231. Only available with 223 through 229. 240 Reticulocyte Count...................................................................................$243 Compatible with automated and manual reticulocyte counting methods. Not for use with brilliant cresyl blue staining methods. Two challenges. 247 Sedimentation Rate.................................................................................$195 Not for use with Sedimat 15 / 15 Plus. Not compatible with Alcor ISED. Two challenges. 248 Sedimat 15 ESR........................................................................................$195 Compatible with the Polymedco Sedimat 15 / 15 Plus instruments only. Two challenges. 250 Fluid Cell Count/Crystals.........................................................................$231 Fluid for Hemocytometer cell count and color photographs for identification of crystals. Two challenges each. Crystal Screening RBC Count WBC Count acponline.org/mle Medical Laboratory Evaluation 2021 5
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Coagulation 320 Coagulation Module.................................................................................$228 Requires 1 mL pipette (see item 121 on page 30). Five challenges each. Fibrinogen INR Partial Thromboplastin Time Prothrombin Time 324 Roche CoaguChek XS INR—Waived......................................................$213 Not for use with CoaguChek XS Plus/Pro. (see 331) Two challenges. INR 328 i-STAT Prothrombin Time.......................................................................$369 Compatible with the i-STAT instruments only. Five challenges each. INR Prothrombin Time 330 CoaguChek XS Plus/Pro PT/INR............................................................$321 For CoaguChek XS Plus/Pro only. Five challenges each. INR Prothrombin Time 331 CoaguChek XS Plus/Pro PT/INR—Waived............................................$213 For CoaguChek XS Plus/Pro only. Two challenges each. INR Prothrombin Time 6 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Blood Bank 451 ABO & Rh Factor (D Type)......................................................................$309 Not for use with slide methods. Five challenges each. 452 Blood Bank................................................................................................$414 Not for use with slide methods. Five challenges each. ABO Group Rh Factor (D Type) Unexpected Antibody Detection 453 Blood Bank 2............................................................................................$444 Not for use with slide methods. Five challenges each. ABO Group Antibody Identification Compatibility Testing (Crossmatch) Rh Factor (D Type) Unexpected Antibody Detection acponline.org/mle Medical Laboratory Evaluation 2021 7
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Provider-Performed Microscopy 534 Provider-Performed Microscopy (PPM)...............................................$141 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. 535 Provider-Performed Microscopy (PPM) (Add-On)................................$45 Same as 534. Only available with 530, 531, 532. 538 KOH Slides.................................................................................................$183 Two fixed glass slides for determining the presence or absence of fungal elements in skin scrapings. Two challenges. 8 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Urinalysis & Occult Blood 530 Urinalysis Module.....................................................................................$138 One challenge each unless otherwise noted in parentheses. Bilirubin Nitrite Blood/Hemoglobin pH Glucose Protein Ketones Specific Gravity Leukocyte Esterase Urobilinogen Microalbumin (dipstick) Urine Sediment Identification (2) 531 Urinalysis Module.....................................................................................$114 hCG not included. One challenge each. Bilirubin Nitrite Blood/Hemoglobin pH Glucose Protein Ketones Specific Gravity Leukocyte Esterase Urobilinogen Microalbumin (dipstick) 541 Urine hCG..................................................................................................$105 Stand-alone module. One challenge each. 540 Urine hCG (Add On)...................................................................................$30 Same as 541. Only available with 530, 531. Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 9
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Urinalysis & Occult Blood (continued) 532 Urine Sediment Identification.................................................................$129 Two challenges consisting of photographs. 533 Urine Sediment Identification (Add-On).................................................$36 Same as 532. Only available with 531, 534. 539 Urine Microalbumin/Creatinine..............................................................$138 Stand-alone module. Compatible with quantitative and semi-quantitative (dipstick) methods. One challenge each. 536 Urine Microalbumin/Creatinine (Add-On)..............................................$96 Same as 539. Only available with 530, 531. 542 Fecal Occult Blood...................................................................................$132 Stand-alone module. Two challenges each. 537 Fecal Occult Blood (Add-On)....................................................................$93 Same as 542. Only available with 530, 531. 10 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Waived Testing Packages Waived Testing—The Importance of Performing Proficiency Testing Tests classified as “waived” are exempt from most federal regulations, including PT requirements. Many labs choose to participate in PT however, to ensure the quality of their patient testing. Performing PT provides an excellent indicator of the accu- racy and reliability of your waived test results. In addition, some states, third-party payers and other regulators require proficiency testing to be performed, even for CLIA-waived procedures. MLE offers economical waived order options designed for the needs of the waived testing laboratory. 901 Waived and PPM Package......................................................................$333 Number of challenges noted in parentheses. Fecal Occult Blood (2) Urinalysis (1) Urinalysis (1) Hemoglobin (2) Urine Urine hCG (1)Sediment (2) Hematocrit (2) Urine Strep Sediment (2) A Antigen (2) PPM (6) WholeWhole BloodBlood Glucose (2) Glucose (2) Strep A Antigen Detection (2) 902 Basic Waived and PPM Package............................................................$291 Number of challenges noted in parentheses. Fecal Occult Blood (2) Urinalysis (1) PPM (6) Urine hCG (1) Urine Sediment (2) Strep A Antigen Detection (2) Whole Blood Glucose (2) acponline.org/mle Medical Laboratory Evaluation 2021 11
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Microbiology • 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 more stringent of the two. The number of challenges is noted in parentheses. • All urine culture specimens are suitable for presumptive identification and/or definitive identification. Note: The specimens included may contain dangerous pathogens and must be treat- ed with extreme care. These specimens must be handled and disposed of only by personnel trained to work with pathogenic microorganism. Bacteriology 630 Bacteriology 1..........................................................................................$351 Six cultures per shipment consisting of the following: Antimicrobial Susceptibility Testing (1) Genital Culture (1) Gram Stain (2) Gram Stain Morphology (2) Miscellaneous Culture (3) * Throat Culture (1) Urine Culture (1) *Possible sources include: Blood, CSF, Ear, Eye, Sputum, Stool, Wound. 640 Bacteriology 2...........................................................................................$333 Antimicrobial Susceptibility Testing (1) Genital Culture (1) Gram Stain (2) Gram Stain Morphology (2) Strep A Antigen Detection (1) Throat Culture (2) Urine Culture (2) Continued on next page 12 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Mircrobiology (continued) 643 Urine Culture...............................................................................................$324 Antimicrobial Susceptibility Testing (1) Gram Stain (1) Gram Stain Morphology (1) Urine Culture (5) 647 Urine Presumptive ID/Colony Count........................................................$363 Best suited for paddle-dipping methods. Antimicrobial Susceptibility Testing (1) Colony Count (2) Gram Stain (1) Gram Stain Morphology (1) Urine Presumptive Identification (5) 648 Colony Count..............................................................................................$228 Colony Count does not contribute to the minimum of five bacteriology challenges. No presumptive identification may be submitted for this module. Two challenges. 653 Genital/Urine Culture.................................................................................$327 Antimicrobial Susceptibility Testing (1) Genital Culture (3) Gram Stain (2) Gram Stain Morphology (2) Urine Culture (2) 646 Genital Culture...........................................................................................$324 Gram Stain (1) Gram Stain Morphology (1) Genital Culture (5) Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 13
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Mircrobiology (continued) 645 Urine/Throat Culture...............................................................................$327 Antimicrobial Susceptibility Testing (1) Gram Stain (1) Gram Stain Morphology (1) Throat Culture (2) Urine Culture (3) 652 Urine Presumptive ID/Throat Culture...................................................$363 Best suited for urine paddle-dipping methods. Antimicrobial Susceptibility Testing (1) Colony Count (2) Gram Stain (1) Gram Stain Morphology (1) Urine Presumptive Identification (2) Throat Culture (3) 641 Throat Culture.........................................................................................$324 Not suitable for Strep A kits. Five challenges. 660 Strep A Antigen Detection....................................................................$201 Not suitable for culture. Five challenges. 662 Strep A Antigen Detection—Waived....................................................$132 For waived Strep A Antigen Detection kits only. Two challenges. 650 Gram Stain...............................................................................................$204 Five fixed glass slides. Five challenges each. Gram Stain Gram Stain Morphology Continued on next page 14 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Mircrobiology (continued) 651 Miscellaneous Cultures (Add-On)........................................................$189 Only available with 640 through 647, 652, 653. Miscellaneous Culture (3) Possible sources include: Blood, CSF, Ear, Eye, Sputum, Stool, Wound. 695 MRSA Culture.........................................................................................$297 Screening for the presence or absence of methicillin-resistant Staphylococcus aureus only. Five challenges. 686 Legionella Antigen Detection..............................................................$261 For use with Binax NOW Legionella Urinary Antigen Detection kits only. Five challenges. 687 Streptococcus pneumoniae Antigen Detection................................$267 For use with Binax NOW Streptococcus pneumoniae Urinary Antigen Detection kit only. Five challenges. 682 C. difficile/Rotavirus Antigen Detection.............................................$291 Five challenges each. C. difficile Rotavirus 675 Chlamydia/GC (EIA, DNA)...................................................................$378 Five challenges each. Chlamydia trachomatis Neisseria gonorrhoeae 673 Chlamydia/GC (EIA, DNA)—Add-On....................................................$189 Same as 675. Only available with 630 through 647, 652, 653. Two challenges. Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 15
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Mircrobiology (continued) 668 Affirm VP III (DNA)..................................................................................$399 Five challenges each. Candida sp. Trichomonas vaginalis Gardnerella vaginalis 692 Bacterial Vaginosis—Waived..................................................................$192 For Sekisui OSOM BVBlue Test Two challenges. Bacterial Vaginosis Screen 693 Trichomonas vaginalis—Waived............................................................$192 For Sekisui OSOM Trichomonas Rapid Test Two challenges. Trichomonas vaginalis Mycology 678 Dermatophyte Culture...........................................................................$282 Five challenges. 538 KOH Slides..............................................................................................$183 Two fixed glass slides for determining the presence or absence of fungal elements in skin scrapings. Two challenges. Continued on next page 16 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Mircrobiology (continued) Parasitology 683 Cryptosporidium/Giardia lamblia Antigen Detection.......................$342 Five challenges each. Cryptosporidium Giardia lamblia 690 PVA Slides (Add On).................................................................$180 NEW! Only available with 691. Zinc polyvinyl alcohol fixed glass slides for the identification of fecal parasites. Two challenges. 691 Parasitology................................................................................$345 NEW! Number of challenges noted in parentheses. Fecal Suspension (4) Blood Smear (1) Virology 681 Respiratory Antigen Detection.............................................................$321 Five challenges each. Influenza A RSV Influenza B 680 Respiratory Antigen Detection—Waived..............................................$213 For waived kits only. Two challenges each. Influenza A RSV Influenza B acponline.org/mle Medical Laboratory Evaluation 2021 17
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Immunology 750 Immunology Module..............................................................................$333 Five challenges each. Anti-Streptolysin O (ASO) Infectious Mononucleosis Rheumatoid Factor 761 Infectious Mononucleosis/Rheumatoid Factor...................................$315 Five challenges each. 762 Infectious Mononucleosis......................................................................$213 Five challenges. 755 Infectious Mononucleosis—Waived.......................................................$135 For waived Infectious Mononucleosis kits only. Two challenges. 751 Rheumatology Module..........................................................................$252 Number of challenges noted in parentheses. C-Reactive Protein (2) (Not for high-sensitivity methods) Rheumatoid Factor (5) 763 Rheumatoid Factor..................................................................................$207 For IgG methods only. Five challenges. 764 C-Reactive Protein (CRP).......................................................................$129 Not for high-sensitivity methods (see 765). Two challenges. Continued on next page 18 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Immunology (continued) 776 C-Reactive Protein (CRP)—Add-On..........................................................$63 Not for high-sensitivity methods. (see 777) Same as 764. Only available with 750. 765 High-Sensitivity C-Reactive Protein (HS-CRP).....................................$138 Two challenges. 777 High-Sensitivity C-Reactive Protein (HS-CRP)—Add-On......................$69 Same as 765. Only available with 750 and 751. 782 ANA Panel................................................................................................$291 Five challenges each. ANA Anti-SSA Anti-dsDNA Anti-SSA/SSB Anti-RNP Anti-SSB Anti-RNP/Sm Anti-Sm 783 ANA Panel (Add-On)...............................................................................$222 Same as 782. Only available with 750 and 751. 784 Complement/Immunoglobulins.............................................................$249 Five challenges each. Complement C3 IgG, Total Complement C4 IgM, Total IgA, Total 771 Rubella.......................................................................................................$207 For lgG methods only. Five challenges. 780 H. pylori Antibody Detection.................................................................$180 Two challenges. Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 19
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Immunology (continued) 781 Mycoplasma Antibody...........................................................................$171 Two challenges. 772 Syphilis Serology.....................................................................................$228 Five challenges each. MHA-TP RPR TPA VDRL 775 Viral Markers............................................................................................$495 Five challenges each. Anti-HAV (IgM) Anti-HCV Anti-HAV (Total/IgG) Anti-HIV Anti-HBc (IgM) HBeAg Anti-HBc (Total/IgG) HBsAg Anti-HBs 791 Anti-HIV....................................................................................................$309 Five challenges. 790 Anti-HIV—Waived.....................................................................................$183 For waived HIV kits only. Two challenges. 770 Specific Allergen Testing........................................................................$369 Number of challenges noted in parentheses. Includes 2 sets of samples for for large large volume volume requirements. requirements. Does Does not not include include Total Total IgE. IgE. Allergen Specific Allergen Specific IgE IgE (14) (14) 773 Diagnostic Allergy...................................................................................$369 Number of challenges noted in parentheses. Allergen Specific IgE (14) Total IgE (5) 20 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry Pay close attention to instrument compatibility notes when selecting any of the chemistry modules. If you need any assistance, call MLE Customer Service at 1-800-338-2746, ext. 4510, or e-mail us at mle@acponline.org. 810 Chemistry Module....................................................................................$384 Five challenges each. Albumin Glucose Glucose Alkaline Phosphatase Iron Iron Alpha-fetoprotein Lactate Lactate(Lactic (Lactic Acid) Acid) ALT (SGPT) LDH LDH Amylase Lipase Lipase AST (SGOT) Magnesium Magnesium Bilirubin, Direct Phosphorus Phosphorus Bilirubin, Total Potassium Potassium Calcium Protein, Protein, Total Total Chloride Sodium Sodium Cholesterol, HDL T3 T3 Uptake Uptake Cholesterol, LDL - Calc Thyroxine Thyroxine (T4) (T4) Cholesterol, LDL – Direct TIBC TIBC -- Calc Calc Cholesterol, Total TIBC TIBC -- Direct Direct CO2 Triglyceride Triglyceride Cortisol Triiodothyronine Triiodothyronine (T3) (T3) Creatine Kinase (CK) TSH TSH Creatinine UIBC- UIBC -Direct Direct Free T3 Urea Urea Nitrogen Nitrogen Free Thyroxine (T4) Uric Uric Acid Acid GGT Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 21
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry (continued) 813 Comprehensive Metabolic Panel.........................................................$309 Five challenges each. Albumin Lactate (Lactic Acid) Alkaline Phosphatase Magnesium ALT (SGPT) Phosphorus AST (SGOT) Potassium Bilirubin, Direct Protein, Total Bilirubin, Total Sodium Calcium TIBC - Calc Chloride TIBC - Direct CO2 UIBC - Direct Creatinine Urea Nitrogen Glucose Uric Acid Iron 812 Waived Chemistry Panel.......................................................................$234 Two challenges each. Albumin Creatine Kinase (CK) Alkaline Phosphatase Creatinine Creatinine ALT (SGPT) GGT Amylase Glucose AST (SGOT) Phosphorus Bilirubin, Total Potassium Calcium Protein, Total Chloride Sodium Cholesterol, HDL Triglyceride Cholesterol, LDL-Cal Urea Nitrogen Cholesterol, Total Uric Acid CO2 833 Waived Chemistry Panel (Add-On).........................................................$81 Same as 812. Only available with 824. Continued on next page 22 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry (continued) 824 Thyroid Profile..........................................................................................$258 Five challenges each. Alpha-fetoprotein Thyroxine (T4) Cortisol Thyroxine (T4), Free T3, Free Triiodothyronine (T3) T3 Uptake TSH 841 Neonatal Bilirubin....................................................................................$243 Five challenges each. Bilirubin, Direct Bilirubin, Total 826 Lipid Profile...............................................................................................$246 Five challenges each. Cholesterol, HDL Cholesterol, LDL - Calc Cholesterol, LDL - Direct Cholesterol, Total Triglyceride 811 Lipid Panel/Glucose—Waived.................................................................$192 For waived testing ONLY. Two challenges each. Cholesterol, LDL - Calculated Cholesterol, HDL Cholesterol, Total Glucose Triglyceride Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 23
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry (continued) 817 i-STAT Chemistry 1..................................................................................$390 Five challenges each. Calcium, Ionized pCO2 Chloride pH Creatinine pO2 Glucose Potassium Hematocrit Sodium Hemoglobin tCO2 Lactate Urea Nitrogen 818 i-STAT Chemistry 2..................................................................................$270 Five challenges each. Calcium, Ionized Hemoglobin Chloride Potassium Creatinine Sodium Glucose tCO2 Hematocrit Urea Nitrogen 832 i-STAT Chemistry—Waived.....................................................................$195 Two challenges each. Calcium, Ionized Hemoglobin Chloride Potassium Creatinine Sodium Glucose tCO2 Hematocrit Urea Nitrogen 847 Blood Gases.............................................................................................$324 Compatible with the i-STAT analyzer as well as other blood gas instruments. Five challenges each. Chloride pH Calcium, Ionized pO2 Lactate Potassium pCO2 Sodium Continued on next page 24 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry (continued) 831 Therapeutic Drugs (Add-On)...................................................................$66 Only available with 810. Five challenges each. Acetaminophen Phenytoin Carbamazepine Salicylate Digoxin Theophylline Gentamicin Valproic Acid Lithium Vancomycin Phenobarbital 835 Serum Alcohol/Acetone..........................................................................$252 Five challenges each. 836 Ammonia...................................................................................................$180 Two challenges. 838 Blood Lead—Waived................................................................................$222 Two challenges. 845 Cardiac Markers.......................................................................................$333 Five challenges each. Quantitative only. BNP NT-proBNP CK-MB Troponin I D-Dimer Troponin T Myoglobin 846 BNP/D-Dimer............................................................................................$237 Two challenges each. BNP NT-proBNP D-Dimer Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 25
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry (continued) 860 Endocrinology/Hematology/Oncology................................................$249 Two challenges each. CEA LH DHEA-S Prealbumin Estradiol Progesterone Ferritin Prolactin Folate Testosterone FSH Transferrin Homocysteine Vitamin B12 863 Endocrinology 2.......................................................................................$219 Lyophilized samples. Two challenges each. C-Peptide Insulin Parathyroid Hormone, Intact (PTH) Vitamin D, 25-Hydroxy 854 SHBG/Testosterone..................................................................................$342 Lyophilized samples. Two challenges each. Sex Hormone Binding Globulin Testosterone Testosterone, Bioavailable Testosterone, Free 861 PSA.............................................................................................................$156 Two challenges. 859 PSA (Add-On)..............................................................................................$69 Same as 861. Only available with 860. 865 Serum hCG................................................................................................$198 Five challenges each. Continued on next page 26 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry (continued) 866 Serum hCG (Add-On)................................................................................$99 Same as 865. Only available with 810, 813, 817, 818, 824, 826. 862 Tumor Markers........................................................................................$399 Two challenges each. Beta (ß)-2 Microglobulin CEA CA 125 PSA CA 15-3 PSA, Free CA 19-9 Thyroglobulin CA 27/29 864 Thyroid Antibodies.................................................................................$261 Two challenges each. Thyroglobulin Antibody Thyroid Peroxidase Antibody (TPO) 850 Glycohemoglobin...................................................................................$210 Not compatible with Afinion analyzer. Two challenges. 851 Afinion Glycohemoglobin......................................................................$225 Two challenges. 870 Whole Blood Glucose............................................................................$282 Five challenges. 871 Whole Blood Glucose—Waived.............................................................$180 Two challenges. Continued on next page acponline.org/mle Medical Laboratory Evaluation 2021 27
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry (continued) 872 Urine Chemistry.........................................................................................$249 Two challenges each. Amylase Phosphorus Calcium Potassium Chloride Protein, Total Creatinine Sodium Glucose Urea Nitrogen Magnesium Uric Acid Osmolality 868 Urine Drug Screen....................................................................................$240 Two challenges -10 mL each. For the qualitative detection of drugs in urine. Each challenge will include one or more of the following: Acetaminophen LSD MDMA Amphetamines MDMA Meperidine Amphetamines/ Meperidine Methadone Methamphetamines Methadone Methamphetamines Barbiturates Methamphetamines Methanol Benzodiazepines Methanol Methaqualone Buprenorphine Methaqualone 6-Monoacetylmorphine Cannabinoids (THC) 6-Monoacetylmorphine Opiates (Morphine Trihydrate) Carisoprodol Opiates Oxycodone (Morphine Trihydrates) Cocaine Metabolites Oxycodone Phencyclidine Cotinine Phencyclidine Propoxyphene EDDP Propoxyphene Tramadol Ethanol (Alcohol) Tramadol Tricyclic Antidepressants Fentanyl Tricyclic ZolpidemAntidepressants Hydrocodone Zolpidem Continued on next page 28 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Chemistry (continued) 873 Ethyl Glucuronide (EtG) (Add-On)...........................................................$78 Only available with 868. Two challenges. 874 Adulterated Urine (Add-On).....................................................................$93 Only available with 868. Compatible with quantitative and semi-quantitative (dipstick) methods. Two challenges each. Creatinine Nitrite Oxidants Specific Gravity acponline.org/mle Medical Laboratory Evaluation 2021 29
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 Other Products & Services Supplies 108 MLE Program Binder.........................................................................................................................$15 121 Pipette - 1mL .....................................................................................................................................$25 Reusable Class A volumetric pipette. 126 Pipette Pump......................................................................................................................................$45 For use with product 121 above. E-notification Service A value-added service to enhance the quality and safety of patient care. The e-mail notification ser- vice 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 mle@acponline.org and request to be added to the recipient list. In the e-mail request, be sure to include your MLE ID number. Continuing Education MLE CEexpress...........................................................................................................................................FREE MLE offers continuing education through COLA’s LabUniversity®. MLE CEexpress courses are pro- vided free of charge to MLE participants. Discounts available on COLA courses. Call MLE at 1-800- 338-2746, ext. 4510 or e-mail us at mle@acponline.org to learn more. Publications 142 National Intelligence Report Subscription..................................................................................$240 Monthly newsletter covering government policy for diagnostic testing and related medical services. 30 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY CMS regulated 1 •CLIA analytes for M2:purposes MAY 10are • M3: SEPTEMBER 13 in bold Test Index ABO Group....................................................................................7 Blood Smear, parasitology...................................................... 17 Acetaminophen, serum............................................................ 25 BNP ............................................................................................ 25 Acetaminophen, urine.............................................................. 28 Buprenorphine........................................................................... 28 Acetone....................................................................................... 25 C-Peptide.................................................................................... 26 Adulterated Urine...................................................................... 29 C-Reactive Protein (CRP).................................................... 18, 19 Affirm VPIII (DNA)...................................................................... 16 C-Reactive Protein, high sensitivity (HS-CRP)........................ 19 Albumin................................................................................ 21, 22 CA 125........................................................................................ 27 Alcohol, serum........................................................................... 25 CA 15-3....................................................................................... 27 Alcohol, urine............................................................................. 28 CA 19-9....................................................................................... 27 Alkaline Phosphatase......................................................... 21, 22 CA 27/29..................................................................................... 27 Allergy Testing........................................................................... 20 Calcium, serum.................................................................... 21, 22 Alpha-fetoprotein (AFP)..................................................... 21, 23 Calcium, urine............................................................................ 28 ALT (SGPT)........................................................................... 21, 22 Calcium, Ionized........................................................................ 24 Ammonia.................................................................................... 25 Candida, Affirm VPIII(DNA)...................................................... 16 Amphetamines........................................................................... 28 Cannabinoids (THC).................................................................. 28 Amphetamines/Methamphetamines...................................... 28 Carbamazepine......................................................................... 25 Amylase, serum................................................................... 21, 22 Carisoprodol.............................................................................. 28 Amylase, urine............................................................................ 28 CEA ...................................................................................... 26, 27 Anti-dsDNA................................................................................ 19 C. difficile, Antigen Detection................................................. 15 Anti-HAV..................................................................................... 20 Chlamydia (EIA/DNA)............................................................... 15 Anti-HBc...................................................................................... 20 Chloride, serum............................................................ 21, 22, 24 Anti-HBs...................................................................................... 20 Chloride, urine........................................................................... 28 Anti-HCV..................................................................................... 20 Cholesterol, HDL ......................................................... 21, 22, 23 Anti-HIV....................................................................................... 20 Cholesterol, LDL .......................................................... 21, 22, 23 Anti-RNP...................................................................................... 19 Cholesterol, Total ........................................................ 21, 22, 23 Anti-RNP/Sm............................................................................... 19 CK-MB......................................................................................... 25 Anti-SSA...................................................................................... 19 CO2 ...................................................................................... 21, 22 Anti-SSA/SSB.............................................................................. 19 Cocaine Metabolites................................................................. 28 Anti-SSB...................................................................................... 19 Colony Count....................................................................... 13, 14 Anti-Sm........................................................................................ 19 Compatibility Testing..................................................................7 Anti-Streptolysin O (ASO)........................................................ 18 Complement C3........................................................................ 19 Antibody Identification...............................................................7 Complement C4........................................................................ 19 Antimicrobial Susceptibility Testing ........................ 12, 13, 14 Cortisol.................................................................................. 21, 23 Antinuclear Antibody (ANA).................................................... 19 Cotinine....................................................................................... 28 AST (SGOT).......................................................................... 21, 22 Creatine Kinase (CK).......................................................... 21, 22 Automated Differential ......................................................... 3, 4 Creatinine, serum......................................................... 21, 22, 24 Bacterial Vaginosis.................................................................... 16 Creatinine, urine........................................................... 10, 28, 29 Barbiturates................................................................................ 28 Crossmatch....................................................................................7 Benzodiazepines........................................................................ 28 Cryptosporidium, Antigen Detection..................................... 17 Beta (ß)-2 Microglobulin........................................................... 27 Crystal Screening..........................................................................5 Bilirubin, Total............................................................... 21, 22, 23 CSF Culture.......................................................................... 12, 15 Bilirubin, Direct............................................................. 21, 22, 23 D-Dimer....................................................................................... 25 Bilirubin, Neonatal.................................................................... 23 Dermatophyte Culture............................................................. 16 Bilirubin, urine ....................................................................... 9, 11 DHEA-S....................................................................................... 26 Blood Cell Identification........................................................ 3, 5 Digoxin....................................................................................... 25 Blood Culture....................................................................... 12, 15 Drug Screen, Urine.................................................................... 28 Blood Gases............................................................................... 24 Ear Culture........................................................................... 12, 15 Blood/Hemoglobin, urine ................................................... 9, 11 EDDP........................................................................................... 28 acponline.org/mle Medical Laboratory Evaluation 2021 31
CMS regulated 2021 SHIP DATES analytes for M1: FEBRUARY 1 •CLIA M2:purposes MAY 10are in bold • M3: SEPTEMBER 13 Eosinophils, Nasal (PPM)...................................................... 8, 11 KOH Skin Prep (Slides).......................................................... 8, 16 Estradiol...................................................................................... 26 Lactate (Lactic Acid) .................................................... 21, 22, 24 Ethanol, urine............................................................................. 28 LDH ............................................................................................ 21 Ethyl Glucuronide (EtG)............................................................ 29 Lead, Blood................................................................................ 25 Eye Culture........................................................................... 12, 15 Legionella, Antigen Detection................................................ 15 Fecal Leukocytes (PPM)........................................................ 8, 11 Leukocyte Esterase, urine..................................................... 9, 11 Fecal Occult Blood.............................................................. 10, 11 LH ............................................................................................ 26 Fecal Suspension, parasitology.............................................. 17 Lipase.......................................................................................... 21 Fentanyl....................................................................................... 28 Lithium........................................................................................ 25 Fern Testing (PPM)................................................................ 8, 11 LSD ............................................................................................ 28 Ferritin......................................................................................... 26 Magnesium, serum.............................................................. 21, 22 Fibrinogen.....................................................................................6 Magnesium, urine...................................................................... 28 Fluid Cell Count............................................................................5 MDMA......................................................................................... 28 Folate.......................................................................................... 26 Meperidine................................................................................. 28 FSH ............................................................................................ 26 Methadone................................................................................. 28 Gardnerella, Affirm VPIII (DNA).............................................. 16 Methamphetamines.................................................................. 28 GC (EIA/DNA)............................................................................ 15 Methanol..................................................................................... 28 Genital Culture.................................................................... 12, 13 Methaqualone............................................................................ 28 Gentamicin................................................................................. 25 MHA-TP....................................................................................... 20 GGT ...................................................................................... 21, 22 Microalbumin...................................................................9, 10, 11 Giardia lamblia, Antigen Detection........................................ 17 Miscellaneous Culture........................................................ 12, 15 Glucose, serum ............................................................ 21, 22, 24 6-Monoacetylmorphine............................................................ 28 Glucose, urine..................................................................9, 11, 28 MRSA Culture............................................................................ 15 Glucose, whole blood................................................. 11, 23, 27 Mycoplasma, IgG....................................................................... 20 Glycohemoglobin...................................................................... 27 Myoglobin.................................................................................. 25 Gram Stain..................................................................... 12, 13, 14 Nasal Eosinophils (PPM)....................................................... 8, 11 Gram Stain Morphology.............................................. 12, 13, 14 Nitrite, urine......................................................................9, 11, 29 Granulocytes, Immature..............................................................4 NT-proBNP................................................................................. 25 HBeAg......................................................................................... 20 Occult Blood, Fecal............................................................. 10, 11 HBsAg......................................................................................... 20 Opiates (Morphine Trihydrate)................................................ 28 hCG, serum........................................................................... 26, 27 Osmolality, urine........................................................................ 28 hCG, urine ............................................................................. 9, 11 Oxidants, urine........................................................................... 29 Hematocrit................................................................... 3, 4, 11, 24 Oxycodone................................................................................. 28 Hemoglobin............................................................ 3, 4, 9, 11, 24 Parasitology............................................................................... 17 Hemoglobin A1C (Glycohemoglobin).................................... 27 Parathyroid hormone (PTH)...................................................... 26 Homocysteine............................................................................ 26 Partial Thromboplastin Time (APTT) or (PTT)..........................6 H. pylori, Antibody Detection.................................................. 19 pCO2........................................................................................... 24 Hydrocodone............................................................................. 28 pH ............................................................................................ 24 i-STAT Chemistry....................................................................... 24 pH, urine................................................................................. 9, 11 IgA, Total.................................................................................... 19 Phencyclidine............................................................................. 28 IgE, Total..................................................................................... 20 Phenobarbital............................................................................ 25 IgG, Total.................................................................................... 19 Phenytoin.................................................................................... 25 IgM, Total................................................................................... 19 Phosphorus, serum.............................................................. 21, 22 Infectious Mononucleosis........................................................ 18 Phosphorus, urine...................................................................... 28 Influenza A, Antigen Detection............................................... 17 Pinworms (PPM)..................................................................... 8, 11 Influenza B, Antigen Detection............................................... 17 Platelet Count.......................................................................... 3, 4 INR ...............................................................................................6 pO2 ............................................................................................ 24 Insulin.......................................................................................... 26 Potassium, serum......................................................... 21, 22, 24 Iron ...................................................................................... 21, 22 Potassium, urine......................................................................... 28 Ketones, urine ....................................................................... 9, 11 Prealbumin................................................................................. 26 KOH Vaginal Prep (PPM)...................................................... 8, 11 Progesterone.............................................................................. 26 32 Medical Laboratory Evaluation 2021 acponline.org/mle
CMS regulated 2021 SHIP DATES analytes for M1: FEBRUARY 1 •CLIA M2:purposes MAY 10are • in M3:bold SEPTEMBER 13 Prolactin...................................................................................... 26 Throat Culture...................................................................... 12, 14 Propoxyphene............................................................................ 28 Thyroglobulin............................................................................. 27 Protein, Total, serum........................................................... 21, 22 Thyroglobulin antibody............................................................ 27 Protein, Total, urine.........................................................9, 11, 28 Thyroid Peroxidase antibody (TPO) ....................................... 27 Prothrombin Time (PT)................................................................6 TIBC ...................................................................................... 21, 22 Provider-Performed Microscopy (PPM).............................. 8, 11 Tramadol..................................................................................... 28 PSA, Total.............................................................................. 26, 27 Transferrin................................................................................... 26 PSA, Free.................................................................................... 27 Treponema pallidum (TPA)...................................................... 20 PVA Slide, parasitology............................................................ 17 Trichomonas vaginalis, Affirm VPIII (DNA)............................. 16 Red Blood Cell Count............................................................. 3, 4 Trichomonas vaginalis (OSOM-Waived)................................ 16 Reticulocyte Count.......................................................................5 Tricyclic Antidepressants.......................................................... 28 Rheumatoid Factor (RA) .......................................................... 18 Triglyceride................................................................... 21, 22, 23 Rh Factor (D Type).......................................................................7 Troponin I................................................................................... 25 Rotavirus, Antigen Detection.................................................. 15 Troponin T.................................................................................. 25 RPR ............................................................................................ 20 TSH ...................................................................................... 21, 23 RSV, Antigen Detection............................................................ 17 UIBC ...................................................................................... 21, 22 Rubella, IgG............................................................................... 19 Unexpected Antibody Detection...............................................7 Salicylate..................................................................................... 25 Urea Nitrogen (BUN), serum........................................21,22, 24 Scabies (PPM)......................................................................... 8, 11 Urea Nitrogen (BUN), urine...................................................... 28 Sedimentation Rate......................................................................5 Uric Acid, serum.................................................................. 21, 22 SHBG........................................................................................... 26 Uric Acid, urine.......................................................................... 28 Sodium, serum.............................................................. 21, 22, 24 Urine Chemistry......................................................................... 28 Sodium, urine............................................................................. 28 Urine Culture................................................................. 12, 13, 14 Specific Gravity, urine.....................................................9, 11, 29 Urine Dipstick...................................................................9, 10, 11 Sperm (PPM)........................................................................... 8, 11 Urine Drug Screen..................................................................... 28 Sputum Culture................................................................... 12, 15 Urine hCG............................................................................... 9, 11 Stool Culture........................................................................ 12, 15 Urine Sediment Identification........................................9, 10 ,11 Strep A Antigen Detection......................................... 11, 12, 14 Urobilinogen, urine............................................................... 9, 11 Strep pneumoniae, Antigen Detection.................................. 15 Valproic Acid.............................................................................. 25 Syphilis Serology....................................................................... 20 Vancomycin................................................................................ 25 T3, Free................................................................................. 21, 23 VDRL............................................................................................ 20 T3, Total................................................................................ 21, 23 Vitamin B12................................................................................ 26 T3 Uptake............................................................................. 21, 23 Vitamin D, 25-Hydroxy.............................................................. 26 T4, Free................................................................................. 21, 23 Waived and PPM packages...................................................... 11 T4, Total................................................................................ 21, 23 Wet Mount Preparations (PPM)........................................... 8, 11 tCO2............................................................................................ 24 White Blood Cell Count......................................................... 3, 4 Testosterone............................................................................... 26 Wound Culture.................................................................... 12, 15 Testosterone, Bioavailable....................................................... 26 Zolpidem..................................................................................... 28 Testosterone, Free..................................................................... 26 Theophylline.............................................................................. 25 acponline.org/mle Medical Laboratory Evaluation 2021 33
2021 SHIP DATESMLE M1: Proficiency FEBRUARY 1 Testing Price • M2: MAY 10 •List M3: SEPTEMBER 13 W=Waived • A=Add-On • *Enroll after the 1st event and prices are prorated by 1/3 per event. Code/Description *Full Year Code/Description *Full Year Code/Description *Full Year HEMATOLOGY 648/Colony Count. . . . . . . . . . . . . . . . . . . . . . . $228 CHEMISTRY 210/Hematology . . . . . . . . . . . . . . . . . . . . . . . . $279 650/Gram Stain . . . . . . . . . . . . . . . . . . . . . . . . . $204 810/Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . $384 212/Hemoglobin/Hematocrit/WBC. . . . . . . . $237 651/Miscellaneous Culture A. . . . . . . . . . . . . . $189 811/Lipid Panel/GlucoseW . . . . . . . . . . . . . . . $192 213/Hemoglobin/Hematocrit W. . . . . . . . . . . $177 652/Throat Culture/Urine 812/Waived Chemistry Panel W. . . . . . . . . . . $234 215/Hemoglobin/Glucose—HemoCue. . . . . . $195 Presump ID . . . . . . . . . . . . . . . . . . . . . . . . . . . $363 813/Comp. Metabolic Panel . . . . . . . . . . . . . . $309 223/Abbott 5-Part Diff. . . . . . . . . . . . . . . . . . . . $372 653/Genital/Urine Culture . . . . . . . . . . . . . . . $327 817/i-STAT Chemistry 1 . . . . . . . . . . . . . . . . . . $390 224/Sysmex 3-Part Diff. . . . . . . . . . . . . . . . . . . $330 225/Hematology 3-Part Diff. . . . . . . . . . . . . . . $321 660/Strep A Antigen Detection. . . . . . . . . . . . $201 818/i-STAT Chemistry 2 . . . . . . . . . . . . . . . . . . $270 226/Hematology 5-Part Diff. . . . . . . . . . . . . . . $372 662/Strep A AntigenW. . . . . . . . . . . . . . . . . . . $132 824/Thyroid Profile . . . . . . . . . . . . . . . . . . . . . . $258 228/Hematology 5-Part diff- 826/Lipid Profile. . . . . . . . . . . . . . . . . . . . . . . . . $246 668/Affirm VP Antigen Testing . . . . . . . . . . . . $399 ACT 5 & Pentra 60C+. . . . . . . . . . . . . . . . . . . $372 831/Therapeutic Drugs A. . . . . . . . . . . . . . . . . . $66 673/Chlamydia/GC A . . . . . . . . . . . . . . . . . . . . $189 229/Hematology 5 or 6-Part 832/i-STAT Chemistry W. . . . . . . . . . . . . . . . . . $195 675/Chlamydia/GC (EIA, DNA ) . . . . . . . . . . . $378 diff-Sysmex . . . . . . . . . . . . . . . . . . . . . . . . . . . $372 833/Waived Chemistry Panel A W . . . . . . . . . . $81 230/Blood Cell Id A. . . . . . . . . . . . . . . . . . . . . . . $48 678/Dermatophyte Culture . . . . . . . . . . . . . . . $282 835/Serum Alcohol/Acetone. . . . . . . . . . . . . . $252 231/Blood Cell Id. . . . . . . . . . . . . . . . . . . . . . . . $138 680/Resp. Antigen DetectionW. . . . . . . . . . . . $213 836/Ammonia. . . . . . . . . . . . . . . . . . . . . . . . . . . $180 240/Reticulocyte Count . . . . . . . . . . . . . . . . . . $243 681/Resp. Antigen Detection . . . . . . . . . . . . . $321 838/Blood Lead W. . . . . . . . . . . . . . . . . . . . . . . $222 247/Sed Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . $195 682/C. diff/Rotavirus Ag Detection.. . . . . . . . $291 841/Neonatal Bilirubin . . . . . . . . . . . . . . . . . . . $243 248/Sed Rate-Sedimat15. . . . . . . . . . . . . . . . . $195 683/Cryptosporidium/ 845/Cardiac Markers. . . . . . . . . . . . . . . . . . . . . $333 250/Body Fluid/Cell Ct/Crystals. . . . . . . . . . . $231 846/BNP/D-Dimer. . . . . . . . . . . . . . . . . . . . . . $237 Giardia lamblia Ag Detection . . . . . . . . . . . $342 847/Blood Gases . . . . . . . . . . . . . . . . . . . . . . . $324 COAGULATION 686/Legionella Antigen Detection. . . . . . . . . $261 850/Glycohemoglobin . . . . . . . . . . . . . . . . . . . $210 320/Coagulation . . . . . . . . . . . . . . . . . . . . . . . . $228 687/Strep pneumoniae Antigen Detection... $267 851/Afinion Glycohemoglobin . . . . . . . . . . . . $225 324/Roche CoaguChek XS INR W . . . . . . . . . $213 690/PVA Slides A. . . . . . . . . . . . . . . . . . . . . . . . $180 854/SHBG/Testosterone. . . . . . . . . . . . . . . . . . $342 328/i-STAT Prothrombin Time. . . . . . . . . . . . . $369 691/Parasitology . . . . . . . . . . . . . . . . . . . . . . . . $345 859/PSA A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $69 330/CoaguChek XS PLUS/Pro PT/INR. . . . . . $321 692/Bacterial Vaginosis W. . . . . . . . . . . . . . . . $192 860/Endocrinology/Hematology/Oncol . . . . $249 331/CoaguChek XS PLUS/Pro PT/INR W. . . . $213 693/Trichomonas vaginalisW. . . . . . . . . . . . . . $192 861/PSA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $156 695/MRSA Culture. . . . . . . . . . . . . . . . . . . . . . . $297 862/Tumor Markers. . . . . . . . . . . . . . . . . . . . . . $399 BLOOD BANK 863/Endocrinology 2. . . . . . . . . . . . . . . . . . . . . $219 451/ABO & Rh Factor (D Type). . . . . . . . . . . . $309 IMMUNOLOGY 864/Thyroid Antibodies. . . . . . . . . . . . . . . . . . $261 452/Blood Bank 1 . . . . . . . . . . . . . . . . . . . . . . . $414 750/Immunology Module . . . . . . . . . . . . . . . . $333 865/Serum hCG. . . . . . . . . . . . . . . . . . . . . . . . . $198 453/Blood Bank 2 . . . . . . . . . . . . . . . . . . . . . . . $444 751/Rheumatology Module. . . . . . . . . . . . . . . $252 866/Serum hCG A. . . . . . . . . . . . . . . . . . . . . . . . $99 URINALYSIS & PPM 755/Infectious Mono W. . . . . . . . . . . . . . . . . . . $135 868/Urine Drug Screening—Qual . . . . . . . . . . $240 761/Infect Mono/Rheumatoid Factor. . . . . . . $315 870/Whole Blood Glucose. . . . . . . . . . . . . . . . $282 530/Urinalysis. . . . . . . . . . . . . . . . . . . . . . . . . . . $138 762/Infectious Mono. . . . . . . . . . . . . . . . . . . . . $213 871/Whole Blood Glucose W . . . . . . . . . . . . . $180 531/Urinalysis Dipstick. . . . . . . . . . . . . . . . . . . $114 872/Urine Chemistry. . . . . . . . . . . . . . . . . . . . . $249 532/Urine Sed Id . . . . . . . . . . . . . . . . . . . . . . . . $129 763/Rheumatoid Factor . . . . . . . . . . . . . . . . . . $207 873/Ethyl Glucuronide A . . . . . . . . . . . . . . . . . . $78 533/Urine Sed Id A . . . . . . . . . . . . . . . . . . . . . . . $36 764/CRP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $129 874/Adulterated Urine A . . . . . . . . . . . . . . . . . . $93 534/PPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $141 765/HS-CRP. . . . . . . . . . . . . . . . . . . . . . . . . . . . $138 535/PPM A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$45 770/Specific Allergen Testing. . . . . . . . . . . . . $369 WAIVED TESTING PACKAGES 536/Microalbumin/Creatinine—Quant A . . . . . $96 771/Rubella. . . . . . . . . . . . . . . . . . . . . . . . . . . . . $207 901/Waived and PPM Package W . . . . . . . . . $333 537/Fecal Occult Blood A . . . . . . . . . . . . . . . . . $93 772/Syphilis Serology. . . . . . . . . . . . . . . . . . . . $228 902/Basic Waived and PPM Package W . . . . $291 538/KOH Slides. . . . . . . . . . . . . . . . . . . . . . . . . $183 773/Diagnostic Allergy. . . . . . . . . . . . . . . . . . . $369 539/Microalbumin/Creatinine—Quant. . . . . . $138 775/Viral Markers . . . . . . . . . . . . . . . . . . . . . . . $495 SUPPLIES & SERVICES 540/Urine hCG A. . . . . . . . . . . . . . . . . . . . . . . . . $30 541/Urine hCG. . . . . . . . . . . . . . . . . . . . . . . . . . $105 776/CRP A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $63 108/MLE Program Binder. . . . . . . . . . . . . . . . . . $15 542/Fecal Occult Blood . . . . . . . . . . . . . . . . . . $132 777/HS-CRP A. . . . . . . . . . . . . . . . . . . . . . . . . . . . $69 121/1mL Pipette. . . . . . . . . . . . . . . . . . . . . . . . . . $25 780/H. pylori Antibody Detection. . . . . . . . . . $180 126/Pipette Pump . . . . . . . . . . . . . . . . . . . . . . . . $45 MICROBIOLOGY 781/Mycoplasma Antibody . . . . . . . . . . . . . . . $171 142/G2 NIR Subscription . . . . . . . . . . . . . . . . . $240 630/Bacteriology 1 . . . . . . . . . . . . . . . . . . . . . . $351 782/ANA Panel. . . . . . . . . . . . . . . . . . . . . . . . . . $291 640/Bacteriology 2 . . . . . . . . . . . . . . . . . . . . . . $333 783/ANA Panel A. . . . . . . . . . . . . . . . . . . . . . . . $222 641/Throat Culture . . . . . . . . . . . . . . . . . . . . . . $324 784/Complement/Immunoglobulins. . . . . . . $249 643/Urine Culture . . . . . . . . . . . . . . . . . . . . . . . $324 790/Anti-HIV W. . . . . . . . . . . . . . . . . . . . . . . . . . $183 645/Urine/Throat Culture. . . . . . . . . . . . . . . . . $327 791/Anti-HIV. . . . . . . . . . . . . . . . . . . . . . . . . . . . $309 646/Genital Culture. . . . . . . . . . . . . . . . . . . . . . $324 647/Urine Culture/Presump.ID/CC. . . . . . . . . $363 34 Medical Laboratory Evaluation 2021 acponline.org/mle
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 2021 MLE Proficiency Testing Order Form CTLG 1 □ New Enrollee 7 □ Activate Auto Renewal at no charge. □ Renewing Participant: MLE ID #_______________________ Module # Description Price 100 Annual Admin Fee $90 2 Bill to: (please print clearly or type) Contact______________________________________________ Facility Name_________________________________________ Address_____________________________________________ ____________________________________________________ City_______________________ State______ ZIP__________ Country (other than U.S.)______________________________ Phone_______________________ Fax_____________________ E-mail_______________________________________________ Note: An additional shipping fee may apply. 3 Lab Director__________________________________________ Contact MLE Customer Service for details. 4 CLIA ID#_____________________________________________ 8 Amount Due Total Cost of Items Above = $____________ 5 Ship To: (no PO boxes for kit delivery) Discount Code ____________ □ Same as “bill to” address. (Please choose only one applicable code from page 37) Contact______________________________________________ + Shipping Fee (if applicable) $____________ Facility Name_________________________________________ Total Amount Due = $____________ Address_____________________________________________ ____________________________________________________ 9 Payment Options City_______________________ State______ ZIP__________ (Tax ID # 23-1520302) (DUNS #: 071625974) Country (other than U.S.)______________________________ □ Purchase Order #____________________________________ Phone_______________________ Fax_____________________ □ Send Invoice E-mail_______________________________________________ (Net 30 days. Payment by check or credit card—Visa □ Ship kit to different address (attach information) or Mastercard accepted). Overdue accounts are subject to holds and/or cancellations. 6 Send a copy of my PT results to: 10 How did you hear about us?__________________________ □ CMS (Provide CLIA ID# in section 4) 11 Laboratory Type:____________________________________ □ State Agency ID#____________________________________ □ COLA ID#___________________________________________ □ TJC/HCO ID#________________________________________ Fax: 1-202-835-0440 □ Technical Consultant (attach name, address and email) E-mail: mle@acponline.org 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. Take note: Cancel a module IN WRITING at least 4 weeks prior to the upcoming shipment to avoid being charged. acponline.org/mle Medical Laboratory Evaluation 2021 35
2021 SHIP DATES M1: FEBRUARY 1 • M2: MAY 10 • M3: SEPTEMBER 13 36 Medical Laboratory Evaluation 2021 acponline.org/mle
MLE DISCOUNT OFFERS Your Solution to Savings Starts Here! Review the table below to see if you qualify for any of the discount offers. Write the Discount Code in section 8 of the PT Order Form. Discount Savings Description Eligibility Code Requirements Ongoing Discounts (applied each year enrolled in MLE) ACP Save $90 ACP Members • Current in or new to MLE and ACP Multisite *Save 5% Multisite • Current in or new to MLE • Must have 5 or more enrolled labs Consultant *Save 5% Consultant affiliation • Current in or new to MLE • Order must indicate independent consultant • Consultant must have 5 or more enrolled labs Goverment *Save 10% State and Federal • Current in or new to MLE agencies (including FQHC and IHS) Ongoing Discounts (applied for 2021 program only) COLA Save $90 COLA accredited For • COLA accredited and new to MLE add’l benefits, visit: www.acponline.org/ mle/acp-cola NEW Save $90 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 is available online. Visit acponline.org/mle
Proficiency Testing at its Best. What’s New for 2021 NEW MODULES Module No. Description Catalog Page No. 651 Miscellaneous Cultures - Add-On 15 691 Parasitology 17 MODULE RECONFIGURATIONS Module No. Description Catalog Page No. 690 PVA Slides-Add-on 17 860 Prealbumin (now included) 26 25 Massachusetts Avenue NW, Suite 700 Washington, DC 20001-7401 MD9333-1
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