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2022 Proficiency Testing Catalog Approved by: CMS, COLA, TJC, U.S. State Agencies and International regulatory bodies.

Proficiency Testing at its Best

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Page 1: Proficiency Testing at its Best

2022Proficiency Testing Catalog

Approved by: CMS, COLA, TJC, U.S. State Agencies and International regulatory bodies.

Proficiency Testing at its Best.

Page 2: Proficiency Testing at its Best

Expert Customer ServiceEnjoy the best-in-class customer service experience with personalized care to support you from module selection to result evaluation.

What you can expect:• Response to your call within two hours

(during standard business hours)• Help in choosing test modules• Verification of orders within one week

Enrollment/Renewal of Proficiency TestingEnroll early to ensure the availability of specimens for the 2022 program year. Once we process your order, you will be mailed an order verification for your review and signature.

How to OrderOnline• Visit aab-mle.org 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 TestingProvides laboratories with an option for immediate, on-demand proficiency testing, a complement to the regular scheduled proficiency testing. For more details on this service, see page 2.

AT A GLANCE

Contact Information p: 800-234-5315, option 3 (M-F, 9 a.m.- 5 p.m. ET) e: [email protected] f: 202-835-0440 w: aab-mle.org

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1 Medical Laboratory Evaluation 2022

Table of Contents

How to Order

2 Ordering

Module Descriptions & Test Index

3 Hematology 6 Coagulation7 Blood Bank8 Provider-Performed Microscopy 9 Urinalysis & Occult Blood

11 Waived Testing Packages12 Microbiology18 Immunology21 Chemistry29 SARS-CoV-231 Test Index

Other Products & Services

30 Supplies & E-notification Services30 Continuing Education & Publication

Ordering and Discounts

34 Price List35 Proficiency Testing Order Form

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.

Save Money! Price Matching for Unmatched Service.

See Inside Back Cover for MLE Discount OFFERS.

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2 Medical Laboratory Evaluation 2022

Ordering InformationMLE accepts enrollments throughout the year. Order early to ensure product specimen availability. If you are enrolling for the entire 2022 program, you should order by December 10, 2021 to ensure product specimen availability. You may enroll anytime during the program year depending on specimen availability at a prorated price.

Please call or email the MLE PT team for a quote or help selecting the appropriate modules for your laboratory.

• Phone: 800-234-5315, option 3

• Email: [email protected]

How To Order• Online at aab-mle.org

• Fax the completed order form included here (w/ PO if applicable) to: 202-835-0440

Next Steps

Order Verification: MLE will process your order and send you an Order Verification within one week for your review. Contact MLE for any corrections.

Invoice: Your invoice will follow within two weeks. Invoices may be paid by check, VISA or Mastercard. Billing terms are net 30 days. Tax ID: 94-6114214DUNS NO: 175337740

Non-Continental U.S. Orders: An additional $30 fee will be added per shipment ($90 annually), Alaska and Hawaii excluded.

Single Module Orders: An additional $20 shipping fee will be added per shipment ($60 annually).

NOTE: Overdue accounts are subject to holds and/or cancellations.

Automatic RenewalActivate Automatic Renewal to ensure uninterrupted yearly enrollment. Prior to the next program year, you will receive an Order Verification for review in late summer and your annual invoice in October. You may make any changes at this time.

Order Changes and CancellationsAll order changes/cancellations/additions must be made in writing. To avoid additional costs, MLE must be notified at least 4 weeks prior to the affected shipment date.

Module additions: Modules may be added throughout the year, depending on availability, at least 4 weeks prior to the next shipment at no additional cost. After that time, an addi-tional shipping fee will apply.

Module cancellations: Modules may be cancelled through-out the year. Cancellation requests received at least 4 weeks 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 shipment.

Analyte cancellation: To cancel an analyte(s), submit a Test Menu Deletion Form available on the MLE web site.

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 and subsequent shipments, if applicable. The annual admin-istration fee is non-refundable.

Automatic Renewal order cancellation: Written notification must be received no later than December 10, 2021 to avoid any charges for the upcoming year.

Off-Schedule Proficiency Testing 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 PTprogram.

Who Needs Off-Schedule Testing?

• Laboratories with unsuccessful performance 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 may be required for the lab to resume testing patients.

• Some laboratories use off-schedule PT to verify that corrective actions were effective. This service is available to every laboratory, regardless of MLE enrollment status.

Contact MLE Customer Service for information on cost and availability at 800-234-5315, option 3, or e-mail us at [email protected].

Failure to return the Order Verification form and/or not paying your invoice are NOT indications of cancellation. Notification must be submitted in writing.

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3 Medical Laboratory Evaluation 2022

Hematology

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

Pay close attention to instrument compatibility notes when selecting hematology modules. Questions? Contact MLE Customer Service. See the “Hematology Instrument List” online at aab-mle.org in the Enrollment Information & Forms section.

Continued on next page

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4 Medical Laboratory Evaluation 2022

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

Hematology (continued)

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5 Medical Laboratory Evaluation 2022

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

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6 Medical Laboratory Evaluation 2022

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

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7 Medical Laboratory Evaluation 2022

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

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8 Medical Laboratory Evaluation 2022

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.

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9 Medical Laboratory Evaluation 2022

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.

540 Urine hCG (Add On)...................................................................................$30 Same as 541. Only available with 530, 531.

Continued on next page

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10 Medical Laboratory Evaluation 2022

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.

537 Fecal Occult Blood (Add-On)....................................................................$93 Same as 542. Only available with 530, 531.

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11 Medical Laboratory Evaluation 2022

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) Hemoglobin (2) Urine Sediment (2) Hematocrit (2) Strep A Antigen (2) PPM (6) Whole Blood Glucose (2) Strep A Antigen Detection (2)

902 Basic Waived and PPM Package ...........................................................$291 Number of challenges noted in parentheses.

Fecal Occult Blood (2) PPM (6) Strep A Antigen Detection (2)

Waived Testing Packages

Urinalysis (1)Urine hCG (1)Urine Sediment (2)Whole Blood Glucose (2)

Urinalysis (1)Urine hCG (1)Urine Sediment (2)Whole Blood Glucose (2)

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12 Medical Laboratory Evaluation 2022

Microbiology

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

• 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.

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13 Medical Laboratory Evaluation 2022

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

Mircrobiology (continued)

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14 Medical Laboratory Evaluation 2022

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

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15 Medical Laboratory Evaluation 2022

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 each.Continued on next page

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16 Medical Laboratory Evaluation 2022

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.

Mircrobiology (continued)

Continued on next page

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17 Medical Laboratory Evaluation 2022

Parasitology

683 Cryptosporidium/Giardia lamblia Antigen Detection......................$342

Five challenges each. Cryptosporidium Giardia lamblia

690 PVA Slides (Add On)..............................................................................$180 Only available with 691. Zinc polyvinyl alcohol fixed glass slides for the identification of fecal parasites.

Two challenges.

691 Parasitology.............................................................................................$345 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

Mircrobiology (continued)

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18 Medical Laboratory Evaluation 2022

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

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19 Medical Laboratory Evaluation 2022

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.

Immunology (continued)

Continued on next page

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Immunology (continued)

781 Mycoplasma Antibody Detection.........................................................$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 large volume requirements. Does not include Total IgE. Allergen Specific IgE (14)

773 Diagnostic Allergy...................................................................................$369 Number of challenges noted in parentheses. Allergen Specific IgE (14) Total IgE (5)

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21 Medical Laboratory Evaluation 2022

Chemistry

810 Chemistry Module....................................................................................$384

Five challenges each. Albumin Glucose Alkaline Phosphatase Iron Alpha-fetoprotein Lactate (Lactic Acid) ALT (SGPT) LDH Amylase Lipase AST (SGOT) Magnesium Bilirubin, Direct Phosphorus Bilirubin, Total Potassium Calcium Protein, Total Chloride Sodium Cholesterol, HDL T3 Uptake Cholesterol, LDL - Calc Thyroxine (T4) Cholesterol, LDL – Direct TIBC - Calc Cholesterol, Total TIBC - Direct CO2 Triglyceride Cortisol Triiodothyronine (T3) Creatine Kinase (CK) TSH Creatinine UIBC - Direct Free T3 Urea Nitrogen Free Thyroxine (T4) Uric Acid GGT

Pay close attention to instrument compatibility notes when selecting any of the chemistry modules.

If you need any assistance, call MLE Customer Service at 800-234-5315, option 3, or e-mail us at [email protected].

Continued on next page

GlucoseIronLactate (Lactic Acid)LDHLipaseMagnesiumPhosphorusPotassiumProtein, TotalSodiumT3 UptakeThyroxine (T4)TIBC - CalcTIBC - DirectTriglycerideTriiodothyronine (T3)TSHUIBC- DirectUrea NitrogenUric Acid

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22 Medical Laboratory Evaluation 2022

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 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.

Chemistry (continued)

Continued on next page

Magnesium

Creatinine

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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

Chemistry (continued)

Continued on next page

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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

Chemistry (continued)

Continued on next page

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25 Medical Laboratory Evaluation 2022

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

Chemistry (continued)

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26 Medical Laboratory Evaluation 2022

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.Continued on next page

Chemistry (continued)

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27 Medical Laboratory Evaluation 2022

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

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28 Medical Laboratory Evaluation 2022

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 Amphetamines MDMA Amphetamines/ Meperidine Methamphetamines Methadone Barbiturates Methamphetamines Benzodiazepines Methanol Buprenorphine Methaqualone Cannabinoids (THC) 6-Monoacetylmorphine Carisoprodol Opiates (Morphine Trihydrate) Cocaine Metabolites Oxycodone Cotinine Phencyclidine EDDP Propoxyphene Ethanol (Alcohol) Tramadol Fentanyl Tricyclic Antidepressants Hydrocodone Zolpidem

Continued on next page

Chemistry (continued)

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29 Medical Laboratory Evaluation 2022

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

SARS-CoV-2

688 SARS-CoV-2 Antigen Detection.............................................................$321

Two challenges.

689 SARS-CoV-2 Molecular Detection.........................................................$345

Two challenges.

792 SARS-CoV-2 Serology.............................................................................$300

Two challenges.

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30 Medical Laboratory Evaluation 2022

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 [email protected] 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 CEexpress courses are provided free of charge to MLE participants. Call MLE at 800-234-5315, option 3 or e-mail us at [email protected] to learn more.

Publications

142 National Intelligence Report Subscription..................................................................................$240

Monthly newsletter covering government policy for diagnostic testing and related medical services.

Other Products & Services

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31 Medical Laboratory Evaluation 2022

CMS regulated analytes for CLIA purposes are in bold

ABO Group ...................................................................................7Acetaminophen, serum ........................................................... 25Acetaminophen, urine ............................................................. 28Acetone ...................................................................................... 25Adulterated Urine ..................................................................... 29Affirm VPIII (DNA) ..................................................................... 16Albumin ...............................................................................21, 22Alcohol, serum .......................................................................... 25Alcohol, urine ............................................................................ 28Alkaline Phosphatase ........................................................21, 22Allergy Testing .......................................................................... 20Alpha-fetoprotein (AFP) ....................................................21, 23ALT (SGPT) ..........................................................................21, 22Ammonia ................................................................................... 25Amphetamines .......................................................................... 28Amphetamines/Methamphetamines ..................................... 28Amylase, serum ..................................................................21, 22Amylase, urine ........................................................................... 28Anti-dsDNA................................................................................ 19Anti-HAV .................................................................................... 20Anti-HBc ..................................................................................... 20Anti-HBs ..................................................................................... 20Anti-HCV .................................................................................... 20Anti-HIV ...................................................................................... 20Anti-RNP ..................................................................................... 19Anti-RNP/Sm .............................................................................. 19Anti-SSA ..................................................................................... 19Anti-SSA/SSB ............................................................................. 19Anti-SSB ..................................................................................... 19Anti-Sm ....................................................................................... 19Anti-Streptolysin O (ASO) ....................................................... 18Antibody Identification ..............................................................7Antimicrobial Susceptibility Testing ....................... 12, 13, 14Antinuclear Antibody (ANA) ................................................... 19AST (SGOT) .........................................................................21, 22Automated Differential ........................................................ 3, 4Bacterial Vaginosis ................................................................... 16Barbiturates ............................................................................... 28Benzodiazepines ....................................................................... 28Beta (ß)-2 Microglobulin .......................................................... 27Bilirubin, Total .............................................................. 21, 22, 23Bilirubin, Direct ............................................................ 21, 22, 23Bilirubin, Neonatal ................................................................... 23Bilirubin, urine ...................................................................... 9, 11Blood Cell Identification ....................................................... 3, 5Blood Culture ......................................................................12, 15Blood Gases .............................................................................. 24Blood/Hemoglobin, urine .................................................. 9, 11

Blood Smear, parasitology ..................................................... 17BNP ........................................................................................... 25Buprenorphine .......................................................................... 28C-Peptide ................................................................................... 26C-Reactive Protein (CRP) ...................................................18, 19C-Reactive Protein, high sensitivity (HS-CRP) ....................... 19CA 125 ....................................................................................... 27CA 15-3 ...................................................................................... 27CA 19-9 ...................................................................................... 27CA 27/29 .................................................................................... 27Calcium, serum ...................................................................21, 22Calcium, urine ........................................................................... 28Calcium, Ionized ....................................................................... 24Candida, Affirm VPIII(DNA) ..................................................... 16Cannabinoids (THC) ................................................................. 28Carbamazepine ........................................................................ 25Carisoprodol ............................................................................. 28CEA .....................................................................................26, 27C. difficile, Antigen Detection ................................................ 15Chlamydia (EIA/DNA) .............................................................. 15Chloride, serum ........................................................... 21, 22, 24Chloride, urine .......................................................................... 28Cholesterol, HDL ........................................................ 21, 22, 23Cholesterol, LDL ......................................................... 21, 22, 23Cholesterol, Total ....................................................... 21, 22, 23CK-MB ........................................................................................ 25CO2 .....................................................................................21, 22Cocaine Metabolites ................................................................ 28Colony Count ......................................................................13, 14Compatibility Testing .................................................................7Complement C3 ....................................................................... 19Complement C4 ....................................................................... 19Cortisol .................................................................................21, 23Cotinine ...................................................................................... 28Creatine Kinase (CK) .........................................................21, 22Creatinine, serum ........................................................ 21, 22, 24 Creatinine, urine .......................................................... 10, 28, 29Crossmatch ...................................................................................7Cryptosporidium, Antigen Detection .................................... 17Crystal Screening .........................................................................5CSF Culture .........................................................................12, 15D-Dimer ...................................................................................... 25Dermatophyte Culture ............................................................ 16DHEA-S....................................................................................... 26Digoxin ...................................................................................... 25Drug Screen, Urine ................................................................... 28Ear Culture...........................................................................12, 15EDDP .......................................................................................... 28

Test Index

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32 Medical Laboratory Evaluation 2022

CMS regulated analytes for CLIA purposes are in bold

Eosinophils, Nasal (PPM) ..................................................... 8, 11Estradiol ..................................................................................... 26Ethanol, urine ............................................................................ 28Ethyl Glucuronide (EtG) ........................................................... 29Eye Culture ..........................................................................12, 15Fecal Leukocytes (PPM) ....................................................... 8, 11Fecal Occult Blood .............................................................10, 11Fecal Suspension, parasitology ............................................. 17Fentanyl ...................................................................................... 28Fern Testing (PPM) ............................................................... 8, 11Ferritin ........................................................................................ 26Fibrinogen ....................................................................................6Fluid Cell Count ...........................................................................5Folate ......................................................................................... 26FSH ........................................................................................... 26Gardnerella, Affirm VPIII (DNA) ............................................. 16GC (EIA/DNA) ........................................................................... 15Genital Culture ...................................................................12, 13Gentamicin ................................................................................ 25GGT .....................................................................................21, 22Giardia lamblia, Antigen Detection ....................................... 17Glucose, serum ........................................................... 21, 22, 24Glucose, urine .................................................................9, 11, 28Glucose, whole blood................................................. 11, 23, 27Glycohemoglobin ..................................................................... 27Gram Stain .................................................................... 12, 13, 14Gram Stain Morphology ............................................. 12, 13, 14Granulocytes, Immature .............................................................4HBeAg ........................................................................................ 20HBsAg ........................................................................................ 20hCG, serum ..........................................................................26, 27hCG, urine ............................................................................ 9, 11Hematocrit .................................................................. 3, 4, 11, 24Hemoglobin ........................................................... 3, 4, 9, 11, 24Hemoglobin A1C (Glycohemoglobin) ................................... 27Homocysteine ........................................................................... 26H. pylori Antibody Detection .................................................. 19Hydrocodone ............................................................................ 28i-STAT Chemistry ...................................................................... 24IgA, Total ................................................................................... 19IgE, Total .................................................................................... 20IgG, Total ................................................................................... 19IgM, Total .................................................................................. 19Infectious Mononucleosis ....................................................... 18Influenza A, Antigen Detection .............................................. 17Influenza B, Antigen Detection .............................................. 17INR ..............................................................................................6Insulin ......................................................................................... 26Iron .....................................................................................21, 22Ketones, urine ...................................................................... 9, 11KOH Vaginal Prep (PPM) ..................................................... 8, 11

KOH Skin Prep (Slides) ......................................................... 8, 16Lactate (Lactic Acid) ................................................... 21, 22, 24LDH ........................................................................................... 21Lead, Blood ............................................................................... 25Legionella, Antigen Detection ............................................... 15Leukocyte Esterase, urine .................................................... 9, 11LH ........................................................................................... 26Lipase ......................................................................................... 21Lithium ....................................................................................... 25LSD ........................................................................................... 28Magnesium, serum .............................................................21, 22Magnesium, urine ..................................................................... 28MDMA ........................................................................................ 28Meperidine ................................................................................ 28Methadone ................................................................................ 28Methamphetamines ................................................................. 28Methanol .................................................................................... 28Methaqualone ........................................................................... 28MHA-TP ...................................................................................... 20Microalbumin ..................................................................9, 10, 11Miscellaneous Culture .......................................................12, 156-Monoacetylmorphine ........................................................... 28MRSA Culture............................................................................ 15Mycoplasma Antibody Detection ........................................... 20Myoglobin.................................................................................. 25Nasal Eosinophils (PPM) ...................................................... 8, 11Nitrite, urine .....................................................................9, 11, 29NT-proBNP ................................................................................ 25Occult Blood, Fecal ............................................................10, 11Opiates (Morphine Trihydrate) ............................................... 28Osmolality, urine ....................................................................... 28Oxidants, urine .......................................................................... 29Oxycodone ................................................................................ 28Parasitology .............................................................................. 17Parathyroid hormone (PTH) ..................................................... 26Partial Thromboplastin Time (APTT) or (PTT) .........................6pCO2 .......................................................................................... 24pH ........................................................................................... 24pH, urine ................................................................................ 9, 11Phencyclidine ............................................................................ 28Phenobarbital ........................................................................... 25Phenytoin ................................................................................... 25Phosphorus, serum .............................................................21, 22 Phosphorus, urine ..................................................................... 28Pinworms (PPM) .................................................................... 8, 11Platelet Count ......................................................................... 3, 4pO2 ........................................................................................... 24Potassium, serum ........................................................ 21, 22, 24Potassium, urine ........................................................................ 28Prealbumin ................................................................................ 26Progesterone ............................................................................. 26

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33 Medical Laboratory Evaluation 2022

CMS regulated analytes for CLIA purposes are in bold

Prolactin ..................................................................................... 26Propoxyphene ........................................................................... 28Protein, Total, serum ..........................................................21, 22Protein, Total, urine ........................................................9, 11, 28Prothrombin Time (PT) ...............................................................6Provider-Performed Microscopy (PPM) ............................. 8, 11PSA, Total .............................................................................26, 27PSA, Free ................................................................................... 27PVA Slide, parasitology ........................................................... 17Red Blood Cell Count ............................................................ 3, 4Reticulocyte Count ......................................................................5Rheumatoid Factor (RA) ......................................................... 18Rh Factor (D Type) ......................................................................7Rotavirus, Antigen Detection ................................................. 15RPR ........................................................................................... 20RSV, Antigen Detection ........................................................... 17Rubella, IgG............................................................................... 19Salicylate .................................................................................... 25SARS-CoV-2 Antigen ................................................................ 29SARS-CoV-2 Molecular ............................................................ 29SARS-CoV-2 Serology .............................................................. 29Scabies (PPM) ........................................................................ 8, 11Sedimentation Rate .....................................................................5SHBG .......................................................................................... 26Sodium, serum ............................................................. 21, 22, 24Sodium, urine ............................................................................ 28Specific Gravity, urine ....................................................9, 11, 29Sperm (PPM) .......................................................................... 8, 11Sputum Culture...................................................................12, 15Stool Culture .......................................................................12, 15Strep A Antigen Detection ........................................ 11, 12, 14Strep pneumoniae, Antigen Detection ................................. 15Syphilis Serology ...................................................................... 20T3, Free ................................................................................21, 23T3, Total ...............................................................................21, 23T3 Uptake ............................................................................21, 23T4, Free ................................................................................21, 23T4, Total ...............................................................................21, 23tCO2 ........................................................................................... 24Testosterone .............................................................................. 26Testosterone, Bioavailable ...................................................... 26

Testosterone, Free .................................................................... 26Theophylline ............................................................................. 25Throat Culture .....................................................................12, 14Thyroglobulin ............................................................................ 27Thyroglobulin antibody ........................................................... 27Thyroid Peroxidase antibody (TPO) ...................................... 27TIBC .....................................................................................21, 22Tramadol .................................................................................... 28Transferrin .................................................................................. 26Treponema pallidum (TPA) ..................................................... 20Trichomonas vaginalis, Affirm VPIII (DNA) ............................ 16Trichomonas vaginalis (OSOM-Waived) ............................... 16Tricyclic Antidepressants ......................................................... 28Triglyceride .................................................................. 21, 22, 23Troponin I .................................................................................. 25Troponin T ................................................................................. 25TSH .....................................................................................21, 23UIBC .....................................................................................21, 22Unexpected Antibody Detection ..............................................7Urea Nitrogen (BUN), serum .......................................21,22, 24Urea Nitrogen (BUN), urine ..................................................... 28Uric Acid, serum .................................................................21, 22Uric Acid, urine ......................................................................... 28Urine Chemistry ........................................................................ 28Urine Culture ................................................................ 12, 13, 14Urine Dipstick ..................................................................9, 10, 11Urine Drug Screen .................................................................... 28Urine hCG .............................................................................. 9, 11Urine Sediment Identification .......................................9, 10 ,11Urobilinogen, urine .............................................................. 9, 11Valproic Acid ............................................................................. 25Vancomycin ............................................................................... 25VDRL ........................................................................................... 20Vitamin B12 ............................................................................... 26Vitamin D, 25-Hydroxy ............................................................. 26Waived and PPM packages ..................................................... 11Wet Mount Preparations (PPM) .......................................... 8, 11White Blood Cell Count ........................................................ 3, 4Wound Culture ...................................................................12, 15Zolpidem .................................................................................... 28

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34 Medical Laboratory Evaluation 2022

MLE Proficiency Testing Price List

Code/Description *Full Year

HEMATOLOGY

210/Hematology . . . . . . . . . . . . . . . . . . . . . . . $279212/Hemoglobin/Hematocrit/WBC . . . . . . . $237213/Hemoglobin/Hematocrit W . . . . . . . . . . $177215/Hemoglobin/Glucose—HemoCue . . . . . $195223/Abbott 5-Part Diff . . . . . . . . . . . . . . . . . . . $372224/Sysmex 3-Part Diff . . . . . . . . . . . . . . . . . . $330225/Hematology 3-Part Diff . . . . . . . . . . . . . . $321226/Hematology 5-Part Diff . . . . . . . . . . . . . . $372228/Hematology 5-Part diff- ACT 5 & Pentra 60C+ . . . . . . . . . . . . . . . . . . $372229/Hematology 5 or 6-Part diff-Sysmex . . . . . . . . . . . . . . . . . . . . . . . . . . $372230/Blood Cell Id A . . . . . . . . . . . . . . . . . . . . . . .$48231/Blood Cell Id . . . . . . . . . . . . . . . . . . . . . . . $138240/Reticulocyte Count . . . . . . . . . . . . . . . . . $243247/Sed Rate . . . . . . . . . . . . . . . . . . . . . . . . . . $195248/Sed Rate-Sedimat15 . . . . . . . . . . . . . . . . $195250/Body Fluid/Cell Ct/Crystals . . . . . . . . . . $231

COAGULATION

320/Coagulation . . . . . . . . . . . . . . . . . . . . . . . $228324/Roche CoaguChek XS INR W . . . . . . . . $213328/i-STAT Prothrombin Time . . . . . . . . . . . . $369330/CoaguChek XS PLUS/Pro PT/INR . . . . . $321331/CoaguChek XS PLUS/Pro PT/INR W . . . $213

BLOOD BANK

451/ABO & Rh Factor (D Type) . . . . . . . . . . . $309452/Blood Bank 1 . . . . . . . . . . . . . . . . . . . . . . $414453/Blood Bank 2 . . . . . . . . . . . . . . . . . . . . . . $444

URINALYSIS & PPM

530/Urinalysis . . . . . . . . . . . . . . . . . . . . . . . . . . $138531/Urinalysis Dipstick . . . . . . . . . . . . . . . . . . $114532/Urine Sed Id . . . . . . . . . . . . . . . . . . . . . . . $129533/Urine Sed Id A . . . . . . . . . . . . . . . . . . . . . . .$36534/PPM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $141535/PPM A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$45536/Microalbumin/Creatinine—Quant A . . . . .$96537/Fecal Occult Blood A . . . . . . . . . . . . . . . . .$93538/KOH Slides . . . . . . . . . . . . . . . . . . . . . . . . $183539/Microalbumin/Creatinine—Quant . . . . . $138540/Urine hCG A . . . . . . . . . . . . . . . . . . . . . . . . .$30541/Urine hCG . . . . . . . . . . . . . . . . . . . . . . . . . $105542/Fecal Occult Blood . . . . . . . . . . . . . . . . . $132

MICROBIOLOGY

630/Bacteriology 1 . . . . . . . . . . . . . . . . . . . . . $351640/Bacteriology 2 . . . . . . . . . . . . . . . . . . . . . $333641/Throat Culture . . . . . . . . . . . . . . . . . . . . . $324643/Urine Culture . . . . . . . . . . . . . . . . . . . . . . $324

645/Urine/Throat Culture . . . . . . . . . . . . . . . . $327

646/Genital Culture . . . . . . . . . . . . . . . . . . . . . $324

647/Urine Culture/Presump.ID/CC . . . . . . . . $363

Code/Description *Full Year

648/Colony Count . . . . . . . . . . . . . . . . . . . . . . $228

650/Gram Stain . . . . . . . . . . . . . . . . . . . . . . . . $204

651/Miscellaneous Culture A . . . . . . . . . . . . . $189

652/Throat Culture/Urine Presump ID . . . . . . . . . . . . . . . . . . . . . . . . . . $363

653/Genital/Urine Culture . . . . . . . . . . . . . . . $327

660/Strep A Antigen Detection . . . . . . . . . . . $201

662/Strep A AntigenW . . . . . . . . . . . . . . . . . . $132

668/Affirm VP Antigen Testing . . . . . . . . . . . $399

673/Chlamydia/GC A . . . . . . . . . . . . . . . . . . . $189

675/Chlamydia/GC (EIA, DNA ) . . . . . . . . . . $378

678/Dermatophyte Culture . . . . . . . . . . . . . . $282

680/Resp. Antigen DetectionW . . . . . . . . . . . $213

681/Resp. Antigen Detection . . . . . . . . . . . . $321

682/C. diff/Rotavirus Ag Detection. . . . . . . . $291

683/Cryptosporidium/

Giardia lamblia Ag Detection . . . . . . . . . . $342

686/Legionella Antigen Detection . . . . . . . . $261

687/Strep pneumoniae Antigen Detection.. $267

688/SARS-CoV-2 Antigen Detection . . . . . . $321

689/SARS-CoV-2 Molecular Detection . . . . . $345

690/PVA Slides A . . . . . . . . . . . . . . . . . . . . . . . $180

691/Parasitology . . . . . . . . . . . . . . . . . . . . . . . $345

692/Bacterial Vaginosis W . . . . . . . . . . . . . . . $192

693/Trichomonas vaginalisW . . . . . . . . . . . . . $192

695/MRSA Culture . . . . . . . . . . . . . . . . . . . . . . $297

IMMUNOLOGY

750/Immunology Module . . . . . . . . . . . . . . . $333

751/Rheumatology Module . . . . . . . . . . . . . . $252

755/Infectious Mono W . . . . . . . . . . . . . . . . . . $135

761/Infect Mono/Rheumatoid Factor . . . . . . $315

762/Infectious Mono . . . . . . . . . . . . . . . . . . . . $213

763/Rheumatoid Factor . . . . . . . . . . . . . . . . . $207

764/CRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $129

765/HS-CRP. . . . . . . . . . . . . . . . . . . . . . . . . . . . $138

770/Specific Allergen Testing . . . . . . . . . . . . $369

771/Rubella . . . . . . . . . . . . . . . . . . . . . . . . . . . . $207

772/Syphilis Serology . . . . . . . . . . . . . . . . . . . $228

773/Diagnostic Allergy . . . . . . . . . . . . . . . . . . $369

775/Viral Markers . . . . . . . . . . . . . . . . . . . . . . $495

776/CRP A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$63

777/HS-CRP A . . . . . . . . . . . . . . . . . . . . . . . . . . . .$69

780/H. pylori Antibody Detection . . . . . . . . . $180

781/Mycoplasma Antibody . . . . . . . . . . . . . . $171

782/ANA Panel . . . . . . . . . . . . . . . . . . . . . . . . . $291

783/ANA Panel A . . . . . . . . . . . . . . . . . . . . . . . $222

784/Complement/Immunoglobulins . . . . . . $249790/Anti-HIV W . . . . . . . . . . . . . . . . . . . . . . . . . $183791/Anti-HIV . . . . . . . . . . . . . . . . . . . . . . . . . . . $309792/SARS-CoV-2 Serology . . . . . . . . . . . . . . . $300

Code/Description *Full Year

CHEMISTRY

810/Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . $384811/Lipid Panel/GlucoseW . . . . . . . . . . . . . . $192812/Waived Chemistry Panel W . . . . . . . . . . $234813/Comp. Metabolic Panel . . . . . . . . . . . . . $309817/i-STAT Chemistry 1 . . . . . . . . . . . . . . . . . $390818/i-STAT Chemistry 2 . . . . . . . . . . . . . . . . . $270824/Thyroid Profile . . . . . . . . . . . . . . . . . . . . . $258826/Lipid Profile . . . . . . . . . . . . . . . . . . . . . . . . $246831/Therapeutic Drugs A . . . . . . . . . . . . . . . . . .$66832/i-STAT Chemistry W . . . . . . . . . . . . . . . . . $195833/Waived Chemistry Panel A W . . . . . . . . . .$81835/Serum Alcohol/Acetone . . . . . . . . . . . . . $252836/Ammonia . . . . . . . . . . . . . . . . . . . . . . . . . . $180838/Blood Lead W . . . . . . . . . . . . . . . . . . . . . . $222841/Neonatal Bilirubin . . . . . . . . . . . . . . . . . . $243845/Cardiac Markers . . . . . . . . . . . . . . . . . . . . $333846/BNP/D-Dimer . . . . . . . . . . . . . . . . . . . . . . $237847/Blood Gases . . . . . . . . . . . . . . . . . . . . . . $324850/Glycohemoglobin . . . . . . . . . . . . . . . . . . $210851/Afinion Glycohemoglobin . . . . . . . . . . . $225854/SHBG/Testosterone . . . . . . . . . . . . . . . . . $342859/PSA A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .$69860/Endocrinology/Hematology/Oncol . . . $249861/PSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $156862/Tumor Markers . . . . . . . . . . . . . . . . . . . . . $399863/Endocrinology 2 . . . . . . . . . . . . . . . . . . . . $219864/Thyroid Antibodies . . . . . . . . . . . . . . . . . $261865/Serum hCG . . . . . . . . . . . . . . . . . . . . . . . . $198866/Serum hCG A . . . . . . . . . . . . . . . . . . . . . . . .$99868/Urine Drug Screening—Qual . . . . . . . . . $240870/Whole Blood Glucose . . . . . . . . . . . . . . . $282871/Whole Blood Glucose W . . . . . . . . . . . . $180872/Urine Chemistry . . . . . . . . . . . . . . . . . . . . $249873/Ethyl Glucuronide A . . . . . . . . . . . . . . . . . .$78874/Adulterated Urine A . . . . . . . . . . . . . . . . . .$93

WAIVED TESTING PACKAGES

901/Waived and PPM Package W . . . . . . . . $333902/Basic Waived and PPM Package W . . . $291

SUPPLIES & SERVICES

108/MLE Program Binder . . . . . . . . . . . . . . . . . .$15121/1mL Pipette . . . . . . . . . . . . . . . . . . . . . . . . . .$25126/Pipette Pump . . . . . . . . . . . . . . . . . . . . . . . .$45142/G2 NIR Subscription . . . . . . . . . . . . . . . . $240

W=Waived • A=Add-On • *Enroll after the 1st event and prices are prorated by 1/3 per event.

Page 37: Proficiency Testing at its Best

2022 SHIP DATES M1: FEBRUARY 7 • M2: MAY 16 • M3: SEPTEMBER 12

35 Medical Laboratory Evaluation 2022

1 □ New Enrollee

□ Renewing Participant: MLE ID # _____________________

2 Bill to: (please print clearly or type)

Contact ____________________________________________

Facility Name ________________________________________

Address ____________________________________________

____________________________________________________

City_______________________ State________ ZIP__________

Country (other than U.S.) _____________________________

Phone_______________________ Fax ____________________

E-mail ______________________________________________

3 Lab Director _________________________________________

4 CLIA ID# ____________________________________________

5 Ship To: (no PO boxes for kit delivery)

□ Same as “bill to” address.

Contact ____________________________________________

Facility Name ________________________________________

Address ____________________________________________

____________________________________________________

City_______________________ State________ ZIP__________

Country (other than U.S.) _____________________________

Phone_______________________ Fax ____________________

E-mail ______________________________________________

□ Ship kit to different address (attach information)

6 Send a copy of my PT results to:

□ CMS (Provide CLIA ID# in section 4)

□ State Agency ID# __________________________________

□ COLA ID# __________________________________________

□ TJC/HCO ID# ______________________________________

□ Technical Consultant (attach name, address and email)

7 □ Activate Auto Renewal at no charge.

Module # Description Price

100 Annual Admin Fee $90

Note: An additional shipping fee may apply. Contact MLE Customer Service for details.

8 Amount Due

Total Cost of Items Above = $____________

Discount Code ____________

(Please choose only one applicable code from page 37)

+ Shipping Fee (if applicable) $____________

Total Amount Due = $____________

9 Payment Options

(Tax ID # 94-6114214) (DUNS #: 175337740)

□ Purchase Order # □ Send Invoice

(Net 30 days. Payment by check or credit card —Visa

or Mastercard accepted).

Overdue accounts are subject to holds and/or cancellations.

10 How did you hear about us?

___________________________________________________

11 Laboratory Type:

___________________________________________________

CTLG

Take note: Cancel a module IN WRITING at least 4 weeks prior to the upcoming shipment to avoid being charged.

Fax: 202-835-0440E-mail: [email protected]

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.

2022 MLE Proficiency Testing Order Form

Page 38: Proficiency Testing at its Best

2022 SHIP DATES M1: FEBRUARY 7 • M2: MAY 16 • M3: SEPTEMBER 12

36 Medical Laboratory Evaluation 2022

Page 39: Proficiency Testing at its Best

Price matching is available. Contact us at [email protected]

MLE DISCOUNT OFFERSYour Solution to Savings Starts Here!

*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.

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.

ACP

DiscountCode

Multisite

Consultant

Goverment

COLA

NEW

Savings Description EligibilityRequirements

Ongoing Discounts (applied each year enrolled in MLE)

Ongoing Discounts (applied for 2022 program only)

Save $90

*Save 5%

*Save 5%

*Save 10%

Save $90

Save $90

ACP Members

Multisite

Consultant affiliation

State and Federal agencies (including FQHC and IHS)

COLA accredited

New to MLE

• Current in or new to MLE and ACP

• Current in or new to MLE• Must have 5 or more enrolled labs

• Current in or new to MLE• Order must indicate independent consultant• Consultant must have 5 or more enrolled labs

• Current in or new to MLE

• COLA accredited and new to MLE

• Never enrolled in MLE• Minimum order of $500

Page 40: Proficiency Testing at its Best

25 Massachusetts Avenue NW, Suite 700Washington, DC 20001-7401

Proficiency Testing at its Best.

MLE0005

What’s New for 2022NEW MODULES

688 SARS-CoV-2 Antigen Detection 29

689 SARS-CoV-2 Molecular Detection 29

792 SARS-CoV-2 Serology 29

Module No. Description Catalog Page No.