XL-A 2015 Kit Instructions CAP 2015

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Customer Contact Center 800-323-4040 option 1 (domestic) or 001-847-832-7000 option 1 (international) 1

Important: Before You Begin

New for this Mailing

An MPV (fL) reporting area has been added to the result form.

Critical Handling and Storage Information

1. Module XUX13, Ruptured Fetal Membrane (XL-D and XL-G only):

a. Store specimens at 2 - 8°C.

Unopened stability: Specimens are stable for 28 days at 2 - 8°C.

Open stability: Use immediately.

b. Remove vials from the refrigerator and allow to warm to room temperature for 15 minutes before analyzing.

2. Modules XU and XU1 (XL-A and XL-G only):

a. Store specimens at 2 - 8°C.

b. Refrigerator temperature allows for the best specimen stability; however, specimens are stable at room temperature for up to 5 days after the ship date.

3. Immediately upon receipt, refrigerate all specimens at 2 - 8°C.

4. Some Survey programs are shipped with a cool pack. If the specimens arrive with a thawed cool pack, but the vials are cool to the touch, the manufacturer has assured the CAP that the specimens are stable.

5. The supernatant in these specimens may have a slight pink tinge. This does not indicate damage during shipment.

Reporting Code Changes

If you have ordered any of the following modules, check your master list(s), or result form, for code changes.

• XL5 • XU • XU1 • XU9 • XC • XC1

Critical Reporting Information.

1. Modules XH1, XH3, XH4, and XH6: A unit of measure (UOM) must be filled in for HGB, HCT, MCHC, and RDW challenges for proper evaluation.

2. For RDW, if your instrument is able to report RDW-CV or RDW-SD, use the reference ranges below:

• The RDW-CV reference range in adults is typically 11.0 - 15.0%.

• The RDW-SD reference range in adults is typically 36 - 47 fL.

Sysmex users: Continue to report RDW as RDW-SD.

3. RDW-CV (%) and RDW-SD (fL) are graded for all instruments.

XL-A 2015

Kit Instructions

EXCEL

^®

Hematology, Coagulation, Urinalysis

Important: See the Biohazard Warning at the end of these instructions.

Reporting Your Results

General Reporting Instructions

Failure to specify an instrument and calibrator code or the selection of an

inappropriate instrument may result in comparison with the wrong peer group and unacceptable performance.

1. For all regulated analytes:

• If your laboratory is discontinuing or beginning any testing, you must check your Analyte Reporting Selection (ARS) document to ensure no changes are needed.

If changes are needed, indicate the modifications and note that they are effective immediately on the document and submit to the CAP.

• A copy of your laboratory’s ARS with your current reporting preferences is available at cap.org via e-LAB Solutions™.

If you are unsure of which analytes your lab reports, click on Proficiency Testing/Quality Management > CMS Analyte Reporting Selections.

If your lab is accredited, click on Laboratory Accreditation > Activity Menu with PT Options.

• If you have any questions, please call the Customer Contact Center.

2. Each mailing, verify the accuracy of your reporting codes (eg, manufacturer, method, instrument, reagent) by reviewing the online result form or the Method Summary Page attached to the front of your result form.

3. Reporting Code Selection:

• If your method summary page states, “Please Provide a Valid Code,” if your code is listed incorrectly, or, if you have changed your methodology, review the master list for an appropriate code and enter it on the result form. If there is no master list, select the code directly on the result form.

• If you cannot find an appropriate code, select Other from the master list or result form and describe your method in the Use of Other section of the result form.

4. The inclusion of reporting codes on the result form(s) or master list(s) does not imply FDA approval.

5. For any testing that you do not routinely perform in your laboratory, leave all reporting areas for that test blank unless otherwise noted.

6. Exception Codes: If you must report an analytical problem for a test or individual analyte, leave the result area for that section blank and fill one of the following bubbles on the result form within that section. The exception code bubble that you fill in will apply only to the result area(s) left blank. Documentation on the use of these codes is the responsibility of the laboratory and should be kept internally.

• 11 Unable to analyze

Use code 11 to indicate why specimens were not analyzed (eg, instrument not functioning, reagents not available, specimen not viable).

• 22 Result is outside the method/instrument reportable range

Use code 22 if you obtain a high or low result outside the reportable range of your method or instrument. Do not use this code if there is the appropriate option to fill a bubble for a greater than or less than result.

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• 33 Specimen unsatisfactory

To use code 33, you must contact the CAP.

If you fill an exception code bubble and enter data on the result form, the data will be graded.

7. Corrections can be made at any time prior to the due date printed on the result form.

• Review all entries for accuracy prior to online approval or before sending by fax or mail.

• For results that are approved online, corrections must also be done online. Faxed or mailed corrections will not be accepted.

8. For Microscopy PT (blood cell or clinical microscopy), the review of photographs must be performed by a single individual who may seek assistance (of the

supervisor, lead tech, pathologist, etc.), if that is the normal process of patient slide review. After submission and receipt of PT results, a group review of the photographs provides an excellent education opportunity. For consistency, report all cell identification challenges from the photographs and not the online images.

Submitting Results

Enter your results online in four easy steps:

1. Opt In: Your laboratory must establish a laboratory web account to submit results online.

2. Request Account: Laboratory staff who will enter results online must first establish a personal web account.

3. Request Access: Once a personal web account is established, laboratory staff can request access to their laboratory’s information.

4. Enter Data: For help, view the online demo and user guide on cap.org. Results must be received at the CAP no later than midnight, Central Time by the due date on the result form. Results cannot be accepted if received after the due date.

Earn CE Credit With This Survey

Earn continuing education (CE) credit by participating in the education activity that will be included in the XL-A 2015 participant summary (PS). Detailed information will be provided with your PS.

Biohazard Warning

All EXCEL specimens should be treated as if potentially infectious and should be handled as if they are capable of transmitting disease.

EXCEL specimens are prepared from blood or other source material obtained from human donors or animals.

When working with EXCEL specimens, precautions should be taken to protect yourself and others from accidental exposure to infectious agents such as HIV, HBV, and HCV.

HIV can be transmitted through accidental parenteral inoculation, mucous membranes, or non-intact skin contact with HIV infected blood or body fluids. HBV and HCV can be transmitted through accidental parenteral inoculation, mucous membranes, non-intact skin contact, aerosolization or ingestion.

Precautions described in CDC and FDA recommendations and OSHA blood borne patho- gen rules should be followed at all times when handling EXCEL specimens and reagents.

Such precautions include the following:

• Gloves should be put on before opening the container and should be kept on throughout the period specimens are handled. Replace gloves if contaminated, or if their ability to function as a barrier is compromised.

Per the Federal Register

• Proficiency Testing (PT) specimens must be tested with the laboratory’s regular workload, using routine methods, and testing the PT specimens the same number of times it routinely tests patient specimens.

• If referral for testing is routinely performed for patient specimens, the practice cannot be followed for PT specimens. Referral is considered to be movement of the specimen from a laboratory with a CLIA identification number to another laboratory that has a different CLIA identification number.

• Laboratories must ensure that personnel do not share results or refer PT specimens for any reflex or testing outside their CLIA identification number.

Disclaimer

Survey specimens, their progeny, unmodified derivatives, or modifications thereof may not be transferred or incorporated into a program intended for sale. Survey specimens, their progeny, unmodified derivatives, or modifications thereof, reagents, and disposable equipment used in PT, when disposed of, should be autoclaved or incinerated and disposed of as hazardous waste.

Disposal must follow local regulations, if more stringent than regulations enforced by the CDC or the FDA.

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4 EXCEL Program 2015

• At high altitudes, specimens should be opened in a hood or biologic safety cabinet.

• There should be no eating, drinking, or smoking in the laboratory.

• Hands should be washed after removing gloves and before leaving the testing area.

• EXCEL specimens and reagents should be kept in separate refrigerators from those containing blood or blood components for transfusion.

• EXCEL specimens, reagents, and disposable equipment used in testing should be autoclaved or incinerated and disposed of as hazardous waste.

• The AFL survey material is intended for in vitro diagnostic use only by trained personnel. Disposal must follow local regulations, if more stringent than regulations enforced by the CDC or the FDA.

Warning: This mailing may contain chemicals known to the State of California to cause cancer, and to cause birth defects or other reproductive harm.

If there has been an accident in which you have been exposed to the EXCEL materials, please call the CAP Hot Line at 800-443-3244 (domestic) or

001-847-470-2812 (international) at any time. You can access Safety Data Sheets (SDS) (formerly known as MSDS) by logging on to cap.org and clicking on the Accreditation and Laboratory Improvement tab.

For Assistance

For replacement materials, please contact the CAP within 10 calendar days of the ship date for information. Provide your CAP number and contact information with all correspondence. Participants in countries serviced by a designated CAP distributor should contact their distributor’s customer service department.

Telephone: 800-323-4040 option 1

(Monday - Friday, 7:00 am – 5:30 pm US Central Time) International Participants: 001-847-832-7000 option 1 Email: [email protected]

Website: cap.org

Address: CAP Surveys Program 325 Waukegan Road Northfield, IL 60093-2750 USA

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Specific Specimen Testing/Handling Information

Centrifugal Hematology (QBC), Module XH6 and QBC Differential, Module XH7 QBC (XH6/XH7): Examine specimens for severe hemolysis. These specimens are stable for 7 days after receipt.

Important: Selecting the correct assay mode is necessary for the appropriate evaluation of your results.

For laboratories using the QBC Autoread, Autoread Plus, or QBC STAR, the identifi- cation of the QBC tube type is automatic.

• For Capillary Standard Tube and AccuTubes, test the tube in the “Control Mode.”

• For Venous Standard Tubes, test the tube in the “Insert QBC Tube (patient test) Mode.” Insert the tube and close the platform door to start the analysis.

• For QBC STAR, promptly insert tube into QBC STAR analyzer. Close analyzer door and press the start button.

Reading Instructions (for manual users only):

1. Move the tube inward until the tip of the arrow is at the interface between the green closure and red cells (1st reading). Press ENTER. The auxiliary white light will illuminate the tube.

2. Move the tube inward until the tip of the arrow is at the interface between the dark red cell layer and light red cell layer (2nd reading).

Press ENTER. The auxiliary white light will turn off.

3. Move the tube inward until the tip of the arrow is at the interface between the red cell layer and orange layer of Granulocytes (3rd reading). Press ENTER.

4. Move the tube inward until the tip of the arrow is at the interface between the orange layer and light green layer of Lymphocytes/

Monocytes (4th reading). Press ENTER.

5. Move the tube inward until the tip of the arrow is at the interface of the light green layer and orange-yellow Platelet layer (5th reading). Press ENTER.

6. Move the tube inward until the tip of the arrow is at the interface of the orange-yellow layer and clear green plasma (6th reading). Press ENTER.

7. Capillary Mode Users: Move the tube inward until the tip of the arrow is at the meniscus of the green plasma layer (7th reading). Press ENTER.

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6 EXCEL Program 2015 6a. Results are displayed upon test completion and must be reported in whole

blood seconds and INR. PT seconds and INR are displayed with 1 decimal place. Whole blood seconds are reported as a whole number.

Signature and Signature+ Versions: At the completion of the test, the PT sec- onds and INR are displayed on the screen alternating flashing between the two results. To display whole blood seconds, press the “START” key and release.*

Elite Versions: All three parameters — INR, whole blood seconds, and PT seconds — are displayed on the screen upon test completion.

6b. Remove cuvette from instrument and discard.

*Warning: If the “START” key is pressed continuously for approximately 4 seconds, the instrument will turn off and the test results will not be stored.

5a. Immediately dispense PT material into the center well of cuvette.

Fill well flush to the top (lower side wall of center specimen well).

5b. Depress the “START” key to initiate testing.

Remove the vial from its protective sleeve and discard the vial and cap.

Note: Retain the protective sleeve for use with remaining specimens.

5a. 5b.

4a. Sharply invert the vial to bring material to the dropper tip; remove the cap.

4b. Dispense first drop into the cap.

4a. 4b.

6a. 6b.

Whole Blood Prothrombin time with INR, Module XC3 Hemochron Fresh Whole Blood PT, Module XC3

Allow specimens and unopened cuvettes to come to room temperature prior to use.

• ITC Hemochron users - Whole Blood Prothrombin Time (Module XC3): Prothrombin Time (PT) results must be reported in Whole Blood seconds. If you do not know how to obtain this result, please contact ITC Technical Support at 800-631-5945. Failure to report in the Whole Blood seconds will result in discrepancies in data which will affect grading.

2a. Remove the top portion of the plastic wrapper from the dropper vial.

2b. Insert dropper vial into protective sleeve.

2.

3a. Break inner glass ampoule by pressing the dropper vial over the edge of a table or pressing between fingers.

3b. Immediately repeat crushing action 1-2 more times at different locations on the vial to ensure adequate mixing.

3c. Quickly invert the vial end to end 10 times. (Do not shake vigorously.)

3a. 3b.

1a. Remove cuvette from pouch.

1b. Insert cuvette into the instrument. Instrument will identify the test type and initiate pre-warming.

Note: Wait for the instrument display to indicate “ADD SAMPLE… PRESS START” before proceeding to PT specimen preparation.

1a. 1b.

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Customer Contact Center 800-323-4040 option 1 (domestic) or 001-847-832-7000 option 1 (international) 7 Whole Blood Prothrombin Time/INR - Module XC19

Handling Note: These specimens are for use with methods such as the Abbott i-STAT and Abbott CoaguSense instruments.

i-STAT Testing Instructions 1. Test one specimen at a time.

2. Remove the cap and stopper from the specimen and its corresponding diluent specimen.

3. Pour entire contents of the diluent into the specimen. Replace the stopper onto the specimen, sealing the vial completely.

4. Allow the reconstituted specimen to sit at room temperature for 1 minute.

5. Mix the contents by gently swirling for 1 minute, then slowly inverting for 30 seconds.

Note: Avoid vigorous or rapid mixing to minimize foaming of the specimen.

6. Visually inspect the reconstituted specimen to ensure that it is fully reconstituted.

7. Using a plastic transfer pipette or plastic syringe, immediately transfer the specimen into the PT cartridge.

8. Immediately seal the cartridge and insert into the analyzer.

9. Repeat steps 2 - 8 for the remaining specimens and corresponding diluents.

CoaguSense Testing Instructions

1. Your kit consists of five vials of lyophilized specimen and five vials of calcium chloride.

2. When ready to begin testing, allow the specimens to stand at room temperature for 45 minutes but no longer than 4 hours. Prepare and test one specimen at a time.

3. Turn the CoaguSense meter on.

4. Remove the cap and stopper from one lyophilized specimen and one vial of diluent.

Be sure the specimen identification numbers are the same on both the specimen vial and diluent vial.

5. Pour all of the proficiency specimen diluent into the vial with lyophilized plasma.

Replace rubber stopper, and let the vial sit for one minute.

6. Remove a PT test strip from its pouch and insert into meter.

7. Swirl vial gently for one minute, then invert vial slowly for 30 seconds.

Note: Avoid vigorous or rapid mixing to minimize foaming of the specimen.

8. Apply 10 µL of specimen to the strip within 30 seconds using a pipettor or specimen transfer tube.

9. Meter will display TESTING. Wait until results are displayed.

SimpliRED and Clearview Simplify – Whole Blood D-dimer, Module XC20 SimpliRED

1. Prior to testing, allow specimens to sit at room temperature for at least 10 minutes.

2. Gently mix first specimen. Do not allow the specimen to settle.

3. Take the specimen and pipette 10 µL into each reaction well marked “Negative Control” and “Test” on the agglutination tray.

4. Prior to use, mix thoroughly and wipe the tips of the reagent bottles needed for testing.

5. Using the dropper bottle labeled “Negative Control,” hold vertically and dispense one drop into the center “Negative Control” well.

6. Using the dropper bottle labeled “Test Reagent,” hold vertically and dispense one drop into the center of “Test” well.

7. Mix the contents of the “Negative Control” well followed by the “Test” well for 3 to 5 seconds with a plastic stirrer, ensuring thorough mixing and spreading of reagent across the entire well surface.

8. Mix by gently rocking the agglutination tray for 2 minutes.

9. Examine each well for the presence of agglutination and record the results.

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8 EXCEL Program 2015 10. If the “Test” well is negative, add one drop of “Positive Control” to the “Test” well and

gently rock the slide. A visible agglutination reaction should be apparent within 15 seconds. The absence of any agglutination renders the test invalid.

11. Follow the manufacturer’s instructions for confirming both negative and positive results. Report the final result as you would report a patient result.

12. Repeat steps 2 - 11 for the second specimen.

Clearview Simplify

1. Prior to testing, allow specimens to sit at room temperature for at least 10 minutes.

2. Gently mix the first specimen. Do not allow specimen to settle.

3. Using the disposable pipettes provided by the kit manufacturer, transfer 1 drop of the specimen to the specimen well.

4. Allow the specimen to penetrate the specimen pad.

5. Transfer 2 drops of buffer from the bottle provided by the kit manufacturer.

6. Set timer for 10 minutes.

7. Leave test device lying flat and read the result at 10 minutes.

8. Report the final result as you would a patient specimen.

9. Repeat steps 2 - 8 for the second specimen.

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XL-A 2015

Hematology, Coagulation, Urinalysis

Module XH1_Page 1

Instrument Master List

Hematology

Module XH1 (Page 1 of 1)

1130 Abbott Cell-Dyn 100, 900

1488 Abbott Cell-Dyn 300, 400, 500, 700, 800 1490 Abbott Cell-Dyn 610

1487 Abbott Cell-Dyn 1200 1075 Abbott Cell-Dyn 1400 1486 Abbott Cell-Dyn 1500 1484 Abbott Cell-Dyn 1600 1160 Abbott Cell-Dyn 1700 1602 Abbott Cell-Dyn 1800 2152 Abbott Cell-Dyn 3200 1150 Abbott Cell-Dyn 3500 1452 Abbott Cell-Dyn 3700 1912 Abbott Cell-Dyn Emerald 1932 Abbott Cell-Dyn Ruby 2130 Coulter Ac•T 8/10

1196 Coulter Ac•T Diff; MD 2, 8, 10, 16 1764 Coulter Ac•T 5diff series (AL, CP, OV) 1064 Coulter Gen-S System

1549 Coulter HmX 1981 Coulter JT, JT2, JT3 1453 Coulter LH 780, 785 1219 Coulter Onyx

1460 Coulter S880, T540, T660, T890 1502 Coulter STKS

1117 Coulter VCS, MaxM, MaxM A/L 1293 Drew Scientific DC-18, I-1800 1902 Drew Scientific DREW3

2094 Drew Scientific EXCELL 10,16,18 1763 Drew Scientific EXCELL 22, 2280 1071 Hemocytometer - bright field 1070 Hemocytometer - phase

1266 Horiba ABX 9000 Diff, 9000+ Diff, 9000RX, 9018+, 9020+

1505 Horiba ABX 9000 Non-Diff, 9010 1049 Horiba ABX 9110+ (Non-Diff)

1050 Horiba ABX 9118+, 9120+ (Diff models) Deleted Codes

None New/Updated Codes

None

1113 Horiba ABX Argos, Helios 1024 Horiba ABX Micros 1114 Horiba ABX Minos 2034 Horiba ABX Pentra 60/80 2109 Horiba ABX Spirit

1408 Hycel Counter 300, 500, 700 or 777 1389 Medonic

1720 Siemens ADVIA 60 1472 Sysmex F-300, 500, 800 1473 Sysmex K-800, K-1000, K-4500 1102 Sysmex K-1000/KCP-1 2135 Sysmex KX-21, KX-21N 1841 Sysmex pocH-100i 1420 Sysmex XP-series 1441 Sysmex XT-1800i, XT-2000i 1443 Sysmex XT-4000i

0010 Other, specify on result form

Waived 1939 Alere/Stanbio HemoPoint H2

1523 Clay Adams Accu-stat 1393 Clay Adams Readacrit 1392 Clay Adams Triac

1272 Critspin/Statspin (glass tubes) 1273 Critspin/Statspin (plastic tubes) 1481 HemoCue Analyzer

1410 Microhematocrit (all PCV)

1745 STI HemataSTAT Easy Read 2030 STI HemataSTAT II/C-70 3430 STI UltraCrit

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1487 Abbott Cell-Dyn 1200 1075 Abbott Cell-Dyn 1400 1484 Abbott Cell-Dyn 1600 1160 Abbott Cell-Dyn 1700 1602 Abbott Cell-Dyn 1800 1912 Abbott Cell-Dyn Emerald 1270 Horiba ABX 9000+, 9018+, 9020+

1050 Horiba ABX 9118+, 9120+ (Diff models)

2109 Horiba ABX Spirit

1473 Sysmex K-800, K-1000, K-4500 1102 Sysmex K-1000/KCP-1 2135 Sysmex KX-21, KX-21N 1841 Sysmex pocH-100i 1420 Sysmex XP-series

0010 Other, specify on result form Deleted Codes

None

Instrument Master List

Hematology with Automated Differential

Module XH3 (Page 1 of 1)

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Deleted Codes

None

1293 Drew Scientific DC-18, I-1800 1902 Drew Scientific DREW3

2094 Drew Scientific EXCELL 10,16,18 1113 Horiba ABX Argos, Helios 1024 Horiba ABX Micros 1114 Horiba ABX Minos 1720 Siemens ADVIA 60 0010 Other, specify on result form 1995 CDS/Medonic M-series

2130 Coulter Ac•T 8/10

1196 Coulter Ac•T Diff; MD 2, 8, 10, 16 1981 Coulter JT, JT2, JT3

1219 Coulter Onyx

1460 Coulter S880, T540, T660, T890 1400 Coulter S-plus IV

1875 Coulter S-plus Jr.

1489 Coulter ST, STKR, S-plus V

Instrument Master List

Hematology with Automated Differential

Module XH4 (Page 1 of 1)

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XL-A 2015

1939 Alere/Stanbio HemoPoint H2 1523 Clay Adams Accu-stat 1393 Clay Adams Readacrit 1392 Clay Adams Triac

1272 Critspin/Statspin (glass tubes) 1273 Critspin/Statspin (plastic tubes)

1481 HemoCue Analyzer 1410 Microhematocrit (all PCV) 1745 STI HemataSTAT Easy Read 2030 STI HemataSTAT II/C-70 3430 STI UltraCrit

None

Module XL5_Page 4

Instrument Master List

Waived Hemoglobin and Hematocrit

Module XL5 (Page 1 of 1)

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Deleted Codes

None

1210 QBC Autoread/Autoread Plus (Capillary Standard Tubes) 1211 QBC Autoread/Autoread Plus (Venous Standard Tubes) 1040 QBC Autoread Plus (AccuTubes)

1387 QBC Star

1214 All Other QBCs (Capillary Standard Tubes) 1215 All Other QBCs (Venous Standard Tubes)

Modules XH6, XH7_Page 5

Instrument Master List

Centrifugal Hematology (QBC)

Modules XH6, XH7 (Page 1 of 1)

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Module XHP_Page 6

Hematology Blood Cell Identification Master List

Module XHP (Page 1 of 1)

Important: Consult the current Hematology and Clinical Microscopy Glossary, which can be accessed at cap.org, for brief descriptions or definitions.

Note: Please read the history that accompanies the photographs or virtual slides before making your selection. If microorganisms, inclusions, or other intracellular findings are seen, choose an identification that indicates their presence.

241 Neutrophil, promyelocyte

238 Neutrophil, promyelocyte, abnormal with/without Auer rod(s) 246 Myeloblast with Auer rod

Lymphocytic and Plasmacytic Cells 265 Lymphocyte

307 Lymphocyte, large granular

266 Lymphocyte, reactive (to include plasmacytoid and immunoblastic forms)

162 Lymphoma cell (malignant)

223 Plasma cell (to include morphologically mature, abnormal, and with inclusion, eg, Dutcher body, Russell body, etc)

Megakaryocytic Cells and Platelets 279 Erythrocyte with overlying platelet

212 Megakaryocytic cell (normal, abnormal, or nuclear fragment) 263 Platelet, giant

285 Platelet, hypogranular 171 Platelet, normal 264 Platelet satellitism Microorganisms 282 Babesia

268 Bacteria (cocci or rod), extracellular 269 Bacteria (spirochete), extracellular 270 Fungi, extracellular

196 Leukocyte with Anaplasma/Ehrlichia 271 Leukocyte with phagocytized bacteria 231 Leukocyte with phagocytized fungi 283 Microfilaria

156 Plasmodium sp. (malaria) 233 Protozoan (non-malarial)

311 Parasite(s) seen, referred for definitive identification (Code 311 should be used only if you would routinely send cell in question to an outside laboratory with another CLIA number)

Miscellaneous 174 Blast cell 200 Cryoglobulin

118 Leukocyte with Alder (Alder-Reilly) anomaly inclusions 119 Leukocyte with Chediak-Higashi anomaly inclusion(s) 184 Metastatic tumor cell or tumor cell clump

204 Mitotic figure

213 Squamous epithelial cell/endothelial cell Artifacts

192 Basket cell/smudge cell 220 Stain precipitate Erythrocytic Cells

140 Acanthocyte (spur cell) 245 Bite cell

299 Blister cell/Prekeratocyte

287 Echinocyte (burr cell, crenated cell) 135 Erythrocyte, normal

279 Erythrocyte with overlying platelet

288 Fragmented red cell (schistocyte, helmet cell, keratocyte, triangular cell)

298 Hypochromasia

229 Macrocyte oval or round (excluding polychromatophilic red cells) 249 Microcyte (with increased central pallor)

253 Nucleated red cell, normal or abnormal morphology 146 Ovalocyte (elliptocyte)

134 Polychromatophilic (non-nucleated) red cell 178 Red cell agglutinates

188 Rouleaux

147 Sickle cell (drepanocyte) 148 Spherocyte

149 Stomatocyte 150 Target cell (codocyte) 151 Teardrop cell (dacrocyte) Erythrocytic Cell Inclusions 152 Basophilic stippling (coarse) 153 Hemoglobin C crystal

155 Howell Jolly body (Wright stain) 157 Pappenheimer bodies (iron stain)

225 Pappenheimer bodies, presumptive (Wright stain) Myeloid: Granulocytic and Monocytic Cells

208 Basophil, any stage 209 Eosinophil, any stage 117 Mast cell

236 Monocyte

237 Monocyte, immature (promonocyte, monoblast) 284 Neutrophil, segmented or band

259 Neutrophil, toxic (to include toxic granulation and/or Döhle bodies, and/or toxic vacuolization)

122 Neutrophil with hypersegmented nucleus

240 Neutrophil with Pelger-Huet nucleus (acquired or congenital) 161 Neutrophil, polyploid

239 Neutrophil with dysplastic nucleus and/or hypogranular cyto- plasm

191 Neutrophil necrobiosis (degenerated neutrophil) 121 Neutrophil, giant band or giant metamyelocyte 112 Neutrophil, metamyelocyte

111 Neutrophil, myelocyte

108 Immature or abnormal cell, would refer for identification (Code 108 should be used only if you would routinely send the cell in question to an outside laboratory with another CLIA number.)

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Module XH8_Page 7 Deleted Codes

None

Manufacturer Master List

Erythrocyte Sedimentation Rate

Module XH8 (Page 1 of 1)

1889 Dispette II Disposable Pipet 1888 Dispette Pipet

1887 Disposable Westergren Blood Sedimentation Tube 1948 Disposable Wintrobe Blood Sedimentation Tube 2851 HemaTechnologies ESR STAT Plus

1890 MicroSed ESR Test Kit (Ulster) 1938 Mini-Ves Analyzer

2991 Mini-Ves II Analyzer 2751 Polymedco Sediten 3406 Sedifast 16 3123 Sedimat Westergren 1876 Sediplast Westergren 1878 Sediplast Wintrobe 3207 Sedi-Rate Westergren

1952 Seditainer

1875 Seditube Wintrobe (marked only at fill line) 1873 Self Zeroing Westergren

1874 Self Zeroing Wintrobe 1932 Streck ESR-10 Manual Rack 2281 Streck ESR-Auto Plus 3276 Vacuette SRS, SRT series 1896 Ves-Matic 10, 20, 30, 60, Easy 2013 Ves-Matic Cube

2977 Vital Diagnostics Excyte 10/M/Mini, Microsed 2982 Vital Diagnostics Excyte 20

1891 Winpette Pipet for ESR Testing 0010 Other, specify on result form

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Modules XC, XC1_Page 8

Prothrombin Time/Activated Partial Thromboplastin Time

Manual 1325 Tilt Tube Fibrin Strand Detection

1335 BBL (Bio-Quest) Fibrometer 1163 Medtronic HemoTec ACT 1153 Medtronic HemoTec Act II 1340 Other, specify on result form Mechanical

1103 Diagnostica Stago ST4, STart4, STart 8 1010 Diagnostica Stago STA Compact 1815 Diagnostica Stago STA Satellite

1929 Diagnostica Stago STA-R, STA-R Evolution 1019 Tcoag AMAX 190/200/400

2000 Tcoag Destiny series 1009 Tcoag KC series Photo-Optical

1377 Astral Medical Systems Coatron Junior 2165 Behnk/Tcoag Thrombolyzer (all models), Coag-A-Mate MAX

1373 Bio-Data MCA 110, 210, 310

1354 Bio-Dynamics Coagulation Unimeter 500 1369 Elvi 818

1105 Fisher ThromboScreen 1000 1137 Helena Cascade M 1022 Helena Cascade POC 1360 Hyland Clotek

1980 IL ACL 100, 200, 300, 1000, 2000, 3000, 6000, 7000 1593 IL ACL 8000, 9000, 10000, Elite, Elite Pro

1036 IL ACL Futura/Advance 1679 IL ACL TOP series

1382 Labor American CD1000, CD2000, CD3000, COA Systems

1362 Lancer Coagulyzer, All Models 1583 Siemens BCS, BCS XP 1060 Siemens BCT

1988 Siemens BFT II

1167 Siemens/Sysmex CA-series 3374 Siemens/Sysmex CS-series

2155 Sysmex CA-series (Japan users only) 3365 Sysmex CS-series (Japan users only) 1006 Tcoag AMAX 190/200/400

2104 Tcoag Coag-A-Mate MTX

2075 Tcoag Coag-A-Mate XC series, RA4 1133 Tcoag Coag-A-Mate XM

2071 Tcoag Destiny series 1371 Other, specify on result form Deleted Codes

None

Instrument Master Lists

Coagulation

Modules XC, XC1 (Page 1 of 2)

Note: Code changes may not apply to all analytes. Please verify your reporting code using the analyte-specific master list below.

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Prothrombin Time

Human Placental Thromboplastin 1848 Helena Cascade POC Test Card 1064 Siemens Thromborel S Pure-Brain Thromboplastin

1309 Diagnostica Stago Neoplastine CI 1310 Diagnostica Stago Neoplastine CI Plus 2056 George King Bio-Medical

2815 Helena Thromboplastin, ISI 2.0-2.5 1146 Helena Thromboplastin MI, ISI 1.55-1.85 1159 HemosIL PT-FIB

1144 HemosIL PT-FIB HS Plus 1551 Tcoag TriniCLOT PT Excel 2139 Tcoag TriniCLOT PT Excel S

2588 Thermo/Pacific Hemostasis Thromboplastin-D 2112 Thermo/Pacific Hemostasis Thromboplastin-DL 1355 Thermo/Pacific Hemostasis Thromboplastin-DS

Recombinant Human Tissue Factor Thromboplastin 1802 HemosIL ReadiPlasTin

2553 HemosIL RecombiPlasTin 2G 2145 Siemens Innovin

1774 Tcoag TriniCLOT PT HTF

Recombinant Rabbit Tissue Factor Thromboplastin 3353 Tulip Diagnostics

1802 HemosIL ReadiPlasTin

Activated Partial Thromboplastin Time

1910 Diagnostica Stago STA-PTT A 2056 George King Bio-Medical 1848 Helena Cascade POC Test Card 1145 HemosIL APTT-SP

3240 HemosIL SynthAFax 1801 HemosIL SynthASil 2179 Siemens Actin 2181 Siemens Actin FS 1520 Siemens Actin FSL

2314 Tcoag Automated APTT Reagent 1066 Tcoag TriniCLOT aPTT HS

1483 Tcoag TriniCLOT aPTT HS (with TriniVeriCAL) 1065 Tcoag TriniCLOT aPTT S

1484 Tcoag TriniCLOT aPTT S (with TriniVeriCAL) 2113 Thermo/Pacific Hemostasis APTT-XL 2561 Thermo/Pacific Hemostasis Kontact 2160 Other, specify on result form Deleted Codes

None

Modules XC, XC1_Page 9

Reagent Master Lists

Coagulation

Modules XC, XC1 (Page 2 of 2)

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XL-A 2015

Modules XC_Page 10

Coagulation - Fibrinogen Master Lists

Module XC (Page 1 of 1)

Fibrinogen Instrument Master List

Deleted Codes

None

Mechanical Fibrin Polymer Detection 1010 Diagnostica Stago STA Compact 1815 Diagnostica Stago STA Satellite

1929 Diagnostica Stago STA-R, STA-R Evolution 1019 Tcoag AMAX 190/200/400

2000 Tcoag Destiny series

2122 Other Mechanical, specify on result form Optical Detection

2165 Behnk/Trinity Biotech Thrombolyzer (all models), Coag-A-Mate MAX

1980 IL ACL 100, 200, 300, 1000, 2000, 3000, 6000, 7000 1593 IL ACL 8000, 9000, 10000, Elite, Elite Pro

1679 IL ACL TOP series

1583 Siemens BCS, BCS XP 1060 Siemens BCT

1167 Siemens/Sysmex CA-series 3374 Siemens/Sysmex CS-series

3365 Sysmex CS-series (Japan users only) 2104 Tcoag Coag-A-Mate MTX

1133 Tcoag Coag-A-Mate XM

1371 Other Optical, specify on result form Prothrombin Time Based Optical Detection 1069 Other Prothrombin Time, specify on result form Other

1884 Manual (Tilt Tube)

Deleted Codes

1802 HemosIL ReadiPlasTin

Fibrinogen Reagent Master List

Clauss Method (Modified Thrombin Time) 1525 Diagnostica Stago

1395 HemosIL Fibrinogen-C 3155 HemosIL QFA

2180 Siemens Fibrinogen Determination (Dade Thrombin)

2313 Tcoag FibriQuik

2053 Tcoag TriniCLOT Fibrinogen (AMAX) 3039 Thermo/Pacific Hemostasis Fibrinogen Assay 2527 Other Clauss, specify on result form

Ellis-Stransky Method (Thrombin Turbidimetric Rate) 2525 Other Ellis-Stransky, specify on result form

Immunologic Fibrinogen Assay 1395 HemosIL Fibrinogen-C

1018 Other Immunologic, specify on result form Prothrombin Time Based Fibrinogen Assay 1159 HemosIL PT-FIB

1144 HemosIL PT-FIB HS Plus 1802 HemosIL ReadiPlasTin 2553 HemosIL RecombiPlasTin 2G

1259 Other PT Based Fibrinogen, specify on result form Other Method

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Modules XU, XU1, XL5_Page 11

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XL-A 2015

Urinalysis and Specific Gravity Master Lists

Modules XU, XU1, XL5 (Page 1 of 1)

Deleted Codes

2922 Biorex DIAZO-CHEK

1095 M-N (Macherey-Nagel) Medi-Test Uryxxon test strips

Method Master List

1733 77 Elektronika Reagent Strips 3367 ACON Mission Reagent Strips 1534 ARKRAY Aution Sticks 2547 Bayer Acetest 2544 Bayer Clinitest, 2 drop 2543 Bayer Clinitest, 5 drop 2922 Biorex DIAZO-CHEK

1626 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips 2574 BTNX Rapid Response Reagent Strips

1030 CTMI/Germaine Labs/Thermo Fisher Reagent Strips 3425 Diagnostic Test Group Clarity Urocheck Reagent Strips 3238 DiaScreen Reagent Strips

1238 Eiken Uropaper

2831 IRIS vChem Reagent Strips

1114 Jant Accustrip URS 10 Reagent Strips 1381 Jant Accutest URS 10 Reagent Strips 3422 McKesson/Teco Reagent Strips 2468 Medline Urinalysis Reagent Strips

1095 M-N (Macherey-Nagel) Medi-Test Uryxxon test strips 2546 pH Meter

2533 Refractometer 3071 Roche Chemstrip LN 2937 Roche Chemstrip/Combur 2492 Roche cobas u Pack Cassette 1221 Roche Urisys Cassette 1313 Schein Urispec

2673 Siemens Clinitek Atlas Reagent 1622 Siemens Clinitek Novus/Pro Cassette 2538 Siemens Ictotest

2936 Siemens Reagent Strips (All) 3427 SMC Direct RefuAH Reagent Strips 1285 Sulfosalicylic acid

2552 Sysmex Reagent Strips 2534 Urinometer

2492 Roche cobas u Pack Cassette 1622 Siemens Clinitek Novus/Pro Cassette

Instrument Master List

1935 77 Elektronika urine chemistry analyzers 3368 ACON Mission U120, U500

2126 ARKRAY Aution Hybrid 2675 ARKRAY Aution JET 2676 ARKRAY Aution MAX

1569 ARKRAY/Thermo BioStar PocketChem UA

3444 BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer 2573 BTNX Rapid Response series

3424 Diagnostic Test Group Clarity Urocheck 120 1106 DiaScreen 50

3371 Eiken US-2100R/2200 3372 Eiken US-3100R/3100Rplus

1062 Germaine Labs AimStrip/CTMI CT-120 Urine Analyzer 1864 Germaine Labs AimStrip Urine Auto Analyzer 1689 Jant Accustrip URS 10 Reader

1096 M-N (Macherey-Nagel) Uryxxon series 3423 McKesson 107-101 UA

3241 Roche Chemstrip 101

1945 Roche Chemstrip Criterion, Criterion II

2097 Roche Chemstrip Urine Analyzer 1171 Roche Chemstrip Mini UA 1790 Roche cobas u411, Urisys 1800 2490 Roche cobas u601

1789 Roche Urisys 1100 1821 Roche Urisys 2400 1579 Siemens Clinitek 10 or 100 1845 Siemens Clinitek 50

1580 Siemens Clinitek 200 or 200+

2292 Siemens Clinitek 500, Advantus 1578 Siemens Clinitek 2000 1465 Siemens Clinitek Atlas 2681 Siemens Clinitek Novus 2532 Siemens Clinitek Status 3426 SMC Direct RefuAH U120 2186 Sysmex UX-2000 2603 Teco Uritek TC-101 2044 Visual

2573 BTNX Rapid Response series

1096 M-N (Macherey-Nagel) Uryxxon series 2490 Roche cobas u601

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XL-A 2015

Modules XU, XU6, XL5_Page 12 Deleted Codes

None

New/Updated Codes None

1735 Abbott TestPack Combo 2027 Abbott TestPack Plus Combo w/

or w/out OBC

1736 Abbott TestPack Plus - Urine 1784 ABI SureStep

1782 ABI SureStep Combo 2938 Acceava Basic II (urine) 3168 Acceava Combo II

2648 ACON One Step (urine only) 2055 Alere hCG Cassette (20) (Acceava) 1959 Alere hCG Cassette (25) (Clearview) 2403 Alere hCG Combo Cassette (20/10) 1299 Alere hCG Combo Cassette (25)

(Clearview) 2404 Alere hCG Dipstick 1161 Beckman Coulter ICON 20 2618 Beckman Coulter ICON 25

2010 BioTron Diagnostics Foremost Combo 2354 Cardinal Health SP Brand Cassette 2355 Cardinal Health SP Brand Combo 2356 Cardinal Health SP Brand Dipstick 2647 Cen-Med Elite Plus One Step hCG 2120 Chembio STAT-PAK

1961 Clearview hCG Combo II 1430 Consult Diagnostics Cassette 1432 Consult Diagnostics Combo 1433 Consult Diagnostics Dipstick 1006 DE Healthcare Products TruView

Cassette

3140 DE Healthcare Products TruView One-Step

2860 Formosa One Sure Pregnancy Kit 1586 Germaine Labs AimStep 1587 Germaine Labs AimStep Combo 1679 Germaine Labs AimStrip 1205 Henry Schein OneStep+ Combo 1382 Henry Schein OneStep+ Urine Cassette

1383 Henry Schein OneStep+ Urine Strip 1117 Immunostics Immuno hCG Detector 1118 Immunostics Immuno hCG Detector

Combi (serum/urine)

1119 Immunostics Immuno hCG Detector Stix 2474 Instant Technologies iPregnancy Cassette

(serum/urine)

2475 Instant Technologies iPregnancy Cassette (urine only)

2476 Instant Technologies iPregnancy Strip (urine only)

1370 Jant Accustrip Value+

3409 Jant Accutest Value+ (serum/urine) 3410 Jant Accutest Value+ (urine only) 2981 LifeSign Status (serum/urine) 2980 LifeSign Status (urine only) 1180 LSC (LABSCO) PEP hCG Strip 1178 LSC (LABSCO) PEP hCG Test 1060 Mainline Confirms (combo) 1468 Mainline Confirms (urine only) 1477 McKesson Medi-Lab Performance

Cassette

1478 McKesson Medi-Lab Performance Combo

1476 McKesson Medi-Lab Performance Dipstick

2276 MediChoice Combi 2277 MediChoice Urine Only 2465 Medline hCG Urine Cassette 2466 Medline hCG Urine Dipstick 3209 Meridian ImmunoCard STAT 1491 NDC Pro Advantage Urine Cassette 1288 NDC Pro Advantage Urine/Serum

Cassette

1492 NDC Pro Advantage Urine Strip 3061 Polymedco Poly stat (serum/urine) 2872 Polymedco Poly stat (urine only)

Manufacturer Master List

Urine hCG

Modules XU, XU6, XL5 (Page 1 of 1)

1372 Pulse Scientific

1414 Quidel QuickVue+One-Step Combo 1475 Quidel QuickVue One-Step Combo 1129 Quidel QuickVue One-Step Urine 1338 Quidel RapidVue (urine only) 2479 Ramco Quik-Trak (urine only) 2480 Ramco Quik-Trak Combi Test (serum/

urine) 3137 Randox Direct

1800 Roche AccuStat Combo 2108 SA Scientific (serum/urine) 2107 SA Scientific (urine only) 2483 SA Scientific (SAS) Ultra 1836 Sekisui OSOM 1837 Sekisui OSOM Combo 2532 Siemens Clinitek Status 2853 Signify hCG Card 2854 Signify hCG Urine 2855 Signify hCG Urine/Serum 2442 SMC Direct RefuAH Combo 2441 SMC Direct RefuAH Urine 1438 Stanbio QuPID

1439 Stanbio QuPID Plus 3425 Stanbio QuPID Plus E.R.

1135 Stanbio QuStick 3424 Stanbio True 20 Plus 1467 Sure-Vue (serum/urine) 1466 Sure-Vue (urine only) 2052 Sure-Vue STAT (serum/urine) 3428 Technologist Choice (serum/urine) 1844 Trinity Biotech UniGold PT 2559 Wampole UCG-Slide Test 3158 Wondfo One Step hCG Urine 3159 Wondfo One Step hCG Urine/Serum 0010 Other, specify on result form

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Modules XU2P, XU5P, XU7P_Page 13

Urine Sediment Identification Master List

Modules XU2P, XU5P, XU7P (Page 1 of 1)

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Crystal

124 Ammonium biurate

137 Ammonium magnesium phosphate (triple phosphate) 126 Amorphous urates/phosphates

127 Ampicillin 167 Bilirubin 129 Calcium oxalate 131 Cholesterol 132 Cystine 155 Hippuric acid 133 Leucine 136 Sulfonamide 138 Tyrosine 139 Uric acid Organisms 168 Bacteria

147 Protozoa, includes Trichomonas 309 Yeast/fungi

Miscellaneous/Exogenous 140 Fat droplets

141 Fiber (exogenous)/fecal contamination 142 Mucus strands

172 Pollen grain 188 Stain precipitate 146 Starch granule Note: If organisms are present, choose an identification that

indicates their presence.

240 Immature or abnormal cell, would refer for identification (Code 240 should be used only if you would routinely send the cell in question to an outside laboratory with another

CLIA number.) Cells

308 Erythrocyte

189 Erythrocyte, dysmorphic

183 Leukocyte (neutrophil, eosinophil, lymphocyte) 204 Monocyte/macrophage

179 Parabasal cell, basal cell (vaginal fluid only) 112 Renal tubular epithelial cell (RTE)

145 Spermatozoa

113 Squamous epithelial cell

175 Squamous epithelial cell with bacteria (clue cell) 114 Transitional epithelial cell (urothelial)

Casts

190 Cellular cast (RTE and/or neutrophil) 115 Fatty cast

116 Granular cast 118 Hyaline cast 154 Muddy brown cast 117 Non-hemoglobin pigment

121 RBC/pigmented/muddy brown casts 123 Waxy cast

Important: Consult the current Hematology and Clinical Microscopy Glossary, which can be accessed at cap.org, for brief descriptions or definitions.

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Deleted Codes

3403 Alfresa Nescauto Hemo Plus 2011 Germaine Labs Compliance Gold 2467 Medline iFOB Test Kit

2384 MedTek HemaWipe 3020 PSS Select/Select-ES

New/Updated Codes 3503 ABON FOB

3173 Beckman Coulter Hemoccult/II/SENSA 3504 BioMerieux bioNexia

3502 Coral/Tulip Hemospot 3501 Dipro Hemdetect

3503 ABON FOB

2092 Aerscher Diagnostics HemaPrompt FG 3402 Alfresa Hemo Techt NS-Plus C 1111 Beckman Coulter Hemoccult ICT 3173 Beckman Coulter Hemoccult/II/SENSA 3504 BioMerieux bioNexia

1264 Cenogenics Corp.

3017 CIDA ColoCheck/ColoCheck-ES 3497 Clarity

2008 Clearview

3443 Consult Diagnostics 3502 Coral/Tulip Hemospot 3501 Dipro Hemdetect

3170 Helena ColoScreen/ColoScreen-ES 3419 Hemosure iFOB

1806 Immunostics Hema Screen/Specific 3459 Kyowa Medex HM-JACK

3171 Laboratory Diagnostics Quik-Cult 2385 MedTek Instaccult

1625 Polymedco OC-Auto Micro 80 3357 Polymedco OC-Light 2951 Polymedco OC-Sensor Diana 3172 Propper Seracult/Seracult Plus 3284 Quidel QuickVue iFOB 1519 Sekisui OSOM iFOB 3247 Siemens Hema-Chek slide 2664 Stanbio

3026 Starline ColoScan/ColoScan-ES 3099 Sure-Vue/Sure-Vue ES 0010 Other, specify on result form

XL-A 2015 Kit Instructions CAP 2015

Important: Before You Begin

XL-A 2015

Kit Instructions

EXCEL

Table of Contents

Reporting Your Results

Earn CE Credit With This Survey

Biohazard Warning

For Assistance

Specific Specimen Testing/Handling Information

Do Not Return

XL-A 2015

Instrument Master List

Hematology

Module XH1 (Page 1 of 1)

Do Not Return

XL-A 2015

Instrument Master List

Hematology with Automated Differential

Module XH3 (Page 1 of 1)

Do Not Return

XL-A 2015

Instrument Master List

Hematology with Automated Differential

Module XH4 (Page 1 of 1)

Do Not Return

XL-A 2015

Instrument Master List

Waived Hemoglobin and Hematocrit

Module XL5 (Page 1 of 1)

Do Not Return

XL-A 2015

Instrument Master List

Centrifugal Hematology (QBC)

Modules XH6, XH7 (Page 1 of 1)

Do Not Return

XL-A 2015

Hematology Blood Cell Identification Master List

Module XHP (Page 1 of 1)

Do Not Return

XL-A 2015

Manufacturer Master List

Erythrocyte Sedimentation Rate

Module XH8 (Page 1 of 1)

Do Not Return

XL-A 2015

Prothrombin Time/Activated Partial Thromboplastin Time

Instrument Master Lists

Coagulation

Modules XC, XC1 (Page 1 of 2)

Do Not Return

Prothrombin Time

Activated Partial Thromboplastin Time

Reagent Master Lists

Coagulation

Modules XC, XC1 (Page 2 of 2)

Do Not Return

XL-A 2015

Coagulation - Fibrinogen Master Lists

Module XC (Page 1 of 1)

Fibrinogen Instrument Master List

Fibrinogen Reagent Master List

Do Not Return

XL-A 2015

Urinalysis and Specific Gravity Master Lists

Modules XU, XU1, XL5 (Page 1 of 1)

Method Master List

Instrument Master List

Do Not Return

XL-A 2015

Manufacturer Master List

Urine hCG

Modules XU, XU6, XL5 (Page 1 of 1)

Urine Sediment Identification Master List

Modules XU2P, XU5P, XU7P (Page 1 of 1)

Do Not Return

XL-A 2015

Manufacturer Master List

Occult Blood