xl-a 2015 - college of american pathologists

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 2015Kit Instructions

© CAP 2015

EXCEL®

Hematology, Coagulation, Urinalysis

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

Table of Contents

Important: Before You Begin....................... 1

Reporting Your Results ............................... 2

Earn CE Credit With This Survey ............... 3

Biohazard Warning ..................................... 3

For Assistance ............................................ 4

Specific Specimen Testing/Handling

Information.................................................. 5

2 EXCEL Program 2015

4. For purposes of proficiency testing (PT) and because the INR is a calculation of the prothrombin time, you must report the prothrombin time, even if your institution only requires the reporting of the INR.

5. Abbott Cell-Dyn Emerald users: At the request of the manufacturer, you have been assigned a new reporting code. You must enter instrument code 1912 Abbott Cell-Dyn Emerald on your result form; failure to do so will result in a penalty.

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 report-ing 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 op-tion to fill a bubble for a greater than or less than result.


• 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 photo-graphs 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 hu-man 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.


• 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]: cap.org

Address: CAP Surveys Program325 Waukegan RoadNorthfield, IL 60093-2750 USA


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 be-

tween 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.


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.


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 Instructions1. 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 Instructions1. 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

SimpliRED1. 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.


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 Simplify1. 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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2015Hematology, Coagulation,

Urinalysis© CAP 2015

Module XH1_Page 1

Instrument Master List Hematology

Module XH1 (Page 1 of 1)

1130 Abbott Cell-Dyn 100, 9001488 Abbott Cell-Dyn 300, 400, 500, 700, 8001490 Abbott Cell-Dyn 6101487 Abbott Cell-Dyn 12001075 Abbott Cell-Dyn 14001486 Abbott Cell-Dyn 15001484 Abbott Cell-Dyn 16001160 Abbott Cell-Dyn 17001602 Abbott Cell-Dyn 18002152 Abbott Cell-Dyn 32001150 Abbott Cell-Dyn 35001452 Abbott Cell-Dyn 37001912 Abbott Cell-Dyn Emerald1932 Abbott Cell-Dyn Ruby2130 CoulterAc•T8/101196 CoulterAc•TDiff;MD2,8,10,161764 CoulterAc•T5diffseries(AL,CP,OV)1064 CoulterGen-SSystem

1549 Coulter HmX1981 CoulterJT,JT2,JT31453 CoulterLH780,7851219 CoulterOnyx1460 CoulterS880,T540,T660,T8901502 CoulterSTKS1117 CoulterVCS,MaxM,MaxMA/L1293 DrewScientificDC-18,I-18001902 DrewScientificDREW32094 DrewScientificEXCELL10,16,181763 DrewScientificEXCELL22,22801071 Hemocytometer-brightfield1070 Hemocytometer-phase1266 HoribaABX9000Diff,9000+Diff,

9000RX,9018+,9020+1505 HoribaABX9000Non-Diff,90101049 HoribaABX9110+(Non-Diff)1050 HoribaABX9118+,9120+(Diffmodels)

Deleted CodesNone

New/Updated CodesNone

1113 HoribaABXArgos,Helios1024 HoribaABXMicros1114 HoribaABXMinos2034 HoribaABXPentra60/802109 HoribaABXSpirit1408 Hycel Counter 300, 500, 700 or 7771389 Medonic1720 SiemensADVIA601472 SysmexF-300,500,8001473 SysmexK-800,K-1000,K-45001102 SysmexK-1000/KCP-12135 SysmexKX-21,KX-21N1841 SysmexpocH-100i1420 SysmexXP-series1441 SysmexXT-1800i,XT-2000i1443 SysmexXT-4000i0010 Other,specifyonresultform

Waived

1939 Alere/StanbioHemoPointH21523 ClayAdamsAccu-stat1393 ClayAdamsReadacrit1392 ClayAdamsTriac

1272 Critspin/Statspin(glasstubes)1273 Critspin/Statspin(plastictubes)1481 HemoCue Analyzer1410 Microhematocrit(allPCV)

1745 STIHemataSTATEasyRead2030 STIHemataSTATII/C-703430 STIUltraCrit0010 Other,specifyonresultform

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1487 Abbott Cell-Dyn 12001075 Abbott Cell-Dyn 14001484 Abbott Cell-Dyn 16001160 Abbott Cell-Dyn 17001602 Abbott Cell-Dyn 18001912 Abbott Cell-Dyn Emerald1270 HoribaABX9000+,9018+,9020+1050 HoribaABX9118+,9120+(Diffmodels)

2109 HoribaABXSpirit1473 SysmexK-800,K-1000,K-45001102 SysmexK-1000/KCP-12135 SysmexKX-21,KX-21N1841 SysmexpocH-100i1420 SysmexXP-series0010 Other,specifyonresultform

Deleted CodesNone


Module XH3_Page 2

Instrument Master List Hematology with Automated Differential


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Deleted CodesNone


1293 DrewScientificDC-18,I-18001902 DrewScientificDREW32094 DrewScientificEXCELL10,16,181113 HoribaABXArgos,Helios1024 HoribaABXMicros1114 HoribaABXMinos1720 SiemensADVIA600010 Other,specifyonresultform

1995 CDS/MedonicM-series2130 CoulterAc•T8/101196 CoulterAc•TDiff;MD2,8,10,161981 CoulterJT,JT2,JT31219 CoulterOnyx1460 CoulterS880,T540,T660,T8901400 CoulterS-plusIV1875 CoulterS-plusJr.1489 CoulterST,STKR,S-plusV

Module XH4_Page 3

Instrument Master List Hematology with Automated Differential


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1939 Alere/StanbioHemoPointH21523 ClayAdamsAccu-stat1393 ClayAdamsReadacrit1392 ClayAdamsTriac1272 Critspin/Statspin(glasstubes)1273 Critspin/Statspin(plastictubes)

1481 HemoCue Analyzer1410 Microhematocrit(allPCV)1745 STIHemataSTATEasyRead2030 STIHemataSTATII/C-703430 STIUltraCrit0010 Other,specifyonresultform

Deleted CodesNone


Module XL5_Page 4

Instrument Master List Waived Hemoglobin and Hematocrit

Module XL5 (Page 1 of 1)

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Deleted CodesNone


1210 QBCAutoread/AutoreadPlus(CapillaryStandardTubes)1211 QBCAutoread/AutoreadPlus(VenousStandardTubes)1040 QBCAutoreadPlus(AccuTubes)

1387 QBCStar1214 AllOtherQBCs(CapillaryStandardTubes)1215 AllOtherQBCs(VenousStandardTubes)

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 ListModule XHP (Page 1 of 1)

Important: ConsultthecurrentHematologyandClinicalMicroscopyGlossary,whichcanbeaccessedatcap.org,forbriefdescriptionsordefinitions.Note: Pleasereadthehistorythataccompaniesthephotographsorvirtualslidesbeforemakingyourselection.Ifmicroorganisms,inclusions,or

otherintracellularfindingsareseen,chooseanidentificationthatindicatestheirpresence.

241 Neutrophil,promyelocyte238 Neutrophil,promyelocyte,abnormalwith/withoutAuerrod(s)246 MyeloblastwithAuerrod

Lymphocytic and Plasmacytic Cells265 Lymphocyte307 Lymphocyte,largegranular266 Lymphocyte,reactive(toincludeplasmacytoidandimmunoblastic

forms)162 Lymphomacell(malignant)223 Plasmacell(toincludemorphologicallymature,abnormal,andwith

inclusion,eg,Dutcherbody,Russellbody,etc)

Megakaryocytic Cells and Platelets279 Erythrocytewithoverlyingplatelet212 Megakaryocyticcell(normal,abnormal,ornuclearfragment)263 Platelet,giant285 Platelet,hypogranular171 Platelet,normal264 Plateletsatellitism

Microorganisms282 Babesia268 Bacteria(cocciorrod),extracellular269 Bacteria(spirochete),extracellular270 Fungi,extracellular196 LeukocytewithAnaplasma/Ehrlichia271 Leukocytewithphagocytizedbacteria231 Leukocytewithphagocytizedfungi283 Microfilaria156 Plasmodiumsp.(malaria)233 Protozoan(non-malarial)311 Parasite(s)seen,referredfordefinitiveidentification(Code311

shouldbeusedonlyifyouwouldroutinelysendcellinquestiontoanoutsidelaboratorywithanotherCLIAnumber)

Miscellaneous174 Blastcell200 Cryoglobulin118 LeukocytewithAlder(Alder-Reilly)anomalyinclusions119 LeukocytewithChediak-Higashianomalyinclusion(s)184 Metastatictumorcellortumorcellclump204 Mitoticfigure213 Squamousepithelialcell/endothelialcell

Artifacts192 Basketcell/smudgecell220 Stainprecipitate

Erythrocytic Cells140 Acanthocyte(spurcell)245 Bitecell299 Blistercell/Prekeratocyte287 Echinocyte(burrcell,crenatedcell)135 Erythrocyte,normal279 Erythrocytewithoverlyingplatelet288 Fragmentedredcell(schistocyte,helmetcell,keratocyte,

triangularcell)298 Hypochromasia229 Macrocyteovalorround(excludingpolychromatophilicredcells)249 Microcyte(withincreasedcentralpallor)253 Nucleatedredcell,normalorabnormalmorphology146 Ovalocyte(elliptocyte)134 Polychromatophilic(non-nucleated)redcell178 Redcellagglutinates188 Rouleaux147 Sicklecell(drepanocyte)148 Spherocyte149 Stomatocyte150 Targetcell(codocyte)151 Teardropcell(dacrocyte)

Erythrocytic Cell Inclusions152 Basophilicstippling(coarse)153 HemoglobinCcrystal155 HowellJollybody(Wrightstain)157 Pappenheimerbodies(ironstain)225 Pappenheimerbodies,presumptive(Wrightstain)

Myeloid: Granulocytic and Monocytic Cells208 Basophil,anystage209 Eosinophil,anystage117 Mastcell236 Monocyte237 Monocyte,immature(promonocyte,monoblast)284 Neutrophil,segmentedorband259 Neutrophil,toxic(toincludetoxicgranulationand/orDöhlebod-

ies,and/ortoxicvacuolization)122 Neutrophilwithhypersegmentednucleus240 NeutrophilwithPelger-Huetnucleus(acquiredorcongenital)161 Neutrophil,polyploid239 Neutrophilwithdysplasticnucleusand/orhypogranularcyto-

plasm191 Neutrophilnecrobiosis(degeneratedneutrophil)121 Neutrophil,giantbandorgiantmetamyelocyte112 Neutrophil,metamyelocyte111 Neutrophil,myelocyte

108 Immatureorabnormalcell,wouldreferforidentification(Code108shouldbeusedonlyifyouwouldroutinelysendthecellinquestiontoanoutsidelaboratorywithanotherCLIAnumber.)

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Module XH8_Page 7

Deleted CodesNone


Manufacturer Master List Erythrocyte Sedimentation Rate


1889 DispetteIIDisposablePipet1888 DispettePipet1887 DisposableWestergrenBloodSedimentationTube1948 DisposableWintrobeBloodSedimentationTube2851 HemaTechnologiesESRSTATPlus1890 MicroSedESRTestKit(Ulster)1938 Mini-VesAnalyzer2991 Mini-VesIIAnalyzer2751 PolymedcoSediten3406 Sedifast163123 SedimatWestergren1876 SediplastWestergren1878 SediplastWintrobe3207 Sedi-RateWestergren

1952 Seditainer1875 SeditubeWintrobe(markedonlyatfillline)1873 SelfZeroingWestergren1874 SelfZeroingWintrobe1932 StreckESR-10ManualRack2281 StreckESR-AutoPlus3276 VacuetteSRS,SRTseries1896 Ves-Matic10,20,30,60,Easy2013 Ves-MaticCube2977 VitalDiagnosticsExcyte10/M/Mini,Microsed2982 VitalDiagnosticsExcyte201891 WinpettePipetforESRTesting0010 Other,specifyonresultform

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Modules XC, XC1_Page 8

Prothrombin Time/Activated Partial Thromboplastin Time

Manual1325 TiltTube

Fibrin Strand Detection1335 BBL(Bio-Quest)Fibrometer1163 MedtronicHemoTecACT1153 MedtronicHemoTecActII1340 Other,specifyonresultform

Mechanical1103 DiagnosticaStagoST4,STart4,STart81010 DiagnosticaStagoSTACompact1815 DiagnosticaStagoSTASatellite1929 DiagnosticaStagoSTA-R,STA-REvolution1019 TcoagAMAX190/200/4002000 TcoagDestinyseries1009 TcoagKCseries

Photo-Optical1377 AstralMedicalSystemsCoatronJunior2165 Behnk/TcoagThrombolyzer(allmodels), Coag-A-MateMAX1373 Bio-DataMCA110,210,3101354 Bio-DynamicsCoagulationUnimeter5001369 Elvi818

1105 FisherThromboScreen10001137 HelenaCascadeM1022 HelenaCascadePOC1360 HylandClotek1980 ILACL100,200,300,1000,2000,3000,6000,70001593 ILACL8000,9000,10000,Elite,ElitePro1036 ILACLFutura/Advance1679 ILACLTOPseries1382 LaborAmericanCD1000,CD2000,CD3000,

COASystems1362 LancerCoagulyzer,AllModels1583 SiemensBCS,BCSXP1060 SiemensBCT1988 SiemensBFTII1167 Siemens/SysmexCA-series3374 Siemens/SysmexCS-series2155 SysmexCA-series(Japanusersonly)3365 SysmexCS-series(Japanusersonly)1006 TcoagAMAX190/200/4002104 TcoagCoag-A-MateMTX2075 TcoagCoag-A-MateXCseries,RA41133 TcoagCoag-A-MateXM2071 TcoagDestinyseries1371 Other,specifyonresultform

Deleted CodesNone


Instrument Master ListsCoagulation

Modules XC, XC1 (Page 1 of 2)

Note:Codechangesmaynotapplytoallanalytes.Pleaseverifyyourreportingcodeusingtheanalyte-specificmasterlistbelow.

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Prothrombin Time

Human Placental Thromboplastin1848 HelenaCascadePOCTestCard1064 SiemensThromborelS

Pure-Brain Thromboplastin1309 DiagnosticaStagoNeoplastineCI1310 DiagnosticaStagoNeoplastineCIPlus2056 GeorgeKingBio-Medical2815 HelenaThromboplastin,ISI2.0-2.51146 HelenaThromboplastinMI,ISI1.55-1.851159 HemosILPT-FIB1144 HemosILPT-FIBHSPlus1551 TcoagTriniCLOTPTExcel2139 TcoagTriniCLOTPTExcelS2588 Thermo/PacificHemostasisThromboplastin-D2112 Thermo/PacificHemostasisThromboplastin-DL1355 Thermo/PacificHemostasisThromboplastin-DS

Recombinant Human Tissue Factor Thromboplastin1802 HemosILReadiPlasTin2553 HemosILRecombiPlasTin2G2145 SiemensInnovin1774 TcoagTriniCLOTPTHTF

Recombinant Rabbit Tissue Factor Thromboplastin3353 TulipDiagnostics

2160 Other,specifyonresultform

Deleted CodesNone

New/Updated Codes1802 HemosILReadiPlasTin

Activated Partial Thromboplastin Time

1910 DiagnosticaStagoSTA-PTTA2056 GeorgeKingBio-Medical1848 HelenaCascadePOCTestCard1145 HemosILAPTT-SP3240 HemosILSynthAFax1801 HemosILSynthASil2179 SiemensActin2181 SiemensActinFS1520 SiemensActinFSL

2314 TcoagAutomatedAPTTReagent1066 TcoagTriniCLOTaPTTHS1483 TcoagTriniCLOTaPTTHS(withTriniVeriCAL)1065 TcoagTriniCLOTaPTTS1484 TcoagTriniCLOTaPTTS(withTriniVeriCAL)2113 Thermo/PacificHemostasisAPTT-XL2561 Thermo/PacificHemostasisKontact2160 Other,specifyonresultform

Deleted CodesNone


Modules XC, XC1_Page 9

Reagent Master ListsCoagulation

Modules XC, XC1 (Page 2 of 2)


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Modules XC_Page 10

Coagulation - Fibrinogen Master ListsModule XC (Page 1 of 1)

Fibrinogen Instrument Master List

Deleted CodesNone


Mechanical Fibrin Polymer Detection1010 DiagnosticaStagoSTACompact1815 DiagnosticaStagoSTASatellite1929 DiagnosticaStagoSTA-R,STA-REvolution1019 TcoagAMAX190/200/4002000 TcoagDestinyseries2122 OtherMechanical,specifyonresultform

Optical Detection2165 Behnk/TrinityBiotechThrombolyzer(allmodels),

Coag-A-MateMAX1980 ILACL100,200,300,1000,2000,3000,6000,70001593 ILACL8000,9000,10000,Elite,ElitePro1679 ILACLTOPseries

1583 SiemensBCS,BCSXP1060 SiemensBCT1167 Siemens/SysmexCA-series3374 Siemens/SysmexCS-series3365 SysmexCS-series(Japanusersonly)2104 TcoagCoag-A-MateMTX1133 TcoagCoag-A-MateXM1371 OtherOptical,specifyonresultform

Prothrombin Time Based Optical Detection1069 OtherProthrombinTime,specifyonresultform

Other1884 Manual(TiltTube)


Deleted CodesNone

New/Updated Codes1802 HemosILReadiPlasTin

Fibrinogen Reagent Master List

Clauss Method (Modified Thrombin Time)1525 DiagnosticaStago1395 HemosILFibrinogen-C3155 HemosILQFA2180 SiemensFibrinogenDetermination

(DadeThrombin)2313 TcoagFibriQuik2053 TcoagTriniCLOTFibrinogen(AMAX)3039 Thermo/PacificHemostasisFibrinogenAssay2527 OtherClauss,specifyonresultform

Ellis-Stransky Method (Thrombin Turbidimetric Rate)2525 OtherEllis-Stransky,specifyonresultform

Immunologic Fibrinogen Assay1395 HemosILFibrinogen-C1018 OtherImmunologic,specifyonresultform

Prothrombin Time Based Fibrinogen Assay1159 HemosILPT-FIB1144 HemosILPT-FIBHSPlus1802 HemosILReadiPlasTin2553 HemosILRecombiPlasTin2G1259 OtherPTBasedFibrinogen,specifyonresultform

Other Method2160 Other,specifyonresultform


Modules XU, XU1, XL5_Page 11Do Not Return

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Urinalysis and Specific Gravity Master ListsModules XU, XU1, XL5 (Page 1 of 1)

Deleted CodesNone

New/Updated Codes2922 BiorexDIAZO-CHEK1095 M-N(Macherey-Nagel)Medi-Test

Uryxxonteststrips

Method Master List

1733 77ElektronikaReagentStrips3367 ACONMissionReagentStrips1534 ARKRAYAutionSticks2547 BayerAcetest2544 BayerClinitest,2drop2543 BayerClinitest,5drop2922 BiorexDIAZO-CHEK1626 BioSys/ConsultDiag/PSSSelect/YDDiagReagentStrips2574 BTNXRapidResponseReagentStrips1030 CTMI/GermaineLabs/ThermoFisherReagentStrips3425 DiagnosticTestGroupClarityUrocheckReagentStrips3238 DiaScreenReagentStrips1238 EikenUropaper2831 IRISvChemReagentStrips1114 JantAccustripURS10ReagentStrips1381 JantAccutestURS10ReagentStrips3422 McKesson/TecoReagentStrips2468 MedlineUrinalysisReagentStrips

1095 M-N(Macherey-Nagel)Medi-TestUryxxonteststrips2546 pHMeter2533 Refractometer3071 RocheChemstripLN2937 RocheChemstrip/Combur2492 RochecobasuPackCassette1221 RocheUrisysCassette1313 ScheinUrispec2673 SiemensClinitekAtlasReagent1622 SiemensClinitekNovus/ProCassette2538 SiemensIctotest2936 SiemensReagentStrips(All)3427 SMCDirectRefuAHReagentStrips1285 Sulfosalicylicacid2552 SysmexReagentStrips2534 Urinometer0010 Other,specifyonresultform

2492 RochecobasuPackCassette1622 SiemensClinitekNovus/ProCassette

Instrument Master List

1935 77Elektronikaurinechemistryanalyzers3368 ACONMissionU120,U5002126 ARKRAYAutionHybrid2675 ARKRAYAutionJET2676 ARKRAYAutionMAX1569 ARKRAY/ThermoBioStarPocketChemUA3444 BioSys/ConsultDiag/PSSSelect/YDDiagUrineAnalyzer2573 BTNXRapidResponseseries3424 DiagnosticTestGroupClarityUrocheck1201106 DiaScreen503371 EikenUS-2100R/22003372 EikenUS-3100R/3100Rplus1062 GermaineLabsAimStrip/CTMICT-120UrineAnalyzer1864 GermaineLabsAimStripUrineAutoAnalyzer1689 JantAccustripURS10Reader1096 M-N(Macherey-Nagel)Uryxxonseries3423 McKesson107-101UA3241 RocheChemstrip1011945 RocheChemstripCriterion,CriterionII

2097 RocheChemstripUrineAnalyzer1171 RocheChemstripMiniUA1790 Rochecobasu411,Urisys18002490 Rochecobasu6011789 RocheUrisys11001821 RocheUrisys24001579 SiemensClinitek10or1001845 SiemensClinitek501580 SiemensClinitek200or200+2292 SiemensClinitek500,Advantus1578 SiemensClinitek20001465 SiemensClinitekAtlas2681 SiemensClinitekNovus2532 SiemensClinitekStatus3426 SMCDirectRefuAHU1202186 SysmexUX-20002603 TecoUritekTC-1012044 Visual0010 Other,specifyonresultform

Deleted CodesNone

New/Updated Codes2573 BTNXRapidResponseseries1096 M-N(Macherey-Nagel)Uryxxonseries

2490 Rochecobasu601

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Modules XU, XU6, XL5_Page 12

Deleted CodesNone


1735 AbbottTestPackCombo2027 AbbottTestPackPlusCombow/

orw/outOBC1736 AbbottTestPackPlus-Urine1784 ABISureStep1782 ABISureStepCombo2938 AcceavaBasicII(urine)3168 AcceavaComboII2648 ACONOneStep(urineonly)2055 AlerehCGCassette(20)(Acceava)1959 AlerehCGCassette(25)(Clearview)2403 AlerehCGComboCassette(20/10)1299 AlerehCGComboCassette(25)

(Clearview)2404 AlerehCGDipstick1161 BeckmanCoulterICON202618 BeckmanCoulterICON252010 BioTronDiagnosticsForemostCombo2354 CardinalHealthSPBrandCassette2355 CardinalHealthSPBrandCombo2356 CardinalHealthSPBrandDipstick2647 Cen-MedElitePlusOneStephCG2120 ChembioSTAT-PAK1961 ClearviewhCGComboII1430 ConsultDiagnosticsCassette1432 ConsultDiagnosticsCombo1433 ConsultDiagnosticsDipstick1006 DEHealthcareProductsTruView

Cassette3140 DEHealthcareProductsTruView

One-Step2860 FormosaOneSurePregnancyKit1586 GermaineLabsAimStep1587 GermaineLabsAimStepCombo1679 GermaineLabsAimStrip1205 HenryScheinOneStep+Combo1382 HenryScheinOneStep+UrineCassette

1383 HenryScheinOneStep+UrineStrip1117 ImmunosticsImmunohCGDetector1118 ImmunosticsImmunohCGDetector

Combi(serum/urine)1119 ImmunosticsImmunohCGDetectorStix2474 InstantTechnologiesiPregnancyCassette

(serum/urine)2475 InstantTechnologiesiPregnancyCassette

(urineonly)2476 InstantTechnologiesiPregnancyStrip

(urineonly)1370 JantAccustripValue+3409 JantAccutestValue+(serum/urine)3410 JantAccutestValue+(urineonly)2981 LifeSignStatus(serum/urine)2980 LifeSignStatus(urineonly)1180 LSC(LABSCO)PEPhCGStrip1178 LSC(LABSCO)PEPhCGTest1060 MainlineConfirms(combo)1468 MainlineConfirms(urineonly)1477 McKessonMedi-LabPerformance

Cassette1478 McKessonMedi-LabPerformance

Combo1476 McKessonMedi-LabPerformance

Dipstick2276 MediChoiceCombi2277 MediChoiceUrineOnly2465 MedlinehCGUrineCassette2466 MedlinehCGUrineDipstick3209 MeridianImmunoCardSTAT1491 NDCProAdvantageUrineCassette1288 NDCProAdvantageUrine/Serum

Cassette1492 NDCProAdvantageUrineStrip3061 PolymedcoPolystat(serum/urine)2872 PolymedcoPolystat(urineonly)

Manufacturer Master ListUrine hCG

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

1372 PulseScientific1414 QuidelQuickVue+One-StepCombo1475 QuidelQuickVueOne-StepCombo1129 QuidelQuickVueOne-StepUrine1338 QuidelRapidVue(urineonly)2479 RamcoQuik-Trak(urineonly)2480 RamcoQuik-TrakCombiTest(serum/

urine)3137 RandoxDirect1800 RocheAccuStatCombo2108 SAScientific(serum/urine)2107 SAScientific(urineonly)2483 SAScientific(SAS)Ultra1836 SekisuiOSOM1837 SekisuiOSOMCombo2532 SiemensClinitekStatus2853 SignifyhCGCard2854 SignifyhCGUrine2855 SignifyhCGUrine/Serum2442 SMCDirectRefuAHCombo2441 SMCDirectRefuAHUrine1438 StanbioQuPID1439 StanbioQuPIDPlus3425 StanbioQuPIDPlusE.R.1135 StanbioQuStick3424 StanbioTrue20Plus1467 Sure-Vue(serum/urine)1466 Sure-Vue(urineonly)2052 Sure-VueSTAT(serum/urine)3428 TechnologistChoice(serum/urine)1844 TrinityBiotechUniGoldPT2559 WampoleUCG-SlideTest3158 WondfoOneStephCGUrine3159 WondfoOneStephCGUrine/Serum0010 Other,specifyonresultform

Modules XU2P, XU5P, XU7P_Page 13

Urine Sediment Identification Master ListModules XU2P, XU5P, XU7P (Page 1 of 1)

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Crystal124 Ammoniumbiurate137 Ammoniummagnesiumphosphate(triplephosphate)126 Amorphousurates/phosphates127 Ampicillin167 Bilirubin129 Calciumoxalate131 Cholesterol132 Cystine155 Hippuricacid133 Leucine136 Sulfonamide138 Tyrosine139 Uricacid

Organisms168 Bacteria147 Protozoa,includesTrichomonas309 Yeast/fungi

Miscellaneous/Exogenous 140 Fatdroplets141 Fiber(exogenous)/fecalcontamination142 Mucusstrands172 Pollengrain188 Stainprecipitate146 Starchgranule

Note: Iforganismsarepresent,chooseanidentificationthat indicatestheirpresence.

240 Immatureorabnormalcell,wouldreferforidentification(Code240shouldbeusedonlyifyouwouldroutinelysendthecellinquestiontoanoutsidelaboratorywithanother CLIAnumber.)

Cells308 Erythrocyte189 Erythrocyte,dysmorphic183 Leukocyte(neutrophil,eosinophil,lymphocyte)204 Monocyte/macrophage179 Parabasalcell,basalcell(vaginalfluidonly)112 Renaltubularepithelialcell(RTE)145 Spermatozoa113 Squamousepithelialcell175 Squamousepithelialcellwithbacteria(cluecell)114 Transitionalepithelialcell(urothelial)

Casts190 Cellularcast(RTEand/orneutrophil)115 Fattycast116 Granularcast118 Hyalinecast154 Muddybrowncast117 Non-hemoglobinpigment121 RBC/pigmented/muddybrowncasts123 Waxycast

Important: ConsultthecurrentHematologyandClinicalMicroscopyGlossary,whichcanbeaccessedatcap.org,forbriefdescriptionsor definitions.

Deleted Codes3403 AlfresaNescautoHemoPlus2011 GermaineLabsComplianceGold2467 MedlineiFOBTestKit2384 MedTekHemaWipe3020 PSSSelect/Select-ES

New/Updated Codes3503 ABONFOB3173 BeckmanCoulterHemoccult/II/SENSA3504 BioMerieuxbioNexia3502 Coral/TulipHemospot3501 DiproHemdetect

3503 ABONFOB2092 AerscherDiagnosticsHemaPromptFG3402 AlfresaHemoTechtNS-PlusC1111 BeckmanCoulterHemoccultICT3173 BeckmanCoulterHemoccult/II/SENSA3504 BioMerieuxbioNexia1264 CenogenicsCorp.3017 CIDAColoCheck/ColoCheck-ES3497 Clarity2008 Clearview3443 ConsultDiagnostics3502 Coral/TulipHemospot3501 DiproHemdetect3170 HelenaColoScreen/ColoScreen-ES3419 HemosureiFOB

1806 ImmunosticsHemaScreen/Specific3459 KyowaMedexHM-JACK3171 LaboratoryDiagnosticsQuik-Cult2385 MedTekInstaccult1625 PolymedcoOC-AutoMicro803357 PolymedcoOC-Light2951 PolymedcoOC-SensorDiana3172 PropperSeracult/SeracultPlus3284 QuidelQuickVueiFOB1519 SekisuiOSOMiFOB3247 SiemensHema-Chekslide2664 Stanbio3026 StarlineColoScan/ColoScan-ES3099 Sure-Vue/Sure-VueES0010 Other,specifyonresultform

Module XU9 _Page 14

Manufacturer Master ListOccult Blood

Module XU9 (Page 1 of 1)

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