2015 excel catalog - college of american pathologists · clinical chemistry. 8. college of american...

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2015 EXCEL®

© 2014 College of American Pathologists. All rights reserved. 23044.0714.6.1779

Deliver excellence and value to your entire team with education by the experts!

You get more from this box.Three more reasons to participate in the CAP Surveys/EXCEL® programs:

1. Prepare staff with the insights and knowledge of more than 500 pathology experts

2. Gain more than 100 CE credits— five times more than any other program

3. Access education for every member of your team at no additional charge

Table of Contents2015 EXCEL® Program

EXCEL Program Overview .......................................................................................................2

New Developments .................................................................................................................3

Continuing Education .............................................................................................................4

Clinical Chemistry ...................................................................................................................7

Hematology ...........................................................................................................................14

Urinalysis and Clinical Microscopy ......................................................................................17

Coagulation ...........................................................................................................................21

Microbiology ..........................................................................................................................24

Immunology ...........................................................................................................................31

Multidiscipline Combination Series .....................................................................................33

Point-of-Care Competency Programs ................................................................................35

Price List ..................................................................................................................................38

Indices ....................................................................................................................................41

Customer Support and Ordering Information .....................................................................51

EXCEL Program Overview

2 College of American Pathologists 2015 EXCEL Program

EXCEL EducationEducation activities are available to all EXCEL customers no matter what module you are enrolled in. You can access all CAP EXCEL education activities with a kit ID, CAP number, and an individual Web account. Refer to page 5 for more details.

Invaluable Online Program Components Available to All EXCEL Participants Access the Proficiency Testing Manual and Hematology and Clinical Microscopy Glossary, provided at no additional cost to all EXCEL participants at cap.org, under the Accreditation and Laboratory Improvement tab.

The Proficiency Testing Manual includes information that will help you:

• Processproficiencytesting(PT)specimensandreportresults

• Understandevaluationreports

• ComplywithCLIA

The Hematology and Clinical Microscopy Glossary, is a unique and invaluable reference designed to help you correctly identify:

• Bloodcellsandplatelets

• Morphologicabnormalitiesandartifacts

• Objectsfoundintheurine(cells,casts,crystals,andorganisms)

The glossary also includes information on vaginal preparations, stool and nasal smears, KOH preparations for fungi, and pinworm preparations.

EXCEL BindersIfyouwouldliketoorderabindertostoreyourproficiencytestingreports,pleaseaddtheprogramcodeXLBINDtoyour2015 order form. EXCEL program binders are not included as a part of your proficiency testing order.

EXCEL Binders XLBIND Program Code Description Price

XLBIND Three-ring binder $18

Price ListFor your convenience, we have included prices in a consolidated list. Please see Section 11.

CAP EXCEL Acceptance by Accrediting AgenciesAnalytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services(CMS)andareacceptedbyCOLAandmanystateregulatoryagencies.Modulesnotcontaining analytes regulated for proficiency testing are recognized by the CMS and CMS designees as an external assessment of quality assurance. State requirements may vary. To determine acceptance in your state, contact your state department of health.

EXCEL Program Overview

NewDevelopments

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New Developments

The 2015 EXCEL program reflects several changes, all designed to provide you with relevant, easy-to-use, and cost-effective modules to meet the needs of laboratories with limited testing menus.

Discontinued Programs

CardiacMarkers(L25)

Customers enrolled in the L25 module will automatically be enrolled in the CAP Surveys equivalent program, CRT. See the 2015 Surveys catalog for more information.

B-TypeNatriureticPeptides(L28)

Customers enrolled in the L28 module will automatically be enrolled in the following CAP proficiency testing programs depending on CAP Accreditation and/or previous instrument/method reporting. See the 2015 Surveys catalog for more information.

• B-Type Natriuretic Peptides (BNP)

• B-Type Natriuretic Peptides, five challenges (BNP5)

• Plasma Cardiac Markers (L30)

Discontinued Analytes

GeneralChemistry(CH)

Carbamazepine

Digoxin

Lithium

Phenobarbital

Phenytoin

Theophylline

Valproic acid

WaivedCholesterol/Lipids(L17)

Alanine aminotransferase (ALT)

Aspartate aminotransferase (AST)

Program Changes

PlasmaCardiacMarkers(L30)

BNP now five challenges per mailing

Troponin I now five challenges per mailing

2 Continuing Education

Don’t miss out on these educational opportunities!When your laboratory participates in the CAP’s EXCEL program, every member of your team can enroll in the education activities to earn continuing education (CE)creditatnoadditionalcharge.SeeyourParticipantSummaryformoredetails.

Continuing Education

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TheCollegeofAmericanPathologists(CAP)istheleadingresourceforeducationinthepracticeandscienceof pathology and laboratory medicine. The CAP Point-of-Care Testing Committee has integrated educational resourcesintotheEXCELprogram.Individualsmayearnuptosixcontinuingeducation(CE)creditsbycompletingtherelatedreadingfoundintheParticipantSummary(onlineorpaper-based)andtheonlinelearningassessmentquestions at cap.org.

Access Your Education Activities Online at Your ConvenienceOnce an educational activity is available, you can access it by registering at cap.org. You will need the EXCEL module’s kit ID and your institution’s CAP number. Follow the instructions included with the Participant Summary.

Ensure that You and Your Team Are at Your BestTopicsacrossallmajorlaboratorydisciplineshelpyoustaycurrentonpractical,usefulissuesinclinicalapplications, scientifictechnology,andresultsinterpretation.BecauseCAPeducationisdevelopedbyateamofrenowned pathologists and content experts who work with the CAP’s own professional learning specialists, you get high-quality, clear, and relevant education.

Fulfill Licensure and Education RequirementsEarn CE credits for participation in these activities. The CAP provides you with an online certificate of CE credits earned and claimed.

Free Personalized Online TranscriptYour personal CAP transcript is a powerful Web-based tracking system that automatically records every online education activity you complete. You can print your transcript or save it electronically any time, day or night. You can even add courses that you take outside the CAP, so your transcript is up to date and complete.

Take Care of Your PatientsThe bottom line, of course, is your patients. Help ensure accurate patient test results by keeping your staff’s knowledge and skills current!



Learning Cycle InformationEach education activitiy provides information on common technical and nontechnical issues encountered in all laboratory settings.

Educational topics for 2015 include:

• XL-A:Urinalysis

• XL-C:OralFluidTesting

• XL-D:RiskAssessment

• XL-E:VitaminD

• XL-G:DisseminatedIntravascularCoaglation

• XL-I:AntibioticResistance

Toreceivecontinuingeducation(CE)credit,youmustcompletetheeducationreadingprovidedinyourParticipant Summary or its online version and answer the online learning assessment questions. Each education activity is available for a maximum of twelve months and must be completed within that time frame. Each Participant Summary includes detailed information on how to access the online components.

Overall Learning ObjectivesUponcompletionoftheseeducationactivities,thelearnerwillbeableto:

• Listpreanalytic,analytic,andpostanalyticvariablesthataffectpatienttesting.

• Identifyqualityimprovementopportunitieswithinhis/herownlaboratorysetting.

• Applyappropriatequalityassurancemeasurestoensureaccuratepatientresults.

Continuing Education (CE)The College of American Pathologists designates these education activities for a maximum of six credits of continuing education. Participants should only claim credit commensurate with the extent of their participation in the activity.

TheAmericanSocietyforClinicalPathology(ASCP)BoardofCertification(BOC)CertificationofMaintenanceProgram(CMP)acceptstheseactivitiestomeetitscontinuingeducationrequirements.ThestatesofCaliforniaand Florida also approve these activities for continuing education credit.

Clinical Chemistry3

Clinical Chemistry

General Chemistry ...................................................................................................................8-9

Hematology/Oncology ............................................................................................................10

NeonatalBilirubin .......................................................................................................................10

Waived Cholesterol/Lipids ........................................................................................................10

WholeBloodGlucose ...............................................................................................................11

Hemoglobin A1c .........................................................................................................................11

Serum Alcohol ............................................................................................................................11

UrineDrugScreen ......................................................................................................................12

Reproductive Endocrinology ...................................................................................................12

Plasma Cardiac Markers ..........................................................................................................13

WholeBloodCreatinine ............................................................................................................13

Clinical Chemistry


Clinical ChemistryAnalytes/procedures in boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).

The matrix below contains commonly used whole blood chemistry instruments. It is not intended to be construed as approval or disapproval of any product or instrument. Please contact a CAP Customer Contact Center representative at 800-323-4040 or 847-832-7000 option 1 or your instrument manufacturer for other compatibility questions.

Whole Blood Chemistry Compatibility MatrixWhole Blood Analyzer/Method Analyte Compatible EXCEL Modules Incompatible EXCEL Modules

HemoCue® Glucose XL6 XL5, L20, L21

Roche Reflotron®Cholesterol

CH, CH3N/A

Glucose XL5, L20, L21

Cholestech LDX®

Total cholesterolHDL cholesterol

Triglycerides L17N/A

Glucose XL5, L20, L21

Whole blood cholesterol meters

Cholesterol CH, CH3, L17 N/A

Whole blood glucose meters Glucose L20, L21, XL5 CH, CH3, L17, XL6

NovaStatSensor®/ E-Z-EM EZ ChemTM Creatinine L31 CH, CH3

General Chemistry CH, CH3 Analyte Program Code Challenges/Shipment

CH CH3

Alanine aminotransferase (ALT/SGPT) z 5

Albumin z 5

Alkaline phosphatase z 5

Amylase z 5

Aspartate aminotransferase (AST/SGOT) z 5

ß-hCG, qualitative and quantitative z z 5

Bilirubin, total z z 5

Calcium z z 5

Carbondioxide(CO2) z z 5

Chloride z z 5

Cholesterol, total z z 5

Cortisol z 5

PRICING ON THE NEXT PAGE

These modules do not fulfill the requirements for neonatal bilirubin PT; refer to module L11 or L14 on page 10.

Program Information• Five5.0-mLliquidserum

specimens

• Conventionaland International System ofUnits(SI)reporting offered

• Threeshipmentsperyear: B,E,andH

Clinical Chemistry

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General Chemistry CH, CH3 continued

Analyte Program Code Challenges/Shipment

CH CH3

Creatine kinase (CK) z 5

Creatinine z z 5

Gammaglutamyltransferase(GGT) z 5

Glucose z z 5

HDL cholesterol z z 5

Iron z 5

Lactate dehydrogenase (LD) z 5

LDL cholesterol z z 5

Magnesium z 5

Phosphorus(inorganic) z 5

Potassium z z 5

Protein, total z 5

Sodium z z 5

T3,free(triiodothyronine,free) z 5

T3, total (triiodothyronine, total) z 5

T3, uptake z 5

T4, free (thyroxine, free) z 5

T4, total (thyroxine, total) z 5

Thyroid-stimulating hormone (TSH) z 5

Triglycerides z z 5

Urea nitrogen (BUN) z z 5

Uric acid z z 5

PRICE (USD) $402 $210

These modules do not fulfill the requirements for neonatal bilirubin PT; refer to module L11 or L14 on page 10.


specimens

• Conventionaland International System ofUnits(SI)reporting offered


Clinical Chemistry


Hematology/Oncology CH9 Analyte Program Code Challenges/Shipment

CH9

CEA z 3

Ferritin z 3

Folate z 3

PSA z 3

VitaminB12 z 3

PRICE (USD) $156

Neonatal Bilirubin L11, L14 Analyte Program Code Challenges/Shipment

L11 L14

Bilirubin,direct z z 2

Bilirubin, total z 5

PRICE (USD) $123 $210

Waived Cholesterol/Lipids L17 Analyte Program Code Challenges/Shipment

L17

Cholesterol z 3

Glucose z 3

HDL cholesterol z 3

LDL cholesterol z 3

Triglycerides z 3

PRICE (USD) $190

Program Information• Three5.0-mLliquidserum

specimens

•Twoshipmentsperyear: BandH

Program Information• L11-Two1.0-mLliquid

serum specimens

•L14-Five1.0-mLliquid serum specimens

•Threeshipmentsperyear: B,E,andH


specimens

• Forusewithwaived methods such as Cholestech LDX® and RocheACCU-CHEKTM Instant Plus

•Notcompatiblewithother whole blood glucose meters

• Twoshipmentsperyear: BandH

Clinical Chemistry

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Whole Blood Glucose L20, L21 Analyte Challenges/Shipment

Program Code

L20 L21

Glucose 3 5

PRICE (USD) $154 $222

Hemoglobin A1c L22 Analyte Program Code Challenges/Shipment

L22

Hemoglobin A1c z 3

PRICE (USD) $186

Beginningwiththe2015proficiencytesting(PT)programyear,theCollegeofAmericanPathologists(CAP)AccreditationProgramwillrequireallaccreditedlaboratories performing non-waived testing for Hemoglobin A1c to complete 15 PT challenges per year. See Survey GH5 in the 2015 Surveys catalog.

Serum Alcohol L23 Analyte Program Code Challenges/Shipment

L23

Ethanol z 5

PRICE (USD) $288

Program Information• L20-Three2.5-mLwhole

blood specimens; two shipments per year: BandH

•L21-Five2.5-mLwholeblood specimens; three shipments per year: B,EandH

•Reportuptofivedifferent testing sites/instruments

Program Information• Threelyophilizedspecimens

with a dropper-tipped vial of diluent



specimens


Clinical Chemistry


Urine Drug Screen L26 Analyte Program Code Challenges/Shipment

L26

Acetaminophen z 3

Amphetamine z 3

Amphetamine/methamphetamine group

z 3

Barbiturategroup z 3

Benzodiazepinegroup z 3

Benzoylecgonine/cocaine metabolites

z 3

Buprenorphine z 3

Delta-9-THC-COOH z 3

Ethanol z 3

Fentanyl z 3

Lysergicaciddiethylamide(LSD) z 3

Methadone z 3

Methadonemetabolite(EDDP) z 3

Methamphetamine z 3

Methaqualone z 3

Methylenedioxymethamphetamine (MDMA)

z 3

Opiate group z 3

Oxycodone z 3

Phencyclidine z 3

Propoxyphene z 3

Tricyclic group z 3

PRICE (USD) $286

Reproductive Endocrinology L27 Analyte Program Code Challenges/Shipment

L27

Estradiol z 3

Follicle-stimulatinghormone(FSH) z 3

Luteinizinghormone(LH) z 3

Progesterone z 3

Prolactin z 3

PRICE (USD) $318

Program Information• Three10.0-mLurine

specimens



specimens

•Twoshipmentsperyear: BandH

Clinical Chemistry

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Plasma Cardiac Markers L30 Analyte Program Code Challenges/Shipment

L30

CK-MB z 5

BNP z 5

Myoglobin z 2

Troponin I z 5

PRICE (USD) $258

Beginningwiththe2015proficiencytesting(PT)programyear,theCollegeofAmericanPathologists(CAP)AccreditationProgramwillrequireallaccreditedlaboratoriesperformingnon-waivedtestingforBNPandTroponinItocomplete 15 PT challenges per year.

Whole Blood Creatinine L31 Analyte Program Code Challenges/Shipment

L31

Creatinine z 5

PRICE (USD) $276

Program Information• Five1.0-mLliquidEDTA

plasma specimens

•Forusewithinstrumentssuch as the Alere Triage and Abbott i-STAT


Program Information• Five4.0-mLwholeblood

specimens

• Forusewiththe NovaStatSensor®/ E-Z-EM EZ ChemTM


Hematology4

Hematology

Routine Hematology ................................................................................................................15

Comprehensive Hematology With Differential .....................................................................15

Centrifugal Hematology ..........................................................................................................16

Erythrocyte Sedimentation Rate .............................................................................................16

Reticulocyte Count ..................................................................................................................16

Hematology

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HematologyAnalytes/procedures in boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).

Routine Hematology XH1, XHP Analyte/Procedure Program Code Challenges/Shipment

XH1 XHP

Blood cell identification z 6

Hematocrit z 5

Hemoglobin z 5

MCV,MCH,MCHC z 5

Platelet count z 5

RBC count z 5

RDW z 5

WBC count z 5

PRICE (USD) $222 $45

Comprehensive Hematology With Differential XH3, XH4

Analyte/Procedure Program Code Challenges/Shipment

XH3 XH4

Automated differential z z 5

Hematocrit z z 5

Hemoglobin z z 5

MCV,MCH,MCHC z z 5

Platelet count z z 5

RBC count z z 5

RDW z z 5

WBC count z z 5

PRICE (USD) $306 $306

For method compatibility, see the instrument matrix on page 16.

Program Information• XH1-Five3.0-mLwhole

blood specimens; also compatible with spun hematocrit methods

•XHP-Siximages:fivegraded and one educational/ungraded; each available as photographs and online images

•Threeshipmentsperyear: A, D, and G

Program Information• Five2.5-mLwholeblood

specimens


Hematology


Hematology, Instrument Compatibility Matrix Instrument Recommended Module

XH3 XH4 XH6

SysmexK-Series,KX-21/21N,pocH-100i,XP-Series z

Abbott Cell-Dyn® 1200, 1400, 1600, 1700, 1800, Emerald z

HoribaABX9000+/9100+Series(3-partdiff),Spirit z

HoribaABXArgos,Helios,Micros,Minos z

SiemensADVIA60 z

CoulterAc•T,JT,MD,Onyx,S880,S-Plus,ST,STKR,T-Series z

Drew Scientific DC-18, I-1800, DREW3, EXCELL Series z

CDS/Medonic M-Series z

QBC z

Pierceable cap z z

Centrifugal Hematology XH6, XH7 Analyte/Procedure Program Code Challenges/Shipment

XH6 XH7

Hematocrit z 5

Hemoglobin z 5

Platelet count z 5

WBC count z 5

WBC differential (2-part) z 5

PRICE (USD) $255 $30

For method compatibility, see instrument matrix above.

Erythrocyte Sedimentation Rate XH8 Procedure Program Code Challenges/Shipment

XH8

All methods except for Sedimat® 15/15+,Alifax®, and ALCOR

z 3

PRICE (USD) $198

Sedimat 15, Alifax, and ALCOR users should order Surveys ESR1, ESR2, or ESR3 in the 2015 Surveys and Anatomic Pathology Education Programs catalog.

Reticulocyte Count XH9 Analyte Program Code Challenges/Shipment

XH9

Reticulocyte count z 3

PRICE (USD) $280

Program Information• XH6-Five0.6-mLwhole

blood specimens

•XH7-MustorderinconjunctionwithmoduleXH6

•ForusewithQBCinstruments; not intended for spun hematocrit methods


Program Information• Three6.0-mLwholeblood

specimens

• Twoshipmentsperyear: D and G

Program Information• Three1.0-mLstabilized

whole blood specimens

• Forusewithmanualandmost automated reticulocyte count methods

• Twoshipmentsperyear: A and G

Urinalys is and Cl in ical Microscopy5

UrinalysisandClinicalMicroscopy

Urinalysis .....................................................................................................................................18

UrineSedimentandClinicalMicroscopy ...............................................................................18

Provider-Performed Microscopy .............................................................................................19

OccultBlood .............................................................................................................................19

Sperm Count and Presence/Absence ..................................................................................20

UrineAlbumin(Microalbumin)Creatinine .............................................................................20

Amniotic Fluid Leakage ...........................................................................................................20

Rupture of Fetal Membrane Testing .......................................................................................20



Urinalysis and Clinical MicroscopyAnalytes/procedures in boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).

Urinalysis XU, XU1, XU6, XU2P, XU4P Analyte/Procedure Program Code Challenges/Shipment

XU XU1 XU6 XU2P XU4P

Urinebilirubin z z 2

Urineblood/hemoglobin z z 2

Urineglucose z z 2

Urineketones z z 2

Urineleukocyteesterase z z 2

Urinenitrite z z 2

UrinepH z z 2

Urineprotein z z 2

Urinereducingsubstances z z 2

Urinespecificgravity z z 2

Urineurobilinogen z z 2

UrinehCG,qualitative z z 2(XU)/5(XU6)

Urinesediment z 3

Clinical microscopy* z 6

PRICE (USD) $150 $108 $156 $42 $42

*See page 19 for specimen types and shipment information. **See Survey CMP1 in the 2015 Surveys catalog.

Urine Sediment and Clinical Microscopy XU7P, XU8P

Analyte/Procedure Program Code Challenges/Shipment

XU7P XU8P

Clinical microscopy z 6

Urinesediment z 3

PRICE (USD) $96 $96

Program Information• XU,XU1-Two10.0-mLurine

specimens

•Notcompatiblewith iChem** methods

•XU2P-Threeimages;eachavailable as photographs and online images

•XU4P-Siximages;eachavailable as photographs and online images


•XU6-Five1.0-mLurine specimens


Program Information• XU7P-Threeimages;each

available as photographs and online images

•XU8P-Siximages;eachavailable as photographs and online images

•Designedasstand-alone optionsofmodulesXU2P andXU4P

•Twoshipmentsperyear: A and G


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Clinical Microscopy, Information MatrixSpecimen Type Shipment

XL-A XL-G

Ferntest(vaginal) z z

KOHpreparations(skinorvaginal) z z

Nasalsmears z z

Pinworm preparations z z

Stool for leukocytes z z

Vaginalwetpreparations(forspermatozoa,trichomonas,cluecells,andepithelialcells)

z z

Provider-Performed Microscopy XU5P Procedure Program Code Challenges/Shipment

XU5P XL-A XL-G

Fern test z 1 1

KOH preparations z 1 1

Nasalsmears z 1 1

Pinworm preparations z 1 1

Stool for leukocytes z 1 1

Vaginalwetpreparations z 1 1

Urinesediment z 3 3

PRICE (USD) $166

Occult Blood XU9 Analyte Program Code Challenges/Shipment

XU9

Occult blood z 3

PRICE (USD) $130

Program Information• Nineimages:threeurine

sediment and six clinical microscopy challenges; each available as photographs and online images

•Designedtomeetfederal quality assurance requirements for provider-performed microscopy techniques


Program Information• Three2.0-mLsimulated

fecal specimens




Sperm Count and Presence/Absence XU10 Procedure Program Code Challenges/Shipment

XU10

Sperm count and presence/absence

z 2

PRICE (USD) $254

Urine Albumin (Microalbumin) Creatinine XUX11 Analyte/Procedure Program Code Challenges/Shipment

XUX11

Creatinine z 2

Urinealbumin(microalbumin), semiquantitative

z 2

Urinealbumin(microalbumin), creatinine ratio

z 2

PRICE (USD) $212

Amniotic Fluid Leakage XUX12 Procedure Program Code Challenges/Shipment

XUX12

pH interpretation z 3

PRICE (USD) $228

Rupture of Fetal Membranes Testing XUX13 Procedure Program Code Challenges/Shipment

XUX13

Rupture of fetal membranes z 3

PRICE (USD) $398

Program Information• Two0.3-mLliquid

specimens

•Twoshipmentsperyear: D and G

Program Information• Two5.0-mLliquidurine

specimens

•Forusewithdipstickand semiquantitative methods


Program Information• Three2.0-mLliquid

specimens

•Forusewithnitrazinepaper (pHstrips)andAmnioTestTM (nitrazinetestswabs)


Program Information• Three0.5-mLsimulated

vaginal specimens

• Forusewithmethodssuchas AmnisureTM and Clinical Innovations


Coagulat ion6

Coagulation

Coagulation ..............................................................................................................................22

WholeBloodCoagulation .......................................................................................................22

WholeBloodD-Dimer ...............................................................................................................23

Coagulation


CoagulationAnalytes/procedures in boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).

Coagulation XC, XC1 Analyte/Procedure Program Code Challenges/Shipment

XC XC1

Activated partial thromboplastin time z 5

Fibrinogen z 5

Internationalnormalizedratio(INR) z z 5

Prothrombin time z z 5

PRICE (USD) $174 $156

ParticipantsreportingINRresultswillreceiveaspecialevaluationtoassesstheINRcalculation.

Whole Blood Coagulation XC3, XC19

Analyte Program Code Challenges/Shipment

XC3 XC19

Internationalnormalizedratio(INR) z z 5

Prothrombin time z z 5

PRICE (USD) $330 $243

For method compatibility, see instrument matrix below.

Whole Blood Coagulation, Instrument Matrix Instrument Recommended Module

XC3 XC19

Abbott CoaguSense z

HelenaCascadePOC–Noncitrated z

ITCHemochronJr.Signature/Signature+,Signature Elite–Noncitratedcuvette

z

ILGEMPCL,PCLPlus–Noncitrated z

i-STAT® z

Program Information• Five1.0-mLlyophilized

plasma specimens; requires a 1.0-mL volumetric pipette to perform testing

•Alsocompatiblewiththe CVDITASinstruments


Program Information• XC3-Five0.5-mLlyophilized

whole blood specimens

•XC19-Five1.0-mL lyophilized plasma specimens

• Threeshipmentsperyear: A, D, and G

Coagulation

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Whole Blood D-Dimer XC20 Analyte Program Code Challenges/Shipment

XC20

D-dimer, qualitative z 2

PRICE (USD) $234

Program Information• Two0.5-mLwholeblood

specimens

• ForusewiththeSimpliREDTM and ClearviewTM Simplify D-dimer methods


Microbiology 7

Microbiology

Hazardous Materials ........................................................................................................... 25 –26

Microbiology Flow Chart .........................................................................................................27

Microbiology Combination .....................................................................................................28

Throat Culture............................................................................................................................28

Rapid Group A Strep Antigen Detection ...............................................................................28

Gram Stain .................................................................................................................................29

UrineColonyCount/UrineCultureIdentification ..................................................................29

ThroatandUrineCulture/RapidAStrepAntigenDetection ...............................................29

Clostridium difficile Toxin Antigen Detection .........................................................................30

ViralAntigenDetection ...........................................................................................................30

Microbiology

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MicrobiologyThe EXCEL modules listed below contain hazardous materials and may require special permits and additional fees.

EXCEL Modules With Dangerous Goods Program Code Name

MM, M20 Microbiology Combination

M1 Throat Culture

M9 UrineColonyCount/UrineCultureIdentification

M10 ThroatandUrineCulture/RapidStrepAAntigenDetection

M17 UrineColonyCount/UrineCultureIdentification

Biohazard InformationTheCentersforDiseaseControlandPrevention(CDC)hasclassifiedallbacterialandviralstrainsusedinPT challengesasnotgreaterthanaBiosafetyLevel2.YoucanfindafulldescriptionofBiosafetyLevel2(BSL-2) handlingrequirements,asdefinedbytheCDCOfficeofHealthandSafetyinBiosafetyinMicrobiologicaland BiomedicalLaboratories,atcdc.gov/biosafety/publications/bmbl5/index.htm.

Your laboratory must handle specimens included in programs of an etiologic nature using precautions appropriateforBSL-2facilities.

KeyelementsofBiosafetyLevel2compliance:

• Limitorrestrictaccesstothelaboratoryatthediscretionofthelaboratorydirectorwhenexperiments are in progress.

• Washhandsafterhandlingviablematerials,afterremovinggloves,andbeforeleavingthelaboratory.

• Donoteat,drink,smoke,handlecontactlenses,orapplycosmeticsinworkareas. Store food outside the work area in cabinets or refrigerators designated for this purpose only.

• Nomouthpipettingallowed;usemechanicalpipettingdevices.

• Institutepoliciesforthesafehandlingofsharps.

• Performallprocedurescarefullytominimizethecreationofsplashesoraerosols.

• Decontaminateworksurfacesoncompletionofworkorattheendofthedayandafteranyspillor splash of viable material with disinfectants that are effective against the agents of concern.

• Decontaminateallcultures,stocks,andotherregulatedwastesbeforedisposalbyanapproved decontamination method such as autoclaving. Place materials to be decontaminated outside of the immediate laboratory in a durable, leakproof container, and close the container for transport from the laboratory. Package materials for off-site decontamination in accordance with applicable local, state, and federal regulations before removing them from the facility.

• Incorporatebiosafetyproceduresintostandardoperatingproceduresorinabiosafetymanual adopted or prepared specifically for the laboratory by the laboratory director. Advise personnel of special hazards and require that they read and follow instructions on practices and procedures.

• Wearprotectivelaboratorycoats,gowns,smocks,oruniformsdesignatedforlabuseonlywhileinthe laboratory. Remove this clothing and leave it in the laboratory before leaving for nonlaboratory areas (eg,cafeteria,library,administrativeoffices).Personnelmustdisposeofallprotectiveclothinginthe laboratory or the institution must launder it; personnel should never take protective clothing home.

Microbiology


IfyourlaboratoryisnotBiosafetyLevel2compliant,pleasecontactyouraccreditationagencyforfurtherinformation regarding fulfillment of PT requirements.

The following icon designates modules that contain material of an etiologic nature:

Biohazard Warning StatementsAll EXCEL modules include a biohazard warning statement appropriate for the handling of the materials included. Your laboratory should still handle modules that do not include etiologic agents in keeping with CDC universal precautions and OSHA bloodborne pathogen rules.

Microbiology

800-323-4040 | 847-832-7000 Option 1 | cap.org 27

ThisflowchartisaguidetohelpyouorderthemostappropriateBacteriologymoduleforyourlaboratory.Ifyouhave any questions, please call the Customer Contact Center at 800-323-4040 or 847-832-7000 option 1.

If you use a Quanti-Cult® method for urine colony count and/or identification, see page 29 for available modules.

Do you perform cultures or antigen detection testing?

Enroll in Gram Stain Module, M8

Do you perform microbiology procedures, including:

• Cultures for urine, throat, and GC • Antimicrobial susceptibility testing • Gram stain

Do you perform microbiology procedures, including:

•Cultures for urine, and/or throat • Antimicrobial susceptibility testing • Gram stain • Rapid Group A Strep Antigen

Do you only perform throat

cultures?

Do you perform: • Throat/urine cultures • Rapid Group A Strep Antigen

Do you perform only antigen

detection testing?

Enroll in Microbiology Combination Module, MM

Enroll in Microbiology Combination Module, M20

Enroll in Throat Culture Module,

M1

Enroll in Throat and Urine

Culture/Rapid Strep Antigen Module, M10

Enroll in Rapid Group A Strep

Antigen Detection

Modules, M6 or M14 (waived)

g

NO

gNO

gNO

gNO

gYES

g

YES

g

YES

g

YES

g

YES

g

YES

NO

g

Microbiology


EXCEL modules MM, M1, M9, M10, M17, and M20 all contain hazardous materials. See the Customer Support and Ordering Information section regarding additional dangerous goods shipping fees.

Microbiology Combination MM, M20 Procedure Challenges/Shipment

Program Code

MM M20

Antimicrobial susceptibility 1 1

GC culture 5

Gram stain 2 1

Rapid group A Streptococcus antigen detection

1 1

Throat culture 2 3

Urine culture 3 5

PRICE (USD) $312 $270

Throat Culture M1 Procedure Program Code Challenges/Shipment

M1

Throat culture z 5

PRICE (USD) $258

Rapid Group A Strep Antigen Detection M6, M14 Procedure Challenges/Shipment

Program Code

M6 M14


5 2

PRICE (USD) $204 $138

Program Information• MM-Tenloopspecimens (twoduplicatesets)and one swab for antigen detection

•M20-Eightloopspecimens (twoduplicatesets)and one swab for antigen detection

•Urinecultureswillonlyhaveone susceptibility challenge

•Threeshipmentsperyear: C, F, and I

Program Information• Fiveloopspecimens

• Threeshipmentsperyear: C, F, and I

Program Information• M6-Fiveswabspecimens;

three shipments per year: C, F, and I

• M14-Twoswabspecimens;two shipments per year: C and F

Analytes/procedures in boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).

Microbiology

800-323-4040 | 847-832-7000 Option 1 | cap.org 29

Gram Stain M8 Procedure Program Code Challenges/Shipment

M8

Gram stain z 5

PRICE (USD) $207

Urine Colony Count/Urine Culture Identification M9, M17

Procedure Challenges/Shipment

Program Code

M9 M17

Urinecolonycount/ urine culture identification

2 5


3

Throat culture 3

PRICE (USD) $198 $333

Throat and Urine Culture/ Rapid Strep A Antigen Detection M10

Procedure Program Code Challenges/Shipment

M10

Antimicrobial susceptibility z 1

Gram stain z 1


z 2

Throat culture, group A Streptococcus

z 3

Urine culture z 3

PRICE (USD) $258

If you are using a waived method for Streptococcus testing, these results will not count toward the required five challenges for the subspeciality of bacteriology.

Program Information• Fiveair-dried,methanol-

fixed, unstained slides


Program Information• M9-Two2.0-mLurine

specimens

•M17-Fiveurinespecimens,three loop specimens, and three swabs for antigen detection

•Threeshipmentsperyear: C, F, and I

Program Information• Sixloopspecimensand

two swabs for antigen detection



Microbiology


C. difficile Toxin Antigen Detection M18 Analyte Program Code Challenges/Shipment

M18

Clostridium difficile toxin z 1

PRICE (USD) $174

Viral Antigen Detection M21 Analyte Program Code Challenges/Shipment

M21

Influenza A antigen z 5

Influenza B antigen z 5

Respiratory syncytial virus (RSV) antigen

z 5

Rotavirus antigen z 5

PRICE (USD) $285

Program Information• One1.0-mLlyophilized

specimen

• Mustorderinconjunctionwith a regulated microbiology module (MM,M1,M6,M8,M10, M17,orM20)


Program Information• Five1.0-mLliquid

specimens

• Forusewithenzyme immunoassay and/or latex agglutination methods



Immunology8

Immunology

Anti-HIV-1andAnti-HIV-1/2,Waived ......................................................................................32

C-ReactiveProtein(CRP) ........................................................................................................32

hCG, Serum ...............................................................................................................................32

Helicobacter pylori Antibody Detection ...............................................................................32

Infectious Mononucleosis ........................................................................................................32

Infectious Mononucleosis, Waived .........................................................................................32

Rheumatoid Factor ..................................................................................................................32

Immunology


ImmunologyAnalytes/procedures in boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).

Immunology XS1, XS2, XS3, XS4, XS5, XS7, XS9 Analyte/Procedure Program Code Challenges/Shipment

XS1 XS2 XS3 XS4 XS5 XS7 XS9

C-reactive protein (qualitative/quantitative)

z 1

Helicobacter pylori antibody detection

z 2

hCG, serum (qualitative/quantitative)

z 5

Infectious mononucleosis z z 5

Infectious mononucleosis, waived

z 3

Rheumatoid factor* z z 5

PRICE (USD) $225 $159 $132 $159 $159 $174 $98

*Rheumatoid factor is a regulated analyte and is graded for both qualitative and quantitative methods. Semiquantitative and/or titer results are ungraded/educational in this module and do not meet regulatory requirements.

Anti-HIV-1 and Anti-HIV-1/2, Waived XB3 Analyte/Procedure Program Code Challenges/Shipment

XB3

Anti-HIV-1andAnti-HIV-1/2,waivedmethods only

z 2

PRICE (USD) $170 $218

Program Information• XS1-Five0.6-mLliquid

serum specimens and five 1.0-mL liquid serum specimens

•XS2-Five0.6-mLliquid serum specimens

•XS3-One0.5-mLliquid serum specimen

•XS4,XS5-Five1.0-mLliquid serum specimens


•XS7-Two1.0-mLliquid serum specimens

•XS9-Three0.6-mLliquid serum specimens

• Twoshipmentsperyear: C and F

Program Information• Two0.5-mLplasma

specimens; report up to five different locations within your institution

•Twoshipmentsperyear: F and I

Mult idiscipl ineCombinationSer ies9

Multidiscipline Combination Series


Multidiscipline Combination SeriesAnalytes/procedures in boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).

Waived Test Combination Series XL5 Analyte Program Code Challenges/Shipment

XL5

Hematocrit z 2

Hemoglobin z 2

Urinalysis/UrinehCG z 2

Whole blood glucose z 3

PRICE (USD) $376

Waived Combination XL6 Analyte Program Code Challenges/Shipment

XL6

Hemoglobin z 2

Whole blood glucose z 2

PRICE (USD) $154

Program Information• Hematocit,hemoglobin,

and urinalysis/urine hCG testing - Two 3.0-mL whole blood specimens and two 10.0-mL urine specimens; two shipments per year: A and G

• Wholebloodglucose testing - Three 2.5-mL whole blood specimens; two shipments per year: BandH

• Forusewithmethodssuch as the HemoCue®

• Toverifyinstrumentcompatibility, refer to the matrix on page 8

Program Information• Two1.0-mLwholeblood

specimens

• ForusewiththeBTNXRapidResponse, HemoCue B-Glucose,HemoCueGlucose201andHb201+Systems, HemoCue Hb 301 Sysetms, and Stanbio HemoPoint H2 instruments


Point-of-Care Competency Programs10


Point-of-Care Competency Programs

POC Competency Programs

POC Competency Challenges are designed to improve waived test results. This program will evaluate instrument and method performance, troubleshoot, assess staff competency, and provide information to train staff. Expected results will be provided. This program is not a proficiency testing program and participants will not return results to the CAP.

POC Competency Challenges may have limited availability and stability.

POC Competency Challenges POC1, POC2, POC3, POC4

Program Name Program Code Challenges/ Shipment

POC1 POC2 POC3 POC4

POC hCG Competency z 10

POC Glucose Competency z 10

POCUrineDipstickCompetency z 10

POC Strep Screen Competency z 10

PRICE (USD) $130 $130 $130 $130

POC Competency Challenges POC5, POC6, POC7, POC8, POC9

Program Name Program Code Challenges/Shipment

POC5 POC6 POC7 POC8 POC9

POCPT/INR,i-STATCompetency z 10

POCPT/INR,CoaguChek XS Plus Competency

z 10

POC Waived Chemistry, Glucose andHgBCompetency

z 10

POCInfluenzaA/BAntigenDetect Competency

z 10

POCFecalOccultBloodCompetency

z 10

PRICE (USD) $130 $130 $130 $130 $130

Program Information• POC1-Onepositive10.0-mL

liquid urine specimen

• POC2-Oneabnormal2.5-mLwhole blood specimen

• POC3-Oneabnormal 10.0-mL liquid urine specimen

• POC4-One1.0-mLpositiveliquid specimen

• Eachprogramwillprovidematerial to test up to 10 staff

• Shipmentsavailableuponrequest

Program Information• POC5-Fiveabnormal1.0-mL

lyophilized plasma specimens

• POC6-Fiveabnormal0.4-mLlyophilized plasma specimens

• POC7-Oneabnormal1.0-mLwhole blood specimen. For use with the HemoCue®B,HemoCue 201, and Stanbio HemoPoint® H2 instruments

• POC8-One1.5-mLvialpositive for Influenza A; One 1.5-mL vial positive for InfluenzaB

• POC9-Onepositive2.0-mLfecal specimen

• Eachprogramwillprovidematerial to test up to 10 staff


800-323-4040 | 847-832-7000 Option 1 | cap.org 37

Point-of-Care Competency Programs

POC Competency Challenges POC10, POC11, POC12


POC10 POC11 POC12

POC Blood Gases Competency z 10

POC Blood Gases, i-STAT Competency

z 10

POC Plasma Cardiac Markers Competency

z 10

POC Competency Challenges POC14, POC15, POC16


POC14 POC15 POC16

POC Medtronic ACT/ACT, i-STAT Competency

z 5

POC Hemochron Jr IL GEM ACT-LR Competency

z 5

POC Hemochron Jr Signature IL GEM PCL ACT Competency

z 5

PRICE (USD) $130 $130 $130

Program Information• POC10-Tenduplicate

abnormal 2.5-mL aqueous blood gas specimens and ten duplicate 2.5-mL hematocrit/hemoglobin specimens

• POC11-Tenduplicateabnormal 2.5-mL aqueous specimens for blood gas and hematocrit/hemoglobin testing

• POC12-Twoduplicateabnormal 1.0-mL plasma specimens; compatible with plasma based tests, such as Alere Triage and i-STAT instruments


Program Information• POC14-Fiveduplicate

abnormal 1.7-mL lyophilized whole blood specimens and one calcium chloride diluent vial; compatible with Medtronic HemoTec ACT/ACT, Medtronic Hepcon HMS, i-STAT Celite ACT, i-STAT Kaolin ACT

• POC15-Fiveduplicateabnormal 0.5-mL unitized specimens; compatible with IL GEM PCL Plus ACT-LR and ITCHemochronJr./SignatureACT-LR

• POC16-Fiveduplicateabnormal 0.5-mL unitized specimens; compatible with IL GEM PCL Plus ACT and ITCHemochronJr./SignatureACT+


11 Pr ice L ist

2015 Price List

800-323-4040 | 847-832-7000 Option 1 | cap.org 39

Program Code EXCEL 2015

Price Page

Point-of-Care Competency ProgramsPOC1 POC hCG Competency $130 36

POC2 POC Glucose Competency $130 36

POC3 POCUrineDipstickCompetency $130 36

POC4 POC Strep Screen Competency $130 36

POC5 POCPT/INR,i-STATCompetency $130 36

POC6POCPT/INR,CoaguChek

XS Plus Competency$150 36

POC7POC Waived Chemistry, Glucose andHgBCompetency

$130 36

POC8POCInfluenzaA/BAntigen Detect Competency

$130 36

POC9POC Fecal Occult

BloodCompetency$130 36

POC10 POCBloodGasesCompetency $156 37

POC11POCBloodGases,i-STAT

Competency$156 37

POC12POC Plasma Cardiac Markers

Competency$148 37

POC14POC Medtronic ACT/ACT, i-STAT Competency

$166 37

POC15POCHemochronJrILGEM ACT-LR Competency

$156 37

POC16POCHemochronJrSignatureIL

GEM PCL ACT Competency$156 37

Clinical Chemistry

CH General Chemistry, comprehensive $402 8, 9

CH3 General Chemistry, basic $210 8, 9

CH9 Hematology/Oncology $156 10

L11 NeonatalBilirubin,2challenges $135 10

L14 NeonatalBilirubin,5challenges $210 10

L17 Waived Cholesterol/Lipids $190 10

L20 WholeBloodGlucose,3challenges $154 11

L21 WholeBloodGlucose,5challenges $222 11

L22 Hemoglobin A1c $186 11

L23 Serum Alcohol $288 11

L26 UrineDrugScreen $286 12

L27 Reproductive Endocrinology $318 12

L30 Plasma Cardiac Markers $258 13

L31 WholeBloodCreatinine $306 13


Price Page

Coagulation

XC Coagulation $174 22

XC1 Coagulation, limited $162 22

XC3 WholeBloodProthrombinTime/INR $330 22

XC19 WholeBloodProthrombinTime/INR $243 22

XC20 WholeBloodD-Dimer $260 23

Hematology

XH1 Routine Hematology $222 15

XH3 Comprehensive Hematology $306 15

XH4 Comprehensive Hematology $306 15

XH6 Centrifugal Hematology $255 16

XH7 CentrifugalHematology,WBC $30 16

XH8 Erythrocyte Sedimentation Rate $198 16

XH9 Reticulocyte Count $280 16

XHP RoutineHematology,BloodCellID $45 15

Immunology

XB3 Anti-HIV-1andAnti-HIV-1/2,Waived $218 32

XS1Infectious Mononucleosis and Rheumatoid Factor

$225 32

XS2 Infectious Mononucleosis $159 32

XS3 C-Reactive Protein $132 32

XS4 Serum hCG $159 32

XS5 Rheumatoid Factor $159 32

XS7 Helicobactor pylori, Antibody $174 32

XS9 Infectious Mononucleosis, Waived $98 32

Microbiology

M1 Throat Culture $258 28

M6Rapid Group A Strep Antigen Detection, 5 challenges

$204 28

M8 Gram Stain $207 29

M9UrineColonyCount/UrineCulture Identification

$216 29

M10ThroatandUrineCulture/ Rapid Strep A Antigen Detection

$285 29

M14Rapid Group A Strep Antigen Detection, 2 challenges

$138 28

M17UrineColonyCount/UrineCultureIdentification

$366 29

M18 C. difficile Toxin Antigen Detection $174 30

M20 Microbiology Combination, basic $270 28

2015 Price List

2015 Price List



Price Page

Microbiology (cont.)

MMMicrobiology Combination, comprehensive

$312 28

M21 ViralAntigenDetection $285 30

Urinalysis and Clinical Microscopy

XU Urinalysis,comprehensive $150 18

XU1 Urinalysis,basic $108 18

XU2P UrineSediment,withXU,XU1,XL5 $42 18

XU4PClinicalMicroscopy,withXU,XU1,XL5

$42 18

XU5P Provider-Performed Microscopy $166 19

XU6 UrinehCG $156 18

XU7P UrineSediment $96 18

XU8P Clinical Microscopy $96 18

XU9 OccultBlood $130 19

XU10Sperm Count and Presence/ Absence

$254 20

XUX11UrineAlbumin(Microalbumin) Creatinine

$212 20

XUX12 Amniotic Fluid Leakage $228 20

XUX13 Rupture of Fetal Membranes Testing $398 20

Multidiscipline Combination Series

XL5 Waived Test Combination Series $416 34

XL6 Waived Test Combination $154 34

Supplemental Programs

XLBIND EXCELBinder $18 2

Indices12

Indices


IndicesAnalytes/procedures in boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).

The XintheLAPENRcolumndenotestheCAPprogramsthatcanbeusedtofulfilltheproficiencytestingenrollmentrequirementsfor CAP-accredited laboratories. Refer to the program description in this catalog to determine compatibility with your specific methodologies.

Analyte/Procedure by Discipline LAP ENR Program Code

Clinical Chemistry Pages 7–13

Acetaminophen X L26

Alanine aminotransferase (ALT/SGPT) X CH

Albumin X CH

Alcohol, serum X L23

Alkaline phosphatase X CH

Amphetamine group L26

Amphetamine/methamphetamine group L26

Amylase X CH

Aspartate aminotransferase (AST/SGOT) X CH

Barbiturategroup L26

Benzodiazapinegroup L26

Benzoylecgonine/cocainemetabolites L26

Bilirubin,direct,neonatal X L11, L14

Bilirubin, total X CH, CH3

Bilirubin, total, neonatal X L14

B-typenatriureticpeptides(BNP) X L30

Buprenorphine L26

Calcium X CH, CH3

Carbondioxide(CO2) X CH, CH3

CEA X CH9

Chloride X CH, CH3

Cholesterol, total X CH, CH3, L17

CK-MB X L30

Cortisol X CH

Creatine kinase (CK) X CH

Creatinine X CH, CH3, L31

Delta-9-THC-COOH L26

Estradiol X L27

Ethanol, serum X L23

Ethanol, urine L26

Fentanyl L26

Ferritin X CH9

Folate X CH9

Follicle-stimulatinghomone(FSH) X L27

Gammaglutamyltransferase(GGT) X CH

Indices

800-323-4040 | 847-832-7000 Option 1 | cap.org 43

Analyte/Procedure by Discipline LAP ENR Module

Clinical Chemistry (cont.) Pages 7–13

Glucose, serum X CH, CH3

Glucose, whole blood, 5 challenges X L21

Glucose, whole blood, 3 challenges X L17,L20,XL5(p.34)

Glucose, whole blood, 2 challenges X XL6(p.34)

hCG, serum, quantitative and qualitative X CH, CH3

HDL cholesterol X CH, CH3, L17

Hemoglobin A1c X L22

Iron X CH

Lactate dehydrogenase (LD) X CH

LDL cholesterol X CH, CH3, L17

Luteinizinghormone(LH) X L27

Lysergicaciddiethylamide(LSD) L26

Magnesium X CH

Methadone L26

Methadonemetabolite(EDDP) L26

Methamphetamine L26

Methaqualone L26

Methylenedioxymethamphetamine(MDMA) L26

Myoglobin X L30

Neonatalbilirubun,direct X L11, L14

Neonatal bilirubin, total X L14

Opiate group L26

Oxycodone L26

Phencyclidine L26

Phosphorus X CH

Potassium X CH, CH3

Progesterone X L27

Prolactin X L27

Propoxyphene L26

Prostate-specificantigen(PSA) X CH9

Protein, total X CH

Sodium X CH, CH3

T3 (Triiodothyronine, total) X CH

T3,free(Triiodothyronine,free) X CH

T3 uptake X CH

T4 (Thyroxine, total) X CH

T4, free (Thyroxine, free) X CH

Thyroid-stimulating hormone (TSH) X CH

Tricyclic group L26

Triglycerides X CH, CH3, L17

Troponin I X L30

Indices



Clinical Chemistry (cont.) Pages 7–13

Urea nitrogen (BUN) X CH, CH3

Uric acid X CH, CH3

Urinedrugscreen X L26

VitaminB12 X CH9

Coagulation Pages 21–23

Activated partial thromboplastin time (APTT) X XC

D-dimer, whole blood XC20

Fibrinogen X XC

Internationalnormalizedratio(INR) X XC, XC1, XC3, XC19

Prothrombin time (PT), plasma X XC, XC1

Prothrombin time (PT), whole blood X XC3, XC19

Hematology Pages 14–16

Automated differential X XH3, XH4, XH7

Blood cell identification X XHP

Erythrocytesedimentationrate(ESR) XH8

Hematocrit X XH1, XH3, XH4, XH6

Hematocrit, waived X XL5(p.34)

Hemoglobin X XH1, XH3, XH4, XH6

Hemoglobin, waived X XL5,XL6(p.34)

MCV,MCH,MCHC XH1, XH3, XH4

Platelet count X XH1, XH3, XH4, XH6

RDW XH1, XH3, XH4

Red blood cell count (RBC) X XH1, XH3, XH4

Reticulocyte count X XH9

WBC differential, automated X XH3, XH4, XH7

White blood cell count (WBC) X XH1, XH3, XH4, XH6

Immunology Pages 31–32

Anti-HIV-1,waived X XB3

Anti-HIV-1/2,waived X XB3

C-reactiveprotein(CRP),qualitativeandquantitative X XS3

hCG, serum, qualitative and quantitative X XS4

Helicobacter pylori antibody detection X XS7

Infectious mononucleosis X XS1, XS2

Infectious mononucleosis, waived X XS9

Rheumatoid factor, qualitative and quantitative X XS1, XS5

Microbiology Pages 24–30

Antimicrobial susceptibility X MM, M10, M20

Beta-lactamasetesting MM

C. difficile toxin antigen detection X M18

GC culture X MM

Indices

800-323-4040 | 847-832-7000 Option 1 | cap.org 45


Microbiology (cont.) Pages 24–30

Gram stain X MM, M8, M10, M20

Influenza A and B antigen detection X M21

Rapid group A strep antigen detection X MM, M6, M10, M17, M20

Rapid group A strep antigen detection, waived X M14

Respiratory syncytial virus (RSV) antigen detection X M21

Rotavirus antigen detection X M21

Throat culture X MM, M1, M10, M17, M20

Urinecolonycount X M9, M17

Urinecolonycount/urine culture identification X M9, M17

Urine culture X MM, M9, M10, M17, M20

Point-of-Care Competency Programs Page 35-37

POC hCG Competency POC1

POC Glucose Competency POC2

POCUrineDipstickCompetency POC3

POC Strep Screen Competency POC4

POCPT/INR,i-STATCompetency POC5

POCPT/INR,CoaguChekXSPlusCompetency POC6

POCWaivedChemistry,GlucoseandHgBCompetency POC7

POCInfluenzaA/BAntigenDetectCompetency POC8

POCFecalOccultBloodCompetency POC9

POCBloodGasesCompetency POC10

POCBloodGases,i-STATCompetency POC11

POC Plasma Cardiac Markers Competency POC12

POC Medtronic ACT/ACT, i-STAT Competency POC14

POCHemochronJrILGEMACT-LRCompetency POC15

POCHemochronJrSignatureILGEMPCLACTCompetency POC16

Urinalysis and Clinical Microscopy Pages 17–20

Amnioticfluidleakage(Nitrazine) XUX12

Clinical microscopy X XU4P,XU8P

Creatinine, urine, semiquantitative X XUX11

Fern test X XU4P,XU5P,XU8P

KOH preparations X XU4P,XU5P,XU8P

Nasalsmears X XU4P,XU5P,XU8P

Occult blood XU9

Pinworm preparations X XU4P,XU5P,XU8P

Provider-performed microscopy X XU4P,XU5P,XU8P

Rupture of fetal membranes XUX13

Sperm count X XU10

Sperm, presence/absence XU10

Stool for leukocytes X XU4P,XU5P,XU8P

Indices



Urinalysis and Clinical Microscopy (cont.) Pages 17–20

Urinealbumin(microalbumin),semiquantitative X XUX11

Urinealbumin(microalbumin):creatinineratio XUX11

Urinebilirubin X XU,XU1,XL5(p.34)

Urineblood/hemoglobin X XU,XU1,XL5(p.34)

Urineglucose X XU,XU1,XL5(p.34)

UrinehCG,qualitative X XU,XU6,XL5(p.34)

Urineketones X XU,XU1,XL5(p.34)

Urineleukocyteesterase X XU,XU1,XL5(p.34)

Urinenitrite X XU,XU1,XL5(p.34)

UrinepH X XU,XU1,XL5(p.34) Urineprotein X XU,XU1,XL5(p.34)

Urinereducingsubstances X XU,XU1,XL5(p.34)

Urinesediment X XU2P,XU5P,XU7P

Urinespecificgravity X XU,XU1,XL5(p.34)

Urineurobilinogen X XU,XU1,XL5(p.34)

Vaginalwetpreparations X XU4P,XU5P,XU8P

Indices

800-323-4040 | 847-832-7000 Option 1 | cap.org 47


Analyte/Procedure LAP ENR Module Page

Acetaminophen L26 12

Activated clotting time POC competency POC14, POC15, POC16 37

Ac tivated partial thromboplastin time (APTT) X XC 22

Alanine aminotransferase (ALT/SGPT) X CH 8

Albumin X CH 8

Alcohol, serum X L23 11

Alkaline phosphatase X CH 8

Amnioticfluidleakage(Nitrazine) XUX12 20

Amphetamine group L26 12

Amphetamine/methamphetamine group L26 12

Amylase X CH 8

Anti-HIV-1,waived X XB3 32

Anti-HIV-1/2,waived X XB3 32

Antimicrobial susceptibility X MM, M10, M20 28, 29

Aspartate aminotransferase (AST/SGOT) X CH 8

Automated differential X XH3, XH4, XH7 15, 16

Barbiturategroup L26 12

Benzodiazepinegroup L26 12

Benzoylecgonine/cocainemetabolites L26 12

Beta-lactamasetesting MM 28

Bilirubin,direct,neonatal X L11, L14 10

Bilirubin, total X CH, CH3 8

Bilirubin, total, neonatal X L14 10

Blood cell identification X XHP 15

B-typenatriureticpeptides(BNP) X L30, POC12 13, 37

Buprenorphine L26 12

C. difficile toxin antigen detection X M18 30

Calcium X CH, CH3 8

Calcium, ionized POC competency X POC10, POC11 37

Carbondioxide(CO2) X CH, CH3 8

CEA X CH9 10

Chloride X CH, CH3, POC10, POC11 8, 37

Cholesterol, total X CH, CH3, L17 8, 10

CK-MB X L30, POC12 13, 37

Clinical microscopy X XU4P,XU8P 18

Cortisol X CH 8

C-reactiveprotein(CRP),qualitativeandquantitative X XS3 32

Creatine kinase (CK) X CH 9

Creatinine XCH, CH3, L31,

POC10, POC119, 13, 37

Creatinine, urine, semiquantitative X XUX11 20

D-dimer, whole blood XC20 23

Delta-9-THC-COOH L26 12

Erythrocytesedimentationrate(ESR) XH8 16

Estradiol X L27 12

Indices




Ethanol, serum X L23 11

Ethanol, urine L26 12

Fecal occult blood, POC competency POC9 36

Fentanyl L26 12

Fern test X XU4P,XU5P,XU8P 18, 19

Ferritin X CH9 10

Fibrinogen X XC 22

Folate X CH9 10

Follicle-stimulatinghormone(FSH) X L27 12

Gammaglutamyltransferase(GGT) X CH 9

GC culture X MM 28

Glucose, serum X CH, CH3, POC10, POC11 9, 37

Glucose, whole blood, 5 challenges X L21 11

Glucose, whole blood, 3 challenges X L17, L20, XL5 10, 11, 34

Glucose, whole blood, 2 challenges X XL6 34

Glucose, POC competency POC2 36

Glucose, POC competency POC7 36

Gram stain X MM, M8, M10, M20 28, 29

hCG, serum, qualitative and quantitative X CH, CH3, XS4 8, 32

hCG, POC competency POC1 36

HDL cholesterol X CH, CH3, L17 9, 10

Helicobacter pylori antibody detection X XS7 32

Hematocrit XXH1, XH3, XH4, XH6,

POC10, POC1115, 16, 37

Hematocrit, waived X XL5 34

Hemoglobin XXH1, XH3, XH4, XH6,

POC10, POC1115, 16, 37

Hemoglobin, waived X XL5, XL6 34

Hemoglobin, POC competency POC7 36

Hemoglobin A1c X L22 11

Infectious mononucleosis X XS1, XS2 32

Infectious mononucleosis, waived X XS9 32

Influenza A and B antigen detection X M21 30

InfluenzaA/Bantigendetect,POCcompetency POC8 36

InternationalNormalizedRatio(INR) X XC, XC1, XC3, XC19 22

Iron X CH 9

KOH preparations X XU4P,XU5P,XU8P 18, 19

Lactate POC10, POC11 37

Lactate dehydrogenase (LD) X CH 9

LDL cholesterol X CH, CH3, L17 9, 10

Luteinizinghormone(LH) X L27 12

Lysergicaciddiethylamide(LSD) L26 12

Magnesium X CH 9

Magnesium, ionized, POC competency POC10, POC11 37

MCV,MCH,MCHC XH1, XH3, XH4 15

Indices

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Methadone L26 12

Methadonemetabolite(EDDP) L26 12

Methamphetamine L26 12

Methaqualone L26 12

Methylenedioxymethamphetamine(MDMA) L26 12

Microalbumin X XUX11 20

Myoglobin X L30, POC12 13, 37

Nasalsmears X XU4P,XU5P,XU8P 18, 19

Neonatalbilirubin,direct X L11, L14 10

Neonatal bilirubin, total X L14 10

Occult blood XU9,POC9 19, 36

Opiate group L26 12

Oxycodone L26 12

PCO2, POC competency X POC10, POC11 37

pH XPOC10, POC11, XU,XU1,XL5

18, 34, 37

Phencyclidine L26 12

Phosphorus X CH 9

Pinworm preparations X XU4P,XU5P,XU8P 18, 19

Platelet count X XH1, XH3, XH4, XH6 15, 16

PO2, POC competency X POC10, POC11 37

Potassium X CH, CH3, POC10, POC11 9, 37

Progesterone X L27 12

Prolactin X L27 12

Propoxyphene L26 12

Prostate-specificantigen(PSA) X CH9 10

Protein, total X CH 9

Prothrombin time (PT), plasma X XC, XC1 22

Prothrombin time (PT), whole blood X XC3, XC19 22

Provider-performed microscopy X XU4P,XU5P,XU8P 18, 19

PT/INRi-STAT,POCcompetency POC5 36

PT/INRCoaguChekXSPlus,POCcompetency POC6 36

Rapid group A strep antigen detection XMM, M6, M10, M14, M17,

M2028, 29

Rapid group A strep antigen detection, waived X M14 28

RDW XH1, XH3, XH4 36

Red blood cell count (RBC) X XH1, XH3, XH4 15

Respiratory syncytial virus (RSV) antigen detection X M21 30

Reticulocyte count X XH9 16

Rheumatoid factor, qualitative and quantitative X XS1, XS5 32

Rotavirus antigen detection X M21 30

Rupture of fetal membranes XUX13 20

Sodium X CH, CH3, POC10, POC11 9, 37

Sperm count X XU10 20

Sperm presence/absence XU10 20

Indices

Analytes/procedures in bold typeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).


Stool for leukocytes X XU4P,XU5P,XU8P 18, 19

Strep screen, POC competency POC4 36

T3,free(Triiodothyronine,free) X CH 9

T3, total (Triiodothyronine, total) X CH 9

T3, uptake X CH 9

T4, free (Thyroxine, free) X CH 9

T4, total (Thyroxine, total) X CH 9

tCO2, POC competency POC10, POC11 37

Throat culture X MM, M1, M10, M17, M20 28, 29

Thyroid-stimulating hormone (TSH) X CH 9

Tricyclic group L26 12

Triglycerides X CH, CH3, L17 9, 10

Troponin I X L30, POC12 13, 37

Urea nitrogen (BUN) X CH, CH3, POC10, POC11 9, 37

Uric acid X CH, CH3 9

Urinealbumin(microalbumin):creatinineratio XUX11 20

Urinealbumin(microalbumin),semiquantitative X XUX11 20

Urinebilirubin X XU,XU1,XL5 18, 34

Urineblood/hemoglobin X XU,XU1,XL5 18, 34

Urinecolonycount X M9, M17 29

Urinecolonycount/urine culture identification X M9, M17 29

Urine culture X MM, M9, M10, M17, M20 28, 29

Urinedipstick,POCcompetency POC3 36

Urinedrugscreen X L26 12

Urineglucose X XU,XU1,XL5 18, 34

UrinehCG,qualitative X XU,XU6,XL5 18, 34

Urineketones X XU,XU1,XL5 18, 34

Urineleukocyteesterase X XU,XU1,XL5 18, 34

Urinenitrite X XU,XU1,XL5 18, 34

UrinepH X XU,XU1,XL5 18, 34

Urineprotein X XU,XU1,XL5 18, 34

Urinereducingsubstances X XU,XU1,XL5 18, 34

Urinesediment X XU2P,XU5P,XU7P 18, 19

Urinespecificgravity X XU,XU1,XL5 18, 34

Urineurobilinogen X XU,XU1,XL5 18, 34

Vaginalwetpreparations X XU4P,XU5P,XU8P 18, 19

VitaminB12 X CH9 10

WBC differential, automated X XH3, XH4, XH7 15, 16

White blood cell count (WBC) X XH1, XH3, XH4, XH6 15, 16


Customer Support

and Ordering

Information13

Customer Support and Ordering Information

Customer Support.....................................................................................................................52

Ordering Information, Forms, and Terms and Conditions .............................................. 53–56

Additional Information for International Customers ....................................................... 57–61

Shipping Calendar ...................................................................................................................62

Customer Support


Customer SupportCustomer Contact Center Hours: Monday–Friday, 7:00 AM–5:30 PM CT Extended Support Hours: Monday–Friday, 9:00 PM–5:00 AM CT (Email correspondence only)

Contact InformationCall us to: • Placeormodifyanorder

• Changecontactinformation(telephone number,emailaddress,faxnumber,oraddress)

• Discussspecialneeds(International)

• InitiateCAPTRAKer SM email

800-323-4040 option 1847-832-7000 option 1

To contact the CAP via email Logontocap.organdselect“ContactUs”atthetopofthe home page.ORSend email to [email protected].

To submit orders or permits Fax: 847-832-8168 Email: [email protected]

Laboratory Accident Hotline800-443-3244 847-470-2812(Forinternationalcustomers) (CountryCode:001)

CAPTRAKer Email The CAP’s electronic PT kit shipment-tracking service offers these services to your laboratory:

• LocateyourPTkitinaninstant.

• ReceiveCAPTRAKer emails notifying you of program shipments.

• LinktoFedExtrackinginformationthroughaCAPTRAKer email.

To initiate the receipt of CAPTRAKer emails, please forward your name, account number, and email address to [email protected]:Thisislimitedtooneshippingcontactemailaddressperaccount.

e-LAB SolutionsTM

Joinover10,000laboratoriesthatusetheCAP’sonlineproficiencytestingservice.Usee-LAB Solutions to take advantage of the following benefits:

• Enterandviewresultsonline.

• Vieworprintcopiesofevaluations,ParticipantSummaryreports,kitinstructions,andresultforms.

• VieworprintyourAnalyteReportingSelectionsdocumenttoensureproperregulatoryreporting.

• Accessthe“MyPTShippingCalendar”feature,whichshowsyour customized proficiency testing shipping calendar.

• Accessaccreditationinformation,includingyourlaboratory’scustomizedaccreditationchecklists.

• AccessthePTTroubleshootingGuideandPTExceptionInvestigationChecklisttools.

• Enhanceyourautomatedreportingcapabilitieswithe-LABSolutionsConnect(availableintheUSonly).

ThesitealsocontainsaUser’sGuidethatwillhelpwalkyouthroughtheprocess.Whenyouoptin,yourlaboratorywillreceive important email notifications regarding proficiency testing events such as nonreceipt of your result forms and evaluation availability online.

Program CertificatesAt the completion of the program year, participating laboratories will receive a program certificate that recognizes each institution’s participation in the CAP EXCEL program and its commitment to patient care.

Ordering Information, Forms, and Terms and Conditions

800-323-4040 | 847-832-7000 Option 1 | cap.org 53

Ordering Information, Forms, and Terms and Conditions

To ensure accurate and timely order placement:

• Return ALL pages of your renewal order form, including payment information.

• Print legibly and follow all instructions for adding and canceling programs. We process order forms using optical character recognition, so legible printing will help ensure the accuracy of your order.

Order Deadline • OrderbyDecember 1st, to ensure full participation.

• Orderearly.Someprogramshavelimitedquantities.

• OrdersreceivedafterDecember1stwillbeprocessedbydateofreceiptandproratedperprogram availability.

Renewal Orders (for current customers) • ProgramsorderedasofAugust1starepreprintedonyourorderrenewalform.

• Reviewallnotes.

• Refertothiscatalogforprogramchangesanddiscontinuedornewprograms.

• Completeformwithpaymentinformationandreturnallpagesbyemailtocdm@cap.orgorfaxallpagestoCustomer Data Management at 847-832-8168.

• Anorderacknowledgmentwillbeemaileduponreceiptofyourorder.

• Onceprocessed,anorderconfirmationwillbeemailedtotheshippingcontact.Orderchangescanbe made at that time.

• Youcanalsoseealistofprogramsunder“MyPTShippingCalendar”atcap.org.

Order Additions and Cancellations • WewillmakeeveryefforttoaccommodateordersreceivedafterDecember1stdependentonthe shipping schedule and specimen availability and stability.

• Duetovendorcommitments,theCAPmustreceivecancellationsnolaterthansix weeks prior to the ship date to receive credit for canceled programs.

CAP and CLIA Numbers • PleasehaveyourCAPnumberavailablewhenplacingorders.IfyouareanewCAPcustomer,aCAP number will be assigned and will appear on your order confirmation.

• USCustomers:Confirmorprovidethelaboratory’sCLIAidentificationnumber,whichisassignedbythe CentersforMedicare&MedicaidServices(CMS)andcanbeobtainedfromyourlaboratorydirector. Contact your CMS Regional Office if you do not have a CLIA ID number.

• OrdersmaybesubmittedpendingassignmentofyourCLIAnumber.ForwardthenumbertotheCAP once assigned.

Prices • Pricesexcludetaxes,duties,andotherapplicablecharges;allpricesaresubjecttochangewithoutnotice.

• TheCAPreservestherighttochangethepublishedpricesandshipdatesforprogramsinthiscatalog.

Customer Support


PaymentComplete the payment section of the order form. To avoid delay in the processing of your order, you must use one of the following methods of payment:

• Check:MakepayabletotheCollegeofAmericanPathologistsinUSdollars.

• Credit Card: Include number, expiration, cardholder’s name, and authorized signature.

• Purchase Order: A purchase order indicates a future commitment to pay using one of the following methods:

m Purchase Order # – Indicate the purchase order number.

m Letter of Authorization – If your institution does not use a purchase order system, a signed letter of authorization on your institution’s letterhead should be included with your order. Please include payment method(draft,banktransfer,etc)informationinyouletterofauthorizationandenter“LetterofAuth”in the purchase order field of the Payment Information section.

Wire Transfer Information • Includeallbankfeeswithyourpayment.

• TheCAPisnotresponsibleforbankfeesincurredwhileremittingpayment.Makearrangementswithyourfinancial institution to include all wire transfer fees, including fees charged by intermediary banks during a funds transfer.

• Shortpaymentduetodeductionofintermediarybankfeeswillleaveanopenbalanceonyouraccount,which you are responsible to pay in your wire transfer to the CAP.

• Remitwiretransferpaymentto:

m BMOHarrisBankN.A.,311WestMonroeStreet,Chicago,Illinois60606USA

m Phone: 312-461-2121

m AccountNumber:223-733-7

m ABANumber:071000288

m SWIFT#:HATRUS44

• Includethefollowinginformation:

m Customer name

m CAP number

m Account number

m Invoice and/or order number

Payment Terms and Conditions • ForordersprocessedbyOctober31,2014,paymenttermsareextendeduntilDecember1,2014.

• AfterNovember1,2014,termswillbenet30daysfromtheinvoicedate.

• Price Quotes: Please contact the CAP if your institution requires a price quote prior to submitting payment. Uponreceiptofthepricequote,submitthecompletedorderform,includingpaymentmethod,totheCAP for processing of your order.

Tax Information • Wewillcalculateandaddappropriatetaxesforyourlocaletoyourinvoiceifyourinstitutionissubjectto sales tax.

• Includeapplicabletaxeswithyourprepaidorder.

• IfyourinstitutionisnotsubjecttosalestaxandyouhavenotpreviouslynotifiedtheCAP,encloseyour tax-exempt certificate with your order form.

• TheCAPfederaltaxidentificationnumberis36-2118323.

Customer Support

800-323-4040 | 847-832-7000 Option 1 | cap.org 55

Shipping • AllshipmentsaremadeCPTDestination.

• TheCAPisnotliableforlossordamagecausedbyforcemajeure.

• Provideacompleteshippingaddress,telephonenumber,faxnumber,emailaddress,andcontactname on your order form.

• TheCAPwillnotacceptpostofficeboxnumbersforshipments.

• Mostproficiencytestingshipmentswillbesentviaovernightortwo-dayservice.

Our goal is to ensure program materials are shipped to maintain stability and reach your laboratory using a reliable transportion carrier. Shipping rates have continued to increase, requiring the CAP to add a 1% shipping fee for all 2015 programshipmentsandassessshippingfeesforprogramsshippedoutsidethecontinentalUS.

Shipping and Handling Fees Destination Shipping Fee Per Program (US $)

Alaska $55

American Samoa $55

Canada $120

Guam $55

Hawaii $55

Puerto Rico $95

VirginIslands $95

Shipments beyond the continental USanddestinationsnotedabove

Refer to your order form or contact us

Hawaiian PermitsThestateofHawaiirequiresimportpermits.YoumayobtainanimportpermitbycontactingthePlantQuarantineBranchofthe State of Hawaii Department of Agriculture. Complete form PQ-7 to obtain an import permit or a letter of authorization.

Program Usage and Materials • Allprogrammaterialsareintendedforproficiencytesting(PT)useonly.

• YoumaynottransferorincorporatePTsamples,theirprogeny,unmodifiedderivatives,ormodifications thereof into a program intended for sale or uses other than proficiency testing, quality assurance or education.

• WhenyoudisposeofPTsamples,theirprogeny,unmodifiedderivatives,ormodificationsthereof,reagents, and disposable equipment used in proficiency testing, you should autoclave or incinerate and dispose of these as hazardous waste.

• Alldirectionsconcerninguseoftheprogrammaterialsareintendedasguidanceonly.

• Nolicenseiseithergrantedorimpliedbythesaleofanyprogram.

• TheCAPcontractswithseveralvendorsinproducingthematerialsforitsproficiencytestingprograms. All vendors selected must abide by the standards set forth in Good Manufacturing Practices and/or hold an ISO certification.

The CAP’s terms and conditions supercede any terms and conditions supplied by the customer.

Customer Support


Laboratory Accident Hotline 800-443-3244 84 7-470-2812 (for international customers)

(Country Code: 001)

Accidental exposures while processing specimens from the CAP, including cuts and contamination of mucous membranes or non-intact skin, should be reported to the CAP hotline for evaluation and questions regarding prophylaxis. Please provide the identification number of the relevant specimen.

Biohazard Information/Warning Statements • TheCentersforDiseaseControlandPrevention(CDC)hasclassifiedallbacterialandviralstrainsusedinPT challengesasnotgreaterthanaBiosafetyLevel2.YoucanfindafulldescriptionofBiosafetyLevel2 handlingrequirements,asdefinedbytheCDCOfficeofHealthandSafetyinBiosafetyinMicrobiological andBiomedicalLaboratories,atcdc.gov/biosafety/publications/bmbl5/index.htm.

• Allmodulesincludeabiohazardwarningstatementappropriateforhandlingofthematerial.

• ModulesthatdonotincludeetiologicagentsarestillexpectedtobehandledinkeepingwithCDCuniversal precautions and OSHA bloodborne pathogen rules.

• TheCAP’sSafetyDataSheets(SDS)areavailableoncap.org.

Prelicensure/Reinstatement Service • TheCAPprovidesPTsamplestolaboratoriesthatmayneedtoperformprelicensuretestingbeforebeginning

patient testing and/or reinstatement testing due to PT failures. Contact the CAP for cost and availability.

• PTsampleswithlimitedstabilityarenotavailableforprelicensure/reinstatementtesting.

• ReinstatementevaluationswillbeprovideduponsubmissionofresultstotheCAP.

Governing Law • AllCAPtransactionsaregovernedbythelawsofthestateofIllinois.

• UnlessotherwisestatedUSCommercialCodeprevails.

CMS Reporting • TheCollegeofAmericanPathologistsmustsubmitPTresultstotheCMSforalllaboratoriesprovidinga

CLIA identification number.

• YourreportingpreferencesareoutlinedontheCMS Analyte Reporting Selections document, which is available online in e-LAB Solutions.

• IfalaboratorydoesnotnotifytheCAPinadvancethattheyhavediscontinuedtestingofaregulatedanalyte,a score of zero will be given.

• Toavoidanypenaltiesandensureappropriatereportinginthefuture,youmustnoteanalyteslistedonthis report for which you do not perform testing.

PT ReferralPlease share this information with anyone who performs proficiency testing and/or manages PT specimens.

Proficiency testing referral has come under greater scrutiny from inspectors for the CMS. The CAP’s PT program reminds participants that per CLIA ’88, a laboratory must test the PT specimens it receives in the same manner as it tests patient specimens—specimens must be tested with the laboratory’s regular workload, using the laboratory’s routine methods, and the same number of times it routinely tests patient specimens. However, laboratories must not communicate results, share proficiency testing specimens, or refer proficiency testing specimens to a laboratory with a different CLIA number for tests not on the laboratory’s menu even if the referral for testing is routinely performed for patient specimens.

800-323-4040 | 847-832-7000 Option 1 | cap.org 57

Information for International Customers

Additional Information for International Customers

What you need to know before your PT program is shipped:

PermitsManycountriesrequireimportpermitsorcertificatesoforiginforcustomsclearance(regardlessofdangerousgoodsstatusofaprogram).

• Workwithyourlocalauthoritiestodetermineifanypermitsarerequired.

• Asarecipient,youareresponsibleforobtaininganyimportpermits/documentsandforwardingthesetothe CAP for inclusion with the program shipment. Provide these same documents to your broker or the local FederalExpress(FedEx)office.

• DonotusetheCAPEXCELcatalogprogramdescriptionsforpermitpreparationandcustomsclearancedocuments. Program specifications may have changed after catalog publication or do not provide sufficient detail. Contact the CAP to obtain such information.

• UseprogramdescriptionsintheCAPcatalogtopreventdiscrepanciesinpermitpreparationandcustoms clearance documents.

• Programswithdangerousgoodsmayrequirespecialpermitsandincuradditionalcharges.

• Youareresponsibleformonitoringpermitexpirationdatesandsubmittinganewpermitsixweekspriortothescheduled ship date.

• Program materials will not ship without required documentation.

Submit permits at the time of ordering, preferably with an extended expiration date of December 31, 2015, in order to cover all shipments. At a minimum, submit permits six weeks prior to the stated program ship date to ensure timely delivery.

Additional DocumentationContact the CAP if you require additional documentation to place orders or receive shipments. Examples of available documentationincludeUSIRSForm6166CertificateofResidency,ArticlesofIncorporation,andtheCAP’staxstatus.

Canadian PermitsCanadian regulations require permits to import animal, plant, and human pathogens. Permit applications should list theCAPprogramcodeandfullprogramname.DonotlisttheProgramFulfillmentGroup(PFG).Donotlistthemailing designation(A,B,C).

These permits must be obtained by the recipient for all infectious modules from:

• ThePublicHealthAgencyofCanada([email protected].)

• CFIAPlantProtectionDivisionpermitsmayalsoberequired.Contactpermitoffice@inspection.gc,ca.

Canadian Broker RequirementsCanadian customers must designate a broker for customs clearance. FedEx may be designated as your broker by signingaPowerofAttorneywithFedEx.ProvideyourGoodsandServicesTax(GST)accountnumberandCFIA numbertoyourdesignatedbroker.RequestingPre-ArrivalsReleaseSystem(PARS)clearancewillexpediteclearanceof your proficiency testing kits.

Saudi Arabian PermitsCurrent Saudi Food and Drug Authority regulations require import permits for all programs. You may obtain permits through the Saudi Food and Drug Authority. Submit permits to the CAP, and your local FedEx office and other appropriate agencies.

Additional International Permit informationInformation for other countries can be found on cap.org.



Programs requiring import permits are listed below and are accurate as of May 1, 2014. This information can be used as a guide to permit requirements in other countries.

Permit Requirements and Dangerous Goods Classification

Program Code Program Name Permit Required Dangerous Goods Classification

M1 Throat Culture YES UN3373

M9 UrineColonyCount/UrineCultureIdentification YES UN3373

M10 ThroatandUrineCulture/RapidStrepAAntigenDetection YES UN3373

M17UrineColonyCount/UrineCultureIdentification,RapidGroup A Strep Antigen Detection/Throat Culture

YES UN3373

M18 C. difficile Toxin Antigen Detection YES -

M20 MicrobiologyCombination,Basic YES UN3373

MM Microbiology Combination, Comprehensive YES UN3373

International Shipping and HandlingFeesshownbelowarecollectedforshipmentssenttolocationsoutsidetheUnitedStatestocovershippingcostsand handling requirements. Additional fees, duties and taxes not reflected in the CAP list price may be imposed on proficiency testing orders; participants should contact their local customs office and local FedEx office regarding any additional charges that may be imposed.

Local duties and tax charges may apply to shipments within your geographic area. CAP recommends contacting your local FedEx office to:

• Discussyourlocaldeliveryrequirements

• IdentifyyourbrokerifyouwillnotbeusingtheincludedFedExbrokerageservices

• ConsiderestablishinganaccountwithFedExfordirectbillingofdutiesandtaxes

• Inquirewhethersigningapowerofattorneyforbrokerageserviceswillexpediteclearanceofyourshipments

• Inquireiftherearedocumentsyoucanprepareinadvanceandplaceonfilefortheprogramyear

Note: CAP cannot issue a refund for any CAP-charged fees once the shipment has been released. Participants are responsible for all costs and expenses related to the return of shipments to the CAP or its designated packagers, if the reason for such return is late program cancellation, refused shipment, or invalid ship-to address.

Category Carrier Shipping Fee Program Delivery Location Notes

Standard International Shipping and Handling

FedExRefer to your order form or contact us

Ship-to address as allowed

Most international shipments fall into this category

Other Fees for Programs Categorized as Dangerous GoodsPrograms listed in the table titled Permit Requirements and Dangerous Goods Classification may require special handling, special import permits, additional CAP shipping fees, and other fees.

International transportation regulations, local requirements, and carriers determine how dangerous goods can be transported to your geographic region. Depending upon your geographic region the appropriate type of service can be established. Service availability noted below may change during a CAP program year due to government regulatory or carrier changes.

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CAP International Dangerous Goods fees listed below replace the standard international Shipping and Handling fees. Note that all fees below are per shipment.

Type of Service Carrier Shipping Fee Program Delivery

Location Brokerage Notes

Standard FedEx$85(USD)per

shipmentShip-to address Included

Standard Airport Only

FedEx$195(USD)

per shipmentCarrier-designated

airportIncluded

FedEx will deliver a shipment only as far as an airport; the laboratory is required to arrange pickup from the airport directly

Freight Forwarder

ToBeDetermined

$370(USD)per shipment

Ship-to address or

Carrier-designated airport

Laboratory to hire a broker

Carrier may deliver a shipment only as far as an airport; the laboratory is required to arrange pickup from the airport directly

Premium Freight Forwarder

World Courier

Per shipment quote will be

providedShip-to address

Laboratory to hire a broker

Please contact CAP for estimated shipping and handling charges.

The following paper/online programs are NOT subject to shipping and handling charges:

No Shipping and Handling Charges Program Code Module Name

XH7 Centrifugal Hematology

XU2P UrineSediment

XU4P Clinical Microscopy

CarriersThe CAP will send all 2015 proficiency testing program shipments via FedEx. In select instances the CAP must use a freight forwarder to ship programs to your destination. If this is the case, the CAP will contact you regarding additional fees. If your organization is specifically requesting shipment via a freight forwarder at your expense, provide the CAP withyourfinalshipmentaddressandthefreightforwarder’sUSdomesticaddressandcontactinformation.

Tax Identification NumberProvide the CAP with your federal tax identification number if your country requires that number be listed on the commercial invoice.

Special RequirementsDiscuss any special shipping requirements or updates with the CAP Customer Contact Center staff.

Communicate all requests for special shipping arrangements to the CAP a minimum of six weeks prior to the stated program ship date.

Duties and Taxes • DutiesandimporttaxesimposedbycountriesoutsideoftheUnitedStatesaretheresponsibilityofthe customer and cannot be waived by the CAP.

• Othergovernmentfeesimposedbyyourcountryaretheresponsibilityofthecustomerandcannotbewaived by the CAP

• ShipmentsareprocessedCPTDestination.



StabilitySome programs have limited stability and may be difficult to transport to some locations.

Please note that replacements are not available for programs with limited stability. Some of the EXCEL module materials that are liquid are shipped with frozen cold packs or dry ice and need to be kept cold as much as possible. If transportation to your location cannot meet these conditions, note that replacements will not be available.

If the CAP accredits your international laboratory, please review options for addressing issues with material instability with the CAP Laboratory Accreditation Program staff.

Dry IceSomeshipmentsarepackedondryicetomaintainstability.DryiceshipmentsareshippedasUN1845dangerousgoods shipment. Due to sublimation, there may not be any dry ice present when you open your kit. This is not an indication that the program material has been compromised. If your country does not allow dry ice shipments, your programs will be packaged with cool packs that may not be as effective in maintaining a cool environment. When you receive your shipment, follow the kit storage instructions as soon as possible.

Products Shipped on Dry Ice Product Code Product Name

CH General Chemistry, comprehensive

CH3 General Chemistry, basic

CH9 Hematology/Oncology

L11 NeonatalBilirubin,2challenges

L14 NeonatalBilirubin,5challenges

L17 Waived Cholesterol/Lipids

L23 Serum Alcohol

L26 UrineDrugScreen

L27 Reproductive Endocrinology

L30 Plasma Cardiac Markers

Local ArrangementsCAP shipments include FedEx brokerage. Some locations require you specifically identify your broker.

Commercial InvoiceCommercial invoices are affixed to packages as required by international shipping conventions. The commercial invoice is an official transaction record between an exporter and an importer. Customs officials use this form to clear your shipment.

The invoice total listed on the commercial invoice is not an amount due to the CAP or your country. The invoice total is listed for the purpose of computing duties and taxes.

DeliveryCAP programs are shipped door-to-door service whenever possible. In instances where your country does not allow delivery to your door, the CAP can only arrange shipment to an airport. In these instances you will be notified when a program has been cleared and is ready for pick up. You must pick up your shipment at that point. If you refuse to pick up your shipment, your order for any remaining shipments may be canceled.

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Carrier ContactCarriers or customs officials may attempt to contact you if there are issues regarding clearing your shipment. Please respond to these requests for additional information as soon as possible. Contact the CAP if you need additional information to expedite clearance.

If you fail to respond to information requests from carriers and customs officials, the following may occur:

• Yourorganizationmayincuradditionalchargesforstorageandmanagementfees.

• Youmayincuradditionalfeesduetodisposalorreturnofyourshipment.

2015 EXCEL Shipping Calendar


2015 EXCEL Shipping Calendar

2015 EXCEL Program Shipment Schedule Discipline Mailing Kit Shipment Date Kit Replacement Deadline

Hematology/UrinalysisandClinical Microscopy/Coagulation

XL-AXL-DXL-G

February 2May 11

September 14

February 11May 20

September 23

ChemistryXL-BXl-EXL-H

March 10June9

October 13

March 19June18

October 22

Immunology/MicrobiologyXL-CXL-FXL-I

March 30August 10

November30

April 8August 19

December 9

If you do not receive your shipment—or if you receive an incomplete or damaged shipment—please contact the CAP Customer Contact Center directly within 10 calendar days of the shipment date to order replacement specimens.

Notes

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Notes

Notes


Notes

We understand the many demands you face.

ONLY THE CAP can provide the comprehensive programs

and services to help you consistently deliver accurate

test results, monitor overall laboratory performance,

and increase and sharpen your staff’s skills.

We can help you discover new ways to achieve your goals.

You always put accurate patient results first.

It is our common mission.

cap.org

2015 EXCEL®

© 2014 College of American Pathologists. All rights reserved. 23044.0714.6.1779

2015 excel catalog - college of american pathologists · clinical chemistry. 8. college of american...

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