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Clinical Chemistry
Coagulation
Education
Hematology
Immunology
Microbiology
Multidiscipline Combination Series
Urinalysis and Clinical Microscopy
2012EXCEL
®
Cynthia F. Bowman, MD, FCAPChair CAP Point-of-Care Testing Committee
“”
To support the CAP EXCEL programs, the Point-of-Care-Testing Committee provides educational exercises covering traditional and emerging technologies for laboratories and point-of-care testing.
Table of Contents2012 EXCEL
New Developments .................................................................................................................2
EXCEL® Program Overview .....................................................................................................3
Continuing Education .............................................................................................................4
Clinical Chemistry ...................................................................................................................7
Hematology ...........................................................................................................................14
Urinalysis and Clinical Microscopy ......................................................................................17
Coagulation ...........................................................................................................................21
Microbiology ..........................................................................................................................24
Immunology ...........................................................................................................................31
Multidiscipline Combination Series .....................................................................................33
Price List ..................................................................................................................................35
Indices ....................................................................................................................................38
Customer Support and Ordering Information .....................................................................48
2 CollegeofAmericanPathologists 2012EXCELCatalog
NewDevelopments
The2012EXCELProgramreflectsseveralchanges,alldesignedtoprovideyouwithrelevant,easy-to-use,andcost-effectivemodulestomeettheneedsoflaboratorieswithlimitedtestingmenus.
Whole Blood Creatinine L31 Analyte Product Code Challenges/Shipment
L31 Creatinine z 5
PRICE (USD) $276
POC/Waived Competency Challenges POC1, POC2, POC3, POC4
Analyte Product Code Challenges/ Shipment
POC1 POC2 POC3 POC4 POC/WaivedhCGCompetency z 10 POC/WaivedGlucoseCompetency z 10 POC/WaivedUrineDipstickCompetency z 10
POC/WaivedStrepScreenCompetency z 10
PRICE (USD) $129 $129 $129 $129
Additional InformationPOC/WaivedCompetencyChallengesaredesignedtoimprovewaivedtestresults.Thisprogramwillevaluateinstrumentandmethodperformance,troubleshoot,assessstaffcompetency,andprovideinformationtotrainstaff.ThisprogramisnotaproficiencytestingprogramandparticipantswillnotreturnresultstotheCAP.
POC/WaivedCompetencyChallengesmayhavelimitedavailabilityandstability.
Discontinued 2011 ProductsWholeBloodCoagulation(XC18)
CustomersenrolledinXC18in2011willautomaticallybeenrolledintheSurveysequivalentproduct,WP4for2012.SeeSurveyWP4onpage146oftheSurveysandAnatomicPathologyEducationProgramscatalogformoreinformation.
New Developments
NewProduct Information• POC1-Onepositive10.0-mLliquidurinespecimen
• POC2-Oneabnormal2.5-mLwholebloodspecimen
• POC3-Oneabnormal10.0-mLliquidurinespecimen
• POC4-One1.0-mLpositiveliquidspecimen
• Eachproductwillprovidematerialtotestupto10staff
• Expectedresultswillbeprovidedtoimmediatelyassesscompetency
• Shipmentsavailableuponrequest
Product Information• Five4.0-mLwholebloodspecimens
• ForusewiththeNovaBiomedicalStatSensor®/EZChemTM
•Threeshipmentsperyear:B,E,andH
New
800-323-4040|847-832-7000Option1|cap.org 3
EXCEL®ProgramOverview
EXCEL® Program OverviewEXCEL EducationAlleducationactivitiesareavailabletoallEXCELcustomersnomatterwhatmoduleyouareenrolledin.YoucanaccessallCAPEXCELeducationactivities.AllyouneedisaKitID,CAPnumber,andanindividualWebaccount.Refertopage5formoredetails.
Invaluable Online Program Components Available to All EXCEL Participants AccesstheProficiencyTestingManualandHematology,ClinicalMicroscopy,andBodyFluidsGlossary,providedatnoadditionalcosttoallEXCELparticipantsatcap.org,undertheAccreditationandLaboratoryImprovementtab.
TheProficiencyTestingManualincludesinformationthatwillhelpyou: • ProcessPTspecimensandreportresults • Understandevaluationreports • ComplywithCLIA
TheHematology,ClinicalMicroscopy,andBodyFluidsGlossaryisauniqueandinvaluablereferencedesignedtohelpyoucorrectlyidentify: • Bloodcellsandplatelets • Morphologicabnormalitiesandartifacts • Objectsfoundintheurine(cells,casts,crystals,andorganisms)
Theglossaryalsoincludesinformationonvaginalpreparations,stoolandnasalsmears,KOHpreparationsforfungi,andpinwormpreparations.
EXCEL BindersIfyouwouldliketoorderabindertostoreyourproficiencytestingreports,pleaseaddtheproductcodeXLBINDtoyour2012orderform.EXCELprogrambindersarenotincludedasapartofyourproficiencytestingorder.
EXCEL Binders XLBIND Product Code Description Price XLBIND Three-ringbinder $13
Price ListForyourconvenience,wehaveincludedpricesinaconsolidatedlist.PleaseseeSection10.
CAP EXCEL Acceptance by Accrediting AgenciesAnalytes/proceduresinboldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS)andareacceptedbyCOLAandmanystateregulatoryagencies.ModulesnotcontaininganalytesregulatedforproficiencytestingarerecognizedbytheCMSandCMSdesigneesasanexternalassessmentofqualityassurance.Staterequirementsmayvary.Todetermineacceptanceinyourstate,contactyourstatedepartmentofhealth.
2 Continuing Education
All education activities are available to everyone!No matter what module you are enrolled in, you have access to all CAP EXCEL education activities. All you need is a Kit ID, CAP number, and an individual Web account.
Visit cap.org; under the Education tab, select EXCEL to view all available courses.
Continuing Education
800-323-4040 | 847-832-7000 Option 1 | cap.org 5
Continuing EducationThe College of American Pathologists (CAP) is the leading resource for education in the practice and science of pathology and laboratory medicine. The CAP Point-of-Care Testing Committee has integrated educational resources into the EXCEL program. Individuals may earn up to nine continuing education (CE) credits by completing the related reading found in the Participant Summary (online or paper-based) and the online learning assessment questions at cap.org.
Learn Without Leaving Your LaboratoryOnline education activities make it easy for you and your staff to earn CE credits without leaving your laboratory, saving you time and money.
Ensure that You and Your Team Are at Your BestTopics across all major laboratory disciplines help you stay current on practical, useful issues in clinical applications, scientific technology, and results interpretation. Because CAP education is developed by a team of renowned pathologists and content experts who work with the CAP’s own professional learning specialists, you get high-quality, clear, 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!
Continuing Education
6 College of American Pathologists 2012 EXCEL Catalog
Learning Cycle InformationEach education activitiy provides information on common technical and nontechnical issues encountered in all laboratory settings.
Educational topics for 2012 include: • Infectious Risks Associated with Point-of-Care Testing Devices • Detection of Respiratory Viruses • Thyroid Testing Standardization • Good Laboratory Practices for Waived Testing • Evidence Based Point-of-Care Testing • New Perspectives in Syphilis Testing
To receive continuing education (CE) credit, you must complete the education reading provided in your Participant 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 ObjectivesUpon completion of these education activities, the learner will be able to: • List preanalytic, analytic, and postanalytic variables that affect patient testing. • Identify quality improvement opportunities within his/her own laboratory setting. • Apply appropriate quality assurance measures to ensure accurate patient results.
Continuing Education (CE)The College of American Pathologists designates these education activities for a maximum of nine credits of continuing education. Participants should only claim credit commensurate with the extent of their participation in the activity.
These activities are acceptable to meet the CE requirements of the ASCP Board of Certification Maintenance Program.
These activities are approved for CE credit in the states of California and Florida.
Clinical Chemistry3Clinical ChemistryGeneral Chemistry ................................................................................................................. 8–9Hematology/Oncology ...........................................................................................................10Neonatal Bilirubin ......................................................................................................................10Waived Cholesterol/Lipids .......................................................................................................10Whole Blood Glucose ..............................................................................................................11Hemoglobin A1c ........................................................................................................................11Serum Alcohol ...........................................................................................................................11Blood Gases ..............................................................................................................................11Cardiac Markers .......................................................................................................................12Urine Drug Screen .....................................................................................................................12Reproductive Endocrinology ..................................................................................................13B-type Natriuretic Peptides ......................................................................................................13Plasma Cardiac Markers .........................................................................................................13Whole Blood Creatinine ...........................................................................................................13
Clinical Chemistry
8 College of American Pathologists 2012 EXCEL Catalog
Clinical ChemistryAnalytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (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 ReflotronCholesterol
CH, CH3N/A
Glucose XL5, L20, L21
Cholestech L•D•X®
Total cholesterolHDL cholesterol
Triglycerides L17N/A
Glucose XL5, L20, L21ALTAST L17 N/A
Whole blood cholesterol meters Cholesterol CH, CH3, L17 N/A
Whole blood glucose meters Glucose L20, L21, XL5 CH, CH3, L17, XL6 Nova Biomedical
StatSensor®/EZ ChemTM Creatinine L31 CH, CH3
General Chemistry CH, CH3 Analyte Product 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 Carbamazepine z 5 Carbon dioxide (CO2) z z 1 Chloride z z 5 Cholesterol, total z z 5 Cortisol z 5
Continued on the next page
These modules do not fulfill the requirements for neonatal bilirubin proficiency testing; refer to module L11 or L14 on page 10.
Product Information• Five 5.0-mL liquid serum
specimens
• Conventional and International System of Units (SI) reporting offered
• Three shipments per year: B, E, and H
Clinical Chemistry
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General Chemistry CH, CH3 continued
Analyte Product Code Challenges/ShipmentCH CH3
Creatine kinase (CK) z 5 Creatinine z z 5 Digoxin z 5 Gamma glutamyl transferase (GGT) z 2 Glucose z z 5 HDL cholesterol z z 5 Iron z 5 Lactate dehydrogenase (LD) z 5 LDL cholesterol z z 2 Lithium z 5 Magnesium z 5 Phenobarbital z 5 Phenytoin z 5 Phosphorus (inorganic) z 2 Potassium z z 5 Protein, total z 5 Sodium z z 5 T3, free (triiodothyronine, free) z 2 T3, total (triiodothyronine, total) z 5 T3, uptake z 5 T4, free (thyroxine, free) z 5 T4, total (thyroxine, total) z 5 Theophylline z 5 Thyroid-stimulating hormone (TSH) z 5 Triglycerides z z 5 Urea nitrogen (BUN) z z 5 Uric acid z z 5 Valproic acid z 5
PRICE (USD) $402 $210
These modules do not fulfill the requirements for neonatal bilirubin proficiency testing; refer to module L11 or L14 on page 10.
Product Information• Five 5.0-mL liquid serum
specimens
• Conventional and International System of Units (SI) reporting offered
• Three shipments per year: B, E, and H
Clinical Chemistry
10 College of American Pathologists 2012 EXCEL Catalog
Product Information• Three 5.0-mL liquid serum
specimens
• Two shipments per year: B and H
Product Information• Three 2.0-mL liquid serum
specimens
• For use with waived methods such as Cholestech LDX® and Roche ACCU-CHEKTM Instant Plus
• Not compatible with other whole blood glucose meters
• Two shipments per year: B and H
Product Information• L11 - Two 1.0-mL liquid
serum specimens
• L14 - Five 1.0-mL liquid serum specimens
• Three shipments per year: B, E, and H
Hematology/Oncology CH9Analyte Product Code Challenges/Shipment
CH9 CEA z 3 Ferritin z 3 Folate z 3 PSA z 3 Vitamin B12 z 3
PRICE (USD) $156
Neonatal Bilirubin L11, L14 Analyte Product Code Challenges/Shipment
L11 L14 Bilirubin, direct z z 2 Bilirubin, total z 5
PRICE (USD) $123 $210
Waived Cholesterol/Lipids L17 Analyte Product Code Challenges/Shipment
L17 Alanine aminotransferase (ALT) z 3 Aspartate aminotransferase (AST) z 3 Cholesterol z 3 Glucose z 3 HDL cholesterol z 3 LDL cholesterol z 3 Triglycerides z 3
PRICE (USD) $190
Clinical Chemistry
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Product Information• L20 - Three 2.5-mL whole
blood specimens; two shipments per year: B and H
• L21 - Five 2.5-mL whole blood specimens; three shipments per year: B, E and H
• Report up to five different testing sites/instruments
Product Information• Three lyophilized speci-
mens with a dropper-tipped vial of diluent
• Two shipments per year: B and H
Product Information• Five 2.0-mL liquid serum
specimens
• Three shipments per year: B, E, and H
Product Information• Five 2.5-mL ampules of
aqueous specimens and five 2.5-mL hematocrit specimens
• Hematocrit reporting for Abbott i-STAT instruments only
• Three shipments per year: B, E, and H
Whole Blood Glucose L20, L21Analyte Challenges/Shipment
Product CodeL20 L21
Glucose 3 5PRICE (USD) $154 $222
Hemoglobin A1c L22 Analyte Product Code Challenges/Shipment
L22 Hemoglobin A1c z 3
PRICE (USD) $186
Serum Alcohol L23 Analyte Product Code Challenges/Shipment
L23 Ethanol z 5
PRICE (USD) $288
Blood Gases L24 Analyte Product Code Challenges/Shipment
L24 Calcium, ionized z 2 Chloride z 5 Hematocrit z 5 PCO2 z 5 pH z 5 PO2 z 5 Potassium z 5 Sodium z 5
PRICE (USD) $441
Clinical Chemistry
12 College of American Pathologists 2012 EXCEL Catalog
Product Information• Three 10.0-mL urine
specimens
• Two shipments per year: B and H
Product Information• Five 2.0-mL serum
specimens
• For immunochemical methods only
• Three shipments per year: B, E, and H
Cardiac Markers L25Analyte Product Code Challenges/Shipment
L25 CK-MB z 5 Myoglobin z 2 Troponin I z 2
PRICE (USD) $234
For Troponin T reporting, refer to the Survey TNT in the 2012 Surveys and Anatomic Pathology Education Programs catalog.
Urine Drug Screen L26 Analyte Product Code Challenges/Shipment
L26 Acetaminophen z 3 Amphetamine z 3 Amphetamine/methamphetamine group z 3
Barbiturate group z 3 Benzodiazepine group z 3 Benzoylecgonine/cocaine metabolites z 3
Buprenorphine z 3 Delta-9-THC-COOH z 3 Ethanol z 3 Fentanyl z 3 Lysergic acid diethylamide (LSD) z 3 Methadone z 3 Methadone metabolite (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
Clinical Chemistry
800-323-4040 | 847-832-7000 Option 1 | cap.org 13
Product Information• Three 5.0-mL liquid serum
specimens
• Two shipments per year: B and H
Product Information• Two 1.0-mL liquid plasma
specimens
• Conventional and International System of Units (SI) reporting offered
• Two shipments per year: B and H
Product Information• Five 1.0-mL liquid EDTA
plasma specimens
• For use with the BioSite Triage and i-STAT instruments
• Three shipments per year: B, E, and H
Product Information• Five 4.0-mL whole blood
specimens
• For use with the Nova Biomedical StatSensor®/EZ ChemTM
• Three shipments per year: B, E, and H
Reproductive Endocrinology L27Analyte Product Code Challenges/Shipment
L27 Estradiol z 3 Follicle-stimulating hormone (FSH) z 3 Luteinizing hormone (LH) z 3 Progesterone z 3 Prolactin z 2
PRICE (USD) $318
B-type Natriuretic Peptides L28 Analyte Product Code Challenges/Shipment
L28 BNP z 2 NT-pro BNP z 2
PRICE (USD) $198
Plasma Cardiac Markers L30 Analyte Product Code Challenges/Shipment
L30 CK-MB z 5 BNP z 2 Myoglobin z 2 Troponin I z 2
PRICE (USD) $258
Whole Blood Creatinine L31 Analyte Product Code Challenges/Shipment
L31 Creatinine z 5
PRICE (USD) $276
New
Hematology4HematologyRoutine Hematology ................................................................................................................15Comprehensive Hematology With Differential .....................................................................15Centrifugal Hematology ..........................................................................................................16Erythrocyte Sedimentation Rate .............................................................................................16Reticulocyte Count ..................................................................................................................16
Hematology
800-323-4040|847-832-7000Option1|cap.org 15
Product Information• XH1-Five3.0-mLwholebloodspecimens;alsocompatiblewithspunhematocritmethods
•XHP-Sixphotographs:fivegradedandoneeducational/ungraded
•Threeshipmentsperyear:A,D,andG
Product Information• Five2.5-mLwholebloodspecimens
•Threeshipmentsperyear:A,D,andG
HematologyAnalytes/proceduresinboldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).
Routine Hematology XH1, XHPAnalyte/Procedure Product Code Challenges/Shipment
XH1 XHP Blood cell identification z 6 Hematocrit z 5 Hemoglobin z 5 Platelet count z 5 RBC count z 5 WBC count z 5
PRICE (USD) $222 $45
Comprehensive Hematology With Differential XH3, XH4
Analyte/Procedure Product Code Challenges/ShipmentXH3 XH4
Automated differential z z 5 Hematocrit z z 5 Hemoglobin z z 5 Platelet count z z 5 RBC count z z 5 WBC count z z 5
PRICE (USD) $306 $306
Formethodcompatibility,seeinstrumentmatrixonpage16.
Hematology
16 CollegeofAmericanPathologists 2012EXCELCatalog
Hematology, Instrument Compatibility Matrix Instrument Recommended Module
XH3 XH4 XH6 SysmexK-Series,KX-21/21N,pocH-100i z
AbbottCell-Dyn®1200,1400,1600,1700,1800,Emerald z
HoribaABX9000/9100Series(3-partdiff),Spirit z
HoribaABXMicros,Minos z
SiemensADVIA60 z
Coulter®T-Series,ST,STKR,MD,ONYX,Ac•TTMz
DrewScientificDC-18/I-1800,DrewScientificExcellSeries,DrewScientificDrew3 z
MindrayBC-3000/3200series z
Becton-DickinsonQBC z
Pierceablecap z z
Centrifugal Hematology XH6, XH7 Analyte/Procedure Product 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
Formethodcompatibility,seeinstrumentmatrixabove.
Erythrocyte Sedimentation Rate XH8 Procedure Product Code Challenges/Shipment
XH8 AllmethodsexceptforSedimat®15 z 3
PRICE (USD) $198
Sedimat15usersshouldorderSurveyESR1inthe2012SurveysandAnatomicPathologyEducationProgramscatalog.
Reticulocyte Count XH9 Analyte Product Code Challenges/Shipment
XH9 Reticulocytecount z 3
PRICE (USD) $280
Product Information• XH6-Five0.6-mLwholebloodspecimens
•XH7-MustorderinconjunctionwithmoduleXH6
•ForusewithBecton-DickinsonQBCinstruments;notintendedforspunhematocritmethods
•Threeshipmentsperyear:A,D,andG
Product Information• Three6.0-mLwholebloodspecimens
• Twoshipmentsperyear:DandG
Product Information• Three1.0-mLstabilizedwholebloodspecimens
• Forusewithmanualandmostautomatedreticulo-cytecountmethods
• Twoshipmentsperyear:AandG
Urinalys is and Cl in ical Microscopy5
Urinalysis and Clinical MicroscopyUrinalysis .....................................................................................................................................18Urine Sediment and Clinical Microscopy...............................................................................18Provider-Performed Microscopy .............................................................................................19Occult Blood .............................................................................................................................19Sperm Count and Presence/Absence ..................................................................................20Urine Albumin (Microalbumin) Creatinine .............................................................................20Amniotic Fluid Leakage ...........................................................................................................20Rupture of Fetal Membrane Testing .......................................................................................20
Urinalysis and Clinical Microscopy
18 College of American Pathologists 2012 EXCEL Catalog
Product Information• XU, XU1 - Two 10.0-mL urine
specimens
• XU2P - Three photographs
• XU4P - Six photographs
• Two shipments per year: A and G
• XU6 - Five 1.0-mL urine specimens
• Three shipments per year: A, D, and G
Urinalysis and Clinical MicroscopyAnalytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).
Product Information• XU7P - Three photographs
• XU8P - Six photographs
• Designed as stand-alone options of modules XU2P and XU4P
• Two shipments per year: A and G
Urinalysis XU, XU1, XU6, XU2P, XU4PAnalyte/Procedure Product Code Challenges/Shipment
XU XU1 XU6 XU2P XU4P Urine bilirubin z z 2 Urine blood/hemoglobin z z 2 Urine glucose z z 2 Urine ketones z z 2 Urine leukocyte esterase z z 2 Urine nitrite z z 2 Urine pH z z 2 Urine protein z z 2 Urine reducing substances z z 2 Urine specific gravity z z 2 Urine urobilinogen z z 2 Urine hCG, qualitative z z 2/5 (XU6) Urine sediment z 3 Clinical microscopy* z 6
PRICE (USD) $150 $108 $156 $42 $42
*See page 19 for specimen types and shipment information.
Urine Sediment and Clinical Microscopy XU7P, XU8P
Analyte/Procedure Product Code Challenges/ShipmentXU7P XU8P
Clinical microscopy z 6 Urine sediment z 3
PRICE (USD) $96 $96
Urinalysis and Clinical Microscopy
800-323-4040 | 847-832-7000 Option 1 | cap.org 19
Clinical Microscopy, Information MatrixSpecimen Type Shipment
XL-A XL-G Fern test z z
KOH preparations z z
Nasal smears z z
Pinworm preparations z z
Stool for leukocytes z z
Vaginal wet preparations z z
Provider-Performed Microscopy XU5P Procedure Product Code Challenges/Shipment
XU5P XL-A XL-G Fern test z 1 1 KOH preparations z 1 1 Nasal smears z 1 1 Pinworm preparations z 1 1 Stool for leukocytes z 1 1 Vaginal wet preparations z 1 1 Urine sediment z 3 3
PRICE (USD) $166
Occult Blood XU9 Analyte Product Code Challenges/Shipment
XU9 Occult blood z 3
PRICE (USD) $130
Product Information• Nine photographs:
three urine sediment and six clinical microscopy challenges
• Designed to meet federal quality assurance requirements for provider-performed microscopy techniques
• Two shipments per year: A and G
Product Information• Three 2.0-mL simulated
fecal specimens
• Two shipments per year: A and G
Urinalysis and Clinical Microscopy
20 College of American Pathologists 2012 EXCEL Catalog
Product Information• Two 0.3-mL liquid
specimens
• Two shipments per year: D and G
Product Information• Two 5.0-mL liquid urine
specimens
• For use with dipstick and semiquantitative methods
• Two shipments per year: D and G
Product Information• Three 2.0-mL liquid
specimens
• For use with nitrazine paper and AmnioTestTM (nitrazine test swabs)
• Two shipments per year: D and G
Product Information• Three 0.5-mL simulated
vaginal specimens
• For use with the AmniSureTM
test method
• Two shipments per year: D and G
Sperm Count and Presence/Absence XU10Procedure Product Code Challenges/Shipment
XU10 Sperm count and presence/absence z 2
PRICE (USD) $254
Urine Albumin (Microalbumin) Creatinine XUX11 Analyte/Procedure Product Code Challenges/Shipment
XUX11 Creatinine z 2 Urine albumin (microalbumin), semiquantitative z 2
Urine albumin (microalbumin), creatinine ratio z 2
PRICE (USD) $212
Amniotic Fluid Leakage XUX12 Procedure Product Code Challenges/Shipment
XUX12 pH interpretation z 3
PRICE (USD) $228
Rupture of Fetal Membrane Testing XUX13 Analyte Product Code Challenges/Shipment
XUX13 Placental alpha microglobulin-1 (PAMG-1) z 3
PRICE (USD) $398
Coagulat ion6CoagulationCoagulation ..............................................................................................................................22Whole Blood Coagulation .......................................................................................................22Whole Blood D-dimer ...............................................................................................................23
Coagulation
22 CollegeofAmericanPathologists 2012EXCELCatalog
Product Information• Five1.0-mLlyophilizedplasmaspecimens;requiresa1.0-mLvolumetricpipettetoperformtesting
•AlsocompatiblewiththeCVDITASinstruments
•Threeshipmentsperyear:A,D,andG
Product Information• XC3-Five0.5-mLlyophilizedwholebloodspecimens
•XC19-Five1.0-mLlyophilizedplasmaspecimens
• Threeshipmentsperyear:A,D,andG
CoagulationAnalytes/proceduresinboldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).
Coagulation XC, XC1Analyte/Procedure Product 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 Product Code Challenges/ShipmentXC3 XC19
Internationalnormalizedratio(INR) z z 5 Prothrombin time z z 5
PRICE (USD) $330 $243
Formethodcompatibility,seeinstrumentmatrixbelow.
Whole Blood Coagulation, Instrument Matrix Instrument Recommended Module
XC3 XC19 AbbottCoaguSense z
HelenaCascadePOC-Noncitrated z
ITCHemochronJr.Signature/Signature+/Signature Elite,andJr.–Noncitratedcuvette z
ILGEM,PCLPlus–Noncitrated z
i-STAT® z
Coagulation
800-323-4040|847-832-7000Option1|cap.org 23
Product Information• Two0.5-mLwholebloodspecimens
• ForusewiththeSimpliREDTM
andClearviewTMSimplifyD-dimermethods
• Twoshipmentsperyear:AandG
Whole Blood D-dimer XC20Analyte Product Code Challenges/Shipment
XC20 D-dimer,qualitative z 2
PRICE (USD) $234
Microbiology 7MicrobiologyHazardous Materials ........................................................................................................... 25 –26Microbiology Flow Chart .........................................................................................................27Microbiology Combination .....................................................................................................28Throat Culture ...........................................................................................................................28Rapid Group A Strep Antigen Detection ...............................................................................28Gram Stain .................................................................................................................................28Urine Colony Count/Urine Culture Identification ..................................................................29Throat and Urine Culture/Rapid A Strep Antigen Detection ...............................................29Clostridium difficile Toxin Antigen Detection .........................................................................29Viral Antigen Detection ...........................................................................................................30
Microbiology
800-323-4040|847-832-7000Option1|cap.org 25
MicrobiologyTheEXCELmoduleslistedbelowcontainhazardousmaterialsandmayrequirespecialpermitsandadditionalfees.
EXCEL Modules with Hazardous MaterialsProduct Code Module Name
MM,M20 MicrobiologyCombination M1 ThroatCulture M9 UrineColonyCount/UrineCultureIdentification M10 ThroatandUrineCulture/RapidStrepAAntigenDetection M17 UrineColonyCount/UrineCultureIdentification
Biohazard InformationTheCentersforDiseaseControlandPrevention(CDC)hasclassifiedallbacterialandviralstrainsusedinPTchallengesasnotgreaterthanaBiosafetyLevel2.YoucanfindafulldescriptionofBiosafetyLevel2(BSL-2)handlingrequirements,asdefinedbytheCDCOfficeofHealthandSafetyinBiosafetyinMicrobiologicalandBiomedicalLaboratories,atcdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm.
YourlaboratorymusthandlespecimensincludedinproductsofanetiologicnatureusingprecautionsappropriateforBSL-2facilities.
KeyElementsofBiosafetyLevel2Compliance: • Limitorrestrictaccesstothelaboratoryatthediscretionofthelaboratorydirectorwhenexperiments areinprogress. • Washhandsafterhandlingviablematerials,afterremovinggloves,andbeforeleavingthelaboratory. • Donoteat,drink,smoke,handlecontactlenses,orapplycosmeticsinworkareas. Storefoodoutsidetheworkareaincabinetsorrefrigeratorsdesignatedforthispurposeonly. • Nomouthpipettingallowed;usemechanicalpipettingdevices. • Institutepoliciesforthesafehandlingofsharps. • Performallprocedurescarefullytominimizethecreationofsplashesoraerosols. • Decontaminateworksurfacesoncompletionofworkorattheendofthedayandafteranyspillor splashofviablematerialwithdisinfectantsthatareeffectiveagainsttheagentsofconcern. • Decontaminateallcultures,stocks,andotherregulatedwastesbeforedisposalbyanapproved decontaminationmethodsuchasautoclaving.Placematerialstobedecontaminatedoutsideofthe immediatelaboratoryinadurable,leakproofcontainerandclosethecontainerfortransportfromthe laboratory.Packagematerialsforoff-sitedecontaminationinaccordancewithapplicablelocal,state, andfederalregulationsbeforeremovingthemfromthefacility. • Incorporatebiosafetyproceduresintostandardoperatingproceduresorinabiosafetymanual adoptedorpreparedspecificallyforthelaboratorybythelaboratorydirector.Advisepersonnelof specialhazardsandrequirethattheyreadandfollowinstructionsonpracticesandprocedures. • Wearprotectivelaboratorycoats,gowns,smocks,oruniformsdesignatedforlabuseonlywhileinthe laboratory.Removethisclothingandleaveitinthelaboratorybeforeleavingfornon-laboratoryareas (eg,cafeteria,library,administrativeoffices).Personnelmustdisposeofallprotectiveclothinginthe laboratoryortheinstitutionmustlaunderit;personnelshouldnevertakeprotectiveclothinghome.
Microbiology
26 CollegeofAmericanPathologists 2012EXCELCatalog
IfyourlaboratoryisnotBiosafetyLevel2compliant,pleasecontactyouraccreditationagencyforfurtherinformationregardingfulfillmentofPTrequirements.
Thefollowingicondesignatesmodulesthatcontainmaterialofanetiologicnature:
Biohazard Warning StatementsAllEXCELmodulesincludeabiohazardwarningstatementappropriateforthehandlingofthematerialsincluded.YourlaboratoryshouldstillhandlemodulesthatdonotincludeetiologicagentsinkeepingwithCDCuniversalprecautionsandOSHAbloodbornepathogenrules.
Microbiology
800-323-4040|847-832-7000Option1|cap.org 27
ThisflowchartisaguidetohelpyouorderthemostappropriateBacteriologymoduleforyourlaboratory.Ifyouhaveanyquestions,pleasecalltheCustomerContactCenterat800-323-4040or847-832-7000option1.
IfyouuseaQuanti-Cult®methodforurinecolonycountand/oridentification,seepage29foravailablemodules.
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
NOg
NOg
NOg
NOg
YES
g
YES
g
YES
g
YES
g
YES
g
YES
NOg
Microbiology
28 CollegeofAmericanPathologists 2012EXCELCatalog
Product Information• MM-Tenloopspecimens(twoduplicatesets)andoneswabforantigendetection
•M20-Eightloopspecimens(twoduplicatesets)andoneswabforantigendetection
•Urinecultureswillonlyhaveonesusceptibilitychallenge
•Threeshipmentsperyear:C,F,andI
Product Information• Fiveloopspecimens
• Threeshipmentsperyear:C,F,andI
Product Information• M6-Fiveswabspecimens;threeshipmentsperyear:C,F,andI
• M14-Twoswabspecimens;twoshipmentsperyear:CandF
Product Information• Fiveair-dried,methanolfixed,unstainedslides
• Threeshipmentsperyear:C,F,andI
Handle With CarePleasebeawarethatEXCELmodulesMM,M1,M9,M10,M17,andM20allcontainhazardousmaterialsandmayrequirespecialhandling.
Microbiology Combination MM, M20 Procedure Challenges/Shipment
Product CodeMM 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 Product Code Challenges/Shipment
M1 Throat culture z 5
PRICE (USD) $258
Rapid Group A Strep Antigen Detection M6, M14 Procedure Challenges/Shipment
Product CodeM6 M14
Rapid group A Streptococcus antigen detection 5 2
PRICE (USD) $204 $138
Gram Stain M8 Procedure Product Code Challenges/Shipment
M8 Gram stain z 5
PRICE (USD) $207
Microbiology
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Product Information• M9-Two2.0-mLurinespecimens
•M17-Threeloopspecimens,threeswabspecimens,andfiveurinespecimens
•Threeshipmentsperyear:C,F,andI
Product Information• Sixloopspecimensandtwoswabsforantigendetection
• Threeshipmentsperyear:C,F,andI
Product Information• One1.0-mLlyophilizedspecimen
• Mustorderinconjunctionwitharegulatedmicrobiologymodule(MM,M1,M6,M8,M10,M17,orM20)
• Threeshipmentsperyear:C,F,andI
Handle With CarePleasebeawarethatEXCELmodulesMM,M1,M9,M10,M17,andM20allcontainhazardousmaterialsandmayrequirespecialhandling.
Urine Colony Count/Urine Culture Identification M9, M17
Procedure Challenges/ShipmentProduct Code
M9 M17 Urinecolonycount/ urine culture identification 2 5
Rapid group A Streptococcus antigen detection 3
Throat culture 3PRICE (USD) $198 $333
Throat and Urine Culture/ Rapid Strep A Antigen Detection M10
Procedure Product Code Challenges/ShipmentM10
Antimicrobial susceptibility z 1 Gram stain z 1 Rapid group A Streptococcus antigen detection z 2
Throat culture, group A Streptococcus
z 3
Urine culture z 3PRICE (USD) $258
IfyouareusingawaivedmethodforStreptococcustesting,theseresultswillnotcounttowardtherequiredfivechallengesforthesubspecialityofbacteriology.
C. difficile Toxin Antigen Detection M18 Analyte Product Code Challenges/Shipment
M18 Clostridium difficile toxin z 1
PRICE (USD) $174
Microbiology
30 CollegeofAmericanPathologists 2012EXCELCatalog
Product Information• Five1.0-mLliquidspecimens
• Forusewithenzymeimmunoassayand/orlatexagglutinationmethods
• Threeshipmentsperyear:C,F,andI
Handle With CarePleasebeawarethatEXCELmodulesMM,M1,M9,M10,M17,andM20allcontainhazardousmaterialsandmayrequirespecialhandling.
Viral Antigen Detection M21Analyte Product Code Challenges/Shipment
M21 Influenza A antigen z 5 Influenza B antigen z 5 Respiratory syncytial virus (RSV) antigen z 5
Rotavirus antigen z 5PRICE (USD) $285
Immunology8ImmunologyAnti-HIV-1 and Anti-HIV-1/2, Waived ......................................................................................32C-reactive Protein (CRP) .........................................................................................................32hCG, Serum ...............................................................................................................................32Helicobacter pylori Antibody Detection ...............................................................................32Infectious Mononucleosis ........................................................................................................32Infectious Mononucleosis, Waived .........................................................................................32Rheumatoid Factor ..................................................................................................................32
Immunology
32 CollegeofAmericanPathologists 2012EXCELCatalog
Product Information• XS1-Five0.6-mLliquidserumspecimensandfive1.0-mLliquidserumspecimens
•XS2-Five0.6-mLliquidserumspecimens
•XS3-One0.5-mLliquidserumspecimen
•XS4,XS5-Five1.0-mLliquidserumspecimens
• Threeshipmentsperyear:C,F,andI
•XS7-Two1.0-mLliquidserumspecimens
•XS9-Three0.6-mLliquidserumspecimens
• Twoshipmentsperyear:CandF
Product Information• Two0.5-mLplasmaspecimens;reportuptofivedifferentlocationswithinyourinstitution
•Twoshipmentsperyear:FandI
ImmunologyAnalytes/proceduresin boldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).
Immunology XS1, XS2, XS3, XS4, XS5, XS7, XS9Analyte/Procedure Product Code Challenges/Shipment
XS1 XS2 XS3 XS4 XS5 XS7 XS9 C-reactiveprotein (qualitative/quantitative) z 1
Helicobacter pylori antibodydetection z 2
hCG, serum (qualitative/quantitative) z 5
Infectious mononucleosis z z 5 Infectious mononucleosis,waived z 3
Rheumatoid factor* z z 5PRICE (USD) $225 $159 $132 $159 $159 $174 $98
*Rheumatoidfactorisaregulatedanalyteandisgradedforbothqualitativeandquantitativemethods.Semiquantitativeand/ortiterresultsareungraded/educationalinthismoduleanddonotmeetregulatoryrequirements.
Anti-HIV-1 and Anti-HIV-1/2, Waived XB2, XB3 Analyte/Procedure Product Code Challenges/Shipment
XB2 XB3 Anti-HIV-1,waivedmethodsonly z 2 Anti-HIV-1/2,waivedmethodsonly z 2
PRICE (USD) $172 $218
Multidiscipline Combination Series
34 College of American Pathologists 2012 EXCEL Catalog
Product 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
• Whole blood glucose testing - Three 2.5-mL whole blood specimens; two shipments per year: B and H
• For use with methods such as the HemoCue
Multidiscipline Combination SeriesAnalytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).
Product Information• Two 1.0-mL whole blood
specimens
• For use with the HemoCue B, HemoCue Hb 201, and Stanbio HemoPoint® H2 instruments
• Two shipments per year: A and G
Waived Test Combination Series XL5Analyte Product Code Challenges/Shipment
XL5 Hematocrit z 2 Hemoglobin z 2 Urinalysis/Urine hCG z 2 Whole blood glucose z 3
PRICE (USD) $376
Waived Combination XL6 Analyte Product Code Challenges/Shipment
XL6 Hemoglobin z 2 Whole blood glucose z 2
PRICE (USD) $154
2012 Price List
36 College of American Pathologists 2012 EXCEL Catalog
Product Code EXCEL 2012
Price Page
Point-of-Care ProgramsPOC1 POC/Waived hCG Competency $129 2
POC2 POC/Waived Glucose Competency $129 2
POC3POC/Waived Urine Dipstick Competency
$129 2
POC4POC/Waived Strep Screen Competency
$129 2
Clinical ChemistryCH General Chemistry, comprehensive $402 8,9
CH3 General Chemistry, basic $210 8,9
CH9 Hematology/Oncology $156 10
L11 Neonatal Bilirubin, 2 challenges $123 10
L14 Neonatal Bilirubin, 5 challenges $210 10
L17 Waived Cholesterol/Lipids $190 10
L20 Whole Blood Glucose, 3 challenges $154 11
L21 Whole Blood Glucose, 5 challenges $222 11
L22 Hemoglobin A1c $186 11
L23 Serum Alcohol $288 11
L24 Blood Gases $441 11
L25 Cardiac Markers $234 12
L26 Urine Drug Screen $286 12
L27 Reproductive Endocrinology $318 13
L28 B-type Natriuretic Peptides $198 13
L30 Plasma Cardiac Markers $258 13
L31 Whole Blood Creatinine $276 13
CoagulationXC Coagulation $174 22
XC1 Coagulation, limited $156 22
XC3 Whole Blood Prothrombin Time/INR $330 22
XC19 Whole Blood Prothrombin Time/INR $243 22
XC20 Whole Blood D-dimer $234 23
HematologyXH1 Routine Hematology $222 15
XH3 Comprehensive Hematology $306 15
XH4 Comprehensive Hematology $306 15
XH6 Centrifugal Hematology $255 16
XH7 Centrifugal Hematology, WBC $30 16
Product Code EXCEL 2012
Price Page
Hematology (cont.)XH8 Erythrocyte Sedimentation Rate $198 16
XH9 Reticulocyte Count $280 16
XHP Routine Hematology, Blood Cell ID $45 15
ImmunologyXB2 Anti-HIV-1, Waived $172 32
XB3 Anti-HIV-1/2, Waived $218 32
XS1 Infectious 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
MicrobiologyM1 Throat Culture $258 28
M6 Rapid Group A Strep Antigen Detection, 5 challenges $204 28
M8 Gram Stain $207 28
M9 Urine Colony Count/Urine Culture Identification $198 29
M10 Throat and Urine Culture/ Rapid Strep A Antigen Detection $258 29
M14 Rapid Group A Strep Antigen Detection, 2 challenges $138 28
M17 Urine Colony Count/Urine Culture Identification $333 29
M18 C. difficile Toxin Antigen Detection $174 29
M20 Microbiology Combination, basic $270 28
MM Microbiology Combination, comprehensive $312 28
M21 Viral Antigen Detection $285 30
Urinalysis and Clinical MicroscopyXU Urinalysis, comprehensive $150 18
XU1 Urinalysis, basic $108 18
XU2P Urine Sediment, with XU, XU1, XL5 $42 18
XU4P Clinical Microscopy, with XU, XU1, XL5 $42 18
XU5P Provider-Performed Microscopy $166 19
2012 Price List
2012 Price List
800-323-4040 | 847-832-7000 Option 1 | cap.org 37
Product Code EXCEL 2012
Price Page
Urinalysis and Clinical Microscopy (cont.)XU6 Urine hCG $156 18
XU7P Urine Sediment $96 18
XU8P Clinical Microscopy $96 18
XU9 Occult Blood $130 19
XU10 Sperm Count and Presence/ Absence $254 20
XUX11 Urine Albumin (Microalbumin) $212 20
XUX12 Amniotic Fluid Leakage $228 20
XUX13 Rupture of Fetal Membranes $398 20
Multidiscipline Combination SeriesXL5 Waived Test Combination Series $376 34
XL6 Waived Test Combination $154 34
Supplemental ProductsXLBIND EXCEL Binder $13 2
Indices
800-323-4040|847-832-7000Option1|cap.org 39
IndicesAnalytes/proceduresinboldtypeareregulatedforproficiencytestingbytheCentersforMedicare&MedicaidServices(CMS).
Analyte/Procedure by Discipline LAP ENR Module Clinical Chemistry Pages 7–13 Acetaminophen X L26 Alanine aminotransferase (ALT/SGPT) X CH,L17 Albumin X CH Alcohol, serum X L23 Alkaline phosphatase X CH Amphetaminegroup L26 Amphetamine/methamphetaminegroup L26 Amylase X CH Aspartate aminotransferase (AST/SGOT) X CH,L17 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 L28,L30 Buprenorphine L26 Calcium X CH, CH3 Calcium,ionized X L24 Carbamazepine X CH Carbondioxide(CO2) X CH,CH3 CEA X CH9 Chloride X CH, CH3, L24 Cholesterol, total X CH, CH3, L17 CK-MB X L25, L30 Cortisol X CH Creatine kinase (CK) X CH Creatinine X CH, CH3, L31 Delta-9-THC-COOH L26 Digoxin X CH 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
40 CollegeofAmericanPathologists 2012EXCELCatalog
Analyte/Procedure by Discipline LAP ENR Module Clinical Chemistry (cont.) Pages 7–13 Glucose, serum X CH, CH3 Glucose,wholeblood,5challenges X L21 Glucose,wholeblood,3challenges X L17,L20,XL5(p.34) Glucose,wholeblood,2challenges X XL6(p.34) hCG, serum, quantitative and qualitative X CH, CH3 HDL cholesterol X CH, CH3, L17 Hematocrit X L24 HemoglobinA1c X L22
Iron X CH Lactate dehydrogenase (LD) X CH LDLcholesterol X CH,CH3,L17 Lithium X CH LuteinizingHormone(LH) X L27 Lysergicaciddiethylamide(LSD) L26 Magnesium X CH Methadone L26 Methadonemetabolite(EDDP) L26 Methamphetamine L26 Methaqualone L26 Methylenedioxymethamphetamine(MDMA) L26 Myoglobin X L25,L30 Neonatalbilirubun,direct X L11,L14 Neonatal bilirubin, total X L14 NT-proBNP X L28 Opiategroup L26 Oxycodone L26 PCO2 X L24 pH X L24 Phencyclidine L26 Phenobarbital X CH Phenytoin X CH Phosphorus X CH PO2 X L24 Potassium X CH, CH3, L24 Progesterone X L27 Prolactin X L27 Propoxyphene L26 Prostate-specificantigen(PSA) X CH9 Protein, total X CH
Indices
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Analyte/Procedure by Discipline LAP ENR Module Clinical Chemistry (cont.) Pages 7–13 Sodium X CH, CH3, L24 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 Theophylline X CH Thyroid-stimulating hormone (TSH) X CH Tricyclicgroup L26
Triglycerides X CH, CH3, L17 TroponinI X L25,L30 Urea nitrogen (BUN) X CH, CH3 Uric acid X CH, CH3 Urinedrugscreen X L26 Valproic acid X CH VitaminB12 X CH9
Coagulation Pages 21–23 Activated partial thromboplastin time (APTT) X XC D-dimer,wholeblood 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) Platelet count X XH1, XH3, XH4, XH6 Red blood cell count (RBC) X XH1, XH3, XH4 Reticulocytecount X XH9 WBC differential, automated X XH3, XH4, XH7 White blood cell count (WBC) X XH1, XH3, XH4, XH6
Indices
42 CollegeofAmericanPathologists 2012EXCELCatalog
Analyte/Procedure by Discipline LAP ENR Module Immunology Pages 31–32 Anti-HIV-1,waived X XB2 Anti-HIV-1/2,waived X XB3 C-reactiveprotein(CRP),qualitativeandquantitative X XS3 Helicobacter pyloriantibodydetection X XS7 hCG, serum, qualitative and quantitative X XS4 Infectious mononucleosis X XS1, XS2 Infectiousmononucleosis,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 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 RapidgroupAstrepantigendetection,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
Urinalysis and Clinical Microscopy Pages 17–20 Amnioticfluidleakage(Nitrazine) XUX12 Clinicalmicroscopy X XU4P,XU8P Creatinine,urine,semiquantitative X XUX11 Ferntest X XU4P,XU5P,XU8P KOHpreparations X XU4P,XU5P,XU8P Nasalsmears X XU4P,XU5P,XU8P Occultblood XU9 Pinwormpreparations X XU4P,XU5P,XU8P Placentalalphamicroglobulin(PAMG-1) XUX13 Provider-performedmicroscopy X XU4P,XU5P,XU8P Spermcount X XU10 Sperm,presence/absence XU10 Stoolforleukocytes X XU4P,XU5P,XU8P Urinealbumin(microalbumin),semiquantitative X XUX11 Urinealbumin(microalbumin):creatinineratio XUX11
Indices
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Analyte/Procedure by Discipline LAP ENR Module Urinalysis and Clinical Microscopy (cont.) Pages 17–20 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
44 CollegeofAmericanPathologists 2012EXCELCatalog
Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).
Analyte/Procedure LAP ENR Module PageAcetaminophen L26 12Ac tivated partial thromboplastin time (APTT) X XC 22Alanine aminotransferase (ALT/SGPT) X CH, L17 8,10Albumin X CH 8Alcohol, serum X L23 11Alkaline phosphatase X CH 8Amnioticfluidleakage(Nitrazine) XUX12 20Amphetaminegroup L26 12Amphetamine/methamphetaminegroup L26 12Amylase X CH 8Anti-HIV-1,waived X XB2 32Anti-HIV-1/2,waived X XB3 32Antimicrobial susceptibility X MM, M10, M20 28Aspartate aminotransferase (AST/SGOT) X CH, L17 8,10Automated differential X XH3, XH4, XH7 15,16Barbiturategroup L26 12Benzodiazepinegroup L26 12Benzoylecgonine/cocainemetabolites L26 12Beta-lactamasetesting MM 28Bilirubin,direct,neonatal X L11,L14 10Bilirubin, total X CH, CH3 8Bilirubin, total, neonatal X L14 10Blood cell identification X XHP 15Buprenorphine L26 12B-typenatriureticpeptides(BNP) X L28,L30 13C. difficile toxin antigen detection X M18 19Calcium X CH, CH3 8Calcium,ionized X L24 11Carbamazepine X CH 8Carbondioxide(CO2) X CH,CH3 8CEA X CH9 10Chloride X CH, CH3, L24 8,11Cholesterol, total X CH, CH3, L17 8,10CK-MB X L25, L30 12,13Clinicalmicroscopy X XU4P,XU8P 18Cortisol X CH 8C-reactiveprotein(CRP),qualitativeandquantitative X XS3 32Creatine kinase (CK) X CH 8Creatinine X CH, CH3, L31 8Creatinine,urine,semiquantitative X XUX11 20
Indices
800-323-4040|847-832-7000Option1|cap.org 45
Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).
Analyte/Procedure LAP ENR Module PageD-dimer,wholeblood XC20 23Delta-9-THC-COOH L26 12Digoxin X CH 9Erythrocytesedimentationrate(ESR) XH8 16Estradiol X L27 13Ethanol, serum X L23 11Ethanol,urine L26 12Fentanyl L26 12Ferntest X XU4P,XU5P,XU8P 18,19Ferritin X CH9 10Fibrinogen X XC 22Folate X CH9 10Follicle-stimulatinghormone(FSH) X L27 13Gammaglutamyltransferase(GGT) X CH 9GC culture X MM 28Glucose, serum X CH, CH3 9Glucose,wholeblood,5challenges X L21 11Glucose,wholeblood,3challenges X L17,L20,XL5 10,11,34Glucose,wholeblood,2challenges X XL6 34Gram stain X MM, M8, M10, M20 28Helicobacter pyloriantibodydetection X XS7 32hCG, serum, qualitative and quantitative X CH, CH3, XS4 8,32HDL cholesterol X CH, CH3, L17 9,10Hematocrit X L24, XH1, XH3, XH4, XH6 11,15,16Hematocrit,waived X XL5 34Hemoglobin X XH1, XH3, XH4, XH6 15,16Hemoglobin,waived X XL5,XL6 34HemoglobinA1c X L22 11Infectious mononucleosis X XS1, XS2 32Infectiousmononucleosis,waived X XS9 32Influenza A and B antigen detection X M21 30InternationalNormalizedRatio(INR) X XC,XC1,XC3,XC19 22Iron X CH 9KOHpreparations X XU4P,XU5P,XU8P 18,19Lactate dehydrogenase (LD) X CH 9LDLcholesterol X CH,CH3,L17 9,10Lithium X CH 9Luteinizinghormone(LH) X L27 13Lysergicaciddiethylamide(LSD) L26 12Magnesium X CH 9Methadone L26 12
Indices
46 CollegeofAmericanPathologists 2012EXCELCatalog
Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).
Analyte/Procedure LAP ENR Module PageMethadonemetabolite(EDDP) L26 12Methamphetamine L26 12Methaqualone L26 12Methylenedioxymethamphetamine(MDMA) L26 12Microalbumin X XUX11 20Myoglobin X L25,L30 12,13Nasalsmears X XU4P,XU5P,XU8P 18,19Neonatalbilirubin,direct X L11,L14 10Neonatal bilirubin, total X L14 10NT-proB-typenatriureticpeptides(BNP) X L28 13Occultblood XU9 19Opiategroup L26 12Oxycodone L26 12PCO2 X L24 11pH X L24, XU,XU1,XL5 11,18,34Phencyclidine L26 12Phenobarbital X CH 9Phenytoin X CH 9Phosphorus X CH 9Pinwormpreparations X XU4P,XU5P,XU8P 18,19Placentalalphamicroglobulin(PAMG-1) XUX13 20Platelet count X XH1, XH3, XH4, XH6 15,16PO2 X L24 11Potassium X CH, CH3, L24 9,11Progesterone X L27 13Prolactin X L27 13Propoxyphene L26 12Prostate-specificantigen(PSA) X CH9 10Protein, total X CH 9Prothrombin time (PT), plasma X XC, XC1 22Prothrombin time (PT), whole blood X XC3, XC19 22Provider-performedmicroscopy X XU4P,XU5P,XU8P 18,19Rapid group A strep antigen detection X MM, M6, M10, M17, M20 28,29RapidgroupAstrepantigendetection,waived X M14 28Red blood cell count (RBC) X XH1, XH3, XH4 15Respiratory syncytial virus (RSV) antigen detection X M21 30Reticulocytecount X XH9 16Rheumatoid factor, qualitative and quantitative X XS1, XS5 32Rotavirus antigen detection X M21 30
Indices
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Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).
Analyte/Procedure LAP ENR Module PageSodium X CH, CH3, L24 9,11Spermcount X XU10 20Spermpresence/absence XU10 20Stoolforleukocytes X XU4P,XU5P,XU8P 18,19T3, total (Triiodothyronine, total) X CH 9T3 uptake X CH 9T3,free(Triiodothyronine,free) X CH 9T4, total (Thyroxine, total) X CH 9T4, free (Thyroxine, free) X CH 9Theophylline X CH 9Throat culture X MM, M1, M10, M17, M20 28,29Thyroid-stimulating hormone (TSH) X CH 9Tricyclicgroup L26 12Triglycerides X CH, CH3, L17 12TroponinI X L25,L30 12,13Urea nitrogen (BUN) X CH, CH3 9Uric acid X CH, CH3 9Urinealbumin(microalbumin):creatinineratio XUX11 20Urinealbumin(microalbumin),semiquantitative X XUX11 20Urinebilirubin X XU,XU1,XL5 18,34Urineblood/hemoglobin X XU,XU1,XL5 18,34Urinecolonycount X M9,M17 29Urinecolonycount/urine culture identification X M9,M17 29Urine culture X MM, M9, M10, M17, M20 28,29Urinedrugscreen X L26 12Urineglucose X XU,XU1,XL5 18,34UrinehCG,qualitative X XU,XU6,XL5 18,34Urineketones X XU,XU1,XL5 18,34Urineleukocyteesterase X XU,XU1,XL5 18,34Urinenitrite X XU,XU1,XL5 18,34UrinepH X XU,XU1,XL5 18,34Urineprotein X XU,XU1,XL5 18,34Urinereducingsubstances X XU,XU1,XL5 18,34Urinesediment X XU2P,XU5P,XU7P 18Urinespecificgravity X XU,XU1,XL5 18,34Urineurobilinogen X XU,XU1,XL5 18,34Vaginalwetpreparations X XU4P,XU5P,XU8P 18,19Valproic acid X CH 9VitaminB12 X CH9 10WBC differential, automated X XH3, XH4, XH7 15,16White blood cell count (WBC) X XH1, XH3, XH4, XH6 15,16
Customer Support
and Ordering
Information12Customer Support and Ordering InformationCustomer Support.....................................................................................................................49Ordering Information, Forms, and Terms and Conditions .............................................. 50–53Additional Information for International and Noncontinental US Customers ............. 54–57Shipping Calendar ...................................................................................................................58
Customer Support
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Customer SupportCustomer Contact Center Hours: Monday–Friday, 7:00 AM–5:30 PM CT
Contact InformationCall us to: • Place or modify an order • Change contact information (telephone
number, email address, fax number, or address) • Discuss special needs (International) • Initiate CAPTRAKer SM email
800-323-4040 option 1847-832-7000 option 1
To contact the CAP via email Log on to cap.org and select “Contact Us” at the top of the home page.ORSend email to [email protected].
To submit orders or permits Fax: 847-832-8168 Email: [email protected]
Laboratory Accident Hotline 800-443-3244 847-470-2812 (For international customers)
CAPTRAKer Email The CAP’s electronic PT kit shipment-tracking service offers these services to your laboratory: • Locate your PT kit in an instant. • Receive CAPTRAKer emails notifying you of product shipments. • Link to FedEx tracking information through a CAPTRAKer email.
To initiate the receipt of CAPTRAKer emails, please forward your name, account number, and email address to [email protected]. Note: This is limited to one shipping contact email address per account.
e-LAB SolutionsTM
Join over 10,000 laboratories that use the CAP’s online proficiency testing service. Use e-LAB Solutions to take advantage of the following benefits: • Enter and view results online. • View or print copies of evaluations, Participant Summary reports, kit instructions, and result forms. • View or print your Analyte Reporting Selections document to ensure proper regulatory reporting. • Access the “My PT Shipping Calendar” feature, which shows your customized proficiency testing shipping calendar. • Access accreditation information, including your laboratory’s customized accreditation checklists. • Access the PT Troubleshooting Guide and PT Exception Investigation Checklist tools.
The site also contains a User’s Guide that will help walk you through the process. When you opt in, your laboratory will receive 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
50 College of American Pathologists 2012 EXCEL Catalog
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 products. We process order forms
using optical character recognition, so legible printing will help ensure the accuracy of your order.
Order Deadline • Order by December 1, 2011, to ensure full participation. • Order early. Some products have limited quantities. • Orders received after December 1, 2011, will be processed by date of receipt and prorated per product availability.
Renewal Orders (for current customers) • Products ordered as of August 1, 2011, are preprinted on your order renewal form. • Review all notes. • Refer to this catalog for product changes and discontinued or new products. • Complete form with payment information and return all pages by email to [email protected] or fax all pages to
Customer Data Management. • An order acknowledgment will be emailed. • Once processed, your order confirmation will be mailed to the shipping contact. Order changes can be made at that time. • You can also see a list of products under “My PT Shipping Calendar” at cap.org.
Order Additions and Cancellations • We will make every effort to accommodate orders received after December 1, 2011, dependent on the shipping schedule, specimen availability, and product stability. • Due to vendor commitments, the CAP must receive cancellations no later than six weeks prior to the ship date to receive credit for canceled products.
CAP and CLIA Numbers • Please have your CAP number available when placing orders. If you are a new CAP customer, a CAP number will be assigned and will appear on your order confirmation. • US Customers: Confirm or provide the laboratory’s CLIA identification number, which is assigned by the Centers for Medicare & Medicaid Services (CMS) and can be obtained from your laboratory director. Contact your CMS Regional Office if you do not have a CLIA ID number. • Orders may be submitted pending assignment of your CLIA number. Forward the number to the CAP once assigned.
Prices • Prices are listed on the Price List in Section 10 of this catalog and on the product pages of the online virtual catalog located at cap.org/catalogs. • Prices are listed in US dollars. • Prices exclude taxes, duties, and other applicable charges; all prices are subject to change without notice. • The CAP reserves the right to change the published prices and ship dates for products in this catalog.
Ordering Information, Forms, and Terms and Conditions
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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: Make payable to the College of American Pathologists in US dollars. • 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, bank transfer, etc) information in you letter of authorization and enter “Letter of Auth” in the purchase order field of the Payment Information section.
Payment Terms and Conditions • For orders processed by October 31, 2011, payment terms are extended until December 1, 2011. • After November 1, 2011, terms will be net 30 days from the invoice date. • Price Quotes: Please contact the CAP if your institution requires a price quote prior to submitting payment. Upon receipt of the price quote, submit the completed order form, including payment method, to the CAP for processing of your order.
Wire Transfer Information • Include all bank fees with your payment. • The CAP is not responsible for bank fees incurred while remitting payment. • Remit wire transfer payment to: m Harris Bank, 311 West Monroe Street, Chicago, Illinois 60606 USA m Phone: 312-461-2121 m Account Number: 223-733-7 m ABA Number: 071000288 m SWIFT #: HATRUS44 • Include the following information: m Customer name m CAP number m Account number m Invoice and/or order number
Ordering Information, Forms, and Terms and Conditions
52 College of American Pathologists 2012 EXCEL Catalog
Tax Information • We will assess and add appropriate taxes for your locale to your invoice if your institution is subject to sales tax. • Include applicable taxes with your prepaid order. • If your institution is not subject to sales tax and you have not previously notified the CAP, enclose your tax-exempt certificate with your order form. • The CAP federal tax identification number is 36-2118323.
Product Usage and Materials • All products are intended for proficiency testing (PT) use only. • You may not transfer or incorporate PT samples, their progeny, unmodified derivatives, or modifications thereof into a product intended for sale. • When you dispose of PT samples, their progeny, unmodified derivatives, or modifications thereof, reagents, and disposable equipment used in proficiency testing, you should autoclave or incinerate and dispose of these as hazardous waste. • All directions concerning use of the product are intended as guidance only. • No license is either granted or implied by the sale of any product. • The CAP contracts with several vendors in producing the materials for its proficiency testing programs.
All vendors so selected must abide by the standards set forth in Good Manufacturing Practices and/or hold an ISO certification.
Laboratory Accident Hotline 800-443-3244 847-470-2812 (for international customers)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 • The Centers for Disease Control and Prevention (CDC) has classified all bacterial and viral strains used in PT challenges as not greater than a Biosafety Level 2. You can find a full description of Biosafety Level 2 handling requirements, as defined by the CDC Office of Health and Safety in Biosafety in Microbiological and Biomedical Laboratories, at cdc.gov/biosafety/publications/bmbl5/. • All modules include a biohazard warning statement appropriate for handling of the material. • Modules that do not include etiologic agents are still expected to be handled in keeping with CDC universal precautions and OSHA bloodborne pathogen rules.
Shipping • All shipments are made CPT Destination. • The CAP is not liable for loss or damage caused by force majeure. • Provide a complete shipping address, telephone number, fax number, email address, and contact name on your order form. • The CAP will not accept post office box numbers for product shipments. • Most proficiency testing shipments will be sent via overnight or two-day service.
The CAP’s terms and conditions supercede any terms and conditions supplied by the customer.
Ordering Information, Forms, and Terms and Conditions
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Prelicensure/Reinstatement Service • The CAP provides PT samples to laboratories that may need to perform prelicensure testing before beginning
patient testing and/or reinstatement testing due to PT failures. • PT samples with limited stability are not available for prelicensure/reinstatement testing. Contact the CAP for cost and availability. • Reinstatement evaluations will be provided upon submission of results to the CAP.
CMS Reporting • The College of American Pathologists must submit PT results to the Centers for Medicare and Medicaid Services
(CMS) for all laboratories providing a CLIA identification number. • Your reporting preferences are outlined on the CMS Analyte Reporting Selections document, which is available online in e-LAB Solutions. • If a laboratory does not notify the CAP in advance that they have discontinued testing of a regulated analyte, a score of zero will be given. • To avoid any penalties and ensure appropriate reporting in the future, you must note analytes listed on this 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.
54 CollegeofAmericanPathologists 2012EXCELCatalog
InformationforInternationalandNoncontinentalUSCustomers
Additional Information for International and Noncontinental US Customers
What you need to know before your PT product is shipped:
PermitsManycountriesrequireimportpermitsorcertificatesoforiginforcustomsclearance(regardlessofhazardstatusofaproduct). • Workwithyourlocalauthoritiestodetermineifanypermitsarerequired. • Asarecipient,youareresponsibleforobtaininganyimportpermits/documentsandforwardingtheseto
theCAPforinclusionwiththeproductshipment.ProvidethesesamedocumentstoyourbrokerorthelocalFederalExpress(FedEx)office.
• UseproductdescriptionsintheCAPcatalogtopreventdiscrepanciesinpermitpreparationandcustoms clearancedocuments. • Productswithhazardousmaterialsmayrequirespecialpermitsandincuradditionalcharges. • Youareresponsibleformonitoringpermitexpirationdatesandsubmittinganewpermit. • Products will not ship without required documentation.
Submitpermitsatthetimeofordering,preferablywithanextendedexpirationdateofDecember31,2012,inordertocoverallshipments.Ataminimum,submitpermitssixweekspriortothestatedproductshipdatetoensuretimelydelivery.
Hawaiian PermitsThestateofHawaiirequiresimportpermits.YoumayobtainanimportpermitbycontactingthePlantQuarantineBranchoftheStateofHawaiiDepartmentofAgriculture.CompleteformPQ-7toobtainanimportpermitoraletterofauthorization.
Canadian PermitsCanadianregulationsrequirepermitstoimportanimalandhumanpathogens.PermitapplicationsshouldlisttheCAPproductcodeandfullproductname.DonotlisttheProductFulfillmentGroup(PFG).Donotlistthemailingdesignation(A,B,C).
Thesepermitsmustbeobtainedbytherecipientforallinfectiousmodulesfrom: • ThePublicHealthAgencyofCanada([email protected].) • TheCanadianFoodInspectionAgency(CFIA)([email protected] byphoneat613-221-7068).
Certainproductsrequirepermitsforoneorbothoftheaboveagencies.Contacttheseagenciesfordetails.
Canadian Broker RequirementsCanadiancustomersmustdesignateabrokerforcustomsclearance.FedExmaybedesignatedasyourbrokerbysigningaPowerofAttorneywithFedEx.ProvideyourGoodsandServicesTax(GST)accountnumberandCFIAnumbertoyourdesignatedbroker.RequestingPre-ArrivalsReleaseSystem(PARS)clearancewillexpediteclearanceofyourproficiencytestingkits.
Saudi Arabian PermitsCurrentSaudiFoodandDrugAuthorityregulationsrequireimportpermitsforallproducts.YoumayobtainpermitsthroughtheSaudiFoodandDrugAuthority.SubmitpermitstotheCAPandyourlocalFedExoffice.
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InformationforInternationalandNoncontinentalUSCustomers
Products requiring Canadian import permits are listed below and are accurate as of May 1, 2011.
Products Requiring Canadian Import Permits Product Code Module NameM1 ThroatCultureM9 UrineColonyCount/UrineCultureIdentificationM10 UrineandThroatCulture/RapidStrepAAntigenDetection
M17 UrineColonyCount/UrineCultureIdentification,RapidGroupAStrepAntigenDetectionThroatCulture
M18 C. difficileToxinAntigenDetectionM20 MicrobiologyCombination,basicMM MicrobiologyCombination,comprehensive
The EXCEL modules listed below contain hazardous materials and may require special permits and additional charges to enter your country:
Products With Hazardous Materials Product Code Module NameM1 ThroatCultureM9 UrineColonyCount/UrineCultureIdentificationM10 UrineandThroatCulture/RapidStrepAAntigenDetection
M17 UrineColonyCount/UrineCultureIdentification,RapidGroupAStrepAntigenDetectionThroatCulture
M20 MicrobiologyCombination,basicMM MicrobiologyCombination,comprehensive
Shipping and Handling ChargesThe CAP charges additional fees of up to $140 (US dollars) per product for products sent outside the United States to cover shipping costs and handling requirements.Alladditionalfees,duties,andtaxesnotreflectedinCAPlistpricesmaybeimposedonorders;customersshouldcheckwiththelocalcustomsofficeregardingthesecharges.Note: We cannot issue refunds for this fee once any of the shipments have been sent. Customers are liable 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 product cancellation, shipment refusal, or invalid ship-to address.
If a special or hazardous material shipping and handling charge is required for your order, the additional fee referenced above will be waived.TheCAPbasesthecalculationofthehazardousmaterialshippingandhandlingchargeuponthemethodofproductdeliverydesignatedforyourcountry.Thechargeis$370USDpershipmenttoshipviafreightforwarderairport-to-airport,$195USDpershipmenttoshipairport-to-airportviacourier,or$85USDpershipmenttoshipdoor-to-doorviacourier.Brokeragefeesarenotincludedinshipmentsviafreightforwarder.
56 CollegeofAmericanPathologists 2012EXCELCatalog
InformationforInternationalandNoncontinentalUSCustomers
The following paper/online products are NOT subject to shipping and handling charges:
No Shipping and Handling Charges Product Code Module NameXH7 CentrifugalHematologyXU2P UrineSedimentXU4P ClinicalMicroscopy
CarriersTheCAPwillsendall2012proficiencytestingprogramshipmentsviaFederalExpress.InselectinstancestheCAPmustuseafreightforwardertoshipproductstoyourdestination.Ifthisisthecase,theCAPwillcontactyouregardingadditionalfees.Ifyourorganizationisspecificallyrequestingshipmentviaafreightforwarderat your expense,providetheCAPwithyourfinalshipmentaddressandthefreightforwarder’sUSdomesticaddressandcontactinformation.
Tax Identification NumberProvidetheCAPwithyourfederaltaxidentificationnumberifyourcountryrequiresthatnumberbelistedonthecommercialinvoice.
Special RequirementsDiscussanyspecialshippingrequirementsorupdateswiththeCAPCustomerContactCenterstaff.
CommunicateallrequestsforspecialshippingarrangementstotheCAPaminimumofsixweekspriortothestatedproductshipdate.
Product StabilitySomeproductshavelimitedstabilityandmaybedifficulttotransporttosomelocations.
Please note that replacements are not available for products with limited stability.SomeoftheEXCELmodulematerialsthatareliquidareshippedwithfrozencoldpacksordryiceandneedtobekeptcoldasmuchaspossible.Iftransportationtoyourlocationcannotmeettheseconditions,notethatreplacementswillnotbeavailable.
IftheCAPaccreditsyourinternationallaboratory,pleasereviewoptionsforaddressingissueswithmaterialinstabilitywiththeCAPLaboratoryAccreditationProgramstaff.
Dry IceSomeshipmentsarepackedondryicetomaintainproductstability.DryiceshipmentsareshippedasUN1845dangerousgoodsshipment.Duetosublimation,theremaynotbeanydryicepresentwhenyouopenyourkit.Thisisnotanindicationthattheproducthasbeencompromised.Ifyourcountrydoesnotallowdryiceshipments,yourmoduleswillbepackagedwithcoolpacksthatmaynotbeaseffectiveinmaintainingacoolenvironment.Whenyoureceiveyourshipment,followthekitstorageinstructionsassoonaspossible.
Products Shipped on Dry Ice Product Code Module NameL25 CardiacMarkersL28 B-typeNatriureticPeptides
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InformationforInternationalandNoncontinentalUSCustomers
Important information once your PT product arrives in your country:
Local ArrangementsTheCAPrecommendsyoucontactthecarriersinyourcountrytodiscussdeliveryrequirements.Youmayneedtocompleteapowerofattorney(POA)oridentifyyourbrokerforcustomsclearance.Establishanaccountwiththeappropriatecarrier(s)toexpeditedeliverybyallowingthecarriertochargedutiesandtaxesdirecttoyouraccount.
Duties and Taxes • DutiesandimporttaxesimposedbycountriesoutsideoftheUnitedStatesaretheresponsibilityofthe customerandcannotbewaivedbytheCAP. • ShipmentsareprocessedCPTDestination.
Commercial InvoiceCommercialinvoicesareaffixedtopackagesasrequiredbyinternationalshippingconventions.Thecommercialinvoiceisanofficialtransactionrecordbetweenanexporterandanimporter.Customsofficialsusethisformtoclearyourshipment.
TheinvoicetotallistedonthecommercialinvoiceisnotanamountduetotheCAPoryourcountry.Theinvoicetotalislistedforthepurposeofcomputingdutiesandtaxes.
DeliveryCAPproductsareshippeddoor-to-doorservicewheneverpossible.Ininstanceswhereyourcountrydoesnotallowdeliverytoyourdoor,theCAPcanonlyarrangeshipmenttoanairport.Intheseinstancesyouwillbenotifiedwhenaproducthasbeenclearedandisreadyforpickup.Youmustpickupyourshipmentatthatpoint.Ifyourefusetopickupyourshipment,yourorderforanyremainingshipmentsmaybecanceled.
Carrier ContactCarriersorcustomsofficialsmayattempttocontactyouifthereareissuesregardingclearingyourshipment.Pleaserespondtotheserequestsforadditionalinformationassoonaspossible.ContacttheCAPifyouneedadditionalproductinformationtoexpediteclearance.
Ifyoufailtorespondtoinformationrequestsfromcarriersandcustomsofficials,thefollowingmayoccur: • Yourorganizationmayincuradditionalchargesforstorageandmanagementfees. • Youmayincuradditionalfeesduetodisposalorreturnofyourshipment.
2012 EXCEL Shipping Calendar
58 College of American Pathologists 2012 EXCEL Catalog
2012 EXCEL Shipping Calendar
2012 EXCEL Program Shipment ScheduleDiscipline Mailing Kit Shipment Date Kit Replacement Deadline
Hematology/Urinalysis and Clinical Microscopy/Coagulation
XL-AXL-DXL-G
January 30May 7
September 10
February 8May 16
September 19
ChemistryXL-BXl-EXL-H
March 6June 5
October 9
March 15June 14
October 18
Immunology/MicrobiologyXL-CXL-FXL-I
March 26August 6
November 26
April 4August 15
December 5
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.
For Proficiency Testing•Reduceclericalerrorswithpre-populatedformswithdrop-downinstrument,reagent,andmethodselections
•CorrectclericalerrorsduetoscanningorfaxingpriortoevaluationandavoidunnecessaryPTfailures
•ReceiveemailnotificationsiftheCAPhasnotreceivedyourdata
•Receiveyourevaluationupto10dayssooneronline
•Accessproficiencytestingimagesonline
•Reviewyourlaboratory’sperformanceforuptosixmailings
•CheckoutMyPTShippingCalendar,yourcustomizedshippingcalendar
•AccessthePT Troubleshooting Guide and PT Exception Investigation Checklisttools
For Laboratory Accreditation Program•Electronicallysubmitanapplication/reapplicationtotheaccreditationprogram
•Update activity menus when changes are made to ensure that the most current and accurate information is communicated to the CAP, CMS, and inspectors
•Maintaindemographicinformationonpersonnel,licensure,changeindirectorshiporlocation,etcthroughout theaccreditationcycle
•DownloadMasterandCustomChecklists—yourself-inspection,inspection,orCAPcurrent/fullsetchecklists
•AccesstheLaboratoryDataReport,acomprehensivereportshowingdemographicinformationaboutyour laboratory,testmenu,andpersonnel
•Viewdeficiencyreportsfromyourcurrentandpreviousinspections
•Createreports,includingtheLaboratoryActivityMenuwithProficiencyTestingOptions,toaidinaccurate proficiencytestingenrollmentandoptions
For Competency Assessment Program•Administerthecompetencyandtrainingprogramforyourentirelaboratory
•Enrolllearnerswhocanquicklyaccessassignmentsthroughe-LABSolutions
•Finduserguidesandmoreinformationaboutcourses
To create an account or to log in, go to cap.org.
Log in to e-LAB Solutions to discover these benefits:
e-LAB Solutions™ Laboratory Information at Your Fingertips
Accreditation for Laboratories Offersthe“goldstandard”for laboratoryaccreditation
Proficiency Testing Ensuresprecisionandconfidence foryourlaboratory
CAP 15189SM RecognizesasustainableQuality ManagementSystem
Accreditation for Biorepositories Provideslaboratorieswiththemeansto establishbestpractices,maintainstandardization,andensureconfidenceinbiospecimenquality
Quality Management Tools Allowsmoretimetofocusonthepatient
Education Servesasaleadingresourceforinformation andeducationinthelaboratory
Advocacy Representstheinterestsofpathologists inthegovernmentandregulatoryarenas andintheprivatesector
Membership Providesvaluablebenefitsandleadership foralllaboratoryprofessionals
SNOMED Terminology Solutions™ (STS) Offersconsultationandeducationservices totransformhealthinformation
ProgramsandResources