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Calibration Verification/Linearity and Instrumentation 83 2008 Surveys & Anatomic Pathology Education Programs www.cap.org Calibration Verification/Linearity Survey Corresponding Survey Survey Validated Material LN1-Chemistry CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2ERVM LN1ER-Chemistry Extended Range CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2ERVM LN2-Chemistry/Lipid/Enzyme CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2ERVM LN2ER-Chemistry/Lipid/Enzyme/Extended Range CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2ERVM LN3-TDM CVL CZ, CZX, CZ2, CZ2X, Z CZVM LN5-Ligand Assay CVL K, KK, KN LLM LN6-Urine Chemistry CVL U LUM LN7-Immunology CVL IG - LN8-Reproductive Endocrinology CVL Y, YY - LN9-Hematology CVL FH Series, HE Series - LN9ER-Hematology Extended Range CVL FH Series, HE Series - LN11-Serum Ethanol CVL AL2 - LN11ER-Serum Ethanol Extended Range CVL AL2 - LN12-C-Reactive Protein CVL CRP - LN13, LN13C-Blood Gas/Critical Care CVL AQ, AQ2 - LN14-Whole Blood Ethanol CVL AL1 - LN15-Glycohemoglobin CVL GH2 - LN16-Homocysteine CVL HMS - LN17-Whole Blood Glucose CVL WBG, WB2 - LN18-Reticuloctye CVL RT, RT2, RT3, RT4 - LN19-Reticulocyte CVL RT3 (Coulter GenS and LH700 series only) LN20-Microalbumin CVL U (Microalbumin and Creatinine) - LN21-High-Sensitivity C-reactive Protein CVL hsCRP - LN22-Flow Cytometry CVL FL - LN23-Prostate-Specific Antigen CVL K (PSA) - LN24-Creatinine Accuracy CVL C1, C3, C3X, CZ, CZX,CZ2, CZ2X - LN25-Troponin I CVL TRP, CRT, CRTI - LN27-Troponin T CVL TRP, CRT (Troponin T), CRTI - LN30-B-type Natriuretic Peptides CVL BNP - LN31-Immunosuppressive Drugs CVL CS - LN32-Ammonia CVL C3, C3X, CZ, CZX, CZ2, CZ2X - LN33-Serum Myoglobin CVL CARM, CRT, CRTI - LN34-CA-125 CVL TM, (CA-125) - Your Total Calibration Verification/Linearity (CVL) Solution Calibration Verification/Linearity and Instrumentation Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services Provides individual evaluation reports by analyte, executive summary report, and graphical plots for linearity and calibration verification.

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Page 1: Calibration Verification/Linearity and Instrumentation · Calibration Verification/Linearity and Instrumentation Analytes/procedures in bold type are regulated for proficiency testing

Calibration Verification/Linearity and Instrumentation 83

2008 Surveys & Anatomic Pathology Education Programs

www.cap.org

Calibration Verification/Linearity Survey Corresponding Survey Survey Validated MaterialLN1-Chemistry CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2ERVMLN1ER-Chemistry Extended Range CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2ERVMLN2-Chemistry/Lipid/Enzyme CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2ERVMLN2ER-Chemistry/Lipid/Enzyme/Extended Range CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2ERVMLN3-TDM CVL CZ, CZX, CZ2, CZ2X, Z CZVMLN5-Ligand Assay CVL K, KK, KN LLMLN6-Urine Chemistry CVL U LUMLN7-Immunology CVL IG -LN8-Reproductive Endocrinology CVL Y, YY -LN9-Hematology CVL FH Series, HE Series -LN9ER-Hematology Extended Range CVL FH Series, HE Series -LN11-Serum Ethanol CVL AL2 -LN11ER-Serum Ethanol Extended Range CVL AL2 -LN12-C-Reactive Protein CVL CRP -LN13, LN13C-Blood Gas/Critical Care CVL AQ, AQ2 -LN14-Whole Blood Ethanol CVL AL1 -LN15-Glycohemoglobin CVL GH2 -LN16-Homocysteine CVL HMS -LN17-Whole Blood Glucose CVL WBG, WB2 -LN18-Reticuloctye CVL RT, RT2, RT3, RT4 -LN19-Reticulocyte CVL RT3 (Coulter GenS and

LH700 series only)LN20-Microalbumin CVL U (Microalbumin and Creatinine) -LN21-High-Sensitivity C-reactive Protein CVL hsCRP -LN22-Flow Cytometry CVL FL -LN23-Prostate-Specific Antigen CVL K (PSA) -LN24-Creatinine Accuracy CVL C1, C3, C3X, CZ, CZX,CZ2, CZ2X -LN25-Troponin I CVL TRP, CRT, CRTI -LN27-Troponin T CVL TRP, CRT (Troponin T), CRTI -LN30-B-type Natriuretic Peptides CVL BNP -LN31-Immunosuppressive Drugs CVL CS -LN32-Ammonia CVL C3, C3X, CZ, CZX, CZ2, CZ2X -LN33-Serum Myoglobin CVL CARM, CRT, CRTI -LN34-CA-125 CVL TM, (CA-125) -

Your Total Calibration Verification/Linearity (CVL) Solution

Calibration Verification/Linearity and InstrumentationAnalytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services

Provides individual evaluation reports by analyte, executive summary report, and graphical plots for linearity and calibration verification.

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84 Calibration Verification/Linearity and Instrumentation

College of American Pathologists

800-323-4040 Option 1 for Customer Contact Center

Calibration Verification/Linearity Surveys advantages:

❚ Receive liquid specimens that cover broad analyte ranges to challenge assays from near zero to the top of the

analytical measurement range for most analytes and methods

❚ Access a comprehensive selection of analytes and programs to encompass a broad testing menu

❚ Satisfy the requirements for scheduled verification of the analytical measurement range of the CAP Laboratory

Accreditation Program and the CLIA calibration verification under 42 CFR493.1255(b)(3) for most analytes

❚ Use a consistent analytical approach for the assessment of the method linearity and calibration agreement with

your peer group

❚ Get custom reports with an Executive Summary for a quick overview of the performance, a Comprehensive

Evaluation Report with specific analyte information, and Linearity & Calibration/Verification graphs

❚ Validate instrument auto dilutor performance on select Linearity Surveys

Note: The College of American Pathologists Laboratory Accreditation Program requires an additional calibrationverification process for methods calibrated less frequently than once every six months. Please review the inspectionchecklist for information about suitable verification material for any method that is calibrated less often than atsix-month intervals. The Calibration Verification/Linearity Surveys are designed to assess agreement of a laboratorywith the method manufacturer’s calibration settings, but do not validate accuracy traceable to reference methods.

Please see the CAP Standards and Instrumentation Resource Committee Web site at www.cap.org or contact a CAPCustomer Contact Center Representative at 800-323-4040 option 1 for additional information and a listing of the specific analyte ranges targeted in these Surveys.

Improve the reliability of your patient results with CAP Survey ValidatedMaterials

Use the same material that is sent in the Surveys Program to:

❚ Identify and troubleshoot instrument/method problems

❚ Correlate results with other laboratories or instruments

❚ Document correction of problems identified in Surveys

❚ Utilize as an alternative external quality control material with confirmed results

❚ Identify potential proficiency testing failures

Results are readily available in the Survey Participant Summary that is included with each Survey Evaluation Report.

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Analyte LN1 LN1ER LN2 LN2ERAlbumin ❚ ❚ ❚ ❚

Bilirubin, direct ❚ ❚ ❚ ❚

Bilirubin, total* ❚ ❚ ❚ ❚

Calcium* ❚ ❚ ❚ ❚

Chloride ❚ ❚ ❚ ❚

CO2* ❚ ❚ ❚ ❚

Creatinine ❚ ❚ ❚ ❚

Glucose ❚ ❚ ❚ ❚

Iron ❚ ❚ ❚ ❚

Magnesium ❚ ❚ ❚ ❚

Osmolality* ❚ ❚ ❚ ❚

Phosphorus ❚ ❚ ❚ ❚

Potassium ❚ ❚ ❚ ❚

Protein, total ❚ ❚ ❚ ❚

Sodium ❚ ❚ ❚ ❚

Urea ❚ ❚ ❚ ❚

Uric Acid ❚ ❚ ❚ ❚

Alanine aminotransferase (ALT/SGPT) ❚ ❚

Alkaline phosphatase (ALP) ❚ ❚

Amylase ❚ ❚

Aspartate aminotransferase (AST/SGOT) ❚ ❚

Cholesterol* ❚ ❚

CK2 (MB) ❚ ❚

Creatine kinase (CK) ❚ ❚

Gamma glutamyl transferase (GGT) ❚ ❚

HDL cholesterol* ❚ ❚

Lactate dehydrogenase (LD) ❚ ❚

Lipase ❚ ❚

Triglycerides* ❚ ❚

Auto dilutor validation report ❚ ❚ ❚ ❚

Chemistry/Lipid/Enzyme Calibration Verification/Linearity

LN1**, LN1ER, LN2**, LN2ER

Product InformationLN1 and LN2 participants mayreport diluted specimen results.A report will be provided thatmay be used to verify that theauto dilutor is working appropriately.

Surveys LN1 and LN2 correspondto CAP Chemistry Surveys C1, C3,C3X, CZ, CZX, CZ2, and CZ2X.Each shipment of Surveys LN1and LN2 will contain six 10.0-mLliquid serum specimens and six3.0-mL liquid serum specimensfor evaluation of direct and totalbilirubin. Each shipment ofSurvey LN2 will also contain one20.0-mL and two 10.0-mL liquidlipid serum specimens fromwhich additional admixtures willbe prepared. Survey LN1ER willinclude all specimens in LN1 andan additional high vial for participants that need higheranalyte ranges than currentlyavailable in Survey LN1. SurveyLN2ER will include all specimensin LN2 and an additional highvial for participants that needhigher analyte ranges thancurrently available in Survey LN2.

Each set of LN2ERVM orderedwill contain all the specimensincluded in LN2ER.

CVL CHEMISTRY/LIPID/ENZYME VALIDATED MATERIAL (LN2ERVM)

*These analytes are not available for extended range reporting.** LN Express is available for only LN1 and LN2 at this time.

E

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CVL LIGAND ASSAY VALIDATED MATERIAL (LLM)

Analyte LN5CEA ❚

Cortisol ❚

Ferritin ❚

Folate ❚

Human chorionic gonadotropin (hCG) ❚

T3, total (Triiodothyronine) ❚

T4, total (Thyroxine) ❚

Thyroid-stimulating hormone (TSH) ❚

Vitamin B12 ❚

Ligand Assay CalibrationVerification/Linearity LN5

CVL TDM VALIDATED MATERIAL (LDM)

Analyte LN3Acetaminophen ❚

Amikacin ❚

Carbamazepine ❚

Digoxin ❚

Gentamicin ❚

Lidocaine ❚

Lithium ❚

N-acetylprocainamide (NAPA) ❚

Phenobarbital ❚

Phenytoin ❚

Primidone ❚

Procainamide ❚

Quinidine ❚

Salicylate ❚

Theophylline ❚

Tobramycin ❚

Valproic acid ❚

Vancomycin ❚

TDM Calibration Verification/Linearity LN3

Product InformationSurvey LN5 corresponds to CAPLigand Assay (General) SurveysK, KK, and KN. Each shipment ofSurvey LN5 will include five 4.0-mL liquid serum specimens.

Each set of LLM ordered willconsist of five 4.0-mL liquidserum specimens.

Product InformationSurvey LN3 corresponds to CAPGeneral Chemistry andTherapeutic Drug MonitoringSurveys CZ, CZX, CZ2, CZ2X, andZ. Each shipment of Survey LN3will include six 4.0-mL liquidserum specimens.

Each set of LDM ordered willconsist of six 4.0-mL liquidserum specimens.

E

E

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CVL URINE CHEMISTRY VALIDATED MATERIAL (LUM)

Analyte LN6Amylase ❚

Calcium ❚

Chloride ❚

Creatinine ❚

Glucose ❚

Osmolality ❚

Phosphorus ❚

Potassium ❚

Protein, total ❚

Sodium ❚

Urea ❚

Uric acid ❚

Auto dilutor validation report ❚

Urine Chemistry CalibrationVerification/Linearity LN6

Product InformationLN6 participants are allowed toreport auto diluted specimenresults. A report will be pro-vided that may be used to verifythat the auto dilutor is workingappropriately. Survey LN6 corre-sponds to CAP Urine Chemistry(General) Survey U. Each ship-ment of Survey LN6 will include15 4.0-mL liquid urine specimens.

Each set of LUM ordered willconsist of 15 4.0-mL liquidurine specimens.

Analyte LN7Alpha-1-antitrypsin ❚

Complement C3 ❚

Complement C4 ❚

IgA ❚

IgG ❚

IgM ❚

Transferrin ❚

Immunology CalibrationVerification/Linearity LN7

Product InformationSurvey LN7 corresponds to CAPImmunology (General) SurveyIG. Each shipment of Survey LN7will include five 2.0-mL liquidserum specimens.

E

E

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800-323-4040 Option 1 for Customer Contact Center

Product InformationSurveys LN9 and LN9ER correspond to the CAP Basic Hematology and Hematology Automated Differentials Surveys HEand FH series. Surveys LN9 and LN9ER are compatible with all instruments. The Surveys provide an indicator ofplatelet accuracy at clinical decision levels. The specimens are designed to span the linear range of most automatedhematology instruments. Each shipment of LN9 will include 18 3.0-mL specimens. Survey LN9ER will include allspecimens in LN9 and four additional high vials for participants that need higher platelet and WBC ranges thancurrently available in Survey LN9. All vials have pierceable caps.

Analyte LN9 LN9ERHemoglobin ❚

Platelet count ❚ ❚

RBC count ❚

WBC count ❚ ❚

Hematology Calibration Verification/Linearity LN9, LN9ER

Analyte LN8Estradiol ❚

Follicle-stimulating hormone (FSH) ❚

Human chorionic gonadotropin (hCG) ❚

Luteinizing hormone (LH) ❚

Progesterone ❚

Prolactin ❚

Testosterone ❚

Reproductive Endocrinology Calibration Verification/Linearity LN8

Product InformationSurvey LN8 corresponds to CAP Ligand Assay (Special) Surveys Y and YY. Each shipment of Survey LN8 will includefive 4.0-mL liquid serum specimens.

E

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Product InformationSurveys LN11 and LN11ER correspond to the AACC/CAP Serum Alcohol/Volatiles Survey (AL2). Each shipment willcontain six 3.0-mL liquid serum specimens. Survey LN11ER will include all specimens in LN11 and one additionalhigh vial for participants that need higher analyte ranges than currently available in Survey LN11.

Analyte LN11 LN11ERSerum Ethanol ❚ ❚

Serum Ethanol Calibration Verification/Linearity LN11, LN11ER

Product InformationEach shipment of Survey LN12 will include six 1.0-mL liquid serum specimens. Note: This Survey is not designedfor reporting high-sensitivity C-reactive protein.

Analyte LN12C-reactive protein ❚

C-reactive Protein Calibration Verification/Linearity LN12

E

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Analyte LN13 LN13C PCO2 ❚ ❚

pH ❚ ❚

PO2 ❚ ❚

Calcium, ionized ❚

Chloride ❚

Glucose ❚

Lactate ❚

Magnesium, ionized ❚

Potassium ❚

Sodium ❚

Product InformationSurvey LN13 corresponds to the blood gas component of the CAP Critical Care Aqueous Blood Gas AQ/AQ2 Surveys.Survey LN13C corresponds to the electrolyte and blood gas components of the AQ/AQ2 Surveys. Each shipment ofSurvey LN13 and LN13C will include ten 2.5-mL ampules of aqueous specimens (five in duplicate) for single instrument reporting.

Blood Gas/Critical Care Calibration Verification/Linearity LN13, LN13C

Analyte LN14Ethanol ❚

Product InformationSurvey LN14 corresponds to the AACC/CAP Alcohol/Volatiles Survey (AL1) for whole blood analysis of ethanol. Eachshipment of Survey LN14 will include six 3.0-mL liquid whole blood specimens.

Whole Blood Ethanol Calibration Verification/Linearity LN14E

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Product InformationSurvey LN15 corresponds to the CAP GH2 Survey for glycohemoglobin.

Each shipment of Survey LN15 will include six 0.7-mL liquid human whole blood specimens. Note: These specimensmust be processed as patient specimens and tested immediately upon receipt.

Analyte LN15Glycohemoglobin (HbA1c) ❚

Glycohemoglobin Calibration Verification/Linearity LN15

Product InformationSurvey LN16 corresponds to the CAP HMS Survey for homocysteine. Each shipment of Survey LN16 will include six1.0-mL liquid serum specimens.

Analyte LN16Homocysteine ❚

Homocysteine Calibration Verification/Linearity LN16

Product InformationSurvey LN17 corresponds to the CAP WBG/WB2 Surveys for whole blood glucose. With each kit, you may report fromten different ancillary testing sites or instruments. Each shipment of Survey LN17 will include five 2.0-mL liquid wholeblood specimens.

Analyte LN17Whole blood glucose ❚

Whole Blood Glucose Calibration/Verification Linearity LN17

E

E

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Product InformationSurvey LN18 corresponds to the CAP RT, RT2, RT3, and RT4 Surveys for all instruments except the Coulter GenS andLH700 series. Survey LN19 corresponds to the RT3 Survey for Coulter GenS and LH700 series users only. Each shipment of Surveys LN18 and LN19 will include five 1.0-mL red blood cell specimens.

Instrument LN18 LN19All instruments except Coulter GenS and LH700 series ❚

Coulter GenS and LH700 series ❚

Pierceable caps ❚

Reticulocyte Calibration Verification/Linearity LN18, LN19

Product InformationSurvey LN20 corresponds to CAP Urine Chemistry Survey U. Each shipment of Survey LN20 will include five 5.0-mL liquid urine specimens.

Analyte LN20Microalbumin ❚

Creatinine ❚

Microalbumin Calibration Verification/Linearity LN20

Product InformationSurvey LN21 corresponds to the CAP High-Sensitivity C-reactive Protein Survey hsCRP. Each shipment of Survey LN21will include six liquid serum specimens. Survey LN21 is for high sensitivity methods only.

Analyte LN21High-sensitivity C-reactive protein ❚

High-Sensitivity C-reactive Protein CalibrationVerification/Linearity LN21

E

E

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Analyte LN22CD3+ ❚

CD3+/CD4+ ❚

CD3+/CD8+ ❚

Flow Cytometry Calibration Verification/Linearity LN22

Product InformationSurvey LN22 corresponds to the CAP Flow Cytometry Survey FL. Each shipment of LN22 will include seven 1.0-mLliquid whole blood specimens.

Analyte LN23Prostate-Specific Antigen ❚

Prostate-Specific Antigen Calibration Verification/Linearity LN23

Product InformationSurvey LN23 corresponds to the CAP Ligand Assay Survey K. Each shipment of LN23 will include twelve 1.0-mL liquidserum specimens. The first seven vials will consist of values specified at a range from 0.1-4.0 ng/mL. Vials eightthrough twelve will consist of values specified at a range from 8.0-90.0 ng/mL.

Analyte LN24Creatinine ❚

Creatinine Accuracy Calibration Verification/Linearity LN24

Product InformationThe LN24 Survey focuses on values for creatinine at the range from 0.5-4.0 mg/dL. Each shipment of LN24 willconsist of six 1.0-mL liquid fresh frozen serum specimens.

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Analyte LN25Troponin I ❚

Troponin I Calibration Verification/Linearity LN25

Product InformationSurveys LN25 corresponds to the CAP Troponins I and T Survey TRP. Each shipment of LN25 will consist of seven 2.0-mL liquid serum specimens. The specimens must be tested on the day of receipt.

Analyte LN27Troponin T ❚

Troponin T Calibration Verification/Linearity LN27

Product InformationSurvey LN27 corresponds to the CAP Troponins I and T Survey TRP. Each shipment of LN27 will consist of six 2.0-mL liquid serum specimens. The specimens must be tested on the day of receipt.

Note: LN25 is now compatible with all instruments, including the Abbott AxSYM.

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Analyte LN30BNP ❚

NT-pro BNP ❚

B-type Natriuretic Peptides Calibration Verification/LinearityLN30

Product InformationSurvey LN30 corresponds to the CAP B-type Natriuretic Peptides Survey BNP. Each shipment of LN30 will include six1.0-mL liquid plasma specimens for BNP and NT-pro BNP. A seventh 1.0-mL liquid plasma specimen will be includedto test only for NT-pro BNP. Note: Linearity Surveys have linearity targets based on clinical relevance and gener-al characteristics of currently available methods. These criteria may not be reflective of the specific character-istics of the currently available single dose unit technology methods. For customers using single dose unittechnology, it is the laboratory's discretion to assess the appropriateness of the linearity targets when applied tothis technology and to the clinical needs of their patients. LN30 ships on dry ice; test immediately upon receipt.

Analyte LN31Cyclosporine ❚

Tacrolimus ❚

Immunosuppressive Drugs Calibration Verification/LinearityLN31

Product InformationSurvey LN31 corresponds to the CAP Immunosuppressive Drugs CS Survey. Each shipment of LN31 will include seven2.0-mL liquid whole blood hemolysate.

Analyte LN32Ammonia ❚

Ammonia Calibration Verification/Linearity LN32

Product InformationEach shipment of LN32 will include seven 2.0-mL liquid serum specimens.

E

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Analyte LN33Myoglobin ❚

Serum Myoglobin Calibration Verification/Linearity LN33

Product InformationSurvey LN33 corresponds to the CAP Cardiac Markers CARM, CRT, and CRTI Surveys for quantitative myoglobin. Each shipment of LN33 will include seven 1.0-mL liquid serum specimens.

Analyte LN34CA-125 ❚

CA-125 Calibration Verification/Linearity LN34

Product InformationEach shipment of LN34 will include seven 3.0-mL liquid serum specimens.

RRS Series 1 RRS2 Series 2Analyte RRS Analyte RRS2Alanine aminotransferase ❚ B-type Natriuretic Peptides (BNP) ❚

Albumin ❚ Pro B-type Natriuretic Peptides (NT-pro BNP) ❚

Amylase ❚ Chloride ❚

Aspartate aminotransferase ❚ CO2 ❚

Bilirubin, total ❚ C-reactive Protein (CRP) ❚

Calcium ❚ Folate ❚

CK-MB ❚ Gamma Glutamyl Transferase (GGT) ❚

Creatinine ❚ Glucose ❚

Ferritin ❚ Potassium ❚

T4, free (thyroxine, free) ❚ Sodium ❚

Iron ❚ Testosterone ❚

Lactate dehydrogenase ❚ Thrombin Time (TT) ❚

Magnesium ❚ Uric Acid ❚

Protein, total ❚ Urea ❚

T4 (thyroxine) ❚ Vitamin B-12 ❚

Total iron binding capacity ❚

Thyroid stimulating hormone (TSH) ❚

Reference Range Service RRS, RRS2

E

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Product InformationThe Reference Range Service (RRS, RRS2, RRS3, and RRS4) is designed for laboratories/laboratory networks toprovide a method to establish and/or verify the validation of reference intervals based on the CLS1 Reference RangeProtocol C28-A2, Vol. 15, No. 4 entitled, “How to Define and Determine Reference Intervals in the ClinicalLaboratory; Approved Guideline – Second Edition,” nonparametric approach.

Laboratories will be required to submit 20 results from “normal/healthy” individuals for each analyte. Exclusionarycriteria will be provided to facilitate identification of appropriate donors. In addition, the participating laboratory willsubmit testing methods and instruments as well as gender, age, and race of each donor, using classifications from the United States Office of Management and Budget, Revisions to the Standards for theClassification of Federal Data on Race and Ethnicity (Federal Register Notice, October 30, 1997). Laboratories participating in these programs will receive a summary report including the reference interval for each analyte forwhich data is submitted. The reference intervals will be provided by platform.

In February 2008 participants will be requested to provide their instruments/reagents/methods to ensure that theminimum number of data sets are available per platform for analysis. In addition, laboratories will be provided withexclusionary criteria for potential donors. All donor results should be returned to the CAP for analysis, includingthose that may be outside of your laboratory’s established reference interval.

Note: The College had determined that Institutional Review Board (IRB) review is not routinely required toparticipate in this reference interval service. However, if the laboratory is in an instituion that requires IRBreview to conduct reference interval studies, be advised that the deadline to return donor results to the CAPwill be May.

Analyte RRS3 RRS4Alkaline Phosphatase ❚

Immunoglobulin A ❚

Immunoglobulin G ❚

Immunoglobulin M ❚

Lipase, serum ❚

Prostate-specific Antigen (PSA) ❚

Myoglobin, serum ❚

Troponin I ❚

Hemoglobin ❚

Hematocrit ❚

Platelets ❚

Red blood cell count ❚

White blood cell count ❚

Reference Range Service Series 3, Series 4 New

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Survey Shipment Instrument A B* CSpectrophotometer Linearity ❚ ❚

pH Meters: Buffers for pH measurements ❚

Wavelength and Photometric Calibration: ❚

Acid potassium dichromate solutions—absorbance check, autodilutor check ❚

Holmium oxide—peak absorbanceThomson’s solutions—wavelength and photometric calibration

Analytical balance ❚ ❚

Fluorescent microscopes ❚

Microtiter plate reader linearity ❚ ❚

Ocular micrometer ❚

Osmometer ❚

Pipette calibration, gravimetric ❚ ❚

Adjustable micropipette calibration verification/linearity ❚ ❚

Refractometer ❚ ❚

Product InformationSurvey I is designed as an assessment tool for instruments not routinely challenged during the proficiency testingprocess. Linearity results (forward and reverse) for the spectrophotometer and microtiter plate reader are evaluatedby linear regression methods. Appropriate material will be provided to assess important functional parameters,including accuracy and linearity.

Please note that some challenges in the I-B Survey shipment, may contain chemically hazardous material and willrequire special handling. The kit instructions and the specimen vials will identify if any chemically hazardous materialis present.

Instrumentation I

*Note: I-B Survey contains potassium dichromate, classified as a toxic chemical.

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Calibration Verification/Linearity and Instrumentation 99

2008 Surveys & Anatomic Pathology Education Programs

www.cap.org

Analyte UTCOBenzoylecgonine ❚

Delta-9-THC-COOH ❚

Opiates ❚

Propoxyphene ❚

Urine Toxicology Carry Over Survey UTCO

Product InformationThe Survey UTCO is designed to help participants evaluate instrument sample probe carry over. Multiple kits may bepurchased. Each shipment of UTCO will consist of a 40.0-mL liquid urine specimen low vial and a 40.0-mL liquidurine high vial. The expiration date of this material is May 31, 2009. A calculation is provided in the kit instruc-tions to assist the participants in determining their instrument sample probe carry over; therefore, data need not bereturned to the CAP.

Analyte SCOCreatinine ❚

hCG ❚

Lactate dehydrogenase (LD) ❚

Phenytoin ❚

Serum Carry Over Survey SCO

Product InformationThe Survey SCO is designed to help participants prove or disprove instrument sample probe carry over. Multiple kitsmay be purchased. Each shipment of SCO will consist of a 10.0-mL liquid serum specimen low vial and a 5.0-mLliquid serum high vial. The expiration date of this material is May 31, 2009. A calculation is provided in the kitinstructions to assist the participants in determining their instrument sample probe carry over; therefore, data neednot be returned to the CAP.

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100 Calibration Verification/Linearity and Instrumentation

College of American Pathologists

800-323-4040 Option 1 for Customer Contact Center

Bilirubin HemoglobinAnalyte Interferent InterferentAlanine aminotransferase (ALT/SGPT) ❚ ❚

Albumin ❚ ❚

Alkaline phosphatase (ALP) ❚ ❚

Amylase ❚ ❚

Aspartate aminotransferase (AST/SGOT) ❚ ❚

Bilirubin, total ❚

Calcium ❚ ❚

Chloride ❚ ❚

CK2 (MB) ❚ ❚

CO2 ❚ ❚

Creatine Kinase (CK) ❚ ❚

Creatinine ❚ ❚

Gamma glutamyl transferase (GGT) ❚ ❚

Glucose ❚ ❚

Iron ❚ ❚

Lactate dehydrogenase (LD) ❚ ❚

Lipase ❚ ❚

Magnesium ❚ ❚

Osmolality ❚ ❚

Phosphorus ❚ ❚

Potassium ❚ ❚

Protein, total ❚ ❚

Sodium ❚ ❚

Urea ❚ ❚

Uric Acid ❚ ❚

Interfering Substance Survey IFSProduct InformationSurvey IFS is designed to assistparticipants in verifying manu-facturing interference specifications and to investigatediscrepant results caused byinterfering substances such asbilirubin and hemoglobin.Multiple kits may be purchased.

Each shipment of IFS willconsist of twelve 10.0-mL liquidserum specimens. The expira-tion date of this material isJune 30, 2009. Participants willreceive their evaluations oneweek after the results have beenreceived by the CAP.