Calibration Verification/Linearity and Instrumentation

Transcription

1 Calibration Verification/Linearity and Instrumentation s/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services Your Total Calibration Verification/Linearity (CVL) Solution Calibration Verification/Linearity Survey Corresponding Survey Survey Validated Material LN1-Chemistry CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2RVM LN1R-Chemistry xtended Range CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2RVM LN2-Chemistry/Lipid/nzyme CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2RVM LN2R-Chemistry/Lipid/nzyme/xtended Range CVL C1, C3, C3X, CZ, CZX, CZ2, CZ2X LN2RVM 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 ndocrinology CVL Y, YY - LN9-Hematology CVL FH Series, H Series - LN9R-Hematology xtended Range CVL FH Series, H Series - LN11-Serum thanol CVL AL2 - LN11R-Serum thanol xtended Range CVL AL2 - LN12-C-Reactive Protein CVL CRP - LN13, LN13C-Blood Gas/Critical Care CVL AQ, AQ2 - LN14-Whole Blood thanol 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) - Provides individual evaluation reports by analyte, executive summary report, and graphical plots for linearity and calibration verification Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 83

2 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 CFR (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 xecutive Summary for a quick overview of the performance, a Comprehensive valuation 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 calibration verification process for methods calibrated less frequently than once every six months. Please review the inspection checklist for information about suitable verification material for any method that is calibrated less often than at six-month intervals. The Calibration Verification/Linearity Surveys are designed to assess agreement of a laboratory with 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 or contact a CAP Customer Contact Center Representative at 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 Validated Materials 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 valuation Report. 84 Calibration Verification/Linearity and Instrumentation College of American Pathologists

3 Chemistry/Lipid/nzyme Calibration Verification/Linearity LN1**, LN1R, LN2**, LN2R LN1 LN1R LN2 LN2R Albumin Bilirubin, direct Bilirubin, total* Calcium* Chloride CO 2 * 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* CK 2 (MB) Creatine kinase (CK) Gamma glutamyl transferase (GGT) HDL cholesterol* Lactate dehydrogenase (LD) Lipase Triglycerides* Auto dilutor validation report CVL CHMISTRY/LIPID/NZYM VALIDATD MATRIAL (LN2RVM) *These analytes are not available for extended range reporting. ** LN xpress is available for only LN1 and LN2 at this time. LN1 and LN2 participants may report diluted specimen results. A report will be provided that may be used to verify that the auto dilutor is working appropriately. Surveys LN1 and LN2 correspond to CAP Chemistry Surveys C1, C3, C3X, CZ, CZX, CZ2, and CZ2X. ach shipment of Surveys LN1 and LN2 will contain six 10.0-mL liquid serum specimens and six 3.0-mL liquid serum specimens for evaluation of direct and total bilirubin. ach shipment of Survey LN2 will also contain one 20.0-mL and two 10.0-mL liquid lipid serum specimens from which additional admixtures will be prepared. Survey LN1R will include all specimens in LN1 and an additional high vial for participants that need higher analyte ranges than currently available in Survey LN1. Survey LN2R will include all specimens in LN2 and an additional high vial for participants that need higher analyte ranges than currently available in Survey LN2. ach set of LN2RVM ordered will contain all the specimens included in LN2R Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 85

4 Option 1 for Customer Contact Center Survey LN3 corresponds to CAP General Chemistry and Therapeutic Drug Monitoring Surveys CZ, CZX, CZ2, CZ2X, and Z. ach shipment of Survey LN3 will include six 4.0-mL liquid serum specimens. ach set of LDM ordered will consist of six 4.0-mL liquid serum specimens. TDM Calibration Verification/Linearity LN3 LN3 Acetaminophen Amikacin Carbamazepine Digoxin Gentamicin Lidocaine Lithium N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic acid Vancomycin CVL TDM VALIDATD MATRIAL (LDM) Survey LN5 corresponds to CAP Ligand Assay (General) Surveys K, KK, and KN. ach shipment of Survey LN5 will include five 4.0-mL liquid serum specimens. ach set of LLM ordered will consist of five 4.0-mL liquid serum specimens. Ligand Assay Calibration Verification/Linearity LN5 LN5 CA Cortisol Ferritin Folate Human chorionic gonadotropin (hcg) T3, total (Triiodothyronine) T4, total (Thyroxine) Thyroid-stimulating hormone (TSH) Vitamin B 12 CVL LIGAND ASSAY VALIDATD MATRIAL (LLM) College of American Pathologists 86 Calibration Verification/Linearity and Instrumentation

5 Urine Chemistry Calibration Verification/Linearity LN6 Amylase Calcium Chloride Creatinine Glucose Osmolality Phosphorus Potassium Protein, total Sodium Urea Uric acid Auto dilutor validation report LN6 LN6 participants are allowed to report auto diluted specimen results. A report will be provided that may be used to verify that the auto dilutor is working appropriately. Survey LN6 corresponds to CAP Urine Chemistry (General) Survey U. ach shipment of Survey LN6 will include mL liquid urine specimens. ach set of LUM ordered will consist of mL liquid urine specimens. CVL URIN CHMISTRY VALIDATD MATRIAL (LUM) Alpha-1-antitrypsin Complement C3 Complement C4 IgA IgG IgM Transferrin Immunology Calibration Verification/Linearity LN7 LN7 Survey LN7 corresponds to CAP Immunology (General) Survey IG. ach shipment of Survey LN7 will include five 2.0-mL liquid serum specimens Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 87

6 Option 1 for Customer Contact Center stradiol Follicle-stimulating hormone (FSH) Human chorionic gonadotropin (hcg) Luteinizing hormone (LH) Progesterone Prolactin Testosterone Reproductive ndocrinology Calibration Verification/Linearity LN8 LN8 Survey LN8 corresponds to CAP Ligand Assay (Special) Surveys Y and YY. ach shipment of Survey LN8 will include five 4.0-mL liquid serum specimens. Hematology Calibration Verification/Linearity LN9, LN9R LN9 LN9R Hemoglobin Platelet count RBC count WBC count Surveys LN9 and LN9R correspond to the CAP Basic Hematology and Hematology Automated Differentials Surveys H and FH series. Surveys LN9 and LN9R are compatible with all instruments. The Surveys provide an indicator of platelet accuracy at clinical decision levels. The specimens are designed to span the linear range of most automated hematology instruments. ach shipment of LN9 will include mL specimens. Survey LN9R will include all specimens in LN9 and four additional high vials for participants that need higher platelet and WBC ranges than currently available in Survey LN9. All vials have pierceable caps. 88 Calibration Verification/Linearity and Instrumentation College of American Pathologists

7 Serum thanol Calibration Verification/Linearity LN11, LN11R LN11 LN11R Serum thanol Surveys LN11 and LN11R correspond to the AACC/CAP Serum Alcohol/Volatiles Survey (AL2). ach shipment will contain six 3.0-mL liquid serum specimens. Survey LN11R will include all specimens in LN11 and one additional high vial for participants that need higher analyte ranges than currently available in Survey LN11. C-reactive Protein Calibration Verification/Linearity LN12 LN12 C-reactive protein ach shipment of Survey LN12 will include six 1.0-mL liquid serum specimens. Note: This Survey is not designed for reporting high-sensitivity C-reactive protein Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 89

8 Option 1 for Customer Contact Center Blood Gas/Critical Care Calibration Verification/Linearity LN13, LN13C LN13 LN13C PCO2 ph PO2 Calcium, ionized Chloride Glucose Lactate Magnesium, ionized Potassium Sodium Survey 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. ach shipment of Survey LN13 and LN13C will include ten 2.5-mL ampules of aqueous specimens (five in duplicate) for single instrument reporting. Whole Blood thanol Calibration Verification/Linearity LN14 LN14 thanol Survey LN14 corresponds to the AACC/CAP Alcohol/Volatiles Survey (AL1) for whole blood analysis of ethanol. ach shipment of Survey LN14 will include six 3.0-mL liquid whole blood specimens. 90 Calibration Verification/Linearity and Instrumentation College of American Pathologists

9 Glycohemoglobin Calibration Verification/Linearity LN15 LN15 Glycohemoglobin (HbA 1c ) Survey LN15 corresponds to the CAP GH2 Survey for glycohemoglobin. ach shipment of Survey LN15 will include six 0.7-mL liquid human whole blood specimens. Note: These specimens must be processed as patient specimens and tested immediately upon receipt. Homocysteine Calibration Verification/Linearity LN16 LN16 Homocysteine Survey LN16 corresponds to the CAP HMS Survey for homocysteine. ach shipment of Survey LN16 will include six 1.0-mL liquid serum specimens. Whole Blood Glucose Calibration/Verification Linearity LN17 LN17 Whole blood glucose Survey LN17 corresponds to the CAP WBG/WB2 Surveys for whole blood glucose. With each kit, you may report from ten different ancillary testing sites or instruments. ach shipment of Survey LN17 will include five 2.0-mL liquid whole blood specimens Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 91

10 Option 1 for Customer Contact Center Reticulocyte Calibration Verification/Linearity LN18, LN19 Instrument LN18 LN19 All instruments except Coulter GenS and LH700 series Coulter GenS and LH700 series Pierceable caps Survey LN18 corresponds to the CAP RT, RT2, RT3, and RT4 Surveys for all instruments except the Coulter GenS and LH700 series. Survey LN19 corresponds to the RT3 Survey for Coulter GenS and LH700 series users only. ach shipment of Surveys LN18 and LN19 will include five 1.0-mL red blood cell specimens. Microalbumin Calibration Verification/Linearity LN20 LN20 Microalbumin Creatinine Survey LN20 corresponds to CAP Urine Chemistry Survey U. ach shipment of Survey LN20 will include five 5.0-mL liquid urine specimens. High-sensitivity C-reactive protein High-Sensitivity C-reactive Protein Calibration Verification/Linearity LN21 LN21 Survey LN21 corresponds to the CAP High-Sensitivity C-reactive Protein Survey hscrp. ach shipment of Survey LN21 will include six liquid serum specimens. Survey LN21 is for high sensitivity methods only. 92 Calibration Verification/Linearity and Instrumentation College of American Pathologists

11 Flow Cytometry Calibration Verification/Linearity LN22 LN22 CD3+ CD3+/CD4+ CD3+/CD8+ Survey LN22 corresponds to the CAP Flow Cytometry Survey FL. ach shipment of LN22 will include seven 1.0-mL liquid whole blood specimens. Prostate-Specific Antigen Calibration Verification/Linearity LN23 LN23 Prostate-Specific Antigen Survey LN23 corresponds to the CAP Ligand Assay Survey K. ach shipment of LN23 will include twelve 1.0-mL liquid serum specimens. The first seven vials will consist of values specified at a range from ng/ml. Vials eight through twelve will consist of values specified at a range from ng/ml. Creatinine Accuracy Calibration Verification/Linearity LN24 LN24 Creatinine The LN24 Survey focuses on values for creatinine at the range from mg/dl. ach shipment of LN24 will consist of six 1.0-mL liquid fresh frozen serum specimens Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 93

12 Option 1 for Customer Contact Center Troponin I Troponin I Calibration Verification/Linearity LN25 LN25 Note: LN25 is now compatible with all instruments, including the Abbott AxSYM. Surveys LN25 corresponds to the CAP Troponins I and T Survey TRP. ach shipment of LN25 will consist of seven 2.0- ml liquid serum specimens. The specimens must be tested on the day of receipt. Troponin T Troponin T Calibration Verification/Linearity LN27 LN27 Survey LN27 corresponds to the CAP Troponins I and T Survey TRP. ach shipment of LN27 will consist of six 2.0-mL liquid serum specimens. The specimens must be tested on the day of receipt. 94 Calibration Verification/Linearity and Instrumentation College of American Pathologists

13 B-type Natriuretic Peptides Calibration Verification/Linearity LN30 LN30 BNP NT-pro BNP Survey LN30 corresponds to the CAP B-type Natriuretic Peptides Survey BNP. ach shipment of LN30 will include six 1.0-mL liquid plasma specimens for BNP and NT-pro BNP. A seventh 1.0-mL liquid plasma specimen will be included to test only for NT-pro BNP. Note: Linearity Surveys have linearity targets based on clinical relevance and general characteristics of currently available methods. These criteria may not be reflective of the specific characteristics of the currently available single dose unit technology methods. For customers using single dose unit technology, it is the laboratory's discretion to assess the appropriateness of the linearity targets when applied to this technology and to the clinical needs of their patients. LN30 ships on dry ice; test immediately upon receipt. Immunosuppressive Drugs Calibration Verification/Linearity LN31 Cyclosporine Tacrolimus LN31 Survey LN31 corresponds to the CAP Immunosuppressive Drugs CS Survey. ach shipment of LN31 will include seven 2.0-mL liquid whole blood hemolysate. Ammonia Ammonia Calibration Verification/Linearity LN32 LN32 ach shipment of LN32 will include seven 2.0-mL liquid serum specimens Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 95

14 Option 1 for Customer Contact Center Serum Myoglobin Calibration Verification/Linearity LN33 LN33 Myoglobin Survey LN33 corresponds to the CAP Cardiac Markers CARM, CRT, and CRTI Surveys for quantitative myoglobin. ach shipment of LN33 will include seven 1.0-mL liquid serum specimens. CA-125 CA-125 Calibration Verification/Linearity LN34 LN34 ach shipment of LN34 will include seven 3.0-mL liquid serum specimens. RRS Series 1 RRS2 Series 2 RRS RRS2 Alanine aminotransferase B-type Natriuretic Peptides (BNP) Albumin Pro B-type Natriuretic Peptides (NT-pro BNP) Amylase Chloride Aspartate aminotransferase CO 2 Bilirubin, total C-reactive Protein (CRP) Calcium Folate CK-MB Gamma Glutamyl Transferase (GGT) Creatinine Glucose Ferritin Potassium T 4, free (thyroxine, free) Sodium Iron Testosterone Lactate dehydrogenase Thrombin Time (TT) Magnesium Uric Acid Protein, total Urea T 4 (thyroxine) Vitamin B-12 Total iron binding capacity Thyroid stimulating hormone (TSH) Reference Range Service RRS, RRS2 96 Calibration Verification/Linearity and Instrumentation College of American Pathologists

15 Reference Range Service Series 3, Series 4 RRS3 RRS4 Alkaline 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 New The Reference Range Service (RRS, RRS2, RRS3, and RRS4) is designed for laboratories/laboratory networks to provide a method to establish and/or verify the validation of reference intervals based on the CLS1 Reference Range Protocol C28-A2, Vol. 15, No. 4 entitled, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline Second dition, nonparametric approach. Laboratories will be required to submit 20 results from normal/healthy individuals for each analyte. xclusionary criteria will be provided to facilitate identification of appropriate donors. In addition, the participating laboratory will submit 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 the Classification of Federal Data on Race and thnicity (Federal Register Notice, October 30, 1997). Laboratories participating in these programs will receive a summary report including the reference interval for each analyte for which 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 the minimum number of data sets are available per platform for analysis. In addition, laboratories will be provided with exclusionary criteria for potential donors. All donor results should be returned to the CAP for analysis, including those 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 to participate in this reference interval service. However, if the laboratory is in an instituion that requires IRB review to conduct reference interval studies, be advised that the deadline to return donor results to the CAP will be May Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 97

16 Option 1 for Customer Contact Center Instrumentation I Survey Shipment Instrument A B* C Spectrophotometer Linearity ph Meters: Buffers for ph measurements Wavelength and Photometric Calibration: Acid potassium dichromate solutions absorbance check, autodilutor check Holmium oxide peak absorbance Thomson 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 *Note: I-B Survey contains potassium dichromate, classified as a toxic chemical. Survey I is designed as an assessment tool for instruments not routinely challenged during the proficiency testing process. Linearity results (forward and reverse) for the spectrophotometer and microtiter plate reader are evaluated by 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 will require special handling. The kit instructions and the specimen vials will identify if any chemically hazardous material is present. 98 Calibration Verification/Linearity and Instrumentation College of American Pathologists

17 Creatinine hcg Lactate dehydrogenase (LD) Phenytoin Serum Carry Over Survey SCO SCO The Survey SCO is designed to help participants prove or disprove instrument sample probe carry over. Multiple kits may be purchased. ach shipment of SCO will consist of a 10.0-mL liquid serum specimen low vial and a 5.0-mL liquid serum high vial. The expiration date of this material is May 31, A calculation is provided in the kit instructions to assist the participants in determining their instrument sample probe carry over; therefore, data need not be returned to the CAP. Benzoylecgonine Delta-9-THC-COOH Opiates Propoxyphene Urine Toxicology Carry Over Survey UTCO UTCO The Survey UTCO is designed to help participants evaluate instrument sample probe carry over. Multiple kits may be purchased. ach shipment of UTCO will consist of a 40.0-mL liquid urine specimen low vial and a 40.0-mL liquid urine high vial. The expiration date of this material is May 31, A calculation is provided in the kit instructions to assist the participants in determining their instrument sample probe carry over; therefore, data need not be returned to the CAP Surveys & Anatomic Pathology ducation Programs Calibration Verification/Linearity and Instrumentation 99

18 Option 1 for Customer Contact Center Survey IFS is designed to assist participants in verifying manufacturing interference specifications and to investigate discrepant results caused by interfering substances such as bilirubin and hemoglobin. Multiple kits may be purchased. ach shipment of IFS will consist of twelve 10.0-mL liquid serum specimens. The expiration date of this material is June 30, Participants will receive their evaluations one week after the results have been received by the CAP. Interfering Substance Survey IFS Bilirubin Hemoglobin Interferent Interferent Alanine aminotransferase (ALT/SGPT) Albumin Alkaline phosphatase (ALP) Amylase Aspartate aminotransferase (AST/SGOT) Bilirubin, total Calcium Chloride CK 2 (MB) CO 2 Creatine Kinase (CK) Creatinine Gamma glutamyl transferase (GGT) Glucose Iron Lactate dehydrogenase (LD) Lipase Magnesium Osmolality Phosphorus Potassium Protein, total Sodium Urea Uric Acid College of American Pathologists 100 Calibration Verification/Linearity and Instrumentation