Transfusion Medicine (Comprehensive, Limited) J, J1

Transcription

1 Transfusion Medicine Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS). Transfusion Medicine (Comprehensive, Limited) J, J1 Procedure J J1 Challenges per Shipment ABO grouping 5 Rh typing 5 Antibody detection 5 Antibody identification 5 Compatibility testing 5 Red blood cell antigen detection 1 Category 1 CME CE Surveys J and J1 are designed for pretransfusion testing by manual techniques. See the Transfusion Medicine Automated Testing Survey (JAT) for automated instruments on page 156. For additional educational challenges to complement your proficiency testing, refer to Survey JE1 (see page 157). For competency assessment of technologists ability to perform comprehensive pretransfusion testing, please refer to Survey TMCA, Transfusion Medicine Competency Assessment Comprehensive Transfusion Medicine. Each shipment will include five 2.0-mL specimens of a 3% red blood cell suspension and five 3.0-mL corresponding serum specimens. Survey J shipments will also include one 2.0-mL donor red blood cell suspension. An education activity is planned that includes reading material found in the Participant Summary/Final Critique and online learning assessment questions. All laboratory staff can participate individually and earn free CME/CE credit without leaving the laboratory Surveys & Anatomic Pathology Education Programs Transfusion Medicine 155

2 Option 1 for Customer Contact Center New Cord Blood CBT Analyte CBT Challenges per Shipment Absolute CD34 2 Absolute CD3 2 Absolute CD45 2 Bacterial culture 2 % CD34+ 2 % CD45+ 2 CFU-GM 2 Fungal culture 2 Hematocrit 2 Hemoglobin 2 Mononuclear cell count 2 % CD3 2 Total nucleated cells 2 Total nucleated red cells 2 Viability 2 WBC count 2 Each shipment will include two specimens for the proficiency testing of assays required for the production of umbilical cord blood stem cell products. Transfusion Medicine Automated Testing JAT Procedure JAT Challenges per Shipment ABO grouping 5 Antibody detection 5 Rh typing 5 Antibody detection 5 Survey JAT is designed for automated blood banking instruments. For antibody identification and compatibility testing by manual techniques, refer to Survey J (see page 155). For additional educational challenges to complement your proficiency testing, refer to Survey JE1 (see page 157). For competency assessment of technologists ability to perform comprehensive pretransfusion testing, please refer to Survey TMCA, Transfusion Medicine Competency Assessment Comprehensive Transfusion Medicine. Each shipment will include five specimens. 156 Transfusion Medicine College of American Pathologists

3 Direct Antiglobulin Testing DAT Procedure DAT Challenges per Shipment Direct antiglobulin testing 3 Survey DAT is designed for laboratories performing direct antiglobulin testing as a stand-alone test or as part of any of the following work-ups: pretransfusion compatibility testing, transfusion reaction, autoimmune hemolytic anemia, and/or hemolytic disease of the newborn. Each shipment will include three 2.0-mL specimens of a 3-4% red blood cell suspension. For competency assessment of technologists ability to perform direct antiglobulin testing, please refer to Survey TMCAD, Transfusion Medicine Competency Assessment Direct Antiglobulin Test. Transfusion Medicine Educational Challenges JE1 Program JE1 Challenges per Shipment Educational challenge 1 Category 1 CME CE Survey JE1 provides maximum educational benefits for laboratories performing comprehensive Transfusion Medicine testing. A variety of Transfusion Medicine challenges comprise Survey JE1. These may include, but are not limited to, paper challenges, serum specimens for antibody detection and identification, red blood cell suspensions for ABO grouping, Rh typing, and direct antiglobulin testing, and/or 35mm slide challenges. An education activity is planned that includes reading material found in the Participant Summary/Final Critique and online learning assessment questions. All laboratory staff can participate individually and earn free CME/CE credit without leaving the laboratory. Product Fulfillment Group J 2008 Surveys & Anatomic Pathology Education Programs Transfusion Medicine 157

4 Option 1 for Customer Contact Center Transfusion Medicine Competency Assessment Comprehensive Transfusion Medicine TMCA Procedure TMCA Challenges per Shipment ABO grouping 2 Antibody detection 2 Antibody identification 2 Compatibility testing 2 Rh typing 2 Note: Shipments may be ordered individually. Survey TMCA is designed for laboratory directors and managers to assess the competency of their technical staff in performing routine pretransfusion testing. Shipments may be ordered individually or for an entire year. Intended responses will be mailed to participants approximately four weeks after receipt, enabling laboratory managers or directors to perform an evaluation of technologist performance. Each shipment of Survey TMCA will contain two 2.0-mL specimens of a 3% red blood cell suspension and two 3.0-mL corresponding serum specimens, along with one donor 3.0-mL 3% red blood cell suspension. Transfusion Medicine Competency Assessment Direct Antiglobulin Test TMCAD Procedure TMCAD Challenges per Shipment Direct antiglobulin testing 2 Note: Shipments may be ordered individually. Survey TMCAD is designed for laboratory directors and managers to assess the competency of their technical staff in performing direct antiglobulin testing. Shipments may be ordered individually or for an entire year. Intended responses will be mailed to participants approximately four weeks after receipt, enabling laboratory managers or directors to perform an evaluation of technologist performance. Each shipment of Survey TMCAD will contain two 2.0-mL specimens of a 3-4% red blood cell suspension. 158 Transfusion Medicine College of American Pathologists

5 Fetal Red Cell Determination HBF Analyte/Procedure HBF Challenges per Shipment F cell value 2 Hemoglobin F, qualitative (fetal screen) 2 Hemoglobin F, quantitative 2 The F cell value is compatible with flow cytometry methods. Qualitative (screen) Hemoglobin F is compatible with E-rosette testing for D(Rh o ) fetal red blood cells in the maternal circulation. Quantitative Hemoglobin F is compatible with Kleihauer-Betke and flow cytometry methods. Each shipment will include two 1.2-mL liquid stabilized red blood cell specimens. For competency assessment of technologists ability to perform fetal red cell quantitation, please refer to Survey TMCAF, Transfusion Medicine Competency Assessment Fetal Red Cell Quantitation. Transfusion Medicine Competency Assessment Fetal Red Cell Quantitation TMCAF Procedure TMCAF Challenges per Shipment Kleihauer-Betke 2 Fetal Screen 2 Note: Shipments may be ordered individually. Survey TMCAF is designed for laboratory directors and managers to assess the competency of their technical staff in performing qualitative and/or quantitative tests for hemoglobin F. Compatible methods include: for qualitative hemoglobin F: E-rosette testing for D(Rh o ) fetal red blood cells in the maternal circulation; and for quantitative hemoglobin F: Kleihauer-Betke and flow cytometry methods. Shipments may be ordered individually or for an entire year. Intended responses will be mailed to participants approximately four to six weeks after kit receipt, enabling laboratory managers or directors to perform a self-evaluation of technologist performance. Each shipment of Survey TMCAF will contain two 1.2-mL specimens of stabilized red blood cell suspensions Surveys & Anatomic Pathology Education Programs Transfusion Medicine 159

6 Option 1 for Customer Contact Center Platelet Serology PS Procedure PS Challenges per Shipment Antibody detection 3 Platelet crossmatch 3 Survey PS participants will crossmatch each plasma specimen provided with ten units of platelets from their institution and report the percentage of units that are serologically incompatible. Participants will also report results of an antibody screen. Note: A low concentration of sodium azide may be present in the specimens and may affect lymphocytotoxicity methods. Each shipment will include three 3.0-mL plasma specimens. This material is compatible with solid-phase red cell adherence, flow cytometry, EIA/ELISA, and RIA methods. Stem Cell Processing SCP Procedure SCP Challenges per Shipment Absolute CD3 2 Absolute CD34 2 Bacterial culture 2 % CD34+ 2 % CD45 2 CFU-GM 2 Fungal culture 2 Hematocrit 2 Mononuclear cell count 2 % CD3 2 Total nucleated cells 2 Total nucleated red cells 2 Viability 2 WBC count 2 Survey SCP is designed for laboratories processing and handling stem cells. The Survey will assess each laboratory s ability to determine if a stem cell product is suitable for use based on the results of the above analytes. The Survey will contain two specimens of peripheral blood for laboratory analysis. 160 Transfusion Medicine College of American Pathologists

7 Viral Marker Chemistry VMC Analyte VMC Challenges per Shipment Alanine aminotransferase (ALT/SGPT) 5 Cholesterol 5 Protein, total 5 Survey VMC is designed for laboratories performing viral markers testing and alanine aminotransferase, cholesterol, or total protein testing. Each shipment will include five 5.0-mL liquid plasma specimens. Transfusion-Related Cell Count TRC Procedure TRC Challenges per Shipment Platelet count (Platelet-Rich Plasma) 5 WBC count (Leukocyte-Reduced Platelet Suspension) 2 WBC count (Leukocyte-Reduced Red Blood Cell Suspension) 2 Survey TRC provides Hematology and/or Transfusion Medicine laboratories with proficiency testing material for various cell count procedures. The Platelet-Rich Plasma material can be utilized for both manual and automated platelet count methods. The Leukocyte-Reduced Red Blood Cell suspensions and Leukocyte-Reduced Platelet suspensions provide laboratories with an opportunity to assess their ability to perform low white blood cell (WBC) counts. Note: The Leukocyte-Reduced Red Blood Cell and the Leukocyte-Reduced Platelet materials must be used with a Nageotte chamber or flow cytometry. Each shipment will include five 1.2-mL suspensions of stabilized mammalian Platelets (Platelet-Rich Plasma), two 1.0-mL vials containing a Leukocyte-Reduced Red Blood Cell material, and two 1.0-mL vials containing a Leukocyte-Reduced Platelet material Surveys & Anatomic Pathology Education Programs Transfusion Medicine 161

8 Option 1 for Customer Contact Center Eluate Survey ELU Procedure ELU Challenges per Shipment Antibody elution 2 Survey ELU is designed for laboratories performing antibody elutions (for non-abo antibodies) as a part of an antibody identification workup or direct antiglobulin test. Each shipment will include two 2.0-mL 50% red blood cell suspension specimens for use in performing antibody elutions. Antibody Titer ABT, ABT1, ABT2 Analyte/Procedure ABT ABT1 ABT2 Challenges per Shipment Anti-A Titer 1 Anti-D Titer 1 Survey ABT is designed for laboratories performing red cell antibody titers as a part of any of the following workups: a prenatal antibody quantification workup; the management of recipients of ABO incompatible bone marrow transplants; to determine eligibility of O or B kidney transplant recipient candidates for receiving an A 2 kidney; and/or to assess the need and monitor the effect of plasma exchange in transplant recipients who are ABO incompatible with their donors. Survey ABT1 is designed for laboratories performing titers for Anti-A. Survey ABT2 is designed for laboratories performing titers for Anti-D. Laboratories ordering Surveys ABT, ABT1, or ABT2 will be able to report using a variety of techniques. Each shipment of Survey ABT will include one plasma specimen for anti-d titer with one corresponding titer cell (3% red blood cell suspension) and one plasma specimen for anti-a titer with one corresponding titer cell (3% red blood cell suspension). Each shipment of Survey ABT1 will include one plasma specimen for anti-a titer with one corresponding titer cell (3% red blood cell suspension). Each shipment of Survey ABT2 will include one plasma specimen for anti-d titer, with one corresponding titer cell (3% red blood cell suspension). 162 Transfusion Medicine College of American Pathologists

9 Transfusion-Transmitted Viruses Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS). The CAP and AABB provide jointly sponsored proficiency testing programs for laboratories involved in testing donor blood and diagnostic clinical patient samples for serologic markers of hepatitis and other transfusion-related diseases, as well as for parentage testing. These programs include Viral Marker Series 1, Series 2, and Series 3 (Surveys VM1, VM2, and VM3), and the Parentage Testing Programs (PAR, PARF). For assistance in determining which Viral Marker Series is appropriate for your laboratory s needs, contact a CAP Customer Contact Center Representative at option 1. AABB/CAP Viral Markers Series 1 VM1 Analyte VM1 Challenges per Shipment Anti-HAV, IgM 5 Anti-HAV, total 5 Anti-HBc, IgM 5 Anti-HBc, total 5 Anti-HBs 5 Anti-HCV 5 Anti-HIV-1 5 Anti-HIV-1/2 5 Anti-HIV-2 5 HBsAg 5 Survey VM1 is designed for laboratories performing general viral marker testing. Reporting areas for HIV-1 and HIV-2 Western Blot testing will be provided. Each shipment will include five 3.5-mL liquid serum specimens. Note: Survey VM1 material is not compatible with rapid anti-hiv-1 or anti-hiv1/2 kits. Please enroll in Surveys RHIV, RHIVW, AHIV, or AHIVW (page 165) if using a rapid kit. Product Fulfillment Group VM Handle with Care Specimens included in this section may contain pathogens and must be handled with extreme care. These specimens must be dealt with and disposed of only by trained laboratory personnel. Treat specimens as though they are capable of transmitting hepatitis and/or other blood-borne diseases Surveys & Anatomic Pathology Education Programs Transfusion-Transmitted Viruses 163

10 Option 1 for Customer Contact Center AABB/CAP Viral Markers Series 2 VM2 Analyte VM2 Challenges per Shipment Anti-HBe 5 HBeAg 5 Each shipment will include five 3.5-mL liquid serum specimens. Product Fulfillment Group VM AABB/CAP Viral Markers Series 3 VM3 Analyte VM3 Challenges per Shipment Anti-CMV 3 Anti-HTLV-I/II 3 HIV-1 p24 antigen 3 Reporting areas for HTLV-I Western Blot testing will be provided. Each shipment will include three 3.5-mL liquid serum specimens. Product Fulfillment Group VM New Viral Markers Series 4 VM4 Analyte VM4 Challenges per Shipment Anti-Trypanosoma cruzi (Chagas Disease) 2 Each shipment will include two 1.0 ml specimens for the qualitative detection of antibodies to T. cruzi. Product Fulfillment Group VM 164 Transfusion-Transmitted Viruses College of American Pathologists

11 Anti-HIV-1/2 AHIV, AHIVW Analyte AHIV AHIVW Challenges per Shipment Anti-HIV-1/2 5 Anti-HIV-1/2, waived 2 Survey AHIV is designed for laboratories performing anti-hiv-1/2 testing using a rapid method. Survey AHIVW is designed for laboratories performing anti-hiv-1/2 testing using a waived method; space will be provided for reporting anti-hiv-1/2 for up to five different locations within your institution. Anti-HIV-1 RHIV, RHIVW Analyte RHIV RHIVW Challenges per Shipment Anti-HIV-1 5 Anti-HIV-1, waived 2 Survey RHIV is designed for laboratories performing anti-hiv-1 testing using a rapid method. Survey RHIVW is designed for laboratories performing anti-hiv-1 using a waived method; space is provided for reporting anti-hiv-1 results for up to five different locations within your institution. Note: Both Survey RHIV and RHIVW are compatible with the OraQuick Rapid HIV-1 Antibody Test kit by OraSure Technologies and the Uni-Gold Recombigen HIV kit by Trinity Biotech. Survey RHIV is compatible with the MedMira Reveal HIV-1 Antibody Test kit. Nucleic Acid Testing NAT Procedure NAT Challenges per Shipment Nucleic acid testing for HBV 5 Nucleic acid testing for HIV 5 Nucleic acid testing for HCV 5 Nucleic acid testing for West Nile Virus 5 Survey NAT is designed for blood donor centers currently performing HBV, HCV, WNV, and/or HIV nucleic acid testing on donor units. Results will be reported qualitatively. Each shipment will include five 6.0-mL plasma specimens Surveys & Anatomic Pathology Education Programs Transfusion-Transmitted Viruses 165

12 Option 1 for Customer Contact Center Parentage/Relationship Testing Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS). AABB/CAP Parentage/Relationship Testing PAR, PARF Analyte/Procedure PAR PARF Challenges per Shipment Calculation challenge 1 DNA testing (PCR) 4 Each shipment of Survey PAR will include three liquid whole blood paternity trio specimens. Survey PARF will include three blood-stained filter paper paternity trio specimens. A buccal swab will be provided for a second alleged father challenge in Surveys PAR and PARF. Participants may report results for short tandem repeats (STRs), Y-STRs, as well as the conclusions. Note: The calculation exercise is a paper challenge. 166 Parentage/Relationship Testing College of American Pathologists