Transfusion Medicine - College of American Pathologists · Transfusion Medicine 155 2008 Surveys & Anatomic Pathology Education Programs.cap.org Procedure J J1 Challenges per Shipment

Transfusion Medicine 155

2008 Surveys & Anatomic Pathology Education Programs

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Procedure J J1 Challenges per ShipmentABO grouping ❚ ❚ 5Rh typing ❚ ❚ 5Antibody detection ❚ 5Antibody identification ❚ 5Compatibility testing ❚ 5Red blood cell antigen detection ❚ 1

Analytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).

Transfusion Medicine

Product InformationSurveys J and J1 are designed for pretransfusion testing by manual techniques. See the Transfusion MedicineAutomated Testing Survey (JAT) for automated instruments on page 156. For additional educational challenges tocomplement your proficiency testing, refer to Survey JE1 (see page 157).

For competency assessment of technologists’ ability to perform comprehensive pretransfusion testing, pleaserefer 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 correspondingserum 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 andonline learning assessment questions. All laboratory staff can participate individually and earn free CME/CE creditwithout leaving the laboratory.

Category 1 CME

CE

Transfusion Medicine (Comprehensive, Limited) J, J1

156 Transfusion Medicine

College of American Pathologists

800-323-4040 Option 1 for Customer Contact Center

Procedure JAT Challenges per ShipmentABO grouping ❚ 5Antibody detection ❚ 5Rh typing ❚ 5Antibody detection ❚ 5

Product InformationSurvey JAT is designed for automated blood banking instruments. For antibody identification and compatibility testingby manual techniques, refer to Survey J (see page 155). For additional educational challenges to complement yourproficiency testing, refer to Survey JE1 (see page 157).

For competency assessment of technologists’ ability to perform comprehensive pretransfusion testing, pleaserefer to Survey TMCA, Transfusion Medicine Competency Assessment–Comprehensive Transfusion Medicine.

Each shipment will include five specimens.

Transfusion Medicine Automated Testing JAT

Analyte CBT Challenges per ShipmentAbsolute CD34 ❚ 2Absolute CD3 ❚ 2Absolute CD45 ❚ 2Bacterial culture ❚ 2% CD34+ ❚ 2% CD45+ ❚ 2CFU-GM ❚ 2Fungal culture ❚ 2Hematocrit ❚ 2Hemoglobin ❚ 2Mononuclear cell count ❚ 2% CD3 ❚ 2Total nucleated cells ❚ 2Total nucleated red cells ❚ 2Viability ❚ 2WBC count ❚ 2

Cord Blood CBT

Product InformationEach shipment will include two specimens for the proficiency testing of assays required for the production of umbili-cal cord blood stem cell products.

New



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Program JE1 Challenges per ShipmentEducational challenge ❚ 1

Product InformationSurvey JE1 provides maximum educational benefits for laboratories performing comprehensive Transfusion Medicinetesting. 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 ABOgrouping, 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 andonline learning assessment questions. All laboratory staff can participate individually and earn free CME/CE creditwithout leaving the laboratory.

Product Fulfillment Group J

Category 1 CME

CE

Transfusion Medicine—Educational Challenges JE1

Procedure DAT Challenges per ShipmentDirect antiglobulin testing ❚ 3

Product InformationSurvey DAT is designed for laboratories performing direct antiglobulin testing as a stand-alone test or as part of anyof 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 bloodcell suspension.

For competency assessment of technologists’ ability to perform direct antiglobulin testing, please refer toSurvey TMCAD, Transfusion Medicine Competency Assessment–Direct Antiglobulin Test.

Direct Antiglobulin Testing DAT




Procedure TMCAD Challenges per ShipmentDirect antiglobulin testing ❚ 2

Product InformationSurvey 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. Intendedresponses will be mailed to participants approximately four weeks after receipt, enabling laboratory managers ordirectors 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.

Note: Shipments may be ordered individually.

Transfusion Medicine Competency Assessment–Direct Antiglobulin Test TMCAD

Procedure TMCA Challenges per ShipmentABO grouping ❚ 2Antibody detection ❚ 2Antibody identification ❚ 2Compatibility testing ❚ 2Rh typing ❚ 2

Product InformationSurvey TMCA is designed for laboratory directors and managers to assess the competency of their technical staff inperforming routine pretransfusion testing. Shipments may be ordered individually or for an entire year. Intendedresponses will be mailed to participants approximately four weeks after receipt, enabling laboratory managers ordirectors 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-mLcorresponding serum specimens, along with one donor 3.0-mL 3% red blood cell suspension.

Transfusion Medicine Competency Assessment—Comprehensive Transfusion Medicine TMCA




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Procedure TMCAF Challenges per ShipmentKleihauer-Betke ❚ 2Fetal Screen ❚ 2

Product InformationSurvey 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 qualitativehemoglobin F: E-rosette testing for D(Rho) fetal red blood cells in the maternal circulation; and for quantitativehemoglobin F: Kleihauer-Betke and flow cytometry methods. Shipments may be ordered individually or for an entireyear. 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 SurveyTMCAF will contain two 1.2-mL specimens of stabilized red blood cell suspensions.


Transfusion Medicine Competency Assessment– Fetal Red Cell Quantitation TMCAF

Analyte/Procedure HBF Challenges per ShipmentF cell value ❚ 2Hemoglobin F, qualitative (fetal screen) ❚ 2Hemoglobin F, quantitative ❚ 2

Product InformationThe F cell value is compatible with flow cytometry methods. Qualitative (screen) Hemoglobin F is compatible with E-rosette testing for D(Rho) 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 toSurvey TMCAF, Transfusion Medicine Competency Assessment–Fetal Red Cell Quantitation.

Fetal Red Cell Determination HBF




Procedure SCP Challenges per ShipmentAbsolute CD3 ❚ 2Absolute CD34 ❚ 2Bacterial culture ❚ 2% CD34+ ❚ 2% CD45 ❚ 2CFU-GM ❚ 2Fungal culture ❚ 2Hematocrit ❚ 2Mononuclear cell count ❚ 2% CD3 ❚ 2Total nucleated cells ❚ 2Total nucleated red cells ❚ 2Viability ❚ 2WBC count ❚ 2

Product InformationSurvey SCP is designed for laboratories processing and handling stem cells. The Survey will assess each laboratory’sability to determine if a stem cell product is suitable for use based on the results of the above analytes. The Surveywill contain two specimens of peripheral blood for laboratory analysis.

Stem Cell Processing SCP

Procedure PS Challenges per ShipmentAntibody detection ❚ 3Platelet crossmatch ❚ 3

Product InformationSurvey 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 resultsof an antibody screen. Note: A low concentration of sodium azide may be present in the specimens and mayaffect lymphocytotoxicity methods. Each shipment will include three 3.0-mL plasma specimens. This material iscompatible with solid-phase red cell adherence, flow cytometry, EIA/ELISA, and RIA methods.

Platelet Serology PS



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Procedure TRC Challenges per ShipmentPlatelet count (Platelet-Rich Plasma) ❚ 5WBC count (Leukocyte-Reduced Platelet Suspension) ❚ 2WBC count (Leukocyte-Reduced Red Blood Cell Suspension) ❚ 2

Product InformationSurvey 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 automatedplatelet 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 materialsmust 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.

Transfusion-Related Cell Count TRC

Analyte VMC Challenges per ShipmentAlanine aminotransferase (ALT/SGPT) ❚ 5Cholesterol ❚ 5Protein, total ❚ 5

Product InformationSurvey 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.

Viral Marker Chemistry VMC




Analyte/Procedure ABT ABT1 ABT2 Challenges per ShipmentAnti-A Titer ❚ ❚ 1Anti-D Titer ❚ ❚ 1

Product InformationSurvey 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 A2 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 bloodcell 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 plasmaspecimen for anti-D titer, with one corresponding titer cell (3% red blood cell suspension).

Antibody Titer ABT, ABT1, ABT2

Procedure ELU Challenges per ShipmentAntibody elution ❚ 2

Product InformationSurvey 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.

Eluate Survey ELU

Transfusion-Transmitted Viruses 163


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Analyte VM1 Challenges per ShipmentAnti-HAV, IgM ❚ 5Anti-HAV, total ❚ 5Anti-HBc, IgM ❚ 5Anti-HBc, total ❚ 5Anti-HBs ❚ 5Anti-HCV ❚ 5Anti-HIV-1 ❚ 5Anti-HIV-1/2 ❚ 5Anti-HIV-2 ❚ 5HBsAg ❚ 5

Transfusion-Transmitted Viruses

Product InformationSurvey VM1 is designed for laboratories performing general viral marker testing. Reporting areas for HIV-1 and HIV-2Western 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 SurveysRHIV, RHIVW, AHIV, or AHIVW (page 165) if using a rapid kit.

Product Fulfillment Group VM

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 bloodand diagnostic clinical patient samples for serologic markers of hepatitis and other transfusion-related diseases, as well asfor 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 appropriatefor your laboratory’s needs, contact a CAP Customer Contact Center Representative at 800-323-4040 option 1.

AABB/CAP Viral Markers—Series 1 VM1

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.

164 Transfusion-Transmitted Viruses



Analyte VM2 Challenges per ShipmentAnti-HBe ❚ 5HBeAg ❚ 5

Product InformationEach shipment will include five 3.5-mL liquid serum specimens.


Analyte VM3 Challenges per ShipmentAnti-CMV ❚ 3Anti-HTLV-I/II ❚ 3HIV-1 p24 antigen ❚ 3

Product InformationReporting areas for HTLV-I Western Blot testing will be provided. Each shipment will include three 3.5-mL liquidserum specimens.




Analyte VM4 Challenges per ShipmentAnti-Trypanosoma cruzi (Chagas Disease) ❚ 2

Product InformationEach shipment will include two 1.0 mL specimens for the qualitative detection of antibodies to T. cruzi.


Viral Markers—Series 4 VM4New

Transfusion-Transmitted Viruses 165


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Analyte AHIV AHIVW Challenges per ShipmentAnti-HIV-1/2 ❚ 5Anti-HIV-1/2, waived ❚ 2

Product InformationSurvey AHIV is designed for laboratories performing anti-HIV-1/2 testing using a rapid method. Survey AHIVW isdesigned 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-1/2 AHIV, AHIVW

Analyte RHIV RHIVW Challenges per ShipmentAnti-HIV-1 ❚ 5Anti-HIV-1, waived ❚ 2

Product InformationSurvey RHIV is designed for laboratories performing anti-HIV-1 testing using a rapid method. Survey RHIVW isdesigned for laboratories performing anti-HIV-1 using a waived method; space is provided for reporting anti-HIV-1results 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 byOraSure Technologies and the Uni-Gold™ Recombigen® HIV kit by Trinity Biotech. Survey RHIV is compatiblewith the MedMira Reveal™ HIV-1 Antibody Test kit.

Anti-HIV-1 RHIV, RHIVW

Procedure NAT Challenges per ShipmentNucleic acid testing for HBV ❚ 5Nucleic acid testing for HIV ❚ 5Nucleic acid testing for HCV ❚ 5Nucleic acid testing for West Nile Virus ❚ 5

Product InformationSurvey NAT is designed for blood donor centers currently performing HBV, HCV, WNV, and/or HIV nucleic acid testingon donor units. Results will be reported qualitatively.

Each shipment will include five 6.0-mL plasma specimens.

Nucleic Acid Testing NAT

166 Parentage/Relationship Testing



Analyte/Procedure PAR PARF Challenges per ShipmentCalculation challenge ❚ ❚ 1DNA testing (PCR) ❚ ❚ 4

Product InformationEach shipment of Survey PAR will include three liquid whole blood paternity trio specimens. Survey PARF will includethree blood-stained filter paper paternity trio specimens. A buccal swab will be provided for a second alleged fatherchallenge in Surveys PAR and PARF. Participants may report results for short tandem repeats (STRs), Y-STRs, as wellas the conclusions. Note: The calculation exercise is a paper challenge.

Parentage/Relationship TestingAnalytes/procedures in bold type are regulated for proficiency testing by the Centers for Medicare & Medicaid Services (CMS).

AABB/CAP Parentage/Relationship Testing PAR, PARF

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Transfusion Medicine - College of American Pathologists · Transfusion Medicine 155 2008 Surveys & Anatomic Pathology Education Programs.cap.org Procedure J J1 Challenges per Shipment