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SECTION III: IMMUNOHEMATOLOGY AND TRANSFUSION SERVICESTS 12 RAre the recorder charts initialed, dated and retained?TS 13 RDoes an audible alarm sound indicating a power failure or other disruption of refrigeration?TS 14 RAre written procedures in place permitting immediate corrective action to occur 24 hours a day in response to anaudible alarm?TS 15 RAre alarm checks performed and documented that verify the temperature at which the audible refrigeration alarmwill sound?TS 16 RAre explanations for temperature deviations documented?TS 17 EAre all blood and blood components stored and shipped at the required temperatures according to applicable FDAguidelines at 21 CFR 610?Guidelines specify:• Whole blood and red blood cell components and liquid plasma — stored between 1-6 degrees C and shipped at1-10 degrees C.• Frozen RBC’s — stored at minus 65 degrees C.• Fresh frozen plasma(FFP) — stored and shipped at -18 degrees C. If needed for coagulation factors, should transfusewithin 24 hours.. Thaw at 30-37 degrees C. and kept at 1-6 degrees C. in the interim prior to transfusion.• Cryoprecipitated Antihemophiliac Factor Human (AFH) — stored and shipped at -18 degrees C. If needed for factorVIII, should transfuse within 6 hours. Thaw at 30-37 degrees C. and held at room temperature in the interim.• Platelets and Platelet-rich plasma — stored and shipped at 20-24 degrees C. or 1-6 degrees C. Blood or plasmashould be held at 20-24 degrees C. prior to separation of platelets that should be done within 4 hours of collection.Once separated, they should be continuously maintained at either 1-6 degrees C. or 20-24 degrees C. If stored at 20-24 degrees C., a continuous gentle agitation (or rocking) must be maintained throughout the storage period.Agitation is optional at 1-6 degrees C.TS 18 RAre special areas defined for the storage of blood and blood components that avoid contamination or exposureto hazardous materials?TS 19 RAre areas clearly designated for the storage of available, crossmatched, quarantined, autologous and directedunits?3-98. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
SECTION III: IMMUNOHEMATOLOGY AND TRANSFUSION SERVICES>TS 20 RIs the maintenance of the proper storage temperatures of blood or blood components assured when units are heldoutside of the laboratory’s control (E.g. ICU, ER, or OR)?This requires a method of assuring that once units are released for transfusion they are used promptly or stored appropriately,then returned to the lab in a timely fashion thus suitable for reissue.TS 21 RDo the containers used for the transport of blood and blood components assure maintenance of the desiredtemperatures during shipping?Record periodic checks performed to verify their capacity to maintain required temperatures.TS 22 RAre all blood and blood components promptly disposed of after the product’s expiration date has passed andretention for further testing is not required and is there a record of disposal?TS 23 RIs there documentation of the visual inspection of units of blood and blood components prior to shipment orrelease for transfusion?Quality ControlTS 24 EAre ABO antisera checked with a positive control each day of use and are the results documented?An easy way to do QC on ABO reagent red cells (antigens) and ABO reagent antisera (antibodies) is to use each to QCthe other. By reacting A cells with anti-A and anti-B and B cells with anti-A and anti-B, you have successfully crosscheckeach reagent.TS 25 EAre Rh antisera checked with positive and negative controls each day of use and are the results documented?TS 26 EIf the laboratory uses a protein based Rh antisera, is a special protein based control reagent, similar to theformulation of the Rh antisera in use, performed to detect possible false positive Rh tests and are the results ofthis testing documented?There are different types of Rh Antisera. The most common reagents presently in use are saline based, monoclonalantisera. These products do not require the use of a separate control to detect false positive Rh tests.Laboratories still using a protein based antisera, should consult the manufacturer’s instructions for selection of aprotein based reagent that matches the formulation of the Rh antisera in use. The laboratory will incubate patientcells with the protein based reagent to detect spontaneous agglutination that may contribute to a false positive result.The patient’s Rh test and the control procedure described above must be performed simultaneously.TS 27 EAre all other antisera in use checked with positive and negative controls each day of use and are the resultsdocumented?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .© 2007 COLA FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org3-99
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COLA LABORATORYACCREDITATION MANUAL
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TABLE OF CONTENTS>I Introduction to
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SECTION I: INTRODUCTION TO ACCREDIT
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SECTION II: THE ROAD TO ACCREDITATI
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SECTION III: COLA CRITERIA FOR QUAL
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SECTION V: APPENDIX>DIRECTOR1. Lice
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