SMILE Johns Hopkins University Baltimore, MD USA Centrifuge Calibration Verification for Platelet Poor Plasma- Guidelines Guideline Number Equ12-04-G Effective Date 20-Oct-08 Page 1 of 1 Centrifuge Calibration Verification Supersedes New Review by Review date 9-Feb-12 Centrifuge Calibration Verification for Platelet Poor Plasma Subject Heidi Hanes SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE. CAP Accreditation Checklist: 1. Limited service laboratory checklist manual, Coagulation Specimen Handling. Background Information: Plasma used for coagulation studies must be platelet-poor. Centrifuge speed and duration must be established by the laboratory to ensure platelet counts are less than 10,000/uL. These parameters should be validated every six months or after repair or preventive maintenance of the centrifuge. Resources 1. College of American Pathologists (CAP) 2006. Commission on Laboratory Accreditation, Laboratory Accreditation Program; Limited Service Laboratory Checklist manual (Revised 2007). 2. CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays, Vol. 28, No 5, fifth Edition, January 2008. 533563218 Version#: 1.0 Page 1 of 5 SMILE Johns Hopkins University Baltimore, MD USA Centrifuge Calibration Verification for Platelet Poor Plasma Heidi Hanes, BS, MT, (ASCP) Author(s), Name SH & Title QA/QC International Coordinator Document Number Effective Date Equ12-04-SOP 20-Oct-08 Name, Title Signature Date Name, Title Signature Date Approved By SOP Annual Review Revision History Version # [1.0] Revision Date [dd/mm/yy] Name (or location) Description (notes) # of copies Distributed Copies to 533563218 Version#: 1.0 Page 2 of 5 Name (or location) # of copies SMILE Johns Hopkins University Baltimore, MD USA I acknowledge that I have read, understand and agree to follow this SOP Name (print) 533563218 Version#: 1.0 Signature Page 3 of 5 Date SMILE Johns Hopkins University Baltimore, MD USA Centrifuge Calibration Verification for Platelet Poor Plasma Purpose This procedure provides instructions and guidelines for validation of centrifuge time and speed for producing platelet-poor plasma for coagulation testing. Analytic Procedure Specimen Information: N/A Reagents/Media: N/A Precautions: Standard precautions should be used while working with any instrument or specimen, refer to laboratory safety procedure (enter the number of your lab’s Safety SOP). Supplies/Equipment 1. Centrifuge 2. Citrated plasma specimens (can be a previously sampled tube or newly drawn at the correct filling content (1:9 ratio of sodium citrate to blood) 3. Tube Size – Use the Sodium citrate (blue-top) tube that is standard for your institution. 4. Hematology instrument to read platelet counts Centrifuge Verification Maintenance: (Note: Procedure can be written in regular step by step format, the use of table form is not necessary.) Step Action 1 Centrifuges used in the laboratory are to be considered as contaminated and should only be handled with gloves and other personal protective equipment and/or thoroughly disinfected before calibration verification. 2 5 If specimens were previously spun mix tubes to disperse cells to simulate un-spun patient blood. Spin at least two citrated specimens at a time in order to balance the centrifuge. After centrifugation, carefully test the upper portion of the plasma on the hematology instrument. Record platelet value on Centrifuge Plasma Check Log. (Appendix B) 6 3 4 7 533563218 Repeat steps 2 through 4 two more times. If Then Platelets <10,000/uL Document time, speed, and average platelet value on Centrifuge daily log.(Appendix A) Version#: 1.0 Page 4 of 5 SMILE Johns Hopkins University Baltimore, MD USA Platelets >10,000/uL 8 Change time or speed until platelet results are less than 10,000/uL. Document time, speed and average platelet value on Centrifuge Preventative log. (Appendix A) Repeat steps 1 though 6 for all centrifuges used for spinning coagulation specimens. Interpretation of Results: All platelets results should be under 10,000/uL. Speed and/or timing should be adjusted until the desired platelet result is obtained. Centrifuge Verification for platelet poor plasma should be performed every six months or after major repairs. References: 1. Joint Commission on Accreditation of Healthcare Organizations, How to Meet the Most Frequently Cited Laboratory Standards1996, Oakbrook Terrace, IL. 2. CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays, Vol. 28, No 5, fifth Edition, January 2008. Appendices A. Appendix A - Example of Centrifuge Preventative Maintenance/Quality Control Log B. Appendix B – Example of Centrifuge Plasma Check Log. 533563218 Version#: 1.0 Page 5 of 5