I asked TJC this question, and here is their response: Hi, In looking through the Standards it sounds clear we can't use expired reagents (QSA 2.14.1 EP5, QSA 2.13.1 EP8) and also that each vial needs to be tested each day of use. So my questions are: 1. For a blood bank that performs complicated antibody identification, are we allowed to develop a policy that allows for the use of expired reagents? These would not be for routine use, but only for complicated antibodies when indated reagents aren't available. 2. For antibody panel cells, are we required to test each vial each day of use? If yes, could you propose a viable plan for doing QC on an example panel of 12 cell with 15 or more identified antigens? Clearly to QC all of these vials would not be effective. Thank you The Joint Commission response: Question #1 Yes but only for complicated antibodies. The FDA [21CFR606.65(e)] still permits the use of “expired” reagents that are considered rare, like anti-U or anti-Le(a). It does not apply to reagents readily available like anti-K and so forth. The Joint Commission (and AABB) standards require that reagents (in-date or for only those rare cases stated above expired, if used) when used, perform as expected with regard to quality control. Question #2: Currently the Joint Commission standard addressed each vial of reagent should be qc’d, Standard QSA.05.06.01 EP 2 is written as follows: "Each day the procedure is performed, and when a new lot of reagents is first used, the laboratory tests each opened vial of antisera, reactive cells, and reagents for reactivity. The reactivity results are documented." The cells used for antibody identification are reagent red cells (reactive cells) . The standard requires quality control each day of patient testing. Regarding a recommended process, unfortunately, the Standards Interpretation Group does not maintain a database of examples or forms or best practices. We would recommend that you check with professional groups for guidelines and best practice such as the the AABB (American Association of Blood Banks). I hope you will find this information helpful. If you have additional questions, please visit our website and complete the online question submission form. Please indicate if you are accredited by The Joint Commission when completing the form. Here is the link to our website: https://web.jointcommission.org/sigsubmission/sigsubmissionform.aspx Please understand that full compliance with the intent of the standards may only be assessed during an onsite survey. Updates to The Joint Commission accreditation and certification requirements are published in the Perspectives Newsletter and via our weekly on-line newsletter. Your organization's Accreditation Coordinator has access to the Perspectives Newsletters. You may also sign up to receive the "Joint Commission Online" newsletter electronically via email by registering at the following website: http://www.jointcommission.org/thickbox/NewsletterSignUp.aspx?KeepThis=true&TB_iframe=true&height=480&width=640
