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Hello everyone, The FDA has put out Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility.http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm072560.htm?source=govdelivery D. Scope of Validation “Your activities should assure that the system components have been validated and are suitable for your specific operations and workload and can accurately and repeatedly meet your needs (as defined in your requirements documents). You should validate your system at your location using the same software, hardware, SOPs, and personnel who will use the system after it is formally implemented. Thus, in cases where a central server is used by multiple locations, not only the main server but also each individual location should have a validation plan that is specific to the functions and configurations at each location. Equipment vendors may provide assistance for equipment qualification and consultants may provide assistance with the validation project. However, you are ultimately responsible for validation of your system in your facility. Validation of your BECS falls under your Current Good Manufacturing Practice (cGMP) requirements and should reflect and anticipate the BECS’ actual use in your establishment. We recognize that it is a common practice for software manufacturers to provide test cases to blood establishments for use in system validation. We recommend that you carefully assess the software manufacturer’s test cases, consider your own intended use of the software, your internal policies and procedures, and add or change test plans as appropriate to ensure that the software will accurately and repeatedly meet your requirements. The test cases should include those that represent “worst case scenarios,” e.g., maximum numbers of users working simultaneously, all possible activities occurring simultaneously, etc. We recognize that BECS validation is difficult because you cannot test indefinitely, and it is hard to determine how much evidence is sufficient. Generally, software validation is a matter of developing a “level of confidence” (Ref. 1) that the software device meets all requirements and user expectations for the automated functions and features of the software.” FDA, April 2013 We have in the past used an outside company to provide validation services for us. With limited staffing we don’t have the time or expertise to complete this testing at least not on our initial conversion. We are due to upgrade soon and wondering; everyone’s take on this new Guidance. Our Validation Company does not come on site; I know that they will be an additional cost if they do. Any comments or suggestion would be helpful. Should we us any outside company or not?

Hello all, Just received this from the FDA, "I apologize for any inconvenience a delayed response may cause. Your inquiry was forwarded within CBER to the Office of Blood Research and Review (OBRR) who provided the following: FDA has participated in discussions with the authors of this recommendation. A modification of the recommendation was published as an “erratum” in the March 30, 2012, issue of the MMWR. The text of the modified recommendation follows: In the MMWR supplement, "Guidelines for Safe Work Practices in Human and Animal Diagnostic Laboratories: Recommendations of a CDC-convened, Biosafety Blue Ribbon Panel," on page 72, the sixth bullet of paragraph 11.4.1 should read, "Gloves should be worn when spiking or otherwise entering blood bags. The blood banks should have written procedures to decontaminate or discard blood or component containers visibly soiled with potentially infectious materials (i.e., wiping with an alcohol pad or swab) (Buchta C, Blacky A, Leitner GC, et al. Surface disinfection of packed red blood cells with 70% ethanol. Int J Surg 2006;4:118–21)." This revised recommendation is more consistent with safe work practices in a blood bank setting. I hope this is helpful. Sincerely, Pauline Manufacturers Assistance and Technical Training Branch Division of Manufacturers Assistance and Training Office of Communication, Outreach and Development Center for Biologics Evaluation and Research/FDA 301-827-2000 or 301-827-4081 800-835-4709 Industry.Biologics@fda.gov Follow us on Twitter: FDA CBER" Hope this will close this issue for us and inspectors.

Barbarakym, Although venders must validate their systems prior to gaining 510k clearance, additional testing must be performed to include site specific build and design. Cerner and other companies offer third party blood bank validation services that meet the FDA requirements. Most of this work is done remotely and the only instance that I’m aware of where additional testing must be performed on site is for Computer Crossmatch. This is due to AABB standard 5.15.2.1 (current edition).

Hello everyone, I contacted the AABB about this recommendation, see below: AABB does not have recommend a disinfectant for the CDC recommendation. That particular recommendation actually was of concern to us, and we reached out to one bag manufacturer to get their thoughts on it before going back to the CDC. If you’d like to discuss this further, or if you have other comments regarding their guidelines document, feel free to give me a call at your convenience Thanks! Eduardo Nunes Senior Director of Policy, Standards, and Global Development AABB 8101 Glenbrook Road Bethesda, MD 20814-2749 tel: +1.301.215.6504 fax: +1.301.215.5704

The issue of blood by non BB tech is fine in my book. If you train them and document it then I see no issue with it. Let consider the use of Hemosafe (blood bank vending machines). They are entering the market in an increasing number. Nursing staff will need to be trained in the visual inspection for the dispense of blood from these machine.

Without knowing what testing you’re talking about exactly (ABO/RH, Type & Screen, type & crossmatch), I will answer this the best I can. You might want to look at AABB (5.13.5) Comparison with previous record. Computer Crossmatch (5.15.2.2) require two separate ABO/RH. From you question I see that you are trying to implement this as a safety standard and it not in accordance with Crossmatch. Medicare and Medicaid have rules against unnecessary testing, and may not pay for another ABO/RH just for verification unless it’s part of the required testing (Type and Screen, Type and Cross,). I don’t know the rules and you might need to check with you business office.

I know this is not our job to police nursing services but, these are just process considerations. How is this getting documented in the medical record? still a Drug under FDA supervision from the Blood Bank. Specimen Transportation, it’s a biological (training needed) and needs to be temperature controlled. Do you directly label the vial or syringe or just the box? Could be an issue with patient safety, Check The Joint Commission standard if you’re a member hospital.

OK, I have a couple of suggestions when dealing with nursing staff. You need to approach this from a political stand point first. Question here, have you engaged the DON in a conversation with documentation why you feel it’s important that a nurse be with the patient for 15 minutes, maybe they just don’t know the stats? Sometime we forget that not even doctors spend time dealing with transfusion medicine in their schooling. If that does not work. You don’t need nursing services on board for you to get what you want. Don’t get me wrong it’s nice to have nurses with buy in, but not mandatory. Your medical director needs to present the stats at the meeting he has each week/month with all the other doctors. Let him drive it from the top down. Doctors can have a more profound effect on nurses then the lab every can. I really think this is where your transfusion committee should be getting involved, not sure who’s on yours or what the purpose of it is, but addressing policy is usually a function of the committee. You audits should be presented at the transfusion committees. The committee told you to report them to the nursing, which I would do only to the DON from now on, place all that liability in the DON lap. Make sure the DON knows that you are placing that “responsibility and liability” on them. Words like that get people’s attention. You must follow up with the transfusion committee and report the feedback you received from nursing. It may also be time to get you executive level (your equivalent to the DON) boss engaged in the conversation with the DON. A sentinel event will potential get the laboratory blood bank closed down even if it’s the nurses not doing their job. As David said it going to happen, just a matter of time. Make sure that your bosses know that this is not on the laboratory if this happens. Make sure you have good solid documentation. It appears it’s time for the lab to start documentation to protect itself from an inevitable law suit. At the very least you need to get them to define in writing what close means. If you are considered about this close, during your audit hit the call button and see how long it takes the nurse to respond to it. It’s your call, but I think I would notify the DON before I tried this. If you present information on why a nurse should stay, make sure to include Anaphylactic Transfusion Reactions, due to the increased risk of patient incapacitation in a very short amount of time (I.E. can’t hit the call button). The current policies for the Armed Services Blood Program mandate that a nurse remains with the patient for the first 15 minutes of the transfusion. There are over 300 Armed forces hospital’s following this protocol. Can only provide this link: http://www.militaryblood.dod.mil/