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Santa Beauchamp

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About Santa Beauchamp

  • Birthday 03/03/1961

Santa Beauchamp's Achievements

  1. Does any one out there have any staffing models they use to address this?
  2. We follow the same procedure as AMcCord. we also have multiple "Outreach" clients who are not on our BBIS but we require the same specimen collection and labeling standards for those patients also; including that the armband is attached to the patient at the time of collection. Just curious as to the rationale for allowing the BB armband to be attached separately from the specimen collection; seems this creates the possibility of a patient mismatch??
  3. No they did not ask these questions. As a matter of fact the standard they sited "Test procedures producing graded or titered results, include a negative control material and a control material with graded or titered reactivity", refers to Control Procedures, not specifically Immunhematology. Their only concern was a negative control and a positive control that titers at least as far as the reportable range, not actual Blood Bank information. We also participate in the 2 CAP surveys per year and were recently inspected by AABB and CAP without this being mentioned. CLIA did not deem this sufficient
  4. On the same subject, sort of.... What type of QC are you performing? Our facility was recently cited by CLIA "The failed to include a negative and a titered control for antibody titration"...This was specifically referring to Anti-A and Anti-B but we also rarely perform titers for alloantibodies. Any advice would be appreciated
  5. We are a Transfusion Service that is writing to ask for an interpretation of 21 CFR 606.60 with regards to Equipment Performance check Frequency Frequency of calibration Temperature recorder Compare against thermometer Daily As necessary All of our storage equipment is monitored with the following: Isensix-NIST traceable 24/7 remote monitoring system with alarms NIST traceable thermometer in liquid located on the interior of the unit (upper and lower for large equipment) Paper continuous trace chart recorders Isensix is checked everyday with a “checkpoint” verification which is described in SOP as reviewing of temperatures, charts and displays to verify that everything is functioning properly and within acceptable temperature ranges. Weekly all of these monitoring devices are compared against each other for acceptability criteria. It is our understanding that many blood centers have discontinued the use of the paper chart recorders and depend solely on the electronic monitoring system. Our question regarding the interpretation of this requirement is this: Do we additionally need to manually read, record and compare the NIST traceable interior thermometer against the paper chart recorder on a daily basis? Do we additionally need to manually read, record and compare the NIST traceable interior thermometer against the Isensix reading on a daily basis?
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