UPDATE!!
I sent an email to and got a reply from Mark Yazer - the SCARF site is down for maintenance. Whew - I was afraid it had gone out of existance.
Malcolm - I tried scarfex.jove.prohosting.com but got the message below. Can you access the site? Forbidden You don't have permission to access / on this server. Apache Server at scarfex.jove.prohosting.com Port 80
We use EtQ Reliance softare for our document control process. All policies, procedures, forms and reference documents are reviewed annually by the document owner (department supervisor/manager), laboratory director and quality assurance department.
The specific CFR section cited in our Transfusion Service assessment was 42 CFR 493.1256 (3) (iii): (3) At least once each day patient specimens are assayed or examined perform the following for - (iii) Test procedures producing graded or titered results, include a negative control material and a control material with graded or titered reactivity, respectively. We also run the previous (base line) sample with our prenatal titers and we could argue that it is the "positive contorl material". We would still be out of compliance for the initial prenatal titer or for the isohemagglutinin titers.
We recently had a CMS/CLIA inspection for our transfusion service (new CLIA number). The assessor told them that they needed to run positive controls with their Anti-A and Anti-B titration procedure [CFR 493.1256]. Our current isohemagglutinin and prenatal titration procedures do not include a control antibody(s). Do you run controls? If yes, what do you use?
During off (on-call) hours and on 2nd shift (only have 1 tech working) we have the tech review their own work with back-up calls to the Supervisor On-Call as needed. The next business day the workup is reviewed by another tech.
Our center only sends out "historical" antigen negative units if the customer has the antisera to perform the confirmatory typings themselves. The "historical" antigen negative units have a tag on them that states that the typings must be confirmed.
We had unresolvable problems with our two CW 2+ cellwashers - washing away cells. Thermo took them back and refunded our money. We now have two Helmer cellwasher and so far no problems.
Recieved mine by email notification. Did think it was "interesting" that the recall was for a product that had expired 10 days prior to the date of the notice.
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