03.30.09 Addendum to Memo 03.16.09 ([email protected]) RE: Additional supporting material to Section VI, Example II, recently discovered. The following memo (Figure 5.) from Dr. Stacy McDonald was accidently discovered on 03.26.2009. It was attached to the inside back cover of the DNA Solutions and Materials Log notebook. This Log notebook was originally used for DNA-related reagents and solutions only, until early September 2008 when entries for Serology-related reagents and chemicals were included (Prior to September 2008, Serology-related reagents and chemicals had its own notebook/binder separate from DNA.) The memo from Dr. Stacy McDonald dated 03.06.2009 is in reference to the notations made in the DNA Solutions and Materials Log notebook (Figures 1 and 2) These notations state that the stock chemical sodium perborate tetrahydrate (J.T. Baker #3811-05, Lot #T20599) “*expired 05/2005”. The serologist’s initials “CJN” was also included next to the notation. Anot her notation next to those states “ok 3/06/09 SM see memo at back of logbook”. This memo has many inaccuracies not consistent with SWIFS policies or Serology Lab practices. 1. It is not SWIFS policy to initial and date additional notations made subsequent to the original notation. (Although, this is a change that Quality Manager Karen Young is attempting to instigate.) 2. Serologist CJN was told by Dr. Stacy McDonald to initial the notation “*expired 05/2005”. Serologist CJN was NOT told to date the notation. Serologist CJN was also told (as were all serologists who made notations in the Log notebook) to initial all line-outs (and lines) drawn by the serologist. 3. There is no SWIFS policy or FBU rule that indicates that the preparer of a reagent is also responsible for entering all the scientifically pertinent information into the Log notebook. In practice, any serologist may enter the pertinent information into the Log notebook. The preparer is responsible, however, for noting initials and date of preparation next to the entry. Similarly, any serologist may QC the new reagent provided that the serologist’s initials and date of QC are noted in the Log notebook. The preparer is not exclusively responsible for QC of the new reagent. Serologist CJN did not prepare the reagent. Serologist AML did (as indicated by her initials and date of preparation, and the notation “1X batch- 158A, 158B”.) Serologist CJN taped the Leuchomalachite Green Reagent sheet (photocopied from the SPM v1.0, Appendix 1, page 41) into the Log notebook and filled in the catalog #, prep dates, lot #, and other scientifically pertinent information. Because this was a new procedure for logging in the serology reagents and chemicals, and there were no specific instructions from Dr. Stacy McDonald as to what information was required and what information was not required, information that was thought to be “scientifically pertinent” (based on experience) was included in the Log notebook. (It was around this same time that serologist CJN had the temporarily assignment as “Serology Reagent Czar”, per Dr. Stacy McDonald. The
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