03.30.09

Addendum to Memo 03.16.09 (Jac.Blake@gmail.com)

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. Another 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

responsibilities of the “Serology Reagent Czar” included assisting the other serologist in

entering scientifically pertinent information into the Log notebook correctly.)

Serologist CJN does not recall when the notation “*expired 05/2005” was added to the

original, but believes it was shortly after the preparation date and well before the 11.25.2008

memo to the Quality Manager.

4. On 01.27.2009, there was an impromptu Serology Lab meeting where Dr. Stacy McDonald

addressed the issues stated in the memo. However, serologist CJN was not asked to

participate in writing of the memo. Serologist CJN was unaware that this memo even existed.

It is unknown at this time if any other serologists are aware of this memo. This memo was

placed in an unusual location, the back inside cover of the DNA Solutions and Reagent Log

notebook. In practice, memos relating to lab activities (i.e. accidents and mishaps) are never

globally distributed to the serologists. Most memos are placed in the related case file or

given to Dr. Stacy McDonald or Dr. Tim Sliter. Therefore, other serologists are unaware of

prior accidents and do not take proactive precautions to prevent reoccurrence.

5. A third page from the DNA Solutions and Materials Log notebook (Figure 3.) has a notation

in the middle of the page marked by an asterisk (*). This notation describes a single-run

experiment performed by serologist PRL to compare the “expired” stock chemicals used to

prepare the critical reagent Brentamine Reagent (1-naphthyl phosphate monosodium salt

monohydrate Lot #91K2621 received 06.07.02, and Fast Blue B salt Lot # 024K0762

received 07.27.04) versus the new stock chemicals in detecting a 1:1000 dilution of semen on

a swab (the QC test for freshly prepared Brentamine Reagent.) It was recorded in the

notebook by PRL on 12.04.2008 at the request of Dr. Tim Sliter (Dr. Stacy McDonald was on

maternity leave from mid-October until late December 2008). The notation declares that the

Brentamine Reagent prepared from the “expired” chemicals worked the same as the

Brentamine Reagent prepared from the new chemicals. Therefore, the “unknown” expiration

date of the stock chemicals was declared to be 3 years from the receive date. Dr. Tim Sliter

told serologist PRL that he would initial the notation, but this has yet to occur.

6. To reiterate the point from Section VI, Example 2, it is not commonly accepted in the

scientific community to use expired chemicals, reagents, or materials. Exceptions are made

when the expired component has been validated experimentally to perform as well as a non-

expired component when tested on samples conditionally similar to those found in routine

items of evidence. This validation must be performed PRIOR to use on real items of

evidence. After validation, the exception is documented into the SPM along with a date of

implementation.

The critical reagent LMG Reagent prepared using the “expired” stock chemical sodium

perborate tetrahydrate (Lot #T20599) may have passed QC (1:10,000 dilution blood on a

swab), however, the use of expired chemicals has not been validated experimentally and the

change in the SPMv1.0 had not been documented prior to use on evidence. The same was

done for the “expired” stock chemicals used to prepare the critical reagent Brentamine

Reagent.

Additional Concerns

It was also noticed that the new SPM v2.0/1 has slightly different procedures than the SPM 1.0, at

least in the procedure for the ABAcard p30 test (Figure 6.). While some in-house validation studies

were being performed for the p30 test just prior to the SPM update, it is unknown if the validation

was successful and the new procedure in SPM v2.0/1 reflects those changes from the validation

studies.

Since SPM v2.0 was transcribed from SPM v1.0, this difference could be a result of human error.

(SPM v1.0 contains images of the original printed SPM v1.0. It was not editable by Word and had to

be re-entered into a Word document in order to make the update to SPM 2.0/1.)

The blue arrows point to the differences between the two procedures.

A side-by-side comparison of the two SPMs has yet to occur.

Figure 1. Photocopy of page in Log notebook

Figure 2. Photocopy of page in Log notebook

Figure 3. Photocopy of page in Log notebook

Figure 4. Cover of DNA Solutions and Materials Log notebook

Figure 5. Photocopy of memo from Dr. Stacy McDonald, 03.06.09

Figure 6. a.) Statement in Corrections and Revisions from SPM v2.0/1

b.) SPM v1.0

c.)SPM v2.0/1

6a.) Statement in Corrections and Revisions in SPM v2.0/1

6b.) SPM v1.0 (Chapter 9, the OneStep ABAcard p30 test for the identification of semen.)

Page 2

6c.) SPM v2.0/1 (Chapter 9, the OneStep ABAcard p30 test for the identification of semen.)

No page number