AMERICAN SOCIETY OF CRIME LABORATORY DIRECTORS LABORATORY ACCREDITATION BOARD

TO: FROM: DATE: SUBJECT:

Ralph Keaton, ASCLD/LAB Executive Director Don Wyckoff, ASCLD/LAB Business Manager June 18, 2010 Complaint against the Southwestern Institute of Forensic Sciences (SWIFS) at Dallas

Introduction
This anonymous complaint initiated as an email sent to Leigh Tomlin at the Texas Forensic Science Commission (TFSC) around February 9, 2009 by Jac.Blake@gmail.com. In this email the complainant provides general background on what he/she considers as problems with the SWIFS serology training program and its serology procedures (SOPs). Two additional addendums to this complaint were submitted to the TFSC around March 16, 2009 and March 30, 2009. The first addendum email consists of seven sections (I-VII) and details the specific complaints made about the SWIFS serology training program and the serology SOPs by the complainant. The second addendum further details the complainants issues with SWIFS policies and personnel in relation to the sections of the March 16, 2009 email and contains copies of SWIFS internal documents. Review of Complaint The author of this report received a request to review this complaint around May 14, 2010 and about three days after that received a CD from the ASCLD/LAB office that contained the background material related to the complaint. Upon review of the background material provided by the ASCLD/LAB office,1 and given the age of the complaint and that previous complaints against Texas forensic laboratories had made regional news, an internet search of SWIFS was also initiated. This internet search was made first using (SWIFS + complaints) and then (SWIFS + employee complaints). The search revealed that at least as far back as mid-October 2009 a similar complaint was made public by a named ex-employee of SWIFS. Further internet searches revealed that around June 2009 a wrongful termination lawsuit was going to be filed against Dallas County and SWIFS. Furthermore some of these same issues/complaints were featured in a WFAA-TV (Dallas) news report that can be found using (SWIFS + WFAA) for the internet search. In this television news release the former employee of SWIFS is interviewed regarding some of the allegations found throughout this complaint. On June 2, 2010 a call was made to Karen Young, SWIFS Quality Manager to set up an appointment for a teleconference with her, other SWIFS management, and myself to discuss the
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Documents consisted of: 1) all three parts of the complaint as received from the Texas Forensic Science Commission; 2) SWIFS response ASCLD/LAB regarding the complaints; 3) Version 1.1 of the SWIFS Serology Training Guide; 4) SWIFS Code of Ethics and Conduct, Version 1.0; and 5) TX DPS review of Version 2.1 of SWIFS Serology Procedures Manual, Version 2.1and SWIFS Serology Training Guide, Version 1.1 and 2.0. 139 J Technology Drive. Garner. NC 27529 Phone (919) 773-2600 FAX (919) 773-2602

complaint. On June 8, 2010 a teleconference was held between myself and three members of SWIFS managementKaren Young, Dr. Stacy McDonald, Deputy Chief of Physical Evidence and Acting Biology Supervisor, and Dr. Timothy Sliter, Chief of Physical Evidence. During this teleconference all of the topics raised in the complaint and the SWIFS responses to those issues were discussed. A number of other documents were requested from SWIFS and these were provided to this author within a few days after the June 8th teleconference.2 A second teleconference was held with the same three SWIFS personnel on June 21, 2010 as follow-up to the complaint assessment. During the first teleconference with SWIFS management, this author did confirm that the anonymous complaint had in fact been initiated by the same individual that was interviewed in the TV report found during the internet search. This fact was also confirmed when Leigh Tomlinson from the TFSC called this author on June 16th to determine the status of the complaint investigation for a report to the TFSC Board. This author contacted and discussed by telephone the issues of this complaint with Richard Frank (on 6/15/2010), the ASCLD/LAB staff inspector who lead the ASCLD/LAB team that inspected the SWIFS operations in February 2008 and Meghan Clement (on 6/14/2010), Forensic Biology Technical Director, Laboratory Corporation of America Holdings and Jodine Zane (on 6/16/2010), DNA Security, Inc. Laboratory Manager and DNA Technical Leader. Ms Clement and Ms Zane were both members of that same inspection team and inspected the SWIFS forensic biology section. Mr. Frank has extensive experience as an ASCLD/LAB team captain/lead assessor while both forensic biology inspectors are currently practicing forensic scientists in the forensic biology discipline and have experience with the ASCLD/LAB inspection/assessment process, along with experience auditing against the FBI DNA Quality Assurance Standards. Conversations with all three individuals covered the general work of the ASCLD/LAB team during the February 2008 inspection in regards to the SWIFS quality program, laboratory security, the serology training program and serology SOPs, case notes, and the reporting of biological testing. Also discussed were the observations of the inspection personnel on the laboratorys order and cleanliness, casework, whether any recommendations were provided to SWIFS by the inspection team, as well as all areas of concern raised by the complaints against SWIFS. Contact was also made with Patti Williams, ASCLD/LAB Proficiency Testing Program Manager on June 16, 2010 to determine if any issues or concerns with any SWIFS proficiency test results were reported to ASCLD/LAB by the forensic biology Proficiency Review Committee between February 2008 and June 2009. Some Chronology of Events at SWIFS during 2008 and 2009 In February 2008, ASCLD/LAB conducted an accreditation inspection of the SWIFS facility based on the ASCLD/LAB Legacy Program. Over a period of approximately six months, SWIFS addressed the findings of the accreditation team and SWIFS was reaccredited in midSeptember of 2008.
Documents included: 1) SWIFS internal audits and reviews for 2008 and 2009; 2) Serology Training Program Guide, version 2.0; 3) Quality Management Program of the Forensic Biology Unit, Serology/DNA Laboratory, version 1.3, Serology Procedures Manuals, Versions 1.0 (11/09/2001) and 2.1 (2/13/2009). ASCLD/LAB Response to SWIFS Complaint
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The individual who raised the complaints with regard to the SWIFS serology program was hired in March 2008 and was involved in the training program for blood and semen identification until the September-October 2008 time frame. At that time, the complainants performance was deemed to be unsatisfactory and he was restarted in the blood and semen training program. The trainer/managers overseeing the complainants retraining again felt that no improvement was shown during the next seven months and he was terminated from SWIFS in May 2009. The complaint against SWIFS came to the TFSC during the February-March 2009 time period and become public sometime around the latter half of 2009.

Addressing the Complaint

As the initial complaint to the TFSC, dated February 9, 2009 provides little detail (and the author also apologizes for remaining vague in names and details [p 3 of 4]), this email is not discussed in this complaint investigation. The third email (3/30/09) is discussed within the particular sections of the second email (dated 3/16/09) and the SWIFS documents that compose part of that email were used to address certain examples of the March 16, 2009 complaint. There are seven sections (I VII) in the March 16, 2009 complaint and each is addressed by the corresponding number below. The format will begin by paraphrasing the various points and complaint examples as laid out, with this authors response following. I) Scientifically incorrect controls stated in the Serology Procedures Manual (SPM), Version 1.0

Example 1: The Serology Procedure Manual (SPM) manual states that before using a new lot of HemaTrace Blood Cards such will be QC-checked using de-ionized water as the negative control; while later in the manual the sample batch results, QC check consisted of using the extraction buffer as a negative control. Response: SWIFS personnel testing serological evidence were deviating from the written manual procedure for the QC of a new lot of HemaTrace Blood cards up until late 2008. At that time, SWIFS made a change in the lot testing procedure wherein the negative control was changed to include the HemaTrace Buffer. This change in procedure follows SWIFS forensic biology personnel initiating a review of the procedure as required by the laboratorys quality system, and empirical data shows that the use of the buffer as a negative control at this point in the process does not affect the results and conclusions that determine whether a sample does or does not continue to further analysis after this preliminary testing. The change in procedure is incorporated into the newest version (2/13/09) of the Serology Procedure Manual (SPM), at that time. Example 2: There are two parts to this complaint: 1) there is no requirement within the brentamine SOP to QC the brentamine reagent prior to use and 2) there is no historical record or traceability for the donated semen used in brentamine testing. Response: Regarding no requirement to QC the brentamine reagent: In interviews with the forensic biologists that made up the 2008 ASCLD/LAB inspection team, neither one found a concern with how the methodology used in preparing the brentamine reagent, how the reagent was used in casework, the reporting of positive and negative results, nor any administrative problems with the worksheets or paperwork employed in casework documentation. This review
ASCLD/LAB Response to SWIFS Complaint 3

is proximally concurrent to the training period of the complainant and this authors interview of SWIFS personnel did not find evidence that the SWIFS serology section had changed its procedures during that time. The methodology employed by the SWIFS serology unit for preparation and use of the reagent is similar to that followed in other accredited forensic laboratories.3 Regarding no historical record for donated semen: The 2008 ASCLD/LAB inspection team found no concerns related to how the donated semen standard was acquired, prepared, stored, or used at the time of the 2008 inspection, which is concurrent to the initial training period of the complainant. The 1:1,000 dilution for use of this semen sample may be different from other forensic laboratories, but empirical data exists within SWIFS to justify use of the control, at this dilution. Example 3: The procedure for the placement and number of positive and negative controls on Ouchterlony diffusion plates is confusing and incorrect. Response: The procedure for the placement and number of positive and negative controls on Ouchterlony plates was in place at the time of the 2008 ASCLD/LAB inspection and the inspection team felt that this procedure was acceptable as found. This author could find no indication that this procedure differs substantially from the published practice used in other forensic laboratories.4 The SWIFS Request for Review/Corrective Action Request (RFR/CAR) Committee evaluated this concern after it was raised by the complainant and also determined that the procedure required no modification. II) Serologists not following protocol as written in the SPM v1.0

Example 1: There are two parts to this complaint: 1) when examining sexual assault kit smears, the SOP has a gap where 8-14 sperm cells/slide are found, as well as the associated term used to describe this condition and 2) no custody transfer occurs between analysts of the Sexual Assault Kit when a second analyst re-analyzes slides/smears. Response: Regarding the lack of terminology for the conditions of a smear having 8-14 sperm/slide: The numerical range of 8-14 sperm cells/slide and an associated term is lacking in the SOP. However, it hardly seems plausible that an analyst who detects 8 to 14 sperm cells on a slide would then enter nothing on the worksheet, whether or not a descriptive term was present in the SOP for that condition. More likely the analyst would enter the numerical value, a term of his/her choosing that he/she defines for the range, or a hybrid term such as Rare/Occasional. In the same example narrative, the complaint states that smears that are described as having 1-7 sperm cells/slide must have up to seven coordinates recorded. Such verbiage was not found in the SOP. Instead it reads co-ordinates of rare spermatozoa should be noted. And in fact, the example at the end of the SOP, where Rare is used to describe a smear, there is only one set of coordinates, alongside a date and analyst initials. The only requirements related to noting smear observations found in the SOP are that negative and rare results must be verified by another analyst and spermatozoa are to be described as intact (head and tail) or heads only.
3

DNA Analyst Training, Laboratory Training Manual, Presidents DNA Initiative, Dept. of Justice, http://static.dna.gov/lab-manual/pdi_lab_userguide.pdf 4 ibid ASCLD/LAB Response to SWIFS Complaint

However, SWIFS management evaluated and addressed this SOP omission in its RFR/CAR process and a change to the SOP was made and put in place on 2/13/2009. The newer SOP incorporates Rare as 1-10 sperm cells/slide and Occasional as 11-20 sperm cells/slide. Regarding custody transfer between analysts re-analyzing smears: ASCLD/LAB criterion 1.4.1.1 requires that the laboratory have a written or secure electronic chain of custody record that provides for the complete tracking of all evidence. The complaint states that no actual evidence transfer occurs when a second analyst affirms the microscopic read of a first analyst. Because the analyst making the initial read maintains control of the smear while being viewed by the second analyst, ASCLD/LAB does not consider there to be a transfer of custody. This authors review of the SOP and interview with SWIFS management did not reveal any shortcomings related to documenting custody transfers of sexual assault (SA) kits or other related evidence. Example 2: SOP requires that all swabs from an autopsy kit be stored, regardless of result, when in fact only swabs that test positive for blood or semen are stored once initial analysis is complete. Response: The practice of the forensic biology section regarding storage of swabs from autopsy kits is different than what was required by SWIFS SOP prior to February 2009. However, SWIFS management did recognize this discrepancy, proceeded through quality review, and instituted new procedural changes on 2/13/2009 (Serology Procedures Manual Version 2.1). Now, all swabs are screened for blood and semen and if positive the swabs are placed in separate sample containers, labeled, and stored frozen. Proper protocol was followed by SWIFS management in using its quality system to address the issue prior to making the SOP change. Example 3: SOP states that condoms should be stored intact (as submitted) in the forensic biology freezer until analysis. Response: The SPM v1.0 SOP uses should in the statement of how to store condoms, while the complaint appears to interpret freezer storage as a requirement. At the same time, SWIFS management did proceed through quality review, rewrote the procedure which was included in its February 2009 revised Serology Procedures Manual. At this time, condoms are sampled and swabs are placed in sub-sample containers and stored at room temperature. Proper protocol by SWIFS management related to the quality system was followed in this process. Example 4: There are two parts to this complaint: 1) no official protocol exists for the preparation and storage of blood, positive control swabs and 2) there is no historical record or traceability for the donated blood used in preliminary testing. Response: Regarding a protocol for the preparation and storage of blood, positive control swabs: The SPM v1.0 does not have an SOP for the preparation of blood, positive control swabs. However, within the leucomalachite green testing procedure, it references that blood control swabs are prepared and that the analyst is to acquire such in QC-testing the LMG reagent. Version 2.1 (2/13/2009) also does not have an SOP for the preparation of blood, positive control swabs. Regarding a record or traceability for the donated blood used in preliminary testing: The SPM
ASCLD/LAB Response to SWIFS Complaint 5

v1.0 does not have as part of any SOP or worksheet, a way to record when donated blood used in preliminary serological testing was acquired. Version 2.1 (2/13/2009) also does not have an SOP or worksheet to record when donated blood was acquired for use in serological testing. III) Supervisors delinquent in maintaining a succinct, understandable, and up-to-date Serology Procedures Manual

Example 1: Evidence that supervisors verbally changed the procedures (without documenting the date) and/or allowed serologists to change procedures without authorization is in the following statement in SPM v2.0 (02.04.09) Response: SWIFS has been generating a record of changes by including the date, description of change, and the individual authorizing the change on the SPM front page, since 2002. These annotations provide documentation history on manual revisions. In both cases cited (complaints italicized phrases), SWIFS management noted that serologists were using different practices. Quality review of the process occurred and the log reflects the change to current laboratory practice. Example 2: The SPM v1.0 contains no references to the scientific literature for the tests described. Response: Although the SPM v1.0 contains no references to the scientific literature for the tests found therein, SWIFS is on record as having adequate standard reference materials related to the discipline of forensic serology at the time of the February 2008 ASCLD/LAB inspection. Considerable literature is also available on-line that addresses background on various serology topics.5 Example 3: The serologists no longer use stickers for any purpose in the laboratory. The use of stickers arises in several locations in the SPM v1.0, none of which are followed. Response: Although item stored stickers are no longer used on evidence packaging, adequate information exists in case files to document the existence of subsamples when such are generated. The subsamples generated are also adequately protected from contamination or loss as required by ASCLD/LAB standard and SWIFS policy. This was borne out in the interviews of the ASCLD/LAB forensic biology inspectors from the 2008 inspection, as well as SWIFS management staff. Updates to the procedure are recorded in the Serology Procedure Manual, Version 2.1. Example 4: There is no expiration date given for the control swabs prepared in-batch. There was no previous in-house experimental study for determining the expiration date of the positive control swabs made in-batch. Response: As mentioned in Example 4 of Section II, SPM v1.0 does not have an SOP for the preparation of blood, positive control swabs and no expiration for these control swabs is provided. The updated Version 2.1 (2/13/2009) of the SPM also does not provide for placing expiration dates on the control swabs that are prepared.

ibid ASCLD/LAB Response to SWIFS Complaint

Example 5: The communal storage cabinet is locked at all times and accessible by everyone who has access to the lab (i.e. the same key opens the entry door into the lab and the locked communal storage cabinet within the lab. It is a redundant key.) However, the communal storage refrigerator and communal storage freezers are never locked. The reasoning for locking some communal areas (that everyone in the FBU has keys for) and not others is not clear to the serologists. Response: The discussion of ASCLD/LAB criteria 1.4.1.5 states .evidence storage space may be shared by laboratory personnel. It is not necessary to place locks on refrigerators and freezer which are maintained in rooms and/or areas which are secured and restricted. Access to each of these areas must be restricted to personnel authorized by the director. SWIFS practice is in keeping with ASCLD/LABs security requirements. Example 6: A letter addressed to various agencies that use SWIFS services is [sic] written after the implementation of SPM v1.0. As such, most of the changes addressed in the letter are not reflected in the SPM v1.0. At the very least, the letter should have been included as an addition to the SPM v1.0 to provide newly hired serologists with the reasoning behind the procedures. Response: This letter addresses protocol changes for the collection of blood/urine samples for toxicology and the length of time that SWIFS will hold sexual assault kits before returning them unanalyzed when no request for analysis is provide to the laboratory. Neither of these topics affects the SOPs or how a serologist performs their analysis. Example 7: The following is a list of errors that demonstrate the general lack of concern and motivation by the Supervisors for maintaining the SPM v1.0. Page numbers and topics are listed in the example for 1) methodology no longer in use, 2) obsolete worksheets, and 3) miscellaneous technical errors. Response: In response to methodology no longer in use by SWIFS: Many training and procedure manuals within the forensic disciplines routinely catalogue methodology no longer in use in the laboratory. Such is often used as a way to provide historical background to the discipline analyst/trainee on forensic methods. This practice does not suggest that a manual is without use, nor that management lacks the motivation to maintain the manual. Concerns by the complainant were address in the new SPM v2.1 (2/13/2009). The laboratory does have a procedure for archiving methods and changes to the SPM are documented within the manual. In response to obsolete worksheets: Although the removal of out-of-date worksheets would be considered best practice, the fact that such worksheets have not been removed from the manual does not reflect a lack of concern on the part of management to maintain the manual. Serological training protocols provide for teaching trainees the proper forms/worksheets to complete, along with expectations on note taking requirements. The concerns raised by the complainant were remedied in the latest rewrite of the SPM. In response to miscellaneous technical errors: The SWIFS controlled document is what is electronically stored and viewed on the SWIFS computer system. The Not a Controlled Document only appears on printed copies and this author had no trouble viewing the SOPs when printed. It appears that SWIFS is transitioning from the ASCLD/LAB Legacy to the ASCLD/LAB-International Program and having such watermarks present on printed copies ensures that personnel are using the most current document as it exists on the SWIFS computer
ASCLD/LAB Response to SWIFS Complaint 7

system. Although the SPM may have pages that are not numbered or that one method is not listed in the Table of Contents, neither are requirements of the ASCLD/LAB Legacy Program. The only requirement of the ASCLD/LAB Legacy Program is that technical procedures in use must be in printed or electronic form. Example 8: Reproductions of emails outline the notification by the Forensic Biology Manager for analysts to review the blood and semen sections of the serology training manual and make recommendations for edits to such. The complaint example states, I do not know if there is documentation of the annual reviews of the SPM. However, given that most of these errors appear to be trivial fixes (excluding the corrective actions for past actions), it is unimaginable as to the possible arguments the Supervisors could claim for not correcting these procedures year after year, or in a timely fashion. Response: In fact the SPM v1.0 has been revised at least four times by Dr. Sliter, since introduced and prior to the complaint. These revision notations can be found as part of the Corrections Log in the SPM v2.1 that was implemented in February 2009. IV) Supervisors delinquent in providing an up-to-date Serology Training Guide v1.1 or a well planned serology training program

The Serology Training Guide v1.1 has not been updated since 2001. . Superfluous and inaccurate information needs to be removed. A number of deficiencies in the training program are noted, including: 1) out-dated techniques still in use within some laboratory units exist within the guide (e.g., SWIFS no longer has a latent print unit), 2) no classroom instruction prior to laboratory training, 3) no specific detail for a trainee to refer to or follow, 4) no specific duties a trainer must follow to assist the trainee in the lab, 5) the Guide does not detail responsibilities of trainers and trainees and address actions for problems as they arise in training, and 6) supervisors do not provide the trainees with performance expectations. Response: In regards to all parts of this section of the complaint, the 2008 ASCLD/LAB inspection team reviewed the serology training program and SOPs both prior to and during the inspection with SWIFS personnel. Neither forensic biologist noted deficiencies in the program. The 2008 inspection team also found no concerns related to the SWIFS library, its reference materials, journals, texts, etc., or other resources available to personnel on-line and on-site. The Guide provides considerable detail on the training goals, objectives, competency testing in two areas, and a final sign-off checklist in the four areas in which the serologist will be evaluated. Included on two pages are even questions related to the various topics that a trainee might be tested on in oral or written examinations. Although the basis for serological examinations has remained fairly constant for a considerable time, as SWIFS became aware of new techniques (e.g., P30 Abacard test for semen and ABA HemaTrace for blood) these were incorporated into the SOP manual (in 2002 and 2003, respectively). The SWIFS Serology Training Guide and SOPs also closely model other modules used by forensic laboratories to train serologists.6 The totality of this information, taken together
6

ibid ASCLD/LAB Response to SWIFS Complaint

with the fact that the complainant came on-board within one month after the 2008 ASCLD/LAB inspection, suggests this portion of the complaint does not have merit. V) Supervisor non-compliance of institute policies and Dallas County Code

Example 1: Case record management and control. Case files stored in unlocked cabinets and accessible to all laboratory personnel, and case file are stored in boxes on the third floor hallway. Response: During the 2008 ASCLD/LAB inspection, the inspection team was aware of the condition and location of similar files described herein by the complainant. However, all files were located within the area controlled by the laboratory. Access to this area is controlled by magnetic card and/pass key which can be tracked by SWIFS electronically; and possession of such a magnetic card/pass key is given under authority of the laboratory director. The inspection team did comment to this author that the laboratory was cramped for space; however, this was in no way impacting the ability of the laboratory personnel to work evidence or maintain security over its operations. Example 2: Equipment and calibration overview, specifically autoclaves. Response: From interviews with inspection team personnel and SWIFS staff, it was determined that the autoclaves are part of the process for preparation of de-ionized water used in the P-30 extraction process and the DNA buffers. The complaint reproduces a log listing the autoclaves for as needed maintenance only and this is consistent with manufacturers requirements. Since the autoclaves are used as part of the overall routine DNA analysis, maintenance logs were reviewed not only by the 2008 ASCLD/LAB inspection team but as part of the external DNA audits performed on the SWIFS forensic biology program. In none of these instances were calibration deficiencies noted as related to these pieces of equipment. Example 3: Changing of laboratory alarm codes. Laboratory alarm codes will be changed at least once annually or after the departure of an employee who has been terminated or who has resigned. Response: As within the reference cited by the complainant the laboratory is changing its alarm codes at least once annually or after an employee has resigned or been terminated. In interviews with SWIFS staff, the code change usually occurs at the years end and since a terminated or resigned employee has returned pass keys/magnetic cards, access to the laboratory still remains secure. The 2008 ASCLD/LAB inspection team was aware of this process. Example 4: Following SWIFS and Dallas County policies on evaluations and performance reviews. Response: Only the first part of the references cited deals with evaluations within laboratory policy. This citation makes the recommendation only that .supervisors meet at least annually with subordinates in order to provide them with performance objectives and as necessary to provide positive and negative feedback on individual job performance. However, given the information needed to be completed by a trainees supervisors related to the activities listed in the Serology Training Checklist, feedback is provided at every turn during the period of approximately two and one-half months that a serologist would normally work under this
ASCLD/LAB Response to SWIFS Complaint 9

training regimen. VI) Supervisors use of scientifically unsound practices

Example 1: There are three parts to this complaint: 1) although serologists are required to wear lab coat and gloves while analyzing evidence, they are not required to wear devices such as hair nets, 2) serologist do not wear gloves when handling smears, and 3) a fan in the serology laboratory was in-use during the time that evidence was being worked. Response: Regarding the wearing of other protective devices: The 2008 ASCLD/LAB inspection team observed proper use of personal protective equipment by laboratory personnel while on site. In interviews with the two forensic biology inspectors, it was their opinion that hairnets would only be required if contamination became an issue further along in the analysis of evidence. In casework review, proficiency test results, validation studies, etc. the inspection team did not note contamination as an issue within the forensic biology section. No such evidence exists from review of the proficiency tests that SWIFS personnel have taken since March 2008. Regarding the wearing of gloves when handling smears: While on-site, the 2008 ASCLD/LAB inspection team observed SWIFS serologists manipulating slides/smears without gloves. If as the complaint alleges, smears were routinely analyzed for DNA evidence where the possibility of contamination could become an issue, wearing gloves while handling smears would become standard laboratory practice. Such was not found to be the case in interviews with SWIFS forensic biology management. Regarding the use of a fan in the serology laboratory while working evidence: The use of a fan within an area where biological evidence is being worked should not be condoned. However, in interviews with SWIFS forensic biology management, the reporter was advised that analysts did not use this fan during times that evidence was being worked within the laboratory area. Management advised that the fan was in use only during periods that personnel were in the laboratory doing report writing and not while evidence is being analyzed. If operation of this fan actually caused contamination of evidence, such contamination would be noted by staff as they worked evidence through the remainder of the forensic biology section. In talking with SWIFS staff, this has not been the case. Example 2: Do not use out-of-date or unlabeled chemicals. An expired bottle of sodium perborate tetrahydrate (JT Baker) was used in the preparation of the LMG reagent. Response: Presumptive tests for blood have been used in serology examinations for a considerable time, but the shortcoming of any presumptive test is that it can give false positive results in certain instances. It is for this reason that positive and negative controls are run concurrently with samples at the time of use. Interviews with the 2008 ASCLD/LAB forensic biology inspectors and SWIFS forensic biology management indicated that SWIFS serologists were routinely running positive and negative controls with casework.

ASCLD/LAB Response to SWIFS Complaint

10

In reviewing the chemistry of sodium perborate,7 background information lists the shelf life of the mono-, tri-, and tetra-hydrate forms as long, and all forms are used as an oxidizing reagent when placed in solution (its use in the LMG test). This long shelf-life is further substantiated by the fact that when SWIFS replaced the JTBaker sodium perborate with Fluka sodium perborate, no expiration date is listed on the Fluka container. Considerable background is provided in the complaint regarding this out-of-date bottle of JT Baker sodium perborate tetrahydrate, some of which outlines SWIFS attempt to deal with the situation. The complaint gives some detail from a 1/27/09 serology section meeting discussion about confirming the expiration date of the sodium perborate, but the bottle is no longer present in the laboratory (. removed for chemical disposal,.). It seems incongruous that at a time when the serology section attempts to address the situation and the complainant might shed light on the case, possibly even providing the chemical for testing and confirmation as to whether it will work pass the expiration date, the complainant offers nothing to that discussion. Yet this supposed bottle of sodium perborate appears pictured in a television news story on October 21, 2009. At the least, the complainant appears to be subverting the SWIFS quality assurance process, as well as not complying with parts of the SWIFS Standards of Business Conduct and Employee Responsibilities.8 VII) Closing Statements

Examples: Citations from the Quality Management Program Quality Manual version 2.3 delineating .a SWIFS employee has responsibilities that include actively participating in the quality management program., and bringing to the attention of management situations that compromise work product integrity., and to diligently and accurately perform the duties of their position.. Response: The complainant states within these concluding remarks that .I cannot reject the possibility that I may [sic] over scrutinizing this labs protocol and performance by its personnel. The complaint conclusion also mentions that the March 16, 2009 complaint email, the Serology Procedures Manual, Version 1.0, and the Serology Training Guide, Version 1.1 were forwarded to the TFSC. At the time of this action the newest versions of both manuals were in existence and in use, but neither of these documents were also forwarded to the TFSC. Given the fact that by February 2009 SWIFS management had already dealt with most of the issues raised in the complaint, this author questions whether the complainant actually grasps how the SWIFS quality process operates, as well as whether the complainant was actually aware of the changes that had already occurred to the serology training and operations manuals, or as the complaint attests, the complainant was purposefully over-scrutinizing SWIFS.

Conclusion
The following was considered when reviewing the three-part complaint: The SWIFS serology program underwent review as part of an ASCLD/LAB inspection in February 2008, and the inspection team was composed of forensic scientists having
Material Safety Data Sheets, The Merck Index, various chemistry websites related to sodium perborate, and textbooks on inorganic chemistry 8 SWIFS Code of Ethics and Conduct, Version 1.0 ASCLD/LAB Response to SWIFS Complaint
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extensive experience in auditing/assessing/inspecting forensic laboratory quality systems and more specifically forensic biology programs and processes. Both members of this ASCLD/LAB inspection team tasked with inspecting the SWIFS forensic biology program also have extensive experience in training laboratory personnel in all aspects of a forensic biology program. Upon completion of this inspection there were no findings written against the serology training program, the serology SOPs in use, or the reports/findings generated by SWIFS serology personnel. During the time frame addressed in this complaint, SWIFS followed its quality system protocol in holding staff meetings on forensic biology issues, as well as with management reviews and/or RFR/CAR responses to the issues outlined in this complaint and before the complaint was issued to the TFSC. During the time that the complainant was employed by SWIFS, the forensic serology program rewrote and updated the serology training and procedures manuals. Most, if not all of the issues raised in the complaint were addressed in the latest version of the serology procedures manual which was in place and in use before the complaint was issued to the TFSC. For whatever reason, the complaint provides only part of the picture as to the processes taking place at SWIFS. Examples within the complaint are exclusive to the SPM v1.0 and STG v1.1, and no mention is made of the newer version of the SPM that was in place before the complaint was issued to TFSC. Over the nearly one and one-half year time frame, between the February 2008 ASCLD/LAB inspection and the issuance of this complaint, no issues or concerns were found with any proficiency test results reported by SWIFS to the ASCLD/LAB Forensic Biology Proficiency Review Committee. Neither were any errors specifically reported in regards to the SWIFS serology program. SWIFS asked for and received from Texas DPS on March 24, 2009 a review of Version 2.1of the Serology Procedures Manual and Versions 1.1 and 2.0 of the Serology Training Guide. Only minor corrections to protocol were listed in the Texas DPS response to SWIFS and these were addressed in the later versions of the respective manuals. In at least one case, while still in the employ of SWIFS and at a time when SWIFS management was attempting to address a quality matter, the complainant likely and purposefully withheld information and laboratory material/property that could have been used to address a number of the examples set forth in the complaint. This information taken as a whole, suggests the complaint is without warrant and that the quality assurance program within SWIFS was operating as required by ASCLD/LAB standards during the approximately 1.5 years following the February 2008 ASCLD/LAB inspection. It further suggests that the overall complaint did not arise from objective review of the processes going on within SWIFS, but very likely arose out of a desire for retaliation against SWIFS. Report Prepared by Donald A. Wyckoff

____________________________________________ Ralph M. Keaton

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ASCLD/LAB Response to SWIFS Complaint