02/12/2009 Dear Sirs: If you will please excuse the anonymity, I have some forensic biology related concerns

that could be grounds for immediate employment termination should my issues become public. I am seeking advice for a solution to a situation that has become potentially very volatile for several forensic biologists in our lab (including myself) which could ultimately have career-ending and legal ramifications. I am a forensic biologist in a Texas Lab. During my training period (past 10 months), I have noticed that our SOP has a large number of technical flaws, scientific flaws, and procedural flaws which are sometimes contradictory to what is performed by the analysts in the lab. That is...what serology analysts claim they are doing (i.e. what the protocol reads), is not exactly what they are doing. Initially written in 2001, the procedures have not been altered or re-written except for 4 Memos introducing new procedures (and removed old ones) in 2002 and 2003. Yet obvious errors still exist. For some procedures, the SOP instructs serologists to use the incorrect controls (e.g. The SOP states to use water as a negative control when the scientifically correct negative control would be buffer only. Sadly, this particular page in our SOP is a photocopy from the validation studies, suggesting that the validation may not have been performed correctly.) For other procedures, the exact opposite of what is instructed in the SOP is being performed by the analysts (e.g. the SOP instructs to store in the freezer ALL samples from an autopsy kit. In practice, however, the analysts only store those samples that test positive.) And yet for other procedures, the SOP is missing detailed instructions, leaving interpretation of the procedural steps to each analyst (e.g. the SOP instructs to QC Reagent X with a positive control swab, but there is no information in the SOP on how to prepare the positive control swab or how our biological "standard" is qualified to be a "standard".) I've only mentioned a few errors, but there are many, many more. Moreover, additional (or altered) procedures expected to be performed by analysts have been "verbally communicated" by Management (i.e. not officially introduced into the SOP via Memo or email.) This method of changing or altering procedures has also extended to the analysts, each with their own personal "protocol improvement". A considerable amount of "protocol drift" exists in the lab with one analyst performing a common task slightly different than the next analyst. Over the generations of analysts and trainees, superfluous and arbitrary steps to procedures have become mandatory while laboratory "rules" no longer have a logic or rational reasoning for their enforcement. (The most common answer by a trainer as to why a specific step or procedure is done is "...because that's the way we've always done it.") This has lead to considerable confusion and frustration among the trainees as to the acceptable and correct lab procedures to follow when analyzing evidence,securing evidence, documenting or writing reports. At any given moment, a trainee can be accused of violating lab protocol by either not performing a task as written in the SOP (because the trainee was told to do otherwise by a trainer), or not following the procedures as taught by trainers (even though the SOP states otherwise.) Several current trainees in the lab are unsatisfied with their progress in training, and have been dubbed by other analysts (and Management) to be "unmotivated",

"argumentative", or have "bad attitudes". Two of the trainees have several years experience from other ASCLD and ISO accredited labs. They are abhorred at the training program and daily operations in the lab. The Management has explained that the SOP was designed and written with "shades of grey", allowing analyst's flexibility in their decisions during evidence examination. Also, official changes in the SOP which result in "clarity" or "specifics" could be detrimental to the analysts from an (Expert Witness) testimonial point-of-view. Management, too, is guilty of not enforcing, or following, the Quality Assurance Program in regards to modifications of the SOP (and many other other rules stated within the QA/QC manuals.) Far too often, when an infraction of the QA/QC program by the management is reported (as a friendly reminder) to the management,the "shoot the messenger" tactic is applied. As a means of demonstrating authority, the management often offhandedly mention "insubordination" and threaten disciplinary actions of "...up to, and including, termination". Because of this management style, the analysts often do not report incidences which could affect the work product. It fosters an atmosphere where mistakes are covered up or blame is transferred to another individual. Moral is often low. I have researched several other forensic lab's SOPs available to the online community and I feel that ours is far below par. One might even suggest that the SOP we are using does not currently meet (nor has it for many years) ASCLD standards. I have been told by management that our SOP has been audited several times by outside agencies and deemed acceptable by the scientific community. Yet, strangely, this year's internal audit (lead by our newly hired Quality Manager) has uncovered several procedural "issues" and prompted managements sudden need to re-write the SOP. From a legal standpoint, our SOP is discoverable. Therefore, an analyst serving as an Expert Witness in court can be questioned as to the details of what they did procedurally while handling and analyzing evidence. If an analyst recounts specific details of a procedure performed during analysis, but contradictory steps are stated in the SOP (because the SOP had been changed "verbally" by the Management without proper documentation), the analyst's professional ethics could be called into question. The analyst could be characterized as a maverick, working outside the SOP, compromising evidence and biasing conclusions. The analyst's career as a forensic biologist could end. Management has done nothing to aleviate the concerns of an analyst in regards to giving erroneous testimony. The issues with the current SOP and Training Program have been presented to the Management both verbally and in a formal document. Sadly, very little has changed. My apologies for remaining vague in names and details, but I feel that disclosing identifying information at this time may get me reprisal from management or terminated from employment. Furthermore, being labeled a "whistleblower" or accused of making false accusations may hinder my chances at finding new employment in the field. This is a situation that I've never encountered before and I am uncertain as to the correct way to approach it, ethically and legally. Is there an immediate course of action that I can take without jeopardizing my employment, or career, as forensics biologists? Is there a way of presenting evidence of my concerns without disclosing my name? Can a third-party act as liaison?

What laws are in place to protect analysts from being targeted as a scapegoat or whistleblower when non-compliance is discovered? In the forensic science field, what are the check-and-balances for preventing higherranking employees from neglecting their responsibilities? Thank-you for your advice in this matter. Sincerely, jac.blake@gmail.com