Approximately 20 percent of the protocol sections we examined lacked the detail necessary for a technically qualified DNA scientist to identify the testing methods that should be in use in the DNAUI. Accordingly, DNAUI management should ensure that the document sections identified as vague in Chapter Five of this report are corrected to describe completely and accurately management expectations, Unit procedures and policies, and “best practices” currently in use in the DNAUI. Specifically, DNAUI management should:
4) Ensure that the Evidence Control Policy of the FBI Laboratory
Division Quality Assurance Manual, the Evidence Control and Facilities (Security) sections of the DNA Analysis Unit I Quality Assurance Manual, and the Procedures for the Examination of Evidence section of the FBI Laboratory Division Caseworking Procedures Manual, contain:
a) Comprehensive guidance regarding the prevention of evidence contamination, loss, and destruction. At a
minimum, this information should be included in Evidence
Control Policy sections 3.2 and 3.5; Evidence Control sections
7.6.1 and 7.6.2; and Procedures for the Examination of
Evidence sections 4.1.3 and 4.5.1.1. The Laboratory-wide
sections should identify procedures that are applicable to all Units. Sections associated with a particular Unit should provide a complete listing of the evidence preservation methods in use in that Unit, even when those methods are identified elsewhere in the other Unit protocols.
b) General guidance regarding DNA evidence handling
procedures that is applicable to all Laboratory Units. This information should be provided in Laboratory-wide
documents, including the Evidence Control Policy of the FBI
Laboratory Division Quality Assurance Manual, and the
Procedures for the Examination of Evidence section of the FBI Laboratory Division Caseworking Procedures Manual, and
should describe the requirements to process the evidence one case at a time, and to handle evidence one item at a time. The guidance also should identify procedures to ensure that one Unit does not compromise the ability of another Unit to test the same item of evidence.
c) Unit-specific guidance on DNA evidence handling
procedures. This information should be included in the
Evidence Control section of the DNA Analysis Unit I Quality Assurance Manual, and should contain all evidence
handling, contamination-prevention, and evidence-
preservation methods universal to all technical DNAUI staff. d) An identification of facility access limitations, including a
description of the context and limitations for access to DNAUI areas by non-DNAUI personnel. This information should be added to Facilities (Security) section 6.1.
5) Ensure that the Evidence Control Policy of the FBI Laboratory
Division Quality Assurance Manual, the Evidence Control and Facilities (Security) sections of the DNA Analysis Unit I Quality Assurance Manual, and the Procedures for the Examination of Evidence section of the FBI Laboratory Division Caseworking Procedures Manual cross-reference other relevant guidance to
ensure that staff members know whether additional information is located in other manuals.
6) Implement a policy that requires staff members to certify that they have read, understand, and will comply with each protocol that governs DNAUI operations, as well as any approved revisions that have not yet been incorporated into the protocols.
7) Revise policies for securing evidence under active examination to reflect the current availability of independently securable storage at staff member workstations, and of a securable bulky evidence examination room. The policies should require the use of these new facilities rather than leaving the security of unattended
evidence under active examination dependent upon facility access limitations.
8) Ensure that the Extraction and Amplification sections of the Short
Tandem Repeat Analysis Protocol include:
a) A requirement that the known and unknown (evidence) samples are processed separately during examination,
extraction, and amplification, including references to guidance that specifies the amount of time and space that meets the intent of the term “separation.”
b) A requirement for the “separation” of high- and low-quantity DNA samples, as well as references to guidance that specifies the amount of time and space that meets the intent of the term “separation.”
9) Ensure that the Extraction, Amplification, and Laboratory Set-up sections of the Short Tandem Repeat Analysis Protocol include: a) Information on the use, cleaning, and decontamination of
the “transport trays” used by PCR Biologists to move samples to the amplification area.
b) General evidence handling information.100
c) In the Extraction section, a prohibition on having two sample
tubes open at once, clarification in section 4.1.3 regarding required incubation times, and further explanation
concerning when the additional organic extractions permitted by section 4.3-9 are appropriate.
d) In the Amplification section, a requirement that control
samples be processed last, and in section 6.7, the
specification of the order in which sample tubes should be set up.
10) Ensure that the Procedures for the Serological Identification of
Biological Substances on Evidentiary Materials includes:
a) Detailed guidance on proper evidence handling methods, similar in content to the guidance contained in the
Laboratory Set-up section of the Short Tandem Repeat Analysis Protocol.
b) In the Procedures for the Preparation of Dried Bloodstains from Coagulated Whole Blood and the Procedures for the Preparation of Dried Bloodstains from Anticoagulated Whole Blood, a requirement to: 1) pretest the cotton sheeting to
100 Currently, this information is included in the Laboratory Set-up section. We
recommend that it be included in all sections of the Short Tandem Repeat Analysis Protocol that call for the handling of evidence, but at a minimum, in the Extraction and Amplification
ensure that there is no DNA contamination; and 2) identify the amount of blood to use when making dried blood stains. c) In the Procedures for the Extraction of Suspected Semen
Stains: Quality Control Procedures and Procedures for the Extraction of Suspected Semen Stains: Questioned Stain Extraction Procedure, guidance regarding: 1) the usable life
of the positive semen control; 2) the size of the swab to use for testing; 3) the need to use disposable paper to reduce the risk of contamination; 4) whether extracts and swabs are both sent to the Biologist for testing; and 5) what happens after the stain extraction procedure has been completed (i.e., what occurs if there is a negative or positive result).
d) Unwritten internal controls that already are in use by DNAUI staff members and management, including (but not limited to): (a) the requirement for a team’s PCR Biologist to record the characteristics of the evidence, supplementing the description generated by the Serologist; and (b) the
requirement for Serologists to perform a “general swabbing” of an item to ensure that no possible sources of DNA on that item have been missed.
11) Ensure that the Case Documentation Policy section found in the
FBI Laboratory Division Quality Assurance Manual contains:
a) A listing of the minimum contents for all Unit case files, along with a reference to that part of each Unit’s case documentation and review protocol that addresses case file contents; and
b) Guidance on notetaking methods and requirements common to all Units, along with a reference to the corresponding Unit-specific protocols.
12) Ensure that the Case Assignment, Documentation, and Review section found in the DNA Analysis Unit I Quality Assurance Manual contains:
a) A detailed description of case file review procedures,
including a checklist to facilitate the review and to document that the review accounts for each key item in the case file;
b) Guidance on notetaking methods to ensure that DNAUI staff members understand how and when they should take notes; and
c) A description of the procedures that must be followed to review and confirm case evidence profiles for entry into CODIS, or at a minimum, a reference to where those procedures are described in another policy document. 13) Ensure that the Guidelines for Control Samples and Interpretation
of Control Samples sections within the Short Tandem Repeat Analysis Protocol contain comprehensive guidance on each of the
following: (a) the procedure to complete a case file review; (b) the difference between the review responsibilities of Examiners and of the PCR Biologists; (c) the circumstances in which a control result should cause an entire analysis run to “fail;” and (d) how and when staff members should use section 10.3.3 of the Interpretation of
Control Samples. Further, these sections should contain a
checklist or summary sheet to assist reviewers to verify the completeness of their work.
14) Ensure that the Organization and Management and Authority and
Accountability sections of the DNA Analysis Unit I Quality Assurance Manual contain:
a) A complete description of the characteristics,
responsibilities, interrelation, and limitations of each job position in the various DNAUI teams;
b) Problem-resolution guidance for each team member position that describes how to respond to operational and personnel problems (such as suspicion of protocol noncompliance), and that clearly delineates the options for resolution available to staff members; and
c) A clear statement identifying Laboratory personnel who have the authority to halt DNAUI operations if a significant
problem is detected.
15) Include comprehensive guidance for problem response and resolution, similar to that contained in the DNAUI Quality
Assurance Manual, in the FBI Laboratory Division Quality Assurance Manual.