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The FBI DNA Laboratory: A Review of Protocol and Practice Vulnerabilities
May 2004
Office of the Inspector General
Appendix VI
This Appendix contains the definition of terms, guidance, and forms that were used by the assessment team to determine which portions of the FBI DNAUI written procedures and protocols were vulnerable to undetected inadvertent or willful noncompliance.
The document sections in the checklists track directly to the table of contents of the various documents listed. Separate tables were completed for both impact rankings and risk rankings, even though the following documents show impact and risk on the same checklist.
FBI DNA Laboratory Vulnerability Assessment
Impact is defined as the measure of how scientifically essential a particular procedure or protocol is to producing a complete and accurate DNA profile. Producing a complete DNA profile includes ensuring that available DNA samples are efficiently and effectively processed for analysis. This definition does not include a consideration of whether a procedure or protocol is essential to the legal utility of a DNA profile.
Descriptions of Rating Criteria
FBI DNA Laboratory Vulnerability Assessment
Risk is the measure of the sufficiency of existing controls to prevent both inadvertent and willful noncompliance and to detect noncompliance when it occurs. Willful noncompliance, in the context of this assessment, is defined as the intentional circumvention of applicable procedures and protocols. We applied this definition with the understanding that protocols alone cannot prevent in the first instance malicious acts by staff members.
Descriptions of Rating Criteria
Impact/Risk Assessment Forms, Phase 1
Impact/Risk Assessment Forms, Phase 2
Instructions for Numeric Ratings of Impact
Low Impact
(Value = 1-3)A procedure or protocol falling into this category is optional, and while it may be beneficial, it is not in any way required. The details of this procedure or protocol, and even whether it is adhered to, have little to no impact on the production of a complete and accurate profile. The general focus of the procedure or protocol is adherence to organization-specific guidelines, or to maintain efficient and consistent operations. Non-adherence has no direct impact on the integrity of the overall evidence or final conclusions.
Medium Impact
(Value = 4-7)A procedure or protocol falling into this category is required by quality standards, and certain aspects of what it includes are specified by quality standards. Failure to fully adhere to the procedure or protocol could compromise the obtaining of complete and accurate DNA results, and could compromise the integrity of the overall evidence or final conclusions, but not necessarily.
High Impact
(Value= 8-10)A procedure or protocol falling into this category, as well as many of its specific contents, are specifically required by quality standards. Proper adherence to the procedure or protocol is essential to obtaining complete and accurate DNA results, as well as preserving the integrity of the overall evidence and the final conclusions.
Instructions for Numeric Rating of Risk
Low Risk
(Value = 1-2)A procedure or protocol falling into this category has several mechanisms in place both to ensure staff compliance and to deter and detect noncompliance. Mechanisms could include hard-wired computerized controls, threshholds or sign-offs; checklists; forms; witnesses or reviews; separation of duties; random checks, etc. Mechanisms would almost exclusively be those in which the process is forced to stop until the procedure or protocol is properly adhered to, and would be very difficult to bypass without the deliberate collusion of staff.
Medium-Low Risk
(Value = 3-4)A procedure or protocol falling into this category has several mechanisms in place to ensure staff compliance and to detect noncompliance. Mechanisms will generally be those that halt the process until the procedure or protocol is properly adhered to, but could also be based somewhat on faith in staff compliance. These mechanisms most likely could not be bypassed by a single individual unless there is negligence by other staff.
Medium Risk
(Value = 5-6)A procedure or protocol falling into this category has a few mechanisms that serve to ensure staff compliance or to detect noncompliance. However, the mechanisms generally rely on faith in staff compliance, and would not halt the process if not complied with. Mechanisms could be bypassed for a short time by a single individual if other unknowing staff are not consistently thorough in their oversight responsibilities.
Medium-High Risk
(Value = 7-8)A procedure or protocol falling into this category has minimal mechanisms to ensure staff compliance or to detect noncompliance. Mechanisms that are in place rely on faith in staff to perform as expected without monitoring to detect otherwise, and could be bypassed for a lengthy time by a single individual, even if other staff are being thorough in their oversight responsibilities.
High Risk
(Value= 9-10)A procedure or protocol falling into this category is not being monitored and has no mechanisms to detect noncompliance. Staff are left to themselves to adhere to the procedure or protocol, and noncompliance could exist indefinitely unless another staff member happens to discover and disclose the noncompliance to management.
= Lab Wide
= Unit Specific
Instructions: rate each of the following major sections for impact and risk. The rating should reflect the highest level of impact or risk of procedures/protocols contained within the section. Put N/A if the section is informational only. If the sections listed below contain subsections that cover too broad an impact or risk range to be assessed as a whole (>3 values), an itemized assessment of each subsection should be completed.
# of
FBI Laboratory Division Quality Assurance Manual1
Sections
Laboratory Policies
1
2
3
4
5
6
7
8
9
10
N/A
1
Statements of Policy
2
Case Documentation Policy
3
Evidence Control Polic
Operational Practices
1
2
3
4
5
6
7
8
9
10
N/A
4
Practices for Authorizing Deviations
Notes:
DNA Analysis Unit I Quality Assurance Manual2
1
2
3
4
5
6
7
8
9
10
N/A
5
Evidence Control
Notes:
FBI Laboratory Division Caseworking Procedures Manual1
1
2
3
4
5
6
7
8
9
10
N/A
6
Procedures for Processing a Request for Examination
7
Procedures for Case Assignment
8
Procedures for Inventorying & Identifying Evidence
9
Procedures for Recording & Acknowledging Evidence
10
Procedures for the Examination of Evidence
11
Procedures for the Formatting and Content of a Report of Examination
12
Procedures for Reviewing a Report of Examination
13
Procedures for Issuing a Report of Examination
14
Procedures for Shipping Evidence
15
Procedures for Transferring Evidence
16
Procedures for Retaining Case-Related Documentation
17
Procedures for Handling Drug and Valuable Evidence
Notes:
Procedures for the Serological Identification of Biological Substances on Evidentiary Materials2
Routine Procedures
Procedure for the Presumptive Identification of Blood
1
2
3
4
5
6
7
8
9
10
N/A
18
Reagents and Supplies
19
Quality Control Procedures
20
Test Procedure
21
References
Procedure for the Confirmatory Identification of Blood
1
2
3
4
5
6
7
8
9
10
N/A
22
Reagents and Supplies
23
Quality Control Procedures
24
Test Procedure
25
References
Procedure for the Preparation of Dried Bloodstains
1
2
3
4
5
6
7
8
9
10
N/A
26
Reagents and Supplies
27
Quality Control Procedures
28
Preparation of Dried Bloodstains from Coagulated Whole Blood
29
Preparation of Dried Bloodstains from Anticoagulated Whole Blood
30
Reference
Procedure for the Presumptive Identification of Semen
1
2
3
4
5
6
7
8
9
10
N/A
31
Reagents and Supplies
32
Quality Control Procedures
33
Test Procedure
34
References
Procedure for the Extraction of Suspected Semen Stains Prior to OneStep ABACard PSA Test
1
2
3
4
5
6
7
8
9
10
N/A
35
Reagents and Supplies
36
Quality Control Procedures
37
Questioned Stain Extraction Procedure
38
Reference
Procedure for Human Semen Identification by the OneStep ABACard PSA Test
1
2
3
4
5
6
7
8
9
10
N/A
39
Reagents and Supplies
40
Quality Control Procedures
41
Test Procedure
42
Interpretation of Results
43
Disposal
44
References
Non-Routine Procedures
Procedure for the Origin Determination of Stains
1
2
3
4
5
6
7
8
9
10
N/A
45
Reagents and Supplies
46
Quality Control Procedures
47
Test Procedure
48
Interpretation of Results
49
Disposal
50
References
Procedure for Evaluating the Specificity of Anti-Species Antisera
1
2
3
4
5
6
7
8
9
10
N/A
51
Reagents and Supplies
52
Quality Control Procedures
53
Test Procedures
54
Interpretation of Results
55
References
Procedure for the Presumptive Identification of Blood Using Luminol
1
2
3
4
5
6
7
8
9
10
N/A
56
Reagents and Supplies
57
Quality Control Procedures
58
Test Procedures
59
Interpretation of Results
60
References
Procedure for the Calibration of OneStep ABACard Tests for the Detection of p30
1
2
3
4
5
6
7
8
9
10
N/A
61
Detection of p30
62
Reagents and Supplies
63
Preparation of p30 Standard Solutions
64
Tests of the p30 Standard Solutions
65
Interpretation of Results
66
Reference
Procedure for the Microscopic Identification of Spermatozoa
1
2
3
4
5
6
7
8
9
10
N/A
67
Reagents and Supplies
68
Quality Control Procedures
69
Test Procedures
70
References
Procedure for the Staining of Smear Slides with Kernechtrotpicroindigocarmine for the Microscopic Identification of Spermatozoa
1
2
3
4
5
6
7
8
9
10
N/A
71
Reagents and Supplies
72
Quality Control Procedures
73
Test Procedures
74
References
Procedures for the Detection of Amylase in Saliva Stains
1
2
3
4
5
6
7
8
9
10
N/A
75
Reagents and Supplies
76
Quality Control Procedures
77
Test Procedures
78
Interpretation of Results
79
References
80
Radial Diffusion Template
Procedure for the Detection of Urea in Urine Stains
1
2
3
4
5
6
7
8
9
10
N/A
81
Reagents and Supplies
82
Quality Control Procedures
83
Test Procedures
84
Interpretation of Results
85
References
86
Radial Diffusion Template
Laboratory Setup
1
2
3
4
5
6
7
8
9
10
N/A
87
Dedicated Equipment and Supply Items
88
Dedicated Laboratory Space
89
Equipment Calibration
Notes:
= Lab Wide
= Unit Specific
Instructions: rate each of the following major sections for impact and risk. The rating should reflect the highest level of impact or risk of procedures/protocols contained within the section. Put N/A if the section is informational only. If the sections listed below contain subsections that cover too broad an impact or risk range to be assessed as a whole (>3 values), an itemized assessment of each subsection should be completed.
# of
FBI Laboratory Division Quality Assurance Manual1
Sections
1
2
3
4
5
6
7
8
9
10
N/A
1
Authorization and Approval Hierarchy
2
Laboratory Quality System
Laboratory Policies
1
2
3
4
5
6
7
8
9
10
N/A
3
Court Testimony Policy
Operational Practices
1
2
3
4
5
6
7
8
9
10
N/A
4
Practices for Corrective Action
5
Practices for Court Testimony Monitoring
6
Practices for Document Control
7
Practices for Instrument Calibration and Maintenance
8
Practices for Internal Audits
9
Practices for Laboratory Security
10
Practices for Open Proficiency Testing
11
Practices for Scientific or Technical Casework Conflict Resolution
12
Practices for Validating Technical Procedures
13
Practices for Writing Standard Operating Procedures
Notes:
DNA Analysis Unit I Quality Assurance Manual2
1
2
3
4
5
6
7
8
9
10
N/A
14
Mission Statement
15
Goals and Objectives
16
Organization and Management
17
Authority and Accountability
18
Job Descriptions, Personnel Qualifications and Training/Continuing Education
19
Facilities (Security)
20
Documentation System
21
Standard Operating Procedures
22
Report Writing
23
Case Assignment, Documentation and Review
24
Quality Control of Reagents and Materials
25
Instrument Calibration and Maintenance
26
Validation
27
Court Testimony Monitoring
28
Addressing Complaints
29
Proficiency Testing
30
Audits
31
Corrective Action
32
Environmental Health and Safety
Notes:
Short Tandem Repeat Analysis Protocol2
1
2
3
4
5
6
7
8
9
10
N/A
33
Scope: Principles of Forensic STR Typing Tests
34
Reagents and Supplies and Equipment
35
Reagents and Supplies for Extraction
36
Reagents and Supplies for Quantitation
37
Reagents and Supplies for Profiler Plus / Cofiler
Amplification and Detection by ABI Prism 310
38
Equipment
39
Special Quality Control Measures
40
Guidelines for Control Samples
41
Equipment
42
Quality Control of Critical Supplies and Reagents
43
Extraction
44
Whole Blood or Bloodstains
45
Vaginal Swabs or Semen Stains
46
Saliva Stains
47
Envelope Flaps or Stamps
48
Cigarette Butts
49
Tissues
50
Hairs
51
Bone
52
Teeth
53
Quantification by Quantiblot
54
Amplification
1
2
3
4
5
6
7
8
9
10
N/A
55
STR Typing by Capillary Gel Electrophoresis
56
Setting up the Instrument
57
Setting up a Run
58
Genescan Analysis
59
Genotyper Analysis
60
Before Applying Genotyper
61
Using a template file
62
Examining data
63
Interpretation
64
Designation of Profiler Plus ID and Cofiler Alleles
65
Preliminary Evaluation of Data
66
Interpretation of Control Samples
67
Interpretation of Specimens
68
Application of Population Frequency Data to
Profiler Plus ID
and Cofiler Typing Results
69
Source Attribution
70
Minimum Allele Frequency
71
Allele Frequencies
72
Report Writing
73
Laboratory Set-up
74
DNA Extraction and Non-amplified DNA Laboratory
75
PCR Set-up
76
Amplified DNA Analysis
77
References
78
Safety
Notes:
Miscellaneous Procedures2
1
2
3
4
5
6
7
8
9
10
N/A
79
Procedure for Monitoring Ultra-Violet Light Intensity
80
Procedure for Pipette Calibration
81
Procedure for One Point Thermometer Calibration
Notes: