Dallas County Southwestern Institute of Forensic Sciences Forensic Laboratory

Quality Management Program of the Forensic Biology Unit, Version 1.2 Serology Laboratory DNA Laboratory

Authorized by: Stacy R. McDonald, Ph.D., Deputy Chief of Physical Evidence/Acting Forensic Biology Supervisor Timothy J. Sliter, Ph.D., Chief of Physical Evidence/DNA Technical Leader Chris Heartsill, Acting Quality Manager

Corrections & Revisions Log Forensic Biology Unit Quality Management Program Authorizing Individual(s) Sliter Sliter Sliter Sliter Sliter Sliter Sliter Sliter McDonald Sliter Sliter/Dempsey McDonald

Date 8/16/2002 8/16/2002 9/30/2002 10/2/2002 1/29/2004 1/29/2004 3/9/2004 4/6/2004 11/17/2004 12/7/2004 7/11/2006 2/27/2008

Description Memo Clarification of policies on processing of items; separation of suspect & victim clothing Memo Clarification of policies re use of personal protective equipment in post amp room Additions to 8.1 8.2.11.1 thru 8.2.11.5 [Version 1.0] Replaced by Version 1.1 Addition Policy memo re chain of custody Addition Policy memo & log sheet room temp maintenance log 310 Room Add: Policy memo re QC testing of tips for P100 pipets Revision Section 15.3 Revision Section 12.5 Revision for Section 16.4 DNA Proficiency Tests Discontinuation of room temp maintenance log in ABI 310 room Version 1.1 replaced with Version 1.2 Reorganization to incorporate previous revisions by memoranda Revised wording to incorporate revised organizational levels (addition of Forensic Biologist 3) Minor changes in wording to improve clarity

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1. Introduction This document describes the Quality Management Program implemented by the Forensic Biology Unit (FBU) of the Dallas County Southwestern Institute of Forensic Sciences (IFS or SWIFS). As a functional area of the Forensic Laboratory, the FBU follows a variety of laboratory-wide and institute-wide quality policies and procedures that are described in other documents, which will be referenced as appropriate. Principle among these are the following: the Forensic Laboratorys Quality Management Program; the Physical Evidence Sections Administrative Policies.

2. Goals and Objectives The FBU serves the Dallas County Medical Examiner's Office, investigative agencies, and the citizens of Dallas County by performing evidence examinations, serology testing and DNA testing of evidence materials, and by performing such testing accurately, impartially, and in a timely manner. The Quality Management Program of the FBU serves to ensure the quality, integrity, and reliability of the analyses performed, the reports generated, and the testimony provided by the staff of the laboratory. Furthermore, this program serves to assure that the operations of the laboratory conform to all relevant standards of good laboratory practice, including a) relevant laboratory-wide policies and procedures; b) relevant national quality standards as established by the FBI as a requirement for participation in the Combined DNA Index System (CODIS); and c) applicable standards of relevant laboratory accreditation bodies.

3. Organization and management structure 3.1. Organization of the Forensic Laboratory. The organization of the Forensic Laboratory is described in the Forensic Laboratorys Quality Management Program. Organizational chart. A current organizational chart for the Institute is attached to the Forensic Laboratorys Quality Management Program. Organization of the Forensic Biology Unit

3.2.

3.3.

3.3.1. The FBU is comprised of two functional units: the Serology Laboratory, and the DNA Laboratory. This division reflects a general division of analytical functions performed by the laboratory.
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3.3.2. Functions of the Serology Laboratory include evidence examinations, presumptive and confirmatory testing of biological materials, and sample collection and storage for later DNA testing. 3.3.3. The DNA Laboratory performs DNA testing of questioned evidence samples, and standards.

4. Staff of the Forensic Biology Laboratory 4.1 The staff of the Forensic Biology Laboratory consists of the following positions (the number of currently authorized staff positions are indicated in parentheses): a) Forensic Biology Supervisor (1) b) Forensic Biologist III (3) c) Forensic Biologist II (11) Current official job descriptions are maintained by the Director. Copies of the current job descriptions are included in the Forensic Biology Units Administrative Manual. 4.1.1. Forensic Biology Supervisor. The Forensic Biology Supervisor supervises and manages all activities of the FBU. The Forensic Biology Supervisor evaluates work assignments, makes specific work assignments as appropriate, and reviews the work product of all staff. As necessary, the Forensic Biology Supervisor will perform case analyses. If the Forensic Biology Supervisor satisfies both the education and experience standards for DNA technical leader, he/she may serve as technical manager of the DNA Unit. 4.1.2. Forensic Biologists II and III. Both the Forensic Biologist II and Forensic Biologist III positions are analytical staff positions whose duties include the testing of evidence items, which may include both serology and DNA testing. In general, the Forensic Biologist I positions are considered entry level positions, and may be filled by individuals with or without previous forensic laboratory experience. Forensic Biologist III positions are typically filled by individuals with significant previous work experience in a forensic laboratory, or other significant DNA laboratory experience. These analysts assist the Forensic Biology Supervisor in the supervision of the analysts in the laboratory. Analytical staff perform testing, issue reports, and offer testimony regarding their testing results. 4.1.2.1.Analytical staff may be assigned exclusively to DNA testing, exclusively to serology testing, or to a combination of the two. These assignments will be made by the Forensic Biology Supervisor based upon the training and experience of individual staff members, and upon the needs of the laboratory.
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4.1.2.2. One Forensic Biologist II or III qualified in DNA testing will be designated CODIS Administrator of the laboratory, and as such will be system administrator for the laboratorys CODIS network.

5. Personnel qualifications 5.1. The minimum education and experience required for the various staff positions in the Forensic Biology Laboratory are detailed in the current official job descriptions which are maintained by the Director. Those qualifications are summarized below. Staff educational qualifications 5.2.1. Forensic Biology Supervisor. The Forensic Biology Supervisor will possess a Ph.D. degree in molecular biology or a related area, and will otherwise satisfy the educational standards for DNA technical leader. 5.2.2. In the event that the Forensic Biology Supervisor does not satisfy the 3 years forensic laboratory experience standard, the laboratory will make suitable arrangements for the Technical Manager responsibilities to be filled. The DNA technical manager position may be filled by other qualified individuals at the Institute or by a contract consultant. 5.2.3. Forensic Biologists III. Forensic Biologists III will possess a masters degree or higher in biology, genetics, forensic science or a related area, and will otherwise satisfy the educational standards for a DNA examiner/analyst established by the FBI Directors Quality Assurance Standards for Forensic DNA Testing Laboratories. Forensic Biologist III who perform DNA testing must satisfy a 6 month DNA laboratory experience standard. This will be typically satisfied by some combination of completion of the DNA training program, participation in DNA testing method validation, previous DNA forensic laboratory experience, and previous DNA research laboratory experience. 5.2.4. Forensic Biologists II. Forensic Biologists II will possess a bachelors degree or higher in biology, genetics, forensic science or a related area, and will otherwise satisfy the educational standards for a DNA examiner/analyst established by the FBI Directors Quality Assurance Standards for Forensic DNA Testing Laboratories. Forensic Biologist II who perform DNA testing must satisfy a 6 month DNA laboratory experience standard. This will be typically satisfied by some combination of completion of the DNA training program, participation in DNA testing method validation, previous DNA forensic laboratory experience, and previous DNA research laboratory experience.
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5.2.

5.3.

Staff performing serology testing. Prior to performing serology testing of evidence materials, analytical staff will complete appropriate training and competency testing as described below. Staff performing DNA testing. Prior to performing DNA testing of evidence materials, the DNA testing staff will satisfy the minimum education and experience standards established by the FBI Directors Quality Assurance Standards for Forensic DNA Testing Laboratories. The DNA testing staff will also complete appropriate training and competency testing in DNA analysis as described below.

5.4.

6. Professional training 6.1. The general policies regarding professional training are detailed in the Forensic Laboratorys Quality Management Program. Training in evidence examination and serology testing

6.2.

6.2.1. Prior to performing independent casework analysis in the areas of evidence examination and basic serology testing, each examiner/analyst will complete a documented training program, and will successfully complete a competency test. 6.2.1.1.Competency tests will include both technical and knowledge-based components. 6.2.2. The evidence examination/serology training program will include training in the following areas: a. evidence handling and chain of custody documentation b. presumptive and confirmatory testing procedures for blood and seminal fluid c. report writing 6.2.3. During the training program, the trainee may as part of the training participate in the analysis of casework evidence under the supervision of a trainer. In these circumstances both the trainer and the trainee will initial/sign the bench notes/worksheets. The trainer will sign the report as the responsible analyst. 6.2.4. The content of the evidence examination/serology training program may be substantially reduced/modified in the case of a new employee who has previous relevant forensic laboratory work experience. However, all staff must complete a competency test before beginning independent case work.

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6.3.

Training in DNA analysis.

6.3.1. Prior to performing independent DNA testing of casework evidence, each staff member will complete a documented training program, and will successfully complete a competency test. 6.3.1.1.Competency tests will include both technical and knowledge-based components. 6.3.2. The training program will include training/instruction in the following areas: a. scientific theory and principles of DNA testing b. contamination issues in DNA testing c. the Combined DNA Index System (CODIS) d. DNA extraction & amplification e. DNA separation technology f. statistical issues in DNA typing g. report writing 6.3.3. Prior to beginning independent casework, each DNA analyst will have a minimum of 6 months DNA laboratory experience. This may be satisfied either by in-house experience in the DNA training program, or by a combination of in-house experience and other DNA laboratory experience. 6.3.4. The content of the DNA training program may be substantially reduced/modified in the case of a new employee who has previous relevant training or forensic laboratory work experience. In particular, portions of the training may be satisfied by training by outside agencies. However, all staff must complete a competency test before beginning independent case work. 6.3.5. For staff performing the validation of a new DNA analytical procedure, the validation studies will substitute for the training program for that procedure, and no knowledgebased competency test will be required. However, these individuals will successfully complete a technical qualifying test using the new procedure prior to use of the new procedure for case work.

7. Continuing education 7.1. A statement of general policies related to continuing education may be found in the Physical Evidence Sections Administrative Policies. The laboratory recognizes the importance of analytical staff maintaining their technical qualifications through annual participation in continuing education, which may include reading of current scientific literature, and/or attending seminars, courses, professional meetings, training sessions and/or classes in relevant subject areas.
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7.2.

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7.3.

Continuing education activities must be approved by the Forensic Biology Supervisor and/or Section Chief. Analysts are responsible for submitting documentation of continuing education activities with the Quality Manager. The management of the laboratory will permit staff to attend approved continuing education activities on regular work hours, subject to applicable county policies and procedures. Subject to fiscal constraints, the management of the laboratory will provide funding for continuing education activities. DNA testing staff will attend at least one seminar, course, professional meeting, or training session/class per year which addresses subject matter related to DNA analysis.

7.4.

7.5.

7.6.

7.7.

8. Facilities 8.1. Security. Policies and procedures related to facilities security are found in the following documents: the Forensic Laboratorys Quality Management Program; the Institutes Facility Security Manual. Physical distribution of evidence examinations. Testing activities of the FBU will be separated in time and/or space, as follows:

8.2.

8.2.1. Evidence examinations for biological stains, and presumptive and confirmatory tests for biological fluids will be performed in the serology laboratory. 8.2.2. A dedicated area in the serology laboratory will be used for processing of dried standards, i.e., blood cards and buccal swabs. This area will not be used for examination of questioned evidence items. 8.2.3. Wet evidence items, and wet samples such as swabbings of evidence items, and bloods on cloth, will be allowed to air dry in the chemical hood located in the serology laboratory. 8.2.4. Processing of samples for DNA extraction and quantitation will be performed in dedicated areas of the DNA laboratory. 8.2.5. A separate room, located at a distance from the main serology/DNA area, will be dedicated to the extraction of low DNA samples for mitochondrial DNA analysis.
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8.2.6. Preparation of PCR master mixes, and set-up of PCR reactions will be done in designated laminar flow hoods. 8.2.7. PCR amplification of DNA, and analysis of amplified DNA products will be conducted in a designated PCR lab. 8.2.8. Suspect and victim clothing or other evidentiary items will be examined separately in time. 8.2.9. The examination area and all utensils that come in direct contact with the evidence items will be cleaned with 10% bleach between processing of suspect and victim evidence. 8.2.10. After examination is complete, each item of evidence must be sealed before another item is opened. This includes all heat sealed envelopes containing evidence to be processed for DNA analysis or other analyses. However, when items of evidence are submitted packaged together (e.g., a bag of clothing), these items may be returned to the same package after individual examination and the package sealed at that time. 8.2.11 DNA extraction of questioned evidence samples (unknowns) will be separated in time from the extraction of known evidence samples (standards). 8.2.11.1 Extractions of questioned samples will be set-up in a batch manner with other questioned samples only. Each batch will include a minimum of two (2) reagent blanks, and one positive control sample. When extractions of unknowns and corresponding standards are performed on the same day, the extractions of unknowns must be set-up, and placed in the 56o water bath before the set-up of corresponding standards is begun. Extractions of known standards will be set-up in a batch manner with other known samples only. Each batch will include a minimum of two (2) reagent blanks, and one positive control sample. When performing extract clean-up of unknowns and standards on the same day, processing of unknowns will be completed before the clean-up of corresponding standards is begun. The Extraction Worksheets are to clearly indicate the separation in time of the unknowns and standards. This will be done by indicating for extraction set-up the time extraction set-up was begun and the time that the samples were placed in the water-bath for both unknowns and standards. Also, this will be done by indicating for extract clean-up the time clean-up was begun and completed for both unknowns and standards. Technical reviewer is to verify that the case file documentation includes
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8.2.11.2

8.2.11.3

8.2.11.4

8.2.11.5

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documentation of the separation in time of extraction set-ups and clean-ups for both unknowns and standards.

9. Limiting and monitoring contamination 9.1. Biological contamination. Biological materials in the form of liquid or dried blood or other body fluids are routine components of the evidence materials submitted to the FBU for analysis. Limiting the accumulation of such materials in the laboratory environment is important from a health and safety perspective, since such materials are potential carriers of infectious disease. Additionally, the presence of such extraneous biological materials represents a possible source of DNA contamination that could compromise the quality of analytical procedures.

9.1.1. Polices and procedures directed toward limiting the exposure of staff to infectious biological agents are detailed in the institute-wide Biological Exposure Control Plan. All such policies and procedures that are applicable to the activities of the FBU will be followed. 9.1.2. As specified in the Biological Exposure Control Plan, the FBU has developed a Procedure for Laboratory Maintenance, with the goal of limiting the accumulation of biologicals in the work environment. 9.2. DNA contamination. It is recognized that the procedures used to limit staff exposure to infectious agents, and to limit the accumulation of biologicals in the laboratory environment will additionally serve to limit the accumulation of DNA contaminants that would interfere with the DNA typing procedures.

9.2.1. Sample processing steps following organic extraction of samples are not considered biohazardous. However, all steps of DNA processing will follow the guidelines described in the Biological Exposure Control Plan as a means of limiting accumulation of DNA contaminants. 9.2.2. Additional guidelines and specific procedures directed toward preventing operator controlled contamination of samples are described in the serology and DNA procedure manuals. 9.3. Monitoring DNA contamination. The presence of DNA contaminants that interfere with DNA analytical testing in casework will be monitored through the use of negative control samples in all DNA extraction batches, and in all DNA amplification batches.

9.3.1. Any failure of an extraction negative control sample or an amplification negative control sample must be immediately reported to the Forensic Biology Supervisor/DNA Technical Leader.
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9.3.2. The Forensic Biology Supervisor/DNA Technical Leader will evaluate the circumstances of the failure, and determine the appropriate response, for instance decontamination of work areas, or preparation and/or QC testing of reagents. 9.3.3. Depending upon the circumstances, possible responses may include suspension of some or all casework activities pending decontamination activities. 9.3.4. The Forensic Biology Supervisor/DNA Technical Leader will maintain a record of all such occurrences of contamination, and the responses taken.

10. Evidence control 10.1. The FBU will follow the evidence control policies and procedures described in the Physical Evidence Sections Administrative Policies.

11. Internal validation of new testing procedures 11.1. General policies regarding validation of new testing procedures are detailed in the Forensic Laboratorys Quality Management Program. Before any new analytical procedure is introduced into case work, it must be tested for accuracy and precision, and a written protocol must be developed and approved by the Forensic Biology Supervisor/DNA Technical Leader and/or Section Chief.

11.2.

11.2.1. As appropriate, the validation studies for a new analytical procedure should include known samples resembling actual evidence, and blind or reference samples. 11.2.2. A new analytical procedure that will replace a previously used procedure must be shown to result in at least equivalent discrimination and sensitivity. 11.2.3. As appropriate, a documented training program will be developed for each new analytical procedure. 11.3. Validation of DNA analytical procedures. Validation studies of DNA analytical procedures will comply with applicable existing national standards, and must include the following components:

11.3.1. Testing of known and non-probative evidence samples. 11.3.2. Demonstration of reproducibility and precision using human DNA controls.
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11.3.3. Development and documentation of match criteria based on empirical data. 11.3.4. Development of procedures and standards of statistical calculations that will be performed in the case of a match to describe the strength of the associations between an evidence sample and a known individual. 11.3.5. For staff performing the validation of a new DNA analytical procedure, the validation studies will substitute for the training program for that procedure, and no knowledgebased competency test will be required. However, these staff will successfully complete a technical qualifying test using the new procedure prior to use of the new procedure for case work. 11.4. Modifications of DNA analytical procedures. Any significant modification made to an existing analytical procedure will be documented and subjected to validation testing.

11.4.1. Decisions regarding which modifications are significant will be made by the Forensic Biology Supervisor/DNA Technical Leader.

12. Analytical Procedures 12.1. General policies regarding documentation of analytical procedures are found in the Forensic Laboratorys Quality Management Program. Documented standard operating protocols will be developed for each analytical testing procedure used by the FBU.

12.2.

12.2.1. These protocols will be collected into manuals for each general area of analytical activity. Manuals must be reviewed and approved by the Forensic Biology Supervisor/DNA Technical Leader, the Section Chief, and the Quality Manager. 12.2.2. Official copies of all protocols will be maintained by the Quality Manager. 12.2.3. Out-of-date protocols will be archived by the Quality Manager. 12.3. Conduct of case work. Analysis of case materials will be conducted using standard operating protocols.

12.3.1. Standard operating protocols used by the FBU represent procedures which are designed to work with the most commonly encountered types of evidence samples. However, given the variable nature of evidence samples, it is recognized that on occasion evidence samples will be received that will require modification of the standard operating protocol. 12.3.2. Minor modifications of standard operating protocols may be made by analysts based
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upon specific case circumstances. Such modifications are to be noted in the bench notes. 12.3.3. Significant modifications of standard operating protocols may be made with the permission of the Forensic Biology Supervisor/DNA Technical Leader and/or the Section Chief. All such modifications are to be noted in the bench notes. 12.3.4. In the case of evidence samples that are not covered by existing standard operating protocols, adaption of existing protocols, or selection of new protocols must be approved by the Forensic Biology Supervisor/DNA Technical Leader, who will determine if any additional validation studies are required. The steps used to process such samples are to be documented in the bench notes. 12.4. In addition to analytical procedures, each protocol manual will include a description of relevant quality control procedures, a listing of reagents, relevant details of reagent preparation, identification of critical reagents, and where appropriate interpretation guidelines. Reagents and solutions for DNA testing. Reagents and solutions used in DNA testing will be recorded in a log notebook, and will be assigned a laboratory inventory number. In addition, containers for reagents and solutions will be marked as having passed quality control testing. The Quality Coordinator for Reagents and Solutions (QCRS) oversees the assignment of quality control testing and documents the results of QC testing for all critical reagents used for DNA analysis. Results of all QC testing of critical reagents used for DNA analysis will be verified by the QCRS, or by the Forensic Biology Supervisor/DNA Technical Leader, prior to being included on the casework Reagent List. As appropriate, only reagents and solutions that have passed the appropriate quality control test will be used for analysis of case work samples. 12.5.1. The expiration dates for critical reagents used for DNA analysis will not be provided on the Casework Reagent List by the QCRS. It will be the responsibility of the DNA analyst to write in the expiration dates for those reagents used by the analyst in the DNA testing. 12.5.2. A current Casework Reagent List will be maintained by the QCRS, and included in the documentation for each DNA case. 12.6. Monitoring DNA test procedures. Proper performance of DNA testing procedures will be monitored with appropriate standards.

12.5.

12.6.1. All batches of DNA test samples will include appropriate positive controls. 12.6.2. DNA amplification and typing procedures will be monitored annually using NIST traceable standard reference materials, subject to the availability of such standards.
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13. Equipment calibration and maintenance 13.1. General policies regarding equipment calibration and maintenance may be found in the Forensic Laboratorys Quality Management Program, and the Physical Evidence Sections Administrative Policies. A current list will be maintained by the FBU of equipment requiring periodic calibration, calibration monitoring, and maintenance. The list will show the schedule of these activities. Log sheets will be maintained showing the completion of these periodic activities.

13.2.

13.3.

14. Reports 14.1. General policies related to reports, supporting case file documentation, and the release of case file information are detailed in the Forensic Laboratorys Quality Management Program, and the Physical Evidence Sections Administrative Policies.

15. Case review 15.1. Administrative review. At the point when the report is finalized, the signing analyst(s) will conduct an administrative review to determine that the report and its package of supporting documentation are consistent with laboratory policies, and are editorially correct. Completion of this review will be indicated by the analyst signing the report, and initialing each page of the supporting documentation package. Technical review. All reports of analytical testing by the FBU will be technically reviewed by a second qualified analyst. The function of the technical review will be to answer the following questions:

15.2.

15.2.1. Have all requested analyses been completed? 15.2.2. Have the analytical tests been performed correctly? 15.2.3. Does sufficient documentation of test results exist in the case file to support the conclusions of the signing analyst(s)? 15.2.4. Have all appropriate chain of custody documents been completed? 15.2.5. Has each page of the supporting documentation package been initialed by the signing analyst, signifying completion of the administrative review?
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15.3.

Supervisory review. All reports of analytical testing by the FBU will be reviewed by the Forensic Biology Supervisor/DNA Technical Leader or by the Section Chief prior to release. 15.3.1. This review will assure that all elements of the review process have been completed, and will provide a final editorial review of the report. 15.3.2. This final administrative review may be delegated by the Forensic Biology Supervisor/DNA Technical Leader or the Section Chief to appropriately qualified analytical staff.

15.4.

Resolution of unresolved discrepant conclusions. In the event that differences of opinion between signing analysts and reviewers can not be resolved, final resolution will be made by the Forensic Biology Supervisor/DNA Technical Leader. Testimony review. Court testimony of staff will be reviewed as described in the Forensic Laboratorys Quality Management Program.

15.5.

16. Proficiency Testing 16.1. Policies regarding the performance and evaluation of proficiency tests are detailed in the Forensic Laboratory Quality Management Program, and the Physical Evidence Sections Administrative Policies. Proficiency tests will be performed by analysts for each subdiscipline in which they conduct case work examinations.

16.2.

16.2.1. The Quality Manager will maintain official records of all proficiency tests in accordance with laboratory policies detailed in the Quality Management Program. 16.3. Serology proficiency tests. Examiners/analysts performing body fluid identification and serology testing will complete an internal proficiency test annually using those testing procedures for which they are qualified. Internal proficiency tests will be either internally generated, or will consist of materials obtained from external test providers.

16.3.1. In addition, one analyst will complete an external proficiency test annually in the area of body fluid identification and serology. For this analyst, the external proficiency test will substitute for the annual internal proficiency test. 16.4. DNA proficiency tests. Analysts performing DNA testing will complete an external proficiency test two times a year. One test will be performed in the first 6 months of the calendar year. The second test will be performed in the second 6 months of the calendar
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year. The period between consecutive tests will be at least 4 months, and will not exceed 8 months. 16.4.1. For the purpose of assessing compliance with the time requirements of DNA proficiency testing, the date that the DNA proficiency test is performed will be the due date of the proficiency test established by the external test provider. 16.4.2. Under circumstances where a DNA analyst is not available to perform a scheduled proficiency test (e.g., maternity leave, family FMLS leave) then upon returning to work she/he will: a) successfully complete a internal competency test consisting of old external proficiency test standards before performing casework analysis, and b) perform the next scheduled external proficiency test. 16.5. Corrective Actions. All discrepancies/errors in proficiency tests will be documented, and corrective actions taken in accordance with policies detailed in the Quality Management Program. Documentation of corrective actions will be maintained by the Quality Manager.

17. Audits of Forensic Biology 17.1. Internal audits of the FBU will be conducted annually as described in the Forensic Laboratorys Quality Management Program.

18. Audits of the DNA program 18.1. The DNA testing program will be audited annually for compliance with the FBI Directors Quality Assurance Standards for Forensic DNA Testing Laboratories.

18.1.1. The audit should be conducted using a appropriate audit checklist, such as the Quality Assurance Audit for Forensic DNA Laboratories drafted by the FBI. 18.1.2. The findings of the audit team will be summarized in a written report that includes identification of problem areas, and recommendations for action. 18.1.3. Recommendations for action should be categorized as critical, important, or suggested. 18.1.4. The audit team will present its findings to the Forensic Biology Supervisor/DNA Technical Leader, Section Chief and Director. 18.1.5. The Forensic Biology Supervisor/DNA Technical Leader will be responsible for
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formulating a plan for addressing problem areas. This plan must be approved by the Section Chief and Quality Manager. 18.2. Once every two years an outside agency will participate in the annual audit. .

19. Safety 19.1. The FBU will comply with all applicable Institute safety policies. Current policies are contained in the following documents: Biological Exposure Control Plan; Hazardous Chemical Safety Training Manual.

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