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Forensic Biology Unit Quality Assurance Manual FBQA01 District of Columbia Department of Forensic Sciences Forensic Biology Unit Quality Assurance Manual FBQA01 FBQA01 - Forensic Biology Unit Quality Assurance Manual Page 1 of 35 Document Control Number: 1521 Issuing Authority: Director Revision: 9 Issue Date: 12/14/2018 2:20:01 PM UNCONTROLLED WHEN PRINTED District of Columbia Department of Forensic Sciences Table of Contents 1. Goals and Objectives 2. Organization, Management Structure and Position Responsibilities 2.1. Forensic Biology Unit Manager 2.2. Forensic Biology Technical Leader 2.3. Forensic Biology Lead Scientist 2.4. Casework CODIS Administrator 2.5. Analyst 2.6. Technician 2.7. Laboratory Support Staff 3. Personnel Qualifications and Training 3.1. Job Descriptions and Qualifications 3.1.1. Unit Manager and Lead Scientist Qualifications 3.1.2. Technical Leader Qualifications 3.1.3. Casework CODIS Administrator Qualifications 3.1.4. Analyst (i.e., Forensic Scientist) Qualifications 3.1.5. Technician Qualifications 3.1.6. Laboratory Support Staff Qualifications 3.1.7. Contract Employee Qualifications 3.2. Training 3.2.1. Training and Qualification File(s) 3.2.2. Training Program 3.2.2.1. Re-training guidelines 3.2.3. Continuing Education 4. Facilities and Security 4.1. Facilities 4.2. Contamination 4.2.1. Contamination Prevention and Clean-up Procedures 4.2.2. Spills 4.2.3. Biohazard Waste Disposal 4.2.4. Chemical Waste Disposal 4.3. Security 5. Evidence and Sample Control 5.1. Receipt 5.2. Chain of Custody 5.3. Sample Handling and Storage 5.3.1. FSL_FBU_QA Database Samples 5.4. Examination and Analysis 5.5. Disposition 5.6. Case Acceptance and Priority Criteria FBQA01 - Forensic Biology Unit Quality Assurance Manual Page 2 of 35 Document Control Number: 1521 Issuing Authority: Director Revision: 9 Issue Date: 12/14/2018 2:20:01 PM UNCONTROLLED WHEN PRINTED District of Columbia Department of Forensic Sciences 6. Validation 6.1. Developmental Validation 6.2. Internal Validation 7. Analytical Procedures 7.1. Analytical Procedures 7.2. Standards and Controls 7.3. Interpretation 7.4. Reagent Quality Control 7.5. Quality Control of DNA Procedures 8. Equipment Calibration and Maintenance 8.1. Equipment Inventory and Operation Manuals 8.2. Calibration/Maintenance Procedures and Logs 9. Reports and Documentation 9.1. Analytical Notes 9.2. Report Writing 9.3. Case Files 9.4. Issuance of Case Reports 10.Review 10.1. Case Review 10.1.1. Elements of Technical Review 10.1.2. Testimony review 11.Proficiency Testing 11.1. Purpose 11.2. Assignment, Frequency and Documentation 11.3. Verification of Performance 12.Corrective Action 12.1. Procedure 12.2. Clean Run 13.Audits 13.1. Annual DNA Audit 13.2. Quality Audit 13.3. Quality Review 14.Safety 15.Outsourcing Casework for DNA Analysis 15.1. Vendor Laboratory Requirements 15.2. On-Site Visits 15.2.1. On-Site Visit Process and Elements FBQA01 - Forensic Biology Unit Quality Assurance Manual Page 3 of 35 Document Control Number: 1521 Issuing Authority: Director Revision: 9 Issue Date: 12/14/2018 2:20:01 PM UNCONTROLLED WHEN PRINTED District of Columbia Department of Forensic Sciences 1. Goals and Objectives The Forensic Biology Unit quality assurance system operates in accordance with the quality policies and practices established in the laboratory’s Quality Assurance Manual (QAM), the Departmental Operations Manuals (DOMs), the Laboratory Operations Manuals (LOMs) and the stated requirements in the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories (QAS). It is the goal of the Forensic Biology Unit (FBU) to: Provide user agencies access to testing services of selected biological materials. Ensure the quality, integrity and reliability of the DNA typing data and its presentation through the implementation of a detailed quality assurance (QA) program. Provide expert testimony regarding laboratory findings resulting from forensic biological analysis of evidentiary materials. It is the objective of the FBU quality assurance program to ensure that: All forensic biology screening and DNA typing procedures are operating within established performance criteria, that the results and conclusions are technically correct, and the presentation of information is clear, accurate and of high quality. The analytical testing and reporting procedures are monitored by means of quality control procedures, proficiency testing and audits. 2. Organization, Management Structure and Position Responsibilities 2.1. Forensic Biology Unit Manager The manager functions as the head of the Forensic Biology Unit. The manager duties and responsibilities include, but are not limited to: Managing and coordinating all programs within the unit. Approving and documenting policies and procedures, standard operating procedures, quality assurance/quality control procedures, and other unit specific documents as necessary. Serving as the supervisor for the Forensic Biology Unit. Ensuring that the Technical Leader is provided with opportunities for training and continuing education. Ensuring that the necessary resources are made available to adequately address deficiencies and potential deficiencies; directing, reviewing and approving implemented quality corrective actions and preventative actions; ensuring the quality corrective and preventative actions have been completed in a timely manner; ensuring appropriate follow-up activities are carried out; and that the associated documentation is maintained. Reviewing and approving training in the laboratory. FBQA01 - Forensic Biology Unit Quality Assurance Manual Page 4 of 35 Document Control Number: 1521 Issuing Authority: Director Revision: 9 Issue Date: 12/14/2018 2:20:01 PM UNCONTROLLED WHEN PRINTED District of Columbia Department of Forensic Sciences Ensuring that unit personnel comply with the applicable health and safety policies and practices. 2.2. Forensic Biology Technical Leader The technical leader oversees the technical operations in the Forensic Biology Unit. As such, the technical leader has the authority to suspend/terminate operations in the Forensic Biology Unit if a determination is made that the current casework operations have been compromised. The technical leader duties and responsibilities include, but are not limited to: Authority to initiate, suspend, and resume DNA analytical operations for the laboratory and individuals. Managing and coordinating all technical programs within the unit. Ensuring that a qualified individual is designated to serve as the unit’s Technical Leader in the Technical Leader’s absence. Approving and documenting technical standard operating procedures, quality assurance/quality control procedures, validation studies and other unit specific documents as necessary. Upon appointment, in the capacity as Technical Leader, this individual will be responsible for a documented review of all FBU quality documents within one year. Assessing and documenting the annual review of the procedures of the unit. Assessing and documenting the review of academic transcripts and training records for newly qualified analysts and approving their qualifications before allowing them to perform independent casework analysis. Ensuring that the lead forensic scientist and forensic scientists (analysts and technicians) are provided with opportunities for training and continuing education and are qualified for their assigned work responsibilities. Ensuring that the Forensic Biology Unit’s quality assurance program complies with the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories. Directing, reviewing and approving implemented quality corrective actions and preventative actions; ensuring the quality corrective and preventative actions have been completed in a timely manner; ensuring appropriate follow-up activities are carried out; and that the associated documentation is maintained. Assessing and documenting the review of internal and external DNA audit documentation. If any corrective actions have resulted from these audits, review and approve the corrective actions to ensure that the findings were appropriately and adequately addressed. Determining the course of action appropriate for resolving a discrepancy between analysts/reviewers and adopting steps to minimize or eliminate a discrepancy from reoccurring. FBQA01 - Forensic Biology Unit Quality Assurance Manual Page 5 of 35 Document Control Number: 1521 Issuing Authority: Director Revision: 9 Issue Date: 12/14/2018 2:20:01 PM UNCONTROLLED WHEN PRINTED District of Columbia Department of Forensic Sciences Reviewing and approving training, quality assurance and proficiency testing programs in the laboratory. Reviewing and approving the technical specifications for outsourcing agreements. 2.3. Forensic Biology Lead Scientist The Lead Scientist is responsible for case management to include discussion with submitting agencies regarding processing decisions, laboratory workflow and efficiency of casework. The lead scientist’s duties and responsibilities include, but are not limited to: Assigning cases to laboratory analysts. Ensuring all submitted paperwork is correct and up to date. Ensuring cases are completed within expected timelines. Communication with submitting agencies regarding case processing questions. Management of laboratory practices for efficient and accurate processing. Recommending updated lab procedures and practices to ensure quality casework and efficient processing. With technical leader coordination, implementation of procedures within the casework team. Raising
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