1 NC SBI QUALITY ASSURANCE PROGRAM for the SBI Reviewed by: Deputy Assistant Director Bill Weis Date: Approved by: Assistant Director Jerry Richardson Date: Originating Unit: SBI Effective Date: July 25, 2003
2 TABLE OF CONTENTS SECTION 1...Planning and Organization SECTION 2...Objectives and Management SECTION 3...Job Descriptions, Continuing Education and Training Records SECTION 4... Case File Records SECTION 5... Equipment and Instruments SECTION 6... Evidence Handling SECTION 7... Manuals SECTION 8...Validation of Analytical Procedures SECTION 9... Data Analysis and Reporting SECTION 10...Proficiency Testing SECTION 11...Internal Quality and Control SECTION Court Testimony SECTION 13...Communication SECTION 14...Audits and Inspections SECTION 15...Safety Quality Assurance Program
3 Provisions for Modification and Updating of this Manual Any updates, modifications, additions, or deletions to this manual prepared after the issue date on the cover sheet will have the following information located at the bottom of each page: Issue Date: Prepared by: Approved by: Supersedes: Date: Date: Originating Unit:
4 1.0 Planning and Organization 1.1. Organization 1.1 The Attorney General of the state of North Carolina is an elected official who will appoint a Director of the SBI and four Assistant Directors who will serve at his/her will. The SBI Director will report directly to the Office of the Attorney General within the North Carolina Department of Justice and supervise the Assistant Directors of the State Bureau of Investigation. 1.2 The Director will be delegated responsibilities as empowered by the Attorney General to carry out law enforcement responsibilities with the assistance of the Assistant Directors who will also act in his/her place. 1.2 Structure The Director of the will serve as an Assistant Director for the State Bureau of Investigation with delegated responsibilities from the Director of the State Bureau of Investigation and is empowered to carry out the daily functions and operations of the. The duties of the Director of the will include all day-to-day functions and operations of the and other duties as assigned by the Attorney General and/or the Director of the SBI The Deputy Assistant Director of the will report directly to the Director of the. The duties of the Deputy Assistant Director will include quality assurance and control, continued compliance with accreditation by the American Society of Crime Laboratory Directors - Laboratory Accreditation Board (ASCLD-LAB), acquisition and implementation of grants, oversight of all budgets appropriated for the purposes of carrying out the programs of the Crime Laboratory Division, assisting the Director with the dayto-day management of the Division, serving as the Director in his/her absence, and completing special projects identified and assigned by the Director of Services or the Director of the State Bureau of Investigation.
5 1.2.3 Each section/unit of the will have a Special Agent in- Charge or Supervisor that will be empowered to carry out the duties and responsibilities of respective sections within the. In the absence of the Special Agent in-charge or Supervisor, a senior agent or designated employee will be assigned in-charge responsibilities during any absences. These designated employees will have the same authority as the Special Agents in-charge/supervisors during these absences. See Appendix A for organizational charts of the Department of Justice, State Bureau of Investigation and the Division.
6 2.0 Objectives and Management 2.1 Objectives: The Objectives of the are: To provide the Criminal Justice System of North Carolina with a full service Forensic Laboratory having state-of-the-art capabilities in the analysis of Latent Evidence, Questioned Documents, Forensic Biology, Trace Evidence, Controlled Substances and Toxicology, Firearms & Toolmarks and Digital Evidence To fulfill our obligation to the Criminal Justice System of the State as required by statute (G.S ) and to ensure that each case submitted to the laboratory for analyses are completed within the time required under G.S. 15A-701. To be prepared to give priority to major crimes and, when justified, be prepared to give immediate assistance to facilitate and aid ongoing investigations. See Appendix B for copies of applicable North Carolina Statues To maintain a sufficient number of highly skilled forensic experts to furnish the various courts of the state with expert testimony on analysis performed as required by the courts To seek and employ individuals of the highest possible ethical and educational standards and to provide them with sufficient training and state-of-the-art equipment in order to enable them to perform their analysis with the highest possible degree of competence and integrity To strive to maintain an open communication with the law enforcement community - sufficient to educate them in: the capabilities of the crime laboratory; the proper procedures for collecting, preserving, and submitting evidence to the laboratory; the proper interpretation of laboratory reports; and to provide on the scene assistance in major crimes.
7 2.1.6 To provide a work environment which is as free of hazards to laboratory personnel as is possible within existing physical facilities. North Carolina State Bureau of Investigation 2.2 Goals: To ensure that the work product of the laboratory is of the highest possible reliability through an ongoing proficiency testing program and regular product review. It is the goal of this laboratory to: Provide the North Carolina Criminal Justice System with full service forensic services having state-of-the-art capabilities in forensic analysis, technical support for state and local law enforcement agencies and crime scene assistance associated with an official criminal investigation Ensure the quality, integrity and scientific accuracy of this analysis through the implementation of a detailed Quality Assurance/Quality Control ( QA/QC) program. 2.3 Scope: The QA/QC program described in this manual is intended to support the forensic analysis of the, to ensure that each analyst is operating within established performance criteria, and to ensure that the quality and integrity of the analysis is maintained and is scientifically sound. 2.4 Program Objectives The objectives of this quality assurance program are to: Ensure uniformity and accountability in records and analytical techniques Measure quality performance with administrative and technical case reviews, and to be able to act on any discrepancies encountered Ensure the accuracy of the analysis conducted.
8 2.4.4 Document corrective actions taken Terminate non-conforming analyses and procedures. North Carolina State Bureau of Investigation Monitor personnel and equipment performance Ensure the use of documented and valid procedures and equipment Provide feedback to management on performance standards Ensure that forensic analysis results are technically sound and/or legally defensible Provide guidelines to employees Ensure that the personnel performing this analysis have the appropriate level of training and education Ensure the analysts are competent in performing the analysis in interpreting results through a series of proficiency tests Provide a safe workplace Provide for competent external audits to see that the operating policies and procedures are being followed and that they are adequate. 2.5 Management Roles and Responsibilities Management Responsibilities The Director of the, Deputy Assistant Director, Special Agents in-charge and Supervisors will support all Quality Assurance Programs established within the and/or immediately provide proper documentation to the Director of the as soon as feasible to support a change or update to existing policy Technical Support All technical support personnel will follow all Quality Assurance Programs
9 established within the respective sections as applicable. North Carolina State Bureau of Investigation Support Services Support Services within the SBI will offer and provide any necessary assistance or other services as prescribed by SBI Policy and Procedures. 2.6 Authority and Accountability The Deputy Assistant Director, Special Agents in-charge, and Supervisors of the with delegated responsibilities are empowered by the Director of the to perform assigned duties as needed and to act in his/her place. Departures from the documented policies and procedures will be done in accordance with the State Bureau of Investigation=s Directive # This means, for example, that each Special Agent in-charge has the authority to modify any procedure which fails to meet specifications or adequately address section or unit needs. The Safety Officer is empowered to take appropriate actions in the event of a potential safety hazard or other contamination problems within the laboratory. Specific delegated responsibilities include: The Deputy Assistant Director, Special Agents in Charge/Supervisors are ultimately responsible for the Quality Assurance program pertaining to audits and all other delegated responsibilities The Deputy Assistant Director, Special Agents in Charge/Supervisors or a designated Senior Analyst within each section has the responsibility to see that the QC functions are being carried out in the Crime laboratory on a day-to-day basis The Special Agents in Charge/Supervisors or a designated Senior
10 Analyst within each section is responsible for the testing and validation of new reagents and equipment, developing, maintaining and communicating new and existing procedures and maintain and update manufacturer information. North Carolina State Bureau of Investigation The Special Agents in Charge/Supervisors are responsible for maintaining adequate supplies and replenishing these supplies as well as coordinating the requisition of new supplies as needed for the laboratory The Special Agents in Charge/Supervisors are responsible for approving all new reagents and ensuring the proper usage of chemicals and equipment within the laboratory as well as all safety related matters The Special Agents in Charge/Supervisors or a designated Senior Analyst is responsible for developing and updating the training program within the laboratory and administering this program appropriately to all new analysts The Special Agents in Charge/Supervisors of each section/unit is responsible for designating a Key Operator(s) for each piece of equipment to include the maintenance of the assigned equipment and ensuring that it is being used properly, and communicating necessary changes and updates to the laboratory personnel The Deputy Assistant Director, Special Agents in Charge/Supervisors of each section/unit is responsible for maintaining ad updating a Quality Assurance Manuals which will be available to all section personnel and available for inspection purposes upon request The Special Agents in Charge/Supervisors of each section/unit is responsible for ensuring that all appropriate manuals are reviewed annually by the Director and the Quality Control Manager (Deputy Assistant Director) of the. Refer to each section/unit for a copy of individual Quality Assurance Manuals.
11 3.0 Job Descriptions, Continuing Education and Training Records 3.1 Job descriptions will be maintained and updated as required for all employees. New, reassigned and recently transferred employees will have a new job description implemented as soon as applicable. Refer to each section/unit for a copy of individual Job Descriptions. 3.2 Statement of Qualifications for all employees will remain on file within each section to include applicable work experience, educational information, completed training activities and any other applicable work experiences. These documents will be maintained, updated, and reviewed on an annual basis by the Special Agent in Charge or designee. Refer to each section/unit for a copy of individual Statement of Qualifications. 3.3 Training Records for all employees will be maintained within each section in a secure location. These records will be updated as necessary to reflect the most current training activities each employee has completed. Refer to each section/unit for a copy of individual Training Records. 3.4 Job description, Statement of Qualifications, and Training Records will be maintained for all support personnel when applicable. Refer to each section/unit for a copy of individual Technical Support Personnel Records. 3.5 Records of continuing education required in the performance of the job will be maintained in each applicable section training files and/or personnel files/
12 Refer to each section/unit for a copy of individual records when applicable. See Appendix C for a copies of these forms. North Carolina State Bureau of Investigation 4.0 Case File Records 4.1 The Evidence Control and Administrative Services Unit will retain the official records for the. These records will include copies of official reports, analysts= notes, technical documentation, and any other related administrative documentation related to the particular case or related cases. 4.2 The Evidence Control and Administrative Services Unit will be responsible for dissemination of all case records maintained by the unless approved by the Director of the Crime Laboratory or designee. 4.3 Case file records will be maintained on the Laboratory Information Management System (LIMS) and this system will reflect the official chain -of-custody for the laboratory.
13 5.1 Equipment and Instruments Procurement All equipment and instruments will be ordered by the Special Agent in Charge under the direction of the Deputy Assistant Director Equipment Inventory Log An inventory log will be maintained on each piece of equipment in the by the Special Agent in Charge. An audit of the inventory log is completed each year by the Special Agent in Charge or his/her designee. This log will include the following information: Equipment Item Sticker Number Serial Number Year Purchased Year to Replace Replacement Cost Life Expectancy Model Type Model Number Operating Status Purchase Price Annual Maintenance Cost Operating Manuals Operating manuals and warranty information provided by the manufacturer will be maintained by each section of the Crime Laboratory Training Operators of scientific instruments will be knowledgeable in their use. Operator training will occur during in-house programs or as needed and will cover the manufacturer=s instructions, theory of application, procedures to be used and any calibration requirements. Newly introduced equipment or procedures will require a training session for all analysts of the section by the Special Agent in Charge (or designees).
14 These training sessions should be documented in the section training file by the Special Agent in Charge. North Carolina State Bureau of Investigation Equipment Maintenance Forms and Annual Inspection Reports Anytime a piece of equipment requiring service or maintenance - outside of routine in-house maintenance - will be documented on a Laboratory Instrument and Equipment Repair Record form Calibration, Certification and Inspection Logs Each piece of equipment which needs to calibrated, certified and/or inspected will be checked on an appropriate schedule deemed appropriate by each section. These logs will be maintained using appropriate standards and will be documented on a log within each section. Some instruments will be inspected and certified routinely by certified external agencies (e.g. Bio-Hood and Fume Hoods) 5.2 Materials, Reagents, Chemicals, and Supplies Sources of Materials, Reagents, Chemicals and Supplies Each section will maintain a listing of commercial sources for all materials, reagents, chemicals and supplies used in the Crime Laboratory. This listing will show the catalog number, supplier, and required grade, when appropriate Procurement All orders for materials, reagents, chemicals and supplies will be placed by a designee within each section and approved by the Special Agent in Charge. Copies of all orders will be maintained and provided to the Deputy Assistant Director of the as appropriate Receipt of Chemicals, Supplies, Reagents and Materials All chemicals, reagents, supplies and materials will be received in each section by an assigned analyst, so that they can be checked off against
15 the orders placed. The chemicals, reagents and some appropriate materials are labeled with a ADate sticker that lists the date opened and the initials of the analyst who opened the container. North Carolina State Bureau of Investigation All inventories will be stored under the conditions specified by the manufacturer. Any materials which require special handling will be handled appropriately and under conditions specified in the Section=s Safety Manuals Material Safety Data Sheets Material Safety Data Sheets will be maintained on all chemicals and reagents used in the Laboratory Prepared Reagents and Solutions All lab-prepared reagents and solutions will be made with great care and using good lab practices. A log for each solution will be maintained for each solution prepared with the following information recorded: chemicals used and their appropriate lot #, amount made, dates prepared, expiration date, and initials of the preparing analyst. All lab-prepared reagents and solutions will be clearly labeled as to the contents of the container, date of preparation, date of expiration, and initials of the preparer. All reagents will be stored under appropriate conditions. Recipes for all approved lab-prepared reagents and solutions will be maintained in the Technical Procedures Manual. The Technical Procedures Manual will give an ingredient list, safety notes, if applicable, preparation instructions and storage instructions Preparation of Glassware and Plasticware All glassware and plasticware will be clean prior to use. Disposable plasticware will be disposed of immediately after use Disposal of Materials, Reagents, Chemicals and Supplies
16 Disposal of hazardous wastes will be handled as described in the Section=s Chemical Hygiene Plan and according to applicable Laboratory Safety Manuals. North Carolina State Bureau of Investigation Calibrations of Equipment Equipment requiring calibration will be calibrated according to section guidelines and maintained on appropriate logs within each section. Refer to each section/unit for copies of manuals, logs and reports.
17 6.0 Evidence Handling 6.1 Evidence Labeling and Documentation All analysts will ensure that all evidence received is in a sealed condition (unless the nature of the evidence makes this impossible). Analysts will identify the evidence container with the appropriate laboratory file number, affix the date received and their initials to the evidence container. The analyst will then place the evidence in their assigned locked evidence storage area unless the nature of the evidence makes it a biological hazard. In this case the analyst will utilize putrid evidence rooms or other appropriate storage areas to protect themselves and others from contamination Upon opening the evidence container the analyst will compare the contents with the SBI-5 and identify the evidence with the assigned laboratory file number, the item number, date and initials. If there is a discrepancy, the analyst will report this to the Special Agent in Charge or his designee for verification. The requesting officer will then be notified. 6.3 When the laboratory analysis is complete, the analyst will return the evidence to the evidence container, seal and identify the container. The analyst will return the evidence to their assigned evidence storage area until it is returned to the appropriate evidence technician, officer, or transferred to another laboratory section for further analysis.
18 7.1 Manuals The Director and Deputy Assistant Director of the will be responsible for maintaining a for the laboratory. This manual will be updated as necessary and provide to each section as appropriate The Director and Deputy Assistant Director of the will be responsible for maintaining a Directives Manual for the laboratory. This manual will be updated as necessary and incorporated into the Directives Manual when applicable. 7.2 Section Policy and Procedure Manuals Each section of the will maintain an individual Policy and Procedure Manual deemed appropriate by the Director, Special Agent in Charge/Supervisor or designee within the section The Special Agent in Charge/Supervisor or designee of each section will update, revise and/or rescind these orders as necessary and provide documentation to the Director of the as appropriate to effect such changes. Refer to each section/unit for a copy of individual Section Policy and Procedures Manuals.
19 8.0 Validation of Analytical Procedures 8.1 procedures used in forensic analysis will be readily available to analysts of the. 8.2 A designated research analyst in each section will be responsible for all research of new reagents, test of new equipment and other experimentation conducted within the section. The Special Agent in Charge may implement or discontinue procedures at any given time based on current forensic practices. 8.3 Each analyst in the may maintain a personal copy of the section=s technical Procedures Manual. A copy of this manual will be maintained in each section conference room. The Special Agent in Charge or designated research analysts will be responsible for distribution of all updates and changes to each of these manuals. 8.4 A designated analyst conducting research on a specific reagent, processing method or equipment may utilize the techniques and chemicals with the approval of the Special Agent in Charge. Research and validation standards must be conducted while obeying all safety and operating guidelines which are available at the time. 8.5 New methodology within the will be researched and validated prior to usage with specific criteria and documentation Standards Each chemical procedure will be tested on various types of applicable substrates to determine the feasibility and practical application in each section. New instrumentation and equipment will be subjected to known standard validation procedures and the results documented when applicable Consistency - Any significant modification made to the analytical procedures provided will be compared to the original procedure using identical samples when possible. Techniques tested will be compared to previously approved or existing applicable procedures and the results compared. Results should be reproducible to ensure consistency.
20 8.5.3 Time - Various substrates with test impressions will be treated and/or tested at various periods of time to compare and document the results. If feasible, various environmental conditions should be included in this process Documented Reports - Methodology Research Reports will include all chemicals necessary for procedure(s), formulations and/or directions for preparation of solution(s), application techniques, preservation methods, type of sample utilized and how treated, any variances of prior methods, safety considerations and final comparisons, conclusions and results All procedures will be supported by available literature and pertinent documentation, research and test records, control samples and/or photographic reproductions, and safety information. This reference material should be compiled and maintained by the research analyst for review by any member of the forensic science community Upon approval and review of procedures by the Special Agent in Charge, Safety Officer and/or the Deputy Assistant Director, the research analyst will develop written procedures on all techniques and equipment. 8.6 Historical and Archive Records Documentation related to any technical procedure removed from the approved list of procedures will be maintained by the Special Agent in Charge or his/her designee.
21 9.0 Data Analysis and Reporting 9.1 Independent Analysis/Review of Data All analysis performed within each section will be independent and conclusions based on scientifically sound premises. Each section should adopt guidelines to ensure analysis is conducted according to quality assurance programs. 9.2 Tolerance Limits for Matches All identifications or positive results will be independently reviewed by a second qualified analyst when appropriate. The reviewing analyst will document this review in the case notes and both analysts must agree on the interpretation of the data to be reported All other results may be verified by another analyst according to section guidelines. 9.3 Corrective Action for Analytical Discrepancies Corrective actions taken whenever analytical discrepancies are detected will be in accordance with the section policies and procedures and the State Bureau of Investigation Policy & Procedures Manual. 9.4 Report Writing and Review Lab reports will be issued on all examinations Review of Reports All lab reports will be reviewed by appropriately designated personnel as approved by the Special Agent in Charge.
22 9.5 Case Statistical Reports Statistical reports will be submitted to the Director=s Office at the end of each week or the last working day by the individual analyst. This information will be compiled each week by the Director=s Office and distributed to each Special Agent in Charge and the SBI Director.
23 10.0 Proficiency Testing 10.1 Open Proficiency Testing All personnel conducting forensic examinations will be tested at least once each year for each trained discipline with an open proficiency test. These tests may be prepared internally and/or may be part of an external proficiency testing program. Each section may adopt additional guidelines as deemed appropriate by the Special Agent in Charge/Supervisor Proficiency Test Files The Special Agent in charge will maintain records of all proficiency tests taken, any deficiencies noted, and - if applicable - corrective action taken. All deficiencies will be corrected according to the SBI Policy and Procedure manual. These records will be maintained by the Deputy Assistant director of the Crime Laboratory.
24 11.0 Internal Quality and Control 11.1 Bulk Evidence Storage Rooms Policy for use of bulk evidence storage rooms will comply with each section policies and procedures Labeling Evidence and Evidence Containers Each analyst will be responsible for properly marking all evidence containers upon receipt. After completing the case, the analyst will be responsible for labeling the evidence with identifying marks to ensure proper identification at a later date Putrid Evidence Rooms Putrid Evidence will be placed in a putrid evidence room for a time not to exceed the time it takes for the evidence to air dry or in and appropriate storage area within the. Once the putrid evidence has dried, the evidence will be removed from this area and prioritized in order to limit exposure of possible contamination Technical Case Review case All laboratory reports and case notes will have a peer review conducted by another analyst with expertise in the discipline used during the analysis. The technical review must be documented on the case note cover sheet or other pages approved by the Special Agent In-Charge. The review will be to such an extent as to determine that the conclusions of the analyst are reasonable and within the constraints of scientific knowledge. The technical review ensures that the results and conclusions drawn in the laboratory report are substantiated by the notes.
25 11.5 Administrative Case Review After the technical review has been conducted, the Special Agent in Charge or a designee will review both the case notes and the report to ensure the result of the analysis is accurate and complete. The scope of the administrative review also includes an overall quality control check of the case notes and report Final Quality Control Check review ensure Each section may implement a final quality review of case notes and reports printed from LIMS. A final quality control check or clerical may be conducted by another analyst or the Office Assistant to the reports and notes are in compliance with section policy and procedures.
26 12.0 Court Testimony 12.1 All analysts, technicians or support personnel testifying in court will be evaluated at least once annually following the evaluation cycle by an appropriate individual according to SBI Policy and Procedures. When an analyst, technician or support personnel does not testify during this period, the Special Agent in Charge will ensure that the Deputy Assistant Director documents this on Crime laboratory logs at the conclusion of this period Court testimony of Analysts will be monitored in accordance with section policies and procedures and the State Bureau of Investigation Policy & Procedures Manual. Court testimony evaluations will be documented on an SBI Expert Evaluation form (SBI-20) Feedback will be provided to each employee testifying and this review documented by the Special Agent in Charge and the testifying employee. Upon completion of this review, the original form should be forwarded to the Deputy Assistant Director of the for inclusion in laboratory files.
27 13.0 Communications 13.1 Complaints Complaints will be dealt within accordance to the State Bureau of Investigation Policy & Procedures Manual Disclose of Information Information will be disclosed and disseminated in accordance with the State Bureau of Investigation Policy & Procedures Manual
28 14.0 Audits 14.1 Audits are an important aspect of the quality assurance program. They are an independent review conducted to compare the performance of a section with a standard within the appropriate disciples. These audits are designed to provide Management an evaluation of the performance of each section in meeting quality assurance policies and objectives. These audits will occur at least once annually and may be conducted by the Special Agent in Charge or designee Annual ASCLD-LAB Internal Audit Each year, except the year of an ASCLD-LAB on-site Inspection, each section will be audited by a special team composed Personnel. These individuals will prepare a report for the Assistant Director of the Laboratory and the Special Agent in Charge of each section. The Special Agent in Charge will review all findings and will maintain this report along with documentation of steps taken to resolve any problems detected. The Special agent in Charge will have the option of responding to all findings and reports and provide documentation of action taken to resolve existing problems SBI Inspection Each section of the is routinely inspected by an SBI Inspection Team. This team is composed of several agents from various field districts or laboratory sections and the Special Agent in Charge of Professional Standards. During this time, all phases of the operation of the section are scrutinized including: evidence handling and accountability, case turn-around-time, report writing, note taking, management practices, leave and time management policies, security, records security, inventory of equipment and supplies and personnel records.
29 15.0 Safety 15.1 Policy The will operate in strict accordance with the regulations of the pertinent federal, state, and local health and safety authorities Written Manuals Written general laboratory safety manuals will be prepared and available to all employees of the. General Laboratory Safety guidelines are covered in the North Carolina Department of Justice Employee Safety and Health Manual and the North Carolina State Bureau of Investigation Safety Procedures Manual Disposal of Biological Waste Disposal procedures for biological wastes are covered in the North Carolina State Bureau of Investigation Safety Procedures Manual, the Blood Borne Pathogens Manual, and Chemical Hygiene Plan. Disposal of biological wastes generated by the should be coordinated with the SBI Molecular Genetics Section.
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