SWIFS Quality Management Program Quality Manual v2.3 (02.28.2008) 53 Pages

This is a non-controlled copy of a controlled document
Dallas County Institute of Forensic Sciences Forensic Laboratory
QUALITY MANAGEMENT PROGRAM Quality Manual, Version 2.3
Authorized by: Jeffrey J. Barnard, M.D. Director and Chief Medical Examiner Chris Heartsill Quality Manager (Acting) Timothy J. Sliter, Ph.D. Chief, Physical Evidence Elizabeth Todd, Ph.D. Chief, Forensic Chemistry Effective date: February 28, 2008
Quality Manual, Version 2.3 Effective Date: 2/28/08
Summary of Changes from Previous Version

Previous version: Current version: Quality Manual, Version 1.0 Quality Manual, Version 2.X
1. Corrections of various typographical and grammatical errors. 2. Various non-substantive changes in wording and format to improve clarity. 3. Revision of Distribution List page and 3.4 to reflect electronic distribution of the manual through the Quality Management System Portal. 4. Addition of 5.4.1.1.2.1, 5.5.8, 17.4.4.1, and 17.4.4.2 to clarify responsibilities of the Executive Committee and Director in instances of alleged serious negligence or misconduct by staff or subcontractors. 5. Revision of 9.1.2 to clarify Custodian of Records responsibilities. 6. Addition of 9.2.3.1.1 to address case number identification of administrative documents in the case file. 7. Addition of 9.2.3.2.4 to clarify responsibility of report signers to initial pages of supporting documentation package. 8. Addition of 9.2.8 concerning policies regarding bench notes. 9. Addition of 11.2.1 concerning distribution of hardcopy and electronic manuals. 10. Addition of 13.9 concerning individual characteristic database samples. 11. Revisions of 16.3 concerning technical/peer review of case records. 12. Revisions of 21 to clarify policies related to media contacts and disclosure of information. 13. Revision to Peer/Technical Review Form to eliminate routine forwarding to Quality Manager.
Quality Manual, Version 2.3 Effective date: 2/28/2008
Revisions & Corrections Quality Management Program Quality Manual, Version 2.X Effective Description Date 10/8/2007 Addition of section: Summary of Changes From Previous Version 10/8/2007 Changes to 16.3 to clarify technical/peer review practices: revisions of 16.3.4 & 16.3.7; additions of 16.3.3.1, 16.3.4.1-8; 16.3.5, 16.3.6, 18.3.8.1, and technical/peer review form 10/8/2007 Revisions of page numbers. 1/13/2008 Addition: 4.4 (re: type and extent of laboratory examinations) 1/13/2008 Addition: 7.1.1 (re: minimum education requirements) 1/13/2008 Revision: 9.3.3.2 (re: distribution of analytical reports) 1/13/2008 Addition: 10.6 (re: measurement standards 1/13/2008 Addition: 14.1.1.1 (re: standards for equipment maintenance & calibration) 1/13/2008 Various non-substantive changes in wording and formatting to improve clairity 1/13/2008 Revisions of page numbering 2/27/2008 Addition of 9.4.2 clarifying that case records are maintained indefinitely 2/27/08 Revision of 10.6 to clarify that certain measurement standards are verified annually against traceable standards 2/27/08 Revision of page numbering Authorized by TJS TJS
TJS TJS TJS TJS TJS TJS TJS TJS ELT ELT ELT
ii
Dallas County Institute of Forensic Sciences Forensic Laboratory QUALITY MANUAL
DISTRIBUTION LIST
The Quality Management Program Quality Manual is maintained as an electronic document that is accessible to all staff through the Quality Management System Portal web page.
iii
Table of Contents Section 1. 2. 3. 4. 5. 6. 7. 8. 9. Page
Policy Statement and Purpose of the Laboratory.................................................................... 3 Objectives of the Quality Management Program ................................................................... 3 Purpose of the Manual ............................................................................................................ 4 Scope and Organization of the Forensic Laboratory .............................................................. 5 Quality Management Responsibilities:................................................................................... 5 Job Descriptions...................................................................................................................... 9 Educational Background and Training Records ..................................................................... 9 Training Programs ................................................................................................................ 10 Case Record Management and Control ................................................................................ 12
10. Quality Assurance of Standards, Controls, and Reagents .................................................... 20 11. Procedure Manual Control and Maintenance ....................................................................... 22 12. Development, Validation, and Verification of New Testing Methods ................................. 23 13. Evidence Handling................................................................................................................ 25 14. Instrument Operation, Calibration, and Maintenance........................................................... 29 15. Facility Security and Maintenance ....................................................................................... 30 16. Quality Assurance/Quality Control ...................................................................................... 31 17. Self-Critical Review and Corrective Action......................................................................... 36 18. Review of Testimony............................................................................................................ 40 19. Departure from Documented Policies and Procedures ......................................................... 41 20. Addressing Complaints......................................................................................................... 42
21. Disclosure of Information ..................................................................................................... 42 22. Reviews and Audits .............................................................................................................. 42 23. Annual Quality System Review............................................................................................ 44 Appendices Peer Technical Review Form Request for Review (RFR) Form Corrective Action Request (CAR) Form
Dallas County Southwestern Institute of Forensic Sciences Forensic Laboratory Quality Management Program 1. 1.1. Policy Statement and Purpose of the Laboratory The Forensic Laboratory of the Dallas County Southwestern Institute of Forensic Sciences (IFS or SWIFS) is committed to serving the needs of the Dallas County Office of the Medical Examiner, submitting agencies, and the citizens of Dallas County by providing a broad spectrum of forensic analyses performed accurately, impartially, and in a timely manner. To support this commitment, a quality management program has been developed to ensure the ongoing quality, integrity, and reliability of analyses performed, reports generated, and testimony provided by IFS personnel. IFS staff acknowledge the unique responsibility inherent in conducting forensic analyses and the expectation that all work performed will be of exemplary caliber. Ensuring a competent and accurate work product requires a personal dedication to quality and an active participation in this quality management program by every employee. The components of the program include 1.4.1. quality control (QC) - activities used to monitor the quality of analytical data and to ensure that it satisfies specified criteria such as positive and negative controls, standards, and blanks, and quality assurance (QA) planned and systematic actions necessary to provide sufficient confidence that a laboratorys work product satisfies specified quality requirements, for example, peer review, proficiency tests, instrument calibration, assay verification, reviews and audits, etc. Objectives of the Quality Management Program IFS staff support this Quality Management Program designed to provide: 2.1.1. Accurate and relevant testing procedures which are scientifically sound and adequately documented utilizing commonly accepted instrumentation and equipment in proper working order; Analytical procedures which are based upon sound scientific principles and which have been validated as to accuracy and reliability; Acceptable operational performance of procedures, critical reagents, and 3
1.2.
1.3.
1.4.
1.4.2.
2. 2.1.
2.1.2. 2.1.3.
instrumentation; 2.1.4. 2.1.5. Testimony which is truthful, complete, and impartial provided in a professional manner; Hiring and training of qualified staff with verification of acceptable competency and provision of ongoing training and professional development for staff as appropriate; Periodic evaluation of procedures and analysts through participation in internal and/or external proficiency testing and peer review; Use of quality analytical standards of known purity and/or composition from reputable manufacturers where available and appropriate; Evidence handling processes which provide care, custody, and control of evidence and case records; Participation as applicable in the Annual Internal Review, ASCLD/LAB Annual Accreditation Audit Report, Annual Quality System Review, and other audits and reviews; and Maintenance of ASCLD/LAB accreditation. Due to the nature of work performed, not all aspects of this program apply to the Breath Alcohol Section; this Program will comply with this program as applicable. 3. 3.1. 3.1.1. Purpose of the Manual The purpose of this manual is as follows: To establish a mechanism to assure that activities conducted by the Forensic Laboratory of the Dallas County Southwestern Institute of Forensic Sciences meet the quality management objectives listed above which are designed to ensure a quality work product, To establish quality control and quality assurance processes as an integral and necessary component in providing competent forensic analyses, To communicate expected quality management activities to laboratory staff; and To ensure a consistent approach to quality management throughout the Forensic Laboratory. Implementation of this manual requires written authorization by the Director, Section Chiefs, and the Quality Manager. The Quality Manual is reviewed annually by the Quality Manager. 3.3.1. The Director, Section Chiefs, and Quality Manager must approve changes 4
2.1.6. 2.1.7. 2.1.8. 2.1.9.
2.1.10. 2.2.
3.1.2. 3.1.3. 3.1.4. 3.2.
3.3.
to the Manual prior to implementation. 3.3.2. 3.4. 3.4.1. 3.4.2. Out-dated Manuals are archived by the Quality Manager. The Quality Manual is readily available to Forensic Laboratory staff. The official copy of the Quality Manual is kept by the Quality Manager. The Quality Management Program Quality Manual is maintained as an electronic document that is accessible to all staff through the Quality Management System Portal web page. Scope and Organization of the Forensic Laboratory The Forensic Laboratory is a division of the Dallas County Southwestern Institute of Forensic Sciences and was established by the Dallas County Commissioners Court in a joint effort with UT-Southwestern Medical School. The Forensic Laboratory is an independent laboratory, and the Director of the Institute reports directly to the Dallas County Commissioners Court and the Chair of the Pathology Department of UT-Southwestern Medical School. With respect to operation of the Forensic Laboratory, funding, operation and reporting responsibilities rest with the Dallas County Commissioners Court. Selected senior science staff also serve as faculty at UT - Southwestern Medical School. A current organizational chart is maintained by the Director. The Laboratory operates on a fee-for-service basis, and its services are available to anyone paying the fees authorized by the Dallas County Commissioners Court within the policies and guidelines established by the Dallas County Commissioners Court and the Director of the Institute. A list of current disciplines and sub-disciplines in the Crime Laboratory is maintained by the Quality Manager. Type and extent of laboratory examinations. 4.4.1. The criminal investigation laboratory performs evidence examinations and testing in the following analytical disciplines: Firearms & Toolmarks, Trace Evidence, and Forensic Biology (Serology & DNA), Toxicology, and Controlled Substances. The specific analyses performed by each analytical unit can be found in the technical procedure manuals of the units. Quality Management Responsibilities:
4. 4.1.
4.1.1.
4.1.1.1.
4.1.2. 4.2. 4.3.
4.3.1. 4.4.
4.4.2. 5.
5.1. 5.1.1.
Employees. Employees have the following responsibilities: To actively participate in the quality management program and follow policies and procedures outlined in this Manual, applicable procedure manuals, and other policy and procedure documents; To diligently and accurately perform the duties of their position; To immediately bring to the attention of their Supervisor, Section Chief, or Director any situation which potentially compromises the integrity of work performed or reported by Institute personnel; To perform proficiency tests in the same manner as regular casework; To complete proficiency tests, peer reviews, and courtroom monitoring in a timely manner and as applicable; and To review results of QC/QA activities with Supervisor or Section Chief, provide written comment if applicable, and implement corrective action as necessary. Section Chiefs. Section Chiefs have the following responsibilities: To support and implement the Quality Management Program; To communicate quality management policies and procedures to employees; To ensure that all personnel receive necessary training and are qualified to perform assigned work; To ensure completeness of case records and reports; To ensure active and timely participation by staff in proficiency tests, peer reviews, courtroom monitoring, and other QC/QA activities; To establish criteria for acceptable performance on proficiency tests, peer reviews, courtroom monitoring, and other QC/QA activities; To approve the selection and use of analytical procedures; To review and update methods and procedures; To establish criteria for method and procedure validation; To implement corrective action as appropriate, review QC/QA performance with the appropriate staff, and provide written comment as necessary to the Quality Manager; To assist the Quality Manager in review and evaluation of quality processes including the Annual Internal Review, ASCLD/LAB Annual Accreditation Audit Report, Annual Quality System Review, and other audits and reviews; and To delegate quality management responsibilities as applicable. 6
5.1.2. 5.1.3.
5.1.4. 5.1.5. 5.1.6.
5.2. 5.2.1. 5.2.2. 5.2.3. 5.2.4. 5.2.5. 5.2.6. 5.2.7. 5.2.8. 5.2.9. 5.2.10.
5.2.11.
5.2.12.
5.3.
Quality Manager. The Quality Manager reports directly to the Director and has primary responsibility and oversight for implementation, documentation, and assessment of the quality management program described in this manual. The Quality Manager has the following responsibilities: 5.3.1. 5.3.2. 5.3.3. 5.3.4. 5.3.5. To maintain and update the quality manual; To monitor laboratory practices to verify continuing compliance with policies and procedures; To maintain official copies of manuals; To ensure documentation of routine instrument calibration, maintenance, and repair; To periodically assess the adequacy of report review activities including peer review; ensure that peer review and courtroom monitoring are conducted and evaluated in a timely manner; To ensure the validation of new technical procedures and instrumentation; To investigate technical problems, propose remedial actions, and verify their implementation; To ensure that appropriate proficiency tests (internal and/or external) are ordered, performed in a timely manner, and evaluated; To select, train, and evaluate internal inspectors; To schedule, coordinate, and conduct the Annual Internal Review, Annual ASCLD/LAB Accreditation Audit, Annual Quality System Review, and other audits and reviews; To maintain applicable training and educational records of laboratory personnel; To recommend training to improve the quality of laboratory staff; To oversee the Request for Review (RFR) and Corrective Action Response (CAR) processes; To maintain a current listing of employees, signatures, and initials; To propose corrections and improvements in the quality system; To communicate with ASCLD/LAB and the Texas Department of Public Safety (DPS) as applicable; and To delegate quality management issues as applicable. Quality Committees At the discretion of the Quality Manager, ad hoc committees and working groups may be established to assist in maintaining and improving laboratory quality and maintaining ASCLD/LAB accreditation. Standing 7
5.3.6. 5.3.7. 5.3.8. 5.3.9. 5.3.10.
5.3.11. 5.3.12. 5.3.13. 5.3.14. 5.3.15. 5.3.16. 5.3.17. 5.4. 5.4.1.
committees include: 5.4.1.1. 5.4.1.1.1. Executive Committee Membership includes the Quality Manager, Section Chiefs, Forensic Coordinator, and other staff as identified by the Director. Duties include managing the request for review and corrective action processes, identifying new quality initiatives, assessing overall effectiveness and compliance with the quality program, ensuring applicability of quality program for all laboratories, participation in the ASCLD/LAB Annual Accreditation Audit Report, Annual Internal Review, Annual Quality System Review and other audits and reviews, providing assistance to the Quality Manager, etc. The Executive Committee has the responsibility to investigate alleged incidents of serious negligence or misconduct by staff or subcontractors that substantially affect the integrity of the scientific analyses performed and reported by the Institute; to report such incidents to the Director for review and referral to the accrediting bodies, the Texas Department of Public Safety, the Dallas County District Attorneys Office, and other agencies as appropriate. Institute Quality Committee Membership includes Quality Manager, Section Chiefs, Supervisors, one analyst from each laboratory, EHS Manager, Deputy EHS Manager, and other staff as identified by the Director. Duties include identification of quality related issues requiring action, implementation of new quality initiatives, dissemination of quality related information to respective laboratories, participation in proposing changes to the Quality program, etc. To ensure an active quality management program within the Forensic Laboratory, investigate concerns regarding QC/QA processes that are brought to his attention, and review QC/QA reports prepared by the Quality Manager; 8
5.4.1.1.2.
5.4.1.1.2.1.
5.4.1.2. 5.4.1.2.1.
5.4.1.2.2.
5.5. 5.5.1.
Director. The Director has the following responsibilities:
5.5.2. 5.5.3. 5.5.4. 5.5.5. 5.5.6. 5.5.7. 5.5.8.
To support and promote implementation of the quality management program; To review and respond as applicable to the Annual Accreditation Audit and Annual Quality System Review; To seek adequate funding to maintain a quality laboratory operation; To identify a Quality Manager to oversee implementation of the quality management program; To resolve disputed quality issues; To delegate quality management responsibilities as applicable. To review allegations received from the Executive Committee of serious negligence or misconduct by staff or subcontractors that substantially affects the integrity of the scientific analyses performed and reported by the Institute; when warranted, to refer such allegations to accrediting bodies, the Texas Department of Public Safety, the Dallas County District Attorneys Office, and other agencies as appropriate. Suggestions for improving the Quality Management Program can be made to the Quality Manager, Section Chief, and/or Director.
5.6.
6. 6.1.
Job Descriptions The Director maintains currently available job descriptions of employees in the Forensic Laboratory which have been approved by the Dallas County Commissioners Court. The Director may approve use of a more detailed statement of job functions, as necessary.
6.2.
7. 7.1.
Educational Background and Training Records The educational background of each Laboratory employee at in-hire is documented on the Dallas County employment application and/or in-hire curriculum vitae which are maintained by the Director.
7.1.1.
The minimum educational requirements for each laboratory position are established in accordance with applicable accreditation standards (ASCLD-LAB) and Dallas County employment policies, and are documented on the official Dallas County job description for each position. Documentation of job prerequisites, such as academic degrees or specific course work, may be required; failure to provide this documentation may result in disciplinary action including termination in accordance with Dallas County policies. 9
7.2.
7.3.
Each analyst will develop a curriculum vitae, resume, or statement of qualifications summarizing education, training, publications, presentations, and other pertinent information which is maintained by the Quality Manager. 7.3.1. This resume is updated annually as necessary by the analyst and under the direction of the Quality Manager. It is the employees responsibility to provide the Quality Manager with documentation of all educational and/or training experiences related to the employees job duties at the Institute. The Quality Manager is responsible for maintaining the following portions of the employees personnel file: documentation of academic degree and/or other educational or training requirements, training records, current resume, and competency testing documentation. 7.4.1. 8. Only the current version of an employees resume is kept. Training Programs Professional Training Employees must receive appropriate training prior to conducting independent casework. Training programs are developed under the direction of the appropriate Section Chief and reviewed by the Quality Manager. The Quality Manager is the official custodian of training records. The purpose of the training program is to ensure that each trainee demonstrates a basic proficiency in the following as applicable: applicable methods used by the Laboratory, academic basis for methods used, the use and basic troubleshooting of equipment, the general theory of the analytical techniques and instrumentation, evidence handling, expectations of a forensic examiner, skills of testimony, and other components of the job duties. The training program is utilized for training new employees prior to conducting casework, training current employees who are newly assigned or 10
7.3.2.
7.4.
8.1. 8.1.1. 8.1.2. 8.1.3. 8.1.4.
8.1.4.1. 8.1.4.2. 8.1.4.3. 8.1.4.4. 8.1.4.5. 8.1.4.6. 8.1.4.7. 8.1.4.8. 8.1.5. 8.1.5.1. 8.1.5.2.
reassigned, and 8.1.5.3. 8.1.6. retraining of current employees as needed. Competency testing is an integral part of a training program and should include evaluation of knowledge of appropriate literature, examination and identification of known and unknown materials, written and/or oral examination, and moot court as applicable. Competency testing protocols are a part of the training program within each Section, and the areas for demonstration of competency are covered in the training manual. Competency test results are reviewed by the Section Chief and forwarded to the Quality Manager for review. Once competency is established, acknowledgement of successful completion is included in the training documents held by the Quality Manager. Individual test results are not required to be kept as long as the specific areas covered are included in the training manual, check list, or other related document. Regardless of academic qualifications or prior employment, new employees and current employees who are reassigned or newly assigned must successfully demonstrate competency in each applicable area of examination prior to performing independent case-connected examinations. When an employee requires retraining, the Section Chief, Supervisor, and Quality Manager will determine the appropriate portions of the training program to be completed. Independent casework in the designated training area may not be performed during a retraining period. Continuing Education and Ongoing Training 8.2.1. 8.2.1.1. It is important that analysts maintain technical qualifications through participation in continuing education and/or training programs. Continuing education and training activities must be documented and may include reading current scientific literature, participation in educational lab meetings, and/or attending seminars, courses, professional meetings, training sessions and/or classes in relevant subject areas. The Director and Section Chief determine appropriate use of training funds and training resources. Funding for training and continuing education is made available by the Dallas County Commissioners Court during the annual budget process. 11
8.1.6.1.
8.1.6.2. 8.1.6.3.
8.1.7.
8.1.8.
8.2.
8.2.2. 8.2.2.1.
8.2.2.2. 8.2.2.3. 8.2.2.4. 8.2.2.5.
Employees may request training by providing a written request to their Section Chief. Supervisors may also identify and recommend appropriate training opportunities for staff. The Quality Manager may recommend training. Training requests are evaluated based upon history of previous training, need of the individual and Institute, availability and location of training, employee performance, availability of funds, recommendation of the Quality Manager, and/or other applicable criteria. The Quality Manager maintains documentation of continuing education and training activities. Training activities are included as a part of the employees annual resume update.
8.2.3. 8.2.3.1.
8.3. 8.3.1. 8.3.2. 8.3.3.
Environmental Health and Safety Training It is the responsibility of each employee to attend environmental, health, and safety training. Details of the safety training program may be found in the Institute of Forensic Sciences Environmental Health and Safety Manual. It is the responsibility of each employee to bring safety concerns immediately to the attention of their supervisor. Case Record Management and Control Definitions 9.1.1. Case Record (Case File) Files containing administrative and examination documentation generated or received by a laboratory pertaining to a particular case and used in reaching the conclusions reported. Administrative Documentation Non-technical or non-analytical records such as case related conversations, evidence receipts, request/submission forms, description of evidence packaging and seals, subpoenas, correspondence, investigative reports, peer review documentation, case reports, and other related information. Examination Documentation Technical and analytical records such as notes, reference to procedures followed, tests conducted, 12
9. 9.1.
9.1.1.1.
9.1.1.2.
standards and controls used, data, worksheets, instrument output/chromatograms, spectra, graphs, sketches, diagrams, printouts, photographs, observations and results of examinations, and other related information. 9.1.1.2.1. Notes The documentation of procedures, standards, controls and instruments used, observations made, results of tests performed, charts, graphs, photos, and other documents generated which are used to support the examiners conclusions. Records Custodian (Custodian of Records) Individual(s) designated by the Section Chief with responsibility for maintaining care, custody, and control of case records including but not limited to Institute Custodian of Records Director Custodian of Records for Section applicable Section Chief and Deputy Section Chief Custodian of Records for a Laboratory applicable Supervisor Deputy Custodian of Records for Section or a Laboratory applicable Evidence Registrar(s), applicable Senior Analysts, and others as designated by Section Chief. Analysts are Deputy Custodians of Records for cases in which they performed work. The case record, i.e. case file, should contain adequate information so that another competent analyst or supervisor can independently evaluate and interpret the data. The Laboratory maintains case documentation in a case file denoted by a unique laboratory case number. Case numbers include a letter designator specific to a particular laboratory or Section: P (Physical Evidence), C (Drug Analysis Laboratory), M or no letter designation (Medical Examiner Toxicology), D (DWI/DUID Toxicology), H (Other Toxicology), B (Breath Alcohol). Case numbers include a year designator. Case numbers within a specific year and letter combination are assigned sequentially. Examples include 98C1234, 03P0011, etc. Medical Examiner cases may be designated as 03M1234 or 1234-03 to allow for historical numbering in the Office of the Medical Examiner. Case records must be identified. 13
9.1.2.
9.1.2.1. 9.1.2.2. 9.1.2.3. 9.1.2.4.
9.2. 9.2.1.
Preparation of Case Records
9.2.2. 9.2.2.1.
9.2.2.2. 9.2.2.3. 9.2.2.4.
9.2.3.
9.2.3.1. 9.2.3.1.1.
Administrative Documentation The case number must appear on the first page of an administrative document packet; multi-page administrative documents which are bound together may be identified by placing a case number on the front page of the packet. It is recommended that all pages of administrative documentation are marked with the case number. All pages of the case report must be signed or initialed by the appropriate analyst. Examination Documentation The laboratory case number and analysts signature and/or initials must appear on each page of the examination documentation. It is acceptable for the laboratory case number to be printed by an analytical instrument; the analysts initials and/or signature must be handwritten. When examination documentation is prepared by a trainee or individual other than the one(s) with responsibility for interpretation of the findings, reporting of results, and/or testimony concerning the documentation, both individuals must sign or initial each page of the documentation. The signer(s) of reports must initial each page of the examination documentation package. If an individual other than a signer of the report is called to testify regarding a case report, the individual must review the case file prior to testimony and sign or initial each page of the documentation. Entries into the case record must be made at or near the time of occurrence. Dates must be recorded throughout the case documentation to indicate when work was performed. All case records must be permanent in nature. Where records or work product are inherently unstable, some type of permanent record should be made as appropriate - for example, thermal paper which fades over time should be copied, photographs can be made, etc. 14
9.2.3.1.2. 9.2.3.1.3. 9.2.3.2. 9.2.3.2.1.
9.2.3.2.2.
9.2.3.2.3.
9.2.3.2.4. 9.2.3.2.5.
9.2.4. 9.2.4.1. 9.2.5. 9.2.5.1.
9.2.5.2. 9.2.5.2.1.
Manual entries onto case records must be in ink, not pencil, unless specific applications are required by procedures. It is recommended that manual entries are made in blue or other non-black ink to assist in distinguishing between photocopies and original documents. Nothing in the examination documentation may be obliterated or erased. Corrections, changes, alterations, and additional notations made in examination documentation must be initialed by the individual making the change or addition. Correction fluids like White-Out cannot be used. Post-it type notes are not recommended and, if used, must be taped securely to prevent accidental loss. Original records are included in the case file where possible. When batch instrument reports are generated, a copy of the instrument report may be included in the individual case files, and the original instrument report must be maintained in a designated location. Staff generated paperwork such as work lists may be photocopied and initialed by staff. By initialing, staff attests that photocopied paperwork is an exact duplicate of the original and as such is considered equivalent to the original. Original casework which cannot reasonably be included in a case file, may be stored in a designated location with appropriate notation made in the case file or procedure. Original records are the hard copy materials contained in the case file or other designated location. Original case records may be originally generated by computer but are not stored or archived permanently in this manner. Abbreviations and symbols may be used within the case record provided that their meaning is readily comprehensible to a knowledgeable reviewer. Scientifically accepted abbreviations and symbols may be used without further explanation. Other abbreviations and symbols must be documented in laboratory procedures or other laboratory manuals. Bench notes Bench notes are original records made contemporaneously with laboratory testing that describe observations, results and 15
9.2.5.3.
9.2.5.3.1. 9.2.5.3.2. 9.2.6. 9.2.6.1.
9.2.6.2. 9.2.6.3.
9.2.6.4.
9.2.6.5.
9.2.7. 9.2.7.1. 9.2.7.2. 9.2.8. 9.2.8.1.
measurements that are integral to the examination and data collection process. Bench notes are a type of raw data that document processes and are utilized in forming final conclusions. 9.2.8.2. Bench notes may take the following forms: handwritten entries on designated forms and worksheets; handwritten notes on paper; electronic forms and worksheets. Electronic forms and worksheets are considered bench notes only if completed contemporaneously with the examination, and without an intermediate handwritten record. Bench notes must be legible and understandable to another qualified examiner. The use of personal abbreviations and short-hand notations is not permitted. Laboratory approved abbreviations/short-hand notations may be used if they have been documented in a procedure manual or other laboratory manual. Personal abbreviations/short-hand notations may be used if an explanation has been provided on the actual bench notes. Handwritten bench notes must be written with a pen, not a pencil. It is recommended that blue ink be used rather than black in order to easily distinguish between original documents and photocopies. Additional color coded notations may be used when appropriate. Laboratories are encouraged to design and utilize appropriate worksheets for the recording of handwritten bench notes. The use of scratch paper (e.g., Post-it notes, envelopes, napkins, paper towels) is greatly discouraged. Scratch paper should only be used under exceptional circumstances beyond the control of the analyst, and are considered bench notes 16
9.2.8.2.1.
9.2.8.3. 9.2.8.3.1. 9.2.8.3.2.
9.2.8.3.3.
9.2.8.3.4. 9.2.8.3.4.1.
9.2.8.3.4.2. 9.2.8.3.5.
9.2.8.3.6.
9.2.8.4. 9.2.8.4.1.
Bench notes are part of the examination record and must be retained in the official case file. The original version of all handwritten bench notes is retained in the case file as part of the supporting documentation package for individual reports. If scratch paper is used for making notes due to exceptional circumstances, then the scratch paper must be taped to standard 8 x 11 paper for retention in the case file. If the original bench notes cannot be retained due to some extenuating circumstances such as contamination by a biological material, then the bench notes will be placed in clear plastic and photocopied. The examiner will verify that the copy is complete, accurate and legible; and will make a notation that the copy is being retained in lieu of the original. The photocopy will then be retained. The original will be disposed of appropriately. Under some circumstances it may be necessary for the sake of clarity to rewrite an entire sheet of bench notes. In this situation, the entire original sheet must be struck through and initialed, and a note should be added to the struck-through sheet to indicate that the corrections are on a separate sheet. The new form or note should be marked to indicate that it is a corrected sheet. The original struck-through bench notes must be retained. A printout of electronic bench notes is retained as the official case record in the hardcopy case file. The electronic document is not considered an official case record, and is not retained.
9.2.8.4.2.
9.2.8.4.3.
9.2.8.4.4.
9.2.8.4.4.1.
9.2.8.4.4.2. 9.2.8.4.4.3. 9.2.8.4.5. 9.2.8.4.5.1. 9.3. 9.3.1. Report Generation
Laboratory reports are written and reviewed by the applicable analyst(s) 17

and/or supervisor(s). 9.3.2. 9.3.3. 9.3.3.1. Results and conclusions must be fully supported by data in the case file. The specific content of reports and the mechanism of report distribution are specified by each Laboratory. At a minimum, reports include identity of the examining laboratory, case identifier, date of receipt, date of the report, identity of the submitter, items analyzed, results and/or conclusions, signature of the person(s) accepting responsibility for the content of the report. A copy of the final report is sent to the agency or individual requesting the analysis. In criminal cases this will typically be the investigating agency. As appropriate to particular case circumstances, copies of the final report may be sent to prosecutors assigned to the case, or to other individuals authorized by the requesting agency/individual or by court order. Under some circumstances reports may be released in accordance with state law regarding government open records. Distribution of reports to other entities is noted in the case record. Additions or corrections to final reports are included in the case file. They are appropriately marked (Corrected Report, Supplemental Report, Amended Report, etc.), and copies are provided to all entities receiving the original report. Corrected Report A report in which a change is made to correct an error in the written portion of the original report. Supplemental and Amended Reports Reports detailing either a) new information not covered on the original report and in which findings from the original report are not repeated, or b) new testing information not covered on the original report in combination with a repetition of the original report contents. A copy of all corrected reports is sent to the Quality Manager for review. The Quality Manager determines if an RFR should be initiated. In some areas the report is routinely signed by more than one analyst, usually one primary analyst and one reviewing analyst. If the two signing 18
9.3.3.2.
9.3.3.2.1.
9.3.3.2.2.
9.3.3.3. 9.3.3.4.
9.3.3.4.1.
9.3.3.4.2.
9.3.3.5.
9.3.4.
analysts cannot agree on the content of the report, it is their responsibility to bring this situation immediately to the supervisor. The supervisor will review the situation and attempts to resolve the disagreement by various means which may include seeking consensus and/or reanalysis. If resolution still cannot be reached, the Section Chief is advised. The Section Chief then reviews the situation and offers suggestions for resolution. If consensus cannot be reached, it is ultimately the responsibility of the Section Chief to determine the final course of action which may include reassigning the case, reanalysis, and/or issuing and signing the case report. 9.4. 9.4.1. Case Record Storage, Security, and Disposition The original contents of the case file must remain at the Institute, in the possession of Institute personnel, or under direction of the Dallas County Records Manager. When it is determined that case reports and other records should be released or provided in court proceedings, only a copy of applicable case contents may be provided. Case records may be maintained on-site at the Institute or offsite under the direction of the Dallas County Records Manager. Case records are not disposed but are maintained indefinitely. Case records are stored in secure areas inaccessible to the general public. Proficiency tests and other quality assurance tests may receive a case number; however, proficiency case records are maintained by the Quality Manager. Case records are maintained in accordance with Dallas County policy as implemented by the Dallas County Records Manager. Release of Case Records and Case Information 9.5.1. Work performed by the Forensic Laboratory is provided on a fee-forservice basis. The agency or entity purchasing the services is the owner of the work product. Typically case results are provided to the submitting agency and/or their designee or in response to proper legal direction. Requests for disclosure of case related information falling outside routine release practices are directed to the submitting agency and/or submitted to the Civil Section of the Dallas County District Attorneys Office for review and direction. This may include responses to subpoenas, court orders, freedom of information requests and other inquiries. When the Office of the Medical Examiner (OME) is the submitting agency, requests to release information must follow 19
9.4.1.1.
9.4.1.2. 9.4.2. 9.4.3. 9.4.4.
9.4.5. 9.5.
9.5.2. 9.5.3.
9.5.3.1.
direction established by OME and/or be reviewed by the OME prior to release. 9.5.3.2. Requests to release information submitted by other Dallas County Departments must be reviewed by the Civil Section of the Dallas County District Attorneys Office prior to action.
10. 10.1. 10.1.1. 10.1.2.
Quality Assurance of Standards, Controls, and Reagents Definitions Critical Reagent - Reagent for which small changes in concentration or activity of ingredients will produce significant changes in assay outcome. Standard or Reference Standard A preparation which has known concentration and/or physical or chemical composition used for the purpose of calibrating equipment and/or as an experimental control. Control A standard of comparison for verifying or checking the finding of an experiment. Positive controls verify the presence of analytes or conditions; negative controls verify the absence of analytes or conditions. Reagent Labels Prepared reagents must be labeled with the identity of the reagent and the date of preparation or lot number. Special storage and handling requirements and expiration dates should also be noted on the label if applicable. Reagent Log A record must be kept of reagent preparation including the individual preparing the reagent and that it was tested and worked as expected. Records may include other information such as how the reagent was prepared, lot number, chemical form of the ingredients, etc. Critical Reagents Critical reagents must be of acceptable quality for the intended purpose and of known purity and chemical form. A log must be kept of all critical reagents prepared including the name of the reagent, initials of preparing analyst, date prepared, lot number of principal component(s), and a notation that the reagent worked as expected. Method of preparation should be included if not covered elsewhere, such as the procedure manual. Details of critical reagents prepared and used only in a single analysis may be included in the appropriate case file.
10.1.3.
10.2. 10.2.1. 10.2.2. 10.3. 10.3.1. 10.3.2. 10.4. 10.4.1. 10.4.2.
10.4.3.
20
10.4.4. 10.5. 10.5.1. 10.5.2.
Critical reagents are identified in procedure manuals. Standards Standards should be obtained from reputable suppliers and be of known purity and/or chemical or physical composition. A certificate of analysis will serve to establish the quality of a chemical standard and should be obtained from the chemical supplier where possible. When a certificate of analysis is not available from the manufacturer, standard composition should be verified internally by an applicable analytical technique. A log must be kept of all standard solutions prepared including the name of the standard, the initials of preparing analyst, date of preparation, method of preparation, and lot number. Newly prepared standard solutions must meet quality control criteria established by each laboratory to ensure proper response. Critical measurements will be made using calibrated devices traceable to NIST or other appropriate standards. The following devices are verified against NIST-traceable standards at least once per year: Weights Pipetters Balances Ruler for barrel length Gauge blocks Stage micrometer Calipers Thermometers The records of yearly calibration checks are maintained by the Quality Manager. Other measurement standards and devices specific to particular analytical units are defined in the technical procedures of those units. Controls As applicable, controls, positive and negative, are analyzed on a routine basis according to quality control procedures established by each laboratory. 21
10.5.2.1.
10.5.2.2. 10.6. 10.6.1. 10.6.2. 10.6.2.1. 10.6.2.2. 10.6.2.3. 10.6.2.4. 10.6.2.5. 10.6.2.6. 10.6.2.7. 10.6.2.8. 10.6.3. 10.6.4. 10.7. 10.7.1.
Measurement Standards
10.7.2.
Acceptable response of controls is further verification that the assay including reagents and standards - is functioning properly. Procedure Manual Control and Maintenance The types of examinations conducted at the Institute are listed in the procedure manual for each laboratory. All procedures routinely used by a laboratory are written and readily available to analysts in that laboratory. Procedure manuals are maintained either as hardcopy documents, or as electronic documents For hardcopy procedure manuals, the official manual is maintained by the Quality Manager, and duplicate copies are distributed to functional units as required. For electronic procedure manuals, the official manual is the electronic version accessed through the Quality Management System Portal web page.
11. 11.1. 11.2. 11.2.1.
11.2.1.1.
11.2.1.2.
11.3.
Components of Technical Procedures - As appropriate, procedures will include assay title, principle and/or scope, equipment used, use and preparation of reagents and controls and standards, assay specific instrument parameters, analytical procedures, calculations, corrective action, interferences and other possible sources of error, interpretation and reporting guidelines, safety precautions, references, date of implementation, and other relevant information. Revision of Procedures Administrative revisions to procedures, including typographical errors or clarification of language, typically do not require additional validation. Material technical revisions to procedures require additional validation. Revisions and corrections to procedures are summarized in the front of each manual including effective date of revision, description of the change, and initials of individual authorizing the change. Revisions may be made by memo or by updating procedures; the effective date of implementation must be noted. Prior to implementation of a revision, the update must be approved by the Supervisor and Section Chief and reviewed by all applicable analysts and the Quality Manager. Archived procedures are maintained by the Quality Manager. Out-dated procedures are immediately removed from general accessibility. 22
11.4. 11.4.1. 11.4.2. 11.4.3.
11.4.4. 11.4.5.
11.4.6. 11.4.7.
11.5. 11.5.1. 11.5.2.
Implementation of New Procedures New procedures must be properly validated prior to implementation. The written procedure must be reviewed by all applicable analysts and the Quality Manager and approved by the appropriate Section Chief and Supervisor. The effective date of implementation must be noted on the procedure. Out-dated procedures must be removed from the procedure manual and archived by the Quality Manager for future reference. Procedure manuals are approved annually by the applicable Section Chief. The Quality Manager maintains the official copy of each procedure manual. 12. Development, Validation, and Verification of New Testing Methods For purposes of this section, new testing method is used in a broad sense to include new or revised testing procedures or techniques, new or upgraded instruments or equipment, and/or non-administrative changes to existing written procedures. For example changing the manufacturer of a GC column (DB1 to HP1) is considered an administrative change; changing from one type of GC column to another (DB1 to DB5) requires validation. All new testing methods - including material modifications to existing procedures must be validated after development and prior to use in casework. Method development is the experimental process of devising, revising, or applying a new method for routine use. The end process of method development is a proposed method which must be validated prior to routine implementation in the laboratory. Method validation is the process of testing an analytical method, technique, or instrument to determine its suitability for meeting its intended purpose and to document its reliability under expected conditions of use. Generally the validation process is expected to Evaluate whether a new testing method meets identified analytical needs and current scientific practices; Compare the new test methods performance with existing laboratory methodology; Describe the conditions under which a testing method will produce valid results; Predict possible sources of error; Determine limitations of a testing method; and Establish baseline characteristics of the testing method (linearity, 23
11.5.3. 11.6. 11.7.
12.1.
12.2. 12.2.1.
12.2.2.
12.2.2.1. 12.2.2.2. 12.2.2.3. 12.2.2.4. 12.2.2.5. 12.2.2.6.
accuracy, etc.) which serve as benchmarks to evaluate future method performance. 12.3. 12.3.1. 12.3.1.1. Validation Process The validation process is performed after method development and once a proposed testing method has been finalized. The validation process may identify the need to make changes in the testing method being validated. In this case, the modified testing method must undergo validation. A written procedure, validation plan, and proposed timetable are developed prior to beginning the validation process and are submitted by the supervisor or Section Chief to the Quality Manager for approval. The complexity and comprehensiveness of the validation process should be consistent with the magnitude of proposed testing method changes. The validation plan is based upon the following: The type of method, technique, or analytical instrument or equipment being validated. The complexity of the new testing method and whether it is a minor modification of an existing assay, major modification of an existing assay, or development of a new assay or technique. The Laboratorys experience and familiarity with similar methods, techniques, or analytical instruments or equipment. Method validation must include the testing of known samples. To the extent possible, known samples should resemble actual specimens to allow evaluation of matrix effects, specimen aging, specimen degradation, and sample homogeneity. Known samples may be obtained internally (for example, split samples), externally (for example, reference samples), collaboratively (for example, exchange of blind or reference samples with another competent laboratory). Where applicable, old and new methods should be run in parallel on split samples and results compared. Validation of quantitative methods should include an assessment of accuracy and precision at concentrations expected in case work. 24
12.3.2.
12.3.2.1.
12.3.2.1.1. 12.3.2.1.2.
12.3.2.1.3.
12.3.2.2. 12.3.2.2.1.
12.3.2.2.2.
12.3.2.3. 12.3.2.4.
12.3.3.
At the conclusion of the validation study, a validation report is generated, reviewed/approved by the Supervisor and Section Chief, and submitted to the Quality Manager for review. The validation report contains a copy of the validated method, a compilation of specific validation results, summary of validation parameters identified in the validation plan, a discussion of method applicability and possible limitations, the date of method implementation, etc. The Quality Manager retains the original validation plan and validation report. Once the validation report is reviewed by the Quality Manager, instrumental records may be discarded provided that the results are adequately summarized in the validation report. The Quality Manager places the new or revised procedure in the official procedure manual. The Supervisor ensures that the new procedure is released for routine work, and that training, as needed, is conducted. The Supervisor ensures that any outdated procedure is immediately removed from use. Evidence Handling Procedures. Each Section or Laboratory specifies procedures for proper submission, packaging, documentation, preservation, storage, and release of evidence. Evidence Seals - Where feasible, all evidence is stored in a sealed condition. A container is properly sealed when the container is secured in a permanent manner to prevent undetected access to the contents, when its contents cannot readily escape, and when its contents are not subject to external contamination. The seal must be marked with an identifying mark or the initials of the person sealing the evidence. Ideally, evidence which is delivered in person and is not properly sealed will be properly sealed by the submitter prior to receipt by the Evidence Registrar. It is the responsibility of the Evidence Registrar or other individual receiving evidence to ensure that all evidence accepted by the laboratory is stored under proper seal and to repackage and/or seal evidence as necessary. Items of evidence which are impractical, inappropriate, or too large to be placed in a sealed container are marked or identified in a permanent 25
12.3.3.1.
12.3.3.2. 12.3.3.3.
12.3.4. 12.3.5.
13. 13.1. 13.2. 13.2.1.
13.2.2. 13.2.3.
13.2.4.
13.2.5.
manner for future identification. Markings may be made using indelible pens/markers, permanent tags, engraving, or using unique numbers permanently affixed to the item such as serial numbers. 13.2.6. 13.2.6.1. 13.2.7. Evidence which is packaged in a manner that may affect the ability of the Laboratory to analyze it should be repackaged properly. Ideally repackaging should be performed by the submitting agency prior to submission to the Laboratory when possible. If evidence can only be recorded or collected by photograph for example with an impression the image or photograph must be recoverable from a computer otherwise a print or negative must be treated as evidence. Evidence Receipt Evidence may be submitted in person, by mail, by package delivery service, by lock-box, or other method. Evidence is stored in a manner and environment that preserves the integrity of the evidence to the extent possible. Case Numbering Each case is assigned a unique case number which is placed on the outside of each evidence container. Item numbers may also be assigned and placed on the outside of evidence containers. As applicable, evidence is logged into a computer tracking system. Chain of Custody Each evidence transfer must be acknowledged at the time that the evidence is transferred. Transfer of evidence between individuals must be acknowledged by both parties at the time of evidence transfer. Transfer of evidence between an individual and a primary evidence storage area must be acknowledged at the time of evidence transfer. Evidence located in a personal evidence storage locker is deemed to be in the personal possession of the locker assignee; therefore, documentation of chain of custody between a personal evidence locker and the locker assignee is not required. Location of evidence in a primary evidence storage area or in the possession of an authorized Evidence Registrar or other individual with authorized access to the primary evidence storage area is deemed to be one and the same for purposes of evidence tracking. Therefore, transfer of evidence among these authorized entities is not required during the performance of routine Evidence Registration duties.
13.3. 13.3.1. 13.3.2. 13.3.3.
13.3.3.1. 13.3.3.2. 13.3.4. 13.4. 13.4.1. 13.4.2. 13.4.3.
13.4.4.
26
13.4.5.
Electronic tracking of chain of custody is acceptable as long as the computerized data is reasonably secure, accessible, and able to be committed to hard copy when needed. Individual, secure personal identifiers are acceptable in lieu of personal signatures. In Texas, legal precedent establishes that chain of custody within the laboratory goes to the weight of the evidence and not to its admissibility:
Norris vs. Texas, 507 S.W. 2d 796 (Tx. Cr. App. 1974) Where testimony established chain of custody up to point that heroin was delivered to criminal investigation laboratory, testimony by employee of the laboratory that he received the exhibits in question from officers of the police department for laboratory analysis, logged them in, and turned them over to a chemist for analysis was sufficient to establish the chain of custody and any objection to absence of chemist as a witness to testify as to receiving the exhibits went only to the weight of that evidence and not to its admissibility. Medellin vs. State 617 S.W. 2d 229 (Tx. Cr. App. 1981) The chain of custody was completed to inside the laboratory, thus any further objection goes to the weight of evidence, rather than to its admissibility. Bueno vs. State 677 S.W. 2d 261 (Tx. App. 13 Dist. 1984) Once the chain of custody is completed to inside the laboratory any further objection goes to the weight of the testimony rather than to its admissibility.
13.4.5.1. 13.4.6.
13.4.6.1.
13.4.6.2.
13.4.6.3.
13.5. 13.5.1. 13.5.2. 13.5.3.
Evidence Identification Institute staff inventory and mark evidence as outlined in applicable laboratory procedures. Evidence or the evidence container must be marked with a unique identifier such as a laboratory case number. When a case consists of multiple items of evidence, the individual items or samples analyzed or examined must be marked with a unique item designator. Evidence should be adequately marked to ensure that it can be identified and to aid in ensuring the integrity of case evidence. In some cases, evidence cannot be marked because marking will alter its evidentiary or intrinsic value. This evidence must be identified by some other means such as placing a permanent tag, placing in a sealed secondary container, etc.
13.5.3.1. 13.5.3.2. 13.5.3.2.1.
13.5.4.
Significant discrepancies or variations between a submitters description of evidence and that of the examiner are noted; the submitting agency is notified as outlined in procedures of the specific laboratories or sections. 27
13.6. 13.6.1.
Evidence Security Evidence received into the Laboratory is maintained in a secure manner at all times; this may include the personal possession of the examiner or evidence registrar, a designated personal secure storage area, a primary evidence storage area, a secure refrigerator, a restricted area with access limited to authorized staff, or similar area. A restricted or limited-access area is accessible to staff who have been authorized by the Director (permanent assignment) or Section Chief (temporary assignment) and given a key to the area. Restricted or limited-access areas are locked when not attended by authorized staff. Unauthorized individuals are allowed in a restricted or limited-access area only if escorted by authorized personnel or in an emergency documented in the Grand Master Key Log. Assignment of keys is documented in the Institute Key Log or on sign-out sheets under the direction of a Section Chief. Some areas are controlled both by key and by security code. Staff assigned a key and security code are authorized unrestricted access to that area. Staff assigned only a key are authorized access only when staff noted in 13.6.1.1.4.1 are present in the building; typically routine business hours.
13.6.1.1.
13.6.1.1.1. 13.6.1.1.2.
13.6.1.1.3.
13.6.1.1.4. 13.6.1.1.4.1. 13.6.1.1.4.2.
13.7. 13.7.1. 13.7.2. 13.7.3.
In-Process Evidence Evidence in the process of examination may be stored unsealed in a secure area with limited access. At all times, in-process evidence must be protected from loss, crosstransfer, contamination and/or deleterious change. Evidence must be properly sealed in a timely fashion once examination or analysis is complete even if the evidence is stored in a personal evidence locker. Because it is common to receive additional testing requests in Toxicology after production of the initial report, the Laboratory has determined that evidence will be sealed within one month of case completion. 28
13.7.3.1.
13.8. 13.8.1. 13.8.2. 13.8.3.
Evidence Release The examiner reseals the evidence, initials (or otherwise marks) the seal for later identification, and returns evidence to Evidence Registration. The Evidence Registrar prepares evidence for disposition and notifies the submitter that the evidence is available for release if appropriate. Evidence is released to the submitting agency in person, by mail, or by package delivery; placed in long term storage; or disposed as outlined in specific procedures for each section. Transfer of evidence to long term storage or disposal of evidence is tracked using appropriate chain of custody. Release of evidence to the submitting agency is documented using appropriate chain of custody. Evidence may only be released to the submitting agency or an entity approved by the submitting agency or in response to subpoena or other legal procedure. If the agent present to receive evidence is not known by the IFS employee, then the IFS employee must require verification of the identity and affiliation of the representative prior to releasing evidence. If a submitting agency does not respond to notification that evidence is ready for release, the Evidence Registrar may send evidence to the submitter via mail or package delivery service per procedures identified by each section. Individual Characteristic Database Samples The laboratory tests the following evidence sample types for inclusion in individual characteristic databases: Questioned and exemplar biological samples (for CODIS databases) Questioned cartridge cases (for NIBIN databases) Exemplar cartridge cases generated from submitted firearms (for NIBIN databases) Samples processed for inclusion in individual characteristic databases are handled in the same manner as any other evidence item. Instrument Operation, Calibration, and Maintenance Instrumentation is calibrated and maintained, as appropriate, to ensure that the instrument/equipment remains in proper working order.
13.8.3.1. 13.8.3.2. 13.8.4.
13.8.5.
13.8.6.
13.9. 13.9.1.
13.9.1.1. 13.9.1.2. 13.9.1.3. 13.9.2.
14. 14.1.
29
14.1.1.
Analytical instrumentation and equipment that have an effect on the accuracy or validity of casework are routinely checked with applicable reference measurement standards - for example, proper operation of a GC/MS is usually verified using perfluorotributylamine (FC-43 or PFTBA), an IR by using polystyrene, and a balance by using certified weights. Appropriate calibration and maintenance for each instrument are determined by the manufacturers specifications, quality control ranges, device tolerances, etc., and are detailed in section specific technical manuals. Documentation of all calibration, maintenance, and repair must be made and kept near the instrumentation/equipment for use as needed by the analyst. New instruments and equipment or instruments and equipment that have undergone repair or maintenance must have proper operation and/or calibration verified prior to analysis of casework. Manufacturers operating and/or repair manuals must be kept readily available to all analysts.
14.1.1.1.
14.1.2.
14.1.3.
14.2.
15. 15.1. 15.1.1.
Facility Security and Maintenance Security The success of any security system depends upon employee commitment to the security plan; therefore, it is each employees responsibility to actively participate in the Institute security program as described in the Institute of Forensic Sciences Security Manual. The Institute is equipped with numerous security devices including secure keys and locks, magnetic card locks, and door contacts and motion detectors in critical areas. Building Maintenance and Repair General Building Maintenance and Repair It is the responsibility of Dallas County Facilities Management to conduct building maintenance and repair activities. Standard operating procedures for the Institute of Forensic Sciences and relevant maintenance records are maintained onsite by Facilities staff assigned to the Institute. Building issues identified by IFS staff are forwarded to Facilities Management usually through IFS Administration. Laboratory Housekeeping 30
15.1.2.
15.2. 15.2.1.
15.2.1.1. 15.2.1.2.
15.2.1.3. 15.2.2.
15.2.2.1. 15.2.2.2. 15.2.2.3. 15.2.2.4.
Laboratory areas must be kept clean and free of relevant contamination. General building cleaning and non-regulated trash removal is the responsibility of Facilities Management. Lab specific cleaning and/or decontamination responsibility of knowledgeable IFS staff. is the
Each laboratory is responsible for developing, implementing, and documenting applicable cleaning/decontamination procedures.
16. 16.1.
Quality Assurance/Quality Control The Institute has developed various quality assurance and quality control procedures to provide ongoing verification that the technical procedures used in the Laboratory are valid and that the quality of each examiners work is maintained at an acceptable level. Components of the Quality Assurance/Quality Control program include but are not limited to: administrative review, technical/peer review, proficiency testing, inter-laboratory comparisons, reanalysis of casework, assay controls, reviews and audits, etc. Used as a whole, these tools are valuable in assessing laboratory and analyst performance; however, a single event is not the sole indicator of laboratory or analyst competence. The goals of a quality assurance/quality control program are as follows: To verify that technical procedures are valid and working properly; To ensure that quality work is being produced; To identify areas where additional training would be beneficial; To evaluate effectiveness and appropriateness of analytical methodology; and To demonstrate current competence of the laboratory and the individual analysts. Administrative review is a procedure used to check for consistency with laboratory policy and procedures and for editorial correctness. An administrative review is conducted on all laboratory reports to ensure that all reports are complete, concise, and consistent with laboratory policy. Administrative review is conducted at the time of final report review and 31
16.1.1.
16.1.2. 16.1.2.1. 16.1.2.2. 16.1.2.3. 16.1.2.4. 16.1.2.5. 16.2. 16.2.1. 16.2.2.
Administrative Review of Reports
16.2.3.
signature; by signing the case report, an individual documents that an administrative review has been conducted. 16.2.4. 16.3. 16.3.1. An administrative review may also be conducted by others including a peer reviewer. Technical/Peer Review of Case Records Peer/technical review is a review of the analytical report and supporting documentation package for technical correctness by an individual - other than the primary analyst - who has expertise in a specific functional area gained through documented training and expertise. The technical reviewer may be either an individual appropriately qualified as a casework analyst in the discipline /subdiscipline under review, or an individual qualified by appropriate training and expertise but who does not perform casework analysis in the discipline /subdiscipline under review. Peer/technical review provides a second evaluation of bench notes, data, and other documents which form the basis for the scientific conclusion described in the report. Technical/peer review must be conducted on a minimum of 20% or six (whichever is fewer) completed cases per examiner per month. At the discretion of the section chief, technical/peer review in specific disciplines/subdisciplines may be performed as a routine review activity for all technical reports. Technical/peer review is typically completed prior to the release of a report and following completion of all relevant quality control and administrative review activities. In some disciplines/subdisciplines, technical/peer review may occur following release of a report. For each case that receives peer/technical review, the reviewer will determine if the following elements have been satisfied: The requested examinations are addressed, and the results are clearly communicated to the reader. The format of the report is consistent with laboratory practice, and the report is editorially and typographically correct. The report adequately describes the evidence. The case number and signing analysts (or analysts) initials appear on all pages of the reports supporting documentation package. The chains of custody for evidence items examined (including 32
16.3.1.1.
16.3.2.
16.3.3. 16.3.3.1.
16.3.3.2.
16.3.3.3. 16.3.4. 16.3.4.1. 16.3.4.2. 16.3.4.3. 16.3.4.4.
16.3.4.5.
internal transfers) are current and adequately documented. 16.3.4.6. 16.3.4.7. The examination results are supported by applicable analytical documentation (graphs, charts, etc.) The tests performed conform to accepted techniques, and appropriate standards and/or control samples were used and adequately documented. The conclusions drawn are fully supported by the data, and are reasonable and within the range of acceptable opinions of peers within the discipline. Conformance to the elements described in section 16.3.4 may be documented by completion of the Peer/Technical Review form. When used, the Peer/Technical Review form is retained in the case file. Alternatively, disciplines/subdisciplines may incorporate the technical/peer review into routine case review activities without use of the Peer/Technical Review form provided that the technical/peer review process is documented in technical or other manuals. Non-conformance to the elements described in section 16.3.4 will be documented by completion of the Peer/Technical Review form. On the Peer/Technical Review form the technical reviewer must provide a description of all instances of non-conformance. If a non-conformance to the elements described in section 16.3.4 is detected during technical/peer review, and if the non-conformance is not otherwise resolved as part of the routine casework quality control process, then it is reported to the Section Chief by the Technical Reviewer. The Section Chief then: Determines the appropriate course of action to resolve the variance and documents this on the Peer Review Form. Forwards the Peer Review Form to the Quality Manager for review. As appropriate, initiates a Request for Review (see the SelfCritical Review and Corrective Action section of this Manual). In any laboratory which has only one qualified examiner in a discipline/subdiscipline, the Section Chief will make arrangements with another forensic laboratory to perform a peer or technical review on the required number of cases; where feasible, the laboratory should be accredited. 33
16.3.4.8.
16.3.5. 16.3.5.1. 16.3.5.2.
16.3.6. 16.3.6.1. 16.3.7.
16.3.7.1. 16.3.7.2. 16.3.7.3. 16.3.8.
16.3.8.1.
For an external review, components of the completed case file necessary to reach final conclusions are copied and sent to a qualified external reviewer with the Peer Review Form The Quality Manager is responsible for tracking participation in the technical/peer review process.
16.3.9. 16.4. 16.4.1.
Proficiency Testing Program Proficiency testing is a process in which analysts perform testing on specimens of unknown composition to the analyst but of known composition to selected Institute staff (internal) or to an independent agency (external). The following information is required for each proficiency test internal or external: How samples were obtained or prepared Who participated in testing Time frame of testing Responsible supervisor
16.4.1.1. 16.4.1.1.1. 16.4.1.1.2. 16.4.1.1.3. 16.4.1.1.4. 16.4.2.
Proficiency testing requirements apply to forensic examiners and to forensic disciplines. A discipline or functional area is a major area of casework for which a laboratory may seek accreditation - for example, Trace Evidence, Drug Analysis, Firearms, etc. A subdiscipline is specialized area of analysis included within a discipline or functional area - for example, hair analysis, fiber identification, and arson are subdisciplines of Trace Evidence. The following minimum proficiency testing standards must be met: All forensic examiners must complete at least one proficiency test (internal or external) annually for each sub-discipline in which they perform frequent analyses. Each discipline or functional area must participate annually in at least one external proficiency test for each forensic discipline in which it provides services. Where available, at least one proficiency test for each discipline must be from an ASCLD/LAB approved provider with results released to ASCLD/LAB. At a minimum, DNA examiners and technical support personnel performing DNA analytical techniques will comply with ASCLD/LAB and DAB standards regarding external proficiency tests.
16.4.3. 16.4.3.1.
16.4.3.2.
16.4.3.2.1.
16.4.3.2.2.
16.4.4.
Response to Proficiency Test Results 34
16.4.4.1. 16.4.4.1.1.
Proficiency test results are assessed as successful, successful with corrective action, or unsuccessful. Successful proficiency results occur when results are deemed acceptable by the external proficiency program or when written criteria for successful completion established by the Section Chief are met. Inconsistent proficiency results occur when results fall outside the acceptable range as defined by the external proficiency provider or the range identified by the Section Chief for in-house proficiencies or when identified as such by ASCLD/LAB. Inconsistent proficiency results are investigated using the Institutes Critical Review and Corrective Action Program. Results are evaluated as follows: Successful with corrective action denotes that an RFR and/or CAR was successfully completed as judged by the ASCLD/LAB Proficiency Review Committee or the Institutes Executive Committee. Unsuccessful proficiency results occur when inconsistent proficiency results are not successfully resolved. The Section Chief, Supervisor, and/or Quality Manager will review inconsistent proficiency results with the analyst. The Quality Manager has authority to reject or render invalid any internal proficiency test samples that are improperly documented, prepared, or otherwise rendered unsuitable for the purpose of proficiency testing.
16.4.4.1.2.
16.4.4.1.2.1.
16.4.4.1.2.2.
16.4.4.1.3.
16.4.4.1.4.
16.4.5. 16.4.6. 16.4.7. 16.5. 16.5.1.
Proficiency testing documentation including any associated corrective action requests is maintained by the Quality Manager. Results of proficiency testing are reported to the Director on an annual basis by the Quality Manager. The Quality Manager is the point of contact between the Institute and ASCLD/LAB as it relates to proficiency test issues. Inter-laboratory Comparisons Laboratories may choose to establish exchange programs with other laboratories for external proficiencies, sample validation of new 35
procedures, etc. 16.6. 16.6.1. 16.6.2. Blind Testing and/or Reanalysis of Casework Laboratories may choose to develop methods for submission and testing of blind samples submitted as normal casework. Laboratories may also choose to have a second analyst reanalyze previously completed casework as a means of assessing quality and providing training. Quality Control Samples Quality control procedures, used routinely in assays, provide a frequent assessment of the performance of analytical methods and the application of these methods by the analyst. Specific quality control procedures are included as a part of individual analytical procedures or described in other documents prepared by a Section or laboratory. Self-Critical Review and Corrective Action Self-critical review of laboratory procedures, processes, and results is a fundamental and routine expectation of a scientific laboratory and an integral component in maintaining consistency with best practices in forensic sciences. Self-critical review occurs routinely during the normal performance and review of case work, quality control/quality assurance activities including proficiency testing and peer review, reanalysis of casework, training or retraining activities, audits and reviews, etc. Certain issues identified through self-critical review are readily anticipated and guidance for response is addressed in routine practices, policies, and procedures. Other issues identified through self-critical review may not be addressed in routine practices, policies, and procedures; action on these issues may be initiated by submitting a Request for Review (RFR) to the Executive Committee. Every isolated variance from policy and procedure does not require an RFR. Isolated administrative errors do not usually require an RFR. The RFR document is an administrative, working document which is not retained once an appropriate course of action is established by the Executive Committee.
16.7. 16.7.1.
16.7.2.
17. 17.1.
17.1.1.
17.1.2.
17.1.3.
17.1.3.1. 17.1.3.2. 17.1.3.3.
17.2.
Requests for Review (RFR) Process 36

17.2.1. 17.2.1.1. 17.2.1.2. 17.2.2.
Internal review of an issue is initiated using the RFR process. A RFR is used to a request review of an issue by the Quality Manager and the Executive Committee. The issue in question may relate to any aspect of Laboratory operation including quality, EHS, personnel, security, etc It is the responsibility of each employee to immediately notify a Supervisor, Quality Manager, EHS Manager, Section Chief and/or the Director if they become aware of any issue that may impact the quality, security, and/or safety of work performed or reported by the Institute. Once advised, any supervisor or manager will evaluate the issue of concern. On the basis of that evaluation, the issue may be forwarded to the Quality Manager as a RFR; the appropriate Section Chief should also be advised. The Quality Manager assesses the RFR with respect to Institute policies and procedures. The RFR is then forwarded to the appropriate Section Chief or Manager for initial evaluation and development of a proposed response. The Section Chief or Manager presents the RFR to the Executive Committee. Executive Committee determines the appropriate course of action such as requesting further information or action, accepting resolution proposed or conducted as part of the RFR, initiating the Corrective Action Response (CAR) process, referring the issue to a more appropriate process such as Human Resources, EHS Manager, Security Manager, determining that no action is necessary, etc. Corrective Action Request (CAR) When an issue raised in an RFR is determined by the Executive Committee to be substantive, it will be investigated, tracked, and resolved through the CAR process. An issue is defined as being substantive if it has the potential to significantly impact the quality of the work of the laboratory even if for a short time. Determination that an issue is substantive should consider the significance, substance, and time-span of the issue. The CAR is a record of the formal investigation and resolution of RFRs deemed substantive by the Executive Committee. To assist in developing a response, the Executive Committee classifies the severity of the issue of concern addressed by the CAR. The Class assignment may be reviewed and reevaluated during the CAR process. 37
17.2.3.
17.2.4.
17.2.5. 17.2.6.
17.3. 17.3.1.
17.3.1.1.
17.3.1.2. 17.3.2. 17.3.3.
The categories of classification are: 17.3.3.1. Class I The issue is systemic, and the nature and cause of the issue raises immediate concern regarding the quality of a laboratorys work product. Class II - The issue is not persistent or serious enough to cause immediate concern for the over-all quality of the laboratorys or individual analysts work product. Class III - The issue is determined to be unlikely to recur, is not systemic, and does not significantly affect the fundamental reliability of the laboratorys or individual analysts work. Class IV The issue is primarily administrative or clerical and does not affect the reliability of the laboratorys or analysts work. The CAR is forwarded to the appropriate Section Chief or Program Manager (i.e. EHS Manager, Quality Manager, etc.) for response and/or action. As appropriate, the Manager and/or Section Chief may delegate the responsibility for formal evaluation of the finding and development of a corrective action plan. Once actions are complete, the CAR is forwarded to the Section Chief/Manager for review and approval. The CAR and applicable documentation is reviewed, evaluated, and verified by the Executive Committee. Once the Executive Committee accepts response to a CAR, it is closed out by the Quality Manager. The Quality Manager is responsible for oversight of the corrective action process including correspondence with accrediting agencies (ASCLD/LAB and Texas DPS) as appropriate. Completed CARs are retained through the next ASCLD/LAB inspection or as required by ASCLD/LAB and/or Texas DPS standards. Response to RFRs and CARs The scope of corrective action should be commensurate with the magnitude of the issue at hand. For example, a situation which questions the quality of a laboratorys work product may warrant taking a procedure or even a discipline out of service with extensive revalidation of procedures whereas a non-systemic, one-time occurrence may warrant a corrected report. Once an issue is identified, an appropriate course of action is initiated 38
17.3.3.2.
17.3.3.3.
17.3.3.4.
17.3.4.
17.3.5.
17.3.6. 17.3.7.
17.3.8.
17.3.9. 17.4. 17.4.1. 17.4.1.1.
17.4.2.
based on the severity (CAR Class) and type of the situation. 17.4.2.1. 17.4.2.1.1. 17.4.2.1.2. 17.4.2.1.3. Types of errors may include Administrative Error - repetitive clerical errors, sample confusion, improper storage, etc. System Error - variance due to methodological, equipment, or environmental factors. Analytical/Interpretive Error - variance due to the choice, use, or implementation of an analytical procedure and/or inaccurate or incomplete interpretation of analytical results. Examples of action include but are not limited to the following which may be performed for a single analyst, multiple analysts, or laboratory-wide as appropriate: Review of the discrepancy with the analyst(s) involved Retraining Performance of a new proficiency test Review of past casework for analyst(s) or a lab usually back to the last successful proficiency Reanalysis of casework with generation of corrected reports as applicable Removal of an analyst from applicable casework Temporary or permanent discontinuation of a procedure or use of equipment Modification of an existing procedure or development of a new procedure with appropriate validation Validation of a method using different equipment
17.4.2.2.
17.4.2.2.1. 17.4.2.2.2. 17.4.2.2.3. 17.4.2.2.4. 17.4.2.2.5. 17.4.2.2.6. 17.4.2.2.7. 17.4.2.2.8. 17.4.2.2.9. 17.4.3.
If an issue of concern is procedure or equipment related, all applicable analysts must be advised of the corrective action taken to minimize recurrence of the situation. Minor issues and/or discrepancies that individually do not warrant a CAR may require increasingly stringent action if they occur repeatedly. If the Executive Committee determines that a quality concern involves serious negligence or misconduct by staff or subcontractors that substantially affects the integrity of the scientific analyses performed and reported by the Institute, then in addition to any other corrective actions taken, a report of the investigation of the concern will be forwarded to the Director for 39
17.4.4. 17.4.4.1.
review. 17.4.4.2. In the event that the Director determines that the quality concern involves serious negligence or misconduct by staff or subcontractors that substantially affects the integrity of the scientific analyses performed and reported by the Institute, then the Director will report the concern to the Texas Department of Public Safety, the Dallas County District Attorneys Office, and other agencies as appropriate The Quality Manager has oversight of the RFR and CAR process. The Quality Manager keeps the Director informed regarding RFR and CAR processes. The Quality Manager oversees reporting of RFR and/or CAR issues to ASCLD/LAB and/or Texas DPS as appropriate. In the event that the Executive Committee is unable to reach consensus regarding resolution of a RFR or CAR, then the issue is forwarded by the Quality Manager to the Director for review and action. Review of Testimony Testimony by Forensic Laboratory employees should provide Accurate presentation of the analysts credentials including academic background, training, research, etc.; An accurate and complete description of the employees involvement in the case; A truthful, clear, straightforward, relevant, and objective response to all questions on both direct and cross-examination; Conclusions that follow logically from the underlying data and analytical results; Clear articulation of the reliability of results, analytical limitations, and conclusions; and Expert opinion that is within the area of expertise of the analyst. Court testimony of each examiner must be evaluated at least once in any calendar year in which the examiner testifies. Courtroom monitoring is necessary to evaluate the delivery of the examiners testimony and to ensure that the testimony is scientifically consistent with the findings documented in the case file.
17.5. 17.5.1. 17.5.2. 17.5.3. 17.5.4.
Oversight of RFR and CAR Processes
18. 18.1. 18.1.1. 18.1.2. 18.1.3. 18.1.4. 18.1.5. 18.1.6. 18.2. 18.2.1.
40
18.2.2. 18.2.3.
Each examiner must ensure that his/her testimony is monitored at least once during each calendar year in which testimony is provided. It is strongly recommended that this review be done through direct observation by a supervisor, Quality Manager, or other knowledgeable individual identified by the Section Chief. If supervisory or peer personnel are not available to personally observe the testimony, the examiner is responsible for making contact with the district attorneys office, defense attorney, or judge to solicit written feedback on the analysts testimony. Feedback should be sent to the Quality Manager. Employees with new responsibility for court testimony should receive court monitoring repeatedly during their first several experiences as an expert witness as outlined in the applicable training manuals. It is recommended that court testimony of support staff is monitored annually. Reviewers complete the Court Testimony Monitoring Form which details the areas to be evaluated including appearance, poise, performance under cross-examination, ability to present scientific information in an understandable manner to a lay jury, and most importantly a determination that the testimony given is scientifically consistent with the work documented in the case file. These forms are submitted to the Supervisor or Section Chief who reviews them with the testifying analyst. The testifying employee may make comments on the review. Court Monitoring forms are maintained by the Quality Manager and summarized annually. If indicated by the review, the Section Chief will implement corrective action.
18.2.4.
18.2.5.
18.3. 18.4.
18.4.1. 18.4.2. 18.4.3. 18.5. 19. 19.1.
Departure from Documented Policies and Procedures Although most of the evidence submitted to the Forensic Laboratory is handled by standard policies and procedures, occasionally evidence is submitted that requires deviation from standard procedures due to the unique nature of evidence, the uncontrolled and unpredictable type and condition of materials taken into custody, the limited amount of evidence, and the inability to resample evidence once collected. With permission from the Section Chief or Supervisor, it is acceptable for an analyst to deviate from standard policies and procedures. It is imperative in these cases that clear documentation be made in the case file detailing the exact procedures used in the analysis. Any limitations placed on conclusions due to deviations in policy and 41
19.2. 19.2.1. 19.2.2.
procedures should be clearly stated in the case report. 20. 20.1. 20.1.1. Addressing Complaints The goal of the Forensic Laboratory is to provide the highest quality service to our submitting agencies and the judicial system. All complaints should immediately be communicated to an employees supervisor who will initiate a request for review as applicable. Disclosure of Information Disclosure of case related information is covered in the Case Record Management and Control section of this manual and in other laboratory manuals. Unauthorized disclosure of work-related information may jeopardize ongoing criminal investigations, violate individual privacy rights and subject the county to legal action. Therefore, unauthorized release of information to other than the submitter or their designee requires prior supervisory review; failure to obtain prior supervisory approval may result in disciplinary action. By County policy, all media contacts and requests for information should be referred to a supervisor with immediate notification to the Director. Per County policy, scheduled media interviews require prior approval of the Commissioners Court. Freedom of information and public information act requests require prompt response and should be immediately forwarded to a supervisor or Section Chief for action and typically review by the Civil Section of the Dallas County District Attorneys Office. Employees are required by County policy to keep business matters confidential. Employees must not release sensitive case-related information either intentionally or unintentionally to unauthorized individuals including friends, family members, and/or others. Computerized case data must be accessed on a need to know basis only. Information requests which include release of copyrighted materials require specific review by the Civil Section of the Dallas County District Attorneys Office. This includes materials such as the ASCLD manual, reference materials, and other documents. Reviews and Audits Annual Internal Review The Annual Internal Review of laboratory operations evaluates ongoing 42
21. 21.1. 21.2.
21.2.1.
21.2.2.
21.2.3.
21.2.4. 21.2.5.
22. 22.1. 22.1.1.
compliance with ASCLD/LAB accreditation standards, this Quality Management Program, and other laboratory requirements. 22.1.2. 22.1.2.1. 22.1.2.2. The Annual Internal Review is conducted under the direction of the Quality Manager. The Quality Manager selects an inspection team and develops the format for the review. At a minimum, the review covers the standards and criteria of the ASCLD/LAB manual in effect at the time of the review, and, at a minimum, the scope of the review includes current ASCLD/LAB requirements for an Annual Accreditation Audit Report and the current IFS Quality Management Program, Quality Manual. The review is scheduled and announced well in advance. The review includes the following operational areas: The staffs awareness of the quality manual Analytical procedure selection, control, and validation Control of reagents and standards Equipment calibration and maintenance of records Adequacy of case reports and notes and their disposition Evidence handling procedures Proficiency testing and inter-laboratory comparison studies Personnel training records Handling of deficiencies and remedial action Laboratory orderliness and health and safety measures
22.1.2.3. 22.1.2.4. 22.1.2.4.1. 22.1.2.4.2. 22.1.2.4.3. 22.1.2.4.4. 22.1.2.4.5. 22.1.2.4.6. 22.1.2.4.7. 22.1.2.4.8. 22.1.2.4.9. 22.1.2.4.10. 22.1.3.
Soon after the conclusion of the review, the Quality Manager with assistance from the inspection team prepares a draft report with recommendations for investigation and action. The Quality Manager with assistance from the Executive Committee initiates applicable RFRs and/or CARs. Major findings should be immediately communicated to the Section Chief, Executive Committee, and/or Director at the time of the review. Substantive non-compliance with essential criterion must be specifically addressed using the CAR process. 43
22.1.4. 22.1.4.1.
22.1.4.2.
22.1.5. 22.1.6. 22.1.7. 22.2. 22.2.1. 22.2.2.
The Quality Manager is responsible for generation of the written Annual Internal Review Report which is provided to the Director. The results of the Annual Internal Review are reviewed with the Institute Quality Committee. The Annual Internal Review is maintained by the Quality Manager. ASCLD/LAB Annual Accreditation Audit Report The Annual Internal Review is relied upon in part for completion of the ASCLD/LAB Annual Accreditation Report. By March 12 of each year, the Quality Manager, with assistance from the Executive Committee, completes the Annual Accreditation Audit Report for the prior year for review and signature by the Director. A copy of the Annual Accreditation Audit Report is submitted to ASCLD/LAB as described in the current ASCLD/LAB accreditation manual. The Annual Accreditation Audit Report is maintained by the Quality Manager. The results of the ASCLC/LAB Annual Accreditation Audit Report are reviewed with the Institute Quality Committee. Other Reviews and Audits Other reviews and audits may be conducted as needed under the oversight of the Quality Manager. Where applicable, other reviews and audits may be concurrent with and/or satisfy portions of the Annual Internal Review. Examples include the DAB Review in Forensic Biology and the annual EHS Audit.
22.2.3.
22.2.4. 22.2.5. 22.3. 22.3.1. 22.3.1.1.
23. 23.1.
Annual Quality System Review By March 12 of each year, the Quality Manager and Executive Committee performs an Annual Quality System Review with assistance from the inspection teams and the Institute Quality Committee. The goal of the review is to assess the effectiveness of the quality system by identifying ways to improve laboratory quality, ensuring that procedures and policies reflect standard accepted practices in forensic laboratories and current legal requirements, and ensuring compliance and consistency with ASCLD/LAB accreditation standards. The Quality Manager solicits recommendations for changes in the quality system from the inspection teams, Institute Quality Committee, and other 44
23.1.1.
23.1.2.
applicable sources. 23.1.3. The Annual Quality System Review is developed by the Quality Manager and Executive Committee and forwarded to the Director for review and action. The Quality Manager implements identified changes to the Quality Management Program as authorized by the Director. The Annual Quality System Review is maintained by the Quality Manager and made available during an ASCLD/LAB inspection as requested.
23.2. 23.3.
45
Institute of Forensic Science Peer/Technical Review

It is essential that a representative number of reports be subjected to a peer/technical review for each individual in each area in which work is performed to ensure that the conclusions reported are reasonable and within the constraints of scientific knowledge and accepted procedures. Laboratory Case Number: __________________________________ Primary Examiner/Analyst: __________________________________ YES ___ ___ NO* ___ ___ N/A ___ ___ Date of Report: _____________________ Discipline for Review: _______________
1. 2.
REPORT Have the requested examinations been addressed? Are the results clearly communicated to the reader? ADMINISTRATIVE REVIEW Is the report correct editorially and typographically? Is the general format of the report consistent with laboratory practice? NOTES Is the evidence adequately described? Do the case number and analysts initials appear on all pages? SUPPORTING DOCUMENTATION Are all graphs, charts, etc. available to support the examinations conducted? Is the chain of custody (including internal transfer sheets) current and adequately documented? CONCLUSIONS Were standards and/or control samples used and adequately documented? Do the tests performed conform to accepted techniques? Were the conclusions drawn fully supported by the data? Are the conclusions reasonable and within the range of acceptable opinions of peers within this discipline?
3. 4.
___ ___
___ ___
___ ___
5. 6.
___ ___
___ ___
___ ___
7. 8.
___ ___
___ ___
___ ___
9. 10. 11. 12.
___ ___ ___ ___
___ ___ ___ ___
___ ___ ___ ___
*Comments required.
Comments: _______________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ Reviewer: __________________________________________________ Date Reviewed: ______________________
Instructions to Reviewer: If a No is recorded for any question, forward this form together with the report and supporting documentation package to the Section Chief for review. If no review is needed (i.e., no No response), attach this form to the report package for filing in the case file.
Section Chief Review Action(s) Taken: __________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ Supervisor Signature: ________________________________________ Quality Manager: ___________________________________________ Date Reviewed: _____________________ Date Reviewed: _____________________

RFR #: _________
Institute of Forensic Sciences

Monitoring Court Testimony
(To be completed by monitor) Monitoring is necessary to evaluate the delivery of the examiner/analysts testimony and to ensure that the testimony is scientifically consistent with the findings documented in the case file. Witness: Laboratory Case Number: Court: Jury Trial: Offense Charged: Trial Before the Court: _________ Discipline: Date(s) of Appearance: Time on Witness Stand: Other: _______________________
Rating Scale: 5 Excellent 4 Commendable 3 Competent 2 Adequate 1 Poor Area

Appearance Demeanor control, alertness, posture Presentation Style - clear, professional, directed to jury Professional Qualifications Evidence Identification Description of analysis or examination Testimony consistent with case record and expertise Nature of Attorneys Prosecution Style Defense Style Comments Rapid Fire Personal Attacks Repetitive Confusing Questions Insinuating Questions Yes or No Questions
Rating Scale
Comments
Comments by Monitor: Monitor Signature/Date: ______________________ Supervisor Signature/Date:________________________ Additional comments attached: Monitor: Y / N Supervisor: Y / N
Analyst signature: I received a complete copy of the evaluation. _______________________ Date: _________ Analyst Comments:__________________________________________________________________________ Additional analyst comments attached: Y / N
This form must be returned to the Quality Manager for the Institute of Forensic Sciences.
RFR Form#2.doc

RFR #: _________ SOUTHWESTERN INSTITUTE OF FORENSIC SCIENCES
Request For Review (RFR)

Quality Physical Evidence Initiating RFR: Tox/Drugs Health/Safety Security Other __________________
Section I: To be completed by individual initiating RFR. Use additional sheets as necessary. Description of Request:
Source (audits, peer reviews, etc.): Initiated by: Section II: To be completed by the Quality Manager. Use additional sheets as necessary. Preliminary Finding:
Date: Date:
Tracking Number: Quality Manager/Date: Section III: To be completed by Section Chief or Program Manager. Use additional sheets as necessary. Description of RFR evaluation and/or RFR Plan including timetable:
Section Chief/Program Manager Signature: Date: Section IV: To be completed by the Executive Committee. Use additional sheets as necessary. Final Finding:
Response Classification (I, II, III, or IV): _____ Comments:
Approval for Initiating a CAR: ____ Yes Executive Committee:

RFR Form#2.doc
_____ No Date:

CAR #: _________ SOUTHWESTERN INSTITUTE OF FORENSIC SCIENCES
Corrective Action Request (CAR)

Quality Physical Evidence Initiating CAR: Tox/Drugs Health/Safety Security Other __________________
Section I: To be completed by individual initiating CAR. Use additional sheets as necessary. Description of Request:
Source (audits, peer reviews, etc.): Initiated by: Section II: To be completed by the Quality Manager. Use additional sheets as necessary. Description of Finding:
Date: Date:
Executive Committee Approved: Response Class (I, II, III, or IV):
Initiating a CAR
Date:
Tracking Number: Quality Manager Date: Section III: To be completed by Section Chief or Program Manager. Use additional sheets as necessary. Responsible for Corrective Action: Response Due Date: Description of CAR evaluation and/or CAR Plan including timetable:
Plan Accepted by: Date: Section IV: To be completed by the individual responsible for corrective action. Use additional sheets as necessary. Description of Actions Taken:
Completed by: Date: Section V: When CAR is complete, include evidence of completion with response and return to the initiating Section Chief/Manager by the response due date. Approval and Final Review of Corrective Action:
Verified by:
CAR Form#2.doc
Date:
Closed by QM:
Date:

SWIFS Quality Management Program Quality Manual v2.3 (02.28.2008) 53 Pages

Hochgeladen von

Dokumentinformationen

Originalbeschreibung:

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

SWIFS Quality Management Program Quality Manual v2.3 (02.28.2008) 53 Pages

Hochgeladen von

Copyright:

Verfügbare Formate

This is a non-controlled copy of a controlled document

Dallas County Institute of Forensic Sciences Forensic Laboratory

QUALITY MANAGEMENT PROGRAM Quality Manual, Version 2.3

Dallas County Institute of Forensic Sciences Forensic Laboratory

Quality Manual, Version 2.3 Effective Date: 2/28/08

This is a non-controlled copy of a controlled document

Summary of Changes from Previous Version

Dallas County Institute of Forensic Sciences Forensic Laboratory

Quality Manual, Version 2.3 Effective date: 2/28/2008

This is a non-controlled copy of a controlled document

Dallas County Institute of Forensic Sciences Forensic Laboratory

Quality Manual, Version 2.3 Effective date: 2/28/2008

This is a non-controlled copy of a controlled document

Dallas County Institute of Forensic Sciences Forensic Laboratory QUALITY MANUAL

Dallas County Institute of Forensic Sciences Forensic Laboratory

Quality Manual, Version 2.3 Effective date: 2/28/2008

This is a non-controlled copy of a controlled document

Table of Contents Section 1. 2. 3. 4. 5. 6. 7. 8. 9. Page

Quality Manual, Version 2.3 Effective date: 2/28/2008

This is a non-controlled copy of a controlled document

Dallas County Institute of Forensic Sciences Forensic Laboratory

Quality Manual, Version 2.3 Effective date: 2/28/2008

This is a non-controlled copy of a controlled document

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

2.1.6. 2.1.7. 2.1.8. 2.1.9.

3.1.2. 3.1.3. 3.1.4. 3.2.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

4.1.2. 4.2. 4.3.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

5.1.4. 5.1.5. 5.1.6.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

5.3.6. 5.3.7. 5.3.8. 5.3.9. 5.3.10.

5.3.11. 5.3.12. 5.3.13. 5.3.14. 5.3.15. 5.3.16. 5.3.17. 5.4. 5.4.1.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

Director. The Director has the following responsibilities:

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

5.5.2. 5.5.3. 5.5.4. 5.5.5. 5.5.6. 5.5.7. 5.5.8.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

8.1. 8.1.1. 8.1.2. 8.1.3. 8.1.4.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

8.2.2.2. 8.2.2.3. 8.2.2.4. 8.2.2.5.

8.3. 8.3.1. 8.3.2. 8.3.3.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

9.1.2.1. 9.1.2.2. 9.1.2.3. 9.1.2.4.

Preparation of Case Records

9.2.2.2. 9.2.2.3. 9.2.2.4.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document

9.2.3.1.2. 9.2.3.1.3. 9.2.3.2. 9.2.3.2.1.

9.2.4. 9.2.4.1. 9.2.5. 9.2.5.1.

Dallas County Institute of Forensic Sciences Forensic Laboratory

This is a non-controlled copy of a controlled document