SWIFS Quality Management Program Quality Manual v2.4 (11.01.2008) 56 Pages

8/2/2019 SWIFS Quality Management Program Quality Manual v2.4 (11.01.2008) 56 Pages

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Dallas County Institute of Forensic Sciences Quality Manual, Version 2.4

Forensic Laboratory Effective Date: 11/01/08

Dallas County Institute of Forensic Sciences

Forensic Laboratory

QUALITY MANAGEMENT PROGRAM

Quality Manual, Version 2.4

Authorized by:

Jeffrey J. Barnard, M.D.Director and Chief Medical Examiner

Karen D. YoungQuality Manager

Timothy J. Sliter, Ph.D.Chief, Physical Evidence

Elizabeth Todd, Ph.D.Chief, Forensic Chemistry

Effective date: November 1, 2008

This is an uncontrolled copy of a controlled document


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Forensic Laboratory i Effective date: 11/01/2008

Summary of Changes from Previous Version

Previous version: Quality Manual, Version 1.0

Current version: 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 theExecutive Committee and Director in instances of alleged serious negligence ormisconduct 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 ofsupporting 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 QualityManager.



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Forensic Laboratory ii Effective date: 11/01/2008

Revisions & Corrections

Quality Management Program Quality Manual, Version 2.X

Effective

Date

Description Authorized by

10/8/2007 Addition of section: Summary of Changes From Previous

Version

TJS

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

TJS

10/8/2007 Revisions of page numbers. TJS

1/13/2008 Addition: 4.4 (re: type and extent of laboratory

examinations)

TJS

1/13/2008 Addition: 7.1.1 (re: minimum education requirements) TJS

1/13/2008 Revision: 9.3.3.2 (re: distribution of analytical reports) TJS1/13/2008 Addition: 10.6 (re: measurement standards TJS

1/13/2008 Addition: 14.1.1.1 (re: standards for equipment

maintenance & calibration)

TJS

1/13/2008 Various non-substantive changes in wording and formatting

to improve clairity

TJS

1/13/2008 Revisions of page numbering TJS

2/27/2008 Addition of 9.4.2 clarifying that case records are maintained

indefinitely

ELT

2/27/08 Revision of 10.6 to clarify that certain measurement

standards are verified annually against traceable standards

ELT

2/27/08 Revision of page numbering ELT

11/01/08 Revision of 8.1.1: Clarify wording to include applicable

competency testing

KDY

11/01/08 Addition:8.1.5.3.1 (re: Competency testing requirements

for returning employees)

KDY

11/01/08 Revision of 8.1.6 to clarify competency testing KDY

11/01/08 Revision of 12.3.4 to improve clarity KDY

11/01/08 Addition of 16.4.1.1: Clarify Quality Managers duties and

responsibilities in the Proficiency Testing Program.

KDY

11/01/08 Renumbering of 16.4. based on the addition of 16.4.1.1 KDY

11/01/08 Deleted 16.4.5 (now covered in 16.4.1.1) KDY11/01/08 Reworded 16.4.6 for clarity KDY

11/01/08 Revision of 16.4.7: Added DPS KDY

11/01/08 Revision of 17.2: Grammar corrections KDY

11/01/08 Addition of 22.1.1.1: Permit an external audit to be used as

part of that years internal annual audit.

KDY



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Forensic Laboratory iii Effective date: 11/01/2008

Effective

Date

Description Authorized by

11/01/08 Updated Table of Contents KDY

11/01/08 Addition of 17.2.1.3 clarifying that an RFR is initiated with a

memorandum to the Quality Manager

KDY

11/01/08 Updated CAR Form KDY11/01/08 Removed RFR Form KDY

11/01/08 Approved by Dr. Barnard JB



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Forensic Laboratory iv Effective date: 11/01/2008

Dallas County Institute of Forensic Sciences

Forensic Laboratory

QUALITY MANUAL

DISTRIBUTION LIST

The Quality Management Program Quality Manual is maintained as an electronic document thatis accessible to all staff through the Quality Management System Portal web page.



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Forensic Laboratory 1 Effective date: 11/01/2008

Table of Contents

Section Page

1. Policy Statement and Purpose of the Laboratory.................................................................... 3

2. Objectives of the Quality Management Program ................................................................... 3

3. Purpose of the Manual ............................................................................................................ 4

4. Scope and Organization of the Forensic Laboratory .............................................................. 5

5. Quality Management Responsibilities: ................................................................................... 6

6. Job Descriptions...................................................................................................................... 9

7. Educational Background and Training Records ................................................................... 10

8. Training Programs ................................................................................................................ 10

9. Case Record Management and Control ................................................................................ 13

10. Quality Assurance of Standards, Controls, and Reagents .................................................... 21

11. Procedure Manual Control and Maintenance ....................................................................... 23

12. Development, Validation, and Verification of New Testing Methods ................................. 24

13. Evidence Handling................................................................................................................ 26

14. Instrument Operation, Calibration, and Maintenance........................................................... 31

15. Facility Security and Maintenance ....................................................................................... 31

16. Quality Assurance/Quality Control ...................................................................................... 32

17. Self-Critical Review and Corrective Action......................................................................... 38

18. Review of Testimony............................................................................................................ 42

19. Departure from Documented Policies and Procedures ......................................................... 44

20. Addressing Complaints......................................................................................................... 44



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21. Disclosure of Information..................................................................................................... 44

22. Reviews and Audits .............................................................................................................. 45

23. Annual Quality System Review............................................................................................ 47

AppendicesPeer Technical Review FormRequest for Review (RFR) FormCorrective Action Request (CAR) Form



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Dallas County Southwestern Institute of Forensic Sciences

Forensic Laboratory

Quality Management Program1. Policy Statement and Purpose of the Laboratory

1.1. The Forensic Laboratory of the Dallas County Southwestern Institute ofForensic Sciences (IFS or SWIFS) is committed to serving the needs of theDallas County Office of the Medical Examiner, submitting agencies, and thecitizens of Dallas County by providing a broad spectrum of forensic analysesperformed accurately, impartially, and in a timely manner.

1.2. To support this commitment, a quality management program has beendeveloped to ensure the ongoing quality, integrity, and reliability of analysesperformed, reports generated, and testimony provided by IFS personnel. IFS

staff acknowledge the unique responsibility inherent in conducting forensicanalyses and the expectation that all work performed will be of exemplarycaliber.

1.3. Ensuring a competent and accurate work product requires a personal dedicationto quality and an active participation in this quality management program byevery employee.

1.4. The components of the program include1.4.1. quality control (QC) - activities used to monitor the quality of

analytical data and to ensure that it satisfies specified criteria such aspositive and negative controls, standards, and blanks, and

1.4.2. quality assurance (QA) planned and systematic actions necessary toprovide sufficient confidence that a laboratorys work productsatisfies specified quality requirements, for example, peer review,proficiency tests, instrument calibration, assay verification, reviewsand audits, etc.

2. Objectives of the Quality Management Program2.1. IFS staff support this Quality Management Program designed to provide:

2.1.1. Accurate and relevant testing procedures which are scientificallysound and adequately documented utilizing commonly acceptedinstrumentation and equipment in proper working order;

2.1.2. Analytical procedures which are based upon sound scientificprinciples and which have been validated as to accuracy andreliability;



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2.1.3. Acceptable operational performance of procedures, critical reagents,and instrumentation;

2.1.4. Testimony which is truthful, complete, and impartial provided in aprofessional manner;

2.1.5.

Hiring and training of qualified staff with verification of acceptablecompetency and provision of ongoing training and professionaldevelopment for staff as appropriate;

2.1.6. Periodic evaluation of procedures and analysts through participationin internal and/or external proficiency testing and peer review;

2.1.7. Use of quality analytical standards of known purity and/orcomposition from reputable manufacturers where available andappropriate;

2.1.8. Evidence handling processes which provide care, custody, andcontrol of evidence and case records;

2.1.9. Participation as applicable in the Annual Internal Review,ASCLD/LAB Annual Accreditation Audit Report, Annual QualitySystem Review, and other audits and reviews; and

2.1.10. Maintenance of ASCLD/LAB accreditation.2.2. 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 asapplicable.

3. Purpose of the Manual3.1. The purpose of this manual is as follows:

3.1.1. To establish a mechanism to assure that activities conducted by theForensic Laboratory of the Dallas County Southwestern Institute ofForensic Sciences meet the quality management objectives listedabove which are designed to ensure a quality work product,

3.1.2. To establish quality control and quality assurance processes as anintegral and necessary component in providing competent forensicanalyses,

3.1.3. To communicate expected quality management activities tolaboratory staff; and

3.1.4. To ensure a consistent approach to quality management throughoutthe Forensic Laboratory.

3.2. Implementation of this manual requires written authorization by the Director,Section Chiefs, and the Quality Manager.



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3.3. The Quality Manual is reviewed annually by the Quality Manager.3.3.1. The Director, Section Chiefs, and Quality Manager must approve

changes to the Manual prior to implementation.

3.3.2. Out-dated Manuals are archived by the Quality Manager.3.4. The Quality Manual is readily available to Forensic Laboratory staff.

3.4.1. The official copy of the Quality Manual is kept by the QualityManager.

3.4.2. The Quality Management Program Quality Manual is maintained asan electronic document that is accessible to all staff through theQuality Management System Portal web page.

4. Scope and Organization of the Forensic Laboratory4.1. The Forensic Laboratory is a division of the Dallas County Southwestern

Institute of Forensic Sciences and was established by the Dallas CountyCommissioners Court in a joint effort with UT-Southwestern Medical School.

4.1.1. The Forensic Laboratory is an independent laboratory, and theDirector of the Institute reports directly to the Dallas CountyCommissioners Court and the Chair of the Pathology Department ofUT-Southwestern Medical School.

4.1.1.1. With respect to operation of the Forensic Laboratory,funding, operation and reporting responsibilities rest with

the Dallas County Commissioners Court.4.1.2. Selected senior science staff also serve as faculty at UT -

Southwestern Medical School.

4.2. A current organizational chart is maintained by the Director.4.3. The Laboratory operates on a fee-for-service basis, and its services are

available to anyone paying the fees authorized by the Dallas CountyCommissioners Court within the policies and guidelines established by theDallas County Commissioners Court and the Director of the Institute.

4.3.1. A list of current disciplines and sub-disciplines in the CrimeLaboratory is maintained by the Quality Manager.

4.4. 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.



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4.4.2. The specific analyses performed by each analytical unit can be foundin the technical procedure manuals of the units.

5. Quality Management Responsibilities:5.1. Employees. Employees have the following responsibilities:

5.1.1. To actively participate in the quality management program andfollow policies and procedures outlined in this Manual, applicableprocedure manuals, and other policy and procedure documents;

5.1.2. To diligently and accurately perform the duties of their position;5.1.3. To immediately bring to the attention of their Supervisor, Section

Chief, or Director any situation which potentially compromises theintegrity of work performed or reported by Institute personnel;

5.1.4. To perform proficiency tests in the same manner as regular casework;5.1.5. To complete proficiency tests, peer reviews, and courtroom

monitoring in a timely manner and as applicable; and

5.1.6. To review results of QC/QA activities with Supervisor or SectionChief, provide written comment if applicable, and implementcorrective action as necessary.

5.2. Section Chiefs. Section Chiefs have the following responsibilities:5.2.1. To support and implement the Quality Management Program;5.2.2. To communicate quality management policies and procedures to

employees;

5.2.3. To ensure that all personnel receive necessary training and arequalified to perform assigned work;

5.2.4. To ensure completeness of case records and reports;5.2.5. To ensure active and timely participation by staff in proficiency tests,

peer reviews, courtroom monitoring, and other QC/QA activities;

5.2.6. To establish criteria for acceptable performance on proficiency tests,peer reviews, courtroom monitoring, and other QC/QA activities;

5.2.7. To approve the selection and use of analytical procedures;5.2.8.

To review and update methods and procedures;

5.2.9. To establish criteria for method and procedure validation;5.2.10. To implement corrective action as appropriate, review QC/QA

performance with the appropriate staff, and provide written commentas necessary to the Quality Manager;



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5.2.11. To assist the Quality Manager in review and evaluation of qualityprocesses including the Annual Internal Review, ASCLD/LABAnnual Accreditation Audit Report, Annual Quality System Review,and other audits and reviews; and

5.2.12. To delegate quality management responsibilities as applicable.5.3. Quality Manager. The Quality Manager reports directly to the Director and has

primary responsibility and oversight for implementation, documentation, andassessment of the quality management program described in this manual. TheQuality Manager has the following responsibilities:

5.3.1. To maintain and update the quality manual;5.3.2. To monitor laboratory practices to verify continuing compliance with

policies and procedures;

5.3.3. To maintain official copies of manuals;5.3.4. To ensure documentation of routine instrument calibration,

maintenance, and repair;

5.3.5. To periodically assess the adequacy of report review activitiesincluding peer review; ensure that peer review and courtroommonitoring are conducted and evaluated in a timely manner;

5.3.6. To ensure the validation of new technical procedures andinstrumentation;

5.3.7. To investigate technical problems, propose remedial actions, andverify their implementation;

5.3.8. To ensure that appropriate proficiency tests (internal and/or external)are ordered, performed in a timely manner, and evaluated;

5.3.9. To select, train, and evaluate internal inspectors;5.3.10. To schedule, coordinate, and conduct the Annual Internal Review,

Annual ASCLD/LAB Accreditation Audit, Annual Quality SystemReview, and other audits and reviews;

5.3.11. To maintain applicable training and educational records of laboratorypersonnel;

5.3.12. To recommend training to improve the quality of laboratory staff;5.3.13. To oversee the Request for Review (RFR) and Corrective Action

Response (CAR) processes;

5.3.14. To maintain a current listing of employees, signatures, and initials;5.3.15. To propose corrections and improvements in the quality system;5.3.16. To communicate with ASCLD/LAB and the Texas Department of



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Public Safety (DPS) as applicable; and

5.3.17. To delegate quality management issues as applicable.5.4. Quality Committees

5.4.1. At the discretion of the Quality Manager, ad hoc committees andworking groups may be established to assist in maintaining andimproving laboratory quality and maintaining ASCLD/LABaccreditation. Standing committees include:

5.4.1.1. Executive Committee5.4.1.1.1. Membership includes the Quality Manager,

Section Chiefs, Forensic Coordinator, and otherstaff as identified by the Director.

5.4.1.1.2. Duties include managing the request for reviewand corrective action processes, identifying newquality initiatives, assessing overall effectivenessand compliance with the quality program, ensuringapplicability of quality program for alllaboratories, participation in the ASCLD/LABAnnual Accreditation Audit Report, AnnualInternal Review, Annual Quality System Reviewand other audits and reviews, providing assistanceto the Quality Manager, etc.

5.4.1.1.2.1. The Executive Committee has theresponsibility to investigate allegedincidents of serious negligence or

misconduct by staff or subcontractorsthat substantially affect the integrity ofthe scientific analyses performed andreported by the Institute; to report suchincidents to the Director for review andreferral to the accrediting bodies, theTexas Department of Public Safety, theDallas County District AttorneysOffice, and other agencies asappropriate.

5.4.1.2. Institute Quality Committee5.4.1.2.1. Membership includes Quality Manager, Section

Chiefs, Supervisors, one analyst from eachlaboratory, EHS Manager, Deputy EHS Manager,and other staff as identified by the Director.

5.4.1.2.2. Duties include identification of quality related



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7. Educational Background and Training Records7.1. The educational background of each Laboratory employee at in-hire is

documented on the Dallas County employment application and/or in-hirecurriculum vitae which are maintained by the Director.

7.1.1.

The minimum educational requirements for each laboratory positionare established in accordance with applicable accreditation standards(ASCLD-LAB) and Dallas County employment policies, and aredocumented on the official Dallas County job description for eachposition.

7.2. Documentation of job prerequisites, such as academic degrees or specificcourse work, may be required; failure to provide this documentation may resultin disciplinary action including termination in accordance with Dallas Countypolicies.

7.3. Each analyst will develop a curriculum vitae, resume, or statement ofqualifications summarizing education, training, publications, presentations, andother pertinent information which is maintained by the Quality Manager.

7.3.1. This resume is updated annually as necessary by the analyst andunder the direction of the Quality Manager.

7.3.2. It is the employees responsibility to provide the Quality Managerwith documentation of all educational and/or training experiencesrelated to the employees job duties at the Institute.

7.4. The Quality Manager is responsible for maintaining the following portions ofthe employees personnel file: documentation of academic degree and/or othereducational or training requirements, training records, current resume, and

competency testing documentation.7.4.1. Only the current version of an employees resume is kept.

8. Training Programs8.1. Professional Training

8.1.1. Employees must receive appropriate training including applicablecompetency testing prior to conducting independent casework.

8.1.2. Training programs are developed under the direction of theappropriate Section Chief and reviewed by the Quality Manager.

8.1.3. The Quality Manager is the official custodian of training records.8.1.4. The purpose of the training program is to ensure that each trainee

demonstrates a basic proficiency in the following as applicable:

8.1.4.1. applicable methods used by the Laboratory,



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8.1.4.2. academic basis for methods used,8.1.4.3. the use and basic troubleshooting of equipment,8.1.4.4. the general theory of the analytical techniques and

instrumentation,

8.1.4.5. evidence handling,8.1.4.6. expectations of a forensic examiner,8.1.4.7. skills of testimony, and8.1.4.8. other components of the job duties.

8.1.5. The training program is utilized for8.1.5.1. training new employees prior to conducting casework,8.1.5.2. training current employees who are newly assigned or

reassigned, and

8.1.5.3. retraining of current employees as needed8.1.5.3.1. Employees who are absent from work at the

Institute for more than six months mustsuccessfully complete competency testing prior toconducting casework analysis.

8.1.6. Competency testing is an integral part of a training program andincludes, as applicable, evaluation of knowledge of appropriateliterature, examination and identification of known and unknownmaterials, written and/or oral examination, and moot court.

8.1.6.1. Competency testing protocols are a part of the trainingprogram within each Section, and the areas fordemonstration of competency are covered in the trainingmanual.

8.1.6.2. Competency test results are reviewed by the Section Chiefand forwarded to the Quality Manager for review.

8.1.6.3. Once competency is established, acknowledgement ofsuccessful completion is included in the training documentsheld by the Quality Manager. Individual test results are notrequired to be kept as long as the specific areas covered areincluded in the training manual, check list, or other relateddocument.

8.1.7. Regardless of academic qualifications or prior employment, newemployees and current employees who are reassigned or newlyassigned must successfully demonstrate competency in eachapplicable area of examination prior to performing independent case-



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connected examinations.

8.1.8. When an employee requires retraining, the Section Chief, Supervisor,and Quality Manager will determine the appropriate portions of thetraining program to be completed. Independent casework in thedesignated training area may not be performed during a retraining

period.

8.2. Continuing Education and Ongoing Training8.2.1. It is important that analysts maintain technical qualifications through

participation in continuing education and/or training programs.

8.2.1.1. Continuing education and training activities must bedocumented and may include reading current scientificliterature, participation in educational lab meetings, and/orattending seminars, courses, professional meetings, training

sessions and/or classes in relevant subject areas.

8.2.2. The Director and Section Chief determine appropriate use of trainingfunds and training resources.

8.2.2.1. Funding for training and continuing education is madeavailable by the Dallas County Commissioners Court duringthe annual budget process.

8.2.2.2. Employees may request training by providing a writtenrequest to their Section Chief.

8.2.2.3. Supervisors may also identify and recommend appropriatetraining opportunities for staff.

8.2.2.4. The Quality Manager may recommend training.8.2.2.5. 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 QualityManager, and/or other applicable criteria.

8.2.3. The Quality Manager maintains documentation of continuingeducation and training activities.

8.2.3.1. Training activities are included as a part of the employeesannual resume update.

8.3. Environmental Health and Safety Training8.3.1. It is the responsibility of each employee to attend environmental,



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health, and safety training.

8.3.2. Details of the safety training program may be found in the Institute ofForensic Sciences Environmental Health and Safety Manual.

8.3.3. It is the responsibility of each employee to bring safety concernsimmediately to the attention of their supervisor.

9. Case Record Management and Control9.1. Definitions

9.1.1. Case Record (Case File) Files containing administrative andexamination documentation generated or received by a laboratorypertaining to a particular case and used in reaching the conclusionsreported.

9.1.1.1. Administrative Documentation Non-technical or non-analytical records such as case related conversations,evidence receipts, request/submission forms, description ofevidence packaging and seals, subpoenas, correspondence,investigative reports, peer review documentation, casereports, and other related information.

9.1.1.2. Examination Documentation Technical and analyticalrecords such as notes, reference to procedures followed,tests conducted, 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 documentsgenerated which are used to support theexaminers conclusions.

9.1.2. Records Custodian (Custodian of Records) Individual(s) designatedby the Section Chief with responsibility for maintaining care,custody, and control of case records including but not limited to

9.1.2.1. Institute Custodian of Records Director9.1.2.2. Custodian of Records for Section applicable Section Chief

and Deputy Section Chief

9.1.2.3. Custodian of Records for a Laboratory applicableSupervisor



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9.1.2.4. Deputy Custodian of Records for Section or a Laboratory applicable Evidence Registrar(s), applicable SeniorAnalysts, and others as designated by Section Chief.Analysts are Deputy Custodians of Records for cases inwhich they performed work.

9.2. Preparation of Case Records9.2.1. The case record, i.e. case file, should contain adequate information so

that another competent analyst or supervisor can independentlyevaluate and interpret the data.

9.2.2. The Laboratory maintains case documentation in a case file denotedby a unique laboratory case number.

9.2.2.1. Case numbers include a letter designator specific to aparticular laboratory or Section: P (Physical Evidence), C(Drug Analysis Laboratory), M or no letter designation(Medical Examiner Toxicology), D (DWI/DUIDToxicology), H (Other Toxicology), B (Breath Alcohol).

9.2.2.2. Case numbers include a year designator.9.2.2.3. Case numbers within a specific year and letter combination

are assigned sequentially.

9.2.2.4. Examples include 98C1234, 03P0011, etc. MedicalExaminer cases may be designated as 03M1234 or 1234-03to allow for historical numbering in the Office of theMedical Examiner.

9.2.3. Case records must be identified.9.2.3.1. Administrative Documentation

9.2.3.1.1. The case number must appear on the first page ofan administrative document packet; multi-pageadministrative documents which are boundtogether may be identified by placing a casenumber on the front page of the packet.

9.2.3.1.2. It is recommended that all pages of administrativedocumentation are marked with the case number.

9.2.3.1.3. All pages of the case report must be signed orinitialed by the appropriate analyst.

9.2.3.2. Examination Documentation 9.2.3.2.1. The laboratory case number and analysts

signature and/or initials must appear on each pageof the examination documentation.



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9.2.3.2.2. It is acceptable for the laboratory case number tobe printed by an analytical instrument; theanalysts initials and/or signature must behandwritten.

9.2.3.2.3. When examination documentation is prepared by atrainee or individual other than the one(s) withresponsibility for interpretation of the findings,reporting of results, and/or testimony concerningthe documentation, both individuals must sign orinitial each page of the documentation.

9.2.3.2.4. The signer(s) of reports must initial each page ofthe examination documentation package.

9.2.3.2.5. If an individual other than a signer of the report iscalled to testify regarding a case report, theindividual must review the case file prior to

testimony and sign or initial each page of thedocumentation.

9.2.4. Entries into the case record must be made at or near the time ofoccurrence.

9.2.4.1. Dates must be recorded throughout the case documentationto indicate when work was performed.

9.2.5. All case records must be permanent in nature.9.2.5.1. Where records or work product are inherently unstable,

some type of permanent record should be made as

appropriate - for example, thermal paper which fades overtime should be copied, photographs can be made, etc.

9.2.5.2. Manual entries onto case records must be in ink, not pencil,unless specific applications are required by procedures.

9.2.5.2.1. It is recommended that manual entries are made inblue or other non-black ink to assist indistinguishing between photocopies and originaldocuments.

9.2.5.3. Nothing in the examination documentation may beobliterated or erased. Corrections, changes, alterations, and

additional notations made in examination documentationmust be initialed by the individual making the change oraddition.

9.2.5.3.1. Correction fluids like White-Out cannot be used.9.2.5.3.2. Post-it type notes are not recommended and, if



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.2.8.1.

.2.8.2.

.2.8.2.1.

used, must be taped securely to prevent accidentalloss.

9.2.6. Original records are included in the case file where possible.9.2.6.1. When batch instrument reports are generated, a copy of the

instrument report may be included in the individual casefiles, and the original instrument report must be maintainedin a designated location.

9.2.6.2. Staff generated paperwork such as work lists may bephotocopied and initialed by staff.

9.2.6.3. By initialing, staff attests that photocopied paperwork is anexact duplicate of the original and as such is consideredequivalent to the original.

9.2.6.4. Original casework which cannot reasonably be included in acase file may be stored in a designated location with

appropriate notation made in the case file or procedure.

9.2.6.5. Original records are the hard copy materials contained inthe case file or other designated location. Original caserecords may be originally generated by computer but are notstored or archived permanently in this manner.

9.2.7. Abbreviations and symbols may be used within the case recordprovided that their meaning is readily comprehensible to aknowledgeable reviewer.

9.2.7.1. Scientifically accepted abbreviations and symbols may beused without further explanation.

9.2.7.2. Other abbreviations and symbols must be documented inlaboratory procedures or other laboratory manuals.

9.2.8. Bench notes9 Bench notes are original records made contemporaneously

with laboratory testing that describe observations, resultsand measurements that are integral to the examination anddata collection process. Bench notes are a type of raw datathat document processes and are utilized in forming finalconclusions.

9 Bench notes may take the following forms: handwrittenentries on designated forms and worksheets; handwrittennotes on paper; electronic forms and worksheets.

9 Electronic forms and worksheets are consideredbench notes only if completed contemporaneouslywith the examination, and without an intermediate



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.2.8.3.

.2.8.4.

handwritten record.

9 Bench notes must be legible and understandable to anotherqualified examiner.

9.2.8.3.1. The use of personal abbreviations and short-handnotations is not permitted.

9.2.8.3.2. Laboratory approved abbreviations/short-handnotations may be used if they have beendocumented in a procedure manual or otherlaboratory manual.

9.2.8.3.3. Personal abbreviations/short-hand notations maybe used if an explanation has been provided on theactual bench notes.

9.2.8.3.4. Handwritten bench notes must be written with apen, not a pencil.

9.2.8.3.4.1. It is recommended that blue ink be used ratherthan black in order to easily distinguish betweenoriginal documents and photocopies.

9.2.8.3.4.2. Additional color coded notations may be usedwhen appropriate.

9.2.8.3.5. Laboratories are encouraged to design and utilizeappropriate worksheets for the recording of

handwritten bench notes.

9.2.8.3.6. The use of scratch paper (e.g., Post-it notes,envelopes, napkins, paper towels) is greatlydiscouraged. Scratch paper should only be usedunder exceptional circumstances beyond thecontrol of the analyst, and are considered benchnotes

9 Bench notes are part of the examination record and must beretained in the official case file.

9.2.8.4.1. The original version of all handwritten bench notesis retained in the case file as part of the supportingdocumentation package for individual reports.

9.2.8.4.2. If scratch paper is used for making notes due toexceptional circumstances, then the scratch paper



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must be taped to standard 8 x 11 paper forretention in the case file.

9.2.8.4.3. If the original bench notes cannot be retained dueto some extenuating circumstances such as

contamination by a biological material, then thebench notes will be placed in clear plastic andphotocopied. The examiner will verify that thecopy is complete, accurate and legible; and willmake a notation that the copy is being retained inlieu of the original. The photocopy will then beretained. The original will be disposed ofappropriately.

9.2.8.4.4. Under some circumstances it may be necessary forthe sake of clarity to rewrite an entire sheet ofbench notes.

9.2.8.4.4.1. In this situation, the entire original sheetmust be struck through and initialed, anda note should be added to the struck-through sheet to indicate that thecorrections are on a separate sheet.

9.2.8.4.4.2. The new form or note should be markedto indicate that it is a corrected sheet.

9.2.8.4.4.3. The original struck-through bench notesmust be retained.

9.2.8.4.5. A printout of electronic bench notes is retained asthe official case record in the hardcopy case file.

9.2.8.4.5.1. The electronic document is notconsidered an official case record, and isnot retained.

9.3. Report Generation9.3.1. Laboratory reports are written and reviewed by the applicable

analyst(s) and/or supervisor(s).9.3.2. Results and conclusions must be fully supported by data in the case

file.

9.3.3. The specific content of reports and the mechanism of reportdistribution are specified by each Laboratory.



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9.3.3.1. At a minimum, reports include identity of the examininglaboratory, case identifier, date of receipt, date of the report,identity of the submitter, items analyzed, results and/orconclusions, signature of the person(s) acceptingresponsibility for the content of the report.

9.3.3.2. A copy of the final report is sent to the agency or individualrequesting the analysis. In criminal cases this will typicallybe the investigating agency.

9.3.3.2.1. As appropriate to particular case circumstances,copies of the final report may be sent toprosecutors assigned to the case, or to otherindividuals authorized by the requestingagency/individual or by court order.

9.3.3.2.2. Under some circumstances reports may be releasedin accordance with state law regarding government

open records.

9.3.3.3. Distribution of reports to other entities is noted in the caserecord.

9.3.3.4. Additions or corrections to final reports are included in thecase file. They are appropriately marked (CorrectedReport, Supplemental Report, Amended Report, etc.),and copies are provided to all entities receiving the originalreport.

9.3.3.4.1. Corrected Report A report in which a change ismade to correct an error in the written portion ofthe original report.

9.3.3.4.2. Supplemental and Amended Reports Reportsdetailing either a) new information not covered onthe original report and in which findings from theoriginal report are not repeated, or b) new testinginformation not covered on the original report incombination with a repetition of the original reportcontents.

9.3.3.5. A copy of all corrected reports is sent to the QualityManager for review. The Quality Manager determines if anRFR should be initiated.

9.3.4. In some areas the report is routinely signed by more than one analyst,usually one primary analyst and one reviewing analyst. If the twosigning analysts cannot agree on the content of the report, it is theirresponsibility to bring this situation immediately to the supervisor.



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The supervisor will review the situation and attempts to resolve thedisagreement by various means which may include seekingconsensus and/or reanalysis. If resolution still cannot be reached, theSection Chief is advised. The Section Chief then reviews thesituation and offers suggestions for resolution. If consensus cannot

be reached, it is ultimately the responsibility of the Section Chief todetermine the final course of action which may include reassigningthe case, reanalysis, and/or issuing and signing the case report.

9.4. Case Record Storage, Security, and Disposition9.4.1. The original contents of the case file must remain at the Institute, in

the possession of Institute personnel, or under direction of the DallasCounty Records Manager.

9.4.1.1. When it is determined that case reports and other recordsshould be released or provided in court proceedings, only acopy of applicable case contents may be provided.

9.4.1.2. Case records may be maintained on-site at the Institute oroff-site under the direction of the Dallas County RecordsManager.

9.4.2. Case records are not disposed but are maintained indefinitely.9.4.3. Case records are stored in secure areas inaccessible to the general

public.

9.4.4. Proficiency tests and other quality assurance tests may receive a casenumber; however, proficiency case records are maintained by theQuality Manager.

9.4.5. Case records are maintained in accordance with Dallas County policyas implemented by the Dallas County Records Manager.

9.5. Release of Case Records and Case Information9.5.1. Work performed by the Forensic Laboratory is provided on a fee-for-

service basis. The agency or entity purchasing the services is theowner of the work product.

9.5.2. Typically case results are provided to the submitting agency and/ortheir designee or in response to proper legal direction.

9.5.3. Requests for disclosure of case related information falling outsideroutine release practices are directed to the submitting agency and/orsubmitted to the Civil Section of the Dallas County DistrictAttorneys Office for review and direction. This may includeresponses to subpoenas, court orders, freedom of informationrequests and other inquiries.

9.5.3.1. When the Office of the Medical Examiner (OME) is the



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submitting agency, requests to release information mustfollow direction established by OME and/or be reviewed bythe OME prior to release.

9.5.3.2. Requests to release information submitted by other DallasCounty Departments must be reviewed by the Civil Section

of the Dallas County District Attorneys Office prior toaction.

10. Quality Assurance of Standards, Controls, and Reagents10.1. Definitions

10.1.1. Critical Reagent - Reagent for which small changes in concentrationor activity of ingredients will produce significant changes in assayoutcome.

10.1.2. Standard or Reference Standard A preparation which has knownconcentration and/or physical or chemical composition used for thepurpose of calibrating equipment and/or as an experimental control.

10.1.3. Control A standard of comparison for verifying or checking thefinding of an experiment. Positive controls verify the presence ofanalytes or conditions; negative controls verify the absence ofanalytes or conditions.

10.2. Reagent Labels10.2.1. Prepared reagents must be labeled with the identity of the reagent and

the date of preparation or lot number.

10.2.2. Special storage and handling requirements and expiration datesshould also be noted on the label if applicable.

10.3. Reagent Log10.3.1. A record must be kept of reagent preparation including the individual

preparing the reagent and that it was tested and worked as expected.

10.3.2. Records may include other information such as how the reagent wasprepared, lot number, chemical form of the ingredients, etc.

10.4. Critical Reagents10.4.1. Critical reagents must be of acceptable quality for the intended

purpose and of known purity and chemical form.

10.4.2. A log must be kept of all critical reagents prepared including thename of the reagent, initials of preparing analyst, date prepared, lotnumber of principal component(s), and a notation that the reagentworked as expected. Method of preparation should be included if not



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covered elsewhere, such as the procedure manual.

10.4.3. Details of critical reagents prepared and used only in a single analysismay be included in the appropriate case file.

10.4.4. Critical reagents are identified in procedure manuals.10.5. Standards

10.5.1. Standards should be obtained from reputable suppliers and be ofknown purity and/or chemical or physical composition.

10.5.2. A certificate of analysis will serve to establish the quality of achemical standard and should be obtained from the chemical supplierwhere possible. When a certificate of analysis is not available fromthe manufacturer, standard composition should be verified internallyby an applicable analytical technique.

10.5.2.1. A log must be kept of all standard solutions preparedincluding the name of the standard, the initials of preparinganalyst, date of preparation, method of preparation, and lotnumber.

10.5.2.2. Newly prepared standard solutions must meet qualitycontrol criteria established by each laboratory to ensureproper response.

10.6. Measurement Standards10.6.1. Critical measurements will be made using calibrated devices

traceable to NIST or other appropriate standards.

10.6.2. The following devices are verified against NIST-traceable standardsat least once per year:

10.6.2.1. Weights10.6.2.2. Pipetters10.6.2.3. Balances10.6.2.4. Ruler for barrel length10.6.2.5. Gauge blocks10.6.2.6. Stage micrometer10.6.2.7. Calipers10.6.2.8. Thermometers

10.6.3. The records of yearly calibration checks are maintained by theQuality Manager.

10.6.4. Other measurement standards and devices specific to particularanalytical units are defined in the technical procedures of those units.



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10.7. Controls10.7.1. As applicable, controls, positive and negative, are analyzed on a

routine basis according to quality control procedures established byeach laboratory.

10.7.2.

Acceptable response of controls is further verification that the assay -including reagents and standards - is functioning properly.

11. Procedure Manual Control and Maintenance11.1. The types of examinations conducted at the Institute are listed in the procedure

manual for each laboratory.

11.2. All procedures routinely used by a laboratory are written and readily availableto analysts in that laboratory.

11.2.1. Procedure manuals are maintained either as hardcopy documents, oras electronic documents

11.2.1.1. For hardcopy procedure manuals, the official manual ismaintained by the Quality Manager, and duplicate copiesare distributed to functional units as required.

11.2.1.2. For electronic procedure manuals, the official manual is theelectronic version accessed through the QualityManagement System Portal web page.

11.3. Components of Technical Procedures - As appropriate, procedures will includeassay title, principle and/or scope, equipment used, use and preparation ofreagents and controls and standards, assay specific instrument parameters,

analytical procedures, calculations, corrective action, interferences and otherpossible sources of error, interpretation and reporting guidelines, safetyprecautions, references, date of implementation, and other relevant information.

11.4. Revision of Procedures11.4.1. Administrative revisions to procedures, including typographical

errors or clarification of language, typically do not require additionalvalidation.

11.4.2. Material technical revisions to procedures require additionalvalidation.

11.4.3. Revisions and corrections to procedures are summarized in the frontof each manual including effective date of revision, description of thechange, and initials of individual authorizing the change.

11.4.4. Revisions may be made by memo or by updating procedures; theeffective date of implementation must be noted.



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11.4.5. Prior to implementation of a revision, the update must be approvedby the Supervisor and Section Chief and reviewed by all applicableanalysts and the Quality Manager.

11.4.6. Archived procedures are maintained by the Quality Manager.11.4.7.

Out-dated procedures are immediately removed from generalaccessibility.

11.5. Implementation of New Procedures11.5.1. New procedures must be properly validated prior to implementation.11.5.2. The written procedure must be reviewed by all applicable analysts

and the Quality Manager and approved by the appropriate SectionChief and Supervisor. The effective date of implementation must benoted on the procedure.

11.5.3. Out-dated procedures must be removed from the procedure manualand archived by the Quality Manager for future reference.

11.6. Procedure manuals are approved annually by the applicable Section Chief.11.7. The Quality Manager maintains the official copy of each procedure manual.

12. Development, Validation, and Verification of New Testing Methods12.1. 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 upgradedinstruments or equipment, and/or non-administrative changes to existingwritten procedures. For example changing the manufacturer of a GC column

(DB1 to HP1) is considered an administrative change; changing from one typeof GC column to another (DB1 to DB5) requires validation.

12.2. All new testing methods - including material modifications to existingprocedures must be validated after development and prior to use in casework.

12.2.1. Method development is the experimental process of devising,revising, or applying a new method for routine use. The end processof method development is a proposed method which must bevalidated prior to routine implementation in the laboratory.

12.2.2. 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 expectedconditions of use. Generally the validation process is expected to

12.2.2.1. Evaluate whether a new testing method meets identifiedanalytical needs and current scientific practices;

12.2.2.2. Compare the new test methods performance with existing



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laboratory methodology;

12.2.2.3. Describe the conditions under which a testing method willproduce valid results;

12.2.2.4. Predict possible sources of error;12.2.2.5. Determine limitations of a testing method; and12.2.2.6. Establish baseline characteristics of the testing method

(linearity, accuracy, etc.) which serve as benchmarks toevaluate future method performance.

12.3. Validation Process12.3.1. The validation process is performed after method development and

once a proposed testing method has been finalized.

12.3.1.1. The validation process may identify the need to makechanges in the testing method being validated. In this case,

the modified testing method must undergo validation.12.3.2. A written procedure, validation plan, and proposed timetable are

developed prior to beginning the validation process and are submittedby the supervisor or Section Chief to the Quality Manager forapproval.

12.3.2.1. The complexity and comprehensiveness of the validationprocess should be consistent with the magnitude ofproposed testing method changes. The validation plan isbased upon the following:

12.3.2.1.1. The type of method, technique, or analyticalinstrument or equipment being validated.

12.3.2.1.2. The complexity of the new testing method andwhether it is a minor modification of an existingassay, major modification of an existing assay, ordevelopment of a new assay or technique.

12.3.2.1.3. The Laboratorys experience and familiarity withsimilar methods, techniques, or analyticalinstruments or equipment.

12.3.2.2. Method validation must include the testing of knownsamples.

12.3.2.2.1. To the extent possible, known samples shouldresemble actual specimens to allow evaluation ofmatrix effects, specimen aging, specimendegradation, and sample homogeneity.

12.3.2.2.2. Known samples may be obtained internally (for



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example, split samples), externally (for example,reference samples), collaboratively (for example,exchange of blind or reference samples withanother competent laboratory).

12.3.2.3. Where applicable, old and new methods should be run inparallel on split samples and results compared.

12.3.2.4. Validation of quantitative methods should include anassessment of accuracy and precision at concentrationsexpected in case work.

12.3.3. At the conclusion of the validation study, a validation report isgenerated, reviewed/approved by the Supervisor and Section Chief,and submitted to the Quality Manager for review.

12.3.3.1. The validation report contains a copy of the validatedmethod, a compilation of specific validation results,summary of validation parameters identified in thevalidation plan, a discussion of method applicability andpossible limitations, the date of method implementation, etc.

12.3.3.2. The Quality Manager retains the original validation planand validation report.

12.3.3.3. Once the validation report is reviewed by the QualityManager, instrumental records may be discarded providedthat the results are adequately summarized in the validationreport.

12.3.4. The Quality Manager updates the official procedure manual with thenew or revised procedure.

12.3.5. The Supervisor ensures that the new procedure is released for routinework, and that training, as needed, is conducted. The Supervisorensures that any outdated procedure is immediately removed fromuse.

13. Evidence Handling13.1. Procedures. Each Section or Laboratory specifies procedures for proper

submission, packaging, documentation, preservation, storage, and release of

evidence.13.2. Evidence Seals - Where feasible, all evidence is stored in a sealed condition.

13.2.1. A container is properly sealed when the container is secured in apermanent manner to prevent undetected access to the contents, whenits contents cannot readily escape, and when its contents are notsubject to external contamination.



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13.2.2. The seal must be marked with an identifying mark or the initials ofthe person sealing the evidence.

13.2.3. Ideally, evidence which is delivered in person and is not properlysealed will be properly sealed by the submitter prior to receipt by theEvidence Registrar.

13.2.4. It is the responsibility of the Evidence Registrar or other individualreceiving evidence to ensure that all evidence accepted by thelaboratory is stored under proper seal and to repackage and/or sealevidence as necessary.

13.2.5. Items of evidence which are impractical, inappropriate, or too large tobe placed in a sealed container are marked or identified in apermanent manner for future identification. Markings may be madeusing indelible pens/markers, permanent tags, engraving, or usingunique numbers permanently affixed to the item such as serialnumbers.

13.2.6. Evidence which is packaged in a manner that may affect the ability ofthe Laboratory to analyze it should be repackaged properly.

13.2.6.1. Ideally repackaging should be performed by the submittingagency prior to submission to the Laboratory when possible.

13.2.7. If evidence can only be recorded or collected by photograph forexample with an impression the image or photograph must berecoverable from a computer otherwise a print or negative must betreated as evidence.

13.3. Evidence Receipt13.3.1. Evidence may be submitted in person, by mail, by package delivery

service, by lock-box, or other method.

13.3.2. Evidence is stored in a manner and environment that preserves theintegrity of the evidence to the extent possible.

13.3.3. Case Numbering13.3.3.1. Each case is assigned a unique case number which is placed

on the outside of each evidence container.

13.3.3.2. Item numbers may also be assigned and placed on theoutside of evidence containers.

13.3.4. As applicable, evidence is logged into a computer tracking system.13.4. Chain of Custody Each evidence transfer must be acknowledged at the time

that the evidence is transferred.

13.4.1. Transfer of evidence between individuals must be acknowledged byboth parties at the time of evidence transfer.



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13.4.2. Transfer of evidence between an individual and a primary evidencestorage area must be acknowledged at the time of evidence transfer.

13.4.3. Evidence located in a personal evidence storage locker is deemed tobe 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.

13.4.4. Location of evidence in a primary evidence storage area or in thepossession of an authorized Evidence Registrar or other individualwith authorized access to the primary evidence storage area isdeemed to be one and the same for purposes of evidence tracking.Therefore, transfer of evidence among these authorized entities is notrequired during the performance of routine Evidence Registrationduties.

13.4.5. Electronic tracking of chain of custody is acceptable as long as thecomputerized data is reasonably secure, accessible, and able to be

committed to hard copy when needed.

13.4.5.1. Individual, secure personal identifiers are acceptable in lieuof personal signatures.

13.4.6. In Texas, legal precedent establishes that chain of custody within thelaboratory goes to the weight of the evidence and not to itsadmissibility:

13.4.6.1. Norris vs. Texas, 507 S.W. 2d 796 (Tx. Cr. App. 1974) Wheretestimony established chain of custody up to point that heroin wasdelivered to criminal investigation laboratory, testimony by employee ofthe laboratory that he received the exhibits in question from officers of

the police department for laboratory analysis, logged them in, and turnedthem over to a chemist for analysis was sufficient to establish the chainof custody and any objection to absence of chemist as a witness totestify as to receiving the exhibits went only to the weight of thatevidence and not to its admissibility.

13.4.6.2. Medellin vs. State 617 S.W. 2d 229 (Tx. Cr. App. 1981) The chain ofcustody was completed to inside the laboratory, thus any furtherobjection goes to the weight of evidence, rather than to its admissibility.

13.4.6.3. Bueno vs. State 677 S.W. 2d 261 (Tx. App. 13 Dist. 1984) Once thechain of custody is completed to inside the laboratory any furtherobjection goes to the weight of the testimony rather than to itsadmissibility.

13.5. Evidence Identification13.5.1. Institute staff inventory and mark evidence as outlined in applicable

laboratory procedures.

13.5.2. Evidence or the evidence container must be marked with a uniqueidentifier such as a laboratory case number.



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13.6.1.1.4.2. Staff assigned only a key are authorizedaccess only when staff noted in13.6.1.1.4.1 are present in the building;typically routine business hours.

13.7. In-Process Evidence13.7.1. Evidence in the process of examination may be stored unsealed in a

secure area with limited access.

13.7.2. At all times, in-process evidence must be protected from loss, cross-transfer, contamination and/or deleterious change.

13.7.3. Evidence must be properly sealed in a timely fashion onceexamination or analysis is complete even if the evidence is stored in apersonal evidence locker.

13.7.3.1. Because it is common to receive additional testing requestsin Toxicology after production of the initial report, the

Laboratory has determined that evidence will be sealedwithin one month of case completion.

13.8. Evidence Release13.8.1. The examiner reseals the evidence, initials (or otherwise marks) the

seal for later identification, and returns evidence to EvidenceRegistration.

13.8.2. The Evidence Registrar prepares evidence for disposition and notifiesthe submitter that the evidence is available for release if appropriate.

13.8.3. Evidence is released to the submitting agency in person, by mail, orby package delivery; placed in long term storage; or disposed asoutlined in specific procedures for each section.

13.8.3.1. Transfer of evidence to long term storage or disposal ofevidence is tracked using appropriate chain of custody.

13.8.3.2. Release of evidence to the submitting agency is documentedusing appropriate chain of custody.

13.8.4. Evidence may only be released to the submitting agency or an entityapproved by the submitting agency or in response to subpoena orother legal procedure.

13.8.5. If the agent present to receive evidence is not known by the IFSemployee, then the IFS employee must require verification of theidentity and affiliation of the representative prior to releasingevidence.

13.8.6. If a submitting agency does not respond to notification that evidenceis ready for release, the Evidence Registrar may send evidence to the



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submitter via mail or package delivery service per proceduresidentified by each section.

13.9. Individual Characteristic Database Samples13.9.1. The laboratory tests the following evidence sample types for

inclusion in individual characteristic databases:13.9.1.1. Questioned and exemplar biological samples (for CODIS

databases)

13.9.1.2. Questioned cartridge cases (for NIBIN databases)13.9.1.3. Exemplar cartridge cases generated from submitted firearms

(for NIBIN databases)

13.9.2. Samples processed for inclusion in individual characteristic databasesare handled in the same manner as any other evidence item.

14. Instrument Operation, Calibration, and Maintenance14.1. Instrumentation is calibrated and maintained, as appropriate, to ensure that the

instrument/equipment remains in proper working order.

14.1.1. Analytical instrumentation and equipment that have an effect on theaccuracy or validity of casework are routinely checked withapplicable reference measurement standards - for example, properoperation of a GC/MS is usually verified usingperfluorotributylamine (FC-43 or PFTBA), an IR by usingpolystyrene, and a balance by using certified weights.

14.1.1.1.

Appropriate calibration and maintenance for eachinstrument are determined by the manufacturersspecifications, quality control ranges, device tolerances,etc., and are detailed in section specific technical manuals.

14.1.2. Documentation of all calibration, maintenance, and repair must bemade and kept near the instrumentation/equipment for use as neededby the analyst.

14.1.3. New instruments and equipment or instruments and equipment thathave undergone repair or maintenance must have proper operationand/or calibration verified prior to analysis of casework.

14.2. Manufacturers operating and/or repair manuals must be kept readily availableto all analysts.

15. Facility Security and Maintenance15.1. Security



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15.1.1. The success of any security system depends upon employeecommitment to the security plan; therefore, it is each employeesresponsibility to actively participate in the Institute security programas described in the Institute of Forensic Sciences Security Manual.

15.1.2. The Institute is equipped with numerous security devices includingsecure keys and locks, magnetic card locks, and door contacts andmotion detectors in critical areas.

15.2. Building Maintenance and Repair15.2.1. General Building Maintenance and Repair

15.2.1.1. It is the responsibility of Dallas County FacilitiesManagement to conduct building maintenance and repairactivities.

15.2.1.2. Standard operating procedures for the Institute of ForensicSciences and relevant maintenance records are maintained

on-site by Facilities staff assigned to the Institute.

15.2.1.3. Building issues identified by IFS staff are forwarded toFacilities Management usually through IFS Administration.

15.2.2. Laboratory Housekeeping15.2.2.1. Laboratory areas must be kept clean and free of relevant

contamination.

15.2.2.2. General building cleaning and non-regulated trash removalis the responsibility of Facilities Management.

15.2.2.3. Lab specific cleaning and/or decontamination is theresponsibility of knowledgeable IFS staff.

15.2.2.4. Each laboratory is responsible for developing,implementing, and documenting applicablecleaning/decontamination procedures.

16. Quality Assurance/Quality Control16.1. The Institute has developed various quality assurance and quality control

procedures to provide ongoing verification that the technical procedures used inthe Laboratory are valid and that the quality of each examiners work ismaintained at an acceptable level.

16.1.1. Components of the Quality Assurance/Quality Control programinclude but are not limited to: administrative review, technical/peerreview, proficiency testing, inter-laboratory comparisons, reanalysisof casework, assay controls, reviews and audits, etc. Used as a whole,these tools are valuable in assessing laboratory and analystperformance; however, a single event is not the sole indicator of



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laboratory or analyst competence.

16.1.2. The goals of a quality assurance/quality control program are asfollows:

16.1.2.1. To verify that technical procedures are valid and workingproperly;

16.1.2.2. To ensure that quality work is being produced;16.1.2.3. To identify areas where additional training would be

beneficial;

16.1.2.4. To evaluate effectiveness and appropriateness of analyticalmethodology; and

16.1.2.5. To demonstrate current competence of the laboratory andthe individual analysts.

16.2. Administrative Review of Reports16.2.1. Administrative review is a procedure used to check for consistency

with laboratory policy and procedures and for editorial correctness.

16.2.2. An administrative review is conducted on all laboratory reports toensure that all reports are complete, concise, and consistent withlaboratory policy.

16.2.3. Administrative review is conducted at the time of final report reviewand signature; by signing the case report, an individual documentsthat an administrative review has been conducted.

16.2.4. An administrative review may also be conducted by others includinga peer reviewer.

16.3. Technical/Peer Review of Case Records16.3.1. Peer/technical review is a review of the analytical report and

supporting documentation package for technical correctness by anindividual - other than the primary analyst - who has expertise in aspecific functional area gained through documented training andexpertise.

16.3.1.1. The technical reviewer may be either an individualappropriately qualified as a casework analyst in thediscipline /subdiscipline under review, or an individualqualified by appropriate training and expertise but who doesnot perform casework analysis in the discipline/subdiscipline under review.

16.3.2. Peer/technical review provides a second evaluation of bench notes,



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data, and other documents which form the basis for the scientificconclusion described in the report.

16.3.3. Technical/peer review must be conducted on a minimum of 20% orsix (whichever is fewer) completed cases per examiner per month.

16.3.3.1.

At the discretion of the section chief, technical/peer reviewin specific disciplines/subdisciplines may be performed as aroutine review activity for all technical reports.

16.3.3.2. Technical/peer review is typically completed prior to therelease of a report and following completion of all relevantquality control and administrative review activities.

16.3.3.3. In some disciplines/subdisciplines, technical/peer reviewmay occur following release of a report.

16.3.4. For each case that receives peer/technical review, the reviewer willdetermine if the following elements have been satisfied:

16.3.4.1. The requested examinations are addressed, and the resultsare clearly communicated to the reader.

16.3.4.2. The format of the report is consistent with laboratorypractice, and the report is editorially and typographicallycorrect.

16.3.4.3. The report adequately describes the evidence.16.3.4.4. The case number and signing analysts (or analysts) initials

appear on all pages of the reports supportingdocumentation package.

16.3.4.5. The chains of custody for evidence items examined(including internal transfers) are current and adequatelydocumented.

16.3.4.6. The examination results are supported by applicableanalytical documentation (graphs, charts, etc.)

16.3.4.7. The tests performed conform to accepted techniques, andappropriate standards and/or control samples were used andadequately documented.

16.3.4.8. The conclusions drawn are fully supported by the data, andare reasonable and within the range of acceptable opinionsof peers within the discipline.

16.3.5. Conformance to the elements described in section 16.3.4 may bedocumented by completion of the Peer/Technical Review form.

16.3.5.1. When used, the Peer/Technical Review form is retained inthe case file.



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16.3.5.2. Alternatively, disciplines/subdisciplines may incorporate thetechnical/peer review into routine case review activitieswithout use of the Peer/Technical Review form providedthat the technical/peer review process is documented intechnical or other manuals.

16.3.6. Non-conformance to the elements described in section 16.3.4 will bedocumented by completion of the Peer/Technical Review form.

16.3.6.1. On the Peer/Technical Review form the technical reviewermust provide a description of all instances of non-conformance.

16.3.7. If a non-conformance to the elements described in section 16.3.4 isdetected during technical/peer review, and if the non-conformance isnot otherwise resolved as part of the routine casework quality controlprocess, then it is reported to the Section Chief by the TechnicalReviewer. The Section Chief then:

16.3.7.1. Determines the appropriate course of action to resolve thevariance and documents this on the Peer Review Form.

16.3.7.2. Forwards the Peer Review Form to the Quality Manager forreview.

16.3.7.3. As appropriate, initiates a Request for Review (see the Self-Critical Review and Corrective Action section of thisManual).

16.3.8. In any laboratory which has only one qualified examiner in adiscipline/subdiscipline, the Section Chief will make arrangements

with another forensic laboratory to perform a peer or technical reviewon the required number of cases; where feasible, the laboratoryshould be accredited.

16.3.8.1. For an external review, components of the completed casefile necessary to reach final conclusions are copied and sentto a qualified external reviewer with the Peer Review Form

16.3.9. The Quality Manager is responsible for tracking participation in thetechnical/peer review process.

16.4. Proficiency Testing Program16.4.1.

Proficiency testing is a process in which analysts perform testing onspecimens of unknown composition to the analyst but of knowncomposition to selected Institute staff (internal) or to an independentagency (external).

16.4.1.1. The Quality Manager provides oversight of the proficiencytesting program, including the development of the



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proficiency testing plan, ordering and distribution ofproficiency tests, receipt and dissemination of test results,coordination of test review process, and maintenance of allproficiency documentation.

16.4.2. The following information is required for each proficiency test internal or external:

16.4.2.1. How samples were obtained or prepared16.4.2.2. Who participated in testing16.4.2.3. Time frame of testing16.4.2.4. Responsible supervisor

16.4.3. Proficiency testing requirements apply to forensic examiners and toforensic disciplines. A discipline or functional area is a major area ofcasework for which a laboratory may seek accreditation - forexample, Trace Evidence, Drug Analysis, Firearms, etc. Asubdiscipline is specialized area of analysis included within adiscipline or functional area - for example, hair analysis, fiberidentification, and arson are sub-disciplines of Trace Evidence.

16.4.4. The following minimum proficiency testing standards must be met:16.4.4.1. All forensic examiners must complete at least one

proficiency test (internal or external) annually for each sub-discipline in which they perform analyses.

16.4.4.2. Each discipline or functional area must participate annuallyin at least one external proficiency test for each forensic

discipline in which it provides services.16.4.4.2.1. Where available, at least one proficiency test for

each discipline must be from an ASCLD/LABapproved provider with results released toASCLD/LAB.

16.4.4.2.2. At a minimum, DNA examiners and technicalsupport personnel performing DNA analyticaltechniques will comply with ASCLD/LAB andDAB standards regarding external proficiencytests.

16.4.5. Response to Proficiency Test Results16.4.5.1. Proficiency test results are assessed as successful, successful

with corrective action, or unsuccessful.

16.4.5.1.1. Successful proficiency results occur whenresults are deemed acceptable by the external



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proficiency program or when written criteria forsuccessful completion established by the SectionChief are met.

16.4.5.1.2. Inconsistent proficiency results occur when resultsfall outside the acceptable range as defined by the

external proficiency provider or the rangeidentified by the Section Chief for in-houseproficiencies or when identified as such byASCLD/LAB. Inconsistent proficiency results areinvestigated using the Institutes Critical Reviewand Corrective Action Program. Results areevaluated as follows:

16.4.5.1.2.1. Successful with corrective actiondenotes that an RFR and/or CAR wassuccessfully completed as judged by the

ASCLD/LAB Proficiency ReviewCommittee or the Institutes ExecutiveCommittee.

16.4.5.1.2.2. Unsuccessful proficiency results occurwhen inconsistent proficiency results arenot successfully resolved.

16.4.5.1.3. The Section Chief, Supervisor, and/or QualityManager will review inconsistent proficiencyresults with the analyst.

16.4.5.1.4. The Quality Manager has authority to reject orrender invalid any internal proficiency test samplesthat are improperly documented, prepared, orotherwise rendered unsuitable for the purpose ofproficiency testing.

16.4.6. Results of proficiency testing are reported to the Director on anannual basis as a part of the annual quality review.

16.4.7. The Quality Manager is the point of contact between the Institute andASCLD/LAB and DPS as it relates to proficiency test issues.

16.5. Inter-laboratory Comparisons16.5.1. Laboratories may choose to establish exchange programs with otherlaboratories for external proficiencies, sample validation of new

procedures, etc.

16.6. Blind Testing and/or Reanalysis of Casework16.6.1. Laboratories may choose to develop methods for submission and



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testing of blind samples submitted as normal casework.

16.6.2. Laboratories may also choose to have a second analyst reanalyzepreviously completed casework as a means of assessing quality andproviding training.

16.7.

Quality Control Samples16.7.1. Quality control procedures, used routinely in assays, provide a

frequent assessment of the performance of analytical methods and theapplication of these methods by the analyst.

16.7.2. Specific quality control procedures are included as a part ofindividual analytical procedures or described in other documentsprepared by a Section or laboratory.

17. Self-Critical Review and Corrective Action17.1. Self-critical review of laboratory procedures, processes, and results is afundamental and routine expectation of a scientific laboratory and an integral

component in maintaining consistency with best practices in forensic sciences.

17.1.1. Self-critical review occurs routinely during the normal performanceand review of case work, quality control/quality assurance activitiesincluding proficiency testing and peer review, reanalysis of casework,training or retraining activities, audits and reviews, etc.

17.1.2. Certain issues identified through self-critical review are readilyanticipated and guidance for response is addressed in routinepractices, policies, and procedures.

17.1.3. Other issues identified through self-critic

SWIFS Quality Management Program Quality Manual v2.4 (11.01.2008) 56 Pages

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