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

8/2/2019 SWIFS Quality Management Program Quality Manual v2.3 (02.28.2008) 53 Pages

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Dallas County Institute of Forensic Sciences Quality Manual, Version 2.3

Forensic Laboratory Effective Date: 2/28/08

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

This is a non-controlled copy of a controlled document




Forensic Laboratory i Effective date: 2/28/2008

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 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.





Forensic Laboratory ii Effective date: 2/28/2008

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





Forensic Laboratory iii Effective date: 2/28/2008

Dallas County Institute of Forensic Sciences

Forensic Laboratory

QUALITY MANUAL

DISTRIBUTION LIST

The Quality Management Program Quality Manual is maintained as an electronic document that

is accessible to all staff through the Quality Management System Portal web page.





Forensic Laboratory 1 Effective date: 2/28/2008

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:................................................................................... 5

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

7. Educational Background and Training Records..................................................................... 9

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

9. 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. Policy Statement and Purpose of the Laboratory

1.1. 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.

1.2. 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.

1.3. 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.

1.4. 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, and1.4.2. quality assurance (QA) – planned and systematic actions necessary to

provide sufficient confidence that a laboratory’s work product satisfies

specified quality requirements, for example, peer review, proficiency

tests, instrument calibration, assay verification, reviews and audits, etc.

2. Objectives of the Quality Management Program

2.1. 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 instrumentationand equipment in proper working order;

2.1.2. Analytical procedures which are based upon sound scientific principles

and which have been validated as to accuracy and reliability;

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






instrumentation;

2.1.4. Testimony which is truthful, complete, and impartial provided in a

professional manner;

2.1.5. Hiring and training of qualified staff with verification of acceptable

competency and provision of ongoing training and professionaldevelopment for staff as appropriate;

2.1.6. Periodic evaluation of procedures and analysts through participation in

internal and/or external proficiency testing and peer review;

2.1.7. Use of quality analytical standards of known purity and/or composition

from reputable manufacturers where available and appropriate;

2.1.8. Evidence handling processes which provide care, custody, and control of

evidence and case records;

2.1.9. Participation as applicable in the Annual Internal Review, ASCLD/LAB

Annual Accreditation Audit Report, Annual Quality System 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 as applicable.

3. Purpose of the Manual

3.1. The purpose of this manual is as follows:

3.1.1. 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,

3.1.2. To establish quality control and quality assurance processes as an integral

and necessary component in providing competent forensic analyses,

3.1.3. To communicate expected quality management activities to laboratory

staff; and

3.1.4. To ensure a consistent approach to quality management throughout the

Forensic Laboratory.

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

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 Quality Manager.

3.4.2. 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.

4. Scope and Organization of the Forensic Laboratory

4.1. 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.

4.1.1. The Forensic Laboratory is an independent laboratory, and the Director of

the Institute reports directly to the Dallas County Commissioners Courtand the Chair of the Pathology Department of UT-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 toanyone 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.

4.3.1. A list of current disciplines and sub-disciplines in the Crime Laboratory 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.

4.4.2. The specific analyses performed by each analytical unit can be found in

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 and follow

policies and procedures outlined in this Manual, applicable procedure

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 the integrity 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 Section Chief,

provide written comment if applicable, and implement corrective 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 are qualified 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 comment as

necessary to the Quality Manager;

5.2.11. 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

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, and

assessment of the quality management program described in this manual. The

Quality 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 activities including

peer review; ensure that peer review and courtroom monitoring are

conducted and evaluated in a timely manner;

5.3.6. To ensure the validation of new technical procedures and instrumentation;

5.3.7. To investigate technical problems, propose remedial actions, and verify

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 System

Review, 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 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 and working

groups may be established to assist in maintaining and improving

laboratory quality and maintaining ASCLD/LAB accreditation. Standing






committees include:

5.4.1.1. Executive Committee

5.4.1.1.1. Membership includes the Quality Manager, Section

Chiefs, Forensic Coordinator, and other staff as

identified by the Director.5.4.1.1.2. 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.

5.4.1.1.2.1.

The Executive Committee has theresponsibility 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 Attorney’s Office, and other

agencies as appropriate.

5.4.1.2. Institute Quality Committee

5.4.1.2.1. 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.

5.4.1.2.2. 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.

5.5. Director. The Director has the following responsibilities:

5.5.1. 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;






5.5.2. To support and promote implementation of the quality management

program;

5.5.3. To review and respond as applicable to the Annual Accreditation Audit

and Annual Quality System Review;

5.5.4.

To seek adequate funding to maintain a quality laboratory operation;5.5.5. To identify a Quality Manager to oversee implementation of the quality

management program;

5.5.6. To resolve disputed quality issues;

5.5.7. To delegate quality management responsibilities as applicable.

5.5.8. 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

Attorney’s Office, and other agencies as appropriate.

5.6. Suggestions for improving the Quality Management Program can be made to the

Quality Manager, Section Chief, and/or Director.

6. Job Descriptions

6.1. The Director maintains currently available job descriptions of employees in the

Forensic Laboratory which have been approved by the Dallas County

Commissioners Court.

6.2.

The Director may approve use of a more detailed statement of job functions, asnecessary.

7. Educational Background and Training Records

7.1. 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.

7.2. 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.






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.

7.3.2. It is the employee’s responsibility to provide the Quality Manager with

documentation of all educational and/or training experiences related to the

employee’s job duties at the Institute.

7.4. The Quality Manager is responsible for maintaining the following portions of the

employee’s personnel file: documentation of academic degree and/or other

educational or training requirements, training records, current resume, and

competency testing documentation.

7.4.1. Only the current version of an employee’s resume is kept.

8. Training Programs

8.1. Professional Training

8.1.1. Employees must receive appropriate training prior to conducting

independent casework.

8.1.2. Training programs are developed under the direction of the appropriate

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,

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 for

8.1.5.1. 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 needed.

8.1.6. 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 oralexamination, and moot court as applicable.

8.1.6.1. 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.

8.1.6.2. Competency test results are reviewed by the Section Chief and

forwarded to the Quality Manager for review.

8.1.6.3. 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 thetraining manual, check list, or other related document.

8.1.7. 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.

8.1.8. 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.

8.2. Continuing Education and Ongoing Training

8.2.1. 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 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.8.2.2. The Director and Section Chief determine appropriate use of training

funds and training resources.

8.2.2.1. Funding for training and continuing education is made available

by the Dallas County Commissioners Court during the annual

budget process.






8.2.2.2. Employees may request training by providing a written request

to their Section Chief.

8.2.2.3. Supervisors may also identify and recommend appropriate

training 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 Quality Manager, and/or other applicable

criteria.

8.2.3. The Quality Manager maintains documentation of continuing education

and training activities.

8.2.3.1. Training activities are included as a part of the employee’s

annual resume update.

8.3. Environmental Health and Safety Training

8.3.1. It is the responsibility of each employee to attend environmental, health,

and safety training.

8.3.2. Details of the safety training program may be found in the Institute of

Forensic Sciences Environmental Health and Safety Manual.

8.3.3. It is the responsibility of each employee to bring safety concerns

immediately to the attention of their supervisor.

9. Case Record Management and Control

9.1. 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.

9.1.1.1. 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.

9.1.1.2. Examination Documentation – Technical and analytical records

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 documents generated which are used to support

the examiner’s conclusions.

9.1.2. 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

9.1.2.1. Institute Custodian of Records – Director

9.1.2.2. Custodian of Records for Section – applicable Section Chief and

Deputy Section Chief 9.1.2.3. Custodian of Records for a Laboratory – applicable Supervisor

9.1.2.4. 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.

9.2. Preparation of Case Records

9.2.1. 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.

9.2.2. The Laboratory maintains case documentation in a case file denoted by a

unique laboratory case number.

9.2.2.1. 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).

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. Medical Examiner

cases may be designated as 03M1234 or 1234-03 to allow for

historical numbering in the Office of the Medical 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 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.

9.2.3.1.2. It is recommended that all pages of administrative

documentation are marked with the case number.

9.2.3.1.3. All pages of the case report must be signed or initialed

by the appropriate analyst.

9.2.3.2. Examination Documentation –

9.2.3.2.1. The laboratory case number and analyst’s signature

and/or initials must appear on each page of the

examination documentation.

9.2.3.2.2. It is acceptable for the laboratory case number to be

printed by an analytical instrument; the analyst’s

initials and/or signature must be handwritten.

9.2.3.2.3. 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.

9.2.3.2.4. The signer(s) of reports must initial each page of the

examination documentation package.

9.2.3.2.5. 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.

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

occurrence.

9.2.4.1. Dates must be recorded throughout the case documentation to

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 over time 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 in blue

or other non-black ink to assist in distinguishing

between photocopies and original documents.

9.2.5.3. 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.

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 used,

must be taped securely to prevent accidental loss.

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 case files,

and the original instrument report must be maintained in a

designated location.

9.2.6.2. Staff generated paperwork such as work lists may be

photocopied and initialed by staff.

9.2.6.3. By initialing, staff attests that photocopied paperwork is an exact

duplicate of the original and as such is considered equivalent to

the original.

9.2.6.4. Original casework which cannot reasonably be included in a case

file, may be stored in a designated location with appropriatenotation made in the case file or procedure.

9.2.6.5. “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.

9.2.7. Abbreviations and symbols may be used within the case record provided

that their meaning is readily comprehensible to a knowledgeable reviewer.

9.2.7.1. Scientifically accepted abbreviations and symbols may be used

without further explanation.

9.2.7.2. Other abbreviations and symbols must be documented in

laboratory procedures or other laboratory manuals.

9.2.8. Bench notes

9.2.8.1. Bench notes are original records made contemporaneously with

laboratory testing that describe observations, results and






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 onpaper; electronic forms and worksheets.

9.2.8.2.1. Electronic forms and worksheets are considered bench

notes only if completed contemporaneously with the

examination, and without an intermediate handwritten

record.

9.2.8.3. Bench notes must be legible and understandable to another

qualified examiner.

9.2.8.3.1. The use of personal abbreviations and short-hand

notations is not permitted.

9.2.8.3.2. Laboratory approved abbreviations/short-hand

notations may be used if they have been documented in

a procedure manual or other laboratory manual.

9.2.8.3.3. Personal abbreviations/short-hand notations may be

used if an explanation has been provided on the actual

bench notes.

9.2.8.3.4. Handwritten bench notes must be written with a pen,

not a pencil.

9.2.8.3.4.1. It is recommended that blue ink be used rather

than black in order to easily distinguish between

original documents and photocopies.

9.2.8.3.4.2. Additional color coded notations may be used

when appropriate.

9.2.8.3.5. Laboratories are encouraged to design and utilize

appropriate 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 greatly discouraged. Scratch

paper should only be used under exceptional

circumstances beyond the control of the analyst, and

are considered bench notes






9.2.8.4. Bench notes are part of the examination record and must be

retained in the official case file.

9.2.8.4.1. The original version of all handwritten bench notes is

retained in the case file as part of the supporting

documentation package for individual reports.

9.2.8.4.2. If scratch paper is used for making notes due to

exceptional circumstances, then the scratch paper must

be taped to standard 8½” x 11” paper for retention in

the case file.

9.2.8.4.3. 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 beingretained in lieu of the original. The photocopy will

then be retained. The original will be disposed of

appropriately.

9.2.8.4.4. Under some circumstances it may be necessary for the

sake of clarity to rewrite an entire sheet of bench notes.

9.2.8.4.4.1. In this situation, the entire original sheet must

be struck through and initialed, and a note

should be added to the struck-through sheetto indicate that the corrections are on a

separate sheet.

9.2.8.4.4.2. The new form or note should be marked to

indicate that it is a corrected sheet.

9.2.8.4.4.3. The original struck-through bench notes must

be retained.

9.2.8.4.5. A printout of electronic bench notes is retained as the

official case record in the hardcopy case file.

9.2.8.4.5.1. The electronic document is not considered an

official case record, and is not retained.

9.3. Report Generation

9.3.1. 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 report distribution

are specified by each Laboratory.

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/or

conclusions, signature of the person(s) accepting responsibility

for the content of the report.

9.3.3.2. 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.

9.3.3.2.1. 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 therequesting agency/individual or by court order.

9.3.3.2.2. Under some circumstances reports may be released in

accordance with state law regarding government open

records.

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

record.

9.3.3.4. 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.

9.3.3.4.1. Corrected Report – A report in which a change is made

to correct an error in the written portion of the original

report.

9.3.3.4.2. 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.

9.3.3.5. A copy of all corrected reports is sent to the Quality Manager for

review. The Quality Manager determines if an RFR 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 two signing






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 forresolution. 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. Case Record Storage, Security, and Disposition

9.4.1. The original contents of the case file must remain at the Institute, in the

possession of Institute personnel, or under direction of the Dallas County

Records Manager.

9.4.1.1. 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.

9.4.1.2. Case records may be maintained on-site at the Institute or off-

site under the direction of the Dallas County Records Manager.

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 case

number; however, proficiency case records are maintained by the Quality

Manager.

9.4.5. Case records are maintained in accordance with Dallas County policy as

implemented by the Dallas County Records Manager.

9.5. Release of Case Records and Case Information

9.5.1. Work performed by the Forensic Laboratory is provided on a fee-for-

service basis. The agency or entity purchasing the services is the owner

of the work product.

9.5.2. Typically case results are provided to the submitting agency and/or their

designee or in response to proper legal direction.

9.5.3. Requests for disclosure of case related information falling outside routine

release practices are directed to the submitting agency and/or submitted tothe Civil Section of the Dallas County District Attorney’s Office for

review and direction. This may include responses to subpoenas, court

orders, freedom of information requests and other inquiries.

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

submitting agency, requests to release information must follow






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 Attorney’s Office prior to action.

10. Quality Assurance of Standards, Controls, and Reagents

10.1. Definitions

10.1.1. Critical Reagent - Reagent for which small changes in concentration or

activity of ingredients will produce significant changes in assay outcome.

10.1.2. 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.

10.1.3. Control – A standard of comparison for verifying or checking the findingof an experiment. Positive controls verify the presence of analytes or

conditions; negative controls verify the absence of analytes or conditions.

10.2. Reagent Labels

10.2.1. 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 dates should

also be noted on the label if applicable.

10.3. Reagent Log

10.3.1. A record must be kept of reagent preparation including the individualpreparing the reagent and that it was tested and worked as expected.

10.3.2. Records may include other information such as how the reagent was

prepared, lot number, chemical form of the ingredients, etc.

10.4. Critical Reagents

10.4.1. 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 the name of

the reagent, initials of preparing analyst, date prepared, lot number of

principal component(s), and a notation that the reagent worked asexpected. Method of preparation should be included if not covered

elsewhere, such as the procedure manual.

10.4.3. Details of critical reagents prepared and used only in a single analysis

may 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 of known

purity and/or chemical or physical composition.

10.5.2. A certificate of analysis will serve to establish the quality of a chemicalstandard 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.

10.5.2.1. 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.

10.5.2.2. Newly prepared standard solutions must meet quality control

criteria established by each laboratory to ensure proper response.

10.6. Measurement Standards

10.6.1. 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 standards at

least once per year:

10.6.2.1. Weights

10.6.2.2. Pipetters

10.6.2.3. Balances

10.6.2.4. Ruler for barrel length

10.6.2.5. Gauge blocks

10.6.2.6. Stage micrometer

10.6.2.7. Calipers

10.6.2.8. Thermometers

10.6.3. The records of yearly calibration checks are maintained by the Quality

Manager.

10.6.4. Other measurement standards and devices specific to particular analytical

units are defined in the technical procedures of those units.10.7. Controls

10.7.1. As applicable, controls, positive and negative, are analyzed on a routine

basis according to quality control procedures established by each

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 Maintenance

11.1. The types of examinations conducted at the Institute are listed in the proceduremanual for each laboratory.

11.2. All procedures routinely used by a laboratory are written and readily available to

analysts in that laboratory.

11.2.1. Procedure manuals are maintained either as hardcopy documents, or as

electronic documents

11.2.1.1. For hardcopy procedure manuals, the official manual is

maintained by the Quality Manager, and duplicate copies are

distributed to functional units as required.

11.2.1.2. For electronic procedure manuals, the official manual is theelectronic version accessed through the Quality Management

System Portal web page.

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.

11.4. Revision of Procedures

11.4.1. Administrative revisions to procedures, including typographical errors orclarification of language, typically do not require additional validation.

11.4.2. Material technical revisions to procedures require additional validation.

11.4.3. 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.

11.4.4. Revisions may be made by memo or by updating procedures; the effective

date of implementation must be noted.

11.4.5. Prior to implementation of a revision, the update must be approved by the

Supervisor and Section Chief and reviewed by all applicable analysts andthe Quality Manager.

11.4.6. Archived procedures are maintained by the Quality Manager.

11.4.7. Out-dated procedures are immediately removed from general

accessibility.






11.5. Implementation of New Procedures

11.5.1. 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 Section Chief and

Supervisor. The effective date of implementation must be noted on theprocedure.

11.5.3. Out-dated procedures must be removed from the procedure manual and

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 Methods

12.1. 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 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.

12.2. All new testing methods - including material modifications to existing procedures –

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 process of method

development is a proposed method which must be validated 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 expected conditions

of use. Generally the validation process is expected to

12.2.2.1. Evaluate whether a new testing method meets identified

analytical needs and current scientific practices;

12.2.2.2. Compare the new test method’s performance with existing

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; and

12.2.2.6. Establish baseline characteristics of the testing method (linearity,






accuracy, etc.) which serve as benchmarks to evaluate future

method performance.

12.3. Validation Process

12.3.1. 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 make changes 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 submitted by

the supervisor or Section Chief to the Quality Manager for approval.

12.3.2.1. 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:

12.3.2.1.1. The type of method, technique, or analytical instrument

or equipment being validated.

12.3.2.1.2. 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.

12.3.2.1.3. The Laboratory’s experience and familiarity with

similar methods, techniques, or analytical instruments

or equipment.

12.3.2.2. Method validation must include the testing of known samples.

12.3.2.2.1. To the extent possible, known samples should resemble

actual specimens to allow evaluation of matrix effects,

specimen aging, specimen degradation, and sample

homogeneity.

12.3.2.2.2. 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).12.3.2.3. Where applicable, old and new methods should be run in parallel

on split samples and results compared.

12.3.2.4. Validation of quantitative methods should include an assessment

of accuracy and precision at concentrations expected in case

work.






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.

12.3.3.1. 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.

12.3.3.2. The Quality Manager retains the original validation plan and

validation report.

12.3.3.3. 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.

12.3.4. The Quality Manager places the new or revised procedure in the official

procedure manual.12.3.5. 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.

13. Evidence Handling

13.1. 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, when its

contents cannot readily escape, and when its contents are not subject to

external contamination.

13.2.2. The seal must be marked with an identifying mark or the initials of the

person sealing the evidence.

13.2.3. 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.

13.2.4.

It is the responsibility of the Evidence Registrar or other individualreceiving evidence to ensure that all evidence accepted by the laboratory

is stored under proper seal and to repackage and/or seal evidence as

necessary.

13.2.5. Items of evidence which are impractical, inappropriate, or too large to be

placed in a sealed container are marked or identified in a permanent






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. Evidence which is packaged in a manner that may affect the ability of the

Laboratory to analyze it should be repackaged properly.

13.2.6.1. Ideally repackaging should be performed by the submitting

agency prior to submission to the Laboratory when possible.

13.2.7. 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.

13.3. Evidence Receipt

13.3.1. 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 the

integrity of the evidence to the extent possible.

13.3.3. Case Numbering

13.3.3.1. 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 the outside 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 by both

parties at the time of evidence transfer.

13.4.2. Transfer of evidence between an individual and a primary evidence

storage area must be acknowledged at the time of evidence transfer.

13.4.3. 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.

13.4.4. 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.






13.4.5. 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.

13.4.5.1. Individual, secure personal identifiers are acceptable in lieu of

personal signatures.

13.4.6. In Texas, legal precedent establishes that chain of custody within the

laboratory goes to the weight of the evidence and not to its admissibility:

13.4.6.1. 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.”

13.4.6.2. 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 objectiongoes 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 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.”

13.5. Evidence Identification

13.5.1. 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 unique

identifier such as a laboratory case number.

13.5.3. 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.

13.5.3.1. Evidence should be adequately marked to ensure that it can be

identified and to aid in ensuring the integrity of case evidence.

13.5.3.2. In some cases, evidence cannot be marked because marking will

alter its evidentiary or intrinsic value.

13.5.3.2.1. This evidence must be identified by some other means

such as placing a permanent tag, placing in a sealed

secondary container, etc.

13.5.4. Significant discrepancies or variations between a submitter’s 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.






13.6. Evidence Security

13.6.1. 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.

13.6.1.1. 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.

13.6.1.1.1. Restricted or limited-access areas are locked when not

attended by authorized staff.

13.6.1.1.2. Unauthorized individuals are allowed in a restricted or

limited-access area only if escorted by authorized

personnel or in an emergency documented in the GrandMaster Key Log.

13.6.1.1.3. Assignment of keys is documented in the Institute Key

Log or on sign-out sheets under the direction of a

Section Chief.

13.6.1.1.4. Some areas are controlled both by key and by security

code.

13.6.1.1.4.1. Staff assigned a key and security code are

authorized unrestricted access to that area.

13.6.1.1.4.2. 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.

13.7. In-Process Evidence

13.7.1. 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 once examination or

analysis is complete even if the evidence is stored in a personal evidencelocker.

13.7.3.1. 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.






13.8. Evidence Release

13.8.1. The examiner reseals the evidence, initials (or otherwise marks) the seal

for later identification, and returns evidence to Evidence Registration.

13.8.2. The Evidence Registrar prepares evidence for disposition and notifies the

submitter that the evidence is available for release if appropriate.13.8.3. 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.

13.8.3.1. Transfer of evidence to long term storage or disposal of evidence

is tracked using appropriate chain of custody.

13.8.3.2. Release of evidence to the submitting agency is documented

using appropriate chain of custody.

13.8.4. 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.

13.8.5. 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.

13.8.6. 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.

13.9. Individual Characteristic Database Samples

13.9.1. The laboratory tests the following evidence sample types for inclusion inindividual 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 databases are

handled in the same manner as any other evidence item.

14. Instrument Operation, Calibration, and Maintenance

14.1. 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 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.14.1.1.1. Appropriate calibration and maintenance for each instrument are

determined by the manufacturer’s specifications, 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 be made

and kept near the instrumentation/equipment for use as needed by the

analyst.

14.1.3. 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.

14.2. Manufacturer’s operating and/or repair manuals must be kept readily available to all

analysts.

15. Facility Security and Maintenance

15.1. Security

15.1.1. The success of any security system depends upon employee commitment

to the security plan; therefore, it is each employee’s responsibility to

actively participate in the Institute security program as described in the

Institute of Forensic Sciences Security Manual.

15.1.2. 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.

15.2. Building Maintenance and Repair

15.2.1. General Building Maintenance and Repair

15.2.1.1. It is the responsibility of Dallas County Facilities Management

to conduct building maintenance and repair activities.

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 to Facilities

Management usually through IFS Administration.

15.2.2. Laboratory Housekeeping






15.2.2.1. Laboratory areas must be kept clean and free of relevant

contamination.

15.2.2.2. General building cleaning and non-regulated trash removal is 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 applicable cleaning/decontamination

procedures.

16. Quality Assurance/Quality Control

16.1. 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 examiner’s work is maintained at an acceptable

level.

16.1.1. 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.

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

16.1.2.1. To verify that technical procedures are valid and working

properly;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 analytical

methodology; and

16.1.2.5. To demonstrate current competence of the laboratory and the

individual analysts.

16.2. Administrative Review of Reports

16.2.1. 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 to ensure

that all reports are complete, concise, and consistent with laboratory

policy.

16.2.3. Administrative review is conducted at the time of final report review and






signature; by signing the case report, an individual documents that an

administrative review has been conducted.

16.2.4. An administrative review may also be conducted by others including a

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 an individual - other

than the primary analyst - who has expertise in a specific functional area

gained through documented training and expertise.

16.3.1.1. 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.

16.3.2. 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.

16.3.3. Technical/peer review must be conducted on a minimum of 20% or six

(whichever is fewer) completed cases per examiner per month.

16.3.3.1. 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.

16.3.3.2. 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.

16.3.3.3. In some disciplines/subdisciplines, technical/peer review may

occur following release of a report.

16.3.4. For each case that receives peer/technical review, the reviewer will

determine if the following elements have been satisfied:

16.3.4.1. The requested examinations are addressed, and the results are

clearly communicated to the reader.

16.3.4.2. The format of the report is consistent with laboratory practice,

and the report is editorially and typographically correct.

16.3.4.3. The report adequately describes the evidence.

16.3.4.4. The case number and signing analyst’s (or analysts’) initials

appear on all pages of the report’s supporting documentation

package.

16.3.4.5. The chains of custody for evidence items examined (including






internal transfers) are current and adequately documented.

16.3.4.6. The examination results are supported by applicable analytical

documentation (graphs, charts, etc.)

16.3.4.7. The tests performed conform to accepted techniques, and

appropriate standards and/or control samples were used andadequately documented.

16.3.4.8. The conclusions drawn are fully supported by the data, and are

reasonable and within the range of acceptable opinions of peers

within the discipline.

16.3.5. Conformance to the elements described in section 16.3.4 may be

documented by completion of the Peer/Technical Review form.

16.3.5.1. When used, the Peer/Technical Review form is retained in the

case file.

16.3.5.2. 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.

16.3.6. Non-conformance to the elements described in section 16.3.4 will be

documented by completion of the Peer/Technical Review form.

16.3.6.1. On the Peer/Technical Review form the technical reviewer must

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 is

detected during technical/peer review, and if the non-conformance is nototherwise 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:

16.3.7.1. Determines the appropriate course of action to resolve the

variance and documents this on the Peer Review Form.

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

review.

16.3.7.3. As appropriate, initiates a Request for Review (see the Self-

Critical Review and Corrective Action section of this Manual).

16.3.8. 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.






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

16.3.9. The Quality Manager is responsible for tracking participation in the

technical/peer review process.

16.4. Proficiency Testing Program

16.4.1. 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).

16.4.1.1. The following information is required for each proficiency test –

internal or external:

16.4.1.1.1. How samples were obtained or prepared

16.4.1.1.2. Who participated in testing

16.4.1.1.3. Time frame of testing

16.4.1.1.4. Responsible supervisor

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 sub-

disciplines of Trace Evidence.

16.4.3. The following minimum proficiency testing standards must be met:

16.4.3.1. All forensic examiners must complete at least one proficiency

test (internal or external) annually for each sub-discipline in

which they perform frequent analyses.

16.4.3.2. Each discipline or functional area must participate annually in at

least one external proficiency test for each forensic discipline in

which it provides services.

16.4.3.2.1. Where available, at least one proficiency test for each

discipline must be from an ASCLD/LAB approved

provider with results released to ASCLD/LAB.16.4.3.2.2. 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.

16.4.4. Response to Proficiency Test Results






16.4.4.1. Proficiency test results are assessed as successful, successful

with corrective action, or unsuccessful.

16.4.4.1.1. “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.

16.4.4.1.2. 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 Institute’s

Critical Review and Corrective Action Program.

Results are evaluated as follows:

16.4.4.1.2.1. “Successful with corrective action” denotes

that an RFR and/or CAR was successfullycompleted as judged by the ASCLD/LAB

Proficiency Review Committee or the

Institute’s Executive Committee.

16.4.4.1.2.2. “Unsuccessful” proficiency results occur

when inconsistent proficiency results are not

successfully resolved.

16.4.4.1.3. The Section Chief, Supervisor, and/or Quality Manager

will review inconsistent proficiency results with the

analyst.

16.4.4.1.4. 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.

16.4.5. Proficiency testing documentation including any associated corrective

action requests is maintained by the Quality Manager.

16.4.6. Results of proficiency testing are reported to the Director on an annual

basis by the Quality Manager.

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

16.5. Inter-laboratory Comparisons

16.5.1. Laboratories may choose to establish exchange programs with other

laboratories for external proficiencies, sample validation of new






procedures, etc.

16.6. Blind Testing and/or Reanalysis of Casework

16.6.1. Laboratories may choose to develop methods for submission and 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 and

providing training.

16.7. Quality Control Samples

16.7.1. 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.

16.7.2. Specific quality control procedures are included as a part of individual

analytical procedures or described in other documents prepared by a

Section or laboratory.

17. Self-Critical Review and Corrective Action

17.1. 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.

17.1.1. 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.

17.1.2. Certain issues identified through self-critical review are readily

anticipated and guidance for response is addressed in routine practices,

policies, and procedures.

17.1.3. 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.

17.1.3.1. Every isolated variance from policy and procedure does not

require an RFR.

17.1.3.2. Isolated administrative errors do not usually require an RFR.

17.1.3.3. The RFR document is an administrative, working document

which is not retained once an appropriate course of action is

established by the Executive Committee.

17.2. Requests for Review (RFR) Process






17.2.1. Internal review of an issue is initiated using the RFR process.

17.2.1.1. A RFR is used to a request review of an issue by the Quality

Manager and the Executive Committee.

17.2.1.2. The issue in question may relate to any aspect of Laboratory

operation including quality, EHS, personnel, security, etc17.2.2. 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.

17.2.3. 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.

17.2.4. The Quality Manager assesses the RFR with respect to Institute policies

and procedures. The RFR is then forwarded to the appropriate SectionChief or Manager for initial evaluation and development of a proposed

response.

17.2.5. The Section Chief or Manager presents the RFR to the Executive

Committee.

17.2.6. 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.

17.3. Corrective Action Request (CAR)

17.3.1. 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.

17.3.1.1. 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.

17.3.1.2. Determination that an issue is “substantive” should consider the

significance, substance, and time-span of the issue.17.3.2. The CAR is a record of the formal investigation and resolution of RFRs

deemed substantive by the Executive Committee.

17.3.3. 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.






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

laboratory’s work product.

17.3.3.2.

Class II - The issue is not persistent or serious enough to causeimmediate concern for the over-all quality of the laboratory’s or

individual analyst’s work product.

17.3.3.3. Class III - The issue is determined to be unlikely to recur, is not

systemic, and does not significantly affect the fundamental

reliability of the laboratory’s or individual analyst’s work.

17.3.3.4. Class IV – The issue is primarily administrative or clerical and

does not affect the reliability of the laboratory’s or analyst’s

work.

17.3.4. The CAR is forwarded to the appropriate Section Chief or Program

Manager (i.e. EHS Manager, Quality Manager, etc.) for response and/oraction.

17.3.5. 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.

17.3.6. Once actions are complete, the CAR is forwarded to the Section

Chief/Manager for review and approval.

17.3.7. 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.

17.3.8. The Quality Manager is responsible for oversight of the corrective action

process including correspondence with accrediting agencies

(ASCLD/LAB and Texas DPS) as appropriate.

17.3.9. Completed CARs are retained through the next ASCLD/LAB inspection

or as required by ASCLD/LAB and/or Texas DPS standards.

17.4. Response to RFRs and CARs

17.4.1. The scope of corrective action should be commensurate with the

magnitude of the issue at hand.

17.4.1.1.

For example, a situation which questions the quality of alaboratory’s 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.

17.4.2. Once an issue is identified, an appropriate course of action is initiated






based on the severity (CAR Class) and type of the situation.

17.4.2.1. Types of errors may include

17.4.2.1.1. Administrative Error - repetitive clerical errors, sample

confusion, improper storage, etc.

17.4.2.1.2. System Error - variance due to methodological,equipment, or environmental factors.

17.4.2.1.3. Analytical/Interpretive Error - variance due to the

choice, use, or implementation of an analytical

procedure and/or inaccurate or incomplete

interpretation of analytical results.

17.4.2.2. 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:

17.4.2.2.1. Review of the discrepancy with the analyst(s) involved

17.4.2.2.2. Retraining

17.4.2.2.3. Performance of a new proficiency test

17.4.2.2.4. Review of past casework for analyst(s) or a lab usually

back to the last successful proficiency

17.4.2.2.5. Reanalysis of casework with generation of corrected

reports as applicable

17.4.2.2.6. Removal of an analyst from applicable casework

17.4.2.2.7. Temporary or permanent discontinuation of a

procedure or use of equipment

17.4.2.2.8. Modification of an existing procedure or development

of a new procedure with appropriate validation

17.4.2.2.9. Validation of a method using different equipment

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.

17.4.4. Minor issues and/or discrepancies that individually do not warrant a CAR

may require increasingly stringent action if they occur repeatedly.

17.4.4.1. If the Executive Committee determines that a quality concerninvolves 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






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 Attorney’s Office, and

other agencies as appropriate

17.5. Oversight of RFR and CAR Processes

17.5.1. The Quality Manager has oversight of the RFR and CAR process.

17.5.2. The Quality Manager keeps the Director informed regarding RFR and

CAR processes.

17.5.3. The Quality Manager oversees reporting of RFR and/or CAR issues to

ASCLD/LAB and/or Texas DPS as appropriate.

17.5.4. 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.

18. Review of Testimony

18.1. Testimony by Forensic Laboratory employees should provide

18.1.1. Accurate presentation of the analyst’s credentials including academic

background, training, research, etc.;

18.1.2.

An accurate and complete description of the employee’s involvement inthe case;

18.1.3. A truthful, clear, straightforward, relevant, and objective response to all

questions on both direct and cross-examination;

18.1.4. Conclusions that follow logically from the underlying data and analytical

results;

18.1.5. Clear articulation of the reliability of results, analytical limitations, and

conclusions; and

18.1.6. Expert opinion that is within the area of expertise of the analyst.

18.2. Court testimony of each examiner must be evaluated at least once in any calendaryear in which the examiner testifies.

18.2.1. Courtroom monitoring is necessary to evaluate the delivery of the

examiner’s testimony and to ensure that the testimony is scientifically

consistent with the findings documented in the case file.






18.2.2. Each examiner must ensure that his/her testimony is monitored at least

once during each calendar year in which testimony is provided.

18.2.3. 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.

18.2.4. If supervisory or peer personnel are not available to personally observe

the testimony, the examiner is responsible for making contact with the

district attorney’s office, defense attorney, or judge to solicit written

feedback on the analyst’s testimony. Feedback should be sent to the

Quality Manager.

18.2.5. 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.

18.3. It is recommended that court testimony of support staff is monitored annually.

18.4. Reviewers complete the Court Testimony Monitoring Form which details the areasto 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.

18.4.1. These forms are submitted to the Supervisor or Section Chief who

reviews them with the testifying analyst.

18.4.2. The testifying employee may make comments on the review.

18.4.3. Court Monitoring forms are maintained by the Quality Manager and

summarized annually.

18.5. If indicated by the review, the Section Chief will implement corrective action.

19. Departure from Documented Policies and Procedures

19.1. 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.

19.2. With permission from the Section Chief or Supervisor, it is acceptable for an analyst

to deviate from standard policies and procedures.

19.2.1. It is imperative in these cases that clear documentation be made in the

case file detailing the exact procedures used in the analysis.

19.2.2. Any limitations placed on conclusions due to deviations in policy and








compliance with ASCLD/LAB accreditation standards, this Quality

Management Program, and other laboratory requirements.

22.1.2. The Annual Internal Review is conducted under the direction of the

Quality Manager.

22.1.2.1.

The Quality Manager selects an inspection team and developsthe format for the review.

22.1.2.2. 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.

22.1.2.3. The review is scheduled and announced well in advance.

22.1.2.4. The review includes the following operational areas:

22.1.2.4.1. The staffs’ awareness of the quality manual

22.1.2.4.2. Analytical procedure selection, control, and validation

22.1.2.4.3. Control of reagents and standards

22.1.2.4.4. Equipment calibration and maintenance of records

22.1.2.4.5. Adequacy of case reports and notes and their

disposition

22.1.2.4.6. Evidence handling procedures

22.1.2.4.7. Proficiency testing and inter-laboratory comparison

studies

22.1.2.4.8. Personnel training records

22.1.2.4.9. Handling of deficiencies and remedial action

22.1.2.4.10. Laboratory orderliness and health and safety measures

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.

22.1.4. The Quality Manager with assistance from the Executive Committee

initiates applicable RFRs and/or CARs.

22.1.4.1. Major findings should be immediately communicated to the

Section Chief, Executive Committee, and/or Director at the time

of the review.

22.1.4.2. Substantive non-compliance with essential criterion must be

specifically addressed using the CAR process.






22.1.5. The Quality Manager is responsible for generation of the written Annual

Internal Review Report which is provided to the Director.

22.1.6. The results of the Annual Internal Review are reviewed with the Institute

Quality Committee.

22.1.7.

The Annual Internal Review is maintained by the Quality Manager.22.2. ASCLD/LAB Annual Accreditation Audit Report

22.2.1. The Annual Internal Review is relied upon in part for completion of the

ASCLD/LAB Annual Accreditation Report.

22.2.2. 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.

22.2.3. A copy of the Annual Accreditation Audit Report is submitted to

ASCLD/LAB as described in the current ASCLD/LAB accreditation

manual.

22.2.4. The Annual Accreditation Audit Report is maintained by the Quality

Manager.

22.2.5. The results of the ASCLC/LAB Annual Accreditation Audit Report are

reviewed with the Institute Quality Committee.

22.3. Other Reviews and Audits

22.3.1. Other reviews and audits may be conducted as needed under the oversight

of the Quality Manager.

22.3.1.1. 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.

23. Annual Quality System Review

23.1. 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.

23.1.1. 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.

23.1.2. The Quality Manager solicits recommendations for changes in the quality

system from the inspection teams, Institute Quality Committee, and other






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.

23.2.

The Quality Manager implements identified changes to the Quality ManagementProgram as authorized by the Director.

23.3. The Annual Quality System Review is maintained by the Quality Manager and

made available during an ASCLD/LAB inspection as requested.




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: __________________________________ Date of Report: _____________________

Primary Examiner/Analyst: __________________________________ Discipline for Review: _______________

YES NO* N/A REPORT

1. ___ ___ ___ Have the requested examinations been addressed?

2. ___ ___ ___ Are the results clearly communicated to the reader?

ADMINISTRATIVE REVIEW

3. ___ ___ ___ Is the report correct editorially and typographically?

4. ___ ___ ___ Is the general format of the report consistent with laboratory practice?

NOTES

5. ___ ___ ___ Is the evidence adequately described?

6. ___ ___ ___ Do the case number and analyst’s initials appear on all pages?

SUPPORTING DOCUMENTATION

7. ___ ___ ___ Are all graphs, charts, etc. available to support the examinations conducted?

8. ___ ___ ___ Is the chain of custody (including internal transfer sheets) current and adequately

documented?

CONCLUSIONS

9. ___ ___ ___ Were standards and/or control samples used and adequately documented?

10. ___ ___ ___ Do the tests performed conform to accepted techniques?

11. ___ ___ ___ Were the conclusions drawn fully supported by the data?

12. ___ ___ ___ Are the conclusions reasonable and within the range of acceptable opinions of peers withinthis discipline?*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 documentatio

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 i

the case file.

Section Chief Review

Action(s) Taken: __________________________________________________________________________________

_________________________________________________________________________________________________

_________________________________________________________________________________________________

Supervisor Signature: ________________________________________ Date Reviewed: _____________________

Quality Manager: ___________________________________________ Date Reviewed: _____________________




RFR #: _________

RFR Form#2.doc

Institute of Forensic SciencesMonitoring Court Testimony

(To be completed by monitor)

Monitoring is necessary to evaluate the delivery of the examiner/analyst’s testimony and to ensure that the

testimony is scientifically consistent with the findings documented in the case file.

Witness: Discipline:

Laboratory Case Number: Date(s) of Appearance:

Court: Offense Charged: Time on Witness Stand:

Jury Trial: Trial Before the Court: _________ Other: _______________________

Rating Scale: 5 Excellent – 4 Commendable – 3 Competent – 2 Adequate – 1 Poor

Area Rating Scale CommentsAppearance

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 Rapid Fire Personal

Attacks

Repetitive Confusing

Questions

Insinuating

Questions

‘Yes or No’

Questions

Prosecution Style

Defense Style

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 #: _________

RFR Form#2.doc

SOUTHWESTERN INSTITUTE OF FORENSIC SCIENCES

Request For Review

(RFR)Initiating RFR:

Quality Physical Evidence 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.): Date:

Initiated by:

Section II: To be completed by the Quality Manager. Use additional sheets as necessary.

Preliminary Finding:

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 _____ No

Executive Committee: Date:




CAR #: _________

SOUTHWESTERN INSTITUTE OF FORENSIC SCIENCES

Corrective Action Request

(CAR)Initiating CAR:

Quality Physical Evidence 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.): Date:

Initiated by:

Section II: To be completed by the Quality Manager. Use additional sheets as necessary.

Description of Finding:

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:

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

S ti Chi f/M b th d d t


Documents

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