based on uncontrolled - harris county, texas

H A R R I S C O U N T Y I N S T I T U T E O F F O R E N S I C

S C I E N C E S C R I M E L A B O R ATO RY

QUALITY MANUAL

Based on

ISO/IEC 17025:2005 General requirements for

the competence of testing and calibration laboratories

-and- 2011 ASCLD/LAB-International Supplemental

Requirements

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Introduction

This Quality Manual is formatted to align the numbering system with the clauses of ISO/IEC 17025:2005 and the criteria of the 2011 ASCLD/LAB-International Supplemental Requirements; Sections 1 and 2 are not included. The table of contents is hyperlinked to the manual.

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TableofContents

3.0 TERMS AND DEFINITIONS ........................................................................................................ 1

4.0 MANAGEMENT REQUIREMENT ............................................................................................... 5

4.1 Organization ................................................................................................................................. 5 4.1.1 Legal Responsibility _______________________________________________________ 5 4.1.2 International Standard Requirement ___________________________________________ 5 4.1.3 Laboratory Facilities _______________________________________________________ 5 4.1.4 Conflict of Interest ________________________________________________________ 5 4.1.5 Laboratory: General Requirements ____________________________________________ 6 4.1.5 a Authority and Responsibility ______________________________________________ 6 4.1.5 b, d Undue Pressure ______________________________________________________ 6 4.1.5 c Confidentiality of Information _____________________________________________ 7 4.1.5 e Organizational Structure _________________________________________________ 7 4.1.5 f Delegation of Authority __________________________________________________ 8 4.1.5 g Supervision ___________________________________________________________ 8 4.1.5 h Technical Management __________________________________________________ 8 4.1.5 i The Quality Director ____________________________________________________ 8 4.1.5 j Top Management, Key Management and Deputies _____________________________ 9 4.1.5 k Personnel Awareness ____________________________________________________ 9 4.1.6 Communication __________________________________________________________ 9 4.1.7 Safety _________________________________________________________________ 10

4.2 Management System .................................................................................................................. 10 4.2.1 Management System Documentation _________________________________________ 10 4.2.2 Quality Manual __________________________________________________________ 11 4.2.2 a Quality Policy Statement ________________________________________________ 11 4.2.2 b Management’s Standard of Service ________________________________________ 12 4.2.2 c Quality Objectives _____________________________________________________ 12 4.2.2 d Familiarity with Quality Documentation ____________________________________ 12 4.2.2 e Commitment to the International Standards and to Continuous Improvement _______ 12 4.2.2.1 The ASCLD/LAB Guiding Principles of Professional Responsibility ______________ 13 4.2.2.2 Annual Presentation of Guiding Principles __________________________________ 13 4.2.3 Management Commitment _________________________________________________ 13 4.2.4 Communicating the Importance of Meeting Requirements ____________________ 13 4.2.5 Supporting Documents ____________________________________________________ 13 4.2.6 Roles and Responsibilities _________________________________________________ 15 4.2.7 Management System Integrity Maintenance ___________________________________ 15

4.3 Document Control ..................................................................................................................... 15 4.3.1 General Requirements ____________________________________________________ 15 4.3.2 Document Approval and Issue ______________________________________________ 15 4.3.3 Document Changes _______________________________________________________ 16 4.3.3.1 Document Revision: Designated Reviewers/Approvers ________________________ 16 4.3.3.2 Identification of Changes ________________________________________________ 16 4.3.3.3 Document Amendments _________________________________________________ 17 4.3.3.4 Electronic Document Control ____________________________________________ 17

4.4 Contracts and Requests ............................................................................................................. 17 4.4.1 Meeting Customer Requirements ____________________________________________ 17 4.4.2 Review of Contract _______________________________________________________ 18 4.4.3 Review of Subcontracted Work _____________________________________________ 18 4.4.4 Contract Deviation _______________________________________________________ 18 4.4.5 Contract Amendment after Analysis has begun _________________________________ 18

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4.5 Subcontracting of Tests and Calibrations .................................................................................. 18 4.5.1 Subcontracting Competence ________________________________________________ 18 4.5.2 Customer Subcontractor Approval ___________________________________________ 19 4.5.3 Subcontractor Work Responsibility __________________________________________ 19 4.5.4 Registration of Subcontractors ______________________________________________ 19

4.6 Purchasing of Services and Supplies ......................................................................................... 19 4.6.1 Purchasing of Supplies ____________________________________________________ 19 4.6.2 Inspection and Verification of Supplies _______________________________________ 19 4.6.3 Purchasing Documentation _________________________________________________ 19 4.6.4 Evaluation of Suppliers____________________________________________________ 20

4.7 Service to the Customer ............................................................................................................. 20 4.7.1 Customer Service and Confidentiality ________________________________________ 20 4.7.2 Customer Feedback ______________________________________________________ 20

4.8 Complaints ................................................................................................................................ 21 4.8.1 Customer Complaints and Resolution ________________________________________ 21

4.9 Control of Nonconforming Tests and/or Calibration Work ....................................................... 21 4.9.1 Nonconforming Test ______________________________________________________ 21

4.10 Improvement .............................................................................................................................. 22

4.11 Corrective Action ....................................................................................................................... 22 4.11.5 Additional Audits ________________________________________________________ 22

4.12 Preventive Action ........................................................................................................................ 23

4.13 Control of Records .................................................................................................................... 23 4.13.1 General Requirements __________________________________________________ 23 4.13.1.1 Record Maintenance ____________________________________________________ 23 4.13.1.2 Records Storage _______________________________________________________ 23 4.13.1.3 Records Security _______________________________________________________ 24 4.13.1.4 Electronic Records Protection _____________________________________________ 24 4.13.2 Technical Records _____________________________________________________ 24 4.13.2.1 Record Retention ______________________________________________________ 24 4.13.2.2 Recording of Technical Data ______________________________________________ 25 4.13.2.2.1 Dates of testing ______________________________________________________ 25 4.13.2.3 Technical Data Corrections _______________________________________________ 25 4.13.2.3.1 Changes Made to Examination Records __________________________________ 25 4.13.2.3.2 Electronically-Recorded Examination Documentation _______________________ 25 4.13.2.4 Examination and Administrative Records ____________________________________ 26 4.13.2.5 Records to Support Conclusions ___________________________________________ 26 4.13.2.6 Unique Case Identifier and Analyst’s Initials _________________________________ 26 4.13.2.7 Analysts’ Examination Records ___________________________________________ 26 4.13.2.8 Unique Identifier on Administrative Records _________________________________ 27 4.13.2.9 Unique Identifier on Examination Records ___________________________________ 27 4.13.2.10 Double-sided Records ________________________________________________ 27 4.13.2.11 Permanence of Records _______________________________________________ 27 4.13.2.12 Independent Checks _________________________________________________ 27 4.13.2.13 Abbreviations and Symbols _____________________________________________ 27 4.14 Internal Audits ___________________________________________________________ 27 4.14.1 Planning, Scheduling and Organizing _______________________________________ 27 4.14.1.1 Internal Audit Frequency ________________________________________________ 28 4.14.1.2 Audit Documentation ___________________________________________________ 28 4.14.2 Audit Findings ________________________________________________________ 28 4.14.3 Recording Audit Findings _______________________________________________ 28 4.14.4 Audit Follow-Up _________________________________________________ 28 4.14.5 Self-Assessment Audits _______________________________________________ 29 4.15 Management Review ______________________________________________________ 29 5.0 TECHNICAL REQUIREMENTS ______________________________________________ 30

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5.1 General Requirements ............................................................................................................... 30 5.1.1 Test Reliability and Correctness _____________________________________________ 30 5.1.2 Factors Affecting Uncertainty of Measurement Policy ____________________________ 30 5.1.3 Reliability of Reagents ____________________________________________________ 30 5.1.3.1 Reagents Prepared In-house ______________________________________________ 31

5.2 Personnel ................................................................................................................................... 31 5.2.1 Personnel Competence ____________________________________________________ 31 5.2.1.1 Training Program ______________________________________________________ 31 5.2.1.2 Court Testimony Training _______________________________________________ 32 5.2.1.3 Ethics and General Training ______________________________________________ 32 5.2.2 Personnel Training _______________________________________________________ 32 5.2.3 Support Personnel Competence _____________________________________________ 33 5.2.4 Job Descriptions _________________________________________________________ 33 5.2.5 Personnel Testing Authorization _____________________________________________ 33 5.2.6 Technical Personnel Qualifications ___________________________________________ 33 5.2.6.1 Education ____________________________________________________________ 34 5.2.6.2 Competence _____________________________________________________ 34 5.2.7 Library and Literature Resources ____________________________________________ 34

5.3 Accommodation and Environmental Conditions ....................................................................... 34 5.3.1 Environmental Effects on Testing ____________________________________________ 34 5.3.2 Monitoring and Recording Environmental Conditions ____________________________ 35 5.3.3 Incompatible Areas Separation ______________________________________________ 35 5.3.4 Laboratory Security and Access _____________________________________________ 36 5.3.5 Laboratory Housekeeping __________________________________________________ 36 5.3.6 Safety in the Laboratory ___________________________________________________ 37

5.4 Test Methods and Method Validation ........................................................................................ 38 5.4.1 General Testing Requirements ______________________________________________ 38 5.4.2 Selection of Testing Methods _______________________________________________ 38 5.4.3 Laboratory-Developed Methods _____________________________________________ 38 5.4.4 Non-Standard Methods ____________________________________________________ 39 5.4.5 Validation of Methods _____________________________________________________ 39 5.4.5.1 Definition of Validation _________________________________________________ 39 5.4.5.2 Validation Procedures and Records ________________________________________ 39 5.4.5.3 Validated Testing Methods Range and Accuracy ______________________________ 39 5.4.5.4 Validation Reliability and Performance Verification ___________________________ 40 5.4.6 Estimation of Uncertainty of Measurement ____________________________________ 40 5.4.6.1 - 5.4.6.2 Uncertainty of Measurement Procedures _______________________________ 40 5.4.6.3 Identifying Components of Uncertainty of Measurement _______________________ 40 5.4.7 Control of Data __________________________________________________________ 40 5.4.7.1 Verification of Calculations and Data Transfers ______________________________ 40 5.4.7.2 Electronic Data Transfer and Integrity (see also 5.10.7) ________________________ 41 5.5 Equipment ____________________________________________________________ 41 5.5.1 Equipment Requirements __________________________________________________ 41 5.5.2 Equipment Specifications and Calibrations ____________________________________ 41 5.5.3 Authorization to Operate Laboratory Equipment ________________________________ 41 5.5.4 Equipment Identification __________________________________________________ 42 5.5.5 Equipment Records _______________________________________________________ 42 5.5.6 Equipment Handling and Maintenance ________________________________________ 42 5.5.7 Out of Service Equipment _________________________________________________ 42 5.5.8-5.5.9 Equipment Calibration Designation ______________________________________ 43 5.5.10 Intermediate Checks____________________________________________________ 43 5.5.11 Equipment Adjustments/Correction Factors ____________________________________ 43 5.5.12 Equipment Protection and Security ________________________________________ 43

5.6 Measurement Traceability ......................................................................................................... 44 5.6.1 Calibration of Equipment __________________________________________________ 44 5.6.1.1 Calibration Checks _____________________________________________________ 44

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5.6.2 Specific Requirements ____________________________________________________ 44 5.6.2.1 Requirements for Calibration _____________________________________________ 44 5.6.2.2 Requirements for Testing ________________________________________________ 44 5.6.3 Reference Standards and Reference Materials __________________________________ 44 5.6.3.1 Reference Standards____________________________________________________ 45 5.6.3.2 Reference Materials ____________________________________________________ 45 5.6.3.2.1 Reference Collections ___________________________________________________ 45 5.6.3.3 Intermediate Checks of Reference Materials and Standards _____________________ 45 5.6.3.4 Transport and Storage of Reference Materials and Standards ____________________ 45

5.7 Sampling .................................................................................................................................... 46 5.7.1 Sampling Plans and Procedures _____________________________________________ 46 5.7.2 Sampling Plan Deviations, Additions, and Exclusions ____________________________ 46 5.7.3 Sampling Records ________________________________________________________ 46

5.8 Handling of Test Items ............................................................................................................... 46 5.8.1 Evidence Handling Procedures ______________________________________________ 46 5.8.1.1 Chain of Custody ______________________________________________________ 47 5.8.1.1.1 Sub-item Tracking ______________________________________________________ 47 5.8.1.1.2 Evidence Seals ________________________________________________________ 47 5.8.2 Identifying Evidence ______________________________________________________ 48 5.8.3 Suitability of Items for Testing ______________________________________________ 48 5.8.4 Handling and Protection of Evidence ________________________________________ 49 5.8.4.1 Security of Test Items ___________________________________________________ 49 5.8.4.2 Unattended Evidence ___________________________________________________ 49 5.8.4.2.1 Evidence in the Process of Examination _____________________________________ 49 5.8.4.3 Evidence Identification _________________________________________________ 50 5.8.4.5 Evidence Collected from a Crime Scene by Laboratory Personnel ________________ 50 5.8.4.6 Individual Characteristic Databases ________________________________________ 50 5.8.4.6.1 Individual Characteristic Database Samples __________________________________ 50 5.8.4.6.2 Identification of Individual Characteristic Database Samples ____________________ 50 5.8.4.6.3 Protection of Individual Characteristic Database Samples _______________________ 50 5.8.4.6.4 Access to Individual Characteristic Database Samples __________________________ 51

5.9 Assuring the Quality of Test Results .......................................................................................... 51 5.9.1 Monitoring Validity of Tests ________________________________________________ 51 5.9.1.1 Recording Control Data _________________________________________________ 51 5.9.2 Quality Control Data _____________________________________________________ 51 5.9.3 Proficiency Testing Program _______________________________________________ 52 5.9.3.1 Methods Used During Proficiency Testing __________________________________ 52 5.9.3.2 Proficiency Test Program Compliance ______________________________________ 52 5.9.3.3 Frequency of Testing ___________________________________________________ 52 5.9.3.3.1 Proficiency Testing for DNA Analysts ______________________________________ 52 5.9.3.3.2 Proficiency Testing within the Scope of Accreditation __________________________ 52 5.9.3.4 Approved Test Providers ________________________________________________ 53 5.9.3.5 Proficiency Test Records ________________________________________________ 53 5.9.3.6 Proficiency Test Record Retention _________________________________________ 53 5.9.4 Technical Review ________________________________________________________ 53 5.9.4.1 Items in Technical Review _______________________________________________ 54 5.9.4.2 Technical Reviewer Qualifications ________________________________________ 54 5.9.4.3 Limitations on Technical Reviewers _______________________________________ 54 5.9.5 Administrative Review ____________________________________________________ 54 5.9.5.1 Administrative Review Guidelines ________________________________________ 54 5.9.5.2 Additional Reviews ____________________________________________________ 55 5.9.6 Court Testimony _________________________________________________________ 55 5.9.7 Court Testimony Evaluations Records ________________________________________ 56

5.10 Results Reporting ...................................................................................................................... 56 5.10.1 General Requirements __________________________________________________ 56 5.10.1.1 Customer Cancellation of Work Requests____________________________________ 56

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5.10.2 Test Reports __________________________________________________________ 56 5.10.3 Additional Reporting Information _________________________________________ 57 5.10.3.1 Test Reports and Interpretation ____________________________________________ 57 5.10.3.2 Testing Record Content for Sampling _______________________________________ 57 5.10.3.3 Release of Test Reports __________________________________________________ 57 5.10.3.4 Review of Examination Records ___________________________________________ 57 5.10.3.5 - 5.10.3.7 Associations and Inconclusive Test Results ___________________________ 58 5.10.5 Opinions and Interpretations _____________________________________________ 58 5.10.6 Subcontractor Testing Results ____________________________________________ 58 5.10.7 Electronic Transmission of Results ________________________________________ 58 5.10.8 Report Format ________________________________________________________ 58 5.10.9 Amendments and Supplements ___________________________________________ 58

References ............................................................................................................................................ 59

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of 59 Quality Manual Rev. 8 Approver: Quality Director Date: 2/2016

3.0 TERMS AND DEFINITIONS

Administrative documentation: Records, such as case related conversations, evidence receipts, description of evidence packaging and seals, and other pertinent information. Administrative review: A procedure used to check for consistency with laboratory policy and editorial correctness. Audit: A review conducted to compare the various aspects of the laboratory’s performance with a standard for that performance. Authorize: “documented” – this meaning is used throughout the requirements. Blind sample: A proficiency test sample for which the analyst is unaware of the test nature of the sample at the time of analysis. Case record: Files containing administrative and examination documentation generated or received by a laboratory pertaining to a particular case. A case record may be made of records from various locations of the laboratory pertaining to a case.

Calibration: (1) To standardize by determining the deviation from a standard so as to ascertain the proper correction factors. (2) Set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by the standards.

Competency test: The evaluation of a person’s ability to perform work in a functional area prior to the performance of independent casework. Control sample: A standard of comparison for verifying or checking the finding of an experiment. Control: Test performed in parallel with experimental samples and designed to demonstrate that a procedure worked correctly. Critical reagent: A reagent which requires special attention because of impact of the reagent on the quality of testing. Failure of the reagent due to improper preparation or degradation would affect the testing process. Deficiency: An inadequacy; lacking in some necessary quality of an element. Deficiencies include missing data, incomplete data, or incomplete reports. Discipline: A major area of casework for which a laboratory may seek accreditation.

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Discrepancy: Being at variance or different from the accepted consensus. Examination records: Includes reference to procedures followed, tests conducted, standards and controls used, diagrams, printouts, audioradiograms, observations and results of examinations. External proficiency: A test program managed and /or controlled independent of the laboratory system. Goal: A statement of purpose that defines the mission of an organization. Inconsistency: Any reported results that differ from the consensus results. Inconsistencies may be classified as administrative, systemic, analytical or interpretive. Internal proficiency: A proficiency testing program managed and controlled within the laboratory system. Known sample: A specimen of an identified source acquired for the purpose of comparison with an evidence sample; synonymous with exemplar. Method: The course of action or technique followed in conducting a specific analysis or comparison leading to an analytical result. Notes: The documentation of procedures, standards, controls and instruments used, observations made, results of tests performed, charts, graphs, photos, and other documents generated that are used to support the examiner’s conclusions. Objective: A measurable, definable accomplishment that furthers the goals of the organization. Objective Test: A test which, having been documented and validated, is under control so that it can be demonstrated that all appropriately trained staff will obtain the same results within defined limits. These defined limits relate to expressions of measurement uncertainty. Open proficiency: A quality assurance program in which the examiner is aware that the sample is a test. Policy: A guiding principle, operating practice, or plan of action governing decisions made on behalf of an organization. Procedure: The manner in which an operation is performed; a set of directions for performing an examination or analysis – the actual parameters of the methods employed. Proficiency tests: Tests to evaluate the competence of analysts, technical support personnel, and the quality performance of a laboratory.

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Quality assurance: The planned and systematic actions necessary to provide sufficient confidence that a laboratory’s product or service will satisfy given requirements for quality. Quality audit: A management tool used to evaluate and confirm activities related to quality. Its primary purpose is to verify compliance with the operational requirements of the quality system. Quality control: Activities conducted according to established standards used to monitor the quality of analytical data and to ensure that it satisfies specific criteria. Quality manager: An individual designated by management who, irrespective of other responsibilities, has the defined authority and obligation to ensure that the requirements of the quality system are implemented and maintained. Quality manual: A document stating the quality policy and describing the various elements of the quality system and quality practices of the organization. Quality management system: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management; includes all activities that contribute to quality, directly or indirectly. Questioned sample: An evidence sample to be examined for the purpose of comparison or identification. Reagent: A substance used because of its chemical or biological activity. Re-exam technique: A quality assurance technique whereby a previously examined sample is re-examined by a different analyst. Reference standard: An acquired or prepared sample that has known properties for the purpose of calibrating equipment and/or for use as a control in experiments. Reliability: Possessing the quality of being dependable; may refer to personnel, materials or equipment. Safety manual: A document stating the safety policy and describing the various elements of the safety system of the organization. Standards: Known materials established by authority, custom, or general consent as a model or example. Sub-discipline: A specific type of analysis within an accredited discipline. Technical procedures: Of or relating to a practical subject organized on scientific principles. Technical review: The review of notes, data, and other documents that form the basis for a scientific conclusion.

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Testimony: The firsthand authentication of a fact. Validation: The process of performing a set of experiments that establish the efficacy and reliability of a technique or procedure or modification thereof.

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4.0 MANAGEMENT REQUIREMENT

4.1 Organization

4.1.1 Legal Responsibility The Harris County Institute of Forensic Sciences (HCIFS) is a department of the Harris County Texas government. The laboratory’s place within the parent organization is indicated in the agency organizational chart which is located on the HCIFS website. 4.1.2 International Standard Requirement The laboratory provides quality forensic testing services in an impartial manner. The laboratory employs standardized and validated methods to satisfy the needs of the customers, the accreditation agency, and to meet the requirements of the International Standards, that is, ISO/IEC 17025:2005 general requirements for the competence of testing and calibration laboratories, the current version of ASCLD/LAB-International Supplemental Requirements, ASCLD-LAB Board Interpretations and Guidance Documents and all applicable requirements of the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories. The Toxicology Laboratory also carries out testing activities in a manner that meets the accreditation requirements of the American Board of Forensic Toxicology. 4.1.3 Laboratory Facilities The Crime Laboratory is located in the Harris County Institute of Forensic Sciences at 1885 Old Spanish Trail, Houston, Texas, 77054. The Forensic Genetics section is located in a separate facility located at 2450 Holcombe Blvd., Suite 7, Houston, Texas, 77021. The Crime Laboratory has developed a management system, as described in this manual, to provide the criminal justice community with the confidence that laboratory results remain accurate, impartial and relevant. The management system is applicable to work carried out at the two permanent facilities and at sites away from the permanent facilities. The Crime Laboratory consists of five laboratory sections (interchangeably referred to as laboratory divisions or simply as laboratories) providing test services in the disciplines of Drug Chemistry, Forensic Genetics, Toxicology, Trace Evidence, Firearms Identification, and Crime Scene Collection. The disciplines are listed in the laboratory’s organizational chart. The Crime Laboratory is committed to carrying out its testing activities to meet or exceed the needs of its customers. 4.1.4 Conflict of Interest

Laboratory personnel are required to follow the HCIFS Conflict of Interest policy (Policy #96-007) which is available to all employees via the intranet and is provided to new hires at the start of employment. The policy directs laboratory personnel to refer all instances of inappropriate influence to the appropriate management or supervisory staff for complete investigation and

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documentation. Case information revealed to laboratory personnel having the potential for a conflict of interest must be immediately reported to management: a supervisor, section manager, assistant director, Quality Director, or the Crime Laboratory Director. The personnel listed below are independent of the framework of the laboratory and influence budgetary matters as well as top-level decision-making:

Chief Medical Examiner has influence over budget and planning processes. Section managers prepare yearly budget requests, including any proposed renovation and/or expansion costs, costs for additional staffing, instrumentation, etc., and submit them to the Laboratory Director. The Laboratory Director reviews the budgets with the section managers prior to submitting the annual budget requests to the Chief Medical Examiner. The Chief Medical Examiner presents the final HCIFS budget, including the Crime Laboratory budget, to the Harris County Commissioners Court.

4.1.4.1 The Laboratory Director has been given the authority and responsibility by the

Chief Medical Examiner to execute the duties described in the Director’s job description.

4.1.4.1.1 The Laboratory Director has been given sufficient authority by the Chief Medical Examiner to make and enforce decisions in the laboratory.

4.1.5 Laboratory: General Requirements 4.1.5 a Authority and Responsibility The managerial and technical personnel have defined authority and responsibilities and the resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system. This is accomplished through a written organizational structure that delegates responsibility and authority, and written job descriptions. The laboratory managerial personnel are responsible for the daily compliance of their respective divisions with all applicable requirements, procedures and policies, and for providing feedback to the executive management on a monthly basis, at a minimum. The entire staff of the laboratory has the responsibility and authority to ensure that all requirements of the management system are met and any non-conformity or departures from quality standards, quality procedures and policies, and/or standard operating procedures are minimized, prevented, or eliminated.

4.1.5 b, d Undue Pressure

The management of the laboratory ensures there are no influences on the professional judgments of employees, including any undue internal and external commercial, financial or other pressures which may adversely affect the quality of their work.

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Laboratory personnel shall not engage in activities which may diminish confidence in the laboratory's competence, impartiality, judgment, or operational integrity. All conflict of interest concerns and situations which could cause undue pressure adversely affecting the quality of the work shall be brought to the attention of management. Division (or section) managers and assistant directors (e.g., Director of Physical Evidence and Director of Toxicology and Chemistry) have the responsibility and authority to receive and take action on employee concerns within their division. Any instances of undue influence on analytical findings or conflicts of interest will be reported to a supervisor, section manager, assistant director, Quality Director, or Laboratory Director. Employees have provisions to present any grievance(s) to the Grievance Coordinator. A grievance may be initiated on the appropriate grievance form.

4.1.5 c Confidentiality of Information Every employee has the responsibility to safeguard from unauthorized distribution all confidential information obtained in his or her official capacity. In addition, employees shall not access or disclose any confidential information except where legally authorized (HCIFS Policy #08-001). The Crime Laboratory has a responsibility to its customers to protect the confidentiality of their information. The laboratory does not release confidential information to unauthorized parties without the prior approval of the investigating agency or by official court order. Protection of electronic storage and electronic transmission is achieved in accordance with the Harris County Information Technology Center procedures and policies. The Harris County computer network is password protected. Every employee has a unique password which must be changed regularly in accordance with the county polices. Directories on the HCIFS servers have restricted access. Access is authorized by employee’s manager, assistant director or the Laboratory Director, and access is granted by the System Administrator based on the employee’s work requirements. 4.1.5 e Organizational Structure The Crime Laboratory organizational chart illustrates the organization and management structure of the laboratory, as well as the organization and management structure of laboratory’s technical operations and support services. The authority and responsibilities of the Laboratory Director, assistant directors, division managers, supervisors, team leaders (where applicable), examiners, analysts and other personnel are well defined and commensurate with their responsibilities. This is accomplished through the use of written job descriptions which summarizes the duties and functions and the associated chain of command.

The Crime Laboratory is a service of the HCIFS as shown in the HCIFS organizational chart. The Crime Laboratory Director reports to the Chief Medical Examiner. Quality management is a

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separate division, headed by the Quality Director who also reports to the Chief Medical Examiner. 4.1.5 f Delegation of Authority The laboratory organizational charts specify the responsibility, authority and the interrelationships of the laboratory personnel. The interrelationships of the personnel who manage, perform or verify work affecting the quality of tests are further described in the job descriptions. Each subordinate shall be responsible to one immediate supervisor for each technical or administrative function. Each examiner/analyst shall be accountable to only one immediate supervisor for each category of testing.

4.1.5 g Supervision Supervisory personnel shall possess the necessary skills and technical knowledge to adequately manage the personnel in their respective section or category of testing. Supervisory personnel ensure examiners, analysts, and technical support personnel under their supervision are qualified to test evidence and that trainees are properly supervised. 4.1.5 h Technical Management Technical management has the authority and responsibility for the quality and reliability of the work product of their respective sections, and technical management has overall responsibility for the provision of resources needed to ensure the required quality of laboratory operations. Technical management is the responsibility of a designated individual who possesses the necessary technical expertise, training and qualification as required by the specific discipline (Drug Chemistry, Forensic Genetics, Toxicology, Trace, and Firearms). The following personnel represent technical management: Drug Chemistry Manager, Forensic Genetics Director/DNA Technical Leader, Director of Physical Evidence, Director of Toxicology and Chemistry, Toxicology Manager, Trace Evidence Manager, and Firearms Identification Laboratory Manager. 4.1.5 i The Quality Director The overall quality of all laboratory functions is the responsibility of the Quality Director. The Quality Director ensures the quality management system is implemented and followed at all times. The Quality Director is responsible for coordinating all activities necessary to implement and maintain the quality requirements of the management system, including ensuring compliance with all applicable accreditation requirements as defined by ASCLD/LAB-International, the Texas Forensic Science Commission, and the American Board of Forensic Toxicology. The Quality Director reports directly to the Chief Medical Examiner, the CEO of the agency.

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4.1.5 j Top Management, Key Management and Deputies Top management shall ensure that the HCIFS Crime Laboratory conforms to all accreditation requirements and the requirements of the HCIFS management system. Key Management includes the Top Managers and those who report directly to them. Deputies are designated by top and other key managers to provide coverage in the event of an expected or unexpected absence. Key management and their deputies are:

Top Management Deputies Laboratory Director Director of Physical Evidence,

Director of Toxicology and Chemistry, and Forensic Genetics Director

Director of Physical Evidence Trace Evidence Manager and Firearms Identification Laboratory Manager

Director of Toxicology and Chemistry Toxicology Manager and Drug Chemistry Manager

Forensic Genetics Director DNA Analyst I

Quality Director Quality Manager

Additional Management Deputies Quality Manager QA/QC Project Coordinator Toxicology Manager Toxicologist I DNA Analyst I DNA Analyst II Trace Evidence Manager Forensic Chemist I Drug Chemistry Manager Forensic Chemist I Forensic Evidence Manager Laboratory Technician

Firearms Identification Laboratory Manager Firearms Examiner I

4.1.5 k Personnel Awareness Staff members are made aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system through regular meetings within disciplines led by division managers or directors. In addition, supervisory personnel may perform feedback assessments (evaluations) of subordinates, providing each employee a review of their performance throughout the year, their past objectives and goals, and their future goals and objectives. 4.1.6 Communication

The laboratory has established a flow and methods of communications so all personnel provide input and receive information from management regarding the management system. Regular staff meetings are held within each section, and managers’ meetings are conducted regularly.

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These meetings are one mechanism for the exchange of information. Another mechanism is the HCIFS Newsletter that is published at least semi-annually. The laboratory management ensures laboratory personnel utilize good communication within the laboratory and also with customers. Direct communication on technical and administrative matters is encouraged among the directors, division managers, supervisors and examiners and analysts within every section of the Crime Laboratory. Outlook group emails (e.g., Crime Lab Managers, Drug Chemistry Laboratory Case Management Team, DCL QC Team, Trace Collection Team, Toxicology Section, etc.) are used to ensure regular, uniform communications from managers to staff members. 4.1.7 Safety The Harris County Institute of Forensic Sciences has an appointed Safety Officer who oversees safety in the Crime Laboratory. Each division of the laboratory has an appointed Safety Representative who monitors safety practices in their respective section, including inspections to ensure compliance with the Safety Manual. It is the responsibility of laboratory management personnel to ensure a safe working environment for all employees. The Safety Officer ensures all new employees undergo safety training and also coordinates annual safety training of all laboratory personnel. Laboratory personnel are required to read the safety manual as well as updates of the safety manual in order to ensure that employees conduct their work in a safe manner.

4.2 Management System

4.2.1 Management System Documentation The laboratory has established, implemented and maintains a management system appropriate to its scope of activities and testing methods. The management system documentation requirement is comprised of the Harris County Institute of Forensic Sciences mission statement, the quality manual, quality procedures, technical standard operating procedures, forms, and records which insure the quality and reliability of all testing results. The management system documentation is described below: Level 1: Harris County Institute of Forensic Sciences Mission Statement and the

Laboratory Quality Policy Statement. Level 2: Quality Manual – a "roadmap" to the laboratory’s quality management system and

addresses all applicable ISO 17025:2005 Standards and ASCLD/LAB- International Supplemental Requirements.

Level 3: Quality Procedures - describes specific steps to comply with the primary

requirements of ISO 17025:2005 and the ASCLD/LAB-International Supplemental Requirements.

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Level 4: Technical Standard Operating Procedures (SOPs) - consist of work instructions (test procedures, drawings, flowcharts etc.), which describe in detail how a particular task is performed.

Level 5: Administrative SOPs/Records/Forms: constitute the basis for documenting the

activity of the laboratory’s management system. Laboratory personnel are required to read this Quality Manual and all applicable documents of the management system upon employment. Subsequently, employees review and acknowledge revisions in Q-Pulse. All reviews, revisions, approvals, distributions and acknowledgements are done through the Q-Pulse software. Records of the distribution and acknowledgement of documents are maintained in Q-Pulse. By acknowledging a document in Q-Pulse, staff members declare having read and understood the document. 4.2.2 Quality Manual This Quality Manual describes the management system of the Crime Laboratory. To ensure quality service is provided to all customers, and to promote a professional awareness among all employees of the laboratory, this Quality Manual and other components of the management system are implemented by laboratory personnel.

The Quality Manual includes the HCIFS Crime Laboratory Mission Statement, Quality Policy Statement, Quality Goals, and Objectives to further establish the laboratory’s commitments to its customers. The ASCLD/LAB Guiding Principles of Professional Responsibility for Crime Laboratories and Forensic Scientists is included in the Quality Manual as Appendix QMA-001.

Adherence to standards of quality is the responsibility of all laboratory personnel. Division managers/directors have the authority and the responsibility for the quality of testing in their respective section and for making process improvements to enhance the effectiveness of the quality management system. Deviations to procedures may at times be required, and shall be done in accordance with good laboratory practices with the approval of the director, assistant director, division manager, or designee. The Quality objectives shall be reviewed during the management review. 4.2.2 a Quality Policy Statement

The purpose of the management system is to ensure that the services offered by the laboratory meet or exceed customer requirements through the implementation of a rigorous quality assurance, quality control program and regular monitoring. The laboratory management is committed to: Good professional practice Highest quality of services

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Continuous improvement of the management system Disseminating up to date information on current policies and procedures as they relate to quality and testing to all laboratory personnel Compliance with ISO/IEC 17025 Provision of reliable results and services that meet or exceed customer expectations with

uncompromised integrity.

To achieve this, management shall ensure the services provided to all customers are in compliance with its documented management system’s policies and procedures, the ISO/IEC 17025:2005 Standards and the most recent ASCLD/LAB-International Supplemental Requirements, the American Board of Forensic Toxicology accreditation standards, and the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories. Laboratory management shall ensure that the ASCLD/LAB Guiding Principles of Professional Responsibility for Crime Laboratories and Forensic Scientists are reviewed annually with all laboratory personnel. A record of this review shall be maintained in the Q-Pulse document module. 4.2.2 b Management’s Standard of Service It is the mission of the Crime Laboratory to provide the Justice System with the highest quality services in the disciplines of Drug Chemistry, Forensic Genetics, Toxicology, Trace Evidence, and Firearms Identification in an unbiased and timely manner with uncompromised integrity.

4.2.2 c Quality Objectives

The quality objectives are to:

Maintain a documented quality management system that meets all accreditation and compliance requirements.

Implement continuous improvement in the quality management system.

4.2.2 d Familiarity with Quality Documentation By reading and acknowledging updated documents and forms in Q-Pulse, laboratory personnel keep up to date with quality policies and implement the revised procedures in their work. 4.2.2 e Commitment to the International Standards and to Continuous Improvement Laboratory Management is committed to adherence to ISO/IEC 17025:2005 Standards and current ASCLD/LAB International Supplemental Requirements, and to continuous improvement of the quality management system.

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4.2.2.1 The ASCLD/LAB Guiding Principles of Professional Responsibility The ASCLD/LAB Guiding Principles of Professional Responsibility for Crime Laboratories and Forensic Scientists is included in the Quality Manual as Appendix QMA-001. 4.2.2.2 Annual Presentation of Guiding Principles Annually, the ASCLD/LAB Guiding Principles of Professional Responsibility for Crime Laboratories and Forensic Scientists are read aloud and reviewed with all crime laboratory analysts, examiners, technicians, and administrative assistants, and a record of attendance is maintained in Q-Pulse.

4.2.3 Management Commitment The Laboratory Management is committed to developing, maintaining and continually improving the effectiveness of the management system:

Laboratory Management meets regularly to review elements of the management

system and, when necessary, to further develop and improve it. Top Laboratory Management meets regularly with the Chief Medical Examiner to

review elements of the management system and, when necessary, develop and improve it.

At least annually, all SOPs are reviewed and an overall management review is conducted.

The agency employs a Quality Director (QD) who reports to the Chief Medical Examiner. The QD supervises a quality management group whose function is to maintain, develop and improve the quality system both in the crime laboratory and agency-wide.

4.2.4 Communicating the Importance of Meeting Requirements The Crime Laboratory fosters a culture of ensuring customer requirements are met and good customer service is provided. This is done in many ways. Examples include providing state-of-the-art test systems (e.g., DNA automation, LC-TOF MS, DART MS, etc.) that meet or exceed customer needs, requiring clear communications with customers, presenting at conferences (e.g., TIFS, evidence collection seminars), providing informational field guides (e.g., DNA Evidence Collection Guide), and others. 4.2.5 Supporting Documents The Quality Manual addresses each of the ISO/IEC 17025:2005 Standards and the current ASCLD/LAB International Supplemental Requirements.

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Specific documents, including procedures and forms, of the management system reside in the Q-Pulse software. All laboratory procedures are formatted similarly with a header and footer with required information. The laboratory maintains technical standard operating procedures in all applicable disciplines and sub-disciplines. The structure of the documentation used in the Quality System is:

The Quality Manual (document number QM 2008 in Q-Pulse) is a document stating the quality policy and describing the various elements of the quality system and quality practices of the organization. The quality procedures (designated with “QP” in Q-Pulse) describe in detail how to carry out the quality assurance activities outlined in the Quality Manual. The Quality Director is the final approver of the quality procedures. The technical standard operating procedures provide step-by-step instructions for performing examinations or operating instruments. Final approval is done by a qualified manager overseeing the discipline. Administrative procedures (designated with “LA” in Q-Pulse) outline administrative functions within the laboratory. The Crime Laboratory Director is the final approver of the administrative SOPs. Records are documents containing administrative information or examination data generated for a case. Approved forms become records once they are filled out by personnel.

Administrative Procedures/Records/Forms

Technical Standard Operating Procedures

Quality Procedures

Quality Manual

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4.2.6 Roles and Responsibilities The Quality Director is the manager of the Quality Management system and is responsible for the coordination and administration of activities required to implement and maintain quality throughout the laboratory. The roles and responsibilities of the Quality Director (and other members of the Quality Management group) and technical management personnel are listed in their job descriptions. The technical management role is performed by the technical manager/director or designee, who possesses the necessary technical skills as described in their job description. Refer to section 4.1.5 h Technical Management 4.2.7 Management System Integrity Maintenance Changes to the management system are planned and implemented to ensure the integrity of the system. All changes to the management system (including all technical procedures) are reviewed for compliance with accreditation requirements by a member of the Quality Management Division and, in some cases, the Crime Laboratory Director. Approval of technical procedures is done only by qualified technical managers or directors. Changes to the management system must be clearly articulated to appropriate staff. Changes shall be documented either in meeting minutes or SOP changes, and are distributed via Q-Pulse.

4.3 Document Control

4.3.1 General Requirements The laboratory has established and maintains procedures to control all documents of the management system. All of these documents are located in the “Active Register” of the document module of the Q-Pulse software. Refer to QP08.0001, QP08.0002, QP08.0003, QP08.0004 and QP08.0005. Documents from external sources used in the laboratory are maintained in the respective sections of the laboratory and are referenced in the applicable SOPs. 4.3.2 Document Approval and Issue 4.3.2.1 All laboratory controlled documents are approved prior to distribution to

laboratory personnel. Only analysts competent in a particular test or method are authorized to review and approve a procedure. Final approval is done by the highest ranking actively qualified manager in a discipline. If neither the lab director nor an assistant director is qualified in a discipline, any qualified manager may be the final approver. Quality procedures are approved by the Quality Director. Additionally, one member of the Quality Management Division is assigned to review and approve each new or revised document to ensure it is in compliance with accreditation and laboratory quality assurance standards.

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4.3.2.2 Document Review 4.3.2.2 a The document module in Q-Pulse is an electronic repository for the approved and

current revisions of all laboratory documents. Q-Pulse is installed on the computers of laboratory personnel and appropriate administrative personnel. Laboratory personnel access Q-Pulse using their unique PIN number and may view and print the current version of all controlled documents. Copies of procedures or forms printed by laboratory personnel for reference are “Uncontrolled.” Refer to QP08.0003, and QP08.0004.

4.3.2.2 b Laboratory management or designees review all documents annually for needed

revisions. The purpose of the review is to ensure that the document reflects current practice. If revisions are made, the revised document is acknowledged by affected personnel in accordance with Q-Pulse procedures QP08.0003 and QP08.0005.

4.3.2.2 c Uncontrolled copies (e.g., printed from Q-Pulse) of any document in the

laboratory are destroyed when a new revision becomes effective. Every employee is responsible for ensuring use of the current version of a document.

4.3.2.2 d Once a document revision is approved, it is moved to the Active Register and the

previous version is archived in Q-Pulse as obsolete. 4.3.2.3 Document Identification Laboratory documents are uniquely identified with the procedure number, version number, approved by, page number and total number of pages. Refer to procedure QP08.0003. 4.3.3 Document Changes 4.3.3.1 Document Revision: Designated Reviewers/Approvers Requests for document changes are made in Q-Pulse in accordance with procedure QP08.0005. The current document owner, or qualified designee, will revise the document via Q-Pulse for review by designated reviewer(s). After final approval, the document is placed into the Active Register in Q-Pulse and must be acknowledged by affected personnel. The designated reviewers, called approvers by Q-Pulse, have access to pertinent background information upon which to base their review and are appropriately qualified to conduct the review. 4.3.3.2 Identification of Changes The revised portion of a document (additions and deletions) is identified in red via the Track Changes function of Microsoft Word which is used for all document editing. Reviewers view the

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Track Changes version of the document in the Draft Register directly. Before acknowledging a revised document, staff members view the Tracked Changes version via a Q-Pulse attachment. A revision history is included at the end of each document.

4.3.3.3 Document Amendments Hand written amendments to procedures printed from Q-Pulse are not permitted as all printed copies are uncontrolled. Amendments should be requested via a “change request” in Q-Pulse. 4.3.3.4 Electronic Document Control All controlled documents are stored electronically in Q-Pulse which secures documents against unauthorized changes. Laboratory personnel can only change documents that they have been given authorization to change.

4.4 Contracts and Requests

4.4.1 Meeting Customer Requirements

The Evidence Submission form is used to submit evidence for laboratory testing. HCIFS pathologists request laboratory testing using the Toxicology Request for Examination form. Upon acceptance by the laboratory, a completed Evidence Submission form serves as an implied contract between the submitting agency and the laboratory. Differences between the services requested by the submitting agency and the services available from the laboratory are addressed prior to the initiation of analyses or as soon as differences are discovered. The crime laboratory does not have a case acceptance policy that limits services provided (e.g., the number of samples we will accept for testing). We strive to respond to customer service requests as submitted. The customer’s request for services and the services available from the laboratory are documented on the Evidence Submission Form. Each form is checked at submission for adequate documentation and clarity. The form is checked again within each section prior to analysis. The contract is subject to the ability, capability and resources of the laboratory to meet customer requirements. A change in physical or personnel resources that will affect normal service capabilities will be discussed during management reviews. The customer will be notified of any differences between services requested and services available. Differences will be resolved prior to testing the submitted evidence. The laboratory determines the most appropriate type of analytical methods or tests to perform. Laboratory customers, primarily law enforcement agencies and the medical examiner’s office, rarely request a particular method to examine evidence. The laboratory endeavors to agree to customer requests, when possible.

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4.4.2 Review of Contract The review of requests is conducted when evidence is submitted to the laboratory. Evidence receiving personnel review the completed Evidence Submission form to ensure that requests are appropriate (e.g., that requests include only services the laboratory provides, that all information is complete). Analysts conduct another review upon commencing analysis (e.g., that requests corresponds to the evidence submitted). Should review prior to analysis identify a need for clarification or modification to the accepted submission or contract, the laboratory will contact the customer. Unresolved issues will be brought to the attention of the appropriate division manager, assistant director and/or Laboratory Director for resolution. Documentation of all communications with customers is maintained in the case record. 4.4.3 Review of Subcontracted Work When the laboratory accepts evidence for testing by a subcontract laboratory, the review will cover the subcontracted work. The utilization of any subcontracted services by the laboratory will be communicated to the customer, if applicable. The subcontractor shall utilize accepted scientific methods of analysis that are defined, documented and available for review. 4.4.4 Contract Deviation Contract deviations shall be handled by direct communication with the customer. Laboratory personnel will clarify deviations and document the resulting agreement within the case file. Corrective and/or preventive actions will be taken in accordance with QP08.0007. 4.4.5 Contract Amendment after Analysis has begun Contract amendments required after analysis has begun will be communicated to the respective laboratory personnel (DNA analysis of a firearm requested after examination of the firearm has begun, etc.) or to the customer (money found in a pocket of submitted clothing, etc.) in a timely manner. Documentation of all communications will be maintained in the case record. Review of contract will be done in accordance with 4.4.2. 4.5 Subcontracting of Tests and Calibrations

4.5.1 Subcontracting Competence Under certain circumstances (e.g., workload or need for further expertise), the laboratory may subcontract all or a portion of a specific customer service request. The subcontractor shall be deemed as competent as demonstrated by compliance with ISO 17025 accreditation requirements, proof of equivalent accreditation or certification or through compliance monitoring presented through auditing records.

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4.5.2 Customer Subcontractor Approval The utilization of any subcontracted services by the laboratory will be communicated to the customer, if applicable. The subcontractor must utilize accepted scientific methods of analysis that are defined, documented and available for review. When appropriate, the laboratory will obtain agreement in writing from the customer. 4.5.3 Subcontractor Work Responsibility The laboratory is responsible for the work of the subcontractor. 4.5.4 Registration of Subcontractors A list of select subcontractors performing work for that section will be maintained, if applicable. If no subcontract work is being performed for a section, a list of subcontractors qualified (and willing) to perform subcontract work will be maintained, if applicable. Documentation of subcontractor qualification will be maintained during (and after) subcontracting.

4.6 Purchasing of Services and Supplies

(Refer to HCIFS Purchasing procedure for more details regarding 4.6.1 – 4.6.4.) 4.6.1 Purchasing of Supplies The laboratory ensures reagents and materials of appropriate quality are purchased for use by each section of the laboratory. Records are kept to show the order and acquisition date, receiver, opened date and expiration date of supplies, if applicable. The open and expiration dates are documented on the container, if applicable. 4.6.2 Inspection and Verification of Supplies Each section of the laboratory shall have and use a procedure to ensure critical reagents and /or critical consumables purchased are inspected for suitability and comply with standard specifications or test requirements prior to initial use. The specifications for reagents and materials may be included, if necessary, within the testing methods of the individual sections. Records will be maintained, when applicable, to verify these procedures have been followed. Services and supplies used shall comply with specified requirements. Records are maintained of the verification of compliance. 4.6.3 Purchasing Documentation Purchasing documents, such as purchase requests and quotations, for items affecting the quality of laboratory output include the description of the services or supplies ordered. All purchase requests are reviewed and approved for technical content by the section’s supervisor/manager

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and the Laboratory Director or designee prior to submission to the HCIFS Finance and Administration Office for processing. 4.6.4 Evaluation of Suppliers Each laboratory section or Quality Management designates critical supplies and services and maintains a list of suppliers of critical items and services. The criteria to evaluate critical supplies and services are established by each section of the laboratory or by Quality Management. Supplies are evaluated prior to use and records of evaluation results are maintained. Critical services supplied by ISO accredited suppliers are required, if available.

4.7 Service to the Customer

4.7.1 Customer Service and Confidentiality The laboratory cooperates and openly communicates with customers or their representatives while still maintaining confidentiality of other customers and cases. The laboratory allows customers or their representatives the opportunity to monitor laboratory performance in relation to the work performed by preparing, packaging, and transferring test material needed by the customer for verification, when requested. Customers and other visitors may not witness testing or examination performed at the HCIFS; however, customers may schedule a tour of relevant areas of the laboratory. 4.7.2 Customer Feedback The laboratory seeks feedback from its customers regarding the quality of work and the contents of its results as a method of quality review. Feedback will be analyzed and used to improve the management system, testing, and customer service. The Crime laboratory elicits feedback from its customers in the following ways:

-Laboratory customers may fill out the “Crime Laboratory Satisfaction Survey” located in the Crime Laboratory Service section of the HCIFS website (http://www.harriscountytx.gov/ifs/clscrimelaboratoryservice.aspx) to provide feedback and comments.

-Laboratory customers may call the telephone number listed in the “Customer Satisfaction” section created in the Quality Management section of the HCIFS website (http://www.harriscountytx.gov/ifs/quality.aspx) to provide feedback pertaining to the quality and level of laboratory services.

-Customers who attend the annual Topics in Forensic Sciences conference receive a survey at the end of the conference, which requests feedback on services provided.

-Feedback may also be requested verbally by direct interaction with the customer.

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4.8 Complaints

All complaints, whether originating from laboratory personnel or from external customers, shall be promptly handled in accordance with procedure QP08.0018. Corrective action, if needed is initiated and monitored in accordance with QP08.0007. The customer will be notified of measures taken to address the complaint and confirmation of complaint resolution, as needed. Records of complaints are maintained. 4.8.1 Customer Complaints and Resolution The procedure QP08.0018 ensures complaints from laboratory personnel related to the management system are investigated and resolved promptly. All complaints shall be directed to the appropriate section supervisor/manager or the Quality Director for resolution. Depending on the nature of the complaint, formal corrective action may be initiated in accordance with procedure QP08.0007 or appropriate supervisory remedial measures will be initiated and documented.

4.9 Control of Nonconforming Tests and/or Calibration Work

4.9.1 Nonconforming Test Nonconforming test sections 4.9.1 a – e, and 4.9.2 are covered in QP08.0007 Nonconformity, Corrective and Preventive Action procedure. It is each employee’s responsibility to report any instances of nonconformity in casework. Any nonconformity shall be addressed in accordance with procedure QP08.0007. Corrective actions may include halting of work, evaluation of previous work, withholding of test reports, recall or amendment of reports that have been released. If nonconformity resulted in recall or amendment of test report, the impacted customer will be informed of the nonconformity, in writing, if needed. Nonconformity, deficiencies or departures from accepted quality standards may be identified through a variety of avenues including but not limited to the following: Technical case review Administrative case review Review of data and controls Proficiency testing Testimony evaluation Case re-examination Audits Customer complaint

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A minor departure from accepted policy may not rise to the level of nonconformity; the error might only require correction. This type of error may be logged as a variance in a Variance Log to monitor trends. A variance can be raised to a non-conformity requiring corrective action(s) subsequently.

4.10 Improvement

The laboratory shall strive to continually improve the effectiveness of its management system and enhance customer satisfaction through: Audits Preventive actions Review, improvement and monitoring of laboratory process Review and improvement of the overall laboratory operations Automation to reduce human error and increase productivity Innovation and re-structuring of the laboratory work areas to improve and streamline

workflow Additional staffing Decrease of laboratory backlogs utilizing awarded grants efficiently Consulting with experts in specific areas utilizing their experience and advice Enhancement of customer satisfaction by conducting in-house classes or meetings with

law enforcement agencies to improve communications, share knowledge, and provide training on relevant forensic science topics

Quality monitoring of all documents Timely corrective and preventive actions Request for customer feedback

The annual management system review will provide an opportunity to review all elements of the management system and any needed improvements.

4.11 Corrective Action

The corrective action procedure QP08.0007 covers sections 4.11.1 – 4.11.4 4.11.5 Additional Audits Situations that bring into question compliance with established policies or procedures may necessitate audits of the appropriate area(s) or of the entire quality system. These audits will be conducted and documented as set forth in 4.14 of this manual. If required, notification of findings and corrective actions will be communicated to any affected customer. All corrective action processes will be documented and maintained within the laboratory in accordance with QP08.0007. Subsequent laboratory auditing and monitoring will be conducted to ensure the success of the corrective action process while demonstrating

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continued compliance with accepted quality procedures, ISO 17025 Standards and the current ASCLD/LAB International Supplemental Requirements.

4.12 Preventive Action

Preventive action procedure sections 4.12.1 and 4.12.2 are covered in procedure QP08.0007. The implementation of a comprehensive quality management system and the monitoring of laboratory standards of quality provide a basis for a preventive action system. Proactive planning will be done to identify opportunities for improvement, enhance laboratory service and provide for improved customer satisfaction (e.g., monthly and annual management review). A variety of information sources such as the Laboratory Information Management System and applications such as Excel are used to maintain information that can be used to identify trends in testing requests, analysis and potential problem areas.

4.13 Control of Records

4.13.1 General Requirements Quality and technical records are maintained to ensure they are readily retrievable, legible, identified, and protected. Quality records can include audit reports, corrective actions, preventive actions, customer complaints, proficiency test records, management reviews, and court testimony evaluations. A technical record is a document that provides evidence of work performed, or activities conducted related to casework. Technical records constitute all data generated in the processing of a case including test data, test reports, instrument calibrations, routine instrument checks, and maintenance records. Derived data and information are recorded in sufficient detail to establish an audit trail. 4.13.1.1 Record Maintenance The laboratory has established procedures for the identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. The laboratory has procedures in place to insure the proper storage and retention of technical and quality records. Refer to QP08.0011 for additional information. 4.13.1.2 Records Storage

Case record folders are filed and maintained in designated areas within each laboratory section. Access to case records is limited to authorized laboratory employees. Records are stored in a manner that prevents damage, deterioration, and loss.

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The Forensic Genetics, Drug Chemistry, and Toxicology sections utilize electronic filing units with restricted access for the temporary storage of case folders. The Trace Evidence and Firearms Identification Laboratories use locked filing cabinets for case folders with restricted access. The completed case folders are transferred to the HCIFS Records Center located on the second floor. These case records are maintained by administrative support personnel for at least one year before they are transferred to the Harris County Central Records Center, 4625 Crites, Houston TX 77011, for long term storage. QC records are also transferred to the long term storage center for storage. All quality assurance records, such as records of proficiency tests, corrective actions and preventive actions, audit records, court testimony reviews, customer complaints, and temperature logs are retained for at least five years or one full ASCLD/LAB-International accreditation cycle. It is permissible to scan original records and dispose of the hard copies after the scan was verified as being complete. Case records are retained for at least one full ASCLD/LAB-International accreditation cycle and in accordance with applicable county regulations. 4.13.1.3 Records Security

All technical and quality records are maintained under security and strict confidentiality. Certain quality records, including audit documents and corrective actions, are secured and maintained by the Quality Management division. 4.13.1.4 Electronic Records Protection

All electronically stored documentation is stored in such a manner as to prevent unauthorized access or destruction. Crime laboratory personnel cannot access electronic folders unless they have been given authorization from the Crime Laboratory Director or assistant directors. All data and records stored on any HCIFS server have an automatic incremental back-up occurring Monday through Thursday to any changed document. A full backup is done every Friday – Sunday. Backups of all HCIFS servers are done by the Harris County Information Technology Center in accordance with the Harris County policies. Technical raw data generated from analytical instruments not stored on the shared drive are backed up on external hard drives on a monthly basis in accordance with procedure QP08.0010.

4.13.2 Technical Records (Refer to procedure QP08.0012 for details.) 4.13.2.1 Record Retention

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The laboratory maintains records of original observations, derived data, and each test report. Records contain sufficient information to maintain an audit trail, calibration records, personnel records, and calibration certificates in accordance with the laboratory record retention schedules. Adequate information is maintained in the technical record so that an independent analyst could interpret the results and be able to reach the same conclusion as the original examiner after assessing the original work, identify factors affecting the uncertainty, and repeat the test under conditions as close as possible to the original analysis. Examination records include the identity of the analyst who performed the test and the technical reviewer, as well as the dates of each function. 4.13.2.2 Recording of Technical Data

The date and initials of the analyst are recorded on case documentation to show when the work was performed and by whom. Technical records shall be updated to include observations, data and calculations associated with specific tasks at the time these activities are performed.

4.13.2.2.1 Dates of testing At a minimum, examination records reflect the starting and ending dates of testing, with the start date being the date examination of evidence began. 4.13.2.3 Technical Data Corrections

Notes, worksheets, and other writings in a case file must be made in ink. Notes must be legible. Annotations must be identifiable to the person making the annotation. Mistakes are crossed out with a single line, the correct value is entered alongside, and correction is initialed and dated by the individual making it. It is not permissible to erase, hide, or obliterate errors. Records stored electronically are protected as much as possible from loss or change of original data. 4.13.2.3.1 Changes Made to Examination Records Any documentation added to the examination record is initialed and dated by the person making the addition. Equivalent measures are taken to the extent possible when any such change is made in the JusticeTrax LIMS.

4.13.2.3.2 Electronically-Recorded Examination Documentation

When laboratory sections utilize JusticeTrax LIMS or other application software to electronically record analytical data and/or generate reports the changes to the records are tracked. Electronic examination records indicate when the analysis started and completed. Examination records are considered complete after the draft report is written and prior to technical or administrative review. Changes made during case review will be tracked either electronically or on a hard copy to maintain an audit trail.

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4.13.2.4 Examination and Administrative Records

(Refer to procedure QP08.0023 for additional details.)

Case records shall include examination and administrative records relating to the testing of submitted evidence items. Case records may contain: Records of conversations relating to the submitted item(s) Evidence receipts and other chain of custody records Subpoenas and other judicial records Description of item packaging and condition of seals Records of observations, data collected and calculations used Diagrams and instrument print-outs Photographs Other documents/records specified in test methods

4.13.2.5 Records to Support Conclusions All case record documentation must support the conclusions reached such that in the absence of the analyst another competent reviewer can evaluate and interpret the data. Descriptions, photographs and photocopies, diagrams and drawings, and worksheets may be used to document the basis for the conclusions derived from the evidence tested. When instrumental analyses are conducted, the instrument operating parameters shall be documented in the method procedure, the examination record, or in a log book. 4.13.2.6 Unique Case Identifier and Analyst’s Initials A unique case number and the analyst’s initials must appear on each page of examination records. The initials must either be handwritten or a secure electronic equivalent. The date of initialing must be printed as well. When an analyst’s initials have been captured in a photograph it is not necessary for the analyst to re-initial the photograph.

4.13.2.7 Analysts’ Examination Records Examples of examination records include test charts, graphs, electropherograms, photographs, and analytical findings. Laboratory personnel who generate examination records must initial and date their respective work. The analyst who interprets the findings and prepares the test report must initial and date each page of the examination record.

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4.13.2.8 Unique Identifier on Administrative Records Examples of administrative records include submission forms, subpoenas, evidence receipts, vault logs, email correspondence, telephone conversations, and dissemination records. Administrative records, either received or generated by the laboratory, are uniquely identified either by a LIMS generated barcode label or by handwritten or instrument-generated laboratory case numbers. 4.13.2.9 Unique Identifier on Examination Records The laboratory case number assigned by LIMS, or otherwise, appears on each page of examination records, including data printouts; it may be handwritten or printed. It is permissible for case numbers to be abbreviated by omitting the “FS” and/or the preceding zeros of the unique identifier (ex: IFS13-00145 may be written or printed as I13-145 or I13-0145). 4.13.2.10 Double-sided Records

When examination records are recorded on both sides of a single page, each side will constitute a page and contain the unique laboratory case number and analyst’s initials.

4.13.2.11 Permanence of Records Examination records shall be permanent in nature. All records are either printed or hand written in ink.

4.13.2.12 Independent Checks

When a testing procedure requires an independent check, verification, witnessing step, or data review to be performed to verify a specific step in a process, only an individual having expertise gained through training and casework experience in the category of testing can perform the verification. Test methods or procedures must specify how independent verifications, when required, are documented in the technical record. 4.13.2.13 Abbreviations and Symbols Abbreviations and symbols may be used if defined in a key or list of abbreviations. 4.14 Internal Audits 4.14.1 Planning, Scheduling and Organizing The Quality Director plans, schedules and organizes at least one internal audit of each section of the laboratory annually. The internal audits focus on compliance to the ISO 17025 Standards and

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the current ASCLD/LAB-International Supplemental Requirements, FBI Quality Assurance Standards for Forensic DNA Testing Laboratories, American Board of Forensic Toxicology, and the laboratory’s own quality assurance procedures. All elements of the management system are addressed in the internal audits, including the testing activities in each laboratory section. The internal audits shall be conducted by the Quality Director, with assistance from the Quality Management Team, selected management, supervisory personnel, and/or qualified personnel who, if possible, are independent of the area of the laboratory being audited. The Quality Director will ensure laboratory personnel scheduled to participate in the internal audit process are trained auditors or have experience performing audits. 4.14.1.1 Internal Audit Frequency The internal audits are conducted at least annually, beginning in June and finishing in or before November, and verify that all components of the quality management system are met. The Forensic Genetics Technical Leader will ensure the audit frequency requirement for the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories is met.

A Toxicology Manager or designee will ensure the American Board of Forensic Toxicology audit requirements are met in the Toxicology section. 4.14.1.2 Audit Documentation The internal audits are documented and records retained by Quality Management through one ASCLD/LAB-International accreditation cycle or five years, whichever is longer. 4.14.2 Audit Findings Any nonconformity identified as a result of an internal audit which casts doubt on the effectiveness of the operations or on the validity of test results will be handled in a timely manner, and in accordance with QP08.0007. The laboratory will notify customer(s) via a written amended report if investigations reveal their laboratory results have been affected. 4.14.3 Recording Audit Findings The area of activity audited, the audit findings, and any corrective or preventive actions are recorded by the auditing personnel. 4.14.4 Audit Follow-Up Follow-up audits will be conducted by Quality Management to verify and record the implementation and effectiveness of the corrective action(s) taken.

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4.14.5 Self-Assessment Audits An Annual Report is submitted to ASCLD/LAB within 30 calendar days following the laboratory’s accreditation anniversary date of December 3rd. The American Board of Forensic Toxicology (ABFT) accreditation cycle for the Toxicology laboratory is every two years. A Mid-Cycle accreditation audit report will be submitted to the accrediting body on or prior to the accreditation anniversary date. The Forensic Genetics section will be audited internally at least every other year (in between external audit years) to check for compliance with the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories. 4.15 Management Review

Sections 4.15.1 – 4.15.2 Executive managers’ meetings, chaired by the Chief Medical Examiner, are held monthly to review the monthly reports of each division of the HCIFS. The Chief Medical Examiner’s office retains a copy of the agenda. The monthly reports include performance, productivity, facility improvements, policy decisions, and agency news updates. Any information and decisions from the executive managers meeting which impact the laboratory or laboratory personnel are communicated to the laboratory management team by the Crime Laboratory Director. Any information and/or decisions are then relayed to remaining laboratory personnel by section managers/directors. These meetings are part of the monthly review of the management system. A comprehensive crime lab management review occurs in the first quarter of each new year to review the activities and events of the previous calendar year. All lab managers participate in this review. Findings from these annual management reviews are recorded in meeting minutes. Required action shall be carried out within an appropriate time frame, as agreed upon by the managers involved. The following factors will be considered during the annual management review: Suitability of policies and procedures Reports from supervisory and managerial personnel Recent audit outcomes Corrective and preventive actions Assessments by external agencies Results of proficiency tests Changes in volume, type of work and backlogs Customer feedback Complaints Recommendations for improvement Quality Control activities Resources, staffing, and training

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New instruments, methods, or tests Courtroom testimony review Improvements achieved and goals for further improvement The management reviews are documented and records retained through one ASCLD/LAB International accreditation cycle or five years, whichever is longer. 5.0 TECHNICAL REQUIREMENTS

5.1 General Requirements

5.1.1 Test Reliability and Correctness Factors which influence the quality of the tests performed by the laboratory may include the following:

Experience of the examiner and other human factors Test methods used and method validation Laboratory equipment and reagents Environmental conditions Measurement Traceability Sampling Evidence handling

5.1.2 Factors Affecting Testing The factors listed above will be taken into consideration when the laboratory trains personnel, selects laboratory equipment, and develops tests and procedures. Laboratory personnel should be aware of the extent these factors contribute to the total uncertainty of measurement, which may differ considerably between tests or types of test. 5.1.3 Reliability of Reagents Each section of the laboratory has developed procedures to test reliability of the reagents used for testing. The recorded use of appropriate controls ensures the continued reliability of reagents. In general, the following guidelines must be followed before a reagent is used: Commercial chemical and reagent containers must be initialed, dated when received,

opened and with the expiration date per the manufacturer or as determined in-house, if applicable.

The lot number must be documented as needed. The quality of all critical reagents is checked for adequacy before they are employed. Reagents are not to be used for casework after their expiration date or shelf life

expectancy.

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5.1.3.1 Reagents Prepared In-house Analysts are responsible for routine testing of reagents as required in the section test method and/or quality assurance procedures. Testing the reliability of a prepared reagent must be done prior to use or, if applicable, concurrent with the test. Records for testing the reliability of critical reagents of any new lot are retained by each section of the laboratory. Each critical reagent prepared in the laboratory is logged with the reagent name, lot number assigned, name or initials of the person preparing the reagent, the date of preparation, and results of the reliability check before it is utilized in any casework. Such records will be retained for at least five years or one ASCLD/LAB-International accreditation cycle.

5.2 Personnel

5.2.1 Personnel Competence The laboratory ensures personnel have adequate education, training and experience to understand the scientific principles of each test they perform. Personnel are trained and verified to be able to follow procedures, operate the equipment necessary to provide reliable examinations, and demonstrate competence in all assigned methods and instrumentation prior to conducting testing on any evidence items. Staff members undergoing training are supervised by qualified personnel. 5.2.1.1 Training Program Each section of the laboratory has a comprehensive documented training program which defines the training needs for new and untrained employees, and for those in need of retraining. Current employees are required to participate in the employee training program so they remain well trained, competent and proficient in their work. Continuing education, proficiency testing, and literature review are some of the methods used to help analysts maintain their skills and expertise. All work performed by analysts in training is supervised by laboratory personnel who are already qualified to perform casework in the applicable area of testing. Retraining of laboratory personnel can take place under different circumstances. The duration and extent of retraining will depend on an individual’s experience and capability as determined by the supervisor.

o If coming from another forensic laboratory, the examiner will need to provide evidence of training and/or competence in the same discipline(s) or sub-discipline(s) in which he/she will be assigned to work.

o In cases of unsatisfactory proficiency test results or casework nonconformities leading to corrective action, retraining may be required. The extent of retraining will be determined by the section manager, assistant director or Crime Laboratory

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Director, and will depend on the level of the nonconformity and the impact it had on casework.

o A lapse of an employee’s proficiency test interval will require re-qualification, at minimum, prior to resuming casework. The section manager, assistant director or director will determine whether retraining is needed. One consideration will be the amount of time elapsed since the last satisfactory proficiency test was taken.

Individual training records consist of copies of diplomas and degrees, transcripts, professional development course records, competency tests and quizzes, and, in some cases, mock trial records. Qualification memos are added to an analyst’s training record as he/she completes assigned training modules. 5.2.1.2 Court Testimony Training Personnel whose laboratory responsibilities may require testifying in court receive courtroom testimony training. This may be accomplished by classroom-style testimony training and/or mock trials. 5.2.1.3 Ethics and General Training Each laboratory section training program includes the application of ethical practices in forensic sciences. General forensic sciences knowledge and applicable criminal and civil law procedures are presented to analysts, examiners, and technicians. Examples include in-house lectures on Federal Rules of Evidence and general forensic science lectures. These began for volunteers seeking ABC certification and are now extended for all staff. In-house ethics training is in the form of small group discussions with management regarding different ethical issues that are relevant to the workplace. 5.2.2 Personnel Training (Refer to procedure QP08.0024 for general training guidelines.) Initial training and continuing education of laboratory personnel is an ongoing function of the laboratory. Section managers/directors determine educational requirements. Training programs are structured to provide a comprehensive level of training to staff, covering all work performed by the laboratory and requiring competency testing upon completion. Continuing education and professional development are essential and strongly encouraged within each department. It is the responsibility of section managers/directors to identify training needs relevant to the current and anticipated work of their staff, and to ensure such training is provided. Laboratory management encourages analysts to seek membership in professional organizations as a means of continuing professional development. To the extent possible, the laboratory sponsors analysts to attend meetings and seminars presented by professional organizations. To the extent possible, this may include duty time, travel, per diem, and lodging for the analyst.

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Each year, laboratory management prepares an anticipated budget of training needs and costs to attend meetings and/or conferences as part of continuous education requirements. Within budget constraints, analysts should attend technical meetings to remain proficient in their field. Alternatively, analysts may be presented with in-house continuing education and/or training sessions. Upon return from external trainings or professional meetings, analysts are expected to report back to the laboratory what topics were covered and if the content was useful. When an in-house training session is given, managers seek feedback from the analysts regarding its effectiveness. 5.2.3 Support Personnel Competence If the laboratory subcontracts technical personnel, the contract employees must demonstrate the same level of competence as laboratory employees before handling casework and must adhere to the established quality standards of the laboratory. Specific job descriptions containing educational requirements, duties and responsibilities, position on the organizational chart, and a documented training program which demonstrates knowledge and skills are maintained. Administrative support staff, whether subcontracted or not, must also adhere to agency-wide and section-specific policies and procedures. 5.2.4 Job Descriptions The laboratory maintains job descriptions in Q-Pulse, which outline educational requirements and specify duties and responsibilities for all personnel including managerial, technical and support personnel involved in testing. Job descriptions are kept current by reviewing at least annually and revising when necessary. Staffing the laboratory will follow the procedures outlined by the Harris County regulations and the Human Resources division. It is the desire and intent of the laboratory to employ only the most qualified persons. Management of the laboratory adheres to and supports the principles of equal opportunity. 5.2.5 Personnel Testing Authorization Training is documented, dated and maintained in individual employee and contractor training files. Once training is complete and competency demonstrated, the analyst is authorized by the Laboratory Director or assistant director to perform casework. Authorization to perform casework is accomplished via a sign-off checklist or a signed, dated memorandum. Record of the authorization document is retained in the analyst’s training file. The analyst’s training file also includes records of competence, educational and professional qualifications, training, skills, and experience. Although hard copies of personnel training documents may be retained in binders, the official record of a training document is the soft copy maintained in the Q-Pulse People Module. 5.2.6 Technical Personnel Qualifications

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5.2.6.1 Education Technical personnel working in the laboratory satisfy the minimum educational requirement mandated by the ASCLD/LAB-International program, the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories, and the American Board of Forensic Toxicology. Individual employee training binders include educational records, transcripts, continuing education sign-off sheets, memos or certificates, training and competency test records. These records are maintained as soft copies in Q-Pulse People module. 5.2.6.2 Competence All analysts and technical support personnel performing casework, regardless of their academic qualifications and or past experience, are required to complete adequate training and a competency test prior to assuming casework responsibility or any task that could affect test results. If an analyst’s job responsibility includes test report writing, their competency test must, at a minimum, include:

Examination of sufficient unknown samples to cover the anticipated spectrum of assigned duties and evaluate the individual’s ability to perform proper testing methods.

A written test report to demonstrate the individual’s ability to properly convey results and/or conclusions and the significance of those results/conclusions.

A written or oral examination to assess the individual’s knowledge of the discipline, category of testing or task being performed.

5.2.7 Library and Literature Resources Each laboratory section has a reference library comprised of current books, journals, and/or periodicals, etc., pertaining to the discipline(s) of that section. These literature resources are accessible to laboratory personnel. Additional journal articles are available to IFS employees through the Texas Medical Center Library’s InterLibrary Loans service, accessed through the following website: http://illiadw.library.tmc.edu/

5.3 Accommodation and Environmental Conditions

5.3.1 Environmental Effects on Testing The laboratory has sufficient space available and a proper design (floor plan) to adequately carry out its functions. All laboratory office and examination areas have proper lighting enabling personnel to safely and efficiently carry out their assigned duties. The safety of all personnel and the integrity of evidentiary items are safeguarded by the physical structure and its components.

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In order for the laboratory to efficiently pursue its goals and objectives, as funding permits, improvements are made to maximize or expand laboratory and office space. The laboratory is properly ventilated with fume hoods available in each section to remove toxic and/or noxious fumes, as needed. Environmental conditions for the laboratory are appropriate for the type of testing being performed. Section managers/directors ensure the environmental conditions in their respective section facilitate the correct performance of tests through the proper maintenance and operation of laboratory equipment, safety, and security, heating/cooling/ventilation, plumbing and electrical systems including backup power, when applicable. The temperature of laboratory areas housing instruments which require operation within a specified temperature range is controlled on a daily basis.

Proper and sufficient space is provided for long-term storage of volatile, flammable and hazardous materials. Volatiles and flammable materials are stored in flammable safety cabinets. Evidence related to fire debris analysis is also stored in flammable safety cabinets. Specific technical requirements for accommodation and environmental conditions that can affect the results of tests are documented in the standard operating procedure for that testing method. If sampling or testing are undertaken at sites other than the laboratory facility, care is always taken to minimize environmental effects on the task at hand. The Drug Chemistry section, for example, follows an SOP for Offsite Bulk Sampling (DC.DR.4019), which instructs the analyst to move the evidence to a proper location before sampling. 5.3.2 Monitoring and Recording Environmental Conditions Any method which requires a controlled environment is addressed in the appropriate test procedure(s). Records of the monitoring shall be maintained as required by technical specifications contained in the test procedure(s). If environmental conditions are such that these conditions could potentially jeopardize the results of testing, adversely affect the required quality or increase measurement uncertainty, testing shall be halted. The section manager and assistant director, the Laboratory Director and the Quality Director will be immediately notified. The Quality Director will ensure that corrective action is implemented in accordance with QP08.0007, if necessary. 5.3.3 Incompatible Areas Separation The design and floor plan of each section of the laboratory effectively separates incompatible activities in order to prevent cross-contamination or deleterious effects. Laboratory disciplines have applicable procedures to reduce the potential for cross-contamination (for example, use of laminar flow hoods or appropriate gowning of laboratory personnel). In extremely sensitive

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areas of analysis (e.g., Trace evidence processing and DNA testing), special measures to reduce and control sources of potential cross-contamination are specified in the sections’ specific procedures. 5.3.4 Laboratory Security and Access 5.3.4.1 (a – f) Access to operational areas of the laboratory is limited and controlled. The distribution of keys and electronic ID cardkeys is limited to individuals granted access to the laboratory by the Laboratory Director. Distribution of keys and ID cardkeys is documented and a record is maintained. Visitors shall not be provided access to operational areas unless they are accompanied by a member of the laboratory staff. Visitors must always display their issued visitor’s tag while in the building. The laboratory has been designed to assure the proper safekeeping of physical evidence and records. All exterior access/egress points to the laboratory have key-operated locks, cardkey-activated locks or touch pad locks. The System Administrator distributes cardkeys and maintains records of all cardkeys distributed. Each cardkey is programmed with the unique identification of the employee to whom it is assigned. Quality Management maintains a key log, documenting all keys (excluding ID cardkeys) and to whom the keys have been assigned. Access to evidence storage areas is restricted to ensure the integrity of stored evidence. Evidence handling procedures provide best practices for the prevention of loss, tampering, and contamination of evidence items, both before and after examination. The laboratory evidence vaults are equipped with locks to controlled access and prevent unauthorized access. Vaults are properly secured when Evidence Section staff members are not present. Lockable, short-term evidence storage areas are available to analysts to be used as needed. It is the responsibility of the analyst to ensure their evidence storage area is secure and preserve the integrity of the evidence during a temporary storage period. If short term evidence storage is needed but no area is available, evidence in progress is returned to the evidence vault for secure storage. Refer to section-specific SOPs on evidence handling for additional information. Security of the facility is handled in accordance with the HCIFS Security procedure. Security cameras have been installed at strategic locations both outside and inside the building. These locations include evidence vaults, hallways, and specific areas inside the laboratory. These cameras make it possible to view and review activities inside and outside the facility. Additional details regarding laboratory security are available in procedure QP08.0014.

5.3.5 Laboratory Housekeeping

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The laboratory is maintained in a clean and safe condition. Analysts follow specific procedures for routine cleaning of their workstations. Cleaning personnel are contracted by Harris County. Approved cleaning personnel are always accompanied by laboratory personnel when cleaning laboratory operational areas. Cleaning personnel may clean non-operational areas (cubicles, break rooms, etc.) afterhours when laboratory personnel are not present. All documents pertaining to casework are locked and secured at the end of each business day to prevent unauthorized access to confidential information, case administrative documentation or case analytical documentation. 5.3.6 Safety in the Laboratory The laboratory has a documented health and safety program, found in the HCIFS Safety Manual. All laboratory personnel must read and acknowledge the Safety Manual during their first days of work at HCIFS. Safety equipment, such as goggles, safety glasses, face protectors, ear protectors, and gloves necessary for examiners to carry out their assigned duties in a safe manner are provided. Depending on the nature of work performed, each laboratory section is equipped with personal protective equipment (PPE) for the safety of laboratory personnel. The stringency of PPE requirements varies among the laboratory sections. First-aid kits are available and conveniently located within the laboratory areas on each floor. Selected laboratory personnel will maintain certification in first aid procedures. Each section of the laboratory is equipped with a safety shower, an eye wash station, a fire blanket, and a fire extinguisher. This equipment is regularly checked to make sure it is in good working order. Documentation of monthly safety inspections are maintained in Q-Pulse. Clean-up equipment and materials are available for the disposal of spilled chemicals. Specially designed storage areas or cabinets are maintained for hazardous chemicals, flammable chemicals, and explosive materials. The HCIFS facility has a fire detection system which is maintained and tested at least annually. All exit points from the laboratory are clearly marked. Laboratory personnel are trained in the building’s evacuation plan and fire drills are held on a regular basis to test the operation of the plan. The laboratory has developed an Emergency Preparedness Plan which shall be put into action in case of emergency. The plan is described in procedure LA06.1002. This procedure is consistent with the HCIFS Hurricane Preparedness SOP, which was developed by the Director of Forensic Emergency Management and approved by the Chief Medical Examiner.

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5.4 Test Methods and Method Validation

5.4.1 General Testing Requirements All testing methods and procedures utilized in the laboratory are documented, approved by section managers or directors, and readily available to the technical personnel of each laboratory section. The scientific methods and procedures employed are accepted in the scientific field and may include sampling, handling, transport, storage, preparation of test items, estimation of measurement uncertainty, and statistical techniques, as applicable. All instructions, standards, manuals, and reference data relevant to the work in each section are kept current and available for personnel. SOPs for equipment operation and the handling of test items are sufficiently detailed to produce accurate and reliable test results. Procedures may have to be adjusted for cases that involve compromised evidence or evidence of limited quantity. All planned SOP deviations must be pre-approved by the section technical manager prior to implementation. All data, documentation and authorization related to any method deviation must be readily available. In addition, if this deviation will result in not meeting the service request of the customer, the supervisor or designee must communicate the deviation to the customer. This communication must be documented and retained in the case folder. 5.4.2 Selection of Testing Methods

The laboratory utilizes appropriate analytical methods and tests for carrying out the customer requests.

Methods published in the latest valid editions of international, national, or regional standards are used by the laboratory, if applicable. Additional details may supplement the standards used in order to ensure consistent application; however, a standard method must not be altered if the laboratory wants to cite its use. Methods published by reputable technical organizations, relevant scientific journals, or equipment manufacturers are preferred and remain the more common methods used in the laboratory. Laboratory-developed methods and methods adopted by the laboratory are validated in-house prior to their use. Once validated, the methods are approved by the section manager/director to ensure they are appropriate for the intended use. Validations and instrument performance verification records are kept within each section. Changes to a method require re-validation before use on casework. The method of analysis is identified in the case reports for the customer’s information. If a customer requests a method of analysis which is inappropriate or out of date, the section manager or designee will inform the customer accordingly. 5.4.3 Laboratory-Developed Methods

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Development of new methods is planned and performed or supervised by qualified laboratory personnel. Management ensures that employees responsible for developing new methods possess the appropriate knowledge and skills and are provided with the necessary resources. Section managers monitor the progress of method development and communicate updates to relevant laboratory personnel. 5.4.4 Non-Standard Methods Laboratory methods not meeting the definition of a standard method are subject to agreement with the requesting customer, if applicable. A clear specification of the customer’s requirements and the purpose of the test must be documented in the case file. As with any method, these methods must be validated and approved prior to use. 5.4.5 Validation of Methods 5.4.5.1 Definition of Validation Validation is the confirmation by examination and the provision of objective evidence that the particular requirements of a specified intended use are fulfilled. 5.4.5.2 Validation Procedures and Records All technical procedures and methods used to analyze and evaluate casework samples are validated before use. The validation process includes testing known samples designed to resemble, as closely as possible, actual evidence materials. Validations should be as extensive as necessary in order to meet the needs of the application. Validation results are recorded and approved by the section manager. Members of the Quality Management Division also review and approve validation results. A note, memo, or summary within the validation states whether the method is fit for its intended use. The records of all validation procedures, data, and results will be maintained and retained as long as the method is utilized for testing evidence in the laboratory. The validation of methods will generally be initiated by the respective section manager. The Quality Management Division may monitor the validation process for compliance with standards. Crime Laboratory validation guidelines are established in procedure QP08.0015. Each laboratory section has specific validation procedures.

5.4.5.3 Validated Testing Methods Range and Accuracy

The approver of a specific validation must verify that the range and accuracy of the values obtained from the validated method meet the customers’ needs and are scientifically valid.

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Depending on the method or procedure being validated, the following factors, among others, should be considered during the validation process; uncertainty of results detection limit selectivity of the method repeatability and/or reproducibility robustness against external influences sensitivity to interference from the matrix of the sample/test object 5.4.5.4 Validation Reliability and Performance Verification The reliability of new method procedures is demonstrated through in-house performance checks prior to implementation. Records of performance checks are maintained by each laboratory section. 5.4.6 Estimation of Uncertainty of Measurement 5.4.6.1 - 5.4.6.2 Uncertainty of Measurement Procedures The laboratory has procedures in place to estimate uncertainty of measurement for tests performed. The Drug Chemistry, Toxicology, and Firearms Identification Laboratories have implemented procedures to report the uncertainty of measurement for all critical measurements. Reasonable estimation of the performance of the method is based on knowledge of performance of the method and on the measurement scope, including previous experience and validation data. For test methods that prove difficult to assess measurement uncertainty with rigorous data, any significant component of uncertainty must be considered in the preparation of a reasonable estimation of uncertainty. The laboratory will report results with an appropriate estimate of uncertainty. 5.4.6.3 Identifying Components of Uncertainty of Measurement Sources which may contribute to the uncertainty include reference standards and materials, analysis methods, instrumentation, environmental factors, and condition of testing items. All identified components of uncertainty of measurement are included in the applicable budget sheet used to calculate a measurement uncertainty value. 5.4.7 Control of Data

5.4.7.1 Verification of Calculations and Data Transfers Calculations and data transfers are subject to appropriate checks in a systematic manner. It is the responsibility of the case analyst and technical reviewer to make certain calculations are accurate and conform to written procedures. The analysts and the technical reviewers are responsible for ensuring data entry and transfers are correctly performed.

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Each section of the laboratory has documented procedures for reviewing and evaluating quality control measures before data is reported. Each section of the laboratory maintains methods for the prevention of calculation errors. Examples include the use of validated Excel worksheets or computerized instrument programs for mathematical calculations. 5.4.7.2 Electronic Data Transfer and Integrity (see also 5.10.7) When computers or automated equipment are used for acquiring, processing, recording, reporting, storing, or retrieving test data the laboratory must ensure that:

a) Software, macros, statistical programs, etc. are described in detail and validated prior to implementation

b) Procedures are in place to protect electronic data from unauthorized access or changes and that data integrity and confidentiality are maintained

Raw data from instruments is backed-up in accordance with procedure QP08.0010. Equipment is always located in a suitable environment for operation.

5.5 Equipment 5.5.1 Equipment Requirements Refer to QP08.0016 for more details. It is the responsibility of a qualified section manager to determine which laboratory instrumentation, equipment and facilities are necessary for achieving quality analyses of physical evidence. The equipment and supplies used for sampling, preparation of test items, processing, and analysis of test data are selected to be appropriate for the type of testing and to enable analysts to obtain correct results. If the laboratory uses equipment outside its permanent control, lab management and Quality Management will ensure that ISO/IEC 17025 requirements will continue to be met. 5.5.2 Equipment Specifications and Calibrations Laboratory equipment and software must meet required specifications and be capable of meeting required accuracy standards as stated within technical standard operation procedures of each laboratory section. Laboratory equipment and software are calibrated and/or checked for compliance prior to initial use and subsequently for their ability to meet the requirements of the test methods for which they are used. They must also be capable of providing meaningful results to the customers. Procedures for instrument and reference standard calibration exist within each section when they have a significant effect on testing results. 5.5.3 Authorization to Operate Laboratory Equipment

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The Laboratory Director or designee will authorize staff members to operate laboratory equipment used in test methods following successful training and proof of competency. “Authorization to perform casework” templates are used for this purpose. The most current SOPs for equipment operation and maintenance are kept in Q-Pulse. Manufacturers’ manuals are kept either beside the equipment or in a centralized location for all appropriate personnel to access. 5.5.4 Equipment Identification Laboratory equipment, including any applicable software, are uniquely identified and recorded on an inventory log. Each section has an instrument inventory log which is updated at least annually. Laboratory instrument information is subsequently entered into the Q-Pulse Assets module. Some laboratory instruments are also identified by Harris County inventory codes. 5.5.5 Equipment Records Equipment requiring calibration/verification and routine performance checks must have an assigned records binder. Instrument binders are maintained in the appropriate laboratory sections. Equipment records are also maintained in Q-Pulse Assets. The records of critical laboratory equipment and applicable software include the following: item identity manufacturer, model and serial number, or other form of unique identification results of checks verifying that equipment complies with specifications equipment/instrumentation location manufacturer’s instructions, if available, or reference to their location calibration records maintenance records damage, malfunction and repairs records 5.5.6 Equipment Handling and Maintenance Each section has written procedures for safe handling, transport, storage, operation, and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration.

5.5.7 Out of Service Equipment

Any laboratory equipment shown to be not functioning properly, suspected of providing questionable results, or not meeting acceptance criteria during calibration/quality control testing, is immediately taken out of service. An “out-of-service” sign is placed on the equipment. The supervisor or section manager will be informed and will take actions to ensure questionable data is reviewed and rerun if necessary. Results from malfunctioning equipment will be evaluated for any effect on previously reported test results. The quality procedure QP08.0007 will be followed if corrective actions are required.

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The laboratory equipment must be clearly marked with its “out of service” status until it is repaired. Once a critical instrument is repaired, a performance check of the instrument must be completed demonstrating acceptable operation. Documentation will be maintained for the repair, performance check, and placement of the equipment back into service.

5.5.8-5.5.9 Equipment Calibration Designation

In-house laboratory equipment requiring calibration shall have labeling affixed or otherwise identified to designate the last calibration date and when the next calibration is due.

Laboratory equipment sent to an outside vendor for calibration, verification of accuracy/precision, repair, or maintenance, will be checked for standard compliance before being returned to service. Maintenance, accuracy verification, and calibration records from the vendor should convey the equipment status is satisfactory and functioning properly prior to being returned to service.

5.5.10 Intermediate Checks

The schedule and protocol for performing intermediate checks are defined in each section’s documented procedures. The intermediate checks are used to determine if the equipment’s calibration remains satisfactory. Intermediate checks are reviewed by section managers and/or Quality Management personnel. An instrument or equipment item that does not pass the intermediate check will be taken out of service for troubleshooting or repair.

5.5.11 Equipment Adjustments/Correction Factors Calibration may give rise to correction factors and some adjustments may be necessary. Any adjustment(s) are formally recorded. Copies, if maintained in computer software such as Q-Pulse, or on the server, will be updated accordingly. 5.5.12 Equipment Protection and Security Section managers have implemented methods and/or policies to safeguard equipment and instruments used within their sections from unauthorized adjustments which could invalidate test results. Methods may include limiting access, password protection and write-protection of calculations and instrument parameters. Laboratory equipment, including adjustable hardware and software, will have sufficient

controls or other measures in place to indicate if any adjustment(s) occurred following calibration, (e.g., run a positive control on a gas chromatograph to show retention time is consistent from beginning to end of the analytical sequence).

Items tested by questionable instrumentation or equipment shall immediately be re-

examined to insure reliability of results.

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5.6 Measurement Traceability

(Refer to measurement traceability procedure QP08.0013.) 5.6.1 Calibration of Equipment Critical laboratory equipment must be properly maintained and calibrated. A formal record of calibration and maintenance will be readily available for instruments and equipment that are used for testing, including those for subsidiary measurements that have a significant effect on the accuracy or validity of a test result. The documented procedure for calibration will be available either within the calibration record log or described in detail within individual section SOPs. All new instrumentation requiring calibration must be calibrated prior to initial use. 5.6.1.1 Calibration Checks Calibration checks or auto-tunes may be performed on critical laboratory equipment prior to running samples and following service or other substantial maintenance. Calibration checks may be carried out using synthetic standards prepared in the laboratory or matrix-matched standards. Standards solutions may also be purchased with the manufacturer’s statements and/or certificates. Wherever possible, standards shall be purchased from suppliers accredited to ISO/IEC 17025. 5.6.2 Specific Requirements 5.6.2.1 Requirements for Calibration The Crime Laboratory is currently not a calibration laboratory.

When an external calibration service is utilized, measurement assurance is confirmed by evidence of the vendor’s competence, capability, and traceability. The external calibration service must provide a calibration certificate containing the measurement results with measurement uncertainty and/or a statement of compliance with an identified metrological specification. 5.6.2.2 Requirements for Testing

The laboratory shall ensure all equipment utilized for measuring functions meet ASCLD/LAB-International Requirements and can provide the level of uncertainty of measurement required. (Refer to Measurement Traceability procedure QP08.0013.) The laboratory utilizes certified reference materials and/or consensus standards to establish traceability, where applicable. 5.6.3 Reference Standards and Reference Materials

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5.6.3.1 Reference Standards Reference standards are only used for checking specific measuring equipment. Reference standards must be calibrated before and after adjustments and according to their respective laboratory section’s predefined schedule. The agency providing calibration services must be accredited by a nationally-recognized accrediting body with a scope that covers the type of calibration needed. 5.6.3.2 Reference Materials Where possible, reference materials are traceable to SI units of measurement. Internal reference materials are checked when needed. 5.6.3.2.1 Reference Collections Reference materials maintained for identification, comparison or interpretation purposes will be fully documented, uniquely identified and properly controlled. Reference collections of data or items/materials may include collections of mass spectra, drug standards, DNA profiles, bullets, cartridges, and frequency databases. If available, manufacturers’ Certificates of Analysis for reference materials will be kept to demonstrate traceability. A listing of certified reference materials used in each laboratory section is maintained. The information may include material name or description, source, manufacturer’s lot number, laboratory lot or batch number, receipt date, and expiration date. Case records may include, if applicable, the identity of reference materials used during analysis of test/calibration items. This information is used to document traceability to the reference material used during analysis.

5.6.3.3 Intermediate Checks of Reference Materials and Standards

Intermediate checks help maintain confidence in the calibration status of standards and reference materials. Any lab section intending to perform intermediate checks of reference materials or standards must have a documented procedure to do so. A reference standard or material believed to be out of calibration will be removed from use and sent to an accredited calibration vendor for check and calibration.

5.6.3.4 Transport and Storage of Reference Materials and Standards

Procedures for the safe handling, transport, storage, and use of reference standards and materials are in place to protect the integrity of these items. These procedures follow manufacturer’s instructions and/or material specifications in order to prevent contamination and deterioration.

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5.7 Sampling 5.7.1 Sampling Plans and Procedures The laboratory will not, as a normal procedure, accept excessive quantities of materials for testing. The laboratory sections have implemented sampling or sample selection procedures to the extent applicable. Customers are asked to submit sufficient amounts of samples for analysis from the bulk items of evidence and to retain the remainder. When samples cannot be taken from the evidence by the agency’s officers due to the nature or quantity of the evidence, qualified laboratory personnel will go to the agency’s location and conduct sampling. Sampling plans (such as for drugs) or sample selection procedures are included in individual laboratory sections’ procedures. A copy of the sampling procedure must be available at the location where sampling is undertaken. The sampling procedure includes factors which are required to be controlled to ensure validity of the results of the sampled items. Statistical methods employed when representative samples of items are analyzed are described in Drug Chemistry procedure DC.DR.4010. 5.7.2 Sampling Plan Deviations, Additions, and Exclusions Laboratory sections have sampling procedures prescribed within their procedure manuals. The availability of certain quantities of materials may limit samples for testing. If the customer requires a deviation, addition, or exclusion from the sampling plan, the request will be recorded and communicated to appropriate personnel. The information recorded should include the customer’s instructions for sample selection and reason for the deviation. Any deviation must be pre-approved by the section manager or assistant director, if the latter is appropriate. If the laboratory is unable to comply with the requested sampling deviation, testing will not begin until the matter is resolved. When deviations, additions, or exclusions from a sampling procedure occurs, the limitations placed upon the analyses should be described within the test results, along with the sampling data, so the customer can be made aware of the procedural changes. 5.7.3 Sampling Records The case record contains observations, photographs, diagrams, or other means of documentation which may be used to support the examiner’s selection of testing items. The case record must refer to the sampling procedure used, identification of the examiner, and environmental conditions, if relevant. The result of any statistical method utilized to select the number of items tested is documented within the case record.

5.8 Handling of Test Items

5.8.1 Evidence Handling Procedures

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For details of the laboratory evidence transporting, receiving, handling, protecting, storing, and retaining procedures refer to procedures QAE.07.0001, QAE07.0002, QAE07.0003, QAE07.0004, QAE08.0005, and QP08.0020. Crime Laboratory personnel are not authorized to dispose of evidence with the exception of medico-legal Toxicology samples. Toxicology samples submitted in-house by the medical examiners may be disposed of after one year. [Refer to the Toxicology procedures on sample disposal for further detail.] Portions of sub-items may be consumed during the normal course of analysis. Work product may be discarded after analysis as outlined in section-specific SOPs. 5.8.1.1 Chain of Custody It is imperative the security and chain of custody of all evidentiary materials be maintained. Evidence submitted to the laboratory must meet specified criteria, be documented by a chain of custody and be returned properly. The chain of custody must be secure, contain the date of evidence receipt, detailed transfer information, and be easily accessible. Each laboratory staff member handling evidence must acknowledge by signature, initials or secure electronic equivalent, at the time of transfer, when they take possession of or transfer evidence. The chain of custody begins with a customer-completed submission form requesting the laboratory to analyze evidence in one or more of the forensic disciplines or sub-disciplines provided by the laboratory. For all disciplines this information is then entered into the JusticeTrax LIMS. The LIMS evidence transfer record details the person transferring the evidence, person taking possession of the evidence, date of transfer, storage location, laboratory case number, item description, and submission number. Two types of barcode labels are generated from the JusticeTrax LIMS for each case:

The evidence barcode label bears a brief description of the evidence package, (e.g., a manila envelope); the unique case identifier (for example, IFS11-01234), and a unique submission number assigned to each item of evidence, (for example, 001, 002, etc.). This barcode label is affixed on the evidence item and on the inner surface of the corresponding case folder.

For IFS cases, the case barcode label bears the unique case identifier and the agency name. For ML cases, the case barcode label bears the unique case identifier. These bar code labels are affixed on the submission form, corresponding case folder and the verification form.

5.8.1.1.1 Sub-item Tracking When evidence is subdivided in the laboratory, the sub-items are tracked through the same chain of custody used to track the original exhibit. Sub-items defined as work product are not tracked. 5.8.1.1.2 Evidence Seals

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All evidence items received by the Crime Laboratory must be sealed. A container is “properly sealed” when its content cannot readily escape and includes the initials of the person who sealed the evidence with tape. When lab examiners, analysts, or technicians must seal or re-seal an evidence item, evidence tape is used, with initials and date being placed across the seal. 5.8.2 Identifying Evidence The unique laboratory case number assigned by LIMS or otherwise appears on each item of evidence belonging to a case. All items belonging to a particular case, including any sub-items, will always be identified by the laboratory number. For all laboratory sections, cases submitted by external agencies are assigned case numbers using LIMS as follows: IFSXX-00001, IFSXX-00002, IFSXX-00003, etc. The “XX” represents the two digit abbreviation of the current year. Case evidence submitted internally by the medical examiners is assigned consecutive case numbers by the investigators of the HCIFS Investigations Division before being submitted to the laboratory. Medico-legal case numbers have the prefix “ML,” followed by the two digit abbreviation for the year and the unique number (ex: ML13-0001). Out of County cases have laboratory numbers that start with the letters “OC” (ex: OC13-0001). The outer packaging of each item or sub-item will always have the case number printed on it and its own submission number. Submission numbers are used to distinguish multiple exhibits packaged separately and submitted for the same case. 5.8.3 Suitability of Items for Testing Evidence submitted to the laboratory must be properly packaged, labeled, and sealed to prevent contamination, loss or deleterious change. If evidence integrity is in question, the Laboratory Director or designee will determine the course of action. If an item submitted appears to be unsuitable for testing, the item’s condition must be photographed and documented in the case notes to explain why suitability for testing is being questioned. Likewise, if the circumstances surrounding the item’s collection or submission is a cause for concern, the details must be documented in the case notes. These items may still be analyzed, if the Director’s approval is given, either with the normal procedure or a deviated procedure. Deviations from SOPs are documented in the case record. If evidence submitted to the crime laboratory does not conform to laboratory requirements, the submitter is asked to correct the deficiency prior to acceptance of the evidence. Unsealed evidence, for example, should be returned to the customer for proper sealing. As an alternative, evidence lacking a proper seal may be sealed by laboratory personnel after inspection and the action is documented in the case record. If there is ambiguity as to which test(s) are required by the customer, laboratory personnel will contact the customer for clarification and record the conversation in the case record before proceeding.

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5.8.4 Handling and Protection of Evidence Access to the Evidence Handling room on the 3rd floor and the Forensic Genetics vault at the Nabisco Building is restricted to evidence technicians and QA/QC personnel. Evidence technicians follow strict protocols for handling evidence items. These rooms are monitored by means of video camera systems. Access to the long term storage evidence vaults is controlled and restricted to evidence technicians. The Drug Chemistry, Forensic Genetics and Trace Evidence vaults are monitored by video camera systems. Evidence areas and vaults are always kept cool and dry to preserve the evidence. The room temperature and humidity of the evidence vaults are controlled by an automatic control system to protect evidence items from deterioration or change. Temperatures of freezers and refrigerators that hold evidence are monitored, recorded on temperature logs, and maintained in the laboratory on a daily or weekly basis. If a portion of an evidence item is to be retained by the laboratory, this portion shall be stored securely under proper environmental conditions, which may be a secured freezer or refrigerator, to protect its integrity. When evidence items are not being held in secured evidence vaults, they are in the custody of a laboratory employee (i.e., an evidence technician, analyst, or manager). The item’s chain of custody will reflect this. 5.8.4.1 Security of Test Items Evidence not in the process of examination is stored under proper seal to protect it from cross contamination, loss, or damage. All evidence items not in the process of examination are stored securely in a long term storage vault. 5.8.4.2 Unattended Evidence Evidence is left open only during processing. Once processed, the evidence is re-sealed and returned to a long term evidence vault until it is released. Procedures allow for analysts to temporarily store their own evidence items in the process of being examined. Laboratory personnel are provided with a secured short-term storage cabinet for overnight or short-term storage of evidence material. At no time shall unsealed or opened evidence be left unattended in the laboratory. Should an examiner need to exit the laboratory for a short period of time during evidence examination, evidence items must be placed in a secured short-term storage area. 5.8.4.2.1 Evidence in the Process of Examination Evidence is processed in a timely manner. Once the process of analysis has begun for an item of evidence, it must be carried through to completion without unreasonable delays. The crime

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laboratory maintains goals of short turnaround times for case completion in all of the laboratory sections. Each section has goals for case turn-around-time. 5.8.4.3 Evidence Identification Each item of evidence is barcoded to ensure it is uniquely identifiable and traceable to a unique case number. Items of evidence which cannot be marked must have an evidence tag affixed or their proximal containers properly marked. Refer to procedure QP08.0020. 5.8.4.5 Evidence Collected from a Crime Scene by Laboratory Personnel Evidence collected from a crime scene by laboratory personnel must be protected from loss, cross transfer, contamination, and/or deleterious change, whether in a sealed or unsealed container, during transportation to the laboratory evidence facility. Where appropriate, further processing to preserve, evaluate, document, or render evidence safe is accomplished back at the laboratory and prior to final packaging. Evidence collected from a crime scene is appropriately identified, packaged, and entered into the evidence control system as soon as practical. 5.8.4.6 Individual Characteristic Databases The laboratory follows procedures promulgated by the National Integrated Ballistics Identification Network (NIBIN) and the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) for the operation of the Integrated Ballistics Identification System (IBIS), individual characteristic database. 5.8.4.6.1 Individual Characteristic Database Samples

Test fired specimens are the only individual characteristic database samples maintained by the laboratory. Test fired specimens will be treated as evidence, with proper chain-of-custody maintained for each.

5.8.4.6.2 Identification of Individual Characteristic Database Samples

Each individual characteristic database sample under laboratory control is uniquely identified using a combination of the case number and specimen identifier.

5.8.4.6.3 Protection of Individual Characteristic Database Samples

Individual characteristic database samples under laboratory control must be protected from loss, cross transfer, contamination, and/or deleterious change. These specimens are maintained in sealed test fire envelopes or other appropriate containers.

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5.8.4.6.4 Access to Individual Characteristic Database Samples

Access to individual characteristic database samples under control of the laboratory is restricted to those persons authorized by the section manager, the Director of Physical Evidence, or the Laboratory Director.

5.9 Assuring the Quality of Test Results

5.9.1 Monitoring Validity of Tests

The laboratory’s measurement assurance program helps maintain measurement traceability. Each section of the laboratory has either developed quality control procedures or has integrated quality control measures within the test procedures for monitoring validity of the test(s) performed. A noted inconsistency may be recorded as a variance in a variance log or may be raised to a corrective action, depending on the severity of the problem. Each section includes the quality control steps followed during the test process in the case record, where appropriate, to ensure the tests are properly monitored. Quality control data for all casework are recorded and reviewed for trends and to determine if nonconformities are present. Statistical techniques may be used to review quantitative measurement results. Appropriate activities to monitor analytical performance are specified in the laboratory methods and may include reference collections, certified reference materials and those generated in the laboratory, statistical tables, positive and negative controls, replicate testing, repeat testing, spiked samples, standard additions, internal standards, and independent checks. Regular participation in proficiency testing programs is another means of testing laboratory methods. 5.9.1.1 Recording Control Data Quality control data will be referred to in the case record, if not already included in the case record. Quality control data not included in the case record will be retained for at least one ASCLD/LAB-International accreditation cycle. 5.9.2 Quality Control Data Quality control data is evaluated for consistency and correctness, according to pre-defined criteria. When quality control data are found to be unacceptable, the analyst will report the matter to an immediate supervisor or higher. The QA/QC liaison and a member of the Quality Management Division may also be notified. Management will refer to the test methods to investigate. Planned action must be taken to correct the problem and prevent reoccurrence. If applicable, a formal corrective action will be initiated in accordance with procedure QP08.0007. A test with unacceptable quality control is considered invalid and results should not be reported.

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5.9.3 Proficiency Testing Program

The laboratory has a documented proficiency test program and schedule. The Quality Director, with the assistance of the Quality Management Division, manages the proficiency testing program. Proficiency test results are reviewed by the Quality Director or designee, and the results of the proficiency test are provided to analysts by means of a memorandum distributed via Q-Pulse. Analysts acknowledge receipt of the results in the Q-Pulse system.

Corrective and/or preventive action will be initiated in accordance with QP08.0007 for any unsatisfactory results.

5.9.3.1 Methods Used During Proficiency Testing

The laboratory’s approved test methods are used when participating in a proficiency test. Proficiency test items are treated in the same manner as evidence items and tested like regular casework. 5.9.3.2 Proficiency Test Program Compliance The laboratory proficiency testing program meets all accreditation and compliance requirements, including the ASCLD/LAB Proficiency Review Program. 5.9.3.3 Frequency of Testing Each laboratory section must participate annually in and successfully complete at least one external proficiency test for each discipline in which it provides services. All analysts and technical support personnel engaged in testing activities within the laboratory must successfully complete at least one internal or external proficiency test per calendar year for each discipline in which he/she performs casework. 5.9.3.3.1 Proficiency Testing for DNA Analysts Proficiency tests for DNA analysts comply with the current Quality Assurance Standards for Forensic DNA Testing Laboratories issued by the Director of the Federal Bureau of Investigation. 5.9.3.3.2 Proficiency Testing within the Scope of Accreditation All analysts and technical support personnel engaged in testing activities must successfully complete at least one proficiency test during each five year accreditation cycle, in each category of testing appearing on the laboratory’s Scope of Accreditation, in which the individual performs testing. Analysts and technical support personnel follow the documented proficiency test schedule which is set by Quality Management before each calendar year commences.

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5.9.3.4 Approved Test Providers The laboratory participates annually in at least one external proficiency test for each discipline of forensic science in which it provides services. Proficiency tests are purchased from an ASCLD/LAB approved provider, when available. If the proficiency test for a particular discipline or sub-discipline is not available commercially, the proficiency test will be prepared in-house or the proficiency test will be performed by retesting case samples. A proficiency test prepared by another crime laboratory or agency through mutual agreement may also be submitted as an external proficiency test. An analyst may be proficiency tested in one or more of the different tasks in which s/he has been trained to perform casework. The proficiency test shall be designed so an analyst is tested in all aspects of the assigned job functions over a period of time. 5.9.3.5 Proficiency Test Records Proficiency test records are retained on the 2nd floor in the HCIFS Record center. Proficiency test records show the test set identifier, test taker, dates of analysis and completion, how samples were obtained, data and notes supporting the conclusions, test results, noted discrepancies, review and feedback provided, and, if necessary, corrective actions. 5.9.3.6 Proficiency Test Record Retention The proficiency test record is retained for at least one full ASCLD/LAB International accreditation cycle or five years, whichever is longer.

5.9.4 Technical Review Every laboratory section has established a procedure for the technical review of examination records and test reports to that conclusions made by the analyst are reasonable, within the constraints of validated scientific knowledge, and supported by examination records. The technical review procedure defines the scope of the review, establishes parameters of the review process, specifies how the review is documented in the case record, and describes the type of action to be taken when a discrepancy is discovered. If a nonconformity is suspected while performing technical review, remedial actions may be taken immediately to address the issue. The analyst and the technical reviewer must agree on the conclusions expressed in the report. If a disagreement regarding the conclusions occurs, the technical reviewer and analyst will work together to resolve the disagreement. If they are unable to resolve it, a third qualified individual shall be named by a supervisor (or will be a supervisor) will join the discussion providing additional input. If there is still disagreement, the section manager, assistant director, or

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Laboratory Director, and if necessary the Quality Director, will join the discussion in order to facilitate a resolution. Each section conducts technical review of 100% of each analyst's work product. Technical reviews are documented in the case record and include, at a minimum, the name of the reviewer(s), the review date and the pages reviewed. 5.9.4.1 Items in Technical Review The technical review, at minimum, evaluates test reports and examination records to ensure:

Test reports are accurate and contain all required information. Analyses conformed with appropriate test methods and applicable laboratory policies and

procedures Results and conclusions are supported by the data Associations are properly supported in the test report The test report contains all the required information

5.9.4.2 Technical Reviewer Qualifications Technical reviews are conducted by individuals authorized by laboratory management to do so. Technical reviewers have expertise gained through training and casework in the category of testing being reviewed. The technical reviewer must have knowledge of the laboratory’s technical procedures but need not be an active analyst or an employee of the laboratory. 5.9.4.3 Limitations on Technical Reviewers The individual conducting the technical review cannot be the author or co-author of the examination records or test report under review. 5.9.5 Administrative Review At the completion of a case and prior to the release of the evidence and test report to the submitting agency, administrative reviews are performed. Each laboratory section has established an administrative review procedure to check for consistency with the section’s policy, procedures, as well as to check for proper spelling, grammar and punctuation.

The Administrative Review is documented by the application of the administrative reviewer’s signature or initials to the report or case record. The individual conducting the administrative review may not be the author or co-author of the test report under review. 5.9.5.1 Administrative Review Guidelines Administrative review includes, at a minimum:

A review of the administrative and examination records to ensure the records are labeled with the laboratory case number

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A review of the test report for proper spelling, grammar and punctuation A review of the test report to ensure all key information is included, (laboratory case

number, agency name, agency number, subject name, etc.) 5.9.5.2 Additional Reviews Some laboratory sections have a third type of review as an extra quality assurance check. The Toxicology section conducts Expert Review. Expert Review is the final step prior to releasing a case and is conducted only by those individuals sufficiently knowledgeable of drug actions and interactions to make an expert interpretation of the case. Typically, expert reviews are conducted by a Toxicologist Level I or higher (Expert Reviewers). The Expert Reviewer will assess the following:

A. Whether the report is a true representation of the findings recorded on the “Toxicology Laboratory Summary Worksheet”

B. Whether all documentation has been technically/administratively reviewed C. Whether the reported data

a. Adequately satisfies the requests of the submitting pathologist or agency b. Are scientifically and technically sound c. Are adequate to allow interpretation of the toxicology report

The Forensic Genetics Laboratory conducts 10% Review, performed by the Technical Leader or designee. 10% Review is a thorough review of the case record and report to make sure conclusions are supported by the data and that all reporting elements, including CODIS entry, are correct.

5.9.6 Court Testimony

The court testimony of lab personnel is monitored at least annually. Court testimony can be evaluated in several ways, including written feedback from attorneys or judges, telephone interviews with attorneys or judges, transcript evaluation, and direct observation. The Court Testimony Evaluation form should be filled out whenever an evaluation is performed. This form elicits opinions from judicial officers or the monitoring lab personnel on the effectiveness of testimony, the objectivity of testimony and the clarity of communication by the witness. Once the form is completed by the evaluator, the expert witness will meet with his/her manager to discuss the assessment. A laboratory supervisor or peer may monitor the analyst's testimony by attending court, listening to the testimony, and providing constructive feedback. This is the preferred method for evaluating new subordinates and first-time testifiers. A less than satisfactory evaluation will result in a corrective action. Corrective action may be in the form of counseling, additional training, and/or repeating a mock trial.

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Analysts who will potentially testify in court as expert witnesses receive court testimony training. A mock trial is one of the methods used by the laboratory to train analysts before attending court. Mock trials may either be conducted in-house or at the Harris County Court House. 5.9.7 Court Testimony Evaluations Records Court testimony reviews are retained through one ASCLD/LAB-International accreditation cycle or five years, whichever is longer.

5.10 Results Reporting

(Refer to QP08.0021 for additional details) 5.10.1 General Requirements

Laboratory test results must be accurate and consistent. The results of laboratory testing must be available to the customer. A test report is produced whenever analytical work is conducted. Reports follow clause 5.10 of ISO/IEC 17025 ASCLD/LAB-International 2011 Supplemental Requirements for the Accreditation of Forensic Science Testing Laboratories and Standard 11 of the FBI’s Quality Assurance Standards for Forensic DNA Testing Laboratories. Case records relating to specific investigations contain all of the relevant information required by ISO/IEC 17025, sub-clauses 5.10.2 and 5.10.3. 5.10.1.1 Customer Cancellation of Work Requests If a customer cancels a request for work before it is processed, the laboratory will issue a report indicating the work was cancelled. Documentation of the customer’s reason for cancellation should be placed in the case record. 5.10.2 Test Reports Each section of the laboratory issues reports that are clearly written, technically accurate and issued within a reasonable period of time after completion. Test methods may include specific reporting criteria to ensure results are reported accurately, clearly, unambiguously and objectively. Each test report includes at least the following information:

A title The name and address of the laboratory Unique identification of the test report and an identification on each page in order to

identify the page(s) as part of the test report An indication of the end of the test report The name and address of the customer An unambiguous identification of the item(s) tested. Date of receipt of the test item(s)

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The test results The name(s), function(s), and signature(s) or equivalent identification of the person(s)

authorizing the test report Where relevant, a statement to the effect that the results relate to the items tested

If not on the report itself, the following information is documented within the case record:

A description of the item(s) tested, as well as the condition upon receipt Identification of the method used Reference of the sampling plan or procedures used, if applicable. The date of testing

5.10.3 Additional Reporting Information 5.10.3.1 Test Reports and Interpretation In addition to interpretations and opinions, test reports may require additional information when deviations from normal testing methods occurred. Additional information, where necessary, may include a description of the method variance and/or an explanation of non-compliance with requirements. Information on the estimated uncertainty of measurement may be included, where applicable. Opinions and interpretations must be documented to include how the conclusion was derived. If an opinion cannot be reached, the reason must be written in the case record. Tests reports, where necessary for the interpretation of the results, can include additional information required by specific methods or customers. 5.10.3.2 Testing Record Content for Sampling Where necessary for the interpretation of test results, case records include the date of sampling or sample selection, sampling location, methods or procedures utilized, and identification of material sampled. The laboratory will include any deviations required from standard sampling methodology, relevant environmental conditions and any other pertinent information required to assist in the interpretation of testing results. 5.10.3.3 Release of Test Reports The laboratory administrative support personnel are authorized to release test reports to customers. Case record information pertaining to a discovery request is performed in accordance with the Open Records Request procedure LA06.1006. 5.10.3.4 Review of Examination Records Laboratory personnel who report findings, including written test reports and court testimony based on examination records generated by another person(s), will complete and document the

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review of all relevant pages of examination records in the case record. Documentation of the review is accomplished by initialing each page of the dated examination record, completing a review checklist, and/or specifying the pages of the records or dates of analysis which were reviewed. 5.10.3.5 - 5.10.3.7 Associations and Inconclusive Test Results The significance of associations made in test reports is well-defined and qualified in the test report. Eliminations of an individual or object are clearly communicated in the test report when comparative evaluations are performed on evidence. When an “inconclusive” result is reported, the reason(s) must be clearly stated in the test report. It is the policy of the laboratory to have the author of a test report conduct, observe, or supervise the testing or examination. 5.10.5 Opinions and Interpretations Opinions and interpretations made are marked as such in the test report. The basis upon which opinions and interpretations are made is documented within the case record. 5.10.6 Subcontractor Testing Results Reports supplied by subcontractors of the laboratory must be included and identified within the test report provided to the customer. The subcontractor report can be submitted electronically or in writing. Calibration certificates are issued by external laboratories after performing calibrations for the crime laboratory. 5.10.7 Electronic Transmission of Results The laboratory utilizes either hand written or electronic signatures on test reports based on the extent of JusticeTrax LIMS capabilities in a particular section. The electronic signature is secure and password protected. Equipment used for the electronic transmission of results is maintained in proper working order and limited for use by personnel in order to protect the integrity and confidentiality of the data. Refer to LA06.1003, LA06.1004 and QP08.0003 for details. 5.10.8 Report Format Efforts are made to format reports to accommodate each type of test provided. Changes to design or presentation of content will be made as needed to improve the clarity of reports. 5.10.9 Amendments and Supplements (Refer to procedure QP08.0021 for details.)

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An amended report is issued when the laboratory reported an erroneous result to the customer. Laboratory reports amending original reports are marked as “AMENDED REPORT.” An amended report is intended to replace the original report. The amended report will accurately identify the original report being corrected and reference the unique laboratory case number. Amended reports are maintained permanently in the case record. Supplemental reports are issued when additional testing is performed on evidence from a case with a previous report.

The additional report is marked as “SUPPLEMENTAL REPORT.” Supplemental reports will reference the original report by the unique laboratory case number. Both the amended and supplemental reports must meet ISO 17025:2005 and ASCLD/LAB International Supplemental Requirements.

References

ISO/IEC 17025: 2005. 2nd Ed. (2005) General requirements for the competence of testing and calibration laboratories. International Organization for Standardization.

ASCLD/LAB-International. (2011 Edition). Supplemental Requirements for the Accreditation of Forensic Science Testing Laboratories. American Society for Crime Laboratory Directors/Laboratory Accreditation Board.

FBI Quality Assurance Standards For Forensic DNA Testing Laboratories (September 1,

2011). ASCLD/LAB-International. Policy on Measurement Traceability. Ver. 1.1 (May 22,

2013). American Society for Crime Laboratory Directors/Laboratory Accreditation Board.

ASCLD/LAB-International. Policy on Measurement Uncertainty. Ver. 1.1 (May 22,

2013). American Society for Crime Laboratory Directors/Laboratory Accreditation Board.

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