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Forensic Science Communications

January 2005 – Volume 7 – Number 1

Standards and Guidelines

Quality Assurance General Practices

Scientific Working Group for the Analysis of Seized Drugs (SWGDRUG)

October 2003

1. Introduction

The recommendations in Quality Assurance General Practices involving the analysis of seized drugs are limited to qualitative analysis only. Issues involving quantitative analysis will be taken up in a later version.

It is the goal of a drug analysis program to provide the customers of the laboratory's services access to quality drug analysis. It is the goal of this document to provide a quality framework for managing drug casework processing, including handling evidentiary material, management practices, analysis, and reporting. These are minimum recommendations for practice.

The term evidence has many meanings in the international community. In this document, it is used to describe drug exhibits that enter a laboratory system.

A documented quality management system must be established and maintained. Personnel responsible for this must be clearly designated and shall have direct access to the highest level of management concerning laboratory policy. The quality management system must cover all procedures and reports associated with drug analysis.

2. Personnel

2.1.	Job Descriptions for all personnel should include responsibilities, duties, and required skills.
2.2.	Designated Personnel and Responsibilities: A person (however titled) may be responsible for one or more of the following duties:
	2.2.1.	Quality assurance manager is a designated person who is responsible for maintaining the quality management system (including an annual review of the program) and who monitors compliance with the program.
	2.2.2.	Health and safety manager is a designated person who is responsible for maintaining the laboratory health and safety program (including an annual review of the program) and who monitors compliance with the program.
	2.2.3.	Technical support personnel are people who perform basic laboratory duties but do not analyze evidence.
	2.2.4.	Technician and/or assistant analyst is a person who analyzes evidence but does not issue reports for court purposes.
	2.2.5.	Analyst is a designated person who
		2.2.5.1.	Independently has access to unsealed evidence in order to remove samples from the evidence for examination.
		2.2.5.2.	Examines and analyses seized drugs or related materials or directs such examinations to be done.
		2.2.5.3.	As a consequence of such examinations, signs reports for court or other purposes.
	2.2.6.	Supervisory chemist is a designated person who has the overall responsibility and authority for the technical operations of the drug analysis section. Technical operations include, but are not limited to, protocols, analytical methodology, and technical review of reports.
2.3.	Qualifications and Education
	2.3.1.	Technical support personnel will have the following:
		2.3.1.1.	Education, skills, and abilities commensurate with their responsibilities.
		2.3.1.2.	On-the-job training specific to their position.
	2.3.2.	Technicians and/or assistant analysts will have the following:
		2.3.2.1.	Education, skills, and abilities commensurate with their responsibilities.
		2.3.2.2.	On-the-job training specific to their position.
	2.3.3.	Analysts will have the following:

		2.3.3.1.	Bachelor's degree (or equivalent, generally a three to four year postsecondary or tertiary degree) in a natural science or in other sciences relevant to the analysis of seized drugs. The degree program shall include lectures and associated laboratory classes in general, organic, and analytical chemistry.
			or
		2.3.3.2.	By January 1, 2005, a minimum of five years' practical experience in seized drug analysis and demonstrated competency following the completion of a formal, documented training program and posttraining competency assessment.
	2.3.4.	Supervisors will have the following:
		2.3.4.1.	All the requirements of an analyst.

		2.3.4.2.	Minimum of two years' experience as an analyst in the forensic analysis of drugs.
		2.3.4.3.	Demonstrated knowledge necessary to evaluate analytical results and conclusions.

2.4.	Initial Training Requirements

	2.4.1.	These minimum requirements allow individual laboratories to structure their training program to meet their needs related to type of casework encountered, analytical techniques, available instrumentation, and level of preparedness of trainees.
	2.4.2.	There must be a documented training program, approved by laboratory management, that focuses on the development of theoretical and practical knowledge, skills, and abilities necessary to examine seized drug samples and related materials. The training program must include the following:

		2.4.2.1.	Documented standards of performance and a plan for assessing theoretical and practical competency against these standards (e.g., written and oral examinations, critical reviews, analysis of unknown samples, and mock casework in specific topic areas).

		2.4.2.2.	Training syllabus with descriptions of the required knowledge and skills in specific topic areas in which the analyst is to be trained, milestones of achievement, and methods of testing or evaluating competency.

		2.4.2.3.	Period of supervised casework representative of the type the analyst will be required to perform.
		2.4.2.4.	Verification document demonstrating that the analyst has achieved the required competence.
2.5.	Maintaining Competence: Minimum annual training required for continuing professional development of analysts is 20 contact hours.


	2.5.1.	Training must be relevant to the laboratory's mission.

	2.5.2.	Training completed must be documented.

3. Physical Plant Requirements

	3.1.	Laboratories shall provide a healthy, safe, and secure environment for its personnel and operations.
	3.2.	Laboratories must have adequate space to perform required analytical functions and prevent contamination.
	3.3.	Chemical fume hoods must be provided. They must be properly maintained and monitored according to an established schedule.
	3.4.	A laboratory cleaning schedule must be established and implemented.
	3.5.	Adequate facilities must be provided to ensure the proper safekeeping of evidence, standards, and records.
	3.6.	Appropriately secured storage must be provided to prevent contamination of chemicals and reagents.

4. Evidence Control

Laboratories shall have and follow a documented evidence-control system to ensure the integrity of physical evidence.

4.1.	Receiving and Identifying Evidence.
Laboratories must maintain records of requests for analysis and of the respective items of evidence. A unique identifier must be assigned to each case file or record. For chain-of-custody purposes, the evidence shall be compared to the submission documentation, any significant observations of irregularity should be documented in the case file or record, and the submitter informed promptly. This file or record must include at a minimum the following:
	4.1.1.	Submission documents or copies.
	4.1.2.	Identity of people requesting analysis and the request date.
	4.1.3.	Description of items of evidence submitted for analysis.
	4.1.4.	Identity of the person who delivers the evidence and the submission date. For evidence not delivered in person, information regarding mode of delivery and tracking information.
	4.1.5.	Chain-of-custody record.
	4.1.6.	Unique case identifier.
4.2.	Evidence Integrity: Evidence must be properly secured. Appropriate storage conditions shall ensure that, insofar as possible, the composition of the seized material is not altered. All items must be safeguarded against loss or contamination. Any alteration of the evidence (e.g., repackaging) must be documented in writing. Procedures should be implemented to ensure that samples are and remain properly labeled throughout the analytical process.
4.3.	Evidence Storage: Access to the evidence storage area must be granted only to persons with authorization and access shall be controlled. A system shall be established to document the chain of custody for evidence in laboratory custody.
4.4.	Evidence Disposition: Records must be kept regarding the disposition of all items of evidence.
4.5.	Documentation Procedures: All laboratory records such as results of analyses, measurements, notes, calibrations, chromatograms, spectra, and reports shall be retained in a secure fashion.

5. Analytical Procedures

5.1.	Analytical Procedures for Drug Analysis
	5.1.1.	The laboratory shall have and follow written analytical procedures.
	5.1.2.	The laboratory shall have protocols in place for the sampling of evidence.
	5.1.3.	Work practices shall be established to prevent contamination of evidence during analysis.
	5.1.4.	The laboratory shall monitor the analytical processes using appropriate controls and traceable standards.
	5.1.5.	The laboratory shall have and follow written guidelines for accepting and interpreting data.
	5.1.6.	Analytical procedures must be validated in compliance with Section 10.
	5.1.7.	The analyst shall determine the identity of a drug in a sample and be ensured that the result relates to the right submission. This is best established by using at least two appropriate techniques based on different principles and two independent samplings.
5.2.	Minimum Requirements for the Verification of Drug Reference Materials for Forensic Drug Analysis
	5.2.1.	Identity of certified reference materials should be verified prior to their first use.
	5.2.2.	Identity of uncertified reference materials must be authenticated prior to use by methods, such as mixed melting-point determination, mass spectrometry, infrared spectroscopy, or nuclear magnetic resonance spectrometry.
	5.2.3.	Verification must be performed on each new drug lot.
	5.2.4.	All verification testing must be documented to include the name of the person who performed the identification, verification date, verification test data, and reference identification.

6. Instruments and Equipment Performance

6.1.	Instrument Performance: Instruments must be routinely monitored to ensure that proper performance is maintained.
	6.1.1.	Monitoring should include the use of reference standards, test mixtures, calibration standards, and blanks.
	6.1.2.	Instrumentation performance monitoring must be documented.
6.2.	Equipment: Only suitable and properly operating equipment shall be employed. Monitoring equipment parameters shall be conducted and documented. The manufacturer's operation manual and other relevant documentation for each piece of equipment should be readily available.

7. Chemicals and Reagents

	7.1.	Chemicals and reagents used in drug testing must be of the appropriate grade for the tests performed.
	7.2.	There must be written formulations for all chemical reagents produced in the laboratory.
	7.3.	Documentation for reagents prepared in the laboratory must include identity, concentration (when appropriate), preparation date, identity of the person preparing the reagents, and the expiration date (if appropriate).
	7.4.	The efficacy of all test reagents must be checked prior to their use in casework. The test results should be documented.
	7.5.	Chemical and reagent containers should be dated and initialed when received and first opened.

8. Casework Documentation, Report Writing, and Review

8.1.	Casework
	8.1.1.	Documentation must contain sufficient information to allow a peer to evaluate case notes and interpret the data.
	8.1.2.	Evidence-handling documentation should include chain of custody, the initial weight and/or count of evidence to be examined (upon receipt by the analyst), information regarding the packaging of the evidence upon receipt, a description of the evidence, and communications regarding the case.
	8.1.3.	Analytical documentation should include procedures, standards, blanks, observations, results of the tests, and supporting documentation including charts, graphs, and spectra generated during an examination.
	8.1.4.	Casework documentation must be preserved according to written laboratory policy.
8.2.	Report Writing: Reports issued by the laboratory must meet the requirements of the jurisdiction served. These may include the following:
	8.2.1.	Examining laboratory identity.
	8.2.2.	Case identifier.
	8.2.3.	Contributor identity.
	8.2.4.	Receipt date.
	8.2.5.	Report date.
	8.2.6.	Descriptive list of submitted evidence.
	8.2.7.	Analyst identity.
	8.2.8.	Results and/or conclusions.
	8.2.9.	Analytical techniques employed.
8.3.	Case Review
	8.3.1.	The laboratory must have a written policy establishing the protocols for technical and administrative case review.
	8.3.2.	The laboratory must have a written policy to determine the course of action if an analyst and reviewer fail to agree.

9. Proficiency and Competency Testing

Each laboratory annually should participate in at least one interlaboratory proficiency testing program and should have written protocols for testing the competency of its laboratory analysts.

9.1.	Proficiency Testing
	9.1.1.	Laboratories shall perform proficiency testing in order to verify the laboratory's performance in comparison to other laboratories. The frequency of the proficiency testing should be at least annually.
	9.1.2.	The proficiency testing samples should be representative of the laboratory's normal casework.
	9.1.3.	The analytical scheme should be in concert with the normal laboratory analysis procedures.
9.2.	Competency Testing
	9.2.1.	Laboratories will monitor at least annually the competency of their analysts (e.g., competency tests).
	9.2.2.	Competency testing samples should be representative of the laboratory's normal casework.
	9.2.3.	The analytical scheme should be in concert with the normal laboratory analysis procedures.

10. Validation and Verification

Method validation is required to demonstrate that the method is suitable for its intended purpose.

	10.1.	For qualitative analysis, the parameters that need to be checked are specificity, limit of detection, and reproducibility.
	10.2.	Minimum acceptability criteria should be described along with means for demonstrating compliance.
	10.3.	Validation documentation is required.
	10.4.	Laboratories adopting methods validated elsewhere should determine their own limit of detection and reproducibility.

11. Laboratory Audits

	11.1.	Audits of laboratory operations should be conducted at least annually.
	11.2.	Records of each audit must be maintained and should include the scope, audit date, name of the person conducting the audit, auditor(s), findings, and corrective actions taken, if necessary.

12. Deficiency Analysis

In the course of examining seized drug samples and related materials, laboratories may expect to encounter operations or results that are deficient in some manner. Each laboratory must have a written policy to deal with such deficiencies. This policy must include the following:

	12.1.	A definition of a deficiency as any erroneous analytical result or interpretation or any unapproved deviation from an established policy or procedure in an analysis. Deviations from established policy must have documented management approval.
	12.2.	A requirement for immediate cessation of the activity or work of the person involved, if warranted by the seriousness of the deficiency, as defined in the written policy.
	12.3.	A requirement for administrative review of the activity or work of the person involved.
	12.4.	A requirement for evaluating the impact that this deficiency may have had on other activities of the people or analysts.
	12.5.	A requirement for documenting the follow-up action taken as a result of the review.
	12.6.	A requirement for communicating to appropriate employees of any confirmed deficiency that may have implications for their work.

It should be recognized that to be effective, the definition for deficiency of analysis must be relatively broad. As such, deficiencies may have markedly different degrees of seriousness. For example, a misidentification of a controlled substance would be very serious and perhaps require that either the methodology or the analyst be suspended pending appropriate remedial action, as determined by management. However, other deficiencies might be more clerical in nature, requiring a simple correction at the first line supervisory level, without any suspension of methodology or personnel. Thus, it may well be advantageous to identify the differing levels of seriousness for deficiencies and make the action required be commensurate with the seriousness.

13. Health and Safety

The laboratory must have a documented health and safety program in place to meet the needs of the laboratory and meet the following health and safety requirements:

	13.1.	All personnel should receive appropriate health and safety training.
	13.2.	Drug analysis laboratories shall operate in accordance with laboratory policy and comply with any relevant statutory regulations.
	13.3.	Laboratory health and safety manual(s) shall be readily available to all laboratory personnel.
	13.4.	Material Safety Data Sheets shall be readily available to all laboratory personnel.
	13.5.	All chemicals, biohazards, and supplies must be stored and disposed of according to applicable government regulations and laboratory policy.
	13.6.	Safety hazards, such as syringes, items with sharp edges, or noxious substances, shall be labeled.

14. Documentation

In addition to casework documentation, the forensic laboratory must maintain documentation on the following topics:

	14.1.	Test methods and/or procedures for drug analysis.
	14.2.	Reference standards, including source and verification.
	14.3.	Reagent preparation and testing.
	14.4.	Evidence-handling protocols.
	14.5.	Equipment calibration and maintenance.
	14.6.	Equipment inventory (e.g., manufacturer, model, serial number, acquisition date).
	14.7.	Proficiency testing.
	14.8.	Personnel training and qualification.
	14.9.	Quality assurance protocols and audits.
	14.10.	Health, safety, and security protocols.
	14.11.	Validation data and results.