DEA Resources, Microgram Journal, Report of the Scientific Working Group for the Anaylsis of Seized Drugs (SWGDRUG) Conference (Montreal)

Analysts should:

2.2.1 Ensure and be able to demonstrate that the integrity and security of evidential materials and the information derived from their analysis have been maintained while in their possession;

2.2.2 Ensure that they have a clear understanding of what the customer needs and all the necessary information, relevant evidential materials and facilities available to reach a meaningful conclusion in an appropriate timeframe;

2.2.3 Employ an appropriate analytical approach, using the facilities available;

2.2.4 Make and retain full, contemporaneous, clear and accurate records of all examinations and tests conducted, and conclusions drawn, in sufficient detail to allow meaningful review and assessment of the conclusions by an independent person competent in the field;

2.2.5 Accept responsibility for all casework done by themselves and under their direction;

2.2.6 Conduct all professional activities in a way that protects the health and safety of themselves, co-workers, the public and the environment.

2.3 Reporting

Analysts should:

2.3.1 Present advice and testimony, whether written or oral, in a clear and objective manner;

2.3.2 Be prepared to reconsider and, if necessary, change their conclusions, advice or testimony in light of new information or developments, and take the initiative in informing their employer and customers promptly of any such changes that need to be made;

2.3.3 Take appropriate action if there is potential for, or there has been, a miscarriage of justice due to new circumstances that have come to light, incompetent practice or malpractice;

2.3.4 Preserve customer confidentiality unless officially authorized to do otherwise.

APPENDIX

This appendix gives EXAMPLES to demonstrate the scope of the various provisions of the Code.

Casework

2.2.1 To ensure and be able to demonstrate that the integrity and security of evidential materials and the information derived from their analysis have been maintained while in their possession:

Keeping a record of the chain of custody;
Making special note of the security of sealing and packaging of the evidential materials as received;
Preserving the evidential materials from contamination, adulteration, deterioration, loss or theft by use of appropriate working practices and utilization of suitable storage facilities with controlled access;
Using a unique identifier for the evidential materials, any sub-sample taken from them and any accompanying documentation, that will minimize the risk of misidentification;
Keeping the evidential materials in their original condition for future reference, insofar as this is possible;
Securely repackaging and resealing the evidential materials after their examination;
Preserving and returning all original packaging, with original seals intact, where this is possible;
Ensuring that access to the evidential materials and all documentation relating to these, before and after their examination, is restricted to authorized personnel.

2.2.2 To ensure that they have a clear understanding of what the customer needs and all the necessary information, relevant evidential materials and facilities available to reach a meaningful conclusion in an appropriate timeframe:

Conferring with the customer, if there is any uncertainty over their requirement;
Establishing what work needs to be performed to provide a fit for purpose response to the customer’s requirement;
Ensuring that all the requisite information and evidential materials have been submitted;
Checking that all the necessary accommodation, equipment, materials and skills will be available when required;
Declining to do the testing if the customer’s requirement cannot be met.

2.2.3 To employ an appropriate analytical approach, using the facilities available:

Adhering to the SWGDRUG recommendations;
Performing only those analyses that are needed to meet the specified customer requirement;
Making best use of the available resources in meeting the customer requirement;
Ensuring that the identification and quantification of any drug reflects what was present in the material submitted.

2.2.4 To make and retain full, contemporaneous, clear and accurate records of all examinations and tests conducted, and conclusions drawn, in sufficient detail to allow meaningful review and assessment of the conclusions by an independent person competent in the field:

Writing legibly;
Avoiding use of personal shorthand;
Recording all pertinent information at the time it is generated, or as soon as practicable thereafter;
Ensuring that there can be no uncertainty about what work has been carried out, how, when, where and by whom;
Complying with local jurisdictional requirements;
Consistently maintaining well-ordered casefiles and ensuring that these are available for review.

2.2.5 To accept responsibility for all casework done by themselves and under their direction:

Providing suggestions for improvement;
Ensuring that all work carried out personally and by others under their direction is in compliance with the laboratory’s procedures and protocols;
Providing clear, documented instructions to persons who do work on their behalf that might subsequently be used to support any advice or evidence they give;
Defending and justifying all work that is carried out by themselves and by others on their behalf.

2.2.6 To conduct all professional activities in a way that protects the health and safety of themselves, co-workers, the public and the environment:

Being aware of and complying at all times with current health and safety legislation;
Ensuring that all relevant risk assessments have been carried out and safe systems of work are in place and being followed;
Ensuring that others in the vicinity of their work are aware of their activities, particularly where these involve the investigation of clandestine laboratories, potential exposure to controlled drugs, especially from bulk seizures, the use of other hazardous materials or the destruction/disposal of drugs and other hazardous materials.

Reporting

2.3.1 To present their advice and testimony, whether written or oral, in a clear and objective manner:

Adhering to the SWGDRUG recommendations;
Using lay terms wherever possible;
Explaining technical terms so that they can be properly understood;
Including only facts and objective interpretations in their advice or evidence that can be justified by the work done and the information available;
Considering and providing alternative explanations or interpretations for their findings, where appropriate;
Making clear the strengths and any limitations in their advice or evidence;
Declaring anything that might undermine the integrity of their evidence or its use (e.g., unsecured packaging; possible contamination).

2.3.2 To be prepared to reconsider and, if necessary, change their conclusions, advice or testimony in light of new information or developments, and take the initiative in informing their employer and customers promptly of any such changes that need to be made;
Accepting an on-going responsibility for any advice or evidence provided;
Immediately bringing to the attention of their employer anything that they have become aware of that might cause them to question the validity of any advice given or evidence provided;
Informing the appropriate external authorities (e.g., police, prosecutor) of their concerns;
Recording in the casefile all such new information, an assessment of its implications and the actions taken.

2.3.3 To take appropriate action if there is potential for, or there has been, a miscarriage of justice due to new circumstances that have come to light, incompetent practice or malpractice:

Informing their employer about the new circumstances;
Informing their employer about relevant concerns they have about the quality of their own work or that of others working under their direction;
Advising their employer of any relevant concerns they may have about the work, advice or evidence provided by others;
Reporting to their employer any relevant concerns that others may have made (e.g., customer complaints; criticisms in court);
Ensuring that the information is brought to the attention of the appropriate external authority.

2.3.4 To preserve customer confidentiality unless officially authorized to do otherwise:

Not disclosing information about a case unless explicitly authorized to do so by the customer, a court, or other body with the relevant statutory powers; required by the law to disclose specified information to a designated person; or an overriding duty to the court and justice system for such disclosure is recognized.

* * * * * * * * * * * * * * * * * * * * * * * * *

PART II - EDUCATION AND TRAINING

SECTION 1: INTRODUCTION

Part II recommends minimum education, training and experience for analysts practicing in laboratories that conduct seized drug analyses. It describes the types of activities necessary to continue professional development and reference literature required in laboratories where they practice.

1.1 Recommendations listed in Part II are intended to apply to any analyst who

Independently has access to unsealed evidential material in order to remove samples for examination;
Examines and analyzes seized drugs or related materials, or directs such examinations to be done; and
As a consequence of such examinations, signs reports for court or investigative purposes.

SECTION 2: EDUCATION AND EXPERIENCE FOR ANALYSTS

2.1 The aim of this recommendation is that all analysts recruited in the future should have at least a bachelor’s degree, while allowing existing analysts without degrees to be retained as analysts. The minimum educational requirements for analysts are either:

2.1.1 A bachelor’s degree (or equivalent, generally a three to four year post-secondary or tertiary degree) in a natural science or in other sciences relevant to the analysis of seized drugs. The degree program shall include lecture and associated laboratory classes in general, organic and analytical chemistry

or

2.1.2 By January 1, 2005, a minimum of five (5) years practical experience in the area of seized drug analysis, and demonstrated competency following the completion of a formal, documented training program and post training competency assessment.

SECTION 3: CONTINUING PROFESSIONAL DEVELOPMENT

3.1 All forensic scientists have an ongoing responsibility to remain current in their field. In addition, laboratories should provide support and opportunities for continuing professional development. Minimum continuing professional development requirements for a laboratory analyst are:

3.1.1 Twenty contact hours of training every year. Contact is defined as face-to-face interaction with an instructor or trainer in a classroom or laboratory setting. It does not include self-paced learning or distance education where the instructor has no active interaction with the student.

3.1.1.1 Training must be relevant to the laboratory's mission. This statement is purposely broad to embrace the laboratory's broader needs such as ancillary duty assignments and supervision/management.

3.1.1.2 Training completed must be documented.

3.1.1.3 Training can be provided from a variety of sources, including, but not limited to the following:

3.1.1.3.1 Chemistry or instrumental courses taught at the post-secondary educational level

3.1.1.3.2 Instrument operation or maintenance courses taught by vendors

3.1.1.3.3 In-service classes conducted by the employer

3.1.1.3.4 In-service training taught by external providers

3.1.1.3.5 Participation in relevant scientific meetings or conferences (e.g., presenting a paper, attending a workshop, providing reports on conferences).

SECTION 4: INITIAL TRAINING REQUIREMENTS

4.1 These minimum requirements allow individual laboratories to structure their training program to meet their needs as it relates to type of casework encountered, analytical techniques, available instrumentation and level of preparedness of trainees.

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:

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 per topic area)

4.2.2 A training syllabus providing 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

4.2.3 A period of supervised casework representative of the type the analyst will be required to perform

4.2.4 A verification document demonstrating that the analyst has achieved the required competence

4.3 Topic areas in the training program will include, as a minimum, the following:

4.3.1 Relevant background information on drugs of abuse (e.g., status of control and chemical and physical characteristics)

4.3.2 Techniques, methodologies and instrumentation utilized in the examination of seized drug samples and related materials

4.3.3 Quality assurance

4.3.4 Expert/Court testimony and legal requirements

4.3.5 Laboratory policy and procedures (such as sampling, evidence handling, safety and security) as they relate to the examination of seized drug samples and related materials.

4.4 An individual qualified to provide instruction must have demonstrated competence in the subject area and in the delivery of training.

SECTION 5: REFERENCES AND DOCUMENTS

5.1 The following references and documents must be available and accessible to analysts:

5.1.1 College/university level textbooks for reference to theory and practice in key subject areas, e.g., general chemistry, organic chemistry and analytical chemistry

5.1.2 Reference literature containing physical, chemical and analytical data. Such references include the Merck Index, Clarke’s Analysis of Drugs and Poisons, laboratory manuals of the United Nations Drug Control Program, in-house produced spectra and published standard spectra, (e.g., Mills And Roberson’s Instrumental Data For Drug Analysis, or compendiums from Pfleger or Wiley)

5.1.3 Operation and maintenance manuals for each analytical instrument

5.1.4 Relevant periodicals (e.g., Journal of Forensic Sciences, Forensic Science International, Microgram, Journal of Canadian Society of Forensic Science, Journal of Japanese Association of Science and Technology of Identification and Analytical Chemistry)

5.1.5 Laboratory quality manual, standard operating procedures, and method validation and verification documents

5.1.6 Relevant jurisdictional legislation (e.g., statutes and case law relating to controlled substances, and health and safety legislation).

* * * * * * * * * * * * * * * * * * * * * * * * *

PART III B - METHODS OF ANALYSIS/DRUG IDENTIFICATION

SECTION 1: INTRODUCTION

The purpose of PART III B is to recommend minimum standards for the forensic identification of commonly seized drugs. It is recognized that the correct identification of a drug or chemical depends on the use of an analytical scheme based on validated methods and the competence of the analyst. SWGDRUG requires the use of multiple uncorrelated techniques. It does not discourage the use of any particular method within an analytical scheme and it is accepted that unique requirements in different jurisdictions may dictate the actual practices followed by a particular laboratory.

SECTION 2: CATEGORIZING ANALYTICAL TECHNIQUES

2.1 Techniques for the analysis of drug samples may be classified into three categories based on their discriminating power. Table 1 provides examples of these techniques listed in order of decreasing discriminating power from A to C.

Table 1: Categories of Analytical Techniques

Category A	Category B	Category C
Infrared Spectroscopy	Capillary Electrophoresis	Color Tests
Mass Spectroscopy	Gas Chromatography	Fluorescence Spectroscopy
Nuclear Magnetic Resonance Spectroscopy	Ion Mobility Spectrometry	Immunoassay
Raman Spectroscopy	Liquid Chromatography	Melting Point
	Microcrystalline Tests	Ultraviolet Spectroscopy
	Pharmaceutical Identifiers
	Thin Layer Chromatography

	Cannabis Only:
	Macroscopic Examination
	Microscopic Examination

SECTION 3: IDENTIFICATION CRITERIA

SWGDRUG recommends that laboratories adhere to the following minimum standards:

3.1 When a validated Category A technique is incorporated into an analytical scheme, then at least one other technique (from either Category A, B or C) must be used.

3.1.1 This combination must identify the specific drug present and must preclude a false positive identification.

3.1.2 When sample size allows, the second technique should be applied on a separate sampling for quality assurance reasons. When sample size is limited, additional measures should be taken to assure that the results correspond to the correct sample.

3.1.3 All Category A techniques must have data that are reviewable.

3.2 When a Category A technique is not used, then at least three different validated methods must be employed.

3.2.1 These in combination must demonstrate the identity of the specific drug present and must preclude a false positive identification.

3.2.2 Two of the three methods must be based on uncorrelated techniques from Category B.

3.2.3 A minimum of two separate samplings should be used in these three tests. When sample size is limited, additional measures should be taken to assure that the results correspond to the correct sample.

3.3.4 All Category B techniques must have reviewable data.

3.3 For the use of any method to be considered of value, test results must be considered “positive.” While “negative” test results provide useful information for ruling out the presence of a particular drug or drug class, these results have no value toward establishing the forensic identification of a drug.

3.4 In cases where hyphenated techniques are used (e.g., gas chromatography-mass spectrometry, liquid chromatography-diode array ultraviolet spectroscopy), they will be considered as separate techniques provided that the results from each are used.

3.5 Cannabis exhibits tend to have characteristics that are visually recognizable. Macroscopic and microscopic examinations of cannabis will be considered, exceptionally, as uncorrelated techniques from Category B when observations include documented details of botanical features. Additional testing must follow the scheme outlined in sections 3.1 or 3.2.

3.5.1 For exhibits of cannabis that lack sufficient observable macroscopic and microscopic botanical detail (e.g., extracts or residues), ?9-tetrahydrocannabinol (THC) or other cannabinoids must be identified utilizing the principles set forth in sections 3.1 and 3.2.

3.6 Examples of reviewable data are:

3.6.1 Printed spectra, chromatograms and photographs or photocopies of TLC plates

3.6.2 Contemporaneous documented peer review for microcrystalline tests

3.6.3 Recording of detailed descriptions of morphological characteristics for cannabis (only)

3.6.4 Reference to published data for pharmaceutical identifiers.

SECTION 4: COMMENT

These recommendations are minimum standards for the forensic identification of commonly seized drugs. However, it should be recognized that they may not be sufficient for the identification of all drugs in all circumstances. Within these recommendations, it is up to the individual laboratory’s management to determine which combination of analytical techniques best satisfies the requirements of its jurisdiction.

PART IV A - QUALITY ASSURANCE/GENERAL PRACTICES

[Note: The Recommendations in this Part Are Currently Being Re-Evaluated and Updated]

SECTION 1: INTRODUCTION

Recommendations IN PART IV 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 laboratory's drug analysis program to provide the customers of the laboratory's services access to quality drug analysis. It is the goal of these guidelines PART IV to provide a quality framework for managing the processing of drug casework, including handling of evidentiary material, management practices, analysis and reporting. These are minimum recommendations for practice. The term “evidence” has many meanings throughout the international community. In this document it is used to describe drug exhibits which enter a laboratory system.

1.1 QUALITY MANAGEMENT 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.

1.1.1 The quality management system must cover all procedures and reports associated with drug analysis.

SECTION 2: PERSONNEL

2.1 JOB DESCRIPTION

The job descriptions for all personnel should include responsibilities, duties and required skills.

2.2 DESIGNATED PERSONNEL AND RESPONSIBILITIES An individual (however titled) may be responsible for one or more of the following duties:

2.2.1 Quality Assurance Manager: 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 & Safety Manager: 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: Individuals who perform basic laboratory duties, but do not analyze evidence.

2.2.4 Technician/Assistant Analyst: A person who analyzes evidence, but does not issue reports for court purposes.

2.2.5 Analyst: A designated person who

2.2.5.1 Examines and analyzes seized drugs or related materials, or directs such examinations to be done

2.2.5.2 Independently has access to unsealed evidence in order to remove samples from the evidentiary material for examination AND

2.2.5.3 As a consequence of such examinations, signs reports for court or other purposes.

2.2.6 Supervisor: 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/EDUCATION

2.3.1 Technical Support Personnel will

2.3.1.1 Have education, skills and abilities commensurate with their responsibilities AND

2.3.1.2 Have on-the-job training specific to their position.

2.3.2 Technicians/Assistant Analysts will

2.3.2.1 Have education, skills and abilities commensurate with their responsibilities AND

2.3.2.2 Have on-the-job training specific to their position.

2.3.3 Analysts will have

2.3.3.1 A bachelor’s degree (or equivalent, generally a three to four year post-secondary or tertiary degree) in a natural science or in other sciences relevant to the analysis of seized drugs. The degree program shall include lecture and associated laboratory classes in general, organic and analytical chemistry or

2.3.3.2 By January 1, 2005, a minimum of five (5) years practical experience in the area of seized drug analysis, and have demonstrated competency following the completion of a formal, documented training program and post training competency assessment.

2.3.4 Supervisors will

2.3.4.1 Meet all the requirements of an analyst (2.3.3),

2.3.4.2 Have a minimum of two (2) years of experience as an analyst in the forensic analysis of drugs and

2.3.4.3 Demonstrate 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 as it relates 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, which 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 per topic area)

2.4.2.2 A training syllabus providing 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 A period of supervised casework representative of the type the analyst will be required to perform

2.4.2.4 A verification document demonstrating that the analyst has achieved the required competence.

2.5 MAINTAINING COMPETENCE

2.5.1 Minimum annual training required for continuing professional development of analysts is twenty (20) contact hours.

2.5.1.1 Training must be relevant to the laboratory's mission. 2.5.1.2 Training completed must be documented.

SECTION 3: PHYSICAL PLANT

3.1 PHYSICAL PLANT REQUIREMENTS

3.1.1 Laboratories shall provide a healthy, safe and secure environment for its personnel and operations.

3.1.2 Laboratories must contain adequate space to perform required analytical functions and prevent contamination.

3.1.3 Chemical fume hoods must be provided. They must be properly maintained and monitored according to an established schedule.

3.1.4 A laboratory cleaning schedule must be established and implemented.

3.1.5 Adequate facilities must be provided to ensure the proper safekeeping of evidence, standards and records.

3.1.6 Appropriately secured storage must be provided to prevent contamination of chemicals and reagents.

SECTION 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 least, the following:

4.1.1 Submission documents or copies

4.1.2 Identity of party requesting analysis and the date of request

4.1.3 Description of items of evidence submitted for analysis

4.1.4 Identity of the person who delivers the evidence, along with date of submission

4.1.4.1 For evidence not delivered in person, descriptive information regarding mode of delivery and tracking information

4.1.5 Chain of custody record

4.1.6 Unique case identifier

4.2 INTEGRITY OF EVIDENCE

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 assure that samples are AND REMAIN properly labeled throughout the analytical process.

4.3 STORAGE OF EVIDENCE

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 DISPOSITION OF EVIDENCE

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.

SECTION 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 in place protocols 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 the acceptance and interpretation of 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 assured that the result relates to the right submission. This is best established by the use of 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 The identity of certified reference materials should be verified prior to their first use.

5.2.2 The 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 individual who performed the identification, date of verification, verification test data, and reference identification.

SECTION 6: INSTRUMENT/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, blanks, etc.

6.1.2 Instrumentation performance monitoring must be documented.

6.2 EQUIPMENT

Only suitable and properly operating equipment shall be employed. Monitoring of equipment parameters shall be conducted and documented.

6.2.1 The manufacturer's operation manual and other relevant documentation for each piece of equipment should be readily available.

SECTION 7: CHEMICALS AND REAGENTS

7.1 CHEMICALS AND REAGENTS

7.1.1 Chemicals and reagents used in drug testing must be of the appropriate grade for the tests performed.

7.1.2 There must be written formulations for all chemical reagents produced within the laboratory.

7.1.3 Documentation for reagents prepared within the laboratory must include identity, concentration (when appropriate), date of preparation, identity of the individual preparing the reagents and the expiration date (if appropriate).

7.1.4 The efficacy of all test reagents must be checked prior to their use in casework. The results of these tests should be documented.

7.1.5 Chemical and reagent containers should be dated and initialed when received and also when first opened.

SECTION 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/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

8.2.1 Reports issued by the laboratory must meet the requirements of the jurisdiction served. These may include:

8.2.1.1 Identity of the examining laboratory

8.2.1.2 Case identifier

8.2.1.3 Identity of the contributor

8.2.1.4 Date of receipt

8.2.1.5 Date of report

8.2.1.6 Descriptive list of submitted evidence

8.2.1.7 Identity of analyst

8.2.1.8 Results/Conclusions

8.2.1.9 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 should an analyst and reviewer fail to agree.

SECTION 9: PROFICIENCY AND COMPETENCY TESTING

Each laboratory should participate in at least an annual inter-laboratory 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 the competency of their analysts. They should do so at least once a year. One of the ways of doing this is by participating in 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.

SECTION 10: VALIDATION AND VERIFICATION

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

10.1.1 For qualitative analysis the parameters that need to be checked are specificity, limit of detection, and reproducibility.

10.1.2 Minimum acceptability criteria should be described along with means for demonstrating compliance.

10.1.3 Validation documentation is required.

10.2 Laboratories adopting methods validated elsewhere should determine their own limit of detection and reproducibility.

SECTION 11: LABORATORY AUDITS

11.1 Audits of laboratory operations should be conducted at least once a year.

11.2 Records of each audit must be maintained and should include the scope, date of the audit, name of the person conducting the audit, findings, and corrective actions taken, if necessary.

SECTION 12: DEFICIENCY OF ANALYSIS

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

12.1 This policy must include the following:

12.1.1 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.

12.1.2 A requirement for immediate cessation of the activity or work of the individual involved, if warranted by the seriousness of the deficiency, as defined in the written policy.

12.1.3 A requirement for administrative review of the activity or work of the individual involved.

12.1.4 A requirement for evaluation of the impact this THAT deficiency may have had on other activities of the individual(S) or other analysts.

12.1.5 A requirement for documentation of the follow-up action taken as a result of the review.

12.1.6 A requirement for communication to appropriate employees of any confirmed deficiency which may have implications for their work.

Comment: 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.

SECTION 13: HEALTH AND SAFETY

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

13.1 HEALTH AND SAFETY REQUIREMENTS

13.1.1 All personnel should receive appropriate health and safety training.

13.1.2 The drug analysis laboratory shall operate in accordance with laboratory policy and comply with any relevant statutory regulations.

13.1.3 Laboratory health, and safety manual(s) shall be readily available to all laboratory personnel.

13.1.4 Material Safety Data Sheets (MSDS) shall be readily available to all laboratory personnel.

13.1.5 All chemicals, biohazards and supplies must be stored and disposed of according to applicable government regulations and laboratory policy.

13.1.6 Safety hazards such as syringes, items with sharp edges or noxious substances should be so labeled.

SECTION 14: DOCUMENTATION

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

14.1 Test methods/procedures for drug analysis.

14.2 Reference standards (including source and verification).

14.3 Preparation and testing of reagents.

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.

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PART IV B - QUALITY ASSURANCE/VALIDATION OF ANALYTICAL METHODS

SECTION 1. INTRODUCTION

1.1 Definition and purpose of Validation

Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. There are numerous documents that address the topic of validation but there are few validation protocols for methods specific to seized drug analysis.

1.2 Analytical scheme

An analytical scheme must be comprised of validated methods that are appropriate for the analyte.

A) The combinations of methods chosen for a particular analytical scheme must identify the specific drug of interest, preclude a false positive and minimize false negatives.

B) For quantification the method should reliably determine the amount of analyte present.

C) If validated methods are used from published literature or another laboratory’s protocols, then the methods must be verified within each laboratory.

D) Verification should, at a minimum, demonstrate that a representative set of reference materials has been carried through the process and yielded the expected results.

1.3 Individual laboratory responsibility

Each laboratory should determine whether their current standard operating procedures have been validated, verified or require further validation/verification.

1.4 Operational environment

All methods must be validated or verified to demonstrate that they will perform in the normal operational environment when used by individuals expected to utilize the methods on casework.

1.5 Documentation

The entire validation/verification process must be documented and the documentation must be retained. Documentation must include, but is not limited to the following:

Personnel involved
Dates
Observations from the process
A statement of conclusions and/or recommendations
Authorization approval signature

1.6 Recommendation

To meet the above requirements, SWGDRUG recommends that laboratories follow the applicable provisions of Section 2 [General Validation Plan] when validating seized drug analytical methods.

SECTION 2. GENERAL VALIDATION PLAN

2.1 Purpose/Scope

This is an introductory statement that will specify what is being tested, the purpose of the testing and the result(s) required for acceptance.

2.1.1 Performance Specification

A list of specific objectives (e.g., trueness and precision) should be determined prior to the validation process.

2.1.2 Process Review

After completion of the validation process the objectives should be revisited to ensure that they have been satisfactorily met.

2.2 Analytical Method

State exactly the method to be validated. It is essential that each step in the method is demonstrated to perform satisfactorily. Steps that constitute a method for the identification and/or quantification of seized drugs may include:

Visual characterization (e.g., macroscopic examination)
Determination of quantity of sample, which may include:

Weight
Volume
Item count

Sampling (representative or random, dry, homogenized, etc.)
Sample preparation

Extraction method
Dissolution
Derivatization
Crystallization
Techniques for introducing the sample into the instrumentation

Instrumental parameters and specifications

A list of the instruments and equipment (e.g., balance and glassware) utilized
Instrument conditions

Software applications
Calculations

Equation(s) to be used
Unit specification
Number of measurements required
Reference values
Significant figure conventions
Conditions for data rejection
Uncertainty determination

2.3 Reference materials in validation

Appropriate reference material(s) must be used for qualitative and quantitative procedures.

2.4 Performance Characteristics

2.4.1 Selectivity

Assess the capability of the method to identify/quantify the analyte(s) of interest, whether pure or in a mixture.

2.4.2 Matrix effects

Assess the impact of any interfering components and demonstrate that the method works in the presence of substances that are commonly encountered in seized drug samples (e.g., cutting agents, impurities, by-products and precursors).

2.4.3 Recovery

May be determined for quantitative analysis.

2.4.4 Accuracy

2.4.4.1 Precision (repeatability/reproducibility)

Determine the repeatability and reproducibility of all routine methods. Conditions under which these determinations are made must be specified. [Note: Reproducibility determination may be limited to studies within the same laboratory.]

A) Within the scope of the validation, determine the acceptable limits for repeatability and reproducibility.
B) For qualitative analysis, run the qualitative method a minimum of ten times.
C) For quantitative analysis, run the quantitative method a minimum of ten times.
D) Validation criteria for non-routine methods may differ from those stated above.

2.4.4.2 Trueness

Trueness must be determined for quantitative methods to assess systematic error. Trueness can be assessed through various methods such as:

A) Comparison of a method-generated value for the reference material with its known value using replicate measurements at different concentrations.
B) Performance of a standard addition method.
C) Comparison to proficiency test results.
D) Comparison with a different validated analytical method.

2.4.5 Range

Determine the concentration or sample amount limits for which the method is applicable.

2.4.5.1 Limit of detection (LOD)

Limit of Detection (LOD) must be determined for all qualitative methods.

A) Determine the lowest amount of analyte that will be detected and can be identified.
B) The results obtained at the LOD are not necessarily quantitatively accurate.

2.4.5.2 Limit of quantitation (LOQ)

Limit of Quantitation (LOQ) must be determined for all quantitative methods. Determine the lowest concentration that has an acceptable level of uncertainty.

2.4.5.3 Linearity

Linearity must be determined for all quantitative methods.

A) Determine the mathematical relationship (calibration curve) that exists between concentration and response over a selected range of concentrations.
B) The LOQ effectively forms the lower end of the working range.
C) Determine the level of acceptable variation from the calibration curve at various concentrations.
D) Determine the upper limits of the working range.

2.4.6 Robustness

Robustness must be determined for both qualitative and quantitative methods. Alter method parameters individually and determine any changes to accuracy.

2.4.7 Ruggedness

Ruggedness may be determined for qualitative or quantitative methods.

Alter the analysts, instrumentation and environment and assess the changes in accuracy.

2.5 Uncertainty

The contribution of random and systematic errors to method result uncertainty must be assessed and the expanded uncertainty derived for quantitative methods.

3. Quality Control

Acceptance criteria for quality control parameters should be adopted prior to implementation of the method.

4. References

A) The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics, EURACHEM Guide, 1998.

B) Federal Register, Part VIII, Department of Health and Human Services, March 1995, pp 11259-62.

C) “Validating Analytical Chemistry Methods”, Enigma Analytical Training Course (Version 2000-1), Breckenridge, CO, 2000, pp 8-4, 8-5.

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SWGDRUG GLOSSARY

These definitions were developed and adopted by the SWGDRUG Core Committee from a variety of sources including The United Nations Glossary of Terms for Quality Assurance and Good Laboratory Practices.

Accreditation Procedure by which an accreditation body formally recognizes that a laboratory or person is competent to carry out specific tasks.

Accreditation Body Independent science-based organization that has the authority to grant accreditation.

Accuracy Trueness and precision compose accuracy.

Analysis Technical operation to determine one or more characteristics of, or to evaluate the performance of, a given product, material, equipment, physical phenomenon, process, or service according to a specified procedure.

Analyst A designated person who:

Examines and analyzes seized drugs or related materials, or directs such examinations to be done. Independently has access to "open" (unsealed) evidence in order to remove samples from the evidence for examination. As a consequence of such examinations, signs reports for court or other purposes.

Audit A review conducted to compare the various aspects of the laboratory’s performance with a standard for that performance.

Blank Specimen or sample not containing the analyte.

Calibration Set of operations that establishes, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a measurand.

Certified Reference Material (CRM) A reference material, one or more of whose property values have been certified by a technical procedure, accompanied by or traceable to a certificate or other documentation that has been issued by a certifying body.

Certifying Body Independent science-based organization that has the competence to grant certification.

Chain of Custody Procedures and documents that account for the integrity of a sample by tracking its handling and storage from its point of collection to its final disposition.

Controls Samples used to determine the validity of the calibration, that is, the linearity and stability of a quantitative test or determination over time. Controls are either prepared from the reference material (separately from the calibrators, that is, weighed or measured separately), purchased, or obtained from a pool of previously analyzed samples. Where possible, controls should be matrix-matched to samples and calibrators.

Control Sample A standard of comparison for verifying or checking the finding of an experiment.

Correlated Techniques Correlated techniques are those that have the same fundamental mechanism of characterization. For example, this would prevent the choice of two gas chromatographic tests both based on a partition mechanism (e.g., methylsiloxane and phenylmethylsiloxane) or two thin layer chromatographic systems both based on an adsorption mechanism.

Deficiency of Analysis Any erroneous analytical result or interpretation, or any unapproved deviation from an established policy or procedure in an analysis.

False Positive Test result that states that a drug is present when, in fact, such a drug is not present in an amount less than a threshold or designated cut-off concentration.

Health & Safety Manager 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.

Independent Test Result Result obtained in a manner not influenced by any previous results on the same or similar material.

Laboratory Facilities where analyses are performed by qualified personnel using adequate equipment.

Limit of Detection: Limit of detection (LOD) is the smallest measured content from which it is possible to deduce the presence of the analyte with reasonable statistical certainty.

Limit of Quantitation: The limit of quantitation (LoQ) is the lowest concentration of analyte that can be determined with an acceptable level of precision and trueness.

Linearity: Defines the ability of the method to obtain test results proportional to the concentration of analyte.

Method Detailed, defined procedure for performing an analysis. See Procedure.

Procedure Specified, documented way to perform an activity.

Proficiency Testing Ongoing process in which a series of proficiency samples, the characteristics of which are not known to the participants, are sent to laboratories on a regular basis. Each laboratory is tested for its accuracy in identifying the presence (or concentration) of the drug using its usual procedures.

Qualitative Analysis Test that determines the presence or absence of specific drugs in the sample.

Qualitative Test See Qualitative Analysis

Quality Assurance (QA) System of activities whose purpose is to provide, to the producer or user of a product or a service, the assurance that it meets defined standards of quality with a stated level of confidence.

Quality Assurance Manager A designated person who is responsible for maintaining the quality management system and who monitors compliance with the program.

Quality Management That aspect of the overall management function that determines and implements the quality policy.

Quality Manual Document stating the general quality policies, procedures and practices of an organization.

Quantitative Analysis Procedure to determine the quantity of drug present in a sample.

Quantitative Test See Quantitive Analysis

Range Set of concentrations of analyte in which the error of a method is intended to lie within specified limits.

Reference Material Material or substance one or more properties of which are sufficiently well established to be used for calibrating an apparatus, assessing a measurement method, or assigning values to materials.

Repeatability Closeness of the agreement between the results of successive measurements of the same measurand carried out under the same conditions of measurement.

Report Document containing a formal statement of results of tests carried out by a laboratory.

Representative Sample Statistically, a sample that is similar to the population from which it was drawn. When a sample is representative, it can be used to make inferences about the population. The most effective way to get a representative sample is to use random methods to draw it. Analytically, it is a sample that is a portion of the original material selected in such a way that is possible to relate the analytical results obtained from it to the properties of the original material.

Reproducibility Closeness of agreement between the results of successive measurements of the same analyte in identical material made by the same method under different conditions, e.g., different operators and different laboratories and considerably separated in time.

Robustness The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

Sample A portion of the whole material to be tested. Statistically, it is a set of data obtained from a population.

Sampling Analytically, the whole set of operations needed to obtain a sample, including planning, collecting, recording, labeling, sealing, shipping, etc. Statistically, it is the process of determining properties of the whole population by collecting and analyzing data from a representative segment of it.

Selectivity Extent to which a method can determine particular analyte(s) in a mixture without interference from the other components in the mixture. A method that is perfectly selective for an analyte or group of analytes is said to be specific.

Specificity See Selectivity.

Standard Operating Procedures (SOPs) A written document which details the method of an operation, analysis, or action whose techniques and procedures are thoroughly prescribed and which is accepted as the method for performing certain routine or repetitive tasks.

Supervisory Chemist A designated person who has the overall responsibility and authority for the technical operations of the drug analysis section.

Technical/Assistant Analyst A person who analyses evidence, but does not issue reports for court purposes.

Technical Support Personnel A person who performs basic laboratory duties, but does not analyze evidence.

Test See Analysis

Traceable Ability to trace the history, application, or location of an entity by means of recorded identification. See also Chain of Custody.

Traceability The property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons.

Trueness: The closeness of agreement between the average value obtained from a large set of test results and an accepted reference value.

Uncertainty: Parameter associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand.

Validation Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled.

Verification Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. (Method works in your lab as well as where it was validated.)

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