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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