SECTION 3:
PHYSICAL PLANT
3.1 Physical Plant Requirements
SECTION 4:
EVIDENCE CONTROL
4.1 Receiving and Identifying Evidence
4.2 Integrity of Evidence
4.3 Storage of Evidence
4.4 Disposition of Evidence
4.5 Documentation Procedures
SECTION 5:
ANALYTICAL PROCEDURES
5.1 Analytical Procedures for Drug Analysis
5.2 Minimum Requirements for the Verification of Drug
Reference Materials
SECTION 6:
INSTRUMENT/EQUIPMENT PERFORMANCE
6.1 Instrument Performance
6.2 Equipment
SECTION 7:
CHEMICALS AND REAGENTS
7.1 Chemicals and Reagents
SECTION 8:
CASEWORK DOCUMENTATION, REPORT WRITING AND REVIEW
8.1 Casework Documentation
8.2 Report Writing
8.3 Case Review
SECTION 9:
PROFICIENCY AND COMPETENCY TESTING
9.1 Proficiency Testing
9.2 Competency Testing
SECTION 10:
VALIDATION AND VERIFICATION
10.1 Method Validation
10.2 Methods Validated Elsewhere
SECTION 11:
LABORATORY AUDITS
11.1 Laboratory Audits
SECTION 12: DEFICIENCY OF ANALYSIS
SECTION 13:
HEALTH AND SAFETY
13.1 Health and Safety Requirements
SECTION 14: DOCUMENTATION
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 to provide a framework of quality management in the processing of drug evidence, including evidence handling, management practices, qualitative analysis and reporting.
1.1 QUALITY MANAGEMENT SYSTEM
A documented quality management system
must be established and maintained. The personnel responsible for this
must be clearly designated and shall have direct access to the highest
level of management concerning laboratory policy.
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 more than one of the following duties:
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: A person who performs basic laboratory duties, but does not analyze evidence.
2.2.4 Technician/Assistant analyst: A person who analyses evidence, but does not issue reports for court purposes.
2.2.5 Analyst: A designated
person who:
2.2.5.2 Independently has access to “open” (unsealed) evidence in order to remove samples from the evidence for examination.
2.2.5.3 As a consequence of such examinations, signs reports for court or other purposes.
2.2.6 Supervisory
Chemist: 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.
2.3.1.2 Have on the
job training specific to their position.
2.3.2.2 Have on the
job training specific to their position.
OR
2.3.3.2 By January 1, 2005, a minimum of five (5) years practical experience in the area of seized drug examination, and have demonstrated competency following the completion of a formal, documented training program and post training competency assessment.
2.3.4.2 Have a minimum of two (2) years of experience as an analyst in the forensic analysis of drug evidence.
2.3.4.3 Exhibit knowledge necessary to evaluate results and conclusions.
The laboratory must establish and document
a training program and qualifying procedure for all new technical personnel.
A written training program, approved by laboratory management, focusing
on the development of the theoretical and practical knowledge, skills and
abilities necessary to examine seized drug samples and related materials,
will include:
2.4.2 Documented standards of performance and a plan for assessing theoretical and practical competency against these standards, (i.e. written and oral examinations, critical reviews, analysis of unknown samples, mock casework etc.) per topic area.
2.4.3 A period of supervised casework representative of the type he/she will be required to perform.
2.4.4 Verification
document demonstrating that the trainee has achieved the desired competence
per specific topic area.
The minimum continuing professional
development requirements for a laboratory analyst are:
2.5.2 Training must be relevant to the laboratory's mission.
2.5.3 Training completed
must be documented in writing.
Section 3:
PHYSICAL PLANT
3.1 PHYSICAL PLANT
REQUIREMENTS
3.1.2 The laboratory must meet required health and safety standards.
3.1.3 The laboratory must contain adequate space to perform required analytical functions and prevent contamination.
3.1.4 Chemical fume hoods must be provided. They must be properly maintained and monitored according to an established schedule.
3.1.5 A laboratory cleaning schedule must be established.
3.1.6 Adequate facilities must be provided to ensure the proper safe-keeping of physical evidence, standards and records.
3.1.7 Appropriately secured storage must be provided to prevent contamination of chemicals and reagents.
The laboratory shall have and follow a documented evidence control system to ensure the integrity of physical evidence.
The laboratory 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. This
file or record must include at least the following:
4.1.2 The identity of the party requesting the analysis and the date of the request.
4.1.3 A description of items of evidence submitted for analysis.
4.1.4 The identity of the person who hands over the evidence, along with the date of submission. For evidence not delivered in person, descriptive information regarding the mode of delivery and tracking information.
4.1.5 Chain of custody record.
4.1.6 Unique case identifier.
4.1.7 A description
of the evidence shall be compared to documentation prior to analysis.
Should significant irregularities be identified at this time, these must
be documented in the case file and the submitter informed promptly.
Evidence must be properly secured (e.g. sealed). 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 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.
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.
5.1 ANALYTICAL PROCEDURES
FOR DRUG ANALYSIS:
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.
5.2.2 The identity of uncertified reference materials must be authenticated prior to use by methods such as mixed melting point determination, Mass Spectrometry, Infrared Spectrophotometry, 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.
6.1 INSTRUMENT PERFORMANCE
Instruments must be routinely monitored
to ensure that proper performance is maintained.
6.1.2 Instrumentation
performance monitoring must be documented.
Only suitable and properly operating
equipment shall be employed. Monitoring of equipment parameters shall
be conducted and documented.
7.1 CHEMICALS AND
REAGENTS
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.
8.1 CASE WORK DOCUMENTATION
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.
b. Case identifier
c. Identity of the contributor
d. Date of receipt
e. Date of report
f. Descriptive list of submitted evidence
g. Identity of analyst
h. Results/Conclusions
i. Analytical
techniques employed
8.3.2 The laboratory must have a written policy to determine the course of action should an analyst and reviewer fail to agree.
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
9.1.2 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.
9.2.2 Competency testing samples should be representative of the laboratory's normal casework.
9.2.3 The analytical scheme should be in concert with the normal laboratory analysis procedures.
10.1 Method validation
is required to demonstrate that the method is suitable for its intended
purpose.
10.1.2 Minimum acceptability criteria should be described along with means for demonstrating compliance.
10.1.3 Validation
documentation is required.
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. This policy
must include the following:
b. 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.
c. A requirement for administrative review of the activity or work of the individual involved.
d. A requirement for evaluation of the impact this deficiency may have had on other activities of the individual or other analysts.
e. A requirement for documentation of the follow-up action taken as a result of the review.
f. 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
13.1.2 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:
b. Reference standards (including source and verification).
c. Preparation and testing of reagents.
d. Evidence handling protocols.
e. Equipment calibration and maintenance.
f. Equipment inventory; (e.g. manufacturer, model, serial number, acquisition date).
g. Proficiency testing.
h. Personnel training and qualification.
i. Quality assurance protocols and audits.
j. Health, safety and security protocols.
k. Validation data and results.