ASCLD/LAB-International Program Applications, Guidance & Board Interpretations – Forensic Science Testing Laboratories

Applies to ISO/IEC 17025 and the ASCLD/LAB-International Supplemental Requirements for Forensic Science Testing Laboratories.

IMPORTANT NOTE:

On May 1, 2013 ASCLD/LAB released new versions of traceability and uncertainty policies. The policies were effective May 1, 2013 with a ‘deadline for implementation date of December 31, 2013.’

ASCLD/LAB Policy on Measurement Traceability (Updated July 24, 2014)

ASCLD/LAB Policy on Measurement Uncertainty

 

CURRENT MEASUREMENT TRACEABILITY and MEASUREMENT UNCERTAINTY GUIDANCE DOCUMENTS ARE AVAILABLE HERE:

The following special group of guidance documents are provided to assist ASCLD/LAB customers in better understanding and applying measurement traceability and measurement uncertainty concepts. These companion guidance documents do not create any new accreditation requirements.

ASCLD/LAB Guidance on Measurement Traceability

ASCLD/LAB Guidance on Measurement Traceability – Measurement Assurance

ASCLD/LAB Guidance on the Estimation of Measurement Uncertainty – Overview

ASCLD/LAB Guidance on the Estimation of Measurement Uncertainty – ANNEX A / Details on the NIST 8-Step Process

ASCLD/LAB Guidance on the Estimation of Measurement Uncertainty – ANNEX B / Drug Chemistry

ASCLD/LAB Guidance on the Estimation of Measurement Uncertainty – ANNEX C / Firearms & Toolmarks

ASCLD/LAB Guidance on the Estimation of Measurement Uncertainty – ANNEX D Toxicology Testing

Blank Measurement Uncertainty Estimation Template

Program applications and guidance entries are applicable on the date of posting unless otherwise indicated.

Applicant and accredited laboratories are expected to be in conformance with ASCLD/LAB Board of Directors Interpretations within one hundred twenty (120) calendar days of the date of posting, unless otherwise indicated.

If a requirement number does not appear on this page that means no current application, guidance or Board interpretation is available. Program Applications, Guidance & Interpretation by Requirement Number – Testing Laboratories

Requirement Source Application, Guidance or Interpretation Date Posted
Section 4

ISO/IEC 17025:2005 and 2011 Supplemental Testing Requirement

ASCLD/LAB Board of Directors Clarification

Recent inquiries to ASCLD/LAB have been made concerning the retention of ‘raw data’ (primarily instrumental data), seeking clarification on what must be retained by a laboratory to meet ASCLD/LAB-International accreditation requirements.

To meet accreditation requirements, sufficient data must be maintained to support conclusions. Records must be sufficient enough that “another competent reviewer,” in the absence of the analyst, can evaluate what was done and interpret the data. Technical records must also be sufficient enough to meet 4.13.2.1 of ISO/IEC 17025:2005. Meeting these accreditation requirements does not necessarily require the retention of all ’raw data’ generated.

However, ASCLD/LAB management does not and will not authorize the destruction of any test data generated by the laboratory. The proper retention period and/or destruction of ‘raw data’ above and beyond that which is needed to meet accreditation requirements is a legal question, not an accreditation question. The top management of each laboratory should consult with appropriate legal counsel to make those decisions.


Posted 5/16/2014: Effective Immediately (because this is a clarification of existing requirements)

4.1.2 ISO/IEC 17025:2005 If a Level 1 Corrective Action Request is issued during an assessment, this requirement will be marked “NO” and it will remain “NO” until corrective action is completed and accepted for all Level 1 Corrective Action Requests. 11/7/2007
4.1.3 ISO/IEC 17025:2005 Accreditation in the Crime Scene discipline remains optional in the ASCLD/LAB-International program. However, opting not to seek accreditation in the Crime Scene discipline does not exempt a laboratory from meeting this requirement. 11/7/2007
4.1.5 b ISO/IEC 17025:2005 “Arrangements” can be any combination of policies, procedures, practices, etc. (this meaning applies throughout the requirements). 11/7/2007
4.1.5 h ISO/IEC 17025:2005 The requirement for “technical management” is applicable to all disciplines. 11/7/2007
4.1.5 i ISO/IEC 17025:2005 “Member of staff” means a position under the control of the laboratory director or laboratory system director. The laboratory director may also serve as the quality manager. 11/7/2007
4.2.1 ISO/IEC 17025:2005 A common nonconformance in first-time applicant laboratories is not implementing one or more documented policies or procedures. 11/7/2007
4.3.1 ISO/IEC 17025:2005

“Management system” documents means any administrative, quality or technical document related to the testing activities of the laboratory.

See the ISO definition for “Management system” provided in Note 1 of 1.4 in ISO/IEC 17025:2005.

11/7/2007
4.3.2.1 ISO/IEC 17025:2005 “Authorized personnel” may be defined by the laboratory as more than the laboratory director. 11/7/2007
4.4.1 ISO/IEC 17025:2005

There are a number of requirements in ISO/IEC 17025:2005 (related to test methods) that call for (or at least discuss in a note) advising the customer of the test method, seeking customer agreement of the test method, etc. See 4.4.1, 4.4.4, 4.5.2, 4.7.1 [note 2], 5.4.1, 5.4.2 [twice], and 5.4.4 (not to mention the language in the 5.10 reporting area).

For all of the clauses above, the current ASCLD/LAB-International application is that the forensic laboratory may either handle these communications and notifications on a case-by-case basis (exactly as indicated in the requirement), or the laboratory may communicate with their customers in a general way (for example, by placing general information about test methods on a web site). A forensic laboratory may inform customers in a general communication that the most appropriate test method will be selected by the laboratory.

If the laboratory chooses the general communication approach, they may construct and provide a general communication to customers that touches on all of the topics covered in the areas cited above.Generally, this application does not apply to private testing laboratories where testing is carried out in accordance with a formal contract and an agreed upon test method(s).

11/7/2007
4.5 ISO/IEC 17025:2005

ASCLD/LAB Board of Directors Interpretation

Transferring a test item(s) to another ASCLD/LAB accredited laboratory in a laboratory system is not considered subcontracting as long as both the sending and receiving laboratory work under the same documented management system.

11/7/2007
4.5 continued ISO/IEC 17025:2005 A subcontractor need not be ISO/IEC 17025:2005 accredited, but the laboratory using the subcontractor must maintain objective evidence of how the subcontractor was determined to be competent to perform the testing in question. 11/7/2007
4.6.2 ISO/IEC 17025:2005 “Standard specifications or requirements” for supplies, reagents and consumable materials may be “defined” in a variety of ways (for example, in the purchasing documents; in the test method; etc.) 11/7/2007
4.6.4 ISO/IEC 17025:2005 Note that 4.6.4 and the requirement to evaluate suppliers only applies to “critical” consumables, supplies and services which affect the quality of testing. This is different than 4.6.2 which applies to any purchased supplies, reagents and consumable materials that affect the quality of tests. 11/7/2007
4.13.2.1 ISO/IEC 17025:2005 An “audit trail” is defined as sufficient records to track a particular case through the laboratory’s management system. 11/7/2007
4.13.2.1 continued ISO/IEC 17025:2005

ASCLD/LAB Board of Directors Interpretation

Audio recordings made at crime scenes, as part of the documentation of observations, must be treated as field notes and be maintained (in addition to transcription) as examination documentation.

11/7/2007
4.13.2.1 continued ISO/IEC 17025:2005

ASCLD/LAB Board of Directors Interpretation

Maintaining Original Examination Records and Tracking Changes in Examination Records

Board Interpretation Concerning Maintaining Original Examination Records and Tracking Changes in Examination Records

This Board interpretation has application to 4.13.2.1, 4.13.2.2 and 4.13.2.3 from ISO/IEC 17025:2005 and 4.13.2.3.1 and 4.13.2.3.2 from the 2011 version of the ASCLD/LAB-International Supplemental Requirements for Testing Laboratories


Announced via email to all customers on 5/10/2012

Effective Immediately

4.13.2.3 ISO/IEC 17025:2005

ASCLD/LAB Board of Directors Interpretation

Laboratories using electronically-recorded examination documentation (technical records) will have a policy declaring when such examination documentation (technical record) is completed. This completion date must be prior to case review. At the time the laboratory considers the examination documentation (technical record) completed, it will be considered as “stored,” and any changes made after that time must be tracked, either electronically or on a hard copy of the examination documentation (technical record).

2/21/2008
4.13.2.6 2011 Supplemental Testing Requirement If electronically recorded examination documentation is printed, the unique identifier for that case must be on each page of the printed documentation; but if the documentation is maintained in electronic form only, the unique identifier must appear visibly on the screen related to the document. 11/7/2007
4.13.2.6 continued 2011 Supplemental Testing Requirement When a CD is used to store examination documentation, the removable media, or its proximal container, which is used to store examination documentation must be marked with a unique identifier. The initials of the preparer(s) of the examination documentation must be recorded on the media or proximal container unless the electronic equivalent is recorded on the media. 11/7/2007
4.13.2.6 continued 2011 Supplemental Testing Requirement When an analyst’s initials have been recorded in a photograph, the analyst is not required to re-initial the photograph that already shows the analyst’s initials. 11/7/2007
4.14.1 ISO/IEC 17025:2005 “Trained and qualified personnel” in this instance means trained and qualified to conduct audits. Objective evidence of audit training and qualification must be maintained by the laboratory. 11/7/2007
4.14.1.2 2011 Supplemental Testing Requirement First-time applicants are not required to have five years of audit records. While first-time applicants need to start maintaining these records, this requirement will be marked “N/A” for the first assessment. For each year of the first cycle of accreditation, this requirement will be marked “Yes” if the laboratory has appropriate records for each year of accreditation. 11/7/2007
4.14.5 2011 Supplemental Testing Requirement Not applicable to first time applicant laboratories in the ASCLD/LAB-International program. 11/7/2007
4.15.1.2 2011 Supplemental Testing Requirement First-time applicants are not required to have five years of management review records. While first-time applicants need to start maintaining these records, this requirement will be marked “N/A” for the first assessment. For each year of the first cycle of accreditation, this requirement will be marked “Yes” if the laboratory has appropriate records for each year of accreditation. 11/7/2007
Section 5 ISO/IEC 17025:2005 and 2011 Supplemental Testing Requirement ASCLD/LAB Board of Directors Interpretation

Hair screening to determine DNA suitability has long been allowed as a “Biology” discipline function – without the need to specify hair screening as a separate category of testing under the Biology discipline. ‘DNA suitability’ generally means to determine the presence or absence of hair root sheath material. As an added clarification, hair ‘screening‘ in the Biology discipline may also include identifying hair as hair, determining human versus non-human and determining somatic origin – and reporting any of those. The Biology training program must include a segment on each hair screening area in which work is being done.


Posted 5/16/2014: Effective Immediately

5.1.3 and 5.1.3.1 2011 Supplemental Testing Requirement

ASCLD/LAB Board of Directors Interpretation

Reagent reliability testing requirements are applicable to serial number restoration reagents.

 


Posted 5/16/2014: Effective 120 days from that date

5.1.3.1 2011 Supplemental Testing Requirement Testing the reliability of a prepared reagent may occur at any time prior to use – not necessarily at the time the reagent is prepared. 11/7/2007
5.2.3 ISO/IEC 17025:2005 A “contract” employee must meet all requirements of regular employees (training, education, qualifications, competency and proficiency testing, and adherence to the laboratory’s management system requirements). 11/7/2007
5.2.6.1.4 2011 Supplemental Testing Requirement

ASCLD/LAB Board of Directors Interpretation

Crime Scene personnel who have been trained and competency tested to perform presumptive screening tests at crime scenes may conduct the same tests in the laboratory as an extension of their crime scene responsibilities without having to meet the educational requirements for the discipline(s) represented by the screening tests which they perform. These individuals may issue reports which are appropriately qualified based upon the limitations of the screening test performed.

As an example, if appropriately trained and competency tested crime scene personnel bring crime scene evidence back to the laboratory and processes the evidence for latent prints due to poor lighting at a crime scene (or for other reasons), the processing of latent prints within the laboratory facility is considered a continuation of crime scene duties. The evidence brought back to the laboratory for processing must be the evidence collected at the crime scene, and it must be processed by the crime scene personnel who collected the item(s) at the scene. The time period between collection at the scene and processing in the laboratory cannot be open-ended.

Crime Scene evidence processed in the laboratory that is not a continuation of the crime scene is considered technical support of the discipline represented. As an example, if crime scene personnel retrieve items of evidence from the property room to process for latent prints in the laboratory, the processing of latent prints is not a continuation of the crime scene and such work is performed as technical support to the latent print discipline. Laboratory personnel functioning as technical support in the laboratory, in any discipline, must meet all applicable accreditation requirements for technical support personnel.

3/17/2009
5.3.6 2011 Supplemental Testing Requirement Any part of the laboratory’s documented health and safety program may be selected by the assessment team for review. 11/7/2007
5.4.1 ISO/IEC 17025:2005 When thin-layer chromatography is used exclusively as a screening test, blanks are not required. However, if the thin-layer testing is used as a part of the confirmation testing, a negative control is necessary. 11/7/2007
5.4.6 ISO/IEC 17025:2005

On May 1, 2013 ASCLD/LAB released a new measurement uncertainty policy. The policy was effective May 1, 2013 with a ‘deadline for implementation date of December 31, 2013′

ASCLD/LAB Policy on Measurement Uncertainty

Please refer to the “IMPORTANT NOTE” at the top of this web page

 

Revised Policy

Posted May 1, 2013

Effective May 1, 2013

Deadline for implementation December 31, 2013

 

5.5.2 ISO/IEC 17025:2005 When using an AFIS terminal or other instruments and equipment at a location external to the accredited laboratory, the user must ensure and document that the terminal and or equipment is in proper working order prior to use. 11/7/2007
5.6 ISO/IEC 17025:2005

On May 1, 2013 ASCLD/LAB released a new measurement traceability policy. The policy was effective May 1, 2013 with a ‘deadline for implementation date of December 31, 2013.’

ASCLD/LAB Policy on Measurement Traceability (Updated July 24, 2014)

Please refer to the “IMPORTANT NOTE” at the top of this web page

Revised Policy

Posted May 1, 2013

Effective May 1, 2013

Deadline for implementation December 31, 2013

 

5.6.2.1.1 ISO/IEC 17025:2005 ASCLD/LAB Program Clarification Endorsed by the Board

External Calibration of of Measuring Instruments – Testing Laboratories

3/17/2009
5.6.3.1 ISO/IEC 17025:2005 “Reference standard” generally means reference standards of units of measurement. 11/7/2007
5.7 ISO/IEC 17025:2005 ASCLD/LAB Board Approved Policy and Guidance Document

“Sampling” requirements are not applicable to the forensic science practice of “sample selection.

Policy on Sampling, Sampling Plans and Sample Selection in the Drug Chemistry Discipline

Guidance Document on Sampling, Sampling Plans and Sample Selection

Revised Policy Posted 10/12/2011

Effective March 1, 2012

5.8.1 ISO/IEC 17025:2005 If the laboratory intends to use test-fired ammunition as evidence for future comparisons, the laboratory must treat the test-fires as evidence from the beginning. Test-fired ammunition, which is treated as reference material by the laboratory, cannot routinely be re-designated as evidence at a future time. 11/7/2007
5.8.1 continued ISO/IEC 17025:2005 There are times and situations in which ESDA lifts are made from evidence which cannot be preserved for reproduction because of the nature of the evidence or because of additional testing of the evidence. Under such circumstances, positive ESDA lifts must be treated as evidence. Laboratories, which use ESDA methodology, must define in their procedure when ESDA lifts must be treated as evidence. 11/7/2007
5.8.1.1.2 and 5.8.4.1 2011 Supplemental Testing Requirement

ASCLD/LAB Board of Directors Interpretation

(1) When a laboratory declares hardcopies of known finger/palm impressions to be evidence, or treats these impressions as evidence, the item does not have to be in a container and the container, if used, does not have to be sealed. All other evidence requirements must be met.

(2) When a firearm is submitted to and accepted by a laboratory solely for the purpose of test firing and entry into a database, the firearm does not have to be in a container and the container, if used, does not have to be sealed. All other evidence requirements must be met.

 


Posted 5/16/2014: Effective Immediately

5.8.4.3 2011 Supplemental Testing Requirement ASCLD/LAB Board of Directors Interpretation

When multiple items or sub-items of evidence are contained within a properly sealed and properly marked container, it is not always required that each item or sub-item be marked with a unique identifier. As an example: if a properly marked and sealed container contains multiple similar packets of white powder and the analyst conducts an analysis on the contents of a portion of the packets, each packet which had its content analyzed must be marked with a unique identifier. As long as the analyst properly documents the existence of the remaining packets and the outer container is properly resealed, it is not required that the unexamined packets be marked with a unique identifier.

11/7/2007
5.8.4.6.1 2011 Supplemental Testing Requirement A laboratory handling individual characteristic database samples for another laboratory (such as a private DNA laboratory processing subcontracted samples) will be assessed against 5.8.4.6.1 through 5.8.4.6.4. 11/7/2007
5.9 ISO/IEC 17025:2005 A laboratory is not required to practice all of the quality control procedures specified in “a” through “e” 11/7/2007
5.9.3.3 2011 Supplemental Testing Requirement ASCLD/LAB Board of Directors Interpretation

A proficiency test may test a specific job related skill or skills, but does not have to test all aspects of an employee’s job function. Laboratories should consider varying the design of proficiency tests so that over time an employee is tested on all aspects of the assigned job functions.

11/7/2007
5.9.3.3 and 5.9.3.3.2 2011 Supplemental Testing Requirement ASCLD/LAB Board of Directors Interpretation

Where creating and/or maintaining an individual characteristic database* is a primary job function, proficiency testing is required for anyone working in that category of testing.

All ASCLD/LAB accredited laboratories are required to have and follow a proficiency testing plan to meet 5.9.3.3.2 of the ASCLD/LAB-International Supplemental Requirements for Testing Laboratories. When developing that plan, a separate individual characteristic database proficiency test is not required for an analyst when the use of a database is an extension of the duties in another category of testing.

* computerized, searchable collection of known specimens


Posted 5/16/2014: Effective 120 days from that date

5.9.3.3.1 2011 Supplemental Testing Requirement ASCLD/LAB Board of Directors Interpretation

Where does DNA analysis begin

For the purposes of determining who must participate in DNA proficiency tests, the ASCLD/LAB Board has determined that DNA analysis begins with the extraction of DNA from cellular material.

3/17/2009
5.9.3.4 2011 Supplemental Testing Requirement ASCLD/LAB Board of Directors Interpretation

Due to challenges in designing and administering proficiency tests for the Crime Scene discipline and the Latent Print Processing category of testing to meet the external proficiency requirement, observation based proficiency tests will be allowed in these two areas as long as the following elements are met (with objective evidence): (1) The observer is approved by the tested laboratory’s management based on training and casework experience; (2) The observer has knowledge of the laboratory’s technical procedures; and (3) All applicable proficiency test documentation shall be maintained in accordance with 5.9.3.5 of the 2011 Supplemental Requirements for Testing Laboratories.


Posted 5/16/2014: Effective Immediately

5.9.3.6 2011 Supplemental Testing Requirement First-time applicants are not required to have five years of proficiency test records. While first-time applicants need to start maintaining these records, this requirement will be marked “N/A” for the first assessment. For each year of the first cycle of accreditation, this requirement will be marked “yes” if the laboratory has appropriate records for each year of accreditation. 11/7/2007
5.9.4.3 2011 Supplemental Testing Requirement ASCLD/LAB Board of Directors Interpretation

Generally, a single technical reviewer will be assigned for each test report; however, ASCLD/LAB recognizes and accepts that more than one technical reviewer may be required under certain circumstances (e.g. batch processing of casework; certain DNA applications where multiple laboratory personnel work on the same case; etc.). As long as no individual technically reviews his/her work, the use of more than one technical reviewer is allowed for a test report.

Posted on June 29, 2011
Effective Immediately
5.9.7 2011 Supplemental Testing Requirement First-time applicants are not required to have five years of testimony monitoring records. While first-time applicants need to start maintaining these records, this requirement will be marked “N/A” for the first assessment. For each year of the first cycle of accreditation, this requirement will be marked “yes” if the laboratory has appropriate records for each year of accreditation. 11/7/2007
5.10.1 ISO/IEC 17025:2005 As stated in the requirement, a documented test report must be prepared for all testing completed in the laboratory, and the laboratory is not exempt from this requirement even when the customer requests that no documented report be provided. As well, this documented report must be available in the laboratory’s case record. 11/7/2007
5.10.1 continued ISO/IEC 17025:2005 Results obtained from non-specific tests must not be reported as unqualified confirmative results. 11/7/2007
5.10.1 continued ISO/IEC 17025:2005 ASCLD/LAB Board of Directors Interpretation

Reporting negative database searches

If a sample (e.g. latent print, test fire or DNA profile) is searched as a one-time event, then a report must be generated clearly stating the results of the search. A “one-time” event means that the sample will not be retained in the database and automatically searched against the database on some routine basis. If a sample is entered into a database(s) and is repeatedly searched with negative results, a report is not required for each search. However, the first time the sample is entered into the database a report (which may be in the form of a simplified notification) must be generated which clearly informs the customer that the sample was entered into the database. Anytime a positive association is made a report or follow-up report must be generated.

3/17/2009
5.10.1 and 5.10.3.5 ISO/IEC 17025:2005 and 2011 Supplemental Testing Requirement ASCLD/LAB Board of Directors Clarification

Special Notice About Reporting DNA Test Results

All ASCLD/LAB-International accredited laboratories are required to report and properly qualify the results of each test or series of tests accurately, clearly, unambiguously and objectively to meet 5.10.1 of ISO/IEC 17025:2005. In addition, laboratories are required to clearly communicate and properly qualify the significance of associations in the test report to meet 5.10.3.5 of the ASCLD/LAB-International Supplemental Requirements for Testing Laboratories (2011). The purpose of this requirement is to ensure that positive associations made by the laboratory are reported in such a way that the reader of the report is able to accurately evaluate the significance of the association. The testing laboratory should have an awareness of and avoid circumstances whereby the reporting language might be misleading and attributes a greater significance to a test than the results for that test support.

With respect to DNA associations, statistical calculations for the results of each test in which a positive association is made must be clearly and properly qualified in the test report. This does not apply to associations made between the profile derived from an intimate sample* and the individual from whom that sample was collected. In addition, statistical calculations for more than one test can be reported together if the results of those calculations are identical or, where applicable, are above a laboratory-defined source attribution threshold.

* Intimate Sample – Defined by ASCLD/LAB for this clarification as a sample that originates directly from an individual’s body such as: fingernails, oral swabs, vaginal swabs, or a swabbing from any skin surface.


Posted 5/16/2014: Effective Immediately (because this is a clarification of existing requirements)

5.10.5 ISO/IEC 17025:2005 ASCLD/LAB Board of Directors Interpretation:

ASCLD/LAB Discussion, Interpretation and Application of Opinions and interpretations, Ver 1.1
Updated version posted on March 17, 2009

The intent of the updated version is to clarify that the Board, by striking one example, has made an allowance that laboratory management may use their own judgment as to whether certain test results in controlled substances and toxicology constitute a conclusion, opinion or interpretation.

3/17/2009