Introduction
1. Proficiency tests are used as a tool to assess the analyst’s technical ability to
determine factual information from physical evidence. The tests can also be designed to determine the analyst’s ability to establish accurate and sound conclusions.
Proficiency testing aids in the assurance of the quality of the analyst’s case test results.
2. Analysts, technical reviewers, technicians/technical support, and other personnel designated by the Technical Leader, must undergo semi-annual external proficiency testing. The laboratory shall use an external proficiency test provider that is in compliance with current proficiency testing manufacturing guidelines as established by ANAB. The applicable test must be included on the proficiency test provider’s scope of accreditation. External proficiency testing must be an open proficiency testing program and must be submitted to the proficiency testing provider in order to be included in the provider’s published external summary report.
3. Analysts, technical reviewers, technicians/technical support, and other personnel designated by the Technical Leader may be required to take an internal proficiency test (e.g., to meet ISO 17025 or ANAB requirements, as a result of a corrective action, or as part of re-training). Internal proficiency testing may be observational or require testing of samples obtained from an external agency and/or intra-laboratory using blind, re-examination, or known standards technique. Internal proficiency testing will be conducted in accordance with the Quality Assurance Manual. 4. Proficiency test samples will be assigned to the analyst by the Quality Assurance
Manager. The proficiency test will be treated as a routine case and all testing, review, and quality issue/non-conformance procedures must be followed.
5. Due dates are assigned by the Quality Assurance Manager and must be met. Extensions may be granted as per the Quality Assurance Manual.
6. For external proficiency tests the analyst must fill out the vendor data sheets as
directed by the test instructions and follow the same format for establishing a case file as they would actual case samples.
7. Analysts assigned to the Forensic Biology Unit will be required to take at least (1) serology proficiency test a year.
8. The Forensic Biology Unit will adhere to the most current Quality Assurance Standards for Forensic DNA Testing Laboratories for conducting proficiency tests semi-annually (semi-annual is used to describe an event that takes place two times during one calendar year with the first event taking place in the first six months of the calendar year and the second event in the last six months of the calendar year, and where the interval between events is at least four months and not more than eight months).
9. For purposes of tracking compliance with the semi-annual proficiency testing requirement, the Forensic Biology Unit will use the received date to document when the proficiency test is performed.
10. The following information will be retained with the proficiency test record: i. Name of test provider
ii. The test set identifier
v. Copies of all data and notes supporting the conclusions vi. The proficiency test results
vii. Any discrepancies noted
viii. Review process has been conducted as per FB Records protocol ix. Corrective actions taken.
11. The Proficiency Checklist Form must be completed by the analyst and submitted along with the FB Case File Technical/Administrative Review Worksheet form. The reviewer must verify the information on the FB Proficiency Checklist Form. The FB Proficiency Checklist Form must be completed by the technical reviewer before submitting the original vendor data sheets to the Quality Assurance Manager. 12. The FB Case File Technical/Administrative Review Worksheet form or the FB
Evidence Screening Case File Technical and Administrative Review Work sheet form (when appropriate) must be completed by the technical reviewer before submitting the original vendor data sheets to the Quality Assurance Manager.
13. The technical and administrative review of an external proficiency must be conducted by an individual not currently taking the same proficiency, i.e. the analyst is not on the same proficiency test cycle.
14. Newly qualified analysts must enter the proficiency test program within eight months of the date of their qualification.
15. The proficiency test results shall be evaluated for the following: i. Serology:
a. All reported serology screening results are graded as correct or incorrect according to the consensus results and/or the laboratory’s interpretation guidelines.
ii. Y-screening
a.All reported Y-screening results are graded as correct or incorrect according to the consensus results and/or the laboratory’s
interpretation guidelines. iii. DNA
a.All reported inclusions are graded as correct according to the consensus results.
b.All reported exclusions are graded as correct according to the consensus results.
c.Inconclusive results are reported in accordance with laboratory guidelines. The technical leader must review any inconclusive conclusions for compliance with laboratory guidelines. The Technical Leader review of inconclusive conclusions for compliance with laboratory guidelines may be part of the
evaluation of the proficiency test results or have occurred prior to the submission of the proficiency test results.
iv. All reported genotypes and/or phenotypes are graded as correct or incorrect according to the consensus results and/or the laboratory’s interpretation guidelines.
16. All final proficiency tests must be evaluated as satisfactory or unsatisfactory. For an original or supplemental proficiency test a satisfactory grade is attained when:
iii. DNA
a.There are no analytical errors for the DNA profile typing data. b.All reported inclusions or exclusions are correct.
17. The Quality Assurance Manager, FBU Manager, Casework Supervisor, or Technical Leader may notify the analyst if the proficiency was satisfactory or unsatisfactory. 18. The Technical Leader must be notified of the results of all participants. The
notification must be documented.
19. All discrepancies or errors and subsequent corrective actions, as applicable, must be documented and maintained as part of the proficiency test record.
20. In the event a discrepancy occurs in a proficiency test result, the guidelines defined in the Quality Assurance Manual will take effect.
21. All discrepancies/errors and subsequent corrective actions shall be documented. 22. Administrative errors and corrective actions, as applicable, shall be documented. 23. The casework CODIS Administrator must be informed of any non-administrative
discrepancies that affect the typing results and/or conclusions.
24. The proficiency test result vendor data sheets, original notes, data, and other
documentation (e.g. discrepancies, root cause analysis, or CAR documents from non-nonconformance associated with proficiency tests, etc.) will be retained as per the Quality Assurance Manual.
25. Any analyst re-entering the FBU after an absence from casework that include missing their proficiency test cycle shall complete a practical competency before resuming casework duties. Once case work has been resumed, the analyst must return to the proficiency testing cycle within eight months.
Serology Proficiency
1. The analyst must conduct all available serological testing protocols used on casework evidence.
2. To satisfy the proficiency testing requirements for bloodstains, the analyst must conduct a presumptive Kastle-Meyer (KM) test and a confirmatory Seratec HemDirect Assay. All appropriate controls must be utilized.
3. To satisfy the proficiency testing requirements for semen, the analyst must conduct a presumptive Acid Phosphatase (AP) test, a confirmatory microscopic slide
examination, and a confirmatory Seratec PSA Semiquant test. All appropriate controls must be utilized. If the proficiency test chosen to satisfy the serology proficiency test requirement does not contain a semen stain, a positive control for a microscopic examination (i.e. a microscope slide containing sperm cells) must be utilized and documented on the FB Evidence Summary Worksheet form.
Y-Screen Analyst (only conduct extraction and quantification)
2. To satisfy the proficiency testing requirements, all unknown samples provided in the proficiency test must have Y-Screen analysis conducted.
3. All appropriate controls must be utilized.
4. Y-Screen Analyst qualified to conduct serological analyst must also meet the annual serology proficiency test requirements.
DNA Proficiency (includes amplification of Y-screen lysates)
1. Analysts qualified in more than one technology shall be proficiency tested in each technology at least once per calendar year. All applicable samples in a single proficiency test shall be worked for each technology. Multiple technologies may be reported on a single proficiency test or each technology may be separately tested. 2. Typing of all CODIS core loci shall be attempted for each technology at least once
per calendar year.
3. Analysts qualified in more than one typing test kit shall be proficiency tested in each typing test kit at least once per calendar year. If an analyst is qualified in only one typing test kit the analyst must take both semi-annual tests with that typing test kit. An analyst qualified to use multiple typing test kits may be separately tested using each typing test kit.
4. Analysts qualified to perform modified Rapid DNA analysis shall be externally proficiency tested on the interpretation of data generated by each Rapid DNA instrument model for each PCR STR typing test kit at least once per calendar year. 5. Individuals that perform analytical procedures on forensic samples or casework
reference samples shall be proficiency tested on at least one method in each methodology at least once per calendar year.
i. Method is a combination of procedural steps used to perform a specific technical process. The method includes the validated steps, reagents, and critical instruments needed to perform the process or portion of a process. ii. Methodology refers to the categories of methods used to perform a stage
of a DNA typing technology or technologies. For example, methodologies for STR technology can include extraction, quantification, amplification, and detection.
6. Analysts must be proficiency tested in the QIAGEN DNA Investigator Kit and Promega Casework Direct Kit at least once per year. Note: differential extractions should be conducted on a proficiency test at least once a year when possible.
7. Probabilistic Genotyping using STRmix™ should be conducted on proficiency test samples as applicable.
8. Newly qualified analysts must enter into the proficiency test cycle within 8 months of their qualification date. The newly qualified analyst must, however be incompliance with Quality Assurance Standards for proficiency testing in the next full calendar year.
9. Results that are reported as inconclusive or not interpretable must be consistent with interpretation guidelines.
11. It is the Technical Leader’s responsibility to determine whether an error in
interpretation or typing shall be classified as an analytical error, based on review of analytical data to ensure consistency with laboratory interpretation guidelines.
Proficiency Tests for Technical Reviewers
1. Technical reviewers must be proficiency tested in the technical review of each technology and typing kit in which they are qualified to review at least once per calendar year. The proficiency test shall cover the CODIS core loci for each technology at least once per calendar year.
2. Technical reviewers qualified to review modified Rapid DNA analysis must be externally proficiency tested on the technical review of data generated by a Rapid DNA instrument model for each PCR STR typing test kit at least once per calendar year.
3. An analyst proficiency tested in the specific technology may serve as a technical reviewer without needing to take an additional proficiency test as a technical reviewer.
4. Technical Casework Review will include a review of bench notes, data, photographs and other documents that form the basis for the conclusions.
5. The analyst conducting the technical/administrative casework review must be proficient in the FBU technical protocols in order to ensure compliance with all discipline procedures and/or protocols, correct conclusion(s), reporting procedures and evidence handling policy and procedures. The Technical Leader is responsible for documenting the analysts who are qualified to perform technical and administrative reviews for serology and DNA.
6. At a minimum, the individual conducting and signing the technical review must be or have been a case working analyst in the discipline or testing method being reviewed. The technical reviewer must have passed a competency test in the testing method. This does not necessarily mean laboratory bench work has been conducted during the training phase of a method.
7. Technical reviewers who are no longer qualified analysts are required to be externally proficiency tested in data interpretation. “Externally proficiency tested in data
interpretation” is interpreted as technically reviewing an external proficiency test. 8. In the event a discrepancy occurs in a proficiency test result, the guidelines defined
