495
edits
Changes
ACMG technical standards and guidelines: microarray analysis for chromosome abnormalities in neoplastic disorders (2013) (view source)
Revision as of 17:00, 27 July 2016
, 17:00, 27 July 2016→Quality Assurance
== Quality Assurance ==
== Quality Assurance ==
'''Laboratory accreditation and personnel qualifications'''
Laboratory personnel must have documentation of education, degrees, and certifications as appropriate for the level of testing, as well as training, competency assessments, and continuing education as required by appropriate regulatory bodies, e.g., College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), Center for Medicare and Medicaid Services (CMS). The testing laboratory must have CLIA certification and state certifications as required to provide clinical testing. CAP accreditation is strongly encouraged.
Laboratory personnel must have documentation of education, degrees, and certifications as appropriate for the level of testing, as well as training, competency assessments, and continuing education as required by appropriate regulatory bodies, e.g., College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), Center for Medicare and Medicaid Services (CMS). The testing laboratory must have CLIA certification and state certifications as required to provide clinical testing. CAP accreditation is strongly encouraged.
'''Indications and ordering for microarray analysis of neoplastic disorders'''
Microarray analysis of tumors should be limited to specimens that contain ample tumor, e.g., diagnostic or relapse. The sample should be accompanied by an appropriate indication for the test. Clinical testing should be limited to neoplastic disorders for which unbalanced genomic anomalies are well documented to have diagnostic, prognostic, and/or therapeutic implication(s).
Microarray analysis of tumors should be limited to specimens that contain ample tumor, e.g., diagnostic or relapse. The sample should be accompanied by an appropriate indication for the test. Clinical testing should be limited to neoplastic disorders for which unbalanced genomic anomalies are well documented to have diagnostic, prognostic, and/or therapeutic implication(s).
Laboratories may facilitate appropriate ordering by providing a directive or disease-specific testing menu. The test requisition should provide sufficient clinical and/or pathological information for the laboratory to assess the appropriateness of the test order.
Laboratories may facilitate appropriate ordering by providing a directive or disease-specific testing menu. The test requisition should provide sufficient clinical and/or pathological information for the laboratory to assess the appropriateness of the test order.
'''Proficiency testing (PT)'''
The laboratory should participate in PT for sample types and tumor types that are included in the laboratory test menu by participating in an external PT program when available through an appropriate-deemed organization, e.g., CAP. In addition, the laboratory may establish external PT of normal and abnormal specimens by the exchange of DNAs, in a blinded manner, with another laboratory performing microarray testing for neoplastic disorders.
The laboratory should participate in PT for sample types and tumor types that are included in the laboratory test menu by participating in an external PT program when available through an appropriate-deemed organization, e.g., CAP. In addition, the laboratory may establish external PT of normal and abnormal specimens by the exchange of DNAs, in a blinded manner, with another laboratory performing microarray testing for neoplastic disorders.
Failure to achieve agreement on external or internal proficiency tests should be documented and followed by investigation of the discrepancy with resolution. If indicated, appropriate remediation should be undertaken.
Failure to achieve agreement on external or internal proficiency tests should be documented and followed by investigation of the discrepancy with resolution. If indicated, appropriate remediation should be undertaken.
'''Turnaround time'''
Laboratory policies should define acceptable standards for microarray analysis test prioritization and turnaround times. Turnaround time should be clinically appropriate so the results are available for patient care management decisions.
Laboratory policies should define acceptable standards for microarray analysis test prioritization and turnaround times. Turnaround time should be clinically appropriate so the results are available for patient care management decisions.
It is suggested that 90% of cases should have a final written report by 21 calendar days. A longer turnaround time is acceptable when custom probes, oligos, or primer sequences must be designed, ordered, validated, and used. Normal or preliminary abnormal results should be available within 14 calendar days.
It is suggested that 90% of cases should have a final written report by 21 calendar days. A longer turnaround time is acceptable when custom probes, oligos, or primer sequences must be designed, ordered, validated, and used. Normal or preliminary abnormal results should be available within 14 calendar days.
'''Documentation of problems'''
A logbook, database, or sample processing form should be created and used to track problems that may occur throughout the processing of samples for neoplasia, from sample intake to final report, e.g., sample adequacy and/or errors. Data from the QC metrics program can provide information for oversight of all processes. Ongoing collection of sample or process variances allows patterns or trends to be recognized and promptly addressed.
A logbook, database, or sample processing form should be created and used to track problems that may occur throughout the processing of samples for neoplasia, from sample intake to final report, e.g., sample adequacy and/or errors. Data from the QC metrics program can provide information for oversight of all processes. Ongoing collection of sample or process variances allows patterns or trends to be recognized and promptly addressed.