6
Highlights
Optimal Internal QA Procedures
➤ Should review and document external and internal controls with each
test and each batch of tests.
• Ongoing quality control and equipment maintenance
• Initial and ongoing laboratory personnel training and competency assessment
• Use of standardized operating procedures including routine use of control
materials
• Revalidation of procedure if changed
• Ongoing competency assessment and documentation of the actions taken as a
part of the laboratory record
Optimal External Proficiency Assessment
➤ Participation in and successful completion of external proficiency
testing program with at least two testing events (mailings) a year.
• Satisfactory performance requires at least 90% correct responses on graded
challenges for either test.
• Unsatisfactory performance will require laboratory to respond according to
accreditation agency program requirements.
Optimal Laboratory Accreditation
➤ Onsite inspection every other year with annual requirement for self-
inspection.
• Reviews laboratory validation, procedures, quality assurance (QA) results and
processes, results and reports.
• Unsatisfactory performance results in suspension of laboratory testing for HER2
for that method.
