MiSeq_Competency_Assessment_Form



Employee Name (Print)AssessmentStart DateTest/Assay NameAssessment Type:(check one)Initial Assessment6-Month AssessmentAnnual Assessment1) Direct Observation of TestingSkill / Knowledge AssessedTask ObservedYesNoN/AAssessor Initial / DateSpecimen Processing: DNA ExtractionPerforms specimen preparation in accordance with approved procedure (DNA extraction) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Ensures positive specimen identification is maintained FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Identifies acceptable specimen types and storage requirements FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Specimen Processing: DNA Quality ControlPerforms quality control of DNA in accordance with approved procedure (Nanodrop, Qubit, Bioanalyzer, or Fragment Analyzer) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Ensures positive specimen identification is maintained FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Specimen Processing: DNA Shearing and Library PreparationPerforms DNA Shearing in accordance with approved procedure (Covaris) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Performs Sheared DNA Quality Control testing in accordance with approved procedure (Bioanalyzer, TapeStation, Fragment Analyzer) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Performs Library Preparation in accordance with approved procedure (TruSeq) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Performs Library Preparation Quality Control Testing in accordance with approved procedure (Bioanalyzer, TapeStation, Fragment Analyzer) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Performs Library Preparation Quantitation in accordance with approved procedure (Qubit, qPCR) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Loading the MiSeq CartridgePerforms Loading of the MiSeq Cartridge in accordance with approved procedure FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX CommentsCriterion 1) Outcome:Pass FORMCHECKBOX Fail FORMCHECKBOX N/A FORMCHECKBOX Assessor Initial / Date2) Monitor Recording and Reporting ResultsSkill / Knowledge AssessedTask ObservedYesNoN/AAssessor Initial / DateRecord NGS process dataComplies with applicable documentation requirements (e.g. completes NGS Run Data Capture Tool) FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX CommentsCriterion 2) Outcome:Pass FORMCHECKBOX Fail FORMCHECKBOX N/A FORMCHECKBOX Assessor Initial / Date3) Review Intermediate Test Results / Worksheets, QC Records, PT Results, PM RecordsSkill /Knowledge AssessedTask ObservedYesNoN/AAssessor Initial / DateUpdates equipment records (calibration, maintenance, etc.)Updates the preventive maintenance equipment log after each sequencing run FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Reviews NGS process quality control checkpoint dataRecords quality control data in the NGS Data Capture Tool and shows ability to make correct decisions on whether to proceed with the NGS process according to the approved procedure FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX CommentsCriterion 3) Outcome:Pass FORMCHECKBOX Fail FORMCHECKBOX N/A FORMCHECKBOX Assessor Initial / Date4) Direct Observation of Instrument Maintenance and Function ChecksSkill /Knowledge AssessedTask ObservedYesNoN/AAssessor Initial / DatePerforms the Post-Run WashPerforms Post-Run Wash in accordance with approved procedure FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Perform Maintenance WashPerforms Maintenance Wash in accordance with approved procedure FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX CommentsCriterion 4) Outcome:Pass FORMCHECKBOX Fail FORMCHECKBOX N/A FORMCHECKBOX Assessor Initial / Date5) Assess Test PerformanceSkill /Knowledge AssessedTask ObservedYesNoN/AAssessor Initial / DateReview of quality control checkpoint data and sequence data demonstrate acceptable performanceThe results of testing one of the below are as expected: (select one; attach record) FORMCHECKBOX Previously tested specimens FORMCHECKBOX Internal blind specimens FORMCHECKBOX Proficiency test specimens result FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX CommentsCriterion 5) Outcome:Pass FORMCHECKBOX Fail FORMCHECKBOX N/A FORMCHECKBOX Assessor Initial / Date6) Assess Problem Solving SkillsSkill /Knowledge AssessedTask ObservedYesNoN/AAssessor Initial / DateTroubleshootingAble to describe potential sources of error and preventive actions FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX CommentsCriterion 6) Outcome:Pass FORMCHECKBOX Fail FORMCHECKBOX N/A FORMCHECKBOX Assessor Initial / DateEmployee AcknowledgementI certify that I completed the assessment outlined above.Name(Print)SignatureDateEmployeeAssessment Result(To be completed by the Technical Supervisor)Criteria for Success:100% Compliance to Procedures FORMCHECKBOX Successful FORMCHECKBOX Remediation RequiredRemediation: (If required)Name(Print)SignatureDateTechnical SupervisorReviewsName(Print)SignatureDateTeam LeadQuality ManagerAssessor ReferenceI certify that I conducted the assessment outlined above and the employee completed activities as identified.Name(Print)SignatureInitials / DateAssessorAssessor ................
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