♦Quality Control Monitoring Programs o Review and investigate unacceptable results to internal and external quality control monitoring programs. Prepare corrective action responses by assigned due date for management review.
o Complete timely review of new or revised SOPs circulated for peer review.
o May assist with timely processing of SOPs for department.
♦ Proficiency Testing Survey Samples
o May provide support to proficiency testing program by coordinating receipt of survey material, coordinating with interdepartmental personnel for sample analysis, and ensuring timely and correct completion of electronic or paper report forms.
o Investigate root cause for unacceptable performance on proficiency surveys and prepare corrective action response by assigned due date.
♦ Training o Assists with training new employees and follows-up to ensure training is understood.
o May assist with the development of training material, training checklists, and competency assessment programs.
♦ Instrument/Equipment/Assay Validation o Assist with assay validations by performing experiments according to departmental SOP. Compile validation data for management review.
o Assist with validation of new equipment and instruments including software validation requirements (e.g., User Acceptance Testing).
♦ Assist staff by providing technical guidance where needed.
♦Only individuals that are verified to qualify as supervisory personnel under regulations/standards applicable to the facility (e.g., New York State, CLIA, CAP) may perform periodic review and approval of quality control program records (e.g. quality control data, instrument logs, reagent logs). The SOPs applicable to the department should be consulted to determine records that can be reviewed and approved.
•Individual must qualify as testing personnel under MoH regulations.
•Bachelor's degree in Medical Technology or completion of at least a 12-month training program in Medical Technology.
•Bachelor's degree in a chemical, physical or biological science from an accredited college or university and one year training and/or experience in the specialty in which testing is to be performed. Such training must be equivalent to that received in a school of Medical Technology.
Individual should have >5 years external clinical laboratory testing experience or 1 year of Covance Laboratory experience performing clinical laboratory testing.
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