Non-Smile Resource

Author: Neal Wetherall Document Number: Per10-08

Effective (or Post) Date: 3 Dec 2009
Document Origin Company: DAIDS
Unknown SMILE Approved by: Penny Stevens
Review by Heidi Hanes Review date 17 Feb 2020
pSMILE Comments: This document is provided as an example only. It must be revised to accurately reflect
your lab’s specific processes and/or specific protocol requirements. Users are encouraged to ensure
compliance with local laws and study protocol policies when considering the application of this document.
If you have any questions contact SMILE.

FUNCTIONS AND RESPONSIBILITIES OF GENERAL SUPERVISOR

(CAP & CLIA)

 Reports to the Clinical Laboratory Director.

 Provides on-site, day-to-day supervision of lab operations and personnel.
 Ensures that the results of the semi-annual proficiency tests are reported on time.
 When results are unsatisfactory, corrective action is taken and documented.
 Ensures that proficiency tests and patient samples are tested the same.
 Correlates and communicates laboratory data for client physicians.
 Interacts with physicians, administration, and government.
 Monitors standards of performance; daily QC.
 Involved in education programs, planning, research and development.
 Sees that laboratory is safe and compliant.
 Involved in selection of equipment and supplies.
 Reviews laboratory procedure manuals and policies.
 Involved in writing and approving new procedures and policies before
implementation.
 Ensures that each laboratorian has a written list of responsibilities specifying the
level of activity each is authorized to perform.
 Interacts with QA/QI to ensure quality results
 Works with laboratory Director and technical staff to ensures that verification
procedures used are adequate to determine accuracy, precision and other pertinent
performance characteristics of the method.
 Ensures that remedial actions are taken and documented whenever significant
deviations from the lab’s established performance characteristics are identified,
and patient test results are reported only when the system is functioning properly.
 Responsible that the laboratory functions in a fiscally responsible manner.

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