Non-Smile Resource

Author: Neal Wetherall Document Number: Per10-05

Effective (or Post) Date: 14 Dec 2006
Document Origin Company: DAIDS
Unknown SMILE Approved by: Erin Gover
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 THE
LABORATORY DIRECTOR
(CAP & CLIA)

 Recommends and approve external proficiency testing program.

 Review results of semi-annual proficiency tests, and ensures that the results 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.
 Approve QI document that spells out goals and objectives of QI; reviews
document annually.
 Assures that transport of specimens meets needs.
 Reviews procedure manual for LIS annually.
 Interprets, correlates, and communicates laboratory data for client physicians.
 Consults with physicians regarding laboratory data.
 Interacts with physicians, patients, administration, and government.
 Monitors standards of performance; QC, QI.
 Involved in education programs, planning, research and development.
 Determines if there are sufficient personnel with training.
 Sees that laboratory is safe and compliant.
 Decision maker in selection of equipment and supplies.
 Reviews laboratory procedure manuals and policies annually.
 Reviews and approves all new procedures and policies before implementation.
 Ensures that testing systems provides quality lab services.
 Ensures that the physical plant and environmental conditions are appropriate for
the testing performed and provides a safe workplace.
 Each laboratorian has a written list of responsibilities specifying the level of
activity each is authorized to perform.
 Supervises a general supervisor that provides on-site, day-to-day supervision of
testing personnel.
 Ensures that methods selected have capability of providing quality results
 Ensures that an approved procedure manual is available to all personnel.

SMILE Received 13 Sep 2006 Page 1 of 1

  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.

SMILE Received 13 Sep 2006 Page 1 of 1