Delegation of Duties by the Laboratory Director

TJUHBB POL 05.001

POLICY

The Laboratory Director is responsible for the over all operation of the laboratory and for assuring compliance with applicable regulatory agencies. CAP defines these responsibilities in the General Laboratory Checklist, GEN.8200 - GEN.82800. The Laboratory Director however, is granted the ability to delegate certain responsibilities to appropriate qualified Managers.

PURPOSE

The purpose of this policy is to designate those responsibilities to be retained by the Laboratory Director and to specify the responsibilities to be officially designated to the Biorepository Manager.

DELEGATION

• A. Duties of the Laboratory Director, which cannot be delegated.
  • a. Ensure that IRB protocols and policies are upheld.
  • b. Ensure that HIPAA is not violated
  • c. Clinical care is not compromised in the process of procuring biospecimens
  • d. Ensure that basic ethical standards related to the collection and distribution of biospecimen are maintained.
  • e. Ensure physical plant and environment is appropriate and safe.
  • f. Ensure that there is sufficient number of qualified employees to perform all functions and responsibilities.
  • g. Ensure that there are written duties and responsibilities for all employees.
  • h. Final review of all method validation/verification packages.
  • i. Final review and signature for all new procedures.
  • j. Monthly review of Quality Control.
  • k. Review of all major QC failures.
• B. Responsibilities delegated to the biorepository manager:
  • a. Ensure test method selections, verification or validations, performance of accurate and reliable results.
  • b. Ensure enrollment in proficiency testing patient samples, returning results on time, review or results and corrective action needed.
  • c. Ensure establishment and maintenance of acceptable levels of analytical performance.
  • d. Ensure remedial actions are taken when systems deviate from performance specifications and results are only reported when systems are functioning properly.
  • e. Ensure establishment and maintenance of QC and QA program and identification of quality failures.
  • f. Ensure that employees are qualified, trained and have documented ability to perform testing operations.
  • g. Ensure policies and procedures are developed for monitoring employees competency, identify needs for remedial training and Continuing Education.
• C. Specific activities of the biorepository manager:
  • a. Procedures: Review new procedures, make changes to procedures, annual review of procedures, review of verification/validation packages.
  • b. Review of weekly QC, all patient results and Action Needed Forms.
  • c. Review of monthly instrument maintenance records.
  • d. Review of monthly temperature charts.

Revisions

POL ID	Date Revised	Author	Summary of Changes
POL 05.001	08/05/2016	Patel,Miraj	Policy finalized.

Version & Approval

POL ID	Category	Approval	Date
05.001	Administration	Stephen Peiper, MD	08/05/2016