Oversee and manage all aspects of laboratory operations, ensuring compliance with regulations, and maintaining quality standards. While there is room for delegation of certain duties, the lab director maintains ultimate responsibility for ensuring the proper execution of all tasks.
Duties and Responsibilities:
Daily responsibility:
Verification that the IQC results are acceptable before patient testing. Follow up any trends in the patients results which may reflect a machine or specific analyte problem. Following up on corrective actions regarding customer complaints and providing preventive action for the repeated reasons.
Weekly responsibility:
On weekly basis, the QC charts should be checked for presence of shifts or trends in the QC
Monthly responsibility:
The QC charts should be checked again, may be the mean needs to be reset by verifying the current month trend with the cumulative mean. The CV% of each parameter to be verified and compared with manufacturer QC %CV as well as previous month CV% thereby reviewing the monthly QC. The maintenance of the analyzers and temperature records should be reviewed. RIQAS and CAP results (if any) should be reviewed and recommend proper corrective action in case of unacceptable results.
Other routine responsibility:
- Ensure effective Quality Management System (QMS) for the laboratory.
- Ensure the physical and environmental conditions of the laboratory are adequate and appropriate for the testing performed.
- The environment for employees is safe from physical, chemical, and biological hazards and safety and biohazard requirements are followed.
- Enough appropriately educated, experienced, and/or trained personnel who provide appropriate consultation, properly supervise, and accurately perform tests and report test results in accordance with the written duties and responsibilities are employed by the laboratory.
- Each employee’s responsibilities and duties are specified in writing.
Ensure that the laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable patient test results including:
- Ongoing monitoring of each testing process in order to identify errors or potential problems that could result in errors.
- Taking corrective action; and
- Evaluating the corrective actions taken, to make sure that they were effective and will prevent recurrence.
- Consultations concerning test results and interpretation of those results as they relate to specific patient conditions.
- Appointing general supervisor to provide day-to-day supervision of all testing personnel and reporting of test results as well as provide on-site supervision for training of new staff.
- Adequate method verification of all analytes according to the accrediting authority requirements.
- Enrollment of the laboratory in proficiency testing (PT) program for the tests performed as appropriate for the accrediting authorities; PT samples are tested in accordance with the program requirements and according to the available policy; PT results are returned within the time frames established by the PT program
- PT reports are reviewed, and corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory. Establish and approve Quality control program with annual review, new test procedures and SOPs are available and initially approved and then reviewed every two years.
- Ensures that personnel have been appropriately trained and demonstrate competency prior to testing patient specimen and training or continuing education needed for other staff are identified and provided.
- Apply all standards for local and international accreditation as required and ensuring the ongoing application of those standards and preparing for accreditation when decision is taken for specific accreditation.
- Ensures a thorough interim self-inspection is performed, and all deficiencies are corrected in a timely manner.
Qualification:
PhD, MD or Masters, Clinical and Chemical Pathology
Professional Experience:
Good experience in managing accredited laboratory as decided by management.
Skills required:
- Recognized license as per ministry’s requirement defined for the respective location.
- Effective communication skills for collaboration with team members.
- In-depth knowledge of laboratory best practices, safety protocols, and compliance regulations.
- Proficiency in laboratory software and data analysis tools.
- Familiarity with industry trends and emerging technologies.
- Excellent communication and interpersonal skills
- Leadership qualities that inspire and motivate a diverse team.
Important Note : Following a change in laboratory directorship, the new laboratory director approves the technical policies and procedures within three months of the change of directorship.