Job Purpose:

 The quality officer is responsible for implementing the quality programs throughout the department. S/He must work with the hospital quality department to understand the impact of the institution’s quality program and implement it in the Laboratory Department. S/He is in charge of ensuring that the results are of the highest quality and create systems to monitor data quality and performance. S/He also confirms that procedures and processes adhere to safety and compliance rules and regulations. The quality officer will conduct audits in a timely manner, reviewing policies and procedures to find the root cause of any non-conformance. The laboratory quality officer also participates in ensuring that all employees receive proper training, orientation and competency assessment. S/He may also work with the procurement department, to verify that the goods and services meet acceptable laboratory standards.

MAIN DUTIES AND RESPONSIBILITIES


Prepare an annual budget plan to run the laboratory quality programs i.e. ISO 15189.
Advice the laboratory director or designee on quality programs and issues related to it.
Maintain communication with accrediting and regulatory bodies.
Ensure laboratory activities comply with ISO 15189:2022
Ensure continuous training and awareness on ISO 15189:2022 requirements.
Ensure all policy documents are current and implemented as written
Ensure that staff are trained and deemed competent with approved and current policy documents.
Ensure mandatory documents and records including patient material are retained in accordance with approved policy documents
Ensure effective continuous medical education programs are implemented in each section
Ensure deficiencies raised by external auditors are closed within the stipulated timelines.
Incorporate SAFE CARE requirements to the laboratory processes.
Advice the laboratory director or designee on POCT programs and issues related to it.
Develop a POCT program in accordance with accrediting and regulatory bodies.
Support the POCT committee chair in implementing the POCT program
Implement and continuously monitor the POCT program.
Ensure POCT equipment are calibrated and QC run as required.
Ensure performance and documentation of routine and preventative maintenance of POCT equipment.
Troubleshoots and reports instrument malfunctions to supplier
Ensure POCT equipment have documented work instructions
Organize, plan and lead ISO15189 audits in the Laboratory department.
Support the department in the running of the Departmental Quality Improvement and Patient Safety committee (DQIPS)
Through the institutions Head of clinical service, develop the annual Department Quality Plan
Oversee the process of validation and/or performance verification of existing and/or new tests, instruments and methods of equipment, tests and methods in the department.
Prepare monthly Quality Variance Reports and present to the DQIPS and the laboratory director or designee.
Ensure process control checks (EQA, IQC) are implemented.
Ensure pre-analytical, analytical and post-analytical aspects of the laboratory comply with approved policies.
Ensure equipment including reagents and other laboratory supplies are used and maintained in accordance with manufacturer’s instructions or approved policy documents
Ensure complaints, incidents, and sentinel events are captured, investigated and resolved.
Perform regular (at least annual) internal audits.
Plan annual Management Review Meeting, communicate to the staff the outcome of the meeting and make follow-up to ensure that tasks identified in the meeting are addressed.
Ensure opportunities for improvement are identified and implemented.
Ensure each section have quality indicators to monitor performance
Capture complaints, follow-up for closure, communicate with the affected clients.
Ensure all occurrences are captured, investigated and resolved
Ensure root cause analysis is done to prevent re-occurrence of occurrences
Ensure preventive action is implemented to prevent potential occurrences
Ensure each section participate in quality improvement activities continuously
Ensure each section set goals and objectives every year and work to achieve them.
Participating in the Facility Management and Safety (FMS) program
Implement safety standards and policies with the coordination of laboratory safety committee.
Monitor the implementation of safety program in the department
Perform other duties as may be assigned from time to time by the laboratory director or designee.


KEY QUALIFICATIONS AND EXPERIENCE


BSc or Higher national Diploma in Medical Laboratory Technology with 5 years’ work experience.
Registered by KMLTTB with a valid practicing license. Minimum 3 years’ experience in leading quality management systems in the healthcare industry, specifically medical laboratories.
Minimum 3 years in quality system maintenance.
Excellent computer skills (Including, but not limited to: Windows, Office, Visio, Project Manager, and Internet).
Excellent communication skills.
Work independently and proactively.
Good ISO/GCLP, CAP, POCT, Blood Bank and JCIA quality system knowledge.
Process Management: Experience in basic process management tools and techniques required.


SKILLS AND COMPETENCIES


Computer literacy.
Must maintain confidentiality.
Have good customer care skill/ experience.
A good team player.
Integrity, truthfulness, and capability of using both hands.
Willingness to train and impart knowledge to staff.
Willingness to learn and develop in the career path.