Lab Quality and Compliance Manager

SCOPE OF POSITION:

The Quality and Compliance Manager is accountable for implementation and performance of the Quality Management Program throughout the Laboratory. In conjunction with the Laboratory Director, the scope of the position includes support of the regulatory laboratory requirements. Reports to Laboratory Director.

RESPONSIBILITIES:

• In collaboration with Laboratory Director and Laboratory Team Leads, ensures the Quality of the Laboratory and all associated programs meet regulatory standards. Ensures maintenance of safety and quality practices in the Laboratory.

• Ensures all new hires receive proper training and competency assessment.
• Responds to internal and external laboratory issues, documenting in the incident reporting system. Works with patients to provide service recovery as needed.
• Schedules Quality Management meetings in conjunction with Laboratory Managers to drive operational performance improvements throughout the Laboratory.
• Represents the Laboratory of hospital wide quality improvement and clinical care council meetings.
• Responsible for Safety in the Laboratory by consistent monitoring of compliance.
• Acts as the Chemical Hygiene Officer by continual review of the chemical inventory in the laboratory.

Reviews and signs the Chemical Hygiene Plan on an annual basis.

• Works with Laboratory Core Manager, and is responsible for CAP, JCAHO, and DPH applications, helps prepare for inspections and assists with responses and corrective action plans.
• Responsible for CAP General checklist requirements.

• Works cooperatively with all areas. Coordinates functions for the team as well as performs various production of service tasks while helping the team accomplish its leadership responsibilities.
• Acts as the compliance representative to oversee compliance activity within the lab and performs periodic monitoring activities.
• Responsible for the complete operation of the clinical point of care (POC) testing program. Develops policies and procedures for the POC program and reviews these policies/procedures annually. Serves as a technical consultant for all areas of the hospital in regards to POC testing. Evaluates and documents new POC tests and instruments, which includes validation studies, instrument maintenance, calibration, and QA/QC procedures. Develops Individualized Quality Control Plans as required. Maintains inventory for all POC testing. Establishes POC training programs and trains new users. Establishes POC testing personnel competency programs and monitors competency records to ensure they are successfully completed. Ensures participation and documentation of required POC Proficiency Testing for all POC tests. Responsible for all POC requirements of regulatory accreditation agencies which include CLIA, TJC, CAP and the State of Connecticut.

• Keeps current on advances in Laboratory Sciences. Participates in and shares continuing education to maintain professional development and competency for the patient population served including: neonate, infant, child, adolescent, adult and older adult patients.
• Performs all other duties as assigned.

REQUIREMENTS:

• Must have basic computer skills and ability to access internet and other programs applicable to Waterbury Hospital procedures.
• Perform automated functions that fall within job responsibility.

• Task-driven, results-oriented.
• Ability to adapt in a dynamic environment including exposure to all patient elements, i.e. bloodborne pathogens, physical requirements: lifting and carrying supplies, standing, walking, and bending.
• Ability to interact with internal as well as external customers with tact and confidentiality.
• Ability to utilize Technical and Human Resources.

• Bachelor of Science Degree in Medical Technology or Biology (ASCP certification preferred)
• 1 year laboratory department oversight and 3 years technical experience.