ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:

• In conjunction with Laboratory and Ambulatory Leadership Teams, designs and implements quality programs, metrics, audits and monitoring systems.

• Maintains knowledge of quality requirements and standards for accreditation and regulatory agencies including CAP, AABB, TJC, PA State, CLIA, ISO:15189 and other agencies. Maintains accreditation readiness organization-wide laboratory licensed locations.

• Prepares and coordinates statistical reports to demonstrate process improvements and quality actions for regulatory review. Tracks and trends data while guiding correction action and follow up. Produce graphical tools for presentation when indicated.

• Initiates and leads project management for projects associated with compliance and accreditation activities. Leads analysis and performance improvement activities across the organization for Laboratory and Blood Bank locations. Implements accreditation projects in association with Laboratory operations.

• Develops and writes policies and procedures required for regulatory compliance and laboratory operations.

• Serves as a consultant and knowledge resource for LGHP, physician practices, all ambulatory services, nursing and laboratory for laboratory, blood bank and testing/quality standards.

• Leads licensure and registration of regulated laboratory sites so that proper licensure is current and renewed. Serves as lead for initial onsite inspections as needed.

• Monitors and coordinates with lab leadership the implementation of corrective action plans as a result of occurrence tracking, quality monitoring and audit assessments. Participate in improved workflow processes and analyses for redesigning Process Improvements as necessary.

• Assists in quality control and test result review to assess error and trends in data. Implements quality control analysis.

• Designs and performs auditing and develops new systems for implementation to meet certification, accreditation, compliance, licensure and accrediting body standards.

• Coordinates training and special classes, conferences and meetings for staff performance and quality implementation.

• Is responsible for oversight of quality and management reviews of work processes to identify opportunities for improvement and lean improvements. Writes and communicates management reports with lab leadership teams to meet regulatory requirements.

• Blood Bank QA Specific:

• Design and perform validations and testing in LIS system, in coordination with LIS analysts.

• Collaborates with medical, laboratory, IT and nursing personnel to develop, optimize, improve, implement, report and educate strategies for transfusing safety, ordering, administration, documentation, assist with development of appropriate order sets and blood conservation.

• Develops reports and audits for nursing blood administration including reporting on incomplete transfusion documentation.

• Develops Knowledge link education modules for topics related to transfusion safety.

• Remains current and updates ISBT codes around evolving products.

• Conducts prospective and retrospective audits on the utilization of blood and blood products and maintains blood usage statistics.

• Prepare QA report for LG, WBH, Donor Center, track occurrences, errors, deviations, FDA reportable events.

JOB REQUIREMENTS

MINIMUM REQUIRED QUALIFICATIONS:

• Bachelor of Science degree or equivalent in an allied health field.

• Medical Technologist certification by the American Society of Clinical Pathology (ASCP) or equivalent.

• Valid PA driver's license.

PREFERRED QUALIFICATIONS:

Five (5) years laboratory or healthcare experience.

EQUIPMENT USAGE REQUIREMENTS

Equipment/Tools: Computer, Phone, Copier, Printer, Fax, Office Supplies, Automobile, Centrifuges

Software: Microsoft Office Products, LIS and HIS

Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The percentages of time spent performing job duties are estimates, and should not be considered absolute. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. Incumbent must be able to perform all job functions safely.