Quality Control and Regulatory Coordinator - Medical Laboratory
- ChristianaCare
- | Newark, DE
$80,115 per year |
FULL_TIME |
May 7th, 2025
-
ChristianaCare -
Newark, DE
-
$80,115 per year
-
FULL_TIME
-
May 7th, 2025
ChristianaCare is recruiting for a Quality Control and Regulatory Coordinator. In this position, you will be responsible for the coordination and maintenance of the internal and external quality control program for the ChristianaCare (CC) General Laboratories. You will review quality management reports to ensure quality of work and provide recommendations to improve performance. You will also ensures compliance and readiness with CAP and other laboratory regulatory agencies. This position will support all CC General Laboratory sites and other areas as requested.
Principal Duties and Responsibilities:
Evaluates QC products for appropriateness, based on instrumentation and methods used. Coordinates QC supply needs.
Work with leaders to ensure the department is meeting all CAP and Joint Commission requirements. Perform self inspection as directed by CAP every 2 years. Assist with CAP inspections when window is open.
Maintains QC database in the LIS. Works cooperatively with Clinical Biochemist, technical specialists, site supervisors and MLS IIs to monitor weekly and monthly QC and overall system performance. Establishes ranges for QC products using statistical analysis and in consult with technical specialists and Clinical Biochemist as necessary. Ensures that up to date targets and ranges are reflected in the LIS. Aids in troubleshooting QC outliers when appropriate. Submits and reviews peer group data for QC products as directed.
For the CHR General Lab, reviews and investigates Report 2 Learn and Unusual Occurrence Reports, providing documentation and follow up as directed. Issues Report 2 Learn reports as indicated. Reviews daily quality management reports for the CC General Laboratories, notifying appropriate site supervisor of problems. Looks for trends and identifies opportunities for performance improvement.
Reviews and maintains critical value reporting data for the and follows up on outliers. Provides critical value analyses and other quality management reports as requested.
Assists in the creation and maintenance of the IQCP program. Ensures IQCP documentation is current for and organized for presentation during CAP inspections.
Coordinates departmental quality assurance and educational efforts related to proficiency testing results. Updates area supervisors and Section Manager on staff performance and participation as appropriate. For the General Lab on the Newark campus, maintains quality assurance data and reviews performance improvement opportunities with MLS staff.
Manages key aspects of the external proficiency testing program for the Department of Pathology and Laboratory Medicine. Orders proficiency testing materials for all sections. Orders and distributes survey material; maintains files, including raw data documentation and attestation pages. Distributes completed reports to appropriate technical specialist/site supervisor and maintains exception report and other proficiency testing documentation. Updates test activity lists to maintain compliance with CAP and CMS.
Supports the Department of Pathology by actively participating in center-wide performance improvement initiatives. Compiles and analyzes data as requested, aids in the implementation of change, and assists in monitoring the effectiveness of improvement efforts.
Maintains all records for at least two years.
Education and experience requirements:
BS Medical Technology or equivalent
Three (3) years of general laboratory clinical experience
Experience with CAP regulations preferred
An equivalent combination of education and experience may be substituted
ASCP certification preferred
When you become an employee at ChristianaCare, you are joining a robust healthcare organization that truly cares about their patients and their caregivers. For the second consecutive year, Forbes magazine has ranked ChristianaCare as one of the best large health systems to work for in the United States! Guided by excellence and love, our Caregivers enjoy a multitude of employee benefits that include:
Full Medical, Dental, Vision and other insurance benefits
403 (b) with an employer match
Diverse and Inclusive culture
Generous paid time off with annual roll-over and opportunities to cash out
12 week paid parental leave
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