Clinical Laboratory Compliance Specialist

Job Overview

Clinical Laboratory Compliance Specialist at Atrium Health Wake Forest Baptist. This role supports regulatory compliance across Wake Forest Baptist Health entities and affiliates with a focus on laboratory compliance, quality assurance, safety, and patient care.

• Assists with the coordination, development, implementation, and evaluation of a compliant laboratory program for all Wake Forest Baptist Health entities. Develops policies and procedures to address regulatory requirements and collaborates with lab and hospital leadership to ensure quality and consistency.
• Develops and coordinates required training and competency assessments for all testing complexities, safety, quality, and compliance regulations.
• Provides assistance for CMS-116 CLIA notification forms for updated lab information or requests for new testing locations.
• Provides consultative support regarding interpretation and implementation of regulatory standards.
• Monitors all ECRI and Recall alerts pertaining to the laboratory and ensures lab sections respond to information requests.
• Monitors Quality Assurance activities for testing sites and maintains regulatory compliance of quality programs; promotes a culture that treats quality assurance as essential to daily operations.
• Provides consultative support for Proficiency Testing (PT) needs across all testing sites; assists labs with PT exception reports within required time frames; participates in applicable accreditation inspections as needed across WFBH entities.
• Provides education and training as needed and promotes the CAPA process for all laboratory areas.
• Promotes patient safety by addressing needs and issues related to all areas of laboratory testing; ensures chemical safety by maintaining the Chemical Hygiene Plan.
• Maintains knowledge of laboratory testing technology and compliance standards/regulations (CAP, COLA, CLIA, TJC); maintains high levels of customer service and effective communication with internal and external customers.
• Maintains skills for development of testing personnel; participates in training and education programs; stays informed on infection control concepts, disaster plans, risk management, confidentiality, and laboratory goals, standards, and operations.

• Bachelor’s degree in clinical laboratory science from an accredited institution or a bachelor’s degree in a Chemical, Physical, or Biological Science required.
• Master’s degree (MBA, MHA, Masters in a Chemical, Physical, or Biological Science) preferred.
• Five years’ clinical laboratory experience required.

• ASCP preferred.
• Specialty certification preferred.

• Department:
  Wake Forest Baptist Medical Center – Lab:
  Compliance POC Q & S
• Status:
  Full time
• Benefits Eligible:
  Yes
• Hours Per Week: 40
• Schedule:
  
  M-F 8:00am – 5:00pm
• Location:
  
  Winston-Salem campus
• Pay Range: $23.65 – $45.25