Regulatory Accreditation Compliance Specialist ACL

Overview

At Atrium Health Wake Forest Baptist, we take pride in offering a dynamic and fulfilling work environment.  Joining our team means becoming an essential part of a leading healthcare institution that is committed to providing exceptional patient care and advancing medical research.

This role will oversee the continuous accreditation readiness for assigned laboratories and provide guidance with respect to regulatory and accreditation requirements.  Will conduct scheduled internal risk assessments of assigned laboratories; identify deficiencies and gaps from regulatory standards; create reports; and share this information with laboratory leaders.

Position Highlights: 

• Shift Schedule:  Full time (40 hours) Days
• Department:  Regulatory Compliance
• Location:  This role will have the Greater Charlotte Market as the home base with the primary focus on laboratories within the Greater Charlotte Market; however, will still be required to serve other locations within the Southeast Region on occasion.  

What We Offer:

• Day 1 Health Coverage: Amazing health insurance with the option of copay or HSA eligible plans
• Wellness Incentives: Up to $1,350/year in wellness incentives through our LiveWELL program
• Education: Eligible for our Prepaid College Tuition Assistance program (up to $5,250/year)!
• Parental Benefits: Six weeks paid birthing-mother maternity leave & four weeks paid parental leave
• Retirement: Up to 7% employer-paid retirement contributions

Education/Experience/Certifications to Qualify:   

• A baccalaureate degree from a regionally accredited college/university in chemical, physical, biological sciences, or Medical Technology (Clinical Laboratory Science) required by CLIA.
• Minimum of 3 years of lab training and experience or both in a non-waived lab (moderate or high complexity).  
• At least 2 years of supervisory experience in a diagnostic laboratory setting highly preferred.
• Must meet the CLIA personnel requirement of a Technical Consultant.
• Basic knowledge of CLIA and accreditation (CAP, ASHI, AABB, etc) requirements preferred.

Essential Functions:  

• Conduct scheduled internal risk assessment of assigned laboratories to identify quality issues, nonconformities and opportunities for improvement.  Provide on-site guidance & education as needed during internal inspections to assist with improved compliance. Compile deficiency reports and distribute them to lab leadership.
• Assists leader with organizing and coordinating on-site inspections, interim self-inspections and reciprocal (off-site) inspections for assigned laboratories.  Participate in regulatory and accreditation inspections. Assist Lab Operational Leaders and the Quality & Patient Safety Teams  as needed in the review and approval process  to regulatory and accreditation findings.
• Maintain the CAP website for all facilities, keeping the website up to date. Complete the reapplication documents for CAP accredited facilities and submit CLIA certficates renewals for CAP accredited sites. 
• Maintain expert competence in regulatory and accreditation standards to include CLIA, College of American Pathologists (CAP), ISO15189, AABB, ASHI, JCAHO, DNV, etc. and communicates relevant changes to appropriate leaders and staff. 
• Maintain close working relationship with leaders of the assigned laboratories to ensure the performance and quality of services conform to established regulatory and accreditation requirements and to support constant state of readiness for accreditation reviews.
• Maintain and coordinate communication between assigned laboratories and provide assistance where indicated on regulatory and accreditation related issues. 
• Provide education and training on compliance and accreditation matters.
• Participate in the review, analysis and development of new tracers and audit plans within the laboratory as needed. 
• Ensure laboratories maintain current federal, state and local licensure and accreditations, as applicable.
• Prepare reports and presentations as requested.
• Assist with enterprise laboratory quality initiatives.

Skills/Qualifications:

• This role requires frequent travel within the enterprise system. 
• Ability to work independently and collaboratively
• Ability to communicate professionally and effectively including verbal, nonverbal, and active listening skills
• Effective leadership, teaching, coaching, and interpersonal skills
• Ability to organize data and generate reports
• Organization, planning, and delegation skills
• Sound and timely decision-making skills
• Highly motivated and results-oriented