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Regulatory Accreditation Compliance Specialist ACL

4 months ago

West Allis, United States Advocate Health Full time

MAJOR RESPONSIBILITIES

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 certificates 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.

MINIMUM EDUCATION AND EXPERIENCE REQUIRED

License/Registration/Certification Required: MT/MLS Certification or equivalent required

Education Required: Bachelor's Degree from a regionally accredited college/university in chemical, physical, biological sciences, or Medical Technology (Clinical Laboratory Science) required by CLIA.

Experience Required: Typically requires 3 years of lab training and experience or both in a non-waived lab (moderate or high complexity). Basic knowledge of CLIA and accreditation (CAP, ASHI, AABB, etc) requirements preferred. At least 2 years of supervisory experience in a diagnostic laboratory setting highly preferred and must at minimum, meet the CLIA personnel requirement of a Technical Consultant.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED

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

Basic to intermediate MS Office skills

PHYSICAL REQUIREMENTS AND WORKING CONDITIONS

This position requires travel, therefore, will be exposed to weather and road conditions.

Operates all equipment necessary to perform the job.

Exposed to a normal office environment.

Must have a current state driver's license.

Must have the ability to travel, sit, stand and walk throughout laboratories.

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.