JOB SUMMARY: Responsible for assisting laboratory staff, managers, directors, medical directors, administrators and CLIA Laboratory Directors with monitoring, coordination and implementation of a variety of regulatory standards (CAP, COLA, CLIA, TJC), quality assurance/quality control practices and safety standards across all Wake Forest Baptist Network entities and affiliates ( WFBH (hospital and clinics), LMC, DMC, Wilkes, Community Physician Practices and Cornerstone) that engage in any level, Waived or Non-Waived, of laboratory testing. Required to work closely with other non-laboratory professionals such as nurse/clinic managers, researchers; members of the Wake One and IT build teams to meet the various needs of the world of compliance such as: point of care testing, laboratory inspections, quality assurance reporting and general safety practices for patients and the employee.

EDUCATION/EXPERIENCE: 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.

LICENSURE, CERTIFICATION, and/or REGISTRATION: ASCP preferred. Specialty certification preferred.

ESSENTIAL FUNCTIONS:

• Assists with the coordination, development, implementation, and evaluation of a compliant laboratory program for all entities of Wake Forest Baptist Health (WFBH, LMC, DMC, Wilkes, Community Physicians and Cornerstone). Develops policies and procedures to address regulatory requirements in each of these areas. Works collaboratively with lab and hospital leadership in each area to ensure quality and consistency is achieved.
• Develops and coordinates required training and competency assessments as needed for all complexities of testing, safety, quality and compliance regulations. Qualifications of the compliance team member must meet the CLIA defined requirements of the posted position.
• Provides assistance to areas that need help with completing the CMS-116 CLIA notification form for updated lab information or the request of a new testing location.
• Provides consultative support regarding interpretation and implementation of regulatory standards.
• Monitors all ECRI and Recall alerts pertaining to the laboratory (Clinical, Anatomic and Point of Care). Ensure that lab sections respond accordingly to requests for information.
• Monitors Quality Assurance (QA) activities for testing sites and ensures regulatory compliance of the Quality programs. Develops a culture that recognizes quality assurance as an integral component of daily operations.
• Provides consultative support for Proficiency Testing needs for all testing sites and locations. Assists labs as needed with PT exception reports within a specified timeframe. Prepares for and participates in all applicable accreditation inspections as needed across all WFBH entities.
• Provides education and training as needed and promotes the CAPA process for all laboratory areas.
• Promotes, educates and ensures patient safety by assessing and addressing needs and issues related to all areas of laboratory testing.
• Promotes and ensures chemical safety for all areas of laboratory by maintaining the Chemical Hygiene Plan.
• Ensures delivery of consistently high-quality professional services by maintaining knowledge and expertise of laboratory testing technology and compliance standards/regulations for CAP, COLA, CLIA and TJC. Maintains exceptional level of customer service; addresses and resolves complaints; serves as an example by providing excellent service to internal and external customers, employees and patients. Promotes collegial management in areas of expertise. Communicates effectively by utilizing appropriate communication channels.
• Maintains skills for the development of testing personnel including participation in training and education programs; maintaining working knowledge of infection control concepts, internal/external disaster plans and risk management concepts related to safe environment, accident prevention, confidentiality, and potential liability; demonstrating knowledge of clinic, interdepartmental and laboratory goals, standards, and operations. Stays abreast of and complies with organizational events through reading posted communications and attending assigned meetings.

SKILLS/QUALIFICATIONS: Ability to make sound and timely decisions. Ability to act as a leader, team player and group facilitator. Effective interpersonal and communication skills, (oral, written and listening). Knowledge of risk management principles and issues regarding patient safety. Ability to discuss testing issues with non-laboratory personnel Strong organizational skills with ability to work in a fast-paced environment independently or as part of a team Detail oriented with strong analytic/problem solving skills; knowledge of laboratory theory and technique. Computer skills to include; Word, Excel, Access, Outlook, and PowerPoint. Basic knowledge of CLIA, CAP, COLA and TJC laboratory and point of care testing standards. Basic knowledge of the OIG Model Compliance Plan for Laboratories.

WORK ENVIRONMENT: Clean, well lit, and comfortable climate. Contact with patients under wide variety of circumstances. Subject to highly stressful situations Moderate noise environment. Possible exposure to infectious and contagious diseases. Possible exposure to radiation hazards. Exposure to housekeeping/cleaning agents/chemicals. Subject to many interruptions. Subject to irregular hours.