Clinical Laboratory Compliance Specialist
About The Position
Your responsibilities may include, but are not limited to: 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.
Requirements
- Bachelor's degree in clinical laboratory science from an accredited institution or a bachelor's degree in a Chemical, Physical, or Biological Science required.
- Five years' clinical laboratory experience required.
Nice To Haves
- Master's degree (MBA, MHA, Masters in a Chemical, Physical, or Biological Science) preferred.
- ASCP preferred.
- Specialty certification preferred.
Responsibilities
- 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.
- 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.
Benefits
- Paid Time Off programs
- Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
- Flexible Spending Accounts for eligible health care and dependent care expenses
- Family benefits such as adoption assistance and paid parental leave
- Defined contribution retirement plans with employer match and other financial wellness programs
- Educational Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
