Lab Compliance & CQI Coordinator

About the role

The Lab Compliance & CQI Coordinator is a dedicated subject matter resource responsible for maintaining the organization's CLIA compliance program, supporting quality improvement initiatives, and partnering with the RN Quality Manager on clinical quality data collection and reporting. This role fills a critical gap in the previous model where lab compliance was a shared duty with no clear owner — creating regulatory exposure and inconsistent documentation. The Coordinator works closely with the RN Quality Manager and reports into Operations, serving all three primary care sites.

Responsibilities

• CLIA Compliance & Laboratory Oversight
  • Serve as the primary CLIA compliance resource across all three sites; maintain the organization's posted Certificates of Waiver and associated documentation
  • Serve as primary VFC/VFA Coordinator for all sites
  • Ensure all point-of-care testing (POCT) is performed in accordance with CLIA waiver requirements and manufacturer instructions
  • Maintain quality control (QC) documentation, equipment logs, reagent logs, and temperature monitoring records for all sites
  • Coordinate and track annual lab proficiency testing; ensure timely completion and documentation
  • Conduct periodic internal audits of lab practices at each site; identify deficiencies and develop corrective action plans in coordination with the RN Quality Manager
  • Serve as the primary MA point of contact for external CLIA surveys, HRSA site visits, FTCA reviews, and other compliance audits affecting laboratory services
  • As the subject matter expert, ensures all MA staff in coordination with the MA Training Specialist, maintain CLIA-compliant POCT procedures and documentation requirements, HRSA site visits, FTCA reviews, and other compliance audits affecting laboratory services
  • Monitor for changes in CLIA regulations, CMS guidance, and POCT manufacturer updates; update SOPs accordingly in a timely fashion
• Quality Improvement (CQI) Support
  • Partner with the RN Quality Manager to support UDS (Uniform Data System) reporting, HEDIS measure tracking, and clinical quality metric collection
  • Assist in data collection, analysis, and preparation for the organization's annual quality improvement plan
  • Assist with gap analysis on clinical quality metrics at the site and patient panel level; maintain ability to present findings to the Quality team when appropriate
  • Support root cause analysis (RCA) for lab-related incidents, near misses, and quality events; document findings and corrective actions
  • Participate in the organization's Quality Committee; present compliance and CQI updates as requested
  • Assist in implementing evidence-based quality improvement interventions related to preventive care, chronic disease management, and clinical support workflows
• Policy, SOP & Documentation Management
  • Own and maintain all laboratory-related policies and standard operating procedures (SOPs) across sites; ensure annual review and updates
  • Maintain organized, audit-ready documentation for all CLIA and compliance-related records
  • Ensure all three sites have consistent, up-to-date reference materials for POCT and lab workflows

Qualifications

• Associate's degree in health sciences, biology, medical assisting, or related field required; Bachelor's preferred
• Minimum 2–3 years of experience in a clinical setting with direct involvement in lab operations, CLIA compliance, or quality improvement required
• MA certification (CMA, RMA, CCMA, or equivalent) preferred; phlebotomy certification a plus
• Experience with UDS reporting, HEDIS measures, or HRSA compliance preferred (FQHC context strongly preferred)

Knowledge, Skills & Abilities

• Knowledge of: Community clinic or medical office operations; pertinent federal, state and local laws and regulations regarding issues affecting licensed community clinics, e.g., OSHA requirements
• Skills in: Oral and written communication; bilingual (English/Spanish) preferred; organization of work and attention to detail; using standard medical office equipment and performing standard clinic medical and laboratory tests; using a computer for word processing, data entry and e-mail
• Ability to: Share the EDCCHC mission and work well in a team environment; develop rapport and work with people of all ages, cultural, religious, social and ethnic backgrounds; be courteous and utilize professional behavior in all interactions with the public and staff; maintain a high level of confidentiality of client information; appropriately deal with difficult situations; make decisions within certain prescribed limits according to Policies and Procedures; determine priorities in workload and meet established deadlines; work in a fast-paced environment with frequent interruptions and maintain a positive disposition at all times; be flexible in accepting, changing or carrying out assignments
• Working knowledge of CLIA regulations, point-of-care testing requirements, and QC documentation standards
• Experience with UDS reporting, HEDIS measures, or HRSA compliance preferred (FQHC context strongly preferred)
• Strong attention to detail and comfort managing documentation-heavy compliance programs
• Data literacy: ability to work with spreadsheets, EMR-based quality reports, and basic data analysis
• Strong written communication skills; ability to draft and maintain clear SOPs and compliance documentation

Core Competency Profile

• Understands and applies CLIA and HRSA requirements accurately and proactively
• Detail Orientation: Catches documentation gaps before auditors do; maintains airtight records
• Comfortable pulling, interpreting, and presenting clinical quality metrics
• Identifies compliance risks and improvement opportunities without being directed
• Maintains consistency across all sites with different staff and cultures

Physical Requirements

Normal health center/interior office environment. See, hear, talk, walk, sit and/or stand for long periods of time, reach, stoop, bend, lift and/or carry up to 50 lb., transfer clients of any weight and may be required to assist patients on to and off of examination table; may be required to assist patients who have a mobility impairment including but not limited to: pushing a wheelchair and assisting patients with crutches or braces, etc. Repetitive hand movement; use and view a computer, operate copier, telephone; read and write English. Significant portions of daily assignment may also involve application of manual skills requiring eye-and-hand coordination in combination of finger dexterity.