Laboratory Quality Coordinator

Under direction of the Director of Laboratory Operations, the Laboratory Quality Coordinator supports the Quality Management System (QMS) for all Clinical Pathology (CP) laboratory sections in compliance with CAP and CLIA regulations. This role functions under the direct oversight of the Director of Laboratory Operations, who retains quality oversight, regulatory communication, committee reporting, and approval of corrective and preventive actions (CAPAs).

The Quality Coordinator is fully integrated into Clinical Pathology laboratory quality activities, supporting daily quality operations, data management, and regulatory readiness while partnering with laboratory supervisors, technical staff, and leadership to maintain high standards of patient care, accuracy, and safety.

Qualifications

Education/Experience:

Required:

Minimum two (2) years full-time clinical pathology laboratory experience.             

Preferred:

Associate’s or Bachelor’s degree in laboratory science. (MLT, MT, MLS)

ASCP/AMT certification (MLS/MLT/MLS)

Required Skills:

• Demonstrates comprehensive theoretical and operational job knowledge in designated specialty.
• Demonstrates knowledge of organizational/departmental policies and procedures.
• Proficiency in Microsoft Office (Word, Excel and Outlook) and Laboratory Information Systems.
• Works in a biohazard environment, practicing good safety habits

Responsibilities

• Support the CP Quality Management System in alignment with CAP and CLIA requirements.
• Assist with implementation and maintenance of CP-specific quality plans, indicators, and performance metrics.
• Assist with CAP accreditation and maintenance of the CAP organizational profile.  
• Promote standardization of quality practices across CP sections.
• Support continuous improvement initiatives related to testing accuracy, turnaround time, and error reduction.
• Monitor and track CAP compliance across CP sections.
• Assist with Proficiency Testing (PT) processes including submission tracking, review of PT failures and corrective action documentation, review PT responses and ensure compliance.
• Support ongoing CAP and CLIA compliance for CP disciplines.
• Assist with coordination of CP self-inspections and internal audits.
• Assist with maintaining inspection readiness documentation.
• Track and coordinate responses to inspection deficiencies under director oversight.
• Track, document, and monitor CAPAs related to revised reports, PT discrepancies, nonconformance’s.
• Collect, document, analyze, review quality indicators.
• Prepare CP quality dashboards and reports for leadership review.
• Maintain accurate quality documentation and data retention in accordance with regulatory requirements.
• Ensure laboratory general and quality SOPs are up-to-date and follow CAP guidelines.
• Support SOP writing and review, scheduled policy and procedure reviews, staff acknowledgment tracking
• Assist in providing laboratory and hospital staff guidance on laboratory quality processes and QMS documentation and regulatory expectations.
• Serve as a CP quality resource for staff questions and audit readiness.
• Assist in preparing laboratory quality data and summaries for laboratory leadership, quality, patient safety, or regulatory committee meetings.
• Support the Director of Laboratory Operations with data preparation and analysis.
• Adheres to all established CLIA, HIPAA, OSHA and laboratory safety requirements.
• Participate in government or regulatory agency inspections, if needed.
• Other duties as assigned. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.

HIPAA:  This position will have access to the Protected Health Information described below, in order to carry out the duties related to the position at Hays Medical Center, based on the following criteria:

• Primary – required (routine) to do the job;
• Secondary – required for the job, but mostly by exception; and
• None – no approved access

Description of Information:

Secondary:

• • Coding Information (clinical information that is in (alpha) numeric format): ICD-9 Codes, Rev Codes, CPT Codes
  • Clinical Information (information that describes a patient’s health status): Diagnosis, Reports/Medical Notes, Test Results, Problem List, Procedures, History and Physical
  • Patient Demographic Information (information used to identify a person): Name, Date of Birth, Address, Race, Marital Status, Religion
  • Financial Information/Insurance (information related to insurance, billing, and payment): Billing Information, Payer Name, Payer ID, Account Balances, Plan Elements Covered, Payment Information, Payment Rates

Infection Control: This position will include initial and ongoing training in dealing with infection control. Training could include, but is not limited to, blood-borne pathogens, bodily fluids, and biohazardous materials, as it applies to your daily work environment.

Patient Interaction: None