The specialist responsible for supporting and maintaining laboratory quality, regulatory compliance, standardization, and continuous process improvement across a multi-campus laboratory system. This position provides technical and quality expertise across Chemistry, Hematology, Blood Bank/Transfusion Services, Microbiology, and Anatomic Pathology, ensuring laboratory practices, procedures, documentation, and quality systems align with applicable CLIA, CAP, regulatory, accreditation, and organizational requirements.

The specialist works collaboratively with laboratory managers, supervisors, pathologists, the Medical Director, Systems Director, Laboratory Operations, and Hospital Quality teams to promote consistent practices, strengthen the Quality Management System (QMS), prepare for inspections, and identify opportunities for process improvement across all three laboratory campuses.

The position should demonstrate the ability to understand discipline-specific regulatory and quality requirements while maintaining a system-wide perspective on laboratory quality and standardization.

Regulatory Compliance & Inspection Readiness

1. Support ongoing compliance with CLIA, CAP, and other applicable regulatory and accreditation requirements.
2. Coordinate and support laboratory inspection readiness activities across three campuses.
3. Assist with preparation for CAP inspections, CLIA surveys, internal audits, and other regulatory reviews.
4. Conduct or support regulatory gap assessments, tracers, audits, and mock inspections.
5. Monitor findings, deficiencies, corrective actions, and follow-up activities to ensure timely resolution.
6. Maintain awareness of changes to regulatory and accreditation requirements and communicate applicable updates to laboratory leadership and staff.
7. Partner with laboratory leaders to ensure required documentation, records, competencies, quality indicators, and corrective actions are maintained.

SOP Development, Review & Standardization

1. Write, review, revise, update, and maintain laboratory Standard Operating Procedures (SOPs) and related controlled documents.
2. Ensure procedures accurately reflect current laboratory practices, regulatory requirements, manufacturer instructions, and best practices.
3. Coordinate SOP review and approval with appropriate laboratory managers, supervisors, pathologists, Medical Director, and other subject-matter experts.
4. Identify opportunities to standardize procedures and practices across all three campuses.
5. Support document control and ensure obsolete procedures are appropriately retired and current versions are readily available.
6. Assist with the development and implementation of standardized workflows, forms, checklists, and quality documentation.

Quality Management System & Quality Indicators

1. Support the development, implementation, monitoring, and continuous improvement of the laboratory Quality Management System (QMS).
2. Monitor laboratory quality indicators and assist leaders in identifying trends, risks, and opportunities for improvement.
3. Assist with data collection, analysis, trending, and reporting of quality metrics.
4. Support investigation of quality events, nonconformances, errors, complaints, and opportunities for improvement.
5. Participate in root cause analysis and development of effective corrective and preventive actions (CAPA).
6. Help ensure quality indicators are meaningful, actionable, consistently defined, and standardized across campuses.
7. Assist with maintaining quality plans, audit schedules, corrective action documentation, and quality reports.

Process Improvement & Standardization

1. Collaborate with laboratory leadership to identify and implement process improvement initiatives.
2. Evaluate laboratory workflows and recommend opportunities to improve quality, efficiency, patient safety, and regulatory compliance.
3. Support standardization of laboratory processes, procedures, documentation, and quality practices across three campuses.
4. Participate in Lean, Six Sigma, PDSA, RCA, CAPA, and other continuous improvement activities as appropriate.
5. Assist with implementation of new processes, equipment, systems, policies, and regulatory requirements.
6. Monitor the effectiveness of implemented improvements and assist with sustainability efforts.

Cross-Departmental Collaboration

1. Establish strong working relationships with:
   • Laboratory Managers and Supervisors
   • Pathologists
   • Medical Director
   • System Director
   • Laboratory Operations
   • Hospital Quality
   • Nurse Educator
   • Nursing Leaders
   • Other clinical and administrative stakeholders
2. Serve as a resource for laboratory staff and leadership regarding quality, regulatory, accreditation, documentation, and standardization requirements.
3. Facilitate communication between campuses to promote consistent interpretation and implementation of laboratory policies and procedures.
4. Participate in laboratory quality, regulatory, operational, and process improvement meetings as assigned.

Technical Laboratory Scope

• Provide quality and regulatory support across multiple laboratory disciplines, including:
  • Chemistry
  • Hematology
  • Blood Bank/Transfusion Services
  • Microbiology
  • Anatomic Pathology

DCH Standards: 

• Maintains performance, patient and employee satisfaction and financial standards as outlined in the performance evaluation.
• Performs compliance requirements as outlined in the Employee Handbook
• Must adhere to the DCH Mission, Vision, and Values including creating positive relationships with patients/families, coworkers, colleagues and with self.
• Performs essential job functions in a manner that ensures the safety of patients, visitors and employees.
• Identifies and reduces unsafe practices that may result in harm to patients, visitors and employees.
• Recognizes and takes appropriate action to reduce risks and hazards to promote safety for patients, visitors and employees.
• Requires use of electronic mail, time and attendance software, learning management software and intranet.
• Must adhere to all DCH Health System policies and procedures.
• All other duties as assigned.

Required:

• • Baccalaureate degree or equivalent in medical laboratory science or biological science with certification as a Medical Laboratory Scientist, Medical Technologist or Clinical Laboratory Scientist by one of the nationally recognized certification agencies: American Society of Clinical Pathologists (ASCP) preferred; the American Medical Technologist (AMT) acceptable.
  • A minimum of three (3) years of certified laboratory experience is required; experience in laboratory quality management preferred. Relevant laboratory or healthcare quality experience.

  OR

  • Associate degree in applied science (AAS) in Medical Laboratory Technology (MLT) with certification as a clinical laboratory scientist or medical technologist by one of the nationally recognized certification agencies: American Society of Clinical Pathologists MLT(ASCP) preferred; the American Medical Technologist MLT (AMT).  
  • A minimum of 5 years certified laboratory experience is required
  • Relevant laboratory or healthcare quality experience.

Preferred:

• Master's degree in a relevant field.
• MLS/MT or other applicable laboratory professional certification.
• Experience with CAP inspection preparation and/or participation in regulatory inspections.
• Experience working with multiple laboratory disciplines.
• Experience with quality improvement methodologies, root cause analysis, CAPA, Lean, Six Sigma, or similar methodologies.
• Experience supporting quality programs across multiple laboratory sites or campuses.
• Experience in laboratory quality management

Other Skills:

• Strong knowledge of CLIA and CAP requirements and laboratory regulatory/accreditation processes.
• Experience developing, reviewing, revising, and maintaining laboratory SOPs.
• Demonstrated knowledge of laboratory Quality Management Systems (QMS) and quality indicators.
• Strong analytical, organizational, communication, and problem-solving skills.
• Ability to work effectively with multidisciplinary teams and laboratory leadership.
• Ability to manage multiple projects and priorities across multiple laboratory locations.
• Strong understanding of laboratory regulatory and accreditation requirements.
• Ability to interpret regulatory requirements and translate them into practical laboratory processes.
• Excellent technical writing and document-management skills.
• Strong attention to detail and ability to identify compliance gaps and process risks.
• Ability to analyze quality data, identify trends, and develop meaningful recommendations.
• Strong interpersonal and collaboration skills.
• Ability to influence standardization without direct supervisory authority.
• Ability to communicate effectively with frontline laboratory staff, technical leaders, pathologists, physicians, and hospital leadership.
• Strong project management and organizational skills.
• Ability to work independently while functioning effectively as part of a multidisciplinary team

Must be able to read, write legibly, speak, and comprehend English.

Working Conditions 

• Must possess manual dexterity and fine motor skills.
• Able to stand, walk, and sit for long periods of time, reach and bend. Is able to lift a maximum of 50 pounds with frequent lifting and/or carrying objects weighing up to 20 pounds.
• Includes exposure to human body fluids, disease, infection, laboratory chemicals and hazardous material. Requires wearing common protective or safety equipment. 
• Frequent interaction with others in the Laboratory and other departments in person, by telephone or by email, to resolve issues with patient care that are impacted by laboratory testing. Due to the emotional and/or emergency nature of patient care some customers may be unpleasant, angry or discourteous in their requests for Laboratory services.
• Must be able to perform the duties with or without reasonable accommodation.
• Hearing and vision must be normal or corrected to within normal range.
• Normal color vision for those tasks requiring color differentiation.
• Physical presence onsite is essential.