Clinical Laboratory Scientist (Quality Manager/Back-up Contracting Officer Representative)

Job Title

Consultant, Facilitator, Trainer, and Technical Advisor

Duties

Serves as a consultant, facilitator, trainer, and technical advisor to staff at all levels to ensure facility compliance with and design, implementation and maintains the PALMS Quality Management Program in alignment with clinical laboratory accreditation and regulatory standards that include, but are not limited to, Joint Commission (JC), College of American Pathologists (CAP), National Enforcement Office (NEO), Veteran's Health Administration (VHA) Food and Drug Administration (FDA), Association for the Advancement of Blood and Biotherapies (AABB), and the Office of the Inspector General (OIG).

Ensures the laboratory maintains continuous readiness and supports the organization's performance improvement and patient safety programs.

Develops, reviews, and maintains service-level policies, SOPs, and quality documentation while overseeing document control, change management and version governance for all PALMS quality documents.

Leads regulatory readiness activities, including gap analyses, tracer activities, document reviews and corrective action planning, conducts risk assessments, FMEAs and root-cause analysis for adverse events, near misses and process failures.

Maintains a laboratory performance improvement program working with laboratory staff at all levels ensuring monitoring of components and customer feedback.

Monitors quality indicators, proficiency testing, Internal audits, and external assessments; analyzes trends and recommends corrective/preventive action.

Co-Chairs Laboratory QA committee and prepares quarterly QA reports and annual assessment of QA program for clinical laboratory, Anatomic pathology QA and ancillary testing QA.

Implements effective processes and system controls with corrective and preventive actions (CAPA) to ensure the highest possible product quality, service quality, and patient safety.

Attends Accreditation committee meetings and other meetings as required.

Advises lab management on quality management concerns that could impact other services and assists with the necessary follow-up.

Investigates patient safety events, JPSRs, develops action plans, and monitors effectiveness of interventions.

Prepares Agenda for Quality Assurance Committee and finalizes minutes. Assists with Ancillary Blood and Laboratory Utilization Committee preparing agenda/reports and finalizing minutes as needed.

Incumbent must possess and maintain a current unrestricted state driver's license.

Occasional travel to Community Based Outpatient Clinics/Community Living Centers is required.

Contracts and Regulatory Oversight

Provides consultative services and documentation management to management at all levels of the organization as it applies to quality management of contracts for supplies and services in a clinical laboratory setting.

Performs maintenance of a laboratory contract quality management program and ensures monitoring of components and customer feedback for all contracts.

Identifies, defines, and resolves issues associated with complex aspects of the collected data and monitors fiscal systems and contract performance indicators. Interacts with management officials in PLMS, Eastern Colorado Health Care System (ECHCS) and VISN 19 Contracting to ensure continuous readiness for regulatory agency inspection and uninterrupted essential laboratory services and supplies be maintained.

Research clinical requirements from all laboratory disciplines and receive information from technical supervisors/specialists sufficient to initiate, maintain and monitor contract requirements in a manner as to provide safety and efficiency of laboratory operations.

Participating in acquisition planning, requirements development, and performance work statements for laboratory services, equipment, and supplies.

Monitoring contractor performance to ensure compliance with contract terms, specifications, and quality standards.

Documenting contractor performance issues and communicating concerns to the Contracting Officer.

Provides technical guidance for sections and writes statements of work, justification of sole source, and independent government estimates and conducts market research in conjunction with Technical Supervisors to maintain uninterrupted clinical laboratory supplies and services.

Work Schedule: Monday thru Friday 7:00 a.m.-3:30 p.m.

Telework: Not Available

Virtual: This is not a virtual position.

Functional Statement #: GS-0644-12-554-613320

Relocation/Recruitment Incentives: Not Authorized

EDRP Authorized: Former EDRP participants ineligible to apply for incentive. Contact View email address on click.appcast.io, the EDRP Coordinator for questions/assistance.

Permanent Change of Station (PCS): Not Authorized