CLS, Quality Assurance Specialist

Job Family:

Travel Required:

Clearance Required:

We are currently searching for a Clinical Laboratory Scientist with quality assurance experience to provide support to the National Institutes of Health (NIH) Department of Laboratory Medicine (DLM). This is a full-time on-site opportunity based in Bethesda MD.

What You Will Do:

• Participate in planning and coordinating the Departments comprehensive quality assurance program in accordance with the requirements of regulatory and accrediting organizations the policies practices and procedures of the NIH and state of the art practices in laboratory medicine medical research patient care and medical training.

• Participate in the development implementation and coordination of goals activities and systems in the departments Quality Assurance Program to ensure compliance with Federal laws and with accrediting agencies requirements.

• Develop and implement departmental quality management standard operating procedures (SOPs) policies and instructions including the Departments Quality Assurance Plan improvement and corrective action plans inspection and assessment protocols records management plans and computer systems validation. Some of these policies address internal audits and error and accident reports.

• Develop implement and coordinate departmental policies for product recalls error and accident reports personnel job specific training requirements personnel competency assessment and internal audits.

• Develop written procedure manuals.

• Ensure manuals are kept current and coordinate the annual update and review of Service and Departmental policies which define the standards for work processes and the interpretation of laboratory reports; develop equipment and maintenance procedures to ensure that equipment and ancillary systems are capable of consistently operating within established limits and that tolerances and schedules exist for equipment monitoring calibration and maintenance.

• Develop and implement procedures concerning fire disaster and safety; monitor compliance with these procedures; and conduct in-service training sessions.

• Participate in or conduct evaluations and studies of department operations to ensure compliance with regulatory requirements of accrediting organizations; HHS NIH and Clinical Center policies procedures and practices; and state of the art practices in patient care and laboratory quality management.

• Advise the Laboratory Manager and the Quality Manager concerning all regulatory practices and compliance matters and on the use of resources reorganizing work and revising procedures to ensure quality improvement and compliance with regulatory agencies.

• Work directly with section leadership technical staff and senior staff in the implementation of new or changing programs and policies (e.g. in response to CLIA88 or CAP) involving staffing training quality assurance/improvement (QA/I) approaches and reports and preparation for inspections.

• Provide consultation to all Service Chiefs (MDs) Supervisory Medical Technologists (Chief Technologists) and Team Leaders in the program for the design development implementation administration supervision over and compliance with the QA/I program as required by accreditation organizations to ensure Quality Assurance Program reviews comply with regulatory agency standards.

• Assist in coordinating self-inspections for accreditation from the CAP on alternate years and with the preparation of laboratory readiness for inspections and the responses to the on-site inspection; assist in the preparation of written responses for the CAP Lab General Checklist.

• Develop policy and coordinate work related changes with other hospital departments; i.e. patient care physicians Nursing Outpatient Services Transfusion Medicine etc. and responds to the recommendations from these departments.

• Inform department personnel of changes in policy and procedures through memoranda and/or meetings and ensures that written standards of procedure and policy are adhered to by the staff with additional responsibility for the training and enforcement of these standards.

• Present training sessions on quality management of clinical laboratories technical information and management theory and assists in conducting discussion sessions for first line and senior supervisors on a variety of management issues. Ensures that each employee is provided with the necessary SOPs to perform assigned duties and that the employee is adequately trained for performing that particular procedure and the employees competency in that procedure is assessed annually.

• Provide guidance to patient-care physicians on specimen collection and handling techniques and the implementation and limitations of test procedures. Reviews and ensures the accuracy of information distributed to patient care providers and provides this information through presentations scheduling and chairing meetings around a particular patient care topic and preparing articles for nursing bulletins.

• Ensure that all record keeping systems (manual and automated) comply with Clinical Center and regulatory guidance.

• Participate in the design and implementation of an internal audit system to evaluate wait times in the outpatient phlebotomy services turnaround times for result delivery number of cancelled specimens and occurrences or sub-par performance due to deviations from practice standards and the number of safety incidents as well as other quality indicators.

• Participate in the oversight of incident reports filed by or against the department in the hospitals electronic incident reporting system. Assist in tracking filings to identify recurrent issues that may indicate a systematic problem that needs to be addressed. Analyze data from the Quality Assurance Program used by nurses and physicians to document problems. Provide documentation in the to outline specifics of the occurrence and determine if the incident reflects a legitimate failure of service.

• For the proficiency testing programs receive and distribute unknowns collects and reviews results and submits results to outside agencies. Maintain files review and compare performance to referee and peer participants investigate discrepancies and institute changes to correct deficiencies. Review reports submitted by Services for appropriate responses and corrective action.

• Prepare reports to monitor laboratory operations and personnel usage to identify operational problems and to compare against like organizations for benchmarking. Prepare and oversees productivity measurements that monitor test procedure performance characteristics.

• Serve on NIH Committees as a representative for the program; collaborate with NIH and researchers and medical staff regarding such issues as quality assurance process improvement and accreditation.

• Perform all other related duties as assigned.

What You Will Need:

• Bachelors Degree in a science-related discipline.

• MT (ASCP) or equivalent certification.

• FOUR (4) years of experience performing various laboratory quality assurance activities including but not limited to proficiency testing (PT) monitoring (not just PT test performance); instrument/method calibrations validation and QC monitoring quality assurance indicator data collection and monitoring.

• Strong communications skills both oral and written.

• Excellent organizational and time management skills

• Strong computer skills

• Ability to lift 10 30 pounds.

• Excellent hand-eye coordination.

• Must be able to OBTAIN and MAINTAIN a Federal or DoD PUBLIC TRUST; candidates must obtain approved adjudication of their PUBLIC TRUST prior to onboarding with Guidehouse. Candidates with an ACTIVE PUBLIC TRUST or SUITABILITY are preferred.

What Would Be Nice To Have:

• Two (2) to five (5) years of experience in clinical laboratory technical supervision may be substituted for the above quality assurance experience requirement.

What We Offer:

Guidehouse offers a comprehensive total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical Rx Dental & Vision Insurance

• Personal and Family Sick Time & Company Paid Holidays

• Parental Leave

• 401(k) Retirement Plan

• Group Term Life and Travel Assistance

• Voluntary Life and AD&D Insurance

• Health Savings Account Health Care & Dependent Care Flexible Spending Accounts

• Transit and Parking Commuter Benefits

• Short-Term & Long-Term Disability

• Tuition Reimbursement Personal Development Certifications & Learning Opportunities

• Employee Referral Program

• Corporate Sponsored Events & Community Outreach

• annual membership

• Employee Assistance Program

• Supplemental Benefits via Corestream (Critical Care Hospital Indemnity Accident Insurance Legal Assistance and ID theft protection etc.)

• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse

Guidehouse is an Equal Opportunity EmployerProtected Veterans Individuals with Disabilities or any other basis protected by law ordinance or regulation.

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