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CLS, Quality Assurance Specialist

Company: Medical Science & Computing (MSC), a Dovel company
Location: Bethesda
Posted on: January 25, 2023

Job Description:

Job Family:

Scientific Research & Analysis (Digital)
Travel Required:

Clearance Required:

Ability to Obtain Public Trust

What You Will Do:
We are currently searching for a CLS (Clinical Laboratory Scientist), Quality Assurance Specialist to support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is onsite in Bethesda, MD.

  • Participate in planning and coordinating the Department's 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 department's 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 Department's 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 hospital's 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.
  • This is an essential worker position.

    What You Will Need:
    • Bachelor's Degree in a science-related discipline and certification as an MT (ASCP) or similar.
    • One (1) to three (3) years of experience performing various laboratory quality assurance activities such as, 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, etc.
    • Two (2) to five (5) years of experience in clinical laboratory technical supervision may be substituted for the above quality assurance experience requirement.
    • 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.
      What Would Be Nice To Have:

      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 Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information . click apply for full job details

Keywords: Medical Science & Computing (MSC), a Dovel company, Bethesda , CLS, Quality Assurance Specialist, Other , Bethesda, Maryland

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