Manager, Clinical Labs - Point-Of-Care Testing

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About Duke University Health System Clinical Laboratories

Pursue your passion for caring and innovation as a team member in the state-of-the-art Duke Health laboratories. Duke Health laboratories are College of American Pathologists accredited and Clinical Laboratory Improvement Amendments certified. The multidisciplinary team is committed to serving the rare and complex testing needs of Duke Health's diverse patient population by providing timely and accurate results, educating the next generation of laboratorians, scientists and physicians, and researching and developing the cutting-edge diagnostics of tomorrow.

General Description
Provide overall administrative direction and oversight for policies, procedures, implementation and maintenance of the Quality Control (QC), Quality Assurance (QA), and Quality Improvement (QI) initiatives for the Duke University Hospital (DUH) Point of Care Testing (POCT) Program's. Interacts with Management from other Duke University Hospital System (DUHS) to standardize, implement, and maintain testing activities within the guidelines set by our regulatory agencies. Responsible for managing and coordinating technical activities, tests and operational support for multiple cost centers and/or >30 FTEs and/or broad spectrum of testing.

Duties and Responsibilities
* Manage the operational policies and procedures of the DUH POCT program. Coordinate with Nurse Managers to implement POC testing into their locations and maintain compliance with the DUH POCT program standards.

* Provide direction and support to the staff in the development and monitoring of laboratory programs to include laboratory quality control procedures, installation and maintenance of laboratory equipment and compliance with federal regulations; develop and monitor recruitment, selection, personnel orientation and development and performance appraisal programs and processes.

* Develop and provide technical assistance, instruction and consultation in the implementation of POCT standards, which address: a) Written policies and procedures, b) Quality Control, c) Patient Test Management, d) Quality Assurance, e) Proficiency Testing, and f) Personnel. While maintaining compliance with federal regulations.

* In concurrence with Senior Management, formulate short and long-range goals for DUH POCT, set priorities, assign responsibilities and establish timetables; project future needs and formulate strategies consistent with projections.

* Determine fiscal requirements, make projections and prepare the annual budget; monitor, verify and reconcile expenditure of budgeted funds on a periodic basis, prepare capital budget requests as needed, and ensure compliance with Laboratory policies and procedures.

* Prepare technical reports reflecting testing volumes, evaluation of Quality Control and failure issues, evaluation of Proficiency Testing results and causes of failures, evaluation of instrumentation or testing kit, and the appropriate recommendations or conclusions.

* Plan and conduct meetings with other staff to ensure compliance with established practices, to implement new policies and to keep employees abreast of current changes and standards; represent the unit in interactions with other units and members of the healthcare team.

* Establish schedules, task assignments and duties, maintain liaison with all levels of manage within and outside of Clinical Laboratories.

* Responsible for recommending and executing various personnel actions including, but not limited to, hiring, performance appraisal, promotions and disciplinary actions.

* Maintain sufficient inventory of material supplies and equipment for performance of duties; clean and maintain standard laboratory equipment with budgetary guidelines.

* Utilize various laboratory and hospital information systems and software.

* Communicate in a professional and courteous manner with patients, family and other medical personnel as necessary to obtain information for laboratory records, explain procedures, clarify orders and communicate status.

* Interact courteously with doctors, nurses and other healthcare providers when answering questions.

* Responsibility for the oversight of the DUH POCT program including quality control, quality assurance, and development of policies and procedures.

* Formulate goals and/or recommend policy, assign objectives, and establish standards of practice.

* Interprets accrediting agencies standards or guidelines for ancillary testing program and translates requirement into policies and procedures; initiates corrective action as soon as deficiency are identified; completes checklist and other information sheets required and coordinates on-site inspection of sections for which responsible.

* Participate as a member of the DUHS CAP inspection team as needed.

* Always maintain contact with laboratory either with on-site presence or via pager.

* Monitor testing to ensure that acceptable levels of analytic performance are maintained.

• Check personnel to assure competence prior to test reporting
• All aspects of Proficiency testing are properly followed, reviewed and remedial action is taken and documented following failures
• Quality assurance and Quality Control programs are established, maintained and are effective in identifying problems.
• Procedure manuals are available and have been reviewed annually by director, manager, supervisor or analytical specialist.

* Responsibilities delegated from the director or technical supervisor include:

• Assure remedial action is taken and documented whenever tests systems deviate from established performance specifications
• Review and document proficiency testing and follow up on outliers.
• Ensure that patient testing results are not reported until corrective action has been taken and the test system is functioning properly
• Participate in the annual evaluation, competency testing and documentation for all testing personnel

* Provide advanced problem solving, troubleshooting, interpretation/consultation, verification of specimen quality and test results.

* Stay abreast of and execute latest technical and management developments including new lab procedures.

* Demonstrate decision-making abilities in all aspects of performance.

* Attend Continuing Education events in order to stay current with new developments within POCT.

* Ensure the POCT Program is covered 24/7/365.

* Monitor, investigate, and communicate to nursing staff patient data transmission problems.

* Responsible for the installation of all testing devices at all (new) locations.

* Confirm schedule for the Train-the Trainer classes. If needed test the classes

* Develop and maintain all the POCT Procedures and Training Modules.

* Represent DUH POC at all NC POCC meetings.

Required Qualifications
Education
Bachelor's degree in Medical Technology or related field, advanced training, desirable. Minimum educational or experience requirements may be modified on a case-by-case basis at the discretion of the CLIA (Clinical Laboratory Improvement Amendment) director as long as minimal CLIA requirements are met by the employee for the tasks being performed.

Experience
Seven years of laboratory experience, some of which must be of a supervisory nature. Alternatively, an equivalent combination of relevant education and/or experience. Prefer over years' experience in Point of Care Testing.

Degrees, Licensure, and/or Certification
Certification by a nationally recognized agency/board is required.

Knowledge, Skills, and Abilities

* Thorough knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.

* Considerable knowledge of laboratory equipment, instrumentation and terminology.

* Considerable knowledge of the clinical laboratory procedures.

* Considerable knowledge of regulatory agencies standards.

* Ability to develop and refine procedures.

* Ability to maintain effective reporting procedures and control workflow.

* Ability to make accurate observations and written reports of test results.

* Ability to train, orient and evaluate the job performance of various laboratory personnel.

* Ability to maintain effective working relationships with other employees.

* Ability to maintain inventory control systems and make budgetary projections.

* Ability to schedule adequate numbers of competent staff on a day to day basis.

Distinguishing Characteristics of this Level

* Responsibility for day-to-day supervision and/or oversight of the laboratory operation and personnel performing testing and reporting test results.

* Formulate goals and/or recommend policy, assign objectives, and establish standards of practice.

* Provide direct supervision of all high complexity testing and maintain contact with laboratory at all times either with onsite presence or via pager.

* Monitor testing to ensure that acceptable levels of analytic performance are maintained.

* Check personnel to assure competence prior to test reporting

* All aspects of Proficiency testing are properly followed, reviewed and remedial action is taken and documented following failures.

* Quality assurance and Quality Control programs are established, maintained and are effective in identifying problems.

* Procedure manuals are available and have been reviewed annually by director, manager, supervisor or analytical specialist.

Responsibilities delegated from the director include:

* Assure remedial action is taken and documented whenever test systems deviate from established performance specifications.

*Review and document proficiency testing and follow up on outliers.

* Ensure that patient testing results are not reported until corrective action has been taken and the test system is functioning properly.

* Participate in the annual evaluation, competency testing and documentation for all testing personnel.

* Receive, review and prepare technical reports reflecting volume of work, procedures utilized and test results; coordinate the preparation of reports and analyses setting forth progress, adverse trends and appropriate corrective action.

* Assist in the annual validation of the Electronic Laboratory Manual.

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