Senior Clinical Manager, Microbiology

Senior Clinical Manager

Microbiology

The Senior Clinical Manager, in their role as Testing Personnel as defined by CLIA, may perform waived and non-waived testing.

Each individual performs only those tests that are authorized by the Laboratory Director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.

Under general supervision, and after successful completion of orientation, training, and competency assessment on all instruments/methods applicable to their role, the Senior Clinical Manager carries out all policies and performs all tests in accordance with the department's standard operating procedures. Works independently in an efficient and organized manner to assure accurate results and records. The work requires a professional level of knowledge to read and interpret accurately test results used by providers in the diagnosis and treatment of diseases.

The Senior Clinical Manager, in their role as Technical Supervisor, Technical Consultant, or General Supervisor as defined by CLIA, is delegated the responsibility of the technical oversight of the laboratory including the day-to-day supervision or oversight of the laboratory operations and personnel performing testing and reporting results. Areas of oversight may include multiple locations or services. In addition, Senior Clinical Manager may be involved in system-wide activities such as Integrated Lab Services (ILS) planning and Lab Information System (LIS)/software implementation or upgrades.

Reports to: Director of Operations, Clinical Laboratories or Department Director and Laboratory Medical Director.

Essential Functions (Key Roles & Responsibilities)

Responsibilities as outlined by CLIA:

Technical Supervisor - (High Complexity Testing) and Technical Consultant - (Moderate Complexity Testing)

1. Responsible for the selection of test methodology appropriate for the clinical use of the test results.

2. Responsible for the verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.

3. Responsible for ensuring enrollment and participation in a CMS-approved proficiency testing (PT) program for the testing performed; that PT samples are tested in accordance with the CLIA requirements; that PT results are returned within the time frames established by the PT program; that PT reports are reviewed by the appropriate staff, including Medical Director, and corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory.

4. Responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytical performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.

5. Responsible for resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.

6. Responsible for ensuring that patient test results are not reported until corrective actions have been taken and the test system is functioning properly.

7. Responsible for identifying the training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of laboratory services provided.

8. Responsible for evaluating the competency of all testing personnel and assuring that staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the competency of the staff include six elements of assessment defined by CLIA.

9. Responsible for evaluating and documenting the performance of individuals at least semi-annually during their first year and annually thereafter unless test methodology or instrumentation changes, in that case, prior to reposting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

General Supervisor - (High Complexity Testing)

10. Must be accessible to test personnel at all times testing is performed and provide on-site telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established in the clinical laboratory.

11. Is responsible for providing day-to-day supervision of high-complexity test performance by qualified testing personnel

and

12. Must be on-site to provide direct supervision when high complexity testing is performed by an individual qualified before 1/19/1993 (FR 493/1489(b)(5). Referred to Federal Register for exceptions when work can be reviewed within 24 hours by a general supervisor qualified under Fr 493.1461. and

13. Is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytical performance are maintained.

Additional responsibilities may include the following under the direction of the Director of Operations or Department Director, Medical Director or Laboratory:

1. All responsibilities outlined in MLS I, MLS II, MLS III, Senior I, Senior II and Clinical Supervisors' job descriptions.

2. Responsible for the daily operations of specific clinical laboratories or services, ensuring daily supervision and assistance to technical and non-technical staff is provided.

3. Ensures the review of daily work including patient results, quality control and maintenance records for accuracy and completeness is completed. Ensures all instrumentation and equipment is maintained. Provides assistance, as needed, in troubleshooting and results interpretation.

4. Ensures that monthly surveillance of quality control, proficiency testing, maintenance records, corrective action and other reports is completed.

5. Responsible for supervising workstations, noting trends, problems, etc., and reviewing with Medical Director, Director of Operations or Department Director and Laboratory Director.

6. Establishes technical and administrative standards, policies and procedures in accordance with hospital and regulatory standards for al laboratory personnel: monitors compliance and initiates action to improve or maintain laboratory performance in consultation with the Medical Director and Laboratory leadership.

7. Responsible for all QA/QI activities within the laboratory.

8. Responsible for Proficiency Testing program including the handling and analysis of Proficiency Testing samples. May be delegated the signing of Proficiency Testing attestation forms.

9. Ensures that the training/orientation of new employees or students is completed and documented. Ensures that the competency assessment of staff is completed and documented.

10. Responsible for the development of training programs for new employees and students and participates in new training initiatives which may include MGB MLS training program. Responsible for the development of competency assessment modules.

11. Participates in system wide leadership training programs as require or invited.

12. Responsible for the evaluation, validation and/or implementation of new methodologies or instruments as required. Establishes technical and analytical standards for method and instrument evaluation in accordance with laboratory policies and procedures and regulatory requirements.

13. Ensures that bi-annual method comparisons and calibration verification studies are performed, reviewed, and documented on time.

14. Ensures that standard operating policies and procedures are written, reviewed, and approved. Review occurs on an annual basis.

15. Manages specific regulatory activities such as the lab's regulatory readiness team and survey preparedness. Conducts audits and provides follow-up for any action items. Participates in on-site surveys.

16. Responsible for special projects. Works independently toward completing projects within assigned timeframe.

17. Participates in the implementation and upgrades of LIS or other laboratory software programs.

18. Conducts performance evaluations for all direct reports as required. Participates in performance evaluations for other staff as indicated.

19. In conjunction with the supervisors, responsible for hiring and evaluating staff performance following the established laboratory and hospital policies and procedures.

20. Responsible for counselling, coaching, and overseeing corrective action.

21. Responsible for monitoring, approving, and modifying time reporting for direct reports.

22. Communicates departmental information to the staff, in addition to system wide changes impacting employee (pay policies, benefits, career development programs).

23. Documents errors using hospital Safety Reporting System; Reviews safety reports daily and provides follow-up. Recommends process improvements and reviews trends and improvements with the Medical Director, Director of Operations or Department Director and Laboratory Director.

24. Works with colleagues across Mass General Brigham (MGB) to build and maintain an enterprise-wide service in their clinical area.

25. Adheres to hospital and laboratory policies and procedures including but not limited to laboratory procedures, hospital procedures, accrediting agencies' guidelines, infection control and safety plans.

26. Addresses all service complaints from all customers, patients, clinical and lab staff; works with lab leadership to formulate appropriate response(s).

27. Responsible for supply inventory and management.

28. Responsible for the operational and capital budgets. In collaboration with Pathology Finance team, is responsible for preparing and monitoring laboratory's operating and capital budgets; maintains fiscal control of areas of responsibility. Regularly reviews laboratory operations to foster cost-containment efforts while maintaining high-quality lab services. Approves laboratory purchases.

29. Responsible for reviewing revenue and statistical reports and maintaining budget within approved levels.

30. Reports to the Medical Director, Director of Operations or Department Director and Laboratory Director regarding overall operations and performance. Plays an integral role in the planning and development of long-term goals and objectives.

31. Effectively manages multiple testing locations or services such as phlebotomy or processing.

32. Participates in enterprise-wide activities including work related to ILS planning. Leads work streams and/or workgroups as requested by the Director of Operations or Department Director, Deputy Clinical Director of MGBELS or Vice President of MGBELS.

33. Ensures service availability 24-hour x 7 days per week for large and complex operations (> 40 employees, operating under management budget > 10M, extensive test menu beyond standard lab)

34. Provides coverage in the absence of the Director of Operations or Department Director.

35. May be delegated duties of the Director of Operations or Department Director. Performs any other duties as required.

Qualifications:

10 Years' experience in Clinical Lab Sciences, with 5 years in supervisory role required.

ASCP Certification Required

Bachelors of Science in Medical Lab Sciences, Chemical, Physical, or Biological science from an accredited college or university Required.

Masters Degree Preferred