GENERAL SUMMARY/ OVERVIEW STATEMENT:Responsible for ensuring that adequate method verification is performed in order to determine the accuracy and precision of the tests. Responsible for ensuring that quality assessment and quality control programs are established and maintained.Responsible for ensuring enrollment of the laboratory 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.Responsible for ensuring that quality assessment and quality control programs are established and maintained.Responsible for ensuring that acceptable analytical test performance is established and maintained for each test system, remedial actions are taken and documented when significant deviations from the laboratory's established performance characteristics are identified, and patient test results are reported only when the system is functioning properly.Responsible for ensuring that personnel have been appropriately trained and demonstrate competency prior to testing patient specimens.Responsible for ensuring that policies and procedures are established for monitoring personnel competency in all phases (pre-analytic, analytic, and post-analytic) of testing to assure the ongoing competency of all individuals who perform testing, and that remedial training or continuing education needs are identified, and training provided.
The Clinical Supervisor, in their role as Technical Supervisor and General Supervisor as defined by CLIA, may be delegated the responsibility of the technical and scientific oversight of the chemistry laboratory including the day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting results.
Under the general supervision of the Technical Director, the Clinical Supervisor is responsible for the overall direction and daily supervision of work activities of personnel engaged in the performance and interpretation of clinical laboratories testing procedures, which are used to aid physicians in the diagnosis and treatment of patients.
The Clinical Supervisor, in their role as Testing Personnel as defined by CLIA, may perform waived and non-waived testing. Under general supervision, 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.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
Responsibilities as outlined by CLIA:
Responsibilities that may be delegated in writing to the Clinical Supervisor (Technical Supervisor - high complexity)
Responsibilities that may be delegated in writing to the Clinical Supervisor (General Supervisor - high complexity) 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. Is responsible for providing day-to-day supervision of high-complexity test performance by qualified testing personnel and 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 Is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytical performance are maintained.
Responsibilities as outlined by CLIA:
Testing personnel are responsible for specimen processing, test performance and for reporting test results.Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results;Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed;Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance;Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director;Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications; andIf qualified under §493.1489(b)(5), perform high complexity testing only under the onsite, direct supervision of a general supervisor qualified under §493.1461.
Exception: For individuals qualified under §493.1489(b)(5), who were performing high complexity testing on or before January 19, 1993, the requirements of paragraph (b)(7) of this section are not effective, provided that all high complexity testing performed by the individual in the absence of a general supervisor is reviewed within 24 hours by a general supervisor qualified under §493.1461.
Additional responsibilities may include the following under the direction of the Technical Director:Provides daily supervision and assistance to technical and non-technical staff in the clinical laboratory. Determines priority of work, assuring timely completion of work. Provides weekend and holiday supervisory coverage. Plans, organizes, and schedules duties and responsibilities of clinical laboratory personnel. Responsible to follow the clinical laboratories' procedures for specimen handling, specimen processing, test analyses, and reporting of patient results, including the handling and analysis of Proficiency Testing material. Reviews daily work including patient results, quality control and maintenance records for accuracy and completeness. Performs routine maintenance, calibrations and troubleshooting on equipment, in addition to quality control for all reagents. Provides assistance, as needed, in troubleshooting and result interpretation. Responsible to document all corrective action procedures undertaken in the clinical laboratory. Maintains records of quality control, maintenance and workload data for assigned workstation according to laboratory policies. Develops and implements training and competency assessment programs for all testing personnel. Provides training and competency assessments for technical staff. Documents training and annual competencies at the time of performance evaluations. Assists with hiring, counseling, evaluating, and terminating employees following the established laboratory and hospital policies and procedures. Maintains all Standard Operating Procedures and required records and reports. Keeps current in developments in technical instrumentation and analytical techniques in clinical laboratory. Recommends, evaluates and validates new methods, instrumentation, and/or procedures. Assist with development and implementation of LIS enhancements. Performs clerical and support services as needed, such as answering the telephone, calling Super Stat, Code sample results, and/or alert values to the appropriate department or Licensed Care Provider, disposing of contaminated specimens, control of inventory, monitoring pending logs, and other assigned duties. Participates in Proficiency Testing program including the handling and analysis of Proficiency Testing material. Assists in the developing an operational budget and in maintaining department fiscal control. Communicates departmental information to the laboratory staff. Communicates with hospital personnel providing assistance related to laboratory policies and procedures, laboratory utilization, and test result interpretation. Is responsible for ordering and maintaining an appropriate level of inventory and laboratory supplies. Promotes the mission and vision of Brigham and Women's Hospital and laboratories, and a spirit of professionalism and excellence in performance among the laboratory staff. Implements hospital and laboratory policies and procedures and plans including infection control and safety plans. Participates in research, development and implementation of laboratory procedures as requested. Performs any other duties as required, which may include but not limited to general laboratory duties such as processing specimens, logging in specimens, putting supplies away, washing pipettes, discarding laboratory samples, racking samples, etc.Qualifications QUALIFICATIONS: Must possess a minimum of a Bachelor of Science Degree in Medical Technology or Chemical, Physical or Biological Science from an accredited college or university.
OROther qualifications as described in the Federal Register, 42 CFR, Subpart M 493.1403 - 1495. Three to five years of current work experience in a clinical laboratory. Specific experience in one or more disciplines may be required. ASCP certification or equivalent required.EEO Statement
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.