Medical Laboratory Scientist II
Brigham & Women's Faulkner Hospital(BWFH)

CLIA Role: Testing Personnel

General Supervisor (High Complexity Testing)

The Medical Laboratory Scientist II (MLS II), 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 Medical Laboratory Scientist II (MLS II) carries out all policies and performs

all tests in accordance with the laboratory'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 Medical Laboratory Scientist II (MLS II), in their role as General Supervisor as defined by CLIA, on occasion, may be

delegated the responsibility of the day-to-day supervision or oversight of the laboratory operations and personnel performing

testing and reporting results, if the number of years experience, required by regulatory agencies, is met.

Under the general supervision of the Clinical Manager and Clinical Supervisors, the Medical Laboratory Scientist II (MLS II) may

assist with assigned workstations including Quality Control (QC) review, instrument maintenance and troubleshooting, training,

competency assessment of staff, operations, and inventory management.

Reports to: Clinical Manager and Clinical Supervisor.

Essential Functions (Key Roles & Responsibilities)

Responsibilities as outlined by CLIA:

General Supervisor - High Complexity Testing

On occasion, may be assigned the following responsibilities, if the number of years experience, required by regulatory agencies,

is met.

1. 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.

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

and

3. 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

4. Is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytical

performance are maintained.

Testing Personnel are responsible for specimen processing, test performance and for reporting test results.

5. Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records

of patient test results;

6. Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;

7. Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural

calibrations and maintenance performed;

8. Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's

established acceptable levels of performance;

9. 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;

10. Document all corrective actions taken when test systems deviate from the laboratory's established performance

specifications; and

11. If qualified under §493.1489(b)(5), perform high complexity testing only under the onsite, direct supervision of a general

supervisor qualified under §493.1461.

Additional responsibilities may include the following under the direction of the Clinical Manager and Clinical Supervisor:

1. Performs qualitative and quantitative tests and procedures using instruments and/or manual methods on

blood, plasma, and other body fluids, according to laboratory policies. Demonstrates the use of two patient

identifiers.

2. Prepares samples and reagents for testing according to laboratory policies.

3. Operates all instruments/analyzers per established procedures or instructions in applicable operator's

manual.

4. Performs routine maintenance, function checks or calibrations on equipment according to policies and

documents.

5. Recognizes instrument malfunctions, documents problems as may be required, performs troubleshooting

and repair according to established guidelines. Alerts supervisor or designee as needed.

6. Performs quality control for all reagents and instruments according to policies. Documents quality control

results according to laboratory policies. Responsible to document all out of range QC results and

corresponding corrective action steps if applicable.

7. Ensures the accuracy, interpretation, and reporting of test results according to laboratory policies.

8. Identifies aberrant patient test results, recognizes factors that affect results, and takes appropriate action;

seeks assistance in resolution as needed. Documents all corrective action procedures undertaken in the

clinical laboratory.

9. Participates in QA/QI activities as required.

10. Participates in Proficiency Testing program including the handling and analysis of Proficiency Testing

samples.

11. Successfully completes orientation, training, and competency for all applicable instruments/methods.

Maintains competency.

12. Keeps current in developments in technical instrumentation and analytical techniques in clinical laboratory.

Participates in internal and external continuing education. Completes mandatory annual training modules.

13. Participates in training/orientation of new employees or students. Participates in the competency

assessment of other staff as required.

14. Participates in the evaluation, validation and/or implementation of new methodologies or instruments as

required.

15. May assist leadership with planning, organizing, and prioritizing work duties to accomplish daily tasks and

objectives. Supports and assists coworkers as needed to ensure the best possible patient care; able to work

independently while functioning as a team member.

16. May provide daily supervision and assistance to technical and non-technical staff. May determine work

priority, assumes timely completion of work. Assumes weekend and holiday supervisory responsibilities in

the absence of a supervisor.

17. May review daily work of others including patient results, quality control and maintenance records for

accuracy and completeness.

18. Documents errors using hospital Safety Reporting System; informs supervisor/manager when safety reports

are entered.

19. 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.

20. Performs clerical and support services as needed, such as answering the telephone, calling Critical, Stat or

Code results to the appropriate department or Licensed Care Provider, monitoring pending logs, and other

assigned duties. Ensures that there is proper documentation of calls.

21. Monitors reagent and supplies, orders as needed, or communicates need to the appropriate person to

maintain adequate inventory of necessary supplies.

22. 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, etc. Stores,

discards, and retrieves samples as required.

Qualifications
Education

Degree Field of Study Required/Preferred And/Or

Bachelor's Degree 1. Minimum: Must possess a Bachelor of Science Degree in

Medical Laboratory Science or Chemical, Physical, or

Biological science from an accredited college or

university OR

Required or

2. Other qualifications as described in the Federal Register,

42 CFR, Subpart M 493.1403 - 1495.

Can this role accept experience in lieu of a

degree?

Refer to Federal Register, 42 CFR, Subpart M 493.1403 - 1495.

EEO Statement
Brigham and Women's Faulkner Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives, and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.