Clinical Lab Scientist Specialist

JOB SUMMARY

Responsible for the administration and maintenance of the Quality Assurance Programs which includes monitoring of Quality Control and Proficiency Test Survey, etc. Performs Internal Audits, assist with external and internal inspections, assist with regulatory compliance, participate in quality improvement task and initiatives, and the leads for the Safety Program initiatives and tasks. Performs other tasks as required.

Workdays and hours are subject to change reflecting the laboratory needs. Monday through Friday, -8:30 AM to 5:00 PM. 

Employee will be working as a hybrid work-on-site and work-at-home, as assigned. Business office location will be at China Basin.

This position requires the flexibility to orient and work in all UCSF Health locations as needed.

DUTIES & ESSENTIAL JOB FUNCTIONS

Task A:            Manages QC Program

1. Performs conditional analysis to detect imprecision, shifts or trends in test systems.   Requests responses from section supervisors as needed.
2. Generates and reviews monthly Statistical Summary Reports.
3. Takes effective action on out-of-control situations in a timely manner to ensure the resolution of problem in laboratory testing. 
4. Generates, reviews and files monthly Levey-Jennings charts. Requests responses and follows up from section supervisors as needed.
5. Reviews and completes Control Range Adjustment with appropriate QA information and records change in Control Action Log.
6. Provides each section with updated Quality Control Action Range Charts on the date change is effective.
7. Coordinates the review of new control products within the agreed time period. 
8. Ensures appropriate collection of quality control data through the use of the laboratory computer.
9. Calculates statistics for new action limits.
10. Enters new control material lots into the computer and generates new range charts.
11. Calculates statistics for new action limits.
12. Enters new control material lots into the computer and generates new range charts.

Task B:            Manages Proficiency Test Survey Program

1. Orders CAP PT Surveys. 

2. Accession tests and distributes to appropriate site section.

3. Contacts CAP to report survey problems.

4. Monitors the progress of CAP Survey performance.

5. Obtain, organize and submit results for Medical Director or designee review. 

6. Maintains a posted activity schedule showing due date on all surveys in progress and completion on day information is available.

7. Receive, process, review and distribute CAP Survey evaluations.

8. Reviews survey results for failures, biases, and outliers. Makes notations on reports.

9. Assures that section supervisors respond to survey failures.

10. Follow-up reminders to site sections that laboratory surveys are completed by the staff and results are submitted by the deadline.

Task C:           Safety Program

1. Demonstrates an understanding of and adheres to safety and infection control policies and procedures.

2. Lead and contact source for internal safety rounds, hospital inspections and external safety inspections.

3. Attends and report out internal safety rounds, hospital inspections, and/or external safety inspections at the Clinlab Safety Meetings.

Task D:           Regulatory Compliance

1. Contact for regulatory compliance and quality inquiries and searches.

2. Assist in maintaining current Clinical Laboratory Licenses (CLIA, State) and accreditations (CAP, AABB, FDA, FACT, etc.), which includes maintaining required data bases, ensuring timely completion of forms, lab director and executive management signatures, tracking renewals and posting current licenses.

    

 Task E:            Audits & Inspections

1. Performs internal audits of identified operational processes, CAP self-inspections, mock inspections, records, documents, etc.

2. Assist external inspection task including logistics, gathering documents, interviewee, close-out, etc.

3. Assist with post self-inspection, post external inspection, post internal audit follow-up and documentation.

Task F:            Additional Duties, as needed

1. Assist in establishing and updating new work methods, processes and procedures.

2. Assist in creating spreadsheets, entering data, etc.

3. Assist and/or participates in identified quality initiatives for clinical lab improvements. This includes collecting and organizing data, findings and results.

4. LIS calculation verification.

5. Performs other duties as assigned.

REQUIRED QUALIFICATIONS

• College Graduate with a BS or BA in a related science

• Valid California Clinical Laboratory Scientist license 

• 3 Years recent experience in clinical laboratory

• Knowledge of QC, PT, and Laboratory Inspections.

• Experience with Quality Assurance practices and procedures

PREFERRED QUALIFICATIONS

• CLS, Generalist 

• Knowledge and experience in Transfusion Medicine

• Experience with current laboratory automated equipment

• Experience in high-volume hospital clinical laboratory setting

REQUIRED LICENSES/CERTIFICATIONS

• California Laboratory Scientist License