Clinical Lab Scientist

%

of time

Essential Function (Yes/No)

Key Responsibilities

50

Yes

To perform procedures related to cellular therapy processing

1. Performs all procedures assigned to the shift in an accurate and efficient manner.
2. Learns and performs any new procedure within a reasonable time frame.

3. Performs procedures in a manner, which does not deviate from the step-by-step procedure write-up. Any deviation from the procedure must be reviewed with a supervisor prior to sending any results.

4. Be responsible for procedural updates by reviewing procedures on an annual basis, checking posted and emailed updates, and by reading and initialing all meeting notes.

5. Completes test procedures and transmits results in the laboratory computer system within established turn-around times (TATs).

6. Reviews results and validates on computer screen before releasing the results to the LIS (Laboratory Information System).
7. Never alters patient test results in any way after they have been released to the LIS except through accepted procedure with documentation.
8. Labels specimens, reagents and worksheets with required information in a legible and neat manner with ink pen.
9. Completes required training and competency assessments within the assigned time frames.
10. Maintains a clean and neat work area. Replenish supplies and prepare reagents as needed.
11. Wears buttoned lab coat, gloves and uses face protection when handling patient samples. Exercises proper care and precautions to protect oneself from health hazards. Refrains from smoking, drinking, or eating in and around work areas.
12. Take full responsibility for errors when committed, notifies required personnel and completes appropriate documentation.
13. Integrates assigned tasks in order to complete the assignments by the end of the work shift.
14. Works well without close or continual supervision.

15. Accepts a reasonable increase in the workload when necessary or assigned by a supervisor.

16. Adheres to all policies and procedures established in the Clinical Laboratory Personnel Policies.

1. Performs special studies or projects when added to routine procedure run or when assigned separately.

2. Process, cryopreserve and distribute all types of cellular therapy products

3. Perform sterility cultures and dispense specimens to appropriate locations. Follow-up results of sterility and document in the appropriate worksheet.

4. Verify the physician's order for transplant and coordinate thaw time with the physician or nurse practitioner.

5. Review donor eligibility determination before the collection day. Follow-up with the nurse coordinator any missing information and report to the supervisor or designee any problem with donor eligibility.

6. Recognize and solve problems, exercising sound judgment to ensure optimal recovery of the cellular therapy products.

7. Thaw the cellular therapy products following the thawing procedure.

8. Receive and transport cellular therapy products accurately by following the existing procedure for shipping and receiving including following the National Marrow Donor Program.
9. Perform nucleated cell count using automated cell counter.
10. Perform CD34, CD3 and 7AAD analysis for cellular therapy products (as applicable). Gate and Analyze the CD34/CD3 population using the Flow analyzer.

35

Yes

To assist in and ensure smooth operation of the BMT Lab operation

1. Keep all equipment and other supplies clean, organized, and in proper order in the BMT laboratory. Maintain adequate inventory levels of supplies. Notify the supervisor of any short supply, short dated, or outdated supplies.

2. Maintain equipment in good working order, including adequate liquid nitrogen levels in storage tanks. Perform alarm quality control on all the storage tanks according to schedule.
3. Monitor and maintain records for quality control of techniques, reagents, tests and equipment.
4. Maintain computer data entry and retrieval system, including engraftment data, bone marrow and aliquot sample inventory, and patient inventory.
5. Accurately discard or issue for research cellular therapy products that have been signed off to be discarded by the attending physician.
6. Ensure that patients are appropriately flagged in the Clinical Lab computer with regards to need for irradiated blood products, and products having specific blood types.
7. Teach residents, fellows and CLS students about ACTL procedures
8. To act as lab liaison with Bone Marrow Transplant team and with the nursing units.
9. Attend the Adult Bone Marrow Conference Meeting as scheduled by the supervisor.
10. Appropriately and accurately write the patients transplant and collections schedule date on the calendar.

11. Follows cGMP (current Good Manufacturing Practices) in all procedures and in record keeping.

10

Yes

Analyze designated quality control material with all procedures

1. Analyzes required quality control material for all procedures.
2. Records QC results on worksheet and/or in the LIS.
3. Repeats test run if controls are outside the posted control range. Initiate troubleshooting of out-of-control situations.
4. Notifies a supervisor whenever results of assays on QC materials are out-of-range.
5. Completes analysis of proficiency testing material within stated turn-around-time.

5

Yes

Perform additional duties, projects, and/or special assignments when requested.

1. Initiates Laboratory Problem Reports or Incident Reports to document complaints, errors, injuries and/or variances from standard procedure.

2. Perform special projects such as validation, Audits, Quality Indicators and other data as instructed by the supervisor within the agreed upon time period.

3. Provide and maintain statistics, as instructed by the supervisor

100%