Should this event be reported to the fda

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Reference no: EM133695675

Assignment:

Scenario 1

You have just started a new job as the transfusion services manager for a hospital laboratory. This is your first supervisory position and you moved to a new state to take the job. During the interview process the director that you now report to mentioned that the transfusion services was experiencing staffing shortages. On the first day at your new job, you introduce yourself to the employees you will be supervising and hold a quick stand-up meeting. You ask the employees to write down their top three concerns by the end of the day. When you review the submissions, you hear multiple times that the employees are unhappy about the amount of overtime they are working. The next day you meet with a human resources advisor and you also review the previous month's budget. You discover that there are currently two full-time positions vacant; one that has been vacant for 6 months and the other 3 months. Your department is over budget on staffing costs.

  • Can you think of any internal factors that you could potentially change that might be contributing to the vacant positions not attracting successful candidates?
  • Can you think of any external factors that might be contributing to the position vacancies remaining open?
  • What part of a robust quality program looks beyond the walls of the organization?

Scenario 2

You decide to research transfusion medicine automation options and come up with one that you think best meets your laboratory's needs. You select an analyzer, conduct all appropriate training, and go live with the instrument. After the new instrument has been up and running for 3 months, a patient experiences a suspected transfusion reaction. Your new procedures specify that employees perform manual methods to check the ABO and Rh(D) type during a transfusion reaction investigation, in addition to running the specimens on the instrument. Both the pre- and post-transfusion specimens on the patient type as group O by both methods. The ABO confirmation on the donor unit typesas group O on the instrument but as a weak positive with anti-A when tested manually. Further investigation reveals that the donor is a subgroup of A making anti-A1.

  • If the unit came from an external blood supplier, when should you notify them and why?
  • Should this event be reported to the FDA? Why or why not?
  • What other action might you consider?

Reference no: EM133695675

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