Here is an example of an FMEA analysis for a phlebotomy training program. This example details the purpose, team members, SOD scales (1-5), RPN score, and the recommended actions.
FMEA Analysis
Purpose: Increase student and instructor safety in a phlebotomy teaching program
Team members: Phlebotomy program director, clinical instructors, phlebotomists, and phlebotomy students
Severity (S) rating:
- 5-- Could threaten the life of instructors or students, require immediate actions (require medical attention)
- 4-- Potential to cause permanent harm to instructors or students (require medical attention)
- 3-- Potential to cause non-permanent harm to instructors or students (require medical attention)
- 2-- Potential to cause non-permanent harm to instructors or students (does not require medical attention beyond first aid)
- 1-- Potential to cause minor discomfort in short duration (does not require medical attention or first aid)
Probability of occurrence (O) rating:
- 5-- Probability of occurrence more than once per lab session
- 4-- Probability of occurrence once per lab session
- 3-- Probability of occurrence every three lab sessions
- 2-- Probability of occurrence at least once with every group of students
- 1-- Probability of occurrence is minimal; may not occur with every group of students
Detectability (D) Rating:
- 5-- No chance of detection
- 4-- Remote chance of detection
- 3-- High chance of detection only if instructors are experienced and pay close attention
- 2-- High chance of detection
- 1-- Close to 100% detection rate
| Item/Process Step | Potential failure mode (defect) | Potential effect(s) of failure potential | S | al causes | O | Student controls | D | RPN
(SxOxD) | Recommended actions |
| Understanding instructions | Students might perform phlebotomy using improper techniques, endangering other students, instructors, or themselves. | Students might be stuck with a dirty needle; potential for bloodborne pathogen infection. Injecting air into the vein when using a syringe to collect blood specimens. | 4 | Student did not take the class seriously, and students did not fully understand the instructor due to a language barrier. | 2 Students | t must perform a mock blood collection on a manikin before collecting blood specimens from humans. Instructors closely supervise students during the blood collection process. | 2 | 16 | Students must pass a pre-lab quiz before performing any new procedure (ie, dermal puncture, venipuncture, syringe draws, and blood collection using a winged device - butterfly needle) in the lab. |
| Student: Instructor AA's | A high student-to-instructor ratio might lead to instructors or students rushing to finish before the end of the instruction period. | Rushing the phlebotomy process, may result in forgetting critical steps and might cause harm to the phlebotomist or others (eg, not disposing of medical waste properly, tripping, or needlestick injury). | 4 | Instructors call in sick; lack of instructors willing to work weekends; students allowed to leave as soon as their group is finished. | 3 | Instructors can only supervise two students at a time. | 1 | 12 | Do not allow students to leave early; extend the lab period by 30 minutes to ensure everyone will have enough time. All instructors must stay for the duration of the session. |
| Student fainting | The lab was not designed for phlebotomy training; improper equipment e.g.no a phlebotomy chair to prevent injury if a student faints during the venipuncture procedure. | If the student faints, he/she might be injured by hitting the corner of the table or the floor. | 3 | Lack of proper phlebotomy chair | 2 | Instructors are required to be by the side of students when they perform phlebotomy. | 2 | 12 | Provide phlebotomy chairs to minimize injury if a student faints during the blood collection procedure. |
| The student has a bleeding tendency due to medication or other cause | Student taking a blood thinner (eg, warfarin) or the student has a known tendency to bleed due to other circumstances. | Excessive bleeding would occur during or after phlebotomy. | 2 students A | A student was on warfarin. Student has bleeding disorder. | 2 | Instructors depend on students to inform them of any bleeding issues they may have before blood collection. | 2 | 8 | Announcement can be made on the first day of class that any students on blood thinning medication or with a known bleeding disorder must notify the lab instructor before participation in the phlebotomy lab. The coban wrap should be available. |
