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5PSQ-046 Fmea (failure mode and effect analysis) application to parenteral nutrition bags manufacturing process: role of hospital pharmacist
  1. E De Luca1,
  2. G Cancellieri1,
  3. M Santonocito1,
  4. C Botto1,
  5. R Giammona2,
  6. D Leonardi Vinci2,
  7. P Polidori2
  1. 1Università Degli Studi Di Palermo, Ssfo – Scuola Di Specializzazione In Farmacia Ospedaliera, Palermo Pa, Italy
  2. 2Ospedali Riuniti ‘Villa Sofia-Cervello’, Uoc Farmacia, Palermopa, Italy


Background and Importance Correct identification of unexpected/unwanted processes variability allows us studying solutions for increasing any system reliability. FMEA (Failure Mode and Effect Analysis) is an inductive method that provides a ‘bottom up’ approach; starting from activities process analysis, it reaches identification of possible inconveniences (failure mode) and effects on an entire system.

Aim and Objectives Our purpose was detecting the most critical phases of Parenteral Nutrition bags (PNB) compounding process through an audit consisting of hospital pharmacists, doctors, nutritionists and nurses.

Material and Methods FMEA was applied to PNB compounding process in a hospital with 639 beds. The process was divided into four phases (prescription, formulation, compounding, quality-control). By making an estimate of severity, probability and detectability, we have defined appropriate actions to be taken for eliminating potential problems’ occurrence. The product between previously identified values (on scale from 1 to 10) provides Risk Priority Index (IPR), an overall criticality measure.

Results The highest IPR value (384) was found in formulation phase where bag’s osmolarity was higher than venous access type chosen. An IPR=168 was found in prescriptive phase concerning patient incorrect selection from software (homonymy cases), followed by data incompleteness, relating to microelements addition (with an IPR=150). An IPR=140 was found during Siframix machine setting up regarding microelements’ housings exchange (danger due to Potassium replacement with microelement required in greater quantities). Finally, IPR=144 was found, during compounding phase, due to confusion about ‘look alike sound alike’ constituents (inframin/siframin replacement); this allowed PNB compounding with a qualitative-quantitative composition different from that requested.

Conclusion and Relevance Joint audit proposed solutions for each phase. For prescriptive one, it would be desirable to take advantage of a software that gives access to medical records in order to check that bag suited patient's needs. During formulation phase, it is necessary that a hospital pharmacist (HP) performs a double check between worksheet drafting and label, verifying correspondence, completeness and overlapping with data indicated in prescription. HPs have to control prescription feasibility and that volume is suitable for access provided for patient. For set-up phase, a double check should be carried out to make sure that each housing contains corresponding nutrient; in addition, at least two technicians should be present to carry out the operations in duplicate.

Conflict of Interest No conflict of interest.

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