Qual Saf Health Care 15:58-63 doi:10.1136/qshc.2005.014902
  • Original Article

Health care failure mode and effect analysis: a useful proactive risk analysis in a pediatric oncology ward

  1. C M van Tilburg,
  2. I P Leistikow,
  3. C M A Rademaker,
  4. M B Bierings,
  5. A T H van Dijk
  1. University Medical Center Utrecht, The Netherlands
  1. Correspondence to:
 C M van Tilburg MD
 University Medical Center Utrecht, KC.03.063.0, P O Box 85090, 3508 AB Utrecht, The Netherlands; C.M.vanTilburg{at}
  • Accepted 22 November 2005


Background: Pediatric inpatient settings are known for their high medication error rate. The aim of this study was to investigate whether the Health Care Failure Mode and Effect Analysis (HFMEA) is a valid proactive method to evaluate circumscribed health care processes like prescription up to and including administration of chemotherapy (vincristine) in the pediatric oncology inpatient setting.

Methods: A multidisciplinary team consisting of a team leader, pharmacy, nursing and medical staff and a patient’s parent was assembled in a pediatric oncology ward with a computerized physician order entry system. A flow diagram of the process was made and potential failure modes were identified and evaluated using a hazard scoring matrix. Using a decision tree, it was determined for which failure mode recommendations had to be made.

Results: The process was divided into three main parts: prescription, processing by the pharmacy, and administration. Fourteen out of 61 failure modes were classified as high risk, 10 of which were sufficiently covered by current protocols. For the other four failure modes, five recommendations were made. Four additional recommendations were made concerning non-high risk failure modes. Most of them were implemented by the hospital management. The whole process took seven meetings and a total of 140 man-hours.

Conclusions: The systematic approach of HFMEA by a multidisciplinary team is a useful method for detecting failure modes. A patient or a parent of a patient contributes to the multidisciplinarity of the team.


  • Competing interests: none.