Critical laboratory value notification: a failure mode effects and criticality analysis

Jt Comm J Qual Patient Saf. 2005 Sep;31(9):495-506. doi: 10.1016/s1553-7250(05)31064-6.


Background: The Failure Mode Effects and Criticality Analysis (FMECA) was applied to improve the timeliness of reporting and the timeliness of receipt by the responsible licensed caregiver of critical laboratory values (CLVs) for outpatients and non-critical care inpatients.

Methods: Through a risk prioritization process, the most important areas for improvement, including contacting the provider, assisting the provider in contacting the patient, and educating the provider in follow-up options available during off hours, were identified.

Actions taken: A variety of systemic improvements were made; for example, the CLV notification process was centralized in the customer service center, with databases to help providers select options and make arrangements for follow-up care and an electronic abstract form to document the CLV notification process. Review of documentation and appropriateness of CLV follow-up care was integrated into the quality monitoring process to detect any variations or problems.

Results: The average CLV notification time for the month steadily declined during an eight-month period. Compliance was 100% for the "read-back" requirement and documentation in patient's health record.

Discussion: This proactive risk assessment project successfully modified the CLV notification program from a high- to a low-risk process, identified activities to further improve the process, and helped ensure compliance with a variety of requirements.

MeSH terms

  • California
  • Communication*
  • Duty to Warn / legislation & jurisprudence*
  • Efficiency, Organizational
  • Joint Commission on Accreditation of Healthcare Organizations
  • Laboratories / legislation & jurisprudence
  • Laboratories / organization & administration*
  • Organizational Case Studies
  • Reference Values
  • Risk Assessment
  • Safety Management*
  • United States