Effective Date: 
Tue, 05/01/2012
Thu, 05/27/2021
Wed, 09/02/2020


To develop an Incident Management Plan to investigate and determine the root cause of an incident and to prevent future occurrences. The focus of the Incident Management Plan is on the failure of the systems and process, not individual performance.

In this context, an incident is defined as:

  • non-compliance with expected laboratory policies and procedures resulting in a significant negative impact on patient care or the safety of patients or staff, and;
  • errors, accidents, or unexpected events that caused, or have the potential to cause, death or serious injury to patients or staff.


INCIDENT:  an event that results in or has the potential to result in death or serious injury for patients or laboratory staff.

INCIDENT MANAGEMENT PLAN:  written policies and procedures that describe the actions to be taken in response to an incident. The plan is a supplement to the overall laboratory Quality Assessment Plan.

SYSTEMS:  the processes an organization has in place to ensure patient safety and to encourage personnel to take the appropriate actions and discourage them from taking inappropriate actions.

SYSTEMIC NON-COMPLIANCE:  a condition where recurring non-compliance with the stated policies and procedures in several phases of related laboratory activities has the potential to seriously impact laboratory testing.

CAUSAL FACTORS:  include equipment problems, control problems, environmental factors or human error.

TRUE (ROOT) CAUSE:  the weaknesses in the system that allows causal factors to occur.

TRUE (ROOT) CAUSE ANALYSIS:  steps taken to investigate the incident and determine the time or underlying cause of the occurrence.


Laboratory staff should be able to identify the difference between laboratory error and incidents. When systemic non-compliance produces errors that have a significant impact on the accuracy and reliability of test results and lead to negative outcomes for patients, they may become incidents. Examples of possible incidents include:

  • Analytical processes such as an incorrect test result that leads to the misdiagnosis or improper treatment of a patient.
  • Safety issues such as accidents or improper disposal of contaminated waste causing to staff or patients. (Needle stick injury, etc.)
  • Test tracking errors such as reporting a result on the wrong patient or mislabeling of a specimen leading to disastrous results.
  • Recurring complaints, such as, patients reporting excessive pain, burning, numbness or tingling from phlebotomy that could indicate an injury from the procedure.

It is important that each employee within the laboratory receive training on incident management, which includes guidance on how to recognize potential incidents and how to report them. This training should be documented in the employee personnel file. The following steps should be taken when investigating an incident:

  1. Immediately report the incident to the Laboratory Director. The observer should initiate filling out the Incident Report via RL Datix with any pertinent information. The Laboratory Director or designee may continue with further investigation. Retain any materials that could be involved in the incident.
  2. The Laboratory Director will determine if any outside agency reporting requirements apply to the incident. (i.e.: FDA, CDC, etc.) The ordering physician will also be notified of the situation.
  3. The Laboratory Director and laboratory staff with technical knowledge and experience will perform the evaluation and investigation of the incident. The Laboratory Director and laboratory staff have the authority to recommend changes in policy, procedure and process to resolve the problem and prevent a recurrence of the incident.
  4. The Laboratory Director and staff will analyze the impact of the incident during the time prior to the initial report of the incident, during the investigation and for future testing. The Laboratory Director and staff have the authority to suspend testing until the problem has been corrected.
  5. If deemed necessary, the ordering physician will notify any affected patients and re-evaluate their treatment.
  6. The Laboratory Director and staff will perform a root cause analysis, asking "Why did this happen?” at least five times, along with questions on who, what, where and when to document the facts of the incident. The analysis may be performed with fact sheets, mapping or flowcharts to assist with documenting the events and circumstances surrounding the event.
  7. The Laboratory Director and staff will document all facts, findings and conclusion, and the report will be given to the Laboratory Director for review and signature.  Documentation also complies with the SHS Risk Managment policy requirements.
  8. The Laboratory Director, in conjunction with the laboratory staff, will determine appropriate corrective action to be taken to prevent a recurrence of the incident, and a timeline for implement and correction will be established. The laboratory staff will document the date that each step is completed. The Laboratory Director ultimately will determine if this event is truly an incident or a mishap, but documentation should still be initiated and corrective action should be taken to prevent further negative events from occurring.
  9. All findings and outcomes will be reported to the staff by the Laboratory Director. Any necessary policy and procedure revisions or retraining of staff will be documented.
  10. Within a pre-determined period, the Laboratory Director and staff will perform a follow-up evaluation of the corrective action to ensure effectiveness and all findings will be documented.
  11. Documentation must be retained for a minimum of two years and records must be available for surveyors when warranted.