Once again, sample processing errors (SPE) are the second most frequently reported "Other" SABRE report following incorrect blood component issued (IBCI). These are errors where samples are incorrectly accepted into the laboratory where discrepancies with patient details on LIMS, sample and documentation. Frequently these are reported to be "human error" due to slips/lapses of concentration without further investigation.

The Good Practice Guide expects that "human error" should only be determined to be the root cause after other improvements to the QMS have been identified, and MHRA inspections frequently identify evidence that investigations are weak and should be more thorough.

With permission from the reporter, I am copying and pasting part of their recent investigation report where they pro-actively identified a trend in their reporting of these errors and undertook a review. They agreed that I shared i, not because their RC and CAPA would apply to everyone, but to demonstrate how a thorough investigation and review might lead to more robust CAPA.

Due to the number of sample registration errors reported within the last year (7 reported sample registration incidents since April 2018) a review of previous similar incidents was performed. This review included 11 sample registration incidents and identified trends in type of shift, grades of staff and type of error.

Noted similarity in incidents

1. Nearly all incidents occur out of routine hours.

2. Large majority (9/11) incidents are registered by BMS staff. BMS staff do not routinely register samples during core hours.

3. Errors much more likely to involve spelling errors of names rather than errors entering numbers (DOB and CHI).

In previous indents a range of corrective actions have been put in place:

1. Standardisation of patient search procedure in documentation and training in correct patient search procedures.

2. Review of out of hours workload and work that can be delayed until core hours.

3. Physical rearrangement of specimen reception area.

4. Refresher training for BMS staff prior to lone working authorisation.

5. Regular self audit of sample registration and data entry process.

6. Specific additional training exercise in sample registration and subsequent checks of LIMS data entry to all staff that focused on typical errors i.e. single letter spelling errors.

4. Root Cause Analysis

  • Failure to follow procedures for sample receipt and registration. Sample was registered with discrepancy in spelling of surname between record & request.

  • Failure to follow procedures for testing, processing & validating sample. Subsequent checks performed pre testing & post validation failed to detect discrepancy in spelling of surname between records & request.

  • The BMS who performed registration & subsequent checks identified during discussion that they have difficulty reading the computer screen if wearing reading glasses therefore did not detect the difference in spelling.

5. Corrective/Preventative Action

  1. Completed Actions

  1. No procedural changes required. All associated SOPs reviewed and found to detail procedure clearly.

  1. The incident was discussed with the member of staff who registered & processed the sample on the 06/01/2019. The importance of checking all patient details at registration, pre-testing and post validation was reinforced.

  1. Follow up with member of staff was performed following optician appointment. Member of staff reported that their new prescription had made a noticeable improvement on their ability to read the computer screen & labels without changing glasses.

  1. Planned actions

  1. Audit of data entry in sample registration has been scheduled for March 2019. This will help detect any further sample registration errors. These will be raised as a quality event and investigated. However, effectiveness monitoring using audit has highlighted that corrective actions implemented to date have not been successful.

  1. Root Cause Analysis to be performed, with a member of staff from another centre as facilitator, on 26th March 2019.