New Risk Priority Numbers (RPNs) and improvement programmes
| Project name | Potential causes | Failure mode | Effects | Corrective actions | New Occurrence | New Detection | RPN change | Indicator |
| Traceability of the kits | Time between sampling and processing too long because of late delivery to the pharmacy | Degraded specimen | False negative | Amendment of instruction to the users, with request to register the date of sampling on the sampling tube | 2 | 1 | 64 → 8 | Percentage FITs tested in laboratory within six calendar days of sampling (target value: 100%) |
| Time between sampling and processing too long because of late delivery from pharmacy to laboratory | Control of sampling date by the pharmacist Registration of specimen’s code by the pharmacist | 2 | 1 | 64 → 8 | ||||
| Time between sampling and processing too long because of delay in the laboratory | Automatic detection by the software of the difference between the date of delivery to a pharmacy and reading in the laboratory | 2 | 1 | 64 → 8 | ||||
| Improving practices in the pharmacy | Wrong code because of manual entry by the pharmacist | Mixed-up kits | Negative test result never communicated to the user | Double-checking of the identity of the specimen’s owner by verbal request Double-typing of the code by the pharmacist Registration of the specimen’s code by the pharmacist Self-certification of barcode-reading software by the pharmacy | 2 | 1 | 60 → 6 | Percentage of anonymous specimens (target value:<1.0%) |
| A person who has not done the test receives communication of a positive result | 2 | 1 | 36 → 6 | Percentage of complaints about communication of a test result to a person who never took the test (target value: 0%) | ||||
| A person who has not done the test receives communication of a negative result | 2 | 1 | 36 → 6 | Percentage of complaints for the communication of a test result to a person who never took the test (target value: 0%) | ||||
| Wrong code because of manual entry by the pharmacist | Anonymous specimen | Negative test result never communicated to the user | 2 | 1 | 45 → 6 | Percentage of anonymous specimens (target value:<1.0%) | ||
| The pharmacist provides the kit without using the programme’s management software | Anonymous specimen | Positive test result never communicated to the user | 2 | 1 | 48 → 8 | Percentage of anonymous specimens (target value:<1.0%) | ||
| Inadequate environmental temperature in the pharmacy | Degraded specimen | False negative | Training for pharmacists on monitoring the storage temperature in the pharmacy | 1 | 4 | 48 → 16 | Percentage FITs tested in laboratory within six calendar days of sampling (target value: 100%) | |
| Lack of control of stocks by the pharmacist | Expired sampling tube | User dissatisfied | Training for pharmacists on monitoring expiry dates | 1 | 2 | 12 → 8 | Percentage of sampling tubes that have not expired (target value: 100%) | |
| Improving information to users | Inadequate environmental temperature at user’s home | Degraded specimen | False negative | Amendment of instruction leaflet for users, including: correct sampling quantity, how to clean the tube, reporting of personal ID, collection modalities, delivery time after collection and preservation | 1 | 4 | 48 → 16 | Leaflet amended |
| Improving laboratory practice | Inadequate environmental temperature in the laboratory | Degraded specimen | False negative | Sharing and updating common procedures with the laboratory | 2 | 2 | 36 → 16 | Regular meetings organised with the laboratory staff |
FIT, faecal immunochemical test.