Overview
The NHS England guidance ‘Assurance of aseptic preparation of medicines’ requires NHS aseptic units undertaking unlicensed preparation to submit quality indicator data each month using the interactive Quality Assurance Aseptic Preparation Services (iQAAPS) system.
Submitting data
A request to submit quality indicators is sent within the iQAAPS system and via email on the 15th of each month. Units are required to submit data for the previous full calendar month e.g. for a request sent April 15th, data covering the calendar month of March should be entered. Following receipt of the request units will have 4 weeks to submit their data.
The first request for data entry will be sent on the 15th April 2023. For the first 3 months data entry is not mandatory, and units will be provided with enhanced support to ensure they are able to collate and enter the required data. QI submissions will be mandatory for all sites from 15th July 2023.
The request for completion of the QIs will be issued to the Accountable Pharmacist. The Accountable Pharmacist may delegate completion of all/part of the data fields to other colleagues with an iQAAPS user account (see “how to” training video 04 Delegating the completion of forms). The Accountable Pharmacist is responsible for submission of the QI form.
Further guidance on how to enter data into the system can be found in the user support section of the iQAAPS system (login required).
How the data is used
QI data may be viewed by Chief Pharmacists and will support them in discharging their overall responsibility for the Pharmaceutical Quality System and governance of their unit. For more details see Section 8 of Assurance of aseptic preparation of medicines guidance.
The data is also used to produce monthly reports for the Regional Quality Assurance Pharmacist to support their oversight of aseptic units within their region. For sites under active compliance management, data may be shared with Regional Chief Pharmacists, NHSE and senior SPS leadership.
Understanding the data requirements
Below is a list of each QI data field for which data must be submitted monthly, along with additional guidance points.
Validation tests performed
This field is labelled “the number of operator validations, process validations, EOSMF* and sterility tests performed”.
*End of Session Media Fill.
The number of tests undertaken in the previous calendar month should be entered. It does not matter if results have not yet been returned.
Only tests which replicate the fill of final products in the grade A work zone, or final products sent for sterility testing should be recorded.
Validation tests failed
This field is labelled “the number of operator validations, process validations, EOSMF and sterility tests failed”.
The number of failed tests reported in the previous month should be entered. The actual test date may have been earlier.
Out of specification results should only be recorded for:
- tests which replicate the fill of final products in the grade A work zone
- final products sent for sterility testing.
Other validations e.g. hand washing, gowning, transfer disinfection etc. should not be included. However, these may need reporting separately to your auditor.
Grade A samples performed
This field is labelled “the number of grade A samples performed e.g. settle plates, contact plates, swabs and finger dabs”.
The number of routine samples performed within previous calendar month should be recorded
Out of specification Grade A results
This field is labelled “the number of out of specification grade A samples e.g. settle plates, contact plates, swabs and finger dabs”.
The number of out of specification results for routine samples which were performed in the previous calendar month should be entered.
Internally detected errors
This field is labelled “number of errors detected internally i.e. prior to release”:
- Only errors made within the aseptic unit should be included e.g. prescription errors or those picked up at the clinical screening stage should not be included.
- Only errors relating to preparation activity occurring under the Section 10 exemption (Pharmacist supervision) should be included. E.g. dispensing errors associated with MS licensed preparation or outsourced products should not be included.
- Self-detected and corrected errors should not be included.
Externally detected errors
This field is labelled “number of errors detected externally i.e. post release”:
- Only errors made within the aseptic unit should be included e.g. prescription errors or those picked up at the clinical screening stage should not be included.
- Only errors relating to preparation activity occurring under the Section 10 exemption (Pharmacist supervision) should be included. E.g. dispensing errors associated with MS licensed preparation or outsourced products should not be included.
Items produced
This field is labelled “number of items produced”.
The number of items produced includes all items made within your aseptic unit under section 10 exemption e.g. MS licence and outsourced products should not be included.
E.g. One item is one syringe or one infusion bag.
Activity over safe working capacity
This field is labelled “number of days over locally defined safe working capacity this month”.
Daily example
If data is collected daily, total the number of days of activity over capacity and enter this figure in the field.
Weekly example
If data is collected weekly, calculate the daily average and enter the number of days on which the activity was above the locally defined safe working capacity.
For example, in a unit where a safe working capacity is 150 items per day, the activity was 750 items each week for the first three weeks. This averaged as 150 items per day and therefore within the safe working capacity.
On week 4, 900 items were made Monday to Friday. This averaged as 180 items per day for that week. Therefore, the average activity was over capacity for all 5 days of that week.
The total number of days over the safe capacity in that month was 5. The number 5 should be entered in the field.
Overdue audit actions
This field is labelled “number of EL audit actions past agreed target date”.
The number of unlicensed aseptic preparation audit actions past agreed target date should be entered.
Resource implications
The QI data being requested should already be being collated by units, and aligns with the Key Performance Indicators (KPI) data that the Pharmaceutical Aseptic Services Group (PASG) recommends that all units should collect as part of an effective quality system. The process of entering the data into the system itself should take no more than 5 minutes each month.
Further information
Other resources available are: