Submitting iQAAPS Quality Indicators (QIs)

Overview

All NHS pharmacy aseptic units undertaking aseptic preparation are required to submit quality indicator (QI) data each month using the interactive Quality Assurance Aseptic Preparation Services (iQAAPS) system, in accordance with NHS England’s guidance on assurance of aseptic preparation of medicines. Our provides information about the system itself.

Note: This does not replace the need for sites to have locally defined key quality and performance indicators.

Submitting data

The Accountable Pharmacist receives a request to submit QI data, via email, on the 15th of each month. Data is submitted via the iQAAPS system for the previous full calendar month e.g. for a request sent April 15th, data covering the calendar month of March are entered. Following receipt of the request units have 4 weeks to submit data.

Failure to submit data may result in escalation in accordance with NHS England’s assurance of aseptic preparation of medicines guidance.

Further guidance on how to submit QI data is available from the iQAAPS system via the menu bar (Help Videos/Guides).

How the data is used

QI data may be viewed by Chief Pharmacists to provide oversight of unit performance. For more details see Section 8 of NHS England’s assurance of aseptic preparation of medicines guidance.

QI data is reviewed by the SPS QA team to support their oversight of aseptic units within their regions and inform a risk-based audit programme. Situation reports are shared with the Chief Pharmaceutical Officer, Regional Chief Pharmacists, and senior SPS leadership.

Understanding the data requirements

It is essential to enter accurate data into the QI data fields. Guidance is provided below.

Note: Supplementary information may be requested by SPS QA regional teams following review of the QI data.

Product simulation tests

This refers to tests that replicate the fill of final products in the grade A work zone, or final products sent for sterility testing only, i.e. operator validation kits, process validations, end of session media fills (EOSMF) and sterility tests.

Do not include:

• product simulation tests associated with unauthorised staff
• product simulation tests performed in clean air devices that are not operational
• grade A environmental monitoring associated with product simulation tests
• other validations e.g. hand washing, gowning, transfer disinfection

Tests performed

This field is labelled ‘the number of operator validations, process validations, EOSMF and sterility tests performed’.

Enter the number of tests performed in the previous calendar month. It does not matter if results have not yet been returned.

Tests failed

This field is labelled ‘the number of operator validations, process validations, EOSMF and sterility tests failed’.

Enter the number of failed tests reported to you in the previous calendar month. The actual test date may have been earlier.

Note: Only failures of the actual product simulation are to be recorded. If an out of specification result is received for other Grade A environmental monitoring (e.g. settle plates, finger dabs) performed during the product simulations, but the product simulation recovers no growth then this is NOT reported as a product simulation failure.

Grade A samples

This refers to all microbiological environmental monitoring of the grade A zone (e.g. isolators, UDAFC etc.) which includes settle plates, contact plates, swabs, finger dabs and active air samples.

Do not include environmental monitoring of other grades (B, C & D) of cleanroom.

Samples performed

This field is labelled ‘the number of grade A samples performed’.

Enter the number of Grade A samples performed in the previous calendar month. It does not matter if results have not yet been returned.

Out of specification results

This field is labelled ‘the number of out of specification grade A samples’.

Enter the number of out of specification results for grade A samples reported to you in the previous calendar month.

Errors

This relates only to errors linked to product quality (e.g. incorrect drug/ dose/ diluent, labelling etc.) made by the pharmacy aseptic unit working within scope of NHS England’s assurance of aseptic preparation of medicines guidance.

Do not include

• errors associated with MS licensed manufacturing
• errors associated with outsourced products
• self-detected and self-corrected errors
• prescribing errors
• complaints linked to non-product quality related issues

Internally detected errors

This field is labelled ‘number of errors detected internally i.e. prior to release’.

Enter the number of errors detected by the pharmacy aseptic unit before product release during the previous calendar month.

Externally detected errors

This field is labelled ‘number of errors detected externally i.e. post release’.

Enter the number of errors detected after product release during the previous calendar month.

Items produced

This field is labelled ‘number of items produced’.

The number of items produced includes all items made within your aseptic unit within scope of NHS England’s assurance of aseptic preparation of medicines guidance. Do not include products manufactured under your MS licence or outsourced products.

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”.

If data is collected daily, total the number of days of activity over capacity and enter this figure in the field.

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.

Overdue audit actions

This field is labelled “number of EL audit actions past agreed target date”.

Enter the number of aseptic preparation audit actions past agreed target date.

Note: the field label refers to EL (97)52. This will be updated with current terminology in the future.

Resource implications

QI data requested should be collated by units 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. 

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