Experimental FASP NIPT metrics
Updated 6 October 2023
Applies to England
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FASP NIPT-S01: coverage: NIPT
Description
The proportion of pregnant women eligible for NIPT screening for whom a conclusive screening result is available at the day of report.
Rationale
To provide assurance that NIPT screening is offered to all eligible women and each woman who chooses to have screening has a conclusive screening result.
Definition
Numerator: number of eligible women for whom a NIPT screening result was available at the day of report.
A conclusive NIPT result can be a higher chance, lower chance or ‘no result’ (see chapter ‘3. Reporting NIPT results’ in Screening for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome: NIPT).
The first NIPT sample must be taken ≤ 21 weeks and 6 days of pregnancy.
Denominator: number of women with a higher chance NHS combined or NHS quadruple screening test result received by maternity services in the reporting period, including twin pregnancies, and excluding women who:
- miscarry between receiving a higher chance NHS combined or NHS quadruple screening result and having a NIPT screening test
- transfer out between receiving a higher chance NHS combined or NHS quadruple screening result and having a NIPT screening test
- have cancer, unless in remission
- received a blood transfusion in the previous 4 months
- had bone marrow or organ transplant
- have immunotherapy in the current pregnancy (excluding intravenous immunoglobulin treatment)
- had stem cell therapy
- have Down’s syndrome or a balanced translocation or mosaicism of T21, T18 or T13
- have a vanished twin pregnancy
The chance cut-off is set at 1 in 150 at term for the combined and quadruple tests. This means women with a result of ≥ 1 in 150 (between 1 in 2 and 1 in 150) are in the higher chance group. These women must be offered an appointment to discuss their results and the option of NIPT or prenatal diagnosis.
We calculate performance by dividing numerator by denominator and multiplying by 100 to give a percentage.
Performance thresholds
Thresholds are not set for this metric. NHS FASP supports personal informed choice for women.
This standard supports the safety of the screening pathway by enabling screening services to be assured that:
- all eligible women are offered the opportunity of screening
- women complete the screening pathway where the offer is accepted
Caveats
None
Data collection and reporting
Data source: maternity service
Responsible for data quality and completeness: maternity service
Responsible for submission: maternity service
Reported by: maternity service
Published by: performance published at England level and completeness of data published by maternity service
Reporting period
Quarterly: data to be collated between 2 and 3 months after each quarter end
Deadlines: 30 September (Q1), 31 December (Q2), 31 March (Q3), 30 June (Q4)
Review dates
Date standard introduced: June 2021
Date standard updated: NIPT evaluative roll out
FASP NIPT-S02: test: timely receipt of NIPT sample
Description
The proportion of all NIPT samples received in the genomic laboratory ≤ 2 working days.
Rationale
Delays in sample receipt increases the chances of deterioration and the need for a repeat sample. Timely reporting of screening results enables women to make personal informed choices.
Definition
Numerator: number of NIPT samples received by the genomic laboratory ≤ 2 working days of sample collection or draw.
Denominator: number of NIPT samples received by the genomic laboratory in the reporting period.
Sample received is when the sample is recorded as received on the laboratory information management system.
Date of sample collection or draw is day zero.
We calculate performance by dividing numerator by denominator and multiplying by 100 to give a percentage.
Performance thresholds
Acceptable level: ≥ 90.0%
Achievable level: ≥ 95.0%
Caveats
None
Data collection and reporting
Data source: genomic laboratories
Responsible for data quality and completeness: genomic laboratories
Responsible for submission: National Congenital Anomaly and Rare Disease Registration Service (NCARDRS)
Reported by: maternity service
Published by: maternity service
Reporting period
Monthly
Review dates
Date standard introduced: June 2021
Date standard updated: NIPT evaluative roll out
FASP NIPT-S03: test: turnaround time NIPT
Description
The proportion of NIPT screening test results reported ≤ 5 calendar days of sample receipt.
Rationale
To enable timely reporting of screening results to women so they can make personal informed choices.
Definition
Numerator: number of NIPT screening results reported by the genomic laboratory to the maternity service ≤ 5 calendar days of sample receipt.
Denominator: number of NIPT screening samples received in the genomic laboratory in the reporting period excluding samples received:
- that are rejected as they do not meet the NHS FASP eligibility criteria (see chapter ‘1. Eligibility’ in Screening for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome: NIPT).
- that are not fit for analysis and a repeat sample is requested
- with missing or discrepant information so the laboratory is unable to proceed with analysis (for example lacks patient identifiers or the request and sample details do not match)
The denominator and numerator include samples that are analysed where the result is ‘no result’. ‘No result’ is where a fit for analysis sample is received in the laboratory and it has failed to generate a result at any point in the analytical or reporting process.
Sample received is when the sample is recorded as received on the laboratory information management system.
Date of sample receipt in the laboratory is counted as day zero.
We calculate performance by dividing numerator by denominator and multiplying by 100 to give a percentage.
Performance thresholds
Acceptable level: ≥ 85.0%
Achievable level: ≥ 95.0%
Caveats
None
Data collection and reporting
Data source: genomic laboratory
Responsible for data quality and completeness: genomic laboratory
Responsible for submission: NCARDRS
Reported by: genomic laboratory
Published by: genomic laboratory
Reporting period
Monthly
Review dates
Date standard introduced: June 2021
Date standard updated: NIPT evaluative roll out
FASP NIPT-S04: referral: timeliness of information and support
Description
The proportion of women with higher chance or ‘no result’ NIPT screening results attending an appointment ≤ 3 working days to discuss their results.
Rationale
To provide assurance that women with higher chance or ‘no result’ NIPT screening results are referred, receive timely information and interventions where appropriate.
Definition
Numerator: number of women attending an appointment ≤ 3 working days to discuss their results.
Denominator: number of women for whom a higher chance or ‘no result’ NIPT screening result is received by the maternity service in the reporting period.
Date the maternity service receives the result is counted as day zero.
Women with higher chance or ‘no result’ NIPT screening results must be offered an appointment to discuss their results and further options including prenatal diagnosis. The appointment can be face to face or virtual depending on the woman’s choice.
We calculate performance by dividing numerator by denominator and multiplying by 100 to give a percentage.
Performance thresholds
Acceptable level: ≥ 97.0%
Achievable level: ≥ 99.0%
Caveats
None
Data collection and reporting
Data source: maternity service
Responsible for data quality and completeness: maternity service
Responsible for submission: maternity service
Reported by: maternity service
Published by: maternity service
Reporting period
Quarterly: data to be collated between 2 and 3 months after each quarter end
Deadlines: 30 September (Q1), 31 December (Q2), 31 March (Q3), 30 June (Q4)
Review dates
Date standard introduced: June 2021
Date standard updated: NIPT evaluative roll out
FASP NIPT-S05: diagnosis and intervention: timeliness of prenatal diagnosis (PND)
Description
The proportion of PND procedures completed ≤ 3 working days of women receiving their higher chance or ‘no result’ NIPT screening results.
Rationale
To enable timely PND procedures where women choose to have a diagnostic procedure.
Definition
Numerator: number of PND procedures completed ≤ 3 working days.
Denominator: number of PND procedures in women receiving a higher chance or ‘no result’ NIPT screening result in the reporting period.
Date the woman receives her result is counted as day zero.
We calculate performance by dividing numerator by denominator and multiplying by 100 to give a percentage.
Performance thresholds
Acceptable level: not yet set
Achievable level: not yet set
Caveats
None
Data collection and reporting
Data source: maternity service
Responsible for data quality and completeness: maternity service
Responsible for submission: maternity service
Reported by: maternity service
Published by: maternity service
Reporting period
Quarterly: data to be collated between 2 and 3 months after each quarter end
Deadlines: 30 September (Q1), 31 December (Q2), 31 March (Q3), 30 June (Q4)
Review dates
Date standard introduced: June 2021
Date standard updated: NIPT evaluative roll out
FASP NIPT-S06: diagnosis and intervention: test turnaround time quantitative fluorescence-polymerase chain reaction (QF-PCR)
Description
The proportion of QF-PCR test results reported in ≤ 3 calendar days of sample receipt.
Rationale
To enable timely reporting of QF-PCR test results to women so they can make personal informed choices.
Definition
Numerator: number of QF-PCR test results reported in ≤ 3 calendar days of sample receipt.
Denominator: number of prenatal diagnostic samples received in the genomic laboratory in the reporting period where the indication for QF-PCR testing is a:
- higher chance NIPT screening result
- ‘no result’ NIPT screening result
Date of sample receipt in the genomic laboratory is counted as day zero.
We calculate performance by dividing numerator by denominator and multiplying by 100 to give a percentage.
Performance thresholds
Acceptable level: ≥ 90.0%
Achievable level: ≥ 95.0%
Caveats
None
Data collection and reporting
Data source: genomic laboratories
Responsible for data quality and completeness: genomic laboratories
Responsible for submission: NCARDRS
Reported by: genomic laboratories
Published by: genomic laboratories
Reporting period
Quarterly: data to be collated between 2 and 3 months after each quarter end
Deadlines: 30 September (Q1), 31 December (Q2), 31 March (Q3), 30 June (Q4)
Review dates
Date standard introduced: June 2021
Date standard updated: NIPT evaluative roll out