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Proforma for the audit and monitoring of the

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Memo : Proforma for the audit and monitoring of the Proforma for the audit and monitoring of theNational Down's syndrome screening programme Initial Specifications: (a) The preferred method of screening adopted by your Trust. (b)The cut off/threshold level used for your programme. (c) The Trust and Strategic Health Authority involved. (d) The number of women delivered within the maternity unit(s) under the jurisdiction of the Trust to include home confinements. - the total number of women actually delivering within the jurisdiction of the Trust and its maternity facilities. Figures to relate to annual totals within the financial year. The criteria described below are based on financial years as discussed at the past meeting of Chairs of the subgroups making up the Down's Syndrome Management Group. The Audit and Monitoring Group have previously suggested that data would be easier to collate if collected in calendar years, especially given the time lag between the episode of screening and the outcome (delivery). In addition the existing Down's Syndrome Register operates in calendar years. Basic requirements and criteria:- The number of women booked for antenatal care before 20 weeks of pregnancy. The total number of women seeing a midwife/GP for an antenatal booking history/visit regardless of the intended place of delivery. Figures to relate to annual totals within the financial year. This group is termed the eligible population. The number of women offered screening for Down's syndrome regardless of the technique employed e.g by serum screening, nuchal translucency or combined/integrated testing before 20 weeks of pregnancy. This should not include fetal anomaly ultrasound screening. The total number of women booked to deliver under the jurisdiction of the Trust who are made aware of the option of screening for Down's syndrome and receive appropriate information leading up to a decision to accept or decline the test, i.e. the informed offer. Statistics relating to the informed offer to be collated as soon as possible as the informed offer has been made and by 20 weeks of pregnancy for accuracy rather than after delivery. Figures to relate to annual totals within the financial year and expressed as a percentage of (1). 3) The number of women accepting the informed offer of screening for Down's syndrome by (a) the Trusts own method (b) other methods. i.e. the screening uptake rates. a. The total number of women having a specific screening test by the Trusts chosen method.b. The total number of women having a specific screening test by an alternative method.Figures to relate to annual totals within the financial year and expressed as a percentage of (3). The following questions relate to the Trust's own screening method unless stated otherwise:- 4) The number of women undergoing risk assessment by serum screening alone who have had a dating scan carried out prior to sampling. The total number of women undergoing serum screening alone in whom the risk assessment has been based of the accuracy of an early dating scan. Screening methods which inherently involve early scanning (in particular nuchal translucency) are excluded from this requirement. 5) The number of women accepting screening in the context of theTrusts own method who receive a low risk result i.e. the screen negative rate. The total number of eligible women accepting the offer of the Trusts own screening method who are allocated as being low risk of Down's syndrome. Figures relate to the annual totals within the financial year. 6). The number of women accepting screening in the context of theTrusts own method who receive a high risk result. i.e. screen positive rate. The total number of eligible women accepting the offer of the Trust's own method who are allocated as being at high risk for Down's syndrome. Figures relate to annual totals within the financial year. 7). The number of women defined as high risk as a result of the Trust's own screening method who are offered a diagnostic test. The number of women classified as screen positive using the Trust's own method who are followed up and offered a diagnostic test. This does not included diagnostic offer rates for other available screening methods.8) The number of women accepting the offer of diagnostic procedure:- (a) after a high risk result using the Trust's own method i.e. the diagnostic uptake rate or (b) as a consequence of other screening methods employed or as a result of other indications e.g. past history, age alone, late ultrasound indications. The total figures for each to be subdivided into (i) amniocentesis and (ii) chorionic villus sampling groups. The total number of eligible women proceeding with an invasive diagnostic test firstly on the basis of the Trusts's high risk screening results and secondly as a consequence of other factors. Figures relate to annual totals within the financial year. Total figures to be subdivided into amniocentesis or chorionic villus sampling groups. 9) The overall pregnancy loss rate following invasive diagnostic procedures for Down's syndrome screening. The total miscarriage and pregnancy loss rate at any stage of pregnancy following invasive diagnostic procedures for Down's syndrome to include method of testing and individual practitioner's pregnancy loss rate. 10) The total number of identified Down's syndrome cases in the total pregnant population. The total number of all cases of Down's syndrome identified in all women receiving antenatal care under the jurisdiction of the Trust within a financial year. 11) The total number of identified Down's syndrome cases in the eligible population. The total number of cases of Down's syndrome identified in women who book for antenatal care under 20 weeks of pregnancy. 12) The total number of identified Down's syndrome cases in the ineligible population. The total number of pregnancies affected by Down's syndrome in women who book for antenatal care after 20 weeks within a financial year. The total number of identified Down's syndrome pregnancies inthe eligible population screened using the Trust's screening method subdivided into those designated as high and low risk. The total number of women in the eligible population screened in a financial year using the Trust's own method who are diagnosed as having a pregnancy affected by Down's syndrome divided into (a) those classified as high risk and (b) those classified as low risk. The total number of Down's syndrome affected pregnancies in the eligible population who were not offered screening. The total number of affected pregnancies diagnosed in the eligible population where screening was not offered. The gestational age at which diagnosis was made and the diagnostic method employed to be documented. 15) The total number of Down's syndrome affected pregnancies in the eligible population who were offered but declined screening. The total number of affected pregnancies in the eligible population offered screening using the Trust's chosen method but where this was declined. 16) The total number identified Down's syndrome pregnancies in the eligible population not screened using the Trust's own screening methods. The total number of women in the eligible population not screened in a financial year using the Trust's own method who are diagnosed as having a pregnancy affected by Down's syndrome. The gestational age at which diagnosis was made, reasons for not screening and the method whereby the diagnosis was made to be documented. 17) The total number of identified Down's syndrome pregnancies diagnosed as a result of late intervention such as fetal anomaly scanning after 20 weeks of pregnancy in the eligible group. The total number of affected pregnancies diagnosed in the eligible population within a financial year where the screening/diagnostic method was employed after 20 weeks gestation regardless of the method of screening/diagnosis. This would also include fetal anomaly ultrasound screening. The gestational age at which diagnosis was made and the diagnostic method employed to be documented. 18) The total number of cases of Down's syndrome diagnosed prenatally by whichever method employed as a percentage of the total identified Down's syndrome cases in the relevant pregnant population. The actual detection rate of Down's syndrome for the Trust regardless of the mechanism of the screening or diagnosis employed. i.e. the overall detection rate. Additional NSC objectives and criteria: 19) The proportion of high risk results issued by the laboratory within three working days of the last phase of the Trust's screening programme following receipt of a sample acceptable for processing. All screening results of the Down's Syndrome Screening Programme are available to women and communicated to them by the agreed method discussed at their previous antenatal visit, the minimum standard being 95% of all high risk results from the last phase of the screening programme being available within three working days of receipt by the laboratory. 20) The proportion of women with low risk results using the Trust's screening programme notified of the result within 7 days of issue of the result. All screening results of the Down's Syndrome Screening Programme are available to women and communicated to them by the agreed method discussed at their previous antenatal visit, the minimum standard being 90% of all low risk results from the last phase of the screening programme being available within seven working days of receipt by the laboratory. 21) The proportion of women with high risk results who are seen and offered a diagnostic test within three working days of the report being issued by the laboratory. All women who have a high risk result are offered a diagnostic test and are given verbal and written information to assist them in making that decision. Minimum standard set is 95% of women classified as being at high risk being seen and offered a diagnostic test within three working days of that report being issued with 100% being given written and verbal information. 22) The proportion of women receiving the result of their diagnostic test within 14 days of receipt of the specimen at the Laboratory. Minimum standard set of 95% of diagnostic Down's syndrome results are available to women within 14 calendar days or receiving specimens in the laboratory and all information and services are available in support of that decision.