Selected Collection of The Qualifying Providing transparency The linkage of Risk of not providing Use Transparent to – Criteria or Review of the qualifying or qualifying criteria to transparency and some users of system Criteria Criteria that the review criteria that specific expected accessible (see security matrix). patient’s define eligibility to clinical outcome data documentation of the No disclosure other condition meets funded Ig treatment is and prescribed qualifying and review than at level of (as selected by a critical element treatment is essential criteria that define aggregated reports the requesting needed for accurate for building the eligibility for each for clinical medical officer) Authorisation of evidence base and patient to access to Ig governance and Ig proposed patient determining the funded under the governance purposes. treatment as dose, efficacy of Ig national blood frequency and treatment. arrangements. treatment schedule is (NBA, Hospital) Inability to undertake different for different clinical governance conditions and activities and indications. performance review of (NBA, Hospital, prescribing practice as Authoriser,) no data would be available for reporting purposes. Evidence Collection of Responses to The collection of The value of Risk of the ongoing Use Transparent to – Evidence evidence items evidence (where measured evidence potential for some users of system Responses to support relevant) is required to will support the inappropriate (see security matrix). selection of provide proof that development of data prescribing practice No disclosure other criteria. qualifying and/or for future analysis of and/or non-compliance than at level of- review criteria have minimum effective with the Criteria for aggregated reports been met, and that dose and efficacy of Ig Use. for clinical
Selected Criteria Collection of Criteria The Qualifying or Review Criteria that the patient’s condition meets (as selected by the requesting medical officer) Providing transparency of the qualifying or review criteria that define eligibility to funded Ig treatment is a critical element needed for accurate Authorisation of proposed patient treatment as dose, frequency and treatment schedule is different for different conditions and indications. (NBA, Hospital, Authoriser,) The linkage of qualifying criteria to specific expected clinical outcome data and prescribed treatment is essential for building the evidence base and determining the efficacy of Ig treatment. (NBA, Hospital) Risk of not providing transparency and accessible documentation of the qualifying and review criteria that define eligibility for each patient to access to Ig funded under the national blood arrangements. Inability to undertake clinical governance activities and performance review of prescribing practice as no data would be available for reporting purposes. Use – Transparent to some users of system (see security matrix). No disclosure other than at level of aggregated reports for clinical governance and Ig governance purposes. Evidence Collection of Evidence Responses Responses to evidence items to support selection of criteria. The collection of evidence (where relevant) is required to provide proof that qualifying and/or review criteria have been met, and that The value of measured evidence will support the development of data for future analysis of minimum effective dose and efficacy of Ig Risk of the ongoing potential for inappropriate prescribing practice and/or non-compliance with the Criteria for Use. Use – Transparent to some users of system (see security matrix). No disclosure other than at level of- aggregated reports for clinical
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