Treating Medical Specialist Critical identification for compliance with Criteria for diagnosis and review requirements. To enable notification of initial authorisation and review requirements for continuing authorisation to the appropriate medical specialist responsible for patient care. Patient safety risk if notifications are not provided to the appropriate clinicians responsible for patient care. Treatment arrangements: Infusion method (intravenous or subcutaneous) Treating facility Administering facility Dispensing facility Product Patient weight & height Dose amount Dose frequency Date required Treatment plan Review date To inform the authorisation assessment. To ensure appropriate dispense of product for the treatment of authorised patients. To enable notification of initial and continuing authorisation to the appropriate dispenser, and where necessary the administering facility. To enable supply planning. Patient safety risk if information is not provided informs the administration, product and dosage to treat the patient in accordance with prescribed therapy. Clinical outcomes (patient) Medical condition and indication for use Build the evidence base for demand management modelling and future iterations for the criteria for access. An inability to build the evidence base to evolve the Criteria to ensure that patients with medical conditions with proven efficacy receive appropriate therapy. Evidence of clinical benefit or no clinical benefit: Supporting evidence including medical test results and measures plus the upload of documents. Free text fields for discretionary information. Build the evidence base for demand management modelling and future iterations of the criteria for access. An inability to build the evidence base to evolve the Criteria to ensure that patients with medical conditions with proven efficacy receive appropriate therapy. Personal identifying information (requesting medical officer)
Remarks A high response to ‘No’ in this question indicates that respondents do not have any concerns with the assumptions. Of the ‘Yes’ responders, 27 provided comments which indicate they were seeking further clarification on the assumptions including the definitions on facility types and therefore do not indicate significant concern with the assumptions. Further comments raise concern around the logistics of gaining consent and registering to access the Ig System in order to prescribe. 4 For the purposes of this survey the “Ig System record” for the patient is made up of identifying information including: name, sex and date of birth; past and present IVIg/SCIg authorisation requests; previous treatments relevant to an authorisation; treatment duration and review; treating medical specialist details; medical condition and indication; patient characteristics (weight); dosage, product and reason for product choice as well as do not prescribe advisories. It may also include: particular infusions and reactions to those infusions. Additionally, the outcomes of Immunoglobulin Therapy will be captured at each review for the purpose of assessing efficacy and continuing access to Immunoglobulin Therapy. IMPORTANT NOTE: the Ig System record is not a copy of the patient’s medical record nor is it a clinical registry. It is therefore important to understand that in many scenarios the Ig System is unlikely contain more detailed information about the patient than the patient record at the hospital/facility at which they're receiving treatment. Do you have any comments to make on the proposed make-up of the 'Ig System record'?
The percentage of Yes responses, compared to previous questions, indicates there is a shift in the need for a nurse to access patient records. The Yes responses indicate that the success in delivery of care to patients rests with the nursing staff. 20 Searching for a patient – Nurse SCENARIO: Patient currently receiving IVIg/SCIg – Nurse – Different Hospital – Different State A patient presents for treatment where the Treating or Administering hospital or the Dispensing Facility is NOT the same as the hospital or the State where the Nurse is logged onto the Ig System (Grey Nomad Scenario). When searching, should the Nurse be able to see the patient's 'Ig System record'? Response Remarks The trend in responses on the Nursing scenarios is consistent, with fewer respondents answering Yes than those scenarios cited for Prescribers and Authorisers. Comments provided on this question are consistent with Questions 18 and 19. 21 Searching for a patient – Dispenser As a Dispenser the default search is all patients that have a relationship with the hospital or hospitals where the Dispenser is logged on to BloodNet. BloodNet is the NBAs electronic blood and blood products ordering system allowing hospitals to communicate directly with the Blood Service. All Ig System capability developed for Dispensers will be delivered within BloodNet. We believe the following scenario is the minimum requirement for Ig System capability when a Dispenser is searching for patient details. SCENARIO: Patient currently receiving IVIg/SCIg – Dispenser – Same Hospital – Same State A patient presents for treatment and the Dispenser is logged onto BloodNet at the Treating or Administering hospital or Dispensing Facility for the patient. The Dispenser searches for the patient. As the patient’s authorisation has the same hospital recorded as either the Treating or Administering hospital or the Dispensing Facility as the Dispenser's, the Ig System record can be seen. Do you Response Remarks
Privacy Impact analysis The following provides an analysis of the functions and processes of BloodSTAR against the requirements set out in the Australian Privacy Principles (APPs). Australian Privacy Principle Consideration Y/N Response Action required to address APPs Gap or compliance evidence APP 1 — open and transparent management of personal information Will personal information or sensitive information be handled? Yes Personal and sensitive information will be collected and used for the purposes of assessing patient eligibility against the qualifying and review criteria specified in the Criteria for the clinical use of intravenous immunoglobulin in Australia. Consent to the collection, use and usual disclosures of personal sensitive information will be sought and recorded in BloodSTAR. Provide Privacy Statement and Notice for the information of individuals of interest to BloodSTAR. Obtain consent from the individuals of interest to BloodSTAR, and record their consent status in the system. Privacy Statement and Notice will be made available in BloodSTAR. Compliant Consent form will be made available in BloodSTAR. The consent form will record explicit written or oral consent and can be uploaded to BloodSTAR for record keeping purposes. Compliant Will reasonable steps be taken to tell the individual about the purpose of the collection and usual disclosures? Yes A Privacy Statement and Notice will be provided for the information of individuals who become of interest to BloodSTAR. The notice will detail the purpose for the collection of sensitive information, its use, usual disclosures and consent. The notice will also explain the consequences of not providing consent.
uploaded to BloodSTAR for record keeping purposes. Compliant Is express consent sought and recorded for the collection of personal or sensitive information? How is it collected (written or oral)? Yes A patient consent form will be made available in BloodSTAR for recording written consent. Verbal consent can also be recorded in the consent form by the clinician whom has obtained verbal consent from the individual. The consent form can be uploaded to BloodSTAR and retained as an attachment to the patient record. Provide Privacy Statement and Notice for the information of individuals of interest to BloodSTAR. Develop a privacy consent form for recording explicit written or verbal consent and make available to the general public on NBAs website. The Privacy Statement and Notice will include information for patients about the requirement to provide consent. Compliant The Consent form will allow for both written and verbal consent to be recorded. This document will be uploaded to BloodSTAR for
personal or sensitive information. collect unsolicited information will be minimised and where the risk exists, the content of collection will be monitored and removed. Compliant APP 6 – Use or disclosure For what purposes will the agency use and disclose personal information and sensitive information? Personal and sensitive information is used to enable assessment of authorisation for initial and continuing access to government funded immunoglobulin products against policy parameters set by Health Ministers. Only authorised users will be able to access data via a secure log in process for the purpose of undertaking their role in patient care and manage the appropriate treatment of the patient’s medical condition. ‘Disclosure' means releasing the personal information you have collected to another agency, body or organisation (this does not include the individual the information is about). However in the context of BloodSTAR, personal and sensitive information is not disclosed beyond the users of the system. None Reporting capability will use summary information that does not include personal and sensitive information that can identify individuals. Compliant APP 7 – Direct marketing Will personal information be used for direct marketing? No This APP does not no direct marketing will be undertaken. None N/A
APP 8 – Cross border disclosure Will personal or sensitive information be sent overseas? No Data will not be sent overseas. None N/A APP 9 - Adoption, use or disclosure of government related identifiers Will government related identifiers be adopted as the agency’s own identifier? (APP9.1) Will government related identifiers be used or disclosed? (APP9.2) No Yes A collection of government identifiers will be used to assist with uniquely identifying individuals together with a BloodSTAR patient identifier. may include: Medical Record Numbers or hospital identifiers in one or more hospitals/treatment facilities; Individual Health Identifier (IHI). Provide Privacy Statement and Notice for the information of individuals of interest to BloodSTAR which describes the purpose for using hospital and health identifiers. The Privacy Statement and Notice will include information for patients about the use of hospital and health identifiers. Compliant APP 10 – Quality Will reasonable steps be taken to ensure that the personal information collected, used or disclosed is up to date, complete and accurate and relevant for the Yes BloodSTAR users will be required to collect and manage information relating to a patient in order to ensure that each entity involved in patient care has the information it needs to fulfil its role. Where errors are detected, users will be empowered to correct errors to ensure that information is as accurate as possible. User terms and conditions will require users to correct errors and maintain accuracy of records. Users in the hospital setting will have access User terms and conditions will include this provision. User terms and conditions will include this provision.
purpose of the use or disclosure? When requested, BloodSTAR users must provide information to patients about information stored about them, and have the opportunity to identify and correct errors. to system functions to correct records when errors are detected. Patients will be advised through the Privacy Statement and Notice of their right to access correct details about them. Privacy Statement and Notice will include this provision. Compliant APP 11 – Security Is the agency taking reasonable steps to ensure that the personal information it collects is protected from misuse, interference, loss and from unauthorised access, modification or disclosure? Yes BloodSTAR, its management and operation will be tightly controlled. NBA systems have one of the highest levels of security available in Australia, housed in a highly secure data centre in Canberra. Stringent security protocols will be built into the system to control access to personal information. All reasonable steps will be taken to protect personal information from misuse, interference and loss, and from unauthorised access, modification or disclosure. Personal and sensitive information will only be stored on a password protected ICT system which complies with the Australian Government Protective Security Policy Framework. This includes ensuring that information is only accessed by authorised users that require access to undertake their official functions and roles. Controls must be in place to authenticate users using unique user names and passwords for roles appropriate to roles supporting patient care. All users established in the system will be authenticated before access is granted. Compliant
Privacy Management In order to minimise the privacy concerns and risks to individuals, BloodSTAR will include the following processes and functions. User terms and conditions User authentication Activity logging and auditing at the user level, including searches and views Privacy Statement and Notice Patient consent to the collection, use and disclosure of their personal and sensitive information. The NBA’s expectation is that the provision of personal and sensitive information in order to obtain access to a high cost publically funded biopharmaceutical product will be regarded as unremarkable by the vast majority of patients. This type of requirement is commonplace for access to many high cost medications and medical services, whether funded publically or by private health insurance, in Australia and in most comparable countries globally. Access to immunoglobulin is available under multiple funding and supply pathways in Australia. While a decision making process may be involved in each case, these alternatives do provide an avenue for the health system to meet the needs of a patient who may be concerned about the provision of personal and sensitive information. Recommendations Recommendation Cross reference to relevant document Provide Privacy Statement and Notice for the information of individuals of interest to BloodSTAR and make it available to the general public on NBAs website. Attachment A – Privacy Statement and Notice Develop a privacy consent form for recording explicit written or oral consent and make available to the general public on NBAs website. Attachment B – Privacy consent form Ensure consent is obtained from the individuals of interest to BloodSTAR, and record their consent status in the system. System control. Develop and publish NBA Privacy Policy. Develop information for patients to explain why pseudonymous and anonymous options are impracticable. Attachment A – Privacy Statement and Notice The search requirements when searching nationally or beyond a user’s usual search scope will include at least two points of identification for an individual i.e. name and date of birth or hospital identifier, to System control.
If you fail to comply then your access to BloodSTAR may be revoked and your supervisor will be notified. The personal information you are required to complete on BloodSTAR User Access Request Form is collected by the NBA for the purpose of assessing and approving your user status and ongoing management of your BloodSTAR user account. As a user of BloodSTAR you will receive regular updates about BloodSTAR to ensure you are kept up to date on the correct operation of the system, any changes or outages that may impact on your use of BloodSTAR. BloodSTAR includes an inbuilt audit log which records when a user logs on, and views or changes to data. This assists validation of changes when accuracy is disputed and enables monitoring of appropriateness of access and use. As your personal information will be managed in accordance with the Privacy Act 1988 it will not be provided to any other person or for any other purpose without your consent (unless authorised by that Act). The information you provide in your BloodSTAR User Access Request Form, and any information you subsequently provide concerning your BloodSTAR User status, must be true and correct to the best of your knowledge at the time the information is provided. The giving of false and misleading information to a Commonwealth entity such as the NBA is a serious offence under Division 137.1 of the Criminal Code 1995 (Cth).
in reporting for prescribing practice. Family Name Text The surname of the patient. Critical identification parameter for maintaining patient record and data integrity -supports correct patient record creation, identification for product authorisation and access during system search by user. (Authoriser, Prescriber, Nurse, Dispenser) NBA – 3 To reduce likelihood of duplicate patient records being created when used with DOB and other patient names. NBA – 1,2 and 5 As above – if we cannot be satisfied of ID then no authorisation via the system or in fact manually since we need ID? Will it impact ability to get the product elsewhere – what is the cost? Patient safety risk due to increased risk of prescriber linking condition (qualifying and review criteria) to incorrect patient record leading to incorrect authorisation, prescription dose, product, dispense and/or infusion. – as above and throughout Use – Transparent to some users of system for particular purpose in accordance with defined role (see security matrix). (see security matrix) Disclosure – not intended for release. What about Distributor for home delivery patients?
Given Name Text The first or given name of the patient Critical identification parameter for maintaining patient record and data integrity - supports correct patient record access and identification during system search by user. (Authoriser, Prescriber, Nurse, Dispenser) NBA – 3 Reduces likelihood of duplicate patient records being created when used with DOB and other patient names. NBA – 1,2 and 5 Patient safety risk due to increased risk of prescriber linking condition to wrong record leading to incorrect authorisation, prescription dose, product, dispense and infusion. Use – Transparent to some of system for particular purpose in accordance with defined role (see security matrix). Disclosure – not intended for release. What about Distributor for home delivery patients? Middle Name Text The middle given name of the patient Critical identification parameter for maintaining patient record and data integrity - supports correct patient record access and identification during system search by user. (Authoriser, Prescriber, Nurse, Dispenser) Reduces likelihood of duplicate patient records being created when used with DOB and other patient names. NBA – 1,2 and 5 Patient safety risk due to increased risk of prescriber linking condition to wrong record leading to incorrect authorisation, prescription dose, product, dispense and infusion. Use – Transparent to some users of system (see security matrix) Disclosure – not intended for release.
not intended for release other than inclusion in aggregated data sets. Hospital Identifiers Collection of Hospital Identifiers A list of hospitals at which the patient has received treatment and the identifier of the patient in that hospital. Provides transparency of all hospital affiliations of patient - reduces the potential for multiple treatments being provided to the same patient And supports contact of correct treating specialist when patient treatment review for access to ongoing therapy is required. (NBA, Prescriber, Nurse, Dispenser) NBA – 3 Facilitates easy retrieval of patient record by hospital staff and confirmation that correct patient record has been identified. (Prescriber, Nurse, Dispenser) Risk of patients receiving multiple treatments at different hospitals Patient safety risk due to increased risk of user linking data (e.g. condition, authorisation, product or infusion) to wrong record leading to incorrect authorisation, prescription dose, product, dispense and infusion. Use – Transparent to some users of system (see security matrix) Disclosure - not intended for release.
Authorisation Requests Collection of Authorisation Requests A list of authorisation requests that the patient has been the subject of. Provides transparency of all authorisation requests relevant to the patient (NBA, Authoriser, Prescriber, Nurse, Dispenser) Reduces the potential for multiple treatments being provided to the same patient. And/or for communication and planned treatment between clinicians for patients with 2 eligible conditions. (NBA, Authoriser, Hospital) NBA – 3 [not individual consequence for patient but this section could serve a purpose beyond privacy ] Use – Transparent to some of system (see security matrix) Disclosure - not intended for release other than inclusion as part of aggregated dataset for reporting.. Authorisations Collection of Authorisations A list of authorisations that have been approved for the patient. Provides transparency of all authorisation requests relevant to the patient - reduces the potential for multiple treatments being provided to the same patient. And/or for communication and Supports contact of correct treating specialist when patient treatment review for access to ongoing therapy is required. (NBA, Authoriser) Risk of patients receiving multiple treatments for multiple conditions, and / or inappropriately attending multiple Use – Transparent to some of system (see security matrix) Disclosure - not intended for release other than inclusion as part of
planned treatment between clinicians for patients with 2 eligible conditions. (NBA, Authoriser, Prescriber, Nurse, Dispenser) NBA – 3 hospitals for treatment. aggregated dataset for reporting to….or for research in….. Do not prescribe Advisories Collection of Do not prescribe advisories A list of advisories to not prescribe a particular product to the patient. Captures and provides transparency of reasons why a particular Ig Product should not be prescribed (Prescriber, Authoriser, Dispenser, NBA) Supports intelligence where advisory is patient preference rather than safety such that at times of preferred product shortage, patient may safely be prescribed non preferred product (as opposed to safety reason). Risk to patient safety if Ig product is prescribed to which the patient has had previous adverse reaction. Use – Transparent to some users of system (see security matrix) Disclosure - not intended for release other than inclusion as part of aggregated dataset for reporting to …… Home Therapy Additional Details Column Type Description Validation Primary Purpose for collection Secondary purpose for collection Consequence to individual if not collected Proposed Use and Disclosure
Device LOV: Devices The type of pump that the patient uses to infuse the product. Provides transparency of the device pump type that is used by the patient to infuse Ig product at home so that consumables, device spare parts & servicing and training can be given to patient. (Authoriser, Prescriber, Nurse, Dispenser) Potential for error in issuing consumables, planning maintenance or replacement pumps to patient in event of breakdown. Inconvenience to hospital staff to identify which device (pump) is being used by the patient for infusions Use – Transparent to some users of system (see security matrix) Disclosure – not intended for release other than ability for local hospital printing to include in patient medical record. Home Therapy Contact Text The Name of a person that can act as the contact for the patient’s home therapy deliveries. Provides transparency of the name of responsible person to provide important information regarding deliveries of product. The contact person might be the Patient or may be another person if carer or patient is a child. (Authoriser, Prescriber, Nurse, Dispenser) ,) Risk to patient safety and convenience as potential for inability to contact conveniently regarding issues related to delivery of product. Use – Transparent to some of system (see security matrix) Disclosure - No plans for disclosure other than ability for local hospital printing to include in patient medical record or as part of de-identified aggregated dataset. – as above
Home Therapy Contact Relationship LOV: Relationships The relationship to the patient of the home therapy contact. Provides transparency of the relationship of contact person to patient (NBA, Authoriser, Prescriber, Dispenser) Lack of validation and identification of contact person and relationship to patient. Will this lead to no delivery? Use – Transparent to some users of system (see security matrix) Disclosure - No for disclosure other than ability for local hospital printing to include in patient medical record. Phone Text A number at the delivery address Provides transparency of telephone contact at delivery address. (Prescriber, Nurse, Dispenser) Supports telephone contact regarding product deliveries. (Hospital,) Inability to readily contact patient regarding changes in product deliveries. Potential patient safety risk product remains unrefrigerated for extended periods and/or product wastage. Use – Transparent to some users of system (see security matrix) Disclosure - No plans for disclosure other than ability for local hospital printing to include in patient medical record. Supply Arrangement LOV: Home Therapy Supply Arrangements Valid Values: Patient collects from dispenser Provides transparency of patient/hospital preference for product deliveries in order to distinguish those Patient home deliveries could not be supported in future and/or Use – Transparent to some of system (see security matrix)
Delivery to Patient’s address patients on home delivery of product from patients attending hospital to collect product. (Authoriser, Prescriber, Dispenser, NBA) increased cost to modify system at a later stage. Disclosure - No plans for disclosure other than ability for local hospital printing to include in patient medical record. Delivery Address Address The address to which deliveries of product shall be sent Required if Supply Arrangement = Delivery to Patient’s Address Provides transparency of the delivery address for product to be sent for infusion by patients. (Authoriser, Prescriber, Nurse, Dispenser, NBA) Home delivery of product cannot be supported without identification of a delivery address. Use – Transparent to some of system (see security matrix). Information would be provided to distributor. Disclosure – (what about to the Distributor to deliver the product?) No plans for disclosure other than ability for local hospital printing to include in patient medical record. Hospital Identifier
A hospital identifier represents the relationship between a patient and a hospital. A Hospital Identifier is created for each hospital at the patient has an interaction (consultation or treatment). Column Type Description Validation Primary Purpose for collection Secondary purpose for collection Consequence if not collected Proposed use and disclosure Patient Patient The patient to which the hospital identifier pertains to. Provides transparency and confirmation of access to the correct patient record to deliver the correct data relevant to the patient and treatment (Prescriber, Nurse, Dispenser, NBA) Patient safety risk user accesses incorrect patient record and enters data activating wrong treatment/product. Increased risk of duplicate patient record being created. Use – Transparent to some users of system (see security matrix). Information would be provided to distributor. Disclosure - No plans for disclosure other than including data in aggregated dataset. – as above Hospital Site The hospital (site) for which this identifier is defined where patients will attend to collect or attend for treatment and/or attend for consultation with doctors. List will default to site for logged on user or selected from list generated from BloodNet the patient to a hospital for treatment thereby enabling transparency of all hospital affiliations for a patient. (Prescriber, Dispenser, NBA) Reduces the potential for multiple treatments being provided to the same patient. And supports contact of correct treating specialist when patient treatment review for access to ongoing therapy is required. Patient safety risk where user accesses incorrect patient record and enters data activating wrong treatment/product. Increased risk of duplicate patient record being created. Use – Transparent to some users of system (see security matrix). Disclosure - No disclosure at record level other than local hospital printing of record for medical case notes.
Patient ID Text The identifier used by the hospital/site to uniquely identify the patient. Supports patient search process and provides an additional check that access has been gained to the correct patient record. (Prescriber, Nurse, Dispenser, NBA) Ease of search by hospital staff where Patient ID is readily accessible. Used as a reference in and Treating Specialist correspondence regarding identifying the correct patient for periodical treatment review prior to authorisation for ongoing therapy. (Hospital) Patient safety risk where user accesses incorrect patient record and enters data activating wrong treatment/product. Increased risk of duplicate patient record being created. Use – Transparent to some users of system (see security matrix). Disclosure - No disclosure at record level other than local hospital printing of record for medical case notes. Authorisation Request A formal request from a medical officer to treat a patient with immunoglobulin under one of the authorisation pathways. A request must be made for a specific patient having a condition set out in the Criteria for Use. Column Type Description Validation Primary purpose for collection Secondary purpose for collection Consequence to individual if not collected Proposed use and disclosure Authorisation Request ID Alphanumeric Characters Unique identifier for the authorisation request Provides transparency of each authorisation request. (Authoriser, Supports reporting and analysis of system activity [ see above – for privacy consideration is consequence to the individual patient if not collected but may assist Use – Transparent to some of system (see security matrix).
generated by the system. Prescriber, Nurse, Dispenser, NBA) (NBA, Hospital) beyond this purpose to include this] Disclosure - No disclosure than at level of aggregated reports. Authorisation Program LOV: Authorisation program The product program under which the authorisation request is made and will be assessed. Values: IVIg SCIg Provides transparency regarding the type of Blood product authorisation request being made e.g. IVIg, SCIg. (NBA, Authoriser, Hospital, Jurisdictional DoH) Supports efficient reporting and data analysis by product type. (NBA, Hospital) Risk of incorrect product being authorised, dispensed or delivered. Use – Transparent to some users of system (see security matrix). Disclosure - No disclosure than at level of aggregated reports. Request Date Date Time The date that the request is made Must not be a past date Provides transparency and accuracy regarding date of request for product. (NBA, Hospital, Authoriser, Dispenser,) Supports performance analysis of time to respond authorisation & treatment processes. Risk of lack of timely management of request. Lack of trigger date for patient clinical review due date regarding ongoing access to treatment. Use – Transparent to some users of system (see security matrix). Disclosure - No disclosure other than at level of aggregated reports.
diagnosis of a condition. compliance with the Criteria for Use. (Authoriser, Hospital, NBA) NBA - 3 reference should clarification or additional information be required in the future. (NBA, Authoriser, Hospital) treatment is not indicated. No disclosure than at level of aggregated reports for clinical governance and Ig governance purposes. Requesting Medical Officer Medical Officer The Medical Officer who has completed the authorisation request form. Capturing the name of the Medical Officer that completes the Authorisation request (which equates a prescription in content) will be important for performance review analysis to support the evaluation of compliance with the Criteria in prescribing behaviour. (NBA, Hospital) NBA - 3 The requesting medical officer will be a junior doctor working under supervision. It is important to differentiate this person from the Responsible Specialist overall. (NBA, Hospital) – as not really patient consequence but may also assist for other purposes to record this. 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.
Condition Condition The Medical Condition for which treatment is being requested. Valid values – Conditions as defined in the Criteria Providing transparency of condition requiring 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,) NBA - 3 The linkage of clinical outcome data to condition and prescribed treatment is essential for ongoing evidence base and determining the efficacy of Ig treatment. (NBA, Hospital) Risk to assessing incorrect dose and infusion plan at authorisation resulting in potential ineffective clinical outcome, inappropriate product and dose/schedule of treatment, determining efficacy of treatment and inability to demand forecast and secure sufficient product supply. 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. Specific Condition Specific Condition The specific condition (as a subset of the Condition) for which treatment is being requested Providing transparency of condition requiring treatment is a critical element needed for accurate Authorisation of proposed patient treatment as dose, frequency and treatment schedule is different for different The linkage of clinical outcome data to condition and prescribed treatment is essential for ongoing evidence base and determining the efficacy of Ig treatment. Risk to assessing incorrect dose and infusion plan at authorisation resulting in potential ineffective clinical outcome, inappropriate product and dose/schedule of treatment, determining efficacy of treatment and inability to demand Use – Transparent to some of system (see security matrix). No disclosure than at level of aggregated reports for clinical governance and Ig governance purposes.
conditions and indications. (NBA, Hospital, Authoriser,) NBA - 3 (NBA, Hospital) forecast and secure sufficient product supply. Indication Indication The indication for which treatment is being requested Providing transparency of the specific indication relating to the condition requiring treatment is a critical element needed for accurate Authorisation of proposed patient treatment (dose, frequency and treatment schedule). This is different for different conditions and indications. (NBA, Hospital, Authoriser,) NBA - 3 The linkage of specific indication and condition to clinical outcome data and prescribed treatment is essential for building the evidence base and determining the efficacy of Ig treatment. (NBA, Hospital) Risk to assessing incorrect dose and infusion plan at authorisation resulting in potential ineffective clinical outcome, inappropriate product and dose/schedule of treatment, determining efficacy of treatment and inability to demand forecast and secure sufficient product supply. 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.
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
patients are eligible for access to Ig funded under the national blood arrangements. This approach is consistent with approach used by the high cost drugs program. (NBA - 3) treatment for some conditions. (NBA) Failure to build the evidence base to support future analysis of treatment effectiveness and dosing. governance and Ig governance purposes. Selected Exclusion Criteria Collection of Exclusion Criteria The exclusion criteria that was selected by the user as applying to the patient’s condition. The collection of exclusion criteria is important to confirm that all patients are eligible for access to Ig the national blood arrangements – that prescribing practice is compliant with the Criteria for Use. (NBA - 3) Failure to collect exclusion criteria as part of the Authorisation request is likely to result in patients inappropriately receiving Ig treatment and non-compliance with the Criteria for Use. Exclusion criteria have been determined as ineffective and inappropriate use of Ig by using a clinical evidence base Use – Transparent to some users of system (see security matrix). No disclosure than at level of aggregated reports for clinical governance and Ig governance purposes.
the majority of treatment is delivered in a regional or rural location or in some instances, home therapy. (Hospital, NBA) Authorisation Jurisdiction LOV: Jurisdiction The jurisdiction under which the authorisation request will be assessed. Valid Values: ACT NSW NT QLD SA TAS VIC WA Capturing and providing transparency of the Authorisation jurisdiction ensures that there is transparency of location of the Authoriser to prescribers and other users to contact the Authoriser where necessary. (Hospital, NBA) Review of Authoriser performance (e.g. to assess the of comparable decision making nationally) is an important part of the ongoing governance of Ig management. (NBA) Prescribers will be unable to easily and contact the relevant Authoriser in the event of clarification of problems with requests. Failure to collect the Authorisation site removes the ability to undertake appropriate performance analysis of this function. Use – Transparent to some of system (see security matrix). No disclosure than at level of aggregated reports for clinical governance and Ig governance purposes. Is Retrospective True / False Indicates that the request is being made retrospectively In some instances, product is required to be dispensed without authorisation approval The frequency of such requests and other relevant process issues can be Failure to allow flagging of retrospective requests in the system will result in incorrect Use – Transparent to some users of system (see security matrix).
(after treatment has begun) (e.g. in an emergency), and data is addressed after the fact. The system must be able to accommodate retrospective data entry of authorisation requests and track them. (Hospital, NBA) evaluated for improvement opportunities as part of performance review using this field. (NBA) treatment dates being recorded and lack of visibility of the practice of dispensing without authorisation approval. No disclosure other than at level of aggregated reports for clinical governance and Ig governance purposes. Is Emergency True / False Indicates that the request is being made in an emergency and that treatment is likely to be given before the assessment has been completed. This is important to distinguish emergency need from other reasons for dispensing without authorisation. While the system must be able to accommodate retrospective data entry of authorisation requests and track them, some emergencies will be able to receive authorisation approval. The frequency of the subset of emergency requests allows investigation of other reasons for retrospective data entry and monitoring of how many emergency requests there are. Process problems can be evaluated for improvement opportunities as part of performance Failure to identify emergency requests denies the opportunity to fully evaluate the frequency of such instances and the degree to which they are able to be accommodated by the Ig management structures including by different Authorisation locations. Use – Transparent to some of system (see security matrix). No disclosure than at level of aggregated reports for clinical governance and Ig governance purposes.
brand of product where supply constraints allow. (Prescriber, Nurse, Dispenser, Authoriser, NBA) (NBA) of product brands within hospitals which may be difficult to manage without this flag. Date Date Time The date of the previous treatment Must not be current or future date. The date of the most recent treatment is important to schedule the next treatment. (Prescriber, Nurse, Dispenser, Authoriser, NBA) Display of previous treatment will avoid duplicate treatments being scheduled and given. Data analysis of treatment timings is an important indicator to support evaluation of treatment effectiveness and Ig performance management. (Hospital, NBA) Failure to collect/display the date of previous treatment will result in paper records needing to be accessed and reduces the efficiency of the system to support Ig treatment. Risk of duplicate treatments at incorrect time intervals being given across different sites. Use – Transparent to some of system (see security matrix). No disclosure other than at level of aggregated reports for clinical governance and Ig governance purposes. Response Text A comment on the patient’s response to the treatment. The recording of the response patients have had to particular brands of Ig product ensures that allocation of the next treatment type is appropriate for patient safety. Failure to collect and display the patient’s response to a previous Ig treatment may result in patients receiving a brand of product to which they have had a reaction. Use – Transparent to some users of system (see security matrix). No disclosure than at level of de-identified aggregated reports for clinical governance and
(Prescriber, Dispenser, Authoriser, NBA) Ig governance purposes. Medical Officer An individual with the qualifications and credentials to prescribe immunoglobulin treatment. The medical officer record may or may not be related to a user account. Column Type Description Validation Primary purpose for collection Secondary purpose for collection Consequence if not collected Proposed use and disclosure Medical Registration Number Text The registration number of the medical officer as assigned by relevant medical board. The collection and display of medical registration number allows the verification of the medical officer against the AHPRA website and as such, as a valid prescriber of Ig products supporting approval for system access. (Prescriber, Nurse, Dispenser, Authoriser, NBA) The registration number is a nationally unique identifier which supports the creation of a single medical officer record that can be transferred across different hospital institutions. In this way, an individual’s prescribing practice can be assessed. (NBA) Risk of BloodSTAR access being granted to non-medical staff as prescribers and duplication of multiple medical officer records for the same individual being created. Use – Transparent to some users of system (see security matrix). No disclosure planned however this indicator will be used to evaluate individual prescribing practice and data inclusion in de-identified reports as part of performance review and management activities.
Given Name Text The name of the Medical Officer Collection and display of given name will help distinguish medical officers with the same surname within the system. (Prescriber, Dispenser, Authoriser, NBA) Failure to display given name will lead to failure identify the relevant medical officer within the system for authorisers and other hospital staff. Use – Transparent to some users of system (see security matrix). No disclosure planned other than in correspondence to the medical officer. Family Name Text The Family Name of the Medical Officer Collection and display of surname is important for identification of medical officers within the system (Prescriber, Nurse, Dispenser, Authoriser, NBA) Failure to display surname will lead to failure identify the relevant medical officer within the system for authorisers and hospital staff. Use – Transparent to some users of system (see security matrix). No disclosure planned other than in correspondence to the medical officer. Designation LOV: Medical Officer Designation The designation of the individual in current role. Valid Values: TBA Collection and display of medical officer designation supports the assessment of the authorisation request and indicates that additional advice may be required to modify the request the The differentiation of medical officer type supports the analysis and determination of education and training needs to particular medical officer segments. Failure to differentiate levels of seniority and experience of medical staff is likely to result in authorisation requests for Ig to not be challenged by authorisers and difficulty in assessing Use – Transparent to some users of system (see security matrix). No disclosure other than at level of aggregated reports for clinical
designation is of junior staff. (Prescriber, Nurse, Dispenser, Authoriser, NBA) (NBA) and targeting education and training needs. governance and Ig governance purposes. Mobile / Pager Text The medical officer’s mobile phone number or pager number The collection and display of medical staffs’ mobile or pager numbers is required by authorisation staff to contact the medical officer for further information or discuss an authorisation request. (Authoriser, NBA) Failure to display the mobile telephone or details of requesting and treating medical staff is likely to result in delays in authorisation and therefore patient treatment and potentially higher doses and longer treatment periods because the prescribing or treating medical officer cannot be contacted easily. Use – Transparent to some of system (see security matrix). No disclosure planned. Contact Details Collection of Contact Details A list of email address, phone and fax numbers at which the The collection and display of contact details for medical staff is important for communication regarding Ig in particular, Communication regarding changes to the Ig Program, changes to eligibility criteria and access, product recalls and Failure to collect and display contact details for medical staff will result in an inability to advise them in a timely manner regarding Use – Transparent to some users of system (see security matrix). No disclosure planned other using to contact
medical officer can be reached the preferred email address (Authoriser, NBA) other relevant advice is needed to be provided to medical staff from time to time. (NBA) changes to the Ig Program, eligibility and access, product recalls and other relevant advice will not be able to be provided to medical staff as the need arises. the specific medical officer. Primary Jurisdiction LOV: Jurisdiction The jurisdiction in the medical officer primarily works. Values: ACT NSW NT QLD SA TAS VIC WA The collection and display of the main jurisdiction in which the medical officer works is important to segment the prescribing practice of medical staff on a jurisdictional basis, for reporting purposes. (NBA) Failure to designate medical staff to primary jurisdictions may result in inaccurate analysis of prescribing practice for performance management purposes. Use – Transparent to some users of system (see security matrix). No disclosure planned other than in aggregated reporting. Postal Address The postal address to which formal correspondence can be sent to the medical officer. Preferred postal address is required when formal correspondence (e.g. relating to patients) must be sent. Examples include that patient clinical review is becoming due. (Authoriser, NBA) Risk of failure to send confidential correspondence regarding the timely notification for patient clinical review being due and need for assessment regarding ongoing Ig treatment, Use – Transparent to some of system (see security matrix). No disclosure planned other using to contact the specific medical officer.
resulting in delays to authorisation and patients losing access to Ig treatment. Is a specialist True / Indicates if the Medical Officer is authorised to be nominated as the Treating Medical Specialist on authorisation requests. Flagging the medical officer as a Specialist is required to enable BloodSTAR to ensure compliance with the Criteria for Use – e.g. for some conditions a specialist medical staff must undertake the patient clinical review for ongoing access to Ig treatment. (NBA, Authoriser) Failure to designate medical officers as specialists within BloodSTAR will result in failure to comply with the Criteria for Use at a system level. Use – Transparent to some of system (see security matrix). No disclosure planned than in aggregated reporting. Speciality Registrations Collection of Specialties A list of specialty areas for which the Medical Officer is registered. mandatory where Is a Specialist = true The capturing of the specific speciality for medical officers is required to support the medical staff verification and credentialing process to gain access to BloodSTAR. The designation of speciality will support the analysis of prescribing practice for each speciality type and in turn help determine education and training needs. Failure to collect the speciality to the medical officer is credentialed will result in incomplete verification data and lack of analysis regarding specialities and inability to Use – Transparent to some users of system (see security matrix). No disclosure planned other than in aggregated reporting.
Rationale requests pertain specifically to a Medical Officer’s own patient. The medical officer cannot gather any more information from a request than they has entered themselves. The authoriser needs to be able to see the request in order to assess it. A nurse does not need to know anything about how an authorisation came to be. A dispenser does not need to know anything how an authorisation came to be. Consent Records Yes Yes Yes Yes Yes Review outcomes (identifiable) Yes Yes No No Yes Condition Can only see review outcomes for authorisations for which the Medical Officer is the Treating Medical Specialist Rationale The Medical Officer cannot gather any more information from review outcomes than that which they have entered themselves. The authoriser must assess review outcomes to ascertain that there has been a clinical benefit before approving continuing access to treatment A nurse does not need to understand the clinical effectiveness of the treatment in order to safely administer treatment. A dispenser does not need to understand the clinical effectiveness of the treatment in order to safely dispense product for treatment. Clinical Outcomes (identifiable) Yes No No No Yes Condition Own - Can only see clinical outcomes for authorisations for
the Medical Officer is the Treating Medical Specialist. Rationale The Medical Officer cannot gather any more information from clinical outcomes than that which they have entered themselves. The authoriser only to know about demonstrated efficacy based on the criteria that will qualify the patient for continued treatment. Clinical Outcomes may contain data in addition to that required above. A nurse does not need to understand the clinical outcomes of the treatment in order to safely administer treatment. A dispenser does not need to understand the clinical outcomes of the treatment in order to safely dispense product for treatment.