The Use of Electronic signatures for Prescribing Chemotherapy and data entries on the Aria MedOncology system V3.0

Transcription

1 The Use of Electronic signatures for Prescribing Chemotherapy and data entries on the Aria MedOncology system V3.0 January 2013

2 Table of Contents 1. Introduction Purpose of this Policy Scope Definitions / Glossary Ownership and Responsibilities Standards and Practice Dissemination and Implementation Monitoring compliance and effectiveness Updating and Review Equality and Diversity Appendix 1. Governance Information Appendix 2.Initial Equality Impact Assessment Screening Form Page 2 of 16

3 1. Introduction 1.1. This policy defines the use of Electronic Signatures for prescribing chemotherapy and data entries on the Aria MedOncology System This version supersedes any previous versions of this document. 2. Purpose of this Policy This policy has been written to establish when and how electronic signatures are used when accessing the Aria MedOncology system. 2.1 Electronic Signatures A definition of electronic signatures - A working definition of an electronic signature is that it is the electronic equivalent of a written signature. Electronic signatures can come in many forms: typewritten scanned in signature format an electronic representation of a hand written signature a unique sequence of characters a digital representation of characteristics e.g. fingerprint, retina a signature created by cryptographic means a virtual e- signature whereby logging onto the system, using a password, the user is defining who they are, their role and access level. Signatures are as good as the business process and technology used to create them. High value transactions need better quality signatures. Such signatures need to be linked to the owner in order to ensure trust in the underlying commercial system. Better quality signatures can offer: authentication linking the originator to the information integrity allowing any modifications to the information to be detected non-repudiation ensuring satisfaction (in a legal sense) as to the signature s origin. Key legislation in Electronic Signatures includes the following: The Electronic Communications Act 2000 The Electronic Signatures Directive 1999/93/EC The Electronic Signatures Regulations 2002 The Electronic Signatures Directive 1999/93/EC Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures was published on 19 January This is a framework Directive designed to assist in the proper functioning of the internal market of the European Union by ensuring the free movement of electronic signatures and supporting services and products. Member States are required to implement the requirements expressed in the Directive in national legislation. The Directive is implemented into UK law by the Electronic Communications Act 2000, and the Electronic Signatures Regulations 2002 (SI 2002 No. 318). Page 3 of 16

4 2.2 The legal status of electronic signatures Article 5.2 of the Directive provides for a harmonised and appropriate legal framework for the use of electronic signatures by ensuring the recognition of all electronic signatures as evidence. This covers the full range of electronic signatures no matter what their form or technology basis from simple to advanced electronic signatures. Article 5.2 is implemented into UK law through Section 7 of the Electronic Communications Act Other linked legislation includes: Prescription Only Medicines (Human Use) Order 1997 The Prescription Only Medicines (Human Use) Order 1997, Article 15 was amended in the Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 to permit prescriptions to be transmitted electronically and using advanced electronic signatures as the signed prescription. This, however, relates to retail pharmacy supply rather than hospital supply. Medicines Act 1968 The Medicines, Ethics and Practice, A Guide for Pharmacists and Pharmacy Technicians July 2007 section states that the Medicines Act 1968 does not specify that the directions of a practitioner need to be in writing, in order to authorise administration. Nevertheless, it is good practice to ensure that this is the case. There is no legislation on the use of electronic signatures as yet. However, see section Connecting for Health (CfH) The Government s Connecting for Health programme supports the use of electronic signatures to electronic prescription messages, which has been included in Release 2 of the project. It perceives one of the many benefits of electronic prescribing with electronic signatures as a reduction in the risk of medication errors as a result of several factors, including: More legible prescriptions. Improved communication between different departments and care settings. Reduction in paperwork-related problems, e.g. fewer lost or illegible prescriptions. Clearer, and more complete, audit trails of medication administration. Improved formulary guidance and management and appropriate reminders within care pathways. Computerised links to hospital pharmacies, facilitating quicker supply. 2.4 Misuse of Drugs Regulations It is not yet legal to generate an electronic prescription for Schedule 1, 2 or 3 controlled drugs, due to there being no provision for electronic signatures in the Act. Controlled drugs Page 4 of 16

5 will not be prescribed using electronic signatures. A paper copy of a prescription containing a Controlled drug will be printed out and hand signed by the prescribing doctor, to comply with this legislation. 3. Scope 3.1. This policy applies to all personnel with access to the Aria MedOncology system Electronic signatures will be used during the prescribing process and all data entry processes for all users. 4. Definitions 4.1. Aria The Aria MedOncology system PTSU - Pharmacy Technical Service Unit epmr Electronic patient medical record Aria Manager The module of the Aria MedOncology System where the electronic patient medical record (epmr) is maintained and electronic prescribing of chemotherapy takes place. Aria Security The module of the Aria MedOncology System where user accounts, passwords, system controls and audit functions are maintained by CITS Support. Institutions An Institution within Aria MedOncology System is an area of the hospital, a clinic or ward. Security settings can be set up individually for each Institution. To Allocate chemotherapy A patient record is opened and diagnosis entered into the system. A Chemotherapy regimen is then selected. Critical patient data is entered into the patient s electronic medical record to enable the system to plan the treatment days and calculate doses. To Approve - An electronic signature is required before approval can take place. Once a process is approved, no changes can be made. If a mistake has been made, the process must be errored and started again. To Approve chemotherapy confirming a cycle effectively locks the prescription, including any changes, indicating that it is the intended treatment. Dispense chemotherapy This is the final step in the prescription validation process and is usually referred to as the Clinical check. The prescription is released for preparation and an electronic signature is required. Drug Administration The nurse administering the chemotherapy and the nurse co-signing, both enter an electronic signature to record the administration of the drugs. Page 5 of 16

6 To Error Once a process had been errored, the process can be repeated from the start again, in order to correct the initial mistake. A record of the original error is kept on the Aria system and can be viewed or hidden, as required. 5. Ownership and Responsibilities 5.1. Role of the Chemotherapy MDT The Chemotherapy MDT is responsible for agreeing the roles and responsibilities of all of the User groups that are set up on Aria Role of Individual Staff These roles and responsibilities have been agreed by the Chemotherapy MDT and are set up in Aria Security. Clinical System Administrator (CLSA) to identify the level of access required by a new member of staff, ensure completion of the new account form, and ensure training and certification are completed. General system management. CITS Support to set up and assign initial password on new accounts and reactivate locked passwords. To audit the use of electronic signatures in Aria Security. To make amendments to the settings in Aria Security as agreed by the Chemo MDT. CITS Training to produce training documentation and e training material and support the training of users as identified by the CLSA. Consultants to allocate and approve first cycles of chemotherapy treatment and subsequent cycles of treatment, add data to the epmr, modify, delay or discontinue treatments and book appointments. SPR and Staff grade doctors - to allocate and approve second and subsequent cycles of chemotherapy treatment under the supervision of a Consultant, add data and messages to the epmr, and modify and delay treatments. F2 Doctors and Independent Prescribers to allocate and approve second and subsequent cycles of chemotherapy treatment under the supervision of a Consultant, add data and messages to the epmr, and delay treatments. Pharmacists to clinically check treatment, add data and messages to the epmr and delay treatments. Pharmacy Technicians to add data and add messages to the epmr. Nurses to administer and co-sign for drug administration, add data and messages to the epmr, delay treatments and book appointments. Page 6 of 16

7 Health Care Assistants to record Vital Signs and messages on the epmr. Trials Staff - to add data and messages to the epmr, delay treatments and book appointments. Medical Secretaries to view and record messages on the epmr. Outpatient Scheduler to record messages on the epmr and book and defer appointments. 6. Standards and Practice 6.1. Aria is a Computerised Chemotherapy Prescribing and Care Management system being used within RCHT. Electronic signatures are used during the prescribing process and all data entry processes by all users Security levels Within Aria Security, the areas of Aria Manager requiring electronic signatures can be chosen and set. These settings are agreed by the Chemo MDT and are set by the Cancer Services Project Pharmacist or other CLSA. Electronic signatures will always be required for the following areas of Aria Manager for all Institutions: Cancer staging Dose recordings Lesion assessment Notes Orders/ Prescriptions Performance Status Questionnaires Test results Toxicities Treatment options This electronic signature box appears before entries can be Approved in each of the above areas of Aria. 6.3 Password protection In applying for access to use the Aria system the user will be asked to remember a unique password by the CITS Support staff. This will be between 6 and 10 characters long, and have a letter as the first character. The user will be reminded that their password is unique and linked to their user name (the user name will be the Page 7 of 16

8 same as their login access required for RCHT Novell system) and of the importance of not sharing their password. A user s password will need to be changed every 90 days. 6.4 Audit trail Every time a user logs on to any module of Aria, a record is made, in Aria Security, of the module logged on to, their name and the date and time of the action. Within Aria Manager, all changes to the patient s electronic medical record are recorded and attributed to the user logged on, together with the time and date of the change. 6.5 Idle time and procedure for leaving the system unattended. The security settings have been set up to automatically lock the application after 20 minutes of inactivity. If a user is logged into Aria and is called away from the screen, the user must click on the switch user drop down at the bottom of the screen, which brings up the log on box as shown below. Anyone needing to access the system, has to log in again before the system is accessible. 6.6 Procedure for producing a prescription and drug administration The doctor will order (prescribe) the treatment and approve the treatment which effectively locks the prescription, including any changes, indicating that it is the intended treatment. It requires an electronic signature matching the user logged in, as shown in the box in section 6.5. No changes can then be made unless the prescription is errored and a new version prescribed. If the cycle has been defined as a partial prescription, a course will only be confirmed up to the next set of critical tests. The pharmacist will then approve i.e. clinically check, the treatment which is the final step in the prescription validation process. The critical test results will be validated against acceptable values set in the regimen summary. Values outside of acceptable limits require confirmation of acceptability by a Consultant before treatment will be approved and the drugs prepared. Pharmacy have the ability, before the prescription is dispensed, to round doses within agreed limits, if it is not practical to produce the dose prescribed. If such a change is made, this will be highlighted to the nurse administering the dose, during the administration process on screen. Before the prescription can be Approved as dispensed, an electronic signature matching the user logged in is required. Page 8 of 16

9 A paper copy of the prescription will be printed out in the Pharmacy Technical Services Unit (PTSU). This paper copy will be printed so that it can be used for the preparation of the chemotherapy drugs within the clean room. This paper prescription copy will remain in PTSU and be filed with the worksheets and stored for 2 years. 6.6 Administration of medication. An electronic signature matching the user logged in is required from the nurse, before drug administration can be recorded. The second nurse who is to Co-sign for the administration does not need to log in. When the Co-sign button is clicked, a box appears requiring the user to reconfirm their identity and password. Once this is completed, that user s details are recorded as the person Co-signing for the drug administration. 7. Dissemination and Implementation 7.1. This document will be stored in the Document Library and will replace v2.0 which has been archived Training Training for all staff using Aria will be undertaken by the Cancer Services Project Pharmacist, the CITS training department and trained Super users, before a Live account is activated. During this training, the importance of security and the use of electronic signatures is emphasized. 8. Monitoring compliance and effectiveness Element to be monitored Adherence to Policy should be monitored as part of the routine monitoring of the Aria Manager module by CITS Support providing ongoing assurance of the process. An annual audit of the electronic signatures, checking that they activate on the expected fields and to ensure that the e signature has been correctly applied and an audit trail is available, will be undertaken. Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be Cancer Services Project Pharmacist The audit trail in Aria will be used to confirm correct use of the e signature.. An annual report will be produced and a report will also be produced as part of the QC of a new version of Aria when an upgrade has taken place. Audit and monitoring reports will be sent to the Chemotherapy MDT. The Chemotherapy MDT will undertake subsequent recommendations and action planning for any or all deficiencies and recommendations within reasonable timeframes Required changes to practice will be identified and actioned within 4 weeks or as agreed in the action plan. The Cancer Services Project Pharmacist will take each change forward where Page 9 of 16

10 shared appropriate 9. Updating and Review 9.1. This Policy will be reviewed one year from the date of issue. However it may be reviewed within this period if there are monitoring or audit reports that suggest that policy review is required Revisions can be made ahead of the review date if there are new versions of Aria implemented within the trust. Any revision activity is to be recorded in the Version Control Table as part of the document control process. 10. Equality and Diversity This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2 Page 10 of 16

11 Appendix 1. Governance Information Document Title Date Issued/Approved: 24 th April 2013 The Use of Electronic signatures for Prescribing Chemotherapy and data entries on the Aria MedOncology System Date Valid From: 24 th April 2013 Date Valid To: 1 st April 2016 Directorate / Department responsible (author/owner): Contact details: Brief summary of contents Diagnostics, Therapeutics and Cancer Lynne Fleming, Cancer Services Project Pharmacist To define how electronic signatures will be used and audited when entering data and prescribing using the Aria Oncology System. An interim document for use until a generic electronic signature Trust policy is developed. Suggested Keywords: Target Audience Executive Director responsible for Policy: Aria, electronic signature, chemotherapy, cancer, haematology, oncology. RCHT PCT CFT Medical Director Date revised: January 2013 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: The Use of Electronic signatures for Prescribing Chemotherapy and data entries on the Aria Oncology Information System version 8.5 / 8.6 Data Protection Officer CITS Support Chemotherapy MDT Medicine Practice Committee Pharmacy department. Information Governance Divisional Manager confirming approval processes Name and Post Title of additional signatories Bruce Daniel Not Required Page 11 of 16

12 Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? {Original Copy Signed} Internet & Intranet Clinical/ Cancer Services See below Intranet Only Medicines Act 1968 Misuse of Drugs Regulations 2001 Prescription Only Medicines (Human Use) Order 1997 Connecting for Health (CfH) The Electronic Communications Act 2000 The Electronic Signatures Directive 1999/93/EC The Electronic Signatures Regulations 2002 No Version Control Table Date Versio n No June August 2009 January 2013 Summary of Changes Created by Lynne Fleming 2.0 Level of security for passwords changed 3.0 Update to Trust format Title change Changes Made by (Name and Job Title) Lynne Fleming, Cancer Services Project Pharmacist Lynne Fleming. Cancer Services Project Pharmacist Lynne Fleming, Cancer Services Project Pharmacist All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 12 of 16

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14 Appendix 2.Initial Equality Impact Assessment Screening Form Name of service, strategy, policy or project (hereafter referred to as policy) to be assessed: The Use of Electronic signatures for Prescribing Chemotherapy and data entries on the Aria MedOncology system Directorate and service area: Oncology and Haematology departments Division Of Diagnostics, Therapeutics and Cancer, RCHT Name of individual completing Is this a new or existing Procedure? Existing Telephone: assessment: Lynne Fleming 1. Policy Aim* To define how electronic signatures will be used and audited when entering data and prescribing using the Aria Oncology System 2. Policy Objectives* The safe use of electronic signatures for data entries into e PMR and prescribing of chemotherapy using the Aria MedOncology System. 3. Policy intended Outcomes* 4. How will you measure the outcome? 5. Who is intended to benefit from the Policy? Safe and efficient data maintenance, chemotherapy prescribing and recording of drug administration using the Aria Oncology System Monitor the Datix errors associated with use of the Aria MedOncology System. An Annual Audit of a random selection of authorised prescriptions will be undertaken by CITS Support to ensure that the e signature has been correctly applied and an audit trail is available. RCHT staff and patients 6a. Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? No b. If yes, have these groups been consulted? c. Please list any groups who have been consulted about this procedure. *Please see Glossary 7. The Impact Page 14 of 16

15 Please complete the following table using ticks. You should refer to the EA guidance notes for areas of possible impact and also the Glossary if needed. Where you think that the policy could have a positive impact on any of the equality group(s) like promoting equality and equal opportunities or improving relations within equality groups, tick the Positive impact box. Where you think that the policy could have a negative impact on any of the equality group(s) i.e. it could disadvantage them, tick the Negative impact box. Where you think that the policy has no impact on any of the equality group(s) listed below i.e. it has no effect currently on equality groups, tick the No impact box. Equality Positive Negative No Reasons for decision Group Impact Impact Impact Age X This policy describes a standard procedure activity appropriate to the age and capability of all relevant staff Disability X Staff with a disability will be provided with assistance / support to meet the requirements of this policy Religion or belief X Gender Transgender Pregnancy/ Maternity Race Sexual Orientation Marriage / Civil Partnership X X X X X X You will need to continue to a full Equality Impact Assessment if the following have been highlighted: A negative impact and No consultation (this excludes any policies which have been identified as not requiring consultation). 8. If there is no evidence that the policy promotes equality, equal opportunities or improved relations - could it be adapted so that it does? How? Full statement of commitment to policy of equal opportunities is included in the policy Please sign and date this form. Page 15 of 16

16 Keep one copy and send a copy to Matron, Equality, Diversity and Human Rights, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Chyvean House, Penventinnie Lane, Truro, Cornwall, TR1 3LJ A summary of the results will be published on the Trust s web site. Signed Date Page 16 of 16