LOAN EQUIPMENT INSTRUMENTS IN THEATRES. Contents

Transcription

1 LOAN EQUIPMENT INSTRUMENTS IN THEATRES Classification: Procedure Lead Author: Samuel Carney Senior Project Manager Additional author(s): Elizabeth McKenna Senior Purchasing Manager Authors Division: Division of Surgery & Neurosciences Unique ID: TWGOP04(15) Issue number: 1 Expiry Date: July 2017 Contents Section Who should read this document 2 Key points 2 Background/ Scope 2 Policy/Procedure/Guideline 3 Documentation 4 Training 4 Timescales 4 Standards 5 Explanation of terms/ Definitions 5 References and Supporting Documents 5 Roles and Responsibilities 6 Appendix R&D Flow 7 Process Flowchart 8 Document control information (Published as separate document) Document Control 9 Policy Implementation Plan 9 Monitoring and Review 9 Endorsement 9 Equality analysis 9 Page Page 1 of 9

2 Who should read this document? This document is aimed at the following staff groups: Service teams Consultant Surgeons For reference, Anaesthetic staff For reference, Theatre staff Senior Managers Key Messages This document provides recommendations regarding best practice for the management of specialised instrumentation supplied by loan equipment services for use in surgical procedures at SRFT. Advances in surgery have seen improvements in patient outcomes through less invasive techniques and the application of new technologies. Consequently there have been rapid changes in instrumentation, implantable components and transport configuration. The management of loan equipment in the perioperative environment is a common event due to complex surgical requirements, due to rapidly changing surgical instrumentation and technology. Background & Scope The purpose of implementing a documented and managed loan set process is to ensure loan instruments are: 1. Appropriate for the patient and the procedure 2. Available in the operating room at the correct time 3. Free from contamination 4. provided in optimum working condition 5. Returned to the provider, cleaned and appropriately disinfected in a timely manner 6. A cost effective strategy for the surgical and orthopaedic service at SRFT 7. managed by staff who are adequately trained in reprocessing loan sets 8. Packaged and transported in a way that prevents damage to the instruments Page 2 of 9

3 RISKS 1. Risks associated with utilising loan sets include: 1.1. Patient safety and the transmission of infection from contamination with foreign material due to sterilized instrument contaminated due to inadequate disassembly and cleaning of complex instruments 1.2. Damaged sets arriving during transportation 2. Cancellation, delay or prolonged surgical procedures related to: 2.1. Loan set not being ordered 2.2. Loan set not delivered 2.3. missing implants 2.4. Untimely delivery of loan sets 2.5. Medical loan equipment companies unable to undertake their quality management processes as loan sets are delivered directly from one facility to another facility (in example SRFT and MOC) 2.6. Damaged/incorrect or missing instruments on a tray rendering the loan set 3. Financial risks associated with utilisation of loan sets within a facility: 3.1. Inappropriate ordering practices 3.2. Budget overspend due to the introduction of new procedures utilising unevaluated loan sets and prostheses 3.3. Replacement costs associated with damage to instruments caused by reprocessing with mixed grade metals instruments 3.4. Application of a surcharge resulting from orders placed in less than 48 hours 3.5. Loan sets ordered and not used 3.6. Consideration not given to consignment arrangements for frequently used loan sets. Policy/ Guideline/ Protocol Evaluation & Audit Utilising data collected through the new loans request website, areas with excessive loan kit expenditure will be reviewed & action will be taken to address any issues leading to an increase in spend. A suite of reports will be developed and reviewed at the monthly Theatres Performance meeting. These reports will highlight loan kit costs, number of requests & compliance with this policy. Page 3 of 9

4 Documentation & Communication Consultants are responsible for the completion of the loan request form via the loan tracker SharePoint site ( It is essential that kit is ordered through this system to remain within the trusts guidelines & policies. Any exception to this must be escalated to the Senior Manager (theatres). All stakeholders have a responsibility to establish & maintain communication between those involved in the management of loan sets. At the monthly theatres performance meeting, compliance with this policy will be reviewed. Communication with Reps All requests for loan kit MUST be communicated via the loans co-ordinator. Staff MUST NOT contact reps unless given written permission to do so from the ADNS, loans co-ordinator or Senior Manager for theatres. Education & Training All staff involved in the ordering, receipt, checking, reprocessing and use of loan sets are to receive appropriate training from the LINK co-ordinator or loans co-ordinator. Training for use of loan sets should be provided by the company rep. This SOP document will be updated & distributed to stakeholders when required/necessary. Timescales/Reasonable Notice & In line with the process, loan requests must be submitted two weeks prior to Surgery. Any loan requests falling outside of this timescale (2-0 weeks) must follow the same escalation and approval process as list alterations (refer to policy). Loan sets for elective surgery MUST arrive onsite a minimum of 24 hours prior to surgery. The designated delivery point is decontamination unit ground floor Mayo building (SRFT) or decon at Trafford. Quality & Use of Loan Kits Once loan kits have been received a Loan Set Management Checklist (refer Appendix 1) should be completed. A copy of this checklist must also be provided to the courier upon dispatch. Once completed these should be stored in the decontamination ground floor Mayo. Theatre staff are to check the instrumentation prior to the surgical procedure to confirm the contents of the loan set are correct and all appropriate documentation is present i.e. tray list, sterilization record. Theatre staff should ensure all instruments are documented in OR counted in by using the loan set tray lists. Theatre staff must record all used implants and Page 4 of 9

5 associated consumable items such as saw blades, guide wires and other single use items, in the patient record. Any damaged instruments or those requiring repair are to be labelled and reported to the LINK co-ordinator. Instruments damaged as a result of improper use may incur a cost therefore instruments should be handled with care to maintain their integrity. Please refer to the SOP for Missing and Faulty Instruments in Theatre. Theatre staff must package instruments in an orderly manner in the original containers for return to the provider. The loans co-ordinator must ensure that the instruments are checked out of theatre against the original inventory, to ascertain all equipment is accounted for and that any used or damaged equipment is reported to loan equipment service provider. The loans co-ordinator must notify the company when the loan set is ready for dispatch. If requests are not submitted through the Loan Tracker SharePoint, the item(s) will not be ordered. Any requests submitted outside of the processes outlined in this document (e.g directly to the reps) will be escalated to the divisional Managing Director and the order in question will be cancelled. Explanation of terms & Definitions MOC Manchester Orthopaedic Centre (Trafford) ADNS Assistant Director of Nursing CD Clinical Director SRFT - Salford Royal NHS Foundation Trust References and Supporting Documents Scheduling Policy Company/External Reps Policy Roles and responsibilities In order to facilitate decision making processes regarding the use of Loan sets it is vital to identify key stakeholders and determine roles and responsibilities of those involved in the process. Page 5 of 9

6 Consultant Registrar Job Title Loans Co-Ordinator ADNS Theatre Team Leader Clinical Director Senior Manager (Theatres) MOC/Trafford Team Service Teams Responsibility Ensure the request form has been completed fully Sending the form to the ADNS via the request website Identify the need for loan equipment Completing a loan request form/signing off request before submission If loan kit is identified as being required in clinic, the registrar must ensure the relevant consultant approves the request Responsible for action of the request once it has been approved Approve or reject loan kit requests Liaise with clinical directors re: approval & rejection Ensure compliance within guidelines Liaise with ADNS to approve loan kit Review rejected requests Ensure consultants aren t abusing the loan system Ensure any changes to this process are communicated trust wide Monitor compliance with guidelines To ensure that equipment is shared in a cost effective manner Adhere to the Manchester Orthopaedic Centre SLA Review loan kit spend/investigate excessive spend Page 6 of 9

7 Appendices Appendix 1 LOAN KIT MANAGEMENT CHECK PROCESS TO BE ACTIONED BY LOANS CO-ORDINATOR The Equipment Arrives; 48 hours prior to surgery check that everything is present; if not arrange for missing components to be sent ASAP. If this isn t possible contact the rep to ask if it s crucial to the case. This could possibly result in a cancellation. Enter the details of each tray onto Scantrack, generating a unique ID sticker which will be attached to the tray throughout its visit with us for reasons of traceability. (Scantrack is an end to end traceability system, that provides track & trace for all sterile trays to & from off-site facilities and this provides an accurate audit trail from SSDU to the individual patients note. Training is required to use this system. Manually check off the checklist and make copies keeping the originals with the request. Check that each item is CE marked, if not contact the company for a Declaration of Conformity. Photograph each tray and attach ID. Complete comprehensive paperwork request forms supplied by SSDU which requires names, amounts of trays and ID numbers a separate one for each tray of instruments, D of C, manufacturer s instructions and checklists. Send to SSDU in the priority tank, for processing. Check any implants. Upload photographs and them to SSDU along with details of the consignment and any special instructions. Day before surgery, check that the equipment has returned and is on the premises, ready for use. Leave instructions for any implants to be taken over to theatre the night before surgery. Appendix 2 Page 7 of 9

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