Explain the process of internal and external audits and why this is important.

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The performance of an Internal Quality Audit is a key process that is undertaken to verify that the working activities of SSD staff members comply with the procedures specified in the SSD policy documents found on the Q-Pulse System (the SSD’s Quality Management System). ‘SOP-37‘ provides detailed information on this process: there is an audit of the entire system and the Quality Manual on at least an annual basis; the Quality Representative will use the Q-Pulse System to assign the Area Audit to an Internal Auditor – there are nine areas that are audited with reference to the policy documents for that area (Dirty Returns & Wash Room/IAP Area/Autoclave Area/Despatch & Sterile Store/Bulk Store/Transport/Management/Production/Training), and nine Internal Auditors (the SSD Operations Manager, the SSD Systems Administrator, the SSD Training Manager, four SSD Supervisors, and two SSD Senior Technicians); the Internal Quality Audit Report will record the Audit Number generated by the Q-Pulse Audit Module, the Audit Title and date, the procedures and work instructions covered, the Auditors present, the previous Audit Status, any observations from the meeting/previous audits that require further consideration/action, and any notes/checklists that are scanned electronically and attached to the Q-Pulse Audit; the audit should take place on the agreed date – where this is not possible, it must be undertaken before the end of the month; all the procedures specified in the relevant SSD policy documents will be checked against actual practice, with variations/omissions considered and logged as an ‘Observation‘ or ‘Non-Conformance‘; the term ‘Observation‘ is used to record anything that would benefit the Quality System/general running of the SSD, minor deviations from standard procedures that have been resolved during the audit, and minor administrative issues that have been resolved during the audit; the term ‘Non-Conformance‘ is used to record anything that would have a negative effect on the Quality System/general running of the SSD; the term ‘Corrective Action‘ is used to record actions that have been taken to correct deviations from standard procedures; and the term ‘Preventative Action‘ is used to record actions taken in order to prevent the reoccurrence of deviations from standard procedures.

Guidance for the creation of an audit on the Q-Pulse System is given in the SSD policy document ‘QP-8‘. The Quality Representative will create the audit in the Audit Module on Q-Pulse, and the Systems Administrator or SSD Operations Manager will assign a start date and an end date to the audit process. Auditees will then be added, with the Scope section being compiled by the Lead Auditor – the Lead Auditor will select the areas of standard for the area they are auditing, before creating a checklist comprising of title, description, name of Auditor, and date completed. In the Create/Edit checklist box, click ‘New‘ -> add the question, response, area of standard, score (optional) and guidance -> repeat for each question that will be asked.

Details for the actual performance of an audit are provided in ‘QP-9‘. Entering the audit that you have been asked to perform, it is necessary to select the actual start date -> perform the audit using the checklist and scope -> report any Observations or Non-Conformances that arise during the course of the audit -> and, if required, add notes pertaining to the auditees.

Two forms that are used during the Internal Audit process are available on the Q-Pulse System: ‘FORM-45‘ provides a template for a ‘Sterile Services Department Internal Audit Timetable‘, with space to record details such as Date/Auditor Name(s)/Area of Audit/Standards, Procedures, and Records audited/previous Non-Conformities/Questions asked/Process Owner (see Evidence 6A); and ‘FORM-56‘ allows a record to be made of the Date/Internal Audit Title/Auditor(s) Name(s), plus any Observations/Non-Conformances that need to be logged (see Evidence 6B).

[the importance of internal and external audits is stated under the following heading, in paragraph two]

Explain why it is important to monitor all aspects of the decontamination cycle in line with legislation, guidance and the quality management system. Explain why there is a Quality Management System in place.

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The Q-Pulse System, serving as the SSD’s Quality Management System, is in place to ensure that the SSD remains compliant with National, European, and International Standards. These Standards are outlined in the Department of Health‘s Choice Framework for local Policy and Procedures 01-01 Management and decontamination of surgical instruments (medical devices) used in acute care, Parts A, B, C, D, and E. Part A details technical concepts concerning the prevention of transmission of conventional pathogens, precautionary policies in respect of human prion diseases (including vCJD, plus advice on surgical instrument management related to surgical care efficiencies and contingency against perioperative non-availability of instruments. Part B contains advice on test equipment and materials, design and pre-purchase considerations, validation and verification. Part C covers standards and guidance on steam sterilisation, and was examined in relation to the SSD Autoclaves in Unit Five. Part D covers standards and guidance on Washer-Disinfectors, and Part E contains advice on low-temperature, non-steam sterilisation processes – such as the use of vaporised hydrogen peroxide gas plasmas and ethylene oxide exposure.

The undertaking of detailed Internal Audits– monitoring all aspects of the decontamination cycle- ensures that the SSD’s Quality Management System is being followed, thus guaranteeing that working practices conform to those set out by the Department of Health. Since the SSD is audited annually by an external, accredited Body, it is vital that all staff members are aware of- and follow to the letter- correct working practices, in order to prove the Department’s compliance to the auditing Body. Failure to demonstrate legislative compliance during the External Audit would result in the SSD being deemed unfit for purpose, and the SSD would not be allowed to continue to provide its vital function.

Prior to becoming an integral part of the SSD’s Quality Management System, the manufacturer of the Q-Pulse System had to audit and test the software, ensuring its fitness for purpose, and also provide a Validation Letter – this process is undertaken for all new software that is used in the SSD, as outlined in ‘SOP-49‘. Once obtained, the Validation Letter is placed within the Systems Manual in the Q-Pulse ‘Documents‘ module – Validation Letters for MMM software, Health Edge software (the traceability system in place in the SSD), and Q-Pulse itself are stored in Q-Pulse [as ‘SYS-1‘, ‘SYS-2‘, and ‘SYS-3‘ respectively].

All documents entered into the Q-Pulse System have to be approved by Matthew Dyer, the Sterile Services Operations Manager. ‘FORM-32‘ (Evidence 6E) can be used as a template in order to create a document, or an existing document can be used. The process for submitting documents for his approval is outlined in ‘QP-3‘: log into the Q-Pulse System -> select ‘Documents‘ -> go to ‘File‘ -> then ‘New‘, ‘Document‘, and ‘Draft Document‘ -> select the correct category for the document to be approved under in the ‘Type‘ section -> enter the appropriate document title in the ‘Title‘ category -> add your own name in the ‘Owner‘ field -> specify the date you would like to start using the document in the ‘Implement By Date‘ field -> click on the icon with three dots (“…“) -> click on ‘Add Files‘ -> navigate to the document’s current file location, select the file and click ‘Open‘ -> after ensuring that the ‘Embed in Q-Pulse (most secure)‘ and ‘Delete Original‘ options are selected, click ‘OK‘ and then click the ‘save‘ icon [denoted by a picture of a floppy disk] -> click the ‘submit draft for approval‘ icon [denoted by a triangle pointing to the right, as used to signify ‘play’ on media players] -> keep the ‘Revision‘ field set as ‘1‘, enter any relevant comments, and click ‘OK‘, an action that results in the document being submitted for approval -> following consideration of the document, an email will then be sent to you, informing you whether Matthew Dyer has approved or rejected the document.

Guidance is given to staff members relating to the completion of Non-Conformances logged on the Q-Pulse System [the manner in which different types of Non-Conformances are logged on Q-Pulse is covered in Unit One]. Staff members with at least a supervisory level of authority within the Department (Band Four and above) are tasked with closing out Non-Conformances correctly, and ‘QP-5‘ highlights the importance of establishing the Root Cause of a Non-Conformance [thus identifying the reason for the non-conformance occurring] and entering these details correctly.

‘QP-4‘ describes the process that must be followed in order to fill in details of Preventive Action that has been taken in order to minimise the risk of repeatedly suffering a specific type of Non-Conformance: log into Q-Pulse -> select the ‘Actions‘ title from the ‘My Actions‘ box, then click the number in brackets next to the words ‘Preventive Action‘, thus navigating to a page of all actions that need to be completed by yourself -> click on the ‘Open Record‘ icon [denoted by an image of an opening folder] -> select a Non-Conformance Record from among the ones presented on the records page -> read through the Details, Root Cause, and Corrective Action details supplied with the Non-Conformance, filling in the ‘Preventive Action‘ text field with details of the steps taken to ensure that this particular type of non-conformance is not repeated; once ‘Preventive Action‘ details have been filled in, specify your name in the ‘Completed By‘ box, select the correct date and time details in relation to the ‘Closed Date‘ field, and click on the ‘Save‘ icon -> click on the ‘Return To List‘ icon [denoted by a left-pointing arrow], proceeding to complete all records in the manner prescribed in the previous step -> and finally, once all the records have been updated, click on the ‘Log Out‘ icon [denoted by an open door].

The management of routine administrative tasks is the responsibility of the SSD Systems Administrator (Darren May), with ‘SOP-32‘ detailing the manner in which Office policies help to maintain a high level of administrative housekeeping and efficiency. Relevant information from this document includes: all official mail is to be received outside the Raw Materials Store, with mail marked “Private and Confidential”/ “Staff in Confidence” passed unopened to the addressee; files on the various departmental PCs are held within sub-directories of the Trust’s network drive directory [“S:\TR15\SSD”], with quality-related documents filed into the Q-Pulse System; departmental forms must not be photocopied – these forms are filed as ‘FORM-…’ within the ‘Documents‘ module in Q-Pulse; relevant departmental telephone extension numbers are made available in the SSD (Decontamination Lead’s Office – 2816/Sterile Services Lead’s Office – 5060/Production Controller – 3360/IAP Area – 2818/Departmental Office – 2817/Sterile Store – 2819/SSD Estates Team – 2815); faults that occur on the green-labelled CITS-purchased equipment must be reported to the Systems Administrator, who will inform the CITS Help Desk on extension 1717, quoting the machine number – all other items are to be reported to the Systems Administrator; pressing the F1 button when on the system brings up the ‘Help File‘, providing details of how to contact the system/software supplier if the Systems Administrator is not contactable (for example, on holiday/out-of-hours); all essential data produced on the main, networked administrative IT systems will be saved and automatically backed up on the CITS Servers; backup disks and tapes are stored in the fireproof cabinet in the Raw Materials Store; power-on and screensaver passwords are used to prevent unauthorised persons from gaining access to the system; the ‘Switch User‘ function can be used if a computer is found ‘locked‘ by another user, ensuring the previous user’s unsaved work is not lost – the computer must not be shut down/restarted prior to the previous user having the chance to save their work; only individuals who have been trained and authorised by the Service Leads are permitted access to the systems; filing cabinets containing sensitive data must be locked- and doors and windows closed- when the offices are vacated at the end of the day or for any length of time during the day; in order to prevent eyestrain, regular breaks away from the computer screen must be taken – twenty minutes every hour, or thirty minutes every two hours; and lastly, office equipment will be cleaned on a weekly basis, with screens and keyboards cleaned using the approved cleaning materials.

A number of provisions have been made in order to ensure that Quality Records are properly maintained and available in a secure environment, as outlined in ‘SOP-33’. A combination of SSD storage, offsite storage, and computerised storage is in place for the following records: Steriliser Plant History Records and Washing Machine Plant History Records are kept on file for twenty-one years – two years in the SSD, the remaining time spent in offsite storage; Process Logs are kept on file for twenty-one years in the SSD; Bowie Dick Test Sheets are kept on file for one year in the Autoclave Area; Steriliser Recorder Charts are kept on file for twenty-one years, situated in the Autoclave Area prior to offsite storage; Traceability data is stored on an offsite Server for twenty-one years; Training Record Matrix/Evidence is kept for one year after employment on Q-Pulse; Sterile Service Lead’s Review Records are kept on file for five years in the Admin Office, prior to being stored on Q-Pulse; Contract Review Records, Internal Quality Audit Records, and Nonconformity Records are kept on file for five years, stored on Q-Pulse; Complaints Records are stored on Q-Pulse and the DATIX System for five years; Notified Body Reports is stored in the Sterile Services Lead’s office for five years; Correspondence is kept for five years in the Decontamination Lead’s office; Requisitioning and Purchase Records are stored for over a year in the Office/Raw Materials Store; Controlled Reference Documents are stored on Q-Pulse (while they remain current); Returned Tray Lists are kept for one day in the Wash Room; the IAP Area Cleaning Record is kept for two weeks in the IAP Area Gowning Room; any superseded Article 12 Declarations (relating to EC Declaration of Conformity – Production Quality Assurance) will be filed and kept available for five years; and all other Quality Documents/Records are stored for five years in an appropriate location.

Records/documents are put in secure storage in order to save on space. Data from the various computer applications used in the SSD and stored on a Server are backed up daily with ‘CITS‘, the NHS IT Department: Q-Pulse and HESSDA’s ‘application data storage directory’ is specified as ‘RCHTDBR2\RCHTDB’, with daily data backup taking place on the Server – Neqis is similarly backed up daily on the Server, with its ‘application data storage directory’ specified as ‘\\Rchtsilo\NeQis’; Belimed’s ‘application data storage directory’ is specified as ‘C:\Programme\Belimed\Station17’ [local to the computer, rather than on a Server], with daily backup taking place in the backup directory ‘E:\Backup\Belimed’; and MMM is stored in the ‘application data storage directory’ specified as ‘C:\MMM\Cycles’ [again, local to the computer rather than on a Server], with daily backup taking place in the backup directory ‘P:\CSSD\Belimed & Dot Matrix Backups\Belimed Backup’.

Further guidance relating to document control- specifically, all checklists, forms, record lists, and operating procedures– is given in ‘SOP-34‘. The Decontamination Lead [responsible for non-controlled management letters, business plans, and reports] or Sterile Services Lead [responsible for Quality Manuals, policies, procedures and forms – retaining Master Copies and distributing copies] will authorise all quality documents used in the SSD, although the Production Controller and Supervisors have the authority to initiate urgent changes to production-related documents [excluding documents held in the Quality or Procedure Manuals]. Members of the Office staff are responsible for documents highlighted in the Document Control Manual (Pack lists, Procedure Set Checklists, Issues, Returns and Requisitions, and Stock Level Holdings), plus non-controlled letters and reports. In conjunction with the Systems Administrator, the Sterile Services Lead ensures that the relevant documents are available at work locations to enable the Quality System to function effectively – for example, SSD policy documents pertaining to the Sterile Store are kept on a shelf in that area, together with relevant Requisition Forms, Incomplete Order Forms, and so on.

Further information included in ‘SOP-34‘ includes: all changes to checklists must be entered on the Q-Pulse System as a ‘Tray List Amendment’, thus ensuring that the correct process is followed regarding the tracking system and that an audit trail is created; changes to all other documents will be effected by using the ‘Change Request’ function on Q-Pulse; current information for Master Forms will be held on the departmental computers, with superseded Master Documents marked as ‘Obsolete or Inactive’ and attached to the ‘Change Requests’; with regards to the Standard Operating Procedures (SOPs), the Service Lead authorising the change will sign these documents – all other new and modified documents will have the issue number, date of issue, and the initials of the SSD staff member who authorised or initiated the change displayed within the document footer; the Sterile Services Lead will produce, distribute, and control guidance documents – these have a yellow header, and a footer displaying the date, filename, and directory path; all Codes of Practice, Guidelines, Procedures, and Standards generated by the Royal Cornwall Hospital NHS Trust must be updated when published – this is the responsibility of the Sterile Services Lead, who will check all such documents for validity on an annual basis; Q-Pulse manages the reviews of all documents, with all documents set to have an annual review – the review history is stored within the record in Q-Pulse; and SSD – Quality Manuals/SSD – Procedure Manuals/Document Control Manual/British and European Standards/Choice Framework Policies and Procedures are all stored within the Q-Pulse System.

The Quality System, the Quality Policy, and Departmental Objectives are subject to a quarterly Service Lead Review Group meeting, organised by the Decontamination Lead with a view to ensuring the continued effectiveness of these three service components. ‘SOP-35‘ establishes that the members of the Management Review Group are: the Theatre and Anaesthetics Divisional Manager; the Decontamination Lead; the Sterile Services Lead; staff representatives; Theatre liaison; and ad hoc representatives (for example, the Estates Manager, certain Theatre Managers, Infection Prevention Nurse). All corrective and preventative actions identified will be noted in the minutes of this meeting, with a review of such actions’ progression undertaken at the start of the following meeting. A Management Review Group meeting follows this broad process: attendance record and apologies for absence -> a discussion of the previous meeting’s minutes -> results of the six-monthly surveillance visit report and the Internal Audit report -> a discussion of the quality of service -> an examination of the Quality Management System -> an analysis of Production -> a discussion of Training -> consideration of Risk Analysis -> and lastly, a discussion of any other business-related matters, followed by the agreement of a date and time suitable for the next such meeting.

Staff meetings will be arranged on at least a quarterly basis in order to give staff members the opportunity to discuss issues concerning quality and management, as well as affording staff members the chance to contribute to the success of the operation – these meetings can be convened on a more regular basis if requested by management or staff. The Sterile Services Lead is responsible for administrative and clerical arrangements regarding staff meetings.

An SSD policy document– ‘SOP-39‘- is in place detailing information relating to staff training and development (as stated in the previous Paragraph, this is one of the topics discussed by the Management Review Group). This document provides the following information: the training of new employees, and updates for existing staff members, is provided mainly by the SSD; training comprises Induction, Trust and Departmental Policies & Procedures; staff are appraised on an annual basis in line with the Trust’s Knowledge & Skills Framework (KSF) Policy – both a personal development review and an examination of departmental and individual objectives are considered; specific technical and practical training is provided using various training aids, including work instructions and catalogues; training highlighting the importance of working in line with the Quality System is given; appropriate members of staff will be sent on external training courses and/or study days; training records are maintained, specifying the key areas of training undertaken in order that training needs can be accurately established – training records will be provided that clearly indicate key objectives and the criteria for success, with both the Trainer and staff member signing the records to indicate agreement that the objectives have been covered to the specified standard; and all technical staff will have the opportunity to undertake a BTEC Level 3 Certificate in Decontamination of Reusable Medical Devices [provided by Eastwood Park and accredited by Edexcel]. ‘FORM-30‘ is used [in conjunction with ‘SOP-39‘] to record the training achievements of SSD staff members (see Evidence 6F), whilst ‘FORM-31‘ serves as a checklist for the Departmental Orientation Programme for new members of the SSD staff (see Evidence 6G) – this orientation programme takes place on the second day of paid employment, following on from the Trust’s Induction Programme.

Use records to identify emerging trends and ensure quality maintenance.

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Analyses of Production (another topic discussed in the aforementioned Management Review Group’s meeting) are facilitated with reference to ‘FORM-80‘ (see Evidence 6H). ‘FORM-80‘ is effectively a ‘Help Sheet’ for production analysis using the ‘Reporting‘ module of HESSDA, with instructions guiding authorised staff members as to how to perform analyses of Daily Production, Weekly Production, Bank Staff hours, Overtime hours, Leave hours [including Maternity, Carer’s, and Compassionate], Sickness hours, and Datix reports. The ‘Reporting‘ module of the HESSDA traceability system can therefore be used to identify emerging trends in terms of Production and Staff Absence, allowing measures to be taken in order to ensure quality maintenance.

Information relating to new requests/tenders for service/product or changes to current service or product provision is contained in ‘SOP-36‘. All current services provided by the SSD fall within the NHS Requisition Procedures and therefore do not require formal contracts – all requests for other services should be recorded in writing, with the following details pertaining thereto: requests for changes to stock levels should be recorded; Service Leads will determine whether the Customer’s requirement can be met, and will inform the Customer as to the cost of the service – if a request cannot be met, alternative solutions will be discussed with the Customer; all tenders must be processed through the NHS Logistics/Purchasing and Supply Agency in accordance with the Trust’s Standing Financial Instructions; once the terms and conditions of a service have been agreed with a new External Customer, a Cost Centre Number will be allocated and the Customer’s details entered into the computer system for invoicing – where appropriate, stock level records and top-up sheets will be prepared; the relevant stock level sheet and/or checklist will be amended following departmental procedures if the change of service is for an existing Customer; records of the Contract Review will be kept; the Production Controller and/or the Sterile Services Lead will oversee all the first orders, ensuring conformity with the Customer’s order; and the final point made in ‘SOP-36‘, related to the Management Review Group details discussed above, is that Contract Review will be discussed at the Service Lead’s Review Meetings to ensure sufficient resources are available to meet the Customers’ needs.

Demonstrate how to use batch codes to identify raw materials.

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The manner in which batch codes are used to identify raw materials, and must be noted on the appropriate form in the Raw Materials Store upon IAP Area issue in order to maintain stock records, is covered in Unit Four. Information relating to batch recall and the process of activating recall is given in Unit Five…

Explain the process of maintaining and using tracking systems. Explain how to ensure tracking and traceability is safe and reliable.

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…This latter Unit also details the way in which the HESSDA Traceability System is maintained, with information on the recording of Process Loads in the extremely unlikely event that the traceability system fails; Unit One (including the diagram of ‘The Traceability Cycle (HESSDA Track Positions)’) gives extra detail on the safe and reliable maintenance and use of this tracking system.

Records – Product Release

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A summary of the checks undertaken by the Despatch Operator prior to product release is provided in Unit Five.

Demonstrate how to test and maintain decontamination equipment in accordance with organisational policy and procedure.

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The importance of testing and maintaining decontamination equipment has been stressed in: Unit Two (in relation to the Benchtop Ultrasonic machines); Unit Three (in relation to the Washer-Disinfectors, Washer Carriages, and the Oscar Cleaning System); Unit Four (in relation to Heat Sealers); and Unit Five (Pre-Heat and Bowie Dick Autoclave cycles, Steam Generator, and in relation to the various testing undertaken on the Autoclaves, as well as the equipment used to test the Autoclaves).

A further process that is vital to maintaining decontamination equipment and has not yet been discussed in previous Units relates to the Self Disinfection of Washers, as detailed in ‘B-25‘. Usually, this procedure takes place on Tuesday (Number 1 Washer) and Wednesday (Number 2 Washer). A ‘Do Not Use‘ sign is placed on the appropriate Washer panel, and a check is made that all four lights on the panel are flashing – if this is not the case, the ‘STOP‘ button is pressed twice. Two empty carriages are loaded onto the ‘runners’ of the appropriate Washer, with a third one ready to push on once the first one has entered the first chamber; button ‘P3‘ is then pressed on the Washer panel, followed by the ‘START‘ button.

When there is space on the ‘runners’ a cone should be placed thereon, in order to stop any other carriages being accidentally loaded. Once all three carriages have been through the Washer, the Washer is ready for the Engineers to perform the Weekly Testing, with the results being recorded on ‘FORM-42: WASHER/DISINFECTOR WEEKLY TEST RESULTS‘ (see Evidence 6C); the results of Washer Three Weekly Testing are logged on ‘FORM-62‘ (see Evidence 6D). When the Engineers have finished the Weekly Testing it is necessary to check the cycle numbers for correctness, remove the ‘Do Not Use’ sign from the Washer panel, and remove the cone from the Washer ‘runners’ prior to use; the cycle numbers will normally be verified by a Supervisor or other senior, authorised individual.

Another vital check of Washer efficacy relates to Bio Burden Testing, a three-monthly test that measures the total number of viable micro-organisms on a medical device prior to its final sterilisation (in line with the advice given in the Department of Health’s CFPP 01-01 Part A). The SSD policy document ‘SOP-51‘ details the Bio Burden Testing process: six separate barcodes are kept in the Raw Materials Store, two barcodes for each of the three Washers – take any instrument from the box where the tags are kept and place in a small, lidded DIN container, along with one of the barcoded tags, and scan onto a carriage, loading the carriage into the appropriate Washer (indicated on the tag) -> repeat this process with the other five barcoded tags; in the IAP Area, unload the Washer following standard procedures, removing the small, lidded DIN container -> open the container but don’t touch the instrument until you have read the message on the tag (there are four possible messages: “Do not touch and pack on discharge” [for use in Washers 1, 2, and 3]/”Pack with handling and inspection” [for use in Washer 1]/”Do not touch and pack after 24 hours” [for use in Washer 2]/”Do not touch and pack after 14 days” [for use in Washer 3]) -> make sure to adhere strictly to the message on the tag – gloves must be worn to handle the instrument if the message is “Do not touch…” -> scan the tag’s barcode and use the Heat Sealer to seal the instrument in single Viewpack without the tag -> leave the instrument and tag by the Raw Materials Store Transfer Hatch FAO Jane Ham (Production Controller) [neither the instrument nor the tag must undergo an Autoclave cycle, since Bio Burden Testing is a measure of a medical device’s total microbial count prior to its final sterilisation].