POCT Quality Manual.doc

Point of Care Testing DepartmentFile name Name of HospitalPage 1 of 16 Date of issue QUALITY MANUAL TRUST LOGO QUALITY MANUAL SUBSECTION POINT OF CARE TESTING DRAFT DOCUMENT This document together with the Pathology directorate Quality Manual represents the Quality Management System of the Point of Care testing department of name of hospital It has been compiled to meet the requirements of the Clinical Pathology Accreditation UK Ltd CPA system and appropriate national and international standards All procedures specified herein are mandatory within the Point of Care Testing Department Edition no Date of Issue Review IntervalState frequency Authorised By AuthorHannah Albery Copy1 of Location of Copies1 2 3 Document Review History Review DateReviewed BySignature Point of Care Testing DepartmentFile name Name of HospitalPage 2 of 16 Date of issue QUALITY MANUAL CONTENTS 1GENERAL INFORMATION 4 1 1TITLE OF LABORATORY OR DEPARTMENT 4 1 2THE QUALITY MANUAL 4 2MANAGEMENT COMMITMENT TO QUALITY 4 3ORGANISATION AND MANAGEMENT 4 3 1RELATIONSHIP WITHIN THE ORGANISATION 4 3 2POCT POLICY 5 3 3POCT COMMITTEE 5 3 3 1MEMBERSHIP OF THE POCT COMMITTEE 5 3 3 2REMIT OF THE POCT COMMITTEE 5 3 3 2RELATIONSHIP OF THE POCT COMMITTEE WITHIN THE ORGANISATION 6 4ORGANISATION AND QUALITY MANAGEMENT SYSTEM 6 4 1NEEDS AND REQUIREMENTS OF USERS 6 4 2QUALITY OBJECTIVES AND PLANS 7 4 3CONTROL OF PROCESS AND QUALITY RECORDS 7 4 4MANAGEMENT REVIEW 8 5PERSONNEL 8 5 1LABORATORY DIRECTOR 8 5 2POCT COORDINATOR 8 5 3STAFF TRAINING AND EDUCATION 8 6PREMISES AND ENVIRONMENT 9 6 1PREMISES AND ENVIRONMENT 9 6 2FACILITIES FOR STORAGE 9 6 3HEALTH AND SAFETY 10 7EQUIPMENT INFORMATION SYSTEMS AND MATERIALS 10 7 1PROCUREMENT AND MANAGEMENT OF EQUIPMENT 10 7 2MANAGEMENT OF DATA AND INFORMATION 10 7 3MANAGEMENT OF MATERIALS 10 8PRE EXAMINATION PROCESSES 11 8 1INFORMATION FOR USERS 11 8 2SPECIMEN COLLECTION AND HANDLING 11 9EXAMINATION PROCESS 11 9 1SELECTION AND VALIDATION OF EXAMINATION PROCEDURES 12 9 2EXAMINATION PROCEDURES 12 9 3ASSURING THE QUALITY OF EXAMINATIONS 12 10THE POST EXAMINATION PHASE 13 10 1REPORTING RESULTS 13 10 2CLINICAL ADVICE AND INTERPRETATION 13 Point of Care Testing DepartmentFile name Name of HospitalPage 3 of 16 Date of issue QUALITY MANUAL 11EVALUATION AND QUALITY ASSURANCE 13 11 1EVALUATION AND IMPROVEMENT PROCESSES 13 11 2INTERNAL AUDIT OF EXAMINATION PROCESSES 14 11 3EXTERNAL QUALITY ASSESSMENT 14 11 4IDENTIFICATION AND CONTROL OF NON CONFORMITIES 14 11 5CONTINUAL QUALITY IMPROVEMENT 15 Point of Care Testing DepartmentFile name Name of HospitalPage 4 of 16 Date of issue QUALITY MANUAL 1General Information 1 1Title of Laboratory or Department The Point of Care Testing POCT department is part of the name of directorate in name of organisation The name of organisation provides acute and community services to the population of insert details Acute services are centred on Name of hospitalno of beds Also list any community hospitals etc 1 2The Quality Manual This sub manual describes the Quality Management System of the POCT Department Throughout the text there are references to CPA UK Ltd Standards in brackets and to procedures indicated in square brackets written in fulfilment of these standards This Quality Manual A6 Quality Manual fulfils two functions It describes the Quality Management System for the benefits of the departments own management and staff and it provides information for users and for inspection accreditation bodies 2Management Commitment to Quality The staff of the POCT Department affirm their commitment to the introduction and maintenance of quality standards as outlined in the quality policy Insert filename within the department Staff working in the department are required to adhere to the department s quality policy and procedures at all times A POCT Coordinator has been appointed who has appropriate training and experience The POCT coordinator ensures that all POCT carried out in name of organisation is appropriate and managed in line with all current guidelines and legislation POCT users are required to adhere to the departments POCT policy at all times Insert filename A quality manager has been appointed who has appropriate training and experience as quality manager responsible for POCT quality this includes a review of the requirements related to POCT Reviews shall be carried out such that every aspect is addressed systematically and clinically significant departures from good control are reported to the Head of Department and to the Clinical Governance department 3Organisation and Management 3 1Relationship within the Organisation The POCT department is part of the name of organisation The department s relationship within the organisation is shown on page of this manual Insert structure of department resources functionality etc Point of Care Testing DepartmentFile name Name of HospitalPage 5 of 16 Date of issue QUALITY MANUAL 3 2POCT Policy The POCT Policy Insert filename has been validated by the name of organisation It is the responsibility of the POCT Management Group Committee to review this policy as per name of organisation policy and to ensure that responsibilities and authorities are defined and communicated within the organisation 3 3POCT Committee The POCT management group committee is responsible to the governing body of the organisation and has ultimate responsibility for defining the scope of POCT taking into consideration the clinical need for POCT its financial implications technical feasibility and in ensuring that appropriate measures are in place to monitor the accuracy and quality of POCT and the ability of the organisation to fulfil the needs and requirements of the user 3 3 1 Membership of the POCT Committee The POCT committee meets state frequency and has membership as follows The medical director or his appointee Chairperson POCT Coordinator Manager Clinical lead e g director of emergency Core members Medicine Director of primary care Nurse lead e g senior nurse medicine service group Diabetes specialist nurse Risk Manager Department of Clinical Governance Information technology manager Medical equipment manager Pharmacist Quality Manager Safety officer infection control Co opted members Finance Manager Procurement Manager Health Economist 3 3 2 Remit of the POCT Committee The remit of the POCT committee is as follows Agree specification for proposed acquisition of POCT devices and their integration into care pathways clinical effectiveness Evaluate effectiveness of training patient safety Evaluate effectiveness of quality assurance program patient safety Responsible for harmonisation of equipment throughout the organisation Responsible for approval of business case for introduction of POCT devices cost efficiency Responsible for compliance with organisational policy on the management of POCT Responsible for compliance with health care standards in relation to POCT Point of Care Testing DepartmentFile name Name of HospitalPage 6 of 16 Date of issue QUALITY MANUAL Provide an annual report to the organisations board and or clinical governance committee 3 3 2 Relationship of the POCT Committee within the Organisation Organsiation Management Executive Trust Governance Committee Medical Devices Committee POCT Management Group Committee POCT Laboratory Management Laboratory Director POCT Coordinator Manager Quality Manager Primary Care Governance Committee 4Organisation and Quality Management System 4 1Needs and Requirements of Users The needs and requirements of users are kept under constant review by the head of department POCT coordinator and quality manager This is done proactively through the use of user satisfaction surveys Information is also gathered in response to complaints by users of the service and also during discussions with users regarding the service As results of questionnaires and users views are fed back they are presented to the directorate to senior staff in the department and the quality manager for consideration and action to be taken This will be demonstrable through the minutes of meetings and the replies to users Insert filenames of meetings The needs are translated into requirements which form the focus of objective setting and planning A5 Quality Objectives and Plans within the QMS Assessment of user satisfaction and complaints H1 Assessment of User Satisfaction and Complaints is conducted on a regular basis and consideration of the findings form part of the annual management review A11 Management Review Where laboratory management have entered into formal agreements to provide medical laboratory services a documented procedure is in place for the establishment and review of such agreements Filename Procedure for Review of Formal Agreements The procedure for these reviews leading to a change in the arrangements for examinations or contracts ensures that Point of Care Testing DepartmentFile name Name of HospitalPage 7 of 16 Date of issue QUALITY MANUAL Requirements including the methods to be used are adequately defined documented and understood The POCT department has the capability and resources to meet the requirements Appropriate procedures are selected which are able to meet the contract requirements The review of capability is to establish that the department possesses the necessary physical personnel and information resources and that the labs personnel have the skills and expertise necessary for the performance of the examinations in question The review may also encompass results of earlier participation in EQA schemes using samples of known value in order to determine uncertainties of measurement limits of detection confidence limits etc Records of reviews are maintained for the time period specified in Filename Procedure for the Control of Process and Quality Records 4 2Quality Objectives and Plans The POCT coordinator in conjunction with the quality manager defines the quality objectives for the department which allow for monitoring and evaluation of the departments contribution to patient care All objectives are measurable and are consistent with the quality policy plans made to meet these objectives are regularly reviewed Plans are implemented to allow for the measurement analysis and improvement processes needed to demonstrate conformity of POCT to the quality system A management review see 4 4 below which is undertaken on an annual basis determines whether the objectives have been successfully completed and provides an opportunity for revising such objectives and plans Insert filename of quality objectives 4 3Control of Process and Quality Records Refer to Filename Procedure for the Control of Process and Quality Records Records may include but are not limited to the following Request forms including the patient chart or medical record only if used as the request form Examination results and reports Instrument printouts Examination procedures Lab work books or sheets Accession records Calibration functions Quality control records Complaints and action taken Records of internal and external audits EQA records interlaboratory comparisons Quality improvement records Instrument maintenance records Lot documentation certificates of supplies package inserts Incident accident records and action taken Staff training and competency records Point of Care Testing DepartmentFile name Name of HospitalPage 8 of 16 Date of issue QUALITY MANUAL 4 4Management Review The management review includes a cost benefit analysis and an evaluation of the clinical need the clinical effectiveness and the cost efficiency of POCT activities the identification of opportunities for improvement and the review of quality objectives and objective setting It is held on an annual basis Input to the management review should include information on Results of audits Healthcare provider patient client feedback Internal audits of the quality management system Process performance and service conformity EQA reviews Status of preventive and corrective actions critical incident reports Follow up actions from previous management reviews Changes that could affect the QMS Recommendations for improvement POCT coordinator reports POCT committee reports Changes are made as necessary to the POCT policy processes and procedures resulting from the management review Insert filename of management review 5Personnel 5 1Laboratory Director The lab director or other suitably qualified person is responsible for Procuring evaluating and selecting all POCT devices reagents and systems including quality control material Establishing documented quality policy and protocols for the performance of all POCT and associated quality control and quality assurance 5 2POCT Coordinator POCT is the responsibility of the POCT coordinator and is performed in keeping with the guidelines of the Welsh Scientific Advisory Committee and the Organisations POCT policy Insert filename 5 3Staff Training and Education All staff training takes place in accordance with the policies of the parent organisation and guidelines from appropriate professional bodies A POCT Coordinator has been appointed with appropriate training and experience to manage the training and competency assessment They have defined responsibility for developing implementing and maintaining an appropriate theoretical and practical training program for all POCT personnel The POCT coordinator may assign responsibility for training on a specific POCT instrument system to an appropriate technical specialist or technologist A theoretical and practical training program has been implemented and in line with Trust policy only personnel who have completed the training and demonstrated competence are authorised to carry out POCT Records of training attestation and re training and re attestation shall be retained Point of Care Testing DepartmentFile name Name of HospitalPage 9 of 16 Date of issue QUALITY MANUAL A formal competency assessment program for POCT users is in use and competency is addressed initially following training and annually thereafter Retraining and reassessment may occur if indicated e g poor EQA results The knowledge skill requirements include the ability to demonstrate an understanding of the appropriate use of the device the theory of the measurement system and an appreciation of the preanalytical aspects of the analysis including Sample collection Its clinical utility and limitations Expertise in the analytical procedure Reagent storage Quality control and quality assurance Technical limitations of the device Response to results that fall outside of predefined limits Infection control practices Correct documentation and maintenance of the results Retraining intervals and a continuing education program shall be established by the management group The following documents outline provision of training list documents and filenames The following competency documents are used during training list documents and filenames Records of training update training and competency assessments are maintained by the POCT coordinator and kept for the length of time specified in Filename Procedure for the Control of Process and Quality Records POCT operator performance is monitored as part of the quality assurance program The personnel making professional judgements with reference to examinations shall have the applicable theoretical and practical background as well as recent experience Personnel should take part in regular professional development 6Premises and Environment 6 1Premises and Environment The premises in which POCT is undertaken and the equipment used conform to applicable national legislation and to regional or local requirements Environmental monitoring is carried out as applicable All monitoring and any action taken is recorded Filename POCT Environmental Monitoring Policy The POCT Coordinator and the POCT committee shall ensure the working environment conforms to POCT requirements and the manufacturers recommendations 6 2Facilities for Storage All chemicals are stored according to COSHH regulations Reagents are stored in designated refrigerators freezers or at room temperature where appropriate the temperatures of which are recorded according to Filename POCT Environmental Monitoring Policy Point of Care Testing DepartmentFile name Name of HospitalPage 10 of 16 Date of issue QUALITY MANUAL Quality records are stored according to Filename Procedure for the Control of Process and Quality Records Clinical material is stored within the laboratory as described in Filename Procedure for the Control of Clinical Material All storage is in accordance with national legislation regulations and guidelines 6 3Health and Safety It is the department s policy to provide and maintain a healthy and safe working environment for all its employees and visitors to the department The department has a designated health and safety officer The department adheres to COSHH regulations and risk assessments and COSHH data files are provided and available to all staff The insert name is the nominated person for infection control 7Equipment Information Systems and Materials 7 1Procurement and Management of Equipment The department evaluates suppliers of critical reagents supplies and services that affect the quality of examinations Records of all evaluations and a list of approved suppliers are maintained by the department Regular reviews are carried out to ensure that POCT equipment is sufficient and appropriate to meet the demands of the service and that it consistently meets the POCT department s quality requirements Equipment procurement is carried out according to Filename Procedure for the Procurement and Management of Equipment All POCT equipment is validated by the POCT department prior to routine use and purchased equipment and consumable supplies that affect the quality of service shall not be used until they have been verified as complying with standard specifications or requirements defined for the procedures concerned The la