POCT Quality Manual.doc

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1、Point of Care Testing DepartmentFile name Name of HospitalPage 16 of 16Date of issue TRUST LOGOQUALITY MANUAL SUBSECTION -POINT OF CARE TESTINGDRAFT DOCUMENTThis document together with the Pathology directorate Quality Manual represents the Quality Management System of the Point of Care testing depa

2、rtment 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

3、 IssueReview IntervalState frequencyAuthorised ByAuthorHannah AlberyCopy1 of Location of Copies1. 2. 3. Document Review History Review DateReviewed BySignatureCONTENTS1GENERAL INFORMATION41.1Title of Laboratory or Department41.2The Quality Manual42MANAGEMENT COMMITMENT TO QUALITY43ORGANISATION AND M

4、ANAGEMENT43.1Relationship within the Organisation43.2POCT Policy53.3POCT Committee53.3.1Membership of the POCT Committee53.3.2Remit of the POCT Committee53.3.2Relationship of the POCT Committee within the Organisation64ORGANISATION AND QUALITY MANAGEMENT SYSTEM64.1Needs and Requirements of Users64.2

5、Quality Objectives and Plans74.3Control of Process and Quality Records74.4Management Review85PERSONNEL85.1Laboratory Director85.2POCT Coordinator85.3Staff Training and Education86PREMISES AND ENVIRONMENT96.1Premises and Environment96.2Facilities for Storage96.3Health and Safety107EQUIPMENT, INFORMAT

6、ION SYSTEMS AND MATERIALS107.1Procurement and Management of Equipment107.2Management of Data and Information107.3Management of Materials108PRE-EXAMINATION PROCESSES118.1Information for Users118.2Specimen Collection and Handling119EXAMINATION PROCESS119.1Selection and Validation of Examination Proced

7、ures129.2Examination Procedures129.3Assuring the Quality of Examinations1210THE POST-EXAMINATION PHASE1310.1Reporting Results1310.2Clinical Advice and Interpretation1311EVALUATION AND QUALITY ASSURANCE1311.1Evaluation and Improvement Processes1311.2Internal Audit of Examination Processes1411.3Extern

8、al Quality Assessment1411.4Identification and Control of Non-conformities1411.5Continual Quality Improvement151General Information1.1Title of Laboratory or DepartmentThe Point of Care Testing (POCT) department is part of the (name of directorate) in (name of organisation).The (name of organisation)

9、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).1.2 The Quality ManualThis sub-manual describes the Quality Management System of the POCT Department. Throughout the text the

10、re 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 manageme

11、nt and staff, and it provides information for users and for inspection/accreditation bodies.2Management Commitment to QualityThe 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

12、department. Staff working in the department are required to adhere to the departments 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 app

13、ropriate 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;

14、 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 Man

15、agement3.1Relationship within the OrganisationThe POCT department is part of the (name of organisation). The departments relationship within the organisation is shown on page of this manual. (Insert structure of department/resources/functionality etc).3.2POCT PolicyThe POCT Policy Insert filename ha

16、s 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 CommitteeThe POC

17、T 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

18、 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.3.3.1Membership of the POCT CommitteeThe POCT committee meets (state frequency) and has membership as follows: The medical director or his appointee(Chairperson)

19、 POCT Coordinator/Manager Clinical lead e.g. director of emergency Core membersMedicine, 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 P

20、harmacist Quality Manager Safety officer/infection control Co-opted members Finance Manager Procurement Manager Health Economist3.3.2Remit of the POCT CommitteeThe remit of the POCT committee is as follows: Agree specification for proposed acquisition of POCT devices and their integration into care

21、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

22、 (cost efficiency) Responsible for compliance with organisational policy on the management of POCT Responsible for compliance with health care standards in relation to POCT Provide an annual report to the organisations board and/or clinical governance committee3.3.2 Relationship of the POCT Committe

23、e within the OrganisationOrgansiation Management ExecutiveTrust Governance CommitteeMedical Devices CommitteePOCT Management Group/CommitteePOCT Laboratory ManagementLaboratory DirectorPOCT Coordinator/ManagerQuality ManagerPrimary Care Governance Committee4 Organisation and Quality Management Syste

24、m4.1 Needs and Requirements of UsersThe 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 use

25、rs 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 demonstra

26、ble 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

27、 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

28、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: Requirements, including the methods to be used, are adequately define

29、d, 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

30、 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 measureme

31、nt, 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.4.2 Quality Objectives and PlansThe POCT coordinator in conjunction with the quality manager defines the quality object

32、ives 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,

33、 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 a

34、nd plans. Insert filename of quality objectives.4.3 Control of Process and Quality RecordsRefer 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 a

35、s 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

36、 improvement records Instrument maintenance records Lot documentation, certificates of supplies, package inserts Incident/accident records and action taken Staff training and competency records4.4 Management ReviewThe management review includes a cost-benefit analysis and an evaluation of the clinic

37、al 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 audit

38、s 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

39、 the QMS Recommendations for improvement POCT coordinator reports POCT committee reportsChanges are made as necessary to the POCT policy, processes and procedures resulting from the management review. Insert filename of management review.5 Personnel5.1 Laboratory DirectorThe lab director or other su

40、itably 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 assurance5.2 POCT

41、 CoordinatorPOCT 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.5.3 Staff Training and EducationAll staff training takes place in accordance with the policies o

42、f 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 appropriat

43、e 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

44、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.A formal competency assessment program for POCT users is in use and competency is addre

45、ssed 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

46、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 predefi

47、ned limits Infection control practices Correct documentation and maintenance of the resultsRetraining intervals and a continuing education program shall be established by the management groupThe following documents outline provision of training list documents and filenames. The following competency documents are used during training list documents and filenames. Records