Point of Care Quality Management. Procedure. Approving Authority: President and CEO, Keith Dewar

Transcription

1 Subject/Title Point of Care Quality Management Procedure Approving Authority: President and CEO, Keith Dewar Manual: Reference Number: Effective Date: Dec 6 th, 2016 Revision Dates: Classification: Quality Health Services Contact for Interpretation: Laboratory Services - Point of Care Supervisor Source: Clinical Support Services See Policy See Form Procedure The purpose of this procedure is to describe the Regional Point of Care Testing Program. Point of Care Testing (POCT) refers to analytical patient testing activities performed outside the physical facilities of a clinical laboratory by personnel whose primary training is not in the clinical laboratory sciences. This bedside or near-patient testing must produce accurate and reproducible results comparable to that of a licensed laboratory. RQHR Laboratory Services uses a Quality Management System for its organizational structure. The Twelve Quality System Essentials (QSE) are the functional units. The QSE provides a systemic process-oriented approach so all aspects of quality are taken into account. The POCT Regional Testing Program is described using the 12 Quality System Essentials. 1.0 Organization 1.1 Medical Department Head of Laboratory Services is responsible for all aspects of the POCT Program 1.2 Laboratory Interdisciplinary POCT Committee will include the Medical Director, Director Operations, Medical Section Heads, Point of Care Supervisor and Manager Regulatory Affairs 1.3 Regional POCT Advisory Group includes representation from outside of Laboratory Services 1.4 Centrally coordinated system with daily operations under the POCT Supervisor 1.5 POCT supervisor may delegate some responsibilities for quality management to the various stakeholders (i.e. Nurse educators, unit supervisors) 1.6 Ensure all Standards and Regulations for POCT are met 1.7 POCT Quality Management System principles are followed Page 1 of 6 January 17, 2017

2 1.8 There are records that the test(s) is approved for use by the Medical Department Head of Laboratory Services, or Medical Section Head designate meeting CAP director qualifications, prior to use in patient testing. 2.0 Documents and Records 2.1 Document control system - Procedure review will follow RQHR Laboratory practices 2.2 Reporting of test results - Procedures will define reporting guidelines 2.3 Record retention guidelines 2.4 Procedure Manuals - Procedures will be written for all POCT systems 2.5 Discipline specific procedures will be written for testing as applicable (i.e. Nursing procedure for glucose testing) 3.0 Facilities and Safety 3.1 Standard precautions will be followed for specimen collection procedures 3.2 All RQHR safety guidelines apply, including the reporting of any safety incidents 3.3 POCT devices will be appropriately situated in designated areas 3.4 Disinfection and cleaning of instruments will follow manufacturer guidelines and be in compliance with regional policies 4.0 Personnel 4.1 Lists of testing personnel will be kept including which tests they are authorized to perform 4.2 Initial training will be provided by qualified personnel based on testing being performed (i.e. fetal fibronectin training is part of orientation to the Labor and Birth unit) 4.3 Training protocol will be stated in the individual test procedure 4.4 Competency assessment requirements will be stated in the test procedure using the CAP guidelines (waived vs. non-waived requirements) 4.5 Testing personnel will be traceable to reported control and patient results (i.e. unique identification number, operator initials in chart) 4.6 Ongoing competency assessment will be performed 4.7 Documentation of training and competency will be kept 4.8 All regional human resource policies will apply 5.0 Purchasing and Inventory 5.1 All reagents, controls and calibrators, supplies and equipment will be stored following manufacturer s instructions 5.2 Expiration dates will be noted as appropriate 5.3 Expired reagents, controls and calibrators will not be used for patient testing 5.4 New lot evaluations will be performed 5.5 Inventory and purchasing management will be handled by the RQHR Materials Management department 6.0 Equipment

3 6.1 All equipment used must be approved by the Medical Department Head of Laboratory Services or designee 6.2 All new systems must be evaluated before implementation using approved validation processes 6.3 General maintenance and function checks will be performed following manufacturer s instructions 6.4 Repair or replacement will be handled by individual contractual agreements 6.5 Temperature logs will be kept as appropriate 6.6 Room temperature supplies that are stored in a central supply area or on nursing units will be under the facility s temperature monitoring system 7.0 Process Control 7.1 Requests for new POCT implementation will follow a standardized process 7.2 Procedures will be in place for all POCT systems and will be available on the Intranet and/or in the unit 7.3 Collection procedure will be part of training and will be either included in procedure or be a separate procedure (i.e. fetal fibronectin specimen collection is part of nursing procedure) 7.4 Training will include pre analytical, analytical and post analytical considerations as well as technique of operation 7.5 Results will be legible and initialed by person performing the test 7.6 Quality Control requirements will be stated in each procedure 7.7 External liquid controls will be tested with each new lot or shipment of reagents, monthly or as stated in the manufacturer s requirements 7.8 Internal controls will be run on day of use 7.9 Individualized Quality Control Plans will be maintained for non-waived testing that meet eligibility for IQCP Control results must be validated before patient testing is done (i.e. Glucose meters can be locked if control testing has not been done in the last 24 hours) 7.11 Quality Control will be reviewed by the Medical Biochemist or alternate monthly 7.12 Linearity and precision testing will be performed with each new lot #, when indicated by quality control, after major maintenance and service, as recommended by manufacturer and at least every six months - as applicable 7.13 Troubleshooting, test limitations and instructions for handling of unusual results will be part of each procedure 7.14 Troubleshooting support is available from key user, POCT supervisor, and vendor technical support as applicable 7.15 Standard Laboratory Quality Assurance procedures must be followed to meet regulatory requirements 8.0 Information Management 8.1 Reference ranges, critical results and standard reporting procedures will be established 8.2 Testing personnel will be traceable to reported control and patient results

4 8.3 Results will be transcribed onto patient record following standard RQHR charting procedures with specification that it is a point of care test, and/or entered into specific programs for patient management 8.4 Establish electronic reporting mechanisms whenever possible that clearly distinguish point of care test results. 8.5 Roche Inform II meters and authorized testing personnel are managed through the Roche Cobas IT system 9.0 Occurrence Management 9.1 Non-conforming events when identified must be documented and reported following standard RQHR and Laboratory Services procedures 9.2 All occurrences will be assessed and followed up 9.3 Recall, Device Alert and other Product Information letters from vendors will be documented and recommended actions will be taken 10.0 Assessments 10.1 POCT is licensed under the Laboratory Licensing Program, Ministry of Health. Accreditation is administered by Laboratory Quality Assurance Program (LQAP), College of Physicians and Surgeons of Saskatchewan All General and Pasqua laboratories are College of American Pathologist (CAP) accredited College of American Pathologists (CAP) or other recognized program will be used for external proficiency testing 10.3 Proficiency testing will be done by a rotation of authorized users of the test and will follow the same guidelines as those used by the Laboratory Services 10.4 Proficiency testing and Quality control will be monitored by the POCT supervisor and Medical Biochemist 10.5 Assessments of Analytical Measurement Range, analyzer to analyzer, POCT device to main analyzer will be performed as required and will be stated in the individual procedure 10.6 Quality Indicators such as critical result audits and clerical audits will be performed 10.7 POCT Quality Management quarterly and annual reports will be prepared and presented at the Laboratory Services Continuous Quality Improvement committee meetings 11.0 Process Improvement 11.1 POCT will be part of the RQHR Laboratory Services Quality Management annual review 11.2 Process improvement will be initiated when data and assessments indicate a need for change Literature review of new methodologies and technologies will aid in keeping current with advances and changes in POCT 12.0 Service and Satisfaction

5 12.1 POCT is a rapidly evolving discipline with new technologies constantly becoming available. New processes and changing client needs will be assessed by the Laboratory Interdisciplinary POCT Committee in collaboration with the stakeholders 12.2 Develop a positive working relationship with all stakeholders in POCT (i.e. Nursing, Materials Management, vendors) 12.3 The POCT Device Request Form will facilitate and standardize POCT requests 12.4 Customer feedback will be encouraged to build a strong quality program References 1. Point of Care, General and All Common Checklists, College of American Pathologists 2. Laboratory Quality Assurance Program, College of Physicians and Surgeons of Saskatchewan 3. CLSI. Quality Management System: A Model for Laboratory Services; Approved Guideline Fourth Edition. CLSI document QMS01-A4. Wayne, PA: Clinical and Laboratory Standards Institute; CLSI. Essential Tools for Implementation and Management of a Point-of- Care Testing Program. 3rd ed. CLSI guideline POCT04. Wayne, PA: Clinical and Laboratory Standards Institute; CLSI. Glucose Monitoring in Settings Without Laboratory Support. 3rd ed. CLSI guideline POCT13. Wayne, PA: Clinical and Laboratory Standards Institute; CLSI. Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline Third Edition. CLSI document POCT12-A3. Wayne, PA: Clinical and Laboratory Standards Institute; The Medical Laboratory Licensing Act, The Medical Laboratory Licensing Regulations, College of American Pathologists, All Common Checklist, , COM Waived Test Implementation and Approval and COM Method Validation and Verification Approval Non-waived Tests Related Documents 1. LABPocOP1001 POCT Regional Policy 2. LABPocOP1001C1 POCT Organizational Chart 3. LABRegOP Proficiency Testing Program

6 Appendixes 1. LABPocOP1000F1 RQHR POCT Device Request Form Revision History Found in SoftTech Health Lab QMS Document Management System Author Tammy Ottenbreit, MLT, ART Geraldine Webb-Young, ART, MLT, C. Admin Revised by: Susan Askin, MLT Revised by: Virginia Marsh, MLT, DBA, CCE