LABORATORY Quality. Effective Date: March 2, 2012 Page: 1 of 8. Applies to: All GASHA staff Involved in the Use of Point of Care Testing.

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1 LABORATORY Quality TITLE: Point of Care Testing NUMBER: POC-001 Effective Date: March 2, 2012 Page: 1 of 8 Applies to: All GASHA staff Involved in the Use of Point of Care Testing. TABLE OF CONTENTS POLICY...1 Note regarding Self Testing...2 PROCEDURE...2 Roles and Responsibilities...2 POCT Quality Team...2 Laboratory Services...3 POC Coordinator...3 Department or Service Providing POCT...4 Staff Performing POCT Responsibilities...4 Materials Management...5 Other Responsibilities...5 Evaluation & Selection of POCT Equipment...5 POCT Implementation...5 Operator Training...5 Quality Control Program...6 Documentation...6 Policies and Procedures...6 Equipment...6 Troubleshooting/Maintenance/Cleaning of POCT Equipment...7 Training...7 Occurrence Management...7 Process Improvement...7 REFERENCES...8 POLICY Point of Care Testing (POCT) is performed near or at the site of the patient, outside the traditional Laboratory, as a quality improvement of patient care in the Guysborough Antigonish Strait Health Authority (GASHA). POCT will provide efficient results for increased utilization of these results, leading to possible change in care of the patient. POCT is performed by a physician, medical technologist, nurse, licensed practical nurse, or other designated

2 Point of Care Testing Page 2 of 8 professionals as approved by GASHA. This testing is performed outside the central laboratory and in close proximity to the patient care area. POCT does not replace the central laboratory but should be seen as an extension of the services provided by the laboratory. POCT is a multi-department service. Cooperation between departments is essential to develop and maintain a high quality service. PURPOSE To ensure that when POCT devices are introduced to a department, they are managed and maintained in a safe condition. To minimize the risk to patients, staff and GASHA. POCT is performed in accordance with the quality standard requirements of the International Standards ISO Point of Care Testing-Requirements for Quality and Competence, CSA Medical Laboratories Particular requirements for quality and competence and Accreditation Canada Point of Care Testing Standard POCT equipment is standardized throughout GASHA. Test results are accurate, reliable and traceable. Note regarding Self Testing Hospital Accreditation does not cover home testing. All POC testing in the hospital is to be performed using GASHA /POCT Operator approved devices. It is not the laboratory s responsibility to operate or maintain patients POCT devices. If POCT is conducted outside the quality framework (example in the circumstances of a self-testing person), it is the responsibility of the individual to ensure that the quality of testing is sufficient for their medical or health purpose. PROCEDURE Roles and Responsibilities POCT Quality Team A multi-disciplinary team comprising medical laboratory technologists, medical director of laboratories, nursing and materials management. To act as Q-mentum team for accreditation purposes. To discuss problems and strive for continuous improvement. Based on the multidisciplinary committee s evaluation of clinical or operational requirements, provide a cost/benefit analysis and the analysis of whether or not the POCT program can be successful in the clinical setting. Rank the purchase of POCT devices in relation to other clinical equipment submissions (if required). Provides expertise and guidance in the evaluation, selection and performance criteria for instruments and reagents used in POCT and assessment of quality management outcomes while striving for continuous improvement.

3 Point of Care Testing Page 3 of 8 Ensures regular review of Point of Care, Patient Safety Learning Reports and audits, recommending suitable corrective measures for non-conformances. Recommends the development and approval of new and existing POCT programs to the Medical Advisory Committee and the Laboratory Utilization Committee. Evaluate the need for Point of Care testing based on improved patient outcomes and effective cost management. In the areas of Quality Assurance, health and safety training documentation, data and occurrence management promotes best practice for POCT according to Accreditation Canada guidelines. Laboratory Services In GASHA the Medical Director of Laboratory Medicine is responsible for the overall POCT Program. To ensure a quality program, the director will designate a POCT Coordinator to liaise with all departments regarding all POCT issues. Laboratory Services will be the resource for all other Departments in the areas of quality, equipment and training. GASHA Laboratory Services will have the overall responsibility of the POCT program. They will ensure all training, competence, QC, QA, document control, process improvement, maintenance, and other areas of the program, are implemented and maintained. Laboratory Services will develop and maintain all Standard Operating Procedures in accordance to the national standards. All GASHA staff performing POCT will follow these procedures. The Laboratory Service complies with the GASHA policies relating to conflict of Interest and Confidentiality. POCT Coordinator identifies suitable POCT equipment for evaluation performs the evaluation installs POCT equipment in conjunction with the Lab Quality Standards Coordinator, writes POCT procedures trains GASHA staff prepares worksheets, log books etc stores maintenance schedules enforces Quality Assurance programs troubleshoots issues and devices monitors and reviews POCT procedures performs competency reviews Identifies the types and locations of all POCT equipment within GASHA. An electronic inventory of all devices is maintained. Is responsible for ensuring that all GASHA staff performing POCT have current competency training and documentation. Is responsible for ensuring regular Quality Assurance is maintained and Quality Control (QC) samples are

4 Point of Care Testing Page 4 of 8 analyzed on POCT devices, with up-to-date documentation and history. Is responsible for the CobasIT (GASHA data manager for POCT). Manages POCT devices, materials, operator certificates, review of QC and linearity, reports, comments and validation of patient results and QC and is the person responsible for investigation of non conformances, complaints and opportunities for improvements. In conjunction with Materials Management, is responsible for setting levels for required supplies of consumables and QC materials and therefore ensure continuity of POCT service. Is responsible for troubleshooting of POCT devices, with up-to-date documentation and history. The POCT Coordinator can be contacted at ext 4143 during normal working hours. After hours, please phone the lab with any urgent issues at the above number. Department or Service Providing POCT Ensure that all POCT programs are approved through the appropriate channels. All POCT be performed only on a written order by a physician Ensure that POCT is performed by trained staff according to the policy and procedure. Recognize, confirm and report critical results according to the Standard Operating Procedure. Promptly remove from storage, any expired, inappropriate, deteriorated, and/or substandard equipment, reagents or supplies. Participate in the point of care Quality Management Program. Follow protocol for remedial actions or notification of responsible personnel. Staff Performing POCT Responsibilities All staff must use the equipment in a safe and responsible manner. All staff must have a unique identifier (password) where applicable. No password must be shared with another staff member. An accurate and up-to-date maintenance log must be maintained, signed and dated each day. All staff members must satisfy the quality control (QC) requirements pertaining to the specific instrument. Understand the principles and limitations of the POCT procedure. All patient and QC results must be documented in the correct manner with correct ID, operator, date and time and clearly indicate the results are a POCT. The manner in which information is documented will be defined in the test standard operating procedure. All staff operating POCT equipment will have up-to-date competency records.

5 Point of Care Testing Page 5 of 8 Materials Management Recognize and enforce procedures developed by the POCT Multidisciplinary Committee for request, purchase and installation of POCT devices Work in conjunction with the POCT Coordinator to ensure adequate supply of consumables and QC material to maintain continuity of service. Other Responsibilities Laboratory Quality Standards Coordinator will help with the support of the quality function and amalgamation of POCT into the Laboratory Quality System Laboratory Information Systems(LIS) Coordinator will provide guidance with LIS related issues Directors of Nursing and Unit Managers, to provide direction to nursing staff performing POCT duties, in order to ensure compliance with all quality requirements. Evaluation & Selection of POCT Equipment The laboratory is responsible to work in close collaboration with Material Management and or the department or service providing an existing or requesting new POCT programs to: Evaluate the need for POCT and investigate alternative solutions. Ensure the result produced for a rapid clinical decision cannot be met by the central laboratory. Perform cost benefit analysis on any new and existing POCT programs. Ensure that the department requesting new equipment will submit an impact analysis with the Request for New Point of Care Device Form and it will be presented at the next POCT Multidisciplinary Committee meeting. The requesting department or service must also follow all GASHA policies and procedures for the acquisition of equipment i.e. Capital funding requests. POCT Implementation Once the POCT device has been recommended by POCT Multidisciplinary Committee, the laboratory, in conjunction with the POCT Coordinator, is responsible to: Select the POCT technology and test reagents. Evaluate the performance of the equipment. Design and monitor the quality management program. Design a training and recertification program. Develop and approve all policies and procedures. Operator Training Persons performing POCT will be thoroughly familiar with the approved policy and procedure, and will have been instructed by one of the following: a designated laboratory staff member or POCT Coordinator a key user trained for instruction by one of the former. a representative of the vendor supplying the product

6 Point of Care Testing Page 6 of 8 Staff may not train each other. Key Users in each unit are responsible for training new employees. Certification of competence with the testing procedure will be documented on a checklist of required skills. Quality Control Program POCT must have the same level of quality assurance as is provided for testing performed within GASHA Laboratories. QC testing shall be performed daily or before each use of the equipment, using the appropriate QC material and testing procedure, as outlined in the standard operating procedure for each test. Corrective action shall be taken for QC results that fall outside the acceptable limits, as defined in the standard operating procedure for each test. If not captured electronically, QC results shall be recorded by the person performing the test, and will include the date, time, and initials of the user. External quality control testing will be carried out on each POCT by non-laboratory staff at the appropriate intervals. Monthly, the laboratory shall perform an ongoing comparison where one patient has a lab draw and a POC Test performed within 30 min. A summary of these results are documented in the POCT Management Review. Results of internal, external and comparison QC testing shall be reviewed regularly by the POCT Coordinator for indications of improper use or function of the devices. Documentation Policies and Procedures Clearly defined roles of authority, responsibility and accountability for POCT shall be documented. Resolution of complaints and feedback from staff or patients shall be documented Technical procedures shall be available for each test offered and will include principle of operation, purpose of the test, specimen collection and handling, preparation of reagents, limitations, reference ranges, troubleshooting and critical values. GASHA Intranet is the centralized area for all staff to view POCT procedures, policies and processes. Equipment An inventory record for all POCT devices shall document the unique identifier, manufacturer, and service history of each device.

7 Point of Care Testing Page 7 of 8 Protocols for maintenance and repair of devices shall be documented. A record for all periodic and episodic maintenance of POCT devices shall be documented. Protocols for the calibration and verification of POCT devices shall be documented. Troubleshooting/Maintenance/Cleaning of POCT Equipment POCT equipment must have a documented preventative maintenance schedule. Appropriate backup must be available in case of breakdown. When fault is found with POCT equipment, it is labeled OUT OF ORDER and must not be used. The POCT Coordinator and other relevant staff must be notified immediately. Preventative Maintenance schedules shall be communicated to the Materials Management department and updates on preventative maintenance which has been performed by the vendor shall be provided to the Materials Management department by the POCT Coordinator. Only approved and appropriately qualified and competent GASHA or external staff must service POCT equipment. A service history must be maintained which includes maintenance, faults, corrective actions and repairs. Procedure for cleaning and decontamination of POCT equipment must be documented and carried out before sent back to manufacturer for repairs. Training A training program for POCT shall be documented that includes safety, sources of error, use of the device, clinical utility, quality control, and troubleshooting. All personnel trained in POCT shall have their training and competency documented. Occurrence Management Investigation of non-conformances and opportunities for improvement will be documented by the POCT Coordinator. Timely investigation and corrective action is required to maintain a quality service. Process Improvement Policies and procedures will be reviewed annually by Laboratory Management or designate. The POCT Multidisciplinary Committee or POCT Coordinator, in conjunction with Laboratory Services, will periodically evaluate the program for clinical need, utilization, and clinical effectiveness. The POCT Multidisciplinary Committee or POCT Coordinator, in conjunction with Laboratory Services, will periodically identify opportunities for improvement. The Laboratory Quality Standards Coordinator will maintain a schedule of internal audits. Audit observations, findings and suitable corrective actions will be discussed at POCT Multidisciplinary Committee meetings. Feedback from patients and/or personnel shall be gathered and reviewed regularly. The POCT Quality Team shall identify opportunities for improvement in POCT activities through user feedback, non-conformities, and review of evidence-based practice.

8 Point of Care Testing Page 8 of 8 REFERENCES Accreditation Canada, Qumentum Program Standard Point of Care Testing Version 4 Cape Breton Health Authority Quality Management Policy for Point of Care Testing POCT.23 * * *