ADMINISTRATIVE MANUAL Policy and Procedure

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1 ADMINISTRATIVE MANUAL Policy and Procedure TITLE: Point of Care Testing NUMBER: CH (Laboratory Diagnostic Bedside Testing) Effective Date: January 2014 Page 1 of 6 Applies To: Holders of Administrative Manual POLICY 1. Pathology and Laboratory Medicine supports point-of-care testing (POCT) (refer to definitions) by employees within Capital Health; under controlled circumstances and in compliance with Accreditation Canada Point-of-Care testing standards and CSA ISO Pathology and Laboratory Medicine has the ultimate accountability for oversight and management of POCT throughout all CDHA facilities and services. 2. All POCT results are part of the Capital Health Patient Health Record as per CH Capital Health Patient Health Record All POCT results will be clearly distinguishable from laboratory generated results When the HCP verbally reports POCT results to clinicians, the results, units of measure and methods used to obtain those results must be documented in a written format and identified as POCT results. 3. Selection of appropriate point of care tests and evaluation of POCT devices will involve multiple stakeholders and decisions should consider quality of results, clinical effectiveness, financial impacts and technical capabilities. 4. POCT is to be performed by healthcare providers who have completed the training and achieved the required competencies Healthcare providers must demonstrate and document their competency annually,

2 Point of Care Testing CH Page 2 of Frequency and process for competency assessment for each specific POCT is to be established by the POCT Interdisciplinary group (Appendix A) and is to be based on degree of complexity, risk and safety The healthcare provider performs a self-assessment for the POCT(s) for which they are accountable. Note: Some POCTs may require a demonstration of competency; if so, this will be identified within the specific POCT policy/procedure When there is clear evidence that a competency requirement as defined is not met, the healthcare providers are not to perform that POCT until remedial action has been taken and the healthcare providers are deemed competent to perform that procedure. 5. POCT requests are initiated by those professionals authorized to request diagnostic laboratory testing as per CC Diagnostic Tests Requesting, Results Reporting and Follow up. DEFINITIONS Point of Care Testing (POCT): Medical diagnostic testing performed outside the clinical laboratory, where the result of the test is used for clinical decision making. Tests performed on POCT devices include, but are not limited to: blood glucose coagulation urine test strips pregnancy tests blood gases electrolytes creatinine urea hemoglobin activated clotting time (ACT), differential blood count cardiac markers cholesterol magnesium bilirubin detection of microorganisms fecal occult blood tests GUIDING PRINCIPLES AND VALUES 1. Point of Care testing (POCT) is performed by health care providers who have completed the required competency process. The devices used provide rapid, reliable test results to support clinical decisions. 2. The POCT program is a collaborative endeavour of multiple departments to provide quality results and support safe patient care. GUIDELINES POCT Program Accountabilities and Responsibilities (Refer to Appendix A for POCT Committees)

3 Point of Care Testing CH Page 3 of 6 1. District Department Chief of Pathology and Laboratory Medicine 1.1. Participates in the selection of POCT Coordinator Reports to District Medical Advisory Committee on POCT issues as required Approves the POCT Quality Management System according to accreditation standards Oversees and monitors the implementation of POCT related regulations within Capital Health Approves quality assurance procedures recommended by the Interdisciplinary POCT Committee 1.6. Acts to discontinue POCT in the event of serious proficiency problem. 2. Capital Health District POCT Advisory Committee 2.1. Evaluates POCT request of need for clinical effectiveness, quality improvement and financial impact Authorizes evaluation of new POCT equipment Determines type and scope of POCT to be used in the district Determines healthcare providers with appropriate qualifications to perform POCT Reviews POCT policies prior to Vice President approval Establishes POCT communications network Reports primarily and at least annually to the District Quality & Patient Safety Council and to the District Medical Advisory Committee, Quality & Patient Safety subcommittee as required. 3. Administrative Director Laboratory 3.1. Appoints POCT coordinator Approves responsibilities of laboratory staff involved in POCT program Authorizes POCT district policies and procedures 3.4. Advocates for resources to support POCT database and program administration Requests resources for the POCT program Assigns administrative support for data entry and POCT Program administration Negotiates for information technology resources. 4. District Division Chief (Pathology and Laboratory Medicine) 4.1. Evaluates and advises on POCT equipment as requested by District Department Chief and the Director of Laboratory Medicine Approves the POCT procedures Collaborates with working group and approves implementation and maintenance for the POCT program.

4 Point of Care Testing CH Page 4 of Approves POCT External Quality Assurance (EQA) material to be used. 5. Interdisciplinary POCT Committee 5.1. Reviews POCT policy and procedures Approves POCT training manuals Monitors compliance with accreditation standards Investigates adverse effects arising from POCT and collaborates with others to resolve them according to Continuous Quality Improvement principles. 6. POCT Coordinator 6.1. Informs the District Department Chief and the Administrative Director on new regulations on POCT in a timely manner Researches and evaluates POCT options to support District Division Chief and the Administrative Director Receives Request of Need form for POCT (Refer to Related Documents) and directs as appropriate Establishes working groups as required for implementation and maintenance of POCT programs Establishes, coordinates and regularly reviews the POCT Quality Management System according to accreditation standards Leads development of and regularly reviews POCT policies and procedures according to Accreditation Canada and standards Establishes and regularly reviews protocols for all POCT training manuals according to accreditation standards and recommends required changes to the POCT Interdisciplinary Committee Oversees and monitors the achievement and maintenance of POCT competencies by health care providers performing POCT Coordinates the education requirements for the POCT program Reviews non-conforming events, extracts or compiles data for auditing and quality improvement Coordinates replacement of POCT devices as indicated Updates the District Department Chief, Division Chief and Administrative Laboratory Director on POCT Committee activities Provides reports to Laboratory Executive Committee as required 7. Health Care Providers 7.1. Perform POCT as indicated and maintain individual competencies Adheres to the quality control (QC) requirements.

5 Point of Care Testing CH Page 5 of Documents all QC results, including the operator's name and the date and time the test was performed When verbally reporting POCT results to clinicians, also documents the results, units of measure and methods used to obtain those results in a written format and identify as POCT results. REFERENCES CLSI Guideline, C30-A2 Point of Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline Second Edition Qmentum Program 2010 Standards Point of Care Testing version 4 ISO Point-of-Care testing- Requirements for Quality and Competence University Health Network Policy & Procedure Manual Clinical Point of Care Testing (POCT) Program Policy Number Revision 01/10 RELATED DOCUMENTS Policies CC Diagnostic Tests Requesting, Results Reporting and Follow up CH Capital Health Patient Health Record (formerly: CH ) CH Patient Identification and Same Name Alert (formerly: CH Forms Request of Need Form (POCT) Appendices Appendix A CDHA POCT Committees Other Terms of Reference POCT Committee * * *

6 Point of Care Testing CH Page 6 of 6 Appendix A CDHA POCT Committees District POCT Advisory Interdisciplinary POCT District Chief of Pathology and Laboratory Laboratory Physician Medicine (Chair) 3-4 Physicians from appropriate services District Division Chief (or delegate) POCT Coordinator POCT Coordinator (Chair) Nurse Educator representative Clinical Chemistry MLT representative Biomedical Engineering representative Hematology MLT representative Information Technology representative District Lab MLT representative Risk Management representative Nurse Educator representative Administrative Director Laboratory Services Materials Management representative Finance and Decision Support representative

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