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Assuring Quality in Point-of-Care Testing

Assuring Quality in Point-of-Care Testing. JOURNAL REPORT Hernandez Jay, Hernandez L, Ishimura M, Pascua R. INTRODUCTION Point-of-Care Testing .

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Assuring Quality in Point-of-Care Testing

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  1. Assuring Quality in Point-of-Care Testing JOURNAL REPORT Hernandez Jay, Hernandez L, Ishimura M, Pascua R

  2. INTRODUCTIONPoint-of-Care Testing • "the provision of a test when the result will be used to make a decision and to take appropriate action, which will lead to an improved health outcome." - Christopher Price • Key objective: • produce a result more quickly  immediacy of response • Area most commonly used POCT: • ER • Intensive Care Unit • Reliability: • technical performance of POCT devices • compliance with treatment protocols.

  3. Objectives of the Article To present the evolving role of technology improvement, informatics, and program management as the key developments to ensure the quality of Point-of-Care Testing

  4. CONTEXT • Ensuring Quality and Compliance with the POC guidelines for improved patient outcomes and increased operational efficiency of clinical services • Issues: • Clinicians limited training in quality lab training • Failure to test and observe compliance to POC • Substandard technology

  5. Data Sources • Authors: • Kent Lewandrowski, MD • Kimberly Gregory, MT(ASCP), NCA, CLS; • Donna Macmillan, MBA, MT(ASCP) • Based on a review of the literature and POCT experience by the authors at the Massachusetts General Hospital (Boston)

  6. HISTORY • Using advancement in technology to improve patient outcome • Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) • Hospital and laboratory accreditation agencies: • College of American Pathologists • TheJoint Commission • POCT is a component during routine inspections

  7. Mandatory Effect Hospitals observed quality managed POCT It also provided a strong incentive for device manufacturers to improve POCT instruments and software to better support compliance

  8. Device Design • Poor quality features that affect the results • Operator-prone error device • Manual documentation of test results • Lack of electronic data management system • Improvements: • Built-inbar code reader to identify the test strips forquality controls • Records the identification of the patient and operator • Automatic lock-out device • Reader device • ensures that tests are performed correctly, eliminates subjectivity, and permits results and documentation data to be transmitted electronically

  9. Quality Control • Issues: • Cost of reagents to maintain QC device • Operator’s neglect to comply with QC • Improvements: • Quality control rules are built into the device software to ensure that patient testing cannot be performed unless the instrument is in control. • Anumber of devices have incorporated ‘‘electronic QC,’’ whereby the instrument automatically checks the electronics of the system to ensure that the device is functioning properly Current Issues: - Many devices still lack this feature

  10. Informatics and Connectivity • Issues: • Lack of Electronic Data Management Systems (EDMS) for POCT • Manual documentation to pt chart, logbook etc • No real-time data management and review • Improvements • September 2000: Connectivity Industry Consortium (CIC) was formed • Goal: develop standards for connectivity of POCT devices to permit bidirectional vendor-independent connectivity. • The standards were eventually transferred to the Clinicaland Laboratory Standards Institute

  11. First Generation • laptop-based POCT data managers • Second Generation • centralized data server via bi-directional Ethernet connection • Third Generation • instruments from different manufacturers can be interfaced to the system (multivendor data management) • Future • Real-time wireless connectivity

  12. Management of a POCT Program • Issue: RESISTANCE • Availability of multidisciplinary POCT management team composed of the POCT manager (or POCT coordinator), a laboratory medical director, representatives from nursing, and sometimes physicians. • RESPONSILITY • Oversight of the program, evaluating new technologies, implementing new tests or device upgrades, and training and educating staff to perform testing. • An essential feature is that the team be granted institutional authority to manage the program and to make decisions concerning policies and the scope of POCT that may be available at different sites

  13. Skill Set for POCT Managers/Coordinators • American Association for Clinical Chemistry has recently offered a POCT coordinator certificate program • The skill set includes specialized professional knowledge with a high level of interpersonal skills, such that the manager will serve as an effective consultant for the POCT program and have the interpersonal and organizational skills to effectively accomplish the objectives of the program. • Support from pathologist, clinicians and laboratory staff

  14. CONCLUSION • Point of Care Testing is a challenge to every health institutions. • Regulatory guidelines from federal and state governments, coupled with accreditation standards developed by the College of American Pathologists and The Joint Commission, have resulted in major improvements in POCT devices. They have also compelled hospitals to establish management programs for POCT. • Advancement in informatics • Key Indicator for success: • Knowledgeable POCT professionals

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