Practical Tips for POCT James H. Nichols, Ph.D., DABCC, FACB Professor of Pathology, Microbiology and Immunology Medical Director, Clinical Chemistry Vanderbilt University School of Medicine Nashville, Tennessee james.h.nichols@vanderbilt.edu 1
Objectives • Define POCT • Examine quality concerns with POCT • Offer tips for managing POCT 2
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POCT Definition • Clinical laboratory testing conducted close to the site of patient care, typically by clinical personnel whose primary training is not in the clinical laboratory sciences or by patients (self-testing). • POCT refers to any testing performed outside of the traditional, core or central laboratory. • Nichols JH (editor) National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Evidence Based Practice for Point of Care Testing. AACC Press: 2007. 6
POCT is a Complex System • Laboratory – One site – Limited instrumentation to perform bulk of testing – Limited staff, focused on same equipment daily – Staff trained in laboratory skills • POCT – Dozens of sites, hundreds of devices and thousands of operators – Staff are clinically focused on patient not on equipment – Staff do not have laboratory training background – Testing delegated to lower level staff (TAs, MAs) 7
Tip: Develop a POC Structure • The number of devices people and testing performed POCT in an institution requires an organization and management structure • Many institutions have a POC Coordinator (often a lab staff) and POCT Committee to oversee practice • POCT Committee can depersonalize the review process for test approval, inspection preparation and actions to deficiencies. 8
Why Do We Need a POCT Program? • Organize the activities involving POCT • Meet federal and accreditation regulations • Identify what tests are conducted outside the formal core laboratory • Approve/disapprove new test requests • Determine who is performing POCT • Document staff competency • Manage POCT test results 9
POCT Management Medical Director POCT Committee POCT Coordinator POCT Staff POCT Staff POCT Staff Affiliate Hospitals and Clinics 10
POCT Management Vanderbilt Medical Center Rehabilitation Ambulances Hillsboro Clinic Helicopters Vanderbilt Medical Center Vanderbilt POCT Williamson County Medical Center Vanderbilt Psychiatric Hospital Children’s Hospital Vanderbilt Medical One Hundred Oaks Group Practices Clinic 11
Department / # [Certificates Name of Medical D. Trainer Test Performed Manager Accrediting/ Area / Clinic filed under cost Director PHONE Address Certifying center #] CAP Agency Proficiency Au # (If applicable ) 1. FAMILY 20323XXXX CLIA Dr. Louis PC 555-1234 , TN. 37067 Flu, strep, Clinitek Loretta PRACTICE 44XXXX Warren Status, urine Lynn (First Floor) Exp.7/1 MD pregnancy, Sure 1/13 Step glucose Hemocue, Hemocult, PPM KOH, wet preps, Dr. Miller 2. 20311XXXX CLIA Kim Jones 555-2121 Clinitek Status Ms. MD PEDIATRIC 44XXXX RN Urine, DCA Price CLINIC Exp. HgBA1C (Second 2/14/14 Advantage Sure Floor) Step, Glucose, Flu, Strep, Hemocult 3. 20322XXXX CLIA Dr. Ron Night 555-0102 Flu, strep, Clinitek Jackie INTERNAL 44XXXX Smith TN 37067 Status, urine Chan MEDICINE Exp. MD pregnancy, Sure (Third Floor) 7/10/13 Step glucose, Hemocult PPM KOH, wet preps GI CLINIC 20326XXXX GI I IM Dr. POCT 555-1212 Third Floor Hemocult Lori ( third floor) share Jones Franklin TN Done lab CLIA MD 37067 12
Tip: Standardize Methods • Standardize instrumentation and methods across the health system – Minimizes number of different devices – One policy can be shared amongst sites – Central management system (ie oversight and data management) – Same methodology, clinical limitations – Share reference intervals (normal values) – Simplifies training and competency, float staff 13
Continuity of Care POCT ER OR Critical Care ICU Unit Core Lab Home POL - Clinic Clinic 14
Tip: Define Staff Roles for POCT • Nursing and Clinical Staff: – Ensure staff are trained/competent – Perform and document device QC – Rotate stock/destroy expired reagents – all other aspects of the day-to-day management of the testing process • Laboratory: – Drafts procedures and training checklists – Validates new reagent/QC lots – Arranges for repair/replacement of devices – Provides technical, training, consultative and QI support of clinical staff and testing process
Case Study: Understanding Staff Roles • Who has heard the similar statements? – “I don’t have the staff to take care of this” – “POCT is a laboratory function” – “I’m being forced to do POCT by the clinicians” – “I’ve never hurt anyone doing it this way before, why should I change my practice?” – “Quality reports criticize the way I do my job.” 16
Nursing Roles • Physical care • Emotional care • Spiritual care 17
Technology and Nursing: A “Love-Hate” Relationship • Technologic Optimism: Technology seen as linked to the science of nursing • Technologic Romanticism: Technology seen as detracting from the art of nursing 18
Technologic Optimism: Bedside Testing • Easily assimilated into patient care • More rapid clinical decision-making • Decreased cost to patient 19
Technologic Romanticism: Bedside Testing • Not easily assimilated into patient care • Time- and labor-intensive for nursing • Takes nurses away from the bedside 20
Multidisciplinary Teams and Point-of-Care Testing Nursing Laboratory Nursing outcomes Laboratory outcomes 21
Interdisciplinary Teams and Point-of-Care Testing Nursing Laboratory Patient outcomes 22
POCT: Nursing Perspectives Laboratory Nursing • Restricted tasks • Broader responsibilities • Large test runs: • Limited test “factory environment” runs: “boutique environment” 23
POCT: Nursing Perspectives Laboratory Nursing • Process • Outcome oriented oriented – Calibration – Time spent with patient – Accuracy – Patient goal – Precision achievement 24
Building an Interdisciplinary Team Lab personnel Nursing & Medicine 25
Service Standards • Respect Customer Relations • Courtesy • Acknowledge different perspectives 26
Acknowledging Differences • Define quality in “subjective” terms • Value clinical utility of results, convenience, Nursing & Medicine “real-time” evaluation 27
Acknowledging Differences • Define quality in Lab “objective” terms personnel • Value that which is constant, measurable, technically-based 28
Service Standards • Teamwork is Teamwork & “work” Communication • Acknowledgment of expertise • Collegiality • Information exchange 29
Service Standards Self-Management & • Ownership of Ownership/Accountability discipline- specific responsibilities • Involvement of all stakeholders 30
Tip: Understand the Nursing Perspective • Think like a nurse not a laboratorian! • Training, policies, everything must be written to a nursing perspective • Focus on patient care • Emphasize the “Why”, let staff figure out the “How” – Why QC is important – Why positive patient ID is necessary – Emphasize POCT a routine patient care 31
Tip: Understand Your POCT • Research testing – results of laboratory test will not be used for patient care, none of the clinicians managing patient have access to test results (CLIA’88 does not apply) • Clinical testing – test results will be used for diagnosis or change in management of the patient (CLIA’88 rules apply) – Pregnancy test to screen patient for drug trial – Creatinine, liver enzymes to monitor patients on trial 32
Case Study: Cardiology Research • Waived coagulation device to be used to manage dosage of coumadin • Cardiologist claims it is research, so don’t need any additional QA/QC documentation. • Device is waived, so test is “waived” of all regulations • The hospital is CAP inspected, so there are additional concerns beyond CLIA license and following manufacturer’s instructions 33
Case Study: Cardiology Research • Waived device generates a coded comment that researcher calls to sponsor for treatment instructions (only way to blind clinicians to coumadin vs placebo) • Offer to get research a “waived” CLIA to conduct testing • Cardiologist very heated, unwilling to listen to regulations, claims lab is overinterpreting regulations and leaves meeting • Lab follow-up with CMS – test is indeed clinical not research, and because the sponsor has modified the device it is no longer waived (ie high complexity testing). This prohibits the physician from applying test to a “waived” research CLIA certificate. • Turned issue over to research administration/Academic Affairs in conjunction with POCT committee limited testing in this setting and required separate CLIC license 34
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