The Future of Community Based Testing Bernadette Jackson Point of Care Manager Naas General Hospital
Accreditation ISO 15189 Inspection M O’Kane – 2012
Quality in Testing Process Internal Quality Staffing Controls - Medical Scientists External Quality (Chief, Specialists, Senior, staff grade) Assurance - Biochemist - NEQAS - WEQAS - Pathologists - IEQAS - DEQAS - RIQAS ISO 15189 – Annual Inspection – INAB (Quality Management System)
Patient Confidence in Treatment
Advances since Teamworks - 2007 Laboratory Accreditation is widespread – ISO 15189 Analyses are provided within externally inspected services - INAB Sample collection systems improved IT Connectivity between GP and laboratory services. IT Connectivity within hospital networks - reports Linked LIS e.g. Maternity Services MedLIS Project SLA’s within networks 24/7
Key Health Trends - 2018 F =83; M=79
Naas General Hospital – Area 7 24 244 + Population 250,000
Teamworks Report -2007 Self Care - patient empowerment Local Care - General practice - Primary Care - Community - Ambulance services
Point of Care Testing Using point-of-care testing in a managed way, in acute hospitals, in local healthcare settings and in the patient’s home, wherever it is clinically appropriate and cost effective.
Healthcare Centres (HSE)
Point of Care Test - 2004 “ An analytical test undertaken by a member of the healthcare team or by a non medical individual in a setting distinct from a normal hospital laboratory”
Point of Care Testing - Where ??
Inspection X Accreditation ISO 15189 /22870 M O’Kane – AACC - 2012
Tests at Point of Care pH, pCO 2 , pO 2 Na + ; K + ; Cl - ; Creat; Lipids; Glucose; Ketone; Lactate; Troponin; C-reactive protein; HbA1c, Natriuretic peptides, hCG; PTH; TBil, Pro Calcitonin Hb; INR Urinalysis; Streptoccal infection; HIV; Hepatitis; Flu Pregnancy Tests ;Toxicology Occult Blood
Devices and Test Systems
Analytical Methods Mark et.al. – 2010 – Chem Soc Review
PST INR - NGH Anticoagulation Clinic Inspection X Accreditation ISO 15189:2012 22870:2016
Accreditation Anticoagulation ISO:15189 Clinic INR = 4.5 M O’Kane – AACC - 2012
Point of Care Testing - Operators – Laboratory Staff – Medical Staff – Nursing staff – Physiotherapist – Pharmacist, GP, Practice Nurse, EMT, Fire Crew – Others e.g. Health Screening – Patient (PST)
AntiCoagulation Service
Training Delivery – acute setting POCT Manager Supplier POCT + supplier Link trainers Non scientific colleagues None !! (agency staff)
POCT Testing Strengths Weaknesses Speed Uniquely vulnerable to error Operators - non laboratory staff Patient interaction Trainers Equipment – fit for purpose ? Change Tx - Comparability with laboratory Diagnosis tests at various levels including for ongoing patient management Reduction in OPD Traceability: user, patient, reagents clinic, hospital and Erroneous results other contacts IT connectivity and middleware management capability Speed
Quality & Risk ?? “However, these Pre- Analytical Error instruments are often - Demographic entry operated by staff not - Infusion site trained in laboratory Analytical medicine and hence - Different Units: HI; LO prone to errors in the - Lower sensitivity / cut analytical phase (as off points / imprecision opposed to the - Interference: laboratory where the analytical phase has haemolysis, bilirubin, the least errors” Post Analytical - Florkowski et. al. (2017) - Records - handwritten, Critical Reviews in Lab paper, no electronic Medicine record
Point of Care Testing - Weaknesses IQC: composition, practice, protocols Historic practices/ equipment Pre analytical factors (Kazmierzak , Clin Chem 2011 ) Lack of understanding of the quality processes in result generation Out of hours support – training, repair
Point of Care Testing - Assumptions Quality Management System in Situ: - Governance - Users trained & competent - Equipment is checked daily for performance - Equipment and reagents are regulated, maintained, history Results are Verified: - Lab comparability for both guidelines and ongoing investigations/ monitoring - System of investigation/ reporting errors/ inconsistencies No pre- analytical, analytical, post analytical errors
Recalibration of Strips lots required and faulty strip lot replaced
Teamworks Report - 2007 We use the term point-of-care testing to mean laboratory tests performed by non-laboratory staff, (typically medical and nursing) at or near the site of patient care in the primary care sector and outside the main laboratory in hospital departments. The types, test repertoire, training, deployment and quality assurance of point-of-care test analysers is controlled by the Laboratory Medicine Service, responsible for implementing a national Point-of-Care Testing strategy.
ISO Standards - POCT “testing that is performed near or at the site of a patient with the result leading to possible change in the care of the patient” 15189 22870 - 2012 -2016 INAB Inspection
Regulation – Point of Care Testing France – ISO 15189/22870 – 2020 Ireland – 5 sites – SJH; Mater; Coombe; BonSecours, Tallaght UK – UKAS – CPA to ISO - 2018 (ongoing) USA - POCT tests currently waived Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria . Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.
Point of Care – Guidance Documents National POCT Consultative Group
POCT- Community The state of point-of-care testing: a european perspective. Larsson et al. (2015) - Upsala Journal of Medical Sciences “When POCT enters the community, issues concerning management and oversight, training, quality assurance, and documentation are all greatly amplified”
March ‘18
Type 2 Diabetes – Aim of Model of Integrated Care • Prevent or delay the onset of Type 2 diabetes • Improve the delivery of diabetes care to people with type 2 diabetes across all four levels of care i.e. specialist inpatient, specialist ambulatory care, specialist support to Primary Care and chronic disease prevention and management in Primary Care, all supported by patient self management. • save the lives, eyes and limbs of people with diabetes • ensure care is in line with the quality, access and cost objectives of the National Clinical Programme for Diabetes
Analyses – Type 2 DM HbA1c ≤ 53 mmol/L (3 per year) (IFCC method) LDL ≤ 2.5 mmol/L (annual) HDL ≥ 1.0 / 1.3 mmol/L (m/f) Trig ≤ 1.7 mmol/L FBC, Creatinine, ACR, TFT
HbA1c Interferences
Glucometer ? Blood Glucose Monitoring - Targets - Technique - Hand Hygiene - Meter calibration & storage - Sharps disposal - Testing frequency Meter performance ??
Results Haem/ Coag Clin Chem 15:12 15:12 - Hb =13.4 Grm/dl - Na + = 140 mmol/L - Platelets = 279 - K + = 4.2 mmol/L - PT >83.2 - Urea =12.5 mmol/L - INR >8.0 - Creat =131 umol/L - APTT > 182 - Fibrinogen <0.4
Results 15:30 - Hb = 7.9 G/L ( POCT Blood Gas ) - Na + = 145 mmol/L; K + = 2.6 mmol/L 15:51 Tx. RCC x 2; Vitamin K (10mgs IV) 17:30 – 18:30 Large Melaena - RCC x 1, FEIBA (4000 IU), Fibrinogen (4 Grms)
Results 19:18 – (Haem /Coag) - Hb =15.0 G/L - Platelets = 177 - INR >8.0 - APTT > 182 - Fibrinogen <0.4 - Na + = 143 mmol/L; K + =4.4 mmol/L (Clin Chem) 00:00 – Hb = 15.8 G/dl (Haem)
Community POCT - Recommendations National policies for POCT Testing POCT Team Oversight by a Coordinator- Senior Scientist Procedures for performance of analysis Operator training, competency assessment IQC & EQA Adverse Incident Investigation & Reporting Business case & risk assessment Quality Management System Inspection
Ter Avest et al. (2015) Point-of-care troponinT is inferior Patient to high-sensitivity troponin T for ruling out acute myocardial infarction in the emergency department. European Journal of Emergency Medicine “ POCT is laboratory testing and must be treated as such, which includes an understanding of the entire testing process from the pre-analytical phase to the post- analytical phase for anyone performing testing” – Shaw J. (2016) – Pract. Lab Medicine
POCT Staffing – Acute Settings 2018 500 - 1010 beds 10 9 8 7 6 5 4 3 2 1 0 1 2 3 4 5 6 7 8 9
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