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The Future of Community Based Testing Bernadette Jackson Point of - - PowerPoint PPT Presentation

Jan 12, 2023 149 likes •631 views

The Future of Community Based Testing Bernadette Jackson Point of Care Manager Naas General Hospital Accreditation ISO 15189 Inspection M OKane 2012 Quality in Testing Process Internal Quality Staffing Controls - Medical

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The Future of Community Based Testing Bernadette Jackson Point of Care Manager Naas General Hospital

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Accreditation ISO 15189 Inspection

M O’Kane – 2012

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Quality in Testing Process

 Internal Quality

Controls

 External Quality

Assurance

  • NEQAS
  • WEQAS
  • IEQAS
  • DEQAS
  • RIQAS

 Staffing

  • Medical Scientists

(Chief, Specialists,

Senior, staff grade)

  • Biochemist
  • Pathologists

ISO 15189 – Annual Inspection – INAB (Quality Management System)

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Patient Confidence in Treatment

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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

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Key Health Trends - 2018

F =83; M=79

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Naas General Hospital – Area 7

24 244 +

Population 250,000

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Teamworks Report

  • 2007

 Self Care

  • patient empowerment

 Local Care

  • General practice
  • Primary Care
  • Community
  • Ambulance services
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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.

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Healthcare Centres (HSE)

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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”

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Point of Care Testing - Where ??

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Inspection X

M O’Kane – AACC - 2012

Accreditation ISO 15189 /22870

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Tests at Point of Care

 pH, pCO2, pO2  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

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Devices and Test Systems

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Analytical Methods

Mark et.al. – 2010 – Chem Soc Review

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Accreditation ISO 15189:2012 22870:2016 Inspection X PST INR - NGH

Anticoagulation Clinic

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M O’Kane – AACC - 2012

INR = 4.5

Anticoagulation Clinic

Accreditation ISO:15189

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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)

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AntiCoagulation Service

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Training Delivery – acute setting

 POCT Manager  Supplier  POCT + supplier  Link trainers  Non scientific

colleagues

 None !!

(agency staff)

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POCT Testing

Strengths

 Speed  Patient interaction  Change Tx  Diagnosis  Reduction in OPD

clinic, hospital and

  • ther contacts

Weaknesses

Uniquely vulnerable to error

Operators - non laboratory staff

Trainers

Equipment – fit for purpose ?

  • Comparability with laboratory

tests at various levels including for ongoing patient management

Traceability: user, patient, reagents

Erroneous results

IT connectivity and middleware management capability

Speed

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Quality & Risk ??

 “However, these

instruments are often

  • perated by staff not

trained in laboratory medicine and hence prone to errors in the analytical phase (as

  • pposed to the

laboratory where the analytical phase has the least errors”

  • Florkowski et. al. (2017)

Critical Reviews in Lab Medicine

 Pre- Analytical Error

  • Demographic entry
  • Infusion site

 Analytical

  • Different Units: HI; LO
  • Lower sensitivity / cut
  • ff points / imprecision
  • Interference:

haemolysis, bilirubin,

 Post Analytical

  • Records -handwritten,

paper, no electronic record

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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

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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

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Recalibration of Strips lots required and faulty strip lot replaced

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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.

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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

  • f the patient”

22870

  • 2016

15189

  • 2012

INAB Inspection

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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.

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Point of Care – Guidance Documents

National POCT Consultative Group

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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

  • versight, training, quality assurance,

and documentation are all greatly amplified”

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March ‘18

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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
  • bjectives of the National Clinical Programme for Diabetes
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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

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HbA1c Interferences

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Glucometer ?

Blood Glucose Monitoring

  • Targets
  • Technique
  • Hand Hygiene
  • Meter calibration &

storage

  • Sharps disposal
  • Testing frequency

Meter performance ??

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Results

Haem/ Coag

 15:12

  • Hb =13.4 Grm/dl
  • Platelets = 279
  • PT >83.2
  • INR >8.0
  • APTT > 182
  • Fibrinogen <0.4

Clin Chem

 15:12

  • Na+= 140 mmol/L
  • K+ = 4.2 mmol/L
  • Urea =12.5 mmol/L
  • Creat =131 umol/L
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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)

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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)

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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

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Patient

“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

Ter Avest et al. (2015) Point-of-care troponinT is inferior to high-sensitivity troponin T for ruling out acute myocardial infarction in the emergency department. European Journal of Emergency Medicine

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POCT Staffing – Acute Settings 2018

1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9

500 - 1010 beds