Accreditation of Point of Care Testing- NHS Lanarkshire action plan Jacqueline McGuire Consultant Clinical Scientist Elaine Kennedy POCT co-ordinator Alison Campbell Quality Manager

Overview of NHS Lanarkshire POCT service Update you on the CPA POCT standards Describe our action plan Company solutions

3 acute hospitals 1607 beds

POCT in NHSL - a challenge! POCT has developed on each site independently. Supported by the laboratory in the majority of cases. Unfunded. POCT Policy - draft stage, awaiting approval Many clinical services are unaware of the consequences of POCT and try to initiate new tests without the support or guidance of the laboratory

Shift to community centred Health Care Devolution of control to primary care –greater emphasis on the prediction and prevention of disease –people are requiring further control over their own healthcare. More alternatives to centralised testing –automation and portable technologies have increasingly made diverse tests available at the point of care. –Exponential increase in the number of POC tests conducted, the array of analytes and available locations for testing in coming years

POCT Tests in NHSL (acute & primary care) Glucose meters Blood Gases Pregnancy testing Urinalysis (including analysers) Cholesterol testing INR testing HIV testing Not all with the support of the laboratory Total cost £309,179 (lab supported)

Staffing (Biochemistry) Lead by a Consultant Clinical Scientist BMS2 POCT co-ordinator. Role: Organising training, reporting, troubleshooting, EQA, IQA, SOPs, liaising with users, quality co-ordinator etc BMS1/2 performing routine POCT functions on each site eg maintenance, troubleshooting Increasing pressure on all labs to support POCT.

Quality Management – 2009/10 Subject to the same document control system as the laboratory Record CAPAs, Datix etc Perform regular audits Staff training & initial competence testing recorded, limited competence testing thereafter. Participate in the laboratory annual review. Have quality objectives and plans set annually.

Blood Gas analysers 8 Siemens 1200 series POCT analysers, 6 laboratory analysers AE, ICU, SCBU, Labour ward Linked to LIMS via RapidComm 3 Significant time resource required for maintenance and troubleshooting 33,000 samples 770 users

Glucose Acute –194 Abbott Xceed Pro connected meters –3007 trained operators (797 retired operators) –380,752 patient tests –WEQAS EQA (bi-monthly) Primary Care –550 Bayer hand held meters –Risen by 100 meters in last year –779 staff have been trained –Frimley Park EQA (monthly)

Urinalysis Siemens CLINITEK Status Pregnancy tests – 5 locations Laboratory = 11,386 POCT = 7,000 –Numbers increasing 10% per yr –eg Dermatology, Day surgery, AE Urinalysis – 5 locations

RSV Testing 4611 tests Winter period Paediatric wards Staff re-trained every year

Additional standards for POCT facilities – CPA (UK) Ltd, V1.01 Required to register your intent to have POCT accredited by 31 ST Dec Based on ISO 22870:2006 (POCT- Requirements for quality and competence). –Require to purchase these standards Should also meet the CPA’s standards for the Medical Laboratory (incorporates ISO 15189:2007)

“… any analytical test performed for a patient by a healthcare professional outside the conventional laboratory.” “…testing that is performed near or at the site of the patient with the result leading to possible change in the care of the patient.” Definition of POCT

Department of Health, 2009 “… any diagnostic test performed on a person by a competent individual, where a result that can be interpreted is provided before the person leaves.”

NHSL POCT accreditation Intention to register Acute site only – from 1 base with 2 satellite services Glucose Blood Gases Pregnancy testing RSV Urinalysis – meters only Will not be applying for community Glucose accreditation – initially ?? INR

Ultimate responsibility “The governing body of the organization shall be ultimately responsible for ensuring appropriate measures are in place to monitor the accuracy and quality of POCT conducted within the healthcare organization” Practical management Laboratory

A Organisation & Quality Management System A1 Organisation & Management A 1.6 (POCT) Laboratory management shall ensure that POCT is organized and operates in conformity with these Additional Standards and the CPA (UK) Ltd “Standards for the Medical Laboratory” A 1.7 (POCT) Top management of the organisation within which POCT is provided, shall ensure that there are procedures in place to monitor the quality of the service. └

A1 Organisation & Management A 1.8 (POCT) The organisation within which POCT is provided, shall ensure that there is a healthcare professional grouping (e.g. a governance group) responsible to its top management for defining the scope of POCT. The scope of POCT shall take into account: a) the clinical need b) its financial implications c) technical feasibility and d) the resources available. NHSL Acute Clinical Governance Committee

A1 Organisation & Management A 1.9 (POCT) The laboratory director or designee, in conjunction with organisation management, shall appoint a multidisciplinary POCT management group to advise on the management and provision of POCT. The group shall ensure that: a) the responsibilities, authority and interrelationships of all personnel involved in POCT are specified and communicated within the organization Responsibilities and relationships details in POCT policy and service level agreements (new). Job descriptions for Clinical director and Clinical Lead already have POCT included.

NHSL POCT Organisational Structure Lab Clinical Director Convenor POCT Committee Acute Clinical Governance Committee POCT Committee POCT Co-ordinator & Quality Co- ordinator Wards ICU, AE Clinics Lab Quality Manager

NHSL POCT Committee Terms of Reference The composition shall include stakeholder representatives –from the supporting laboratory services (POCT / Quality co-ordinators) –and from the key clinical users (Diabetes, A&E, Anaesthetics/ ITU, Obstetrics, Neonatology, Theatres). Key link personnel will be co-opted as required from Pharmacy, Infection Control, Procurement and Information Technology. Where deemed necessary, the POCT committee will establish sub-groups to deal with policy development and monitoring of specific POCT processes (eg blood glucose monitoring) working with other groups as appropriate.

A1 Organisation & Management b) staff performing POCT receive appropriate training, supervision and competence testing. Training Supervision – built into POCT policy, SOPs and service level agreements. Competence testing

A1 Organisation & Management c) all proposals to introduce any product, device, or system for POCT are evaluated for their clinical effectiveness and cost efficiency the selection of POCT devices and systems includes their practicability and the comparability of their results with those obtained in the laboratory. Business Case: –capital cost of the equipment –the revenue costs of consumables –the cost of Quality Assessment material and scheme registration –repair and maintenance costs – details of staff costs to perform the test and the availability of laboratory and other staff to support the facility on site or the cost of provision of additional staff to provide this support. May include published evaluation reports or evaluation performed locally

A1 Organisation & Management d) the selection of POCT devices and systems includes their practicability and the comparability of their results with those obtained in the laboratory. Comparability: Gases & Pregnancy Tests – all analysers evaluated prior to install Glucose – capillary v plasma Urinalysis - Not run in the lab

Selection of equipment Diagnostic capability Rule in or rule out Technical Validation Underpinning performance Concordance with laboratory Location of equipment Power Water Drainage Space IT infrastructure

A1 Organisation & Management e) the reports of the POCT quality assurance programme(s) are reviewed by the group and advice on improvement is provided and implemented. Registered all POCT with an EQA scheme. Results will be reviewed by the Committee and local QA meetings. CAPA’s logged. The Committee has the power to stop any POCT service if required.

A2 Needs and Requirements of Users A 2.5 (POCT) Where the laboratory provides POCT to another healthcare organization, (a separate (legal) entity), and uses resources, including staff, provided by that organisation, the ultimate responsibility for the examination results/reports shall be defined in a formal agreement (see A 2.4). Not applicable

A4 Quality management system A 4.4 (POCT) Laboratory management shall establish a quality management system for POCT. Included POCT in the Quality Policy and added the quality co-ordinator to the Quality Manual. Already included POCT under lab document control procedures. Added it to the laboratory annual review documentation. Require to increase auditing of the service

A7 Quality manager A 7.4 (POCT) Laboratory management shall appoint an individual with defined responsibility for ensuring that the POCT quality management system is implemented and maintained. Already in the Quality Managers job description

A8 Document control A 8.4 (POCT) Manuals and instructions for use of POCT shall be subject to document control and readily available to users. Documentation on QP5 Available to users on local intranet. Limited instructions printed for Glucose Analysers Full instructions printed for other services Watermark ‘Uncontrolled when printed’

A11 Management review A 11.4 (POCT) Laboratory management shall conduct an annual review of POCT. The review shall include: a) the clinical need for POCT b) the clinical effectiveness of POCT c) the cost effectiveness of POCT Included in Annual Review Documentation Identify areas for improvement (Quality Improvement & Plans)

B PERSONNEL B1 Laboratory Director B 1.6 (POCT) The laboratory director or designee shall appoint a multidisciplinary POCT management group (A 1.9) B 1.7 (POCT) The laboratory director or designee shall implement a periodic management review that includes an ongoing evaluation of the clinical effectiveness and cost efficiency of POCT activities provided and identifies opportunities for improvement. POCT already in Laboratory Director and Clinical Lead job descriptions

B2 Staffing B 2.4 (POCT) The POCT management group shall ensure that there are appropriate numbers of staff to implement the POCT Quality Management system and provide training to personnel performing POCT. Staffing – will require significantly more time for lab staff to be involved in POCT Ensure all staff trained in Quality Management / audit (include MLAs) Ensure training programmes in place for POCT

B6 Staff records B 6.3 (POCT) The POCT management group shall designate staff performing POCT and maintain a record of their competency. Maintaining Competency – DIFFICULT!

B9 Staff training and education B 9.7 (POCT) The POCT training programme shall, as appropriate, include the following: a) the context and clinical utility of POCT b) the theoretical aspects of the measuring system c) sample collection and handling d) reagent storage e) quality control f) infection control g) limitations of the measuring systems h) response to results outside predefined limits i) documentation and reporting of results

POCT training programme Checked all SOPs, COSHH, training logs and company provided training materials to ensure all areas covered. May require to add to company provided training. Regular training already provided. Training schedules on the intranet site. Use the company provided training as much as possible!

B9 Staff training and education B 9.8 (POCT) Competency to perform POCT tasks shall be assessed following training and periodically thereafter. Retraining and reassessment shall occur when necessary. Records of competency assessments shall be kept (B6). All initial training includes a competence assessment Thereafter - partial compliance Risk assessed each POCT service to identify level of competence assessment required

Blood Glucose – competence & audit Require ‘good low and high IQC’ once every 12 months (post training) and users sent for re-training if their registration expires. Have sent staff for retraining resulting from –CAPA incidents –EQA assessment –Results of audits Auditing – assess glucose meters stations – annually (MLA) Now require: – random examination audits (1 per hospital per year) –Vertical (1 per year) –Horizontal (1 per year for POCT service– additional stds only)

Blood Gases – competence & audit No electronic way of re-assessing competence. Automatic IQA and lab staff performing EQA CAPA incidents - could send staff for re-training Now require –1 examination audit to be performed for each analyser per yr (8 audits). Bolt on 3 hours of competence assessments. –Remove staff from server who have not tested for > 1year. –1 vertical audit

Pregnancy test – competence & audit No electronic way of re-assessing competence. Automatic IQC on cassettes Can send staff for retraining resulting from –CAPA incidents –EQA assessment –Results of audits Now require –examination audit to be performed for each analyser per yr (5 audits) plus 3 hrs of competence assessments –1 vertical audit –Connectivity - could remove users who have not used the device >1yr

E-learning /Competence Assessment However: –Integration with hospital system –Time allowed to complete –Need to integrate results into the data management system IL GEM Blood Gas analysers Nova Statstrip Glucose meters

C PREMISES AND ENVIRONMENT C 1.5 (POCT) The healthcare organization shall ensure the premises within which the POCT is performed, provide a working environment in which staff can undertake required functions in accordance with national legislation and guidelines. Generally comply but can be difficult to control eg storage facilities, if reagents are stored at ambient temperature is this monitored

D EQUIPMENT, INFORMATION SYSTEMS AND MATERIALS Make sure all POCT equipment in the equipment inventory Record all maintenance, engineer visits etc as you would for a lab equipment – raise a CAPA Ensure back-up of connected data systems Inventory management (difficult for glucose meters)

E PRE EXAMINATION PROCESS E3 Specimen collection and handling E 3.4 (POCT) Where a POCT sample may be unsuitable for analysis there shall be procedures to report this to the POCT user and records shall be maintained. SAN notices (actions recorded) Communication: Letters to users via contacts, newsheets etc Change to SOP

F EXAMINATION PROCESS F3 Ensuring the quality of examinations F 3.6 (POCT) Where results are obtained by POCT and the laboratory, the comparability between the methods used shall be determined and made available to users upon request

G THE POST EXAMINATION PHASE G2 The report G 2.6 (POCT) Results of POCT shall be recorded in the patient’s medical record and be distinguishable from results provided by the laboratory. A record shall be kept of the person performing the POCT.

G2 The report Issues: –Manual Tests – provide log books for reagent logs etc and instruct staff to transcribe results into notes –Often operator information is missing –Thermal Paper –Patient identification

Connected glucose meters & blood Gases All information available on server. Test results, IQC, EQA results, operator ID, time/date, reagent lot numbers. Can extract IQC for analysis Glucose – record competence Nurses transcribe glucose results to notes and print out of gas results entered into patient notes. Stock control! Future – results to PMS, identified as POCT glucose and POCT user recorded.

Pregnancy & Urinalysis Testing Currently unconnected but user access via barcode. IQC lot of hCG cassettes through pharmacy Manual log book –Stock Control – new! –IQC results (urinalysis) –test results –Records user –Lot numbers –Date / time Future : To connect all Clinitek Status analysers to RapidComm.

H EVALUATION AND QUALITY ASSURANCE H5 External quality assessment H 5.5 (POCT) There shall be participation in external quality assessment schemes. Where such a scheme is not available an alternative internal quality assessment scheme shall be implemented * *This may involve circulation of a sample to multiple POCT analysers and comparison of results.

Problems!!! User identification – using others barcodes Patient identification – ‘emergency barcodes’ overuse –Using there own barcode –Wrong patients Transcription errors- unknown! Reagent storage and stock control Personnel Management – will they ask nursing staff if they have had an AJR??

Competence assessments Do we have the man power to comply? Will a random selection assessment be adequate? Medical staff and competence!!!

Solutions Connected POCT – where ever possible! On-line competence testing. Barcode users ID and patient ID Buy in from Board Level, Patient Safety and Nursing Education and Training Treat POCT as you would a lab test

Guidance and Stds for POCT – some examples 1996 Near Patient Testing - A Statement of Best Practice for Scotland. Scottish Office, Department of Health; National Advisory Committee for Scientific Services Medicines and Healthcare products Regulatory Agency (MHRA). Management and use of in vitro diagnostic devices for point of care testing 2006 ISO 22870:2006 Point-of-care testing (POCT) Requirements for quality and competence 2007 Safe, Accurate and Effective: An Action Plan for Healthcare Science in NHS Scotland. The Scottish Government

CLINITEK Status Connect System

Solution 2010: CLINITEK Status Connect System Timing Mis-reading of the strip Permanent record of the result Patient ID (lab no) - barcode entry No transcription errors – direct to LIMS through RAPIDComm

Addition benefits Increased patient results storage (950 compared with 200 on Clinitek Status Classic) Operator ID storage / lockout (700) QC compliance - ability to set reminders / lockouts Urinalysis - Strip integrity & sample interference alerts, QC compliance (reminder/ lockout)

Additional benefits of Status + connected system Operator ID –lock out untrained users (Send from RAPIDComm) –Re-validation –Audit trail Reagent traceability –Lot and expiry date entry for hCG cassettes QC result storage –QC testing (rather than running QC as a patient) and storage of 200 QC results