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POINT OF CARE TESTING (POCT) PROCEDURE

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					                             POINT OF CARE TESTING (POCT) GUIDELINES




    These Guidelines underpin section 3.14: POCT in the Medical Devices Policy




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1. INTRODUCTION/PURPOSE OF THE GUIDELINES
1.1 Definition of Point of Care testing
1.1.1 Point of care Testing (POCT) is defined as any analytical test performed for a patient by a healthcare
professional outside the conventional Pathology laboratory setting and is a valuable procedure used in patient
care.

Examples of POCT include: -

                 o Blood glucose monitoring
                 o Blood gas/ co-oximetry analysis
                 o Electrolyte analysis
                 o Blood coagulation measurement
                 o Blood HbA1c analysis
                 o Urine analysis
                 o Rapid tests for infectious disease markers
                 o Pregnancy testing

1.1.2 POCT is now an established part of clinical practice. However it is important that it is viewed as part of an
integrated activity in which the objective is caring for the patient in the best clinical and most cost-effective
way.

The main strengths and weaknesses of POCT are summarised as follows: -

                         Strengths                                        Weaknesses
 Improved turnaround time allowing                   Duplication of testing and equipment
     rapid therapeutic intervention                  Cost-per-test invariably greater than equivalent
     informed counselling for therapeutic            laboratory tests
     management                                      Incompatibility with laboratory results leading to
 Smaller sample volumes reducing iatrogenic          clinical confusion
 blood loss                                          Tests performed by staff with a non-analytical
 Economic benefits associated with reduced           background – leads to increased risk of
 length of stay in hospital                          adverse incidents
 Possibility for reduced sample transport costs.     May encourage inappropriate testing



These strengths and weaknesses must be carefully considered when addressing whether POCT should be
implemented and in reviewing situations in which POCT has grown in an unregulated and uncontrolled
manner.


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1.2 GUIDELINES FOR POCT

1.2.1 In 1999, the Joint Working Group on Quality Assurance (JWG) published guidelines highlighting that
POCT is a Clinical Governance issue and emphasising the central role that Pathology must have in the
implementation and management of POCT.

1.2.2 The MDA Device Bulletin (2002), Management and Use of IVD Point of Care Test Devices are
consistent with and based on the JWG Guidelines. It provides definitive guidance on all issues relevant to
implementation and management of POCT.

1.2.3 These above guidelines are used as standards for POCT by Clinical Pathology Accreditation UK Ltd that
is an independent body that assesses the standard of Pathology services, including POCT.


1.2.4 The European In Vitro Diagnostic Medical Devices Directive 18 regulates most of the equipment used for
POCT. The Directive, which came fully into force on 7th December 2003, aims to ensure that; devices will not
compromise the health and safety of patients and users; devices are designed and manufactured to achieve
the performance specified by the manufacturer for the stated medical purpose. Devices that meet the relevant
essential requirements of the Directive will carry a CE mark to denote compliance.


1.3      Aim of the Guidelines
1.3.1There is a requirement to ensure that all POCT equipment used within the Trust: -

              o Is suitable for its intended purpose
              o Meets safety and quality assurance standards
              o Can be supported adequately
              o Is operated only by appropriately trained staff

1.3.2 This requirement can only be met by Trust-wide Guidelines on POCT based on the JWG and MDA
guidelines which will ensure consistent procedures are in place throughout the Trust. These Guidelines will
facilitate adherence to the principles of Clinical Governance by defining responsibility and procedures for:

              o Training, certification and proficiency testing of POCT operators
              o Standardisation of equipment where practical thereby facilitating use, training and maintenance
              o Effective risk management
              o Compliance with Health and Safety legislation and infection control measures




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1.3.3 If not used appropriately there is a risk that patients may be put at risk from inappropriate testing or wrong
results. Therefore for the successful use of POCT devices it is essential that the purchase, implementation and
quality assurance assessment be carried out appropriately.


1.3.4 The appropriate use of these tests should be considered as a Clinical Governance issue and subject to
examination of clinical effectiveness.


1.3.5 To achieve the best possible results from POCT devices it is essential that there is the closest possible
liaison with the Pathology services relating to all aspects of such tests.
To ensure reliable performance and manage the risks associated with point of care testing, the Pathology
laboratory must have a central role in management of these devices.

                  o On-going quality control, quality assurance and auditing of POCT
                  o Negotiation of cost effective bulk discounts with suppliers of equipment and consumables
                  o Networked IT support to facilitate audit trails and faster troubleshooting.



2. APPLICATION: TO WHOM THESE GUIDELINES APPLY

These guidelines apply to all those working in the Trust, in whatever capacity.              A failure to follow the
requirements of this procedure may result in investigation and management action being as considered
appropriate. This may include formal action in line with the Trust’s disciplinary or capability procedures for
Trust employees; and other action in relation to other workers, which may result in the termination of an
assignment, placement, secondment or honorary agreement.


3. SUMMARY OF THE GUIDELINES
These guidelines are set out to ensure complete quality assurance with regards to all issues surrounding Point
of Care Testing.
Roles and responsibilities are set out and lines of accountability are clearly defined.


4. THE GUIDELINES


4.1 Trust POCT Committee
4.1.1 The Trust POCT Committee is a sub committee of the Medical Devices Committee and will oversee
POCT across the Trust to ensure that POCT is appropriate and accreditable. It is chaired by the Consultant
Chemical Pathologist with responsibility for POCT and has a wide membership to ensure all relevant expertise
is incorporated, as follows:

              o Trust POCT Co-ordinators
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              o Trust Risk Management
              o Pathology Laboratory Management
              o Diabetes Nurse Specialists
              o Medical Representatives (Consultant Physician)

                 Nursing Representatives (Medicine and Critical Care)

              o Pharmacy/Supplies Representative
              o Medical Engineering and Maintenance



4.1.2 The Committee will co-opt additional members where appropriate as the practice of POCT expands e.g.
Primary Care Representative

4.1.3 The Committee will co-opt representatives from additional fields on a temporary basis to ensure that
there can be an informed discussion on agenda items.           This will particularly apply to Infection Control and
Medical Audit representatives.


4.1.4 The Committee shall ensure that POCT Devices are implemented and used appropriately. The POCT
committee will report to the Medical Devices Group, which itself reports to the Clinical Governance committee.
These report to the Trust Board.

4.1.5 The MDA Notices and the Joint Working Group on Quality Assurance emphasise the central role that
Pathology has in ensuring that POCT Devices are used appropriately.              This subcommittee reflects that
recommendation.


4.1.6 No POCT Devices should be used within the Trust unless approval has been obtained from the POCT
Committee.

4.1.6 The POCT committee will have responsibility for: -

              o considering the case for introduction of POCT in a particular location prior to procurement.

              o determining budgetary responsibility for individual POCT services.

             o ensuring compatibility between instrumentation (POCT and laboratory) in use Trust-wide.
             o establishing the presence of a link nurse at ward level.
             o ratifying Standard Operating Procedures (SOPs), Service Level Agreements (SLAs), Risk
              Assessments and COSHH assessments.
             o ascertaining the complexity of a device and therefore grades of staff that would be authorised to
              use that device following training.
              o internal quality control material and participation in external quality assessment scheme

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              o accreditation scheme compliance e.g. CPA (UK) Ltd
              o consumables
              o record keeping e.g. data handling system
              o cleaning and waste disposal


4.2 Cost Benefit Analysis and Procurement.
4.2.1 All POCT devices are subject to the criteria described in this document irrespective of whether the
equipment has been purchased (including from endowment funds), hired, loaned or received as a donation

4.2.2 Proposals to introduce POCT must be supported by a Cost Benefit Analysis, which includes a clear
definition of the problem that a POCT device would solve so that a full examination of all possible solutions
can be made.

4.2.3 The Pathology Department will, in conjunction with the requesting clinical department, be responsible for
the production of the Cost Benefit Analysis, which will be presented to the POCT committee for evaluation and
approval before submission to the Trust for financial support.

4.2.4The Cost Benefit Analysis must detail all the financial consequences to Pathology and the proposed
POCT site. These will include capital and revenue costs associated with the equipment itself and all staffing
resources required by both the laboratory and the clinical area to provide the service. These costs can be
further broken down as follows:

              o initial purchase of equipment and accessories.
              o provision of a safe environment e.g. health and safety improvements
              o site alterations to accommodate POCT
              o interfacing with information management systems
              o staff time (clinical and laboratory) required for patient analysis, support, training, quality
              assurance and audit.
              o routine and preventative maintenance e.g. external service contracts with manufacturers
              o internal quality control material and participation in external quality assessment scheme
              o accreditation scheme compliance e.g. CPA (UK) Ltd
              o consumables
              o record keeping e.g. data handling system
              o cleaning and waste disposal

4.2.5 The Cost Benefit Analysis must recognise the need for any device to be compatible with existing
equipment, both in the laboratory and in other areas of the hospital. The Pathology Department will address
issues of compatibility and be responsible for producing a shortlist of potential suppliers.


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4.2.6 The Pathology laboratory will evaluate the technical quality of the equipment and any interfacing
requirements. Short-listed suppliers will be invited to submit their equipment for demonstration and/or trial.

4.2.7 When funding has been identified, an operational specification will be drawn up jointly by Pathology and
the clinical users and companies will be invited to tender. The final selection will be made by a panel
composed of representatives from Pathology and the clinical unit and will be ratified by the POCT committee.


         o ensuring that all users are trained and certified in the use of POCT devices.
         o ensuring that internal quality control (IQC) and external quality assessment (EQA) schemes are
                    employed effectively.
         o ensuring that all POCT services within the Trust are assessed for CPA Accreditation in conjunction
                    with the relevant Pathology Department,
         o monitoring and recording all adverse incidents involving POCT devices.

4.3 Risk management

4.3.1 It is essential that training and support from the Pathology departments and the POCT Committee
properly manage the risks associated with the use and interpretation of results obtained. No POCT devices
are totally fail-safe.

4.3.2 In accordance with current guidelines, POCT devices with network connectivity are the preferred option.
Instruments that can be connected directly to the Point of Care Connectivity system allow transfer of data
directly to the laboratory computer, ensuring accountability and a complete audit trail. It is for this reason if a
connectivity version is available this is what must be purchased.

4.3.3 The Cost Benefit Analysis must recognise the need for any device to be compatible with existing
equipment, both in the laboratory and in other areas of the hospital. The Pathology Department will address
issues of compatibility and be responsible for producing a shortlist of potential suppliers. The Pathology
laboratory will evaluate the technical quality of the equipment and any interfacing requirements. Short-listed
suppliers will be invited to submit their equipment for demonstration and/or trial.

4.3.4 When funding has been identified, an operational specification will be drawn up jointly by Pathology and
the clinical users and companies will be invited to tender. The final selection will be made by a panel
composed of representatives from Pathology and the clinical unit and will be ratified by the POCT committee.

4.3.5 Lines of accountability should be clearly written into local policies and procedures. (see appendix A)

4.4 Health & Safety

4.4.1 Managers of the Clinical service involved together with the Pathology service must jointly develop and
enforce policies consistent with current legislation and Guidance. For example: the Health & Safety at Work
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Act 1974, Consumer Protection Act 1987, the Control of Substances Hazardous to Health (COSHH)
Regulations 1988, Safe Working and the Prevention of Infection in Clinical Laboratories – Model Role for Staff
and Visitors, HSC 1981, Protection against Blood-born infections in the workplace: HIV and hepatitis (ACDP)
1995.

4.4.2 There should be close liaison between the Safety Officers responsible for the testing site and Pathology.

4.4.3 A Decontamination certificate (see Trust Policy), providing evidence of appropriate decontamination,
must be issued before servicing or repair of equipment.

4.4.4 The Infection Control Physician/Medical Microbiologist must be involved in decisions on placement and
maintenance of equipment.

4.4.5 The manufacturer prior to installation must provide a Master Indemnity Agreement.


4.5 Budgetary Management and Stock Control

4.5.1 The designated budget holder for each particular POCT service will be ultimately responsible for
managing the budget.

4.5.2 The clinical department will, jointly with Pathology, agree necessary measures to resolve budgetary
problems.

4.5.3 The clinical department will ensure that there is a rotation system in operation and that all reagents are
within their shelf life.


4.6 Maintenance

4.6.1 It is mandatory that all POCT devices must be regularly maintained. The POCT Co-ordinator will be
responsible for overseeing the maintenance of all such devices and the POCT Co-ordinator will be responsible
for training designated operators as necessary. Responsibility of the ward and the laboratory for carrying out
maintenance procedures will be outlined in the SOP for each device.

4.6.2 The manufacturers’ engineers according to the company service schedule will perform Service visits.
The POCT Co-ordinator will determine responsibility and procedures for liasing with the manufacturer
regarding all equipment problems and failures.

4.6.3 Each device must have a “Device Record Book” or logbook in paper or electronic form in which
maintenance records, faults, corrective actions and repairs by named individuals are documented. These
records are the management responsibility of the Pathology laboratory and must be accessible for inspection
at all times.


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4.7 POCT Operators and Training

4.7.1 Only staff whose training and competence has been established and documented will be authorised to
use any POCT device.
4.7.2 The training course must be specified and supervised by the relevant Pathology department and provided
by the manufacturer or local staff trained to the satisfaction of the relevant Pathology department.

4.7.3 The training course must include:-

         o patient preparation

         o sample collection

         o sample suitability and stability

         o sample analysis

         o quality assurance procedures

         o interpretation of results

         o recording results

         o limitations and contraindications

         o health and safety issues and liability issues.

4.7.4 Once competence has been achieved and documented, the user can be added to the "Named Operator
List" and a password to gain access to the device issued if appropriate.
4.7.5 POCT Operator ID barcodes and passwords must NEVER be shared or given out to any other
member of staff. POCT Operators must only use their own POCT barcode and password.

4.7.6 Additional training, as specified and supervised by the relevant Pathology department, will be provided for
designated staff responsible for maintenance.

4.7.7 All trained staff must undergo proficiency assessments and refresher/update training as specified in the
SOP in order to retain their operator status.

4.7.8 The Pathology department will provide input into the development and delivery of appropriate Continuing
Professional Development (CPD) programmes.


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4.7.9 Responsibilities of POCT operators and those of the POCT Co-ordinator are listed in Appendix C.




4.8 Standard Operating Procedures (SOPs).

4.8.1 All POCT devices must have SOPs that are available to and followed by all operators of the device with
no deviations.

4.8.2 All devices must have an SOP which includes information on:-

         o sample suitability and stability

         o quality assurance procedures

         o performing the analyses
         o method of recording results

         o interpretation of results
         o reference ranges

         o limitations and contraindications

         o health and safety issues.
         o action required in case of suspected device failure or an unexpected result.

4.8.3 All SOPs must be written to the standard required by Clinical Pathology Accreditation. A master copy of
the SOP must be held by Pathology and be available to Assessors from Clinical Pathology Accreditation, or
equivalent accreditation agencies.

4.8.4 Additional supporting documents must be stored with the SOP including COSHH and Risk Assessments,
Manufacturers Operator Manuals, relevant MDA notices, Named Operator Lists. Duplicate copies of these
documents will be stored in Pathology.


4.9 Quality Assurance and Audit

4.9.1 Quality assurance is a mandatory component of POCT and includes all the measures taken to ensure
that investigations are reliable – test selection, obtaining a satisfactory specimen, analysing it and recording
the results promptly, interpreting the result accurately, taking appropriate action, and documenting all
procedures for reference.




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4.9.2 There are two components to quality assurance: internal quality control (IQC) and external quality
assessment (EQA). The Pathology laboratory is responsible for ensuring that they are applied to the same
rigorous standard as in the laboratory setting, such as would satisfy CPA inspection criteria.

4.9.3 Internal Quality Control is a means of checking that results are reliable before they are issued. Results
obtained must be recorded appropriately (electronically or on paper), compared with acceptance limits and the
appropriate action taken as defined in the SOP.

4.9.4 EQA involves the analysis of samples with unknown value from an external source. These samples will
be issued and administered by the Pathology laboratory. EQA samples must be analysed by a user of the
instrument as if they were normal patient samples. It is the responsibility of the ward manager to allow time for
users to perform EQA analysis. Results should be recorded and returned to the laboratory.

4.9.5 The Pathology department is responsible for evaluation of QC and QA data, liasing with clinical users
regarding performance and determining appropriate action in the event of unsatisfactory performance.
4.9.6 The Pathology department must carry out regular audits of the reliability and effectiveness of the tests
being carried out.




4.10 Recording of Results

4.10.1 All patient and Quality Control/Quality Assessment (QC/QA) results must be recorded. This record must
include unequivocal patient identity, time of test, the result, relevant QC results and the identity of the user.
4.10.2 Management of these records is the responsibility of the POCT Co-ordinator who must have free
access to all data.

4.10.3 A more permanent record of documentation in the patient’s notes must replace temporary reports
issued by POCT devices. This should take the form of a laboratory report (paper or electronic) in the case of
devices with connectivity.

4.10.4 All patients’ results must be treated as confidential and kept in a secure place. If patient results are
stored in a computer system, local rules on access to the system, whether stand-alone or networked, should
be maintained.


4.11 Support

4.11.1 There must be a Service Level Agreement defining the level of support for the device with respect to
stock control, maintenance, troubleshooting, repairs, continuing training and QA monitoring.
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4.11.2 A device that fails or is suspected of failing to perform to specification must be withdrawn immediately

from service and Pathology informed. If devices are not used or cared for appropriately the Pathology

department will have the authority to remove the device from service. If multiple use of an individual’s password

is suspected that password will be withdrawn from use and the individual’s supervisor informed.



4.12 POCT Analysers

Specific POCT analysers and their respective procedures (SOP’s, Training, QC procedures) are listed on the

Point of Care Testing Microsite on the Trust’s Intranet.

A summary of these specific procedures are listed in Appendix B.




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    Flow chart for the Implementation of New and Replacement
                   Point of Care Testing Devices
   Idea to                                        Stage 1: Ask the POCT                              Preliminary discussions
   introduce a new                                Co-ordinator for advice                            with POCT Co-ordinator,
   POCT service                                                                                      Pathology Dept and
    or replace a                                                                                      Clinical Lead
    POCT device                                 Produce Proposal
                                                   document
                                                                                                     POCT Chair may act to
                                                                                                     initiate urgent approval

                                           Stage 2: Submit Proposal                      Recommendation to obtain further
                                          Document to POCT Committee                     supporting information or
                                                                                         agreement not to proceed

                                               Recommendation to proceed
                                                                                             Involvement of supplies for procurement
                                                                                                of suitable POCT analyser
   Laboratory evaluations
                                          POCT Co-ordinator organises collection
    Operator evaluations                     of information on devices                            Secure capital and consumable
                                                                                                   costs for project

 Advice from IT, Infection
 Control, Risk Management             Clinical Area and Laboratory work together to
                                      prepare Cost Benefit Analysis & Business                  Identify POCT Link Nurse and
                                      Plan for preferred option(s)                               staffing implications for Clinical
Review relevant literature                                                                      Area and Laboratory support.



                                     Stage 3: POCT Committee considers               Rejected            A letter outlining the
                                          procurement of named device                  or                reasons will be issued
                                                                                     deferred
                                                       Approved

  Clinical Area make changes to ward fabric                                POCT Co-ordinator arranges Training protocols,
  e.g. IT links, reagent storage                                           SOPS, COSHH, SLA, EQA and IQC, record
                                                                           keeping, maintenance logs etc



                                  Stage 4: Approval Process          Referred                        A letter detailing
                                  POCT Committee approves             for                            the specific reasons
                                  SOPs, SLAs, training & EQA         amendments                      will be issued

                                                    Approved


                                                  POCT service goes live



On-going audit of POCT impact                                                          On-going audit of quality of testing
 on patient care

                                                  Stage 5: POCT
                                                Committee Review
                                                    Process




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The diagram illustrates all the possible stages involved in the POCT implementation and audit process. In practice some
of the implementation stages will merge although which stages will depend on the POCT device and service.




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Appendix A

1. Issue                                       2. Process       3. Action by       4. Responsible        5. Evaluated by
                                               Co-ordination                          for action
Cost benefit analysis (business                POCT Committee   Purchasing         Trust Management      Trust Management
case)                                                           Advisory Group
                                                                and POCT
                                                                committee
Risk Management                                POCT Committee   Trust Risk         Trust Management      Trust Management
                                                                Management
                                                                Group
Health & Safety                                POCT Committee   Trust Risk         Trust Management      Trust Management
                                                                Management
                                                                Group
Budgetary arrangements                         POCT Committee   Pharmacy           Trust Management      POCT committee

Maintenance                                    POCT Committee   POCT Co-           Trust Management      POCT Committee
                                                                ordinator                                Pathology
Training                                       POCT Committee   POCT coordinator   Trust Management      Trust Management
(including record of trained staff)                             Training Dept.
                                                                Key Trainers
Standard Operating Procedures                  POCT Committee   Pathology and      Trust Management      CPA (UK) Ltd.
                                                                POCT
                                                                Committee
Routine Operation                              POCT Committee   Users              Line Manager (e.g.    POCT committee/audit
                                                                                   Ward Sister through
                                                                                   Link Nurse)
Recording Results                              POCT Committee   Users              Line Manager          POCT committee/audit

Support                                        POCT Committee   POCT coordinator   Trust Management      Trust Management

Quality Control & EQA- internal                POCT Committee   Users              Trust Management      POCT committee
                     - external                                 POCT coordinator                         Pathology



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Appendix B

Blood Glucose Meters
       Roche Advantage III glucose meter.
      1. Standard Operating Procedure
      2. Training Competency Form
      3. Procedure for External and Internal Quality Control Testing

Blood Gas Analysers
       Roche Cobas b221 blood gas analyser
      1. Standard Operating Procedures.
      2. Training Competency Forms
      3. Procedure for External and Internal Quality Control Testing.

Hemocue Hb Analyser
     1. Standard Operating Procedure
     2. Training Competency Form
     3. Procedure for External and Internal Quality Control Testing.

Oximcom 3000 Oxygen Saturation Analyser
     1. Standard Operating Procedure
     2. Training Competency Form
     3. Procedure for External and Internal Quality Control Testing.

ACT Plus Analyser
     1. Standard Operating Procedure
     2. Training Competency Form
     3. Procedure for External and Internal Quality Control Testing.

Urine Pregnancy Testing
       Emergency Department
      1. Standard Operating Procedure
      2. Procedure for External Quality Control testing




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Appendix C
                                         Responsibilities of Users of POCT devices

No staff member must use any POCT equipment unless they are certified to do so.
No staff member may train another in the use of POCT equipment unless they are authorised to do so.
All staff members must use the equipment in a safe and responsible manner.
All staff members must have a unique identifier (password) where applicable.
No password must be shared with another staff member.
An accurate and up to date maintenance log must be maintained, signed and dated each day.
All staff members must satisfy the quality control (QC) requirements pertaining to the specific instrument.
All patient and QC results must be documented. Included with the results should be the operator's initials and
the date and time of the test.
All staff members operating POCT equipment will have up to date competency records.
In the event of an instrument failure, staff members will immediately notify the POCT Coordinator or if out of
hours, the laboratory (extension 4048).

                                       Responsibilities of Point of Care Co-ordinator

Works within the constraints of the Pathology laboratory service.
Is responsible for ensuring that all POCT is performed to the same standard as would be expected from
regular laboratory testing.
Identifies the types and locations of all POCT equipment within SHH. An electronic record of all equipment is
maintained.
Is responsible for ensuring that all of the SHH staff performing POCT, has current competency training and
documentation. Included is an awareness of health and safety issues pertaining to samples and equipment.
Is responsible for ensuring regular Quality Assurance (QA) is maintained and Quality Control (QC) samples are
analysed on POCT devices, with up-to-date documentation and history.
Is responsible for ensuring that adequate supplies of consumables and QC materials are maintained, to
ensure continuity of service.
Is responsible for troubleshooting of all POCT devices, with up-to-date documentation and history.

Discussion
All SHH staff members who perform a Point of Care Test must assume responsibility for the result(s) they
generate. In effect, for the duration of the test, they become a surrogate laboratory scientist, governed by the
same rules and strictures as laboratory workers. The SHH POCT Guidelines must be complied with. Non-
compliance may result in a disciplinary hearing.
Therefore it is in both the hospital's and the laboratory's interests to promote awareness of POCT: quality
assurance and quality control, analyser maintenance, ongoing training and competency testing are all matters
pertaining to POCT, which by definition involves both hospital and laboratory Quality Implementation (QI)
practices.
The SHH POCT Guidelines are available as a reference for QI. POCT issues such as competency documents,
audit trails, quality assurance and maintenance records may be investigated by accreditation authorities during
forthcoming certification process.

Erroneous results
If a patient was adversely affected by an incorrect POCT result, an investigation into the circumstances
surrounding the incident would occur. Procedures already well established within SHH would be used. POCT is
no different in this respect to any other enquiry that would be undertaken in similar circumstances.
Remember:
     Never share your ID or password with other staff members.
     Always sign and date any printouts or transcription of results

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        If a new staff member commences work, ensure they have the necessary POCT training from the
         POCT Coordinator or a credited staff member.
        Don't train new staff members yourself.
        Make sure your competencies are up to date.
References

Medical Devices Agency Device Bulletin: Management and Use of IVD Point of Care Test Devices; MDA
DB2002(03); March 2002.

Joint Working Group on Quality Assurance Point of Care Testing Guidelines: ACB News: May 1999; 433; 16-
23

Point of Care Testing: Ed Christopher Price and Jocelyn Hicks, Pub AACC Press, 1999.

Clinical Governance: Implications for point of care testing: D B Freedman, Ann Clin Biochem, Vol 139, No5,
Sept 2002, 421-423

Guidelines for implementation of point of care testing: International Federation of Clinical Chemistry (IFCC)
1999 (on line)

CPA New Standards: Clinical Pathology Accreditation (UK) Ltd. Can be downloaded from the CPA website
www.cpa-uk.co.uk

NCCLS Communications Standards: Connectivity Industry Consortium (CIC). Can be downloaded from the
CIC website www.poccic.org




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Description: POINT OF CARE TESTING (POCT) PROCEDURE