Roche Cobas point of care device SOP

1 Aim

To provide clear written instructions to colleagues so that they can safely complete the required blood testing for patients on the severe mental illness (SMI) register as part of an annual physical health check. Patients are required to provide a finger prick blood sample which the device will analyse and produce a test result during the appointment.

2 Scope

This procedure applies to any clinical colleague who will be completing physical health checks for patients on the severe mental illness (SMI) register.

3 Link to overarching policy

The overarching policy for this standard operating procedure is the medical devices management policy.

Other associated documents that should be read in conjunction with the procedure are:

For Cobas documents, see appendix A.

4 Procedure

4.1 Colleague training

The device can be used by any suitably trained member of a trust Healthcare team as part of their clinical activity. Training on device use will be delivered by the manufacturer Roche via their monthly online training course, or via a peer within the clinical team. Peer trainers must have received training delivered by the manufacturer. For day-to-day use of the device, users will refer to their training on the device and the manufacturer’s user manuals embedded in this document.

Colleagues will need to be competent in:

operating the device
taking a sample
testing the sample
interpreting the results
safe disposal of waste
quality control
device maintenance

Colleagues are responsible for evaluating their own level of competence and should access refresher training if they consider this is needed. Colleagues will be required to undertake refresher training if there is an issue with their use of the device.

Each team will need to keep a local list of colleagues who are trained to use the device.

4.2 Testing samples

Colleagues should follow the instructions on testing blood samples for lipids, and HbA1c provided in their training and reference the detailed guidance in the operator manual. Colleagues should ensure they have the standard blood collection equipment:

safety Lancets, disposed of in a yellow lidded sharps container
gauze pads
clinical waste disposal container, each area will need to undertake an assessment of which type of container they will use within their clinical setting depending on the processes they undertake locally
for the blood sample disc, community colleagues will need a clinical waste bag (yellow and black strip (tiger stripe)) unless the individual has a blood born virus then use an orange waste bag

Colleagues should explain the process to the patient and gain their consent to proceed with the blood test, including the sample from a finger prick, and give them reassurance throughout. Hands must be decontaminated and personal protective equipment (PPE) donned before collecting the sample. The patient’s hands should be washed with soap and water and dried well before obtaining the blood sample. Following the sample collection procedure PPE should be removed and hands decontaminated.

4.3 Interpretation and recording of results

The device will display the test results on the LED screen. Users should refer to clinical guidance on results which are outside of normal range.
Lipids, blood test within normal range if Chol/HDL (ratio) is 5.0 mmol/l or less.

Hb1Ac, blood test was within normal range if HBA1c is less than 42 mmol/mol.

4.3.1 Recording results

Results should be recorded in the patient’s clinical record on SystmOne as part of their clinical entry, and in the cardiometabolic assessment tool in the case of Lipids (cholesterol section) and HbA1c (diabetes section).

4.3.2 Escalation of abnormal results

Patients under the care of the Primary Care Network Mental Health team, abnormal results are escalated to the patients general practitioner (G.P) via the tasking system on the patient’s electronic record.

Patients under the care of secondary mental health services, abnormal results are escalated to the patient’s responsible clinician within the service.

4.4 Device cleaning and infection prevention and control clean using Clinell universal wipes

The inside and outside of the instrument must be kept clean at all times. If there is a spillage, clean it immediately. To guarantee the required standards of cleanliness, perform the following cleaning tasks regularly and follow the infection control procedures as described in the infection prevention and control manual when handling the instrument:

leaning the outside of the instrument
cleaning the inside of the instrument
cleaning the touch screen
cleaning the barcode sensor window

The device should be cleaned after each use as per manufacturer’s instructions and adhering to IPC guidance.

Refer to the manufacturer’s guidance for cleaning outside and inside of the device if it becomes contaminated with blood.

Colleagues using the device are advised to wear PPE (gloves and apron). Any blood contaminated spillage (though this is considered a rare event by the manufacturers) should be dealt with as documented in the trust’s blood and body fluid spillage procedure.

4.5 Waste disposal

All used discs must be disposed into the yellow and black strip (tiger stripe) waste bag unless the individual has a blood born virus then use an orange waste bag. Safety lancets must be disposed of in a yellow lidded sharps container.

4.6 Equipment failure

Colleagues using the equipment will follow the trust procedure for incident reporting on Ulysses:

the equipment should be quarantined and labelled as ‘Faulty, Not In Use’ and dated for when the failure occurred
colleagues should contact Roche via 08081 008010 or email burgesshill.tsgpm@roche.com to determine the cause of the failure. If they are unable to rectify the fault with advice over the telephone, they will need to get support from a service engineer from Roche, who provide a 5-year warranty from date of purchase
during equipment down time, teams should see if a device can be shared with another service or utilise phlebotomy methods of blood collection and laboratory analysis

4.7 Calibration or optical check

The optical check is designed to check the optical function of the instrument. For this test, the optical check disc supplied with the instrument is to be used. If the optical check disc is lost or damaged, please order a new one from your Roche representative. If the test passes, the optical functions of the instrument are considered to work normally. The optical check (which takes a few seconds) should be performed in the following circumstances, before the instrument is used for patient testing for the first time:

on each visit for community-based use, and at the beginning of each session for clinic-based use
if a message for optical check lockout is displayed (the instrument can be configured to block patient testing if there is no valid result for the optical check)
if an error message concerning the optical system is displayed
if you want to check the optical function of the instrument
after impact on the instrument (for example, after accidentally knocking the instrument)
each time the instrument is moved
after the instrument has been transported from one location to another, before patient testing is initiated in the new location

Please refer to the user manual for more details and instructions on performing a test.

Each team will need to develop a local process for monitoring calibration checks.

4.8 Quality control (QC)

QC measurements are performed to ensure that the instrument and the technique used in testing give accurate results of patient tests.
Performing patient tests when the current control test results are no longer valid may lead to incorrect patient results.

4.8.1 Internal QC

Internal QC for the device is via the liquid QC tests. Teams will need to ensure they have these stocked for use. A different liquid QC test is needed for lipid, and HbA1c, depending on what the device is being used for. A liquid QC test is performed in the same manner as a blood sample test, using a specific test disc and test solution. Please refer to the user manual for more details and instructions on performing a liquid QC test.

Liquid QC tests should be run in the following circumstances:

Before using the instrument for patient testing for the first time
at the beginning of every month
when using a new QC solution vial for the first time
when using the first disc of a new lot
if questionable test results are displayed repeatedly
if you wish to test the performance of the instrument
if a previous control test is out of range

Each team will need to develop a local process for monitoring this and capturing the results.

The following information is stored for every liquid QC test:

liquid QC test result
lot number of the QC solution
operator ID (if configured)
level of control solution (level 1 or level 2)
lot number of the test disc
time and date of test
comments (if entered)
out of range measurements

The measured value should be within the acceptable limits stated for the control material.

If the result obtained for the control is outside the acceptable limits, make sure that:

patient samples are not analysed until control results are within acceptable limits
the control vial has not passed its expiry date
the control vial has not been open past its use date

If the device fails a liquid QC test:

retest the control material
retest the control material using a new control vial
contact point of care testing for advice before analysing patient samples

4.8.2 External quality assurance proficiency testing

Proficiency testing should be undertaken on an annual cycle, with the first one within the first 12 months of the device’s use.

Proficiency tests are run on samples whose values are unknown to the operator performing the test. These samples are provided by an outside source, and the results should be forwarded to the appropriate source after completing the test. The supplied samples are treated in the same manner as regular patient samples.

Proficiency testing provides another means to verify that your technique, reagents, system, and testing performance are as they should be. Proficiency tests should be performed for each of the patient tests used on the device.

Please refer to the user manual for more details and instructions on performing a proficiency test.

5 Appendices

5.1 Appendix A Manufacturer’s instructions

Document control

Version: 1.
Unique reference number: 1060.
Date ratified: 5 September 2023.
Ratified by: Clinical policy review and approval group.
Name of originator or author: PCN mental health service manager.
Name of responsible individual: Executive director of nursing and AHP.
Date issued: 2 October 2023.
Review date: 31 October 2025 (New document).
Target audience: All colleagues undertaking annual SMI physical health checks.
Description of changes: New SOP.

Page last reviewed: May 07, 2024
Next review due: May 07, 2025

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