STANDARD OPERATING PROCEDURE

Cardiovascular risk assessment for the NHS Health Check service

STANDARD OPERATING PROCEDURE

Cardiovascular risk assessment for the

NHS Health Check service This document is intended to guide all providers with setting up a service to provide the risk assessment service for the NHS Health Check. These procedures apply to all providers of a service. The procedures cover the measurement and assessment of cardiovascular risk factors in adults aged between 40-74 without a previous diagnosis of diabetes, stroke, heart attack, angina and lipid disorders. CONTENTS

Page 1. Operator Training 3

2. Vaccination 3

3. Premises 3

4. Equipment 4

5. Equipment quality procedures 4

6. Documentation 4

7. Confidentiality 5

8. Patient consent 5

9. Clinical governance 5

10. Health & safety 5

11. Waste 5

12. Service provision process 6

13. Communication of risk 6

14. Referral thresholds 6

15. Lifestyle advice 6

16. Appendices

Appendix 1 Measurement of cholesterol 8

Appendix 2 Measurement of BMI 9

Appendix 3 Measurement of blood pressure 10

Appendix 4 Risk assessment management pathway 11 & 12

Appendix 5 Quality assurance records 14

Appendix 6 Dealing with emergencies 15

Appendix 7 Staff responsibilities 16

Appendix 8 Infection control 17

1. Operator Training 1.1 All operators must have read and understood this Standard Operating

Procedure 1.2 All Operators must be competent to provide the Service 1.3 All Operators must have been trained to have a: • basic knowledge of Nature of Vascular Risk • background to Cardiovascular Disease 1.4 All Operators must have been trained and certificated to use the equipment

chosen. 1.5 Those involved in taking lipid measurements must be able to: • take finger prick blood samples and understand all the associated health

and safety issues • follow the operating instructions of the device being used, and be aware of

the consequences of improper use • be able to undertake the appropriate calibration and quality control

processes • be able to interpret the results (using the Joint British Societies charts in the

back of the BNF or alternative risk analysis tool), know the limitations of the results and be able to explain the results to patients.

1.6 Those involved in taking BP measurements must be able to: • measure blood pressure using the appropriate technique • follow the operating instructions of the device being used • interpret BP measurements • explain the results to patients • maintain comprehensive records 2. Vaccination 2.1 All Operators are recommended to have up to date Hepatitis B cover. 3. Premises 3.1 The area used for the Health Check service must be large enough to

hold the necessary equipment and have adequate access to facilities such as running water or hand washing facilities and a computer terminal.

3.2 Blood monitoring must take place in an area designated for this purpose and there must be facilities for washing hands and disposing of clinical waste including sharps.

3.3 Equipment and consumables must be stored according to manufactures guidelines.

3.4 The area used must comply with NHS infection control standards. 3.5 The Health Check service area should reflect a professional image and

aural and visual privacy must be considered 3.6 The Health Check must not be carried out in any area where food or drink is

consumed.

4. Equipment 4.1 All equipment used must be CE marked, fit for purpose and must have been

externally accredited or validated. 4.2 For measuring blood pressure, a device that has been validated to the British

Hypertension Society (BHS) standard must be used 4.3 Blood pressure measuring devices used must be properly validated,

maintained, and regularly recalibrated according to manufacturers’ instructions. 4.4 The Lipid analyser used must be CE marked under the InVitro Diagnostic

Medical Devices (IVD) Directive. For independent information on individual devices the NHS Purchasing and Supply Agency (PASA) publishes buyer’s guides on devices on their website http://www.pasa.nhs.uk

4.5 Lancing devices used to obtain finger-prick blood samples must be a single use disposable system or designed for multiple patient use. [Lancing devices intended for personal use will not be used when carrying out testing and screening services]

4.6 All consumables must be stored in accordance with the manufacturer’s instructions and batch numbers and expiry dates should be recorded.

5. Equipment Quality Procedures 5.1 The Lipid near patient testing device will be quality checked on a locally agreed

regular basis, by following the guidelines for quality assurance in accordance with the manufacturers instructions supplied with the device.

5.2 Internal quality control (IQC) procedure will be followed by the analysis of an appropriate control material (supplied by the manufacturer of the device), providing reassurance that the system is working correctly. The results of the IQC must be recorded appropriately and performed at an appropriate frequency.

5.3 External quality assessment (EQA) of samples with unknown values from an external source will be performed on a scheduled basis. This will be operated through dedicated EQA providers, such as the UK National External Quality Assessment service or the local hospital laboratory.

5.4 All QA results, faults, repairs and maintenance must be documented and held by the operator of the Health Check service.

5.5 Adverse incidents involving medical devices will be reported to the manufacturer and to the MHRA.

6. Documentation 6.1 Full records of the NHS Health Check Service will be maintained. 6.2 Patient details must be stored, electronically or otherwise, along with their

consent forms, measurements and any recommendations made. 6.3 Record keeping and data transfer methods will be agreed with the PCT,

depending on the preferred method of in the area. Whichever record system is used it is important that data exchange issues are considered to minimise the risk of repeated checks on the same patient.

7. Confidentiality 7.1 All information received, stored and transferred concerning patients will be kept

confidential. The Data Protection Act and the NHS Code of Confidentiality will be considered.

8. Patient Consent 8.1 Written consent of the patient must be sought before commencement of the

test and recorded on an appropriate record form. 9. Clinical Governance 9.1 Operators must have undertaken the required training for the Service, which

includes reading and understanding the Standard Operating Procedure and be trained on the proper use of all equipment used to provide the Service.

9.2 To ensure that equipment is operated correctly and functioning accurately to ensure that results are consistent and accurate. Operators must complete the manufacturer’s quality procedures prior to starting the clinic

9.3 All records (paper and electronic) must be completed in accordance with this SOP.

10. Health & Safety 10.1 All staff involved must have had adequate training to ensure their competence

with the equipment for blood sampling an the procedures to be used in the event of spillages and disposal of waste.

10.2 All staff who have direct contact with any blood sampling procedure should be immunised against Hepatitis B.

10.3 Local infection control policies and an infection control audit will be completed.

10.4 Consideration will be given to the Control of Substances Hazardous to Health (COSHH) regulations, and a risk assessment of the screening process carried out. Any risks identified will be documented and consideration given as to how these risks could be minimised.

11. Waste 11.1 Arrangements must be made with a waste contractor for disposal of clinical

waste consisting of used gloves or aprons, blood, swabs or dressings. 11.2 Needles or finger pricking devices or lancets will be disposed of immediately in

suitable sharps containers. These containers will be kept away from the public but accessible to staff when needed.

11.3 Blood contaminated waste will be disposed of in approved containers which

should be stored in a designated area which is safe and secure.

12. Service Provision 12.1 The following process must be followed to adequately provide the NHS Health

Check Service: • Direct the patient to the designated consultation area. • If the operator is with another patient, give the patient an estimate of how

long he/she is likely to have to wait. • Ask the patient to ensure that any mobile phones are switched off to avoid

potential interference with the measuring devices. • Explain the process to the patient and the tests and measurements that

you will be taking. • Ask the patient if they are taking any medicines. • If the patient is ineligible for the cardiovascular risk assessment explain the

reasons and refer for further help and guidance as necessary 12.2 The patient check will be performed as specified in the assessment form. 13. Communication of risk 13.1 In order to inform the person of the results of the risk assessment the following

steps will be undertaken : • Assess the patient’s results and calculate their CVD risk using the locally

agreed risk evaluation tool • Explain the results to the patient and discuss their calculated CVD risk.

Take care not to alarm the patient. • Provide the patient with a written copy of their results and their calculated

CVD risk. 14. Referral Thresholds

Patients should be referred according to the risk assessment management pathway (Appendix 4) 15. Lifestyle Advice 15.1 Persons at moderate risk should be provided with healthy lifestyle advice and

advised to return for a further risk assessment every 5 years. They will be signposted accordingly:

• All patients, even those at low risk, should be given advice to help them reduce their CVD risk further. This should include advice on physical activity, weight reduction, a healthy diet, relaxation and limiting alcohol and salt intake.

• Signpost to the online NHS Mid life Lifecheck tool (www.nhs.uk/lifecheck) which provides further lifestyle advice for people aged 45-60.

• Offer smoking cessation advice to people who smoke and are interested in stopping. Signpost to the local NHS Stop Smoking Service.

• Offer weight management advice to patients if applicable and signpost to local weight management services.

• Encourage patients to eat a healthy diet (i.e. increase fruit and vegetable

intake (“5-a-day”) and lower intake of saturated fat. Two portions of fish should be eaten each week, including a portion of oily fish

• Encourage patients to take regular physical activity such as swimming, cycling, jogging, dancing, brisk walking, or anything that causes mild breathlessness. At least 30 minutes’ exercise, at least five times a week, is recommended. Some people may be suitable for referral for exercise on prescription or other local schemes

• Advise to cut back on alcohol. Men should limit their alcohol intake to 3-4 units per day, women should limit their intake to 2-3 units per day. Everyone should avoid binge drinking.

Appendix 1 Measurement of cholesterol profile Framingham requires cholesterol to be measured as total serum cholesterol (TC) and high density lipid cholesterol (HDL). QRISK2 requires the ratio of total serum cholesterol to high density lipoprotein cholesterol (TC/HDL ratio) • Wash hands. • Wear the personal protective equipment provided (gloves, apron etc) • Switch the measuring device on in accordance with the manufacturer’s

instructions. • Follow the manufacturer’s instructions for preparation of the meter. • Disruption should be minimised as far as possible when carrying out the

measurements. Obtaining a finger prick blood sample • Use the middle finger of the non-writing hand. If an insufficient blood sample is

obtained, another finger can be used. • The hand should be warm and relaxed to ensure there is sufficient blood

volume for the sample. • Clean the finger with an alcohol swab and dry thoroughly with sterile gauze. • Using a single use lancet, perform a firm puncture on the side of the finger,

deep enough for blood to flow freely. • Immediately dispose of the used lancet in the sharps bin to minimise the risk of

sharps injuries. • Wipe off the first large drop of blood with a sterile dressing or gauze because

the first drop can contain tissue fluid and will not give a representative blood sample.

• Keeping the patient’s hand below heart level, squeeze the finger gently until a second large drop of blood forms.

• Depending on the analyser used, collect blood into a capillary tube (which is used to dispense the recommended volume of blood for testing) or guide the patient’s finger to the test strip.

• Wipe off any excess blood from the finger and get the patient to apply pressure with the sterile dressing or gauze until the bleeding stops.

• Cover the puncture wound with a waterproof dressing. • Dispose of used swabs, gauze, test strips or cassettes and personal protective

equipment in the appropriate clinical waste container. Record keeping • Record the identity of the person performing the test. • Record the lot number and expiry date of the reagent strip or test. • Record the lipid levels and other measurements in the patient notes or other

relevant place together with any recommendations made. • Give a copy of the results to the patient.

Appendix 2 Measurement of BMI The DH recommends that the following best practice guidelines should be followed and considered alongside any local guidelines or policies. Height measurement • The height should be measured with the base plate on a firm and level surface,

preferably with a perpendicular surface to ensure the measure is vertical. • Ask the individual to remove their shoes and stand on the base plate with their

back to the measure. • If the subject has a ponytail or other hair dressing that may affect the result, ask

them to remove it. • Ask the subject to stand as tall and straight as possible with feet together and

arms loosely at the side and shoulders relaxed. • The head should be placed in the Frankfurt Plane, such that an imaginary line

joining the upper margin of the external auditory meatus and the lower border of the eye is horizontal. (Ensure that the subject is looking straight ahead with the back of their head against the plate.)

• Lower the head plate so that it gently rest on the highest part of the subject’s head. Press down to flatten hair.

• Read the height measurement form where the arrow points to on the measure to the nearest cm.

Weight measurement (in metric) • The individual should remove their shoes and coat and heavy outwear for this

test. • Ensure scales have been calibrated/serviced within the specified time range. • Set scale to ‘0’. • Ask the individual to step on scales. • Wait for weight to register properly. • Record weight (in kg). Calculating the BMI Take the weight in kilograms (kg) and divide it by the height in meters (m). Then divide the result by the height in metres (m) again. A useful online BMI calculator can be found at: hhtp://www.nhs.uk/Tools/Pages/Healthyweightcalculator.aspx?r=1&rtitle=interactive+tools+-+BMI+tool .

Appendix 3 Measurement of blood pressure This procedure covers the measurement of blood pressure in adults without diabetes using an automated sphygmomanometer • The procedure should be fully explained to the patient and patient consent

obtained and recorded before any readings are taken. • Ensure the device has been calibrated recently. • If the patient is having a repeat BP measurement, try to ensure that it is carried

out at the same time of the day as the previous one where possible. • Thick clothing such as coats and jumpers should be removed. Check that the

monitor can work through thin clothing such as a shirt. If so, sleeves should not be rolled since they can restrict blood flow.

• Ideally, standardise the environment when measuring blood pressure. Provide a relaxed, temperate setting, with the person quiet and seated with their arm outstretched and supported in a horizontal position in line with mid-sternum.

• The patient should be sitting with feet flat on the floor. Legs should not be crossed. • Ensure the hand is relaxed, and avoid talking during the measurement procedure. • Measure the circumference of the bare upper arm at the midpoint between the

shoulder and the elbow in order to check that the cuff is an appropriate size. • Using the wrong size cuff is a common source of error in BP measurement. • Wrap the cuff around the middle of the upper arm at the level of the heart as

denoted by the mid-sternum. Not having the cuff at the same level as the heart is a common source of error in BP measurement.

• The cuff should be placed over the upper arm so that the tube inlet is positioned over the brachial artery.

• Fasten the cuff comfortably without it being too tight (it should be possible to fit two fingers between the cuff and the arm). The bladder should encircle at least 80% of the arm but not more than 100%.

• Switch the machine on and take the measurement in accordance with the manufacturer’s instructions

• Initially measure the blood pressure in both arms, as there can be a large difference between arms (greater than 10 mmHg). Use the arm with the higher values for subsequent measurements.

• If the first measurement exceeds 140/90 mmHg then a second confirmatory reading should be taken at the end of the consultation if practicable.

• You may need to consider “white coat” effect when the blood pressure is increased as a reaction to the healthcare setting or healthcare professional measure the BP.

• Record the results and the identity of the person performing the test. The BHS also has a useful poster on taking accurate blood pressure measurements to remind you of the key points. http://www.bhsoc.org/how_to_measure_blood_pressure.stm.

Risk Assessment Management pathway

Diabetes filter

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Vascular Risk Assessment Management Guidance The information below is to aid assessors in making appropriate referrals to the patient’s GP in the light of patient testing and screening level results. Clinical judgement should be used by assessors, but it is important that the GP receives a clinically appropriate referral. Referral definitions Patients should be advised that for routine or prompt referrals they may be seen by the GP or Practice Nurse according to practice policy. Routine referral = advise patient to make an appointment to see their GP within the next 14 days. Urgent referral = advise patient to make an appointment to see their GP within the next 7 days. Signpost = Provide patient with lifestyle advice and take away information and refer to services in the community. Health Parameter Level Action Absolute CVD risk score (JBS)

20% Routine referral to patient’s GP.

Where the absolute risk score is lower than 20% but there are levels indicated below on individual parameters then the following levels and advice applies: BMI = or > 30 Do not refer to GP. Provide lifestyle advice

and signposting. Blood Pressure = or >200/110 Take second reading a minimum of an hour

later. If second reading is = or >200/110 then immediate referral to GP or out of hour service.

= or >160/100 Arrange and take three separate readings on separate days. If third reading is = or >160/100, then routine referral to GP.

Cholesterol = or >7mmol/l not fasted

Arrange and take second reading, the patient having fasted for 12 hours. If second (or fasted) reading is >7mmol/l arrange a third reading 8 weeks later. If third reading is = or >7mmol/l then routine referral to GP.

TC/HDL ratio = or >6 Routine referral to GP. Glucose = or >7mmol/l not

fasted Arrange and take second reading, the patient having fasted for 12 hours. If fasted reading = or>7mmol/l then routine referral to GP

Random sugars = or >11.1mmol/l

= or >11.1mmol/l then routine referral to GP.

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Appendix 5

Quality assurance records

• The blood pressure measuring device and cholesterol meter used by this operator is subject to regular maintenance in accordance with the manufacturer’s instructions

• Records of regular maintenance are kept ………………………………………………. • The blood pressure measuring device and cholesterol meter used by this operator

is subject to regular internal and external assurance checks to ensure accuracy. • QA records are kept ……………………………………………………………………….. • Records of repairs to and maintenance of equipment are kept……………………….. ……………………………………………………………………………………………….. • Recalibration is undertaken in accordance with manufacturer’s instructions. • Recalibration records are kept …………………………………………………………… • In the event of device failure or breakdown, contact the manufacturer on ………….. .............................................. • For adverse events associated with medical devices or in-vitro diagnostic tests,

contact the MHRA

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Appendix 6 Dealing with emergencies In the event of a patient fainting:- • Contact the nominated first aider • Lay the patient flat with the legs raised • Loosen restrictive clothing around the neck • Check airway, breathing and pulse • If patient has vomited, put in recovery position to prevent choking • If a full recovery does not occur, contact the emergency services In the event of excessive bleeding from the finger prick:- • Contact the nominated first aider • Apply pressure with a clean dressing for at least five minutes • Raise the hand up to decrease blood flow to the finger • If bleeding does not stop, contact the emergency services • Dispose of bloodstained dressings etc with other clinical waste In the event of a needle stick injury:- • Any needle stick injury should be reported to the pharmacist immediately. • Gloves, aprons and forceps should be used before moving the sharp. • Encourage the wound to bleed and wash it with running water. • Keep the offending sharp for analysis. • The affected person should attend the nearest Accident and Emergency

Department immediately. • Make a record in the accident book In the event of blood spillage in the consultation area:- • Do not touch the spillage • A fully trained member of staff should retrieve the spillage kit from its storage

place. • Cover any existing cuts and grazes with waterproof plasters • Put on a pair of strong gloves, apron and/or mask • Treat the spillage with the solidifying and/or disinfecting powder kept in the spillage

kit. • Place the solid or semi-solid waste in a bag • Place this bag into the waste container for healthcare waste • If necessary, the area should be cleaned • Dispose of the gloves, mask and apron • Wash hands thoroughly • Reorder another spillage kit In the event of a sharps container spillage in the consultation area: • Politely ask the patient to vacate the consultation area until you have dealt with the

spillage • Do not touch any needles or lancets

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• Put on strong, protective gloves and make sure you are not wearing open-toed shoes

• Use a pair of tongs or forceps to return the used equipment to a sharps container. • Clear away the equipment as quickly and safely as possible • Check the area thoroughly for loose sharps • Clean the affected area thoroughly with a disinfectant

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Appendix 7 Staff responsibilities (list names and dates) CVD risk assessment service coordinator:…………………………………………………… Staff member responsible for ensuring regular calibration checks and maintenance of lipid measuring equipment: …………………………………………………………………… Staff member responsible for ensuring regular calibration checks and maintenance of lipid measuring equipment: ………………………………………………………………… Staff who have had Hepatitis B vaccinations:……………………………………………….. …………………………………………………………………………………………………………………………………………………………………………………………………………….. Staff trained in obtaining blood samples for lipid screening: ……………………………….. ……………………………………………………………………………………………………… ……………………………………………………………………………………………………… Staff trained and assessed as competent in CVD risk assessment: ……………………….. ……………………………………………………………………………………………………….……………………………………………………………………………………………………... Staff trained and assessed as competent in blood pressure measurement: …………….. …………………………………………………………………………………………………………………………………………………………………….……………………………………… Staff trained and assessed as competent in measuring height and weight and calculating BMI:…………………………………………………………………………………………………………………………………………………………………….…………………………………. Staff trained and assessed as competent in providing the results to the patients and counselling on lifestyle advice: …………………………………………………………………. …………………………………………………………………………………………………………………………………………………………………….……………………………………… Staff trained to deal with spillages and loose sharps: ........................................................ ……………………………………………………………………………………………………………………………………………………………………………………………………………… Staff trained to deal with emergencies such as fainting: …………………………………….. ……………………………………………………………………………………………………………………………………………………………………………………………………………… First aiders: ……………………………………………………………………………………….. ………………………………………………………………………………………………………

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Appendix 8 Infection Control Audit A copy of this audit should be completed and attached to your SOP together with a copy of the local infection control policy (available from your PCT). • Staff have been trained in hand washing techniques including removing wrist and

hand jewellery before hand washing • Staff wash their hands before and after contact with each patient • Staff cover any wounds and lesions with waterproof dressings • Staff have access to liquid soap, running water, disposable paper towels and

alcohol hand rub • Disposable gloves and aprons are worn for testing and cleaning equipment and

spillages. • Spillages of blood are cleared up promptly using a spillage kit • Staff have been trained on emergency procedures including needle stick injury • Staff have been trained on safe disposal of sharps and waste contaminated with

body fluids • Sharps containers are available in the area used for the service • Testing of body fluids is carried out only in the designated testing area • The designated testing area is regularly cleaned and disinfected