Cold chain incidents Learning Objectives Learning Outcomes Prevent

Cold chain incidents Learning Objectives Learning Outcomes Prevent future patient harm by applying To update colleagues about the consequences effective cold chain management policies of cold chain failure and procedures Know how to respond to a breach in the To review cold chain guidelines and promote cold chain, including when and who to consistent (best) practice escalate concerns to All colleagues will know: They have a duty of candour and legal responsibility to protect the public To understand the legal implications on When a PSD must replace a PGD practice when things go wrong When and how vaccines must be wasted / when and how they can be used after an excursion from the cold chain To clarify education and standards connected to administration of vaccines and medicines Where, at what level and how frequently to access education and how to document confirmation of competence

31 cold chain incidents added to Datix between 01. 04. 16 – 1. 03. 17 £ 124, 227. 39 worth of vaccines destroyed in West Yorkshire since 01. 06. 16 (NHS England). The most common reasons are: • Fridge failures • Fridges turned off • Vaccines expired £ 1, 000 per practice is spent on excess vaccine ordering by providers (Imm. Form) ü All NHS schedule wastage should be reported on Imm. Form ü All breaches in the cold chain should be recorded on Datix ü Breeches in the cold chain resulting in any vaccine wastage should be recorded via Immform and Datix and also to CQC if patents are recalled for vaccination

Serious incidents in Leeds In 2016 a serious incident was declared; the cold chain had been breached over a period of time. Approximately 500 patients were recalled A potential serious incident is being assessed and likely to be declared; a similar number of patients may need to be recalled

Do you know how to manage all these situations? Incident Description Vaccines placed on bottom shelf of fridge. Why might this not be a good thing to do? Expired vaccines given. What happens then? What happens in the event of a power cut that lasts 5 mins/ 3 hours/all weekend? What happens if a patient collects a vaccine from a chemist. How do we advise them in maintaining the cold chain? How do we ensure that vaccines are in date when patient arrives?

Incident Description Vaccines placed on bottom shelf of fridge. Why might this not be a good thing to do? Vaccines may freeze rendering them inactive and unusable. Vaccine should be stored with space between the vaccine and the refrigerator sides to allow for cold air circulation around the vaccine & ensure the correct temperature is maintained. Expired vaccines given. What happens then? The manufacturers cannot guarantee efficacy of the vaccination. Re-vaccination is often required. Practices should have a robust stock control system. What happens in the event of a power cut that lasts 5 mins/ 3 hours/all weekend? Establish time frame of failure. Isolate stock in another fridge & contact the manufacturer for further information on use/destruction of vaccines. What happens if a patient collects a vaccine from a chemist. How do we advise them in maintaining the cold chain? Patients need to be informed of the storage requirements & ideally collect the vaccine immediately before their administration appointment. It should be passed to the reception/nursing team at arrival. How do we ensure that vaccines are in date when patient arrives? Practices should have a robust stock control system & check all expiries prior to administration.

Incident Description Fridge turned off in error, what do I do? Fridge temperature recorded at 13◦ What is your process when vaccines are delivered to practice to maintain the cold chain? What happens if the fridge alarm sounds? What happens if I do not have a tiny tag in my fridge or any similar software to monitor temperatures of fridges?

Incident Description Fridge turned off in error, what do I do? Quarantine all stock in another fridge. Establish time frames of cold chain break. Check with manufacturer for further information on use/destruction of vaccines. Take steps to stop error again e. g. hardwire fridge/label plugs etc. Fridge temperature recorded at 13◦ Manufacturer’s recommended temperature range is +2˚C to +8˚C. Being exposed to higher temperatures can cause loss of potency. What is your process when vaccines are delivered to practice to maintain the cold chain? Reception team should be aware of importance of cold chain. Nursing team should be notified & the delivery refrigerated asap. What happens if the fridge alarm sounds? Check temperatures & duration of time outside range. Is it explainable e. g. cleaning? Move stock to another fridge & quarantine if necessary. Label fridge as ‘do not use’ whilst investigating. Ensure appropriate staff members are aware. What happens if I do not have a tiny tag in my fridge or any similar software to monitor temperatures of fridges? All fridges should have at least one maximum-minimum thermometer that is independent of mains power (as well as any integrated thermometer). Err on the side of caution – assume temperature out of range since last check.

• Good quality cold chain documentation • How tiny tags are used, alarms set and how are things recorded • How the team manage fridge temperature recording (training etc. ) • How to manage vaccine deliveries • Who to contact for support • Stock control/ordering /rotation/maintenance

Reception Supplier Clinical People at the top

A successful cold chain needs teamwork!

Contact the Regional Drug & Therapeutics Centre Medicines Information Department for an up to date template: Tel. 0191 282 4631 Fax. 0191 261 8839 E-mail. rdtc. mi@nuth. nhs. uk

Useful contacts Internal practice colleagues (Nursing team, Practice Manager, GPs) Locality leaders / Networks CCG colleagues: NHS Leeds North CCG NHS Leeds S&E CCG NHS Leeds West CCG Cath Johnson cathjohnson@nhs. net 07906 310541 Lead PC Nurse Andrea Mann andrea. mann@nhs. net 07590 028637 Lead PC Nurse Gil Ramsden gil. ramsden@nhs. net 0113 8435431 Lead PC Nurse LENOCCG. prescribingteam@nhs. net medicines. leedssouthandeast@nhs. net medicinesleedswest@nhs. net Tel: 0113 8432937 Tel: 0113 8431618 Tel: 0113 84 35480 Val Stewart valerie. stewart@nhs. net City Wide Governance Team Public Health England colleagues: Sarah Mc. Murray sarahmcmurray@nhs. net 0113 825 2734 Leanne Riley leanne. riley@nhs. net 0113 825 3227 Education provider - Leeds Beckett University: https: //www. leedsbeckett. ac. uk/short-courses-and-cpd/continuing-professional-development-cpd/clinical-skills/ Professional indemnity providers

Datix incident reporting system allows CCGs to monitor incidents and trends to enable quality improvement Immform is the website used to order national vaccinations and report vaccine wastage CQC need to be notified if an incident occurred and results in significant harm

1. Go to Vaccine Supply 3. Add incident and complete details of the incident in the boxes and record the number of vaccines wasted 2. Go to Stock Incident

Example of IMMFORM incident report What needs to be recorded? • Details of incident • Location, date and time • Vaccines stored • Quarantined vaccines • Tiny tag details • Advice received • Datix completed • Details of disposed vaccines • Reason for incident if known • Actions taken

Do you… • Know how to report an incident or near-miss in practice? • Get involved and own cold chain incidents? • Investigate and put your findings on Datix? Access a PC and type in the following link to get to an incident form: https: //leedswestccg. datix. thirdparty. nhs. uk/Live/index. php

Datix reporting process Incident / Near-miss occurs Record on Datix 1) Lessons learned & Actions shared actions identified in across the city practice Investigate to ensure 2) CCG uses SEA completed system wide information to analyse learning themes/trends Must complete final 2 stages to ensure the incident does not reoccur

Example of a DATIX incident report

Recording the incident

Recording the learning

‘Off-License’ Vaccines An ‘Off License’ vaccine is A vaccine that for what ever reason has breached its license, for example: was stored in a fridge that went out of normal/safe storage range (+2 to +8 Degrees C) but deemed safe and effective from clinical trials performed by the manufacturer It should never be administered under a PGD It should always be administered under a PSD The patient receiving the vaccine should always be made aware it is an off license vaccine but still safe to use

PSD Vs PGD Patient specific Direction - PSD Patient Group Directive - PGD Used for individual patients only Used only by registered health care professionals enabling them to administer vaccines to a group of patients meeting specific criteria. Used for vaccines given ‘Off License’ Must be written & signed by prescriber either by hand or electronically Must contain: patient name & DOB, route of administration, dose, frequency. Ideally also a start and finish date. Used by both registered and nonregistered health care professionals Cannot be used for administration of ‘off License’ Products Leeds PGDs can be found on NHS Leeds South and East CCG website https: //www. leedssouthandeastccg. nhs. uk/pgd-hosting-page/

Duty of Candour It means be open and honest when things go wrong https: //www. nmc. org. uk/standards/guidance/the-professional-duty-of-candour/

Whistleblowing If you notice something that isn't right – Tell someone! Raise your concerns in confidence so this can be appropriately investigated and dealt with. Examples: Poor clinical practice or other malpractice which may harm patients Failure to safeguard patients Maladministration of medications Untrained or poorly trained staff Lack of policies creating a risk of harm Who to? Internally: Managers or senior clinicians (if possible) Externally: CCG Nurse leads, NHS England, NMC

Vaccination Training Availability Leeds Beckett University hold ‘New Starter’ and ‘Immunisation Update’ sessions New starter training dates Wednesday 10 May; 9 am - 4 pm Immunisation updates Thursday 27 April; 9 am -12 noon Thursday 8 June; 9 am – 4 pm Friday 16 June; 1 pm - 4 pm Thursday 13 June; 9 am – 4 pm Thursday 20 July; 9 am – 12 noon To book: https: //www. leedsbeckett. ac. uk/short-courses-and-cpd/continuingprofessional-development-cpd/clinical-skills/