NHS Pharmaceutical Aseptic Services Group
Guidance on implementing the Health and Safety (Sharp Instruments in Healthcare) Regulations 2013
in NHS Pharmacy Aseptic Services
Appendix to Guidance
The following pages are an editable version of the Appendix to the above guidance, issued May 2014. They are made available for use in NHS aseptic services units, without copyright, control, or any implication. If used locally, they should be used as a guide to inform local risk assessment. Since there is no write-protection on this version, users should ensure that all text in the document meets their needs.
Peter Rhodes, May 2014
On behalf of NHS Pharmaceutical Aseptic Services Group
References
1. The Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 http://www.legislation.gov.uk/uksi/2013/645/made#f00002 (accessed 24.04.13)
2. Health Services Information Sheet 7 - Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 - Guidance for employers and employees, March 2013 http://www.hse.gov.uk/pubns/hsis7.pdf (accessed 24.04.13)
3. Council Directive 2010/32/EU of 10 May 2010 - Implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:134:0066:0072:EN:PDF (accessed 24.04.13)
4. A report on HSE’s consultation on proposals to implement European Directive 2010/32/EU on preventing sharps injuries in the hospital and healthcare sector, HSE, 21.12.12. http://www.hse.gov.uk/consult/condocs/cd244-analysis.pdf
5. Further guidance on the EU Directive, HSE http://www.hse.gov.uk/healthservices/needlesticks/eu-directive.htm
6. The Management of Health and Safety at Work Regulations 1999 http://www.legislation.gov.uk/uksi/1999/3242/regulation/3/made
7. Risk Management, HSE http://www.hse.gov.uk/risk/index.htm
8. National Patient Safety Agency Risk Matrix for Risk Managers http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/risk-assessment-guides/risk-matrix-for-risk-managers/ Accessed 26/07/2012
9. Sharps Safety – RCN Guidance to support the implementation of the Health and Safety (Sharp Instruments in Healthcare Regulations) 2013, Royal College of Nursing 2013, http://www.rcn.org.uk/__data/assets/pdf_file/0008/418490/004135.pdf (accessed 29.04.14)
This guidance is published by the NHS Pharmaceutical Aseptic Services Group, and is available at http://civas.co.uk
PASG Guidance on Implementing the 2013 Sharps Regulations Page 1 of 8
Appendix 1
Example for adaptation following local risk assessment
Risk Assessment Form
Section(s) this assessment relates to:
Chemotherapy / ü / Radiopharmacy / ü / Nuclear Medicine / ü / [other] / ûTPN / ü / CIVAS / ü / Quality Control / ü / [other] / û
Document History
Document version / Date implemented / Changes from previous version / Issue location1 / New document
No / Risk Identification / Risk Analysis / Existing Controls / Evaluation 6 /
Rationale for the process / Consequence of not performing the process / Remaining Hazard / Likeli-hood 6 / Conse-quence / Risk score
(LxC) 6 / Action /
1a to 1g / Use of unprotected sharps in preparation & QC processes / · Aseptic process must be undertaken using closed systems of work 5.
· Vials and infusion bags are widely used for storing and presenting drugs for administration.
· In order to maintain the closed system, access to these containers is via a self-sealing rubber (etc) septum, using a needle.
· Non-sharp plastic spikes and blunt-ended needles have been employed where possible but are not suitable for these remaining processes because they leave a large, non-sealing hole in the septum.
· Most safer-sharp devices are intended for single use during administration and are not available for preparative use
· Needles will not be microbiologically contaminated since products are sterile and handled in an aseptic environment; preparative staff will not be administering the prepared doses to patients.
· Needle-stick injury due to un-sheathed needles in sharps bin / · Vials and infusion bags would not be able to be accessed
· Clinical care would be compromised because of the non-availability of these medicines.
· Otherwise closed-systems would be breached, which may:
· allow contamination to enter the sterile product (risk of infection for the patient)
· allow potentially hazardous drugs to escape (risk to the operator and clinical staff) / · Non-sharp plastic devices and blunt-ended needles used where these are practicable.
· Safer-sharp devices(side-sheathing needles) used where these are practicable.
· Training of staff specifically focuses on safe handling of needles
· Production staff do not handle potentially infectious sharps / · Infection
· Needle-stick injury (if left unsheathed)
· Contamination of environment with hazardous drug
· Contamination of product through breach of asepsis / 0
4
5
4 / 5
1
3
3 / 0
4
15
12 / None
Re-sheath
Re-sheath
Re-sheath /
2a to 2e / Re-sheathing of needles referred to in 1a-1g above / · Although medicine preparation is undertaken in an ultra-clean environment, there is still a risk of contamination from environmental microbes. Re-sheathing is considered to be essential to maintain asepsis
· Some cytotoxic drugs and anti-virals handled in the unit are hazardous when operators are exposed repeatedly at low levels. Re- sheathing ensures any spillage from the needle is contained
· Handling exposed needles in the confines of an isolator increases the risk of needle-stick compared to a more open environment. Re-sheathing (done following training and using a re-sheathing block) is consider to present less risk than handling unsheathed needles
· The presence of unsheathed needles in sharps bins presents a risk to the operator, eg when putting further waste in the bin or if the bin is knocked over due to the constrained working environment of the isolator. / · Microbial contamination would lead to growth in the product and potentially catastrophic infection in a patient receiving the dose
· Continued low level exposure may lead to deficiencies in fertility, birth abnormality in pregnant female staff, and cancer
· Needle-stick incidents cause direct harm to operators, and may carry small quantities of drug into the wound. In addition, the integrity of the aseptic environment is compromised, requiring time-consuming cleaning and replacement of gloves. / · Needles only used where essential
· Re-sheathing is done using a re-sheathing block to hold the sheath, using a one-handed technique
· Production staff receive structured training for their role, including safe-handling of sharps.
· Production staff do not handle potentially infectious sharps
/ · Infection
· Needle-stick injury (using re-sheathing device)
· Contamination of environment with hazardous drug
· Contamination of product through breach of asepsis / 0
1
1
1 / 5
1
3
3 / 0
1
3
3 / None
Training & monitor incidents.
None (consider surface residue testing).
None (monitor via operator & process broth validations) /
Acknowledgements
· Source of this example risk assessment – NHS Pharmaceutical Aseptic Services Group 5
· Risk Assessment template design – Adam Hocking, Principal Pharmacist QA, University Hospital Southampton NHSFT
· Risk evaluation scores - Máiréad O’Mahony, Anne Black & Alison Beaney 6
Version: 1 / Master template effective from: / Supersedes: None / Page 8 of 8Written by: [Name]
Template Review date: