Targeted literature review:

Targeted literature review: What are the key infection prevention and control recommendations to inform a central vascular catheter (CVC) maintenance care quality improvement tool? Version 3.0: September 2014

HPS ICT Document Information Grid Purpose: To present a review of the evidence to inform the content of HAI related quality improvement tools for NHSScotland. This supports the functions of HPS in developing effective guidance, good practice and a competent workforce and translating knowledge to improve health outcomes. Target audience: All NHSScotland staff involved in patient care activities where interventions can lead to HAI, particularly those interventions that can cause bloodstream infections such as line insertion. Infection prevention and control teams in NHS boards and other settings. Partner organisations particularly Healthcare Improvement Scotland and National Education for Scotland to ensure consistent information across similar improvement documentation. Description: Literature critique summary and presentation of key recommendations to inform HAI quality improvement tools, based around a framework that evaluates these against the health impact contribution and expert opinion/practical application. Update/review schedule: Every three years; however if significant new evidence or other implications for practice are published updates will be undertaken. Cross reference: Standard Infection Control Precautions Policies in the National Infection Prevention and Control Manual. Data on HAI incidence and prevalence and process compliance data. Implementation support from Healthcare Improvement Scotland and/or others, education and training support from National Education Scotland. Page 2 of 27

Contents 1. Executive summary... 4 2. Aim of the review... 5 3. Background... 5 3.1 The problem... 5 3.2 Why CVCs are needed... 5 3.3 How infections associated with maintenance of CVCs can be prevented... 5 3.4 Out of scope for this review... 6 3.5 Assumptions... 6 4. Results... 7 4.1 Review of evidence base... 7 4.1.1 Final recommendation - Ensure that the need for the CVC in situ is reviewed.. and recorded on a daily basis. (Category 1A)... 7 4.1.2 Final recommendation - Ensure that the CVC dressing is intact. (Category 1B) Final recommendation - Ensure that the CVC dressing has been changed in... the last seven days. (Category 1B)... 7 4.1.3 Final recommendation - Ensure that a single-use application of 2%... chlorhexidine in 70% isopropyl alcohol is used for cleaning the insertion site... during dressing changes. (Category 1A)... 8 4.1.4 Final recommendation - Ensure that hand hygiene is performed immediately.. before accessing the line/site (WHO Moment 2). (Category 1A)... 9 4.1.5 Final recommendation - Ensure that an antiseptic containing 70% isopropyl... alcohol is used to clean the access hub prior to accessing rub the access... hub for at least 15 seconds ( scrub the hub ) (Category 1B)... 9 4.2 Review of additional evidence based on initial search findings... 10 4.2.1 Administration set replacement. (Category 1A)... 10 5. References... 12 Appendix 1: Previous criteria under review... 16 Appendix 2: Framework tool to evaluate evidence based recommendations alongside the health impact contribution & expert opinion... 17 Appendix 3: Literature review methodology... 23 Appendix 4: Search Strategy... 25 Appendix 5: Summary of key recommendations for CVC insertion and maintenance... 27 Page 3 of 27

1. Executive summary Central vascular catheters (CVCs) are the leading cause of device-related bacteraemias (blood stream infections) which are a major cause of morbidity, with increased severity of patient illness and prolonged hospital stays. 1 The Scottish National HAI Prevalence Survey (2011) reported 4.0% of patients having CVCs in situ at the time of the survey. 1 The use of CVCs is an essential clinical requirement for certain patient populations. However, the invasive nature of these devices along with the vulnerability of the patients and the resulting duration of use increases the risk of CRBSIs. Microorganisms can gain entry at any manipulation site including the hub/access port/connection, or at the insertion site itself. 2 Additionally, organisms from a distal site of infection can travel via the blood and infect the CVC. 3 Due to the invasive nature of the device, critical aspects of care related to CVCs include: ensuring the CVC is clinically required; and reducing the risk of contamination during access of the CVC and during care of the insertion site and dressing changes. Therefore, there has been a focus on methods to ensure optimal care of CVCs that are in place. 4;5 The recommendations result from a review of scientific evidence and the process of assessing these within a health impact and expert opinion framework. The key recommendations and their scientific grade of evidence for the CVC maintenance quality improvement tool are: Ensure that the need for the CVC in situ is reviewed and recorded on a daily basis (Category 1A)* Ensure that the CVC dressing is intact (Category 1B) Ensure that the CVC dressing has been changed in the last seven days (Category 1B) Ensure that a single-use application of 2% chlorhexidine gluconate in 70% isopropyl alcohol is used for cleaning the insertion site during dressing changes (Category 1A) Ensure that hand hygiene is performed immediately before accessing the line/site (WHO Moment 2) (Category 1A) Ensure that a single-use antiseptic containing 70% isopropyl alcohol is used to clean the access hub prior to accessing rub the access hub for at least 15 seconds ( scrub the hub ) (Category 1B) * to find out more information on the categories of these recommendations see Appendix 3 Note: this review identifies the resulting key evidence based recommendations and does not aim to identify all the elements of a checklist or standard operating procedure covering CVC management. A review and recommendations on CVC insertion is available on HPS web pages. In conclusion: It is advised that the key recommendations listed here and summarised in Appendix 5 are considered for application into practice as supported by quality improvement tools including care bundles. Note: All medical and nursing staff involved in the use of all medical devices and medicinal products containing chlorhexidine should be aware of the risk of an anaphylactic reaction due to chlorhexidine allergy. The full details of the alert are available from the following weblink 74 http://www.mhra.gov.uk/publications/safetyw arnings/medicaldevicealerts/con197918 Page 4 of 27

2. Aim of the review To review the previous HPS CVC maintenance quality improvement tool content alongside the currently available guidelines and evidence to ensure that the key recommendations are still the most important for optimal maintenance of CVCs in patients who require these. 3. Background 3.1 The problem National surveillance identified 1564 Staphylococcus aureus bacteraemias (SAB) in Scotland in the year April 2013 March 2014 6 with these infections continuing to have a significant adverse impact on Scotland s hospital inpatient population. As such, preventing infections associated with interventions that lead to SAB in particular is paramount. 7 CVCs are the leading cause of device-related bacteraemias which are a major cause of morbidity resulting in increased severity of patient illness and prolonged hospital stays. 8 The Scottish National HAI Prevalence Survey (2011) reported 4.0% of patients having CVCs in situ at the time of the survey. 1 CVCs can cause CRBSIs by enabling microorganisms to gain direct access to the blood stream. There is strong evidence that CRBSIs can originate from the patient s skin at the insertion site, from hub contamination, from the hands of Healthcare Workers (HCWs) or from infusate contamination where aseptic technique has not been practiced during the preparation of drugs. 9-11 Once microorganisms enter and settle on the catheter surface, biofilm can form on the catheter lumen and parts of the biofilm can float into the bloodstream giving rise to a bloodstream infection (BSI). 10;12;13 3.2 Why CVCs are needed CVCs are used for the repeated administration of drugs such as chemotherapy, fluids and blood products, as well as for blood sampling. They are indicated for use when long term vascular access is anticipated. 14 Due to the nature of their illness, many of the patients who require CVCs tend to be prone to infection a large proportion are immunosuppressed patients undergoing cancer therapy, those undergoing long-term treatment such as renal dialysis, and those in intensive care units (ICUs). 12 3.3 How infections associated with maintenance of CVCs can be prevented There have been a number of infection prevention and control strategies aimed at minimising the risk of CRBSIs, with a focus on the use of evidence based interventions. These include insertion checklists and quality improvement tools which, alongside surveillance and audit, allow analysis of data to adjust and improve systems, performance and outcome. 7;12-15 Critical aspects of CVC maintenance include ensuring that the CVC is still clinically required and reducing the risk of contamination during access and care of the CVC. The evidence base for procedures pertaining to the care and maintenance of CVCs has a high number of scientific studies which are considered high quality including randomised control trials (RCTs). There are Page 5 of 27

also Cochrane systematic reviews available on aspects of CVC maintenance in addition to evidence based guidance. 3.4 Out of scope for this review This literature review does not address any issues specific to: Paediatric patients Tunnelled CVCs Peripherally inserted central catheter (PICC) Anti-microbial impregnated catheters Multiple lumen CVCs 3.5 Assumptions There are a number of aspects related to healthcare delivery that were not within the remit of this review as it is clear that they are the responsibility of other professionals. These include that: Staff are appropriately trained and competent in all aspects of the management of CVCs preferably using an approved educational package The overall approach to the delivery of healthcare is supported by patient safety and improvement approaches and organisational readiness. Page 6 of 27

4. Results The recommendations presented are based on a review of the current evidence. The previous recommended criteria within the HPS bundles and checklists were used as a basis for the question set as seen in Appendix 1. To further aid the process of deciding what final key recommendations to be included, all the recommendations resulting from the review of the evidence were assessed using the health impact and expert opinion framework seen in Appendix 2. The final key recommendations were identified as a result of this evaluation as well as being informed by the process of wider consultation. The methodology for this is described within Appendix 3; the specific search strategy in Appendix 4 and finally a summary page of the resulting recommendations can be found in Appendix 5. 4.1 Review of evidence base 4.1.1 Final recommendation - Ensure that the need for the CVC in situ is reviewed and recorded on a daily basis. (Category 1A) The most effective way of reducing the risk of CRBSI is by removal of the CVC when no longer clinically indicated. 15 This emphasises the importance of regular evaluation of the ongoing clinical need. 16 The Department of Health (DH) High Impact Intervention incorporates a recommendation that the catheter is removed if no longer required or alternatively, the decision not to remove is recorded and records are kept including date, location, and name of healthcare worker. 4 Assessment and removal of non-essential CVCs is a highly graded recommendation within Centers for Disease Control and Prevention (CDC) guidelines and graded Category 1A, which is defined as a strong recommendation based on moderate to high quality evidence. 10 The importance of periodically assessing the knowledge and training of staff to ensure CVCs are removed when clinically indicated is also highlighted. There is a clear consensus of evidence that ensuring ongoing monitoring of the continuing clinical requirement of CVCs is vital and they should be removed as soon as possible to reduce the risk of CRBSI. Accurate record keeping regarding the clinical need should be maintained and updated on a daily basis as a way of supporting this action. 4.1.2 Final recommendation - Ensure that the CVC dressing is intact. (Category 1B) Final recommendation - Ensure that the CVC dressing has been changed in the last seven days. (Category 1B) CDC guidelines include a number of evidence based recommendations on aspects of CVC dressings and include replacement of the dressing if damp, loosened, or visibly soiled. In addition it is recommended that when short-term CVCs are used, gauze dressings should be changed every 2 days, whereas transparent dressings should be replaced at least every 7 days. 10 Manufacturer s instructions must be followed for the use of all dressings. The Department of Health (DH) High Impact Intervention includes an action that a sterile, semi-permeable, transparent dressing is used allowing observation of insertion site. 4 This is based on evidence presented Page 7 of 27

within the epic2 and epic3 guidelines 17;18 which concludes that a sterile, transparent, semi-permeable polyurethane dressing should be used to cover the catheter insertion site or that if a patient has profuse perspiration or if the insertion site is bleeding or oozing, a sterile gauze dressing is preferable to a transparent, semi-permeable dressing. However although the use of a transparent dressing is recommended, there is no supporting evidence provided. It has been reported that the rates of colonisation found in catheters dressed with either gauze or semi-permeable transparent dressings are comparable. 10 In addition, a Cochrane review (updated in 2011) concluded that the uncertainty regarding the effect of different CVC dressings on the risk of infection meant that the choice of dressing should be based on patient preference and/or cost. 19 What is clear is that a sterile dressing provides protection of the insertion site following insertion of a CVC. 10; 17;20 Transparent dressings provide the added value of enabling viewing of the insertion site and could result in improved outcome. Based on the review of evidence it is recommended that either sterile gauze, or transparent, semi-permeable dressings are used to cover the catheter site and that assessment of the CVC occurs daily by palpation through the dressing or inspection if the dressing is transparent. If the dressings are not intact or have become loosened, this increases the risk of microorganisms gaining entry via the CVC. Therefore dressings should always be replaced if damp, loosened or visibly soiled. 21 4.1.3 Final recommendation - Ensure that a single-use application of 2% chlorhexidine in 70% isopropyl alcohol is used for cleaning the insertion site during dressing changes. (Category 1A) Infection can arise from microorganisms which are present on the patient s skin. Antisepsis of the insertion site is therefore crucial in minimising the risk of microbial seeding of the external surface of the CVC as it is inserted and the risk of microorganisms migrating down the lumen post insertion and resulting in biofilm formation, ultimately leading to infection. 3;10;12 The DH High Impact Intervention states the insertion site should be disinfected with 2% chlorhexidine gluconate in 70% isopropyl alcohol prior to the dressing being changed. 4 Epic3 guidelines recommend the use of a single-use application of 2% chlorhexidine gluconate in 70% isopropyl alcohol (or povidone iodine in alcohol for patients with sensitivity to chlorhexidine) for cleaning the catheter site during dressing changes, allowing the antiseptic to air dry 18. The Center for Disease Control (CDC) guidelines 10 recommend skin is prepared with a preparation of >0.5% chlorhexidine with isopropyl alcohol before insertion of CVCs and during dressing changes, but state that tincture of iodine (an iodophor) or 70% isopropyl alcohol can be used as alternatives if chlorhexidine is not suitable for the patient. This is graded as Category 1A, which is defined as a strong recommendation based on moderate to high quality evidence. There is therefore strong consensus from the evidence base that chlorhexidine in isopropyl alcohol is suitable for the purpose of skin disinfection during dressing changes. It can be concluded that the combination of residual antiseptic effect of the chlorhexidine combined with the rapid antiseptic effect of isopropyl alcohol makes this suitable for this purpose. 16 Page 8 of 27

A Cochrane systematic review on preoperative skin antiseptics for preventing surgical wound infections after clean surgery noted that multiuse bottles of antiseptic can become contaminated once opened 22. This evidence has been strengthened by reports of outbreaks of HAI associated with contaminated aqueous solutions of chlorhexidine 23-27. There were no reports identified in this search specifically associated with contaminated 2% chlorhexidine, 70% isopropyl alcohol however outbreaks of infection have been associated with 70% and 95% ethanol used for skin decontamination as well as 70% isopropyl alcohol skin preparation pads, which may show a potential for this solution to become contaminated 28-30. Therefore for the purposes of skin preparation prior to surgical procedures, the use of single use sterile containers of 2% chlorhexidine 70% isopropyl alcohol should be considered best practice. Note All medical and nursing staff involved in the use of all medical devices and medicinal products containing chlorhexidine should be aware of the risk of an anaphylactic reaction due to chlorhexidine allergy. The full details of the alert are available from the following weblink 74 http://www.mhra.gov.uk/publications/safetyw arnings/medicaldevicealerts/con197918 4.1.4 Final recommendation - Ensure that hand hygiene is performed immediately before accessing the line/site (WHO Moment 2). (Category 1A) This recommendation, and the importance of hand hygiene performance, is consistent with all current evidence, guidelines and the DH high impact intervention. 4;10 The World Health Organization (WHO) Guidelines on Hand Hygiene in Health Care (2009) 31 clearly describe the indications for hand hygiene and present these within the WHO My 5 Moments for Hand Hygiene approach, including emphasising the importance of performing hand hygiene before clean/aseptic procedures to prevent HAI. These 5 Moments are widely promoted within NHSScotland and hand hygiene performance is measured against these Moments. Accessing the site has been emphasised as a key factor in acquiring infection and therefore this moment is crucial to protect the patient at a vulnerable time. 4;21 In summary, in relation to the risk associated with CVC maintenance, the clearest indication for hand hygiene is Moment 2: before clean/aseptic procedures. 4.1.5 Final recommendation - Ensure that a single-use antiseptic containing 70% isopropyl alcohol is used to clean the access hub prior to accessing rub the access hub for at least 15 seconds ( scrub the hub ) (Category 1B) There is substantial evidence that CVC access ports and hubs are generally contaminated and must be disinfected prior to access by HCWs. 4;10;32 Needleless connectors were originally introduced to reduce the risk to staff from needlestick injuries. 33 Subsequent developments have resulted in numerous different designs of connectors which include splitseptum devices, mechanical valve devices, and devices with positive fluid displacement. However, it is Page 9 of 27

possible that complex designs of connectors may make them more likely to harbour bacteria. Indeed, there have been reports of increased CRBSIs which have been observed after their introduction and subsequently a focus on the importance of adequate and thorough decontamination of these needleless ports. 34-39 The Department of Health (DH) High Impact Intervention therefore recommends that ports or hubs are cleaned with 2% chlorhexidine gluconate in 70% isopropyl alcohol prior to catheter access and that the lines should be flushed with sterile 0.9% sodium chloride when in frequent use. 4 The Center for Disease Control (CDC) guidelines recommend to minimize contamination risk by scrubbing the access port with an appropriate antiseptic (chlorhexidine, povidone iodine, an iodophor or 70% isopropyl alcohol) and accessing the port only with sterile devices. 10 The evidence for the use of 2% chlorhexidine gluconate in 70% isopropyl alcohol results mainly from studies where catheters are left in situ long term. 13 There is some debate on whether it is the method of cleaning or the choice of disinfectant which is the most important factor. Two microbiological studies which examined decontamination of different designs of needleless access hubs showed that 15 seconds of a scrubbing action with 70% isopropyl alcohol was as effective as 2% chlorhexidine in 70% isopropyl alcohol. 40;41 Despite being relatively small scale they have provided evidence that the duration of disinfectant contact along with the method of decontamination which is important. This is of particular importance when considering the different designs of the needleless connector components. Epidemiological evidence to support the inclusion of the scrub the hub intervention for CVCs has been provided by a number of observational studies. Following introduction of this intervention within a number of ICUs, significant reductions were observed in the CRBSI rate, even within settings where the baseline rate was already low. 39-41 Other methods of hub decontamination, such as the use of antiseptic chambers, have also been described. However, despite some recent epidemiological and microbiological data, there is currently insufficient evidence to support routine use. 42;43 4.2 Review of additional evidence based on initial search findings 4.2.1 Administration set replacement. (Category 1A) The DH High Impact Intervention recommends replacement immediately after administration of blood, blood products and all other fluid sets after 72 hours. 4 The CDC guidelines recommend that administration sets which are continuously used, including secondary sets and add on devices, are changed no more frequently than at 96 hour intervals but at least every 7 days 10 (and immediately after blood, blood products or lipid). This is consistent with a Cochrane Review. 44;45 Epic3 guidelines advise that administration sets in continuous use do not need to be replaced more frequently than every 96 hours unless for blood and blood components in which case they should be changed when the transfusion episode is complete or every 12 hours, whichever is sooner. 18 Despite the availability of evidence on the timing of administration set replacement, it is clear that there is not one single recommendation that can be incorporated in a quality improvement tool, but rather a list of Page 10 of 27

instructions needed to ensure clear guidance for practice. The potential of including this as an additional recommendation was considered within the context of the overall aims of quality improvement tools and it was concluded that this would not fit but that changing administration sets should be considered separately to avoid confusion in practice. The inclusion of a quality improvement tool element which reminds of the importance of awareness of the different timing of administration set replacement may be useful and this should be included within additional supporting material/tools e.g. within a cause and effect chart. In conclusion: It it is advised now advised that the that key the recommendations key listed listed here as and a summarised result of this in review Appendix (appendix 5 are 5) considered are considered for application for application into into practice practice as supported as supported by quality by quality improvement tools tools including including care care bundles. These activities bundles. can These also activities be supported can also by be national supported patient by safety/quality national patient improvement safety /quality work improvement (as directed work by Healthcare (as Improvement directed by Healthcare Scotland). Improvement Scotland). Page 11 of 27

5. References (1) Health Protection Scotland. Scottish National Point Prevalence Survey of Healthcare Associated Infection and Antimicrobial Prescribing 2011. 2012. (2) Fletcher SJ. Central venous catheter related infection. Anaesth Intensive Care 1999 Aug;27(4):425. (3) Pascual A. Pathogenesis of catheter-related infections: lessons for new designs. Clin Microbiol Infect 2002 May;8(5):256-64. (4) High Impact Intervention: Central venous catheter care bundle. Department of Health 2011 [cited 2012 Mar 30];Available from: URL: http://hcai.dh.gov.uk/whatdoido/high-impact-interventions/ (5) CVC Maintenance Care Bundle and Insertion Checklist. Health Protection Scotland 2012 [cited 2012 Mar 13];Available from: URL: http://www.hps.scot.nhs.uk/haiic/ic/cvcmaintenancecarebundle.aspx (6) Health Protection Scotland. Quarterly Scottish Staphylococcus aureus bacteraemia surveillance report, January - March 2014. HPS Weekly Report 2014 Jul 2;48(26):339. (7) Collignon PJ, Dreimanis DE, Beckingham WD, Roberts JL, Gardner A. Intravascular catheter bloodstream infections: an effective and sustained hospital-wide prevention program over 8 years. Med J Aust 2007 Nov 19;187(10):551-4. (8) Coello R, Charlett A, Ward V, Wilson J, Pearson A, Sedgwick J, et al. Device-related sources of bacteraemia in English hospitals--opportunities for the prevention of hospital-acquired bacteraemia. J Hosp Infect 2003 Jan;53(1):46-57. (9) Maki DG, Crnich CJ. Line sepsis in the ICU: prevention, diagnosis, and management. Semin Respir Crit Care Med 2003 Feb;24(1):23-36. (10) O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, et al. Guidelines for the Prevention of Intravascular Catheter-related Infections. Clin Infect Dis 2011 Apr 1. (11) Vonberg RP, Gastmeier P. Hospital-acquired infections related to contaminated substances. J Hosp Infect 2007 Jan;65(1):15-23. (12) Morales M, Mendez-Alvarez S, Martin-Lopez JV, Marrero C, Freytes CO. Biofilm: the microbial "bunker" for intravascular catheter-related infection. Support Care Cancer 2004 Oct;12(10):701-7. (13) Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SR, et al. epic2: National evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect 2007 Feb;65 Suppl 1:S1-64. (14) Bishop L, Dougherty L, Bodenham A, Mansi J, Crowe P, Kibbler C, et al. Guidelines on the insertion and management of central venous access devices in adults. Int J Lab Hematol 2007 Aug;29(4):261-78. (15) Weber DJ, Rutala WA. Central line-associated bloodstream infections: prevention and management. [Review]. Infectious Disease Clinics of North America 2011 Mar;25(1):77-102. (16) Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SR, et al. epic2: National evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect 2007 Feb;65 Suppl 1:S1-64. (17) Pratt RJ, Pellowe CM, Wilson JA, Loveday HP, Harper PJ, Jones SR, et al. epic2: National evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect 2007 Feb;65 Suppl 1:S1-64. Page 12 of 27

(18) Loveday HP, Wilson JA, Pratt RJ, Golsorkhi M, Tingle A, Bak A, et al. epic3: National Evidence- Based Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals in England. Journal of Hospital Infection 2014 Jan;86, Supplement 1(0):S1-S70. (19) Gillies D, O'Riordan L, Carr D, Frost J, Gunning R, O'Brien I. Gauze and tape and transparent polyurethane dressings for central venous catheters. Cochrane Database Syst Rev 2010;(4):CD003827. (20) Webster J, Gillies D, O'Riordan E, Sherriff KL, Rickard CM. Gauze and tape and transparent polyurethane dressings for central venous catheters. Cochrane Database Syst Rev 2011;(11):CD003827. (21) O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, et al. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control 2011 May;39(4 Suppl 1):S1-34. (22) Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev 2013;3:CD003949. (23) Vigeant P, Loo VG, Bertrand C, Dixon C, Hollis R, Pfaller MA, et al. An outbreak of Serratia marcescens infections related to contaminated chlorhexidine. Infect Control Hosp Epidemiol 1998 Oct;19(10):791-4. (24) Maroye P, Doermann HP, Rogues AM, Gachie JP, Megraud F. Investigation of an outbreak of Ralstonia pickettii in a paediatric hospital by RAPD. J Hosp Infect 2000 Apr;44(4):267-72. (25) Espinosa de los Monteros LE, Silva-Sanchez J, Jimenez LV, Rojas T, Garza-Ramos U, Valverde V. Outbreak of infection by extended-spectrum beta-lactamase SHV-5-producing Serratia marcescens in a Mexican hospital. J Chemother 2008 Oct;20(5):586-92. (26) Heo ST, Kim SJ, Jeong YG, Bae IG, Jin JS, Lee JC. Hospital outbreak of Burkholderia stabilis bacteraemia related to contaminated chlorhexidine in haematological malignancy patients with indwelling catheters. J Hosp Infect 2008 Nov;70(3):241-5. (27) Molina-Cabrillana J, Santana-Reyes C, Gonzalez-Garcia A, Bordes-Benitez A, Horcajada I. Outbreak of Achromobacter xylosoxidans pseudobacteremia in a neonatal care unit related to contaminated chlorhexidine solution. Eur J Clin Microbiol Infect Dis 2007 Jun;26(6):435-7. (28) Centers for Communicable Disease Prevention and Control. Notes from the field: Contamination of alcohol prep pads with Bacillus cereus group and Bacillus species--colorado, 2010. MMWR Morb Mortal Wkly Rep 2011 Mar 25;60(11):347. (29) Dolan SA, Littlehorn CMSA, Glod MP, Dowell EMSA, Xavier KBMA, Nyquist A-CMM, et al. Association of Bacillus cereus Infection with Contaminated Alcohol Prep Pads. Infection Control and Hospital Epidemiology 2012 Jul 1;33(7):666-71. (30) Hsueh PR, Teng LJ, Yang PC, Pan HL, Ho SW, Luh KT. Nosocomial Pseudoepidemic Caused by Bacillus cereus Traced to Contaminated Ethyl Alcohol from a Liquor Factory. Journal of Clinical Microbiology 1999 Jul 1;37(7):2280-4. (31) World Health Organization. WHO guidelines on hand hygiene in health care: first global patient safety challenge clean care is safer care. Geneva: WHO; 2009. (32) Mermel LA. Prevention of intravascular catheter-related infections.[erratum appears in Ann Intern Med 2000 Sep 5;133(5):395]. Annals of Internal Medicine 2000 Mar 7;132(5):391-402. (33) Chittick P, Sherertz RJ. Recognition and prevention of nosocomial vascular device and related bloodstream infections in the intensive care unit. [Review] [132 refs]. Critical Care Medicine 2010 Aug;38(8:Suppl):Suppl-72. Page 13 of 27

(34) Danzig LE, Short LJ, Collins K, Mahoney M, Sepe S, Bland L, et al. Bloodstream infections associated with a needleless intravenous infusion system in patients receiving home infusion therapy. JAMA 1995 Jun 21;273(23):1862-4. (35) Field K, McFarlane C, Cheng AC, Hughes AJ, Jacobs E, Styles K, et al. Incidence of catheter-related bloodstream infection among patients with a needleless, mechanical valve-based intravenous connector in an Australian hematology-oncology unit. Infect Control Hosp Epidemiol 2007 May;28(5):610-3. (36) Salgado CD, Chinnes L, Paczesny TH, Cantey JR. Increased rate of catheter-related bloodstream infection associated with use of a needleless mechanical valve device at a long-term acute care hospital. Infect Control Hosp Epidemiol 2007 Jun;28(6):684-8. (37) Do AN, Ray BJ, Banerjee SN, Illian AF, Barnett BJ, Pham MH, et al. Bloodstream infection associated with needleless device use and the importance of infection-control practices in the home health care setting. J Infect Dis 1999 Feb;179(2):442-8. (38) Field K, McFarlane C, Cheng AC, Hughes AJ, Jacobs E, Styles K, et al. Incidence of catheter-related bloodstream infection among patients with a needleless, mechanical valve-based intravenous connector in an Australian hematology-oncology unit. Infect Control Hosp Epidemiol 2007 May;28(5):610-3. (39) Zack J. Zeroing in on zero tolerance for central line-associated bacteremia. American Journal of Infection Control 2008 Dec;36(10):S176-2. (40) Kaler W. CR. Successful disinfection of needleless access ports: A matter of time and friction. Journal of the Association for Vascular Access 2007;12(3):140-2. (41) Lockman JL, Heitmiller ES, Ascenzi JA, Berkowitz I. Scrub the hub! Catheter needleless port decontamination. Anesthesiology 2011 Apr;114(4):958. (42) Leon C, Alvarez-Lerma F, Ruiz-Santana S, Gonzalez V, de la Torre MV, Sierra R, et al. Antiseptic chamber-containing hub reduces central venous catheter-related infection: a prospective, randomized study. Critical Care Medicine 2003 May;31(5):1318-24. (43) Menyhay SZ, Maki DG. Preventing central venous catheter-associated bloodstream infections: development of an antiseptic barrier cap for needleless connectors. American Journal of Infection Control 2008 Dec;36(10):S174-S175. (44) Gillies D, O'Riordan L, Wallen M, Rankin K, Morrison A, Nagy S. Timing of intravenous administration set changes: a systematic review. Infect Control Hosp Epidemiol 2004 Mar;25(3):240-50. (45) Ullman AJ, Cooke ML, Gillies D, Marsh NM, Daud A, McGrail MR, et al. Optimal timing for intravascular administration set replacement. Cochrane Database Syst Rev 2013;9:CD003588. (46) The AGREE Collaboration. Appraisal of Guidelines For Research & Evaluation (AGREE) Instrument. 2001. (47) Umscheid CA, Agarwal RK, Brennan PJ. Updating the guideline development methodology of the Healthcare Infection Control Practices Advisory Committee (HICPAC). Am J Infect Control 2010 May;38(4):264-73. (48) Berenholtz S, Pronovost PJ. Barriers to translating evidence into practice. Curr Opin Crit Care 2003 Aug;9(4):321-5. (49) Gurses AP, Murphy DJ, Martinez EA, Berenholtz SM, Pronovost PJ. A practical tool to identify and eliminate barriers to compliance with evidence-based guidelines. Jt Comm J Qual Patient Saf 2009 Oct;35(10):526-32, 485. Page 14 of 27

(50) Marwick C, Davey P. Care bundles: the holy grail of infectious risk management in hospital? Curr Opin Infect Dis 2009 Aug;22(4):364-9. (51) O'Connor PJ. Adding value to evidence-based clinical guidelines. JAMA 2005 Aug 10;294(6):741-3. (52) Pulcini C, Defres S, Aggarwal I, Nathwani D, Davey P. Design of a 'day 3 bundle' to improve the reassessment of inpatient empirical antibiotic prescriptions. J Antimicrob Chemother 2008 Jun;61(6):1384-8. (53) Sax H, Allegranzi B, Uckay I, Larson E, Boyce J, Pittet D. 'My five moments for hand hygiene': a user-centred design approach to understand, train, monitor and report hand hygiene. J Hosp Infect 2007 Sep;67(1):9-21. (54) IHI, Institute of Healthcare Improvement. Institute of Healthcare Improvement 2011 [cited 2012 Mar 30];Available from: URL: www.ihi.org (55) Weiser TG, Haynes AB, Lashoher A, Dziekan G, Boorman DJ, Berry WR, et al. Perspectives in quality: designing the WHO Surgical Safety Checklist. Int J Qual Health Care 2010 Oct;22(5):365-70. (64) Weber DJ, Rutala WA, Sickbert-Bennett EE. Outbreaks associated with contaminated antiseptics and disinfectants. Antimicrob Agents Chemother 2007 Dec;51(12):4217-24. Note: A number of references listed above are cited within the literature review methodology which has been placed in Appendix 3 for ease of reading of this document. Page 15 of 27

Appendix 1: Previous criteria under review The CVC care bundle and associated tools were first published on the HPS website in 2008. The criteria below were used as the question set to frame this review of the evidence base Checking the need for a CVC has been reviewed and recorded today Ensuring the CVC dressing is intact and was changed within the last 7 days Ensuring alcohol CVC hub decontamination is performed before each hub access Checking hand hygiene before and after, is performed on all line maintenance/access procedures. Ensuring Chlorhexidine gluconate 2% in alcohol is used for cleaning the insertion site during dressing changes. Page 16 of 27

vascular catheter (CV C) maintenance care quality improvement tool? Appendix 2: Framework tool to evaluate evidence based recommendations alongside the health impact contribution & expert opinion Recommendation for review Grade of recommendation (based on review of evidence) Health impact contribution (based on Healthcare Quality Strategy for NHSScotland) Expert opinion/consultation & practical considerations Ensure that the need for the CVC in situ is reviewed and recorded today (on a daily basis) Category 1A Safe: This recommendation encourages timely removal of CVCs, reducing the risk of associated infectious complications Effective: This recommendation reduces the risk of complications from this invasive device, including on occasions systemic (blood stream) infections Efficient: This recommendation reduces the risk from an invasive device by ensuring that a CVC is only in place if there is a clinical indication and therefore may result in releasing time for other care and a reduction in the associated NHS cost Equitable: This recommendation promotes a standard of care for all patients, that may result in a reduction in avoidable personal and NHS costs which is also beneficial to all Timely: This recommendation, daily checking, fits with other aspects of care required on a daily basis, contributing to streamlining of care Person Centred: This is a person centred action to reduce harm which could be caused by the invasive device; in every patient with a CVC and provides the opportunity to undertake simple, safe checks and care on each patient with a CVC Measurement & feedback Potential for measurement through e.g. observation Easi l y implemented within current culture and will improve the quality of care now Feasibility & sustainability Potential for consistent delivery Easily implemented based on reliably available resources/products/prompts Stealth integration into natural workflow/logical clarity of concept (also see Cause & Effect Chart) Unambiguous Applicability & reach Potential for applicability to a wide range of setti ngs Avoids unintended consequences/perverse behaviour Training & informing Potential for congruency in design and meaning, with HCW, trainer and observer training and education Y Y Y Y Y Y Y Y Y Is this a Key recommendation? Yes Health Protection Scotland Page 17 of 27 v2.0 December2012

vascular catheter (CV C) maintenance care quality improvement tool? Recommendation for review Grade of recommendation (based on review of evidence) Health impact contribution (based on Healthcare Quality Strategy for NHSScotland) Expert opinion/consultation & practical considerations Ensure that the CVC dressing is Intact Category 1B Safe: Not implementing this recommendation may put the patient at risk of harm Effective: This recommendation reduces the risk of complications from this invasive device, including systemic (blood stream) infections Efficient: This recommendation reduces the risk of introducing infection complications and may result in releasing time for other care and a reduction in the associated NHS cost Equitable: This recommendation promotes a standard of care for all patients, that may result in a reduction in avoidable personal and NHS costs which is also beneficial to all Timely: This recommendation, fits with other aspects of care required on a daily basis, contributing to streamlining of care Person Centred: This is a person centred action to reduce harm which could be caused by the invasive device; in every patient with a CVC and provides the opportunity to undertake simple, safe checks and care on each patient with a CVC Measurement & feedback Potential for measurement through e.g. observation Easi l y implemented within current culture and will improve the quality of care now Feasibility & sustainability Potential for consistent delivery Easily implemented based on reliably available resources/products/prompts Stealth integration into natural workflow/logical clarity of concept (also see Cause & Effect Chart) Unambiguous Applicability & reach Potential for applicability to a wide range of setti ngs Avoids unintended consequences/perverse behaviour Training & informing Potential for congruency in design and meaning, with HCW, trainer and observer training and education Y Y Y Y Y Y N Y Y Is this a Key recommendation? YES Health Protection Scotland Page 18 of 27 v2.0 December2012

vascular catheter (CV C) maintenance care quality improvement tool? Recommendation for review Grade of recommendation (based on review of evidence) Health impact contribution (based on Healthcare Quality Strategy for NHSScotland) Expert opinion/consultation & practical considerations Ensure that the CVC dressing has been changed in the last 7 days Category 1B Safe: Not implementing this recommendation may put the patient at risk of harm. Effective: This recommendation reduces the risk of complications from this invasive device, including systemic (blood stream) infections Efficient: This recommendation reduces the risk of introducing infection complications and may result in releasing time for other care and a reduction in the associated NHS cost Equitable: This recommendation promotes a standard of care for all patients, that may result in a reduction in avoidable personal and NHS costs which is also beneficial to all. Timely: This recommendation, fits with other aspects of care required on a daily basis, contributing to streamlining of care Person Centred: This is a person centred action to reduce harm which could be caused by the invasive device; in every patient with a CVC and provides the opportunity to undertake simple, safe checks and care on each patient with a CVC Measurement & feedback Potential for measurement through e.g. observation Easi l y implemented within current culture and will improve the quality of care now Feasibility & sustainability Potential for consistent delivery Easily implemented based on reliably available resources/products/prompts Stealth integration into natural workflow/logical clarity of concept (also see Cause & Effect Chart) Unambiguous Applicability & reach Potential for applicability to a wide range of setti ngs Avoids unintended consequences/perverse behaviour Training & informing (Y/N) Potential for congruency in design and meaning, with HCW, trainer and observer training and education Y Y Y Y Y Y N Y Y Is this a Key recommendation? YES Health Protection Scotland Page 19 of 27 v2.0 December2012

vascular catheter (CV C) maintenance care quality improvement tool? Recommendation for review Grade of recommendation (based on review of evidence) Health impact contribution (based on Healthcare Quality Strategy for NHSScotland) Expert opinion/consultation & practical considerations Ensure that 2% chlorhexidine gluconate in 70% isopropyl alcohol is used for cleaning the insertion site during dressing changes Category 1A Safe: Not implementing this recommendation may put the patient at risk of harm Effective: This recommendation reduces the risk of complications from this invasive device, including systemic (blood stream) infections Efficient: This recommendation reduces the risk of introducing infection complications and may result in releasing time for other care and a reduction in the associated NHS cost Equitable: This recommendation promotes a standard of care for all patients, that may result in a reduction in avoidable personal and NHS costs which is also beneficial to all Timely: This recommendation, fits with other aspects of care required on a daily basis, contributing to streamlining of care Person Centred: This is a person centred action to reduce harm which could be caused by the invasive device; in every patient with a CVC and provides the opportunity to undertake simple, safe checks and care on each patient with a CVC Measurement & feedback (Y/N) Potential for measurement through e.g. observation Easi l y implemented within current culture and will improve the quality of care now Feasibility & sustainability (Y/N) Potential for co nsi stent delivery Easily implemented based on reliably available resources/products/prompts Stealth integration into natural workflow/logical clarity of concept (also see Cause & Effect Chart) Unambiguous Applicability & reach (Y/N) Potential for applicability to a wide range of setti ngs Avoids unintended consequences/perverse behaviour Training & informing (Y/N) Potential for congruency in design and meaning, with HCW, trainer and observer training and education Y Y Y Y Y Y Y? Y Is this a Key recommendation? Yes Health Protection Scotland Page 20 of 27 v2.0 December2012

vascular catheter (CV C) maintenance care quality improvement tool? Recommendation for review Grade of recommendation (based on review of evidence) Health impact contribution (based on Healthcare Quality Strategy for NHSScotland) Ensure that hand hygiene is performed immediately before accessing the line/site (WHO Moment 2). Category 1A Safe: Not implementing this recommendation may put the patient at risk of harm Effective: This recommendation has been shown to be effective in reducing the risk of complications resulting from contaminated hands of healthcare workers. This includes contamination of the insertion/access site which enables access to the patient s blood stream infection which may result occasionally in systemic blood stream infections. Efficient: This recommendation reduces the risk of infection complications and may result in releasing of time for other care and a reduction in the associated NHS cost Equitable: This recommendation promotes a standard of care for all patients, that may result in a reduction in avoidable personal and NHS costs, which is also beneficial to all Timely: This recommendation should be an integral part of healthcare worker activity and patient/ individual care Person Centred: This is a patient centred action to reduce harm caused by the invasive device in every patient with a CVC. It also provides the opportunity to undertake simple, safe checks and care on each and every patient with a CVC and allows for patients/individuals to be aware of the importance of hand hygiene and their role in this Expert opinion/consultation & practical considerations Measurement & feedback Potential for measurement through e.g. observation Easi l y implemented within current culture and will improve the quality of care now Feasibility & sustainability Potential for consistent delivery Easily implemented based on reliably available resources/products/prompts Stealth integration into natural workflow/logical clarity of concept (also see Cause & Effect Chart) Unambiguous Applicability & reach Potential for applicability to a wide range of setti ngs Avoids unintended consequences/perverse behaviour Y Y Y Y Y? Y Y Training & informing Potential for congruency in design and meaning, with HCW, trainer and observer training and education Y Is this a Key recommendation? YES Health Protection Scotland Page 21 of 27 v2.0 December2012

vascular catheter (CV C) maintenance care quality improvement tool? Recommendation for review Grade of recommendation (based on review of evidence) Health impact contribution (based on Healthcare Quality Strategy for NHSScotland) Ensure that an antiseptic containing 70% isopropyl alcohol is used to clean the access hub before accessing, rub for at least 15 secs ( scrub the hub ) Category 1B Safe: Not implementing this recommendation may put the patient at risk of harm Effective: This recommendation reduces the risk of complications from this invasive device, including systemic (blood stream) infections Efficient: This recommendation reduces the risk of introducing infection complications and may result in releasing time for other care and a reduction in the associated NHS cost Equitable: This recommendation promotes a standard of care for all patients, that may result in a reduction in avoidable personal and NHS costs which is also beneficial to all. Timely: This recommendation, fits with other aspects of care required on a daily basis, contributing to streamlining of care Person Centred: This is a person centred action to reduce harm which could be caused by the invasive device; in every patient with a CVC and provides the opportunity to undertake simple, safe checks and care on each patient with a CVC Expert opinion/consultation & practical considerations Measurement & feedback (Y/N) Feasibility & sustainability (Y/N) Applicability & reach (Y/N) Training & informing (Y/N) Potential for measurement through e.g. observation Easi l y implemented within current culture and will improve the quality of care now Potential for consistent delivery Easily implemented based on reliably available resources/products/prompts Stealth integration into natural workflow/logical clarity of concept (also see Cause & Effect Chart) Unambiguous Potential for applicability to a wide range of setti ngs Avoids unintended consequences/perverse behaviour Potential for congruency in design and meaning, with HCW, trainer and observer training and education Y Y Y Y Y Y N Y Y Is this a Key recommendation? YES Health Protection Scotland Page 22 of 27 v2.0 December2012

Appendix 3: Literature review methodology The evidence underpinning the criteria for a quality improvement tool was reviewed using a targeted systematic approach to enable input and resource to be concentrated where needed. This methodology is fully described within a separate paper Rapid method for development of evidence based/expert opinion key recommendations, based on health protection network guidelines. Initial rapid search and review The initial search rapid literature search was carried out to identify mandatory guidance, or recent national or international evidence based guidance which either agrees or refutes that the current key recommendations are the most important to ensure optimal CVC care: The main public health websites were searched to source any existing quality improvement tools Relevant guidance and quality improvement tools e.g. Department of Health (DH), Centers for Disease Control and Prevention (CDC) etc were reviewed Additional literature identified and sourced e.g. from the relevant Cochrane reviews. The quality of evidence based guidance was assessed using the AGREE instrument 46 and only guidance which achieved either a strongly recommend or recommend rating was included. Targeted systematic review As a result of initial rapid search and review, recommendations requiring a more in depth review were identified. This involved searching of relevant databases including OVID Medline, CINAHL, EMBASE. All literature pertaining to recommendations where evidence was either conflicting or where new evidence was available were critically appraised using SIGN checklists and a considered judgement process used to formulate recommendations based on the current evidence for presentation and discussion with the National HAI Quality Improvement Tools Group in Scotland. Grading of recommendations Grading of the evidence is using the Healthcare Infection Control Practices Advisory Committee (HICPAC) method. 47 In addition to the overall assessment of the evidence underpinning the recommendation, other factors are considered which affect the overall strength of the recommendation such as the health impact and expert opinion on the potential critical outcomes. The HICPAC categories are as follows: Category 1A strong recommendation based on high to moderate quality evidence Category 1B strong recommendation based on low quality of evidence which suggest net clinical benefits or harms or an accepted practice (e.g. aseptic technique) Category 1C a mandatory recommendation Health Protection Scotland v2.0 December 2012 Page 23 of 27

Category II a weak recommendation which shows evidence of clinical benefit over harm No recommendation not sufficient evidence to recommend one way or another Framework for identifying final key recommendations One way of improving implementation of evidence based guidance is by the identification of key recommendations which if applied will improve practice and outcome. 48-53 This is the foundation of care bundles and other quality improvement tools which rely on the identification of key evidence based recommendations to ensure application in practice. 54 A method has been developed which aims to reflect graded recommendations in line with ensuring healthcare quality, attention to cost and practical application. It combines approaches used by the Institute of Healthcare Improvement (IHI) and World Health Organisation, among others, in identifying the critical factors from the evidence to ensure patient safety in a range of fields. 53;55 The method considers the current NHSScotland Quality Strategy dimensions and finally expert opinion applied within a formal framework. This framework includes a range of practical considerations under the headings measurement and feedback, feasibility and sustainability, applicability and reach, training and informing. Ultimately, HPS key recommendations are presented taking all of these factors into account, with the aim of improving practice and outcome. The search strategy used is described in Appendix 4. Health Protection Scotland v2.0 December 2012 Page 24 of 27

Appendix 4: Search Strategy Database: Ovid MEDLINE(R) <1948 to June Week 3 2011> Search Strategy: -------------------------------------------------------------------------------- 1 exp Catheterization, Central Venous/ (10107) 2 connector*.mp. (2382) 3 hub*.mp. (5434) 4 *Catheterization, Central Venous/ or *Catheters, Indwelling/ or access port*.mp. (14794) 5 Catheterization, Central Venous/ or Infusions, Intravenous/ or Infection Control/ or needleless.mp. (69300) 6 2 or 3 or 4 or 5 (83017) 7 exp Chlorhexidine/ (5198) 8 exp Disinfectants/ or exp Disinfection/ or disinfect*.mp. or exp Antisepsis/ (62871) 9 exp Anti-Infective Agents, Local/ or antiseptic*.mp. or exp Antisepsis/ (161728) 10 isopropyl.mp. or 2-Propanol/ (8941) 11 scrub the hub.tw. (3) 12 7 or 8 or 9 or 10 or 11 (213261) 13 1 and 6 and 12 (423) 14 limit 13 to (english language and humans and yr="2000 -Current") (247) *************************** Key literature from e.g. the relevant Cochrane reviews were also sourced and critically appraised using SIGN methodology 2014 Update: Databases: Ovid MEDLINE(R) 1946 to Present with Daily Update; Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations July 22, 2014 Search Strategy: -------------------------------------------------------------------------------- 1. exp Cental Venous Catheters/ or exp Catheterization, Central Venous/ (12063) 2. central venous catheter?.mp (8112) 3. central vascular catheter?.mp (105) 4. 1 or 2 or 3 (15645) 5. exp Infection/ or exp Cross Infection/ or exp Infection Control/ (661268) 6. exp Chlorhexidine/ (6224) 7. exp Hand Disinfection/ (4450) 8. exp Hand Hygiene/ (4655) 9. hub?.mp (4873) 10. 5 or 6 or 7 or 8 or 9 (672521) Page 25 of 27

11. 4 and 10 (4751) 12. limit 11 to (English language and y= 2012 Current ) (659) *************************** Page 26 of 27

vascular catheter (CV C) maintenance care quality improvement tool? Appendix 5: Summary of key recommendations for CVC insertion and maintenance Page 27 of 27