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<strong>WHO</strong> GUIDELINES ON HAND HYGIENE IN HEALTH CARE 1. Hand hygiene as a performance indicator Monitoring hand hygiene adherence serves multiple functions: system monitoring, incentive for performance improvement, outbreak investigation, staffing management, and infrastructure design. 60,648,651,663,666,670,676,684,686,713,714 It has to be kept in mind, however, that hand hygiene performance is only one node in a causal tree leading to the two major infectious outcomes: HCAI and health care-associated colonization with multi-resistant microorganisms. As a process element in this causal chain, hand hygiene performance itself is influenced by many factors, not least the structural aspects related to the quality and availability of products such as alcoholbased handrub at the point of care. The correct moment for hand hygiene is usually termed “opportunity”. According to an evidence-based model of hand transmission, 1,885 the opportunity corresponds to the period between the moment in which hands become colonized after touching a surface (either environment or patient) and the moment in which hands touch a receptor surface. This transition can potentially result in a negative infectious outcome. Opportunities constitute the denominator in the calculation of compliance with optimal hand hygiene. As a consequence, measurement technologies and methods can be divided into two main categories: those with a measured denominator, and those without. An ideal indicator of hand hygiene performance would produce an unbiased and exact numerical measure of how appropriately HCWs practise hand hygiene so that its preventive effect on negative infectious outcomes is maximized. Ideally, such an indicator implies a technology that does not interfere with the behaviour of those observed, assesses the microbiological outcome of each hand cleansing action in real time, and reliably captures each moment requiring hand hygiene even during complex care activities. Furthermore, the method used should not require excessive staffing time and other incurred costs to provide sufficient data to exclude selection bias and underpowering. Bias and insufficient sample size represent the two major threats to meaningful monitoring outputs (see Part III, Section 1.1 below). Today, such an ideal method does not exist. All current measurement approaches produce approximate information on real hand hygiene performance, each with certain advantages and disadvantages (Table III.1.1). Hand hygiene performance in health care can be monitored directly or indirectly. Direct methods include direct observation, patient assessment or HCW self-reporting. Indirect methods include monitoring consumption of products, such as soap or handrub, and automated monitoring of the use of sinks and handrub dispensers. 1.1 Monitoring hand hygiene by direct methods Detection of hand hygiene compliance by a validated observer (direct observation) is currently considered the gold standard in hand hygiene compliance monitoring. 58 It is the only method available to detect all occurring hand hygiene opportunities and actions and to assess the number of times and appropriate timing when hand hygiene action would be required in the sequence of care. Observations are usually performed by trained and validated observers who observe care activity directly and count the occurring hand hygiene opportunities and determine the proportion being met by hand hygiene actions. It is essential that hand hygiene opportunities, indications, and actions are clearly defined (see Part III, Section 1.2). The validation of observers is essential for the quality of observation data (see under 1.2.3). Opportunities for hand hygiene action using alcoholbased handrubs can be distinguished from those requiring handwashing with soap and water. If pre-established in the selected methodology, direct observations allow to collect more detailed information. This can comprise glove use, handrubbing technique, application time, and other quality parameters that affect hand hygiene efficacy such as the wearing of jewellery and fingernail status (see Part I, Sections 23.4 and 23.5). Whereas routine monitoring needs to be kept simple and straightforward, observations for research purposes can be even more detailed. A major drawback of direct observation is the large effort required (trained and validated staff and many working hours). For example, with a typical average density of 10 hand hygiene opportunities per hour, a total observation time of 80 hours is required to obtain 500 opportunities. Causes of potential bias arising from hand hygiene direct observation are listed in Table III.1.2. The most important are observation, observer, and selection bias. Observation bias is generated by the presence of an observer who influences the behaviour of the observed HCWs towards a higher compliance or by an increased attention to the topic under study. In a recent study, compliance found to be 45% with overt observations was in reality only 29% when observations were covert. 736 Observation bias can also induce increased recourse to hand hygiene action at inappropriate times during the sequence of care, i.e. not associated with true improvement in compliance. If observational surveys are conducted periodically, this bias would be equally distributed among all observations. 831 Observation bias might be eliminated by keeping observations covert. Such observations, however, are not recommended in conjunction with promotional interventions because they can induce mistrust in the observed HCWs. Furthermore, hiding the true reason for the presence of an observer can hardly be maintained in the case of repeated observations. If a baseline observation is covert, then the results of overt follow-up observations would be confounded by the change in method. The observation bias can also be attenuated by desensitizing HCWs through the frequent presence of observers or an unobtrusive conduct during observation sessions. Some 158
PART III. PROCESS AND OUTCOME MEASUREMENT investigators call this effect the “Hawthorne effect” following ergonomic studies in the early 20th century at the Hawthorne factory of Western Electrics in the USA. 334,810,1032,1033 On the other hand, this effect can be used deliberately to stimulate hand hygiene compliance in a promotional intention, rather than to obtain objective quantitative results. 334,810,1033 Obtaining a sustained and never-ending Hawthorne effect associated with improved compliance with hand hygiene and decreased infection and cross-transmission rates could certainly represent an ideal perspective. 810 Observer bias refers to the systematic error introduced by interobserver variation in the observation method (Table III.1.2). To reduce this bias, observers have to be validated. It is noteworthy that even the same observer can unconsciously change his/her method over time. Selection bias results from systematically selecting HCWs, care settings, observation times, or health-care sectors with a specific hand hygiene behaviour. In practical terms, this bias can be minimized by randomly choosing locations, times during the day, and HCWs. Another threat to meaningful hand hygiene compliance results is the inclusion of a small sample size. In a comparative quantitative analysis of hand hygiene performance during two different periods, a large enough sample is needed to exclude the influence of chance. A sample size calculation should therefore be performed at the design stage of every hand hygiene monitoring scheme. For example, to show a difference between 40% and 60% compliance in two different measurements with a power of 90% and an alpha error of 5%, twice 140 (140x2) opportunities have to be observed. The sample size increases to twice 538 (538x2) opportunities when a difference between 40% and 50% is to be detected. Another more innovative statistical approach for measuring improvement over time and determining whether statistical improvement has really occurred is described in Appendix 4. However, because this method has not yet been applied to the analysis of hand hygiene data, further research is needed to consolidate its use in this field. If hand hygiene monitoring is used for comparison between health-care sectors or periods, confounding factors should be included in the dataset and corrected for by stratification, adjustment, or by keeping them unchanged between the monitoring sets. Typical confounders in this field are professional category, time of day, and health-care setting. Critical reviews of observation methods have been published. 809,1034,1035 Patients could be observers of HCWs’ hand hygiene compliance. In two studies, patients were encouraged to find out if HCWs had washed their hands before patient contact. 804,805 Patient monitoring of hand hygiene compliance is not well documented, however, and has never been objectively evaluated. 1036 Patients may not feel comfortable in a formal role as observers and are not always physically or mentally able to execute this task. 737,1037 Self-assessment by HCWs can be carried out. It has been demonstrated, however, that self-reports of compliance do not correlate well with compliance measured by direct observation, and self-assessment markedly overestimates compliance with hand hygiene. 218,220,666,667,676,733 1.2 The <strong>WHO</strong>-recommended method for direct observation Observation is a sophisticated activity requiring training, skill and experience. Observers have to be aware of the multiple potential biases introduced with the observation process and they can help to minimize these by gaining a full understanding of the methodology. A stringent adherence to the same methodology over space and time is required. <strong>WHO</strong> proposes a standardized hand hygiene observation method based on an approach validated through several studies. 60,652,686,738 All relevant theoretical and practical aspects related to this method are detailed in the Hand Hygiene Reference Technical Manual that is included in the Implementation Toolkit (available at http://www.who.int/gpsc/ en/). An “Observation form” for data collection, consistent with the proposed method and including concise user instructions, is also availabletogether with a “Compliance calculation form” to facilitate the immediate performance feedback. Observation of hand hygiene practices is an essential component of the <strong>WHO</strong> Hand Hygiene Improvement Strategy (See Part I, Sections 21.2 and 21.3). 1.2.1 Profile and task of observers The task of observers is to observe HCWs during their usual care activity and to assess their compliance with the recommended indications for hand hygiene. To be able to accomplish this task, observers have to be able to understand the logic of care. Ideally, they have training and experience in patient care as professionals. 1.2.2 Training of observers Observers have to be trained according to the principles of “My five moments for hand hygiene” and, ideally, have become excellent monitors of the application of hand hygiene during health-care delivery. Their excellence should be confirmed through observations performed by a senior observer, if feasible, depending on the setting. They have then to be instructed in hand hygiene observation according to the present methodology. This should take a relatively short time if they have already proved to be proficient in the application of the five moments. 1.2.3 Validation of observers Once knowledgeable in the use of the observation form and process, observers must be validated either by parallel observation jointly with a confirmed observer, or by being tested through the use of the <strong>WHO</strong> Training Film included in the <strong>WHO</strong> Implementation Toolkit (available at http://www.who.int/gpsc/ en/). In the first case, two observers engage in an observation session during a real-life care situation and each completes an observation form separately while observing the same HCW and the same care sequence. Results are then compared and discordant notifications discussed. This process is repeated until concordance is reached in the number and nature of each occurring hand hygiene opportunity. It is recommended that the person in charge of validation remains the same for 159
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