Guidelines for testing

To address the emergent global threat of carbapenem resistance, many national and international bodies developed guidelines that help to identify the potential carriers and apply relevant infection prevention measures to avoid further CRE transmissions. Based on a systematic review on the prevention of the spread of CRE and expert opinions, European Centre for Disease Prevention and Control (ECDC) built a comprehensive guideline that offers suggestions for best practices related to the identification of patients

‘at-risk’ for CRE carriage already at admission to the healthcare setting and effective infection prevention and control measures to avert the entry and spread of CRE (Magio-rakos et al., 2017). EDCD distinguishes between three groups of measures applied in a healthcare setting, which are standard precautions, so-called ‘contact precautions’, and additional precautions. First, standard precautions are the core measures that should be applied to any patient admitted to a hospital throughout their stay regardless of their CRE status. Second, contact precautions are the preliminary supplemental measures that should be applied to all the patients who are at-risk for CRE carriage, while additional precautions are additional supplemental measures applied to patients with confirmed CRE positive status.

Based on the ECDC guideline, the identification of patients ‘at-risk’ of CRE carriage should be done by the frontline HCW admitting the patient. During admission interview, the HCW has to inquire information regarding the patient’s exposures and situations that would qualify the patients as ‘at-risk’ for carriage of CRE. Hence, acquiring detailed med-ical and travel history is a must. Fulfilling any of the criteria presented in Table 6, accord-ing to ECDC, defines a patient as a possible carrier of CRE.

Table 6. Patients at-risk for CRE carriage (Magiorakos et al., 2017).

If the patient fulfils any of the criteria stated in Table 6, he is qualified as a patient at-risk of CPE carriage and supplementary measures should be applied in case of such a pa-tient. Those measures include:

• pre-emptive isolation

• active screening for CRE

• contact precautions.

First, pre-emptive isolation means that a patient is directly placed in a room alone, either in a standard single room or in a special isolation room, instead of being included in the general patient flow. Second, active screening for CRE happens by obtaining rectal sam-ples or samsam-ples from any other body side that is already actively infected or can be considered as colonized. Last, contact precautions mean that anyone who enters the

Any patient who has one of following risk factors is ‘at-risk’ for carriage of CRE:

a. A history of an overnight stay in a healthcare setting in the last 12 months

b. Has been either dialysis-dependent or received cancer chemotherapy in the last 12 months c. Known history of previous carriage of CPE in the last 12 months

d. Has been previously epidemiologically linked to a patient known to be a carrier of CPE

patient’s room should follow specific contact rules, such as wearing personal protective clothing or performing proper hand hygiene.

If a result of screening for CRE is positive, supplementary precautions are continued and additional precautions measures, like active screening of contact patients or enhanced environmental screening, are advised. If the screening result is negative and there are no other reasons, such as colonization with another multidrug-resistant organism or transmissible infection, to continue supplemental measures, isolation and contact pre-cautions discontinuation may be considered. The decision of discontinuation of the con-tact precautions based on screening results must be followed by risk assessment, espe-cially in the case of a patient that has a history of CRE carriage. In practice this means, that a patient who is screened at admission, has no history of CRE carriage and obtains negative result(s), can be released from supplemental precautions and join general pa-tient flow.

The guidelines proposed by ECDC are not compulsory for each European hospital but rather present a set of best practices to fight the spread of carbapenem resistance. As stated in the document (Magiorakos et al, 2017), hospitals may adapt or adopt proposed practices to the local CRE epidemiological needs, and financial and structural resources availability. Therefore, decisions regarding when and how to screen, type and quality of precaution measures taken vary greatly between hospitals in different countries and may even vary between different regions within one country. For example, it is not uncommon practice that a patient must have not just one but two or three consecutive negative screens to discontinue supplemental measures, and those screens might be taken in different intervals in different hospitals. Decisions about multiple screenings are based on the possibility of a test giving a false-negative result due to non-standardized proto-cols for sampling and microbiological testing. Furthermore, many hospitals isolate only positive patients. That happens especially in the case when a facility lacks single or iso-lation rooms to isolate patients, and isoiso-lation of one patient in a multiple-patient room is not financially feasible for that facility.

As this section shows, despite the guidelines, there are no unified practices and proce-dures of how patients ‘at risk’ of CRE carriage are handled in the hospital. Thus, each institution approached by the case company may have its own practices and processes built on general guidelines. This illustrates that, while the company’s offering is relatively standard, the use of the offering in different healthcare settings may result in a difference in the value perceived by the case company’s customers. Concluding, the use situation may have a high impact on the potential and actual customer value to be derived from the use of the case company’s offering.