1. What patient data need to be collected for the survey?

Essential data to collect are:

• the patients’ age and sex
• antimicrobial agent
• dose per administration
• number of doses per day
• route of administration
• quality indicators for prescribing:
  • documentation of reason in notes
  • Guideline compliance
  • Documentation of stop/review date

Other mandatory variables include:

• diagnosis or reason for prophylaxis based on a provided list of diagnoses/reasons, following the anatomical site.
• indication for therapy (community versus hospital-acquired infection, medical versus surgical prophylaxis).
• whether cultures were sent to the lab to document infection, and if the treatment choice is targeted based on identified micro-organisms and available microbiological or biomarker data.

For the optional HAI module, extra details on invasive devices are collected (e.g. peripheral vascular catheter, indwelling urinary catheter etc.).

2. Do I need to record the weight for adult, pediatric and neonatal patients?

Weight is an optional variable. You can leave it open, but preferably fill in the information for pediatric and neonatal patients (if this is known), since weight can be of great interest and relevance for this subgroup of patients.

3. When should I consider a treatment based on a biomarker?

You should consider a treatment based on a biomarker if the result of the biomarker is available at 8 a.m. on the day of the survey, and if the result solely or complementary to other clinical signs or microbiological tests contributed to the decision to treat with an antimicrobial and/or to the choice of a treatment.

Example:

• If CRP results are used as an indicator for the presence of an infection, and hence supported the decision to start an antimicrobial treatment, you can score this treatment as based on a biomarker, even though the CRP result is not used for the choice of the antimicrobial drug.
• If a biomarker result was obtained after 8 a.m. on the day of the survey, or a few days after the survey, and was used for review and follow-up of the antimicrobial treatment, score the treatment as not based on a biomarker, i.e. treatment based on a biomarker is ‘no’, because this result was not available at the time of the survey.

4. What is classified under the category “other biomarker” regarding the type of biomarker?

Category ‘other’ refers to lab biomarkers other than CRP, PCT or WBC.

Example:

• If a prescription is based on the WBC and temperature of a patient, do not classify this as ‘other’, but please choose WBC as option.
• Other non-biomarker diagnostic tests cannot be scored as ‘other biomarkers’. These include for example polymorphonuclear leukocytes (PMN, PML, or PMNL) in articular fluid. However, ‘erythrocyte sedimentation rate’ (ESR or sed rate), an indirect measure for the rate of inflammation, can for example be scored as ‘other biomarker’.

5. What should I record for the start date of the antimicrobial?

Please record the date when the antimicrobial was started, if this information is known. If this is not known, you may leave this field blank, as it is an optional variable.

Please do not write down the day of the survey if the actual start date is unknown.

6. How should I report the route of administration?

Please choose between the following routes of administration: Oral (O), Parenteral (P), Intramuscular (IM), Inhalation (I) and Rectal (R).

The parenteral route includes the following routes of administration: intravenous (IV), subcutaneous (SC or SQ), intraosseous (IO), intraperitoneal (IP) and intrathecal (IT). While the intramuscular (IM) route of administration is also a form of parenteral administration, it should be coded as ‘Intramuscular’ (IM) rather than ‘Parenteral’ (P).

Example:

• A patient receives antimicrobial treatment through intraperitoneal administration. The route of administration here is ‘Parenteral’ (P).

7. How should I report the dose?

You need to report the dose in (1) Single Unit Dose and (2) Number of doses per day (N doses/day).

Single Unit Dose records the dosage given for 1 dose. Number of doses per day records how many doses are given each day.

8. How should I report the dose for children?

For children, the dose is often expressed in mg/kg/day. Please convert this to mg per single dose by multiplying it by the weight of the child.

Example: 20 mg/kg/day for a 45 kg child, divided into 3 doses: Single Unit dose = 300 mg. N doses/day = 3.

(Total dose per day = 20 mg * 45 kg = 900 mg/day. The doses are administered 3 times a day: 900 mg / 3 = 300 mg. Hence, the Single Unit dose = 300 mg, and the N doses/day = 3.)

9. How should I record the dose of an antibiotic with enzyme inhibitor?

If an antibiotic with enzyme inhibitor was prescribed, such as piperacillin with tazobactam, or amoxicillin-clavulanate, please record only the dose of the antibiotic. Exclude the dose of the enzyme inhibitor. For example:

• 3.375 g piperacillin/tazobactam, of which 3 g is piperacillin. Only these 3 g should be reported.
• 1.2 g amoxicillin/clavulanic acid, of which 1 g is amoxicillin. Only the 1 g should be reported.

For fixed-dose combinations of active antimicrobials (such as co-trimoxazole), please record the dose of both antimicrobials!

10. How should I record fixed-dose combinations of active antimicrobials?

For fixed-dose combinations of active antimicrobials, such as sulfamethoxazole and trimethoprim (co-trimoxazole), please record the dose of both antibiotics. For example:

960 mg co-trimoxazole, of which 800 mg is sulfamethoxazole and 160 mg trimethoprim. You should report the 960 mg.

Please record fixed-dose combinations as one antimicrobial in Global-PPS! For these combination therapies, add the dose of the first antimicrobial (800 mg) to the dose of the second antimicrobial (160 mg).

Exception: if a physician prescribes two antimicrobials for one diagnosis, but this is not a fixed-dose combination (e.g. amoxicillin and clarithromycin), you should record this as two separate antimicrobials for the same diagnosis, and record for each their own dose.

A few examples of fixed-dose combinations include

• Sulfamethoxazole and trimethoprim
• Artesunate and amodiaquine
• Ampicillin and cloxacillin (“Ampiclox”)
• Rifampicin, isoniazid, pyrazinamide, and ethambutol
• Emtricitabine, tenofovir alafenamide and rilpivirine

11. How should I report the dose for antimicrobials prescribed a few times per week?

If a patient receives an ongoing antimicrobial treatment a few times a week, e.g. 3 times a week (even if the patient does not receive the treatment on the day of the survey itself), you should write down the single unit dose as the actual dose that the patient receives, but change the N doses/day to 0.5 (every other day), 0.43 (twice a week), 0.33 (every 72 hours), 0.29 (twice a week), 0.14 (once a week), etc.

Examples:

• 500 mg every other day: Single Unit Dose = 500 mg. N doses/day = 0.5 (= 1 dose / 2 days)
• 750 mg every 72 hours: Single Unit Dose = 750 mg. N doses/day = 0.33 (= 1 dose / 3 days)
• 2 g every week: Single Unit Dose = 1.2 g. N doses/day = 0.14 (= 1 dose / 7 days)
• 1 g twice a week: Single Unit dose = 1 g. N doses/day = 0.29 (= 1 dose / 3.5 days)

12. How should parenteral (IV) continuous infusion be reported?

For parenteral continuous administration, such as continuous 24 hours administration of vancomycin through a pump system, please provide the total dose divided by the number of hours of administration.

Example:

• Drug name = vancomycin
• Administered single dose= total dose over 24 hours / 24 (=total dose divided by 24)
• Unit of dose = mg
• Times a day = 24
• Route = P

13. How should I record the diagnosis?

Please record the diagnosis as the reason to administer antimicrobials to the patient. For the diagnostic code, use the list of codes in the inpatient Patient Forms, which is split up into treatment and prophylaxis and outlined by anatomical site (see Appendix II in the data collection templates under 調査用書類).

If the antimicrobial was prescribed for more than one reason, choose the most relevant reason. Request additional information from doctors, nurses, or pharmacists if needed. If there is no ‘most relevant option’, you could choose the first identified infection.

Examples:

14. Which diagnostic code should I choose if the diagnosis is uncertain?

If the diagnosis is uncertain, the diagnostic code that should be assigned depends on a few things:

• If the diagnosis or reason for treatment is not documented in the notes, you can ask for clarification from the ward staff or prescribers if possible. In this case, please remember to answer ‘No’ to the question ‘Reason documented in notes’.

Specific scenarios to consider:

• If you have a policy in your setting that certain patients (e.g. premature newborns with or without certain risk factors) get treated with antibiotics directly after admission (or delivery), not based on any clinical signs and symptoms, please code this as Medical or Surgical Prophylaxis (NEO-MP for premature newborn patients).
• If the treatment is based on clinical signs and symptoms, whether they are due to infection or otherwise, please do not encode this as prophylaxis, but rather as the most appropriate clinical diagnosis. If fear of sepsis is the reason for treatment, you could indicate sepsis as diagnostic code.
• If a treatment was started e.g. for a suspected infection, but this was ruled out earlier and changed to a non-infectious diagnosis (e.g. thrombosis of the iliac veins), and the treatment was not stopped, please choose the diagnosis ‘Other’ (and the indication ‘).
• If an antibiotic is started based solely on a biomarker result, e.g. elevated CRP levels, the diagnosis and indication should be ‘Other’.

15. What diagnosis should I choose for patients with sepsis of  known origin, e.g. urosepsis?

If a patient has sepsis with a known origin, such as urosepsis, please choose the appropriate anatomic site for the diagnostic code. Do not choose the code sepsis since this code is only meant for cases of sepsis where the anatomic site is unknown.

For example: For patients with urosepsis, this would be Pye/Cys (preferably Pye, since this will more likely cause sepsis). For patients with meningitis, please choose CNS.

16. What if an incorrect diagnosis was made and was only discovered during the audit?

If an incorrect diagnosis was made, e.g. due to incorrect interpretation of the microbiology data, and this was discovered during the audit, please continue the PPS as if the correct diagnosis was made: consider the given diagnosis on 8 a.m. of the survey for the guideline compliance, reason in notes, etc.

If the incorrect diagnosis and consequently the prescription might be harmful in any way for the patient, please inform the prescriber immediately to safeguard patient care. Please record the original (incorrect) diagnosis in the survey, even if this diagnosis and treatment were later changed, since this would have been the practice if the auditor had not informed the prescriber.

17. When should I classify an infection as a Community-Acquired Infection (CAI) and when as a Hospital-Associated Infection (HAI)?

By definition, if symptoms started before 48 hours after admission, then you should classify it as community-acquired. If symptoms occurred 48 hours after admission, encode it as hospital-associated. 

Exception: if a patient was re-admitted with a surgical site infection, this is by definition code HAI1.

Specific scenarios to consider::

• If an infant is admitted directly after birth from the delivery room and is now under treatment for sepsis, this is classified as community-acquired, since symptoms started <48 hours after admission. In addition, all early onset sepsis (i.e. at age <48 hours) is classified as community acquired (CAI) according to the protocol.
• If a patient is admitted for sepsis, but the patient was on dialysis, chemotherapy or was a recipient of OPAT in the past month, you should still classify this as CAI, since sepsis was acquired <48 hours after admission. Outpatient-related infections are not defined in the Global-PPS, therefore, to keep it simple, please record this as CAI.
• If a patient was admitted after 4 days with a surgical site infection, this is classified as HAI1.
• If a burn patient undergoes debridement early during their hospital stay and subsequently obtains an infection, it is considered CAI if this is <48 hours after admission. It is considered HAI if >=48 hours after admission.

Can I record multiple diagnoses and indications?

No, you can only score one reason to treat. You cannot score multiple diagnoses and indications. If your prescription was based on multiple diagnoses and indications, please choose the most relevant one. Request additional information from doctors, nurses, or pharmacists if needed. If there is no ‘most relevant option’, you could choose the first identified infection.

18. How should I encode an antimicrobial prescribed for prophylaxis?

Please choose for the Diagnostic code the prophylaxis option for the most appropriate anatomic site. When the prophylaxis is for general use, not targeting a specific organ or site, please choose Medical Prophylaxis in General (MP-GEN).

After choosing the appropriate diagnostic code, select the appropriate indication code to record whether it concerns a Medical or Surgical Prophylaxis. For Surgical Prophylaxis, additionally choose between a single dose Surgical Prophylaxis (SP1), one day Surgical Prophylaxis (SP2), or >1 day Surgical Prophylaxis (SP3).

Examples:

• Please choose Prophylaxis for Respiratory pathogens (Proph RESP) if e.g. azithromycin is prescribed as prophylaxis for exacerbations of COPD. Since this is not prescribed as surgical prophylaxis, please choose Medical Prophylaxis as Indication.
• Please choose Prophylaxis for Gastro-Intestinal pathogens (Proph GI) if e.g. rifaximin is prescribed as prophylaxis for hepatic encephalopathy. Since this is not prescribed as surgical prophylaxis, please choose Medical Prophylaxis as Indication.

19. How should I record the Reason in Notes?

Reason in Notes captures information on whether the reason for prescribing an antimicrobial is documented in the notes (medical, nursing, or other files) at the start of treatment. It must be clearly written down so anyone (e.g. a replacing clinician or other staff member) can easily understand the rationale when consulting the medical or nursing files. 

Specific scenarios to consider:

• Even if all staff are aware that e.g. amoxicillin-clavulanate (Augmentin) is prescribed for pneumonia in a certain patient, but this is not recorded in the patient’s files, you should score ‘no’ for Reason in Notes.
• If the reason is very briefly but clearly described somewhere in the patient’s files, please score ‘yes’ for Reason in Notes.
• If the prescriber did not record it, but e.g. the nurse or pharmacist recorded the reason for prescription, then the reason is still visible in the patient’s files, which is the aim of this variable. In this case, score ‘yes’ for Reason in Notes.
• If a surgery report includes a section listing all administered medications, you can mark ‘yes’ for Reason in Notes if an antimicrobial is present, even if it is not explicitly labelled as surgical prophylaxis. It is reasonable to assume that the antibiotic was given for this purpose, given its context within perioperative care.

20. How do I record guideline compliance?

To record guideline compliance for an antimicrobial prescription, you need to check:

• Whether local guidelines exist. Please refer to the guidelines that are used on the wards, whether these are institutional, national, or international guidelines (e.g. WHO guidelines).
• Whether the drug is compliant with these guidelines:
  • Y – Yes
  • N – No
  • NA – Not Assessable because of absence of local guidelines for the specific indication
  • NI – No Information because diagnosis/indication is unknown).

Please tick ‘No Information’ if the diagnosis is completely unknown or if the diagnosis is ‘Other’, in this case you cannot be certain whether the prescription is according to local guidelines.

Following the advice of an infectious disease specialist is considered as guideline-compliant.

21. How do I record guideline compliance for combination therapies?

Guideline compliance must be recorded for each antimicrobial: if one patient receives multiple antimicrobials, please assess for each prescription whether it was according to the local guidelines.

If multiple antimicrobials are prescribed for one diagnosis, but the guidelines recommend monotherapy, please score one of these antimicrobials as guideline-compliant (if the guidelines do recommend monotherapy with this antimicrobial) and score the other antimicrobials as non-compliant.

In the feedback report, we analyze guideline compliance at patient- & diagnosis-level:

• If all antimicrobials are compliant for one diagnosis = treatment is guideline-compliant
• If one antimicrobial is non-compliant but other antimicrobials are compliant for one diagnosis = treatment is not guideline-compliant

22. What if the dose or duration of the prescription are not compliant to guidelines?

In the inpatient protocol, compliance to guidelines refers to the choice of drug, not the dosing, and also not the route of administration or duration of therapy. To keep it simple, in this case the treatment is according to the guidelines because the choice or type of antibiotic was according to the guidelines.

23. What does the question mean: “Is a stop/review date documented?”

This question assesses whether an end date for stopping antibiotic treatment or prophylaxis, or a review date for re-evaluating it, is documented in the patient file or another written document. It must be recorded in writing, not just communicated verbally.

Specific scenarios to consider:

• If the antimicrobial is prescribed ‘until cultures are ready’ or ‘awaiting infectious disease physician to review’, then the prescription will be reviewed later. In these cases, you can select ‘Yes’ for ‘Is a stop/review date recorded?’.
• In case of an automatic stop order (ASO) of e.g. 3 days on all antibiotics/antimicrobials: according to the protocol, the stop or review date should be documented in the notes. If the day of therapy is displayed in the patient chart or medical record (e.g. ‘day 1 of 3’), answer ‘Yes’. However, if the day of therapy or duration of treatment is not explicitly stated in the record, answer ‘No’, even if the prescribing physician is aware of the ASO of 3 days.

24. When should I consider a treatment as Targeted treatment, and when as Empiric?

The treatment should be considered as empiric:

• When no microbiological examinations (culture and sensitivity testing) were done to guide treatment,
• When microbiological examinations were done, but the results were not yet available at the time of the PPS,
• When the results of the microbiological examinations were negative or not assessable (e.g. ‘no growth’).

The treatment should be considered as targeted:

• When the treatment is based upon a positive microbiological result. This can be any culture and/or sensitivity result from a relevant clinical specimen. If a microbiological result is available at 8 a.m. on the day of the survey and the treatment is in line with this result, we assume there is enough evidence to say that the treatment is targeted.
• If a specific microorganism has been identified and it is either susceptible, no specific resistance type was found, or sensitivity testing was not performed, you can still score the treatment as ‘targeted’ and complete the microorganism fields but leave the resistance type fields blank.

For prophylactic prescriptions (surgical or medical), score empiric treatment or leave this field open.

Specific scenarios to consider:

• If the microbiological result is outdated and not currently relevant, then the treatment counts as empiric. If the microbiological result is old but still relevant, such as an ever-recurring infection, then the treatment counts as targeted.
• In case the microbiological result is known, yet the antimicrobial treatment is not adapted to this result (e.g. not de-escalated) and hence is not the most appropriate choice, please still choose targeted treatment. You can still record the microbiological result data in the form. However, be sure to take this potentially inappropriate choice into consideration for the ‘Guideline compliance’ variable.
• In case the microbiological result is obtained, but the treatment is not yet adapted to this result because the prescriber has not had the time yet at 8 a.m. to revise the prescription, please record the original antimicrobial prescription on 8 a.m. on the day of the survey and score this as empirical if the microbiological results were not available when this prescription was originally prescribed.

25. What microorganisms and resistance types should I report for targeted treatments?

Choose up to three of the (most relevant) microorganisms found based on the microbiology results. Please find a list of all available microorganisms and resistance types to choose from in the Inpatient Data Collection Forms (Appendix IV) under 調査用書類.

All relevant microorganisms should be reported, even if they are sensitive to all tested drugs. For sensitive microorganisms, do not fill in any resistance type. Please only fill in the resistance type fields if you have a confirmed resistance type (e.g. by antibiogram).

If you have any microorganism that is not included in this list, please choose ‘other Enterobacterales’, ‘other bacteria’ or ‘other fungi’. If you have any resistance type that is not included in the list, please choose ‘other MDRO’. 

Example:

• Resistance types for Amp C-producers, such as Serratia marcecens, or Morganella morganii, fall under ‘other MDROs’.

26. Which invasive devices are scored under the HAI module — HAI MODULE QUESTION

All invasive devices that can be scored are the following, and can also be found in the HAI Inpatient Data Collection Forms under 調査用書類:

• Indwelling Urinary Catheter (UC)
• Peripheral Vascular/intravenous Catheter (PVC)
• Central Vascular Catheter (CVC)
• Non-invasive positive and negative mechanical ventilation (CPAP, BiPAP, CNEP, etc.)
• Invasive respiratory endotracheal intubation (IRI)
• Inserted tubes and drains (T/D)

Example:

Invasive devices which can be scored are:

• Percutaneous endoscopic gastrostomy (PEG) should be encoded as Tube/drain.

Invasive devices which should not be scored are:

• Although a Nasogastric tube (NGT) and Nasojejunal tube (NJT) are essentially considered as an invasive device, these are not scored as Tubes and drains. They are not passing the skin as such where we want to make the relation with SST infections; and they do not belong to any other category either e.g. (not IRI)
• Arteriovenous fistula is considered as a minimally invasive treatment option for hemodialysis, but is not scored as an invasive device for the Global-PPS.
• The invasive device Port-a-Cath as an implantable venous port is not scored as a central line.