Summary of major changes

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Summary of major changes The first SSI surveillance protocol was produced in 2002. Changes have been applied, either based on the issue of Scottish Government directives or to align Scotland s SSI surveillance programme internationally to enable comparison. This document is an update of SSI surveillance protocol 6 th edition and incorporates changes mandated in HAI DL (2015) 19 and in addition aligns to ECDC SSI surveillance updated protocol (in press). The main changes include: 1. Elective vascular and large bowel procedures are added to the mandatory requirements of SSI surveillance. This enables clinical decisions for improvement to be informed by reliable data for procedures highlighted within the HAI point prevalence studies of 2009 and 2011. 1 2. Revision of presentation to surgery definitions; elective surgery procedures include operations that have been planned at a time to suit both patient and surgeon, emergency surgery procedures are unplanned, immediate lifesaving operations. 3. For mandatory procedures inpatient and readmission surveillance is required, to 30 days (voluntary for caesarean section) if no implant is left in place or to 90 days if an implant is left in place. This reduces the previous surveillance period when an implant is in place from one year to 90 days. 4. When NHS boards provide CHI and operation dates HPS will conduct readmission checks between 31days and 90 days. HPS will obtain these readmission data from linked data sources and report annually. However local data analysis of readmission SSI is valuable for clinical improvement. 5. Mandatory SSI surveillance of caesarean section and hip arthroplasty continue as light surveillance with standard SSIS surveillance a requirement for large bowel and vascular procedures. 6. Voluntary SSI procedures, when selected by NHSboards for submission to HPS, must as a minimum include readmission surveillance to 30days. 7. Structure and process indicators (SPI) have been added to provide data for improvement. 2 8. Duration of operation includes any reoperation performed through the same incision within 24hrs of commencement of the original operation instead of previously within 72hrs. 9. An additional level of readmission data has been added, to collect information on the outcome of the readmission. 2

Contents 1. Specific objectives of Surgical Site Infection (SSI) surveillance... 4 2. Data Collection... 5 2.1. Inclusion criteria... 5 2.2. Monitoring patient for SSI... 6 2.2.1. Standard SSI surveillance... 6 2.2.2. Light SSI Surveillance... 7 2.2.3. Detection of SSI after discharge... 8 2.3. National SSI core dataset... 9 2.3.1 National Core Dataset... 10 2.4 Specific data for additional procedures... 13 2.5. Data definitions for core dataset... 15 2.5.1. Pre-operative... 15 2.5.2. Peri-operative... 17 2.5.3. Post-operative... 21 2.5.4. Microorganism and Antimicrobial... 25 3. Definitions... 27 3.1. SSI case definitions... 27 3.2. SSI Risk Index... 28 3.3. Wound Contamination Class... 29 3.4. The ASA Physical status classification (ASA Score)... 29 3.5. Duration of operation... 30 3.6. Cumulative incidence of SSI by category... 31 3.7. SSI incidence density... 31 3.8. Antimicrobial resistance markers and codes... 31 Reference List... 32 Appendices... 33 3

1. Specific objectives of Surgical Site Infection (SSI) surveillance At Hospital level: To monitor the incidence of SSI infection. Lower the incidence of SSI by collaborating with clinicians to: comply with evidence based guidelines correct or improve specific practices develop, implement and evaluate new preventative practices through follow-up, inter-hospital comparisons of adjusted (where possible) SSI rates and of compliance with key preventative measures. At National level: Monitor trends, including the detection of outbreaks and provide early warning and investigation of problems and subsequent planning and intervention to control. Provide analysis at national level Examine the impact of interventions. Gain information on the quality of care. Prioritise the allocation of resources. Healthcare providers can conduct SSI surveillance for each procedure either using the light or standard surveillance methodologies unless any mandatory requirements are in place. Light surveillance methods are only recommended after a period of full surveillance, this is to ensure the risk factors for SSI are fully understood within the patient population. Therefore it is a requirement that new mandatory procedures (large bowel and vascular procedures) are conducted using standard surveillance until further notice. 4

2. Data Collection 2.1. Inclusion criteria Data is collected at hospital level. Each healthcare provider should undertake surveillance on all patients within the four mandatory operation categories, these are: caesarean section, hip arthroplasty, large bowel* and vascular* procedures where these operation categories are carried out. Where mandatory procedures are not carried out surveillance must be conducted on at least two operational categories by the addition of voluntary procedures. *Mandatory large bowel and vascular procedures only include elective procedures NB The denominator for the SSI surveillance programme is procedures, not patients. Appendix 1 lists all included OPCS codes (http://www.hps.scot.nhs.uk/guidelines/detail.aspx?id=827 ) Mandatory procedures: caesarean section hip arthroplasty large bowel surgery - (elective only) vascular surgery - (elective only) Voluntary procedures: abdominal hysterectomy breast surgery cardiac surgery coronary artery by-pass grafting (CABG) cranial surgery knee arthroplasty reduction of long bone fracture repair of neck of femur 5

Identification of study population A method must be in place locally to ensure that all patients who have had the specified operations are included in the surveillance. Theatre and ward staff should be fully aware of which groups of surgical patients are under surveillance and reminded of this at regular intervals by local surveillance staff. NB. Vascular and large bowel procedures exclude emergency procedures 2.2. Monitoring patient for SSI 2.2.1. Standard SSI surveillance Standard surveillance includes both inpatient and readmission surveillance; to 30 days (voluntary for caesarean section) if no implant is left in place, or to 90 days with an implant in place. HPS will obtain readmission data from 31-90 days to report annually. Medical and nursing records, information from clinical personnel and positive microbiology cultures can be used as sources for potential identification of SSIs. Date and signs and symptoms of SSI onset must be recorded on the surveillance form. The discharge date is required unless it is after 30 days surveillance. If no infection is detected this should be recorded on the form on completion of the surveillance i.e. transfer, death, reoperation at same site, end of 30 day surveillance. Surveillance of the surgical wounds ends by end of 30 days surveillance, regardless of whether an SSI is confirmed, or if patient outcome is transfer or death. 6

If a patient is transferred during the surveillance period surveillance must continue. Mechanisms should be in place locally for any patients who are transferred, and to ensure that completed forms are returned from all hospitals to the local surveillance co-ordinator. Data is uploaded onto SSIRS website and is completed by the specified data (supplied by HPS) to enable report data to be analysed by HPS. All SSI reporting timescales can be found http://www.hps.scot.nhs.uk/guidelines/detail.aspx?id=800 For Web Based Reporting, see Appendix 3, SSIRS user manual (http://www.hps.scot.nhs.uk/guidelines/detail.aspx?id=827 ) 2.2.2. Light SSI Surveillance Denominator and SSI data All procedures within the chosen category (all included OPCS codes ) must be totalled and entered monthly onto the SSIRS denominator page. Local processes should be in place to ensure that all patients diagnosed with an SSI are captured locally. Mechanisms are required locally to ensure that all patients diagnosed with an SSI, (as an inpatient or readmitted due to SSI) have surveillance data recorded. Patients diagnosed with an SSI must have ALL data collected as per the Standard SSI surveillance. This may be data collected from local software systems and/or patient records. Infection data are required to be uploaded onto SSIRS website by the specified dates in the reporting timescale. 7

2.2.3. Detection of SSI after discharge All categories of surgery included in the national surveillance programme must undertake readmission surveillance for 30 days (voluntary for caesarean section) post operatively or 90 days if an implant is left in place. When NHS boards provide CHI and operation date HPS will conduct readmission checks between 31-90 days from linked data sources. Currently hospitals undertaking caesarean section surveillance must undertake PDS for this category until day 10 post operatively. Voluntary SSI procedures must as a minimum include readmission surveillance to 30 days. 8

2.3. National SSI core dataset The table shows data that are required for each procedure. Remember Where patients have bilateral procedures, two forms should be completed, i.e., one for the left side and one for the right side. In case of a reintervention within 24hrs after the primary procedure, the duration of the reintervention will be added to the duration of the primary procedure. Record both readmission admission and discharge date. If patients undergo reoperation at the same site of the original surgery within 30 days or 90 days if an implant is left in place, the surveillance form relating to the initial operation should be completed, if still being utilised, and a new one commenced for the new episode of surgery (if second procedure is under surveillance). Elective surgery definition This includes operations that have been planned at a time to suit both patient and surgeon (for example elective hip or knee replacements), and early operations on more serious cases arranged around theatre time. For example, open reduction of fracture or fractured hip repair on patients admitted following trauma and classified as emergency admission but where there is time to carry out pre-operative preparation. Emergency surgery definition - This should be applied to unplanned, immediate life-saving operations, and operations conducted as soon as possible after resuscitation. For example, patients admitted as an emergency with critical conditions or inpatients whose condition suddenly deteriorates for example bowel obstruction/perforation, CABG following myocardial infarction and arrest or leaking aneurism. 3 Note: Elective operations include patients admitted as an emergency but scheduled into theatre after pre-operative preparation. 9

2.3.1 National Core Dataset Pre operative Hospital code CHI (Community Health Index) Number Presentation to surgery (elective/ emergency) Sex Age Date of admission Date of operation Height Weight Hair removal Mandatory Mandatory Peri operative Procedure category Anaesthesia type ASA classification Prophylactic antibiotics given Name of prophylactic antibiotics Antibiotic administration date and time Alcohol-based skin preparatory agents for preoperative antisepsis in the operating room Start time of operation (knife to skin) Completion time of operation (skin closure) Mandatory Mandatory Mandatory Mandatory 10

Operator Grade Laterality of procedure (if applicable) Perioperative glucose monitoring performed and documented Office of Population Censuses and Surveys (OPCS) code Wound class (contamination) of operative procedure Implant More than one procedure performed Minimally invasive surgery Ensuring the patient's normothermia within one hour of the end of operation (36-38 C (rectal measurement) or 35,5-37,5 C (non-rectal measurement)): Re-intervention within 24hours Start time of re-intervention Completion time of re-intervention Mandatory Mandatory Mandatory Mandatory Post-operative Was patient given thromboprophylaxis? Date & Time antibiotic last given Is patient receiving antibiotics >24hrs following surgery? Reason if patient receiving antibiotics >24hrs following surgery Was antibiotic prophylaxis in line with local guidelines? SSI diagnosed Type of SSI Mandatory 11

Site of organ space SSI Criteria used to determine SSI Detection of SSI Patient readmitted for SSI Date of confirmed SSI Date of discharge, transfer or death (post-operative stay) Date of re-admission to hospital Date of discharge, transfer or death following re-admission Date surveillance discontinued Reason surveillance discontinued Death related to SSI Microorganisms isolated (List up to 3) Antimicrobial sensitivities for microorganisms isolated Is the patient receiving antimicrobials? Antimicrobials received (List up to 3) Mandatory 12

2.4 Specific data for additional procedures Pre operative Cranial radiation treatment in the last year Chemotherapy in last month Long term (>one week) steroid therapy Diabetic patient? Extension Type for Cranial Surgery for Cranial Surgery for Cranial Surgery for Large Bowel Surgery and Major Vascular Surgery Renal failure? for Major Vascular Surgery Critical limb ischemia? for Major Vascular Surgery Claudication? for Major Vascular Surgery Diagnosis / Reason for surgery for Cranial Surgery, Large Bowel Surgery and Orthopaedic Surgery Peri operative Duration of labour If more than one dose given (antibiotic prophylaxis) state reason for Caesarean Section for Caesarean Section Name of antibiotic(s) given (list up to 4) for Caesarean Section, Large Bowel Surgery, Major Vascular Surgery and Orthopaedic Surgery Was blood loss greater than 1.5 litres? Laparoscopic-assisted approach Was a consultant present during the operation? for Caesarean Section for Large Bowel Surgery for Large Bowel Surgery, Major Vascular Surgery and Orthopaedic Surgery 13

Consultant code responsible for patient care Locum Was antibiotic loaded cement used? Cranioplasty type Intracranial monitoring in place Revision surgery Drain type for Large Bowel Surgery, Major Vascular Surgery and Orthopaedic Surgery for Orthopaedic Surgery for Orthopaedic Surgery for Cranial Surgery for Cranial Surgery for Cranial Surgery for Cranial Surgery Individual data collection forms can be designed for hospitals. Some additional local reporting data fields can be accommodated. Please contact HPS to discuss addition of local fields. These items will be collected and the facility to extract this data locally is available however local data items will not be analysed or reported on by HPS. 14

2.5. Data definitions for core dataset 2.5.1. Pre-operative Notes for completion: Data item Description Format Hospital Patient CHI Number Hospital in which the operation is performed and surveillance is taking place. National Patient Healthcare Number Alphabetic frame of 16 character on paper form 10 digit numeric frame Presentation to surgery Whether patient was taken to theatre as an emergency (unplanned) or was on an elective (including pre operative preparation) theatre list: Sex Gender of the patient Age Age of patient on day of operation 3 digit numeric frame. If not documented, record as 999. Date of admission Date patient was admitted to the hospital Date frame. DD/MM/YYYY If the exact date is not documented, record as 09/09/9999 Date of operation Date of operative procedure Date frame. DD/MM/YYYY If the exact date is not documented, record as 09/09/9999 Height Weight Hair removal Height of patient in centimetres For caesarean section procedures, booking height should be recorded Weight of patient in kilograms For caesarean section procedures, booking weight should be recorded What was hair removal technique if any was used pre-op 3 digit numeric frame. If not documented, record as 999. 3 digit numeric frame. If not documented, record as 999. 15

Diabetic patient? Renal failure? Critical limb ischemia? Claudication? Does the patient suffer from diabetes mellitus? Does the patient suffer from chronic kidney disease or acute kidney failure? Does the patient suffer from ischemic leg pain, ulcers and gangrene, attributable to arterial disease? Does the patient suffer from pain and cramping caused by reduced blood flow to the legs? for Large Bowel Surgery and Major Vascular Surgery for Major Vascular Surgery for Major Vascular Surgery for Major Vascular Surgery Diagnosis / Reason for surgery The diagnosis and reason for colorectal surgery. Has patient undergone any of the following? for Large Bowel Surgery, Orthopaedic Surgery and Cranial Surgery Cranial radiation treatment in the last year Chemotherapy in last month Long term (>one week) steroid therapy Has the patient received cranial radiation treatment in the last year pre operatively? Has the patient received chemotherapy treatment in the last month pre operatively? Has the patient received long term, i.e. of duration greater than one week, steroid therapy? ( for Cranial Surgery only) ( for Cranial Surgery only) ( for Cranial Surgery only) 16

2.5.2. Peri-operative Notes for completion: Data Item Description Format Duration of labour Duration of labour is the length of time the state of labour lasts from onset to the delivery of the placenta, expressed as the number of completed hours Anaesthesia type Type of anaesthetic given for the procedure. This can be general (GA) where drugs or gases are given to render the patient unconscious, local (LA) where the area being operated on is infiltrated with chemicals or regional (Spinal) where the lower area of the body is paralysed with chemicals ASA classification An assessment by the anaesthetist of the patient s preoperative physical condition using the American Society of Anaesthesiologists (ASA) classification of physical status. This is an element of the National Nosocomial Infection Surveillance (NNIS) SSI risk index Was patient given antibiotic prophylaxis If more than one dose given (antibiotic prophylaxis) state reason Name of antibiotic(s) given (list up to 4) This is an antibiotic given to prevent infection that is not therapeutic i.e. for treatment of infection for Caesarean Section Which antibiotic prophylaxis was given to the patient? 4 digit numeric frame (24hr clock). If not documented, record as 9999 ( for Caesarean Section Surgery only Select all options that apply Open text ( for Caesarean Section Surgery only) / Open text on paper forms. for Caesarean Section, Large Bowel Surgery, Major Vascular Surgery and Orthopaedic Surgery 17

Date prophylactic antibiotics first given Time prophylactic antibiotics first given Use of alcoholbased skin preparatory agent for pre-op antisepsis Start time of operation Completion time of operation Which grade of surgeon performed the operation Was a consultant present in the theatre Consultant code responsible for patient care Was operation carried out by a locum Date of administration of the first prophylactic antibiotic dose. Conditional on patient receiving antibiotics Time (in 24 hour clock) of administration of the first prophylactic antibiotic dose. Conditional on patient receiving antibiotics Was alcohol-based antisepsis agent used for skin preparation in the operating room (if no patients contraindication exist) Time (in 24 hour clock) of skin incision Time (in 24 hour clock) of skin closure Grade of surgeon, who performed operation, includes grade of locums. Where more than one surgeon performs the operation, the principle operator should be recorded Surgeon present in the theatre for the majority (at least half) of the procedure Enter code of named consultant responsible for the care of the patient. A 3-digit code is provided by participating hospital / board Does the surgeon who is operating hold a locum appointment? Date frame. DD/MM/YYYY If the exact date is not documented, record as 09/09/9999 4 digit numeric frame (24hr clock). If not documented, record as 9999 4 digit numeric frame (24hr clock). If not documented, record as 9999 4 digit numeric frame (24hr clock). If not documented, record as 9999 ( for Orthopaedic, Large Bowel and Vascular Surgery) 3 digit numeric frame. If not documented, record as 999 ( for Orthopaedic, Large Bowel and Vascular Surgery ( for orthopaedic Surgery only) 18

Category of procedure Perioperative glucose monitoring performed and documented Laterality of procedure OPCS code Cranioplasty type Is intracranial monitoring in place Wound class of procedure Prosthetic implant inserted An operation category is the category that the specific operation fits into. Is the glucose monitoring in place and documented in patient charts or checklists Side procedure performed on, if applicable. If a bilateral procedure is carried out two forms should be completed stating the laterality of each procedure. Classification of operations and surgical procedures produced by the Office of Population Censuses and Surveys. If this is not known then operative procedure in full text should be provided in part b of the field. Which cranioplasty type has been used? Is Intracranial monitoring in place? An assessment of the likelihood and degree of contamination of a surgical wound at the time of the operation. Wounds are divided into four classes; clean, cleancontaminated, contaminated and dirty or infected. (see SSI risk index wound class Pg 28) A nonhuman-derived foreign body that is permanently placed in the patient during an operative procedure and is not routinely manipulated for diagnostic or therapeutic purposes. Examples are joint prosthesis, nonhuman vascular graft, and mechanical heart valves. Screws, wires and mesh that are left permanently must also be considered implants. Non absorbable sutures and ( for orthopaedic Surgery only) 4 digit alphanumeric frame or open text ( for cranial Surgery only) ( for cranial Surgery only) 19

Was antibiotic loaded cement used? More than one procedure performed Minimally invasive surgery Laparoscopicassisted approach sternal wires are not counted as implants. Was antibiotic loaded cement used during the surgery More than one procedure was performed through the same incision during the same trip to the operating theatre. The entire operative procedure was performed using an endoscope/laparoscope Part of the operative procedure was carried out using a laparoscope. for Orthopaedic Surgery only for Large Bowel Surgery Was blood loss greater than 1.5 litres Was this revision surgery Drain type Patient's normothermia within one hour of the end of operation Major significant blood loss during the surgery greater than 1500ml Is this revision surgery i.e. the patient has had a previous procedure which is being revised. ( for caesarean section only) ( for cranial Surgery only) Which type of drain has been used ( for cranial Surgery only) Was the patient's temperature checked within one hour of the end of operation (36-38 C (rectal measurement) or 35,5-37,5 C (non-rectal measurement)), if no contraindication 20

2.5.3. Post-operative Data Item Description Format Re-intervention required within 24 hours Start time of reintervention Completion time of reintervention Was patient given thromboprophyl axis Date prophylactic antibiotic last given Time prophylactic antibiotic last given A re-intervention within 24 hours after the primary procedure e.g. for haematoma evacuation Time (in 24 hour clock) of skin incision Time (in 24 hour clock) of skin closure Thromboprophylaxis given any time during the inpatient stay? Date patient was given the last dose of antibiotic prophylaxis ( if more than one administration) Time patient was given the last dose of antibiotic prophylaxis Select one option 4 digit numeric frame (24hr clock). If not documente d, record as 9999. 4 digit numeric frame (24hr clock). If not documente d, record as 9999 Select one option Date frame. DD/MM/YY YY If the exact date is not documente d, record as 09/09/9999 4 digit numeric frame (24hr clock). If not documente d, record as 9999. 21

Is patient receiving prophylactic antibiotics >24hrs following surgery If yes, reason why? Indicate whether the patient is being given antibiotic prophylaxis for longer than 24 hours after the skin incision State the reason for why the patient is being given antibiotic prophylaxis for longer than 24 hours after the skin incision Select one option Open text Was antibiotic prophylaxis in line with local guidelines Surgical site infection has the patient developed an SSI Type of SSI Specific site of organ space Criteria used to determine SSI If there are local guidelines and policies set up for the use of antibiotic prophylaxis, was this administration in line with that If SSI is considered to be present. For surveillance classification purposes, SSI is divided into incisional SSI and organ/space SSI. Incisional SSIs are further classified into those involving only the skin and subcutaneous tissue (called superficial incisional SSI) and those involving deep soft tissues of the incision (called deep incisional SSI e.g., fascia and muscle layers). Organ/space SSI involve any part of the anatomy (e.g. organs or spaces), other than the incision, opened or manipulated during the operative procedure. (see 3.1) Specific sites are assigned to organ/space SSI to further identify the location of the infection. ( http://www.hps.scot.nhs.uk/guidelines/detail.asp x?id=827 ) Indicate which of the listed criteria were used to diagnose SSI. Select one option Select one option Select one option Select all options that apply Select all options that apply When was SSI detected Identification of when the infection was detected Select one option 22

Was patient readmitted for SSI within 30 (10) days Date of confirmed SSI Date if discharge, transfer or death Date of hospital re-admission Date of discharge, transfer or death following readmission Was the patient readmitted for a confirmed infection within 30 days of the operation this would be 10 days for caesarean section The date when the first clinical evidence of the SSI appeared or the date the specimen used to make or confirm the diagnosis was collected, whichever comes first Date the patient was discharged or transferred from hospital where surgery was carried out or date of death if precedes discharge or transfer. Date the patients was re-admitted during the follow up period to the hospital where the operation took place Date the patient was discharged from hospital where they were re-admitted during the follow-up period after the operation. If the readmission lasts until after the end of follow-up period, complete the record by entering date of end of surveillance (30 days post operation). Select one option Date frame. DD/MM/YY YY If the exact date is not documente d, record as 09/09/9999 Date frame. DD/MM/YY YY If the exact date is not documente d, record as 09/09/9999 Date frame. DD/MM/YY YY If the exact date is not documente d, record as 09/09/9999 Date frame. DD/MM/YY YY If the exact date is not documente d, record as 09/09/9999 Date surveillance discontinued Date the surveillance was discontinued Date frame. DD/MM/YY YY 23

Reason surveillance discontinued Death related to SSI Reason why surveillance has ceased for this individual patient An assessment of the relationship of the death of the patient to SSI If the exact date is not documente d, record as 09/09/9999 Select one option Select one option 24

2.5.4. Microorganism and Antimicrobial Notes to complete Data Item Description Format Microorganism 1 Microorganism codes from wound sample result Select microorganism from dropdown list, if there is no micro data, one of the following option should be selected: -examination not done -results not available -micro-organism not identified -Sterile examination Microorganism 1 antibiotic susceptibility Microorganism 2 Microorganism 2 antibiotic susceptibility Microorganism 3 Microorganism 3 antibiotic susceptibility List up to 5 antibiotics for each microorganism reported in the lab result that microorganism shows sensitivity, resistance and intermediate reaction Microorganism codes from wound sample result List up to 5 antibiotics for each microorganism reported in the lab result that microorganism shows sensitivity, resistance and intermediate reaction Microorganism codes from wound sample result List up to 5 antibiotics for each microorganism reported in the lab result that microorganism shows sensitivity, resistance and intermediate reaction Select relevant codes from list Select microorganism from dropdown list (if more than 1 identified) Select relevant codes from list Select microorganism from dropdown list (if more than 2 identified) Select relevant codes from list 25

Is the patient receiving antimicrobials? Antimicrobial Is patients receiving antibiotic for wound infection? List up to 3 antimicrobial prescribed for patients Select relevant codes from list 26

3. Definitions 3.1. SSI case definitions Table 1 SSI Case definitions 4;5 These definitions are the same as previous except implant* SSI surveillance to 90 days. SUPERFICIAL INCISIONAL Infection occurs within 30 days after the operation and infection involves only skin and subcutaneous tissue of the incision and at least one of the following: 1. Purulent drainage with or without laboratory confirmation, from the superficial incision 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative. 4. Diagnosis of superficial incisional SSI made by a surgeon or attending physician. DEEP INCISIONAL Infection occurs within 30 days after the operation if no implant* is left in place or within 90 days if implant* is in place and the infection appears to be related to the operation and infection involves deep soft tissue (e.g. fascia, muscle) of the incision and at least one of the following: 1. Purulent drainage from the deep incision but not from the organ/space component of the surgical site. 2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms: fever (>38 C), localized pain or tenderness, unless incision is culture-negative. 3. An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination. 4. Diagnosis of deep incisional SSI made by a surgeon or attending physician. ORGAN/SPACE Infection occurs within 30 days after the operation if no implant* is left in place or within 90 days if implant* is in place and the infection appears to be related to the operation and infection involves any part of the anatomy (e.g., organs and spaces) other than the incision which was opened or manipulated during an operation and at least one of the following: 1. Purulent drainage from a drain that is placed through a stab wound into the organ/space. 2. Organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space. 3. An abscess or other evidence of infection involving the organ/space that is found on direct examination, during reoperation, or by histopathologic or radiologic examination. 4. Diagnosis of organ/space SSI made by a surgeon or attending physician. *Implant definition: a nonhuman-derived implantable foreign body (prosthetic heart valve, nonhuman vascular graft, machanical heart or hip prosthesis) that is perminantly placed in a patient during surgery. For specific site of organ/space infection definitions see Appendix 2 (http://www.hps.scot.nhs.uk/guidelines/detail.aspx?id=827 ) 27

3.2. SSI Risk Index The SSI Risk Index is the index used by National Healthcare Safety Network NHSN and assigns surgical patients into categories based on the presence of three major risk factors: 1. Operations lasting more than the duration cut point hours, where the duration cut point is the approximate 75 th percentile of the duration of surgery in minutes for the operative procedure, rounded to the nearest whole number of hours. 2. Contaminated (Class 3) of Dirty/Infected (Class 4) wound class. 3. ASA classification of 3, 4 or 5. The patient s SSI risk category is the number of these factors present at the time of the operation. Table 2 Calculation of SSI Risk Index Calculation Score =0, if: Score=1, if: Wound contamination class W1, W2 W3 W4 ASA classification A1 A2 A3 A4 A5 Duration of operation T >T T (value in table 5) Basic SSI Risk Index = Sum of scores 28

3.3. Wound Contamination Class Wound contamination class as described by Altemeier et al. 6 Table 3 Wound Contamination Classification W1 A CLEAN WOUND is an uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital or uninfected urinary tracts are not entered. In addition clean wounds are primarily closed and, if necessary, drained with closed drainage. Operative incisional wounds that follow non-penetrating trauma should be included in this category W2 CLEAN-CONTAMINATED WOUNDS are operative wounds in which the respiratory, alimentary, genital or uninfected urinary tracts are entered under controlled condition and without unusual contamination. Specifically operations involving the biliary tract, appendix, vagina and oropharynx are included in this category provided no evidence of infection or major break in technique is encountered. W3 W4 CONTAMINATED WOUNDS include open, fresh, accidental wounds. In addition operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract, and incisions in which acute, nonpurulent inflammation is encountered are included in this category. DIRTY OR INFECTED WOUNDS include old traumatic wounds with retained devitalised tissue and those that involve existing clinical infection or perforated viscera. This definition suggests that the organisms causing postoperative infection were present in the operative field before the operation. 3.4. The ASA Physical status classification (ASA Score) Physical status classification developed by the American Society of Anaesthesiology (ASA) 7. Table 4 ASA Physical status Classification A1 A2 A3 A4 A5 NORMALLY HEALTHY PATIENT. Patient with MILD SYSTEMIC DISEASE. Patient with SEVERE SYSTEMIC DISEASE that is not incapacitating. Patient with an INCAPACITATING SYSTEMIC DISEASE that is a constant threat to life. MORIBUND patient who is not expected to survive for 24 hours with or without operation. 29

3.5. Duration of operation The table below shows the 75 th percentile cut-off values for the included operative procedures. In case of a reintervention or in case of multiple operations through the same incision within 24hrs after the primary procedure, the duration of the reintervention needs to be added to the duration of the primary procedure. Table 5 Cut-off values for duration of operative procedure categories * Description Cardiac CABG chest & donor site CABG chest only Craniotomy Breast Caesarean Section Abdominal Hysterectomy Reduction of long bone fracture Hip Arthroplasty Knee Arthroplasty Vascular Other nervous system Colon Rectal Amputation 75 th percentile cut-off value, in hours 5 hrs 5 hrs 4 hrs 4 hrs 3hrs 1hr 2 hrs 2hrs 2 hrs 2 hrs 3 hrs 2 hrs 3 hrs 4 hrs 1 hrs *The reference for most of these procedures is ECDC guideline 8. Where the procedure was not included in ECDC guideline, CDC 9 and PHE 3 guidelines have been used as references. 30

3.6. Cumulative incidence of SSI by category The cumulative incidence of infection is the number of new infections that occur in a defined population during a given period of time. This measure is reported as the number of SSIs per 100 operations. The cumulative incidence of SSI is calculated as: 3.7. SSI incidence density To allow for differences in post operative length of stay it is possible to calculate a rate of SSI that uses the number of post operative days of follow-up as the denominator rather than the number of procedures. This rate is called the incidence density and is calculated as: Confidence Intervals: All confidence limits within reports are produced using the Wilson s approximation to the binomial distribution 8. 3.8. Antimicrobial resistance markers and codes The antimicrobial resistance (AMR) marker should be reported according to ECDC protocol 8. Recommended methods to collect these markers can be found at: https://ecdc.europa.eu/sites/portal/files/documents/hai-net-ssi-protocol-v2.2.pdf 31

Reference List (1) Health Protection Scotland. Scottish National Point Prevalence Survey of Healthcare Associated Infection and Antimicrobial Prescribing 2011. 2012 http://www.documents.hps.scot.nhs.uk/hai/sshaip/prevalence/report-2012-04.pdf Accessed:2016 (2) WHO. Global guidelines on the prevention of surgical site infection. 2016 http://www.who.int/gpsc/ssi-prevention-guidelines/en/ Accessed:27-2-2017 (3) Public Health England. protocol for the surveillance of surgical site infection. 2013 https://www.gov.uk/government/publications/surgical-site-infectionsurveillance-service-protocol-procedure-codes-and-user-manual Accessed:16-5-2016 (4) Centers for Disease Control and Prevention. National Healthcare Safety Network (NHSN):surgical site infection (SSI) event. 2011; 2011. (5) Mangram AJ HTPMSLJWR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999;20:250-78. (6) Altemeier W BJPBSW. Manual on control of infection in surgical patients. 2nd ed. Philadelphia, PA: JB Lippincott.; 1984. (7) Owens WD FJSEJ. ASA physical status classifications: a study of consistency of ratings. Anesthesiology 1978;49:239-43. (8) ECDC. Surveillance of surgical site infections and prevention indicators in European hospitals. HAI-Net SSI protocol.version2.2. 2017 https://ecdc.europa.eu/sites/portal/files/documents/hai-net-ssi-protocolv2.2.pdf Accessed:2017 (9) Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med 1991 Sep 16;91(3B):152S-7S. 32

Appendices 1 OPCS coding 2 Specific site of organ/space infection definitions 3 SSIRS User Manual 4 SSI Data Management 5 SSI Microorganism & Antimicrobial List 6 SSI Questions & Answers 7 SSI Posters Wound Class and SSI Definitions 33