Il risk management nelle infezioni ospedaliere. Nicola Petrosillo. Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani - Roma

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1 Il risk management nelle infezioni ospedaliere Nicola Petrosillo Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani - Roma

2 Risk management in sanità Il risk management in sanità rappresenta l insieme di varie azioni complesse messe in atto per migliorare la qualità delle prestazioni sanitarie e garantire la sicurezza del paziente, sicurezza basata sull apprendere dall errore. Errore: componente ineliminabile della realtà umana; fonte di conoscenza e miglioramento per evitare il ripetersi delle circostanze che hanno portato l individuo a sbagliare e mettere in atto iniziative che riducano l incidenza di errori Min. Sal.-Dip. Qual. Comm. Tecn Rischio Clin (DM 5/3/03)

3 Risk management in sanità Il risk management, perché sia efficace, deve interessare tutte le aree in cui si può manifestare durante il processo clinico assistenziale del paziente. Gestione integrata del rischio. Min. Sal.-Dip. Qual. Comm. Tecn Rischio Clin (DM 5/3/03)

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5 D. Formisano. R. Emilia 2005

6 Pittet D et al. Int J Infect Dis 2006; 10:

7 Infectious diseases consultation: impact on outcomes for hospitalized patients and results of a preliminary study. 496 cases (seen by an ID consultant) were matched with 3,117 controls. Cases had longer lengths of hospital stays, longer intensive care unit lengths of stays, and higher antibiotic costs than did matched controls, and if the consultation occurred in the last one-third of hospitalization, cases had shorter lengths of hospital stay and lower antibiotic costs than did controls. Classen DC, Burke JP, Wenzel RP. Clin Infect Dis 1997; 24:468-70

8 Error incidence density of 4.8 errors per 100 patient-days; Sandora TJ, et al. Infect Control Hosp Epidemiol 2005;26:417-20

9 80% compliance rate 85% adherence to crucial recomm Higher when therapy instead of diagnosis if was legible and organized Lo E, et al. Clin Infect Dis 2004;38:1212-8

10 Ragioni per una non aderenza alle lineeguida di controllo delle infezioni In primo luogo, si deve riconoscere che l umanità, non è stata sempre in accordo con la razionalità.

11 Ragioni per una non aderenza alle lineeguida di controllo delle infezioni...lo spirito è pronto, ma la carne è debole Matteo 26.41

12 Ragioni per una non aderenza alle lineeguida di controllo delle infezioni Much of the population has regularly failed to comply with public health recommendations against: smoking drinking and driving driving without seatbelts driving too rapidly through dense fog experimenting with drug abuse MMWR 1999;48:1-156

13 Una quota significativa di infezioni è prevenibile Tipo di infezione N studi Contesto Periodo Effetto intervento (riduzione %) Tutte 10 Ospedale (5), Chirurgia (2), Pat.Neonatale (1), Chir+ICU (1), Ostetricia (1) Mediana 29% (11-55%) Ferita 1 Cardiochirurgia % chirurgica VAP 4 ICU Mediana 54,5% (38-70%) CVC-BSI 8 Ospedale (1), ICU Mediana 54% (14- (5), NICU (2) 71%) UTI 2 Ospedale, ICU 1992, %, 66% Harbarth S, J Hosp Infect 2003

14 Il controllo

15 Preventing ventilator-associated pneumonia in adults: sowing seeds of change. Multiple risk factors for VAP involve complex host factors and ubiquitous pathogens that require several different types of prevention strategies. Prevention efforts should focus on reducing bacterial colonization, and limiting aspiration, antibiotic exposure, and use of invasive devices. Craven DE. Chest 2006;130:251-60

16 La prevenzione del rischio infettivo in ICU nel singolo paziente rivolta all equipe

17 la prevenzione nel singolo paziente: - il miglioramento di condizioni patologiche di base - la sorveglianza delle colonizzazioni in pazienti selezionati - la soppressione della flora endogena che potenzialmente potrebbe divenire responsabile di eventi infettivi a rilevanza clinica

18 e quella rivolta all equipe che ruota intorno al paziente critico: - misure di igiene e antisepsi, - le misure di barriera nelle condizioni standard e negli isolamenti specifici, - le procedure per contenere la diffusione di agenti infettivi multiresistenti o altamente diffusivi - strategie di politica antibiotica.

19 Alp E, Voss A. Ann Clin Microbiol Antimicrob 2006;5:7

20 Perioperative Glucose Control 1,000 cardiothoracic surgery patients Diabetics and non-diabetics with hyperglycemia Patients with a blood sugar > 300 mg/dl during or within 48 hours of surgery had more than 3X the likelihood of a wound infection! Latham R, et al. Infect Control Hosp Epidemiol

21 Antibiotic prophylaxis to reduce respiratory tract infections and mortality in adults receiving intensive care. A combination of topical and systemic prophylactic antibiotics reduces respiratory tract infections and overall mortality in adult patients receiving intensive care. A treatment based on the use of topical prophylaxis alone reduces respiratory infections but not mortality. The risk of occurrence of resistance as a negative consequence of antibiotic use was appropriately explored only in the most recent trial by de Jonge which did not show any such effect. Liberati A, et al. Cochrane Database Syst Rev 2004;(1):CD

22 Pan A et al. Infect Control Hosp Epidemiol 2005;26:

23 Antibiotic usage in intensive care units: a pharmaco-epidemiological multicentre study 979 pts in 43 ICU 153 had sepsis 3rd gen. cephal. 42% Mean duration 4.6d Combination 31% Mean duration 3d 164 pts (20.9%) Malacarne P et al. JAC 2004; 54:221-4

24 Antibiotic Policies in Italian Hospitals: Still a Lot to Achieve Questionnaire survey (2000): response rate 80% (428/535) Hospital formulary 89% Hospital pharmacy committee 73.1% (50% met at least one in 1999) Written justification for a list of AB 41.4% (No. of antibiotics in the list 7 [1-49]) Hospitals with periodical pharmacy reports->54% Data on DDD - 12% Written protocols for surgical prophylaxis 37% Moro ML, Petrosillo N, Gandin C. Microb Drug Resist 2003;9:

25 Ventilator Associated Pneumonia (VAP) Patients with VAP Mortality up to 46% Additional days of mechanical ventilation 14.3 (VAP) vs 4.7 days (no VAP) Longer ICU stay (11.7 vs 5.6) Longer hospital stay (25 vs 14 days) Additional charges - $40,000 Ibrahim EH, Chest Aug;120(2): Rello J. Chest 2002 Dec: 122:

26 *Rate of Ventilator Associated Pneumonia (VAP) in the Intensive-Critical Care Pooled Mean Range Coronary Medical Surgical Neurosurgical Trauma Expressed as incidence density of VAP/1000 ventilator days. Source: NNIS Report, Jan 1992-June Am J Infect Control 2004;32:

27 Guidelines on Prevention of Ventilator Associated Pneumonia US Centers for Disease Control & Prevention (CDC) 2003 US Agency for Healthcare Research & Quality 2001 American Thoracic Society/Infectious Disease Society of America, 2005 Canadian Critical Care Society, 2004

28 Guidelines differ in the strength of the recommdations Available studies Study designs/results Types of publications accepted Interpretation of the results Expertise of committee members Judgement

29 Collard HR et al. Ann Intern Med 2003;138:

30 Continuous aspiration of subglottal secretions (CASS) Meta-analysis of CASS 1 50% reduction in incidence of VAP 3 days less in intensive care united Delayed onset of VAP by 6 days Randomized controlled trial of both semirecumbent position and continuous subglottic suctioning No difference in colonization 1 Dezfulian Am J Med 2005; 118: Girou Intensive Care Med; 2004; 30:225-33

31 Continuous aspiration of subglottal secretions Comparison of Recommendations Based on Strength of the Evidence CDC AHRQ ATS-IDSA Canada Levels 1-3 Levels 1-3 Levels 1-3 Levels Lowest 1-Highest 1-Highest 2 Medium 1 US Centers for Disease Control and Prevention, Agency Healthcare Research & Quality American Thoracic Society/Infectious Disease Society of America, Canadian Critical Care Society, 2004

32 Surveillance of Ventilator Associated Pneumonia (VAP) to VAP cases per 1000 ventilator days Evaluate Control Measures Baseline period Intervention Period Intervention: Daily assessment for weaning Targeted sedation 45 degree head of bed elevation Use of sulcralfate Small enteral feedings Baynes PS. Impact of NNIS surveillance on device-associated infection rates in medical ICU. Fourth Decennial Int Conf on Nosocomial Inf. Mar 2000.

33 New Approach to Prevention of VAP Rather than focus on each individual evidence-based practice.implement them as a bundle or group Improved outcome

34 Bundling of Evidence-Based Practices Evidence-based practices Implemented in a series or group Have better outcomes than when implemented individually

35 The Ventilator Bundle Elevation of the head of bed (30-45º) Consider daily interruption of sedation and assessment of readiness to extubate Consider stress ulcer prophylaxis (high risk patients*) Deep Vein Thrombosis (DVT) prophylaxis (unless contraindicated) *Respiratory failure, shock, coagulopathy

36 Elevate Head of Bed o Can Prevent VAP Randomized controlled trial Patients supine - 23% VAP Patients semi-recumbent 5% VAP Drakulovic MB Lancet 1999; 35 (9193): 1851

37 Feasibility and effectiveness of semi-recumbent vs prone positioning Compare supine (<10 degrees) vs semirecumbent (45 degrees) Results: 45 degrees -only 15% of time during study Difference in VAP rate - not significant Groups similar in enteral feeding, stress ulcer prevention, duration of ventilation Van Nieuwenjoven Critical Care Med 2006; 34(2):

38 Collard HR et al. Ann Intern Med 2003;138:

39 Daily reduction in sedation and assess readiness to discontinue ventilator Randomized controlled trial Sedation vacation and daily assessment to remove from ventilator Reduction in duration of ventilation from 7.3 days to 4.9 days Kress JP N Engl J Med 2000; 342 (20): 1471

40 Stress Ulcer Disease Prophylaxis H2antagonists elevates ph and decreases gastric colonization by pathogens Sucralfate allows less gastric colonization with pathogens without changing ph H2 blockers preferable to sucralfate because of lower risk of GI bleeding Cook D N Engl J Med 1998; 338: 791

41 Collard HR et al. Ann Intern Med 2003;138:

42 *Comparison of Recommendations for Prevention of VAP CDC; AHRQ; ATS-IDSA; Canada CDC 1 AHRQ 2 ATS IDSA 3 Canada 4 Level 1-3 Level 1-5 Level 1-3 Level 1-3 Semi Recumbent position 3 -Lowest 2 - High 1- Highest 3- Highest Stress ulcer prophylaxis Unresolved 4-Low 1-Highest Not recommended Daily sedation interruption Medium 1 US Centers for Disease Control and Prevention, Agency Healthcare Research & Quality 2001Greatest; 3 American Thoracic Society/Infectious Disease Society of America, Canadian Critical Care Society, 2004

43 St. Lukes Hospital Jacksonville FL VAP rate after implementing Ventilator bundle Burger and Resar (Ltr to Editor) Mayo Clin Proc June (6):849

44 Success Reported 120 participating ICUs in 70 hospitals in Michigan Keystone Project Implemented BSI and VAP bundle, and Daily goals and multidisciplinary rounds RESULTS 68 of 120 ICUs - ZERO VAP for > 6 mos SAVED 1500 lives; 81,000 hospitals days $166 million FROM: Michigan Hospital Association (MHA) Keystone Project press release: Oct 15, 2005

45 Surgical Infection Prevention

46 Surgical Site Infections (SSI) 2 to 5% of operated patients will develop SSI 40 million operations annually in the U.S million SSI s occur annually in the U.S. SSI increases LOS in hospital average 7.5 days Excess cost per SSI: *$2,734-26,019 (1985, US$) US national costs: $ million/year *Jarvis, Infect Control HospEpidemiol. 1996;17.

47 Misure pre-operatorie di prevenzione delle infezioni della ferita chirurgica secondo la Linea Guida dei CDC, Preparazione del paziente Identificare e trattare tutte le infezioni prima degli interventi elettivi, posticipare l intervento fino alla risoluzione dell infezione Evitare la tricotomia a meno che i peli nell area di incisione non interferiscano con l intervento Se necessaria, eseguirla prima dell intervento e utilizzando rasoi elettrici Controllare la glicemia nei pazienti diabetici; non iperglicemia nel perioperatorio Incoraggiare la cessazione del fumo o non fumo nei 30 giorni precedenti Non negare gli emoderivati ai pazienti chirurgici con lo scopo di prevenire ISC Far eseguire al paziente una doccia o un bagno con antisettico la notte prima Lavare e pulire accuratamente l area della incisione per rimuovere le macrocontaminazioni prima della antisepsi del campo operatorio Utilizzare una appropriata preparazione antisettica per la cute 2. Preparazione dell equipe chirurgica Tenere le unghie corte ed evitare l uso di unghie artificiali Effettuare il lavaggio chirurgico con antisettico per 2-5 minuti. Lavare mani e avambracci fino ai gomiti Dopo essersi lavati, mantenere le braccia e le mani in alto e lontane dal corpo in modo da far scolare l acqua dalle dita verso i gomiti. Asciugare con un telo sterile e indossare guanti e camice sterili 3. Gestione del personale sanitario colonizzato o infetto Istruire e incoraggiare il personale della sala operatoria che presenti eventuali segni/sintomi di malattie trasmissibili a segnalarlo prontamente Mettere a punto protocolli specifici per l allontanamento o la riammissione dal lavoro in caso di infezione trasmissibili del personale di sala operatoria A scopo precauzionale, allontanare dal lavoro il personale con lesioni cutanee essudative e ottenere colture appropriate della lesione Non escludere dal lavoro personale colonizzato con Staphylococcus aureus o Streptococco di gruppo A, in assenza di dimostrata relazione epidemiologica con i casi

48 Misure intraoperatorie, CDC Sistemi di ventilazione Nella sala operatoria mantenere aria a pressione positiva rispetto ai locali adiacenti Garantire almeno 15 ricambi l ora di cui 3 di aria fresca Filtrare tutta l aria, ricircolante e fresca, con filtri appropriati Far entrare l aria dal soffitto e farla uscire dal pavimento Non usare raggi ultravioletti in sala operatoria per prevenire ISC Tenere le porte della sala operatoria chiuse 2. Pulizia e disinfezione dell ambiente In caso di contaminazione visibile del pavimento, di superfici o attrezzature con sangue o altri liquidi biologici pulire prima del successivo intervento utilizzando un disinfettante approvato dalla apposita commissione locale Non effettuare interventi speciali di pulizia/chiusura della sala dopo int. contaminati/ sporchi Non usare tappetini adesivi all ingresso dell area operatoria 3. Campionamento microbiologico ambientale Non effettuare campionamento di routine. Ottenere campioni ambientali dell aria e delle superfici della sala operatoria solo nel contesto di specifiche indagini epidemiologiche 4. Sterilizzazione degli strumenti chirurgici Sterilizzare tutti gli strumenti chirurgici secondo protocolli approvati Ricorrere alla sterilizzazione flash solo per gli strumenti da riutilizzare immediatamente 5. Indumenti e teli chirurgici All ingresso della SO indossare mascherina, cuffia o copricapo Non indossare soprascarpe allo scopo di prevenire le ISC Indossare i guanti sterili, farlo dopo aver indossato un camice sterile Usare camici e teli che mantengano efficacia di barriera anche quando bagnati Cambiare l abbigliamento chirurgico se visibilmente sporco o contaminato con sangue o altro 6. Asepsi e tecniche chirurgiche Norme di asepsi se si posiziona catetere vascolare, anest. spinale o epidurale o farmaci e.v. Manipolare i tessuti con cura, eseguire una buona emostasi, rimuovere i tessuti devitalizzati Portare la ferita a guarigione per seconda intenzione se il sito chirurgico è contaminato Laddove sia necessario un drenaggio, utilizzare un drenaggio chiuso. Posizionarlo attraverso incisione separata e distante dalla incisione chirurgica. Rimuovere il drenaggio appena possibile 7. Medicazione della ferita Proteggere le ferite chirurgiche per ore con medicazioni sterili Lavarsi le mani prima e dopo aver effettuato la medicazione o aver toccato il sito chirurgico

49 Surgical Care Improvement Project Performance measures - Process Surgical infection prevention Antibiotics» Administration within one hour before incision» Use of antimicrobial recommended in guideline» Discontinuation within 24 hours of surgery end Glucose control in cardiac surgery patients Proper hair removal Normothermia in colorectal surgery patients

50 Single vs Multiple Dose Surgical Prophylaxis: Systematic Review All studies, fixed All studies, random Multi > 24h Multi < 24h McDonald. Aust NZ J Surg 1998;68:388 Favors single dose Favors multiple dose

51 Impact of Prolonged Antibiotic Prophylaxis 2,641 CABG patients Grp1-<48 hours of antibiotics Grp 2 - > 48 hours of antibiotics SSI Rates Grp 1-8.7% (131/1502) Grp % (100/1139) Antibiotic resistant pathogen - Grp 2 Odds Ratio 1.6 (95% CI: ) Harbarth S, et al. Circulation

52 Hyperglycemia and Risk of SSI after Cardiac Operations No increased risk: Elevated HgbA1c Preoperative hyperglycemia Increased risk: Diagnosed diabetes Undiagnosed diabetes Post-op glucose > 200 mg% within 48h Latham. Inf Contr Hosp Epidemiol. 2001;22:607 Dellinger. Inf Contr Hosp Epidemiol. 2001;22:604

53 Hyperglycemia and Risk of SSI after Cardiac Operations Hyperglycemia - doubled risk of SSI Hyperglycemic: 48% of diabetics 12% of nondiabetics 30% of all patients 47% of hyperglycemic episodes were in nondiabetics Latham. Inf Contr Hosp Epidemiol. 2001;22:607 Dellinger. Inf Contr Hosp Epidemiol. 2001;22:604

54 Perioperative Glucose Control 1,000 cardiothoracic surgery patients Diabetics and non-diabetics with hyperglycemia Patients with a blood sugar > 300 mg/dl during or within 48 hours of surgery had more than 3X the likelihood of a wound infection! Latham R, et al. Infect Control Hosp Epidemiol

55 Glucose Control and Deep Sternal Wound Infections Furnary et al. Ann Thorac Surg 1999:67:352

56 Shaving and SSI

57 Pre-operative shaving Shaving the surgical site with a razor induces small skin lacerations potential sites for infection disturbs hair follicles which are often colonized with S. aureus Risk greatest when done the night before Patient education be sure patients know that they should not do you a favor and shave before they come to the hospital!

58 Hair removal Authors/ref Sellick JA, et al. Infect Control Hosp Epidemiol 2004 Ko W, et al. Ann Thorac Surg 1992;52:301-5 Bekar A, et al. Acta Neurochir 2001;143:533-6 Tang K, et al. Pediatr Neurosurg 2001;35:13-17 Study Switching from razor shaving to clipper removal rate of deep sternotomy SSI rate of venectomy site SSI Electrically clipped pts had 1/3 lower rate of mediastinitis than those manually shaved (OR: %CI ) Retrospective cohort study in neurosurgery: shaving of head hair prior to surgery did not reduce the rate of SSI vs pts who had their hair spared (shampoo 4% chlorexidine within 24 h) Prospective trial in pediatric neurosurgery pts found similar infection rate in children who had thei hair shaved and those who did not.

59 Influence of Shaving on SSI No Hair Group Removal Depilatory Shaved Number Infection rate 0.6% 0.6% 5.6% Seropian. Am J Surg 1971; 121: 251

60 Shaving, Clipping and SSI % Infected 2,5 2 1,5 1 0,5 0 Shave Clip Neither Cruse. Arch Surg 1973; 107: 206

61 Hair Removal Techniques and SSI % Infection 12 8 Clean Clean-Contam 4 0 PM Razor AM Razor PM Clipper AM Clipper Alexander. Arch Surg 1983; 118: 347

62 Shaving vs Clipping Cardiac Surgery Number Infected (%) Shaved (1.3%) Clipped (0.4%) p < 0.03 Ko. Ann Thorac surg 1992;53:301

63 Temperature Control 200 colorectal surgery patients control - routine intraoperative thermal care (mean temp 34.7 C) treatment - active warming (mean temp on arrival to recovery 36.6 C) Results control - 19% SSI (18/96) treatment - 6% SSI (6/104), P=0.009 Kurz A, et al. N Engl J Med Also: Melling AC, et al. Lancet (preop warming)

64 Some see things as they are and ask why. [Others] see things as they should be and ask why not John F. Kennedy

65 Hospital-acquired infections in Italy: a region wide prevalence study - inappropriate use - Glycopeptides: enterobacteria, Ps. aeruginosa, MSSA 3rd and 4th gen. cephalosporins: enterococci 3rd generation cephalosporins: 35% in surgical prophylaxis Glycopeptides: 5% surgical prophylaxis (only 26.4% - prosthetic device complied with GL) Clean surgery: 512 pts (30.9%) received prophylaxis Mean duration of surgical prophylaxis: 3.1 d (31% more than 4 d) Zotti CM et al. J Hosp Infect 2004; 56:142-9

66 Paterson DL. Clin Infect Dis 2006; 42:S90-5

67 Antibiotic policy in the hospital setting a. Implementation of educational programmes on use of antimicrobial agents (including pharmacokinetics and pharmacodynamics); b. Establishment of guidelines and antibiotic audits for an evidence-based and standardized use of antimicrobials; c. Identification of those procedures that need and do not need antimicrobial prophylaxis either for surgical or non-surgical purpose (select the drugs for prophylaxis which are not needed for subsequent therapy); Petrosillo & Struelens, ESCMID 2002

68 Antibiotic policy in the hospital setting d. Implementation, with human and economic resources, of an antibiotic restriction programme, and identification of antibiotic molecules that need restriction; e. Adoption of antibiotic cycling strategies, for empiric therapy, in hot hospital zones and based on local antibiotic resistance surveillance system programmes, better defining the molecular basis of antibiotic resistance; f. Establishment of cost-effective surveillance systems using existing laboratory generated data. Petrosillo & Struelens, ESCMID 2002

69 Use of a Front-End Approach as a Means to Decrease Antimicrobial Resistance need for preapproval before the administration of restricted agents, antimicrobial cycling. use of special antimicrobial request forms, Paterson DL. Clin Infect Dis 2006; 42:S90-5

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71 Pittet D et al. Int J Infect Dis 2006; 10: