Il risk management nelle infezioni ospedaliere

Nicola Petrosillo

Istituto Nazionale per le Malattie Infettive“Lazzaro Spallanzani” - Roma

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 realtàumana; 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

Risk management in sanità

Min. Sal.-Dip. Qual. – Comm. Tecn Rischio Clin (DM 5/3/03)

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.

Risk management in sanità

Min. Sal.-Dip. Qual. – Comm. Tecn Rischio Clin (DM 5/3/03)

D. Formisano. R. Emilia 2005

Pittet D et al. Int J Infect Dis 2006; 10: 419-24

Infectious diseases consultation: impact on outcomes for hospitalized patients

and results of a preliminary study.

Classen DC, Burke JP, Wenzel RP. Clin Infect Dis 1997; 24:468-70

•496 cases (seen by an ID consultant) were matchedwith 3,117 controls.

•Cases had longer lengths of hospital stays, longerintensive care unit lengths of stays, and higherantibiotic 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.

Sandora TJ, et al. Infect Control Hosp Epidemiol 2005;26:417-20

Error incidence density of 4.8 errors per 100 patient-days;

Lo E, et al. Clin Infect Dis 2004;38:1212-8

80% compliance rate

85% adherence tocrucial recomm

Higher when therapyinstead of diagnosis

if was legible andorganized

Ragioni per una non aderenzaalle lineeguida di controllo

delle infezioni

In primo luogo, si deve riconoscere chel’umanità, non è stata sempre in accordo con la razionalità.

Ragioni per una non aderenzaalle lineeguida di controllo

delle infezioni

...lo spirito è pronto, ma la carne èdebole…

Matteo 26.41

Ragioni per una non aderenzaalle lineeguida di controllo

delle infezioniMuch of the population has regularly failed tocomply with public health recommendationsagainst:•smoking•drinking and driving•driving without seatbelts•driving too rapidly through dense fog•experimenting with drug abuse

MMWR 1999;48:1-156

Tipo di infezione

N° studi Contesto Periodo Effetto intervento

(riduzione %) Tutte 10 Ospedale (5),

Chirurgia (2), Pat.Neonatale (1), Chir+ICU (1), Ostetricia (1)

1987-98 Mediana 29% (11-55%)

Ferita chirurgica

1 Cardiochirurgia 1991-94 34%

VAP 4 ICU 1987-98 Mediana 54,5% (38-70%)

CVC-BSI 8 Ospedale (1), ICU (5), NICU (2)

1992-2000 Mediana 54% (14-71%)

UTI 2 Ospedale, ICU 1992,1997 46%, 66%

Harbarth S, J Hosp Infect 2003

Una quota significativa di infezioni Una quota significativa di infezioni èè prevenibileprevenibile

Il controllo

Preventing ventilator-associatedpneumonia in adults: sowing seeds of

change.•Multiple risk factors for VAP involve complexhost factors and ubiquitous pathogens thatrequire several different types of preventionstrategies.

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

La prevenzionedel rischio infettivo in ICU

nel singolo paziente

rivolta all’equipe

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

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 multiresistentio altamente diffusivi

- strategie di politica antibiotica.

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

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. 2001.

•A combination of topical and systemic prophylacticantibiotics reduces respiratory tract infections and overall mortality in adult patients receiving intensive care.

•A treatment based on the use of topical prophylaxisalone reduces respiratory infections but not mortality.

•The risk of occurrence of resistance as a negative consequence of antibiotic use was appropriatelyexplored only in the most recent trial by de Jonge whichdid not show any such effect.

Antibiotic prophylaxis to reduce respiratory tract infections and mortality in adults receiving intensive care.

Liberati A, et al. Cochrane Database Syst Rev 2004;(1):CD000022.

Pan A et al. Infect Control Hosp Epidemiol 2005;26:127-133

Antibiotic usage in intensive care units: a pharmaco-epidemiological multicentre study

Malacarne P et al. JAC 2004; 54:221-4

153 had sepsis

164 pts (20.9%)

979 pts in 43 ICU

Combination 31%Mean duration 3d

3rd gen. cephal. 42%Mean duration 4.6d

Antibiotic Policies in Italian Hospitals: Still a Lot to Achieve

Moro ML, Petrosillo N, Gandin C. Microb Drug Resist 2003;9:219-22.

• 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%

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. 2001 Aug;120(2):555-561.Rello J. Chest 2002 Dec: 122: 2115-21

*Rate of Ventilator Associated Pneumonia (VAP) in the Intensive-Critical Care

• Coronary 4.4 0 - 9.8• Medical 4.9 0.5 - 8.9• Surgical 9.3 2.2-17.9• Neurosurgical 11.2 0 – 16.8• Trauma 15.2 4.3-25.3

Pooled Mean Range

•Expressed as incidence density of VAP/1000 ventilator days. •Source: NNIS Report, Jan 1992-June 2004. Am J Infect Control 2004;32:470-85.

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

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

Collard HR et al. Ann Intern Med 2003;138:494-501.

Continuous aspiration of subglottal secretions (CASS)

• Meta-analysis of CASS1– 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 semi-recumbent position and continuous subglottic suctioning– No difference in colonization

1 Dezfulian Am J Med 2005; 118:11-182 Girou Intensive Care Med; 2004; 30:225-33

Continuous aspiration of subglottal secretions Comparison of Recommendations Based on Strength of the Evidence

1 US Centers for Disease Control and Prevention, 20032 Agency Healthcare Research & Quality 20013 American Thoracic Society/Infectious Disease Society of America, 20054 Canadian Critical Care Society, 2004

AHRQLevels 1-3

CDCLevels 1-3

ATS-IDSALevels 1-3

CanadaLevels 1-3

3- Lowest 1-Highest 1-Highest 2 Medium

Surveillance of Ventilator Associated Pneumonia (VAP) to

Evaluate Control Measures• Intervention:

– Daily assessment for weaning

– Targeted sedation

– 45 degree head of bed elevation

– Use of sulcralfate– Small enteral

feedings

0

2

4

6

8

10

12

14

Baselineperiod

InterventionPeriod

VAP casesper 1000ventilatordays

Baynes PS. Impact of NNIS surveillance on device-associated infection ratesin medical ICU. Fourth Decennial Int Conf on Nosocomial Inf. Mar 2000.

New Approach to Prevention of VAP

• Rather than focus on each individual evidence-based practice….Implement them as a “bundle” or group

• Improved outcome

Bundling of Evidence-Based Practices

• Evidence-based practices• Implemented in a series or group• Have better outcomes than when

implemented individually

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

Elevate Head of Bed 30-45oCan Prevent VAP

• Randomized controlled trial• Patients supine - 23% VAP• Patients semi-recumbent – 5% VAP

Drakulovic MB Lancet 1999; 35 (9193): 1851

Feasibility and effectiveness of semi-recumbent vs prone

positioning

• Compare supine (<10 degrees) vs semi-recumbent (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): 559-61

Collard HR et al. Ann Intern Med 2003;138:494-501.

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

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 sucralfatebecause of lower risk of GI bleeding

Cook D N Engl J Med 1998; 338: 791

Collard HR et al. Ann Intern Med 2003;138:494-501.

*Comparison of Recommendations for Prevention of VAP

CDC; AHRQ; ATSCDC; AHRQ; ATS--IDSA; CanadaIDSA; Canada

Semi Recumbent position

Stress ulcer prophylaxis

Daily sedation interruption

AHRQ2CDC1

ATS IDSA3 Canada4

2 - High3 3 --LowestLowest 11-- HighestHighest 3- Highest

4-LowUnresolved 1-Highest Not recommended

1 US Centers for Disease Control and Prevention, 20032 Agency Healthcare Research & Quality 2001Greatest; 3 American Thoracic Society/Infectious Disease Society of America, 20054 Canadian Critical Care Society, 2004

2-Medium

Level 1-3 Level 1-5 Level 1-3 Level 1-3

- -

St. Lukes Hospital Jacksonville FLVAP rate after implementing

Ventilator bundle

Burger and Resar (Ltr to Editor) Mayo Clin Proc June 2006 81 (6):849

Success Reported120 participating ICUs in 70 hospitals in

Michigan Keystone Project

• Implemented BSI and VAP bundle, and• Daily goals and multidisciplinary roundsRESULTS• 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

Surgical Infection Prevention

Surgical Site Infections (SSI)

• 2 to 5% of operated patients will develop SSI – 40 million operations annually in the U.S.– 0.8 - 2 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: $130-845 million/year

*Jarvis, Infect Control HospEpidemiol. 1996;17.

1. 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

Misure pre-operatorie di prevenzione delle infezioni della ferita chirurgica secondo la Linea Guida dei

CDC, 1999

Misure intraoperatorie, CDC 19991. 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 24-48 ore con medicazioni sterili • Lavarsi le mani prima e dopo aver effettuato la medicazione o aver toccato il sito chirurgico

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

Single vs Multiple Dose Surgical Prophylaxis: Systematic Review

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Impact of Prolonged Antibiotic Prophylaxis

• 2,641 CABG patients– Grp 1 - < 48 hours of antibiotics– Grp 2 - > 48 hours of antibiotics

• SSI Rates– Grp 1 - 8.7% (131/1502)– Grp 2 - 8.8 % (100/1139)

• Antibiotic resistant pathogen - Grp 2– Odds Ratio 1.6 (95% CI: 1.1-2.6)

Harbarth S, et al. Circulation. 2000.

Hyperglycemia and Risk of SSI after Cardiac Operations

• No increased risk:Elevated HgbA1cPreoperative hyperglycemia

• Increased risk:Diagnosed diabetesUndiagnosed diabetesPost-op glucose > 200 mg% within 48h

Latham. Inf Contr Hosp Epidemiol. 2001;22:607Dellinger. Inf Contr Hosp Epidemiol. 2001;22:604

Hyperglycemia and Risk of SSI after Cardiac Operations

• Hyperglycemia - doubled risk of SSI

• Hyperglycemic:48% of diabetics12% of nondiabetics30% of all patients

• 47% of hyperglycemic episodes were in nondiabetics

Latham. Inf Contr Hosp Epidemiol. 2001;22:607Dellinger. Inf Contr Hosp Epidemiol. 2001;22:604

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. 2001.

Furnary et al. Ann Thorac Surg 1999:67:352

Glucose Control and Deep Sternal Wound Infections

Shaving and SSI

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!

Hair removal

Prospective trial in pediatric neurosurgery ptsfound similar infection rate in children who hadthei hair shaved and those who did not.

Tang K, et al. Pediatr Neurosurg2001;35:13-17

Retrospective cohort study in neurosurgery: shaving of head hair prior to surgery did notreduce the rate of SSI vs pts who had their hairspared (shampoo 4% chlorexidine within 24 h)

Bekar A, et al. ActaNeurochir2001;143:533-6

Electrically clipped pts had 1/3 lower rate of mediastinitis than those manually shaved(OR: 3.25 95%CI 1.11-9.32)

Ko W, et al. AnnThorac Surg1992;52:301-5

Switching from razor shaving to clipper removalrate of deep sternotomy SSI 1.2 0.2rate of venectomy site SSI 1.6 0.4

Sellick JA, et al. Infect Control HospEpidemiol 2004

StudyAuthors/ref

Influence of Shaving on SSI

No HairGroup Removal Depilatory Shaved

Number 155 153 246

Infection rate 0.6% 0.6% 5.6%

Seropian. Am J Surg 1971; 121: 251

Shaving, Clipping and SSI

Cruse. Arch Surg 1973; 107: 206

% Infected

00,5

11,5

22,5

Shave Clip Neither

Hair Removal Techniques and SSI

% Infection

0

4

8

12

PMRazor

AMRazor

PMClipper

AMClipper

CleanClean-Contam

Alexander. Arch Surg 1983; 118: 347

Shaving vs ClippingCardiac Surgery

Number Infected (%)

Shaved 990 13 (1.3%)

Clipped 990 4 (0.4%)

p < 0.03

Ko. Ann Thorac surg 1992;53:301

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. 1996.

Also: Melling AC, et al. Lancet. 2001. (preop warming)

Some see things as they areand ask why.[Others] see things as theyshould be and ask why not

John F. Kennedy

Hospital-acquired infections in Italy: a region wide prevalence study

- inappropriate use -

Zotti CM et al. J Hosp Infect 2004; 56:142-9

• 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)

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

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

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

Use of a Front-End Approach as a Means to Decrease Antimicrobial

Resistance

antimicrobial cycling.

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

need for preapprovalbefore the administration

of restricted agents,

use of special antimicrobialrequest forms,

Pittet D et al. Int J Infect Dis 2006; 10: 419-24