IMPROVEMENT IN PATIENT MANAGEMENT THROUGH THE USE OF A Clostridium difficile PCR REAL TIME STAND ALONE TEST IN ACUTE HOSPITAL SETTING

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1 IMPROVEMENT IN PATIENT MANAGEMENT THROUGH THE USE OF A Clostridium difficile PCR REAL TIME STAND ALONE TEST IN ACUTE HOSPITAL SETTING Dr. Erminia Casari Director Microbiology Department Humanitas Hospital, Milan

2 Agenda Presentation of Humanitas Hospital: organization of the Microbiology Department Relationship with Epidemiology Unit Diagnosis of CDI : the old diagnostic algorithm The new Era: Xpert C.difficile assay New algorithm for diagnosis of CDI to improve the patient management Analysis of the results: impact of the new assay on the Hospital Overall Costs. Conclusion & Questions

3 Istituto Clinico Humanitas ICH Humanitas is a consortium of three Private Hospitals (Scientific Institute of Admission and Care) recognized by the Ministry of Health as a center of excellence in terms of the quality of its healthcare services. The mission: constant improvement of the efficacy of treatment through innovative medical methods. Investment in technology to guarantee increasingly higher quality standards. More than 600 beds and admissions every year. First Italian General Hospital to obtain certification from the Joint Commission International. Its diagnostic, therapeutic and rehabilitation work respond to the needs of local, national and international patients. Humanitas Rozzano beds: 570 Humanitas Gavazzeni beds: 210 Humanitas Mater Domini beds: 182

4 Humanitas Rozzano Wards: 23 Employee: 1500 High Index of Case Mix Complexity Clinical Departments: Cardiovascular surgery Plastic surgery Orthopedics Gastroenterology Oncology and Hematology Gynecology and IVF Internal Medicine Neurosurgery

5 Humanitas: HAI Core Team Health Director Hospital Infections Commission (HIC) Clinical Departments Diagnostic Laboratories Pharmacy Technical office MD Igienist Core Team of HIC Epidemiology Office Support & Assistance

6 Members of the Hospital Infection Commission (HIC) in Humanitas Health Director Pharmacy Diagnostic Laboratory Support & Assistance Area Members of HIC Clinical Department Infectovologist Surgery Department Intense Care Unit

7 Epidemiology office: activities Check all patients that are placed in the Isolation Area Education of Heath Co-Workers (HAI procedure & hand washing ) Intervention in case of Infective Emergency Managing of operational activities of HAI control projects Monitoring of Sentinel Bacteria of HAI Inform and report the results to the Core Team of Hospital Infections Commission

8 HAI Surveillance process Operative Unit Microbiology Laboratory Sending Biological Samples Speciments collection Isolation of Sentinel Bacteria Epidemiology Office Check the mandatory Notification of Infection Disease Epidemiological Survey

9 THE ICH MICROBIOLOGY LAB IN NUMBERS blood cultures 2500 respiratory tract cultures urine cultures identification and susceptibility tests

10 THE ICH MICRO LAB LAYOUT Cytocentrifuge Automatic gram stain (Previcolor, biomèrieux) RT-PCR instrument (GeneXpert, Cepheid) Blood culture (Bactec FX 100,BD) Automated ID and ATB (Phoenix 100,BD)

11 INTRODUCTION OF A NEW LAB TEST FOR C.difficile DIAGNOSIS As literature and guidelines suggests is mandatory to established a new algorithm for patient management in the hospital

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13 The Clostridium difficile paradigm ASSAY WITH HIGH SENSITIVITY AN INTEGRATED INFECTION CONTROL PROGRAM EVALUATION ONLY OF CLINICAL SIGNS FOR STOPPING ISOLATION

14 C.difficile: the old diagnostic algorithm The test used for CDI diagnosis: TOXA/B QUIK CHEK. Rapid format that uses antibodies specific for toxins A and B of C. difficile. The fecal sample is added to Diluent and Conjugate. The mixture is transferred to the Sample Well and the device is incubated for 15 minutes. A positive result is indicated by the formation of a blue line at the test (T) side of the Reaction Window. Sensitivity 60% TOX A/B QUIK CHEK

15 ICH PATIENT MANAGEMENT BEFORE GENEXPERT PAT Emergency HOME DIA R Suspect CLDF?? Other??? ISOL ATIO N IN Emergency IN THE WARD DE- ISOLA TION 3 CLDF test EIA Toxin A/B NEGATIVE PAT ICU WARD DIA R POS CLDF TEST ISOL ATIO N IN ICU IN THE WARD DE- ISOLA TION 3 CLDF test EIA Toxina A/B NEGATIVE

16 THE OLD DIAGNOSTIC ALGORITHM (EIA Toxin A/B) NO limit in the number of specimens tested for the same patient NO selection of the quality of specimen No evaluation of the specimen Analysis of every specimen during the day and the night Three NEG TEST for the patient deisolation

17 The new era: Xpert C.Difficile assay Integrated Platform based on Real Time PCR technology Detects toxin B gene (tcdb), Binary Toxin and tcdc nt 117 gene. Calls out epidemic C. difficile 027/NAP1/BI strain from other toxigenic strains System requires instrument, computer, preloaded software and single use disposable cartridges Cross contamination is avoided Specimen: unformed stool in a clean container Reporting: Toxigenic C. difficile POSITIVE 027-NAP1-BI PRESUMPTIVE POS 027-NAP1-BI PRESUMPTIVE NEG Toxigenic C. difficile NEGATIVE

18 ICH PATIENT MANAGEMENT AFTER GENEXPERT: PAT EMERGE NCY HOME DIA R Suspect CLDF?? Other??? ISOL ATIO N IN EMERGE NCY IN THE WARD DE- ISOLA TION RESOLUTI ON OF CLINICAL SIGN PAT ICU WARD DIAR CLDF TEST + ISOLAT ION IN ICU IN THE WARD DE_IS OLATI ON RESOLU TION OF CLINIC AL SIGN

19 THE NEW ERA (RT-PCR STAND ALONE TEST) NO analysis of formed stool 2 runs per day (12.00 a.m. and p.m.) Only one test for patient In case of a precedent positive results In case1 run for day in the WE of a precedent positive results

20 ICH Clostridium difficile INFECTION CONTROL PLAN Fecal specimen Micro Lab POS HAI office

21 Results

22 Hospital Costs Hospitalization: Antibiotic therapy: Disposable: Laundry: 3.15 Room disinfection: 23.00

23 EPIDEMIOLOGY IN ICH Number of positive C.difficile cases

24 NUMBER OF SAMPLES TESTED

25 LABORATORY COSTS In-lab Costs 23,360 21,308 20,

26 HOSPITAL COSTS FOR ISOLATION Isolation Days (average value)

27 HOSPITAL COSTS FOR ISOLATION Therapy and Decontamination Costs Therapy Decontamination Costs 124,605 88,054 34,726 49,140 22,240 56,

28 OVERALL HOSPITAL COSTS Impact on overall costs (xe3) Hospitalization Costs 2,849 3,043 Overall Costs 2,013 2,157 1,484 1,

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30 Conclusions 1) The routine use of the Xpert C. difficile test reduces the number of repeated tests necessary to obtain CDI diagnosis for a rapid and a better treatment of the patient; 2)The high sensitivity of the test leads to a reduction of the number of positive patients and the rapidity of diagnosis in shortening isolation procedures ; 3)The shortening of isolation days results in a reduction of decontamination and isolation procedures; 4) The end results is a general overall saving of hospitalization costs despite the cost of PCR testing per samples that is higher than the method used in the previous years.

31 Thank you for your attention For questions don t hesitate to send a message to erminia.casari@humanitas.it