1.2 billion ambulatory care visits in US: physician offices, outpatient hospital and ED

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1 Overview More patients obtain healthcare in specialty clinics and physicians offices in the United States than in hospitals 1.2 billion ambulatory care visits in US: physician offices, outpatient hospital and ED 60.5% of those visits are to primary care physicians offices CDC: 2010

2 Overview, Outbreaks outbreaks of viral hepatitis related to healthcare reported to CDC during ; of these, 36 (94%) occurred in nonhospital settings outbreaks in nonhospital health care settings 12 in outpatient clinics 6 in hemodialysis centers 15 in long-term care facilities 448 persons acquired HBV or HCV infection The mechanism of infection was patient-to-patient transmission through failure of health care personnel to adhere to fundamental principles of infection control and aseptic technique Plan: Guidelines, standards, regulations: CDC, TJC, CMS, OSHA, states Do: 2 scored visits per year Study: Data collection Analysis Risk assessment based on data Act: Infection Prevention intervention Action plan 4

3 This is an example of a tool used for a comprehensive infection prevention assessment of an ambulatory care facility. It is only an example. Feel free to edit to conform to your facility. 5 6

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6 Safe Injection Practices: Are you getting the point? 11

7 Safe Injections A safe injection does not harm the recipient, does not expose the provider to any avoidable risks (safety devices!) and does not result in waste that is dangerous for the community New York, 2001 MD reinserting used needles in multidose vials of fentanyl Subsequently used medication from contaminated vial on at least the next 18 patients Review of medical supply orders revealed that 4,950 needles were required for the corresponding number of procedures performed 600 needles had been ordered by the clinic 12 clinic-associated hepatitis C infections

8 Nebraska Hepatitis C Outbreak September, newly diagnosed HCV infections received chemotherapy at one ambulatory care cancer clinic Infection control breach related to catheter flushing -- RN drew blood from indwelling IV catheter, reusing same syringe to perform saline flush New syringe used for each patient 500cc solution bag used for multiple patients 99 clinic-acquired HCV infections identified Oncologist and RN licenses revoked Oklahoma Pain Remediation Clinic August 2002 Single syringe filled with sedation medication to treat up to 24 sequential patients Administered through heparin locks Look-back investigation for entire two year time period of clinic operation Serologic results for 795/908 (88%) patients 71 (9%) clinic-associated HCV infections 31 (4%) clinic-associated HBV infections $25 million settlement Comstock et al. ICHE, 2004, 25:

9 New Jersey, 2009 HBV transmission related to reuse of single dose vials and common source saline bag 4,600 patients notified 29 cancer patients infected w/ HBV MD had license revoked Arizona, 2012 MRSA transmission secondary to unsafe compounding 3 patients with severe infections requiring hospitalization ranging for 9 41 days 1 patient died from drug overdose; however, invasive MRSA infection could not be ruled out

10 Delaware, patients infected w/ MRSA secondary to joint injections Reuse of single dose vials implicated Infected patients required average hospital stays of 6 days Massachusetts, 2012 New England Compounding Center (NECC) Improper sterilization and testing Improper management of sterilizer Methylprednisolone acetate vials contaminated with Exserohilum spp and Aspergillus spp 751 patients infected: 64 died NECC surrendered its license 7 days after start of investigation

11 Las Vegas, Nevada Endoscopy Center February, 2008, Initial Findings 6 known acute cases linked to one location Genetic match of 4 patients with procedures on same date Unsafe practices occurred over time Anesthesia logs showed fewer single dose vials used than patients treated 21 Las Vegas to Date 114 patients have acquired an outbreak-associated case of hepatitis C. 53,000 patients have been notified of their exposure and many more may have been exposed. Two $200 million suits against Teva, propofol manufacturer. Two patients have died. MD convicted of 2 nd degree murder, insurance fraud, negligence resulting in bodily harm. MD will be eligible for parole in 18 years.

12 Nevada May 16, 2008 / 57(19); CMS and Infection Control Conditions: Ambulatory Care and Inpatient Hospital Regulation Multiple page document specifically for inspecting infection prevention practices in acute and ambulatory care facilities. Among many other elements of infection prevention, the survey tool addresses: Injection practices Single dose vials Inspectors must list all multidose vials in use in facility Medication prep areas Syringe use only one patient Septums disinfected before piercing

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14 A problem and its solution Multidose lidocaine Buffered with single dose bicarbonate Spike left in all day Solution: clinic has lidocaine and bicarbonate prefilled syringes prepared at compounding pharmacy, approved by our pharmacists, and per CMS and CDC advisory

15 Single Dose Medication Vials Injectable medications labeled by the manufacturer as single dose or single patient use may be used for only ONE dose for ONE patient and the remainder discarded immediately. Injectable medications should be drawn up as needed not ahead of time. Administer medications drawn from a single dose vial as soon as feasible. Back to the assessment tool

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19 Instrument Processing in Outpatient Care Facilities Access to complex and invasive procedures in healthcare facilities other than hospitals: 1. Saves time and money 2. Brings heightened risk of infection to patients and staff 37 Spaulding Classification System Instruments are categorized according to the degree of risk for infection 1. Critical items 2. Semi-critical items 3. Non-critical items

20 Critical Items Items enter sterile tissue or the vascular system. Sterilization for Critical Items Complete destruction of all microbial life. Examples: surgical instruments, cardiac and urinary catheters, implants, and ultrasound probes used in sterile body cavities. 39 Semi-Critical Items Items contact mucous membranes or nonintact skin. High Level Disinfection for Semi- Critical Items Examples: some endoscopes, laryngoscope blades, cystoscopes, ultrasound probes. Complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores.

21 High level disinfection and sterilization processes that fail to comply with scientifically-based guidelines lead to outbreaks of infection. Rutala & Weber 41 Switch to disposables wherever possible. 42

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23 Instruments 45 The Sterilizers 46

24 Sterilizers 47 Steam Sterilization Highly, highly, highly effective Nontoxic to patients and staff Cycle is easy to control and monitor Rapid cycle time Penetrates medical packing and device lumens Least affected by organic/inorganic soils 48

25 49 Biological Indicators (BIs) 50

26 Biological indicators should be used at least weekly, with each load that contains implants, and, ideally, daily. BIs must be intended specifically for the type of sterilizer in use. 51 Monitoring the Sterilization Cycle Mechanical parameters Chemical parameters Biological parameters Time Temperature Pressure Chemical indicators Sterilizers that do not have recording devices should not be used Biological indicators Bacillus spores that directly measure sterilization 52

27 Your clinics may process semi-critical devices manually Or in an automated endoscope reprocessor 53 Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 William A. Rutala, Ph.D., David Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC)

28 Disinfection and Sterilization in Health Care Facilities: What Clinicians Need to Know Rutala and Weber, Clinical Infectious Diseases 2004; 39:702 9 Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011 Gastrointestinal Endoscopy 2011; vol. 73, No. 6: Manufacturer s IFUs 55 Back to the assessment tool

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32 Where does all this data go? 63 64

33 Thank you! The Big Outbreaks Don t Happen in the Hospital Judie Bringhurst RN, MSN, CIC UNC Healthcare Hospital Epidemiology Chapel Hill, North Carolina jbringhu@unch.unc.edu 65