Unsafe Injection Practices in The U.s. Healthcare System

THE ARTICLES LIFTED HERE ARE A SAMPLING OF THIS MONTH'S SELECTION. THE FULL LISTING IS AVAILABLE AT CDC.GOV/SCIENCE CLIPS OR VIA ELECTRONIC SUBSCRIPTION. TODAY'S SPEAKERS INCLUDE DR. JOSEPH BERTH, DR. GUESS BERKHEAD AND DR. THOMAS HAMILTON FROM THE CENTER OF MEDICARE AND MEDICAID SERVICES, DR. MICHAEL BELL, FROM CDC'S DIVISION OF HEALTH CARE QUALITY PROMOTION WILL SERVE AS OUR CLOSING SPEAKER AND DISCUSSION LEADER TODAY. WE'RE PUTTING ON THIS GRAND ROUNDS AT A TIME OF EXTRAORDINARY DEDICATION AND EFFORT BY OUR SPEAKERS, THEIR COLLEAGUES AND THE ENTIRE PUBLIC HEALTH COMMUNITY IN RESPONDING TO MULTIPLE COMPLEX HEALTH EMERGENCIES. I JUST WANTED TO TAKE A MOMENT TO RECOGNIZE AND THANK ALL OF THEIR LEADERSHIP AND SERVICE. PRIOR TO COMMENCING OUR SESSION, WE WILL HEAR INTRODUCTORY REMARKS FROM THE CDC DIRECTOR, DR. THOMAS FRIEDEN. >> OVER THE PAST FEW MONTHS, MORE THAN 400 PEOPLE HAVE CONTRACTED LIFE THREATENING FUNGAL MENINGITIS. HEALTH CARE SHOULD NEVER SPREAD BLOOD PATHOGENS OR CONTAMINANTS. CDC'S CAMPAIGN RAISES AWARENESS AMONGST PATIENTS AND HELPS IMPROVE PRACTICES. WE CAN IMPROVE SAFETY BY EFFECTIVELY ENFORCING EVIDENCE-BASED STANDARDS. INDIVIDUALS, HEALTH CARE SYSTEMS AND GOVERNMENT AGENCIES HAVE DONE A LOT TO IMPROVE INJECTION SAFETY, BUT MORE PROGRESS IS NEEDED. I'VE ALWAYS THOUGHT THAT DO NO HARM WAS FAR TOO LOW A BAR TO AIM FOR, BUT IT'S ONE THAT WE SHOULD DEFINITELY ACHIEVE. >> IT'S NOW MY PLEASURE TO INTRODUCE OUR FIRST SPEAKER, DR. JOE BERST. >> THANK YOU. I APPRECIATE THE OPPORTUNITY TO PRESENT AND DISCUSS ON THE TOPIC OF INJECTIONS WITHOUT INFECTIONS. I HOPE YOU'LL ALL AGREE THAT THIS REPRESENTS AN ESSENTIAL AND BASIC FORM OF PATIENT SAFETY. INJECTIONS AND INFUSIONS REPRESENT THE MOST COMMON INVASIVE PROCEDURE ACROSS ALL HEALTH CARE. EXAMPLES INCLUDE CHEMOTHERAPY, INTRAVENOUS ANTIBIOTICS, VACCINATIONS, SEDATION ANESTHESIA, JOINT INJECTIONS, INJECTIONS GIVEN AS PART OF COSMETIC OR ALTERNATIVE MEDICAL PROCEDURES AND SO ON. BECAUSE THESE ARE INVASIVE PROCEDURES, THEY POSE A RISK OF INFECTION AND BASIC PROTECTIONS MUST BE IN PLACE TO ENSURE THEIR SAFETY. TO PUT THIS AFTERNOON'S PRESENTATIONS IN PERSPECTIVE, LET'S REVIEW THE BROADER CONTEXT. SAFE INJECTIONS REQUIRE THAT WE HAVE SOUND SYSTEMS THAT SUPPORT SAFE PRODUCTION OF STERILE MEDICATIONS. SAFE PREPARATION OF THE APPROPRIATE MEDICATION, WHICH IS TYPICALLY DRAWN UP IN A SYRINGE, SAFE ADMINISTRATION OF THE MEDICATION IN A MANNER THAT MAINTAINS SISTER SS STERILITY AND MINIMIZES RISK OF INFECTION ENDING WITH SAFE DISPOSAL. AS NOTED ON THIS SLIDE, HEALTH CARE WORKER SAFETY IS ONE IMPORTANT DIMENSION OF SAFE INJECTION PRACTICE. LIKEWISE, CONSIDERING THE PRODUCTION AND PREPARATION STAGES, SAFE MANUFACTURING AND PHARMACY PRACTICES ARE ESSENTIAL AS EVERY INJECTION MUST BEGIN WITH STERILE PRODUCT. TODAY'S PUBLIC HEALTH GRAND ROUNDS WILL FOCUS ON THE PATIENCE RISKS AND CLINICAL PRACTICES AT THE POINT INJECTIONS ARE ADMINISTERED. AS I'LL DESCRIBE LATER, SAFE ADMINISTRATION DEPENDS ON ADHERENCE TO SAFE PRACTICES AS OUTLINED IN CDC'S EVIDENCE BASED STANDARD PRECAUTIONS. TRADITIONALLY, INJECTION SAFETY WAS RECOGNIZED AS A PUBLIC HEALTH ISSUE MAINLY IN LOW AND MIDDLE INCOME COUNTRIES. ESTIMATES OF THE GLOBAL BURDEN OF DISEASE ASSOCIATED WITH UNSAFE INJECTIONS IN THE YEAR 2000 INCLUDED MORE THAN 20 MILLION NEW HEPATITIS B VIRUS INJECTIONS INJECTIONS, MORE THAN 20 MILLION NEW HELP TITUSGHT HELP TITUS C VACCINATIONS. REUSE OF INJECTION EQUIPMENT AS ILLUSTRATED IN THIS PHOTO TAKEN SOME YEARS AGO IN SOUTH ASIA DROVE SOME OF THIS TRANSMISSION. NOTE THAT THE CDC SUPPORTED THE ESTABLISHMENT OF THE WORLD HEALTH ORGANIZATIONS, SAFE INJECTION GLOBAL NETWORK IN THE 1990s WITH MUCH PROGRESS HAVING BEEN MADE SINCE THAT TIME. OUTBREAKS INVESTIGATED BY CDC AND STATE AND LOCAL HEALTH DEPARTMENTS HAVE HELPED ILLUSTRATE THE POINT THAT OUR U.S. HEALTH CARE SYSTEM IS NOT IMMUNE TO THE DANGERS OF UNSAFE INJECTIONS. THIS SLIDE SHOWS THE MECHANISM BY WHICH HEPATITIS C INFECTIONS WERE TRANSMITTED IN A 2008 LAS VEGAS, NEVADA OUTBREAK. THIS WAS A BUSY CLINIC THAT USED PROPOFOL WHICH IS SUPPLIED IN SINGLE DOSE VIALS. AS SHOWN ON THE LEFT AT THE START OF THE PROCEDURE, A NEW CLEAN NEEDLE AND SYRINGE WERE USED TO DRAW UP MEDICATION. WHEN USED ON AN HCV INFECTED PATIENT, BACKFLOW CONTAMINATED THE SYRINGE. PATIENTS TYPICALLY REQUIRED ADDITIONAL MEDICATIONS TO MAINTAIN SEDATION. NURSES IN THIS CLINIC REUSED THE PATIENT'S SYRINGE AS SHOWN HERE IN THE CIRCLE TO DRAW THE MEDICATION AFTER REPLACING THE NEEDLE. BY PUTTING THE REUSED SYRINGE IN CONTACT WITH THE VIAL, CONTAMINATION TRANSFERRED TO THE VIAL. THIS CLINIC ROUTINELY REUSED THESE SINGLE DOSE VIALS FOR MULTIPLE PATIENTS, WHICH ESTABLISHED A PATHWAY FOR THE SPREAD OF HEPATITIS C FROM ONE PATIENT TO ANOTHER AS SHOWN ON THE RIGHT. CHANGING THE NEEDLE IN THIS SITUATION DID NOT PREVENT CONTAMINATION OF THE VIAL. IT DID, HOWEVER, EXPOSE THE NURSE TO RISK OF SHARPS INJURIES AND OCCUPATIONAL DISEASE TRANSMISSION. THIS OUTBREAK WAS IDENTIFIED BY THE LOCAL HEALTH DEPARTMENT WHICH INITIALLY RECEIVED TWO REPORTS OF ACUTE HEPATITIS C AND DETERMINED THE PATIENTS SHARED A COMMON EXPOSURE TO THIS ENDOSCOPY CLINIC WHICH AS WE LEARNED LATER WAS A CMS CERTIFIED AMBULATORY SERVICE CENTER. THE INVESTIGATION UNCOVERED UNSAFE PRACTICES AND CONFIRMED SIX ADDITIONAL CASES OF TRANSMISSION. HOWEVER, THE IMPACT TRANSMITTED WELL BEYOND THESE AES INFECTED PATIENTS. SINCE REUSE OF SINGLE DOSE VIALS WERE CONTINUALLY AT USE IN THIS CLINIC, MANY PATIENTS WERE EXPOSED TO HEPATITIS C, WHICH IS TYPICALLY A SILENT INFECTION. THIS INVOKES THE PUBLIC HEALTH ETHICS PRINCIPAL OF DUTY TO WARN. ULTIMATELY, OVER 50,000 PATIENTS WERE NOTIFIED BY PUBLIC HEALTH AUTHORITIES OF THEIR POTENTIAL EXPOSURE AND ADVISED TO SEEK TESTING. THIS OUTBREAK WAS SIGNIFICANT IN THAT IT LED TO COLLABORATION WITH CMS, WHICH YOU'LL HEAR MORE ABOUT LATER IN THE HOUR. TO SUMMARIZE, THEN, UNSAFE INJECTION PRACTICES CAN BE THOUGHT OF AS FALLING INTO TWO INTERSECTING CATEGORIES. REUSE OF SYRINGES AND MISHANDLING OF MEDICATION. WE DO STILL ENCOUNTER DIRECT REUSE IN WHICH A SINGLE SYRINGE IS USED FOR MORE THAN ONE PATIENT. SOMETIMES HEALTH CARE PROVIDERS HAVE THE MISTAKE AND BELIEF THAT INJECTIONING THROUGH A LENGTH OF IV TUBING IS A SAFE PRACTICE OR REMOVING THE NEEDLE MAKES THE SYRINGE SAFE FOR REUSE. INSULIN PENS ARE AN EXAMPLE OF A NEWER TYPE OF DEVICE THAT INTEGRATES A PREFILLED SYRINGE. WHILE THESE ARE APPROVED FOR SINGLE USE ONLY, SOME BELIEVE CHANGING THE NEEDLE MAKES THEM SAFE TO USE FOR MULTIPLE PATIENTS. NARCOTICS TAMPERING HAS EMERGE AS AN ISSUE AND RESULTED IN EXPOSURE OF PATIENTS TO REUSED CONTAMINATED SYRINGES. MORE COMMONLY, WE HAVE SEEN DOUBLE DIPPING AND WAS ILLUSTRATED IN THE NEVADA EXAMPLE I SHARED A FEW MINUTES AGO. MISHANDLING AND INAPPROPRIATE SHARING OF MEDICATION CONTAINERS INCLUDES CONTAMINATION FROM DOUBLE DIPPING AS WELL AS REUSE OF SINGLE DOSE VIALS TO OBTAIN MEDICATION FOR MULTIPLE PATIENTS BECAUSE SINGLE DOSE VIALS TYPICALLY LACK PRESERVATIVES, THIS PRACTICE CARRIES SUBSTANTIAL RISKS FOR BACTERIAL CONTAMINATION, GROWTH AND SPREAD OF INFECTION. SIMILARLY, INTRAVENOUS SOLUTION BAGS ARE OFTEN MISHANDLED, FOR EXAMPLE, WHICH USED AS A COMMON SOURCE OF SUPPLY FOR MULTIPLE PATIENTS. THE U.S. EXPERIENCE WITH OUTBREAKS DUE TO UNSAFE INJECTION PRACTICES HAS GROWN SUBSTANTIALLY OVER RECENT YEARS. SINCE 2001, AT LEAST 48 OUTBREAKS HAVE OCCURRED THAT CDC IS AWARE OF. BEAR IN MIND THAT ALL THESE OUTBREAKS WERE DUE TO CONTAMINATION AT THE POINT OF PREPARATION AND ADMINISTRATION. IN OTHER WORDS, NOT FROM INTRINSICALLY CONTAMINATED PRODUCTS RECEIVED FROM A PHARMACY OR DRUG COMPANY. 21 OF THESE OUTBREAKS INVOLVED TRANSMISSION OF HEPATITIS B OR HEPATITIS C. THE OTHER 27 REPRESENTED OUTBREAKS OF BACTERIAL INFECTION MOST OF WHICH INVOLVED INVASIVE BLOODSTREAM INFECTION. 90% OF THE OUTBREAKS IDENTIFIED HERE OCCURRED IN OUTPATIENT SETTINGS WITH AN OVERREPRESENTATION OF PAIN CLINICS WHERE INJECTIONS ARE MADE INTO THE SPINE AND OTHER STERILE SPACES YOOD USES PRESERVATIVE FREE MEDICATION. CANCER CLINICS ARE ALSO OVERREPRESENTED. THESE CLINICS CARE FOR VULNERABLE PATIENTS, MANY OF WHOM ARE IMMUNE COMPROMISED. WITH MANY OF THEM HAVING EXPOSURE TO CONTAMINATED CATHETER FLUSH SOLUTIONS. WHILE HUNDREDS OF PATIENTS BECAME INFECTED IN THE OUTBREAKS I JUST DESCRIBED, EQUALLY SIGNIFICANT ARE THE MASSIVE NUMBERS. OVER 150,000 TO DATE, WHO HAVE REQUIRED NOTIFICATION TO ADVISE BLOODBORNE PATH AGAIN TESTING FOLLOWING POTENTIAL EXPOSURE TOES UNSAFE INJECTIONS. NOTE THAT THE THRESHOLD FOR NOTIFICATION IS NOT THE PRESENCE OF IDENTIFIED INFECTIONS OR CONFIRMED TRANSMISSIONS. WHILE THOSE CONDITIONS ARE OFTEN THE SIGNAL THAT LEADS TO IDENTIFICATION OF SYRINGE REUSE AND RELATED USES, INCREASINGLY, WE ARE SEEING NOTIFICATION TRIGGERED BY THE DISCOVERY OF SYRINGE REUSE ITSELF. AND IT IS IMPORTANT TO REMIND OURSELVES THAT BEHIND THE STATISTICS AND HEADLINES, THERE ARE REAL PEOPLE, REAL LIVES THAT HAVE BEEN IMPACTED AND AFFECTED. AT LEFT, WE HAVE A PATIENT POTENTIALLY EXPOSED AS A RESULT OF NARCOTICS TAMPERING. AT RIGHT, A NONOUTBREAK SITUATION INVOLVING REUSE OF INFLUENZA REUSE SYRINGES. OBVIOUSLY, RECEIVING A NOTIFICATION LETTER IS DISTRESSING FOR PATIENTS AND THEIR LOVED ONES. IT INVOLVES SIGNIFICANT COSTS RELATED TO THE FOLLOW-UP TESTING AND MEDICAL MANAGEMENT AS WELL AS A BREACH IN TRUST. UNSAFE INJECTION PRACTICES ARE NOT LIMITED TO OUTBREAKS OR IDENTIFIED EVENTS. A RECENT SURVEYS OF PHYSICIANS AND NURSES ILLUSTRATES THE POTENTIAL MAGNITUDE OF THE HIDDEN RISKS. 1% ADMITTED THAT THEY SOMETIMES OR ALWAYS REUSE A SYRINGE ON A SECOND PATIENT. 1% SOMETIMES ARE ALWAYS REUSED -- WOULD REUSE A MULTI DOSE FILE TRADITIONAL PATIENTS AFTER ACCESSING IT WITH A USED SYRINGE AND 6% SAID THAT THEY USED SINGLE DOSE VIALS FOR MORE THAN ONE PATIENT. IT'S DIFFICULT, OF COURSE, TO KNOW THE TRUE PREVALENCE OF UNSAFE PRACTICES SINCE THIS WAS A VOLUNTARY STUDY. WHICH DID NOT INCLUDE MEDICAL ASSISTANTS, OTHER TYPES OF PROVIDERS AND, AGAIN, THIS WAS BASED ON RESPONSES WHICH MAY BE BIAS AND NOT CONFIRMED BY OBSERVATION. NONETHELESS, ONE CAN APPRECIATE THE REPERCUSSIONS OF THIS ADHERENCE GAP IN TERMS OF BACKGROUND TRANSMISSION. SO HAVING MENTIONED WHAT I POLITELY TERMED AS AN ADHERENCE GAP, I'D LIKE TO BRIEFLY MENTION THE ONE AND ONLY CAMPAIGN. OUR GOAL IS TO PREVENT OUTBREAKS, INFECTIONS AND THE NEED FOR PATIENT NOTIFICATIONS. WE DO NOT WANT ANY HEALTH CARE PROVIDER TELLING US THEY DIDN'T KNOW BETTER WHEN IT COMES TO SYRINGE REUSE AND OTHER UNSAFE INJECTION PRACTICES. THE ONE AND ONLY CAMPAIGN IS LED BY THE CDC AND ITS PARTNERS IN THE SAFE INJECTION PRACTICES COALITION. OUR ULTIMATE GOAL IS TO ENSURE THAT PATIENTS -- AND THAT INCLUDES EVERY ONE OF US IN THIS ROOM, THOSE VIEWING, OUR PATIENTS, FRIENDS, FAMILY MEMBERS, THAT EACH OF US IS PROTECTED EVERY TIME THEY RECEIVE AN INJECTION. AS I INDICATED EARLIER, SAFE INJECTION PRACTICES ARE A KEY COMPONENT OF CDC'S STANDARD PRECAUTIONS GUIDANCE. KEY ELEMENTS INCLUDE NEVER ADMINISTERING MEDICATIONS FROM THE SAME SYRINGE TO MULTIPLE PATIENTS, NOT REUSING A SYRINGE TO ENTER A VIAL AND LIMITING SHARING OF MEDICATION VIALS AMONG MULTIPLE PATIENTS. IT IS THE STANDARDS THAT FORM THE BASIS FOR OUR EDUCATIONAL OUTREACH AND EFFORTS TO INCREASE IMPLEMENTATION AND ENFORCEMENT OF SAFE INJECTION PRACTICES. WHICH BRINGS ME TO MY FINAL SLIDE. INJECTION SAFETY IS A COMPLEX PUBLIC HEALTH ISSUE THAT REQUIRES A MULTI DIMENSIONAL APPROACH. INNOVATIVE SOLUTIONS AND PARTNERSHIPS. AND I CAN OFFER AT LEAST THREE Es FOR ENSURING SAFE INJECTIONS. FIRST, WE RELY ON EPIDEMIOLOGIC CAPACITIES RELATED TO SURVEILLANCE, REPORTING, MONITORING AND INVESTIGATING. SECOND, WE RECOGNIZE THE NEED FOR SOUND EDUCATIONAL INITIATIVES TO PROMOTE UNDERSTANDING OF SAFE INJECTION PRACTICES AND BASIC INFECTION CONTROL. RECOGNIZING THAT EDUCATION IS NECESSARY BUT NOT ALWAYS SUFFICIENT, WE ALSO RELY ON ENFORCEMENT AND OVERSIGHT. THAT IS, POLICIES AND MECHANISMS THAT SUPPORT AND ENSURE ADHERENCE TO SAFE INJECTION PRACTICES AND OTHER BASIC INJECTION CONTROL. BEING MINDFUL OF THE NEED TO EXTEND THIS REACH TO ALL SETTINGS WHERE INJECTIONS ARE DELIVERED. AND SO WITH THAT, I'LL TURN THE PODIUM OVER TO DR. BURKEHEAD. THANK YOU. >> THANKS VERY MUCH, JOE, AND THANKS FOR INVITEING ME TO SHARE OUR EXPERIENCES IN NEW YORK WITH INJECTION RELATED OUTBREAK INVESTIGATIONS. IN THE NEXT FEW SLIDES, I WILL PROVIDE A BRIEF OVERVIEW OF SOME INVESTIGATIONS WE HAVE CONDUCTED. EXCUSE ME. GETTING OVER A COLD HERE. AND ALSO SUMMARIZE WHAT NEW YORK HAS BEEN DOING TO ADDRESS THIS PUBLIC HEALTH ISSUE. THIS SLIDE SHOWS A NUMBER OF INVESTIGATIONS OF KNOWN OR POTENTIAL BLOOD BORN PATH AGAIN TRANSMISSIONS TO THE STATE HEALTH DEPARTMENT HAS BEEN INVOLVED IN OVER THE LAST DECADE. THE PREDOMINANT MODES OF EXPOSURE OR TRANSMISSION RELATE TO POOR INJECTION PRACTICES OR TO DIALYSIS. I WILL FOCUS MY REMARKS ON POOR INJECTION PRACTICES AND MR. HAMILTON WILL SAY A LITTLE MORE ABOUT DIALYSIS IN HIS TALK. THESE 11 INVESTIGATIONS INVOLVE NOTIFICATION OF ALMOST 10,000 PEOPLE. ONE OF THE FIRST AND THE LARGEST INVESTIGATIONS WE HAVE BEEN INVOLVED IN INVOLVED A PAIN MANAGEMENT CLINIC. THIS OUTBREAK INVESTIGATION HELPED US DEVELOP THE EPI METHODS WE HAVE USED IN SUBSEQUENT OUTBREAKS AND LED US TO DEVELOP A MUCH MORE SYSTEMIC APPROACH TO THESE INVESTIGATIONS WHICH I WILL DESCRIBE LATER. THIS INVESTIGATION BEGAN SIMILAR TO THE EPISODE THAT JOE DISCUSSED WHEN AN ASTUTE COUNTY PUBLIC HEALTH NURSE CONDUCTING A ROUTINE HELP TITUS SURVEILLANCE INVESTIGATION IDENTIFIED TWO CASES OF ACUTE HEPATITIS C INFECTIONS IN PATIENT WHOSE RECEIVED EPIDURAL INJECTIONS DURING THE SAME -- FROM THE SAME PHYSICIAN IN A PRIVATE PAIN MANAGEMENT CLINIC. A SITE VISIT TO THE PHYSICIAN'S PRACTICE WAS CONDUCTED TO OBSERVE INFECTIOUS CONTROL PRACTICES. IN THE COURSE OF GIVING SPINAL INJECTIONS, THE PHYSICIAN WAS OBSERVED RE-ENTERING MULTI DOSE VIALS OF MEDICATION WITH A SYRINGE ALSO USED TO INJECTION DRUGS THROUGH THE END DWELLING SPINAL NEEDLE, HAVING CHANGED OWN THE NEEDLE ON THE SYRINGE TO RE-ENTER THE VIAL. THE CONTAMINATED VIAL WAS THEN PUT ASIDE TO BE USED FOR SUBSEQUENT PATIENTS. THE PHYSICIAN WAS NOT AWARE HIS PRACTICE PRESENTED AN INFECTION CONTROL RISK AND HE WAS IMMEDIATELY INSTRUCTED TO DISCONTINUE THAT PRACTICE. TO CONFIRM THE TRANSMISSION HAD, INDEED, OCCURRED IN THIS PRACTICE AND TO IDENTIFY OTHER PATIENTS AT RISK, WE CONDUCTED AN ACTIVE SURVEILLANCE FOR OTHER CASES BY FIRST MATCHING THE PATIENTS -- THE PRACTICE'S PATIENT LIST AGAINST THE STATE HEPATITIS C SURVEILLANCE REGISTRY. AN ADDITIONAL CASE OF HEPATITIS C WAS IDENTIFIED BY DOING THIS. NEXT, WE CONTACTED 98 PATIENTS WHO RECEIVED INJECTIONS THE WEEK BEFORE, THE WEEK OF OR THE WEEK AFTER THE THREE KNOWN CASES. SEVEN OF THOSE TESTED WERE POSITIVE FOR HEPATITIS C, A MUCH HIGHER PREVALENCE THAN WE HAD EXPECTED. AND FINALLY, TRANSMISSION WAS CONFIRMED IN ONE INSTANCE BY MOLECULAR TESTING IN OUR STATE PUBLIC HEALTH LABORATORY. THE TWO PATIENTS HAD RECEIVED PAIN INJECTIONS ON THE SAME DAY IN THE CLINIC. WITH EVIDENCE OF AN INFECTION CONTROL BREACH AND DISEASE TRANSMISSION, WE FELT AN OBLIGATION TO NOTIFY OTHER POTENTIALLY EXPOSED PERSONS SO THEY COULD SEEK TESTING FOR BLOODBORNE PATHOGENS. IF INFECTED, THIS WOULD ALLOW THEM TO SEEK MEDICAL CARE FOR THEIR OWN HEALTH AND REDUCE TRANSMISSION TO OTHERS. PATIENT NOTIFICATIONS PRESENT A NUMBER OF CHALLENGES, INCLUDING HOW TO SELECT WHICH PATIENTS TO NOTIFY AND BALANCING THE MESSAGE SO AS TO IMPART FACTUAL INFORMATION. AND MOTIVATE PEOPLE TO SEEK TESTING WITHOUT CAUSING UNDUE HARM. IN THIS CASE, WE ALSO HAD CHALLENGES DETERMINING HOW TO MOST EFFICIENTLY GET CONTACT INFORMATION FROM THE PROVIDER'S OUTDATED ELECTRONIC BILLING SYSTEM. WE INITIALLY NOTIFIED 627 PATIENTS IDENTIFIED FROM THE BILLING SYSTEM WHO HAD SPINAL INJECTIONS DATING BACK TO WHEN THE PHYSICIAN STARTED TO PRACTICE AT THIS SITE. HOWEVER, DUE TO PUBLICITY, WHEN SOME PATIENTS GAVE NOTIFICATION LETTERS TO THE PRESS, WE QUICKLY LEARNED OF ADDITIONAL PATIENTS WHO HAD HAD SPINAL INJECTIONS DURING THE TIME FRAME BUT WERE NOT INCLUDED IN THE LIST OF PATIENTS PROVIDED BY THE PRACTICE. THEREFORE, THE DECISION WAS MADE TO NOTIFY ALL 8,532 PATIENTS IN THE PRACTICE'S DATABASE, REGARDLESS OF THE TIME FRAME OR TYPE OF PROCEDURE AND WE ALSO AT THIS POINT ISSUED OUR FIRST PRESS RELEASE. WE ALSO OFFERED FREE TESTING FOR HEPATITIS B AND C AND *** SO THAT THERE WOULD BE NO BARRIERS TO PEOPLE GETTING TESTED IF THEY SO WISHED. THESE INVESTIGATIONS GARNER SIGNIFICANT HEALTH SIGNIFICANCE AND ATTENTION. AS I MENTIONED, THE ORIGINAL PUBLICITY AROUND THIS INVESTIGATION OCCURRED WHEN PATIENTS WHO RECEIVED NOTIFICATION LETTERS GAVE THEM TO THE PRESS. THIS RESULTED IN A VERY DIFFICULT GAME OF CATCH UP TO GET OUR PUBLIC HEALTH MESSAGES OUT. FROM THIS EPISODE, WE LEARNED TO BE MUCH MORE PROACTIVE IN ISSUING PRESS RELEASES WHEN DOING LARGE PATIENTS NOTIFICATION. WE ALSO LEARNED THAT THESE INVESTIGATIONS CAN HAVE SIGNIFICANT RAMIFICATIONS FOR HEALTH CARE PROVIDERS, PATIENTS AND PUBLIC HEALTH AGENCIES. IN THIS CASE, THE PHYSICIAN GOT SUBSTANTIAL NEGATIVE MEDIA ATTENTION, MULTIPLE LAWSUITS WERE FILED AGAINST THE INDIVIDUAL AND CONDITIONS WERE PLACED ON HIS MEDICAL LICENSE FOR THREE YEARS BY OUR STATE PROFESSIONAL CONDUCT OFFICE. BOTH THE STATE AND COUNTY HEALTH DEPARTMENTS RECEIVED A GREAT DEAL OF MEDIA ATTENTION RELATED TO HOW THE INVESTIGATION WAS HANDLED. LAWSUITS WERE FILED RELATED TO THE STATE'S DUTY TO INFORM PATIENTS SOONER OF POTENTIAL INFECTION RISKS AND NUMEROUS TESTING RESULTED IN A GREAT DEAL OF RESOURCE NECESSARY OUR DEPARTMENT. PUBLIC ATTENTION TO OUTBREAK INVESTIGATIONS MAY HAVE UNINTENDED CONSEQUENCES, THOUGH THE IMPACT OF THESE ARE NOT WELL UNDERSTOOD. FOR EXAMPLE, PUBLICITY AROUND SUCH INVESTIGATIONS MAY AFFECT HEALTH SEEKING BEHAVIORS. FOR EXAMPLE, WE'VE HAD AN EPISODE OF REUSE OF SYRINGES FOR FLU VACCINATIONS. ALTHOUGH WE HAVE NO EVIDENCE THIS THAT OCCURRED IN THIS PARTICULAR CASE, THE ISSUE HAS NOT BEEN STUDIED AND REMAINS A POTENTIAL CONCERN. WE'VE ACTED ON A NUMBER OF THE LESSONS THAT WE LEARNED IN THIS INVESTIGATION. FIRST, WE MADE CHANGES IN THE PUBLIC HEALTH LAW TO STRENGTHEN THE ABILITY OF THE DEPARTMENT TO INVESTIGATE AND HOLD PHYSICIANS ACCOUNTABLE FOR POOR INFECTION CONTROL PRACTICES. WE UPDATED THE INFECTION CONTROL AND COSTS FOR TRAINING. THE COMMISSIONER FORMED A MILLION TIE DISCIPLINARY USE WITHIN THE DEPARTMENT TO BRING TOGETHER ALL THE PROGRAM AREAS AND THIRD, WE EMBARKED ON PA PROVIDER AND PUBLIC EDUCATION DEPARTMENT AS PART OF THE ONE AND ONLY CAMPAIGN WHICH HAS BEEN MENTIONED ALREADY. RECENTLY, NEW YORK HAS INCREASED REGULATION OF AMBULATORY SURGERY, AS JOE MENTIONED WAS THE CASE IN THE ENDOSCOPY RELATED OUTBREAK. I'LL ADDRESS THE FIRST THREE POINTS ON THIS SLIDE IN A LITTLE MORE DETAIL HERE. DUE TO THE CONCERN ABOUT *** INFECTED HEALTH CARE WORKERS IN THE 1990s, NEW YORK HAS A LAW REQUIRING MEDICAL PROFESSIONALS TO TAKE AN INFECTION CONTROL AND BARRIER PRECAUTIONS COURSE EVERY FOUR YEARS. AS A RESULT OF THIS INVESTIGATION, THE CURRICULUM OF THE MANDATED COURSE WAS ENHANCED TO INCLUDE SAFE INJECTION PRACTICES AS WELL AS MEDICAL EQUIPMENT CLEANING DISINFECTION AND STERILIZATION. TO IMPROVE COORDINATION OF INVESTIGATIONS AND COMMUNICATION WITHIN THE HEALTH DEPARTMENT ON THESE ISSUES OF MULTI DISCIPLINARY HEALTH CARE DISEASE TRANSMISSION WORK GROUP WAS FORKED. THE WORK GROUP INCLUDES REPRESENTATIVES FROM EPIDEMIOLOGY, LABORATORY, LEGAL, PUBLIC AFFAIRS, HEALTH CARE REGULATORY AND PHYSICIAN DISCIPLINE OFFICES IN THE DEPARTMENT, EACH OF WHICH HAS A VERY DISTINCT ROLE TO PLAY IN THESE INVESTIGATIONS. THE WORK GROUP MEETS REGULARLY TO REVIEW ACTIVE INVESTIGATION TOES ENSURE CONSISTENT, COORDINATED AND TIMELY RESPONSE. IN THE BEGINNING, THE WORK GROUP DEVELOPED GUIDE LINES FOR INVESTIGATING REPORTS OF HEALTH CARE ASSOCIATED BLOODBORNE PATH AGAIN TRANSMISSION. I'LL SHOW AN EXAMPLE ON THIS NEXT SLIDE. THIS IS A TERRIBLE FROM THE GUIDELINES WHICH WE USE TO ASSURE THAT WE HAVE A CONSISTENT APPROACH AS POSSIBLE FROM INVESTIGATION TO INVESTIGATION GIVEN THAT EACH INVESTIGATION IS UNIQUE. THE GUIDELINES DO INDICATE SOME CIRCUMSTANCES, FOR EXAMPLE, IN THE UPPER RIGHT WHERE WE WILL NOT INVESTIGATE FURTHER BALANCING THE PUBLIC HEALTH WITH THE NEED TO BE EFFICIENT IN THE DEPLOYMENT OF PUBLIC HEALTH RESOURCE RESOURCES. FOR EXAMPLE, IN THE UP RIGHT, SINGLE CASES OF HEPATITIS B OR C WHILE GENERALLY WILL NOT TRIGGER FURTHER INVESTIGATIONS IF THE PATIENT HAS NONHEALTH CARE RELATED EXPOSURES SUCH AS INJECTION DRUG USE OR HAS MULTIPLE POTENTIAL HEALTH CARE RELATED EXPOSURES WHICH WOULD MAKE AN IN-DEPTH INVESTIGATION LOGISTICALLY COMPLEX AND LESS LIKELY TO LEAD TO A DEFINITIVE ANSWER. A SINGLE CASE WITH ONLY A SINGLE HEALTH CARE RELATED EXPOSURE IN THE UPPER LEFT WILL TRIGGER AN INITIAL EPI INVESTIGATION TO GATHER MORE FACTS TO SEE IF IT IS WORTH TO PROCEEDING TO A FULL INVESTIGATION. EVEN IF WE DON'T FOLLOW UP AT THIS POINT, WE KEEP THESE CASES ON MONITOR STATUS AND CAN REACTIVATE A FULL INVESTIGATION IF MORE INFORMATION BECOMES AVAILABLE OR IF ANOTHER CASE OCCURS. AT THE OTHER EXTREME, IF WE HAVE MULTIPLE CASES OF HEPATITIS B OR C WITH A SINGLE HEALTH CARE SETTING EXPOSURE IN THE LOWER LEFT, WE THEN EMBARK ON A FULL INVESTIGATION. WE HAVE THE FLEXIBILITY, OBVIOUSLY, TO DEVIATE FROM THESE GUIDELINES IF CIRCUMSTANCES DICTATE, BUT THIS TABLE PROVIDES OUR GENERAL MARCHING ORDERS. WHEN NEVADA HAD ONE OF THE LARGEST OUTBREAKS OF HEALTH CARE ASSOCIATED BLOODBORNE NOTIFICATION A FEW YEARS AFTER OURS, REPROVIDED TECHNICAL ASSISTANCE WITH THEM BASED ON THESE GUIDELINES THAT WE USE. AS I MENTIONED, NEW YORK HAS EMBARKED ON A PROVIDER AND PUBLIC EDUCATION CAMPAIGN, PART OF THE ONE AND ONLY CAMPAIGN. THE NAME IS BASED ON THE PRINCIPAL THAT EACH NEEDLE AND SYRINGE SHOULD BE USED FOR ONE AND ONLY INJECTION. THE ONE AND ONLY CAMPAIGN IS FUNDED BY THE CDC AND THE SAFE INJECTION PRACTICES CORPORATION. NEW YORK AND NEVADA WERE THE TWO CHARTERS STATES IN THIS CAMPAIGN. TO GUIDE OUR CAMPAIGN, WE HAVE ESTABLISHED A WORK GROUP OF EXTERNAL STAKEHOLDERS, INCLUDING 30 HEALTH CARE ORGANIZATIONS SUCH AS PROFESSIONAL HEALTH CARE ORGANIZATIONS, PATIENT ADVOCACY GROUPS AND QUALITY IMPROVEMENT ORGANIZATIONS. WITH WORK GROUP PARTNERS, WE HAVE GIVEN PRESENTATIONS TO INFECTION CONTROL PRACTITIONERS ACROSS NEW YORK STATE AND OTHER JURISDICTIONS, WE'VE PRESENTED TO OUR STATE BOARD TO ADVOCATE ON NATIONAL BOARD EXAMS AND TO MALPRACTICE CARRIERS AND LARGE PRACTICES THEY INSURE. AS A RESULT, ONE LARGE MALPRACTICE CARRIER HAS SET UP A COLLABORATIVE COMMITTEE TO DISCUSS MESSAGES AND MATERIALS IN ITS FIVE NEW YORK CITY HOSPITALS THAT IT ENSURES. AND WE HAVE WORKED WITH OTHER STATES TO JOINTLY PROVIDE A TOOL KIT TO ASSIST OTHER DEPARTMENTS IN GETTING INTO THIS AREA. THIS SLIDE SHOWS A NUMBER OF PRODUCTS OF OUR NEW YORK ONE AND ONLY CAMPAIGN. FOR HEALTH CARE PROVIDERS IN THE UPPER LEFT, WE'VE FOCUSED -- HAD FOCUS GROUP TESTED EDUCATIONAL MATERIALS TO PROPOSE CDC'S INJECTION SAFETY GUIDELINE WITH THE ONE NEEDLE, ONE SYRINGE ONE TIME ONLY MESSAGE. THESE WERE MAILED TO OUTLINE PROVIDERS. TO COVER -- TO OVERCOME HEALTH CARE PROVIDER DENIAL THAT INJECTION ERRORS HAPPEN ALL TOO EASILY, WE INCORPORATED RISK COMMUNICATION PRINCIPLES TO DEVELOP THE IT'S REAL, IT'S REAL RECENT, IT COULD BECOME YOUR FLYER IN THE WERE RIGHT WHICH INCLUDED HEADLINES ABOUT REAL STORIES OF HEALTH CARE WORKER PROVIDER ERRORS. THE LOWER RIGHT SHOWS US THE SET OF OUR PUBLIC HEALTH LIVE WEB CAST, OUR NEW YORK STATE HUB HEALTH GRAND ROUNDS EQUIVALENT ON SYRINGE SAFETY. PUBLIC HEALTH LIVE REACHES ABOUT 5800 PROVIDERS IN 1600 LOCATIONS AND IT'S EVEN PICKED UP INTERNATIONALLY. FOR THE GENERAL PUBLIC, THE MESSAGE HAS BEEN AIMED AT GETTING PEOPLE WHO ARE ABOUT TO UNDERGO MINOR SURGICAL PROCEDURES OR INJECTIONS TO ASK THEIR HEALTH CARE PROVIDER ABOUT SYRINGE SAFETY PRECAUTIONS THEY WILL TAKE. FOLLOWING THE RECENT HEPATITIS C OUTBREAK IN NEW HAMPSHIRE, I PROMOTED THIS MESSAGE IN AN INTERVIEW ON OUR LOCAL NPR HEALTH SHOW IN THE LOWER LEFT, WHICH IS NATIONALLY SYNDICATED AND THE PROGRAM WAS PICKED UP IN 180 U.S. CITIES. THE NEW YORK CAMPAIGN IS ALSO PROVIDED MENTORSHIP AND TECHNICAL ASSISTANCE TO OTHER JURISDICTIONS, INCLUDING A CME PRESENTATION FOR 100 PHYSICIANS THAT A RHODE ISLAND HOSPITAL AND WE'VE ALSO PRESENTED AT THIS NORTHEAST EPI CONFERENCE TO HEALTH DEPARTMENTS FROM THE EIGHT NORTHEASTERN STATES AND HAVE PROVIDED ASSISTANCE TO OTHER STATES IN DEVELOPING EITHER THEIR INVESTIGATIONS OR DEVELOPING CAMPAIGN EFFORTS. SO IN CONCLUSION, HEALTH CARE ASSOCIATED BLOODBORNE PATH AGAIN TRANSMISSION OCCURS MORE OFTEN THAN REALIZED. ACTIVE SURVEILLANCE AND FOLLOW-UP INVESTIGATIONS WILL UNCOVER PREVIOUSLY UNDETECTED TRANSMISSION. STANDARDIZED AND COLLABORATIVE INVESTIGATIONS AREN'T NECESSARY, BUT ARE RESOURCE INTENSIVE. PROVIDERS NEED TO BE EDUCATED AND THEIR DENIAL ADDRESSED TO RAISE AWARENESS AND DECREASE RISK AND PATIENTS SHOULD BE ENCOURAGED TO ASK THEIR PROVIDER ABOUT BLOODBORNE PATH AGAIN SAFETY AS PART OF INCREASED PATIENT SAFETY OVERALL IN MEDICAL DECISION MAKING. THANKS VERY MUCH AND I'LL TURN IT OVER TO THE NEXT SPEAKER. >>> GOOD AFTERNOON AND THANK YOU FOR INVITEING ME TO BE HERE TODAY. I'M HERE REPRESENTING CMS, THE SINGLE LARGEST PURCHASER OF HEALTH CARE IN THE UNITED STATES AND PROBABLY THE WORLD PURCHASING MORE THAN $800 BILLION WORTH OF HEALTH CARE EVERY YEAR. BUT I'M ALSO HERE REPRESENTING A PUBLIC HEALTH AGENCY THAT SEEKS TO BE A TRUSTWORTHY PARTNER IN THE PROMOTION OF HEALTH CARE INNOVATION AND PROMOTING THE ADOPTION AND SPREAD OF USEFUL INFORMATION AND BEST PRACTICES AND PROMOTING THE CONSISTENT ADVANCEMENT OF SAFETY AND QUALITY OF CARE. AND INCREASINGLY, WE SEEK TO ALIGN OUR VARIOUS CAPABILITIES AND TOOLS IN THE SAME DIRECTION FOR USING OUR PAYMENT POLICY, FOR EXAMPLE, TO ADVANCED VALUE BASED PURCHASING, FOR INCREASING QUALITY MEASUREMENT AND TRANSPARENCY TO THE PUBLIC, FOR INCREASING COLLABORATION WITH THE CDC AND OTHER AGENCIES, FOR INCREASING TECHNICAL ASSISTANCE TO THE QUALITY IMPROVEMENT ORGANIZATION, THE DIALYSIS FACILITY NETWORKS AND MOST RECENTLY THE HEALTH CARE ENGAGEMENT NETWORKS. AND TO DIRECT INSPECTION OF QUALITY OF CARE AND SAFETY THROUGH THE SURVEY AND CERTIFICATION PROCESS IN PARTNERSHIP WITH STATES AND ACCREDITING ORGANIZATIONS. SO TODAY, I WOULD LIKE TO FOCUS ON THE SURVEY AND CERTIFICATION ACTIVITIES IN SUPPORT OF INJECTION SAFETY AND INFECTION CONTROL. BUT FIRST, A LITTLE BACKGROUND. BEFORE MOST PROVIDERS CAN PARTICIPATE IN MEDICARE AND MEDICAID, THEY'RE REQUIRED TO DEMONSTRATE THAT THEY MEET BASIC PUBLIC EXPECTATIONS FOR SAFETY AND QUALITY OF CARE. AND THEY DO THIS IN PART THROUGH AN ON-SITE, UNANNOUNCED SURVEY CONDUCTED BY TRAINED OBJECTIVE INDIVIDUALS WHO ASSESS THEIR DEGREE OF COMPLIANCE WITH WHAT WE CALL THE CONDITIONS OF COVERAGE OR CONDITIONS FOR PARTICIPATION IN MEDICARE AND MEDICAID. EXAMPLES OF SUCH REGULATED PROVIDERS ARE AMBULATORY SURGICAL CENTERS, CLINICAL LABORATORIES, DIALYSIS FACILITIES, HOSPITALS OF ALL TYPES, NURSING HOMES, RURAL HEALTH CLINICS, HOME HEALTH AGENCIES AND MANY OTHERS. SO WE HAVE A VARIETY OF FUNCTIONS WITH SURVEY AND CERTIFICATION BEGINNING WITH THE SURVEYS AND THEN THE CERTIFICATION, BUT WE ARE ALSO BACKED UP BY TREMENDOUS AUTHORITY TO REQUIRE THAT IF THERE ARE HEALTH CARE PROBLEMS OR SAFETY PROBLEMS, THAT THOSE PROBLEMS ARE REMEDIED PROMPTLY AND EFFECTIVELY. SO FOR A PROVIDER THAT'S ALREADY PARTICIPATING IN MEDICARE, IF THERE ARE SERIOUS PROBLEMS, THEY MAY BE REQUIRED TO FILE A PLAN OF CORRECTION AND THEY MAY HAVE A REVISIT TO VERIFY THAT THE REMEDIAL ACTION THAT THEY HAVE UNDERTAKEN HAS RESTORED THEM TO FULL COMPLIANCE WITH THE MEDICARE AND MEDICAID CONDITIONS OF CORAGE OR CONDITIONS FOR PARTICIPATION. INFECTION CONTROL IN AMBULATORY CARE SETTINGS REPRESENTS A VERY SIGNIFICANT CHALLENGE FOR A NUMBER OF REASONS. FIRST, THEY ARE LARGE IN NUMBER. THEY EXIST IN MANY DIVERSE AND DISBURSED SETTINGS. THERE ARE GREAT DIFFERENCES IN THEIR SIZE, SCOPE, COMPLEXITY OF PRACTICE. THERE'S A HIGH PREVALENCE OF THE FOR PROFIT BIT MODEL AND THEY ARE THE FASTEST GROWING FACILITIES IN TERMS OF NUMBER AMONGST ALL MEDICARE PARTICIPATING PROVIDERS AND SUPPLIERS. SO ONE FORM OF AMBULATORY CARE SETTING IS AMBULATORY SURGICAL CENTERS. AND HERE IN THIS SLIDE, YOU CAN SEE THE TREMENDOUS GROWTH IN THOSE FACILITIES FROM 3094 IN FISCAL YEAR 2000 TO 5,368 IN FISCAL YEAR 2011, A 74.4% INCREASE OVER THAT TIME PERIOD. IN TERMS OF MEASURING THEIR QUALITY OF CARE AND SAFETY RELATIVE TO INFECTION CONTROL, WE, OF COURSE, HAVE THE CONDITION FOR COVERAGE THAT THEY MAINTAIN AN ONGOING INFECTION CONTROL PROGRAM, THAT THEY ADHERE TO PROFESSIONAL STANDARDS SUCH AS THOSE PROMULGATED BY THE CDC. THAT THEY HAVE A DESIGNATED QUALIFIED INFECTION CONTROL PROFESSION AND THAT THEY IMPLEMENT NATIONALLY RECOGNIZED INFECTION CONTROL GUIDELINES THAT ARE INTEGRATED INTO A SECOND IMPORTANT CONDITION FOR COVERAGE, AND THAT IS THE QAPI REQUIREMENT, THE REQUIREMENT THAT EVERY AMBULATORY SURGICAL CENTER MAINTAIN AN EFFECTIVELY FUNCTIONING QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT SYSTEM THAT CONTINUOUSLY STREAMS PERFORMANCE INFORMATION BACK TO THE INDIVIDUALS WHO CAN AND WILL USE THAT INFORMATION TO IMPROVE QUALITY AND TO PREVENT RECURRENCE OF ANY ADVERSE EVENTS THAT HAVE OCCURRED. ANOTHER TYPE OF AMBULATORY CARE SETTING THAT IS QUITE IMPORTANT RELATIVE TO INFECTION CONTROL IS DIALYSIS FACILITIES OR IN-STAGE RECENTLY DISEASE FACILITIES. HERE IN THIS SLIDE, YOU CAN SEE, AGAIN, A TREMENDOUS RATE OF GROWTH FOR THIS PARTICULAR TYPE OF AMBULATORY CARE SETTING FROM 3,957 IN FISCAL YEAR 2000 TO 5,006 IN FISCAL YEAR 2011. SO, AGAIN, WE HAVE A NUMBER OF IMPORTANT CONDITIONS FOR COVERAGE THAT APPLY TO DIALYSIS FACILITIES. THE INFECTION CONTROL REQUIREMENTS WITH ONE DIFFERENCE FROM AMBULATORY SURGICAL CENTERS HERE WITH THE DIALYSIS FACILITIES, WE BUILT INTO THE REGULATION THAT THEY APPLY NOT ONLY NATIONALLY RECOGNIZED STANDARDS, BUT THAT THEY ADHERE TO THE CDC GUIDELINES IN SPECIFIC. WE ALSO HAVE THE QAPI REQUIREMENT APPLICABLE TO DIALYSIS FACILITIES AND AN ADDITIONAL REQUIREMENT THAT'S IMPORTANT FOR INFECTION CONTROL, THE REQUIREMENT THAT EACH DIALYSIS FACILITY ACTIVELY PARTICIPATE IN THE ESRD TECHNICAL ASSISTANCE NETWORK AND THAT THEY ACT ON NETWORK RECOMMENDATIONS. THE CHALLENGE OF INFECTION CONTROL IS LARGER THAN ANY ONE AGENCY OR PROVIDER. FORTUNATELY, THERE'S A GREAT ARRAY OF FEDERAL AGENCIES AND STATE AGENCIES THAT ARE DEDICATED TO IMPROVING INFECTION CONTROL AS WELL AS PROFESSIONAL SOCIETIES. ONE OF OUR CHALLENGES IS ALIGN ALIGNING ALL OF OUR VARIOUS CAPABILITIES IN THE SAME DIRECTION SO THAT WE CAN BE MOST EFFECTIVE. THIS NEXT SLIDE IS MY VERY FEEBLE ATTEMPT TO MAKE THIS SIMPLE POINT MORE MEMORABLE. AND THE POINT IS THIS -- OUR BEST PROSPECT FOR SUCCESS IN ANY LARGE SCALE NATIONAL ENDEAVOR IS IN ALIGNING THE ACTIONS AND AUTHORITATIVE EXPERTISE OF THE MAJOR ACTORS IN PURSUIT OF THAT GOAL. SO BORROWING FROM THE ASTRONOMICAL TERM FOR THE ALIGNMENT OF CELESTIAL BODIES, WHEN WE HAVE SOME VISIGY, WE WILL HAVE SYNERGY. WE WILL HAVE A SITUATION IN WHICH THE TOTAL IS INDEED GRATER THAN THE SUM OF ITS PARTS. SO LET'S SEE HOW THIS WORKS IN PARTICULAR BETWEEN CMS AND THE CDC. WE EACH BASICALLY HAVE STRENGTHS AND STRUGGLES. AND WE'RE A PERFECT MATCH IN THAT REGARD. CMS HAS A TREMENDOUS ON-SITE PRESENCE, CONDUCTING ON-SITE INSPECTIONS IN EACH OF THOSE FACILITIES THAT I DESCRIBED EARLIER. WE HAVE TREMENDOUS ENFORCEMENT AUTHORITY TO REQUIRE THE IDENTIFIED PROBLEMS BE REMEDIED. BUT WE DON'T HAVE THE SAME SCIENTIFIC BASIS AND UP TO DATE EXPERTISE OF THE CDC AND THE CDC OFFERS THAT. SIMILARLY, THE CDC HAS TREMENDOUS GUIDANCE, BUT SOMETIMES HAS DIFFICULTY MOTIVATING THE POORER PERFORMERS TO COME TO THE TABLE AND MAKE USE OF THAT GUIDANCE. WELL, CMS HAS GREAT MOTIVATING ABILITY. AND BETWEEN US, WE ARE STRONGER. SO LET'S SEE HOW THIS WORKED OUT IN A PARTICULAR CASE, THE CASE THAT DR. BURKE HAD JUST MENTIONED, NEVADA OUTBREAK OF HEPATITIS C IN 2008. AND IN THAT EXPERIENCE, THE CDC AND CMS CAME TOGETHER AND THE CDC HELPED US DEVELOP A SPECIAL SURVEYOR WORKSHEET THAT THE SURVEYORS TOOK ON-SITE AND HELPED US CONDUCT TRAINING FOR THE SURVEYORS SO THAT THEY COULD BETTER IDENTIFY LAPSES IN INFECTION CONTROL. AND FROM THAT 2008 EXPERIENCE IN NEFF NEGATIVE, WE THEN RECRUITED THREE VOLUNTEER STATES TO TAKE THESE WORKSHEETS AND ENLARGE THE ENTERPRISE BY SELECT AGO NUMBER OF AMBULATORY SURGICAL CENTERS IN A STRATIFIED RANDOM SAMPLE TO GET A BETTER SENSE OF WHETHER OR NOT THE NEVADA EXPERIENCE WAS MORE TYPICAL OF OTHER STATES. WHAT WE FOUND IN THIS CASE IS INDEED, THE RESULTS WERE QUITE ALARMING. IN THIS THREE-STATE PILOT OF 68 RANDOMLY SELECTED AMBULATORY SURGICAL CENTERS, ALMOST 68% HAD INFECTION CONTROL LAPSES AND 57% OF THOSE AMBULATORY SURGICAL CENTERS WERE CITED FOR SOME FORM OF DEE EFFICIENCY IN RESPECTS TO INFECTION CONTROL. IN THAT TOTAL, THE TOPIC OF TODAY, THE INJECTION SAFETY AND THE MULTI USE -- MULTI PATIENT USE OF SINGLE-USE VIALS LOOMED QUITE LARGE. THE RESULTS OF THESE PILOT WERE PUBLISHED IN THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION IN 2010. AND THE RESULT SO IMPRESSED THE EDITORIAL BOARD THAT THEY PUT FORWARD AN EDITORIAL THAT BASICALLY SAID THAT THIS RISK WAS NOT ACCEPTABLE AND MUST BE CORRECTED IMMEDIATELY AND DEFINITIVELY IF THE THREE STAY PILOT RESULTS WERE GENERALIZABLE. SO WE WANTED TO KNOW FOR SURE IF THE RESULTS WERE INDEED GENERALIZABLE. SO WE WENT FORTH IN 2010 AND EXPANDED THIS TO ALL STATES. AND WE, AGAIN, RANDOMLY SELECTED AMBULATORY SURGICAL CENTERS, ABOUT A THIRD OF ALL AMBULATORY SURGICAL CENTERS IN EACH STATE. UNFORTUNATELY, THE RESULTS WERE SIMILARLY ALARMING. IN THAT YEAR, 2010, 51% OF THE AMBULATORY SURGICAL CENTERS WERE FOUND TO HAVE DEE EFFICIENCIES COMPARED TO THE 57% IN THE THREE STATE PILOT. NOW, I'M PLEASED TO SAY THAT THAT NUMBER IS IMPROVING A LITTLE BIT. WE MADE THIS INFECTION CONTROL WORKSHEET AND THE IMPROVED SURVEY PROCESS A STANDARD PART OF EVERY AMBULATORY SURGICAL CENTER SURVEY BEGINNING IN 2011. AND ONCE WE DID THAT, IT TRIGGERED THE REQUIREMENT THAT THE CMS APPROVE ACCREDITING ORGANIZATIONS SUCH AS THE JOINT COMMISSION DO LIKEWISE. IN 2011, WE FOUND THAT THE NUMBER HAD DROPPED DOWN A LITTLE BIT TO 43% AND DOWN TO 42% IN 2012. STILL, MUCH TOO HIGH. BUT IMPROVING. IN ANY PARTNERSHIP, ONE THING TENDS TO LEAD TO ANOTHER AND WE TOOK THIS EXPERIENCE AND DETERMINED THAT WE COULD MAKE BETTER INROADS, AS WELL, IN THE HOSPITAL ENVIRONMENT. AND SO THE CDC, AGAIN, HELPED US ADAPT AN INFECTION CONTROL WORKSHEET FOR THE MORE COMPLEX SET OF ENVIRONMENTS IN HOSPITALS AND WE DID THE SAME THING WITH THE QAPI AREA AND ALSO DISCHARGE PLANNING INSOFAR AS IT IS A DEPARTMENTWIDE GOAL TO REDUCE HEALTH CARE ASSOCIATED CONDITIONS BY 40% IN HOSPITALS AND REDUCE UNNECESSARY 30-DAY HOSPITAL READMISSIONS BY 20% AND INFECTIONS, AGAIN, REPRESENT AN IMPORTANT SOURCE OF BOTH HEALTH CARE ASSOCIATED CONDITIONS FOR HOSPITALS AND READMISSIONS. SO WE INCLUDED DISCHARGE PLANNING AS A SPECIAL TOOL. WE PILOTED THOSE INSTRUMENTS IN 2010 AND WERE GOING FORWARD IN 2013 WITH A SOMEWHAT DIFFERENT APPROACH. WE'RE STARTING WITH AN EDUCATIONAL APPROACH WITH THE INFECTION CONTROL WORKSHEET EXPANDED AND ADAPTED FOR THE HOSPITAL SETTING IS USED AS A RISK MANAGEMENT TOOL THAT WE HOPE HOSPITALS WILL USE TO IMPROVE THEIR PRACTICES. THE SURVEYORS ARE CONDUCTING SURVEYS, BUT THE SURVEYORS WILL DESCRIBE THE DEGREE OF RISK THAT THEY PERCEIVE, EXPLAIN THE TYPES OF RISKS AND ENCOURAGE THE HOSPITAL TO USE THE INFECTION CONTROL WORKSHEET ON THEIR OWN FOR THEIR OWN INTERNAL AND HOPEFULLY MORE FREQUENT SELF-ASSESSMENTS. ASK WE HOPE THAT THE HOSPITALS IN PARTICULAR WILL USE THE TOOLS IN THEIR QAPI PROCESSES AND EVENTUALLY WE EXPECT THAT THOSE WORKSHEETS WILL BECOME PART OF A STANDARD PROCESS LATER. I HOPE THAT THIS OVERVIEW AND THIS PARTICULAR CASE EXAMPLE IS USEFUL TO YOU AS YOU THINK ABOUT WAYS IN WHICH WE CAN COORDINATE OUR MUTUAL AGENCY TALENT AND CAPABILITIES AND THE ADVANCEMENT OF THE SAFETY AND QUALITY AGENDA. ONE AREA IN WHICH WE MIGHT DO SO IS IN FIGURING OUT WAYS TO GET MORE KNOWLEDGE AND TRAINING TO THE FRONT LINES, ESPECIALLY TO THE FRONT LINES AT THE ASC STAFF. ANDER THOUGH THOSE PROVIDERS THAT SEEM TO HAVE SERIOUS OR REPEATED PROBLEMS, SINCE WE HAVE THE AUTHORITY TO REQUIRE PLANS OF CORRECTION, WE MIGHT COLLABORATE MORE IN FIGURING OUT WAYS IN WHICH DIRECTED PLANS OF CORRECTION INCLUDE KEY ELEMENTS THAT WE THINK ARE INSTRUMENTAL, WE MIGHT INCORPORATE THOSE INTO A STANDARD TEMPLATE. IN THE MEANTIME, I'LL LEAVE YOU WITH THE ASSERTION THAT ALIGNING OUR CAPABILITIES IS ONE OF THE BEST THINGS THAT WE CAN DO AND FISIOGY IS MORE THAN JUST A GOOD SCRABBLE WORD AND NOTE IN THE PROCESS THAT I THINK I HAVE JUST ELEVATED THE CDC TO THE STATUS OF A CELESTIAL BODY WHERE IT PROBABLY BELONGS. SO IT'S APPROPRIATE AT THIS TIME FOR ME TO CONVEY A SPECIAL THANKS TO THE MANY TALENTS IN CDC WHO WORKS SO CLOSELY WITH US IN THE PAST FEW YEARS THAT MADE MORE PROGRESS IN INFECTIOUS CONTROL THAN I THOUGHT POSSIBLE. THANK YOU. AND NOW I'D LIKE TO INTRODUCE YOU TO DR. BELL, WHO YOU KNOW VERY WELL. >> HI, EVERYBODY. BY WAY OF WRAP UP, I'D LIKE TO THANK BY THANKING OUR THREE SPEAKERS FOR ACTUALLY BEING HERE, DESPITE RECOVERY EFFORTS ONGOING FROM THE RECENT HURRICANE AND I'M SURE COUNTLESS OTHER PUBLIC HEALTH CRISES THAT ARE EARN WAY. THANK YOU. WHAT I'D ALSO LIKE TO THANK THEM FOR IS FOCUSING ON THIS PARTICULAR ISSUE. IT IS NOT CUTTING EDGE SCIENCE. IT IS NOT TERRIBLY FUN 20 THINK ABOUT. IT IS, IN FACT, APPALLING. I THINK YOU'LL AGREE THAT THE FACT THAT IN THE UNITED STATES IN 2012 YOU HAVE A 50/50 CHANCE OF BEING EXPOSED TO AN INFECTION IF YOU GO TO AN AMBULATORY SURGERY CENTER BASED ON WHAT YOU JUST SAW. A COIN TOSS IS NOT THE KIND OF HEALTH CARE QUALITY THAT WE EXPECT IN THIS COUNTRY. I THINK THAT IF YOU EXTENSION WHAT WE HEARD TODAY TO THE BROADER AREA OF PUBLIC HEALTH IN GENERAL, A COUPLE OF OUR MAJOR THRUSTS ARE CLEARLY THREATENED BY AN INABILITY TO RELY ON SAFE CARE WHEN IT COMES TO INJECTION. THINK ABOUT IMMUNIZATION. THINK ABOUT WHAT WE SAY ABOUT IMMUNIZATION BEING SO INCREDIBLY VALUABLE TO PUBLIC HEALTH. IF YOU ADD HEPATITIS TO THE IMMUNIZATION, YOU'VE UNDERMINED AN INCREDIBLY IMPORTANT TOOL. THINK ABOUT CANCER SCREENING. IF WE'RE TELLING PEOPLE THAT NEXT YEAR YOU NEED TO GET FOR YOUR 50-YEAR-OLD COLONOSCOPY BUT YOU HAVE A REASONABLE CHANCE OF BEING GIVEN CONTAMINATED PROPOE FOLLOW AND LEAVING WITH HEPATITIS C, THIS IS NOT A GOOD MESSAGE TO BE SENDING TO THE PEOPLE OF THE COUNTRY. SO I THINK THAT EVEN THOUGH IT IS APPALLING AND THE WORK SEEMS OVERWHELMING, THE FACT THAT WE AS A NATION AT THE STATE HEALTH DEPARTMENT LEVEL AND ACROSS THE FEDERAL GOVERNMENT ARE FOCUSING ON THIS IS VERY, VERY IMPORTANT. I THINK, THOUGH, THAT DESPITE THE STRIDES THAT HAVE BEEN MADE FROM AMBULATORY SURGERY CENTERS, AND THEY ARE SUBSTANTIAL, BY COMBINING WHAT WE KNOW ABOUT INFECTION PREVENTION WITH THE ACTIVITY OF SURVEYORS ON THE GROUND WE'VE BEEN ABLE TO MAKE A SUBSTANTIAL CHANGE IN HOW THINGS ARE DONE. THIS IS VERY GOOD. AND THE 5,000 AND GROWING AMBULATORY SURGERY CENTERS ARE A BIG AND IMPORTANT TARGET. BUT WHAT ABOUT THE 16,000 NURSING HOMES WHERE INJECTIONS TAKE PLACE? WHAT ABOUT THE DIALYSIS CENTERS? WHAT ABOUT THE ONCOMING INFUSION CENTERS? THERE ARE THOUSANDS AND THOUSANDS OF PLACE THAT'S DESERVE SIMILAR ATTENTION. THE UNCOUNTED PILOT PHYSICIAN OFFICES WHERE INJECTIONS TAKE PLACE ESSENTIALLY UNMONITORED. THIS IS A HUGE MOUNTAIN OF WORK THAT REMAIN TOES BE DONE. AND UNTIL IT'S ACCOMPLISHED, I FIND IT VERY CONCERNING. FRANKLY, I'M ANXIOUS WHEN I GET MY ANNUAL FLU SHOT. I LOVE GETTING IT HERE AT CDC BECAUSE THE PEOPLE WHO GIVE IT TO ME ARE DOING THE RIGHT WAY IN FRONT OF ME. I HAD IT ONCE AT A PHARMACY BECAUSE I WAS TRAVELING OUT OF THE COUNTRY AND DIDN'T HAVE TIME TO GET IT HERE. AND THE PHARMACIST DISAPPEARED INTO THE INNER SAN ITEM AND CAME BACK WITH A SYRINGE. AND I SERIOUSLY THOUGHT ABOUT ASKING -- I DIDN'T BECAUSE I WAS IN A HURRY. BUT I SHOULDN'T HAVE TO FEEL THAT WAY. AND SO JOE HAD MENTIONED A COUPLE OF Es. HE MENTIONED EDUCATION AND IMPORTANCE. EDUCATION AND ENFORCEMENT ARE CRITICAL, WITHOUT A DOUBT. BUT CLEARLY EVEN WITH THE ADDED FOCUS, THEY'RE NOT ALWAYS ENOUGH. AND SO AS YOU THINK ABOUT QUESTIONS AND COMMENTS THAT YOU MIGHT HAVE FOR OUR PANEL TODAY, I'D LIKE TO TEE IT OFF WITH MAYBE A QUESTION FOR ONE OR MORE OF YOU, WHICH IS WHAT ABOUT THE ADDITIONAL MEANS? ARE THERE ENGINEERING SOLUTIONS? CAN WE DESIGN THINGS THAT PREVENT INDIVIDUALS FROM MAKING THESE MISTAKES? WHAT ABOUT ECONOMIC STRATEGIES? ARE THERE WAYS IN WHICH THE WAY WE PAY FOR CARE CAN BE USED TO MAKE IT LESS AND LESS LIKELY THAT THESE FOR-PROFIT ORGANIZATIONS ARE GOING TO PRIORITIZE THE COSTS BENEFIT OF REUSING SOMETHING OVER THE SAFETY OF THE MEDICINE? JOE, DO YOU WANT TO TAKE A STAB AT THE ENGINEERING END? >> OKAY. WELL, I'M GLAD THAT YOU MENTIONED THE IDEA THAT, YOU KNOW, PREVENTION WILL TAKE OTHER APPROACHES. AND PUSHING ON DIFFERENT LEVERS, INCLUDING ENGINEERING. THE IDEA OF BUILDING A SAFER SYSTEM, YOU KNOW, FROM THE GROUND UP, YOU KNOW, IS APPEALING, MAKING -- MAKING INJECTIONS DELIVER MORE FOOL PROOF, IF YOU WILL, IS IMPORTANT. AND AN EXAMPLE OF THAT IS WE TALKED ABOUT THE RISKS RELATED TO NARCOTICS TARCHL SS TAMPERING. THIS IS A SERIOUS AND UNDERAPPRECIATED RISK. AND IN VERY LARGE MULTI STATE OUTBREAK THAT'S WE'VE INVESTIGATED AND HAVE BEEN AFFECTED BY IN THE LAST COUPLE OF YEARS, TECHNICIANS WHO DON'T HAVE PRIMARY ACCESS TO THE NARCOTIC HAVE BEEN ABLE TO ACTUALLY SWAP A DEE COY SYRINGE FOR A SYRINGE THAT HAS BEEN DRAWN UP FOR THE PATIENT. AND IT SHOULDN'T BE SO EASY TO PULL THE WOOL OVER THE EYES OF, YOU KNOW, PEOPLE WORKING IN THESE CASE NECESSARY HOSPITAL OUTPATIENT DEPARTMENTS. YOU SHOULD BE ABLE TO TELL A USED SYRINGE APART FROM AN UNUSED SYRINGE. AND THINKING, TOO, SYRINGE REUSE IS AT THE ROOT OF MUCH OF THE -- I WANT TO JUST SAY EVIL. OH, I GUESS I'LL SAY IT. THE HARM, YOU KNOW, THAT WE'RE WITNESSING. WHAT ABOUT AUTO DISABLE SYRINGE TECHNOLOGIES? THAT'S SOMETHING THAT WE PROMOTED IN THE INTERNATIONAL SETTINGS FOR YEARS NOW TO, YOU KNOW, MAINTAIN THE SAFETY OF OUR IMMUNIZATION PROGRAM. SO THINKING MORE ABOUT ENGINEERING SOLUTIONS, I THINK, YOU KNOW, HAS A LOT OF GOOD POTENTIAL. >> I THINK ON THE ECONOMIC SIDE, OF COURSE, THERE ARE SOME EXTREMES IN WHICH CMS, FOR EXAMPLE, HAS SAID NO, WE'RE NOT GOING TO PAY FOR THE ADDED COST OF COMPLICATIONES AND SO ON. BUT THERE'S ALSO A DANGER IN GETTING TOO SPECIFIC IN THESE ECONOMIC LEVERS. AND I THINK THAT'S PARTLY WHY WE ARE LOOKING AT THE QAPI REQUIREMENT TO BOLSTER THAT WHICH IS ANOTHER -- IT'S HUMAN FACTORS ENGINEERING. AND BASICALLY WHAT WORRY TRYING TO DO THERE IS BE THE EXTERNAL CHAMPIONS OF THE PEOPLE INSIDE THE ORGANIZATION FOR STRIVING MIGHTILY TO IMPROVE SAFETY PRECAUTIONS AND ADOPT PROTOCOLS NO MATTER WHAT THEY ARE, ENGINEERING OR EDUCATION OR ANY OF THE OTHER THAT WE WANT TO BE THE ONES THAT ARE CHEERING THEM ON AND BASICALLY CALLING ATTENTION TO TOP MANAGEMENT, THE CEO, FOR EXAMPLE, TO THE NEED TO HAVE THOSE PEOPLE REINFORCE AND SUPPORT THEM. >> I THINK I'LL JUST COME BACK TO THE IDEA THAT HEALTH CARE PROVIDERS REALLY NEED TO APPRECIATE THAT THIS IS A RISK. I THINK WE'VE EXPERIENCED IN, FOR EXAMPLE, OUR REQUIRED INFECTION CONTROL COURSE THAT WE OFFER IN NEW YORK THAT PROVIDERS COME AND SIT IN THE FRONT ROW AND OPEN UP THE NEWSPAPER, SORT OF IN DISDAIN OF THE MESSAGE, LIKE THIS IS TOO ELEMENTARY. ON THE OTHER HAND, WE SEE PROVIDERS DOING STUPID THINGS EVERY DAY. WE HAD A PHYSICIAN DRAW UP A TEN-DOSE VIAL OF FLU VACCINE INTO ONE SYRINGE AND GO DOWN THE LINE OF HIS EMPLOYEES, CHANGING THE NEEDLE BUT USING THE SAME SYRINGE. SO IT'S A LITTLE HARD TO UNDERSTAND HOW TO GET THAT MESSAGE ACROSS, BUT THE OVERCOME THIS SORT OF DENIAL, I THINK, IS A BIG CHALLENGE BECAUSE IF PROVIDERS REALLY UNDERSTAND THE PRINCIPLES AND THINK THEY WOULDN'T DO THESE THINGS. I WAS GOING TO JUST ADD THAT I THINK WITH THE MULTI DOSE VIAL ISSUE, I THINK SOME OF THESE DRUGS MAY BE EXPENSIVE AND THERE MAY BE SOME ECONOMIC INSENSITIVE TO USE A SINGLE DOSE VIAL ON MORE THAN ONE PATIENT. AND I THINK WE NEED TO FIGURE OUT HOW TO OVERCOME THAT KIND OF AN ISSUE. BUT OTHER THAN THAT, I THINK IT'S REALLY EDUCATIONAL AND IT'S NOT EVEN EDUCATIONAL, IT'S GETTING THE PROVIDERS TO BUY INTO THAT THERE'S EVEN A PROBLEM HERE. >> I WAS JUST GOING TO SAY THAT THAT SENSE OF NEEDING TO DO THE RIGHT THING BRINGS US TO THE "E" FOR ETHICS, BACK TO THE FIRST DO NO HARM EXAMPLE, NOT LETTING THE ECONOMICS OVERRIDE THE ETHICAL IMPLICATIONS. >> THANK YOU. ARE THERE QUESTIONS OR COMMENTS FROM ENVISION? HEARING NONE, I'LL SOLICIT QUESTIONS OR COMMENTS FROM OUR AUDIENCE. DR. CARTER. >> SO IT LOOKS SO SIMPLE AND SO WHY IS IT NOT HAPPENING? WHO DOES NOT AGREE WITH IT? BECAUSE I KNOW THERE ARE GROUPS THAT DON'T AGREE WITH US. >> I'LL TRY. YEAH, IT HAS BEEN SOMEWHAT SURPRISING THAT SOME OF THE GUIDANCE WHICH WE TAKE AS ALMOST SELF-EVIDENT HAS BEEN CHALLENGED IN SOME CORNERS IN RECENT TIMES. THE NOTION THAT A SINGLE DOSE VIAL IS ONLY FOR SINGLE PATIENT USE, YOU KNOW, THAT'S SORT OF INHERENT IN THE FDA APPROVAL OF THAT LABEL. THAT IS THE EXPECTATION. AND YET WE WERE ASKED THIS YEAR BY PERSONS IN THE PAIN PHYSICIAN COMMUNITY TO BASICALLY PROVE THAT THERE IS RISK OF HARM. WHAT WE GET A LOT OF TIMES ARE WHAT WE REFER TO AS THE BIG IFS. IF I ONLY ACCESS THAT VIAL WITH A NEW NEEDLE AND A NEW SYRINGE AND MY FINGERS CROSS BEHIND MY BACK AND SO ON AND SO FORTH, PROVE TO ME THAT THAT'S BAD. AND THAT'S CHALLENGING. YOU KNOW, WE DO HAVE SOME WAY TO GO, I WOULD SAY, IN TERMS OF MEETING THE PROVIDER DENIAL ISSUE. BUT ALSO, IT SPEAKS OF THE NEED TO GET THAT RIGHT SIZED MEDICATION IN A READY TO DELIVER FORMAT. BECAUSE THE MORE THAT WE -- TO THE EXTENT THAT WE CAN MOVE PREPARATION SORT OF UPSTREAM TO THE MANUFACTURING REALM WHERE THERE ARE TIGHTER CONTROLS IN TERMS OF MAINTAINING STERILITY, WE MIGHT ALL BENEFIT. >> I'LL JUST TAKE THE LIBERTY OF ADDING THAT EVEN THOUGH WE HAVE ENCOURAGED PRIVATE CLINICIANS TO LOOK TO COMPOUNDING PHARMACIES FOR APPROPRIATE PACKAGING OF SMALLER DOSES AS YOU'RE WELL AWARE, THAT IS NOT ALWAYS PERFECT, EITHER. SO THE WORDS THAT JOE USED, MANUFACTURING WHERE THERE ARE ACTUAL STANDARDS FOR POST PACKAGING STERILITY PACKAGING AND SO ON, THAT'S MORE THE DIRECTION WE'RE LOOKING AT. I THINK REGARDLESS OF WHERE IT'S DONE, WE WANT TO SEE THAT MEDICATION RES HANDLED CORRECTLY AND WITHOUT CONTAMINATION. WHEN WE THINK ABOUT ENGINEERING, IT'S NOT JUST SYRINGES WE'RE TALKING ABOUT, ALSO THE FACILITY THAT'S USED FOR PREPARING MEDICATION. RIGHT NOW, THE STANDARDS THAT EXIST POINT TOWARDS A VERY HIGH TECH HOSPITAL PHARMACY, SOMETHING THAT DOESN'T EXIST FOR MOST AMBULATORY SURGERY CENTERS. BUT COULD THERE BE SOMETHING BUILT DESIGNED TO PREVENT CONTAMINATION? IMAGINE A SMALL PLEXIGLASS THAT BOLTS TO THE HALLWAY WHERE IT'S AWAY FROM THE CHAOS OF CLINICAL CARE, LESS PRONE TO CONFUSION LABELLING, BUT STILL PROVIDES A LEVEL OF SAFETY. I THINK CREATIVE SOLUTIONS LIKE THAT ARE PROBABLY ON THE HORIZON. >> WITH HE A QUESTION FROM ONE OF OUR TWITTER FOLLOWERS. WHAT IS THE RULE FOR MULTI DOSE VIALS OF VACCINE? FOR EXAMPLE, FLU VACCINE. DO YOU DISCARD AFTER 28 DAYS OR FOLLOW THE EXPIRATION DATE? >> SO THAT'S AN EXAMPLE OF WHERE, YOU KNOW, MANUFACTURERS TYPICALLY HAVE SUBMITTED DATA TO DEMONSTRATE THAT STERILITY OF THE PRODUCT CAN BE MAINTAINED BEYOND 28 DAYS. SO WHEN THAT KIND OF DATA HAS NOT BEEN SUBMITTED TO FDA, THEN WE'LL USE A 28-DAY DEFAULT. AND, AGAIN, YOU KNOW, MULTI DOSE VIALS CAN BE USED SAFELY FOR MULTIPLE PATIENTS. BUT IT DOES REQUIRE REALLY CAREFUL ATTENTION TO THE WHOLE SUITE OF INJECTION PRACTICES TO MAINTAIN THE STERILITY OF THAT PRODUCT. >> LAST CALL FOR QUESTIONS. THANK YOU VERY MUCH, GENTLEMEN. >> I'D LIKE TO THANK ALL OF OUR SPEAKERS FOR THEIR CONTRIBUTIONS TO TODAY'S GRAND ROUNDS. PLEASE JOIN US IN FIVE WEEKS FOR THE DECEMBER SESSION ON PUBLIC HEALTH AND DISABILITY.