Unsafe Injection Practices in the U.S. Healthcare System


Uploaded by CDCStreamingHealth on 15.11.2012

Transcript:
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 HIV 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 HIV 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.