Compounding Errors: Corrective Actions

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Compounding Errors Corrective Actions
Medical Seminar Presented By Malcolm H. Philips,
Jr. CEO, CDEX Inc.
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Problem this Seminar Addresses

• One is Correct, One Will Permanently Harm a
  Patient!
• Can You Tell the Difference?

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Seminar Purpose

• Understand Impacts and underlying causes of
  critical compounding errors that most impact
  patients
• Develop strategies for addressing these causes
• Understanding how to implement and monitor
  strategies that may be most helpful

4
Seminar Approach

• Examine Global Studies of Compounding Practices
• Draw Conclusions on the Primary Problems that
  Cause the Greatest Harm to Patients
• Discuss Strategies to Minimize Those Problems
• Analyze How to Implement Those Strategies

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What Do Studies Show? March 12, 2009 report
published in the BritishMedical Journal (BMJ
2009338b814)

• Scope Errors in administering IV drugs to1300
  patients in 113 ICUs over a 24-hour period across
  27 countries errors are universal
• 441 patients affected by medication errors (many
  with two errors), 12 permanently harmed, 5 deaths
• While only 20 of the errors relate to wrong
  drug/dose, 50 of permanent harm and 60 of
  deaths related to wrong drug/dose
• Self reporting bias errors underreported

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What Do Studies Show? January 1, 2008 18 Month
Study for verification of High Risk IV
Medications (Am J Health-Syst Pharm--Vol 65, pp
49-54)

• Study led by Dr. Jim Stevenson, Director of
  Pharmacy Services University of Michigan
  Hospitals and Health Centers and Professor and
  Associate Dean for Clinical Sciences University
  of Michigan College of Pharmacy
• Pharmacist of the Year Michigan Society of
  Health-system Pharmacists and the Michigan
  Pharmacists Association
• Board of Directors of the American Society of
  Health-system Pharmacists

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What Do Studies Show? 1/1/08 18 Month Study
for verification of High Risk IV Medications (Am
J Health-Syst Pharm--Vol 65, pp 49-54). Recipient
of the ASHP 2009 Pharmacy Practice Research Award

• Scope C.S. Mott Childrens Hospital (one of the
  best in the US), 18 months analysis of 7
  med/dose/diluent compounded combinations
• All Meds tested by ValiMed after all final
  checks
• Samples rejected by ValiMed sent out to labs for
  confirmation testing
• Results 5 major medication errors were caught
  all were wrong drug or dose errors that would
  have substantially harmed patients

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What Do Studies Show? Consistent Conclusions

• Errors Reported Generally Underestimate Errors
  Made Self Reporting and Observation Bias
• Wrong Drug/Dose Errors Cause Disproportionately
  Higher Permanent Injuries
• Despite best efforts of good, well trained people
  major medication errors continue to be made
• Average Pharmacy compounding 7 or more
  medications will likely make at least 5 major
  wrong drug or wrong dose medication errors over
  an 18 month period

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Impacts of Major Medication Errors

• Life Long Impact on Patient and Family
• Life Long Emotional Impact on Pharm Tech who made
  the Compounding Mistake
• Major Impact on the Medical Institution
• Reputation
• Financial
• Major Impact on the Director of Pharmacy
• Emotional, Career, Potential Penalties

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What is the Culprit?

• Studies Consistently Show that HUMAN ERROR is at
  the root of virtually all wrong drug/wrong dose
  compounding errors
• Human error is a constant in virtually all
  industries
• We must accept human error as inevitable and
  design around that fact.
•  Donald Berwick, MD, MPP, President and CEO,
  Institute for Health Care Improvement
•  

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Human Errors -- How to Minimize them?

•   Procedural Controls and Standardization
• Standardize the way compounding is performed
• Written Procedures
• Staff Acceptance (Use Team Development)
• Accepted Practice by All Major Industries
• Problem How to Objectively Monitor Results
  How do you know that you are really improving the
  end performance?

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Objective Data Supports Standardization ValiMed
Chart shows 2 techs in the same pharmacy
compounded 5 samples of Gentamycin 4mg/ml D5W.
Each was consistent for their 5 samples. One was
wrong! If you do not have standardization, this
is happening in your pharmacy today!
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Human Errors -- How to Minimize them?

•   Organizational Controls and Improvements
• Physical Organizational Changes Simplify,
  Simplify, Simplify
• Staff Organizational Changes The Right Org with
  the Right People in the Right Places!
• Does Redundancy Help?
• Somewhat, but redundancy and diversity minimize
  common mode failures!
• Problem How to Objectively Monitor Results
  How do know that you are really improving the end
  performance?

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After Changes, you should be able to Objectively
Observe greater compounding Accuracy!
How?ValiMed Report Showing compounding Accuracy
of every sample of any Med, Compounded by any or
All Pharm techs (or robotics) over time

•  q

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Human Errors -- How to Minimize them?

•   Personnel Hiring and Review Practices
• Assure New Hires have Compounding Aptitude
  (testing for precision, withstanding stress,
  etc)
• Annual Reviews Check Compounding performance
  against set standards people focus on what the
  boss focuses on!
• Problem How to Objectively Monitor Results
  How do you know that you are really improving the
  end performance?

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During Personnel reviews, You should be able to
Discuss objectively the compounding accuracy of
any Member of youR staff! How?ValiMed Report of
compounding accuracy of each pharm tech over time
per Medication.

•  

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Human Errors -- How to Minimize them?

•   New Employee and On the Job Training
• New Employee Training is essential to set
  standards and teach the system used
• Refresher training is essential to maintain
  standards set and constantly reinforce your
  personal expectations
• Problem How to Objectively Monitor Results
  How do you know you are really improving the end
  performance?

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ValiMed Provides real-time, OJT feedback of
compounding accuracy that improves compounding
performance people want to do a good job,
they simply need objective feedback to improve!
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Human Errors -- How to Minimize them?

•   Summary of Actions
• Standardize Procedures Written and with Staff
  Buy In
• Organizational Controls and Improvements
  Simplify and Provide both redundancy and
  diversity
• Personnel Hiring and Review Practices Set Your
  Standards and Reinforce Them
• New Employee and On the Job Training
• CONTINUING PROBLEMS?

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Human Errors -- How to Minimize them?

•   Three Major Continuing Problems
• Problem We must accept human error as
  inevitable and design around that fact. None
  of the Personnel Related Corrective Actions Will
  Eliminate Human Error
• Problem How to Objectively Monitor Results So
  that you can know that you are really improving
  the end performance?
• Problem How do you deal with harmful
  counterfeit medications?

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Human Errors -- How to Stop them?

•   Technological Safety Net (ValiMed) Between
  The Pharmacy and the Patient
• Provides redundancy to and diversity from human
  checks of compounding accuracy
• Provides objective monitoring of Compounding
  Practices individually and as a Group You can
  tell if your changes are really effective!
• Provides instantaneous training feedback
• Provides carryover improvement for all
  medications compounded
• Rejects harmful counterfeit medications

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ValiMed has the ability to take human error out
of the equation, save lives and give peace of
mind to everyone!
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Break

•  

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• Introducing ValiMed
• Medication Validation System from CDEX, Inc
• The Right Drug At The Right Dose

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CDEX Inc Company Overview
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Five potentially serious medication errors were
averted over an 18-month period in a test at C.S.
Mott Children's Hospital in the University of
Michigan Health System by using the ValiMed
technology.
"Errors in compounding these types of medications
are rare. However, when they occur they can have
a significant negative impact on patients and
staff "We know from having this technology in
place we've deterred five errors that might have
happened. I really believe having technology like
this needs to be the standard around the country
said Jim Stevenson, associate dean of Clinical
Sciences at the UM College of Pharmacy and
Director of Pharmacy Services at the U-M Health
System
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Examples of Errors caught by ValiMed

• Vancomycin 50 under dose in bulk compounding.
  
• Morphine 300 overdose
• Lorazepam 2000 overdose
• Dopamine and Dobutamine Interchanging
• Lorazepam Not dispersing high viscosity
  lorazepam in the total mixture. risk of hot zones
  
• Dopamine Mistaken use of naloxone instead of
  dopamine in the compounded solution
• Significant dilution of return Fentanyl
  potential diversion

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The Technology How it Works Complex
Technology Made Deceptively Simple
ValiMed uses a technology referred to as Enhanced
Photoemission Spectroscopy to validate
medications. ValiMed generates high energy UV
light energy which excites the medication sample.
As a result, the sample produces a unique UV
response that ValiMed compares to a reference
signature stored in an internal database.
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The Technology How it Works Complex
Technology Made Deceptively Simple
Each medication reveals its own distinct and
easily readable signature. By comparing the
fingerprints of a tested medication against the
signature for that medication in our data
library, the ValiMed technology indicates
virtually in real time a match, presuming there
is one.
This Chart shows ValiMeds ability to indicate
the concentration of a given medication. The
tested concentration also can be validated by
comparing it to the standard concentration on
file in the data library.
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ValiMed Solutions Applications
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Patient Safety Solution

• Medication errors are among the most common
  medical errors, harming at least 1.5 million
  people every year in the United States, costing
  the nation at least 3.5 billion.
• On average, there is at least one medication
  error per hospital patient per day and studies
  indicate that 400,000 preventable drug-related
  injuries occur each year in US hospitals.
• Bar coding and double checks can help catch
  errors but, until now, there has been no cost
  effective, time-sensitive means to objectively
  check liquid medication prior to them leaving the
  pharmacy or being administered to the patient.
• The ValiMed Patient Safety Solution provides
  validation of IV admixtures (including high alert
  medications) at the time of compounding. ValiMed
  provides the assurance that medications have been
  prepared accurately. This reduces undetected
  errors in medication selection, the manufacturing
  of admixtures, inadvertent substitution,
  purposeful counterfeiting or the mislabeling of
  the medication, container or package.

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Narcotics Return Solution

• Clinicians shoulder a burden most of their fellow
  citizens do not easy access to controlled
  substances. As many as 9 of clinicians with
  access to controlled substances are, in the
  discreet language of the professional,
  impaired.
• ASHPs Guidelines on Surgery and Anesthesiology
  Pharmaceutical Services, recommends Qualitative
  testing of returned controlled substances.
• The ValiMed Narcotics Return Solution provides
  fast, easy, accurate and OBJECTIVE analysis of
  returned narcotics (including Fentanyl) prior to
  disposal and use.
• ValiMed can help identify problem areas before
  they become crises while meeting regulatory
  guidelines for the accounting of controlled
  substances.

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Counterfeit Medication Solution

• According to the OECD, up to 15 of all drugs
  around the world are counterfeit (Up to 60 of
  drugs in developing countries).
• Counterfeit drugs account for 32 billion
  annually and could potentially grow to 75/
  billion annually in 5 years.
• Counterfeit Drugs from originally lifestyle drugs
  (Viagra, Oxycontin) to lifesaving drugs
  (AIDS/HIV therapy, over-the-counter pain
  medications, antibiotics, insulin, cholesterol
  drugs, medications, cancer drugs, antiarthritis
  drugs, cardiac drugs, anti-parasitic drugs,
  antihistamines ... and more that are
  undiscovered).
• The ValiMed Counterfeit Medication Solution
  diminishes the risk of counterfeiting at any
  point in the supply chain from the manufacturer
  to the wholesaler to the distributor to the
  hospital to the retailer.
• ValiMed provides assurance that the medication is
  indeed an authentic product from the
  manufacturing facility. Real time medication
  validation provides the ability to spot
  counterfeits and easily generate reports for
  quality assurance documentation.

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Compliance Training Solution

• Pharmacies are required to comply with guidelines
  almost as strict as those required of
  pharmaceutical manufacturers. This includes
  standards in technique, training, and
  environmental concerns. The USP, ASHP, JCAHO, and
  the State Boards of Pharmacy are working to
  update the standards that regulate how pharmacies
  compound sterile preparations.
• USP lt797gt states that a provider of Compounded
  Sterile Products (CSPs) must have in place a QA
  Program intended to provide a mechanism for
  monitoringactivities and processes and must
  demonstrate effectiveness of all procedures
  critical to the accuracy and purity of finished
  CSPs Such testing can be very costly and time
  consuming.
• The ValiMed Regulatory Compliance Solution
  provides validation of your sterile preparations
  and documentation of your quality process to meet
  the USP lt797gt recommendations and other
  regulatory guidelines.

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Compliance Training Solution

• ValiMed provides the assurance that sterile
  admixtures have been compounded accurately.
• Daily activity reports can be easily generated to
  comply with regulations / guidelines and to
  facilitate JCAHO or other quality assurance
  surveys.
• ValiMed plays an important role in the training
  and continued education of pharmacy staff and
  care givers involved in the compounding and
  administration of high-risk IV admixtures.

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ValiMed sets New Safety Standards

• The ValiMed Medication and Narcotic Validation
  System brings unique value to hospital medication
  safety programs and quality control processes by
  
• Providing immediate, real-time validation of the
  substance itself
• Providing an opportunity to standardize and
  optimize internal medication safety processes
  including Training, Auditing QA and Regulatory
  Compliance.
• Providing a real-time means of validating
  narcotic returns and mitigating narcotic
  diversion
• Providing pharmacy staff and clinicians with a
  simple, fast, straightforward and cost-effective
  way to ensure that the RIGHT drug in the RIGHT
  dose is administered to the patient.

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ValiMed Key Features

• Touch screen menu
• Only 0.15 ml sample required
• Average Test less than 30 seconds
• Ability to print and export reports
• Right Medication
• Right Concentration
• No Interpretation of Results means Protection
  for users

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ValiMed Touch Screen
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Test result window flashes green for successful
test, red for failure. Also produces audible
result validated/not validated and gives
immediate feedback on compounding accuracy
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ValiMed Provides real-time and objective
feedback of compounding accuracy that improves
compounding performance people want to do a
good job, they simply need objective feedback to
improve!
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ValiMed Drug Validation Report- A Record of
Acceptance that gives Peace of Mind!
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After Changes, you should be able to Objectively
Observe greater compounding Accuracy!
How?ValiMed Report Showing compounding Accuracy
of every sample of any Med Tested over time

•  q

43
During Personnel reviews, You should be able to
Discuss objectively the compounding accuracy of
any Member of youR staff! How?ValiMed Report of
compounding accuracy of each person over time per
Medication.

•  

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Pharm Tech Compounding Variations of Cefuroxime
25mg/ml D5W (Data from ValiMed)
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Deter Narcotic Diversion with ValiMed EPSIs
this happening in your pharmacy? (red 50
fentanyl vs. blue 100 fentanyl)
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ValiMed Main Benefits
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ValiMed Medication Signatures

• Robust medication signatures have been developed
  from nearly 400 individual medication sample
  scans ensuring accurate readings every time.
• Development of new medication signatures based on
  client needs is a CDEX priority. We currently
  have 200 signatures in our library as of Oct 1st
  and continue expanding it driven now by customer
  request.
• We want to know what your signature needs are and
  we will work with you to develop new signatures
  to meet those needs.
• The following list shows and example of
  signatures that are currently available to our
  clients.

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ValiMed Medication Signature Library, (example)

• Acyclovir 5 mg-ml NS EPT
• Acyclovir 10 mg-ml SW EPT
• Acyclovir 5 mg-ml SW EPT
• Acyclovir 10 mg-ml NS EPT
• Acyclovir 7 mg-ml SW EPT
• Amikacin 10 mg-ml NS EPT
• Amikacin 5 mg-ml NS EPT
• Amikacin 10 mg-ml D5W EPT
• Amikacin 5 mg-ml D5W EPT
• Amiodarone 1.8 mg-ml D5W EPT
• Ampicillin 20 mg-ml NS EPT
• Ampicillin 100 mg-ml SW EPT
• Ampicillin-Sulbactam 20 mg-ml NS EPT
• Ampicillin-Sulbactam 45 mg-ml NS EPT
• Ampicillin-Sulbactam 30 mg-ml NS EPT
• Cefazolin 125 mg-ml D5W EPT
• Cefazolin 20 mg-ml D5W EPT
• Cefazolin 50 mg-ml D5W EPT
• Cefazolin 100 mg-ml SW EPT

• Epinephrine 0.05 mg-ml NS EPT
• Epinephrine 0.008 mg-ml
  NS EPT
• Epinephrine 0.05 mg-ml D10W EPT
• Epinephrine 0.02 mg-ml D5W EPT
• Fentanyl 10 mcg-ml D5W EPT
• Fentanyl 50 mcg-ml NR
• Gentamicin 10 mg-ml D5W EPT
• Gentamicin 10 mg-ml NS EPT
• Gentamicin 4 mg-ml D5W EPT
• Dobutamine 0.5 mg-ml D5W EPT
• Dobutamine 1 mg-ml D5W EPT
• Dobutamine 1 mg-ml D10W EPT
• Dobutamine 0.5 mg-ml NS EPT
• Dobutamine 2 mg-ml D10W EPT
• Dobutamine 2 mg-ml D5W EPT
• Dobutamine 4 mg-ml D5W EPT
• Dopamine 1 mg-ml D5W EPT
• Dopamine 0.5 mg-ml NS EPT
• Dopamine 1 mg-ml D10W EPT

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ValiMed Medication Signature Library, page 2
(example)

• Gentamicin 5 mg-ml D5W EPT
• Heparin 5 units-ml NS EPT
• Heparin 7 units-ml 1/2 NS EPT
• Heparin 1 units-ml NS EPT
• Heparin 3 units-ml NS EPT
• Heparin 7 units-ml NS EPT
• Heparin 10 units-ml 1/2 NS EPT
• Heparin 3 units-ml 1/2 NS EPT
• Hydrocortisone 5 mg-ml D5W EPT
• Hydromorphone 0.4 mg-ml NS EPT
• Hydromorphone 0.5 mg-ml NS EPT
• Hydromorphone 0.2 mg-ml BNS EPT
• Hydromorphone 0.5 mg-ml BNS EPT
• Hydromorphone 2 mg-ml NR
• Hydromorphone 2 mg-ml BNS EPT
• Hydromorphone 0.2 mg-ml NS EPT
• Hydromorphone 0.1 mg-ml NS EPT
• Insulin 0.1 units-ml NS EPT
• Insulin 0.1 units-ml D10W EPT

• Methadone 1 mg-ml NS EPT
• Metoclopramide 0.5 mg-ml
  NS EPT
• Metoclopramide 0.5 mg-ml D5W EPT
• Midazolam 5 mg-ml NR
• Midazolam 1 mg-ml D5W EPT
• Morphine 1 mg-ml NS NR
• Morphine 1 mg-ml D5W EPT
• Morphine 1 mg-ml BSW EPT Morphine 1 mg-ml NS EPT
• Morphine 15 mg-ml D5W EPT
• Morphine 2 mg-ml NS EPT
• Morphine 1.5 mg-ml NS EPT
• Morphine 3 mg-ml NS EPT
• Morphine 10 mg-ml NR
• Morphine 4 mg-ml NR
• Morphine OC 20 mg-ml NR
• Morphine PF 0.5 mg-ml NR
• Norepinephrine 50 mcg-ml D5W EPT
• Norepinephrine 200 mcg-ml D5W EPT
• Norepinephrine 4 mcg-ml D5W EPT

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Some of the finest US Hospitals already use the
CDEX ValiMed Medication Validation Systems

• All Childrens Hospital, Inc. (St. Petersburg,
  Florida)
• Brigham and Womens Hospital (Boston, MA)
• Cedars-Sinai Medical Center (Los Angeles, CA)
• Childrens Medical  Center of Dallas (Dallas
  Texas)
• Cleveland Clinic Foundation (Cleveland, Ohio)
• Geisinger Medical Center (Danville, PA)
• Henry Ford Health System (Detroit, Michigan)
• Loyola University Medical Center (Maywood,
  Illinois)
• Mission Hospitals (Ashville, NC)
• Primary Childrens Medical Center (Salt Lake
  City, Utah)
• Stanford Hospitals and Clinics (Stanford,
  California)
• U.C. Davis Health System (Sacramento, California)
  
• University of Maryland Medical Center (Baltimore,
  Maryland)
• University of Michigan Health System (Ann Harbor,
  Michigan)

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Questions and Answers?
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Questions?

• www.ValiMed.com
• www.CDEXINC.com
• Gregory A Firmbach
• 412-563-3355 (Eastern US offices)
• or
• 520-745-5172 (Corporate offices)
• Email Greg.Firmbach_at_cdex-inc.com

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EXTRA SLIDES FOR QUESTIONS AND ANSWERS

• VALIMED

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ValiMed Technical Specification

• Amikacin 5 mg-ml D5W

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ValiMed Technical Specification
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ValiMed Technical Specification
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ValiMed Model CCT SensitivityCCT MODEL vs VM
MODEL
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INITIAL VALIMED SETUP (SAMPLES 1-10)(COMPOUNDED
BY MANY PTs TO SET THE INITIAL PARAMETERS)
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INITIAL VALIMED SETUP FOR SAMPLES 11-67
SAMPLES WITH 0-3 SDs
SAMPLES WITH gt 7 SDs
SAMPLES WITH 3-7 SDs
SAMPLES THAT FAILED SIG