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					                                         Maryview Medical Center
 Pre-operative Prophylactic Antibiotic Administration




Black Belt: Cheryl Samuels, BSN, MSEd, RN

Division: Bon Secours Hampton Roads

Location: Maryview Medical Center
      Define                                                                                                  Maryview Medical Center
                                          Pre-operative Prophylactic Antibiotic Administration
             Project Definition                                                               Project Deliverables/Benefits
                                                                                          Project Goals
Problem Statement                                                                                     As recommended by CMS, 7th Scope of Work
Inappropriate or sub-optimal use of antimicrobial prophylaxis process prior to
surgery.
                                                                                                1.     Proper timing of administration of antimicrobial agent prior to
                                                                                                       surgical incision.
Project Scope                                                                                   2.     Appropriate choice of antimicrobial agents.
Pre-surgical patients receiving antibiotic prophylactic therapy.

                                                                                                Key Deliverables
                                                                                                1.     To provide the pre-surgical antimicrobial prophylaxis within 0-60
                                                                                                       minutes prior to surgical incision to assure that a bactericidal
                                                                                                       concentration of the drug is established in the serum.

        Roles & Responsibilities                                                                2.     To select the correct antimicrobial that will reduce gram+
                                                                                                        organisms, such as staphylococcus aureus and streptococcus
                                                                                                        that often cause post operative infections.
         Champions:                                 Stephen Moore, MD, Medical Director
                                                    JoAnn Burke, RN Surgical Services
                                                    Director
                                                                                          Financial and Operational Benefits
                                                                                                Cost of poor quality.
         Process Owner:                             Tami Brisson, RN ACU/PACU Manager
                                                                                                       Each post operative Infection approximately increases LOS by
         Project BB/GB:                             Cheryl Samuels, RN, PI Coordinator                 7.3 days at cost of an additional $3,152 in extra charges (1992).
                                                                                                       MMC averaged 7.2 infections per month prior to improvement,
                                                                                                       approximately 86 infections per year at a total cost of $271,072.
          Process area:                            Joann Hoffnagle, RN, OR Manager and                 If the infections are reduced by 50% a savings of about
                                                                                                       $135,536 could occur.
                                                   Dan Ostrowski, RPH, Pharmacy
    Define                                                            Maryview Medical Center
                       Pre-operative Prophylactic Antibiotic Administration

                                     Business Case
• Ethical responsibility to decrease the gap between evidence-based care and actual care and to
    adhere to best practice processes (studies stem from the 1960’s and current MMC practitioners
    are not following the guidelines).


• To follow the Medicare National Surgical Infection Prevention Project guidelines.


•    To reduce post-operative infections and resource consumption.


• Consequences of not engaging this project:
       * Increased surgical infections, which are seen as potentially preventable adverse events.
       * Increased medical errors which decrease patient safety and customer
         confidence.
       * Death or loss of limb from a nosocomial infection is classified as a Sentinel Event.
       *Increased cost of poor quality.
Define                                                          Maryview Medical Center
                Pre-operative Prophylactic Antibiotic Administration


                            Voice of the Customer

           FRAME                PROBE AND PRIORITIZE               TRANSLATE
    Voice of the Customer                Key Issue                      CTQ

     “Are we providing the      The standard of the providing     The correct time
    ABX at the right time to     the correct ABX is 0 – 60            window
      obtain pre-operative       minutes before the incision
         prophylaxis?”


     “Are we providing the        Incorrect ABX are being       The use of the correct
    right drug to obtain pre-           administered                    ABX
    operative prophylaxis?”
     Define                                                              Maryview Medical Center
                     Pre-operative Prophylactic Antibiotic Administration

  SUPPLIER          INPUT          PROCESS       OUTPUT                  CUSTOMER         CTQ
                                                                                     CRITICAL TO QUALITY

• Physician   • Pre-operative                 • Appropriate pre-         • Patient
                                                                                     • Selecting the
                antibiotic                      operative antibiotic
                                                medication is ordered                  correct Antibiotic
                medication
                order
                                                                                     • Administering the
• Pharmacy    • Provision of the              • Pre-operative                          Antibiotic at the
                antibiotic                      antibiotic medication                  correct time
                                                is provided via PYXIS
                                                or picked up
                                                                                     • Reducing the risk
• Nursing     • Administering                 • Pre-operative
                                                                                       of Post-operative
                the ordered pre-                antibiotic medication                  Infections
                                                is administered in the
                operative
                                                correct timeframe
                antibiotic
                medication




                         High-Level Process Map
  Measure                                                                    Maryview Medical Center
                          Pre-operative Prophylactic Antibiotic Administration
Process Measures Defined                                            CTQs and Specifications
                                                           CTQ #1
   Measure : Data Collection
                                                            • The appropriate antimicrobial is selected for
 Input Measures                                               administration 90% of the time.
   • Appropriate choice of antimicrobial agent:
       The number of times the correct drug is selected.    CTQ #2

                                                            • The appropriate antimicrobial is administered 0-60
                                                              minutes prior to the incision 90% of the time.



 Output Measures
  • Correct antimicrobial and timing:                                 Data Collection Plan
     The number of times the correct medication is
     given during the correct time.                                              Discrete Data
                                                            • How often is the correct antimicrobial given at the
                                                              correct time?

                                                            • How often is the correct antimicrobial given at the
                                                              incorrect time?

                                                            • How often is the incorrect antimicrobial given at the
                                                              correct time?

                                                            • How often is the incorrect antimicrobial given at an
                                                              incorrect time?
Measure                                                              Maryview Medical Center
                  Pre-operative Prophylactic Antibiotic Administration




            DATA COLLECTION PLAN FOR ABX TIME AND DRUG SELECTION

   Historical and go forward data is present in the Medical Record

   Validated ability to retrieve and access data

   Confirmed that key stratification variables were part of each record

   Verified rules used by collectors to abstract time, drug, surgery and physician and
   record on data collection tool.

   All data analysis and graphical display would be completed by the PI Coordinator
Measure                                               Maryview Medical Center
             Pre-operative Prophylactic Antibiotic Administration
                           ABX Data Collection Tool
    MD    ABX     OR Cut
   Name   Start    Time               Surgery            ABX Given
          Time
             Measure                                                                                                                                                  Maryview Medical Center
                                                                     Pre-operative Prophylactic Antibiotic Administration
                                        Collected Data                                                                                    Baseline Process Measures
                                                                                                                                                                            Descriptive Statistics
          Process Baseline Performance                                                                                                                                                                                           Variable: Baseline

          The PI Coordinator collected baseline data to determine current                                                                                                                                                     Anderson-Darling Normality Test
                                                                                                                                                                                                                                  A-Squared:                      0.445
          status of the process and to determine whether an improvement was                                                                                                                                                       P-Value:                        0.273
          indicated . Data revealed a normal process that was not operating                                                                                                                                                       Mean                           86.0000
                                                                                                                                                                                                                                  StDev                          45.5206
          with best practice specifications. The baseline data (removing cases                                                                                                                                                    Variance                       2072.12
                                                                                                                                                                                                                                  Skewness                     0.279840
          where no ABX was given or given after the cut) indicates on average                                                                                                                                                     Kurtosis                      -5.6E-01
                                                                                                                                                                                                                                  N                                   50
          the patient receives the antibiotic 86.2 minutes prior to surgery. A                                                            0                 40        80         120         160
                                                                                                                                                                                                                                  Minimum                         3.000
          median of 81.5 minutes. 52% of baseline cases exceeded the time                                                                                                                                                         1st Quartile                   50.000
                                                                                                                                                                                                                                  Median                         81.500
          window of 60 minutes. 17% of the patients did not receive any                                                                                                                                                           3rd Quartile
                                                                                                                                                                                                                                  Maximum
                                                                                                                                                                                                                                                                121.000
                                                                                                                                                                                                                                                                185.000
                                                                                                                                                         95% Confidence Interval for Mu
          antibiotic and 12% of the patients received an incorrect antibiotic                                                                                                                                                  95% Confidence Interval for Mu

          prior to the surgeon’s incision. 5% of the patients received the                                                           56         66               76           86             96          106
                                                                                                                                                                                                                                   73.063                        98.937
                                                                                                                                                                                                                             95% Confidence Interval for Sigma
          antibiotic at time exceeding 60 minutes prior to the incision or after                                                                                                                                                   38.025                        56.725

          the incision.                                                                                                                            95% Confidence Interval for Median
                                                                                                                                                                                                                             95% Confidence Interval for Median
                                                                                                                                                                                                                                   60.000                       101.641



                                         Graphical Overview                                                                                   Baseline Process Sigma
                                                          ABX Baseline Data
                                                                                                                                                       Baseline Pareto Chart of Opportunities for Defects
                                                                                                                          n=59
                                                                                                                                   59                                                                                              98%                                 100%
Incorect Time and Incorrect Drug                                                    29%
                                                                                                                                                                                                                                                                       90%
                                                                                                                                51.625
                                                                                                                                                                                                                                                                       80%
                                                                                                                                 44.25                                                             75%
                                                                                                                                                                                                                                                                       70%
                                                                                                                                36.875                                                                                                                                 60%
Incorrect Time and Correct Drug                                                                             46%
                                                                                                                        Cases



                                                                                                                                  29.5             27                                                                                                                  50%
                                                                                                                                                                      46%
                                                                                                                                22.125                                                                                                                                 40%
                                                                                                                                                                                 17
                                                                                                                                                                                                               14                                                      30%
                                                                                                                                 14.75
 Corect Time and Incorrect Drug         1.7%
                                                                                                                                                                                                                                                                       20%
                                                                                                                                 7.375                                                                                                                                 10%
                                                                                                                                                                                                                                                  1
                                                                                                                                    0                                                                                                                                  0%
                                                                                                                                              and Correct Drug




                                                                                                                                                                                                          Correct Time and




                                                                                                                                                                                                                                            Correct Time and
                                                                                                                                                                            Incorrect Time
                                                                                                                                                                             and Incorrect
                                                                                                                                               Incorrect Time




                                                                                                                                                                                                                                             Incorrect Drug
         Correct Drug and Time                                                24%




                                                                                                                                                                                 Drug




                                                                                                                                                                                                               Drug
                                                                                                                                                                                                                      Represents 24%
                                   0%          5%   10%   15%        20%      25%   30%   35%   40%   45%         50%                                                                                                   or 0.8 Sigma


                                                          Baseline Data
Measure                                                    Maryview Medical Center
                   Pre-operative Prophylactic Antibiotic Administration
Process Map Inpatient and ACU ABX administration
MD orders pre-op
meds for surgery




     Nurse
                             Has the OR
  administers                                   No        wait for
                              called and
    the pre-                                               call
                              requested
   operative
                             the patient?
      ABX                                                On call to
                                                           OR


                             Yes




                       Send patient to the OR
                                                                          End of Process
                            for surgery
Analyze                                                                   Maryview Medical Center
                 Pre-operative Prophylactic Antibiotic Administration

Process Map Analysis



    The current process of giving the antibiotic at a unit location does not permit a method
    to control and manage the antibiotic administration time within the window prior to surgery.


    The data and the current process indicates an obvious flaw in meeting the time requirement.




                                           Prioritizing X’s
                              Current process viewed as unsalvageable
      Used multi-voting among team members to select most critical factors form Ishikawa diagram
                          Used FMEA to explore and prioritize those factors
Analyze                                                                             Maryview Medical Center
                         Pre-operative Prophylactic Antibiotic Administration

                      Ishikawa Diagram for Correct ABX Timing

                                     Plant                           Policies


                                                                                            Assist surgeons with
                                                                                             awareness of Best
                  Have the Unit only set                                                  Practice Protocol for ABX
                       up the ABX                                                                    time
                 administration to be run
                          in OR




                                                                                                  To Administer the
                                                                                                 ABX at the correct
         Have the Anesthesiologist begin the                                                            time.
        ABX administration before the incision.                                                     (Discrete Y)
                                                             Relocate the process
                                                                  to the OR
                                                                    "BFO"
                                                                                             Have Pharmacy assure
Educate staff about the of Best Practice window                                                back -up drugs are
    of time is 0-60 minutes prior to incision                                                 availablr in OR PYXIS

                                                      Have OR staff document
                                                  the ABX time administered on a
                                                             sticker.




                                      People                          Procedures
 Analyze                                                                     Maryview Medical Center
                         Pre-operative Prophylactic Antibiotic Administration


                          Ishikawa Diagram for Correct ABX

                                      Plant                     Policies             Develop a protocol that
                                                                                           addresses
                                                                                        pre-surgical ABX
                                                                                             "BFO"


                                                                                               Assist surgeons with
          Make sure the Protocol ABX is                                                         awareness of Best
       avilable on units in the PYXIXS from                                                    Practice Protocol for
                    Pharmacy.                                                                        ABX drug




                                                                                                   To Administer the
                                                                                                      correct ABX
                                                                                                      (Discrete Y)
                                                               Have the Unit only set
                                                                    up the ABX
                                                              administration to be run
                                                                       in OR
                                                                                              Have Pharmacy assure
Educate staff about the of Best Practice of ABX                                              back drugs are availablr
                   selection                                                                       in OR PYXIS
                                                   Have OR staff document
                                                  the ABX administered on
                                                         a sticker.
EducatePhysicians re ordering Cirpo                                                       Cease having patient on-call to
    and other ineffective ABX's                                                          the OR and do not give the ABX
                                                                                             with pre-op medications


                                      People                     Procedures
      Analyze                                                                                                                   Maryview Medical Center
                                          Pre-operative Prophylactic Antibiotic Administration
           Failure Mode, Effect, and Criticality Analysis (FMECA) Worksheet
   Step or Link             List all potential              Potential    Severity        Frequency     Discover-       Criticality      Possible cause(s)        Recommended
    in process               Failure Modes                   effect      of effect        of failure     ability          RPN             (from RCA)               redesign

Ordering Medication   Antibiotic not ordered           No Rx                     10               10               9          900 Knowledge deficit         ABX order sheet
                      Incorrect Antibiotic ordered     Inadequate RX             10                9          10              900 Knowledge deficit         ABX order sheet
                      Patient allergic to antibiotic   Alternative RX                6            10               6          360 Knowledge deficit         ABX order sheet
                      Weight not on chart              Correct dose RX               6             5               6          180 Nursing assessment        Education
                      Order not legible                Delay in RX                   7             7          10              490 Handwriting               Pre-printed order sheet
                      Wrong dose                       Inadequate RX                 9             6               5          270 Knowledge deficit         Pre-printed order sheet
                      Non-formulary                    Delay in RX                   4             5               4            80 Knowledge deficit        Pre-printed order sheet
                      Not transcribed on MAR           Delay in RX                   5             9               6          270 Process problem           Education
                      Felt tip pen used                Delay in RX                   5             6               7          210 Policy problem            Pre-printed order sheet
                      Wrong chart / patient            Wrong RX                      3             6               5            90 Process problem          Education
                      Order not signed                 Delay in RX                   6             4               8          192 Process problem           Education
                      Patient name not on order        Delay in RX                   8             9               2          144 Process problem           Education
                      No order for another dose        Inadequate RX             10               10               6          600 Process problem           Education
                      Drug ordered too early           Wrong RX timing           10               10               9          900 Process problem           Education
 FAX to Pharmacy      Felt tip pen used                Not legible                   5             6               7          210 Policy problem            Pre-printed order sheet
                      Not legible                      Delay in RX                   7             7               9          441 Process problem           Pre-printed order sheet
                      No patient name on order         Potential no RX               5             7               9          315 Process problem           Education
                      FAX machine malfunction          Delay in RX                   5             6               3            90 Process problem          Education
                      Sent to wrong FAX number         Delay in RX                   5             7               3          105 Process problem           Education
                      Not Faxed or delay               Delay in RX                   6             6               7          252 Process problem           Education
                      Fax "copy" used versus
                      "send"                           Delay in RX                   8             6               4          192 Process problem           Education
                      Written on blue sheet            Not legible                   3             6               4            72 Policy problem           Education
                      Fax only partial page            Delay in RX                   3             6               4            72 Process problem          Education
                      Wrong patient name               Delay in RX                   3            10               4          120 Process problem           Education
Entered by Pharmacy   Order on wrong patient/chart     Delay in RX                   3            10               2           60 Process problem           Education
                      Patient allergic to antibiotic   Delay in RX                   6            10               3          180 Nursing assessment        Education
                      No current weight                Delay in RX                   5             7               9          315 Nursing assessment        Education
                      Wrong drug                       Inadequate RX             10               10               7          700 Knowledge deficit         Pre-printed order sheet
                      Wrong dose                       Inadequate RX             10                8               9          720 Knowledge deficit         Pre-printed order sheet
                      Wrong time                       Inadequate RX             10                9               9          810 Knowledge deficit         Pre-printed order sheet
                      Computer down                    Delay in RX                   3             5               3            45 Process problem          Education
                      Patient not in computer
                      system                           Delay in RX                6                5               9          270    Process problem        Education
  ABX sent to Unit    Sent to wrong floor              Delay in RX                4                5               4           80    Process problem        Education
                      Courier not available/delay      Delay in RX                5                7               4          140    Process problem        Education
                      Unit staff can't pick up         Delay in RX                9                7               5          315    Process problem        Education
                      Wrong antibiotic                 Inadequate RX             10               10               7          700    Knowledge deficit      Pre-printed order sheet
                      Wrong dose                       Inadequate RX             10                9               7          630    Knowledge deficit      Pre-printed order sheet
                      No tubing                        Delay in RX                7                6               6          252    Knowledge deficit      Pre-printed order sheet
                      Wrong patient name               Delay in RX                9               10               5          450    Process problem        Education
                      Antibiotic expired               Inadequate RX              9                3               4          108    Knowledge deficit      Move to OR
                      Wrong dilution                   Inadequate RX              2                5               7           70    Knowledge deficit      Move to OR
  ABX from PYXIS      Not in PYXIS                     Delay in RX                7                7               6          294    Process problem        Relocate ABX to OR
                      Wrong med selected               Delay in RX                9               10               7          630    Knowledge deficit      Pre-printed order sheet
                      Nurse has no access              Delay in RX                3                6               7          126    Process problem        Education
                      PYXIS failure                    Delay in RX                4                6               6          144    Process problem        Education
                      Not aware med in PYXIS           Delay in RX                5                6               5          150    Process problem        Evaluate
                      Sidetracked - delay              Delay in RX                8                7               3          168    Process problem        Move to OR
                      Analyze                                                                                                                                    Maryview Medical Center
                                                    Pre-operative Prophylactic Antibiotic Administration

                                                                                           FMEA Pareto Chart by RPN

                       21644                                                                                                                                                                                        100%

                                                                                                                                                                                                                    90%
                      18938.5
                                                                                                                                                                                                                    80%
                       16233
                                                                                                                                                                                                           14265    70%
Risk Prioity Number




                      13527.5
                                                                                                                                                                                                                    60%

                       10822                                                                                                                                                                                        50%

                                                                                                                                                                                                                    40%
                       8116.5
                                                                                                                                                                                                           34%
                                                                                                                                                                                             31%                    30%
                                                                                                                                                                      27%
                        5411                                                                                                                        24%
                                                                                                                                  20%                                                                               20%
                                                                                                           16%
                       2705.5                                                               12%
                                   900             900                  8%
                                                                         900                  810              810                 810                 800                729                                       10%
                                                                                                                                                                                              720
                                                 4%
                           0                                                                                                                                                                                        0%

                                                                                                                                                    Delay due to pt
                                Antibiotic not




                                                                                                                                                                                                            OTHER
                                                                        Drug ordered too




                                                                                                                                                                                              Wrong dose
                                                                                                                                                                      Antibiotic given too
                                                                                                                                   Calls too late
                                                 Incorrect Antibiotic




                                                                                                           Patient leaves prior
                                                                                              Wrong time
                                  ordered




                                                                                                               to antibiotic




                                                                                                                                                       transfer
                                                                             early
                                                       ordered




                                                                                                                                                                             early
     Analyze                                                                   Maryview Medical Center
                                       Pre-operative Prophylactic Antibiotic Administration
Graphical Analysis
Baseline Data, excluding cases of no
ABX administered or given after the incision.



                                                     I Chart for Baseline

                                                                                      UCL=227.0
                                 200
              Individual Value




                                 100
                                                                                      Mean=86



                                  0


                                                                                      LCL=-55.01


                                       0       10       20      30       40      50
                                                    Observation Number
  Analyze                                                                          Maryview Medical Center
                           Pre-operative Prophylactic Antibiotic Administration
Graphical Analysis
Baseline Data, excluding cases of no
ABX administered or given after the incision.


                                                                             Histogram of Baseline, w ith Normal Curve
                        Boxplot of Baseline

                                                                    10




                                                        Frequency
                                                                     5




                                                                     0
    0                           100              200
                                                                         0    20    40    60    80   100   120   140     160   180
                             Baseline
                                                                                                Baseline
Analyze                                                                                                  Maryview Medical Center
                           Pre-operative Prophylactic Antibiotic Administration

             Baseline Histogram with Specification Limits of 0-60 Minutes
         n=49

                                                   LSL=0.0        USL=60.0
        12    This data does not include
              cases when no ABX was given
              Median=80.0
              Mean=80.2
        10
              Mode=120.0


        8
Cases




        6



        4



        2



        0
                       -66.0 to -   -33.0 to 0.0    0.0 to 33.0   33.0 to 66.0   66.0 to 99.0 99.0 to 132.0   132.0 to   165.0 to   198.0 to
                         33.0                                                                                  165.0      198.0      231.0

                                                                                 Minutes
Analyze                                                                   Maryview Medical Center
                  Pre-operative Prophylactic Antibiotic Administration

Baseline ABX Selection


     29% receive no drug or incorrect drug
                                               Cefotan
                                                                  None
                                                14%
                                                                  17%


                                Vancomycin
                                    7%



                                                                             Cipro
                                                         n=59                12%



                                                                          Cleocin
                                                                            5%
                                       Ancef
                                       30%                                                   Correct ABX
                                                                Zinacef                 71% Compliance rate
                                                                 14%           2.0 sigma or 30 defects per 100 surgeries
Analyze                                                                           Maryview Medical Center
                         Pre-operative Prophylactic Antibiotic Administration
          Statistical Analysis

                           #1                                                             #2
                                                                     The drug selection at baseline indicates a 71%
 Individuals control chart (next page) demonstrate a mean
                                                                     compliance rate. 29% receiving the wrong or no
 of 86 minutes for the ABX administration, operating
                                                                     antibiotic.
 outside the 0-60 minutes. The data indicates a lower
 control limit of 55 minutes and the upper control limit of
 227 minutes. Data is not operating within the
 specifications limits of 0-60 minutes.



                           #3                                                             #4
The histogram demonstrates normal data in a bell curve.
The box plot shows the mean and upper and lower limits          FMEA indicates opportunities are with drug selection,
of data. The histogram shows the specifications limits (in      drug location, dosage and order protocol.
green) and how the process is operating outside (in red)
those limits.



                                                The Vital Few Xs are the:

                                Hospital location of where the antibiotic administered

                             Protocol/Standing order for selecting the correct antibiotic
  Improve                                                                      Maryview Medical Center
                           Pre-operative Prophylactic Antibiotic Administration
   Solution Alternatives                                                   Selection Criteria
    Potential Solutions
Team wanted the nurse on the floor to hang the ABX but
not open the flow on the IV and assure the medication is      The team used location change as the key driver in the
sent with the patient. Strength: ABX ready for infusion       improvement process. Also, the team realized a
and no longer responsibility of unit nurse who can not        Standing order was required to assure the Physician was
control the timing.                                           selecting the correct antibiotic.

The team selected to move the administration of the
antibiotic to the OR. Strength: Able to judge infusion
time and administer the ABX within the 0-60 minute
window

                 Selection Process                                        Selected Solution
                                                               The team decided relocate the process to the OR,
   Chose to use multi-voting among team members to
                                                               developed and had approved the ABX standing order
   select 5 most critical factors form Ishikawa diagram.
                                                               and a sticker to collect data in a central location in the
   Used FMEA to explore and prioritize those factors of why
                                                               chart.
   we fail to meet the time and drug selections.
 Improve                                                                        Maryview Medical Center
                          Pre-operative Prophylactic Antibiotic Administration
           Refine Solution
                           #1                                                             #2
Team decided to remove non-value added work from the                Moved the process to OR Holding were capability exists
nursing unit, not giving ABX with the pre-op medications.           to give ABX within the time window.




                             #3                                          Cost/Benefit Analysis

   To facilitate in the correct drug selection by developing      Expected financial implications related to a
    a pre-operative ABX protocol.                                 reduced post-operative infection rate and related
                                                                  expenses.




                         The process jumped to 85% - 100% compliance to drug and time and
                         continues to stay within this range. Infection rate showed a decline
                                  in 1st Quarter 03, will need to continue to monitor.
  Improve                                                                    Maryview Medical Center
                Pre-operative Prophylactic Antibiotic Administration
Sticker to record all ABX information in one central location,
preparing for re-dose project

                             Preoperative Antibiotic Administration Documentation
                        Patient Name:

                        Date:

                        Drug:

                        Dose:

                        Time:

                        Signature:

                                           INTRAOPERATIVE REDOSE
                                        Redose Drug Times: See order sheet
                        If surgery lasts beyond time:

                        Drug:

                        Dose:

                        Time:

                        Signature:
                                                                              09/24/2002
Improve                                                                             Maryview Medical Center
                        Pre-operative Prophylactic Antibiotic Administration
      SURGERY TYPE           RECOMMENDED PROPHYLAXIS              ALTERNATIVE PROPHYLAXIS REGIMEN
                                    REGIMEN                             (PENICILLIN ALLERGY)                   ABX

APPENDECTOMY                CEFOTETAN 1-2 GM ONCE            GENTAMICIN 1.5 MG /KG ONCE NOT TO EXCEED
                                                                                                             Standing
                                                             120 MG AND CLINDAMYCIN 900 MG ONCE               Order

BILIARY TRACT               CEFAZOLIN 1-2GM ONCE OR          GENTAMICIN 1.5 MG /KG ONCE, NOT TO EXCEED
                            UNASYN 3 GM ONCE FOR             120 MG AND CLINDAMYCIN 900 MG ONCE
                            CHOLANGITIS

COLORECTAL                  CEFOTETAN 1-2 GM ONCE            GENTAMICIN 1.5 MG /KG ONCE NOT TO EXCEED
                                                             120 MG AND CLINDAMYCIN 900 MG ONCE

GASTRODUODENAL              CEFAZOLIN 1-2 GM ONCE            GENTAMICIN 1.5 MG /KG ONCE, NOT TO EXCEED
                                                             120 MG AND CLINDAMYCIN 900 MG ONCE


HEAD AND NECK               CLINDAMYCIN 900MG ONCE AND       CEFAZOLIN 1-2 GM (IF NOT PENICILLIN ALLERGIC)
                            GENTAMICIN 1.5MG /KG ONCE, NOT
                            TO EXCEED 120MG

NEUROSURGERY-CRANIOTOMY,    CEFAZOLIN 1-2 GM ONCE            VANCOMYCIN 1 GM ONCE INFUSED SLOWLY OVER
LAMINECTOMY                                                  ONE HOUR BEGINNING ONE HOUR BEFORE
                                                             SURGERY*

ORTHOPEDIC-PROSTHETIC       CEFAZOLIN 1-2 GM ONCE            VANCOMYCIN 1 GM ONCE INFUSED SLOWLY OVER
JOINTS, OPEN SURGERY                                         ONE HOUR BEGINNING ONE HOUR BEFORE
                                                             SURGERY*
                                                            VANCOMYCIN 1 GM ONCE INFUSED SLOWLY OVER
VASCULAR SURGERY,           CEFAZOLIN 1-2 GM ONCE            ONE HOUR BEGINNING ONE HOUR BEFORE
INCLUDING A/V SHUNT                                          SURGERY*
                                                             FOR GROIN INCISIONS ADD GENTAMICIN 1.5 MG /KG
                                                             ONCE NOT TO EXCEED 120 MG

THORACIC, PULMONARY,        CEFAZOLIN 1-2 GM ONCE            VANCOMYCIN 1 GM ONCE INFUSED SLOWLY OVER
ESOPHAGEAL                                                   ONE HOUR BEGINNING ONE HOUR BEFORE
                                                             SURGERY*

HYSTERECTOMY                CEFAZOLIN OR CEFOTETAN           GENTAMICIN 1.5 MG /KG ONCE, NOT TO EXCEED
VAGINAL OR ABDOMINAL        1-2 GM ONCE                      120 MG AND CLINDAMYCIN 900 MG ONCE
      Improve                                                                                                             Maryview Medical Center
                                       Pre-operative Prophylactic Antibiotic Administration
ABX Administration Policy

 POLICY: It is the policy of Maryview Medical Center to ensure the appropriateness and timeliness of antibiotic prophylaxis for patients undergoing surgical procedures. A
 medical staff endorsed order sheet for surgical prophylaxis is available to facilitate this policy. It will be reviewed and updated periodically.


 PURPOSE:            To ensure that our patients receive appropriate and timely antimicrobial prophylaxis according to the standards of practice in the surgical community.


 PROCEDURE:

 1.   When the physician orders the pre-operative antibiotic, the circulating nurse documents the time the antibiotic was given and anesthesia (MD or CRNA) staff will start
      the administration of the antibiotic in the HOLDING AREA. This will occur even when physician orders to give the antibiotic “ON CALL to OR".

 2.   The Nursing Unit or ACU will send the mixed antibiotic and the necessary tubing with the patient to the OR.

 3.   When the physician utilizes the 2002 Order Sheet for Adult Antimicrobial Prophylaxis Administration for Surgery, the type of surgery will be indicated and the
      anesthesia staff in the HOLDING AREA will administer the appropriate antimicrobial as indicated.

 4.   The unit nurse, perioperative nurse and anesthesia staff will check for patient allergies. Nausea, vomiting, diarrhea are not allergic reactions.

 5.   The anesthesia staff in the HOLDING AREA will administer the antibiotic 0-60 minutes prior to the incision.

      a)   Cefazolin and cefotetan may be given IV push or by infusion. To push these drugs, dilute in 10-20ml of NS and administer the IV push over 3-5 minutes. Please
           note that Maryview policy: V:16, prohibits LPN's from administering IV push medications. A RN must administer IV push medications.

      b)   Vancomycin should be infused slowly – at a rate not to exceed 1 gm/hr. The infusion should ideally begin 1 hour prior to the procedure.
Improve                                                                                  Maryview Medical Center
                       Pre-operative Prophylactic Antibiotic Administration
  To:
  From: Thomas Thames, MD                                        When there is a violation in the drug choice:
        Interim Medical Director Maryview Medical Center         A letter is sent to the MD, Chair of the MD’s
  Date:                                                          Department, Surgical Services Chair and placing the
  Re:   CIPRO as preoperative antibiotic choice
                                                                 individual MD’s Quality File.
  Dear Dr.

         In an ongoing study evaluating the prevention of surgical site infections, CIPRO has been found in random studies to be
  used prophylactically in 12-17% of cases preoperatively. In addition, there has been a recent clustering of staph infections
  following surgical procedures. CIPRO use was discovered to be a key root cause for two of the eight infections. You are one of
  a handful of surgeons who continue to choose the use of CIPRO prior to surgery.

         Based upon the most recent antibiogram at Maryview Medical Center, CIPRO and the other flouroquinolones have less
  than 40% effect upon staph and strep species. The use of this antibiotic class is not recommended by the CDC in its most recent
  publication of Prevention of Surgical Site Infections.

         Please discontinue your use of CIPRO as the sole preoperative antibiotic of choice. If you have concerns for intra-
  abdominal infection you may add CIPRO to the recommended agents. To summarize, the recommended agents are first
  generation cephalosporins such as Ancef. Alternatives for Penicillin allergic patients and those at high risk for MRSA infection
  is Vancomycin over 40-60 minutes prior to skin incision.

          The standing order sheet in the OR for Preoperative Antibiotic use is available for you. In fact, the Department of
  Surgery has adopted that sheet as the departments guide. In order to best protect our patients and prevent subsequent outbreaks,
  please adhere to these guidelines.

         Thank you so very much for your participation in quality improvement at Maryview Medical Center.

  Cc:    Dr. , Chair, Department of Surgery
         Dr. , Department of
         Cheryl Samuels, PI Coordinator
  Control                                                                       Maryview Medical Center
                          Pre-operative Prophylactic Antibiotic Administration
     Process Controls                                                         Response Plan
  Process Control Plan                                       A letter from the Medical Director (see appendix) is sent
                                                             the physician who continues to use Cipro.
Surgical Services has taken this process on as a
quarterly indicator and reports results to the Performance   A copy of the letter is placed in the physician’s quality
Improvement Council.                                         file, more than two letter will result in action by the
                                                             Authorities of the Medical Staff.

                                                             A copy of the letter is sent to the Chair of the Department
                                                             of Surgery.

                    Training Plan                                             Miscellaneous

 The Surgical Services departments have taken over the
 ongoing education and reward.                                 CMS is moving to begin an antibiotic re-dosing during
                                                               long surgeries and the team will begin that aspect of
 Posters and communication plans were provided to all          improvement next.
 units.
 Hershey candy bars wrapped in “ABX” paper were
 provided to staff. The Medical Director (champion) had a
 pizza party for he staff to thank them for the change.

 In August Surgical Services is having ABX Awareness
 Month!
  Control                                                                  Maryview Medical Center
                          Pre-operative Prophylactic Antibiotic Administration
Implementation Schedule                                              Process Ownership
  Implement Solution                                       The surgical service areas of Maryview Medical Center
This process was replicated at the two sister Hospitals    are the key players to ensure the process is monitored
and the Out-patient Surgery Center of Maryview.            and the improvements are maintained.




                   Verify Results                                       Project Wrap-Up
 The ABX data from surgical services is submitted on a     The expected financial benefits and costs associated
 quarterly basis to the Performance Improvement Council.   with implementing this solution will continue to be
 We will continue to monitor results                       evaluated as we observe the post-operative infection
                                                           rates..

                                                           The key lessons learned from this project are how easy
                                                           we were able to replicate this project at the Out-Patient
                                                           Surgical Center and two sister Hospitals.
    Control                                                                   Maryview Medical Center
                             Pre-operative Prophylactic Antibiotic Administration
                                           Incorrect Drug or No ABX




1st Quarter 03       1
                              1.7% defect or 98.3% correct
                              Sigma: 3.6




     Baseline                                                                                   18




                                       31% defect or 69% correct
                                       Sigma: 2.0
                 0       2         4        6              8   10      12            14   16   18    20

                                                Baseline            1st Quarter 03
     Control                                                                               Maryview Medical Center
                                     Pre-operative Prophylactic Antibiotic Administration
                                     Improved ABX Administration from Baseline to 1st Quarter 2003




                                      0
Incorect Time & Incorrect Drug
                                                              17




                                                 9
Incorrect Time & Correct Drug
                                                                           27




                                      1
Correct Time & Incorrect Drug
                                      1




                                                                                                      49
         Correct Time & Drug
                                                         14




                                 0               10                20           30           40       50       60


                                                  Baseline                1st Quarter 03
   Control                                                                Maryview Medical Center
                         Pre-operative Prophylactic Antibiotic Administration
Data points                                     Descriptive Statistics
are now within
specifications limits                                                      Variable: 1st Quarter
with the exception
                                                                          Anderson-Darling Normality Test
of a few outliers
                                                                              A-Squared:           3.278
                                                                              P-Value:             0.000

                                                                              Mean              28.9200
                                                                              StDev             24.2772
                                                                              Variance          589.381
                                                                              Skewness          3.16578
                                                                              Kurtosis          14.3734
                                                                              N                      50
                    0    24       48      72     96     120    144
                                                                              Minimum             5.000
                                                                              1st Quartile       15.000
                                                                              Median             25.000
                                                                              3rd Quartile       36.250
                              95% Confidence Interval for Mu                  Maximum           155.000
                                                                           95% Confidence Interval for Mu
                                                                               22.021            35.819
                    20             25            30            35        95% Confidence Interval for Sigma
                                                                               20.280            30.253
                                                                         95% Confidence Interval for Median
                         95% Confidence Interval for Median
                                                                               20.000            25.000
Control                                                              Maryview Medical Center
                             Pre-operative Prophylactic Antibiotic Administration

                                 I Chart for 1st Quarter

                                                                            Mean is now 28.92 and upper
                       150                                                  and lower control limits are
                                                                            within the specification limits
                                                                            and variation is reduced.
    Individual Value




                       100




                       50                                                   UCL=46.61
                                                                            Mean=28.92
                                                                            LCL=11.23
                        0

                             0        10       20     30        40     50
                                           Observation Number
  Control                                                                          Maryview Medical Center
                          Pre-operative Prophylactic Antibiotic Administration
                                    Boxplots of Baseline and 1st Quarter
                                          (means are indicated by solid circles)

                200




Analyzing       100

baseline and
1st Quarter data


                   0

                                      Bas el i ne                                  1s t Quar

                                Two-sample T for Baseline vs 1st Quarter

                                             N        Mean       StDev      SE Mean
                               Baseline     50        86.0        45.5          6.4
                               1st Quar     50        28.9        24.3          3.4

                          Difference = mu Baseline - mu 1st Quarter
                               Estimate for difference: 57.08
                            95% CI for difference: (42.54, 71.62)
        T-Test of difference = 0 (vs not =): T-Value = 7.82 P-Value = 0.000                    DF = 74
         P value is 0, P is low and null must go, reject Ho that there is no significant difference,
             accept Ha that there is a significant difference between baseline to 1st Quarter 03
            Demonstrates there is a statically significant improvement in the current process from the
                                                 baseline process.
    Control                                                                              Maryview Medical Center
                            Pre-operative Prophylactic Antibiotic Administration
                                        Boxplots of Baseline and 1st Quarter
                                 Data of Correct Drug and Time Baseline vs 1st Quarter
                                 (means are indicated by solid circles)

                       60
  Discrete data of
                       50
  correct drug and
  time from baseline   40

  to 1st Quarter 03
                       30


                       20


                       10


                        0

                                           Baseline                                1st Quar
                 Two-sample T for Baseline Correct drug and time vs 1st Quarter Correct drug and zt

                                                   N        Mean      StDev     SE Mean
                                      Baseline    14        37.5       18.7         5.0
                                      1st Quar    46        23.5       12.0         1.8

                Difference = mu Baseline Correct drug and time - mu 1st Quarter Correct drug and zt
                                           Estimate for difference: 14.00
                                        95% CI for difference: (2.74, 25.26)
                   T-Test of difference = 0 (vs not =): T-Value = 2.64 P-Value = 0.018 DF = 16
P value is 0.018, P is low and null must go, reject Ho that there is no significant difference, accept Ha that there
                           is a significant difference between baseline to 1st Quarter 03
    Demonstrates there is a statically significant improvement in the current process from the baseline process.
Control                                                                               Maryview Medical Center
                        Pre-operative Prophylactic Antibiotic Administration

                      Boxplot of 1st Quarter                                   Histogram of 1st Quarter, w ith Normal Curve

                                                                      20




                                                          Frequency
                                                                      10




                                                                       0

                                                                           0                 50                 100           150
  0              50                       100   150
                                                                                                  1st Quarter
                            1st Quarter



      The 1st Quarter data has an acceptable mean and is within specification limits
      There are still outliers (low volume) receiving ABX after the cut or too late prior to surgery
      All data points have tightened up within the specifications limits
    Control                                               Maryview Medical Center
                  Pre-operative Prophylactic Antibiotic Administration

              Review of Infection Volume Data

•       Descriptive statistics, to evaluate normality of infection data


•       Individuals Control Chart of Pre and Post Improvement


•       2 Sample T Test to determine if there is a significant change in
        infection volume from Pre to Post improvement

•       Continue to monitor to observe change in infection volume per month
Control                                                                                                         Maryview Medical Center
                                         Pre-operative Prophylactic Antibiotic Administration
                          Descriptive Statistics                                                                    Descriptive Statistics
                                                                                                                                                     Variable: Post Improve
                                                      Vaiable: Pre Improve
                                                       Anderson-Darling Normality Test                                                               Anderson-Darling Normality Test
                                                           A-Squared:           0.305                                                                    A-Squared:           0.317
                                                           P-Value:             0.526                                                                    P-Value:             0.468

                                                           Mean               7.20000                                                                    Mean              7.00000
                                                           StDev              2.39643                                                                    StDev             3.31662
                                                           Variance           5.74286                                                                    Variance               11
                                                           Skewness           -4.2E-01                                                                   Skewness         0.237881
                                                           Kurtosis          5.98E-02                                                                    Kurtosis         0.431523
                                                                                                                                                         N                       9
2       4           6         8            10              N                        15     2    4       6       8       10       12       14
                                                                                                                                                         Minimum            2.0000
                                                           Minimum             2.0000
                                                                                                                                                         1st Quartile       4.5000
                                                           1st Quartile        5.0000
                                                                                                                                                         Median             7.0000
                                                           Median              8.0000                                                                    3rd Quartile       9.0000
                                                           3rd Quartile        9.0000                                                                    Maximum           13.0000
                                                           Maximum            11.0000            95% Confidence Interval for Mu
        95% Confidence Interval for Mu
                                                                                                                                                      95% Confidence Interval for Mu
                                                        95% Confidence Interval for Mu
                                                                                                                                                          4.4506            9.5494
                                                           5.8729              8.5271
                                                                                           4        5       6       7        8        9        10   95% Confidence Interval for Sigma
5.5           6.5            7.5                8.5   95% Confidence Interval for Sigma
                                                                                                                                                          2.2402            6.3539
                                                           1.7545              3.7794
                                                                                                                                                    95% Confidence Interval for Median
                                                      95% Confidence Interval for Median       95% Confidence Interval for Median
      95% Confidence Interval for Median
                                                                                                                                                          3.6837            9.5442
                                                           5.3735              8.6265

                                                                              Special Cause Variation: MRSA outbreak in November 02
 Control                                                                      Maryview Medical Center
                                      Pre-operative Prophylactic Antibiotic Administration


Pre-Improvement:                          I Chart for ABX Pre-Improvement
Infections per month

                                 15
                                                                                     UCL=14.23
          Infections per Month




                                 10


                                                                                     Mean=7.2

                                 5




                                 0                                                   LCL=0.1711


                                      0             5             10            15
                                                 April 02 - June 02
 Control                                                                         Maryview Medical Center
                                      Pre-operative Prophylactic Antibiotic Administration


Post-Improvement:                         I Chart for ABX Post Improvement
Infections per month

                                 20

                                                                                       UCL=16.64
          Infections per Month




                                 10

                                                                                       Mean=7




                                 0

                                                                                       LCL=-2.641


                                      0     1   2     3    4   5   6     7   8     9
                                                    July 02 - March 03
Control                                                              Maryview Medical Center
               Pre-operative Prophylactic Antibiotic Administration
                    Boxplots of Pre and Post Improvement
                            (means are indicated by solid circles)



          12




           7




           2

                          Pre Impr                                   Pos t Imp



               2 Sample T Test
                          N      Mean      StDev    SE Mean
               Pre Impr 15       7.20       2.40     0.62
               Post Imp   9      7.00       3.32      1.1
               Difference = mu Pre Improvement - mu Post Improvement
               Estimate for difference: 0.20
               95% CI for difference: (-2.22, 2.62)
               T-Test of difference = 0 (vs not =): T-Value = 0.17
               P-Value = 0.865    DF = 22 Both use Pooled StDev = 2.77
               Ho: Pre Imp equals Post Imp
               Ha: Pre Imp does not equal Post Imp
               P value is greater than 0.05, fail to reject the null hypothesis
               Will continue to monitor to see if infections are effected.
 Control                                                  Maryview Medical Center
                  Pre-operative Prophylactic Antibiotic Administration

DPMO

 1,000, 000
                    24% baseline time 0.8 SIGMA


 100,000                            85% 1st Quarter 03 time 2.5 SIGMA
                                            Goal 90% time 2.8 SIGMA

  10,000


   1,000


       10

                   ABX Timing Quality Imperative
       1
              0     1        2          3        4         5             6   SIGMA
Appendix                                                                                                                Maryview Medical Center
                                   Pre-operative Prophylactic Antibiotic Administration
Project Plan
              week ending:   07/30/02   08/29/02   09/28/02   10/28/02   11/27/02   12/27/02   01/26/03   02/25/03   03/27/03   04/26/03   05/26/03   06/25/03   07/25/03   08/24/03
          Define
Charter
SIPOC
         Measure
Process Map
Data Collection
Baseline Performance
          Analyze
Data Analysis
Identify Root Cause
         Improve
Select Solution
Testing
          Control
Control Plan
Transfer to Business
Monitor Results
Appendix                                                                    Maryview Medical Center
                    Pre-operative Prophylactic Antibiotic Administration




       Define
       Define             Measure
                          Measure                Analyze
                                                 Analyze                 Improve
                                                                          Improve                   Control
                                                                                                    Control




Start Date: 7-02    Start Date: 8-02       Start Date: 12-02       Start Date: 3-03          Start Date: 6-03
End Date: 11-02     End Date: 10-02        End Date: 2-03          End Date: 5-03            End Date: 9-03

Ø Customer CTQ’ s   Ø Identify Project     Ø Identify Vital Few    Ø Generate Solutions      â Implement
Ø High Level          Y(s)                   Root Causes of        Ø Prioritize Soluti ons     Sustainable
  Process Map       Ø Identify Possible      Variation Sources     Ø Assess R isks             Process Controls –
Ø Project Charter     Xs                     & Improvement         Ø Test Solutions            Validate:
Ø Formal Champion   Ø Develop & Execute      Opportunities         Ø Cost Benefit            â Control System
  Approval            Data C ol lection      (Pareto Chart)          Analysis                â Monitoring Plan
                      Plan                 Ø Define                Ø Develop &               â Response Pl an
                    Ø Measurement            Performance             Implement               â Standardize &
                      System Anal ysis       Objective               Execution Plan            Translate
                    Ø Establish Baseline     (Histogram)                                     â $ B enefits
                      Performance          Ø Quanti fy $ Benefit                               Validated
                                           Ø Formal Champion                                 â Formal Champion
                                             Approval                                          Approval


¨ Not Complete
Ø Complete
v Not Applicable
Appendix                                                               Maryview Medical Center
                          Pre-operative Prophylactic Antibiotic Administration
Project Benefits

    Financial (Hard) Benefits                                          Soft Benefits

                                                          To follow the best practice for antimicrobial
A breakdown and analysis of the projected, quantifiable
                                                          prophylaxis process will potentially effectively reduce
financial benefits for this project are still to be
                                                          post-operative infections.
determined. Goals include:
                                                          To reduce surgical infections, which are seen as
Reduce the cost of poor quality.
                                                          preventable adverse events,decreases potential sentinel
                                                          events and improves patient safety and customer
Reduce resource consumption, cost avoidance
                                                          confidence.

                                                          To be ethically responsible and to decrease the gap
                                                          between evidence-based care and actual care

                                                          To follow the Medicare National Surgical Infection
                                                          Prevention Project.

                                                          To adhering to best practice processes.
Appendix                                                                                         Maryview Medical Center
                            Pre-operative Prophylactic Antibiotic Administration

Data Collection Plan
PACU Nursing Staff use the data tool and glean                             PI Coordinator responsible for data analysis and
information from the Medical Record. Seeking the ABX                       graphical display of results.
selected, time given and time of the surgical incision.




                                                          Collection Plan
ABX Selected            ABX selected for pre-surgical prophylaxis         PACU RN        OR Sheet in the Medical Record The days charts
                        (discrete recommended ABX )                                      or Sticker - record on data
                                                                                         collection tool
ABX Process Time        The minutes from ABX administration to the        PACU RN        OR Sheet in the Medical Record The days charts
                        incision by the Surgeon (discrete 0-60                           or Sticker - record on data
                        minutes)                                                         collection tool
Time to Conduct Audit   Review charts at the end of the day from that     PACU RN        record on data collection tool The days charts
                        day's surgeries.
Time to Process         Submit completed reviews to the PACU Nurse        PACU RN        record on data collection tool   From the data
                        Manager daily                                                                                     tool
Error Type              A catagorization of the errors (discrete)       PI Coordinator   From data collection tool        From the data
                                                                                                                          tool
Appendix                                                 Maryview Medical Center
                Pre-operative Prophylactic Antibiotic Administration


MSA
                                  Reproducibility? Yes

                   The evaluation demonstrated different users were able
      to obtain the same results as the PI Coordinator using the same medical record.


                                    Accuracy? Yes

                Since all data is present in the medical record there was an
            acceptable “reference” value, there was agreement with the results.


                                  Repeatability? Yes

                The evaluation demonstrated how the same user obtained
                    the same data twice to the same medical record.
Appendix                                              Maryview Medical Center
              Pre-operative Prophylactic Antibiotic Administration

Resources
   • JAMA 1997; 277:1794
   • Medical Letter 2001;43:98
   • Center of Medicaid and Medicare, National Surgical Infection
     Prevention Project

				
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