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					  Spring 2009 IDN Summit
Getting Our Arms Around “Never Events”:
        Do the Solutions Lie With
        New Medical Technologies
             Winifred S. Hayes, PhD
               President & CEO
                  Hayes, Inc.
                Disclaimer
Hayes, Inc., including its employees and
contractors, have received no financial support,
contributions, or remuneration of any kind from
device manufacturers, pharmaceutical companies,
biotech firms, or other organizations with a
material or financial interest in medical
technologies, including the products/technologies
that will be discussed in the presentation that
follows.


                                                    2
              Learning Objectives
1. Review the current federal and state payers‟ and commercial insurers‟
   positions on “never events,” listing current and potential future events
   that are excluded or likely to be excluded from coverage and
   reimbursement.
2. Review those health technologies promoted as effective preventive
   strategies relevant to “never events,” noting the quality of supporting
   scientific evidence and the case for cost-effectiveness.
3. Using catheter-associated urinary tract infections (CAUTIs), a “never
   event,” as a case study, explore an evidence-based approach to
   determining the cost-effectiveness of silver-coated urinary catheters as a
   potential solution to this problem.
4. Discuss systems and approaches that participants and their teammates
   can use to prevent “never events,” including the cost-effective use of
   medical technologies.



                                                                           3
               Who We Are
• Founded and incorporated in 1989 by President
  and CEO Winifred S. Hayes, PhD
• An independent health technology research and
  consulting organization providing evidence-
  based, clinically focused information on health
  technologies




                                                    4
                  What We Do
• Track new and emerging health technologies likely to
  have significant impact on the cost, utilization, and
  quality of healthcare
• Evaluate best available evidence and provide in-
  depth, rigorous analysis of relevant clinical trial data
• Provide assessments of safety, efficacy, and
  potential health benefit and operational/financial
  impact of a wide variety of health technologies




                                                             5
            Our Information Is
• Independent – no affiliation with any
  companies or manufacturers in the healthcare
  field
• Evidence-based – assessments rely on the
  best available scientific data from formal
  studies and clinical trials, not on expert opinion
  or user surveys




                                                       6
  The High Cost of Medical Mistakes
 and Preventable, Unintended Events
• Tens of thousands of lives lost or negatively impacted each year.
   – More deaths than those caused by car accidents, breast
     cancer, or AIDS.1
• Eighteen (18) types of medical errors account for 2.4 million extra
  hospital days and $9.36 billion in excess charges each year. 2
• Since the 1999 IOM report, To Err Is Human, estimates indicate
  patient safety is only improving at about 1% each year. 3
• Many of these events can be eliminated – they should “never”
  happen!
1IOM, To Err Is Human: Building a Safer Health System; Washington, DC,
  National Academy Press; 1999
2JAMA,   Excess Length of Stay, Charges, and Mortality Attributable to Medical
  Injuries During Hospitalization; 2003
3National   Healthcare Quality Report AHQR; 2007




                                                                                 7
         Never Events: A History
1999 Institute of Medicine (IOM) releases To Err is Human. Report
     estimates that medical errors in U.S. hospitals cause 44,000 to
     98,000 deaths annually.
2000 National Quality Forum (NQF) releases Serious Reportable
     Events in Healthcare. Report includes 27 “never events,” defined
     as events that could have been anticipated and prepared for, but
     occur because of an error or other system failure.
2006 President signs Deficit Reduction Act (DRA) of 2005, requiring
     the Secretary of Health and Human Services to identify by
     October 2007 at least two conditions that are:
       • High cost or high volume or both
       • Result in a DRG that has a higher
         payment
       • Could have been reasonably
         prevented through the application of
         evidence-based guidelines
                                                                       8
 National Quality Forum (NQF)‟s
Serious Reportable Events (SREs)
• Based on a consensus among representatives of
  all parts of the healthcare system
• Very serious, largely preventable
• Twenty-eight (28) events
• Classified as 1 of the following 6 categories:
  surgical, product of device, patient protection, care
  management, environment, or criminal
Twenty five (25) states (and
growing) require licensed
healthcare facilities to report
SREs in full or in part.
                                                      9
On October 1, 2008, the Centers for Medicare &
Medicaid Services (CMS) reduced payment
associated with costs to treat a list of complications
(the MS-DRG rate) CMS deems preventable with
good care – events that should “never” happen.

Many of these hospital-acquired conditions (HAC),
or never events, overlap with NQF‟s SREs.

CMS‟s “never event” list continues to grow.



                                                    10
 NQF Serious Reportable Events
Surgical Events:
• Surgery performed on the wrong body part
• Surgery performed on the wrong patient
• Wrong surgical procedure on a patient
• Retention of a foreign object in a patient after surgery or other procedure
• Intraoperative or immediately postoperative death in a normal health patient
     (defined as ASA Class 1 patient)
Product or Device Events:
• Patient death or serious disability associated with the use of contaminated drugs,
    devices, or biologics provided by the healthcare facility
• Patient death or serious disability associated with the use or function of a device in
    patient care in which the device is used or functions other than as intended
• Patient death or serious disability associated with intravascular air embolism that
    occurs while being cared for in a healthcare facility




                                                                                       11
 NQF Serious Reportable Events
Patient Protection Events:
• Infant discharged to the wrong person
• Patient death or serious disability associated with patient elopement
     (disappearance) for more than 4 hours
• Patient suicide, or attempted suicide resulting in serious disability, while being cared
     for in a healthcare facility
Criminal Events:
• Any instance of care ordered by or provided by someone impersonating a
    physician, nurse, pharmacist, or other licensed healthcare provider
• Abduction of a patient of any age
• Sexual assault on a patient within or on the grounds of a healthcare facility
• Death or significant injury of a patient or staff member resulting from a physical
    assault (i.e., battery) that occurs within or on the grounds of a healthcare facility




                                                                                            12
 NQF Serious Reportable Events
Care Management Events:
• Patient death or serious disability associated with a medication error (e.g., error
    involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate,
    wrong preparation, or wrong route of administration)
• Patient death or serious disability associated with a hemolytic reaction due to the
    administration of ABO-incompatible blood or blood products
• Maternal death or serious disability associated with labor or delivery on a low-risk
    pregnancy while being cared for in a healthcare facility
• Patient death or serious disability associated with hypoglycemia, the onset of which
    occurs while the patient is being cared for in a healthcare facility
• Death or serious disability (kernicterus) associated with failure to identify and treat
    hyperbilirubinemia in neonates
• Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility
• Patient death or serious disability due to spinal manipulative therapy




                                                                                       13
 NQF Serious Reportable Events
Environmental Events:
• Patient death or serious disability associated with an electric shock while being
    cared for in a healthcare facility
• Any incident in which a line designated for oxygen or other gas to be delivered to a
    patient contains the wrong gas or is contaminated by toxic substances
• Patient death or serious disability associated with a burn incurred from any source
    while being cared for in a healthcare facility
• Patient death associated with a fall while being cared for in a healthcare facility
• Patient death or serious disability associated with the use of restraints or bedrails
    while being cared for in a healthcare facility




                                                                                      14
 AHRQ is also weighing in with its
  Patient Safety Indicators (PSIs)
Many of these overlap with NQF‟s SREs and
CMS‟s “never events,” but there are some new
events as well, including:
 • Postoperative physiologic and metabolic derangements
 • Postoperative hemorrhage or hematoma
 • Iatrogenic pneumothorax
 • Obstetric trauma
 • Birth trauma – injury to neonate
 • Etc.

                                                          15
                         CMS HACs
    As of October 2008                             For 2009
1. Foreign object retained after      1. Surgical site infections following
   surgery                               certain elective procedures,
2. Air embolism                          including certain orthopedic
3. Blood incompatibility                 surgeries, and bariatric surgery for
                                         obesity
4. Stage 3 and 4 pressure
   ulcers                             2. Certain manifestations of poor
                                         control of blood sugar levels
5. Falls and trauma
                                      3. Deep vein thrombosis and/or
6. Catheter-associated UTI               pulmonary embolism following
7. Vascular catheter-associated          total knee replacement and hip
   infections                            replacement procedures
8. Surgical site infection (SSI) or
   mediastinitis after CABG



                                                                          16
CMS will no longer pay the higher MS-DRG
rate for the 11 Hospital-Acquired Conditions
    (HAC) under the Medicare Inpatient
  Prospective Payment System, unless the
   condition was present upon admission.




                                           17
                Also . . .
Under a 2009 National Coverage
Determination (NCD) process, Medicare will
not pay for 3 additional “never events”:
• Surgery on wrong body part
• Surgery on wrong patient
• Performing the wrong surgery on a patient



                                          18
  Hospital-Acquired Conditions:
             Future
• Many other payers and states are following suit
• The list is expected to grow significantly each
  year
• Significant step toward Value-Based Purchasing
  – Major shift in paying for outcomes versus activities
  – HCAHPS performance is also an important part of this
    change




                                                      19
                               FY 2009
               CMS Hospital-Acquired Conditions (HAC) and
                   Proposed Product Solutions (PPS)
               HACs                                            PPSs
Foreign object retained after   • Radiofrequency identification (RFID) tagging sponges ClearCount
surgery                           SmartSponge®
                                • Individually bar-coded surgical sponges: SurgiCount's Safety-
                                  Sponge™ System

Air embolism                    • Connectors (i.e., Luer lock) between catheter and tubing
                                • Pumps with an in-line air detector

Blood incompatibility           • Preoperative autologous blood donation (PABD) for elective hip
                                  surgery
                                • Intraoperative blood recovery and filtration systems

Falls and trauma                • Tai Chi (martial art)




                                                                                             20
                                Continued HACs & PPSs
              HACs                                                       PPSs
Pressure ulcers stages III-IV       • Support surfaces for prevention of pressure ulcers (i.e., pressure-relief
                                      mattresses, integrated bed systems, mattress overlay)
                                         –   Silkair® Low Air Loss Therapy System (Hill-Rom Inc.)
                                         –   Tempur-Pedic Swedish Mattress™ (Tempur-Pedic International Inc.)
                                         –   TheraPulse® ATP™ (Kinetic Concepts Inc.)

Catheter-associated urinary tract   • Silver-coated urinary catheters (Bardex® I.C.; Kendall DOVER Silver
infection                             Foley)

Vascular catheter-associated        • BIOPATCH® Antimicrobial Dressing (Integra LifeSciences Corp.;
infection                             Ethicon Inc., Div. of J&J Medical Ltd.)
                                    • StatLock® Stabilization Devices (Bard® Medical/Venetec International
                                      Inc.)
                                    • Antimicrobial central venous catheters (i.e., 2nd generation)
                                      Chlorhexidine-Silver Sulfadiazine (ARROWg+ard Blue PLUS® -Arrow),
                                      Minocycline-Rifampin (Glide Spectrum® - Cook Medical), Silver-
                                      Platinum-Carbon (Vantex® - Edwards Lifesciences), 5-FU (Angiotech)
                                      Benzalkonium/heparin (AMC Thromboshield - Edwards Lifesciences)




                                                                                                            21
                                Continued HACs & PPSs
             HACs                                              PPSs
Surgical site infection,          • Antibacterial Sutures (MONOCRYL™ Plus, Vicryl™ Plus, PDS™
mediastinitis, following CABG       Plus; Ethicon Inc., Div. of J&J Medical Ltd.)
                                  • Covidien AMD™ Antimicrobial Dressings (Kendall, Covidien-
                                    Covidien)
                                  • BIOPATCH® Antimicrobial Dressing (Integra LifeSciences Corp.;
                                    Ethicon Inc., Div. of J&J Medical Ltd.)
                                  • ChloraPrep® for skin antisepsis (Cardinal Health Inc.)
Surgical site infections follow   • Antibacterial Sutures (MONOCRYL™ Plus, Vicryl™ Plus, PDS™
certain orthopedic procedures       Plus; Ethicon Inc., Div. of J&J Medical Ltd.)
                                  • Covidien AMD™ Antimicrobial Dressings (Kendall, Covidien-
                                    Covidien)
                                  • BIOPATCH® Antimicrobial Dressing (Integra LifeSciences Corp.;
                                    Ethicon Inc., Div. of J&J Medical Ltd.)
                                  • ChloraPrep® for skin antisepsis (Cardinal Health Inc.)




                                                                                           22
                               Continued HACs & PPSs
              HACs                                               PPSs
Surgical site infection following   • Antibacterial Sutures (MONOCRYL™ Plus, Vicryl™ Plus, PDS™
bariatric surgery for obesity         Plus; Ethicon Inc., Div. of J&J Medical Ltd.)
                                    • Covidien AMD™ Antimicrobial Dressings (Kendall, Covidien-
                                      Covidien)
                                    • BIOPATCH® Antimicrobial Dressing (Integra LifeSciences Corp.;
                                      Ethicon Inc., Div. of J&J Medical Ltd.)
                                    • ChloraPrep® for skin antisepsis (Cardinal Health Inc.)

Deep vein thrombosis and            • ActiveCare+SFT® Medical Compression Systems, DBN Ltd.
pulmonary embolism following        • Sequential Compression Devices, or SCD‟s (also known as
certain orthopedic procedures         Lymphodema pumps)
                                    • A-V Impulse System® Foot Pump (Orthofix/Novamedix Ltd.)
                                    • Pradaxa® (dabigatran etexilate), Boehringer Ingelheim GmbH
                                    • Rivaroxaban (Xarelto®), Bayer Health Care & Ortho-McNeil
                                      Pharm. Inc. (J&J)




                                                                                             23
The list of proposed product solutions (PPSs)
continues to grow – after all, our medical
industry is inventive if not innovative!
 So the questions we all are asking are:
 • Do these products live up to the vendors‟ claims?
 • Do they prevent “never events?”
 • To what degree are these PPSs effective?
 • Are they cost-effective?



                                                  24
   How should these questions be
           answered?

Are there “models” that we can use to
   ensure that our decisions yield
measurable clinical benefits using the
    most cost-effective methods?

                YES!


                                         25
  Evidence-Based Technology
      Acquisition (EBTA)
• Embedded as part of Value Analysis
• Core process within a New Product or
  Health Technology Assessment
  Committee
• Core element within a Capital Equipment
  Committee


                                            26
CEO‟s Top Issues Confronting Hospitals
                                       Issue                             2008                 2007                 2006
                       Financial challenges                                77%                  70%                    72%
                       Patient safety and quality1                         43%                   NA                    NA
                       Care for the uninsured                              41%                  38%                    37%
                       Physician-hospital relations                        32%                  35%                    40%
                       Personnel shortages                                 30%                  30%                    30%
                       Governmental mandates                               26%                  22%                    23%
                       Patient satisfaction                                22%                  17%                    16%
                       Capacity                                            16%                  11%                    11%
                       Technology                                           9%                   8%                    8%
                       Issues about not-for-profit status                   2%                   4%                    3%
                       Malpractice insurance                                2%                   2%                    3%
                       Disaster preparedness2                               1%                   1%                    1%
                       Patient safety                                       NA                  29%                    27%
                       Quality                                              NA                  33%                    29%




1In   2008, this issue was composed of both patient safety and quality. In prior years, they were two unique issues.
2In   2008, this issue was broadened and changed from “biodisaster” to “disaster” preparedness.
American College of Healthcare Executives, 2008, Annual CEO Survey of Top Issues Confronting Hospitals
http://www.ache.org/Pubs/Releases/2009/CEOTopIssues_2008.pdf                                                                 27
                  Patient Safety and Quality
             Redesigning care processes

    Redesigning work environment to
                      reduce errors
        Compliance with accrediting
 organizations (i.e., Joint Commission)

                            Medication errors

                     Nosocomial infections

       Nonpayment for “never events”

                       Pay for performance
Leapfrog demands (i.e., computerized
   physician order entry; ICU staffing by
trained intensivists; and evidence-based
                        hospital referral)
    Public reporting of outcomes data

                           Surgical mistakes

                                             Other




  American College of Healthcare Executives, 2008, Annual CEO Survey of Top Issues Confronting Hospitals
  http://www.ache.org/Pubs/Releases/2009/CEOTopIssues_2008.pdf                                             28
     What does it mean to be
      “evidence-based?”
• Evidence derived from formed scientific
  research/clinical trials
• Synthesizes and critiques all the best
  available research
• Not based on opinion, survey data, or
  usual clinical practices


                                            29
• What is EBTA?
• How does EBTA work?
• What benefits are derived from EBTA?
• What role does health technology
  assessment play in EBTA?
• What role does health technology
  assessment play in value analysis?


                                         30
   Definition of Key Concepts

• Evidence-Based Medicine (EBM)
• Health Technology Assessment (HTA)
• Value Analysis and Evidence-Based Value
  Analysis (VA & EBVA)
• Evidence-Based Technology Acquisition
  (EBTA)


                                        31
        Evidence-Based Medicine
      EBM is the conscientious, explicit, and
      judicious use of current best evidence in
          making decisions about the care of
                  individual patients.
        Integrates clinical expertise with the
            best available external clinical
         evidence from systematic research.

Adapted from Sackett DL, et al. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312(7023):71-72.


                                                                                                                    32
           What is Health Technology
                 Assessment?
Health Technology Assessment is the
systematic, evidence-based evaluation of
the properties, effects, and/or other impacts
of health care technologies.




David Hailey, Alberta Heritage Foundation for Medical Research, 2003



                                                                       33
Health Technology Assessment
            (HTA)
•   Systematic literature search
•   Critical appraisal of the evidence
•   Analysis of the body of evidence
•   Conclusions about safety, efficacy,
    clinical effectiveness



                                          34
        What is Value Analysis?
“A creative analytical study and evaluation
of a product, service or technology‟s
function, with the objective being to
determine the lowest cost approach to
providing an equivalent or better
performance of a required function”


(Adapted from the HCP Group, LTD Certified Value Analysis Workbook, @ 2002)



                                                                              35
  Why use a systematic, objective,
    evidence-based approach?
1. Acquire health technologies that yield
   high-quality care at a sustainable cost.
2. Avoid acquiring ineffective or unsafe
   technology.
      Goal: Improved patient care and
              financial viability


                                              36
Why should we link VA and HTA?
• To improve patient safety and clinical outcomes
• To promote efficient utilization of resources
• To support strategic technology planning and
  reduce conflict
• To guide the appropriate implementation of
  health technologies
• To maximize cost-effectiveness
   Transforming Healthcare with Evidence



                                                    37
Where would HTA fit?
          Product
           Users



          VAT’s
            &
           HTA


Finance             Purchasing




                                 38
                  EBTA
EBTA is a health technology acquisition
decision that begins with a comprehensive
assessment of the best available scientific
evidence.
               Value Analysis Process
1. Information Phase                                             5. Development Phase
2. Function Analysis                                             5. Presentation Phase
    Phase                                                        7. Implementation
3. Creative Phase                                                    Phase
4. Evaluation/                                                   8. Re-evaluation Phase
    Analytical Phase
    (HTA is used here)


 Orr, T. A Value Analysis Approach to Healthcare Revenue Improvement.




                                                                                          40
        CASE STUDY:
  A value analysis opportunity
When urinary catheterization is necessary,
what is the most cost-effective approach to
achieving this function while preventing
„unintended adverse outcomes,‟ including
catheter-acquired urinary tract infections
(CAUTI)?



                                              41
Step One: Information Phase

    “Gather data regarding current
 process/product and context of use.”




                                        42
                               Elements of Risk:
•   80% of UTIs related to catheters
•   Risk of UTI increases over time
•   13,000 deaths attributed to UTI in 2002
•   Costs to treat range from $500-$5682



    Kleevins (CDC-NNIS). Available at:
    http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf




                                                                      43
   Step One: Environmental
   factors that increase risk
• Poor basic hand and perineal hygiene
• Non-adherence to aseptic catheter
  insertion and catheter care
• Failure to remove catheters as soon as
  possible
• “High-risk” critical care units


                                           44
  Step One: Patient factors that
         increase risk
“At-risk” patient populations:
 • Diabetics
 • Obesity
 • Immunocompromised
 • Urinary or fecal incontinence
 • Surgical wounds
 • Poor personal hygiene



                                   45
                     Step One
Additional relevant information:
  • Baseline CAUTI rates, overall and by subgroups
    (department, patient characteristics, nursing team/unit,
    catheter type)
  • Current catheter usage (types and distribution)
  • Clinical impact of CAUTIs on costs (per case) –
    nationally; hospital-specific
  • Clinical impact of CAUTIs on LOS
  • Clinical impact of CAUTIs on mortality (#, rates)
  • Achievable CAUTI benchmark rates
  • CMS CAUTI “never event” goal



                                                           46
                     Step One
Additional relevant information (cont.):
  • Catheter insertion evidence-based (EB) practice protocol
  • Catheter care and handling EB practice protocol
  • EB patient indications for catheterizations
  • EB patient contraindications for catheterization
  • Rates of catheterization by patient category and clinical
    department
  • Average number of indwelling catheter days prior to
    removal
  • Comparable national catheterization rates by above
    variables



                                                          47
           Step Two:
   Functional Analysis Phase
 “Consider primary functions/processes/products
              and discuss in detail.”
• Compliance with EB insertion protocol
• Compliance with EB care and handling protocol
• Compare catheterization rates with national
  benchmarks
• Compare CAUTI rates with “achievable” and
  CMS benchmarks


                                                  48
  Step Two: Functional Analysis
         Phase (cont.)
• Correlation of types of catheter with CAUTI rates
• Identification of unintended outcomes (and
  frequency) in addition to CAUTI
• Conclusions regarding factors contributing to
  CAUTI occurrence
• Basic functional requirements of urinary catheter
  and closed urine collection system



                                                      49
  Step Two: Functional Analysis
Practices that impact infection control:
  • Patient hygiene (preparation protocol prior to catheter
    insertion and with catheter insertion)
  • Hand-washing protocols for staff
  • Standing orders for nurses to discontinue catheters
  • Flagging of patients that need to be considered for
    catheter discontinuation
  • Catheter care protocols
  • Urinary collection systems and patient transfers




                                                              50
           Recent Changes
Have there been any internal process
changes or material changes within your
institution over the past year relevant to
urinary catheter usage?
Any change that has been made could
potentially have an impact on the infection
rates that you are experiencing.


                                              51
      Step Three: Creative Phase
“Brainstorming to identify improvement alternatives.”
Brainstorming regarding methods of providing for
necessary urinary catheterization without CAUTI or
other unintended adverse outcomes:
  •   Hygiene and insertion process changes
  •   Managing duration of use (tracking system)
  •   Silicon versus latex
  •   Silver hydrogel-coated catheters (SCC)
  •   Etc.



                                                   52
   Silver-hydrogel Coated Catheter
The silver-hydrogel coated catheter (either latex or
silicone) protects the urethra by creating an environment
that microorganisms do not like to adhere to, thus
minimizing biofilm formation.
  • The silver-hydrogel coated catheter (either latex or silicone)
    protects the urethra by creating an environment that
    microorganisms do not like to adhere to, thus minimizing biofilm
    formation.
  • Catheters eliminate the mechanical protection provided by
    micturation and create a conduit to the bladder on which
    pathogens can form a protective biofilm against both antibiotics
    and the host's immune system.



                                                                       53
  Prior to making a decision -

Let‟s look at the clinical studies of silver-
hydrogel coated versus non-coated
catheters for the reduction of CAUTIs.




                                                54
    Value Analysis Process
 Step 1: Information Phase +
 Step 2: Function Analysis Phase +
 Step 3: Creative Phase +

Step 4: Evaluation/Analytical Phase




                                      55
          Step Four: Evaluation/
             Analytical Phase
Critically examine and weigh all the evidence and data.
Alternative approaches/products are critically
evaluated, modeled, and ranked for acceptability and
clinical/financial impact.
 •   Product knowledge
 •   Problem
 •   Causes
 •   Actions taken to control UTIs
 •   Cost benefit with use of SCC using calculator




                                                      56
57
 57
58
59
60
61
62
What did we learn from our
 review and critique of the
        evidence?



                              63
   Silver-Coated Urinary Catheters
               (SCC)
• Some proof that SCCs reduce the incidence of
  bacteriuria in patients with indwelling urinary catheters
  for > 3 days and < 30 days (or < 10 days)
• Rates of effectiveness vary greatly (50% to 0%
  reduction)
• Underlying base infection rates are critical to SCCs
  impact
• Most studies‟ endpoints are bacteriuria, not symptomatic
  urinary tract infections



                                                        64
Questions?




             65
Are SCCs cost-effective?




                           66
            CAUTI Calculator
IMPACT OF USING SILVER/HYDROGEL-COATED CATHETERS ON CATHETER
              ASSOCIATED URINARY TRACT INFECTIONS




                                                               67
Note: User must enter data in the orange cell. User may enter data in the pink cells, or
use the default data provided. Yellow and green cells should not be changed.
Model Overview and Instructions:
This model estimates the cost-effectiveness of using SCCs for short-term catheter
use. The model calculates the annual cost of CAUTI at an institution, the projected
savings resulting from reduced CAUTIs as a result of the use of SCCs, the
estimated additional cost of using SCCs, and the overall net savings to the facility of
using SCCs for short-term catheter use. This model is based on estimated cost
savings from a review of seven published reports. The table below summarizes the
data included in those reports.
The cost-effectiveness of SCCs depends on a number of factors: background
prevalence of CAUTIs at an institution, anticipated reduction in CAUTI after the
introduction of SCCs, likelihood of complications (symptomatic CAUTI or
bacteremia) among patient population, cost of treating complications, and the cost
difference between SCCs and standard catheters. While defaults are provided in
the model, the user can alter any of these variables and get very different estimates
of cost-effectiveness.




                                                                                    68
                                                         Default Data
Table 1. Estimates of Cost Savings from the Use of Silver/Hydrogel-Coated Catheters (SHCs)
       Source             Base            Expected           % CAUTIs           Cost          Extra Cost           Projected Savings
                        CAUTI Rate        Reduction       Incurring Costs     per CAUTI      per Catheter


 Bologna et al (1999)       8.1%             40%         100%               $2,471           $5.00          $98,021 for 108 ICU beds/yr
 Blind, prospective         (ICU)
 MCT
 Karchmer et al.           1.36%             19%         100%               $839-$4,693      $107,225/yr    $14,456-$573,293/yr for a 600
 (2000) RC              (ICU & step-                                                                        bed hospital
 Crossover Trial        down units)

 Saint (2000)               3%               47%         24% for SNUTI;     SNUTI=$74 to     $5.30          $4.09 per patient
 Lit. Review with       (5 studies-                      4% for BSI         $402;
 Economic Analysis        Unit type                                         BSI=$2,041
                         unknown)
 Maki and Tambyah           26%              42%         65% diagnosed      $1,000           $5.00          $6.05/100 catheters
 (2001)                      (8                          and treated
 Meta-Analysis with     Prospective
 Cost Analysis            studies)

 Plowman et al.            7.3%              11.4%       Assumes 100%       3.6 additional   $13.00         Break even; any higher reduction
 (2001)                  (Medical /         surgical;                       HDs                             in CAUTI rate expected to result
 Lit Review and          Surgical )      14.6% medical                                                      in savings
 Economic Model
 Kwan (2002)                4.9%             45%         Assumes 100%       mean $1,214;     $8.00          Median cost of $12,563/yr; Mean
 Prospective Case       (Tertiary care                                      median $613                     cost of $142,314/yr for 350-bed
 Series (Single           including                                                                         tertiary hospital
 Institution Study)         ICUs)

 Rupp et al. (2004)        6.3%              57%         Assumes 100%       $700 - $5,682    $4.86          $5,811-$535,452/yr for ICUs in a
 Prospective             (10 Units-                                                                         600-bed tertiary hospital
 Surveillance Study      Adult and
 (with cost analysis)     pediatric
                           ICUs)




                                                                                                                                          69
            CAUTI Calculator
IMPACT OF USING SILVER/HYDROGEL-COATED CATHETERS ON CATHETER
              ASSOCIATED URINARY TRACT INFECTIONS




                                                               70
            CAUTI Calculator
IMPACT OF USING SILVER/HYDROGEL-COATED CATHETERS ON CATHETER
              ASSOCIATED URINARY TRACT INFECTIONS




                                                               71
            CAUTI Calculator
IMPACT OF USING SILVER/HYDROGEL-COATED CATHETERS ON CATHETER
              ASSOCIATED URINARY TRACT INFECTIONS




                                                               72
What is the appropriate protocol for
the use of SCCs in XYZ Hospital?
• Clinical application
  – Patient population
  – Projected decrease in CAUTI rates
  – Training of staff
• Financial
  – Cost
  – Savings


                                        73
                     Summary
“Evidence-based Value Analysis Process” includes the
incorporation of Health Technology Assessment to
maximize both clinical and financial benefits.
•Acquire health technologies that yield high-quality care at
a sustainable cost.
•Avoid acquiring ineffective or unsafe technology.
•Minimize overall costs associated with UTI “never events”
and SCC usage.
   Patient safety, treatment effectiveness, and long-term
  financial viability should be the “Goal” of each decision.



                                                           74
                           References
Cutler DM, McClellan M. Is technological change in medicine worth it? Health
   Aff (Millwood). 2001; 20(5):11-29.

Hayes Inc. Hayes Medical Technology Directory. Silver-Coated Urinary
   Catheters for the Prevention of Urinary Tract Infections. Lansdale, PA:
   Hayes, Inc.; December 16, 2008.

Eden J, Wheatly B, McNeil B, Sox H, eds. Knowing What Works in Healthcare:
   A Roadmap for the Nation. Institute of Medicine (IOM). 2008. National
   Academies Press. Available at: http://www.nap.edu/catalog/12038.html.

Johnson JR, Kuskowski MA, Wilt TJ. Systematic review: antimicrobial urinary
   catheters to prevent catheter-associated urinary tract infection in
   hospitalized patients. Ann Intern Med. 2006;144 (2):116-126. Available at:
   http://www.annals.org/. http://www.annals.org....




                                                                             75
                     References cont.
Kaiser Family Foundation (KFF) [website]. Snapshots: How Changes in
   Medical Technology Affect Health Care Costs. March 8, 2007.
   Available at: http://www.kff.org/insurance/snapshot/chcm030807oth.cfm.

Keefe S. Ahead of the Curve. Advance for Nurses [website].
   2008;10(14):19. Available at: www.advanceweb.com/nurses.

Kleinpell RM, Munro CL, Giuliano KK. Targeting Health Care-Associated
   Infections: Evidence-Based Strategies. Chapter 42. Patient Safety
   and Quality: An Evidence-Based Handbook for Nurses; 2006.

Klevens RM, Edwards JR, Richards CL, et al. Estimating health care-
   associated infections and deaths in U.S. Hospitals, 2002. Public
   Health Rep. 2007;122(2): 160-166. Available at:
   http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf.




                                                                            76
                      References cont.
Lo E, Nicolle L, Classen D, et al. Strategies to prevent catheter-associated
   urinary tract infections in acute care hospitals. Infect Control Hosp
   Epidemiol. 2008;29(Suppl 1):S41-S50.

Redberg RF. Evidence, appropriateness, and technology assessment in
   cardiology: a case study of computed tomography. Health Aff (Millwood).
   2007;26(1):86-95.

Reed SD, Shea AM, Schulman KA. Economic implications of potential
   changes to regulatory and reimbursement policies for medical devices. J
   Gen Intern Med. 2007;23(1):50-56.

Rothenberg BM. Medical Technology as a Driver of Healthcare Costs:
   Diagnostic Imaging. BlueCross and BlueShield Association [website]
   October 2003. Available at:
   http://www.bcbscom/blueresources/cost/diagnostic-
   imaging.html?templateName=templat.



                                                                               77
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      157 S. Broad Street
           Suite 200
     Lansdale, PA 19446
     Phone: 215.855.0615
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     www.hayesinc.com



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