IP-Value Analysis · Value Analysis Program at HealthEast • 18 committees meeting regularly • Review products, processes, services • Network, problem solve, standardize •

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3M Infection PreventionLearning Connection

The Role of the Infection Preventionist on the Value A l i C itt

May 8, 2012

Making a Business Case for Evaluating New Products

Analysis Committee

© 2012. All Rights Reserved.

Disclosure

Boyd Wilson• System Director

• Infection Prevention & Control

• HealthEast Care System

• St. Paul, Minnesota

• 3M sponsored speaker


Housekeeping• Questions

• Mute feature (*7 = unmute, *6 = mute)

• “Chat” feature• Chat feature

• Technical difficulties

• CE credits

• Post session follow-up

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How do I get a CE Certificate?Next week, all of today’s meeting participants will be sent an email containing instructions for obtaining a CE Certificate for today’s meeting.

Th il ill b t t th il dd The email will be sent to the email address you provided when you logged-in to today’s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate email to them.

Learning Objectives

• Identify key considerations for product evaluation.

• Describe the role of the infection preventionist on the value analysis committee

• Discuss the importance of being able to make a business case for evaluation of a clinically relevant product to improve patient outcomes

Background


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Infection Prevention and Product Evaluation in the Current Era of Healthcare Reform

• Managed care, hospital acquired conditions, reimbursement capitation, value based purchasing . .

• Cost control and quality of care

• Federal Government, State Government, Third Party Payers

• Outcome focused improvement measures

Infection Prevention and Product Evaluation in the Current Era of Healthcare Reform

Healthcare associated infection (HAI) metrics• CMS Core Measures

• Pneumonia• Pneumococcal immunization

• Influenza immunization

• Antibiotics in the ED

• SCIP (Surgical Care Improvement Project)• Antibiotic prophylaxis

• Hair removal

• Urinary catheter removal Post Op Day 1 or 2

• Central line associated bloodstream infections

• Catheter associated urinary tract infections

• Surgical site infections

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Throwing Money at a ProblemCentral Line Blood Stream Infections (CLABSI)

Surgical SiteInfections(SSI)

Catheter Associated Urinary Tract Infections (CAUTI)

Product Evaluation


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What is Product Evaluation?

A process of appraisal that considers the value and significance of quality, cost, safety and practitioner choice for product selection.

Murray, M et al. Product Evaluation and Process Improvement. J Nurs Qual. 1994.

Products, Products, EVERYWHERE!

Product Evaluation Process?!

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Product Review Process• Need identified

• Complete request form

• Submit to value analysis committee

• Reviewed by committee

• Crunch the numbers• Crunch the numbers

• Communicate with other key stakeholders

• Conduct trial, if needed

• Approved or denied (more information needed; resubmit)

• If approved, develop implementation plan

• Add product to system and inventory

• Education/Training/Communication

Key Considerations• Quality

• Clinically Effective

• Evidence-based

• Safety – Patienty

• Safety – Worker

• Productivity Enhanced

• Process Improvement

• Economically Efficient

• Inventory Management

Products and Risk for Infection

Many products have infection prevention considerations:

Increasing/decreasing risk for infection or contamination:

Design• Design• Material properties• Clinical utility• Ability to clean, disinfect or sterilize• Reusable vs. disposable• Safety

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Value Analysis


Programs

Value Analysis Program at HealthEast• 18 committees meeting regularly

• Review products, processes, services

• Network, problem solve, standardize

• Collaborate with other committees councils initiatives• Collaborate with other committees, councils, initiatives

• Focus – quality and total cost

Value Analysis Committees (VAC) Structure

Lab

Nursing

Imaging

Nursery L&D

Engineering

EVS

Nutrition

ImplementationVascular Access

Needle Safety

Pharmacy Clinics

CVIC

Surgery

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VAC Interface and Communication

18 Specialty VACs• Standard process and tools• Receive requests from their stakeholders• Identify opportunities, respond to regulatory changes, recalls

C d t l ti d t i l di t d ti• Conduct evaluations, recommend trials, coordinate education• Members accountable to their dept/unit and the VAC• VAC may be accountable to system leadership group

• Vascular Access Nurse Practice• Contract manager is liaison with other VACs• Contract manager is member of Implementation VAC

VAC Interface and Communication

Implementation VAC

• Oversight for all VACs• System-wide authority• Big picture• Problem resolution, barrier busting• Standardization

• Approval/denial

The Role of


Infection Prevention

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Competing Goals/Values?

Collaboration!

What Infection Prevention Brings to the Table• Analytical ability

• Detail oriented and organized

• Evidence-based clinical literature review

• Ability to interpret scientific research

• Regulatory knowledge

• Quality improvement skills

• Clinical knowledge

• Global perspective (big picture)

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Infection Prevention Support in the Evaluation• Published studies

• Best practices

• Guidelines

• Regulations

• Policies and procedures

• Experiences

• Practice of IP colleagues• Outcomes data/surveillance findings

Infection Prevention Public Health Guidelines (CDC)

http://www.cdc.gov/hicpac/cauti/001_cauti.html

Infection Prevention Public Health Guidelines (CDC) – Strength of Evidence

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Infection Prevention Professional Organization and Consensus GuidelinesI. Basic/Core Strategies

II. Special Approaches• Recommended for use in locations and/or populations within the hospital that have unacceptably

high rates despite implementation of the Basic/Core prevention strategies

III. Approaches that should not be considered routine

Infection Control and Hospital Epidemiology, October 2008, vol. 29, supplement 1.

Regulatory Requirements

• Needlestick Safety and Prevention Act

• Revision to Bloodborne Pathogens Standard

• Effective April 18, 2001

Specified in greater detail the engineering controls such as safer medical devices • Specified in greater detail the engineering controls, such as safer medical devices, which must be used to reduce or eliminate worker exposure.

• Document consideration and use of appropriate, commercially-available, and effective safer devices.

• Employers must solicit input from non-managerial employees responsible for direct patient care regarding the identification, evaluation, and selection.

• Must maintain a sharps injury log.

Product


Considerations

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• Kills germs you didn’t even know were there

• Safe for the patient

• Safe for the user

Safe for the environment (“green”) INFECT

Revolutionary Product

• Safe for the environment (“green”)

• Evidence-based activity

• Tested on 3000 organisms

• Demonstrated patient outcomes

• Excellent shelf-life

• Meets ALL standards

INFECTAWAY3000

Things to Consider About a New Product/Technology• Clinical effectiveness

• Evidence-based

• Patient safety

U f• User safety

• Compatibility with equipment/surfaces

• Cleaning, disinfection, sterilization requirements

• Disposal requirements

• Shelf-life/Beyond-use date

• Regulatory requirements (Federal, State, Local)

• Manufacturer instructions

More things to consider• Cost

• GPO (Group Purchasing Organization) Opportunity/Compliance

• Packaging

• Product labeling

• Storage space

• Inventory requirements

• Ease of implementation

• Process changes needed

• Training (Type and Time)

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Business Case


So, you want to get that new thing that is supposed to prevent infections?

I’m sure it is too expensive.

WHO ELSE IS USING IT?

Is it evidence-based?

What does it replace?

Product Request Form

• Requestor Name/Dept

• Sponsor/Clinical Champion

• Date of Request

• Name of Product

• Manufacturer

• Product description/purpose

• Cleaning/disinfection instructions?

• Disposal instructions provided?

• MSDS provided?

• Product safety information provided?

• Clinical evidence provided?

• Education/training level needed?• Product description/purpose

• Has product been evaluated previously?

• Has product been introduced to other committees?

• What depts does this product affect?

• Patient charge item?

• Procedure codes?

• New product? Duplicate? Replacement?

• How would be stocked?

• Is product reusable? Disposable?

• Education/training level needed?

• Explain problem/need that product will resolve or fill

• Process improved?

• Work time saved?

• Cost for evaluation?

• Projected annual usage?

• Annual usage or product replaced?

• Additional cost or cost savings?

• GPO compliance?

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Product Questions & Value Analysis• Will the product improve patient satisfaction?

• Will the product improve patient safety/clinical outcomes?

• Will the product improve user satisfaction?

• Will the product improve user safety?

• Will the product change/improve a process?

• Will the product replace an existing product or is it add on?

Money Questions & Value Analysis• Will the product increase supply costs?

• Will the product decrease costs through standardization?

• NOTE: need to consider total cost in the value analysis process, not just purchasing price• Cost of labor

• Utilities and maintenance

• Cost avoidance (infections/injuries/exposure prevented)

• What is the incremental cost of the product versus the expected benefit to the patient (or user/worker)

Product Standardization

• Eliminates unnecessary redundancy/duplication

• Reduces inventory/storage needs

• Encourages a standard procedure

• Can reduce education need for multiple products

• Can improve patient safety

• Saves money

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Examples


IV Pumps: Infection Prevention Considerations (L1) Ease of cleaning

Manufacturer instructions for cleaning/disinfection

IV tubing components

Needless connectorsNeedless connectors

• IT considerations

• Pharmacy considerations

• Clinical education considerations

• Stores considerations

• Patient Safety considerations

VAP Oral Care Product –IP Considerations (L2)New product or replacement?

VAP focus rationale: Patient Safety, Public Reporting, VBP

Evidence of importance of oral care to prevent VAP

Studies demonstrating VAP prevention with oral care interventionStudies demonstrating VAP prevention with oral care intervention

Guidelines to support product/practice

Regulatory reference for product/practice

Current practice for oral care

Current VAP rate

Clinical evidence, efficacy information, process improvement and outcomes data for product

Information from other product users

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VAP Oral Care Product – Basic Value Analysis

1. Cost of product

Annual product usage

Replacement for similar product – increase or decrease in cost

New product – increase in cost or decrease with change practice and

supplies used

GPO contract compliance opportunities impacting product cost

2. Attributable cost of 1 VAP (published data or internal data)

Additional cost consideration – length of stay

3. VAP prevention opportunity (# of VAP in past year)

4. # of VAP to prevent to help justify cost of product

VAP Oral Care Product – Basic Value AnalysisAlso consider,

• Length of stay impact and improved patient flow

• Process improvement with product changeProcess improvement with product change

• Productivity improvement with product change (RT, RN time)

• Staff satisfaction

• Patient/family satisfaction

Monitor and report back after implementation

HAI Cost Calculators

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Vendor Supported Product vs. HAI Cost Calculators

Vendor Supported Product vs. HAI Cost Calculators

Product # and cost per unit

CAUTIONS• Manufacturer sponsored information only

• Shiny brochures with claims you want to read, but no real data

• Lack of data to support manufacturer claims

• In vitro data and no clinical outcomes data (may be the case for new products)

• Not scientifically sound

• Clinical evidence/efficacy data lackingClinical evidence/efficacy data lacking

• Pending approval from FDA, EPA …

• Data based only on observation and not randomized control study

• Compatibility not confirmed

• Product not used at organization that did the studies

• Off-label use

• Low cost to bring in the product and then . . .

• When HAI rate is low, it can be difficult to demonstrate impact on outcomes in the short term

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Summary


Value Analysis Keys to Success (Based on the HealthEast VA Experience)• Clear focus (quality and total cost)

• Performance is measured and reported

• Multidisciplinary involvementp y

• Stakeholders are involved and empowered

• There is a tangible, visible impact

• It is a consistent process

• It is a dynamic program

• It has become part of our culture

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Keys to Success for the Infection Preventionist• Understand your Product Review/Value Analysis Process

• Have knowledge of supply chain management/purchasing

• Have a strong voice

• Be respected and trusted expertp p

• Flexible and open-minded

• Be prepared• Educated and informed

• Evidence-based (when possible)

• Data-driven (when possible)

• Identify/collaborate with champions for your cause

• Be cost conscious

• Avoid conflict of interest

Final Points

• Many products have infection prevention considerations.• A formal structured process for product evaluation is

important for effective value analysis to balance quality and cost.

• Infection preventionists are a critical resource and • Infection preventionists are a critical resource and partner in the product evaluation process.

• Value Analysis must consider the total cost when considering impact of products on infection prevention.

• If you are not a regular participant of your product evaluation process at your organization, change that today!

Thank You


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How do I get a CE Certificate?

Next week, all of today’s meeting participants will be sent an email containing instructions for obtaining a CE Certificate for today’s meeting.

The email will be sent to the email address you provided when you logged-in to today’s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate email to them.

Documents

IP-Value Analysis · Value Analysis Program at HealthEast • 18 committees meeting regularly • Review products, processes, services • Network, problem solve, standardize •