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inglês inglês Presentation Transcript

  • Product Selection Based on Criteria and Standards Pat Solkshinitz, R.N. Product Facilitator Product Standardization Calgary Health Region Calgary, Alberta, Canada
  • Calgary Health Region
    • Calgary has 4 acute care hospitals
      • Foothills Medical Centre
      • Alberta Children’s Hospital
      • Rockyview General Hospital
      • Peter Lougheed
    • Care in the Community
    • Healthy Communities
    • Regional Warehouse for Inventory Products
    • Regional Surgical Specialties Assembly Centre
  • Regionalization of Health Care Systems in Calgary:
    • Standardization of Practices has led to standardization of products and medical equipment. (see handout #1 “ Definition and Process for Product Standardization and Evaluation”)
    • Standardization of products/equipment has resulted in decreased costs and improved quality of patient care.
  • Standardization of Medical Products and Equipment Recommendations prior to Tender/Purchase
      • Research Technology
        • Utilize Clinical Specialists in Product Review
        • Research Government Guidelines
        • Utilize ECRI Product Reports/Testing Data
        • Benchmark with other Institutions or Regions
      • Identify current products being used (numbers used, types, brands, specifications)
      • Identify Practice (Current and Changing)
  • Identify Current Products
    • Initial Information Gathering
      • how many products are used annually
      • who uses the product
      • how many products have similar characteristics/specifications
      • how many variations/sizes of the product are used
    • what is the cost of each product
    • obtain samples of all current products
  • Identify Current Practice
    • Current Practice
      • identify steps in practice where the product is utilized
      • identify the group of staff/patients that are dedicated to this practice
    • Change in Practice
      • identify where steps could be streamlined
      • incorporate emerging technology that will improve patient outcomes
  • Research Product Information
    • Benchmark
      • with other health facilities/regions
    • Research technology using:
      • clinical staff members
      • clinical publications
      • Government Regulations/Standards/Guidelines
      • ECRI Testing and Reports
  • Therapeutic Products Program
    • Health Canada’s Therapeutic Products Program is the national authority which regulates drugs, medical devices and other therapeutic products used in Canada.
      • Medical Device Problem Reporting
      • Medical Devices Bureau
  • Medical Devices Bureau Regulations
    • This is a branch of the TPP which monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.
    • Web Site: www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/schedule.html#1101 (New Medical Devices Regulations - May 27, 1998)
      • Medical Device Licence Classifications (see handout #2 “Medical Device Classifications”)
        • Class I
        • Class II
        • Class III
        • Class IV
  • Selection of Criteria
    • Criteria for Tendering Purposes
      • current product information/specifications
        • size, shape, function, material, packaging
        • (See handout #3 “Product Specifications Profile”)
      • staff members agreed upon “new” specifications
        • may use new/emerging technology specifications
        • may use current product specifications chosen as “standardized” product by staff members
    • Note any changes to practice with new product criteria
    • Note any change in usage related to new product criteria and/or practice
  • Steps in Product Selection
    • Identify Problem or Need (see handout #4 “Needs Assessment Worksheet”)
    • Establish Product Specifications
    • Tender Process
    • Decision to Evaluate pre or post tender
    • Review Evaluation results
    • Award Product
    • Implement Product
    • Re-assess product in 6-12 months post-implementation
  • Mandatory versus Non-Mandatory Weighted Criteria
    • Establish what the product must do
      • if the product does not contain this property - you cannot use it)
    • Establish what you would like the product to do that is not mandatory
      • these are specifications that are “nice to have”
    • Weigh the non-mandatory criteria according to its importance (scale of 1-10)
    • Include all mandatory and non-mandatory criteria in the RFP document (see handout #5 and #6 “Mandatory and Non-Mandatory Criteria Sample)
  • Mandatory Criteria
    • Do not make the mandatory criteria so rigid that there is only once choice of product that could ever meet your needs
      • costs can be affected if choice is removed
      • supply of product could be limited and sporadic
      • potentially you could have no bid responses from vendors (re-tendering time and costs would be involved)
    • Ensure that criteria is simple and fully defined
  • Non-Mandatory Criteria
    • Weigh the specific function so that it best meets your needs and offers you more than one choice of product
    • Use a simple scale of 1-10 to keep the results workable
    • Ensure that not all criteria is weighted “10” - this will allow for easier identification of “best” product once results are tabulated
  • Tendering Process
    • Outline specific products, usage, specifications
    • Prepare Request for Proposal (RFP) Document based on hospital purchasing standards (see handout #7 “Calgary Health Region RFP” )
    • Ensure timelines are appropriate:
      • Responding Vendors have enough time to organize an appropriate bid
      • Your Purchasing Department has enough time to organize all of the bids and samples received
      • Time is allowed for staff members to review bids and move to evaluation if required
      • Time to allow for ease of transition from old to new product
  • Product Selection Weighting
    • Inform vendors in the RFP that product will be selected based on varying % of the following:
      • Clinical Acceptability
      • Latex-free Product
      • Price and Price Protection
      • Value Added Content
      • Overall Best Value
      • Acceptance of Standard Terms and Conditions
    • Percentage used to award product varies - Price is usually 30-50% of equation - clinical can be 50-70% depending on the clinical needs
  • Organizing Bids
    • Review bids on all levels (i.e. grouping certain products or analyze each single item)
    • Analyze current costs versus potential costs related to “grouping” and “single”
    • Organize products for review by staff members on a low cost to high cost basis
    • Organize and ensure samples of all products are available for staff members to review
    • Ensure that all requested “product specification” material has been received by the bidding company (i.e. data relating to product performance, third party research material)
  • Review of Product Bids
    • Use Staff Member “group” established to assist with this process
      • include high use areas, specialty use areas
      • Ensure no conflict of interest issues with group members (see handout #8 “Statement of Full Disclosure”)
    • Ensure samples of products are available for review and discussion
      • hands on review of products is required to make informed decision
      • have current product samples available to compare
  • Review of Product Bids (continued)
    • Systematically review all clinical requirements and how well those are met by the vendors ( do not include pricing during this phase - “best product” to be chosen based on meeting clinical needs first)
    • Total up non-mandatory scores
    • Establish which product best meets clinical needs based on criteria
    • Apply % weighting to this product from RFP document
    • Evaluate product selection if required
  • Evaluation Process
    • Select Appropriate Products for Evaluation (based on need, tender) (see handout #9 and #10 “Evaluation Process Model” and “Product and Equipment Review Questions”)
    • Write reasonable, obtainable product criteria
    • Target appropriate areas in which to try a new product (include them in the criteria development)
    • Write Evaluation Criteria that thoroughly encompasses the important points of the product and its function
    • Write Evaluation Forms that are easy to utilize and analyze (see handout #11 “Central Venous Catheter Kit Criteria”)
  • Forming Evaluation Criteria
    • Obtain information from staff members as to the most important factor/function of the desired product
    • Organize the product evaluation criteria from start to finish (turning the machine on to turning the machine off - and include everything in between) (see handout #12 and #13 “Neonatal Cardiac Monitor Evaluation” and “Vital Signs Monitor”)
    • Ensure that specific considerations related to its use are evaluated (i.e. the acceptable weight of the product if it has to be carried)
  • Evaluation Criteria Weighting
    • Add weighting factors to those items that are not considered mandatory but are more important than others
    • Weigh the specific criteria/function in relation to its importance (scale of 1-10 with 10 being the most important)
    • Allow for “comments” to be made in addition to answering specific questions
    • Keep questions as simple and low in number as possible to maintain ease of use/completion
  • Analyzing Evaluation Results
    • Tabulate all answers and number of responses (see handout #14 “Summary Central Venous Catheter Kit”)
    • “ Comments” need to be reviewed and added to final analysis as they will many times verify the “numbers” results (see handout #15 Summary Epidural Tray”)
    • Apply weighting factor to those questions that have been pre-selected (see handout #16 “Summary Cardiac Electrodes”)
  • Analyzing Evaluation Results (continued)
    • Organize summary for presentation to staff members involved in the process (keep it simple)
    • Allow staff members to review and make a recommendation/decision based on the results
    • Document summary and outcome for review with bidding companies
  • Award of Product
    • Product awarded based on tender results or evaluation process (see handout #17 “Product Award Sheet”)
    • Notify companies and allow for ample lead time to stock product
    • Education requirement related to product implementation must be addressed before product is implemented
    • Changes to policy/practice must be in place
    • Important to use up old product before implementing the new (as time will allow)
  • Award of Product (continued)
    • Communicate decision of product award to all users of current products involved
    • Ensure all necessary “parts” have been awarded for use with the product (i.e. disposable associated with equipment)
    • Prepare cost analysis related to product award for period of contract term
    • Ensure that “alternate” products have also been chosen by this group (i.e. acceptable substitute products if required for backorder situations, manufacturing problems, etc.)
  • Follow-Up Post Implementation/Award
    • Assemble updated usage and cost information data on products 6 to 12 months post-award
    • Communicate with departments using new product/equipment as to satisfaction level
    • Clinical Engineering review of awarded equipment (repairs, etc.)
    • Review findings with Vendor - make any changes as necessary (i.e. number of supplied products/equipment needs to increase)