Product Selection Based Product Selection Based on Criteria and on Criteria and StandardsStandards

Pat Solkshinitz, R.N.Pat Solkshinitz, R.N.Product FacilitatorProduct FacilitatorProduct StandardizationProduct StandardizationCalgary Health RegionCalgary Health RegionCalgary, Alberta, CanadaCalgary, Alberta, Canada

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Calgary Health RegionCalgary Health Region• Calgary has 4 acute care hospitalsCalgary has 4 acute care hospitals

– Foothills Medical CentreFoothills Medical Centre

– Alberta Children’s HospitalAlberta Children’s Hospital

– Rockyview General HospitalRockyview General Hospital

– Peter LougheedPeter Lougheed

• Care in the CommunityCare in the Community

• Healthy CommunitiesHealthy Communities

• Regional Warehouse for Inventory ProductsRegional Warehouse for Inventory Products

• Regional Surgical Specialties Assembly CentreRegional Surgical Specialties Assembly Centre

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Regionalization of Health Regionalization of Health Care Systems in Calgary: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.

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Standardization of Medical Standardization of Medical Products and EquipmentProducts and Equipment Recommendations prior to Tender/PurchaseRecommendations prior to Tender/Purchase

– Research TechnologyResearch TechnologyUtilize Clinical Specialists in Product ReviewUtilize Clinical Specialists in Product ReviewResearch Government GuidelinesResearch Government GuidelinesUtilize ECRI Product Reports/Testing DataUtilize ECRI Product Reports/Testing DataBenchmark with other Institutions or RegionsBenchmark with other Institutions or Regions

– Identify current Identify current products being used products being used (numbers used, (numbers used, types, brands, types, brands, specifications)specifications)

– Identify Practice Identify Practice (Current and (Current and Changing) Changing)

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Identify Current ProductsIdentify Current Products• Initial Information GatheringInitial Information Gathering

– how many products how many products are used annuallyare used annually

– who uses the productwho uses the product

– how many products have how many products have similar similar characteristics/specificationscharacteristics/specifications

– how many variations/sizes of how many variations/sizes of the product are usedthe product are used

– what is the cost of what is the cost of each producteach product

– obtain samples of all obtain samples of all current productscurrent products

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Identify Current PracticeIdentify Current Practice• Current PracticeCurrent Practice

– identify steps in identify steps in practice where the practice where the product is utilizedproduct is utilized

– identify the group identify the group of staff/patients of staff/patients that are dedicated that are dedicated to this practiceto this practice

• Change in PracticeChange in Practice– identify where identify where

steps could be steps could be streamlinedstreamlined

– incorporate incorporate emerging emerging technology that will technology that will improve patient improve patient outcomesoutcomes

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Research Product Research Product InformationInformation

• BenchmarkBenchmark– with other health facilities/regionswith other health facilities/regions

• Research technology using:Research technology using:– clinical staff membersclinical staff members

– clinical publicationsclinical publications

– Government Regulations/Standards/GuidelinesGovernment Regulations/Standards/Guidelines

– ECRI Testing and ReportsECRI Testing and Reports

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Therapeutic Products Therapeutic Products ProgramProgram

• Health Canada’s Therapeutic Products Health Canada’s Therapeutic Products Program is the national authority Program is the national authority which regulates drugs, medical which regulates drugs, medical devices and other therapeutic devices and other therapeutic products used in Canada.products used in Canada.– Medical Device Problem ReportingMedical Device Problem Reporting

– Medical Devices BureauMedical Devices Bureau

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Medical Devices Bureau Medical Devices Bureau RegulationsRegulations

• This is a branch of the TPP which monitors and This is a branch of the TPP which monitors and evaluates the safety, effectiveness and quality of evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in diagnostic and therapeutic medical devices in Canada.Canada.

• Web Site: Web Site: www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/schedule.html#www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/schedule.html#11011101 (New Medical Devices Regulations - May 27, 1998) (New Medical Devices Regulations - May 27, 1998)

Medical Device Licence Classifications Medical Device Licence Classifications (see handout (see handout #2 “Medical Device Classifications”)#2 “Medical Device Classifications”)

Class IClass IClass IIClass IIClass IIIClass IIIClass IVClass IV

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Selection of CriteriaSelection of Criteria• Criteria for Tendering PurposesCriteria for Tendering Purposes

– current product information/specificationscurrent product information/specifications• size, shape, function, material, packagingsize, shape, function, material, packaging• (See handout #3 “Product Specifications Profile”)(See handout #3 “Product Specifications Profile”)

– staff members agreed upon “new” specificationsstaff members agreed upon “new” specifications• may use new/emerging technology specificationsmay use new/emerging technology specifications

• may use current product specifications chosen as “standardized” product by staff membersmay use current product specifications chosen as “standardized” product by staff members

• Note any changes to practice with new product criteriaNote any changes to practice with new product criteria

• Note any change in usage related to new product Note any change in usage related to new product criteria and/or practicecriteria and/or practice

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Steps in Product SelectionSteps in Product Selection• Identify Problem or Need Identify Problem or Need (see handout #4 (see handout #4

“Needs Assessment Worksheet”)“Needs Assessment Worksheet”)

• Establish Product SpecificationsEstablish Product Specifications

• Tender ProcessTender Process

• Decision to Evaluate pre or post tenderDecision to Evaluate pre or post tender• Review Evaluation resultsReview Evaluation results

• Award ProductAward Product

• Implement ProductImplement Product

• Re-assess product in 6-12 months post-implementationRe-assess product in 6-12 months post-implementation

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Mandatory versus Non-Mandatory versus Non-Mandatory Weighted Mandatory Weighted CriteriaCriteria• Establish what the product Establish what the product mustmust do do

– if the product does not contain this property - you if the product does not contain this property - you cannot use it)cannot use it)

• Establish what you would like the product to do Establish what you would like the product to do that is not mandatorythat is not mandatory– these are specifications that are “nice to have”these are specifications that are “nice to have”

• Weigh the non-mandatory criteria according to Weigh the non-mandatory criteria according to its importance (scale of 1-10)its importance (scale of 1-10)

• Include all mandatory and non-mandatory Include all mandatory and non-mandatory criteria in the RFP document criteria in the RFP document (see handout #5 and #6 (see handout #5 and #6 “Mandatory and Non-Mandatory Criteria Sample)“Mandatory and Non-Mandatory Criteria Sample)

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Mandatory CriteriaMandatory Criteria• Do not make the mandatory criteria so Do not make the mandatory criteria so

rigid that there is only once choice of rigid that there is only once choice of product that could ever meet your needsproduct that could ever meet your needs– costs can be affected if choice is removedcosts can be affected if choice is removed

– supply of product could be limited and sporadicsupply of product could be limited and sporadic

– potentially you could have no bid responses potentially you could have no bid responses from vendors (re-tendering time and costs from vendors (re-tendering time and costs would be involved)would be involved)

• Ensure that criteria is simple and fully Ensure that criteria is simple and fully defineddefined

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Non-Mandatory CriteriaNon-Mandatory Criteria• Weigh the specific function so that it best meets your Weigh the specific function so that it best meets your

needs and offers you more than one choice of productneeds and offers you more than one choice of product

• Use a simple scale of 1-10 to keep the results workableUse a simple scale of 1-10 to keep the results workable

• Ensure that not all criteria is weighted Ensure that not all criteria is weighted “10” - this will allow for easier “10” - this will allow for easier identification of “best” product once identification of “best” product once results are tabulatedresults are tabulated

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Tendering ProcessTendering Process• Outline specific products, usage, specificationsOutline specific products, usage, specifications

• Prepare Request for Proposal (RFP) Document Prepare Request for Proposal (RFP) Document based on hospital purchasing standards based on hospital purchasing standards (see handout (see handout #7 “Calgary Health Region RFP” )#7 “Calgary Health Region RFP” )

• Ensure timelines are appropriate:Ensure timelines are appropriate:– Responding Vendors have enough time to Responding Vendors have enough time to

organize an appropriate bidorganize an appropriate bid

– Your Purchasing Department has enough time to Your Purchasing Department has enough time to organize all of the bids and samples receivedorganize all of the bids and samples received

– Time is allowed for staff members to review bids Time is allowed for staff members to review bids and move to evaluation if requiredand move to evaluation if required

– Time to allow for ease of transition from old to Time to allow for ease of transition from old to new productnew product

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Product Selection Product Selection WeightingWeighting• Inform vendors in the RFP that product will be Inform vendors in the RFP that product will be

selected based on varying % of the following:selected based on varying % of the following:– Clinical AcceptabilityClinical Acceptability

– Latex-free ProductLatex-free Product

– Price and Price ProtectionPrice and Price Protection

– Value Added ContentValue Added Content

– Overall Best ValueOverall Best Value

– Acceptance of Standard Terms and ConditionsAcceptance of Standard Terms and Conditions

• Percentage used to award product varies - Price is usually 30-50% of Percentage used to award product varies - Price is usually 30-50% of equation - clinical can be 50-70% depending on the clinical needsequation - clinical can be 50-70% depending on the clinical needs

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Organizing BidsOrganizing Bids• Review bids on all levels (i.e. grouping Review bids on all levels (i.e. grouping

certain products or analyze each single item)certain products or analyze each single item)

• Analyze current costs versus potential costs Analyze current costs versus potential costs related to “grouping” and “single”related to “grouping” and “single”

• Organize products for review by staff Organize products for review by staff members on a low cost to high cost basismembers on a low cost to high cost basis

• Organize and ensure samples of all products Organize and ensure samples of all products are available for staff members to revieware available for staff members to review

• Ensure that all requested “product Ensure that all requested “product specification” material has been received by specification” material has been received by the bidding company (i.e. data relating to the bidding company (i.e. data relating to product performance, third party research product performance, third party research material)material)

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Review of Product BidsReview of Product Bids

• Use Staff Member “group” established to Use Staff Member “group” established to assist with this processassist with this process

– include high use areas, specialty use areasinclude high use areas, specialty use areas

– Ensure no conflict of interest issues with Ensure no conflict of interest issues with group members group members (see handout #8 “Statement of Full (see handout #8 “Statement of Full Disclosure”)Disclosure”)

• Ensure samples of products are available for Ensure samples of products are available for review and discussionreview and discussion

– hands on review of products is required to hands on review of products is required to make informed decisionmake informed decision

– have current product samples available to have current product samples available to comparecompare

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Review of Product Bids Review of Product Bids (continued)(continued)• Systematically review all Systematically review all clinicalclinical requirements requirements

and how well those are met by the vendors and how well those are met by the vendors ((do do not include pricing during this phase - “best not include pricing during this phase - “best product” to be chosen based on meeting clinical product” to be chosen based on meeting clinical needs first)needs first)

• Total up non-mandatory scoresTotal up non-mandatory scores

• Establish which product best meets clinical Establish which product best meets clinical needs based on criterianeeds based on criteria

• Apply % weighting to this product from RFP Apply % weighting to this product from RFP documentdocument

• Evaluate product selection if requiredEvaluate product selection if required

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Evaluation ProcessEvaluation Process• Select Appropriate Products for Evaluation Select Appropriate Products for Evaluation

(based on need, tender) (based on need, tender) (see handout #9 and #10 (see handout #9 and #10 “Evaluation Process Model” and “Product and Equipment Review “Evaluation Process Model” and “Product and Equipment Review Questions”)Questions”)

• Write reasonable, obtainable product criteriaWrite reasonable, obtainable product criteria

• Target appropriate areas in which to try a Target appropriate areas in which to try a new product new product (include them in the criteria development)(include them in the criteria development)

• Write Evaluation Criteria that thoroughly Write Evaluation Criteria that thoroughly encompasses the important points of the encompasses the important points of the product and its functionproduct and its function

• Write Evaluation Forms that are easy to Write Evaluation Forms that are easy to utilize and analyze utilize and analyze (see handout #11 “Central (see handout #11 “Central Venous Catheter Kit Criteria”)Venous Catheter Kit Criteria”)

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Forming Evaluation Forming Evaluation CriteriaCriteria• Obtain information from staff members as to the most Obtain information from staff members as to the most

important factor/function of the desired productimportant factor/function of the desired product

• Organize the product evaluation criteria from start to finish Organize the product evaluation criteria from start to finish (turning the machine on to turning the machine off - and (turning the machine on to turning the machine off - and include everything in between) include everything in between) (see handout #12 and #13 “Neonatal (see handout #12 and #13 “Neonatal Cardiac Monitor Evaluation” and “Vital Signs Monitor”)Cardiac Monitor Evaluation” and “Vital Signs Monitor”)

• Ensure that specific considerations related Ensure that specific considerations related to its use are evaluated (i.e. the to its use are evaluated (i.e. the acceptable weight of the product if it has acceptable weight of the product if it has to be carried)to be carried)

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Evaluation Criteria Evaluation Criteria WeightingWeighting• Add weighting factors to those items that are not Add weighting factors to those items that are not

considered mandatory but are more important than othersconsidered mandatory but are more important than others

• Weigh the specific criteria/function in relation to its Weigh the specific criteria/function in relation to its importance (scale of 1-10 with 10 being the most importance (scale of 1-10 with 10 being the most important)important)

• Allow for “comments” to be made in addition Allow for “comments” to be made in addition to answering specific questionsto answering specific questions

• Keep questions as simple and low in number Keep questions as simple and low in number as possible to maintain ease of use/completionas possible to maintain ease of use/completion

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Analyzing Evaluation Analyzing Evaluation ResultsResults• Tabulate all answers and number of responses Tabulate all answers and number of responses

(see handout #14 “Summary Central Venous Catheter Kit”)(see handout #14 “Summary Central Venous Catheter Kit”)

• ““Comments” need to be reviewed and added to Comments” need to be reviewed and added to final analysis as they will many times verify the final analysis as they will many times verify the “numbers” results “numbers” results (see handout #15 Summary Epidural (see handout #15 Summary Epidural Tray”)Tray”)

• Apply weighting factor to those questions Apply weighting factor to those questions that have been pre-selected that have been pre-selected (see handout #16 (see handout #16 “Summary Cardiac Electrodes”)“Summary Cardiac Electrodes”)

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Analyzing Evaluation Analyzing Evaluation Results Results (continued)(continued)

• Organize summary for presentation to staff Organize summary for presentation to staff members involved in the process (keep it members involved in the process (keep it simple)simple)

• Allow staff members to review and make a Allow staff members to review and make a recommendation/decision based on the recommendation/decision based on the resultsresults

• Document summary and outcome for Document summary and outcome for review with bidding companiesreview with bidding companies

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Award of ProductAward of Product• Product awarded based on tender results Product awarded based on tender results

or evaluation process or evaluation process (see handout #17 “Product (see handout #17 “Product Award Sheet”)Award Sheet”)

• Notify companies and allow for ample lead Notify companies and allow for ample lead time to stock producttime to stock product

• Education requirement related to product Education requirement related to product implementation must be addressed before implementation must be addressed before product is implementedproduct is implemented

• Changes to policy/practice must be in placeChanges to policy/practice must be in place

• Important to use up old product before Important to use up old product before implementing the new (as time will allow)implementing the new (as time will allow)

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Award of Product Award of Product (continued)(continued)

• Communicate decision of product award to all Communicate decision of product award to all users of current products involvedusers of current products involved

• Ensure all necessary “parts” have been awarded Ensure all necessary “parts” have been awarded for use with the product (i.e. disposable for use with the product (i.e. disposable associated with equipment)associated with equipment)

• Prepare cost analysis related to product Prepare cost analysis related to product award for period of contract termaward for period of contract term

• Ensure that “alternate” products have also Ensure that “alternate” products have also been chosen by this group (i.e. acceptable been chosen by this group (i.e. acceptable substitute products if required for backorder substitute products if required for backorder situations, manufacturing problems, etc.)situations, manufacturing problems, etc.)

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Follow-Up Post Follow-Up Post Implementation/AwardImplementation/Award• Assemble updated usage and cost information Assemble updated usage and cost information

data on products 6 to 12 months post-awarddata on products 6 to 12 months post-award

• Communicate with departments using new Communicate with departments using new product/equipment as to satisfaction levelproduct/equipment as to satisfaction level

• Clinical Engineering review of awarded Clinical Engineering review of awarded equipment (repairs, etc.) equipment (repairs, etc.)

• Review findings with Vendor - make any Review findings with Vendor - make any changes as necessary (i.e. number of changes as necessary (i.e. number of supplied products/equipment needs to supplied products/equipment needs to increase)increase)