AHFMR SCREENING PROCEDURE for Use when Considering the ...

HTA Initiative # 6 • April, 2002AHFMR SCREENINGPROCEDUREfor Use when Consideringthe Implementationof Health Technology

Copies of this andour other publicationsare availableelectronically atwww.ahfmr.ab.caThis screeningprocedure is alsoavailable on the web inWord format and canbe customized to theuser’s needs.Health Technology Assessment UnitAlberta Heritage Foundationfor Medical ResearchSuite 150010104 – 103 Avenue nwEdmonton, AlbertaCanada t5j 4a7Tel: 780 423 5727Fax: 780 429 3509

HTA Initiative # 6 • April 2002AHFMR SCREENINGPROCEDUREfor Use when Consideringthe Implementationof Health TechnologyPrepared by:Don JuzwishinDirector, Health Technology AssessmentAlberta Heritage Foundation for Medical ResearchWendy L. SchneiderConsultant, Health Services Research Associates

HTA Initiative #6AHFMR Screening Procedurefor use when Consideringthe Implementation of Health TechnologyCopyright © Alberta Heritage Foundationfor Medical Research, 2002isbn 1–896956–52–1All rights reserved.Design: Interpret Design Inc.Alberta Heritage Foundationfor Medical ResearchSuite 1500, 10104 – 103 Avenue nwEdmonton, AlbertaCanada t5j 4a7Tel: 780 423 5727Fax: 780 429 3509www.ahfmr.ab.ca

Table of ContentsIntroduction 1BackgroundPersonnel involved 2Diagram showing screening processOverview of the procedure 3DefinitionsChecklists and Reporting Sheets for theAHFMR Health Technology Screening Procedure 5Record of Progress 6Checklist I: Prescreening Needs Assessment 8Checklist II: Evidence of Effectiveness 9Checklist III: Impact on Operations 10Checklist IV: Financial Assessment 11Executive Summary 12Vendor and Equipment Checklist I: Overview of Cost Estimates 13Vendor and Equipment Checklist II: Vendor Comparison 14Vendor and Equipment Checklist III: Cost Comparison 15Vendor and Equipment Checklist IV: Overview of Cost Estimates 16

AHFMR SCREENING PROCEDURE 1Introduction“This screening process shouldbe applied in the regional contextaccording to the criteria ofvolume, risk, cost, quality, andaccessibility to healthcare.”Note: This Health Technology ScreeningProcedure is not intended to be usedfor evaluating Programs.An additional document is being developedthat will be specific to screening forProgram addition, deletion and/orexpansion.As part of its strategic plan the Health Technology Assessment Unit(HTA) of the Alberta Heritage Foundation for Medical Research (AHFMR)is committed to assisting Regional Health Authorities (RHAs) developand maintain a capacity for using evidence in their policy and decisionmaking.The Framework for Regional Health Authorities 1 describes how RHAs canimplement an applied HTA process.This report presents the AHFMR Screening Procedure which is made upof a series of checklists designed to guide RHAs through an applied HTAprocess and help them decide on suitable health technologies for theirregion. The process serves to structure the manner by which proposalsfrom physicians and staff advance the introduction of new technology,procedures, or standards of care.The purpose of these checklists is to identify the evidence necessary fordecision-making and to assist RHAs with their annual business planningcycle. This effort will in turn provide health regions with a structuredframework for determining whether to introduce an emerging health caretechnology or if they should reassess a technology currently in use. Thisscreening process should be applied in the regional context according to thecriteria of volume, risk, cost, quality, and accessibility to healthcare.BACKGROUNDFour sources have been referred to in the development of these checklists:the New York Hospital Association, the Capital Health Region in BritishColumbia, the Surgical Suites of the Calgary Regional Health Authority andthe University HealthSystem Consortium in Illinois. In addition, workshopparticipants from various Alberta Regional Health Authorities are gratefullyacknowledged for providing valuable feedback during three workshops heldin Red Deer, Grande Prairie and Lethbridge. It was this contribution thathelped develop and customize the screening procedure for use in Alberta.A final workshop was held in March 2002 to validate the contents of thechecklist and make improvements.The checklist was developed in a generic sense, leaving ample room forhealth regions to customize it to their own needs and requirements.1. Juzwishin, D. Framework for Regional Health Authorities to Make Optimal Use of Health Technology Assessment(HTA Initiative #1). Alberta Heritage Foundation for Medical Research, March 2000.

2 AHFMR SCREENING PROCEDUREPersonnel involvedPrescreening.....of technology...indicates..further research.....should not be.......undertaken.........New technologyis notapprovedNOSponsor of technologyinitiates processPrescreeningchecklistis completedCompleteresearch andcompile informationrequired onchecklists I–IVWriteExecutive Summaryand presentto RHA ExecutiveFollow-upevaluation oftechnologyYESFurther researchis approvedand a projectteam is selectedNew technologyis approved andimplementedIf the complexity of the technology involves other health care providers,has requirements beyond existing resources, and/or has special spacerequirements, then a project team should be formed to help review theappropriateness of the health care technology. Roles of the individualsinvolved are described here:Sponsor The person requesting the acquisition of a new technology, orthe assessment or re-application of an existing technology. Typically thesponsor would have clinical involvement with the particular technology. Thisperson is responsible for completing the Prescreen and, together with teammembers, the rest of the checklists.Project Leader The project leader will most often be the clinical sponsorof the technology. However, it could also be a program head or a seniormanager. Whoever it is, he/she should have the support of someoneknowledgeable in accessing, appraising and applying health servicesresearch to policy or decisions (e.g. SEARCH participant or knowledgebroker).Project Team Members The project leader can then select team membersto join the team who will represent the different disciplines or relevantparts of the organization that will be impacted by the introduction ofthe technology. It is appropriate to involve as many significant players aspossible on the team to fully appreciate the implications of introducing a newtechnology.Knowledge Broker The team will require the expertise of an individualwho is knowledgeable about where to find the relevant evidence, assessits usefulness to the questions being asked, and to apply it to the localcircumstances.DIAGRAM SHOWING SCREENING PROCESS.

AHFMR SCREENING PROCEDURE 3Overview of the procedureDEFINITIONSFollowing are several terms that shouldbe clarified.Accessibility Ability of client to reachor use services; the services are eitherrequired or available, provided in themost appropriate setting and at theright time, and based on clientsrespective needs.Cost Anticipated expenditure on a unitand also cumulative basis.Materiality The monetary value ofsupplies, equipment and/or servicesthat is significant to the RHA thattriggers the use of the checklist.Risk Chance or possibility of danger,loss or injury.Technology This includes medicaldevices, drugs, procedures, equipment,as well as the organization of services.Volume Number of cases projectedover a period of time (caseload).Step 1: Prescreen the particular health technology by completingChecklist I – Prescreening Needs AssessmentIf no need is established for the technology then do not proceed.Step 2: Form the project teamIf the technology is complex and has significant implications for potentialintroduction or reapplication in the organization it is recommended that aproject team of impacted individuals be formed to study and inform thematter.The sponsor acts as project leader or delegates this role to a team member.Step 3: Complete Checklist II – Evidence of EffectivenessDetermine if there is peer reviewed scientific evidence to support theintroduction of the new technology, or the continuing reapplication of anexisting technology. Include the ‘level of evidence.’ The HTA Unit of theAHFMR may be approached to assist with access to evidence.If there is a lack of published evidence and therefore uncertainty to supportthe introduction of the technology then a decision will have to be made withinthe local context as to whether the sponsor should proceed with the screeningprocedure.The sponsor or project team must complete the checklist to the extent thata decision-maker can clearly determine if the technology being sponsored isappropriate for introduction in the setting being proposed.Step 4: Complete Checklist III – Impact on OperationsDetermine the potential impact of the technology on internal operations andthe quality of care.This checklist may involve all members of the project team – each examiningthe impact of the technology on their areas.Step 5: Complete Checklist IV – Financial AssessmentDetermine the financial impact of the new technology by comparing the newtechnology with current systems. This includes capital costs, staffing costs,operating costs as well as offsetting revenue, cost avoidance, and cost savingvis a vis existing technology. These financial implications are considered bothfor startup and continuing costs.

4 AHFMR SCREENING PROCEDUREStep 6: Prepare Executive SummarySynthesize the information from the completed checklists, ensure fulldisclosure of the implications of the technology’s introduction. Include thenames, departments, and signatures of the sponsor, team leader and teammembers. Potential conflicts of interest should also be disclosed.Step 7: Present findings to the RHA ExecutiveAfter the sponsor and team members have signed off the completedchecklists, and composed the Executive Summary, the package is forwardedto the appropriate decision-making body within the RHA.Step 8: Approval or disapproval by the RHA ExecutiveThe executive of the health authority will approve, disapprove or request moredetails in respect to the proposal.• If the proposal is approved it will require that an implementation strategyfor the introduction of the technology is developed.• If it is disapproved the rationale will be provided to the sponsor.• If more information is required before a decision can be made, this will bedirected to the sponsor or project leader.Step 9: Implementation of technologyOnce the technology is approved, then the process of acquiring, installing,training begins.Step 10: Follow-up evaluation of technologyOnce technology is operational it should be evaluated according to originalparameters after a given period of time.Step 11: Prepare Post-Implementation Evaluation ReportDescribe the outcome measures, timelines, and processes that will be usedto evaluate the initiative if approved for implementation. Accountability forcompleting the evaluation must be indicated and acknowledged within theplan.

AHFMR SCREENING PROCEDURE 5Checklists andReporting Sheetsfor theAHFMRHealth TechnologyScreening ProcedureThese checklists and reporting sheets are alsoavailable on the web in Word format,and can be customized to the user’s needs.

6 AHFMR SCREENING PROCEDURERecord of ProgressThis reporting sheet is used to record milestones in the screening procedure in order to ensure the correct sequenceis followed.Health technology being considered1. Initial Presentation to RHA ExecutiveA) Sponsor completes Prescreen then requests approval to move forward:Sponsor signatureDateB) Health authority executive approves prescreen, Sponsor moves forward with Screening Exercise:Senior Executive signatureDateC) Executive does not approve proposal for further development:Returned to sponsor Yes Date returnedwith reasonsNoSenior Executive signatureDate2. Proposal Development by Project TeamA) Project Leader selected DateB) Project Team Members selected Date(select members from affected/related areas)Team MembersDepartment

AHFMR SCREENING PROCEDURE 7C) Screening Exercise Tracking: completion of checklistsI Prescreening Needs AssessmentSignatureII Evidence of EffectivenessSignatureIII Impact on OperationsSignatureIV Financial AssessmentSignatureDateDateDateDateD) Project Leader presents completed proposal to executive for final review.Senior Executive Signature* If approved, the proposal is integrated into the RHA business plan.Date4. Presentation to Board of Trustees(if required)Approved by Board Yes DateNo5. Implementation of TechnologyStart up date6. Technology Evaluation ReportSix months after introduction of the technology the Sponsor is responsible for evaluating itand providing the RHA senior executive with an evaluation report.Presentation to Senior ExecutiveDate

8 AHFMR SCREENING PROCEDURECHECKLIST IPrescreening Needs Assessment(to be completed by sponsor)This checklist relates the technology under review to the characteristics of the health region communitythat affect the provision of quality health care. The community is surveyed to identify health care needs,resources, opportunities for the organization and possible barriers to the implementation andoperation of the technology.Health technology being considered—describe the proposed initiative or change in practice in relation to the currentstandard of care in the region.Materiality threshold for this Health Technology Screening Procedure $(to be determined by RHA Executive)Identifying a threshold avoids unnecessary work on something that is obvious – or stops work on something thatis unrealistic.Sponsor name(attach findings to this cover page)Title1) Describe the criteria or clinical indications for the use of thistechnology in the proposed population.2) Is there a caseload volume necessary for clinician maintenance of skills?3) Identify the potential patient caseload (project 3–5 years).4) Describe the profile of the population that willbenefit by the technology.5) Identify major governmental, credentialing, and regulatory issues(e.g. Health Canada, U.S. FDA approvals, etc).6) Identify issues of duplication of services. Are substitutions possible?7) Identify opportunities for partnerships with other RHAs.8) Are there resource issues that arise in your community asa result of introducing this technology? (brief explanation).9) Are those that will be affected aware of the potential impact?Date completedSponsor signatureDate of completion

CHECKLIST IIEvidence of Effectiveness(to be completed by sponsor and project team)AHFMR SCREENING PROCEDURE 9This checklist involves searching the scientific literature for good quality studies that examine recent experience withthe efficacy and effectiveness of the proposed technology. Be aware of the distinction between clinical effectiveness and costeffectiveness. It is important to broadly survey the evidence, as emerging developments may render the technology obsolete.In addition to appraising the scientific literature, information may be obtained from regulatory bodies, other users, andfacilities that have experience with the technology. It is not prudent to rely solely on information from vendors, or technologymanufacturers(attach findings to this cover page)Health technology being considered1) Have you obtained approval to proceed from your Program Director/Department Head?2) a) Describe the Technology – in relation to the current standard of care in the region.Describe anticipated outcomes.b) Identify what the new technology is replacing, OR what indication is the entirely newtechnology treating/diagnosing, OR describe the reapplication of an existing technology.3) Is this technology being requested or changed as a result of an audit by the CSA, WCB,or other regulatory body?4) Are there other alternatives to this technology? What are they?5) a) Can this technology be accommodated in an alternative setting?(i.e. common location, shared services)b) Is this technology currently available elsewhere?c) Are there opportunities for partnering with neighbouring RHA’s?d) Why would the health authority want to introduce this technology?e) Describe and assess the appropriateness of this technology to the health authority.6) Complete an appropriate literature search* and critical appraisal of the literature.• Clearly state the objectives for introduction of a technology or reapplication of an existing technology.• Identify the supporting evidence (level of evidence) related to the proposed technology.• Include a brief history of the technology.• If applicable, describe current standard of care for which the technology is being requested.• Summarize the findings from critically reviewed published evidence that shows the newtechnology/application is more effective/efficacious than standard of care.7) Where within the region will this technology be ideally located?8) Does this technology require specialized training or credentialing?9) Is there potential to use this technology in other settings in the health authority?10) What is the potential impact of implementation of this technology on otherprograms/departments/services?Date completed* If you require assistance in performing a thorough literature search or review contact a SEARCH participant in your health authority or the HTA Unit of the AHFMR.Sponsor name Sponsor signature Date of completion

10 AHFMR SCREENING PROCEDURECHECKLIST IIIImpact on Operations(to be completed by sponsor and project team)The purpose of this checklist is to examine internal operational factors related to the introduction of the new technology.This helps to determine the organization’s requirements related to the new technology and identify any barriers or limitations.This checklist is also designed to determine the potential impact of the technology on quality of care.The initial screening for a new technology must include the following information. Subsequent screenings need only be updated.(attach findings to this cover page)Health technology being considered1) Explain how the technology is consistent with the health regions business plan(Mission, Philosophy, Role Statement, Goals & Objectives)?2) Explain how the technology is consistent with the business plans of thePrograms/Departments directly involved in implementing the technology?3) Is the technology complementary to other programs and services in the health region?Please describe.4) How does the technology impact access to care?5) How does the technology enhance the quality of care in the health region andhow does it tie in with the Total Quality Management of the RHA?6) Do we have the resources to properly identify the patients that will benefitfrom the technology?7) Is health region staff currently trained/certified to operate this technology?If not, what education/training is required?8) Describe the impact this technology will have on other programs, departments and/or services(eg. laboratory, OR, booking, etc.). Obtain signatures of all program leaders ofaffected departments.9) Will the provision of this technology generate additional demands on existing technologies?Specify the technologies affected and what the impact will be.10) Does implementation of this technology require additional space and/orrenovation work? Please provide provisional plans/estimates, as required.11) If possible, identify the lifespan of the technology.Date completedSponsor / Team Leader name Sponsor / Team Leader signature Date of completion

CHECKLIST IVFinancial Assessment(to be completed by sponsor and project team)The initial acquisition cost of a new technology – i.e. whether it is expensive or inexpensive - may not be indicative of thepotential ongoing operating costs. A technology may have a low initial acquisition cost, but its frequency of use could resultin considerable operating costs. In order to assess the financial impact of the new or newly applied technology, a comparisonof the operating costs of the new versus the current technology is required. It is important that this analysis reflects thecost for all departments impacted by the implementation of the new technology.(attach findings to this cover page)AHFMR SCREENING PROCEDURE 11Health technology being consideredSignature1) Compare the current standard of care and new technology:a) Identify workload volumes – and assumptions supporting themb) Determine staffing levels (Regular + Relief )– and implications for support areasc) Calculate:• Staffing costs• Supply costs• Offsetting revenue• Building systems• OtherDate completed2) Identify the technology that will be removedfrom service and replaced with new technology.(schedule of substitution must be included)3) Summarize the incidental “costs/savings,” andhow these can be captured.4) Identify Capital Costs(equipment and construction/renovation)5) Identify operating costs (at different volumes of service)• Startup-operating costs (staffing and supplies,training)• Year 2/Year 3 operating costs (step-wise costs – variable + fixed)• Life of the technologySponsor / Team Leader name Sponsor / Team Leader signature Date of completion

12 AHFMR SCREENING PROCEDUREExecutive SummaryHealth technology being consideredProvide a high level summary of the proposed technology, the proposed benefit to the region and the primaryrecommendations. (Attempt to place values on the benefits if possible.)Disclosure of potential conflict of interest: Provide specifics of any funding that you as sponsor or to your knowledge yourcolleagues and the program have received in the last five years from the company that manufactures and/or marketsany product associated with the initiative described above. This includes research (funding, grants, professional retainers,product evaluation initiatives, and /or educational support.Sponsor(s) Department Sponsor signatureTeam Leader Department Team Leader signatureTeam Members Department Members’ signatures

AHFMR SCREENING PROCEDURE 13VENDOR AND EQUIPMENT CHECKLIST IOverview of Cost Estimates(to be completed by purchasing department and customized accordingly)The purpose of this checklist is to examine the advantages and benefits of each vendor and/or item under consideration. Thecompletion of this checklist should determine the full operating requirements of the technology, the reliability and businessstrength of the vendor, and the scope of possible contractual agreements with the vendor. The unit under consideration shouldbe evaluated against comparable models available from other vendors, including the available options.A special warning is in order for technology that has recently been introduced. In many cases, no reliable information willbe available, the price is likely to drop considerably the year following its introduction, and it may be rendered obsolete bya more refined version.Health technology being considered(attach findings to this cover page) Quote all prices in Canadian dollars.SignatureDate completed1) Proposed Equipment:User Department: Will this equipment/instrumentationreplace existing equipment/technology?2) Equipment Description:3) Approximate Price*: $4) Options/Accessories*: $5) Consumables:(Estimated annual cost) $6) Manufacturer/Distributor:7) Additional Information:8) Approximate Installation Price: $9) Estimated Construction/Renovation Costs: $(including drawing, if appropriate)*If at all possible obtain a written quotation from the vendor; avoid estimates.

14 AHFMR SCREENING PROCEDUREVENDOR AND EQUIPMENT CHECKLIST IIVendor Comparison(to be completed by purchasing department and customized accordingly)Health technology being considered(attach findings to this cover page)1) Manufacturer:Vendor #1 Vendor #2 Vendor #32) Distributor:3) Brand/Model :4) Market Release Date*:5) Head Office:6) Service Department:7) Delivery:8) Current UsersComparison Info:* (Health Canada/U.S.FDA/CSA/UL Approval) For completion after approval of technology in some cases.

VENDOR AND EQUIPMENT CHECKLIST IIICost Comparison(to be completed by purchasing department and customized accordingly)AHFMR SCREENING PROCEDURE 15Health technology equipment being considered(attach findings to this cover page) Quote all prices in Canadian dollars.1) Base Price :Vendor #1 Vendor #2 Vendor #32) GST :3) Other Expenses:4) Freight:5) Customs/Brokerage6) Installation:(By vendor)7) Installation:(by Health Region) *a) Utilities- Air- Plumbing- Electricalb) Construction- Weight/ Dimensions8) Consumables:(Estimated annual cost)* to be completed by Plant Services

16 AHFMR SCREENING PROCEDUREVENDOR AND EQUIPMENT CHECKLIST IVService and Warranty Comparison(to be completed by purchasing department and customized accordingly)Health technology being considered(attach findings to this cover page) Quote all prices in Canadian dollars.1) Warranty Period:Warranty Cost:Vendor #1 Vendor #2 Vendor #32) Service Contract:Term:Type:Price:3) Inservice Education:On site/Off site:Duration:4) Service Training:Level:Price:On site/Off site:5) Manuals:Operation:Service:Schematics:Troubleshooting:Other:

www.ahfmr.ab.ca