ZWI 73.900Effective Date 12/01/08
OSP Product Samples for EvaluationRevision 0
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ZWI 73.900
ORTHOPAEDIC SURGICAL PRODUCTS (OSP) PRODUCT SAMPLES FOR EVALUATION
OVERVIEW
Purpose
/ The purpose of this work instruction is to describe the processes and standards of conduct when furnishing OSP Product Samples to Healthcare Facilities (HCFs).Scope
/ This document provides an overview of the process which will be followed when an HCF requests an OSP Product Sample. To the extent that there are any conflicts between Zimmer Product Samples SOP 73.809 and this ZWI, the provisions of this ZWI govern with respect only to OSP Product Samples.Intended Audience
/ The intended audience for this document applies to Legal, OSP Marketing Management, OSP Finance, Compliance, Distribution and Field Personnel.Prerequisites
/ Zimmer Sample Policy – “Zimmer Product Samples ZP 72.409”, “Zimmer Product Samples”, SOP 73.809 “Zimmer Product Samples” and the Zimmer Code of Business Conduct.Definitions
/ Listed below are the definitions that pertain to this document.OSP – Zimmer Orthopaedic Surgical Products, Inc.
OSP Products – tourniquet cuffs, power consumables, skin grafting consumables, bone cement, cement accessories, autotransfusion, closed wound drainage, wound debridement, pain management and such other consumables as may be included in OSP’s product line from time to time.
OSP Product Samples – OSP Product(s) furnished to a HCF without charge because (i) the HCF is unfamiliar with such OSP Product(s) and has a Bona Fide interest in using or purchasing such OSP Product(s), or (ii) the HCF wants to demonstrate an OSP Product on patients or potential patients.
OSP Product Sample Request Form – means Zimmer Form F-73.900.1.
OVERVIEW, Continued
General Overview
/ OSP Product Samples furnished pursuant to this work instruction must(i)be used in a manner that is consistent with the approved uses indicated on the label of such OSP Product Sample;
(ii)not be related in any manner to the volume or value of purchases of OSP Products or other business generated for OSP or Zimmer;
(iii)not be offered, given or granted as a condition of any contract or service; and
(iv)be available on the same or similar terms to all HCFs.
In addition, HCFs being furnished OSP Product Samples will be prohibited from selling the OSP Product Samples to third parties and from charging the patient or third party payor for such OSP Product Samples.
OSP Product Samples are of a low value and may require use in a human patient to demonstrate the effectiveness and usefulness of such OSP Product Samples. For instance, the disposable blades used in the power equipment sold by OSP have a nominal value per blade. Because the cost associated with each blade is nominal, a HCF will not acquire a cadaver or sawbones to demonstrate the effectiveness of the product because of the cost of such demonstrations. Further, certain blood management devices may only be demonstrated when blood is circulating in a live patient.
To help ensure that all OSP Product Samples furnished to an HCF in any calendar year are of low value and could not reasonably be expected to influence the HCF’s purchasing decisions on the basis of receiving the OSP Product Samples without charge, an overall limitation on the quantity of OSP Product Samples available for evaluation by a HCF would be as follows:
PRODUCT / MAXIMUM EVALUATION PERIOD / EST. # of UNITS
Tourniquet Cuffs / 1 week / 25
Power Consumables / 2 weeks / 20-30
Skin Grafting Consumables / 1 week / 15
Bone Cement / 1 week / 20
Bone Cement Accessories / 1 week / 10
Autotransfusion / 2 week / 20
Closed Wound Drainage / 2 week / 25
Wound Debridement / 1 week / 30
Pain Management / 1 week / 15
Continued on next page
OVERVIEW, Continued
General Overview (continued) / The limitation permits the HCF sufficient time to evaluate the product but allows for differences in use based on the relative size of the HCF and the number of practitioners required to evaluate OSP Products. Each HCF will be limited to sampling one product within each of the above-listed Product types or families per calendar year. Thus, for example, if Hospital A has sampled 2 weeks of blades (up to 20-30 power consumables), Hospital A could not also sample another type of blade or another power consumable during the same calendar year.As long as the above limitations are satisfied with respect to each individual HCF, there is no limitation on the number of unique HCF’s that may receive OSP Product Samples within a calendar year or month. However, eachZimmer independent distributor only will be permitted to furnish OSP Product Samples in accordance with this work instruction a predetermined amount of OSP Product Samples during each month without charge to the distributor. For purposes of determining whether the distributor has exceeded its monthly allotment, the OSP Product Samples will be valued at cost. Additional OSP Product Samples will be made available to the distributor for distribution consistent with the work instruction at the independent distributor price. Charges to independent distributors are strictly for business and accounting purposes between Zimmer and its independent distributors in accordance with their distribution agreements and do not reflect any difference in policy with respect to HCFs under this work instruction.
FLOWCHART
Process Flow Diagram
/ The flow chart below is an overview of the Sample for Evaluation process.SAMPLES FOR EVALUATION
Processing Samples
/ Follow these steps to process samples for evaluation purposes.Step / Action / Parties Responsible
1 / Submit to OSP Marketing a completed OSP Product Sample Request Form F- 73.900.1 and a “No-charge Purchase Order” from the HCF requesting the evaluation. / Field or Distributor Personnel
2 / Review the OSP Product Sample Request Form (“Request Form”) and verifies that the requested volume of OSP Product Samples is:
- within the approved limits for the item requested; and
- meets the guideline for one product within each Product
If the volume requested…. / OSP Marketing will …
within the approved limits and meets the guideline / continue processing the request.
either exceeds the approved limits or outside the guidelines / inform the distributor that the request cannot be processed.
/ OSP Marketing
3 / Enter the evaluation request into the “Distributor Sample Log” maintained by OSP Marketing (Appendix A). / OSP Marketing
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SAMPLES FOR EVALUATION, Continued
Processing Samples(continued)Step / Action / Parties Responsible
4 / Verify through the Distributor Sample Log that the requesting distributor has not exceeded their monthly allotment (in dollars) of OSP Product Samples.
If the distributor is…. / OSP Marketing will …
under budget / process the No-charge Purchase Order so that the requested products ship directly to the account.
OSP Marketing will place “No-charge Evaluation Sample – Customer is responsible for complying with all laws, statutes, codes, rules and regulations relating to the use of product samples including use consistent with labeling and not billing the patient or third party payor for such product sample.” in the comments section of the invoice.
over budget / inform the distributor and advise Warsaw Customer Service in order to place the sample request and charge the distributor the appropriate amount.
Warsaw Customer Service will place “No-charge Evaluation Sample – Customer is responsible for complying with all laws, statutes, codes, rules and regulations relating to the use of product samples including use consistent with labeling and not billing the patient or third party payor for such product sample.” in the comments section of the invoice.
/ OSP Marketing, Customer Service
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SAMPLES FOR EVALUATION, Continued
Processing Samples(continued)Step / Action / Parties Responsible
5 / Print the no-charge invoice through standard processes and ship the sample product(s) to the instructed account location. / Distribution (OSP Dover, Statesville or Warsaw, as applicable)
6 / Maintain the Distributor Sample Log in accordance with Zimmer SOP for proper record retention. / OSP Marketing
7 / Distributor Log information must be input into the “Arrangements Database” pursuant to “Reporting & Tracking of In-Kind Remuneration to HCPs, SOP 73.106”. / OSP Marketing
9 / Follow up with the recipient HCF within ten (10) business days of delivery of the OSP Product Samples to ensure that the samples are being used appropriately at the HCF and to address any potential questions about the products. / Field and Distributor Personnel
APPENDIX A – EXAMPLE DISTRIBUTOR SAMPLE LOG
Example Distributor Sample Log
/ This form is an example of the Distributor Sample Log to be utilized by marketing for the purpose of logging and tracking sample requests.NOTES:
- This log will be utilized to track sample requests for requesting facilities.
- The log will be kept by distributor, by month, with a total page.
- The log will be analyzed on a quarterly basis by reviewing both the “Fair Market Value” (FMV) of samples for specific accounts and the cost of the samples against the distributor sample budgets.
Distributor Sample Log
SUPPORT DOCUMENTATION
Revision Summary
/ Listed below are the changes that resulted in the revision of this work instruction.Applicable Documents
/ Listed below are the documents that are applicable to this work instruction.Appendix A Distributor Sample Log
F- 73.900.1OSP Product Sample Request Form
SOP 73.809Zimmer Product Samples
ZP 72.409Zimmer Product Samples
Zimmer Code of Business Conduct
APPROVAL
Change Management
/ The approved CMS#__MC0000033489__.Prepared by (Process Owner):
P. N. Daniels11/18/08
P. Daniels, Director, OSP MarketingDate
Approved by:
K. Dehaan-Fullerton11/21/08
K. Dehaan-Fullerton, Associate Counsel, LegalDate
W. M. Dorris11/21/08
M. Dorris, President OSPDate
Becky Osowski11/21/08
B. Osowski, Associate Director, Compliance InfrastructureDate
Bruce Robinaugh11/25/08
B. Robinaugh, Manager, Global Customer ServiceDate
Charles J. Pribble Sr.11/19/08
C. Pribble, Finance Director/ControllerDate
Jeff Garr11/25/08
J. Garr, Associate Director, Quality SystemsDate
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APPROVAL, Continued
Approver Responsibility
/ The following shall be responsible for the review and approval of this procedure. The specific reviewing responsibility for each reviewer/approver is also listed.Title / Responsibility
Associate Counsel, Legal / Legal Application
President OSP / OSP Marketing Application
Assoc. Director, Compliance Infrastructure / Compliance Application
Manager, Global Customer Service / Customer Service Application
Finance Director/Controller / Finance Application
Associate Director, Quality Systems / Quality Application
Distribution
Location / A hard copy will be distributed to Location 77 (Document Control - Building 5).UNCONTROLLED COPY
This copy will not be updated. Refer to online documentation for the most current specification.