Attachment D-8 Technical Scenarios 1 2 and 3.pdf

ATTACHMENT D-8

Technical Scenarios #1, #2 and #3

Technical Scenario #1: Provision of Comprehensive Service Plans, Repair-only plans, and Preventive maintenance plans on specific instruments or groups of instruments (Attachment D- 9_ TableA1.xlsx).

The FDA has a several instruments for which it requires instrument-specific service plans, designated as Firm Fixed Price Comprehensive Plans (FFP CP), Firm Fixed Price Repair-Only (FFP RP) plans and Firm Fixed Price Preventive Maintenance (FFP PM) Plans. See the Statement of work for definitions. Table A1 lists instruments for which such plans are required. Column definitions for Table A1 are listed below and as footnotes to Table A1.

Provide a response that addresses questions Section A for the information in Table A1. Some answers will be provided directly in the table (as indicated) and the remainder of the questions will be answered in a short narrative.

A. Comprehensive service plans (CP), repair-only plans (RP), and preventive maintenance (PM) plans for specific instruments in Table A1.

1. Can the Offeror provide its own Firm Fixed Price Comprehensive Plans (FFP CP), Firm Fixed Price Repair-Only (FFP RP) plans and Firm Fixed Price Preventive Maintenance (FFP PM) Plans on the specific instruments in question, wherein the instrument OEM or OEM qualified repair provider will provide the service? Provide Yes or No answer in column J.

2. If the answer in column J is No, please explain in column K the type of coverage that could be provided. Briefly indicate the nature of the coverage, who would provide the repair service and how it would be coordinated. Provide a more detailed general explanation for all such instruments in a separate paragraph.

3. In the event you do not offer FFP CP, FFP RO and FFP PM coverage on the specific instrument in question, or in the event of a specific FDA request for an OEM service contract or PM agreement, are you able to purchase OEM service contracts or PM agreements for the specified instruments on behalf of the FDA? Provide the answer in column L.

4. Describe any coverage exclusions for FFP CP or FFP RO plans in column M. For example, if turbomolecular pumps are not covered in the plans for mass spectrometers, or image intensifiers are not included for optical instruments, list those components in this column for the specific instrument in question.

5. Provide the price to add the excluded components to the FFP coverages in column N (or simply indicate that they must be handled under time and material repairs if that is your approach).

6. Describe the number of preventive maintenance visits that would be included in FFP CP coverage in column O.

7. Describe any coverage exclusions for FFP PM plans in Column P.

8. Indicate in column P the number of preventive maintenance visits provided in the FFP

PM plan.

9. There are 43 Original Equipment Manufacturers represented in Table A1 and about 180 different instruments or components listed. Most of the instruments come from the following OEMs: Agilent, Thermo Fisher Scientific, Waters, Hanson, SOTAX, AB Sciex, Bahnson, BD Biosciences, Renishaw, Teraview, and Illumina. Explain briefly in a summary separate from Table A1, how the Offeror would work with each of these OEMs to provide repairs or preventive maintenance on instruments covered under the Offeor’s instrument-specific plans. Explain whether the Offeror have a working relationship with each OEM (or list those OEMs) and how the Offeror would work with them to provide repairs under your instrument-specific plans. There is no need to provide a separate narrative for each OEM if the general process would be the same for all of them. Please indicate whether there are any OEMs with whom the Offeror does not have relationships or would not be able to establish relationships.

10. If there are situations where the Offeror cannot provide FFP CP, FFP RO and FFP PM coverages (as noted in column K), please explain generally how the Offeror would address this situation for the FDA and provide a specific example (if applicable).

11. Provide a short discussion explaining why there are exclusions from the FFP coverages (Columns M and P) and explain how the Offeror would offer and price supplementary coverage for those components if requested by the FDA (as requested in column N).

For example, if turbomolecular pumps are excluded from the FFP coverages, would the Offeror be able to offer an addendum to the FFP coverage for that instrument to include turbomolecular pump repairs, and how would the Offeror establish the price of those repairs?

A. Definitions of column headers in Table A1:

1. Index: Line Number (for reference).

2. Instrument category: general category of instrument (LC/MS/MS triple quadrupole MS, NMR).

3. Type of Instrument: specific Instrument type (more detailed identifier).

4. OEM: original equipment manufacturer (OEM) name.

5. Model: model name or number.

6. Serial Number.

7. System Identifier/unifier (where multiple components of an instrument are to be quoted as a single system, this identifier unifies the components).

8. Installation Date: approximate date instrument was installed in the FDA.

9. Value: approximate value when installed.

10. Can the Offeror provide instrument-specific plans for this instrument that provide repairs by OEM or OEM-qualified repair provider (Yes/No): Indicate (Yes or No) whether Firm Fixed Price Comprehensive, Repair-only and Preventive Maintenance Plans can be offered for this instrument (or linked components) that provide repairs by the OEM or OEM-qualified repair provider, if specified by the FDA.

11. Comments or Qualifications for Answer in Column J: Provide additional comments to the answer in column J, if the Offeror is unable to provide FFP coverage for this instrument.

12. Can the Offeror purchase firm fixed price service plans for this instrument on behalf of the FDA if the Offeror cannot provide the Offeror’s own coverage?

13. Coverage Exclusions for Comprehensive (FFP CP) and Repair-only (FFP RO) plans:

Identify any components not covered under Comprehensive or repair-only coverage plans (e.g., turbomolecular pumps, lasers, image intensifiers).

14. Cost of adding coverage for excluded components to FFP plans.

15. Number of Preventive Maintenance visits in Comprehensive Plans (FFP CP): Indicate the number of Preventive Maintenance Visits in the specified Comprehensive Plan.

16. Coverage Exclusions in Preventive Maintenance Plans (FFP PM): Identify any exclusions from Preventive Maintenance Plans.

17. Number of Preventive Maintenance visits in Preventive Maintenance Plans (FFP PM):

Indicate the number of preventive maintenance visits in the Preventive Maintenance Plan.

Technical Scenario #2: Time and materials repairs. See (Attachment D-10_Table 2_Technical Scenario #2.xlsx), and (Attachment D-11_ TableA3_Technical Scenario #3.xlsx)

FDA has the need to facilitate 300-400 time and materials (“as-needed”) repairs (as defined in the Statement of Work) per year over its various laboratory locations.

A. Table A2 is a representative list of the instruments for which FDA might need to request “as-needed” repairs, though it is expected that this list will change from year- to-year and within a specific fiscal year. It is not expected or a requirement that this list be updated for an instrument to be covered under time and materials coverage, since the cost of repairs from the OEM will be treated as a direct cost to the Offeror and will be billed as part of the coverage.

B. Table A3 provides information on the expected volume of time and materials repairs and the expected direct costs of those repairs. As noted in the SOW, it is expected that in most cases the FDA will request a repair from the OEM or an OEM-qualified repair provider. Direct costs are defined as all charges associated with a time and materials repair that would be invoiced or charged to the Offeror by the OEM or designated repair provider. Direct costs could include, but are not limited to, labor charges for the repairs, costs of parts and necessary consumables to complete the repair, travel charges to and from the repair site, fees to expedite repairs, and any other customary charges associated with the repair. As direct costs, it is expected that the repair provider would bill these to the Offeror, and the Offeror would pass these costs through to the FDA.

C. Table A3 projects the expected direct repair costs in a typical year, broken down into the groups based on the expected direct cost of the repairs from the OEM or third- party repair provider.

i. Group 1: < $7500; Group 2: $7500-$15000; Group 3: $15000-$25000; Group 4:

$25000-$50000; Group 5: > $50000.

ii. Column B gives an average repair cost for the specified group, and column C gives the expected number of repairs for that cost group.

iii. Column D contains the calculated total direct costs for the specified repair group. For example, for Group 2 ($7500-$15,000 direct cost of repairs), it is estimated that FDA would have 74 calls yearly in that cost range, with an assumed average cost of $13,500 per repair, and a total direct cost of

$999,000. The offeror will use this information to address the questions below and ultimately prepare expected costs to facilitate time and materials repairs for the FDA in the time and materials pricing table.

Provide the information below:

A. In a typical year, 70% of the time and material repairs would be expected to come from the following OEMS/repair providers: Agilent, AB Sciex, Thermo Fisher Scientific, Waters, Life Technologies, Diversified Labs, Shimadzu, Bio-Rad, Diversified, Barber Optics, Perkin Elmer, Milestone, Illumina, Biomerieux, Qiagen, TA Instruments, Microbiology, Luminex, Triangle Analytical and Nova Biomedical. Prepare a response to the following: For the OEMs listed, explain how the Offeror would work with the OEMs to provide as needed repairs for FDA. Include the following, but it is not necessary to repeat this for each OEM.

Summarize for all and note any exceptions for specific OEMs.

1. Does the Offeror have relationships with the identified OEMs or can the Offeror establish relationships with the OEMs to facilitate repairs or one-time preventive maintenance visits (PMs, e.g. not part of a firm-fixed price PM coverage) for FDA instruments? Note any OEMs for which you could not establish relationships to facilitate repairs or one-time PMs.

2. Explain how would the Offeror address the different level of services (turn-around time) the FDA might require, as specified in the SOW? If the FDA requires short turn-around time (2-day or less), how would the Offeror work with the OEM to obtain priority service if the FDA requests it and is willing to pay the additional cost of priority service?

B. Explain whether the Offeror plans to use non-OEM third-party service providers for time and materials repairs, and if so, explain how will the Offeror verify they meet the qualification standards outlined in the SOW. Explain how the Offeror will obtain FDA approval to use such providers?

C. On occasion, FDA may initiate a time and materials service request and terminate the request before the service is actually ordered or performed. Explain how the Offeror will address situations where the FDA may ask the Offeror to perform only part of the service call process and how the Offeror would charge for those cases.

D. Refer to the Time and Materials Pricing Table and explain how the Offeror will arrive at the fee per repair (for the average repair, as defined as direct cost, in that group). For example, if the fee is based on a fixed percentage of the direct cost, explain this, whether the percentage will change each year, and by how much the percentage would change each year. Explain whether the percentage changes based on the average cost of the repair, and whether there is a cap on the total fee that will be charged for the most expensive repairs. If the fee is based on estimated man-hours employed in facilitating (working with the FDA and the repair provider) to have the OEM perform the repair, or any other mechanism that might vary on a per repair basis, please explain this as well. Define any hourly rates and provide any information about assumptions about the number of the Offeror man-hours required to facilitate each repair.

Technical Scenario #3: Management and Coordination of services. See (Attachments D-9, D-10 and D-11)

This information will be used to provide the response for Factor 1 (Technical Response to IDIQ), Section C (IDIQ Management and Coordination of Repair Services). For the situations outlined in section A below, describes how repair services would be handled. Provide at minimum the information required under section B and if an electronic or web-based service call system is used, please indicate how it is integrated into the process. If the system would be the same in each case, there is no need to repeat information under each situation; simply note any new elements in that situation.

A. Situations:

1. Emergency repair (2-day turnaround) for Illumina NexSeq2000 sequencing instrument under Firm Fixed Price Comprehensive Plan (FFP CP). (Line 135 of Table A1).

2. Preventive maintenance visit for AB Sciex 6500+ QTrap under Firm-fixed Price

Preventive Maintenance Plan (FFP PM) agreement (line 109 of Table A1).

3. 7-day turnaround repair of a Thermo QExactive Mass Spectrometer under time and materials (T&M, “as-needed”) coverage.

4. Depot repair for Agilent liquid chromatograph pump component (pump, degasser or similar item) under T&M coverage.

5. Repair with exchange for Agilent liquid chromatograph degasser component under T&M coverage.

B. Information required:

1. Mechanism for taking a service request from the FDA.

2. Actions upon receipt of service call.

3. Process for obtaining quotes for service from the OEM or repair provider, if necessary, under the coverage.

4. Process for setting a “Not to Exceed” level and approval of service at the FDA Center level (individual task order level), if necessary, under the specified coverage.

5. Processes used for real-time tracking of service in progress and providing FDA information on status of the service call.