Amendment 0004 Submitted Questions and Answers.pdf

Amendment 0004 Submitted Questions and Answers

1. FAR 52.216-18 Ordering

a. Question: FAR 52.216-18 states that the ordering period is 24 months from the effective date of award and three possible additional 24-month option periods.

Should FAR 52.216-18 be revised to be 30-months?

i. Answer: yes, that will be revised to 30 months.

ii. Action: The language shall be amended.

2. SOW Section 1.A – Program Overview

a. Question: For OCONUS orders, does the PPV get to choose which of their DCs services OCONUS orders, regardless of location/geography?

i. Answer: Additional language was added as follows:

Note: The distribution center for servicing OCONUS must be within the CONUS United States (excluding Hawaii and Alaska) within the awarded region.

3. SOW Section 1.A. Program Overview

a. Question: Please confirm if the requirement for "a dedicated customer service line staffed 24 hours per day, 7 days a week" is applicable only to Fleet or if it is a requirement for all services?

i. Answer: No, it is applicable to all primary regions, but the language will be clarified to state:

“NOTE: All Primary Suppliers must provide a dedicated customer service line staffed 24 hours per day, 7 days a week for all sites, CONUS and

OCONUS.”

4. SOW Section 1.M. Specialty Pharmaceuticals

a. Question: How would DLA like those items to be communicated for consideration to evaluate appropriately?

i. Answer: Submit to the contracting officer.

b. Question: The RFP states that the BS may (but is not mandated to) order from the specialty pharmaceutical list but is not eligible for a separate distribution fee. Can the Government clarify if the BS is allowed to charge separate distribution fees for Brand/ Generic items and Specialty items?

i. Answer: yes, the BS is allowed to charge two separate distribution fees for brand/generic and specialty.

5. SOW Section 1.N – Implementation Plan

a. Question: How strict is the implementation guideline?

i. Answer: You will have the full 15 days to provide a plan. Language will be updated because testing will most likely take longer than 60 days. We will ensure there is sufficient time for implementation.

ii. Action: Language in SOW Section 13.I.9. Electronic System Requirements will be updated.

6. SOW Section 2.G.9 - Delivery of Routine Orders Submitted

a. Question: We request the Defense Logistics Agency's consideration for including a provision that highlights the importance of notifying the prime vendor if there are any planned closures during normal business hours due to reasons outside of federal business holidays. In cases where we are not informed about such closures, our vendor attempts delivery and incurs costs, resulting in a $50 missed or refused delivery fee as per standard practice.

i. Answer: The customer shall notify the Prime Vendor if there is a planned based closure (e.g. training event, planned construction, etc.). If the prime vendor attempts delivery during a planned closure without receiving notice 24 hours prior from the customer, the PV may submit a re-delivery fee of $50 from the customer credit account, subject to KO approval.

7. SOW Section 2.O.3 - Drop Shipments

a. Question: We request clarification regarding the appropriate Incoterms to be applied when supplier requests drop shipments directly to OCONUS. Is there a specific Incoterm that should be used in these instances? Additionally, please clarify who bears the responsibility for the shipment from the supplier until it reaches the final delivery point.

What incoterms should be provided to suppliers that request it for drop shipments? The incoterms indicate who holds responsibility for shipping and export clearance. Is it possible for more clarity in the SOW?

i. Answer: Incoterms are FOB destination. For OCONUS orders, destination is the PPV distribution center. Drop shipments are FOB destination.

ii. Action: No action required.

8. SOW Section 3.E.2 Electronic Data Interchange Capability

a. Question: The RFP states that the PPV shall transmit Purchase Order

Acknowledgement (855 transaction) after receipt of an order and at “…a minimum, the confirmation shall include the item identification number (National Stock Number (NSN) quantity to be delivered, unit of issue, price, shelf-life status and delivery order number.” Can the Government confirm that they want the NSN number as opposed to the NDC number? Price is determined by NDC and in many instances several NDCs share the same NSN.

Can the Government provide a list of the National Stock Numbers (NSN) corresponding to each NDC?

Can the Government confirm that the NSN field can be blank on the 855 transactions if the product does not have an NSN?

i. Answer: The government does not want the NSN as the order is placed via NSN, the buyer generates the order via NDC. To confirm, the government wants the NDC number on the 855 transactions. A list of NSNs is not needed as the buyer provides the NDC. The NSN field can be blank on the 855 transactions as the government uses the NDC. The language will be changed from NSN to NDC/PVON.

ii. Action: The language shall be amended.

b. Question: is the RFP going to be amended from NSN to PVON?

i. Answer: It will be amended from NSN to NDC/PVON.

9. SOW Section 10.C. Quarterly Usage Report

a. Question: Can you please clarify the timing requirement for submitting the Excel file containing the Quarterly Usage Report? The section mentions providing the report on a quarterly basis, but also states that the file should be submitted within thirty days of the initial request. Could you confirm whether the file should be provided within thirty days after the end of each quarter or if there is a different timeline for submission?

i. Answer: Language will be amended to remove quarterly and change to “upon request.”

10. SOW Section 11.B.6. Unique Entity ID (UEI)/Dun & Bradstreet (DUNS) Number

a. Question: Will the buyer location value in the N1*BY on 850s also change along with the sender/receiver IDs, or does the document only refer to the impact on

EDI sender/receiver IDs? Our current understanding is that the changes mentioned in the document pertain to EDI sender/receiver IDs, but as we currently use DUNS to look up accounts, it would be beneficial to know if there is a potential impact on the ship-to value as well.

i. Answer: Language will be amended to the following: The UEI/DUNS number will be used as the Sender and Receiver ID for EDI transactions that are sent between the Prime Vendor and DMLSS/TEWLS/other EDI retail systems. At some point in time during this contract, the GLN may replace the UEI/DUNS for identification of Sender and Receiver IDs. Any changes to the use of UEI/DUNS number will be communicated via modification in the future.

11. SOW Section 11.C.4 - Distribution Center File #1

a. Question:

#141 ORIGIN_COUNTRY_CD (Country code of product origin) #142 API_ORIGIN_COUNTRY_CD (Country code of drug’s Active Pharmaceutical Ingredient) #143 FINAL_MFG_COUNTRY_CD (Country code of the Final Manufacturing Location) Can the Government share the rationale for why this information is being requested from the PPV?

The majority of Program Items distributed by the PPV are items that are listed on a Federal contract (e.g., DVA FSS, DLA DAPA, TRICARE UF BPA, DoD National Contract, DVA National Contract, etc.). For these items to appear on these Federal contracts, the manufacturers had to provide information to substantiate that these items comply with the TAA. If these items were already vetted by the Federal Government, this effort would be duplicative.

What if the manufacturer is unwilling to supply this information to the PPV? Will there be an option for “U” unknown?

Please clarify the difference between #141 and #143.

i. Answer: #141 Country of Origin is where the production began. #143 Final-Mfg-Country is where production is finished. These could be the same location. These fields will remain mandatory but there will be an option to indicate unknown. If data is available, it should be transmitted.

Having a product on a government pricing vehicle (FSS, DAPA, etc) does not change the need for the most current data.

12. SOW Section 11.C.9 - Distribution Center File #6

a. Question: Please consider removing Velocity Code as a requirement of this file.

This field is considered proprietary and not something that translates into actionable data for a customer.

i. Answer: DMD_FORECAST_30_DAY, DMD_FORECAST_60_DAY, Class Code, and Velocity Code are all optional fields. At least one of the three fields (1. Velocity code, 2. Class code, or 3.

DMD_FORECAST_30_DAY or DMD_FORECAST_60_DAY). This field should encompass ALL demand for the item (commercial and government). The intent is to allow the customers to make sourcing decisions based on the overall demand for an item.

b. Question: The RFP sates that the following fields are mandatory:

#10 DMD_FORECAST_30_DAY

#11 DMD_FORECAST_60_DAY

Can the Government please confirm that this is mandatory for PS only and not applicable to the BS? The BS will not have insight or access to the demand forecast. Accordingly, the BS would be unable to provide the 30-day and 60-day demand forecast.

i. Answer: DMD_FORECAST_30_DAY, DMD_FORECAST_60_DAY, Class Code, and Velocity Code are all optional fields. At least one of the three fields (1. Velocity code, 2. Class code, or 3.

DMD_FORECAST_30_DAY or DMD_FORECAST_60_DAY). This field should encompass ALL demand for the item (commercial and government). The intent is to allow the customers to make sourcing decisions based on the overall demand for an item.

13. SOW Section 11.C.12 – Product Sourcing Request

a. Question: Is it possible to eliminate the requirement for the Product Sourcing Request (PSR) as stated in the current Statement of Work (SOW)? Instead, could usage data be submitted directly to the PPV without the need for a separate request submission process?

i. Answer: We will remove this requirement.

14. SOW Section 12 and Attachment #5 – Preservation, Packaging, Packing, Labeling, and Marking (PPPL&M)

a. Question: While it is not standard commercial practice, understanding the requirement to add temperature indicators to all CONUS Temperature Sensitive Shipments, will indicators be solely used to determine product viability by DLA?

i. Answer: Yes.

ii. Action: No action needed.

b. Question: If a CONUS Temperature Sensitive Shipments is accidentally packaged without a temperature indicator, would product be deemed unusable?

i. Answer: Each case would be evaluated on a case-by-case basis. The process will be outlined during the implementation period.

c. Question: Will the Prime Vendor be expected to replace temperature sensitive product, at no cost to the customer, if an indicator shows a potential issue may have occurred while in transit? If yes, what would be the expectation for replacement product – same day, next day, or next scheduled delivery?

i. Answer: If the product is determined to be compromised during transit, appropriate disposition instructions would be issued. Possible outcomes would be credit issued to the customer by DLA or the Prime Vendor, depending on the situation. The customer would reorder product using normal ordering process.

d. Question: Does DLA have the ability to store and quarantine the suspected excursion product until the disposition is determined?

i. Answer: The receiving activity would be responsible for securing alarmed product until disposition is provided.

e. Question: Are temperature indicators required to be passive or active monitoring devices? Is there a specific device that will be required?

i. Answer: All temperature monitoring devices must be passive (vs. GPS, RFID, Bluetooth, etc.). Specific devices are suggested in the PPPL&M.

Alternative devices can be reviewed and approved by DLA.

f. Question: How will false positives be managed?

i. Answer: They will be evaluated on a case-by-case basis by the Cold

Chain program manager.

g. Question: Should the Prime Vendor expect that salable product returns will also contain a temperature indicator?

i. Answer: No, CONUS MTFs are not required to maintain a cold chain redistribution program.

h. Question: Would DLA TS be agreeable to a pilot of this process, or is the expectation that this requirement will be enforced for the Prime Vendor at a specified date?

i. Answer: The expectation is that it would begin on the go live date. If it is determined during implementation planning that additional time is required, we will work with the prime vendor to establish a roll out plan.

i. Question: The attachment lists two vendors: AcuTemp and Minnesota Thermal Science. AcuTemp, which was acquired by CSafe Global, no longer sells shipping containers that meet the dimensions pre-approved by the DoD. Can the Government provide an alternate DoD approved vendors for CONUS Temperature Sensitive Shipments? A second source is preferred for contingency purposes and/or to mitigate supply chain constraints."

i. Answer: Two additional options and additional language were provided in the SOW Section 12.A.B. Note that these are pre-approved options; the prime vendor can offer alternative solutions for evaluation by DLA.

ii. Action: Language shall be amended.

j. Question: With DODs prohibition against USB plug ins, how would it be handled if a temp monitor with USB was used on a drop shipment?

i. Answer: This would be handled on a case-by-case basis by the cold chain program managers.

k. Question: Will there be the ability for the customer to send back cold chain packaging to the PV if high-cost reuseable packaging is used?

i. Answer: This can be explored during implementation. Historically, efforts to have customers return packaging have had mixed results.

l. Question: Can you please clarify if there is any distinction in requirements between temperature monitoring devices for items that are shipped parcel vs those delivered via cold chain totes.

i. Answer: Vendors utilizing dedicated pharmaceutical tote container systems to move refrigerated and frozen materials via ground courier services (i.e. in-house and/or contracted trucks) in support of locations within the Continental United States (CONUS). The vendor will use one of the temperature monitoring devices in the revised language in SOW Section 12.A.B. within each container or submit an alternative industry acceptable temperature monitoring device to DLA for approval. Vendors utilizing parcel commercial carriers (i.e. FedEx or UPS) in support of

CONUS and/or Domestic locations Outside the Continental United States (i.e. Hawaii and Alaska), will prepare refrigerated and frozen materials utilizing the same stringent cold chain management packaging supplies and protocols that are specified within for the International OCONUS Pharmaceutical Prime Vendor requirements; to include, TempTale®4 Bio (TT4) Temperature Monitors.

ii. Action: Language has been amended.

15. SOW Section 13.I.9. Electronic System Requirements

a. Question: Under what circumstances would the Government expect to shorten the 60-day testing completion to 30 days?

i. Answer: Language shall be amended to remove the option to lessen testing to 30 days.

16. FAR 52.212-1 Addendum #2 Solicitation Provisions- Preparation & Organization of Proposals

a. Question: The RFP states that “the contractor shall submit ONE (1) electronic copy via DIBBS of its non-price proposal which must include: volume 1 and 2.

Can the Government confirm that both the Non-Price Proposal and Price Proposal should be submitted electronically via DIBBS?

i. Answer: The vendor should submit one copy of its proposal which includes volume 1 and 2. Language will be amended.

17. FAR 52.212-1 Addendum #2 Solicitation Provisions- Preparation & Organization of Proposals

a. Question: Please provide further clarification as to whether past performance is required and how it will be used in the evaluation?

i. Answer: Previously, we stated that we shall only review the systems listed in the solicitation for past performance. It was not required. After receiving a few comments about this, we will require vendors to provide some past performance information to review as well.

ii. Action: Language will be amended to include vendor submitted past performance as a requirement.

b. Question: Since the Past Performance evaluation criteria only provides a favorable score (“Acceptable”) and unfavorable score (“Unacceptable”), how can an offeror without a past performance record be rated as neutral in accordance with FAR 15.305(a)(2)(iv)? Will the Government consider requiring all offerors to submit Past Performance information with their proposal?

i. Answer: As per DLA source selection procedures, the lack of past performance can be evaluated favorably or unfavorably. We allow vendors with no record of past performance to be considered “neutral” which is acceptable. They can be deemed technically acceptable but prior to award, they must be determined responsible. To be determined responsible, the contracting officer will request a pre-award survey as per FAR 9.106-1 which will determine if a company can be responsible and perform the requirements. The Government will require all offerors to submit past performance information with their proposal.

ii. Action: Language will be amended to require vendors to submit past performance information.

c. Question: Will DLA consider updating the Attachment 6 – PVR/WRM

Spreadsheet so that both tabs provide, and request the same information?

i. Answer: For the WRM, we were able to provide the NDCs and coverage support qty by region.

ii. Action: Attachment 6 will be updated via amendment.

18. FAR 52.212-1 Addendum #3 Solicitation Provisions

a. Question: quoting as a backup supplier, the requirement would be to have 5% breadth, and 10% depth coverage - On the day-to-day list, there are many items under quantity of 10, meaning if I have at least the quantity of 1 for that item, it would meet the requirement towards 5% breadth?

i. Answer: Breadth is the number of items and depth is the quantity of each item. example - if there are 100 different products and each product has an annual quantity of 100, you would have to provide at least 5 of those products and a quantity of 10 each. The breadth requirement for the backup supplier will be changed via amendment.

ii. Action: Breadth requirement for the backup will be changed via amendment.

19. FAR 52.212-2 – Lowest Evaluated Price & RFP Attachment 2

a. Question: The examples of how offers will be evaluated in the RFP are not consistent with the formulas in RFP Attachment 2 - Price Proposal Submission Spreadsheet.

i. Answer: An updated spreadsheet will be provided.

ii. Action: Attachment 2 will be updated via amendment.

b. Question: Attachment 2 (Price Proposal Workbook) lists the contract time periods as 24 months while the solicitation documents list 30 months. Would you please confirm the total dollar amounts on attachment 2 are based on a 30-month period rather than the stated 24 months?

i. Answer: Typo - The total dollar amounts are based on attachment 2 are based on a 30-month period. An updated spreadsheet will be provided.

ii. Action: Attachment 2 will be updated via amendment.