Attachment 2 - W81XWH20Q0111 Amendment 02.pdf

Question and Answers (Q&A) – W81XWH20Q0111 USAMDA UltraSound Human Portable

AMENDMENT 0002

QUESTION AND ANSWERS

As of 04 August 2020

The Questions due date and time has passed and additional Questions will not be accepted.

The response due date has been changed from 13 August 2020 10:00 AM EST to 25 August 2020 10:00

AM EST.

Vendors are reminded to acknowledge all Amendments with their proposal Submission.

Notice: The Government provides the best answer to those Questions asked. Offeror’s proposal shall be based on the amended Solicitation.

QUESTION SET 1:

QUESTION 1: I know that these systems are to be deployed and I am curious if the systems are required to be laptop style systems.

RESPONSE 1: These are not required to be laptop style systems.

QUESTION SET 2:

QUESTION 1: For the items requested in W81XWH20Q0111- are you able to let us know where these items will be shipping to (facilities where the items will be used)?

RESPOSNE1: These items shall be shipped to Fort Detrick, MD and Tracy Army Depot, CA. However, these are not the facilities where the devices will be used. These ultrasound systems are being procured for use in the Army’s Role of Care 2 and 3 facilities located throughout the world. This includes the Army’s Forward Resuscitative and Surgical Team (FRST) as well as the Triage / Emergency / Pre-op sets.

QUESTION SET 3:

QUESTION 1. Will a single BPA be awarded or multiple BPAs?

RESPONSE 1. Reference Description of Requirement 1.1. The Government intends to issue one (1) Blanket Purchase Agreement (BPA).

QUESTION 2. Is this a Part 12 or Part 15 Acquisition?

RESPONSE 2. Reference Combined Synopsis Solicitation/Instructions 7.1. “ This is a combined synopsis/solicitation issued as a Request for Quote (RFQ) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice.”

QUESTION 3. Is there an Economic Price Adjustment Clause that will be incorporated over the 5 years?

RESPONSE 3. No.

QUESTION 4. Can items be added to the BPA after award and what is the process?

RESPONSE 4. Yes, however this is based on customer needs and determination by the Contracting Officer that it is within scope of the BPA.

QUESTION 5. Will there be an open season for new Ultrasound vendors or products?

RESPONSE 5. No.

QUESTION 6. Paragraph 3.3.2 “Contractor shall provide all available User and Maintainer Manuals”. Can you define when and the format? Can we provide them electronically? Is a copy required in the case with the system?

RESPONSE 6. Need digital copy at time of submission Need hard copy with each unit and a copyright release for digital version (ability to host digital version on Army reference website and reference CDs).

QUESTION 7. Paragraph 3.4.5 Clarify the times are EST.

Time zone may be defined by the vendor.

RESPONSE 7. The Contractor shall provide Operator/Maintainer telephone support during the hours of 8:00 AM to 5:00 PM EST for the entire life of the system.

QUESTION 8. Will non-Army agencies have access to place orders against this BPA?

RESPONSE 8. No, non-Army Agencies will not have access to place order against this BPA.

QUESTION 9. Page 9 states a 10 yea DOD Standardization and the Solicitation states a 5 year BPA for USAMMDA – can you clarify? This is a BPA for a five (5) year ordering period.

RESPONSE 9. This is a BPA for a five (5) year ordering period. A follow-on contract may be awarded thereafter.

QUESTION 10. Essential Characteristics identifies threshold and objective, but the objective is not listed in the table.

RESPONSE 10. The following statement: The threshold (T) is the minimum acceptable essential characteristic value while the objective is a desired level of performance above the threshold, has been removed.

QUESTION 11. Essential Characteristics Number 10 Power. Is a Battery required?

RESPONSE 11. Yes. EC11 Power requires both operation and charging off of standard power supplies.

QUESTION 12. Essential Characteristics Number 14 Cybersecurity. Can you define the requirements?

RESPONSE 12. No

QUESTION 13. Is Needle Recognition Software Required?

RESPONSE 13. No

RESPONSE: 14. Is DICOM Required?

RESPONSE 14. No

QUESTION 15. Is Image Storage Required?

RESPONSE 15. No

QUESTION 16. Is there a requirement to transfer the Ultrasound Images?

RESPONSE 16. No

QUESTION 17. Is there a requirement to display the information on a screen?

RESPONSE 17. Yes

QUESTION 18. Executed Solicitation Documents: I did not see a SF1449 posted to sign.

RESPONSE 18. IAW FAR 12.603(b); This solicitation was issued using the combined synopsis procedures;

therefore the SF1449 is not used when issuing the solicitation.

QUESTION 19. Cost/Pricing Evaluation, c. Options. Can you define Options vs. Basic Requirement? Is the Training costs considered Options?

RESPONSE 19. Yes

QUESTION SET 4:

QUESTION 1. Page 1, Paragraph 7: “Establishment of a Blanket Purchase Agreement”. Can you verify the contractual vehicle that the BPA will be established under?

RESPONSE 1. Reference: Description of Requirement 1.2 “The resultant BPAs will be issued on a DD 1155 and will include Contract Line Items Numbers (CLINs).

QUESTION 2. Page 1, Paragraph 7: “Establishment of a Blanket Purchase Agreement”. Does USAMMRA have ordering authority against the DLA Troop Support Radiology Imaging Contracts?

RESPONSE 2. No.

QUESTION 3. Page 1, Paragraph 7: “Establishment of a Blanket Purchase Agreement”. DLA Troop Support has established Imaging Contracts which include Ultrasound Products and DLA Troop Support is the Executive Agency for Medical Material: Could an RFO be issued under that contract vs. a separate contractual action by USAMMRA?

RESPONSE 3. No.

QUESTION 4. Page 2, Paragraph 9.7 Quotes. Is there a limit to the size of the email message for the proposal? Some of the RFQ items (manuals) required have File sizes are very large and can’t be emailed.

Could an alternate file transfer process be used?

RESPONSE 4. There is a size restriction of 20MB for email. For the electronic copy submissions for manuals shall submitted in MS Word 2000 or higher, but not greater than MS Word 2013, or searchable PDF format. The firewall utilized by the Government contracting office does not authorize or accept zip files.

QUESTION 5. Page 3, Paragraph 1.4 “The Contracting Officer shall review at least annually the resultant BPA and, if necessary, update at that time to maintain awareness of changes in market conditions, sources of supply, and other pertinent factors that may warrant making new arrangements with different suppliers or modifying existing arrangements.” Can you define making new arrangements with different suppliers or modifying existing arrangements?

RESPONSE 5. The BPA is reviewed annually to update any price lists and changes within scope. Any new arrangements with different suppliers would be a new requirement. Modifying existing arrangements would need to be within scope only.

QUESTION 6. Page 3, paragraph 2.3 The cumulative ceiling amount of all Call orders issued against the resultant BPAs for the five (5) year ordering shall not exceed $530,000.00. Does this cost just include the cost of the system or does it include repair parts, accessories, consumables, or Training?

RESPONSE 6. Yes, all of the above are included.

QUESTION 7. Page 4, Paragraph 3.1.1 approximately 11 systems. Is this quantity correct over 5 years?

RESPONSE 7. Reference Paragraph 3.1.1. the estimated quantity is approximately 11 Ultrasound units during the ordering period of the BPA.

QUESTION 8. Page 4, Paragraph 3.1.1 approximately 11 systems. The Army has purchased many more of the current Ultrasound system – can you verify this is the correct quantity over 5 years?

RESPONSE 8. Reference Paragraph 3.1.1. the estimated quantity is approximately 11 Ultrasound units during the ordering period of the BPA.

QUESTION 9. Page 4, Paragraph 3.1.1 approximately 11 systems. Can this quantity or the $530,000.00 dollar value be exceeded in a time of Emergency or during a Pandemic?

RESPONSE 9. No. This is the ceiling amount.

QUESTION 10. Page 5, paragraph 3.3.3 “Contractor shall offer, as part of the contract, training options” Can you define the locations and class size of the training? Can the training be provided remotely?

RESPONSE 10. The government is asking the vendor to provide what they offer to meet the objectives of training. Training must be available for an individual, and for groups. The vendor may choose to provide training at their facility, or at the government’s facility. The vendor may define the size(s) of group training offered. (example: government later determines 22 people need to be trained. If the vendor has group training with a maximum of 25 people, the government will purchase one group class.

If the vendor has group training with a maximum of 5 people, the government will purchase five group classes or four group classes and two individual classes).

QUESTION 11. Page 6, Paragraph 5 Can the ordering period of 5 years be exceeded or can the quantity of 11 systems be exceeded at any time?

RESPONSE 11. No, the ordering period is five (5) years. The quantity is an estimate and may be somewhat higher or lower.

QUESTION 12. Page 9 Paragraph 2 Under the Essential Characteristics they state a threshold and objective, but only the Minimum Requirement is listed in the table. Are these missing?

RESPONSE 12. The following statement: The threshold (T) is the minimum acceptable essential characteristic value while the objective is a desired level of performance above the threshold, has been removed.

QUESTION 13. Page 9, Essential Characteristics Number 1, FDA Approved as a medical device prior to issuance of first Delivery Order. Can you define how a device that is not FDA approved for sale can meet the RFQ Requirement for Maintenance Data (MTBF and MTTR)?

RESPONSE 13. No. it must be FDA approved

QUESTION 14. Page 9, Essential Characteristics Number 2 lists Pelvis exam but an Endocavitary Probe is not required.

RESPONSE 14. Correct. The endocavitary probe is not required as part of the package. If a unit purchases this probe on their own, the device shall be capable of performing the pelvic exam.

QUESTION 15. The Essential Characteristics do not list information on Battery Power. Is a Battery required?

RESPONSE 15. A battery is required (see EC 11’s power requirement to both operate and charge on standard power), but we did not want to set a strict requirement for battery life.

QUESTION 16. Page 10, Essential Characteristics Number 12 Probe Capability. Are three physical probes required?

RESPONSE 16. Yes. All three probes are required.

QUESTION 17. Page 10, Essential Characteristics Number 14 Cybersecurity. Do we have to meet the DOD CyberLOG Cybersecurity requirements? Are there any Post award Cybersecurity Maintenance Requirements?

RESPONSE 17. Yes, The RMF system requires that the product remains secure throughout its life.

QUESTION 18. DICOM was not listed in the Essential Characteristics. Is it required? Are Imaging Storage Requirement on the Ultrasound System required?

RESPONSE 18. No storage requirement.

QUESTION 19. Page 10, Essential Characteristics Is Cardiac Scanning Required?

RESPONSE 19. Yes. See EC 3.4

QUESTION 20. Page 10, Essential Characteristics. Are there any Environmental Characteristics or Aeromedical Requirements?

RESPONSE 20: No.

QUESTION 21. Page 18, Pricing. “It is expected that there will be adequate price competition; therefore, the Offeror is not required to certify cost or pricing data IAW FAR 15.403-1(c).” If an Offer submits a COTS System available on an existing Government Contract, can the requirement for certified cost and pricing data be waived?

RESPONSE 21. There is no requirement for certified cost or pricing data.