Attachment_7-QA_Document-16Q5004.pdf

SP3300-16-Q-5004

Attachment 7 - Previous Questions & Answers

1. Note: Reference Solicitation SP3300-16-Q-5004, Page 16 of 39: paragraph (2)1.b. "One (1) sample of an orange front face label as indicated in Paragraph 3.3.10.1 of the specification".

2. Each question has been redacted to ensure anonymity. The Government response is provide in the far right-hand column for each question.

No. Contractor Question RFQ Reference RFQ Reference Paragraph

Government Response

1 Attachment 1 Schedule of Supplies only lists TT4 P/N T4100-01-360 which is the standard 2 to 8 C temperature monitor. Is this the only monitor to be quoted?

Attachment 1 NA Yes; however, it should be noted that Attachment 1 Schedule of Supplies/Services includes “or the item must be equivalent to the salient characteristics listed in Attachment 3 – Specification Sheet No. 1”.

2 Attachment 1 Schedule of Supplies only lists TT4 P/N T4100-01-360 which is the standard 2 to 8 C temperature monitor. Are we to quote single use or multiple use or both or either?

Attachment 1 NA Single use

3 What is a non-RFID shipment? Attachment 3 1.2 and 2.1 These temperature monitors will be used on Class VIII medical material shipments, which cannot include RFID tags for cargo monitoring.

4 How is non-RFID defined?

"How is non-RFID defined?" more clarification is needed. It is well understood that the acronym RFID means Radio Frequency Identification. The question goes deeper into which types and use cases for RFID are excluded. Most consider RFID to be an automatic information technology (AIT) that would be used to interrogate a tag when co-located with the product. What if the device were removed from the carton containing product before any one or two way wireless interaction occurred?

There a a number of low power desktop readers on the market today - some with serial port connections. This procedure is the same as removing and reading a Sensitech Temptale using

Attachment 3 3.3.1 Radio Frequency Identification – the temperature monitors used with Class VIII medical material cannot function using RFID tagging to monitor time and temperature.

Radio Frequency Identification – the temperature monitors used with Class VIII medical material cannot function using RFID tagging to monitor time and temperature. It cannot use RFID transmissions to transmit the time and temperature data while the shipment is in transit. That technology would be acceptable as a means by which to "download" the data from the monitor itself once the shipment is received, and the material and monitor are unpacked and separated from each other.

Government Response a docking station with a wired serial port connection.

5 Are single use or multiple use units preferred?

How will prices for single use and multiple use units be compared?

Attachment 3 3.3.1 Single use

6 Which is required 2k or 16k EEPROM? These are vastly different memory capacities.

Attachment 3 3.3.4 For the purposes of this solicitation, 2K

7 Why is Flash memory excluded? Flash or EEPROM are equally applicable memory formats for these units.

Attachment 3 3.3.4 Flash memory is an acceptable option

8 Which is required 1970 data points or 16000 data points? These are vastly different data capacities.

Attachment 3 3.3.5 For the purposes of this solicitation, 1920 data points

9 When does the LCD need to display data? At packing and unpacking or also in transit?

Attachment 3 3.3.7 Unpacking

10 The operational ranges go from –80C to 70C but monitor to be quoted needs to measure product in the 2C to 8C range. Why the huge operational range for a very small measurement range?

Attachment 3 3.3.8 The US Military logistics transit lanes present considerable risk to these temperature sensitive medical items being shipped. It is not unreasonable to expect that exposures to the products could get up to 70C (i.e. Southwest Asia) or as low as -30C (i.e. Greenland)…so while the material itself has a small measurement range for storage, the ambient ranges that could be applied to the shipping container far exceed that.

NOTE: The Dry-Ice parameters of this specification do not apply to this solicitation, so the applicable operational range is 70C to -30C only.

11 The Dry Ice Monitor alarm ranges start at – 80C.

This is the lower edge of the operational range of the Dry Ice Monitor. So how is an alarm at –80C possible when the unit can’t even operate below this level?

Attachment 3 3.3.9 The Dry-Ice portions of this specification are not applicable to this solicitation.

12 Is the unique identifier on or under the removable adhesive tape?

Attachment 3 3.3.10.3.1 Both – Attachment 3 paragraph 3.3.10.3.1 has been revised to indicate the unique identifier shall be on the device itself and on the removable adhesive tape.

13 The temperature accuracy ranges are conflicting.

+/-1.7C from –80C to 30C is in conflict with all other ranges from –30C to 70C.

Attachment 3 3.4.1 The Dry-Ice -80C range is not applicable for this solicitation.

Government Response

14 Except for –1C to 10C all other accuracy ranges are irrelevant to measuring 2C to 8C.

Attachment 3 3.4.1 The desired packaging is 2-8C, and while the ideal is to confirm the packaging remained in that range…when it doesn’t (i.e. up to 70C or down to -30C), we need to be able to obtain specific, accurate readings of those exposures in order to determine material efficacy

15 Max 30 days of recording? So DLA does not want to be able to record any more than 30 days?

Attachment 3 3.4.4 - Yes, only 30 days

- No, we do not require more data than that

16 Does there need to be an actual physical button or just the ability to be started manually? It is possible activate a device manually using light, sound, radio frequencies, etc. with and without other electronic devices. A mechanical push button is old, expensive technology. The requirement should indicate the need for a manual start.

Attachment 3 3.4.6 The ability to start manually is the requirement.

17 What time should be displayed? Time of day?

Time of event? Length of event? Something else?

Attachment 3 3.4.7 Length of event

18 What is the purpose of marking a timestamp event?

Device is in a shipping carton. How can an event be marked that is not already programmed to be marked? Does someone open the carton and push a button to mark an event?

Attachment 3 3.4.8 Yes, there are scenarios where the boxes are opened and repackaged for another leg of the supply lane…or the cold chain status has to be determined while enroute before it can move again. In these instances we require that the event be marked so that it can be part of the entire supply chain evaluation at final material receipt

19 Specs to this hardware need to be provided so that compatibility can be determined. There does not appear to be any desktop hardware with optical communications on the Sensitech site.

Attachment 3 3.7.1 If the vendor is not part of the current infrastructure, the TTMD reference is not applicable to them.

20 Can offerer sell used and recycled monitor back to DLA? This will impact pricing.

Attachment 3 3.8.1 No. The temperature monitor device shall be new.

21 Hardware/Software requirements.

Shall be compatible with the Government’s current hardware/software infrastructure (TempTale Manager Desktop (TTMD) Software and Interface Plus optical communications hardware). As an alternate, the Contractor shall provide the required

Attachment 3 3.7 3.7.1

The number of hardware/software unit replacement as required in accordance with paragraph 3.7 of the Specification Sheet No.1 is listed in Attachment 1 – Schedule of Supplies, Item No. 0002.

Government Response number of hardware/software units to replace the current infrastructure, as determined by the Government. We would need to know the number of users so we can match up to the seats required.

No. Contractor Question Government Response 22 The offeror shall provide with their quote for evaluation

What will be the test procedures for these samples be and will they be returned after the testing has taken place?

Providing a sample set of the hardware/software infrastructure could be cost prohibitive if not returned.

Is there the possibility of an onsite demonstration and user instruction session and an opportunity to address questions after the technical team evaluates the samples when retrieving the samples in person? This could include the contracting team. Since new systems are in competition with existing systems that the technical team has used for years, these sessions seem like the fairest path. Generally new systems get rejected because of a lack of user familiarity rather than lack of functional competency.

The monitor will be started, used to monitor a test shipment from DDSP, and then downloaded on the provided hardware/software.

After the Government completes the final technical evaluation, a sample set of the hardware/software infrastructure used for the test can be returned to the offerors if the offerors desire. Each offeror is required to provide shipping instructions of returned sample set of the hardware/software. NOTE: the Government is not responsible for the shipping costs of the returned sample set of the hardware/software.

An on-site demonstration can be arranged, but will be conducted on a voluntary basis by each offeror, including the OEM after the closing date of the solicitation. Each offeror will be queried within seven (7) days after the closing date of the solicitation as to their interest in presenting an on-site demonstration of their product. There will be no discussion of the demonstrated product at the time of the on-site demonstration. In addition, the Government is not responsible for any costs the offerors incur for this demonstration.

23 Volume 2: Technical Quote: Past Performance - As we will be providing the Brand Name, are you still requiring a technical quote including past performance details. Should the past performance details be required, should the questionnaire be sent to DoD contacts only?

Past performance standard is based upon the offeror’s ability to substantiate credible examples of past performance associated with their commercial and Government offerings, inclusive of delivery, schedule compliance, product quality, and overall customer satisfaction. Offerors may send their questionnaire to government/commercial contacts.

24 Subcontracting Plan: If we are exempt from submitting the technical quote, is the subcontracting plan part of Volume 2 and thus we do not need to complete it?

Should we be required to submit the subcontracting plan, page 19 states that the plan is required within 3 business days of notice before the contract is awarded? Does this mean we do not need to submit the plan with the quote by the 29th?

Subcontracting plan is required for ALL large businesses.

The subcontracting plan from a large business is not required to be submitted by the closing date of the quote. However, the submission of a subcontracting plan is required within three (3) business days following notification by the Contracting Officer or Acquisition Specialist.

25 Is this an IT exemption for the Buy American Act? The Contracting Officer has determined a waiver to the Buy American Act is no longer applicable for this acquisition. FAR 2.101 definition of “Information Technology”, sub paragraph (3)(ii) makes clear that temperature monitors do not qualify as Information Technology. Accordingly, evaluation of foreign products will be in accordance with DFARS 225.105.

26 Reference Attachment 3, paragraph 3.1 Will the unit material be required to meet international protection class 65 (IP65) and/or restrictions on hazardous substances equivalent to 2002/95 EC Directive (RoHS)?

No.

27 Reference Attachment 3, paragraph 3.3.5 Please confirm that the storage capacity of 16000 temperature data points (including time and date stamp) versus 1920 points as listed.

For the purposes of this solicitation, the requirement is 1920 data points.

28 Reference Attachment 3, paragraph 3.4.3 Is there a desired Tau rating per US Pharmacopeia general chapter <1118> (attached - i.e. pg5, par3: 5 minutes or less for goods in transit)?

No.

29 Reference Attachment 3, paragraph 3.3.9 Specifications describe alarm capabilities. Is there a requirement for a time/date stamp and ability to differentiate alarm type via display for all alarms?

Reference paragraph 3.4.8, Attachment 3 - Specification Sheet: “Shall have the ability to create a marked event date stamp”.

The device will be required to indicate an alarm trigger for any exposure above 8 degrees C or below 2 degrees C.

30 Reference Attachment 3, paragraph 3.3.10.3 Is the unique identifier required to be both human readable and machine readable?

No, only human readable is required.

31 Reference Attachment 3, paragraph 3.4.7 The device will be required to indicate an alarm trigger for any exposure above

Does the unit need to be able to identify which alarm has been triggered and provide duration of alarm times?

8 degrees C or below 2 degrees C.

Reference Government Response #17.

Contractor Question Government Response

32 If in Question/Answer 22, the Government is going to ship a sample from point A (DDSP) to point B, where is point B and wouldn't the Government possibly need two (2) sets of the hardware/software sample?

Only one set of hardware/software will be needed.