Temperature Monitoring Questions and Answers- 6.5.2020 Final.pdf

Restricted Use /CDC FTE Only

Additional Temp Monitoring Questions

1. Is there a good cellular service inside the facilities at all locations?

A: To be determined by the contractor

2. Do you have a specific subcontract management plan template you want created?

A: No

3. For the 15 cache site with more than 4 containers, is it be possible to know how many total containers there are at those 15 sites?

A: The cache site with the most containers currently has 19 containers. “Appendix A – Site Listing - Note: This table is intended for estimation purposes only and may not contain the exact number of locations and containers at time of award.”

14 cache sites with > 4 containers however WMD trucks aren’t included in numbers. 2 WMD trucks with 6 containers on each truck and 2 2050s supporting each truck for data collection.

Cache Site Cont # S2050 #

Site A 19 6

Site B 9 3

Site C 8 2

Site D 6 2

Site E 6 2

Site F 6 2

Site G 6 2

Site H 6 2

Site I 5 2

Site J 5 2

Site K 5 3

Site L 5 2

Site M 5 2

Site N 5 2

4. Will we be able to install on Sat.?

A: No.

5. What are the hours for install during the week?

A: Sites will be available for installments Monday – Friday/ 8AM-4PM as coordinated per the state and government.

6. Do the installers get badged at each location or does the Federal Government give them a badge that gets them in all location?

A: We do not supply badges for entrance, but we (Government) do coordinate with the location POC for entrance into the facility. The vendor must supply a list of personnel in advance that will be supporting the mission prior to trip. Please see Appendix B for more site information regarding sites requiring additional controlled access.

7. Can you clarify that only the service portion of the contract has a limitation of subcontracting?

A: Yes, it only applies to services. This is primarily a services contract.

8. Reference: Solicitation Section & Page: Section 3.5.1 Provide 24/7 phone access for response to any phone or email notifications for SNS, State, and local entities. (Page 18)

1. Contractor shall provide staff to respond to alert notifications and questions 24/7.

2. The contractor shall be responsible for triaging and responding to all alerts/alarms that are caused by a malfunction of their hardware. However, the contractor shall notify the SNS/ASPR POCs if a facility is out of established temperature range or a door alarm has occurred within 15 minutes of incident. All other incidents will be reported within 24 hours after initial alarm.

Q: Please explain the purpose of the live call center and what steps the live responder will need to take?

A: Vendor Technical Support must be able to communicate directly with Site POCs and SNS Logistics POCs and ensure corrective actions are taken when an alarm or alert occurs. The contractor is responsible to investigate alerts/alarms and to perform and/or facilitate for corrective actions. Remote troubleshooting with Site POCs is often part of the process to provide corrective actions. SNS Logistics POCs will be able to assist as a liaison between the site and the contractor concerning the completion of investigations or corrective actions as necessary. The SNS currently conducts monitoring and site support utilizing one on-call technician with secondary technician support as necessary. Many of the current alerts are due to connectivity issues. Our current system utilizes analog telephone lines. The on-call technician currently reports an average of 20 alerts/alarms per week. The on-call technician provides notification of deviations. The on-call technician contacts the appropriate personnel when an alert/alarm notification occurs, investigates the alert/alarm, and resolves the alert/alarm. The on-call technician monitors door alarms for product rotation. Please review the requirements and response times for each type of alert or alarm. “Contractor support staff shall be reachable by phone 24/7.” “Contractor shall provide staff to respond to alert notifications and questions 24/7.” “During a natural or manmade disaster, which SNS classifies as “an event,” the contractor shall provide a status report of temperature monitoring device connectivity. This information must be provided 2 to 4 times daily for requested locations as specified by the SNS Logistics POCs.” Please also see Question 22.

9. In lieu of having a call center, would it be acceptable if the system is capable of providing an automated voice telephone, email, or text message directly to designated SNS/ASPR POCs during an identified excursion or alarm? The system would identify and report the affected device, probe number, location, parameters, high and low limits, and current reading etc.

A: No. The contractor is responsible to investigate alerts/alarms and to perform and/or facilitate for corrective actions. While automated notification systems would be an additional beneficial tool, the contractor will be required to remedy any problem and must be able to be contacted by telephone for questions. “Contractor support staff shall be reachable by phone 24/7.” Please also see Questions 8 and 22.

10. Reference: Solicitation Section & Page: Section 3.5.1 Types of Alerts/Alarms (Page 18)

• Door opened

Q: Door Opened – An alarm, alert, or logged datapoint when the door is opened?

Q: Door Closed – An alarm, alert, or logged datapoint when the door is closed?

Q: Door Opened for amount of minutes before alarm – Alarm Delay or Timer?

• Please add as required.

A: Data points should be logged for all door openings and door closings. Configurations for alarms, alerts, delays, and timers will be provided by the government post-award when analyzing the contractor system and software capabilities. The current delay for the door opening before alarm is 30 seconds but may be required to be changed to meet security and quality control standards. The contractor should present their minimum and maximum delay time capabilities.

11. Reference: Solicitation Section & Page: Technical Approach Item 4 Page 91 The Offerer must provide validation documentation that the information system used for temperature monitoring in the proposal is cGMP compliant.

Q: The Bid requests Validation Documentation that shows cGMP Compliance. Our cGMP documents will take us over the minimum page limit. Is a password protected link to our documentation or a disc mailed to the contract officer acceptable? An appendix with all of the pages will result in an extremely large file that may not be accepted via email. Please provide preference.

A: Password protected link (or zip file) is fine.

12. Reference: Response to Questions: The on-call technician currently reports an average of 20 alerts/alarms per week.

Q: Are these 20 alerts/alarms per week System Wide or 20 alerts/alarms per week Per Site?

A: Systemwide

13. Solicitation Section & Page: Section 3.5.3 Container Moves Page 22 There are three special types of container moves: Special events, Emergency, and Planned moves. All container moves will be determined, initiated, and carried out by SNS. For all of these moves, coordination with SNS Logistics POCs will be needed. Due to the specific need, there may be some locations where maintenance support is required for ensuring connectivity, power connection, and device configuration. As sensors should record data for 30 days, they should report all data once reconnected. SNS will notify the contractor to reconnect the container once it reaches its destination as needed. Once the container has arrived and been connected at the final destination, the contractor shall notify the COR or designee.

Contactor will be responsible for travel to sites as necessary upon coordination with SNS Logistics

POC.

SNS Logistics POCs shall direct contractor to disable specific locations, cache sites, containers, or sensors that need to be disabled permanently or temporarily.

Q: How many container moves are expected each year?

A: “The SNS currently relocates approximately 30 containers per year to various cache sites or special event locations.”

14. Is cellular communications protocol acceptable to all sites? Do we need individual site approvals?

A: Cellular communications is acceptable to the government but needs to be coordinated with each facility manager to ensure noninterference with local equipment.

15. Will the design document include technical and workflow (configuration)?

A: “Prior to conducting any installation and testing, the Contractor shall provide written protocols of the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for the temperature monitoring system at the SNS sites in order for SNS to review and provide approval before the Contractor can execute the protocols. As protocols are executed, reports of progress and any departures from expectations can be noted and provided to the SNS. In addition, the Contractor shall conduct site assessments, develop design documentation, and provide end-of-contract transition support. The Contractor shall provide a single point of contact (Implementation Manager) to oversee the overall/Environmental System implementation.”

16. Could we utilize workflow designs from the existing system, or do they need to be fully and independently developed? A current workflow design or current technical design would be helpful for an accurate quotation.

A: The current system consists of Sensaphone 2050 hardware and software utilizing analog telephone communications. Sensors for up to four containers are hardwired to a single Sensaphone 2050 device which utilizes a telephone modem to relay data to a central server. Workstations are used to interface with individual Sensaphone 2050 devices. The solicitation seeks the best innovative solution possible which may be independently developed to meet the requirements.

17. Are there existing project plans?

A: No, this solicitation is the means by which the government plans to meet its requirements.

18. Are implementation models in the works with historical vendor?

A: No, this solicitation is the means by which the government plans to meet its requirements.

19. Can we review current installation technical and workflow design documents?

20. Are there any Covid-19 restrictions to any of these sites?

A: The vendor will follow health and safety procedures mandated by each individual site to include local, state, and federal (CDC, NIH, etc.) guidelines. The vendor should understand and be prepared that these COVID procedures will vary at different locations and have the potential to change at any given time.

21. System installation: Can the customer assume any responsibility for installation of hardware on-site? Will each site will require an IQ/OQ/PQ certification upon installation, or can we do one overall certification for the entire system installation?

A: No regarding the customer assuming any responsibility for installation of hardware on site. The vendor is expected to perform installation of hardware on-site. Some collaboration with Site POCs and SNS Logistics POCs is expected.

A: One protocol to test the system is acceptable with additional documentation as each facility is brought online. The protocol and process to install in the facilities will require review and approval prior to execution. 21CFR Part11 Compliance and Validation of Computerized System - The contractor shall be responsible to ensure that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21CFR Part11 compliant and are validated as per Software Development Life Cycle (SDLC) concept. A periodic performance review process must also be in place to ensure that all such systems remain in the validated state throughout their lifecycle. Prior to conducting any installation and testing, the Contractor shall provide written protocols of the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for the temperature monitoring system at the SNS sites in order for SNS to review and provide approval before the Contractor can execute the protocols. As protocols are executed, reports of progress and any departures from expectations can be noted and provided to the SNS.

The vendor is responsible to install and configure the system/components based on an approved standard operating procedure (SOP).

Testing after installation will include:

• Alarm testing and all parameters are checked (e.g. door opening, battery, etc.)

• Calibration information before and after installation (all certifications need to be

NIST traceable)

• All system functions check that demonstrate system communicate and functions as intended.

After each installation, the vendor will be required to provide documentation of a successful Installation at each facility/site to include but not limited to the following:

• Site location

• Equipment information (unique equipment identifier)

• Review and approval of installation documentation by Quality and/or appropriate

Department/group certifying installation at each site is successful.

22. Troubleshooting/Repair. Will there be any capability for on-site assistance for troubleshooting or repair from employees at the site? Many issues are easily addressable by the local employees.

A: Site POCs may be asked to assist only in basic troubleshooting and repair procedures such as verifying site power or environmental conditions, checking external LEDs, verifying device connections are secure, visually inspecting cables or devices, visually inspecting containers or doors. Site POCs currently remotely support the on-call technicians as they are able. Communication is with Site POCs is documented and conducted by phone and email. Any concerns or issues regarding requested Site POC support should be directed to SNS Logistics POCs.

23. Will 28 days of direct sensor data storage suffice?

A: Proposals are technically evaluated on criteria such as strengths, weaknesses, and risk to the government. “The hardware must be able to record temperature and door breaches to support temporary moves, temporary power outages, etc. and generate reports once re-connected. Temperature data should be recorded every hour. Sensors should be able to retain a minimum of 30 days of data available for upload at a future time if connectivity is not active. Alert or alarm event data should also be retained for a minimum of 30 days for upload at a future time if connectivity is not active.”

24. Does the client NOT require any alerts while the containers are in route to a new location? Is it acceptable to read and transmit the stored temperature data only upon arrival at the new location?

A: Yes.

25. When the containers are moved, are they always transferred to a site that is identified and configured?

A: Vendor Technical Support will be notified by the Site POCs and/or SNS Logistics POCs of any planned container moves. SNS Logistics POCs ensure a site survey is conducted and the site is identified during a planned permanent container move. The vendor is responsible to perform or maintain any technical or system configurations as needed for all types of container moves. In certain circumstances, this may require vendor on-site support. The vendor should be prepared to remotely support any unscheduled container moves. Collaboration with Site POCs and SNS Logistics POCs is expected. “The SNS currently relocates approximately 30 containers per year to various cache sites or special event locations.”

26. What is the chain of custody of the container and is there ever a delivery to an unknown or unconfigured site? Is there ever an instance upon delivery where monitoring would no longer be required?

A: (1st question) Never a delivery to an unknown site. Yes, we do have deliveries to sites that are not configured. (2nd question) Only when they are returned back to the government (DSNS).

27. Is there a requirement for notification of tampering of the container while it is in route?

A: Yes

28. Is there a requirement for monitoring of humidity?

A: Not at this time

29. . Can the door open/ temperature systems be two different systems? Do the reports from both need to be integrated?

A: Please provide the best solution for the government’s requirements.

30. Would there be a way to assess basic known cellular signal strength at all facilities prior to install?

A: No

31. What is the preferred recalibration frequency?

A: Per Appendix D (12) annually. Not to exceed 18 months based on past documented performance.

Please provide the best solution for the government’s requirements. A system that requires less frequent maintenance is desirable, but the system must also be fully validated to perform at acceptable quality standards.

32. Is it possible to confirm that the definition of “wireless” in this application is incorrect when comparing to Wi-Fi

A: A specific wireless standard was not listed to allow contractors the flexibility to choose a technology best suited for the site which the equipment is located. Typical standards include Zigbee, Z-Wave, Lo-RaWan, LTE-M, IEEE 802.11af, IEEE,11ah, Cellular and WI-FI.

33. What is the estimate for system training (to include US government, state, and local entities?

A: No system training is required for government, state, and local staff. Training and certification documentation are required for vendor personnel as addressed in the solicitation.

34. Online visits by contractors: How often would on site visits by contractors be needed?

A: A system that requires less frequent maintenance is desirable, but the system must also be fully capable to perform at acceptable quality standards. “Temperature sensors must be calibrated on an annual basis (within 12 months of the last calibration date).”

“The SNS currently relocates approximately 30 containers per year to various cache sites or special event locations.” Please also see question 31.

35. Does the Government have any expectations on data ownership?

A: “All data related to the temperature monitoring system including, but not limited to, temperature data, maintenance records, and calibration activities shall be saved and archived for 5 years by the Contractor. Contractor shall retain all sensor data collected for the life of the contract and provide a complete digital copy of the data to the SNS at contract expiration, in a format specified by the SNS.”

36. Does the vendor need to have an on-call technician available 24/7?

A: “The contractor shall provide staff to respond to alert notifications and questions 24/7. The contractor shall notify the SNS/ASPR POCs if a facility is out of established temperature range or a door alarm has occurred within 15 minutes of incident. All other incidents will be reported within 24 hours after initial alarm.” Please also refer to answers within the initial Q&As already provided to all.

37. Reference: PWS 3.2.2 states that “Contractor shall submit an initial schedule with dates and cities per day for entire implementation with proposal.” The Performance Standard for PWS 3.2.2 states that “All the facilities identified for SensaPhone replacement or new installation are operationally functional by 30 September 2020.” The time required to order and receive FedRAMP certification, the significant amount of equipment needed, ship it, coordinate scheduling, and installing at all sites will realistically take six months from the date of the first installation.

Q: Will the Government please consider removing the 30 September 2020 due date and replace it with 180 days from the date of the first installation?

A: No, this date coordinates with fiscal year end and is therefore advantageous to the Government. The Government has the flexibility to extend the current contract to allow for additional transitional time if needed but would prefer to avoid this.

38. Page 88 of the solicitation states, “Document the decision-making authority of the project director as related to other elements of the organization, yet the Answers to the Questions state “key personnel consists of a Project Manager, Financial POC, and Technical POC”.

Is the Project Director referenced on page 88 actually supposed to by the Project Manager or are the Project Manager and Project Director different positions?

A: They are the same position.

39. Two different RFP numbers appear in the solicitation - 75A50120R0019 and 75A50120R00019. Which solicitation number is correct?

A: 75A50120R00019.

40. The solicitation does not specify any font style and size; line spacing (e.g., double-spaced, single-space); margin sizes; and/or other formatting requirements/restrictions. Does the Government have any formatting preferences?

41. The solicitation does not specify a naming convention for proposal files to be submitted via email. Does the Government have a preferred naming convention?

A: No, but it needs to be clear which is the technical proposal, and which is the cost proposal.

42. Will the Government allow Offerors to submit descriptive literature (e.g., system brochures, technical drawings, spec sheets) in an Appendix to supplement our Technical Approach? If so, will the Government exclude such literature from the page count?

A: Yes. Yes.

43. Page 89, Item M. 4, Similar Experience says “The Offeror shall provide a one-page description of three contracts or task orders completed within the past three years….”

Question: Is it acceptable if an Offeror provides similar experience descriptions where the experience was for the same contract but the experience was for different entities within the same government organization? i.e., Can one contract be counted as two past similar experience references if the work was for two different entities within the same agency?

44. If an Offeror has a long-running, often-renewed contract for more than a dozen years, is it possible to use this one contract to take the place of more than one of the three required descriptions?

A: No, but failure to have three required descriptions is not disqualifying. It may, however, result in a lower score in that particular area.

45. If an Offeror submits a proposal that has only two references for Similar Experience, will it be evaluated/considered by the Government?

A: Yes, see answer to 44 above.

46. The subsection numbering on the Performance Work Statement, Section C, is not consistent and in some cases duplicative. Please assist with the following:

Under 2.3, Contract Administration and Management, the PWS says that 2.3.1 is Contract Management, page 11. It also says on page 11 that 2.3.2 is Contract Administration; however, on page 12, there is a different subsection also called Contract Administration that is numbered 2.3.3.

Which of the sections should be 2.3.2? which should be 2.3.3? and if there should be a different title and/or number on the subsections, what should it be?

A: The numbering and labeling in the original solicitation is correct. There was a computer error when creating the revised solicitation that resulted in incorrect numbering. Numbering and labeling has been revised back to what was in the original solicitation.

The 2.3.3 header has been eliminated and both sections of text now appear under 2.3.2.

47. Also, under 2.3, if changes are made to the numbering, the current subsections 2,3,4, 2.3.5, and 2.3.6 will overlap and need to be changed. Please advise to what these numbers should be changed.

A: See answer to 46 above. The new sections are 2.3.3. Contract Project Management Plan, 2.3.4. Kickoff Meeting, and 2.3.5. Ongoing Progress meetings.

48. On page 13, there is a section 3.1 “Prepare Project Plan.” However, there is no 3.2 to follow it. What should 3.2 be titled?

A: See answer to 46 above. 3.2 is titled Equipment installation and removal.

49. On page 14 there are two different sections numbered 3.2.2—one at the top of the page with no content under it, and one in the middle of the page. Should the one at the top of the page be renumbered?

A: See answer to 46 above. There is only one 3.2.2. in the revised solicitation.

50. On page 14, under 3.2.2 (1) b, it says “Within 10 days of contract award the contractor shall submit a schedule for the first 30 days of site visits. Thereafter, the contractor shall submit a schedule every 30 days where the first visit on the schedule is no sooner than 30 days from the date of submission.”

Question: Does the second sentence mean that the second such schedule must begin 41 days after the date of submission? Could the Government please clarify this with an example using Day 1 to mean the date of submission, and provide details regarding the subsequent dates?

A: The Government simply wants you to submit a monthly report of planned site visits at least 30 days in advance. So, on January 1, you would submit all planned visits for February. No later than Jan. 29th, you would submit for March and so on.

51. On page 15 the PWS says 3.3.3 is Reporting…but there is no 3.3. Should this number be changed to 3.3 for Reporting?

A: See answer to question 46 above.

52. On page 16 the PWS says 3.4.4 is Maintenance. But there is no 3.4. Should this number be changed to 3.4 for Maintenance?

A: See answer to question 46 above. It has been revised to 3.3. as in the original solicitation.

53. On page 18 the PWS lists 3.5.5 as the Monitoring and Help Desk subsection. But there was no 3.5, Should this number be changed to 3.5 for Monitoring and Help Desk?

54. Will the Government consider an extension given that so many questions that have a significant impact on proposal content were answered less than 2 weeks prior to submission?

A: An extension is being granted to 6/12. There will be no further extensions.

55. Does the Davis Bacon or Service Contract Act apply to this solicitation?