Temp Monitoring Solicitation Final.pdf

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CODE 18a. PAYMENT WILL BE MADE BY

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FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

ASPR/SNS

ATLANTA, GA 30341

2945 FLOWERS ROAD

ASPR/SNS

ASPR/SNS

OS CODE 16. ADMINISTERED BYCODE

X

X

X

334513

SIZE STANDARD:

100.00 % FOR:SET ASIDE:UNRESTRICTED ORASPR/SNS

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

05/29/2020 1700 ET

04/28/2020

240-401-5253Caleb Owen (No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75A50120R00019

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 127 OS252000OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Washington DC 20201 200 Independence Ave. S.W.

Office of the Secretary

OS

15. DELIVER TO

ATLANTA, GA 30341

2945 FLOWERS ROAD

ASPR/SNS

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

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TION UNLESS BLOCK IS

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SEE SCHEDULEX

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

ASPR/SNS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The Department of Health and Human Services (HHS)/the Assistant Secretary for Preparedness and Response (ASPR), the Division of the Strategic National Stockpile (SNS) has a need to replace its current temperature monitoring and alert system in accordance with the guidelines of the attached solicitation. In particular, the Government is seeking replacement of the old system with a new system (and all associated hardware and software), continued WIFI support, continued 24/7 customer support, and continued

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

Caleb W. Owen

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

monitoring and maintenance of the new system.

Period of Performance: 09/30/2020 to 09/29/2021

1 Base - Temperature Monitoring Units Sensors

System Hardware and Software

Delivery: 09/29/2021

2 Base - WIFI connectivity costs

Delivery: 09/29/2021

3 Base - 24/7 Help Desk Customer Support

Delivery: 09/29/2021

4 Base - Installation/Uninstall, Maintenance

Support and Monitoring

Delivery: 09/29/2021

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

127 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 127

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75A50120R00019

5 Option 1 - WIFI connectivity costs

(Option Line Item)

Delivery: 09/29/2022

Period of Performance: 09/30/2021 to 09/29/2022

6 Option 1 - 24/7 Help Desk Customer Support

(Option Line Item)

Delivery: 09/29/2022

Period of Performance: 09/30/2021 to 09/29/2022

7 Option 1 - Maintenance Support and Monitoring

(Option Line Item)

Delivery: 09/29/2022

Period of Performance: 09/30/2021 to 09/29/2022

8 Option 2 - WIFI connectivity costs

(Option Line Item)

Delivery: 09/29/2023

Period of Performance: 09/30/2022 to 09/29/2023

9 Option 2- 24/7 Help Desk Customer Support

(Option Line Item)

Delivery: 09/29/2023

Period of Performance: 09/30/2022 to 09/29/2023

10 Option 2 - Maintenance Support and Monitoring

(Option Line Item)

Delivery: 09/29/2023

Period of Performance: 09/30/2022 to 09/29/2023

11 Option 3 - WIFI connectivity costs

(Option Line Item)

Delivery: 09/29/2024

Period of Performance: 09/30/2023 to 09/30/2024

12 Option 3 - 24/7 Help Desk Customer Support and

Monitoring

(Option Line Item)

Delivery: 09/29/2024

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

4 127

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75A50120R00019

Period of Performance: 09/30/2023 to 09/29/2024

13 Option 3 - Maintenance Support and Monitoring

(Option Line Item)

Delivery: 09/29/2024

Period of Performance: 09/30/2023 to 09/29/2024

14 Option 4 - WIFI connectivity costs

(Option Line Item)

Delivery: 09/29/2025

Period of Performance: 09/30/2024 to 09/29/2025

15 Option 4 - 24/7 Help Desk Customer Support and

Monitoring

(Option Line Item)

Delivery: 09/29/2025

Period of Performance: 09/30/2024 to 09/29/2025

16 Option 4 - Maintenance Support and Monitoring

(Option Line Item)

Delivery: 09/29/2025

Period of Performance: 09/30/2024 to 09/29/2025

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

75A50120R0019

PART I – THE SCHEDULE

Section B – Supplies or Service and Cost/Price

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This Solicitation (#) is to replace Strategic National Stockpile’s (SNS) current temperature monitoring and alert system, which has reached its end of life, with a new system that is expandable, automated, and meets the program’s needs for regulatory compliance with the FDA's Good Manufacturing Practices

(cGMP) to ensure the safety and efficacy of stored countermeasures.

ARTICLE B.2. CONTRACT TYPE

The Government anticipates the award of a Firm-Fixed Price Contract. However, the Offeror may propose other contract types if it believes them to be most beneficial to the Government.

B.3 CLIN STRUCTURE

This CLIN structure is a suggestion and is not required. Please propose a CLIN structure that you feel best fits the Government’s requirement as the ultimate CLIN structure is dependent on each proposed solution.

Base Period (12 Months)

ITEM SUPPLIES / SERVICES UNIT PRICE NOT TO EXCEED

0001 Temperature Monitoring Units Sensors Systems Hardware and Software

0002 WIFI Connectivity Costs $ $

0003 24/7 Help Desk Customer Support and Monitoring

0004 Installation/Uninstall and Maintenance Support

Option 1 (12 Months)

0005 WIFI connectivity costs

0006 24/7 Help Desk Customer Support and Monitoring

0007 Maintenance Support $ $

Option 2 (12 Months)

0008 WIFI connectivity costs $ $

0009 24/7 Help Desk Customer Support and Monitoring

0010 Maintenance Support $ $

Option 3 (12 Months)

0011 WIFI connectivity costs $ $

0012 24/7 Help Desk Customer Support and Monitoring

0013 Maintenance Support $ $

Option 4 (12 Months)

0014 WIFI connectivity costs $ $

0015 24/7 Help Desk Customer Support and Monitoring

0016 Maintenance Support $ $

SECTION C – Performance Work Statement (PWS)

Stockpile Temperature Monitoring System (STMS)

1. Vision Statement To replace Strategic National Stockpile’s (SNS) current temperature monitoring and alert system, which has reached its end of life, with a new system that is expandable, automated, and meets the program’s needs for regulatory compliance with the FDA's Good Manufacturing Practices (cGMP) to ensure the safety and efficacy of stored countermeasures.

1.1 Background

The Office of the Assistant Secretary for Preparedness and Response Division of the Strategic National Stockpile (SNS) is the Nation's repository for medical supplies, drugs, vaccines and other related equipment. The SNS’s stockpile exists to re-supply state and local emergency medical responders in disaster events, especially biological or chemical terrorism. The stockpile is stored at multiple locations to ensure rapid delivery to areas in need. A CHEMPACK storage site consists of one or multiple standardized purpose-built storage containers, located in a state and/or U.S. territory designated storage facility. See Appendix C for specific information on the storage containers. There are approximately 1,350 storage sites located in the U.S. and its territories. In addition to the CHEMPACK sites, SNS has other medical storage sites which are part of the National Disaster Medical System (NDMS), which also require temperature monitoring. NDMS sites are storage rooms, not containers, that require monitoring.

The current temperature and door monitoring system for CHEMPACK program consists of a SensaPhone 2050 remote monitoring unit connected to an analog telephone line along with internal container sensors and connections to the containers’ dry contacts to monitor to the door status.

The following lists the approximate number of containers at each site:

875 cache sites have a single (primary) container

375 cache sites have two containers

50 cache sites have three containers

35 cache sites have 4 containers

15 cache sites have more than 4 containers

10 NDMS cache sites do not have containers but are monitored.

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

The SensaPhone system has reached its end of life and must be replaced. This is essential to ensure the safety and efficacy of the countermeasures for extended storage per the Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP), and the shelf life extension program.

1.1.1 Purpose

The purpose of the acquisition is to replace SNSs current temperature monitoring system. This includes:

Remove the current system

Replace with a new wireless-based cGMP compliant temperature monitoring system

Provide operation and maintenance of the replacement system

Disseminate alarms and system reports as required.

1.2 Scope

The selected Stockpile Temperature monitoring system (STMS) will be installed in designated storage locations and undergo installation qualification, operational qualification, and report review by the COR or his/her designee. The devices’ status and monitoring functions (i.e., container door alarm, environmental conditions) shall be monitored in an automated, reliable way and on a continuous basis. The monitoring system shall have the capability of remote monitoring and disseminating alarms 24hr/7day a week basis covering all the storage sites identified in Appendix A. The contractor shall provide recurring monitoring and maintenance reports as identified in the SOW.

The list of facility locations and numbers of containers are listed in Appendix A. Due to the confidential nature of the specific site locations, the government will provide the site-specific information once contract is awarded.

The Contractor shall remove the current system and return the removed equipment and sensors, to a location provided by the COR/Designee. The contractor will then install a new wireless system so that designated environmental temperature and door security will be monitored.

The contractor shall use wireless or radio frequencies and protocols that do not interfere in hospital or health care environments and must meet Joint Commission and FDA regulations.

For CHEMPACK cache sites, there are approximately 1963 containers that shall require internal temperature and door monitoring at approximately 1350 locations. For NDMS cache sites, there are approximately 10 locations that shall require room temperature and door monitoring.

For equipment placement, the contractor shall:

Install data collection and transmission equipment in or on the primary CHEMPACK container. The SNS Logistics POCs, will provide a list of primary containers.

o Additional auxiliary equipment, installed in the facility, to facilitate communication between the primary container and the contractor’s communication network is authorized.

o Hardware within containers (not including sensors) shall not exceed 12.1” W, 7.2” H, 1.6” D.

Ensure each CHEMPACK container is equipped with temperature and door sensors/dry contact connection, and these sensors transmit the data collected to the data collection equipment on the primary container.

o Contractor may install a contractor provided door sensor or use the dry contact connections in the SATCO door for monitoring the door status.

o Temperature sensors shall record temperature information hourly.

o Sensors shall be able to retain a minimum of 30 days of data, and the data shall be available for upload at a future time when communication connectivity is restored.

Equip CHEMPACK sites that only have one container with two temperature sensors and one door sensor or dry contact connections.

Install data collection and transmission equipment in NDMS storage locations.

o Additional auxiliary equipment to facilitate communication between the storage location and the contractor’s communication network is authorized.

o Equip NDMS sites with two temperature sensors and one door sensor.

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.

The Contractor shall provide, install, configure, and test a Temperature/Environmental Monitoring System.

The Contractor shall provide hardware and software components and deliver training services. 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.

SNS may require the system to be installed at additional locations.

The contractor shall provide all activities to maintain and repair the system when needed. Equipment will require periodic maintenance and calibration to meet cGMP regulatory compliance.

The Base Period will be funded in full upon execution of the contract. The Options are as follows:

Base Year: 12 months from contract award Option Year 1: 13-24 months from contract award Option Year 2: 25-36 months from contract award Option Year 3: 37-48 months from contract award Option Year 4: 49-60 months from contract award

2. General Requirements This section describes the general requirements for this effort. The following sub-sections provide details of various considerations on this effort.

SNS locations and hosted CHEMPACK sites with Sensaphone telephone gateways (that use traditional landlines), and sensors are to be changed over to wireless state of the art gateways and sensors that use contractor provided communications methods. The replacement system shall be standalone and does not require the local facilities’ communications systems.

We request that solicitors use FEDRAMP authorized applications or use providers that use FEDRAMP authorized applications for this project. We request that solicitations provide FedRAMP authorized temperature monitoring applications or use providers that have FedRAMP authorized temperature monitoring applications. Private contractor-owned/contractor-operated information systems shall comply with the security requirements in section 4.1.1 Security. FedRAMP authorized providers shall comply with the security requirements in sections 4.1.1 Security, and 4.1.2 HHS FedRAMP Privacy and Security Requirements.

After the installation, the contractor shall remain under contract to conduct periodic system and hardware maintenance (e.g., software upgrades, unscheduled services/repairs to the hardware, scheduled calibrations, support scheduled container moves, provide cGMP reports, etc.)

Government users and selected Site staff must receive system generated alarms via voice, text, and, e-mail (i.e., Hi/Low temperature breaches, door openings, power failures, etc.). See Section 3.5.

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.

Contractor shall meet all Quality requirements outlined in Appendix D of this document.

2.1 Non-Personal Services

No personal services shall be performed under this contract. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor must promptly notify the Contracting Officer of this communication or action.

The Contractor must not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee may state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with the contract, Contractor employees must identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government Contractors in connection with this contract, the Contractor employee must state that they have no authority to in any way change the contract and that if the other Contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor must insure that all of its employees working on this contract are informed of the substance of this clause. Nothing in this clause limits the Government's rights in any way under any other provision of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this clause must be included in all subcontracts at any tier.

2.2 Business Relations

The contractor shall successfully integrate and coordinate all activity needed to execute the Stockpile Temperature Monitoring System (STMS) requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

2.3 Contract Administration and Management

The following subsections specify requirements for contract, management, and personnel administration.

2.3.1 Contract Management

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor must maintain continuity between the support operations between sub-contractor locations and the contractor's corporate offices.

2.3.2 Contract Administration

The contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact (Project Manager) between the Government and Contractor personnel assigned to support contracts or task orders. The Contractor Project Manager will be responsible for:

Ensuring proper documentation is delivered to the SNS

Coordinating, escalating, and resolving Contractor-related project issues

Representing the Contractor in status meetings and providing timely status reports

2.3.3 Contract Administration

The contractor shall provide the following management and support as required. The contractor shall provide for employees during designated Government non-work days or other periods where Government offices are closed due to weather or security conditions. The contractor shall maintain the currency of their employees by providing initial and refresher training as required to meet the PWS requirements. The contractor shall make necessary travel arrangements for employees. The contractor shall provide necessary infrastructure to support contract tasks

2.3.4 Contract Project Management Plan

The Contractor shall produce a Contractor Project Management Plan (CPMP) which includes the approach and timeline in execution of the contract. The CPMP shall be updated and amended as outlined in the deliverables table. The Contractor shall update and maintain the COR-approved CPMP throughout the period of performance. The CPMP shall contain a comprehensive Project Schedule including milestones and deliverable dates for the deployment of each Application at each SNS Facility. The Project Schedule shall be broken out by facility and application

Deliverable: Contractor Project Management Plan

2.3.5 Kick off Meeting

The Contractor shall conduct a project kick-off meeting within 15 days after award to introduce the Government team to the Contractor’s overall operating plans and approach to this requirement. The Contractor shall present its draft Contractor Project Management Plan (CPMP) for review with the Government. The Contractor shall update the CPMP based on the outcomes of the kick-off meeting. This meeting shall be virtual or held on-site.

2.3.6 Ongoing Progress Meetings

Monthly, the Contractor shall submit a Monthly Progress Report to include:

Completed activities for the reporting period

Planned activities for the next reporting period

Tracking of current issues and risks

Deliverable: Monthly Progress Report

2.4 Subcontract Management

The contractor shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance on this requirement. The prime contractor will manage work distribution to ensure there are no Organizational Conflict of Interest (OCI) considerations. Contractors may add subcontractors to their team after notification to the Procuring Contracting Officer (PCO) or Contracting Officer Representative (COR).

Cross teaming may or may not be permitted.

2.5 Travel / Temporary Duty (TDY)

The Government anticipates travel under this effort to perform the tasks associated with the effort, as well as to attend program-related meetings or conferences throughout the period of performance. Travel to other government facilities or other contractor facilities may be required and will be specified in the PWS.

All travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the Government (subject to local policy procedures) and is on a strictly cost reimbursable basis. Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs (subject to local policy & procedures; may reference FAR). There are specific CHEMPACK locations that require additional control access in order to gain access. These locations are addressed in Attachment C.

3. Performance Requirements The Period of Performance (PoP) for this contract is 12 months + four option years.

As holidays vary across locations, and this system requires 24/7 coverage, the contractor is expected to provide 24/7 support. Access to installation facilities will require coordination with the COR/designee and the CHEMPACK Regional Coordinators.

3.1 Prepare Project Plan (Project Schedule Report and Project Plan Report)

Using information from the inception meeting, the Contractor shall provide a draft work plan outlining the approach, resources, outputs or products, overall project timeline and key milestones for completing installation of equipment at listed locations.

Information to complete this task will be given during the inception meeting.

Deliverables:

1. Project Plan Report This report shall include the steps in completing the replacement project. Should be delivered within 30 days of contract award. Shall include:

a) Hardware procurement plan

b) Resource management plan

c) Roles and responsibilities

d) Quality Assurance plan

e) Communication plan

f) Risk management plan

2. Project Schedule Report

The updated project schedule will be provided monthly during the replacement project. The minimum requirements of the report shall include the following:

a) Resource loaded schedule

b) Equipment orders

c) Site installations:

1) Location name

2) State

3) Site Location (name of facility/city/state)

4) Date completed

d) Contract Deliverables

3.2 Equipment installation and removal

3.2.1 Use only certified service personnel.

All installation and service personnel shall be fully certified by the manufacturer to install, program, test, and work on systems of this type, and must be either employees of the system manufacturer, or have completed a manufacturer certified training program. The contractor shall provide documentation to SNS from the manufacturer upon award and thereafter annually of all installation and service personnel that have met and maintained certification requirements.

Deliverables:

A007 Certified Service Personnel Report

3.2.2 Develop and coordinate equipment installation plan with the SNS sites Contractor shall provide a schedule for installation which will be given to the designated SNS Logistics POC for coordination. Sites have been provided in Appendix A. Some additional sites may be added if needed.

1) Scheduling will be submitted to the designated SNS Logistics POCs for coordination.

a.) 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.

b.) Contractor shall submit an initial schedule with dates and cities per day for entire implementation with proposal.

c.) Contractor shall submit site schedule to the designated SNS Logistics POCs.

d.) After coordination is complete the designated SNS Logistics POCs will provide the approved listing along with contact information for the contractor to conduct installations.

e.) The designated SNS Logistics POCs will confirm dates/times with Project Areas Coordinators.

a) The designated SNS Logistics POCs will resolve any scheduling conflicts with the Project Area/sites within 10 business days.

b) The designated SNS Logistics POCs will be available for any scheduling conflicts.

Performance Standards Standard: All the facilities identified for SensaPhone replacement or new installation are operationally functional by 30 September 2020.

Acceptable Quality Level (AQL): 100% of installed equipment is calibrated to meet industry and cGMP requirements and is reporting to the central monitoring application. See Appendix D for Quality requirements on qualification testing (IQ, OQ, PQ) of the temperature monitoring system prior to use.

Deliverable: A001 Installation Schedule

3.2.3 Remove SensaPhone equipment installed at SNS sites

Contractor shall remove SensaPhone hardware and return to the SNS. The Contractor shall pack and ship SensaPhone equipment to a designated location. Shipping box shall include legacy monitor and all sensors removed from the container at that site.

Performance Standard Standard: Removal of SensaPhone hardware and functional installation of new equipment is completed on the same day to prevent loss of monitoring data.

AQL: 100% of the time.

3.2.4 Install monitoring equipment at identified sites

Contractor shall provide a schedule for installation which will be given to the designated SNS Logistics POC for coordination. Sites have been provided in Appendix A. Some additional sites may be added if needed.

Performance Standards Standard: All equipment shall be installed per manufacturer’s specifications and the applicable ordinances and codes.

AQL: 100% of the time.

3.2.5 Configure, and test installed monitoring sensors at all sites The Contractor shall configure and test installed door sensor(s), primary and back up temperature sensors at all sites for monitoring and alarm operation. See 3.4.1.

Contractor shall provide detailed wireless and/or radio frequency and protocol information used by devices to SNS Logistics POCs for coordinated wireless deployment approval with health care facilities in order to obtain written clearance from each facility manager prior to installation to ensure that equipment is not interfering with essential facility equipment.

Test Instrument Calibration Records and sensor calibration information will be required upon completion.

See Appendix D

Performance Standards Standard: Contractor maintains National Institute of Standards and Technology (NIST) traceable calibration documents for each sensor installed for the life of the contract.

AQL: 100% of the time

Deliverable: A002 RF and Wireless Protocol Specifications

3.2.6 Provide data archiving by SNS cache location and container 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.

3.3 Reporting

3.3.1 Deliver a monthly temperature monitoring report and monthly planned activity report The Contractor shall submit:

Monthly report of Planned activities for at least 60 days prior to planned event(s)

Report of Mean Kinetic Temperatures (MKT) for all SNS sites for the prior month. The contractor shall be responsible to report Mean Kinetic Temperature calculation in accordance with the current edition of the United States Pharmacopeia (USP) as outlined in Appendix D.

a) Standard: Contractor will provide SNS Logistics POCs a monthly report with projected activities 60 days prior to the planned event(s).

AQL: 100% of the time.

b) Standard: MKT report lists the mean Kinetic temperature for all monitored sites.

AQL: 100% of the time.

Deliverables:

A008 Monthly Planned Activities Report A003 Mean Kinetic Temperature (MKT) Report

3.3.2 Deliver Event Status Reporting

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.

AQL: 100% of the time.

Deliverable: A009 CHEMPACK Container Event Report

3.3.3 Notify the COR/Designee of deviation conditions

1) A deviation is defined as a departure from standard procedures or specifications that could result in non-conforming products and or processes, or where there have been unusual or unexplained events which have the potential to impact product quality or failure to follow quality systems. At a minimum, the following are reportable deviations:

a) Failure to calibrate temperature sensor per Section 3.4.1

b) Failure to follow the contract

c) Failure to use qualified/trained technicians/personnel for a task/job

d) Failure to notify the SNS/ASPR POCs of alarms and deviations per Section 3.5.1

e) Failure to follow contractor’s established written SOPs

f) Failure to repair sensors/equipment on a timely manner per Section 3.4.3

g) Temperature exceeds 86 degrees Fahrenheit for 24 continuous hours

h) Temperature exceeds 104 degrees Fahrenheit for over 120 continuous minutes

i) Temperature is below 46 degrees Fahrenheit for over 120 continuous minutes

j) Data Loss for any reason, including but not limited to, loss of power, connectivity, hardware failure, etc.

2) In the event of a deviation, the contractor is responsible for the following:

a) Report the deviation to Quality Control (QC) Section, CHEMPACK and COR by telephone or email within 24 hours from time of discovery.

b) Resolve the deviation under the guidance of QC Section, CHEMPACK, or COR as appropriate

c) Create documentation in compliance with relevant vendor SOPs

d) Keep a record of deviation and manage trend analysis report

3) See Appendix D for additional quality-related event notifications requirements.

a) Standard: Deviations are reported to the QC, SNS Logistics POCs, COR/Designee within 24 hours AQL: 100% of the time

Deliverables:

Telephone and/or email notification of deviation; Actual telephone numbers and email addresses to be provided after award

3.4 Maintenance

3.4.1 Perform and document initial and periodic validation, calibration, and maintenance of systems at all locations The contractor shall review and check all system configurations and components. Maintenance shall include software updates, battery replacements (due to malfunction or pre-scheduled manufacturer recommendations), and annual measurements of system functionality and connection status.

1) Service will be performed according to manufacturer specifications

2) Systems shall be validated on-site using Installation Qualification (IQ) and Operational

Qualification (OQ) testing and protocols per 21 CFR 211.

3) Temperature and Sensors shall be calibrated with NIST traceable devices.

4) Software shall be validated in accordance with current FDA regulations for electronic system.

5) Validation documentation, manuals, and test results shall be maintained by contractor throughout length of contract and provided as a record of reliable system functions.

Validation protocols must meet compliance with The Joint Commission, the FDA 21 CFR, and CAPA process.

6) Contractor must coordinate all site visits directly with SNS Logistics POCs.

7) Contractor will provide in a spreadsheet format a quarterly validation/calibration/preventive maintenance (scheduled) service report with due date and service completion dates by location or all locations

a) Standard: NIST traceable calibration documents are on file for each sensor installed

b) Standard: Validation documentation, manuals, and test results shall be maintained by contractor and provided as a record of reliable system functions and corrective and preventive actions.

AQL: 100% of the time

Deliverables:

A005 Validation/Calibration Report A010 Scheduled Maintenance Due/Completion Date Report (Quarterly)

3.4.2 Repair monitoring equipment

1) Contractor shall provide technical support, maintenance and repairs necessary to ensure the effective operations of the installed system. Contractor support staff shall be reachable by phone 24/7.

2) Contractor shall provide 24/7 service and support of all equipment and systems to include but not limited to hardware, firmware, software, networking devices, telecommunication devices, wiring, and cables. Service shall be provided on-site if repairs cannot be completed remotely.

3) Contractor shall be responsible to provide all on-site labor, parts, materials, travel, personnel, and shipping for corrective maintenance at all locations. Contractor shall be responsible to coordinate service visits directly with SNS Logistics POCs.

4) Contractor shall send a notification of incident or service requirement within 24 hours to email addresses defined after contract award

5) Contractor shall send a Monthly Alarm and Service report by the 10th day of the month for the previous month to email addresses defined after contract award.

Performance Standards:

a) Standard: Calls answered or responded to within 15 minutes AQL: 98% of the time

b) Standard:

a. Response time: System shall be returned to operational condition within 96 business hours after Government coordination and approval

b. Uptime Rate: 99% of all locations; Uptime is defined as the time equipment and system are operational without restrictions.

Deliverables:

A006 Monthly Alert and Services Report (See 3.5.1) A011 Weekly Unresolved Alert and Services Report (See 3.5.1)

3.5 Monitoring and Help Desk

3.5.1 Provide 24/7 phone access for response to any phone or email notifications for SNS, State, and local entities.

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.

3. The following designees will receive initial alarm notifications:

A. For a temperature, power or door alarm:

1) Site primary or alternate POC

2) The designated SNS Logistics POCs

3) The COR or designees

B. For connectivity and battery alarm:

1) The designated SNS Logistics POCs

2) The COR or designees

4. The contractor shall be responsible for investigating and identifying root cause(s) of all alerts/alarms within 24 hours when requested by the government. The contractor shall be responsible for resolving all alarms in consultation with the COR or designee, in order to minimize interruption of data collection.

5. Contractor support staff shall be reachable by phone 24/7.

6. All responses to alerts/alarms and resolutions shall be recorded and auditable.

Types of Alerts/Alarms:

Temperature exceeds 86 degrees Fahrenheit for 24 continuous hours

Temperature exceeds 104 degrees Fahrenheit for over 120 minutes

Temperature is below 46 degrees Fahrenheit for over 120 minutes

Door opened

Power failure

Connectivity failure (to include Telecommunications/Network/Hardware/Software Issues)

Battery failure

A. A Monthly Alerts and Services Report (A006) will be supplied to represent issues addressed during that month. This report should include all incidents, alarms and service reports from the previous month. This report is due on the 10th business day of the month. This report shall be emailed in pdf form to addressees which will be provided upon contract award. Additional emails if necessary, will be added.

This report shall include the following:

1) Site

2) Container Number (as applicable)

3) Issue

4) Date of Alert or Service Required (Work order initiated)

5) Open or Closed (Status)

6) Date Issue Resolved

7) Actions performed to resolve the issue or why issue is still open. Estimated time for completion.

B. A Weekly Unresolved Alert and Services Report will be supplied to identify any current unresolved alerts and services. This report should include all current open incidents, alarms and service reports. This report is due weekly. This report shall be emailed to addressees which will be provided upon contract award. Additional emails, if necessary, will be added.

This report shall include the following:

1) Site

2) Container Number (as applicable)

3) Issue

4) Date of Alert or Service Required (Work Order Initiated)

5) Actions performed to resolve the issue or why issue is still open. Estimated time for completion.

Performance Standards

a) Standard: Calls answered or responded to within 15 minutes AQL: 98% of the time

b) Standard: Calls no more than 15 minutes on hold AQL: 90% of the time

c) Standard: No more than four (4) validated complaints per quarter AQL: 75% of the time

d) Standard: Notify the Designees via phone, text, and email within 15 minutes of an alert/ alarm.

SNS Logistics POCs will provide the name of the designees upon award.

AQL: 99% of the time

Deliverables:

A006 Monthly Alert and Services Report A011 Weekly Unresolved Alert and Services Report

3.5.2 Disable/Reenable Door Alarms during Product Rotation

Contractor shall coordinate with SNS Logistics POCs concerning planned daily/weekly container door openings where the door alarm will be disabled and then reenabled during product rotation by SNS personnel or onsite local staff. Contractor will provide Scheduled Door Opening report daily to indicate alerts of doors that have been opened during the coordinated period of time.

Performance Standards Standard: Submit daily/weekly Scheduled Door Opening Report as coordinated with SNS Logistics POCs AQL: 98% of time Deliverable:

A004 Scheduled Door Opening Report

3.5.3 Container Moves

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.

SECTION D – PACKAGING, MARKING AND SHIPPING

ARTICLE D.1. POSTAGE AND FEES

All postage and fees related to submitting information, including forms, reports, etc., to the

Contracting Officer or the Contracting Officer Representative shall be the responsibility of the

Contractor. All items to be delivered under the contract shall be preserved, packaged, and packed in accordance with normal commercial practices to meet the packing requirements of the carrier and ensure safe delivery at the intended destination.

ARTICLE D.2. MARKING

All information submitted to the Contracting Officer or the Contracting Officer’s Representative under this contract shall be clearly marked to show the following information on the cover:

Name of the contractor

Contract Number

Consignee’s Name and Address

The title of the deliverables

Date of the Deliverables

ARTICLE D.3. GOVERNMENT ADDRESS

ASPR will inform the Contractor of the address where to ship any purchased equipment or supplies.

Addresses may vary depending on where the items are neede

Section E – Inspection and Acceptance

ARTICLE E.1. SCOPE OF INSPECTION AND BASIS OF ACCEPTANCE

a. Scope of Inspection:

All deliverables will be inspected for content, completeness, accuracy and conformance to Task Order requirements by the COR. The scope and nature of this testing will be sufficiently comprehensive to ensure the completeness, quality and adequacy of all deliverables. The Government requires a period not to exceed fifteen (15) workdays after receipt of final deliverable items for inspection and acceptance or rejection.

b. Basis of Acceptance:

The basis for inspection/acceptance shall be compliance with the requirements set forth in the Task

Order, the contractor's proposal and other terms and conditions of the contract including the

Government Quality Assurance Surveillance Plan (QASP). Deliverable items rejected shall be corrected in accordance with the applicable clauses.

Reports, documents and narrative type deliverables will be accepted when all discrepancies, errors or other deficiencies identified in writing by the Government have been corrected.

If the draft deliverable is adequate, the Government may accept the draft and provide comments for incorporation into the final version.

All of the Government's comments to deliverables must either be incorporated in the succeeding version of the deliverable or the contractor must demonstrate to the Government's satisfaction why such comments should not be incorporated.

If the Government finds that a draft or final deliverable contains spelling errors, grammatical errors, improper format, or otherwise does not conform to the requirements stated within this Task Order, the document may be immediately rejected without further review and returned to the contractor for correction and resubmission. If the contractor requires additional Government guidance to produce an acceptable draft, the contractor shall arrange a meeting with the COR.

c. Written Acceptance/Rejection by the Government:

The Government shall provide written notification of acceptance or rejection of all final deliverables within fifteen (15) workdays. All notifications of rejection will be accompanied with an explanation of the specific deficiencies causing the rejection.

d. Non-Conforming Products or Services:

Non-conforming products or services will be rejected. Deficiencies will be corrected, by the contractor, within ten (10) workdays of the rejection notice. If the deficiencies cannot be corrected within ten (10) workdays, the contractor will immediately notify the CDC CO of the reason for the delay and provide a proposed corrective action plan within ten (10) workdays.

ARTICLE E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This section or other parts of this contract may incorporate one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/far/

FAR 52.246-2 – Inspection of Supplies – Fixed Price (August 1996)

FAR 52.246-4 -- Inspection of Services- Fixed Price (August 1996)

ARTICLE E.3. CONTRACTOR’S PERFORMANCE

At the COR’s discretion, he/she and the Contractor’s program manager will meet to evaluate the manner in which the Contractor is performing in accordance with the contract requirements and standards such as: good workmanship, the Contractor’s record of forecasting and controlling cost; the Contractor’s adherence to contract schedule, Contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction, and generally, the Contractor’s business like concern for the interest of the customer. The Contracting Officer may attend these meetings. Formal performance reviews will be conducted at least annually on or about the anniversary date of the contract.

ARTICLE E.4. BASIS OF ACCEPTANCE

The Contractor’s performance and the quality of services provided hereunder shall be subject to final inspection and acceptance by the Contracting Officer in conjunction with the Contracting Officer’s Representative (COR). The Basis for Acceptance shall be compliance with the requirements set forth within the Performance Work Statement, Contractor’s Proposal and other terms and conditions of the Contract.

Deliverable items rejected under the contract shall be corrected in accordance with the applicable clauses.

https://www.acquisition.gov/far/ https://www.acquisition.gov/far/

SECTION F – DELIVERIES/PERFORMANCE

ARTICLE F.1. FAR 52.252-2 – Clauses Incorporated by Reference (JUN 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Full text may be accessed electronically at https://www.acquisition.gov/far/index.html

FAR 52.242-15 STOP-WORK ORDER (AUG 1989)

FAR 52.242-17 GOVERNMENT DELAY OF WORK (APR 1984)

FAR 52.247-34 F.O.B. DESTINATION (Nov 1991)

ARTICLE F.2. PERIOD OF PERFORMANCE

The period of performance of the base period shall be one (3) three month trial period, four twelve (12) month option periods, and one, final nine (9) month option period consisting of a total period of performance of (5) five years if all options are exercised. All options are to be exercised at the sole discretion of the Government.

ARTICLE F.3. DELIVERABLES AND DELIVERY SCHEDULE

All deliverables will be sent to the COR via email in accordance with the timeframe stated below.

Deliverable Table

Deliverable ID Number

Name Frequency Quantity

A001 Installation Schedule Required 30 days after contract award, a schedule showing how installation of all required sensors will be completed within six months

Within 30 days of contract award

A002 RF and…