Warehouse RFI.pdf

Warehouse, Inventory, and Storage Support Services Sources Sought Notice

Document Type: Request for Information (RFI)

Release Date: November 4, 2020

Response Date: November 19, 2020 by 3:00 p.m. EDT via email to Caleb.Owen@hhs.gov

Description of Services/Supplies: Warehouse, Inventory, and Storage Support Services in the Caribbean (SOW is attached)

The Office of the Assistant Secretary for Preparedness and Response (ASPR) is conducting market research to identify potential sources that meet the requirements generally described in this notice as well as obtain feedback from industry. The intent of this announcement is to:

a) Notify potential sources about the upcoming Warehouse, Inventory, and Storage Support Services requirement in the Caribbean

b) Help ASPR identify interested vendors, particularly, but not limited to, small businesses,

c) Obtain feedback from industry to assist ASPR in determining whether or not the industry is capable of accomplishing the requirement.

This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of ASPR for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of ASPR’s view of the information received. Do not send any material that requires a non- disclosure agreement or that may be business sensitive. Responses to this solicitation will not be returned. This is strictly market research.

There is no formal question and answer period and the Government may or may not respond to any questions received at its discretion.

I. Information Requested

Vendors interested in this RFI may provide a response (capability briefing) that includes the following information for ASPR internal use and consideration:

1. Company Name and Address:

2. DUNS and TIN numbers:

3. Point of Contact (Phone and Email):

4. NAICS code, business size, and socioeconomic status (if applicable):

5. Sufficient descriptive literature that unequivocally demonstrates the technically capability of the requested service to determine if the company can meet the requirement:

6. Company’s availability via GSA or any other GWAC (if applicable):

7. Informational Pricing:

8. Total package should not exceed fifteen (15) pages

II. Instructions for Submittal

Written responses shall be provided electronically, by 3:00 p.m. Eastern time on November 19, 2020. The subject line of the e-mail message shall read: “Warehouse, Inventory, and Storage Support Services Sources Sought Response” and shall be addressed to Caleb.Owen@hhs.gov.

ASPR will not accept telephone, facsimile, courier, mail, or hand delivered responses. Further, access by ASPR to information in any files attached to a response is the responsibility of the submitting party. ASPR is not responsible for any failure to access information. Therefore, please ensure that files are easily accessible by ASPR – Microsoft Word or .pdf files are preferred.

ASPR will not notify respondents of the results of this market research. Information submitted will not be returned and will not be accepted after the due date for responses.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

mailto:Caleb.Owen@hhs.gov

SECTION C

WAREHOUSE, INVENTORY, AND STORAGE SUPPORT SERVICES

PERFORMANCE WORK STATEMENT (PWS)

C.1 OVERALL SCOPE

The contractor shall provide all personnel, necessary licensing, permits, equipment, racks, refrigeration, support, and space to manage the inventory requirements for Site P (Caribbean Island, exact location to be disclosed after award). The contractor shall ensure that all Government products stored in the contractor-provided facilities remain viable based on the requirements provided below. The Contractor shall provide the Government adequate space for a maximum of 300 pallet spaces (single stacked) at ambient (20 -25C) temperature, three Reach-in Refrigerators (2 to 8C), and three Reach-in Freezers (-25 to -15C), and space to park three transport vehicles on-site.

Due to the limited quantity of product, the Government will only accept a section (rows) of an existing warehouse to meet this Scope of Work. This section will require a demising wall, such as a fence, to secure the Government’s interest. In addition, the contractor shall meet or exceed (provide) all necessary physical, electronical, and mechanical security measurements to stay in compliance with Government requirements. To ensure a secure environment, the contractor shall not be allowed to propose, locate, and/or store Government product supporting Tasks 1-4 in more than one facility unless prior approval is received in writing from the Strategic National Stockpile (SNS). The Government prefers to receive and ship whole pallets and tries to avoid mixed lots, however, sometimes mixed lots are received, and piece picking will be required; the Contractor must be able to complete this without a significant impact to the operational tempo or traceability of inventory. The Government will periodically monitor the environment to ensure compliance. The Contractor shall also ensure that surge requirements, whereby larger than normal quantities of product are received for storage or require packaging and distribution, can be met.

The facilities and services provided under this contract shall integrate and interoperate with other similar facilities and services provided to the Government under other contracts. The Government will provide and coordinate all transportation to and from the facility and on and off the island, to include moving product via ground transportation in the event of a surge or emergent activity from Site P to the nearest airport. The contractor will accommodate the Government provided transportation processes in the most effective and efficient manner. However, this contract will have an unfunded CLIN in the event the Government elects to utilize the contractor’s transportation services. At which time, the contractor will become financially responsible for and will coordinate all transportation activities in support of SNS’s mission. All cost will be reimbursed via this CLIN.

If a Transition-in event is required, the contractor is financially responsible for and will coordinate all transportation activities in support of the Transition-In activities. Prior to transporting product, contracted drivers will need to be vetted by the U.S. Marshals. The drivers’ information shall be forwarded via email by the contracted trucking company to the contractor and the assigned U.S. Marshals. Details will be provided at time of award. During the Transition-In operation, stacking of pallets for transportation shall be done in a manner consistent with all applicable product manufacturer recommendations regarding proper handling and shipping of product. The Government's primary concern is that the products are not damaged at any point during the process of product transport; accordingly, the offeror's chosen stacking method for product transportation purposes shall protect the product to the greatest degree possible.

For planning purposes and notwithstanding initial load-in and surge requirements, the number of trucks delivering and/or removing products from the facility may average 10 per year. Also, for planning purposes, there may be an average of 10 small-scale (one or two boxes) cold chain shipments per year.

Cold Chain refers to a temperature-controlled, uninterrupted series of storage and distribution activities. There will be domestic and international shipments, some requiring special handling. Special handling refers to processes such as controlled substance and hazardous material shipping and receiving, certified and non-certified paperwork, palletizing, certified weighing, wrapping heavy shipments, and working with cold-packed items, all of which the contractor will be responsible for completing. The Government anticipates that approximately 95 percent of the product received by the contractor will be on standard pallets weighing no more than 2,500 pounds per pallet. Normal hours of operation are Monday-Friday 7 a.m. - 5 p.m. local time, and site coverage is required during these hours. Core hours of support provided by the contractor shall coincide with Federal holidays. The contractor shall provide after-hours operations as needed for emergency shipments or shipments that arrive later than the schedule time. All contractor support shall be provided at the contractor-provided facilities.

The contractor shall also support emergency operations, (Deployment) Inspection, as needed, for rapid response.

When a deployment is required, pallet picking, and staging should commence not later than 120 minutes from the time of notification. In this 120-minute window, the Government is providing a 90-minute grace period for contractor staff to get on-site, then a 30-minute window to prepare for pallet picking and staging. From the time the first pallet is picked, it is expected that the contractor will pick and stage pallets at a rate of 150 pallets/60 minutes. For planning purposes, the contractor shall estimate one unannounced deployment exercise annually.

As learned in COVID-19, maintaining a safe and healthy working environment is critical to the United States in providing life-saving medical supplies and equipment. Having preventative measurements outlined in Standard Operating Procedures prior to such event will be a requirement to address essential personnel, personal protective equipment, cleanliness, restrictive areas, etc. Therefore, when deemed necessary and appropriate by SNS, during certain human to human transmitted diseases or viruses, or Chemical, Biological, Radiological, Neurological (CBRN) attack, or certain State of Emergencies, or terrorist attack, etc., the Contractor shall work with SNS and limit the location of the building where Government supplies are shipped, received, and stored on the warehouse floor. Also, at a minimum and as approved by SNS, the Contractor will be required to follow the most stringent requirements from agencies within the Department of Health and Human Services, Department of Homeland Security, and Department of Justice in dealing with the above environments. These guidelines will be provided by SNS and if needed, modified based upon risk level. At a minimum, all designated Key and warehouse operating positions will be assigned as “Essential” personnel and shall be notified of such requirements prior to assuming employment for such positions.

C.2 TASKS

The contractor shall perform the following tasks in support of this solicitation.

Task 1: Provide Project Management

Task 2: Establish and Maintain the Working Environment

Task 3: Receive, Manage, Package, and Distribute Inventory

Task 4: Provide Surge/Emergent Support

TASK 1 – PROVIDE PROJECT MANAGEMENT

The contractor shall provide project management support under this Contract for Site P and shall meet the requirements of each Project Management subtask. This includes the management and oversight of all activities performed by contractor personnel, including subcontractors, to satisfy the requirements identified in this Performance Work Statement (PWS). The contractor shall provide support for the following subtasks.

SUBTASK 1.1 - COORDINATE A PROJECT KICK-OFF MEETING

The contractor shall schedule and conduct a Project Kick-Off Meeting (Section F, Deliverable 01). At a minimum, the attendees shall include Key contractor Personnel, key Government personnel, and the Contracting Officer’s Representative (COR). At a minimum, the contractor shall discuss the following:

a. Conditioning Schedule

b. Performance metrics, to include methods and schedule for achieving them.

c. Security requirements.

d. Government-furnished information.

e. Meeting dates.

f. Points of Contact (POCs).

g. Roles and responsibilities.

h. Prioritization of contractor activities.

The contractor shall prepare and deliver a Project Kick-off Agenda (Section F, Deliverable 02) that includes, at a minimum, the above referenced items. The contractor shall prepare and deliver a Project Kick-Off Report (Section F, Deliverable 03) that documents the results of the meeting.

SUBTASK 1.2 - FACILITY CONDITIONING MANAGEMENT

If required, the contractor shall ensure successful management of the Facility Conditioning phase, to include:

a. The contractor shall prepare and deliver a Successful Completion of Establish the Working Environment

(Conditioning and Transition-In/Initial Movement) (Section F, Deliverable 16).

b. The contractor shall ensure efficient and continual lines of communication through Bi-Weekly Status Calls

(Section F, Deliverable 04) with the Government and submission of pictures documenting the progress.

c. Project status to be provided by the Project Manager during the Bi-Weekly Status Calls with the

Government. The contractor shall prepare minutes of the Bi-Weekly Status Calls (Section F, Deliverable 05).

d. Efficient and continual lines of communication with all subcontractors associated with or affected by facility conditioning milestones. This shall be discussed during the Weekly Status Calls.

e. If determined to be required, accommodate any site visits by the Government personnel, during which the contractor shall ensure and demonstrate facility conditioning progress as reported on the conditioning schedule, and be prepared to review all other information required within the Monthly Status Report (MSR).

SUBTASK 1.3 - PREPARE A MONTHLY STATUS REPORT (MSR)

The contractor shall prepare an MSR (Section J, Attachment E) (Section F, Deliverable 06) containing, at a minimum, the following information:

a. Activities during reporting period, by task (include ongoing activities, new activities, and activities completed; progress to date on all aforementioned activities). Start each section with a brief description of the task.

b. Problems and corrective actions taken. Also include issues or concerns and proposed resolutions to address them.

c. Personnel gains, losses, and status (security and training status – contractor/ subcontractor).

d. Government actions required.

e. Conditioning schedule (show major tasks, milestones, and deliverables; planned and actual start and completion dates for each).

f. A list of incidents for the month and the resulting action and impact.

g. Any changes to the facility’s or contractor’s Quality Systems, to include current Good Manufacturing

Practice (cGMP), facility maintenance, environmental monitoring, Standard Operating Procedures (SOPs), and any of the other elements of the quality system called out in Section C.4.1.4, including both written documents and the contractor’s actual practices.

h. Expiration dates for License(s) for the holding and distribution of pharmaceuticals.

i. Changed/added location of a hazardous materials site within one quarter mile of the facility.

j. Federal, State, and Local Jurisdiction Inspection Audit Reports.

k. Changes to drawings of the facility interior and exterior.

SUBTASK 1.4 - QUALITY CONTROL

Contractor shall be responsible to adhere to all applicable current Good Manufacturing Practices (cGMP) requirements and Government quality assurance requirements to ensure the appropriate operation of a Government-contracted storage facility in regards to receiving, holding and shipping preparation of finished pharmaceuticals, medical devices, Investigational New Drug (IND) products, and/or other Government assets.

Contractor shall be responsible to maintain comprehensive Quality System programs, which shall comply with all, applicable federal, state, and local regulations, and the Government performance requirements cited throughout this existing contract for the warehousing (receiving, holding and shipping preparation) of finished pharmaceuticals, medical devices, pre- licensed Investigational New Drug (IND) products, and/or other Government assets.

a. Contractor Qualification – Annually, the Government shall assess the contractor’s facility and Quality

Systems and make a determination in regarding the site’s acceptability and compliance to properly and safely store and handle the Government-owned product. The assessment agenda will include, but not be limited to, a review of the following areas covering the receiving, holding, and shipping preparation of product:

1. Standard Operating Procedures

2. Inventory management

3. Software and equipment validations

4. Deviation system

5. Corrective Action and Preventive Action system

6. Quality Assurance

7. Change Control

8. Training management system

9. Facility maintenance

10. Equipment maintenance and calibration

11. Environmental monitoring

12. Facility sanitation program

13. Document control system

14. Vendor management program

15. Organization and personnel qualifications and responsibilities

16. Regulatory inspection history (FDA Notices and Observation Forms 482 and 483, warning letter, etc.)

Upon completion of a Government quality assessment site visit, the contractor shall receive a written formal assessment report. Upon the contractor’s receipt of the Government’s written formal assessment report, the contractor shall have 30 calendar days to respond in writing (Section F, Deliverable 07) to the Government’s required and/or suggested improvement recommendations with proposed corrective actions and target dates for completion. The Government, based on the requirements of this agreement, shall determine if and when the contractor’s completed/proposed corrective actions are sufficient to allow Government-owned product to remain being stored at the facility. The Government may conduct “for cause” audits to address product quality or safety concerns within ten (10) business days of notification to contractor.

1. The Government shall schedule Quality Assessments 30 calendar days in advance when possible. A Quality Assessment agenda shall be provided prior to the assessment date.

2. Additional manufacturer audits may be conducted during each calendar year. The manufacturer shall schedule Quality Assessments with the Government 30 calendar days in advance when possible. A Quality Assessment agenda shall be provided prior to the assessment date.

b. Document Control Program - The contractor shall be responsible for maintaining a formal document control program to manage the approval, distribution, archival, and change control of all cGMP-relevant documents. This program shall minimally include standard operating procedures (SOPs), manuals and protocols, software and equipment validation documents, and training records covering the receiving, holding, and shipping preparation of product, and shall be made available to the Government.

c. Standard Operating Procedures (Section F, Deliverable 13) - The contractor’s performance responsibilities and activities shall be described and controlled in their SOPs covering the receiving, holding, and shipping preparation of product. All contractor employees performing under the contract, shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks in areas that may affect Government-owned products or equipment. Current, approved, and controlled SOPs shall be readily available to contractor employees at the facility. At the Government’s request, the contractor shall make available contractor’s SOPs to the Government for review.

d. Training Program - The contractor shall be responsible to implement a training program that defines the training requirements for all employees performing under the contact, covering the receiving, holding, and shipping preparation of product. Contractor provided training shall be in accordance with operations and performances identified in the cGMP. Annual cGMP training shall be provided by the contractor and conducted by qualified individuals to assure that employees remain familiar with cGMP’s. All training shall be documented, and records properly maintained.

e. Facility Temperature/Humidity Monitoring System - The contractor shall be responsible for maintaining written procedures describing the equipment installation, operation, performance, maintenance (including scheduled storage temperature alarm testing), and Out-Of-Specification (OOS) reporting (including emergency contact information with back-up personnel) of all temperature-controlled storage areas/units.

The contractor shall be responsible for monitoring relative humidity in all storage areas (excluding reach-in units) and will have a sufficient number of probes to accurately record the relative humidity.

The contractor shall be responsible to report Mean Kinetic Temperature (MKT) calculation in accordance with the current edition of the United States Pharmacopeia (USP). If an electronic monitoring system is used, the system shall comply with all applicable federal, state, and local regulations and Government performance requirements cited throughout this Performance Work Statement for the warehouse (receiving, holding and shipping preparation of finished pharmaceuticals/biopharmaceuticals, IND products, medical devices, and other Government assets).

1. Each Cold-Storage Unit (CSU) temperature monitored area will have a preapproved number of primary temperature probes and back-up temperature probes, which will be positioned in the coldest and hottest spots of the unit based on the latest temperature mapping.

2. Controlled Room Temperature (CRT) areas will have primary and back-up temperature probes to accurately record the environmental conditions.

3. Each Reach-in Unit (Cooler/Freezer) temperature monitored area will have a minimum of two primary temperature probes and two back-up temperature probes positioned in the coldest and hottest spots of the unit based on the latest temperature mapping.

f. Monthly Temperature Reports - The contractor shall be responsible to provide the Government a report of the previous month’s temperature data for all storage units (including units that have been validated but contain no product) holding Government-owned products by the fifth business day of each month. The report shall include, but not be limited to:

1. Facility code name

2. Unit number identification

3. Storage temperature range

4. Graphical representation of the monthly readings from each storage area

5. Relative Humidity for each storage area (excluding reach-in units)

6. Deviations and corrective/preventative actions

7. Detailed temperature readings and explanations for all reportable excursions

8. Explanation for all temperature excursions

9. MKT for the month and previous rolling 12 months

10. Report should cover continuous data from the beginning of the month to the end the month

i. Monthly reports shall be generated from the primary validated temperature monitoring system for each storage area holding (including units that have been validated but contain no product) Government-owned product.

ii. The contractor shall provide additional supporting information regarding monthly reports as requested by the Government.

g. Deviations/Non-conformances and Corrective Action Tracking - The contractor shall be responsible for maintaining deviation and corrective action/preventive action (CAPA) systems and documenting non-conformances to approved procedures including root cause analysis and actions taken. These systems shall track and trend all deviations, system non-conformances, and CAPAs. All deviations that can potentially impact product(s) safety, identity, strength, quality, or purity shall be evaluated by the Government. The Government is responsible for product impact evaluation and providing product disposition to the contractor, when applicable.

h. Incident Notification and Reporting - Contractor shall be responsible to report to the Government, as applicable, of the following:

1. Any CRT excursion outside of 68-77°F (20-25°C) for a continuous 24-hour period. Additional notification if CRT excursion falls outside of 59-86°F (15-30°C) for a continuous 24-hour period.

2. Any refrigeration or freezer temperature excursion outside the established range for greater than 0 minutes or preapproved alarm delays.

3. Any temperature monitoring system software and/or equipment failure upon discovery.

4. Any temperature data loss or gaps upon discovery.

5. Any event that may result in product loss, damage or the potential to impact product quality requires notification to the Government upon discovery.

6. A detailed incident report (Section F, Deliverable 14) shall be provided to the Government at no later than two business days after incident. More critical deviations or incidents may require an immediate interim written report upon request by the Government. (Section F, Deliverable 17) If the incident results in a deviation, the deviation report shall be submitted within 30 calendar days from the date of the incident. All associated CAPA reports shall be forwarded to the Government upon completion. The contractor shall provide additional supporting information as requested by the Government.

7. For situational awareness, if any Government personnel are present on site during an incident, the contractor shall include them when making notification to the COR and Quality group.

i. Facility Design and Maintenance/Sanitation Program - The contractor shall be responsible to provide a maintenance program that shall document storage facilities are maintained in a good state of repair and cleanliness and that all facility documents associated with the maintenance program are retained in appropriate files. The contractor shall institute appropriate measures concerning cleaning, refrigeration, maintenance, pest control, and the quality system governing these procedures to ensure that the storage specifications for Government-owned products are met.

The contractor shall be responsible for implementing a system to track equipment and software systems required for cGMP compliance including but not limited to temperature monitoring; heating; ventilation; air conditioning (HVAC); cold storage; primary and back- up power. This tracking system shall log and schedule all preventive maintenance, validations, and calibrations. Any corrective, scheduled, and non-scheduled maintenance shall be documented, and the documentation included in the records for each piece of equipment.

The contractor shall be responsible to establish and manage a calibration, maintenance, preventive maintenance and unscheduled maintenance repair program for all temperature- controlled equipment, medical devices and monitoring systems. Appropriate schedules, as established by the contractor’s procedures and equipment specifications, for all calibration, maintenance, preventive maintenance and regular replacement of components, as well as the responsibilities for the execution of the schedules shall be clearly defined within this program. All calibrations, preventive maintenance and unscheduled maintenance, shall be the responsibility of the contractor and shall be completed by qualified technicians. Documentation of technician’s qualifications shall be maintained by contractor and made available to the Government upon its request.

All calibration, maintenance, preventive maintenance and unscheduled maintenance, shall be documented and maintained by the contractor and made available to the Government upon request. All calibrations shall be performed in accordance with manufacturer specifications and current National Institute of Standards and Technology (NIST) standards.

j. Comprehensive Validation Program - The contractor shall be responsible to validate all CRT, refrigerated and frozen storage areas; temperature monitoring systems; and any electronic document control, inventory management, change control, training management, CAPA, and deviation systems. The contractor shall establish a re-calibration/re-validation program to assure proper performance of the automatic, mechanical, or electronic equipment or other types of equipment, including computerized systems. All validation documentation shall be available to the Government for review. Equipment used during the qualification shall have a current NIST traceable calibration status.

For initial validation, temperature mapping of temperature-controlled areas is required. The backup temperature probes shall be placed in close proximity to the primary temperature monitoring probe(s). The primary and secondary temperature monitoring systems data shall be compared to each other. The temperature mapping shall include at a minimum, 72 hours of temperature data to determine hot and cold spot probe locations.

The contractor shall be responsible for re-qualification and mapping (and/or re-mapping) of the refrigerated and frozen storage areas when significant repairs/changes are made that could affect the temperature within the area, previous validation or product quality, when storage capacity of the unit reaches 50%, 75%, or 100% and at 5 years after the previous validation, whichever comes first. For reach-in units, the storage capacity and 5 years requirements will not apply. The primary and secondary temperature monitoring systems shall be compared to each other.

The contractor shall be responsible to ensure that all equipment and system validations/re- validations are performed in a timely and accurate manner. The Government shall review protocols prior to initial execution for adequacy. A complete report including raw data shall be provided to the Government by the contractor after each protocol is executed. This report shall contain a synopsis of the purpose of the validation, the tests performed, the acceptance criteria for each test, departures from a protocol, and the results of the validation including a “Pass” or “Fail” declaration. The Government shall review the report for each completed validation to determine its adequacy. The Government shall require the contractor to correct any errors and/or omissions within 30 calendar days of identification. After Government final acceptance, an acceptance document shall be sent to the contractor and shall be filed with the completed validation and retained on site with the contractor qualification report.

k. 21CFR Part 11 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. Upon request by the Government the contractor shall be responsible to provide the Government with a written statement to the Government confirming that a periodic performance review process is in place to ensure that all such systems remain in the validated state throughout their lifecycle.

l. Contractor or Subcontractor Qualification - The contractor shall be responsible to ensure that all subcontractors utilized by the contractor perform functions that may have an impact on Government-owned products have the training and skills to perform under the existing contract. All subcontractors shall be regularly evaluated by the primary contractor to ensure performance and quality compliance. Records identifying acceptable subcontractors, their evaluation, and evaluation criteria used shall be documented and available for review by the Government upon request.

m. Redundant Systems - Contractor shall be responsible to provide and maintain the following redundant systems:

1. Installed secondary critical cooling system components for each walk-in Cold Storage Unit (CSU)/area, if applicable.

2. Back-up generator power to maintain and monitor temperature-controlled environments.

3. Uninterrupted Power Source (UPS) for all data capture.

4. Back up temperature monitoring system. Each temperature monitored area will have at a minimum two back-up temperature probes positioned in the coldest and hottest spot of the unit based on the most recent temperature mapping.

5. Data back-up of electronic data capture.

n. Change Control - The contractor shall be responsible to document changes to validated systems utilized to monitor and hold Government-owned products. The contractor shall notify the Government, in advance of implementation, any system changes that may impact Government-owned products for assessment and approval.

o. Facility Inspection Notifications - The contractor shall be responsible to immediately notify the

Government of any notice of inspection and unscheduled inspections or actions by regulatory agencies, other enforcement agencies (e.g., FDA, DEA, OSHA), and third-party vendors that may involve and/or impact Government-owned products. If no advance notice is given, the Government should be notified immediately upon the arrival of the inspector(s). The Government shall be permitted to delegate at least two persons to observe the inspection. The Contractor shall immediately provide Government with any FDA 483 observations, FDA Establishment Inspection Reports (EIRs) and/or other inspection reports/summaries.

p. Licensing - The contractor (or at least one member of the Joint Venture, if applicable) shall possess - prior to acceptance of the proposed facility - and thereafter maintain current Federal, state, and/or local jurisdiction licenses for the holding and distribution of pharmaceuticals in accordance with the state and local jurisdictions where the facility is located. In the event that the local jurisdiction does not require licensing for the holding and distribution of pharmaceuticals, the contractor (or at least one member of the Joint Venture, if applicable) shall meet and maintain specific legal requirements that exist and provide acceptable documentation to the Government on demand. At a minimum, the contractor shall have registered the storage and distribution of pharmaceuticals with the FDA.

UPDATE QUALITY CONTROL MANUAL

The contractor shall update the draft quality Control Manual (QCM) submitted with its proposal and then provide a final baseline QCM as required in Section F (Section F, Deliverable 11). The contractor shall periodically update the QCM, as required in Section F (Section F, Deliverable 12), as changes in program processes are identified.

Within the QCM, the contractor shall identify its approach for providing quality control in meeting the requirements of the contract. The contractor’s QCM shall describe its quality control methodology for accomplishing contract performance expectations and objectives. The contractor shall fully discuss its validation processes and procedures that provide high quality performance for each Task Area. The QCM shall describe how the processes integrate with the Government’s requirements.

TRAINING PLAN

The contractor shall implement a successful training plan that defines the training requirements for employees performing under this contract including the receiving, holding, and distributing of product. The contractor-provided training shall be in accordance with operations that the contractor performs and based upon cGMP practices. Contractor employees performing under the contract shall be trained on all approved SOPs applicable to the assigned tasks prior to performing the tasks in areas that may affect Government-owned products or equipment. Annual cGMP training shall be provided by the contractor and conducted by qualified individuals to ensure that employees remain familiar with cGMPs.

The contractor shall ensure subcontractors used by the contractor to perform functions that may have an impact on Government-owned products have the training and skills to perform under any resulting contract.

Subcontractors shall be regularly evaluated by the primary contractor to ensure performance and quality compliance meets the acceptable level of performance. Subcontractor Evaluation Records identifies acceptable subcontractors, their evaluation, and evaluation criteria used shall be documented and available for review by the Government upon its request.

TRANSITION-IN

The contractor shall update the Transition-In Plan and plan shall be included with price and technical proposal in Section F (Section F, Deliverable 08) as required. The contractor shall ensure that there shall be minimal service disruption to vital Government business and no service degradation during and after transition. The plan shall include organizational and communication flow charts for the Facility Conditioning Phase, the Transition-in Phase, and the Operational Phase. The contractor shall implement its Transition-In Plan No Later Than (NLT) one calendar day after final acceptance, and transition activities - shall be completed 5 calendar days after final acceptance of the conditioned site. In order to achieve final acceptance, the Government requires a 100% visual verification of inventory.

The contractor is financially responsible and will coordinate transportation activities in support of the Transition-In activities. Prior to transporting product, contracted drivers shall be vetted by the U.S. Marshals.

The contracted trucking company drivers’ information shall be forwarded via email to the contractor and the assigned U.S. Marshals. Details will be provided at time of award. Stacking of pallets for transportation during Transition-In should be done in a manner consistent with the applicable product manufacturer recommendations regarding proper handling and shipping of product. Special shipping requirements will apply to cold chain product. The Government's primary concern is the products are not damaged at any point during the process of product transport; accordingly, the offeror's chosen stacking method for product transportation purposes should protect the product to the greatest degree possible. For all other functions within this PWS, single stacking is the required method to protect product and minimize damage. This plan will need to be carefully coordinated with SNS for security, quality control, controlled substance, and product locators.

TRANSITION-OUT

The contractor shall provide a Transition-Out Plan in Section F (Section F, Deliverable 09) that facilitates the accomplishment of a seamless transition from the incumbent to incoming contractor and/or Government personnel at the expiration of the Contract. The contractor shall implement its Transition-Out Plan NLT 60 calendar days prior to expiration of the contract or upon notification by the Government that the option period will not be exercised. Should the contract be cancelled, the contractor shall implement the Transition-Out Plan immediately upon receipt of notice of cancellation. The contractor shall document how it shall coordinate with the incoming and/or Government personnel to accomplish the following:

a. Transfer knowledge regarding:

1. POCs.

2. Quality performance documentation.

3. Product status and labeling system.

4. Inventory supply listing (hard copy and electronic copy).

b. Identify schedules and milestones.

c. Identify actions required of the Government.

d. Establish and maintain effective communication with the incoming contractor/Government personnel for the period of the transition via weekly status meetings.

The products stored in the facility shall be moved to a new facility (if required) prior to the end of the performance under this contract. The contractor shall package and load for distribution the inventory remaining products at this time.

Unless specified in writing, regardless of purchaser, all attached structural, mechanical, electrical, or security related equipment and any modification to the warehouse or property during the initial conditioning or throughout the life of this contract will become the property of and is the sole responsibility of the contractor.

TASK 2 - ESTABLISH AND MAINTAIN THE WORKING ENVIRONMENT

The contractor shall establish the Working Environment (Deliverable 16) under CLIN 0006. The contractor shall provide Project Management support while maintaining the Working Environment in accordance with the PWS to include capacity, security, systems redundancy, environmental controls, safety, and functionality. The contractor shall provide successful project management support and shall meet the requirements of each project management and oversight of activities performed by contractor personnel, including any subcontractors, to satisfy the requirements identified in this requirement. The contractor shall provide ongoing organizational and communication flow charts that display how successful management and successful lines of communication occur throughout each phase of the working environment; successful communication between contractor personnel, the contractor PM, the Government; and successful communication with subcontractors. The contractor shall ensure streamlined, ongoing service, compliance with cGMP regulations and strong relations among Government and contractor stakeholders.

Compliance with the below established Service Level Agreement (SLA) is required:

Metric Name Business Objective/ Description Acceptable Quality Level Exception(s)

Facility Badge Accessibility

Day to day support related to receiving and managing inventory and site accessibility.

Allow access to the Government on an authorized access list within 60 minutes of notification.

N/A

SECURITY – Contractor will be required to provide and meet security requirements. The following requirements are based on utilizing space inside an existing business.

a. All equipment shall be Underwriter Laboratories (UL) approved.

b. The central station shall be UL approved. The Intrusion Detection System (IDS) must be monitored by an approved UL central station.

c. All work shall meet National Electric Code (NEC), National Fire Protection Association Code (NFPA), all applicable local codes, and be compliant with the American with Disabilities Act (ADA).

d. All wiring shall be in conduit from device to ceiling deck and tied off at 24” intervals. Magnetic contacts shall have flexed stainless steel conduit from the device to standard conduit.

e. The contractor shall prepare and submit, 14 working days in advance, Shop Drawings for all systems prior to start of work and equipment ordering.

f. The contractor shall provide technical specifications and cut sheets on all equipment used.

g. The provider shall also indicate how all electronic systems will be integrated. The Government turnaround time on approval of the Shop Drawings will be no more than five working days.

h. The contractor shall provide equipment and user manuals for all equipment/systems.

i. The contractor shall provide a minimum of two days of training for selected personnel to complete and understand the various systems.

j. The contractor shall provide a complete equipment list of all components.

k. All points of access to the secured area will be protected.

CLOSED CIRCUIT TELEVISION (CCTV)

a. Camera Specs – general

1. Cameras shall provide quality clarification and a clear view of all personnel doors from top to bottom and three feet in front of the door.

2. Cameras shall clearly capture an individual entering in diminished environmental conditions, positioned to not have capabilities diminished by sunlight or perimeter lighting, etc.

3. Unless there are unusual circumstances, sun exposure, obstacle, etc., exterior fixed cameras covering personnel doors shall be mounted on the opposite side of the door hinges.

4. The exterior cameras shall be mounted on brackets to provide the required view stated above and mounted approximately 12 to 14 feet above ground level and approximately 12 feet to the side.

5. Cameras shall be suspended from the ceiling structure for mounting where columns are not available.

6. All wiring shall be tied at 24” on center and run so as to not be seen from below.

7. Access to SNS product will be via card key and issuance of card keys will be limited to only those personnel designated by SNS.

b. Cameras covering the overhead doors must provide quality, clarification, and a clear view of all personnel utilizing/working the area immediately in front of the doors (a minimum of 15 feet).

c. Camera Requirements:

1. Fixed cameras

a) Flexi dome High Definition (HD) 1080p, High Dynamic Range (HDR), 3-9-millimeter (mm), Super Resolution (SR) lens, Automatic Verifocal (AVF) lens, Low Bandwidth Consumption (LBC), capable of integrating with Intelligent Video Analysis (IVA) software.

b) The interior cameras shall be mounted approximately 10 to 12 feet above floor level unless located in the office area, in which case they shall be mounted in the ceiling.

c) Personnel door cameras shall be mounted approximately 12 feet from the door.

d) Auto dome IP dynamic HD 1080P/720P 30X day/night indoor/outdoor impedance 50/60HZ, clear acrylic bubble high Power over Ethernet (PoE) or 24 Volts Alternating Current (VAC).

e) Auto dome pendant arm, 24 VAC (no transformer), white fixed cameras.

f) Cameras Covering Overhead Doors:

d. Coverage:

1. All doors

2. Two cameras (interior and exterior) covering the personnel entrance door (on a pendant).

3. Two cameras (interior and exterior) covering the cargo door (on a pendant).

4. Two cameras on the DEA cage.

e. Digital Video Recorder

1. Enough storage capacity to record 30 days of images at continuous recording settings.

a) Provide DVD/CD write capability with password protection

b) Provide an UPS for the DVR and CPU to prevent lightning damage and protect against power surges and spikes

c) Provide an environmental secure metal cabinet which is bolted to solid permanent facility fixture to house all DVR equipment that will not diminish equipment capabilities (heat) but will prevent vandalism or tampering and allow for a clear chain of custody for access. i.e. lock and keys unique to that cage only)

f. Color monitors:

g. Provide 1 HD 1080 LCD monitor and install in rack

INTRUSION ALARM SYSTEM (IDS)

a. Head end equipment - install Individual Point ID UL Listed alarm Control Panel with access control feature to operate the reader described below

1. Point to point annunciation

2. Minimum of 8 partitions (zones)

3. Install radio/cellular backup communication

4. Back-up battery for continued operation in loss of power event

5. One keypad installed inside the entrance door

b. Siren – install siren to sound locally

c. Partitions (zones)

1. All motions

2. Door contacts

3. Eyebeam(s)

d. Coverage:

1. Install commercial rated magnetic contacts on all overhead, rollup and pedestrian doors

2. Install a motion detector to cover both pedestrian doors (should also cover the forklift rollup door)

3. Install 360 motion detection around DEA cage. DEA cage to have its own partition.

e. Connect IDS to an UL approved central station and provide opening and closing reports either via mail or web access.

ACCESS CONTROL

a. Access control system will be located in the secured equipment rack and will record all entrances, exits, and card access attempts for a minimum of 180 days.

b. Electric strikes are preferred if application is acceptable

c. Magnetic Locks, if used:

1. All mag locks are to have a minimum pull of 1200 lbs. and be mounted so the gate cannot be pried open at the top or bottom

2. The proximity readers are to be installed at 48 inches from the walking surface to meet ADA regulations.

d. Coverage:

1. All doors

PERIMETER

a. Install latch guards (minimum of 12”) on both pedestrian doors

SITE CRITERIA

The contractor’s site shall conform to the following criteria:

a. Be located within a 20-mile driving radius of the specified Site P International Airport.

b. Be located no more than five miles from a major interstate. The site shall have access to multiple routes to the highway system and airport.

c. Have property terrain that is flat and level.

d. Not be located over watersheds, wetlands, and/or floodplains.

e. Any hazardous material capable of creating an explosive, biological, or hazardous event within a quarter mile radius (as measured from the nearest property line of the facility in question to the nearest property line of the proposed facility) shall be identified. The Government shall assess risk and provide waivers on a case-by-case basis. Current exceptions include hazardous material dedicated to airport operations and gasoline stations.

f. Be of an architectural make-up that does not cause undue attention to it within the context of an industrial park.

g. Be positioned in an industrial park in such a way that it is readily identifiable from the industrial park’s main thoroughfare so it can be found during an emergency response.

h. Not be located in an area with high crime rates at the time of award (that is above the national average) or showing evidence of gang or other criminal activity as identified by police in the Government-designated cities (i.e., Site P). Such information shall be made available to the Government if sought.

i. For purposes of constant accessibility, not be located near any high traffic entity such as sports stadiums, concert venues, historical sites, or religious attractions.

j. Have a minimum of a 50’ setback from…