Draft_Section_C for RFP GSC-QF0B-11-0002.docx

SECTION C – DESCRIPTION/ SPECIFICATIONS /STATEMENT OF WORK

C.1 PURPOSE

The purpose of these requirements is to provide the Government with Contractor support that provides all necessary expertise, labor, materials, and space to safely and securely receive, store, stage, and ship pallets. The space occupied will consist of pallets of varying heights in accordance with International Organization for Standardization (ISO). A typical pallet is 48“x 42“at the base. Ten percent of floor positions should accommodate 83” high pallets with the remaining positions accommodating 60” high pallets. The Government will be storing pharmaceuticals, medical supplies, and medical equipment in two separately managed sites. For planning purposes, the National Fire Protection Association (NFPA) classification for the stored products in Class IV.

· Site A: Will be located within 20 driving miles of Baltimore International Airport in Maryland. It will be used to manage ambient, refrigerated/freezer and Schedule III, IV, and V (refer to Title 21 Code of Federal Regulations (CFR), Part 1308) controlled products as well as equipment and related medical items. The Contractor shall manage a minimum of 43,000 pallets of medical products at this site, broken out as 38,200 pallets ambient and 4,800 pallets of refrigerated/frozen. Throughout the document this site will be referred to as Site A.

· Site B: Will be located within 20 driving miles of Memphis International Airport in Tennessee. It will be used to manage ambient, refrigerated/freezer and Schedule III, IV, and V (refer to Title 21 Code of Federal Regulations (CFR), Part 1308) controlled products as well as equipment and related medical items. The Contractor shall manage a minimum of 9,000 pallets of medical products at this site, broken out as 7,000 pallets ambient and 2,000 pallets of refrigerated/frozen. Throughout the document this site will be referred to as Site B.

There are existing facilities located in each of the above locations. If an award is made to a contractor proposing a facility other than the existing facility, the Contractor will be responsible for the transportation of all pallets currently being held at the existing facility. The Government will coordinate and supply all future transportation to and from each newly awarded facility.

C.2 BACKGROUND

The Government stores, manages, and distributes pharmaceuticals, medical supplies, and medical equipment at and from sites located throughout the United States and territories in order to maintain the health of the nation’s people. There have been multiple minor and major emergency situations over the last five (5) years that have required the deployment of the stored product. The Contractor shall meet the Quality Control criteria outlined in Subtask 6. The Quality Control Subtask contains the guidelines of the Government’s expectations for the operation of the facilities.

The Government will work with the Contractor to approve the managed service site for usage as conditioning steps are completed. This includes the Government conducting regular teleconferences and traveling regularly to review and provide comment on the progress of the site. Incremental steps that must be approved and that can be approved in advance of final acceptance include:

· Active pest control in place

· 30 days of temperature data supplied

· Employee training completed and documented

C.3 SCOPE

The Contractor shall provide all personnel, support, and space to fulfill the requirements for each awarded site, i.e., Sites A and B. 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 ensure that surge requirements, whereby larger than normal quantities of product are received for storage or require packaging and distribution, can be met based on the requirements (as specified in Section C.4.4). In addition, the Contractor shall provide all necessary space for Government-provided security staff (as specified in Section C.4.2.6); for office duties and conferencing (as specified in Section C.4.2.4); and shall provide all required security capabilities for the grounds and in the facilities (as specified in Section C.4.2.5).

For planning purposes and notwithstanding initial load in and surge requirements, the number of trucks delivering and/or removing products from the facilities may average 20 per week. There will be domestic and international shipments, some requiring special handling; however, the Government will provide and coordinate all transportation. Special handling refers to processes such as palletizing, weighing and wrapping heavy shipments, completing Hazmat materials, and working with cold-packed items. 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 pallets.

Normal hours of operation are Monday-Friday 7am-5pm local time. The Contractor shall provide after hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time. For planning purposes, estimate up to 2 after hour shipments per month with each shipment taking 2-4 hours. All Contractor support shall be provided at the Contractor-provided facilities. The Contractor’s environment shall be ready to accept products within 120 calendar-days of award.

To ensure a secure environment, the Contractor shall not be allowed to propose, locate and/or store Government product in more than one facility at each site location.

C.4 TASKS

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

Task 1: Project Management Task 2: Establish and Maintain the Working Environment Task 3: Receive, Manage, Package, and Distribute Inventory Task 4: Provide Surge Support

C.4.1 TASK 1 – PROVIDE PROJECT MANAGEMENT

The Contractor shall provide successful program management support under this Contract for each site independently and shall meet the requirements of each Project Management subtask independently by site. This includes the management and oversight of all activities performed by Contractor personnel, including subcontractors, to satisfy the requirements identified in this Statement of Work (SOW). The Contractor shall ensure successful program management support throughout the following three project phases: (1) Facility Conditioning, if needed, (2) Transition-In/Initial Movement of Product, if needed, and (3) Facility Operation. The Contractor shall provide support for the following subtasks.

C.4.1.1 SUBTASK 1 – COORDINATE A PROGRAM KICK-OFF MEETING

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

a. Schedule

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

c. Security requirements

d. Government-furnished information

e. Monthly meeting dates

f. Points of Contact

g. Roles and responsibilities

h. Prioritization of Contractor activities

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

C.4.1.2 SUBTASK 2 – MONITOR FACILITY CONDITIONING

If facility conditioning is required, the Contractor shall ensure successful management of the phase, to include:

a. Successful completion within the 5 month period (final acceptance of the facility is to be no later than the beginning of month 6).

b. Efficient and continual lines of communication through Weekly Status Calls with the Government and pictures documenting progress.

c. Project status to be provided by the Project Manager during the Weekly Status Calls with the Government. The Contractor shall prepare minutes of the Weekly Status Calls (See Section F, Deliverable 04).

d. Maintain efficient and continual lines of communication with all Subcontractors associated with or affected by facility conditioning milestones. To be discussed at the Weekly Status Calls.

e. Daily project review to be completed by the onsite Conditioning Contractor Project Manager (who shall be separate from the overall Contract Project Manager) in order to ensure: progress of the conditioning schedule, completion of milestones, any issues, problems or delays encountered, and any training completed. To be documented within the Monthly Status Report (MSR) and discussed during weekly status calls.

f. Accommodate Monthly Site Visits by 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 MSR.

C.4.1.3 SUBTASK 3 – PREPARE A MONTHLY STATUS REPORT (MSR)

The Contractor shall prepare an MSR (See Section F, Deliverable 05) containing at a minimum the following information:

a. Activities during reporting period, by task (Include: On-going activities, new activities, activities completed; progress to date on all above mentioned 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)

d. Government actions required.

e. Schedule (Shows major tasks, milestones, and deliverables; planned and actual start and completion dates for each).

f. Accumulated invoiced cost for each CLIN up to and including the previous month.

g. Comparison data / monthly performance reports.

h. A list of incident for the month and the resulting action and impact.

i. Contractor/subcontractor training status.

C.4.1.4 SUBTASK 4 – TRANSITION IN/INITIAL MOVEMENT OF PRODUCT

If an award is made to a contractor proposing a facility other than the existing facility, the Contractor shall support and provide transportation (in compliance with Department of Transportation regulations) of all pallets currently being held at the existing facility. If required, all products shall be moved into the Contractor’s new facility within 60 calendar days from the final acceptance of their new facility.

The Contractor shall provide a Final Transition-In plan (See Section F, Deliverable 06) that facilitates the successful accomplishment of a seamless transition into their new facility. The Contractor shall document how it will coordinate the movement/transportation of the existing product into their new facility. At a minimum, the Contractor will identify the following:

a. Points of contact.

b. Identify schedules and milestones.

c. Identify actions required of the Government.

d. Inventory listing of all products being moved, if required.

e. Establish and maintain effective communication with the Government throughout the entire transition via weekly status meetings.

f. Provide a weekly update by facility of pallets moved and pallets remaining to move.

C.4.1.5 SUBTASK 5 – TRANSITION OUT

The Contractor shall provide a Transition-Out plan (See Section F, Deliverable 07) that facilitates the accomplishment of a seamless transition from the incumbent to an incoming Contractor /Government personnel at the expiration of the contract. The Contractor shall document how it will coordinate with the incoming and or Government personnel to transfer knowledge regarding the following:

a. Points of contact

b. Quality performance documentation.

c. Product status and labeling system.

d. Inventory listing (hard copy and disk).

e. Identify schedules and milestones.

f. Identify actions required of the Government.

g. 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 will be moved to a new facility (as appropriate) prior to the end of the performance under this contract. The Contractor shall package and load for distribution by the Government all remaining products at this time.

The Contractor shall implement its Transition-Out Plan no later than 60 work days prior to expiration of the contract or upon notification by the Government that a yearly optional period will not be exercised. Should the contract be cancelled, the Contractor shall implement the Transition-out Plan no later than 60 work days before the end of the period.

C.4.1.6 SUBTASK 6– QUALITY CONTROL

The Contractor shall conform to the following quality control practices and provide the following documents. All references to “cGMP” in this RFP refers to the current Good Manufacturing Practice (cGMP) Regulations promulgated by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug and Cosmetic Act.

a. Contractor shall be responsible to adhere to all applicable current good manufacturing practice (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, vaccines/biologics and/or investigational new drug (IND) products.

b. 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, vaccines/biologics and/or pre-licensed IND products.

c. Contractor Qualification - Initially and annually the Government shall assess the Contractor’s facility and Quality Systems and make a determination in regards to the site’s acceptability and compliance to properly and safely store and handle the Government-owned product. The assessment agenda will include a review of the following areas covering the receiving, holding, and shipping preparation of product.

· Standard Operation Procedures

· Software and equipment validations

· Deviation system

· Corrective Action and Preventive Action System

· Quality Assurance

· Change Control

· Training management system

· Facility maintenance

· Equipment maintenance and calibration

· Environmental Monitoring (Excludes Microbiological and Particulate Monitoring)

· Facility Sanitation program

· Document control system

· Vendor management program

· Organization and personnel qualifications and responsibilities

· Regulatory inspection history (482, 483, warning letter, etc.)

Upon completion of a Government quality assessment site visit, the Contractor shall receive a written formal assessment report from the Contracting officer (CO). Upon the contractor’s receipt of the government’s written formal assessment report from the CO, the contractor shall have 30 calendar days to respond in writing to the CO regarding the Governments 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 Quality Control Unit (QCU) may conduct “for cause” audits to address product quality or safety concerns within ten (10) business days of notification to Contractor.

d. Document Control Program - The Contractor shall be responsible for maintaining a formal document control program (See Section F, Deliverable 08) 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.

e. Standard Operating Procedures - The Contractor’s performance responsibilities and activities shall be described and controlled in their SOPs (See Section F, Deliverable 09) covering the receiving, holding, and shipping preparation of product. All Contractor employees performing under the existing 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.

f. Training Program - The Contractor shall be responsible to implement a training program that defines the training requirements for all employees performing under the existing contact, covering the receiving, holding, and shipping preparation of product. Contractor provided training shall be in the particular operations that the Contractor performs and in 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.

g. Facility Temperature/Humidity Monitoring System – The Contractor shall be responsible for maintaining written procedures (See Section F, Deliverable 10) 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 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 contract for warehousing (receiving, holding and shipping preparation of finished pharmaceuticals, medical devices, vaccines/biologics and/or investigational new drug (IND) products). Each Cold Storage Unit (CSU) temperature monitored area will have a preapproved number of primary temperature probes and back-up temperature probes (positioned in the coldest and hottest spot of the unit based on the latest temperature mapping).

· Controlled Room Temperature (CRT) areas will have a sufficient number of probes to accurately record the environmental conditions and identify areas not suitable for CRT product storage.

· Temperature mapping of the CRT area is required. The backup temperature probes shall be placed in close proximity of the primary temperature monitoring probe(s) and if through an annual Performance Qualification (PQ) (or the predefined times in the Comprehensive Validation Section), it is determined that the coldest and/or hottest spot of the unit has changed, then the Contractor shall be responsible to relocate the backup probe(s) to the newly identified cold and/or hot spot. The last PQ can be used to identify the cold and hot locations for the CSU’s.

h. Monthly Temperature Reports - The contractor shall be responsible to provide the Government’s QCU a report (See Section F, Deliverable 11) 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:

· Facility code name

· Unit number identification

· Storage temperature range

· Graphical representation of the monthly readings from each storage area

· Relative Humidity for each storage area

· Alarm reports and resolutions (including deviations and corrective/preventive actions)

· Detailed temperature readings for all reportable excursions

· MKT for the month and previous rolling 12 months

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

i. Deviation 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 and fully documented by the Government in accordance with their standard procedures. The Government is responsible for product impact evaluation and contacting appropriate manufacturer, if and when required. The completed deviation report including product disposition, when applicable, may then be provided to the Contractor by the Government QCU.

j. Incident Notification and Reporting – The Contractor shall be responsible to report to the Government of the following:

· Any controlled room temperature (CRT) initial excursion outside of 68-77°F (20-25°C) for a continuous 2-hour period. Additional notification if CRT excursion falls outside of 59-86°F (15-30°C) for a continuous 2-hour period. (Notify Government Facility Manager)

· 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. (Notify Government QCU).

· Any refrigeration or freezer temperature excursion outside the established range for greater than 15 minutes (Notify Government QCU and Facility Manager).

· Any temperature monitoring system software and/or equipment failure upon discovery. (Notify Government QCU and Facility Manager).

· Any temperature data loss or gaps upon discovery. (Notify Government QCU).

· Any event that may result in product loss, damage or the potential to impact product quality requires notification to the Government upon discovery. (Notify Government QCU and Facility Manager).

· A detailed incident report shall be provided to the Government’s Facility Manager, with a copy to the CO and the QCU no later than two business days after incident. More critical deviations or incidents may require an immediate interim written report upon request by the QCU. 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 QCU, Facility Manager and CO upon completion. The Contractor shall provide additional supporting information as requested by the Government QCU. (Forward to QCU)

Contact Information – To be provided at time of award.

Facility Manager Contact:

Provided at time of award.

QCU Contact Email Alert Notification System: The email will identify the unit/area/site that experienced the excursion/quality issue, provide as much information as is currently known and include a point of contact (POC) name and telephone number. A QCU representative will contact the POC within 1 hour of receiving the email to acknowledge receipt of the notification and request any necessary additional information. If the point of contact receives no reply from the QCU within 1 hour, he/she will call the Facility Manager.

QCU Daily Contact Group Email: This email is used for daily communication to the QCU that does not involve potential impact to product.

k. Facility Design and Maintenance/Sanitation Program- The Contractor shall be responsible to provide a maintenance program that shall document that all 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 nonscheduled 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 and maintenance/repair program for all temperature controlled equipment and monitoring systems. Appropriate schedules, as established by contractor’s procedures, for all calibration, 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, maintenance/repair, 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/repair, shall be documented and maintained by the contractor and made available to the Government upon its request. All calibrations shall be performed according to manufacturer specifications and current National Institute of Standards and Technology (NIST) standards.

l. Comprehensive Validation Program - The Contractor shall be responsible to validate all CRT, refrigerated and frozen storage areas, if applicable; temperature monitoring systems; and any electronic document control, inventory management, change control, training management, CAPA, and deviation systems. Temperature mapping of the CRT area is required. 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 (See Section F, Deliverable 13). Equipment used during the qualification shall have a current NIST traceable calibration status.

· The Contractor shall be responsible for re-qualification and mapping (and/or re-mapping) of the refrigerated and frozen storage area 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.

· 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 final acceptance by the Government, 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.

· Annual Performance Qualifications (PQ) will be conducted for each area being monitored. The PQ will collect data (within 30 calendar days) after the annual calibration of probes has be completed for a minimum of 72 hours. The PQ will document the alarm testing of all probes. The report will include a review of the previous year’s temperature, deviations and change controls to assess the need to conduct revalidation of the area.

· 21CFR Part11 Compliance and Validation of Computerized System - The Contractor shall be responsible to ensure that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21CFR Part11 compliant and are validated as per Software Development Life Cycle (SDLC) concept. 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.

m. Contractor or Subcontractor Qualification - The Contractor shall be responsible to ensure that all subcontractors utilized by the Contractor to 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 its request (See Section F, Deliverable 14).

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

· Installed secondary critical cooling system components for each Cold Storage Unit (CSU).

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

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

· 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.

· Data back-up of electronic data capture.

o. Change Control - The Contractor shall be responsible to document changes to all validated systems utilized to monitor and hold Government-owned products. The Contractor shall notify the Government, in advance of implementation, for assessment and approval of any planned system changes that may impact Government-owned products. Notification of any unplanned change, such as a system repair, that is not a “like for like” change, that may affect the qualification of the system impacting Government-owned product processing shall be provided to the Government within two business days.

p. Quality Assessment Compliance - Quality Assessments of Contractor facilities and quality systems as defined in the Contractor Qualification requirement shall be annually, unless noncompliance, to the required scope of work was found and a Government/manufacturer re-assessment visit is deemed necessary. The agenda to be followed during Quality Assessment is described in the Contractor Qualification section.

· 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.

· 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.

· Upon completion of a Government/manufacturer Quality Assessment site visit, the Contractor shall receive a written formal assessment report from the CO. Upon the Contractor’s receipt of the Government/manufacturer written formal assessment report from the CO, the Contractor shall have 30 calendar days to respond in writing to the CO regarding the Government/manufacturer required and/or suggested improvement recommendations with proposed corrective actions and target dates for completion.

q. Facility Inspection Notifications - The Contractor shall be responsible to immediately notify the Government QCU with a copy to the CO and Facility Manager of any notice of inspection and unscheduled inspections or actions by regulatory agencies, other enforcement agencies (for example, FDA, The Drug Enforcement Administration (DEA), Occupational Safety & Health Administration (OSHA)), and third party vendors that may involve and/or impact government-owned products. If no advance notice is given, QCU 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.

C.4.1.7 SUBTASK 7 - TRAINING

The Contractor shall implement a successful training program that defines the training requirements for all employees performing under the contract, covering the receiving, holding, and distribution of product. The Contractor provided training shall be for the particular operations that the Contractor performs and based on cGMP practices. 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. Annual cGMP training shall be provided by the Contractor and conducted by qualified individuals to assure that employees remain familiar with cGMPs.

The Contractor shall ensure all subcontractors utilized 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. All subcontractors shall be regularly evaluated by the primary Contractor to ensure performance and quality compliance. Subcontractor Evaluation Records identifying acceptable subcontractors, their evaluation, and evaluation criteria used shall be documented and available for review by the Government upon its request.

C.4.2 TASK 2 – ESTABLISH AND MAINTAIN THE WORKING ENVIRONMENT

The Contractor-provided environment for the site shall support the required services described in the requirements below, to include capacity, security, systems redundancy, environmental controls, safety, and functionality.

C.4.2.1 SITE CRITERIA

The Contractor-provided environment for each of the two sites shall support the required services described in the requirements below, to include capacity, security, systems redundancy, environmental controls, safety, and functionality.

C.4.2.1 SITE CRITERIA

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

a. Be located within a 20 driving miles of the specified Site A and B International Airports.

b. Be located no more than 5 driving miles from a major interstate. Within 3/4 mile, the site shall provide access to multiple routes to the highway system and airport.

c. Facility, parking areas, and truck courts shall be a devoid of any dips, inclines, or uneven terrain which would impede the safe and free movement of trucks and other motorized vehicles.

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

e. Not be located within a 1/2 mile radius of any fuel farm (excluding car/truck gas stations), chemical plant, power distribution station, liquefied natural gas plant (as measured from the main gate of the facility in question to the driveway of the proposed facility), landfill (open, proposed, or closed), or other hazardous material capable of creating an explosive, biological, or hazardous event. Contractors are encouraged to contact local Planning Commission’s in any proposed jurisdiction. The Government defines a power distribution station as meeting the following criteria:

· It has transformers that step transmission voltage (in the tens or hundreds of thousands of volts range) down to distribution voltages (typically less than 10,000 volts).

· It has a “bus” that can split the distribution power off in multiple directions.

· It has circuit breakers and switches so that the substation can be disconnected from the transmission grid or separate distribution lines can be disconnected from the substation when necessary.

f. For purposes of constant accessibility, not be located a 2 mile radius of any current or planned and documented high traffic entity such as major league sports stadiums or a large venue with a capacity over 10,000 (excluding the airport).

C.4.2.2 GROUNDS CRITERIA

The Contractor’s grounds shall conform to the following criteria:

a. Provide visitor and employee parking areas for at least forty (40) vehicles, and be in compliance with all local codes regarding standards.

b. Provide parking areas for at least thirty (30) 53’ trailers and 11’-0” tractors for storage beyond dock parking areas.

c. Landscaping and vegetation shall not impede access-egress of trucks from site and shall not obscure line of vision around perimeter and fencing of facility.

d. Perimeter fence will have a single entrance for employees, visitors, trucks, and trailers. A secondary vehicle gate may be required by local governing authority.

e. Support the requirement of fencing. The perimeter gate shall be powered with electronic access and shall be secured when the facility is unoccupied.

C.4.2.3 FACILITY CRITERIA

The Contractor’s facility shall conform to the following criteria:

a. Be a standalone facility. However a multi-tenant facility may be considered if it can be demonstrated that the space for this contract is separated and secured from other tenants to include external points of egress.

b. Internal roof access is preferred. If external is utilized, the access must be secured.

c. Have a minimum of 50’ setback (fence) from the building.

d. Glass frontages and skylights are not preferred. If present, the Contractor shall install tinted security film or other physical barriers.

e. Comply with local zoning requirements and cGMP requirements as applicable.

f. Be cGMP complaint regarding the handling and holding of pharmaceuticals, medical surgical items, and IND products.

g. Provide the Government adequate space as specified for Sites A and B for pallets and equipment.

h. Provide the following redundant systems:

· Installed secondary critical cooling system components for each CSU. The chambers cooling capability shall be uninterrupted due to mechanical failure.

· 100% back-up generator power to maintain and monitor temperature controlled environments and to support all warehouse and office operation.

· Uninterrupted Power Source (UPS) for all data capture and security systems.

· Back up temperature monitoring system.

· Data back-up of electronic data capture.

i. All outside communications services are provided with conduit diversity and provide redundancy to allow for the Government to contract with multiple communication service vendors. Conduit diversity is a building with an additional wire line conduit entry point.

j. All communications, water, fire, natural gas, power, and sewer service connections are all located within 5 feet of building.

k. Facilities constructed after 2000 shall have been constructed utilizing International Building Code (IBC). Facilities constructed prior to 2000 shall have been constructed utilizing Uniform Building Code (UBC). The Government reserves the right to verify compliance with these building codes.

C.4.2.4 SPACE CRITERIA

The Contractor’s facility shall provide space for the following:

a. Ambient Warehouse: (Required Temperature Range 20-25 degrees Celsius)

· Space for 190 rolling Container Vents Storage. Each unit draws 3 amps during charging. (Site A only).

· Space for 124 rolling Container Vents Storage. Each unit draws 3 amps during charging. (Site B only).

· Space for storage and staging of product.

· Space for 260 racked pallets and for storage of Schedule III, IV, V (requiring 840 Specification fence separation and as specified in 29 CFR 1301.72) products (Site A only).

· Space for 4 racked pallets and for storage of Schedule III, IV, V (requiring 840 Specification fence separation and as specified in 29 CFR 1301.72) products (Site B only).

· Toilet facilities in accordance with 29 CFR 1910.141.

· Ball mat floor to facilitate loading (Site B only). The dimensions for the ball mat room are 160’ deep by 30’ wide for a total of 4,800 sq ft. The dimensions for the ball mat area of the dock are 48’ deep by 30’ wide for a total of 1,440 sq ft.

b. Refrigerated/Freezer Warehouse: (Required Temperature Range -25 to 8 degrees Celsius)

· Space for multiple chambers (mm.4) with redundancy and the capability of adjusting size and temperature of each chamber for current and future requirements.

c. Loading Dock/Staging area: Loading, staging unloading, packaging and shipping control areas.

· Space for Ambient Dock.

· Space for Refrigerated Dock.

· Space for critical packing and shipping.

· Shipping/control office.

d. Turn-key, Furnished Office Area: Product management, operations and control areas:

Site A only: Provide a minimum of 600 usable square feet to include three (3) private offices (min. of 65 sq. ft. each), conference room (min. of 300 sq. ft.), and an open work area (min. of 100 sq. ft.).

Site B only: Provide a minimum of 600 usable square feet to include two (2) private offices (min. of 50 sq. ft. each), conference room (min. of 400 sq. ft.), and an open work area (min. of 100 sq. ft.).

In addition to the above space requirements the following space will also be required.

· Toilet facilities to include Contractor-provided surge personnel in accordance with 29 CFR 1910.141

· Security Control Room (400 sq. ft.)

· One (1) locker room. (100 sq.ft.)

· Common area

· Alarm room (25 sq.ft.)

· Telco room (50 sq.ft.)

· Two (2) Storage Rooms (200 sq.ft ea.)

· Utility Room (25 sq.ft.)

C.4.2.5 SECURITY CRITERIA

The Contractor’s facility shall meet the following security criteria. The Contractor shall ensure that all security requirements are coordinated with Government Security Personnel.

a. General:

· All equipment shall be UL approved.

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

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

· All wiring shall be in conduit from device to ceiling deck.

· When not in conduit it shall be tied off at 24” intervals. Magnetic contacts shall have flexed stainless steel conduit from device to standard conduit.

· Prepare and submit shop drawings (See Section F, Deliverable 15) for all systems prior to start of work and equipment ordering. The provider shall also indicate how the all electronic systems shall be integrated. The Government turnaround time on approval of the Shop Drawings will be no more than five (5) days.

· The Contractor shall obtain approvals on all security equipment prior to purchase/install.

· The security systems installer shall provide equipment and user manuals for all equipment/systems.

· The security systems installer shall provide a minimum of two days of training for selected personnel for complete understanding of all systems.

· All security systems shall be connected to the generator. Also, all systems are to have a separate UPS system to operate all security systems for an 8 minute period.

· Prepare and deliver complete set of CAD As Built Drawings, both a hard copy and electronic, (See Section F, Deliverable 16) indicating all wiring, device locations, head end equipment, etc. for all security systems.

· Record all serial numbers on equipment for all systems.

· All head end equipment at each site shall be located in the Command Post or segregated Alarm room.

· Provide rack for DVRs and monitors in alarm room and provide easy access to the rear of the cabinet.

· The Contractor shall provide maintenance for all security equipment purchased on behalf of the Government for use under this contract (See Section J, Attachment A).

b. Closed Circuit Television (CCTV):

1. Camera Specifications – general

· Cameras shall provide quality, clarification and a clear view of all personnel doors from top to bottom and 3 feet in front of door.

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

· 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.

· 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 10 feet to the side.

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

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

· RG6 or better wiring for CCTV equipment.

2. Fixed cameras

· Fixed cameras shall be equipped with varifocal lens to accommodate the mounting height and target distance required to be determined by the field of view.

· The interior cameras shall be mounted approximately 10 – 12 feet above floor level unless located in the office area and then mounted in the ceiling.

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

3. Cameras covering the overhead doors shall:

· 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).

4. Provide 4 extra wire runs to each corner of the building with additional wire coiled and tied off on deck trusses for future use. The wire runs are to originate from head end equipment. There should be sufficient cable remaining to connect to the DVR.

5. Camera Requirements – Make – Bosch (or equal):

· Fixed cameras

· Color – minimum 540 tvl.

· Day / night (automatically allows more light for clearer picture).

6. Coverage – Exterior P/T/Z

· Environmental Auto Dome (PTZ) color cameras shall be installed on the roof corners with parapet mounts (if applicable) at the exterior corners at 3 to 4 feet above the roof line on poles to give complete visibility/coverage of the entire exterior grounds, fence lines, entrances, etc. An additional two to four PTZs will be required equi-distant between the corner PTZs depending on the size of the building.

7. Exterior – Fixed - color cameras with environmental housing with window heater/defogger shall be installed to provide coverage:

· On all personnel doors into the facility mounted on the opposite side of the hinges (8 to 10 feet away from the door) approximately 12 to 14 feet high.

· Provide camera coverage at the outside guard house to record incoming and outgoing traffic and to record the side of the truck and driver when stopped for presenting identification to the guard. This requires at least three fixed cameras with two on a pedestal to cover auto and truck drivers for identification.

· Fixed camera to provide coverage on the generator.

8. Interior Coverage - Fixed color cameras (provide as specified above)

· On all perimeter personnel doors, operational overhead doors and dock areas.

· All freezer/refrigerator entrance doors are to be environmental units with heaters.

· On all personnel doors exiting the office area into the warehouse area.

· On the weapons storage door.

· DEA cage entrances.

· Provide camera coverage of all interior guard posts.

9. Digital Video Recorder shall:

· Provide 16 channel DVR’s (Bosch units, or equal) with a minimum of a terabyte of hard drive per DVR.

· Provide DVD/CD rite or thumb drive capability with password protection.

· Provide remote access capability via T1 line.

· Provide enough inputs so all doors are slaved to cameras (via door contacts) to provide alarm and non alarm status in all three of the interior guard posts.

· Provide analogs outputs for monitors.

· All cameras providing coverage on doors shall be slaved to the DVR to present an immediate camera view of the door at all interior guard posts.

· Provide a UPS for the DVR’s and CPU’s to prevent lightning damage and protect against power surges and spikes.

· All head end equipment is to be secured in the Command Post.

· DVR shall be capable of accepting the highest number of camera TVL.

· Provide remote view software.

10. Color (Bosch, or equal) Monitors shall: All guard posts shall have sufficient monitors to view all cameras simultaneously. The Contractor shall:

· Provide color rack mounted monitors per DVR.

· Provide 20” color monitor for each of the 3 interior guard posts.

· Provide a monitor for the exterior guard house.

· Provide a monitor in the three interior guard posts for alarm call up video only.

· All of the cameras covering the perimeter doors (and others as deemed necessary) shall be programmed to call up when the door is open whether the IDS system is armed or not.

c. Intrusion Alarm System (IDS)

1. Head end equipment - install Bosch (or equal) Individual Point ID UL Listed alarm Control Panel with:

· Point to point annunciation.

· A minimum of 8 partitions (zones).

· A visual display panel for alarm notification in main guard post.

· Installed radio/cellular backup communication.

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

· Keypad shall be located in the Command…