RFP_GSC-QFOB-13-32711_06.28.2013.docx

Request for Proposal

GSC-QFOB-13-32711

Managed Service Support for Government-Owned Pharmaceutical, Medical Supplies and Medical Equipment

For the:

Government Agency

Conducted under FAR Part 12, In accordance with FAR Part 15

Issued by:

General Services Administration Federal Systems Integration and Management Center (FEDSIM) 2100 Crystal Drive Suite 800 Arlington, VA 22202

June 28, 2013

FEDSIM Project Number 29086HHM

Request for Proposals GSC-QFOB-13-32711 PAGE 53

REQUEST FOR PROPOSAL

GS-QFOB-32711

Government Agency

TABLE OF CONTENTS

CONTRACT CLAUSES Page 3

52.212-4, Contract Terms and Conditions – Commercial Items Page 3 Addendum to 52.212-4, Contract Terms and Conditions – Commercial Items Page 8 52.212-5, Contract Terms and Conditions Required To Implement Statutes and Executive Orders Page 39

SOLICITATION PROVISIONS Page 42

52.212-1, Instructions to Offerors – Commercial Items Page 42 52.212-3, Offeror Representations and Certifications – Commercial Items Page 56

ATTACHMENTS

a. Service Contract Act Wage Determinations (by State)

b. Security System Maintenance Requirements

c. Pallet Racking Naming Scheme

d. Employee/Contractor Non-Disclosure Agreement (accessing SBU information)

e. Problem Notification Report Sample

f. Container Schematic

g. Consolidated list of applicable regulations

CONTRACT CLAUSES

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (FEB 2012)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to the Contract Disputes Act of 1978, as amended (41 U.S.C. 601-613). Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration, or 52.232-34, Payment by Electronic Funds Transfer—Other Than Central Contractor Registration), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected contract line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in Section 611 of the Contract Disputes Act of 1978 (Public Law 95-563), which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. 3701, et seq., Contract Work Hours and Safety Standards Act; 41 U.S.C. 51-58, Anti-Kickback Act of 1986; 41 U.S.C. 265 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. 423 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, and Compliance with Laws Unique to Government Contracts paragraphs of this clause.

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments.

(9) The specification.

(t) Central Contractor Registration (CCR).

(1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the CCR database, and for any liability resulting from the Government’s reliance on inaccurate or incomplete data. To remain registered in the CCR database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the CCR database to ensure it is current, accurate and complete. Updating information in the CCR does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(2)(i) If a Contractor has legally changed its business name, “doing business as” name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in FAR Subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day’s written notification of its intention to (A) change the name in the CCR database; (B) comply with the requirements of Subpart 42.12; and (C) agree in writing to the timeline and procedures specified by the responsible Contracting Officer.

The Contractor must provide with the notification sufficient documentation to support the legally changed name.

(ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the CCR information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the “Suspension of Payment” paragraph of the electronic funds transfer (EFT) clause of this contract.

(3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the CCR record to reflect an assignee for the purpose of assignment of claims (see Subpart 32.8, Assignment of Claims). Assignees shall be separately registered in the CCR database. Information provided to the Contractor’s CCR record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be considered to be incorrect information within the meaning of the “Suspension of payment” paragraph of the EFT clause of this contract.

(4) Offerors and Contractors may obtain information on registration and annual confirmation requirements via CCR accessed through https://www.acquisition.gov or by calling 1-888-227-2423 or 269-961-5757.

End of clause)

ADDENDUM TO 52.212-4, CONTRACT TERMS AND CONDITIONS –COMMERCIAL ITEMS (FEB 2012)

1.1 PURPOSE

The Contractor shall provide managed services support to one site (referred to as Site B; the Government will provide the actual location after the offeror signs the Non-Disclosure Agreement) for storage, management/maintenance of the medical products, monitoring, logistics, reporting, and emergency delivery of Government-provided medical supplies to the site of a national emergency (e.g., hurricane, earthquake, man-made disaster, etc.). These products are used to supplement state and local resources during a large-scale public health emergency. The Contractor shall support a complement of 130 containers comprised of medical supplies and shall provide managed service support for pallets of medical supplies. See Attachment F for a schematic of a container and a typical pallet is 48” x 42” at the base by 60”.

1.2 BACKGROUND

The Government has the mission to deliver critical medical assets to the site of a national emergency (e.g., man-made disaster, flu outbreak, earthquake, etc.). The Government manages a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, and medical supplies that can be used to supplement state and local resources during a large-scale public health emergency. The Contractor shall provide storage and delivery of immediate response 12-hour containerized medical supplies and pharmaceuticals designed to provide rapid delivery of a broad spectrum of assets for an ill defined threat in the early hours of an event. This support is being procured for one site.

1.3 SCOPE

The Contractor shall provide all personnel and support to fulfill the requirements. The Contractor shall ensure that all Government products stored in the Contractor-provided facility remains viable based on the requirements provided below. Normal hours (core hours) of operation are Monday-Friday 7 a.m. - 5 p.m. local time for the site. Core hours of support by the Contractor shall coincide with Federal holidays. The Contractor shall also support emergency operations as needed for rapid response and ground transportation. When directed by the Government, the Contractor shall provide support and vetted ground transportation (e.g., trucks and drivers) for up to 130 containers of product from the Contractor’s facility to the stated international airport within 3.5 hours or to a Government-designated destination not to exceed 44 miles within 7 hours. (For planning purposes, the Government may conduct emergency response exercises no more than twice a year, or during an actual emergency.). The Contractor shall provide all required security capabilities for the grounds and in the facility.

The Contractor shall be ready to accept products within 90 calendar-days of award. The Contractor shall provide additional pallet space for supplies. The amount of pallet space is shown below:

Site B: Store a complement of approximately 50 tons of Government-provided containerized medical supplies (130 containers), 225 pallets of Government-provided medical supplies and work area to support Tasks 1-3.

There is an existing facility located in the region of Site B. If an award is made to a contractor proposing a facility other than the existing facility, the awardee shall be responsible for the relocation of all assets currently being held (approximately 130 containers and 20 pallets) at the existing facility within 5 working days.

The Contractor shall provide management, preservation, and handling of all medical products in accordance with current Good Manufacturing Practice (cGMP) specifications and other Federal guidelines/regulations (see Attachment G).

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

1.4 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

1.4.1 TASK 1 – PROVIDE PROJECT MANAGEMENT

The Contractor shall provide Project Management while the Contractor is establishing the Working Environment (Facility Conditioning and Transition-In/Initial Movement) under CLIN 0003. The Contractor shall provide Project Management while the Contractor is maintaining the Working Environment (Managed Service Operations) under CLINs 0001, 1001, 2001, 3001, and 4001.

The Contractor shall provide successful program management support under this contract 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 requirement. 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) Managed Service Operations. The Contractor shall provide support for the following subtasks.

1.4.1.1 SUBTASK 1 – COORDINATE A PROJECT KICK-OFF MEETING

The Contractor shall schedule and conduct a Project Kick-Off Meeting (Section 12.0, Deliverable 01). At a minimum, the attendees shall include Contractor personnel, Government personnel, and the FEDSIM 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

i. A blueprint of the warehouse to include container storage location and pallet storage area.

The Contractor shall prepare and deliver a Project Kick-off Agenda (Section 12.0, Deliverable 02) that includes at a minimum the above referenced items. The Contractor shall prepare and deliver a Project Kick-off Report (Section 12.0, Deliverable 03) that documents the results of the meeting.

1.4.1.2 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 three month period. Final Government acceptance of the facility will start no later than the beginning of month 4.

b. Efficient and continual lines of communication through Weekly Status Calls with the Government and submission of 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.

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. If determined required, accommodate a site visit 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 MSR.

1.4.1.3 SUBTASK 3 – PREPARE A MONTHLY STATUS REPORT (MSR)

The Contractor shall prepare an MSR (Section 12.0, Deliverable 04) containing at a minimum the following information:

a. Activities during reporting period, by task (include on-going 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. Schedule (show major tasks, milestones, and deliverables; planned and actual start and completion dates for each).

f. Comparison data / monthly performance reports.

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

h. Any changes to the facility’s or contractor’s Quality Systems, to include cGMP, facility maintenance, environmental monitoring, standard operating procedures, and any of the other elements of the quality system called out in Section 1.4.1.5, and including both written documents and the Contractor’s actual practices.

1.4.1.4 SUBTASK 4 – TRANSITION OUT

The Contractor shall provide a Transition-Out Plan (Section 12.0, Deliverable 05) 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 accomplish the following:

a. Transfer knowledge regarding:

1. Points of contact.

2. Quality performance documentation.

3. Product status and labeling system.

4. Inventory listing (hard copy and disk).

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 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 calendar 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 immediately upon receipt of notice of cancellation.

1.4.1.5 SUBTASK 5– QUALITY CONTROL

The Contractor shall conform to the following quality control practices and provide the following documents. All references to “cGMP” in this requirement 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. General: Contractor shall be responsible for adhering to all applicable Federal, state, and local quality assurance regulations in addition to the Government performance requirements cited throughout to ensure the proper operation of a Government-contracted facility in regards to receiving, holding and distributing finished pharmaceuticals, and medical surgical products.

The Contractor shall maintain comprehensive Quality System programs which shall comply with all applicable Federal, state, and local regulations and the Government performance requirements cited throughout for receiving, holding, monitoring, and distributing finished pharmaceuticals, and medical surgical products.

b. Contractor Qualification: The Government will assess the Contractor’s facility and Quality Systems and make a determination regarding the site’s acceptability and compliance to properly and safely store 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 distributing finished pharmaceuticals, and medical surgical products:

1. Standard Operating Procedures

2. Software and equipment validations

3. Deviation system

4. Corrective Action and Preventive Action system

5. Change Control

6. Training management system

7. Facility maintenance

8. Equipment maintenance and calibration

9. Environmental Monitoring

10. Document control system

11. Vendor management program

12. Organization and personnel qualifications and responsibilities

13. 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 contracting CO, the Contractor shall have 30 calendar days to respond in writing to the CO regarding the Government’s required and/or suggested improvement recommendations with proposed corrective actions and target dates for completion. The Government, based on the requirements, 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.

c. Document Control Program: The Contractor shall maintain a formal document control program to manage approval, distribution, archival, and change control. This program shall minimally include standard operating procedures (SOPs) and protocols, software and equipment validation documents, and training records covering the receiving, holding, and distribution of product, and shall be made available to the Government.

d. Standard Operating Procedures: The Contractor’s performance responsibilities and activities shall be described and controlled in their SOPs covering the receiving, holding, and distribution 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.

e. Training Program: The Contractor shall implement a training program that defines the training requirements for all employees performing under these requirements, covering the receiving, holding, and distribution 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.

f. Facility Temperature Monitoring System: The Contractor shall maintain 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 monitor relative humidity in all storage areas and will have a sufficient number of probes to accurately record the relative humidity.

The Contractor shall 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 solicitation for warehousing (receiving, holding and distributing of finished pharmaceuticals/ biopharmaceuticals, IND products, and medical surgical products). 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.

g. Monthly Temperature Reports: The Contractor shall provide the Government Quality Control Unit (QCU) 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

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

7. Detailed temperature readings for all reportable excursions

8. MKT for the month and previous rolling 12 months

A. 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.

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

h. Deviation and Corrective Action Tracking: The Contractor shall maintain deviation and corrective action/preventive action (CAPA) systems and document 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.

i. Incident Notification and Reporting: The Contractor shall report to the Government the following:

1. 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)

2. 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 QCU).

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

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

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

6. A detailed incident report shall be provided to the Government’s Facility Manager, with a cc 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, Government Facility Manager and CO upon completion. The Contractor shall provide additional supporting information as requested by the Government (QCU).

Contact Information

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.

j. Facility Design, Equipment and Maintenance Program: The Contractor shall provide a maintenance program that shall document that the storage facility is 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 implement a system to track equipment and software systems required for compliance including but not limited to: temperature monitoring, heating, ventilation, and air conditioning (HVAC), primary and back-up power. The tracking system shall log and schedule all preventive maintenance, validations, and calibrations. Any corrective, scheduled, and nonscheduled maintenance shall be documented with the documentation included in the records for each piece of equipment.

The Contractor shall establish and manage a calibration and maintenance/ repair program for all temperature controlled equipment and monitoring including back-up systems. Schedules, as established by the 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 their 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.

k. Comprehensive Validation Program: The Contractor shall validate all CRT, temperature monitoring systems, document control, change control, training management, CAPA, deviation system, and all other electronic systems used. All validation documentation shall be available to the Government for review. Equipment used during the qualification shall have a current NIST traceable calibration status.

The Contractor shall ensure that all equipment and system validations are performed in a timely and accurate manner. The Contractor shall maintain, re-calibrate and re-validate the facilities and equipment periodically according to all applicable laws and regulations. The Government shall review protocols prior to initial execution for adequacy. A complete report 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.

21 CFR Part 11 Compliance and Validation of Computerized System - The Contractor shall 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 21 CFR Part 11 compliant and are validated as per Software Development Life Cycle (SDLC) concept. A periodic performance review process must also be in place to ensure that all such systems remain in the validated state throughout their lifecycle.

l. Contractor or Subcontractor Qualification: The Contractor shall 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.

m. Redundant Systems: Contractor shall provide and maintain the following redundant systems.

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

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

3. Back up temperature monitoring system.

4. Data back-up of electronic data capture.

n. Change Control: The Contractor shall document changes to SOPs and 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.

o. Quality Assessment Compliance: Quality assessments of Contractor’s facility and quality systems as defined in the Contractor Qualification requirement shall be performed six months after an initial qualification and annually thereafter unless noncompliance, to the required scope of work was found and a Government re-assessment visit is deemed necessary by the Government. The agenda to be followed during quality assessment is described in the Contractor Qualification section.

The Government will schedule Quality Assessments 30 calendar days in advance when possible. A Quality Assessment agenda will 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.

p. Facility Inspection Notifications: The Contractor shall 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 QCU and Government Facility Manager 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 the Government with any FDA 483 observations, FDA Establishment Inspection Reports (EIRs) and/or other inspection reports.

q. Licensing: The Contractor (or at least one member of the Mentor/Protégé 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 as required by 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 Mentor/Protégé Joint Venture, if applicable) shall meet and maintain whatever specific legal requirements do exist and provide acceptable documentation in this regard to the Government on demand. At a minimum, the Contractor shall have registered for the storage and distribution of pharmaceuticals with the FDA.

1.4.1.6 SUBTASK 6 - 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 ensure 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.

1.4.2 TASK 2 – ESTABLISH AND MAINTAIN THE WORKING ENVIRONMENT

The Contractor shall establish the Working Environment (Section 12, Deliverable 07) under CLIN 0002. The Contractor shall maintain the Working Environment under CLINs 0001, 1001, 2001, 3001, and 4001.

1.4.2.1 SITE CRITERIA

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

1.4.2.1.1 SITE LOCATION

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

a. Be located within 25 driving miles of the International Airport for Site B.

b. (Reserved)

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. (Reserved)

e. Not be located within a 1/4 mile radius (as measured from the nearest property line of the facility in question to the nearest property line of the proposed facility) of hazardous material capable of creating an explosive, biological, or hazardous event (excluding those dedicated to airport operations).

f. (Reserved)

1.4.2.2 GROUNDS CRITERIA

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

a. Provide visitor and employee parking area, and be in compliance with all local codes regarding standards.

b. Provide sufficient parking space for staging trucks during an exercise or an actual event.

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

1.4.2.3 FACILITY CRITERIA

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

a. The agency’s storage area (if shared) will be separated from other tenants via a demising wall meeting building codes or secure chain link fencing (15 feet in height). The actual footprint shall have a covering on the fencing (if utilized). The dock area does not have to have covering. There can be a shared building, but no shared space.

b. If external roof access is utilized, the access must be secured with alarms and locks.

c. If glass frontages and skylights are present, the Contractor shall install tinted security film or other physical barriers on windows and burglar bars on skylights. If security film is used it shall be a minimum of 4-mil and meet or exceed ANSI Z97.1 standards.

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

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

f. Provide the Government adequate space for containers, pallets, equipment required and work area.

g. Provide the following redundant systems:

1. 100% back-up generator power to maintain and monitor temperature controlled environments and to support all warehouse and office operation.

2. UPS for all data capture and security systems.

3. Back up temperature monitoring system.

4. Data back-up of electronic data capture.

h. 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.

i. The client Agency reserves the right to conduct up to two response exercises per year (Section 12, Deliverable 08).