RFP_17-223-SOL-00019_.pdf

Solicitation Number: 17-223-SOL-00019 Scientific Instrument Maintenance and Repair Services - IDIQ

PART I – THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Brief Description of Supplies or Services

The U.S. Food and Drug Administration operates and maintains a wide variety of laboratory instruments and related laboratory equipment. To fulfill the Agency’s regulatory and public health mission, these instruments require timely and cost-effective maintenance and repair.

In performing the work as described in detail in Section “C” the Offeror shall consider the following:

This is an Indefinite Delivery, Indefinite Quantity (IDIQ) task order oriented contract. This IDIQ will consist of hybrid task order contract types which include: firm-fixed price (FFP), time and materials (T&M), or Labor Hour (LH).

As the need for services covered by this contract arises, the Government will issue a Task Order (TO) to the Offeror with all the necessary documentation of project requirements, under cover of a written request for proposal to perform the required services.

B.2 Maximum Total Contract Amount

The Government guaranteed $850,000.00 as the minimum order amount for the life of the contract.

The total cumulative amount payable under this contract shall not exceed $20,000,000.00 (Contract Schedule Modification Effected by Option Exercise) for services and materials furnished to the Government under such Task Orders as may be issued by the Government. This is the maximum ceiling amount allowed under this contract, and it is not intended to imply that it is an estimate of the total services that will be required.

B.3 Pricing / Equipment Schedule

The Master Equipment List (MEL) is in spreadsheet form which contains all information about each instrument eligible for maintenance and repair services called for under this contract. See Attachment J-1.

(End of Section B)

SECTION C – STATEMENT OF WORK

C.1 Background

The U.S. Food and Drug Administration (FDA) is a regulatory agency with responsibility for the safety of food for humans and animals and the safety and efficacy of drugs, devices and other medical products. In support of this regulatory mission FDA operates laboratories which conduct analyses using scientific instruments. FDA laboratories are located at sites across the United States. The FDA now requires the use of a Contractor to manage and coordinate maintenance and repair services for scientific instruments at FDA facilities nationwide.

The prime customers for the Scientific Instrument Maintenance and Repair Services contract are FDA laboratory scientists based in roughly twenty-one laboratory facilities around the United States and Puerto Rico. Across these facilities, hundreds of FDA scientists perform testing, surveillance, and research in support of the Agency’s mission to protect and promote public and animal health. FDA’s laboratory capacity is divided among various Centers according to regulatory responsibility: Food Safety, Veterinary Medicine, Drug Evaluation, Biologics Evaluation, Device Evaluation and Regulatory Affairs (i.e., field operations). Within each Center there may be various Offices with responsibility for a limited set of instruments or a specific facility location. Laboratory instruments and apparatus are engaged in supporting research, method development and analytical testing for drugs, biologics, medical products and devices, food, animal feed, animal medical products and tobacco products.

C.2 Business Objectives

The business objectives for maintenance and repair services of the FDA’s laboratory capacity consist of the following:

A. Manage risks of maintenance and repair and unpredictable equipment failure to limit costs associated with high-risk instruments and reduce repair and maintenance expenses for low-risk instruments, while ensuring timeliness and streamlined processing.

B. Schedule and complete servicing after the need is identified; ensuring prioritization and timeliness - based on the criticality of the equipment to the FDA mission – as well as using quality of work and efficient processes.

C. Ensure maintenance and repair meets FDA specifications; that all laboratory equipment remains operational at levels acceptable to FDA or performs to the original specifications of the instruments.

D. Streamline administrative processes associated with management and coordination of maintenance and repairs to achieve efficiencies, and create shorter maintenance and repair turnaround times.

E. Comply with FDA’s laboratory standard operating procedures (SOPs) and quality management systems.

C.3 Scope

The instruments to be covered include laboratory instruments and associated laboratory equipment at twenty-one (21) FDA facilities in the United States and Puerto Rico. A list of eligible instruments shall be provided with the solicitation (a sample representative Master Equipment List (MEL) can be found in Attachment J-1). The types of instruments to be covered include, but are not limited to those listed below:

A. Mass spectrometer B. Liquid chromatograph C. Gas chromatograph D. Fume hood/Safety cabinet E. Freezer/refrigerator F. Centrifuge G. Other Spectrometer H. Microscope I. DNA Sequencers and Analyzers

Standards and guidelines that must be considered in the execution of this IDIQ SOW include:

A. Requirements for Endorsed Calibration Certifications from an A2LA Accredited Laboratory

a. In accordance with International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025, an international independent lab accrediting body and the American Association for Laboratory Accreditation (A2LA), FDA must maintain compliance with calibration program requirements. It is important that FDA labs request an accredited, endorsed calibration certificate when receiving calibration services in order to ensure metrological traceability is established.

Therefore, contractor management, coordination, maintenance and repair of laboratory equipment must ensure equipment is in compliance with the calibration program requirements to which FDA is held.

b. Acceptable Components and Parts

i. An acceptable component meets original equipment manufacturer (OEM) specifications and is OEM certified for replacement of an equivalent component on a non-performing or non-operational instrument.

ii. An acceptable part meets OEM specifications and is OEM certified for replacement of an equivalent part on a non-performing or non-operational instrument.

B. OEM Certified or Qualified Engineers

a. Maintenance services shall be performed by an OEM certified or qualified maintenance engineer who carries out procedures and/or installs acceptable parts for replacement of an equivalent component required under OEM maintenance protocols.

b. Repair services shall be performed by an OEM certified or qualified repair engineer who carries out procedures and/or installs acceptable parts for replacement of an equivalent component so the instrument is returned to full operation.

C. Acceptable Third Party Service Provider

In some cases, the OEM may approve a commercial entity other than themselves to provide maintenance or repair services on a specified instrument. If so, this entity is an acceptable third party service provider with a certification from the OEM of their qualifications to maintain and repair that OEM’s products. The FDA shall approve or disapprove offeror recommended third party service providers.

D. Acceptable Instrument Performance

FDA defines acceptable instrument performance as meeting one or more of the following:

i. Performance specifications set by the OEM for a particular instrument.

ii. Performance specifications set by an FDA standard operating procedure or quality management program applicable to that instrument.

iii. Performance specifications defined in a method standard operating procedure for a method validated for that type of instrument.

C.4 Technical Requirements

During the contract period, the contractor shall offer service coverage plan options to support the maintenance and repair needs of FDA-owned laboratory instruments. Service coverage plan options provided by the contractor shall include full service coverage plans for specified instruments, repair only coverage plans for specified instruments, preventive maintenance service plans for specified instruments, and as-needed repair coverage plans, but not limited to what is described in the below Table A and Attachment J-2. FDA’s maintenance and repair service request and approval processes as illustrated in Attachment J-3.

C.5 Reporting Requirements

The contractor shall provide a mechanism for each FDA Center to obtain the service history, service activities, and service status of instruments.

Representative activities in support of service tracking services include, but not limited to:

A. The contractor shall provide the ability to look up the current status of service performed for a single instrument.

B. Upon completion of service, the contractor shall request and provide the Field Service Report.

C. The contractor shall provide the ability to trace the service history of instruments listed in the

MEL

D. The contractor shall provide the FDA with reporting that shall include, but is not limited to:

financial reports, monthly maintenance reports, annual financial summary reports, and annual maintenance summary reports. All reports shall be submitted electronically to the FDA Point of Contact (POC) and/or COR.

C.6 Specific Task Service Plans

Task 1: Full Service Plan The contractor shall provide full service that includes repair preventive maintenance, and technical support for a specified instrument or sets of instruments. Such a plan shall consist of a range or combination of repair coverage, preventive maintenance and technical support. The services shall be included as a total, or as options within tiered plans - with different levels of support in each tier of the plan.

Task 2: Preventive Maintenance Plan The contractor shall provide preventive maintenance service that includes the preventative maintenance services necessary to maintain the full operation for a specified instrument or sets of instruments. A preventive maintenance plan shall be offered in total, or in tiered levels, with different levels of support in each plan.

Task 3: Repair-only Plan the contractor shall provide repair-only service under which some or all of the below listed services shall be offered and or coordinated by the contractor for specific instruments or sets of instruments. Repair-only services shall be offered in total or as options in tiered plans, with different levels of support in each tier of the plan.

Task 4: As-needed Plan The contractor shall provide as-needed repair service that are time and materials (T&M) agreements, which cover ad hoc repairs on instruments not covered under instrument-specific plans, and are charged at a price determined by the value of the specific repair or service. As-needed repair services shall be offered or coordinated by the contractor, or both.

TABLE A

FULL SERVICE

PLAN

PREVENTIVE

MAINTENANCE PLAN

REPAIR-ONLY

PLAN

AS-NEEDED

PLAN (T&M)

Coordinating and providing priority on-site service and repairs for a specified instrument or sets of instruments by OEM, OEM-qualified or approved third-party technicians with an on-site response time (service level) of three (3) business days or less, for instruments used in performing critical FDA laboratory operations.

Service that include performing replacement of specified components and consumables for a specified instrument or sets of instruments.

Coordinating and providing priority on-site service and repairs for a specified instrument or sets of instruments by OEM, OEM-qualified or approved third-party technicians with an on-site response time (service level) of three (3) business days or less, for instruments used in performing critical FDA laboratory operations.

Coordinating and providing priority on-site service and repairs by OEM, OEM-qualified or approved third-party technicians with an on-site response time (service level) of three (3) business days or less, for instruments not specified in instrument-specific plans and used in performing critical FDA laboratory operations.

Coordinating and providing standard priority on-site service and repairs by OEM, or OEM-qualified technicians with an on-site response time (service level) of seven (7) business days or less.

Service that allows for a set number of preventive maintenance visits at specified intervals.

Coordinating and providing standard priority on-site service and repairs by OEM, or OEM-qualified technicians with an on-site response time (service level) of seven (7) business days or less.

Coordinating and providing standard priority on-site service and repairs by OEM, or OEM-qualified technicians with an on-site response time (service level) of seven (7) business days or less.

Coordinating and providing standard on-site service and repairs by OEM, OEM-qualified, or approved third-party technicians with an on-site response time (service level) of twenty (20) business days or less.

Arranging, coordinating and managing scheduling and calendars for preventive maintenance services, ensuring service level requirements are met.

Coordinating and providing standard on-site service and repairs by OEM, OEM-qualified, or approved third-party technicians with an on-site response time (service level) of twenty

(20) business days or less.

Coordinating and providing standard on-site service and repairs by OEM, OEM-qualified, or approved third-party technicians with an on-site response time (service level) of twenty (20) business days or less for instruments not specified in instrument-specific plans.

Provision of parts, consumables, labor and travel to effect repairs on instruments is included in service.

Performing acceptance testing to demonstrate full operation of instruments following service as specified.

Provision of parts, consumables, labor and travel to effect repairs on instruments is included in service plan.

Provision of parts, consumables, labor and travel to effect repairs on instruments is included in the service plan

Providing and managing the depot repair process of components to include providing priority or standard component shipment and exchange, component removal and replacement of components.

Communicating with service providers and FDA as needed.

Providing and managing the depot repair process of components to include providing priority or standard component shipment and exchange, component removal and replacement of components.

Providing and managing the depot repair process of components to include providing priority or standard component shipment and exchange, component removal and replacement of components.

Providing phone and email technical support.

Providing phone and email technical support.

Performing acceptance testing to demonstrate full operation of instruments following service as specified.

Performing acceptance testing to demonstrate full operation of instruments following service as specified.

Allowing one or more annual preventive maintenance visits for specified components;

Performing acceptance testing to demonstrate full operation of instruments following servicing as specified.

Communicating with service providers and FDA as needed.

Providing phone and email technical support.

Providing personnel dedicated to support instrumentation at a specific site or entity.

Providing phone and email technical support.

C.7 Timeliness of Response

FDA defines timeliness of response as the time to respond on-site to a request for service within the applicable service level indicated in the initial request for service. One of the following service levels will be specified for each service request:

A. Three-business-day response (priority). The preferred on-site response time for emergency repairs involving instruments used in performing critical FDA laboratory operations.

B. Seven-business-day response (standard priority). The on-site response time applicable to instruments performing non-critical FDA laboratory operations.

C. Twenty-business-day (not time critical). The standard on-site response time applicable to instruments or equipment servicing

C.8 Data Management Services

Data Management services tasks necessitate the contractor to track service events through their entire life cycle and communicate information related to on-going and completed service events. Such communication shall take the form of an access-controlled web site, service request forms, weekly (near real-time) and monthly reports, and or some other near real-time process.

Data management service activities include, but are not limited to:

A. Managing the Master Equipment List (MEL)

a. The FDA will provide to the contractor the MEL containing all laboratory instruments and related equipment eligible under the contract. The MEL includes key information about each instrument, such as manufacturer, model name, model number, and serial number or other unique identifier, physical location, point of contact and year of purchase.

b. The contractor shall maintain the MEL and support the FDA in facilitating a flexible streamlined process for updating the list.

c. The contractor shall maintain and update the MEL with additional information applicable to each instrument including, but not limited to:

i. Keeping the list formatted and up to date as instruments are added, dropped or shipped to different sites

ii. Recording and maintaining the service history for each instrument, the current type of service coverage and coverage time frame, and preferred and alternate service providers applicable to each instrument (based on make, model and location)

B. The MEL shall be maintained to allow each FDA Center to easily query and view information about their respective instruments separately from the agency-wide list.

C. Any changes made to the MEL by the contractor shall be discussed and agreed to between the Contracting Officer’s Representative (COR) and the Contractor’s Program Manager.

D. Any increase or decrease to the MEL shall be approved by the Contracting Officer by way of a modification to the contract.

E. The contractor shall provide the FDA access to an electronic copy of the MEL on a monthly basis at a “minimum”.

F. The contractor shall recommend service and support coverage options for select items in the MEL based on FDA’s request.

C.9 Project Management Services

For the task orders released under this contract, the Contractor shall perform project management activities for all aspects of the Scientific Instrument Maintenance and Repair Services contract.

These management activities shall establish planning, control, management, monitoring, and notification mechanisms and shall include working with and reporting to the Government’s COR and Instrument Points of Contact (POCs). Representative activities include, but are not limited to:

A. Receiving, responding to and administering service repair requests.

B. Planning, organizing, securing, and managing resources with appropriate knowledge and skills.

C. Maintaining necessary relationships with OEM's and Third Party contractors and managing risks resulting from OEM changes.

D. Developing and maintaining project management plans throughout the period of performance, and modifying and updating the plans as necessary.

E. Ensuring that all project documentation is complete and up-to-date.

F. Participating in meetings in different capacities including, but not limited to: Project reviews, management briefings, stakeholder presentation.

G. Creating all required status reports including, but not limited to the following types of information:

a. Status and progress of tasks for maintenance and repair of equipment;

b. Instrument information tracking reports;

c. Significant risks to the ability to deliver the required services in a timely manner, ability to provide service contracts and plans to mitigate them; and,

d. Concerns, issues and recommendations.

C.10 Management and Coordination of Repair Services The contractor shall manage and coordinate instrument maintenance and repair services and resolve repair issues with scientific instruments through standard and agreed-to processes. The service request process is illustrated in Attachment J-3.

C.11 Requests for Service

Upon the need for service, FDA Instrument POC’s will initiate a service request electronically to the Contractor’s designated POC. The contractor shall receive and acknowledge receipt of service requests from Instrument POC’s. See Attachment J-4: Example Service Request Form (SRF).

The data elements captured for each service request includes at a minimum:

a. FDA Center, Office, and Center PM(s)

b. Request Date

c. Original equipment manufacturer (OEM)

d. Instrument Type

e. Instrument Model (name and/or number)

f. Instrument Bar Code

g. Instrument Serial Number

h. Repair Provider or OEM POC name, address, phone and email

i. Instrument Location (street address, state, zip)

j. Instrument POC (name, phone, & email)

k. Service Type

l. Service Level

m. Not to exceed (NTE) cost for T&M only

n. Description of problem or service required. Quote or estimate for T&M (if available)

o. COR, Center PM, or designee comments

Representative tasks in support of FDA’s service request process include, but not limited to:

a. The contractor shall verify information provided in service request forms as required;

b. The contractor shall provide the COR the following:

i. The documented unique tracking number awarded to the service provider.

ii. The quote for planned service for T&M

c. The contractor shall provide a mechanism for real time status tracking of service;

d. The contractor shall provide electronic notification to the FDA POC and COR of the status of instruments during the service or repair, e.g. when an instrument needs to be replaced vs repaired.

e. The contractor shall request approvals from the FDA if the cost of repairs exceeds a preset Not to Exceed (NTE) value as specified in the SRF.

f. The contractor shall provide a Field Service Report (FSR) to the COR and the Instrument POC upon completion of any service.

g. The contractor shall perform acceptance testing as specified in the SRF.

h. The contractor shall provide a mechanism for the FDA end user to provide feedback on the service provided for instrument repairs (e.g. through surveys) and act upon any issues identified by end users.

i. The contractor shall provide a mechanism for measuring customer satisfaction of service, e.g. confirming service is satisfactory to the FDA POC based on user feedback with metrics.

j. The contractor shall receive and acknowledge notification by the COR of unsatisfactory service including a description of deficiencies, and provide an updated FSR with a confirmation that service is satisfactory.

C.12 Preventative Services Management

The contractor shall perform activities in support of preventive maintenance services. Representative activities include, but not limited to:

a. Managing the maintenance calendar for selected instruments and monitoring maintenance services to ensure maintenance activities are performed.

b. Coordinating preventive maintenance service.

c. Contacting the service provider and FDA as needed.

d. Notifying the instrument POC and COR if maintenance activities uncover a need for equipment repair.

C.12(a) Off-site (Depot) Repairs

There are two types of off-site repairs when the repair required for an instrument need not be performed on-site:

A. The instrument or its defective component will be shipped for repairs and returned to the

FDA.

B. The instrument or its defective component will be exchanged with a replacement component.

Instrument or component exchanges are solely dependent upon laboratory standard operational protocols (SOPs) and shall be confirmed by the laboratory POC prior to an exchange agreement.

Representative activities in support of off-site depot repairs include, but not limited to:

a. Coordinating depot repairs to include preparing shipping labels, packing and shipping instruments or components.

b. Facilitating instrument, part or component replacements, and traceability of such, to include managing the property transfer process.

c. Providing appropriate transportation of the instrument and disclosing the location of off-site repairs upfront prior to moving the instrument off FDA facilities, and obtaining approval from the COR. Upon completion of repair services, a written field service report (FSR) shall be given to the laboratory POC and accompany the instrument being returned.

This documentation’s primary purpose serves as regulatory confirmation of the instrument’s maintenance history.

d. Providing a FSR to the instrument POC detailing information regarding the cause of instrument malfunction and corrective action taken (to bring the instrument to OEM standards), to include the time required to complete the work, a list of parts replaced with the cost of each part.

C.12(b) On-site Repairs

Service engineers arranged by the Contractor must have FDA approval to enter an FDA site. On-site repairs shall be carried out during normal operation hours (Monday through Friday from 7:30AM- 4:30PM). During other than normal operating hours, the service engineer must report to the site’s security desk to sign in.

Representative activities in support of on-site repairs include, but not limited to:

a. Upon completion of services, a written field service report (FSR) shall be provided to the Instrument Point-of-contact (POC) or their designated representative on site;

b. The service field report will provide detailed information about the cause of instrument malfunction and corrective actions taken, to include:

i. The time required to complete the work.

ii. The price of labor (hourly rate).

iii. A list of any parts replaced with prices for each part.

c. In the event all information is not available to the service engineer when services are performed, the initial field service report shall include all information stated above except for prices (parts and labor hour). The Contractor shall provide the required information in writing to the COR, not later than ten (10) business days after services are completed.

d. The Instrument POC will initiate all requests for services. The Contractor shall contact the COR for any issues, or concerns regarding repair of instruments covered under this contract. The Contractor shall not provide any services not covered by the contract without prior approval from the COR and Contracting Officer (CO).

e. If maintenance and calibration is performed, the following shall be provided to the instrument POC and COR:

i. A copy of the calibration worksheet (included with the FSR)\

ii. An accredited, endorsed calibration certificate if requested

A list of test instruments will include the Nomenclature, Model Number, Serial Number, and Date of Next Calibration of each piece of test instrument. This is particularly important on any repairs and calibrations. This is needed to support laboratory standard operating procedures (SOPs) and quality management systems.

(End of Section C)

SECTION D - PACKAGING AND MARKING

D.1 Marking Instructions for Reports

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the Contract Task Order Number and Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

D.2 Payment of Postage and Fees

All postage and fees related to distribution of deliverables including forms, reports, etc., shall be paid by the Contractor.

(End of Section D)

SECTION E - INSPECTION AND ACCEPTANCE

E.1 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at this/these address:

http://farsite.hill.af.mil/vffara.htm

NUMBER TITLE DATE

52.246-2 Inspection of Supplies – Fixed Price Aug 1996

52.246-4 Inspection of Services - Fixed Price Aug 1996

52.246-6.1 Inspection – Time and Material and Labor Hour May 2001

52.2.49-16 Responsibility for Supplies Apr 1984

E.2 Inspection and Acceptance (Feb 1998)

Pursuant to the appropriate inspection clause as provided below, final inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer.

a. The Contracting Officer or the Contracting Officer’s duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, To Be Named at time of award is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at individual Food and Drug Administration Facilities Nationwide.

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

The Government reserves the right to an Inspection period of 30 calendar days, unless a different time period is stated when (task orders/elsewhere in the contract). The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).

(End of Section E)

SECTION F - DELIVERIES OR PERFORMANCE

F.1 Reports/Deliverables

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at https://www.acquisition.gov/far/

NUMBER TITLE DATE

52.242-15 Stop-Work Order Aug 1989 52.242-17 Government Delay of Work Apr 1984 52.247-35 F.O.B. Destination Within Consignee’s Premises Apr 1984

F.2 Period of Performance

Performance of this contract shall begin on September 11, 2017 and shall not extend beyond September 10, 2018 plus four (1) year option periods which may be exercised at the Government’s discretion.

Option Years Option Periods

Option Year 1 September 11, 2018 to September 10, 2019

Option Year 2 September 11, 2019 to September 10, 2020

Option Year 3 September 11, 2020 to September 10, 2021

Option Year 4 September 11, 2021 to September 10, 2022

F.3 Place of Performance

The places of performance for this contract shall include, at a minimum, the following FDA laboratory locations, but not limited to the noted twenty-three known locations that are listed below.

Note: This list is not inclusive of all FDA Center locations. As more FDA Centers join the IDIQ contract, more locations will be added. Specific location information will be specified in each Task Orders.

1. CBER, Center for Biologics Evaluation and Research, White Oak, MD

2. CDER Center for Drug Evaluation and Research, White Oak, MD

3. CDER Center for Drug Evaluation and Research, St. Louis, MO

4. CDRH, Center for Devices and Radiological Health, White Oak, MD

5. CFSAN Center for Food Safety and Technology, College Park, MD

6. CFSAN Center for Food Safety and Technology, Dauphin Island, AL

7. CFSAN Center for Food Safety and Technology, Laurel, MD

8. CFSAN Center for Food Safety and Technology, Moffett CTR, IL

9. CVM Center for Veterinary Medicine, Office of Research, Laurel, MD

10. ORA/ARL Office of Regulatory Affairs, Jefferson, AR

11. ORA/DenLab Office of Regulatory Affairs, Lakewood, CO

12. ORA/DetLab Office of Regulatory Affairs, Detroit, MI

13. ORA/FCC Office of Regulatory Affairs, Cincinnati, OH

14. ORA/ KanLab Office of Regulatory Affairs, Lenexa, KS

15. ORA/NRL Office of Regulatory Affairs, New York NY

16. ORA/PEV Office of Regulatory Affairs, Fort Lauderdale, FL

17. ORA/PhiLab Office of Regulatory Affairs, Philadelphia, PA

18. ORA/PRL-NW Office of Regulatory Affairs, Bothell, WA

19. ORA/SanLab Office of Regulatory Affairs, Alameda, CA

20. ORA/SNJ Office of Regulatory Affairs, San Juan, PR

21. ORA/SRL Office of Regulatory Affairs, Atlanta, GA

22. ORA/PRL-SW Office of Regulatory Affairs, Irvine CA

23. ORA/WEAC Office of Regulatory Affairs, Winchester, MA

F.4 Deliveries

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule described in SECTION C of this contract.

Reporting Requirements, Data Management, Required Documents and Reports:

General Provisions: The Offeror shall prepare and deliver all reports and documents to the Contracting Officer Representative (COR) as specified in this section. Unless specified otherwise herein all reports shall be delivered electronically in spreadsheet or database format by email. The Offeror's reports shall be complete, accurate and prepared in a professional manner. Reports delivered by the Offeror shall become a part of the FDA’s official records and subject to review by regulatory authorities and the general public. Unless otherwise specified herein the format for all reports shall be subject to the approval of the COR.

Ownership and Security of Data and Documents:

All FDA and Contractor collected, maintained and delivered data files, reports, logs or other documents developed relative to contractual operations are the sole property of the FDA and shall not be released or given to other parties in any form without the prior written consent of the COR.

The Offeror shall take all measures necessary to secure and safely protect all hardware, software, data and documents from theft, destruction and unauthorized access. The Offeror shall report any information security or privacy incidents/violations to COR immediately when such incidents/violations occur. Additionally, to the above reports, the Offeror may be requested by the COR or Contracting Officer to provide special reports on an as needed basis.

(End of Section F)

SECTION G - CONTRACT ADMINISTRATION DATA

G.1. Contracting Officer’s Representative (COR)

The COR is responsible for the acceptance of work provided hereunder will be designated by separate correspondence. The term ‘‘COR’’ means the person who monitors the technical aspects of contract performance. The COR is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. The COR is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.

G.2 Invoice Submission Requirements (Three-Way Match)

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(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 (Prompt Payment terms other than NET 30);

(vii) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

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

(ix) Taxpayer Identification Number (TIN);

(x) (banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Approving Official (i.e., Contracting Officer (CO) or Contract Specialist (CS), as referenced in the award document);

(xii) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced in the award document;

(xiii) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiv) Any other information or documentation required by the contract/order award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (xii) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

[amend/delete, as necessary]

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A.

G.3 Invoice Payment

Payment will be made after performance of lump sum services on a monthly basis. It is the requirement of the Government to obtain complete and satisfactory performance in accordance with the terms of the specifications and quality standards of this contract. The Government is contracting for satisfactory performance of all work identified in the performance work statement, and deductions will, therefore, be made for any service not provided.

It is agreed that failure to: accomplish any work required under this contract; to satisfactorily accomplish such work; or to comply with any provisions of this contract, where due to the carelessness, neglect, or fault of the contractor, shall constitute a deficiency for which a permanent reduction of payment will be made in accordance with the provisions of this contract.

Payment for Task Orders will be made upon inspection and acceptance of each individual order as evidenced by the submission of Form GSA 220 with the monthly invoice.

G.4 Key Personnel

HHSAR 352.237-75 Key Personnel (Dec 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances.

The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause)

The following three labor categories shall be considered key personnel for this contract:

1. Project Manager

2. Service Coordinator

3. Account Manager

Project Manager Manages multiple aspects of a single/multiple projects at one time, including overseeing quality control. Communicates clearly and articulately in written and oral form. Assesses complex coordination issues, applies appropriate strategies and plans, and interprets data.

Service Coordinator Receives service requests from end-users, verifies coverage under offered service plans, arranges for repairs with OEM or qualified third-party service providers, receives notification of completion of service and ensures that field service reports are provided.

Account Manager Coordinates payment of vendors after completion of service and ensures that proper invoices are submitted to the government.

G.5 Contract Administration

a. Nicole Craig Contracting Specialist/Officer

FDA, OAGS

5630 Fishers Lane, HFA-500 Room 2057 Rockville, Maryland 20852-0001 Phone: 240-402-5116 Email: nicole.craig@fda.hhs.gov

Gina Jackson Contracting Officer Email: gina.jackson@fda.hhs.gov

b. Contractor’s Point of Contact

To be completed at Award.

c. Technical Point of Contact- Contracting Officer’s Representative (COR) To be completed at Award

G.6 Post Award Evaluation of Offeror Performance

Offeror Performance Evaluations

Interim and final evaluations of Offeror performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted within 14 calendar days following the anniversary date of the contract if any options are exercised pursuant to the Option

Provision provided under Section H of the contract.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebuttal statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

(End of Section G)

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1. Smoke Free Environment

The Department of Health and Human Services is the Federal Governments principal agency for furthering the health of Americans and providing them with essential human services. The health risks of smoking and exposure to smoke are clearly documented by reports of the Surgeon General.

It is essential that the Department, in the accomplishment of its mission, provide a smoke-free environment in all HHS owned and leased building space.

It is, therefore, the Departments policy to establish a smoke-free environment in all HHS building space. All HHS owned and leased building space is designated as no-smoking areas. This policy applies to Government employees as well as Contractor employees who are assigned to work at HHS owned or leased building space.

H.2. HHSAR 352.223-70 Safety and Health. (December 2015)

To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the Federal, State, and local levels.

In addition, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects:

(i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR part 1910. These regulations are available at https://www.osha.gov/.

(ii)Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001.

The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities:

Biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at http://www.cdc.gov/biosafety/publications/index.htm.

(ii) Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW., Lockbox 285, Washington, DC 20055 (ISBN 0–309–05229– This publication is available at http://www.nap.edu/catalog/4911/prudent-practices-in-the-laboratory-handling-and-disposal-of-chemicals.

Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the Contracting Officer’s Representative or other appropriate officials, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, the Contracting Officer will make an equitable adjustment in accordance with the applicable “Changes” clause set forth in this contract.

The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report citing all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed.

The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall form the basis for a request for extension or costs or damages by the Contractor.

The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause.

H.3. Restriction on Employment of Unauthorized Alien Workers

The Offeror shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows:

"(3) Definition of unauthorized alien. - As used in this section, the term 'unauthorized alien' means, with respect to the employment of an alien at a particular time, that the alien is not at that time either

(A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General."

H.4 Government Furnished Equipment (GFE) Government Furnished Information (GFI)

FDA shall provide a Master Equipment List (MEL) with all laboratory equipment and instruments, along with key information about each instrument, including manufacturer, model name, model number, serial number or other unique identifier, physical location, point of contact, year of purchase, and purchase price. The MEL will also include an evaluation of risks associated with each item in terms of service level, type of coverages sought, and eligibility for unscheduled (T&M) repair services.

H.5 Identification Badges

Contractor employees shall be required to wear the required identification badges at all times when working in Government facilities, which may vary based on the facility…