RFQ-FDA-18-SOL-1100591.docx

COMBINED SYNOPSIS/SOLICITATION

FOR

PREVENTIVE MAINTENANCE AND CALIBRATION SERVICES

SOLICITATION NUMBER: RFQ-FDA-18- SOL-1100591

i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. In accordance with FAR 13.106-1(b) this is a sole source requirement.

ii) The solicitation number is RFQ-FDA-18- SOL-1100591

iii) The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-97, Effective 24 Jan 2018

iv) The associated North American Industry Classification System (NAICS) Code is 621511 – Medical Testing Laboratories.

v) The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes to be valid until September 30, 2018.

1. Base Year: Period from (MM/DD/YYYY) to (MM/DD/YYYY)

2. Option Year One (1): Performance Period from (MM/DD/YYYY)

3. Option Year Two (2): Performance Period from (MM/DD/YYYY)

3.b

3.c

Schedule of Items:

1. Base Year: The requirements of the Preventative Maintenance (PM) services requirements have described in Part 3 for the aforementioned pieces of equipment. For the Preventive Maintenance services that the Contractor shall rendered and certified by the COR, the Government will pay the contractor the fixed price of $__________

2. Option Year One (1): The requirements of the Preventative Maintenance (PM) services requirements have described in Part 3 for the aforementioned pieces of equipment. For the Preventive Maintenance services that the Contractor shall rendered and certified by the COR, the Government will pay the contractor the fixed price of $__________

3. Option Year Two (2): The requirements of the Preventative Maintenance (PM) services requirements have described in Part 3 for the aforementioned pieces of equipment. For the Preventive Maintenance services that the Contractor shall rendered and certified by the COR, the Government will pay the contractor the fixed price of $__________

vi) Description

STATEMENT OF WORK (SOW)

a. Background The Food and Drug Administration (FDA), Pacific Southwest Medical Products Laboratory (PSMPL), Northeast Medical Products Laboratory (NMPL) and Winchester Engineering and Analytical Center (WEAC) at Winchester, MA, conduct a range of chemistry analyses on medical products to determine if they meet USP and other regulatory requirements.

b. Purpose The purpose of the requirement is to procure the preventative maintenance and calibration services for FDA's Leak Testing systems to ensure that they are kept in working order.

c. Scope The Government has a need for a Contractor to conduct Preventative Maintenance (PM) services, on-site calibration, qualification and training for existing Leak Testing Systems (Brand Name Manufacturer: Advanced Test Concepts (ATC), Inc).

One system is in use at PSMPL, located in Irvine, CA, and the other system is in use at NMPL in Jamaica, NY. The ATC Leak Testing System and its Components at PSMPL are (a) Sterile Container Test System (Serial# FDA01-ME2-03), (b) Mass Extraction Leak Test Instrument (Serial# IPE21114-03), and Sterile Container Preconditioning Chamber (Serial# FDA01-DC03). This approximate age of this equipment system is approximately 1 year and 8 months. It was last serviced in August 2016. It is in good condition. The ATC Leak Testing System and its Components at NMPL are (a) Sterile Container Test System (Serial# FDA01-ME2-01), (b) Mass Extraction Leak Test Instrument (Serial# IPE21114-01), and (c) Sterile Container Preconditioning Chamber (Serial # FDA01-DC01). This approximate age of this equipment system is approximately 1 year and 10 months. It was last serviced in June 2016. It is in good condition.

The Contractor shall also provide training for a minimum of 4 hours for at least 2 analysts, who are the primary and secondary custodians of this equipment system. Training should include the operation, function and daily maintenance of this system. Appropriate training material will be provided to the trainees.

AND (Option Years) The Government has a need for a Contractor to conduct Preventative Maintenance (PM) services, on-site calibration, qualification and training for two additional option years on three existing Leak Testing systems (Manufacturer Name: Advanced Test Concepts (ATC), Inc), one system in use at PSMPL, Irvine, CA, and the second system in use at NMPL at Jamaica, NY, (see instrument details above for PSMPL and NMPL).

The third system is in use at Winchester Engineering and Analytical Center (WEAC) at Winchester, MA. The ATC Leak Testing System and its Components at WEAC are (a) Sterile Container Test System (Serial# FDA01-ME2-02), (b) Mass Extraction Leak Test Instrument (Serial# IPE21114-02), and (c) Sterile Container Preconditioning Chamber (Serial # FDA01-DC02). This approximate age of this equipment system is approximately 2 years and 1 month. It was last serviced in March 2018. It is in good condition. The Contractor shall also provide training for a minimum of 4 hours for at least 2 analysts, who are the primary and secondary custodians of this equipment system. Training should include the operation, function and daily maintenance of this system. Appropriate training material will be provided to the trainees.

d. Requirements The Contractor shall provide Preventative Maintenance (PM) services, on-site calibration, qualification and training for two existing Leak Testing Systems (Brand Name Manufacturer: Advanced Test Concepts (ATC), Inc). This requirement is being solicited in accordance with FAR 52.211-6, Brand Name. The detail scope for preventive and maintenance service has been specified in Scope in Part 3.

· The Contractor's employees working on this instrument must be OEM-trained and the Contractor shall have access to genuine OEM parts.

· PM visit includes replacing parts subject to wear as defined by OEM specific PM checklist with OEM factory parts.

· Services shall be performed on-site shall be Monday through Friday, 8:00 am to 5:00 pm local time, excluding federal holidays.

· At a minimum, the Contractor shall:

· Inspect overall system operation;

· Perform calibration service using traceable calibrated Leak Tester;

· Perform OQ per Manufacturer ATC, Inc. protocol. Verify readings are all accepted at the specified range;

· The Contractor shall also provide training for a minimum of 4 hours for at least 2 analysts, who are the primary and secondary custodians of this equipment system. Training should include the operation, function and daily maintenance of this system. Appropriate training material will be provided to the trainees. Prices for second and third year include replacement of wear items and vac. pump rebuild, as needed.

· (Vacuum pump rebuild be done at ATC with an exchange program).

· Parts, labor, and travel/per-diem costs for PM and repairs to the FDA shall be included in the price of the service agreement.

· Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA COR and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required.

Offerors are afforded the opportunity to inspect the system by contacting the Contract Specialist/Contracting Officer identified in the solicitation to schedule an appointment. Failure to inspect the system will not relieve the successful offeror from fully meeting the requirements of the resulting contract at the price offered.

e. Deliverables or Delivery Schedule Table 1. Deliverables / Schedule

f. Period of Performance The period of performance begins on the date of contract award. All requirements shall be completed no later than 30 calendar days after contract award.

Preventive Maintenance and Calibration Services period start/end dates are contingent upon the award date of the contract. The estimated dates could potentially be as follows:

Estimated contract award date: mm/dd/yyyy (TBD) Base Period: mm/dd/yyyy through mm/dd/yyyy (TBD).

Option Year 1: mm/dd/yyyy through mm/dd/yyyy (TBD).

Option Year 2: mm/dd/yyyy through mm/dd/yyyy (TBD).

Actual performance dates will be revised if necessary and formally documented in the contract award.

vii) Deliverables or Performance:

Place of Performance: Deliveries shall be made to:

Base Year Place of Performance for two (2) existing Leak Testing systems:

PSMPL, Irvine, CA

FDA/PSMPL

19701 Fairchild Irvine, CA 92612

NMPL at Jamaica, NY

FDA/ NMPL

158-15 Liberty Avenue Jamaica, NY 11433

Option Years 1&2 Place of Performance for three (3) existing Leak Test systems:

PSMPL, Irvine, CA FDA/PSMPL 19701 Fairchild, Irvine, CA 92612 NMPL at Jamaica, NY. FDA/NMPL 158-15 Liberty Avenue, Jamaica, NY 11433

WEAC at Winchester, MA FDA/WEAC 109 Holton St, Winchester, MA 01890

POC: To be Identified at Time of Award

Satisfactory performance of this contract shall be deemed to occur upon delivery of Preventive Maintenance and Calibration Services described above. Deliveries required by the Contractor shall be made F.O.B. destination as soon as possible from receipt of the award of the order to the addresses listed above. Delivery of performance shall occur during regular business hours (Monday-Friday between 9:00am and 3:00pm), excluding Federal Holidays and weather-related closures in accordance with the delivery location time zone (Eastern time, Central time, or Pacific time). The Contractor shall provide the FDA laboratory with a minimum of one (1) weeks’ notice prior to delivery.

Period of Performance: Preventive Maintenance and Calibration Services shall be delivered by mm/dd/yyyy (TBD) to the FDA offices. Service delivery schedules for each of the equipment Preventive Maintenance and Calibration Services shall be provided from mm/dd/yyyy (TBD) through mm/dd/yyyy (TBD).

viii) Contract Administration Data

The following personnel shall represent the Government for the purpose of this contract:

Program Office Technical Representative:

To be determined upon contract award

The Technical POC is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to (1) Direct or negotiate any changes in the RFQ;

(2) Modify or extend the period of performance; (3) Change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

ix) The provision at 52.212-1, Instructions to Offerors—Commercial Items (Jan 2017), applies to this acquisition with the following addenda to the provision.

Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2018.

x) The provision at 52.212-2, Evaluation—Commercial Items (Oct 2014), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under v) and vi) 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable.

A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

xi) The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2017), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal.

xii) The clause at 52.212-4, Contract Terms and Conditions—Commercial Items (Jan 2017), applies to this acquisition with the following addenda:

Invoice Submission:

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. Provide a copy marked courtesy to the COR. The COR is (TBD)

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 official to whom payment is to be sent (must be the same as that in the purchase order/award, 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 Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, 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:

(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;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) 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.

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

xiii) The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items (Jan 2018), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition:

· 52.219-06 Notice of Total Small Business Set-Aside (Nov 2011)

· 52.222-21 Prohibition of Segregated Facilities (Apr 2015)

· 52.222-26 Equal Opportunity (Sept 2016) (E.O. 11246)

· 52.222-35 Equal Opportunity for Veterans (Jul 2015) (38 U.S.C. 4212)

· 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793)

· 52.222-50 Combating Trafficking in Person (Mar 2015)

· 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513)

· 52.232-33 Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332)

xiv) Additional contract requirement(s) or terms and conditions

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to the expiration of the current period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 2 years.

(End of clause) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html By reference:

· 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

In full text:

· 342.239-74 Electronic Information and Technology Accessibility (Dec 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

· 1194.21 systems

· 1194.22 web based

· 1194.31 functional requirements

· 1194.41 documentation, support

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause) It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

xv) All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-18-RFQ-1100591. The quotes are due by email to the point of contact listed below on or before July 30, 2018 by 12:00 pm ET.

xvi) Point of Contact: Krishna Poudyal at (240) 402-7665 or email at Krishna.Poudyal@fda.hhs.gov .