Preventative Maintenance (PM) services for 4500-QQQ liquid chromatograph-mass spectrometer (LC-MS) in Nutrient Analysis Brach (NAB) of Southeast Food and Feed Laboratory (SFFL)

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation, and a written solicitation will not be issued.

“Brand Name or Equal product only”.  The following FAR Clause applies: Clause 52.211-6 - Brand Name or Equal (AUG 1999)

This requirement is “Subject to the Availability of Funds” The Following FAR Clause applies: AVAILABILITY OF FUNDS (52.232-18) (APR 1984)

This synopsis, NAICS code 334516, identified as REQ#1253279 is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures.

GENERAL DUTIES / DESCRIPTION OF WORK

Nutrient Analysis Branch (NAB) of Southeast Food and Feed Laboratory (SFFL) is the national servicing lab for the analysis of nutrients in infant formulas, dietary supplements, human and animal food and feeds program for the FDA.  NAB is requesting the acquisition of Preventive Maintenance (PM) Service for a 4500-triple quadruple (QQQ) LC-MS instrument (FDA No. 5146217), manufactured by Sciex, first installed in Dec 2019. Aforementioned LC-MS instrument is the sole instrument used for vitamin D analysis in the regulatory samples utilizing an AOAC Official Method. Its application will be expanded to a number of other analyses of different fat-soluble vitamins and water-soluble vitamins, present in the diverse matrices of regulatory samples including infant formulas and dietary supplements, among others.

ORA Lab Manual 5.5.1 (Equipment Records) states “All measuring equipment has an established schedule specifying performance checks, including the testing frequency and acceptable performance specifications. These performance checks ensure the equipment is operating properly and consistently prior to analysis”. The proposed planned maintenance (PM) service will help maintain overall performance of 4500-QQQ, thus ensure the entire system to operate under the best condition for the regulatory sample analysis. The service must be performed by the personnel who had been trained by the manufacturer for the specified task, with readily available access to the real-time monitoring/diagnostic software for the instrument. 

1) Service shall be provided by the qualified personnel who are trained and certified by the original manufacturer of the instruments.  Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures, among others. 

2) The proposing vendor shall provide all travel and labor at no additional charge.  Certain consumables necessary for PM (equivalent to an annual PM if the instrument was under a service contract) shall be provided by the vendor.

 

SALIENT CHARACTERISTICS

All the following are minimum requirements.  Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government.

**Offerors shall address each of the salient characteristics in order to be considered.**

Specifications:  The proposed service shall comply with all the followings at the very minimum for the PM service of the 4500-QQQ mass spectrometer with Agilent 1290 Infinity II HPLC system. It should include a period of warranty (90 day at the very minimum) from the date of service. After completion of PM, the instrument must meet or exceed the performance specifications set by the vendor. PM of HPLC could be delivered by any qualified engineers who have been certified for the necessary trainings (preferably by the instrument manufacturer).

Key specifications for the PM of 4500-QQQ Mass Spectrometer

1. Run vacuum system test with diagnostic software to measure operational values of the turbo pump parameters (e.g., temperature, current, voltage, and others). Test vacuum chamber pressure.
    
2. Inspect the contamination of the front-end. Clean the front-end (including Ion Guide, IQ0 lens, Q0 quadruple, among others) if it’s necessary after the charging test.
    
3. Run a number of MS tests with PPG solutions for a number of specific masses under both Positive and Negative conditions (including, Q1 Positive/Negative and Q3 Positive/Negative) to ensure that the mass shift results are within 0.1 Da for all assigned masses and meet the expected intensity and peak width.
    
4. Run a MS/MS transmission test (e.g., with reserpine solution) to see whether the result of transmission efficiency is ≥ 10%.
    
5. Inspect the roughing pump and oil for leak. Replace oil and/or exhaust filter if required. Inspect the exhaust system, clean or replace consumable parts when necessary. Clean the curtain plate and other parts of front-end. Verify gas systems to see gas pressures for the system meet the specification.
    
6. Conduct the maintenance of other parts including Turbo Ion Source. Replace the electrode for probes if necessary. Verify temperature reaches the recommended set point. Inspect the RF tuning voltages, detector voltages and run other voltage tests.
    
7. Apply/install any applicable updates for the software (e.g., Analyst, MultiQuant, Sciex OS).  Inspect the status of the RAID hard drives of the computer.
    
8. Carry out necessary Post-PM system tests to ensure the mass shift results are within 0.1 Da for all assigned masses, and the transmission efficiency is ≥10% for MS/MS transmission test.
    
   Warranty
   
   All labor, replacement parts and components (excluding consumables) shall be warrantied for 90 days (at the very minimum) from the date of service completion.
    
    
   Place of Performance
    
   US Food & Drug Administration
   60 Eighth St, NE
   Atlanta, GA 30309
   
   
   Contracting Officer Representative, (COR)
    
   TBD
   Unless otherwise specified, deliveries and installation shall occur at the Place of Performance specified above, Monday through Friday (excluding Federal Holidays between the hours of 9:00 a.m. and 3:00 p.m. EST.

Period of Performance

The period of performance shall be for a one (1) base year, including the warranty.

Deliverables

Deliverable

Quantity

Delivery Date

PM Visit

1

Within 3 weeks after contract awarded

Service Report

    1

  Within 1 weeks after service render

The Government will award a contract resulting from this solicitation to the responsible quoter as
a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method.
Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost
factor (technical conformance to the requirements of the solicitation). The Quoter’s initial
quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be
considered for award.

 

FAR provisions can be found on the following website: http://Acquisition.gov

The following provisions apply to this acquisition:

FAR 52.212-1, Instructions to Offerors-Commercial Items;

52.225-2 Buy American Certificate;

52.212-4 Contract Terms and Conditions-Commercial Items;

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs:

52.222-3, Convict Labor

52.222-19, Child Labor-Cooperation with Authorities and Remedies

52.222-21, Prohibition of Segregated Facilities

52.222-26, Equal Opportunity

52.222-36, Affirmative Action for Workers with Disabilities

52.222-50, Combating Trafficking in Persons

52.225-1, Buy American Act--Supplies

52.225-13, Restrictions on Certain Foreign Purchases

52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration.

In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are Registered in SAM.gov under NAICS code; 334516 delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA.


FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email to Maryrose.nicol@fdahhs.gov  and be received by 5:00 PM (1700) on March 7, 2022 to the attention of Mary Rose A. Nicol, maryrose.nicol@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email.

ALL QUESTIONS REGARDING THIS SYNOPSIS/SOLICIATION MUST BE SUBMITTED IN WRITING NO LATER THAN 5:00 PM (1700) EST March 2, 2022.

FAX QUOTES SHALL NOT BE ACCEPTED