75F40122Q00038_1253169_Sources Sought Notification.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this source sought announcement on behalf of the Office of Regulatory Affairs (ORA)/Arkansas Laboratory (ARKL) in order to determine if there are existing small business sources capable of providing annual certification of Biological Safety Cabinets (BSCs) Class I and II, Laminar Flow Units (LFUs), and Chemical Fume Hoods (CFHs) to comply with federal regulations, local procedures, and manufacturer recommendations with 4 (1-year Option periods).

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 541380 – Testing Laboratories; with a Small Business Size Standard of $16.5 Million and believe that your firm would be able to provide the FDA with the services described below, please submit an email to Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all the minimum performance requirements.

Background: The FDA/NCTR/ARKL analyst perform analyses using hazardous chemicals and biological materials. The potential safety and health hazards are reduced by incorporating safety measures, such as engineering controls. ARKL utilizes multiple types of these engineering controls, to include Biological Safety Cabinets (BSCs), Laminar Flow Units (LFU), and Chemical Fume Hoods (CFHs). In order to ensure the equipment continues to provide optimal performance to keep employees safe, Occupational Safety and Health Administration (OSHA) requires annual certification of these engineering controls. The ARKL needs annual certification of BSCs Class I and II, LFUs, and CFHs to comply with federal regulations, local procedures, and manufacturer recommendations.

Minimum Trade and Service Specifications:

• Contractor shall have ISO 17025:2017 accreditation for outlined testing.

• Contractor shall be a National Sanitation Foundation (NSF) accredited certifier for BSCs or have their work overseen and signed off by NSF accredited certifier.

• Contractor shall provide ninety-one (91) test reports for each engineering control.

• Contractor shall perform onsite test and certification of seventy-five (75) chemical fume hoods.

a. Ensure that chemical fume hoods are functioning properly per manufacturer’s specifications, ANSI-AIHA Z9.5, and other applicable federal/state/local regulations.

b. Performance testing shall be conducted using air flow meters and a visible smoke or a tracer gas tests for each unit. Additionally, the number of measurements per hood shall vary based on hood width.

c. For each hood, the contractor shall ensure air velocities fall between established, current safe thresholds, at a minimum of 80 linear feet per minute.

d. Testing and certification shall include but not be limited to: airflow (inflow) testing and airflow smoke patterns.

e. Place arrow indicator labels on the adjustable sashes to provide the end user a visible indicator of the safe height that was used to determine hood performance.

• Contractor shall perform onsite test and certification of two (2) Class I biosafety cabinets, also called microscope and/or analytical balance cabinets.

f. Ensure that Class I BSCs are functioning properly per manufacturer’s specifications and applicable federal/state/local regulations.

g. Airflow smoke pattern testing shall be conducted using visible smoke or a tracer gas tests for each unit.

h. Testing and certification shall include but not be limited to: site installation test, airflow (supply and inflow) test, non-viable particle counts, airflow smoke patterns, high efficiency particulate air (HEPA) filter leak testing, and secondary checks (light, noise, vibration, electrical).

• Contractor shall perform onsite test and certification of nine (9) Class II biosafety cabinets.

i. Ensure Class II BSCs are functioning properly per manufacturer’s specifications, NSF/ANSI 49, and applicable federal/state/local regulations.

j. Airflow smoke pattern testing shall be conducted using visible smoke or a tracer gas tests for each unit.

k. Testing and certification shall include but not be limited to site installation test, airflow (inflow and downflow) test, non-viable particle counts, airflow and dynamic smoke patterns, HEPA filter leak test, and secondary checks (light, noise, vibration, electrical).

• Contractor shall perform onsite test and certification of six (6) Laminar Flow Hoods.

l. Ensure LFHs are functioning properly per manufacturer’s specifications and applicable federal/state/local regulations.

m. Airflow smoke pattern testing shall be conducted using visible smoke or a tracer gas tests for each unit.

n. Testing and certification shall include but not be limited to: airflow test, non-viable particle counts, airflow smoke patterns, HEPA filter leak test, and secondary checks (light, noise, electrical).

• All tests shall be performed using NIST-traceable equipment.

• Contractor shall place an annual, dated certification label on each piece of equipment. The label shall include, but not be limited to, the name and contact information of the contractor, testing date, and retest date.

• Testing shall be conducted during normal facility hours (6 AM – 6PM, M-F) and must be coordinated with the Contracting Officer Representative. Weekend work is not permitted in the fulfillment of this contract.

*Please note: This is an annual certification and retest shall be performed before the current certification expires:

• BSC Class II certification expiration date: June 31, 2022

• LFH certification expiration date: June 31, 2022

• CFH certification expiration date: August 31, 2022

• BSC Class I certification expiration date: August 31, 2022

Period of Performance: Base + 4 (1-year Option periods)

Base: 06/01/2022 thru 05/31/2023

Option Year 1: 06/01/2023 thru 05/31/2024 Option Year 2: 06/01/2024 thru 05/31/2025 Option Year 3: 06/01/2025 thru 05/31/2026 Option Year 4: 06/01/2026 thru 05/31/2027

Place of Performance:

Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Building 26 Jefferson, AR 72079

Service Records and Reports The Contractor shall, commensurate with the completion of each service, provide the point of contact (POC) with a copy of a test report for each engineering control identifying the equipment name, manufacturer, model number, serial number (if applicable), and FDA identification number of the equipment being tested/certified. The test report will also include but is not limited to results of all testing performed; pass/fail overall summary; test date; equipment used for testing, including calibration dates; applicable standards followed for testing; technician name performing service, and indications of any malfunctioning equipment that can be provided to Occupational Safety and Health Administration (OSHA) as proof of performance and assurance of a safe occupational environment for employees.

Though the target audience is small business vendors or small businesses capable of supplying a U.S.

service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address.

Provide this same information again if responding to provide a service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent.

• The offeror shall advise if the product and/or service is on a Best in Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before March 4, 2022 by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov. Reference: 75F40122Q00038_1253169.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.