Active

Contract Opportunity

Sources Sought Notice

This is a Sources Sought Notice

(a) The Government does not intend to award a contract on the basis of this Sources Sought or to otherwise pay for the information solicited.

(b) Although "proposal," "offeror," contractor, and "offeror" may be used in this sources sought notice, any response will be treated as information only. It shall not be used as a proposal. The Government is seeking information for market research purposes only.

(c) Any information received from a contractor in response to this Sources Sought may be used in creating a solicitation. Any information received which is marked with a statement, such as "proprietary" or "confidential," intended to restrict distribution will not be distributed outside of the Government, except as required by law.

(d) This Sources Sought is issued by VISN 2 Contracting Office in Albany, NY, for the purpose of collecting information about USP 797 Pharmacy Quality Testing at Hudson Valley Healthcare System. The VA is seeking to provide for this requirement as of April 1, 2024, to establish a new contract. The NAICS code identified for this requirement is 541380 Equipment and Materials Testing Instruments and Laboratory Equipment. The requirement is detailed in the Statement of Work section of this document.

(e) Cursory market research has identified small businesses that may be able to provide for this requirement. Contractors that are able to meet the requirements in the attachment and possess an interest in performing these services, are encouraged to email a capability statement and full information to Levi Russin at Levi.Russin@va.gov.

- Part of the purpose of this sources sought is to determine the viability of set aside to a specific socio-economic category(service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business). Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, DUNS number and address, point of contact and social-economic.
If contractor is a Service-Disabled Veteran-Owned Small Business (SDVOSB), a Veteran-Owned Small Business (VOSB), or any other special category of contractors, then contractor is responsible for providing documentation in support of this. This information will be used to determine the viability of a set aside for this requirement. If any of the requested information is not supplied with the response, this may result in the contractor not being considered in the Government s Procurement Strategy.
The following information is required for determining procurement strategy and viability of sources:
Set aside requirements have limitations on subcontracting. This service is located in Hudson Valley, NY. Provide your site location and supporting documentation. Given your location and proximity to the service site, how do you plan to accomplish self-performance of this work?
If your intention is to subcontract work, what tasks will be performed by you as the prime contractor? What tasks will require a subcontractor due to your inability to perform them within your company?
How many years experience does your company have in performing tasks of this nature, of this scope and this complexity? How many years of service do your proposed technicians have performing tasks of this nature, this scope, and this complexity? How many years does your proposed subcontractor have in performing tasks of this nature, this scope, and this complexity?
How many jobs of this of this nature, of this scope and this complexity have you performed in the past five years?
How many certified/licensed technicians does your company currently employ?
- Contractors shall also identify any Federal Supply Schedules that may carry the desired services.
- Contractors shall identify pertinent point of contact for company, contractor DUNS number for size standard and socioeconomic verification in SAM and VIP, as well as for any intended subcontractors.
- Contractor shall provide 2 to 3 instances of past experience which demonstrate that they are a firm regularly engaged in this type of work, to include subcontractors for those jobs.
- Contractor shall provide a listing of any teaming agreements they intend to employ in the performance of this requirement if awarded.
- Contractor shall supply proof of any applicable certification or training required to meet the regulatory requirements, if applicable.
- Contractors shall include any relevant comments about the Attachment(s) if applicable.
Below is the Limitation on Subcontracting Certificate of Compliance Clause. Please complete this as part of your response.
852.219-77Â VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction.
As prescribed in 819.7009(c) insert the following clause:
VA NOTICE OF LIMITATIONS ON SUBCONTRACTING CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (SEP 2021) (DEVIATION)
(a) Pursuant to 38 U.S.C. 8127(k)(2), the offeror certifies that
(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: [Contracting Officer check the appropriate box below based on the predominant NAICS code assigned to the instant acquisition as set forth in FAR 19.102.]
(i) [ ] Services. In the case of a contract for services (except construction), the contractor will not pay more than 50% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-10 or VOSBs as set forth in 852.219-11. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Other direct costs may be excluded to the extent they are not the principal purpose of the acquisition and small business concerns do not provide the service as set forth in 13 CFR 125.6.
(ii) [ ] General construction. In the case of a contract for general construction, the contractor will not pay more than 85% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-10 or VOSBs as set forth in 852.219-11. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 85% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.
(iii) Special trade construction contractors. In the case of a contract for special trade contractors, the contractor will not pay more than 75% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-10 or VOSBs as set forth in 852.219-11. Any work that a similarly situated subcontractor further subcontracts will count towards the 75% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.
(2) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.
(3) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:
(i) Referral to the VA Suspension and Debarment Committee;
(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and
(iii) Prosecution for violating section 1001 of title 18.
(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract. The Contracting Officer may, at their discretion, require the Contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the Contracting Officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.
(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance with the limitations on subcontracting requirement. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.
(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed, and returned with the offeror s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.
Certification:
I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].
Printed Name of Signee: _________________________________
Printed Title of Signee: ________________________________
Signature: ______________________________________________
Date: ___________________________________________________
Company Name and Address: _______________________________
_________________________________________________________
(End of clause)

STATEMENT OF WORK
USP 797 Employee Competency Testing

Introduction and Overview

To provide pharmacy quality testing in compliance with USP by a certified ISO/IEC 17025 laboratory. VA will submit samples for analysis to laboratory for proper testing.

Background

VA Hudson Valley Healthcare System Clinical Laboratory Services has historically performed United States Pharmacopeia Chapter 797 (USP ) pharmacy quality testing for all VA Hudson Valley Healthcare System compounding personnel to ensure competency per USP regulations.

Updated Department of Veteran Affairs regulations state this process can no longer be performed under the laboratory s Clinical Laboratory Improvement Amendments (CLIA) license. Clinical Laboratory Services must obtain International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certification to continue this testing. VA Hudson Valley Healthcare System Clinical Laboratory Services has decided not to seek ISO/IEC 17025 certification and therefore this testing must be conducted externally by a certified ISO/IEC 17025 laboratory. Any lapse in testing may lead to pharmacy cleanroom to be shut down and negatively affecting patient care.

Scope of Work
Vendor will comply with USP and provide the following services to submission of samples:

Media Fill Testing, Glove Finger Testing, and Direct Compounding Area Surface Sampling Testing
Perform the incubation in controlled temperature environments in accordance with latest USP 797 requirements.
Identify microorganism if growth occurs regardless CFU level.
Document dates of incubation and the person who reads and documents the number of CFU this information is automatically captured by our laboratory information system (LIMS) and is available upon request for audit purposes.
Provide TSA plates and certificates of analysis (COA)

Testing to be performed for a maximum of 60 employees biannually.

Period of Performance

The period of performance will be 4/1/2024 3/31/2025 with provision of four option years.

Projected Cost
Variable based on pharmacy compounding personnel staffing and testing results. Each staff member requires at least a Media Fill Testing, Glove Finger Testing, and Direct Compounding Area Surface Sampling Testing biannually. Additional testing will be required if negative test results occur. Maximum of 60 employees biannually.

Requirements
Lab must meet all criteria and maintain all certifications needed to function as an International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certified laboratory.

Tasks
General Specifications:

Media fill test is the first measure of the aseptic technique of compounders simulating the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean casein digest media.
Vendor must perform the incubation for sampling in controlled temperature environments in accordance with USP 797 and reading of media fill test done by VA staff. The sample will be documented with the name of the person evaluated, evaluation time & date, media manufacturer, expiration date, and lot #.
Incubate for 7 days at 20-25°C and then 7 days at 30-35°C
Complete clarity of the test solution indicates a negative test result (Pass). Turbidity (cloudiness) of the test medium, or non-resoluble sedimentation present at many times during the incubation period constitutes a positive test result.
Document dates of incubation, the result, and the person who reads and documents the results.
Vendor must perform incubation and reading for approximately sixty (60) samples from VA staff (one sample per staff) twice a year. Total 120 for year.
Commercially available MFT kits that are made from sterile microbial growth media will be used for media fill testing and will be provided by vendor. A certificate of analysis (COA) must be provided.
Gloved fingertip and thumb sampling (GFS) testing.
Vendor must perform the incubation in controlled temperature environments in accordance with USP 797 and reading of each sample collected by VA staff.
Each sample shall:
be labeled with a personnel identifier,
whether it was from the right or left hand,
the date and time of sampling,
will include the name of the person evaluated,
evaluation date/time,
media and components used, including manufacturer, expiration date and lot number.
Incubate the sampling at a temperature of 30-35°C for 48 hours. Examine for growth. Record the total number of discrete colonies of microorganisms on each device as colony-forming units (CFU) per sample.
Incubate at 20-25°C for 5 additional days. Examine the device for growth. Record the total number of discrete colonies of microorganisms on each device as CFU per sample.
Identify microorganism if growth occurs regardless CFU level.
Document dates of incubation and the person who reads and documents the number of CFU.
Vendor must perform incubation and reading for minimum of 424 samples to determine employee competency. There are approximately 53 employees that will need testing twice a year.
Four (4) samples per existing employee for total 400 samples (50 employees X2 hands, pre and post media fill testing)
Eight (8) samples per newly hired employee for total of 24 samples for initial testing. (Currently hired 3 new employees).
Vendor will provide at least 424 Tryptic Soy Ager plates for said testing. These must be ordered periodically as supply needs replenishing. A certificate of analysis (COA) must be provided.
Direct Compounding Area Surface Sampling Testing is performed at the end of a media fill activity but before the area has been cleaned and disinfected to confirm that the required environmental quality is maintained.
Vendor must perform the incubation in controlled temperature environments in accordance with USP and reading of each sample collected by VA staff.
Each sample report to indicate:
Name of person evaluated,
site location,
media manufacturer,
lot #,
expiration date, and
time/day of sampling.
Incubate at 30° 35° for 48 hours. Examine for growth. Record the total number of discrete colonies of microorganisms on each device as colony-forming units (CFU) per sample.
Incubate at 20° 25° for 5 additional days. Examine the device for growth. Record the total number of discrete colonies of microorganisms on each device as CFU per sample.
Identify microorganism if growth occurs regardless CFU level.
Vendor must perform incubation and reading for estimated 60 samplings twice yearly.
Vendor must provide TSA plates for said testing. A certificate of analysis (COA) must be provided.

Services and media supplies to be provided upon request:

USP Microbial Monitoring
Single Plate
1 plate for bacteria & fungus
Counts Only or No growth air, surface, garb
Counts Only or No growth fingertip set
Genus identification
Species identification (ID)
Swabs Count w/genus identification
Pre-incubated Plate
Counts w/Genus identification
Counts w/Species identification (ID)
Negative Control
Positive Control inoculated with 5 ATCC bacterial & fungal stains
Media Fill
Incubated by lab presence / absence of growth
Enverify
Surface Sampling Competency Kit
Monthly Surface Sampling Kits includes materials, analysis, controls, shipping
Media
USP Agar Media
Triple bagged
Gamma irradiated
Room Temperature Storage
Tryptic Soy Agar 90 mm
Tryptic Soy Agar w/ lecithin & polysorbate 80 (LP) 90 mm & 55 mm
Sabouraud Dextrose Agar w/ lecithin & polysorbate 80 (LP) 90 mm & 55 mm
Media Fill Supplies
Low Complexity Kit
Medium Complexity Kit - Basic
Medium Complexity Kit Comprehensive
High Complexity Kit
Individual media fill components

Regulatory Mandates:
To meet regulatory requirements in accordance with USP and to ensure compliance with VHA Directive 1108.12.

Verification of Services completed:
The Compliance and Quality Program Manager within Pharmacy Service will conduct all testing and will evaluate the reports received from the lab.

Attachments/Links