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COMBINED SYNOPSIS/SOLICITATION USP 797 TESTING EAST ORANGE VA MEDICAL CENTER
(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, and FAR 13.5 Simplified Procedures for Certain Commercial Items as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.
(ii) This solicitation is issued as a request for quote (RFQ). Request for Quote will be submitted through beta.sam.gov on RFQ reference number 36C24223Q0233.
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-08 (eff. 10/28/2022), VAAR 2008-33 (eff. 11/17/2022).
(iv) This solicitation is a Total Small Business set-aside open market solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 541380- Testing Laboratories and Services and has a small business size standard of $16.5 Million. The FSC/PSC is H266 Equipment and Materials Testing Instruments and Laboratory Equipment.
(v) This is a services contract to provide USP 797 Testing Lab Services for Inpatient IV Room at the East Orange VA. Below is a sample template for pricing. Contractors may provide their own pricing document, but it must be broken down to allow for price reasonableness determination and must include all option years.
PRICING TABLE: See Attached Excel Spreadsheet.
(vi) The required work is as contained below in the Statement of Work.
STATEMENT OF WORK

Title: USP 797 Testing at East Orange VA

Description: The contractor shall perform USP 797 testing for environmental monitoring of sterile compounding areas. The USP establishes standards for sterile compounding room including environmental monitoring and competencies for the preparation and handling of compounded sterile products (CSPs). To meet regulatory requirements in accordance with USP and to ensure compliance with VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounding Sterile Preparations, the VA New Jersey Healthcare System requires to perform:
Microbiological surface monitoring testing of primary engineering controls (PECs)
Microbiological surface monitoring testing of secondary engineering controls (SECs)
Testing of compounding personnel for aseptic technique by
Gloved fingertip and thumb sampling
Media fill testing

The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities and the Joint Commission (TJC) establishes compounding standards for sterile compounded preparations based on the United States Pharmacopeia (USP) standards. Any lapse in testing for any of the items listed above shall be scrutinized by said agencies and may lead to IV room being shut down.

Scope of Work:
Microbiological/viable surface sampling is performed at the end of a compounding activity or shift 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 797 and reading of each sample collected by VA staff.
Each sample report to indicate:
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 eight (8) samplings per month.
Two (2) samples from each ISO Class 5 area (PECs)
Vendor must provide TSA plates for said testing. A certificate of analysis (COA) must be provided.

Gloved fingertip and thumb sampling (GFS) test are a direct measure of the aseptic technique of compounders (for on-going GFS) and their ability to don PPE and sterile gloves without contaminating them (for initial GFS for newly hired).
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 eighty-two (82) samples to determine employee competency. There are approximately 40 employees that will need testing per year.
Two (2) samples per existing employee for total of 70 samples (35 employees X2 hands)
six (6) samples per newly hired employee for total of 12 samples (Currently hiring 2 new employees).
Vendor will provide 90 Tryptic Soy Auger plates for said testing. These must be ordered periodically as supply needs replenishing. A certificate of analysis (COA) must be provided.

Media fill test is the second 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 thirty (40) samples from VA staff (one sample per staff) every 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.
Period of Performance:
The estimated period of performance is 2/01/2023 to 1/31/2024 with a provisional 4 option years.

Technical certifications:
Lab must be certified to monitor microbiology as previously stated under General
Specifications A.

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

Verification of Services completed:
The USP Program manager within pharmacy service will conduct all testing and will evaluate the reports received from the lab.

Place of Performance:
VA New Jersey Health Care System
East Orange Campus Inpatient Pharmacy on 8th floor
385 Tremont Ave
East Orange, NJ 07018
CONTRACTING OFFICE ADDRESS:

VISN 2 Network Contracting Office
Albany Stratton VA Medical Center
113 Holland Ave
Albany, NY 12208
(vii) Awardee shall coordinate with the Contracting Officer s Representative (COR) prior to performance.
(viii) The following solicitation provisions apply to this acquisition:
The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html
FAR 52.212-1, Instructions to Offerors Commercial Items (NOV 2021)
Solicitation number for this requirement as 36C24223Q0233;
The time specified in the solicitation for receipt of offers;
Name, address and telephone number of offeror;
Technical description of services to be performed in accordance with the Statement of Work. This Technical description should address the requirement specifically. Capability statements that are merely an overview of what the contractor offers will be determined incomplete. Please address all the technical evaluation sub-factors. Failure to address all the sub-factors will result in your package being determined incomplete;
Terms of any express warranty;
Price should be for all services detailed in section v of this document. The pricing must be broken down in a manner that allows for price reasonableness to be determined. Failure to provide complete pricing will result in contractors package being determined to be incomplete;
Remit to address, if different than mailing address;
A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);
Acknowledgement of any solicitation amendments;
Past performance information;
A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation.
Offers that fail to furnish required representation or information or reject the terms and conditions of the solicitation will be excluded from consideration.
The following solicitation provisions are included as addenda to FAR 52.212-1:
52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)
52.204-7 System for Award Management (OCT 2018)
52.204-16 Commercial and Government Entity Code Reporting (AUG 2020)
52.217-5 Evaluation of Options (JUL 1990)
852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008)

Addendum to FAR 52-212-1 INSTRUCTIONS TO OFFERORS COMEMRCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021):
This Request for Quote (RFQ) is issued in accordance with FAR Part 12 in conjunction with Simplified Acquisition Procedures at FAR 13.5. All instances of FAR 15 procedures in FAR 52.212-1 shall not apply to this RFQ and are hereby substituted with FAR 13 procedures.
Eligibility: In order for a quote to be eligible for award, offerors submitting a quote must have the NAICS 541380- Testing Laboratories and Services and current registration in the System for Award Management (SAM): https://www.sam.gov/portal/public/SAM.
Submission Instructions: Technical packages shall be submitted to Levi.Russin@va.gov by 12:00 PM ET on 12/27/2022. The email subject shall identify Solicitation 36C24223Q0233. Offerors that do not adhere to these instructions may be determined to be incomplete and, therefore, risk being rejected without further consideration for award. Offer submissions must include:
(ix) The provision at FAR 52.212-2, Evaluation Commercial Items (NOV 2021), applies to this acquisition.
Award shall be made to the contractor whose quotation offers the best value to the government, considering technical capability, past performance, and price.
The Government may perform a comparative evaluation (comparing offers to each other) to select the contractor that is best suited and provides the best value, considering the evaluation factors in this solicitation.
The government shall evaluate information based on the following evaluation criteria.

Evaluation Factors:
(1) Technical capability - Contractor shall provide a maximum 10-page capability statement demonstrating their ability to meet all of the requirements of the SOW.
a) Technical Proficiency: Contractor shall submit a proposal that demonstrates its understanding of the requirement in accordance with the Statement of Work and the extent to which potential risks are identified and mitigated. Contractor shall include names of key personnel for prime and subcontractors. Contractor shall provide an anticipated proposed schedule to perform testing based on description in SOW.
b) Contractor Experience: The offeror shall provide 3-5 instances of past experience of similar scope within the past 5 years. The contractor shall be a firm regularly engaged in the testing of system components described in this Statement of Work.
Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.
c) Licensing/Certifications: Quoter will be evaluated on how well they meet the requirement to provide proof that it is a lab certified to monitor microbiology.
(2) Past performance: Contractor must provide three references for contract of similar scope and magnitude to be evaluated. Relevant past performance information shall include key personnel who have relevant experience, predecessor companies, and subcontractors who will perform major or critical elements of this solicitation. The contractors Past Performance shall also be reviewed in PPIRs; Individuals with no past performance shall receive a neutral rating for this evaluation factor.
(3) Price: The government will evaluate offers for award purposes based on the pricing for the total requirement. Offers for partial requirement will not be evaluated and will be deemed non-responsive upon receipt.
(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).
(c) 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.
Failure to provide the information requested in the evaluation criteria may result in being found non-responsive.

(End of Provision)

(x) The provisions at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (OCT 2022) applies to this acquisition. * All firms or individuals submitting a quote shall include a completed copy of this provision OR have current Representations and Certifications in the System for Award Management (SAM - https://www.sam.gov). Representations, Certifications, and SAM must be current at award. IF NOT CURRENT AND/OR YOU DO NOT SUBMIT A COMPLETED COPY OF THIS PROVISION, YOUR QUOTE WILL BE CONSIDERED NON-RESPONSIVE.
(xi) FAR 52.212-4, Contract Terms and Conditions Commercial Products and Services November 2021 applies to this acquisition.

The following clauses are incorporated into Addendum to FAR 52.212-4,
52.252-2 Clauses Incorporated by Reference (FEB 1998)
52.204-13 System for Award Management Maintenance (OCT 2018)
52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020)
52.217-9 Option to Extend the Term of the Contract (MAR 2000)
a) Within 30 days; written notice of its intent to extend at least 60 days; c) shall not exceed 5 years
52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)
852.212-70 Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020)
- 852.203-70 Commercial Advertising.
- 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors
- 852.232-72 Electronic Submission of Payment Requests
- 852.242-71 Administrative Contracting Officer (OCT 2020)
- 852.270-1 Representatives of Contracting Officers.

(xii) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Products and Commercial Services (OCT 2022) (JUL 2021) (DEVIATION)
The following subparagraphs of FAR 52.212-5 are applicable:
52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020)
52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021)
52.219-6 Notice of Total Small Business Set-Aside (NOV 2020)
52.219-28 Post Award Small Business Program Representation (SEP 2021)
52.219-32 Orders Issued Directly Under Small Business Reserves (MAR 2020)
52.222-3 Convict Labor (JUN 2003)
52.222-21 Prohibition of Segregated Facilities (APR 2015)
52.222-26 Equal Opportunity (SEP 2016)
52.222-36 Equal Opportunity for Workers with Disabilities (JUN 2020)
52.222-41 Service Contract Labor Standards (AUG 2018)
52.222-42 Statement of Equivalent Rates for Federal Hires (MAY 2014)
Employee Class: 23465
Monetary Wage-Fringe Benefits: $33.87
52.222-50 Combating Trafficking in Persons (NOV 2021)
52.222-55 Minimum Wages Under Executive Order 14026 (JAN 2022)
52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2022)
52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020)
52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008)
52.232-33 Payment by Electronic Funds Transfer System for Award Management (OCT 2018)

(xiii) The Service Contract Act of 1965 does apply to this procurement.
See attached Wage Determination

(xiv) All quoters shall submit the following: one copy of technical capability and pricing, and an additional redacted copy.
All quotations shall be sent ONLY to Evelyn Peguero at Evelyn.Peguero@va.gov
This is a Total Small Business Set Aside for USP 797 Testing at East Orange VA. The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:
"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."
OR
"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"
Quoter shall list exception(s) and rationale for the exception(s).
Submission shall be received not later than 4:00 pm on 1/19/2023 at Levi.Russin@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Faxed or postal mailed quotes will NOT be accepted.
Request for information (RFI) shall be received no later than 12:00 pm on 1/12/2023. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contracting Officer Levi Russin at Levi.Russin@va.gov.

All communication shall have RFQ number and requirement title in the subject line.

Point of Contact
Levi Russin, Contracting Officer
Levi.Russin@va.gov

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