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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 for VISN 2, which includes of collecting information about USP 797 Testing at the New Jersey VA Medical Campus-East Orange at 385 Tremont Ave, East Orange, NJ 07018. The VA is seeking to provide for this requirement as of 10/1/2022 to establish a new service. The NAICS code identified for this requirement is 541380-Testing Laboratories. The requirement is detailed in the Statement of Work section of this document. The requirement is detailed in the Statement of Work section of this document.

(e) Cursory market research has identified several large 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 service are encouraged to email a capability statement and full information to Evelyn Peguero at Evelyn.Peguero@va.gov no later than 10/18/2022 at 4:00pm EST.

- 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.

- 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.

- Contractors shall include any relevant comments about the Attachment(s) if applicable.

Statement of Work:
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:
1. Microbiological surface monitoring testing of primary engineering controls (PECs)
2. Microbiological surface monitoring testing of secondary engineering controls (SECs)
3. Testing of compounding personnel for aseptic technique by
a. Gloved fingertip and thumb sampling
b. 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.
Place of Performance:
VA New Jersey Health Care System
East Orange Campus Inpatient Pharmacy on 8th floor
385 Tremont Ave
East Orange, NJ 07018

General Specifications:
A. 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.
1. 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.
a. 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
b. 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
c. Identify microorganism if growth occurs regardless CFU level
2. Vendor must perform incubation and reading for estimated fourteen (8) samplings per month.
a. Two (2) samples from each ISO Class 5 area (PECs)
3. Vendor must provide TSA plates for said testing. A certificate of analysis (COA) must be provided.
B. 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).
1. 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
a. 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.
b. 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.
c. Identify microorganism if growth occurs regardless CFU level
d. Document dates of incubation and the person who reads and documents the number of CFU
2. 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.
a. Two (2) samples per existing employee for total of 70 samples (35 employees X2 hands)
b. six (6) samples per newly hired employee for total of 12 samples (Currently hiring 2 new employees).
3. 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.

C. 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.
1. 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 #.
a. Incubate for 7 days at 20-25°C and then 7 days at 30-35°C
b. 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.
c. Document dates of incubation, the result, and the person who reads and documents the results.
2. Vendor must perform incubation and reading for approximately thirty (40) samples from VA staff (one sample per staff) every year.
3. 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.

D. Period of Performance:
The estimated period of performance will be for the financial year 11/01/2022 to 10/31/2023.

E. Technical certifications:
Lab must be certified to monitor microbiology as previously stated under General
Specifications A.
F. Regulatory mandates:
To meet regulatory requirements in accordance with USP and to ensure compliance
With VHA Directive 1108.12.
G. Verification of Services completed:
The USP Program manager within pharmacy service will conduct all testing and will evaluate the reports received from the lab.

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