Q301--Notice of Intent to Sole Source -Environmental & Personnel Sampling & Reporting Albany VA Medical Center, Albany, NY Base plus 4 Year Option

Active

Contract Opportunity

Notice Type:
Special Notice of Intent to Sole Source
This is a SPECIAL NOTICE ANNOUNCEMENT ONLY. The Department of Veteran Affairs, VISN 2 Network Contracting Office intends to award a sole source contract for the Albany VA Medical Center. This proposed contract action is for a service in which the Government intends to award a Base Period plus four (4) Option Periods, firm fixed-price contract with only one source; US Micro-Solutions, Inc. (SAM UEI: FJWJKSHCW1R) located at 302 Unity Plz., Latrobe, PA, 15650-3490 under the authority Federal Acquisition Regulation (FAR) Part 6.302-1 (a)(2), only one responsible source.
Place of Performance:

Department of Veterans Affairs
Samuel Stratton VA Medical Center
113 Holland Ave
Albany, NY 12208

Purpose and Objectives:

The contractor will provide a one (1) year base plus four (4) option years sampling and reporting service for the VA Medical Center Pharmacy located at the Albany VA Medical Center in accordance with The United States Pharmacopeia (USP) Chapter 797 that requires environmental microbiological surface sampling for variable particles and personnel sampling to ensure aseptic gloving and technique.

General Requirements
The contractor must comply with the following general requirements:

GENERAL INFORMATION

The United States Pharmacopeia (USP) Chapter 797 is an enforceable standard that requires environmental microbiological surface sampling for viable particles and personnel sampling to ensure aseptic gloving and technique.

Environmental Surface Sampling:
Is required monthly and whenever there is a change to the placement of equipment in the room or any other alteration within the cleanroom suite that affects the quality of the air
Is required in response to identified problems and trends
Is required in response to changes that could impact the sterile environment (changes in cleaning agents)
Personnel Sampling: Media fill
Is required for each inpatient pharmacy staff member initially in triplicate and every 6 months thereafter, along with repeated testing in the event of competency failure
Personnel sampling: gloved fingertip test (GFT)
Is required for each inpatient pharmacy staff member initially in triplicate and every 6 months thereafter, along with repeated testing in the event of competency failure
USP 797 compliant growth media plates are required for both personnel and environmental testing.
Evaluation of Surface Sampling Performance:
Is required annually for surface sampling competency testing (Enverify Kit, or equivalent)

SCOPE OF WORK
To secure sufficiently accredited microbiological laboratory testing services and testing supplies for USP 797 compliance associated with environmental surface sampling, media fill testing and gloved fingertip testing with detailed report of testing results provided to the pharmacy by the laboratory via email.
TEST
SAMPLE TYPE
COUNTS ONLY
(NEGATIVE)
GENUS ID
(POSITIVE)
TURN-AROUND TIME
ESTIMATED QUANTITY
(ANNUALLY)
SINGLE PLATE METHOD
(1 PLATE FOR BACTERIA & FUNGUS)
CONTACT PLATE
YES
YES
8 DAYS
 250-275 PLATES
SINGLE PLATE METHOD
(1 PLATE FOR BACTERIA & FUNGUS)
FINGERTIP PLATE
YES
YES
8 DAYS
250-275 PLATESÂ
MEDIA FILL FROM KIT
( RL2, CHEMOTEQ OR EQUIVALENT)
MEDIA FILL
YES
YES
15 DAYS
65-85 MEDIA FILLS
ENVERIFY KIT (OR EQUIVALENT)
MICROBIAL COATED TEST SURFACES
YES
NO
3 DAYS
2-4 KITS
PRODUCT
TYPE
DESCRIPTION
ESTIMATED QUANTITY
(ANNUALLY)

USP AGAR MEDIA
(GAMMA-IRRADIATED, ISOLATOR WRAP)
TRYPIC SOY W/ LECITHIN AND POLYSORBATE 80
(TSA W/ LP)
55MM - 60MM AGAR PLATES WITH NEUTRALIZERS FOR CONTACT/SURFACE SAMPLES
25 30 PACKS
(10/PK)Â

USP AGAR MEDIA
(GAMMA-IRRADIATED, ISOLATOR WRAP)
TRYPIC SOY W/ LECITHIN AND POLYSORBATE 80
(TSA W/ LP)
90MM - 100MM AGAR PLATES WITH NEUTRALIZERS FOR FINGERTIP SAMPLES
 25-30 PACKS
(10/PK)

ENVERIFY KIT (OR EQUIVALENT)
MICROBIAL COATED TEST SURFACES
SURFACE SAMPLING TESTING COMPETENCY
2-4 KITS

Laboratory Service must be able to provide the following:

Accreditations for the testing being performed: A2LA accreditation, ISO 17025 accreditation, and cGMP/GLP compliant testing services
Microbial growth media plates
Must include: certificates of analysis from the manufacturer that verify the plates meet the expected growth promotion, pH and sterilization requirements consistent with USP 797
Must contain TSA supplemented with neutralizing additives (lecithin and polysorbate 80)
Must have a raised convex surface
Must support both bacterial and fungal growth on the same plate
Must be USP 797 compliant
Must be irradiated
Samples sent to the laboratory service must be incubated in accordance with current USP Chapter 797 requirements for duration and temperature
A report of the total number of discrete colonies of microorganisms for each sample (as CFU per sample) along with sample type, location and date must be provided to the facility
Any recovered organisms (bacterial and fungal) must be identified at least to the genus level
Report must indicate a statement of compliance or non-compliance with USP 797 based on results of testing
Results of all testing must be emailed to the specified email addresses or posted to an online account with facility access within 15 business days.

Growth media plates and Enverify kits must be sent upon request, based on facility needs as outlined in General Information above.

Response:

Responses to this Special Notice should be able to demonstrate the firm's ability, capability, and responsibility to deliver the service listed above. The purpose of this Special Notice announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. No funds have been authorized, appropriated, or received for this effort. Responses should include the following information: Business name, address, business size and Socioeconomic Category (HUBZone, 8(a), Service Disabled Veteran, Small Business, Large Business, etc.), and point of contact to include e-mail address and telephone number. All offerors must be registered in the System for Award Management (www.sam.gov) and Representations and Certifications must be completed prior to any future award. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to provide the full maintenance and repair service on equipment listed.

Determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.

Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 541380 ($19 Million).
Any offeror capable of providing this service shall notify the Contracting Officer by email within 7 calendar days from the date of the publication of this Special Notice.
All information must be submitted via e-mail to: Julie.monaganbarnard@va.gov

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