SOURCES SOUGHT
65 -- Molecular Diagnostic Testing Analyzer
- Notice Date
- 6/15/2020 11:11:50 AM
- Notice Type
- Sources Sought
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- W40M USA HLTH CONTRACTING ACT JBSA FT SAM HOUSTON TX 78234-0000 USA
- ZIP Code
- 78234-0000
- Solicitation Number
- PR0011490143
- Response Due
- 6/22/2020 8:00:00 AM
- Archive Date
- 07/07/2020
- Point of Contact
- Shenecqua Soares
- E-Mail Address
-
shenecqua.n.soares.civ@mail.mi
(shenecqua.n.soares.civ@mail.mi)
- Description
- This is a Sources Sought Notice announcement; market survey for information only, to be used for preliminary planning purposes. No proposals are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. Any requests for a solicitation in response to this notice will not be honored. The Region Health Contract Office-C, Fort Hood, TX, has an upcoming requirement to solicit for and award a contract to provide Molecular Testing Equipment with capability of testing FDA approved CT/GC, HPV/HPV Genotype, and Trichomonas vaginalis/Candida/Bacterial vaginosis assays to include the supplies of associated test kits on a monthly recurring basis for Carl R. Darnall Army Medical Center, Fort Hood, Texas 76544. This request is anticipated to result in a Firm Fixed-Priced contract. The type of solicitation to issue will be based upon the responses to this synopsis. Contact with Government Personnel, other than the Contract Specialist identified at the bottom of this notice, by any potential offeror, or their employees�, regarding this requirement is strictly prohibited. � The purpose of this synopsis is to gain knowledge of interest, capabilities and qualifications of various members of the Small Business Community to include Section 8(a), Historically Underutilized Business Zones (HUB-Zone), Women-Owned Small Business, and Service-Disabled Veteran-Owned Small Business (SDVOSB), as well as the interest, capabilities and qualifications of various members of the Large Business community, to compete and perform a Firm Fixed Price Contract for these supplies. The type of solicitation to issue will depend upon the responses to this sources sought synopsis. The Government must ensure there is adequate competition among the potential pool of responsive contractors. The North American Classification System (NAICS) code for this requirement is 325413� �In-Vitro Diagnostic Substance Manufacturing� The Small Business Size Standard in millions of dollars is 1,250 number of employees.�� ���������������������������������������������������������������������������������������������������������������������������� Responses to this Sources Sought Notice should demonstrate the firm�s ability, capability, and responsibility to provide and deliver the products listed below. In response to this notice, interested parties shall submit a written Statement of Capability limited up to 5 pages and shall include the following information: �Offeror�s name, address, point of contact, phone number, and e-mail address. �Offeror�s interest in providing a proposal/quote on the solicitation when it is issued. �Offeror�s capability to provide the products being requested. �For reference the proposed offeror must be able to provide the following items: Delivery must be able to be made to Carl R. Darnall Army Medical Center, Fort Hood, Texas 76544 Molecular Testing Must provide FDA approved test kits, equipment, upgrades, and technical support to enable molecular testing of FDA approved CT/GC, HPV/HPV Genotype, and Trichomonas vaginalis/Candida/Bacterial vaginosis assays.� Analyzer Salient Characteristics FDA approved, assays for the following specimen types from asymptomatic and symptomatic patients age 14 and older. Male and/or female urine Female Endocervical Swabs Male Urethral Swabs System must not require more than two types of collection devices to support the test menu. Simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhea from a single specimen. System must be a closed system minimizing any potential aerosols.� (Minimal specimen handling, no manual specimen uncapping to avoid cross contamination.) Able to result minimum 500 specimens in a 12 hr. period No more than 30 minutes required to put machine into operation on a daily basis Operator maintenance, not related to start-up, should not exceed 1 hr. per month Room temperature storage of reagents, cold storage (4�C) should require less than 23 ft3 of storage for 10,000 tests. System must have active decontamination that does not require large quantities (>1 Gal) of bleach or other hazmat for operation per run cycle (pre, during and post run). All reagents must be ready for use The system must fit into the allocated space Minimum next business day technical support in the event of instrument failure to include weekend support under emergency conditions System software must provide: automated data reduction� qualitative result interpretations notify user if quality controls or other system parameters would invalidate the test result Specimen stability after collection, minimum 30 days at room temperature (25�C) � HPV and HPV Genotype Salient Characteristics Productivity and efficiency will include greater than 50 results in a 12-hour period and over 4,800 tests annually. At a minimum, the platform should have available FDA approved assays for the detection of HPV and HPV 16 18/45 in PreservCyt solution from cervical or vaginal specimens. No more than two collection device types will be required to cover the menu of testing above. 4. Following collection specimens should be stable in the collection device for not less than 105 days at room temperature. Instrument maintenance must be minimal, day of use maintenance will not exceed 20 min, other maintenance will not require more than one hour per month of technician time. System must have an active, either chemical or biological, decontamination system; contamination rates should be included in the proposal. The majority of assay reagents must be stable at room temperature; refrigerated reagents must not require more than 233ft of storage for 5,000 tests. System must have integrated software that performs all calculations required for the final patient result. � TRICHOMONAS VAGINALIS/BACTERIAL VAGINALIS/CANDIDA A vaginitis panel that is able to simultaneously detect the three most common causes of infectious vaginitis: bacterial vaginosis, candida vaginitis and trichomoniasis all from one collection using molecular nucleic acid amplification test (NAAT). System must not require more than two types of collection devices to support the test menu 3. System must be a closed system minimizing any potential aerosols.� Able to result minimum 500 specimens in a 12 hr. period No more than 30 minutes required to put machine into operation on a daily basis Operator maintenance, not related to start-up, should not exceed 1 hr. per month Room temperature storage of reagents, cold storage (4�C) should require less than 23 ft3 of storage for 10,000 tests. System must have active decontamination that does not require large quantities (>1 Gal) of bleach or other hazmat for operation per run cycle (pre, during and post run). All reagents must be ready for use The system must fit into the allocated space Minimum next business day technical support in the event of instrument failure to include weekend support under emergency conditions System software must provide: automated data reduction� qualitative result interpretations notify user if quality controls or other system parameters would invalidate the test result Specimen stability after collection, minimum 30 days at room temperature (25�C) � Offeror�s capability to perform a contract of this magnitude and complexity (include offeror�s capability to provide FDA approved test kits, equipment, upgrades, and technical support to enable molecular testing of FDA approved CT/GC, HPV/HPV Genotype, and Trichomonas vaginalis/Candida/Bacterial vaginosis assays for Carl R. Darnall Army Medical Center, Fort Hood, Texas 76544 provide at least three (3) examples. Documentation of appropriate products must be presented in sufficient detail for the Government to determine that your company possesses the necessary means to compete for this acquisition. Offeror�s type of small business and Business Size (Whether 8(a), HUB Zone, Women-Owned Small Business, Service Disabled Veteran Owned Small Business, etc.), or Large Business Status, should be documented in the Statement of Capability. � Interested parties are responsible for marking information that is proprietary in nature. No reimbursement will be made for any costs associated with providing information in response to this notice or any follow up information requests. The Government is not obligated to, nor will it, pay for or reimburse any costs associated with responding to this sources sought notice. 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 subcontracting opportunity is anticipated. A determination by the Government to not compete this proposed contract action based on the responses to this notice is solely within the discretion of the Government. � Interested Offeror shall respond to this Sources Sought Notice no later date and time posted to the this notice. All interested businesses must be registered in the System for Award Management (SAM) at www.sam.gov to be eligible for award of Government contracts. Email your response to Shenecqua N. Soares, Contract Specialist at email: shenecqua.n.soares.civ@mail.mil. Telephonic inquiries will NOT be honored. EMAIL IS THE PREFERRED METHOD.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/f3a45ea389e3429ebbbb5c980cd11a38/view)
- Place of Performance
- Address: Fort Hood, TX 76544, USA
- Zip Code: 76544
- Country: USA
- Zip Code: 76544
- Record
- SN05691692-F 20200617/200615230218 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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