SOURCES SOUGHT
Q -- USP797 Pharmacy Environmental & Personnel Sampling & Reporting
- Notice Date
- 9/13/2022 2:40:30 PM
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- 242-NETWORK CONTRACT OFFICE 02 (36C242) ALBANY NY 12208 USA
- ZIP Code
- 12208
- Solicitation Number
- 36C24222Q1242
- Response Due
- 9/20/2022 7:00:00 AM
- Archive Date
- 09/21/2022
- Point of Contact
- Enell Riley, Contracting Officer, Phone: 716-862-7461
- E-Mail Address
-
Enell.Riley@va.gov
(Enell.Riley@va.gov)
- Awardee
- null
- Description
- 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 Cheektowaga, NY for the purpose of collecting information about USP797 Environmental & Personnel Sampling & Reporting for the James J. Peters VAMC, 130 W. Kingsbridge Road, Bronx, NY 10468. The VA is seeking to provide for this requirement as of October 14, 2022 to establish a new service. The NAICS code identified for this requirement is 541380. The requirement is detailed in the Statement of Work section of this document. (e) Cursory market research has identified a large business 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 Enell Riley at enell.riley@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 at the James J. Peters VAMC, 130 W. Kingsbridge Road, Bronx VAMC, NY 10468. 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 Unique Entity ID (UEI) 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. 852.219-77 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) [X] 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 Environmental & Personnel Sampling & Reporting James J Peters VA Medical Center- Pharmacy Department Bronx, NY 10468 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. a. 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) b. Personnel Sampling: Media fill Is required for each inpatient pharmacy staff member initially in triplicate and every 6 months thereafter c. Personnel sampling: gloved fingertip test (GFT) Is required for each inpatient pharmacy staff member initially in triplicate and every 6 months thereafter d. USP 797 compliant media fill testing kits and growth media plates are required for testing II. PERIOD OF PERFORMANCE Base Year: October 14, 2022 October 13, 2023 Option Year #1: October 14, 2023 October 13, 2024 Option Year #2: October 14, 2024 October 13, 2025 Option Year #3: October 14, 2025 October 13, 2026 Option Year #4 October 14, 2026 October 13, 2027 III. 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 EST QUAN ANNUALY Single plate method (1 plate for bacteria and fungus) Contact plate Yes Yes 8 days 130-160 plates Single plate method (1 plate for bacteria and fungus) Fingertip plate Yes Yes 8 days 100-120 plates TEST SAMPLE TYPE COUNTS ONLY GENUS ID (positive) TURN AROUND TIME EST QUAN ANNUALLY Media fill (Dual temp incubation) Media fill units (vials or bags) Yes Yes 14 days 40-60 kits PRODUCT TYPE DESCRIPTION ESTIMATED QUANTITY USP Agar media (gamma irradiated isolator wrap) Tryptic soy w/lecithin and polysorbate 80 55MM -60MM AGAR PLATES WITH NEUTRALIZERS FOR CONTACT/SURFACE SAMPLES 13-16 PACKS USP Agar media (gamma irradiated isolator wrap) Tryptic soy w/lecithin and polysorbate 80 55MM -60MM AGAR PLATES ( OR LARGER) WITH NEUTRALIZERS FOR CONTACT/SURFACE SAMPLES 10-12 PACKS Media fill kits Low complexity kit- comprehensive AS PER KIT INSTRUCTIONS 40-60 KITS IV. Laboratory Service must be able to provide the following: American Industrial Hygiene Association (AIHA) accredited services, ISO/IEC 17025 accreditation a. 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 b. Media fill testing kit designed to simulate medium complexity sterile IV compounding, must be USP 797 compliant c. Prepaid mailer for properly sending samples to the laboratory for testing d. Samples sent to the laboratory service must be incubated in accordance with current USP Chapter 797 requirements for duration and temperature e. 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. f. Growth media plates, media fill testing kits and prepaid mailer must be sent upon request, based on facility needs as outlined in General Information above.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/2c22e28346ef4e25a0b80248d4bc2967/view)
- Place of Performance
- Address: James J. Peters VA Medical Center 130 W. Kingsbridge Road, Bronx 10468
- Zip Code: 10468
- Zip Code: 10468
- Record
- SN06463989-F 20220915/220913230136 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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